Operator’s Manual

For use with Stellaris Elite™ BL14455 and BL15455

Preface

Preface
Preface
 Preface

Indications for Use

The Bausch + Lomb Stellaris Elite™ vision enhancement system is intended for the emulsification and removal
of cataracts, anterior and posterior segment vitrectomy. The system is designed for use in both anterior and
posterior segment surgeries. It provides capabilities for phacoemulsification, coaxial and bimanual irrigation/
aspiration, bipolar coagulation, vitrectomy, viscous fluid injection/removal and air/fluid exchange operations.
The Bausch + Lomb Stellaris Elite™ vision enhancement system configured with the laser module is
additionally intended for retinal photocoagulation and laser trabeculoplasty.

WARNING: 
Use only accessories approved, manufactured, or distributed by Bausch + Lomb that are
designated for use with this system. Failure to do so may affect system performance and
create hazards. Use of accessories approved, manufactured, or distributed by Bausch + Lomb
on systems for which they are not designated may affect system performance and create
hazards.

Operator Profile
The Bausch + Lomb Stellaris Elite™ vision enhancement system is intended for use only by qualified
physicians, nurses, and other trained medical professionals.

The laser functionality is intended for use only by qualified physicians. If you are not a qualified physician,
do not attempt to operate the laser system for any reason. Specific indications for Laser Modes are retinal
photocoagulation and laser trabeculoplasty. Available delivery devices include the EndoProbe for intraocular
Endolaser surgery and Laser Indirect Ophthalmoscope (LIO) for transpupillary laser delivery for patients treated
in a supine position.

Contraindications
Use of accessories not designated by Bausch + Lomb for use with this equipment may result in serious
permanent patient injury, adverse surgical outcome, or damage to the equipment, and may void warranty
coverage. See page 1-1 for precautions relevant to patients with implantable defibrillators and cardiac
pacemakers.

This manual contains precautions (Cautions, Warnings, Notes, etc.) throughout that should be observed when
using this equipment. For safety’s sake, please heed these precautions.

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Preface

Reporting of Adverse Reactions

Any side effects, adverse events, product complaints, or device malfunctions that may affect safety,
should be reported to the manufacturer and competent authority. Contact information can be found on
www.bausch.com/contactus.

Patents
See patents.bausch.com for applicable US patents.

Power Outputs
COAG
BF
7.5 W, 0.274 A
100 Ω
1 MHz

U/S
BF
35 W
900 Ω
28.5 kHz

VITESSE
BF
250V
25 – 42 kHz

Training
Following system delivery at a surgical facility, Bausch + Lomb personnel or authorized representatives will
provide on-site training to those who will operate the system. The training is essentially an on-site review of
system startup, accessories and connections, priming and settings adjustment consistent with the instructions
provided in the operator’s manual. Subsequent training may be provided for new staff, when the system is
upgraded, or as requested by the facility.

Preface-2 Operator’s Manual 4135904EN

 Preface

Manual Concept
Our goal is to provide you with the information you need, with minimal searching.

Chapter 1 provides information for a quick setup and answers general questions about the Stellaris Elite™
vision enhancement system. Numerous pictures enhance understanding. Chapter 2 describes the connections
to operate the system, including the Graphical User Interface and the Primary (Integrated) Foot Control.
Chapter 3 describes information on how to customize the system to suit your particular needs. Chapter 4
details each function and feature, how to set up the function and its associated disposables, and how to interact
with each function. Chapter 5 provides cleaning and sterilization information. Chapter 3-Chapter 5
are reference for questions of a technical nature. Chapter 6-Chapter 8 contain information that you may
rarely need, such as unpacking, installing modules, system check-out, meanings of error messages, service
information, and system specifications. Make sure that you read and follow all safety precautions set forth
in this manual. Information presented in this manual relating to surgical procedures is a suggestion only,
and does not constitute any warranty of fitness or claim of responsibility, or undertaking of liability
resulting from any surgical techniques practiced. The surgeon is ultimately responsible for determining
the appropriate procedure for each patient.

Note:  he user interface screens displayed in this manual may differ from what is on your system.
T
While the information on the screens is the same, the depiction of the screens may change. The
screen illustrations should not be used in place of the instructions in the manual.

Symbols and Notes

The following are general definitions of the symbols and precautions used on this equipment and in this manual.
See www.bausch.com/symbols for additional symbol information.

WARNING: 
Calls attention to an operating procedure, practice, or condition, which if disregarded or
incorrectly performed, could result in serious and/or permanent injury to personnel and/or
patients.

CAUTION: 
Calls attention to an operating procedure, practice, or condition, which if disregarded or
incorrectly performed, could result in damage to the product and/or equipment.

Note:  alls attention to an operating procedure, practice, or condition providing essential

C
information.

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Preface

Authorized Representative in
Aiming beam
Switzerland

Aiming beam, blinking Cloud

Consult operating instructions for

Alternating Current use or consult operating electronic
instructions for use

Always wear eye protection or face

mask when installing or removing the Date of manufacture
lamp

Aspiration Dispose of Properly

Aspiration Cassette Do not re-use

Authorized representative in the

European Community Do not resterilize

Battery Condition Indicator Do not use if package is damaged

Battery Direct Current Electrostatic-sensitive device

Catalogue number Electrosurgery, coagulation mode

Caution Equipotential Ground

Caution or warning to consult

accompanying documents to avoid
patient or operator hazard. ETL Listed Number (Intertek)

CE Mark

Preface-4 Operator’s Manual 4135904EN

 Preface

Ethernet Laser

Extrude Laser Emergency Stop

Eye Laser Indirect Ophthalmoscope

FCC Laser Key Off

Fibre-optic handpiece Laser Key On

Fluid/Air Exchange Manufacturer

Frequency in Hertz Medical device

Fuse Fee paid for waste management

Importer Microscope Camera

Infusion bottle Model number

Infusion Cassette Monitor

Never touch the silica glass bulb of

Irrigation
the lamp with bare hands

Non Ionizing Electromagnetic

Irrigation/Aspiration
Radiation

4135904EN Operator’s Manual Preface-5

Preface

Non-sterile
Transport Tipping Hazard
Symbol
Ω ohms
See page 1-34
VA Volt Amps
A Amperes

Phacofragmentation
Type BF Applied Part

Phone
UK Conformity Assessed

Prescription only (USA)

U/S vitrectomy

Primary (Integrated) Foot Control

USB

Primary (Integrated) Foot Control

ready
Viscous Fluid Control

Remote interlock connector

Vitrectomy

Serial number
Warning: Hot surface

Stellaris Elite™
vision enhancement system
Wireless

Sterilized using ethylene oxide

Xenon

Sterilized using irradiation

Xenon-Mercury

System Mass

Preface-6 Operator’s Manual 4135904EN

Table of Contents

Table of Contents
Table of Contents
 Table of Contents

Table of Contents

1. Getting Started
1.1. Components Shipped with the System................................................................................................. 1-3
1.2. System Description.............................................................................................................................. 1-4
1.2.1 System Console................................................................................................................................... 1-4
1.2.2 Pack Compatibility with Older Systems.............................................................................................. 1-6
1.2.3 System Alarm....................................................................................................................................... 1-6
1.3. Connections and Setup......................................................................................................................... 1-7
1.4. Setting Up Your System..................................................................................................................... 1-11
1.5. Starting a New Procedure................................................................................................................... 1-20
1.6. Using Your System in Surgery........................................................................................................... 1-27
1.7. Concluding a Surgical Procedure....................................................................................................... 1-29
1.8. Shutting Down the System................................................................................................................. 1-33
1.9. Power Interruptions............................................................................................................................ 1-33
1.10. Moving Your System to Another Location......................................................................................... 1-34
1.11. System Components.......................................................................................................................... 1-35
1.12. Foot Control....................................................................................................................................... 1-43
1.13. Illumination Function........................................................................................................................ 1-66
1.14. Laser Function (Stellaris Elite™ BL15455 system only).................................................................. 1-71

2. User Interface
2.1. Basic Interface Controls....................................................................................................................... 2-1
2.2. Surgical More Screen........................................................................................................................... 2-6
2.3. Surgical Screen Layout...................................................................................................................... 2-26

3. Customizing Your System

3.1. Manage Settings................................................................................................................................... 3-4
3.2. Surgeon Level Settings...................................................................................................................... 3-11
3.3. Manage Surgeon Files........................................................................................................................ 3-17
3.4. System Setup..................................................................................................................................... 3-22
3.5. System Configuration........................................................................................................................ 3-26
3.6. System Calendar................................................................................................................................ 3-26
3.7. Customization.................................................................................................................................... 3-28

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Table of Contents

4. Detailed Reference
4.1. Advanced Vacuum System Fluidics..................................................................................................... 4-1
4.2. Posterior Functions.............................................................................................................................. 4-6
4.3. Anterior Functions............................................................................................................................. 4-43
4.4. Coagulation Function (Posterior & Anterior Modes)......................................................................... 4-62
4.5. Combined Domain............................................................................................................................. 4-67

5. Cleaning and Sterilization Requirements

5.1. Routine Cleaning................................................................................................................................. 5-1
5.2. Reusable Accessories........................................................................................................................... 5-2
5.3. Laser Protective Eyewear..................................................................................................................... 5-2

6. Troubleshooting
6.1. User Troubleshooting........................................................................................................................... 6-1
6.2. Power Issues........................................................................................................................................ 6-1
6.3. Laser Calibration Verification (Stellaris Elite™ BL15455 only)......................................................... 6-3
6.4. Laser Interlocks (Stellaris Elite™ BL15455 only).............................................................................. 6-4
6.5. System Messages................................................................................................................................. 6-8
6.6. System Configurations, Replacement Parts, and Medical Device Accessories.................................. 6-39

7. Service and Warranty

7.1. Service Information............................................................................................................................. 7-1
7.2. Environmental Protection.................................................................................................................. 7-10
7.3. Warranty Information........................................................................................................................ 7-11

8. Specifications
8.1. Environmental and Physical Specifications......................................................................................... 8-1
8.2. Primary System Specifications............................................................................................................ 8-4
8.3. System Labels.................................................................................................................................... 8-17

9. Glossary

TOC-2 Operator’s Manual 4135904EN

1. Getting Started

1. Getting Started
1. Getting Started
 1. Getting Started

1. Getting Started
This chapter is for people who have used this type of ophthalmic vision enhancement system before and want
to use the system without reading large portions of the manual. It also provides information on setting up your
Stellaris Elite™ vision enhancement system and making the necessary connections.

WARNING: 
The use of flammable anaesthetics, flammable disinfectants, aerosol sprays, or oxidizing
gases such as nitrous oxide (N2O) and oxygen should be avoided unless the gaseous agents
are sucked away and the liquid agents are fully dried or evaporated. Ensure the flammable
liquids are not pooled beneath the patient drape.

WARNING: 
Implantable defibrillators present a risk of injury if triggered by a fibrillatory event during
intraocular surgery, due to involuntary motion by the patient. Patients being considered for
intraocular procedures must be questioned to determine if they have such a device and, if so,
the defibrillator manufacturer must be consulted to determine the appropriate action.

WARNING: 
Electromagnetic interaction between the phacoemulsification (phaco) handpiece and
an implanted cardiac pacemaker is unlikely, but cannot be ruled out. Patients should be
questioned to determine if they have such an implant and, if so, the manufacturer of the
implant should be consulted to determine the proper course of action.

WARNING: 
All external wiring must be in accordance with local electrical code requirements and NEC
Class II signaling system twisted wire with outer shield. The wire length must not exceed
20 meters (60 feet). The wire gauge must be 26 AWG to 12 AWG gauge, with ends stripped
from 9 mm to 10 mm (3/8 in.). At no point should the wire be untwisted more than 5 cm
(2 in.).

WARNING: 
The PATIENT should not come into contact with metal parts which are earthed or which
have an appreciable capacitance to earth (for example operating table supports, etc.).

WARNING: 
Avoid skin-to-skin contact of the patient while using the bipolar output, using gauze or similar
as needed.

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1. Getting Started

WARNING: 
Use of other high-frequency (HF) output equipment in the vicinity of the device or equipment
failure could result in an unintended increase in the output power of the bipolar function.

WARNING: 
Grounding reliability can only be achieved when the equipment is connected to an equivalent
receptacle marked “Hospital Only” or “Hospital Grade.”

WARNING: 
To avoid risk of electric shock, this equipment must only be connected to a supply mains with
protective earth.

WARNING: 
Care should be taken to prevent intraocular pressure changes that may cause damage to the
patient’s eye.

CAUTION: 
Preventative scheduled maintenance is recommended once a year to ensure that the
Stellaris Elite™ vision enhancement system meets its optimum performance, reliability
and safety standards set by the manufacturer. The maintenance shall be done by a
Bausch + Lomb certified individual only.

Note: The equipotentiality lug is provided to ground the system if the receptacle is not sufficient.

Note:  luidic stability in the eye during surgery is crucial for safe and effective phacoemulsification
F
(phaco) surgery. During phaco surgery, fluid is aspirated out of the eye through the phaco
needle, and fluid is infused into the eye through the irrigation sleeve. Balancing these two flows
maintains acceptable intraocular pressure throughout the surgical procedure.

Factors that affect the aspiration rate through the phaco needle include the vacuum setting
(mmHg), and the internal diameter of the needle and tubing. Factors that affect the infusion rate
are the bottle height, incision size, and dimensions of the needle-sleeve interface.

The Stellaris Elite™ vision enhancement system provides vacuum settings up to 660 mmHg
(Vacuum Fluidics Module (VFM)). The higher the vacuum setting, the higher the aspiration
rate. Higher aspiration rates increase the risk of fluidic instability, which could lead to
anterior chamber collapse during phacoemulsification or soft eye during posterior surgery.
The maximum safe vacuum setting for each needle-sleeve combination depends on the surgical

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 1. Getting Started

technique being performed and the surgeon’s level of proficiency. It is the surgeon’s sole
responsibility to use the system settings to achieve optimal operating conditions.

Note: I f Infusion pressure is elevated an alarm will sound. Go to page 4-35: Fluid Tamponade for
further detail.

1.1. Components Shipped with the System

Before unpacking, inspect all packages for damage. Report any damage from shipping to the carrier. Before
discarding packaging material, ensure all parts are accounted for. Smaller parts may be attached to packing
materials. If shock label indicator on shipment carton is red, do not refuse shipment. Make notation on delivery
receipt and inspect for damage. If damage is discovered, leave in original container and packaging and request
immediate inspection from carrier within 3 days. Contact Bausch & Lomb Surgical Technical Support at:
1-636-226-3705 (Outside U.S.A.)
+49-05221-823-171 (Within Europe).

Standard components shipped with the system include:

• System Main Console
• Primary (Integrated) Foot Control with Battery
• Primary (Integrated) Foot Control Wall Charger
• Extra Foot Control Battery
• Primary (Integrated) Foot Control Backup Cable
• Operator’s Manual (CD)
• System Power Cord
• Mayo Tray
• Foot Control Battery Charging Cradle
• Air Hose
• Zero Level Bottle Hanger
• Remote Control

Systems equipped with laser functionality also include two Laser Keys, one pair of safety glasses, and a
Connectivity Kit (interlock keys, see page 6-4).

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1. Getting Started

1.2. System Description

1.2.1 System Console

The Stellaris Elite™ vision enhancement system’s modular design enables easy upgrades as technology
advances. The system consists of a main housing unit, a user interface screen, surgical modules, a Primary
(Integrated) Foot Control, and an infrared remote control (for anterior application only, optional accessory).
Handpieces, packs and other accessories are supplied separately. The Stellaris Elite™ (BL15455) vision
enhancement system with laser functionality ships with all essential laser accessories.

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 1. Getting Started

Figure 1.1. Stellaris Elite™ Posterior/Combined Configuration (with Laser Module)

1. IV Pole. 2. Pneumatic Actuation Port. 3. Posterior Handpiece Connectors. 4. Laser.
5. One-Touch Wheel Locking. 6. User Interface screen. 7. System Switch “On/Off”.
8. Handpiece Connectors. 9. Fluidic Module. 10. System Tray.

Your Stellaris Elite™ vision enhancement system is easily upgraded to take advantage of future technology
innovations. The primary interface with the system is a 19 inch, 5:4 aspect ratio color touch screen display. The
display screen may be tilted 10 degrees forward and 15 degrees back, and swiveled 90 degrees to the right or
left. The brightness of the display is controlled through the More Screen A/V (see page 2-19).

An infrared receiver, at the bottom of the display screen, interfaces with the remote control.

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1. Getting Started

The computer system includes both audio and visual capabilities, which provide warning messages, alarms,
and other audio indications, as well as allowing you to view setup screens, surgical settings, and video from a
microscope camera. The volume is adjustable via the touch screen setting globes on the More Screen A/V tab.

Two USB ports on the back of the display allow you to save, load, and transfer your customized settings
between systems.

There are two air outputs built into the system to provide filtered atmospheric air for anterior and posterior
surgeries. A single port on the front of the system provides filtered atmospheric air for both Fluid/Air Exchange
(F/AX) and Air Forced Infusion (AFI) for posterior and combined surgery. The port near the IV Pole on the
back of the system provides air for Pressurized Infusion (PI) and Adaptive Fluidics in anterior surgery.

The system can be set for either gravity infusion (IV Pole) or infusion using pressurized air (AFI and PI,
respectively) through the More Screen Infusion Tab or through the programming interface (see Chapter 3).

Both air output ports have lighted rings surrounding them. The ring light will be solidly lit if that function is
active and within correct pressure range. If the pressure moves outside of the specified range, the ring will begin
blinking. If the pressure remains outside the set range, an error message will appear on the screen.

Laser functionality is only available on the Stellaris Elite™ (BL15455) vision enhancement system. The laser
functionality is integrated and shipped with a new Stellaris Elite™ (BL15455) vision enhancement system.

Service Life: The expected service life is 10 years.

1.2.2 Pack Compatibility with Older Systems

Posterior and Combined Procedure Packs designed for use on the older Stellaris posterior combined
systems cannot be used on the new Stellaris Elite™ PC. Likewise, Posterior and Combined Procedure
Packs designed for use on the new Stellaris Elite™ PC system should not be used on the older systems. In
addition, Stellaris Elite™ PC supports the use of anterior Adaptive Fluidics packs (see Adaptive Fluidics™ on
page 4-53)

1.2.3 System Alarm

The Stellaris Elite™ has one Low-Priority alarm with a Delayed harm effect. The single-alarm is activated
immediately when the operator selects a tamponade pressure setting above 59 mmHg or 80 cmH20. The elevated
tamponade (elevated infusion) pressure is selected on the Graphical User Interface screen. Therefore, the
operator’s position is in front of the Stellaris system, within reach of its display, when the low priority alarm is
activated. The alarm only occurs when the user sets a tamponade pressure above a preset point.

See manual Section 4 Air and Fluid Tamponade functions for detailed operation of the elevated infusion
pressure low priority alarm.

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 1. Getting Started

1.3. Connections and Setup

WARNING: 
When using gravity infusion, the ophthalmic irrigation source shall be at or above the
patient’s eye level to avoid patient injury.

WARNING: 
Do not add unapproved accessories that modify the effective IV Pole Height.

WARNING: 
For optimum aspiration and reflux performance, the patient’s eye must be at the same level
as the Stellaris Elite™ vision enhancement system aspiration port on the fluid collection
cassette. If this is not possible, use the patient eye level offset feature in the programming
screen.

Note:  he out-of-factory Wireless System Setup is “Disabled”. Performing a software upgrade will
T
also reset the Wireless System Setup to “Disabled”. To set up wireless operation, see Wireless
Primary (Integrated) Foot Control System Setup on page 1-51.

This connections and setup section applies to systems without laser function only. For systems with laser
functionality, see Laser Function on page 1-71.

The Stellaris Elite™ vision enhancement system is pre-configured at the factory to minimize setup and
installation requirements.

The power cable, Primary (Integrated) Foot Control and Ethernet connections are located at the lower rear of the
system.

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1. Getting Started

Figure 1.2. Lower Rear of System (Stellaris Elite™ PC+L)

1. Fuse Holder. 2. Main Power Switch, disconnects system from mains voltage. 3. Ethernet Port.
4. Secondary (LIO) Foot Control Port. 5. Primary (Integrated) Foot Control Backup Cable Port.
6. Microscope Filter Interlock. 7. Room Interlock. 8. Potential Equalization Connector.
9. Power Cord Input. 10. Power Cord Retention Clip.
Note: Systems without laser functionality will not have 4, 6, or 7.

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 1. Getting Started

Note: Turning off the Main Power Switch will disconnect the system from mains.

Primary (Integrated) Foot Control

The Primary (Integrated) Foot Control shipped with all systems contains a laser firing switch, and can use either
wired or wireless communication. The first time the Stellaris Elite™ vision enhancement system is used, you
must use the wired connection to establish communication between the Primary (Integrated) Foot Control and
the Stellaris Elite™ vision enhancement system.

For wired communication, connect the Primary (Integrated) Foot Control backup cable from the back of the
Primary (Integrated) Foot Control to the lower rear of the Stellaris Elite™ vision enhancement system.

See page 1-43 for details on use of the Primary (Integrated) Foot Control.

Figure 1.3. Primary (Integrated) Foot Control.

Ethernet Cable (optional)

The Ethernet cable connects the Stellaris Elite™ vision enhancement system with the Digital Media System
(DMS) to provide video overlay function. If you have the optional DMS module, connect the Ethernet cable to
the port at the bottom of the Stellaris Elite™ vision enhancement system and the other end of the cable to the
DMS.

When the Ethernet cable is not in use, install the attached protective cap into the open socket.

Compressed Air Connection

Connect the external air hose to the rear of the system as shown, and then to an appropriate air source.

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1. Getting Started

WARNING: 
For optimum aspiration and reflux performance, the patient’s eye must be at the same level as
the Stellaris Elite™ vision enhancement system aspiration port. If this is not possible, use the
patient eye level offset feature in the programming screen.

To set up the Stellaris Elite™ vision enhancement system:

a. Plug the power cord into the wall.

b. Turn on the power switch, located on the back of the bottom of the system console, and wait for the
software to load.
c. Connect the Foot Control backup cable to the system to initiate wireless operation.
d. The battery in the Foot Control must charge at least overnight before it can be used wirelessly. To charge
the battery, you can use one of three methods. See page 1-55. To use the system immediately, use the
provided cable to connect the Primary (Integrated) Foot Control directly to the Stellaris Elite™ vision
enhancement system.
e. If you purchased the DMS, see DMS Operator’s Manual for setup details.

Figure 1.4. Rear of system, showing air connection.

Note:  he system requires filtered medical grade air or medical grade nitrogen, at 72.5 psig to
T
100 psig (500 kPa to 690 kPa or 5.0 bar to 6.9 bar) and a flow rate of 2.25 SCFM (63.7 SLPM).

See 1.12. Foot Control on page 1-43 for a detailed description of Primary (Integrated) Foot Control operation.

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 1. Getting Started

1.4. Setting Up Your System

WARNING: 
The use of flammable anaesthetics, flammable disinfectants, aerosol sprays, or oxidizing
gases such as nitrous oxide (N2O) and oxygen should be avoided unless the gaseous agents
are sucked away and the liquid agents are fully dried or evaporated. Ensure the flammable
liquids are not pooled beneath the patient drape.

WARNING: 
This system should only be operated by personnel who have been trained and are qualified to
use this system.

WARNING: 
Do not manually force the IV Pole downward if the system is on.

WARNING: 
Do not modify the pole height or manually force the pole height, as this could cause an
incorrect indication of the bottle height, leading to patient injury.

WARNING: 
When using gravity infusion, the ophthalmic irrigation source shall be at or above the
patient’s eye level to avoid patient injury.

WARNING: 
Do not add unapproved accessories that modify the effective IV Pole Height.

CAUTION: 
Do not block air vents.

Before the first use of the Stellaris Elite™ vision enhancement system, connect the Primary (Integrated) Foot
Control to the system with the Primary (Integrated) Foot Control backup cable provided with the system.

The following pages contain an overview for setup and use of your Stellaris Elite™ vision enhancement system
in a typical surgery without laser functionality. This information is intended for use by someone who is already
familiar with this type of system.

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1. Getting Started

Turning System On
Plug the power supply cord into the wall. Connect the compressed air hose to the system.

If desired, connect the Ethernet cable to the port at the bottom of the Stellaris Elite™ vision enhancement
system, and the other end to the optional DMS system for Video Overlay function.

Turn on the switch at the bottom of the system console.

WARNING: 
Ensure that the power cord is routed away from traffic areas to prevent accidental
disconnection or tripping hazards.

WARNING: 
Do not disconnect system from power while in use.

CAUTION: 
Do not turn this switch off until the system has been properly shut down.

Note: Turning off the Main Power Switch will disconnect the system from mains.

Connect the air supply to the back bottom of the system.

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 1. Getting Started

Figure 1.5. Back bottom of system.

1. Air hose connection. 2. Main Power Switch.

Note:  he system requires filtered medical grade air or medical grade nitrogen, at 72.5 psig to
T
100 psig (500 kPa to 690 kPa or 5.0 bar to 6.9 bar) and a flow rate of 2.25 SCFM (63.7 SLPM).

Press the power button on the front of the system, and wait for the screen to come on and the software to load.
The front power switch is brighter when the system is off, and dims when you turn the system on.

The Stellaris Elite™ vision enhancement system performs a self-check each time the power is turned on. The
system automatically checks its configurations for any changes since the last time it was turned on.

CAUTION: 
Observe system diagnostic messages when powering up system for first use each day and take
appropriate action if required. Also observe first cassette priming or calibration, phaco/frag
handpiece tuning and/or vitrectomy handpiece testing for correct completion.

After the Primary (Integrated) Foot Control has been synchronized to the specific Stellaris Elite™ vision
enhancement system (see page 1-43), you may use wireless communication.

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1. Getting Started

Note:  he out-of-factory Wireless System Setup is “Disabled”. Software upgrade will also reset the
T
Wireless System Setup to “Disabled”. See System Setup Instructions on page 1-51 to configure
Primary (Integrated) Foot Control to wireless operation.

If you are going to use the Primary (Integrated) Foot Control in wireless mode, ensure the Foot Control
battery is charged, then hold down any button on the Primary (Integrated) Foot Control until the green ready
light comes on, indicating that communication has been initiated. This light will turn solid green when full
communications have been established.

When the system check is completed following system power-up, the Splash screen will appear (see Figure 1.6
on page 1-14).

Note:  ollowing system shutdown, wait a minimum of 15 seconds before restarting the system. The
F
system is fully shut down after the front panel power button light changes from dim to bright.

Figure 1.6. Opening Splash Screen.

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 1. Getting Started

Once the software has finished loading, the Select Procedure Screen will appear, unless a default procedure
has been set (see page 3-26).

Figure 1.7. Select Procedure Screen.

A Select Surgeon Screen (as shown in Figure 1.8 on page 1-16) will appear when you select any type of
procedure from the Select Procedure Screen.

If your system is programmed to default to either the Anterior Domain, Posterior Domain or the Combined
Domain, the Select Procedure Screen will not appear, and the system will move directly to the Select Surgeon
Screen, as shown in Figure 1.8 below.

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1. Getting Started

Figure 1.8. Select Surgeon Screen.

Select Surgeon
Touch the name of a surgeon on the list to highlight it, then select Confirm to load the parameters for that
surgeon and advance to the Setup Screen.

Note:  search function is available to filter the surgeon names list when selecting a surgeon file to
A
load. If the Confirm button is not active, this indicates one or more modules were not detected
in the system and further operation is not allowed.

See page 3-17 to create a new surgeon preference file.

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 1. Getting Started

Setup Screen
The Setup Screen allows you to set certain procedure parameters, and prepare the system for surgical
procedures.

The Insert Cassette option will be highlighted when you initially see this screen.

If desired, select the specific technique, needle, grade, vitrectomy gauge, extrude gauge, and fragmentation
needle (Posterior Domain) for the current procedure.

Figure 1.9. Anterior Domain Case Menu Screen.

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Figure 1.10. Posterior Domain Case Menu Screen.

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Figure 1.11. Combined Domain Case Menu Screen.

Advance to the open pack step by selecting Insert Cassette from the Clock Menu.

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1.5. Starting a New Procedure

The Stellaris Elite™ vision enhancement system is user-friendly, and will highlight whichever step is next
in a typical procedure. The steps shown on the display screen will vary slightly depending on which optional
features are installed on your machine. On-screen instructions take precedence over information in this manual.

WARNING: 
Before beginning a procedure, ensure that there is sufficient volume of irrigation solution for
the entire procedure.

WARNING: 
Visually inspect all sterile barrier systems prior to opening to determine if breaches of
integrity are present. If damaged, do not use.

Note: Ensure tube set connection is secure when connecting to the handpiece and system.

1. Set up the sterile field

Open the disposable pack and drop contents onto a sterile surface.

Note:  ake sure to use the proper pack for the mode you are using. Packs will not work for other
M
modes. The Packs are color-coded. Anterior packs are green and/or light blue. Posterior Packs
and Combined Packs are color-coded by needle gauge: 20 gauge is gray, 23 gauge is green,
25 gauge is blue, and 27 gauge is purple.

Attach the sterile screen drape by placing the drape over the top of the Stellaris Elite™ vision enhancement
system screen and secure with the adhesive strip to top, not the front, of the display as shown in the illustration
below.

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Figure 1.12. Schematic diagram of Sterile Draping.

1. Adhere screen drape on the top of the screen panel. 2. Screen drape. 3. Anterior Remote control drape.
4. Mayo Tray drape.

CAUTION: 
Do not exceed a maximum load of 3 lbs. when system tray is fully extended.

2. Set Up Fluid Collection System

WARNING: 
Before beginning a procedure, ensure that there is sufficient volume of irrigation solution for
the entire procedure.

Insert the fluidics cassette into the slot on the front of the system and hold until it is automatically captured
by the system. The cassette housing backlight will stop blinking and remain on when the system captures the
cassette.

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The system will automatically conduct a vacuum sensor and calibration check. Wait until the progress bar shows
successful completion to proceed. If the system does not pass, corrective actions will be suggested. Following
the successful cassette check, the screen will automatically advance to the Prime and Tune steps.

Adaptive Fluidics is a new fluidics function for phacoemulsification surgery during lens removal and I/A only.
It is not available for anterior vitrectomy and all posterior phases. The new function is to be used with Adaptive
Fluidics surgical packs. Please see page 4-53 for detailed information on Adaptive Fluidics, and page 2-30 for
Adaptive Fluidics changes to the GUI.

3. Connect the proper accessories to the system for an Anterior, Posterior,

or Combined procedure

Note: I f you are using a vented Air Forced Infusion (AFI) pack, make sure to connect the Fluid/Air
Exchange filter to the F/AX port on the front of the machine.

Detailed setup instructions for each configuration are provided in Chapter 4. Use the following list to
navigate to the appropriate page and surgical setup instructions for the desired configuration.

Posterior Domain -
• Vitrectomy - See page 4-8
• Illumination - See page 4-24
• Fluid/Air Exchange - See page 4-32
• Viscous Fluid Injection - See page 4-37
• Viscous Fluid Extraction - See page 4-38
• Fragmentation - See page 4-41
• Laser Photocoagulation - See page 1-71

Anterior Domain -
• Irrigation/Aspiration - See page 4-45
• Phacoemulsification - See page 4-50
• Planned Anterior Vitrectomy - See page 4-57
• Unplanned Anterior Vitrectomy - See page 4-58

Coagulation -
• Fixed Coagulation - See page 4-64
• Linear Coagulation - See page 4-65

Combined Domain - See page 4-67

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Note: Ensure tube set connection is secure when connecting to the handpiece and system.

Note:  ragmentation uses the same power connection as the ultrasound handpiece. Only one function
F
can be used at a time.

Note: I f a linear coagulation in setup is enabled or a Primary (Integrated) Foot Control button is
programmed for coagulation, begin by plugging in the coagulation cord.

For on-screen instructions, select Show Me Steps from the Prime and Tune Screen and a list will appear,
detailing the required steps and showing animations of how to perform each step. Multiple video sequences can
be selected and played. Available videos include:
• Anterior Domain - Phaco, Vitrectomy
• Posterior Domain - Pressurized Infusion, Gravity Infusion, Coagulation, Vitrectomy, Fragmentation,
VF Inject, VF Extract, Illuminator, Easy Prime, EndoProbe, LIO
• Combined Domain - Pressurized Infusion, Gravity Infusion, Coagulation, Vitrectomy, Fragmentation,
VF Inject, VF Extract, Illuminator, Easy Prime, EndoProbe, LIO, Phaco, Anterior Vitrectomy

WARNING: 
The animations illustrate the steps, but do not represent sterile technique.

4. Prime and Tune

Note:  he system will not provide feedback as to whether or not fluid is present during priming.
T
Inspect tubing and confirm that it is filled with fluid and free of bubbles after each Prime and
Tune. Repeat the priming process if the tubing is not adequately filled with fluid.

When the cassette has been inserted and captured by the machine, and all accessories, tubing and handpieces
have been connected, the system is ready for Prime and Tune. To proceed to the Prime and Tune phase, select
the appropriate options for the domain in which you are operating. Available options are described below.

For Posterior Domain:

• Select the Easy Prime button from the Prime and Tune Screen to fill the left and right tubing with
Balanced Salt Solution, and then perform a test of the pneumatic cutter. During this process, the gravity
feed infusion IV pole will raise to 140 cm or lower if maximum ceiling height is set lower than 140 cm
for the anterior. In the posterior/combined domains, IV pole will raise to the maximum ceiling height
programmed for the system. With the air pressured infusion, the pressure will raise to 103 mmHg for
posterior/combined domains.

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• Select the Prime/Test Vit button to activate the vacuum on right side aspiration line and test the
pneumatic vitrectomy function. The handpiece tip must be submerged in Balanced Salt Solution during
this process. After the line has been primed, this button will become Test Vit, which will activate the
cutter test without aspiration.
• Select the Prime/Tune U/S button to activate aspiration on the left line and tune the fragmentation
handpiece. The electric connector on the fragmentation handpiece must be inserted into the
Stellaris Elite™ vision enhancement system and the tip submerged in Balanced Salt Solution before
this option is selected. After the line has been primed, this button will become Tune U/S, which will
activate a shorter cycle of aspiration and tuning.
• Select the Prime/Aux button to activate aspiration to fill the left aspiration line with Balanced Salt
Solution. After the first use, subsequent priming cycles will be slightly shorter.

For Combined Domain:

• Select the Easy Prime button from the Prime and Tune Screen to fill the left and right tubing with
Balanced Salt Solution, and then perform a test of the pneumatic cutter. During this process, the gravity
feed infusion IV pole will raise to 140 cm or lower if maximum ceiling height is set lower than 140 cm
for the anterior. In the posterior/combined domains, IV pole will raise to the maximum ceiling height
programmed for the system. With the air pressured infusion, the pressure will raise to 103 mmHg for
posterior/combined domains.
• Select the Prime/Test Vit button to activate the vacuum on right side aspiration line and test the
pneumatic vitrectomy function. The handpiece tip must be submerged in Balanced Salt Solution during
this process. After the line has been primed, this button will become Test Vit, which will activate the
cutter test without aspiration.
• The operation of the Prime/Tune U/S button differs, depending on which ultrasound handpiece is
connected to the system.
• Fragmentation Handpiece: Select the Prime/Tune U/S button to activate aspiration on the left line
and tune the fragmentation handpiece. The electrical connector on the fragmentation handpiece
must be inserted into the Stellaris Elite™ vision enhancement system and the tip submerged in
Balanced Salt Solution before this option is selected. After the line has been primed, this button will
become Tune U/S, which will activate a shorter cycle of aspiration and tuning.
• Ultrasound Handpiece: Select the Prime/Tune U/S button to initiate priming of the irrigation and
left aspiration line, followed by tuning of the ultrasound handpiece and a vacuum test. During this
process, the IV bottle will be raised to 140 cm or the system will use a pressure of 73 mmHg if AFI
is used. The irrigation line and the aspiration line need to be connected to the ultrasound handpiece
with the test chamber attached to the tip of the ultrasound handpiece. After the line has been
primed, this button will change to Tune U/S which will activate a shorter cycle of aspiration and
tuning without the vacuum test.
• Select the Prime/Aux button to activate aspiration to fill the left aspiration line with Balanced Salt
Solution. After the line has been primed, subsequent priming cycles will be slightly shorter.

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For Anterior Domain:

• Select the Prime and Tune button from the Prime and Tune Screen to initiate priming of the
irrigation and left aspiration line, followed by tuning of the ultrasound handpiece and a vacuum
test. During this process, the IV bottle will be raised to 100 cm or the system will use a pressure
of 73 mmHg if AFI is used. The irrigation line and the aspiration line need to be connected to the
ultrasound handpiece with the test chamber attached to the tip of the ultrasound handpiece. After the
line has been primed, this button will change to Tune Only which will activate a shorter cycle of
aspiration and tuning without the vacuum test.
• Select the Prime Only button from the Prime and Tune Screen to initiate priming of the irrigation
and left aspiration line, followed by a vacuum test. The irrigation line and the aspiration line need to
be connected to the ultrasound handpiece with the test chamber attached to the tip of the ultrasound
handpiece. During this process, the IV bottle will be raised to 100 cm or the system will use pressure
if AFI is used. After the line has been primed, the button will activate a shorter cycle of aspiration
without the vacuum test.
• Select the Prime/Test Vit to activate aspiration and a test of the pneumatic cutter.
• In the anterior domain, the remote control can be used to activate functions in the “Prime and Tune”
window of the setup screen. The remote control UP/DOWN buttons are used to move the arrow and
select options in the “Prime and Tune” window:

“Prime and Tune”

Window on Setup
Screen

Figure 1.13. Prime and Tune Window.

1. Enter. 2. Up. 3. Down.

• Pressing the “Enter” button on the remote control activates the selected function as indicated by the
arrow.

Once Prime and Tune is initiated by any of these options, a Cancel button will appear. Selecting the Cancel
button will immediately stop the priming and tuning process.

When Prime and Tune is in progress, a progress bar at the lower left-hand corner is displayed to indicate the
status of the Prime and Tune cycle.

If the system does not pass the Prime and Tune test, suggestions for corrective action will be displayed.

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Figure 1.14. Prime and Tune Screen. This is an example of a posterior domain screen.

5. Advance to Surgery Phase

WARNING: 
Inadvertent activation of functions that are intended for priming or tuning handpieces while
the handpiece is in the eye can create a hazardous situation that could result in patient injury.

Once the system has been successfully primed and tuned, it will automatically move to the main surgical screen.
Manually selecting Advance to Surgery produces the same result.

Note: I f the system is not primed and tuned, the aspiration, vitrectomy and ultrasound functions will be
unavailable.

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1.6. Using Your System in Surgery

Default parameters and settings are saved in the surgeon preference file, but can be modified during a procedure
using the on-screen controls and surgical settings screens (see page 2-6).

Your system will display the appropriate surgical screen for the current surgical mode. The interface is visibly
different depending on the current operational mode. See Figure 1.15 for an example of a Posterior Surgical
Screen, or Figure 1.16 for an example of an Anterior Surgical Screen or Figure 1.17 for an example of a
Combined Surgical Screen. When the appropriate screen appears, your Stellaris Elite™ vision enhancement
system is ready for the surgical procedure to begin.

Figure 1.15. Posterior Surgical Screen.

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Figure 1.16. Anterior Surgical Screen.

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Figure 1.17. Combined Surgical Screen.

1.7. Concluding a Surgical Procedure

Select End from the Clock Menu. Confirm that you are ready to end the case and eject the cassette, and you
will be reminded to close the clamps on the irrigation tube set. A similar End function is accessible from the
Setup Screen.

WARNING: 
Make sure to close the Irrigation Clamp on the Irrigation Tube Set before pressing End
Procedure or fluid may continue to flow from the handpiece and into the cassette.

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The system will then advance to the End of Case Screen (shown below), lower the IV Pole, and eject the
cassette.

Figure 1.18. Anterior End of Case Screen.

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Figure 1.19. Posterior End of Case Screen.

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Figure 1.20. Combined End of Case Screen.

Remove the fluidics cassette immediately.

Remove all disposables from the system. Select Show Me Steps, then Remove Disposables to see a list of
which disposables need to be removed, and animations of how to remove each of them.

Selecting End of Case Data will capture the End of Case screen as an image. The stored End of Case screen
images may be exported to a USB memory device.

Select Next Patient to return to the Setup Screen and prepare the machine for the next procedure, or select
Shut Down System to power down the system.

Note:  n selecting Shut Down System, a message reminding you to charge the battery will be
O
displayed.

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1.8. Shutting Down the System

CAUTION: 
Never turn the power switch off or disconnect the power without proper system shutdown.
Equipment damage can occur.

Although there is no maximum activation (on) time or minimum deactivation (off) time defined for the
Stellaris Elite™ system, Bausch + Lomb recommends the system to be shut down at the end of each surgical
day. This allows for the system to perform self-check when powered on the next day and allows for refresh of
system memory.

From the System End Screen, select Shut Down System. Select Yes to confirm shut down, or No to go back
to the End Screen. The system may take a few minutes to shut down. The front panel light will glow brighter
when shut down is complete.

When shutting down the system, make sure to recharge the Primary (Integrated) Foot Control, as described on
page 1-55.

Note:  n selecting Shut Down System, a message reminding you to charge the battery will be
O
displayed.

1.9. Power Interruptions

If the Stellaris Elite™ vision enhancement system requires continued operation during power main
interruptions, the system should be powered from an uninterruptible power supply (not provided).

In the event the power source is interrupted causing the system to shut down, the cassette will be ejected
automatically. Perform the steps listed below according to the type of surgery.

Anterior Segment surgery:

Remove the handpiece from the eye safely and pinch off the irrigation clamp to stop fluid flowing into the
cassette.

Posterior Segment surgery:

Remove handpiece from the eye safely, and use sclera plugs to stop fluid leakage from the eye. Pinch off
irrigation clamp only after sclera plugs have been inserted to prevent fluid leakage.

When the power supply resumes, reboot the system, insert the cassette, open the irrigation clamp and perform
prime and tune according to the system setup procedures (see page 1-23). Remove the infusion cannula or
clamp off the infusion line near the infusion cannula before Priming and Tuning the system.

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WARNING: 
Do not Prime and Tune with the infusion line clamp in the open position and the infusion
cannula attached to the eye. Remove the infusion cannula, or clamp off the infusion line
clamp near the infusion cannula before priming and tuning the system.

1.10. Moving Your System to Another Location

WARNING: 
Do not pull the system by the IV Pole.

CAUTION: 
Do not transport or move your system from room to room or up an inclination unless you
have followed the steps below.

This unit is designed to provide mobility within the environment of the operating room.

Care must be taken as to avoid sloped floors greater than 5 degrees during use.

If you want to move your system to another location, follow the steps as listed below.

1. Power down normally by selecting “Shut Down” from the end of case screen
or pressing and holding the front button for at least 8 seconds, ensuring the IV
Pole is fully retracted.
2. Remove any objects from mat on top of unit.
3. Depressurize the compressed air supply that feeds your unit.
4. Disconnect the pneumatic air hose from the lower left corner (facing the rear
end of the unit).
5. Store the tray all the way in the unit’s tray receptacle.
6. Fully close the front drawer.
7. Roll the power cord in its proper hooks at the rear end of the unit.
8. Place the Primary (Integrated) Foot Control on its dedicated hook, at the rear 114
end of unit. kg
015000624 / 4111900

9. Remove the bottles and tube sets from the unit’s pole hanger and store
separately from the unit.
10. Make sure no objects such as air hose, electrical cord, video cables, etc., lie in the moving path.
11. Disengage the front brake lever.

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12. Always maneuver the unit using the handlebar designed for this purpose.

Note: Do not store anything on top of the system.

1.11. System Components

The Stellaris Elite™ vision enhancement system has an advanced modular design with independent modules
concealed in a uniquely designed exterior housing. The top level of the system is the user interface screen and
computer unit. The surgical modules are concealed inside the main housing and strategically positioned to
provide optimum user interaction and surgical functions. The Primary (Integrated) Foot Control is connected to
the system by either wired or wireless connections.

WARNING: 
Use only handpieces, cables, tube sets and accessories manufactured or distributed by
Bausch + Lomb that are designated for use with this system. Failure to do so may affect
system performance and create hazards. Use of accessories manufactured or distributed by
Bausch + Lomb on systems for which they are not designated may affect system performance
and create hazards.

WARNING: 
Manufacturers of cardiac pacemakers advise against use of bipolar cautery devices on
patients with such implants. When conducting surgery on such a patient, a battery-powered
thermal cautery may be used, or the manufacturer of the pacemaker should be consulted to
determine appropriate steps to take in order to use the bipolar cautery function.

WARNING: 
Manufacturers of implantable defibrillators recommend that these devices be temporarily
disabled when using bipolar cautery on patients with implants. The surgeon should determine
if the patient has such a device and consult the manufacturer for appropriate actions.

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User Interface Screen

The User Interface Screen is the way the user communicates with the system. See Chapter 2 for basic user
interface controls. Technical specifications can be found in Chapter 8. A typical interface setup screen is
shown below.

Figure 1.21. Typical interface screen.

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System Console

Figure 1.22. Front of Stellaris Elite™ Posterior/Combined Configuration.

1. IV Pole. 2. Pneumatic Actuation Port. 3. Posterior Handpiece Connectors. 4. Laser.
5. One-Touch Wheel Locking. 6. User Interface screen. 7. System Switch “On/Off”.
8. Handpiece Connectors. 9. Fluidic Module. 10. System Tray.

This is the main unit, which contains the connections for all handpieces, Mayo tray, Ethernet connection and
system housing. On the rear of the main unit (see Figure 1.23 on page 1-38), near the IV Pole, are three buttons
that move the IV Pole up, down or back to the preset height for the current mode of operation. The console also
contains the power supply.

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For systems left idle more than seven days, the Primary (Integrated) Foot Control must be charged for six hours
before use to ensure proper operation.

CAUTION: 
To prevent loss of data, save data before the system shuts down.

Figure 1.23. Rear of Stellaris Elite™ Posterior/Combined Configuration.

1. USB Port Access. 2. IV Pole Control Buttons. 3. Cord Wrap Hooks.
4. Primary (Integrated) Foot Control Hook. 5. Air Pressure Output connector.

The front of the system (see Figure 1.24 on page 1-39) contains multiple ports for connecting system
accessories.

There are five ports on the left side of the system for connecting specific system accessories.
• The first port (1 in figure below) is for laser (if available, see page 1-71).
• The second port (2 in figure below) is for ultrasound (see page 1-40).

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• The third port (3 in figure below) is for coagulation (see page 4-64).
• The fourth port (4 in figure below) is power for the LIO (available as distributed product, see
page 1-76).
• The fifth port (5 in figure below) is for Vitesse (see page 4-14).

There are five ports down the right side of the system for connecting specific system accessories.
• The first port (6 in figure below) is for Viscous Fluid Injection & Aspiration.
• The second port (7 in figure below) is for Air Forced Infusion and Fluid/Air Exchange.
• The third port (8 in figure below) is for Lamp 2 and provides illumination (see page 1-66).
• The fourth port (9 in figure below) is for Lamp 1 and provides illumination with selectable filters (see
page 1-66).
• The last port on the front of the panel (10 in figure below) is for Vitrectomy.

Figure 1.24. Front panel with handpiece connectors.

1. Laser (Optional Laser module only). 2. Ultrasound. 3. Coagulation. 4. Power to the lamp-type LIO.
5. Vitesse. 6. Viscous Fluid Injection and Aspiration. 7. AFI and F/AX.
8. Lamp 2 and provides illumination. 9. Lamp 1 and provides illumination with selectable filters.
10. Vitrectomy.

Systems without laser functionality (shown) will not have 1 or 4.

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Ultrasound Functions (Phacoemulsification and Fragmentation)

WARNING: 
Manufacturers of implantable defibrillators recommend that these devices be temporarily
disabled when using phacoemulsification systems on patients with these implants. This is
especially important when using pulsed phaco modes of operation. Although the implanted
devices are designed to reject electromagnetic interference, and Bausch + Lomb vision
enhancement equipment is designed to minimize such interference, a chance interaction
cannot be ruled out. Patients should be questioned to determine if they have such an implant
and, if so, the manufacturer should be consulted to determine the proper course of action.

The second port on the left side of the system is for ultrasound handpieces. These support phacoemulsification
and fragmentation procedures in continuous, pulsed, and burst modes.

Coagulation
The third port on the left side of the system is for a coagulation handpiece which provides coagulation power in
either Fixed or Linear modes. See page 4-62 for details of use and page 8-7 for technical specifications.

The front of the system contains a total of 10 ports for connecting system accessories. All ports should be
utilized now with Vitesse.

Primary (Integrated) Foot Control

The Primary (Integrated) Foot Control contains the Foot Pedal and four programmable buttons, and provides the
main interface between the user and the vision enhancement system for controlling most functions. The Primary
(Integrated) Foot Control can be used in a wired or wireless mode. See page 1-43 for detailed instructions for
its use and Chapter 8 for technical specifications.

Fluidics Function
This function uses a vacuum-based pump to control the output vacuum range from 0 mmHg to 660 mmHg,
and uses a rigid 300 ml collection cassette with attached irrigation and aspiration tubing. Pneumatic vitrectomy
supports both a Linear Cut Rate and a Fixed Cut Rate from 0 cuts per minute (CPM) to 7500 CPM. See
page 4-6 for details of use and page 8-11 for technical specifications.

Illumination Function
The illumination function provides two light sources, both with an adjustable attenuator. More than 25 lumens
output is available at maximum settings. With a xenon lamp in Lamp 1 location, any one of three color filters
(yellow, green and amber) may be used. Both ports incorporate permanent filtration to reduce ultraviolet, violet,
deep red and infrared light. See page 4-24 for details of use and page 8-12 for technical specifications, and
page 1-66 gives additional guidance on output setting.

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Air Compressor
The compressor provides air pressure to drive various pinch valves, Pressurized Infusion (Anterior domain), Air
Forced Infusion (Posterior/Combined domains) and Fluid/Air Exchange. It also houses the air pump to drive the
Viscous Fluid injection function and the venturi regulator for vacuum control. See Chapter 8 for technical
specifications.

IV Pole

WARNING: 
Use of an IV Pole extension or other means of altering the bottle height may cause inaccurate
setting displays resulting in serious permanent patient injury.

WARNING: 
When using Pressurized Infusion with Balanced Salt Solution bottle hung on the system-
automated IV pole, the actual intraocular pressure will be higher than the air pressure
displayed in the machine. The actual intraocular pressure would be equal to air pressure
combined with hydrostatic pressure created from the gravity force.

CAUTION: 
Do not manually force the IV Pole or use the IV Pole as a handle.

The Stellaris Elite™ vision enhancement system IV Pole is an integral part of the system console. It can be
directly moved up, down, or to a specific preset height by any of several methods. It can be controlled through
the touch screen, Primary (Integrated) Foot Control (if programmed), remote control (optional accessory), or
directly by using the buttons on the back of the system console. The IV Pole can also be pre-programmed to a
certain height for various surgical modes. The system will not compensate if the bottle height is altered through
the use of IV Pole extensions or other hardware not provided with the system.

To change the bottle height during surgery, use the up and down arrows on the IV Pole control section of the
Surgical Screen (see page 2-27), or use the buttons on the back of the system console.

In the lowest (stowed) position and with a 500 ml bottle, the IV Pole will provide approximately 30 cm (12 in.)
of infusion pressure, measured from the aspiration port to the middle of the Balanced Salt Solution drip
chamber. This is an equivalent pressure (not Intraocular Pressure) of 22.4 mmHg. The IV Pole can extend to
140 cm (55 in.) high, an equivalent pressure of 102.74 mmHg.

To change the programmed bottle height settings for the current surgical mode, select the More Screen
Infusion Tab (page 2-7) if in Posterior Mode, or the More Screen Vacuum Tab (see page 2-7), then select
the Infusion Tab to change the actual height, preset height, or the maximum the IV Pole is allowed to reach.

The maximum IV Pole Height should be set when installing the Stellaris Elite™ vision enhancement system in
a particular medical facility. You can do this using the programming interface (see Chapter 3).

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Remote Control (Anterior Domain Only, Optional Accessory)

CAUTION: 
The remote control is not waterproof and is not sterilizable. The remote control must be
placed in a sterile cover prior to use in the sterile field.

The remote control transmits an infrared signal to a receiver at the bottom of the touch screen. For critical
functions you can activate a command directly through the remote control. The commands which may be given
from each remote control button are shown in Figure 1.25.

The remote control is powered by two AA batteries, which should be replaced when the low battery light comes
on. Access the remote control batteries by removing the battery cover on the back of the remote.

Figure 1.25. Remote Control Functions.

1. Low Battery Light. 2. Transmitting Signal Light. 3. Next Phase.
4. Bottle Height or Pressurized Infusion.
5. Phaco, Vitrectomy or Coagulation. 6. Up and Down. 7. Flow. 8. Vacuum. 9. Previous Phase.
10. Reserved for Future Use. 11. Enter.

In the anterior domain, the remote control can be used to activate functions in the “Prime and Tune” window of
the setup screen. The remote control UP/DOWN buttons are used to move the arrow and select options in the
“Prime and Tune” window. Pressing the “Enter” button on the remote control activates the selected function.

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Note:  he batteries should be removed from the remote control if the system is to be idle for more than
T
30 days.

Note: I t is your responsibility to dispose of batteries in a safe and environmentally-responsible manner

in accordance with local regulations.

Digital Media System (DMS) (Optional)

The DMS (if available) receives streaming of surgical settings from Stellaris Elite™ and combines surgical
video to provide overlay capability. See DMS Operator’s Manual for setup details.

Laser (Stellaris Elite™ BL15455 system only)

See 1.14. Laser Function on page 1-71 for details on use of the laser function (if available).

1.12. Foot Control

The Foot Control is the main interface between the surgeon and the Stellaris Elite™ vision enhancement
system. The surgeon can control most of the available functions from the Primary (Integrated) Foot Control. The
Primary (Integrated) Foot Control can be connected through a physical cable, or through a wireless Bluetooth
connection. When the Primary (Integrated) Foot Control cable is not in use, make sure to install the attached
protective caps into the cable ports.

This device complies with Part 15 of the FCC (U.S. Federal Communication Commission) Rules. Operation is
subject to the following two conditions: 1) this device may not cause harmful interference, and 2) this device
must accept any interference received, including interference that may cause undesired operation.

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Summary of Wireless Specifications for Wireless Foot Controller

Item Specification
Bluetooth version V4.0 compliant
Operating frequency 2402.0 MHz to 2480.0 MHz (per FCC ID RFRMSR)
Operating distances No minimum
Ranges 10 meters (maximum)
Wireless functions/ Wireless functionality is the same as that in the wired configuration and is configurable
capabilities by the user as described in Section 1.12.
FCC Compliance Complies with Part 15 of the FCC Rules. Operation is subject to the following two
conditions: 1) this device may not cause harmful interference, and 2) this device must
accept any interference received, including interference that may cause undesired
operation.

The Stellaris Elite™ vision enhancement system is compatible with the Primary (Integrated) Foot Control.
The Primary (Integrated) Foot Control contains a laser firing switch, and can use either wired or wireless
communication. The foot control charger and battery are interchangeable.

Note: I n this manual, the term “Foot Control” will indicate information that applies to the Primary
(Integrated) Foot Control.

Figure 1.26. Primary (Integrated) Foot Control.

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 1. Getting Started

Figure 1.27. Placement of Primary (Integrated) Foot Control During Storage.

The Primary (Integrated) Foot Control contains an internal, rechargeable battery. The battery cover has the
battery symbol on it.

The battery must be charged overnight prior to initial wireless use, or if the system is idle for more than seven
days. Refer to the battery charging options section on page 1-55.

Foot Control Battery Replacement:

Note:  eplacing the battery when the system is powered up will disable the Primary (Integrated) Foot
R
Control wireless setup. To re-enable wireless setup, see page 1-51.

1. Place the Primary (Integrated) Foot Control upside down on a flat, dry surface.
2. Open the battery door by pressing the targets on the door toward the battery compartment and turn the
two latches 90 degrees away from the center.
3. Remove the battery with two fingers holding on to the battery.

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1. Getting Started

4. Before installing the replacement battery, check the battery electrical contacts to ensure they are clean
and free of contamination.
5. Install the new battery.
6. Press the door toward the compartment and engage door latches to securely close the battery door.

Note:  ollowing system shutdown, wait a minimum of 15 seconds before restarting the system. The
F
system is fully shut down after the front panel power button light changes from dim to bright.

Figure 1.28. Battery compartment with recess (arrows) to facilitate battery replacement.

Note: Be sure to securely close battery door.

Note:  battery must be installed in the Primary (Integrated) Foot Control at all times, while operating
A
either wired or wireless, to ensure proper operation.

LED Symbol for Battery on Primary (Integrated)

Foot Control

Note:  he out-of-factory Wireless System Setup is “Disabled”. Software upgrade will also reset the
T
Wireless System Setup to “Disabled”.

Note:  eplacing the battery when the system is powered up will disable the Primary (Integrated) Foot
R
Control wireless setup.

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 1. Getting Started

Note:  he system setup is for enabling wireless functionality; it does not affect the wired functionality.
T
The wired option is always available and active when connected.

Note:  he system will disable wireless operation once it detects loss of wireless communication at
T
the setup and surgery screens. Once wireless connectivity is lost, the wireless operation must
be manually re-configured, using the system setup screens or the Action button on the last
connectivity message. Irrigation/Infusion will be turned on if the wireless connection is lost.

Note:  he system will disable wireless operation when the battery is replaced or removed while system
T
is in surgical or setup screens. To configure system to wireless operation, see section on Wireless
Primary (Integrated) Foot Control System Setup, page 1-51.

The first time a Primary (Integrated) Foot Control is used, it must be connected via the backup cable to set the
configuration. Once this is set, the Primary (Integrated) Foot Control will only communicate wirelessly with
that specific system. To begin wireless operation, make sure the Stellaris Elite™ vision enhancement system
is on, then press any Primary (Integrated) Foot Control Button and wait for communication to be established,
which may take up to 10 seconds.

The ready light, identified by the symbol below, will turn solid green when the Primary (Integrated) Foot
Control is communicating wirelessly with the Stellaris Elite™ vision enhancement system. During operation
when system is not detecting Primary (Integrated) Foot Control wireless connection, the system will disable
wireless operation. This happens when the system is in setup and surgery screens. To resume wireless operation,
refer to the Wireless Primary (Integrated) Foot Control System Setup (page 1-51).

LED Symbol for Ready on Primary (Integrated)

Foot Control

When not in use, the Primary (Integrated) Foot Control can be stored on the back of the Stellaris Elite™ vision
enhancement system.

In some operating configurations the surgeon can change surgical phases using the Primary (Integrated) Foot
Control.

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1. Getting Started

Figure 1.29. Back of Primary (Integrated) Foot Control.

1. Pedal Pitch Tension Adjustment Knob. 2. Backup Power Cord Connection.

Figure 1.30. Top of Primary (Integrated) Foot Control.

1. Left Toe Button. 2. Foot Pedal. 3. Right Toe Button. 4. Wireless Indicator. 5. Battery Indicator.
6. Right Heel Button. 7. Laser Firing switch (cover closed) [not functional on the Stellaris Elite™
Anterior systems]. 8. Left Heel Button.

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Figure 1.31. Bottom of Primary (Integrated) Foot Control.

1. Pedal Offset Switch. 2. Battery Compartment Door. 3. Pedal Pitch Tension Adjustment Knob.

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1. Getting Started

Figure 1.32. Pedal Offset Switch Indicator (4) and Pedal Offset Positions (5, 6, and 7).
4. Pedal Offset Switch Indicator. 5. Left Offset (for system setup of left foot operation).
6. Center Position (for system setup for left or right foot).
7. Right Offset (for system setup for right foot operation).

Note:  he pedal offset switch indicator must align with either Left, Right or Center pedal offset
T
position. Failure to align the indicator appropriately will cause the Primary (Integrated)
Foot Control to become inoperable. Left or Right offset position selections strictly follow
system software programming for Left or Right foot operations. For example, if the system is
programmed to Right foot operation, the indicator (4) can only be set to Center (6) or Right
Offset Position (7).

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Wireless Primary (Integrated) Foot Control System Setup

Note:  he out-of-factory Wireless System Setup is “Disabled”. Software upgrade will reset the
T
Wireless System Setup to “Disabled” also.

To set up wireless operation, follow steps below:

Step 1: Select “Programming” from Setup or “Select Surgeon” screens.

Step 2: Select “System Setup” from the programming screen, as shown below.

Figure 1.33. Programming Screen.

Step 3: Select “Primary (Integrated) Foot Control” tab from the System Setup screen.

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1. Getting Started

Figure 1.34. System Setup Screen, Foot Control Tab.

Step 4: Select Wireless “Enabled” or “Disabled” to configure Primary (Integrated) Foot Control connection
mode.

Primary (Integrated) Foot Control Status and Wireless Signal Strength

Meter Display
The status of Primary (Integrated) Foot Control operation is represented by an icon displayed next to the
Foot Pedal activation status indicator. Wired connectivity is represented with a cable icon and the wireless
connectivity is indicated with a signal strength meter icon. See table below:

Display Type Primary Status Action

(Integrated) Foot
Control Setup
Wired or Wireless System detecting wired No action required
Primary (Integrated)
Foot Control

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 1. Getting Started

Display Type Primary Status Action

(Integrated) Foot
Control Setup
Wired (Wireless System NOT detecting Check Primary
disabled) wired connection. (Integrated) Foot
Possible cause: Control cable
Primary (Integrated) connection.
Foot Control cable not If Wireless System
connected. Setup is on “enabled,”
wireless connection
will be activated
momentarily when
system detects loss of
wired connection.
The wireless signal
strength icon will be
displayed indicating
system is now in
wireless operation.
Wireless System NOT detecting 1. Initiate wireless
wireless connection Primary (Integrated)
signal. Foot Control
Possible cause: connectivity by
1. Primary (Integrated) pressing one of the
Foot Control wireless Primary (Integrated)
function has not been Foot Control buttons
activated. momentarily, the left
2. Wireless connectivity LED will light up.
not functioning due to 2. Check battery if
battery issue. Primary (Integrated)
Foot Control wireless
function not established
after Step 1.
Wireless System detecting No action required.
Excellent signal
strength.

Wireless System detecting Good No action required.

signal strength.

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Display Type Primary Status Action

(Integrated) Foot
Control Setup
Wireless System detecting No action required.
Moderate signal
strength.

Wireless System detecting Low No action required

signal strength.

Wireless (System System lost wireless Connect Primary

disabled wireless setup) connection signal during (Integrated) Foot
procedure. Control backup cable to
System will resume operation.
automatically configure
to wired operation. Note:
The icon remains System will remain in
until connected with wired configuration
Primary (Integrated) the next time system
Foot Control cable or is powered up. To
manually re-configures configure system to
system to wireless wireless operation, see
configuration. section on Wireless
Primary (Integrated)
Foot Control System
Setup, page 1-51.

Note: I rrigation or infusion will be turned ON and other functions will be disabled when the system
does not detect Primary (Integrated) Foot Control connectivity in surgical mode. Irrigation or
infusion can be turned OFF from the touch screen.

Battery Management

This symbol on the battery indicates that the product must be disposed of separately and safely.
Therefore, it is your responsibility to dispose of this waste equipment by handing it over to a
designated collection point or organization that specializes in the recycling of waste electrical and
electronic equipment. The separate collection and recycling of waste equipment at the time of
disposal will help conserve natural resources and ensure that it is recycled in a manner that protects both human

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health and the environment. For more information about where you can drop off your waste equipment for
recycling, please contact your local recycling office or electronic waste hauler.

CAUTION: 
Do not expose the battery to any fluids.

The battery, when fully charged, will last for 12 hours. You may rely on a single battery, or choose to keep one
charging in a battery charging cradle (BL4393) while the other battery is being used.

Figure 1.35. Foot Control battery Charging Cradle.

Battery Charging Options

Note:  he battery should be removed from the Primary (Integrated) Foot Control if the system is to be
T
idle for more than seven days.

Note:  o maximize performance, the Primary (Integrated) Foot Control batteries (BL4390) should be
T
rotated every two months. Upon removal, battery must be charged before it is stored.

Note:  se only Bausch + Lomb supplied wall chargers (BL4391), charging cradles (BL4393), and
U
batteries (BL4390) with the Stellaris Elite™ vision enhancement system.

The Foot Control battery should be charged whenever the system is not in use. Any one of three methods can be
used to charge the battery.
• With the system power cord plugged into the electric source and the Primary (Integrated) Foot
Control connected to the system, the battery will be charged if the main power switch is turned ON.
This charging method applies with or without the Graphical User Interface being turned ON. See
Option 1 in Figure 1.36.
• The Primary (Integrated) Foot Control can be directly connected to the wall charger. Connect the wall
charger cable into the back of the Primary (Integrated) Foot Control, into the same receptacle used for
the backup cable. See Option 2 in Figure 1.36.

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• With an extra battery and battery charging cradle, you can connect the wall charger cable to the battery
charging cradle. A green light indicates the cradle is on, a second light is yellow when charging is
in progress, and green when the battery charging is complete. Once the battery is fully charged, you
can take it out of the cradle and replace the battery in the Primary (Integrated) Foot Control. See
Option 3 in Figure 1.36.

Note:  hen the Primary (Integrated) Foot Control is connected to the wall charger it will not
W
communicate with the system and cannot be used in surgery.

Note:  o connect the backup cable or wall charger to the Primary (Integrated) Foot Control, align the
T
red dot of the connectors to the 12 o’clock position.

Note: The Primary (Integrated) Foot Control is only to be used with wall charger BL4391.

Figure 1.36. Foot Control Battery Charging Options.

1. Using Primary (Integrated) Foot Control Backup Cable.
2. Using Wall Charger. 3. Using Charging Cradle.
A = Electrical Power Source.

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 1. Getting Started

Note: The battery charging cradle MUST be connected to the wall charger to charge the battery.

Wireless communication is disabled when the backup cable is in place.

The Stellaris Elite™ vision enhancement system will provide a warning message when the battery is nearing
the end of its life. Call your customer service representative for a replacement battery. See Chapter 7 for a
list of local Bausch + Lomb offices.

Primary (Integrated) Foot Control Operation

The Primary (Integrated) Foot Control has four side buttons, and a center Foot Pedal with two axes of
movement to control two linear functions simultaneously. In addition, there is a laser firing switch at the heel
resting area protected with a laser firing switch cover. To control two linear functions simultaneously, the Foot
Pedal operates with both the pitch (up and down) and yaw (side to side) travel. The yaw movement simulates the
side switches used on some systems, and can be set and programmed for left-foot or right-foot users. Reflux (if
selected) is always activated by inward yaw displacement. The center Foot Pedal may be programmed to operate
two linear functions simultaneously (Dual Linear control). The control of linear functions is proportional to
the amount of Foot Pedal travel. See page 1-60 for description of linear control. In single linear mode, pitch
controls the linear functions selected, and yaw movement provides on/off control in both directions. In Dual
Linear mode, one linear function is controlled by pitch travel, and the other linear function is controlled by yaw
travel. The table on page 1-63 shows the possible combinations of linear control.

Figure 1.37. Primary (Integrated) Foot Control, labeled.

1. Left Toe Button. 2. Foot Pedal. 3. Right Toe Button. 4. Wireless Indicator. 5. Battery Indicator.
6. Right Heel Button. 7. Laser Button Cover. 8. Left Heel Button.

There are two lights on the Primary (Integrated) Foot Control itself. The top light on the right indicates
that the wireless connection on the Primary (Integrated) Foot Control is active. This light will flash until
communications are established with the system. When the light is non-flashing green, the Primary (Integrated)
Foot Control is ready to be used wirelessly. The bottom light on the right indicates battery status, as described in
the table below.

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1. Getting Started

Color Status
Green More than one hour of battery life remains
Yellow Battery is charging
Red and Blinking Less than one hour of battery life remains

Note: T
 he GUI will provide an auditory and visual indication that less than one hour of battery life
remains and requires engagement by the user for the condition to be dismissed. In addition to
the GUI messaging, the red blinking LED (on the Foot Control) also indicates less than one
hour of battery life, though it is out of the user’s immediate line of sight.

Basic Button Operation

Note:  oice confirmation (if enabled) responds to Primary (Integrated) Foot Control and remote
V
control operation. For surgical phase changes, voice confirmation also will be activated if
changes are made through the touch screen.

All four buttons on the Primary (Integrated) Foot Control are user programmable. They are initially set in the
surgeon preferences file, and can be modified either through the programming interface (see Chapter 3), or
in some cases through the More Screen Foot Control Tab (see page 2-13).

The More Screen Foot Control Tab is used to convey the current Foot Pedal configuration and status to the
surgical team, and is accessed by selecting the More Screen button.

For a description of the laser firing switch, see page 1-76.

Foot Pedal
The Foot Pedal itself, located in the center of the Primary (Integrated) Foot Control, provides two axes of
movement and thus allows simultaneous control of two system parameters. Both controls are programmable
with respect to function and control parameters. In the pitch direction, the Foot Pedal will provide
approximately 15° of up/down movement. In the yaw direction, the center pedal will provide approximately
10° of travel from center in both the left and right directions; however, the center (home) position may be set
to be offset approximately 5° in either direction as explained on page 1-60. When released, the Foot Pedal will
return to the home (up or center) position. The table on page 1-63 shows the possible combinations of control
available. The programmable detents provide tactile feedback to the pitch movement when it moves between
different regions.

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 1. Getting Started

Single Region Pitch Control (one detent position)

The pitch movement is programmed to provide linear control as a function of relative Foot Pedal displacement
(e.g., 0° to 15° down corresponds to 0% to 100% output). Examples of single region pitch control are the linear
coagulation function and linear vitrectomy function.

Figure 1.38. Single Region Pitch Control.

Two Region Pitch Control

There are two programmable regions (two detent positions). When programmed for linear control, the pitch
movement is a function of relative Foot Pedal displacement in Region 2 (e.g., 5° to 15° down corresponds to 0%
to 100% output). An example is Irrigation/Aspiration I/A control, where Region 1 is for irrigation, and Region 2
is for linear vacuum or flow.

Figure 1.39. Two Region Pitch Control.

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Three Region Pitch Control

There are three programmable regions (three detent positions). When programmed for linear control, pitch
movement is a function of relative Foot Pedal displacement as shown below. An example is single linear
ultrasound phases, where Region 1 is irrigation, Region 2 is fixed aspiration, and Region 3 is linear ultrasound
power.

Figure 1.40. Three Region Pitch Control.

Programmable Yaw Positions

The Primary (Integrated) Foot Control may be set and programmed to give greater linear yaw movement for
either right or left foot operation. Turn the Primary (Integrated) Foot Control over and adjust the Pedal Offset
Switch to the left or right for preferred direction.
• Set and programmed for a right footed operator with the pedal home position offset to the left of center
by approximately 5° to give approximately 15° of motion to the right and approximately 5° of motion
to the left. See Dual Linear Yaw Setup description on page 1-61.
• Set and programmed for a left footed operator with the pedal home position offset to the right of center
by approximately 5° to give approximately 15° of motion to the left and approximately 5° of motion to
the right. See Dual Linear Yaw Setup description on page 1-61.
• Set and programmed for a right or left footed operator with the pedal home position in the center
giving approximately 10° of motion in both directions.

The pedal offset switch indicator must align with either left, right or center pedal offset position. Failure to
align the indicator appropriately will cause the Foot Control to become inoperable. Left or right offset position
selections strictly follow system software programming for Left or Right foot operations. See page 1-50.

Single Linear Setup

In Fixed Cut Vitrectomy Mode, the outward yaw movement provides ON/OFF cutting control. Each successive
outward movement toggles the programmed tool ON or OFF. In ultrasound mode, outward yaw control could be
programmed to toggle between different ultrasound submodes. When the Foot Pedal is released, it returns to the
center position. Inward yaw movement controls reflux.

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Dual Linear Setup

The outward yaw movement provides linear control of the programmed function, relative to Foot Pedal
displacement (e.g., 0° to 15° displacement corresponds to 0% to 100% output). When the Foot Pedal is released,
it returns to the center position. Inward yaw movement controls reflux.

Yaw Control of Reflux

The Foot Pedal may be programmed for use with either the right or left foot. Reflux (if selected) is always
activated by inward yaw displacement. For a right foot configuration, reflux is to the left (inward). For a left
foot configuration, reflux would be to the right. Reflux may only be activated when aspiration is not activated.

Yaw Control of Ultrasound Submode

For single linear setup, the ultrasound submode sequence (if programmed) is activated by inward or outward
yaw when the Foot Pedal is in Region 2 or Region 3. In a Dual Linear Setup, the yaw control of the ultrasound
submode can only be activated (if programmed) by inward yaw when the Foot Pedal is in Region 2 or Region 3.

Yaw Control of Continuous Irrigation On/Off

This function is available in software version 5.3 and above. The system can be configured so that outward
yaw turns continuous irrigation on/off. This function applies only to the Irrigation, Single Linear Phaco, and
Irrigation/Aspiration (I/A) phases. This function can be enabled/disabled in two ways: 1. Customize Technique
screen under the Foot Control tab. 2. Customize Phase screen under the Foot Control for Irrigation, Single
Linear Phaco, and I/A. The system will notify users with voice confirmation when continuous irrigation is
turned on or off using outward yaw in the Primary (Integrated) Foot Control.

Linear Coagulation Control

The control power is varied linearly from preset minimum to the preset limit. Power begins when entering Foot
Pedal position 1 and ends at the completion of travel.

Note:  ue to compliance with 60601-2-2, position 1 will not start until approximately 35% of pedal
D
travel is attained in the linear coagulation mode.

Use of Laser Functions on Foot Controls

The Stellaris Elite™ vision enhancement system can support up to two Foot Controls in simultaneous use.
Either foot control can be used for either laser function, LIO or Endo. By default, the Primary (Integrated) Foot
Control is selected for use when in an Endo mode, and the Secondary (LIO) Foot Control is selected for use in
LIO modes.

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Primary (Integrated) Foot Control (BL2295)

The laser firing switch is concealed in the heel resting area of the Primary (Integrated) Foot Control (BL2295).
To access the laser firing switch, lift the safety cover. The door may be opened to any angle up to 45 degrees. To
activate the laser, depress the laser firing switch. This is a momentary ON switch that automatically returns to
the OFF position when released. In all Laser Modes, depressing the main pedal activates linear aspiration.

All four of the side buttons on the Primary (Integrated) Foot Control are user programmable. The buttons can
be programmed using the More Screen Laser Tab to adjust laser power up, laser power down, toggle Single
Shot/Repeat and toggle laser Standby/Ready.

Figure 1.41. Primary (Integrated) Foot Control.

1. Laser firing switch, under open Safety Cover.

Secondary (LIO) Foot Control (BL2296)

The Secondary (LIO) Foot Control has a main pedal, and one switch on either side. Pressing down on the pedal
activates the laser.

The two side buttons on the Secondary (LIO) Foot Control increment laser power up and down, and are enabled
through the More Screen Laser Tab (page 2-23), or the Phase Programming Screen (page 3-9).

The LIO (Secondary) Foot Control operates in wired mode only, and connects to the system to the right of the
connection port for the Primary (Integrated) Foot Control.

Figure 1.42. Secondary (LIO) Foot Control.

See Chapter 3 for details on customizing your Foot control.

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Center Primary (Integrated) Foot Control

Phase Type Dual Linear Region Pitch Yaw Out

Control
Ultrasound Disabled R1 Irrigation Next
R2 Fixed aspiration submode
R3 Linear ultrasound
Disabled R1 Irrigation Continuous
(Continuous R2 Fixed aspiration Irrigation On
Irrigation On/Off in all positions
Activation in Yaw) R3 Linear ultrasound Continuous
Irrigation Off
in R0 and R1
Disabled (with R1 Irrigation Next
Region 2 Linear R2 Aspiration R2 submode
Vacuum Enabled minimum to fixed
or aspiration vacuum or vacuum
control feature on) limit
R3 Fixed aspiration &
linear ultrasound
Disabled (with R1 Irrigation Next
Region 2 Linear R2 Linear Aspiration submode
Vacuum Disabled disabled
or aspiration
R3 Fixed aspiration &
control feature off)
linear ultrasound
Aspiration on yaw R1 Irrigation
(with Region 2 R2 Minimum Linear
Linear Vacuum aspiration aspiration
Disabled or
R3 Linear ultrasound
aspiration control
feature off)
Aspiration on yaw R1 Irrigation
(with Region 2 R2 Aspiration R2 To max.
Linear Vacuum minimum to fixed aspiration
Enabled or vacuum or vacuum
aspiration control limit
feature on)
R3 Min. aspiration and
linear ultrasound
Aspiration on Pitch R1 Irrigation
R2 Linear aspiration Linear
ultrasound
Dual Linear R1 Irrigation
Ultrasound R2 Fixed Aspiration
R3 Linear U/S Linear
Function Ultrasound

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Phase Type Dual Linear Region Pitch Yaw Out

Control
Irrigation/ Disabled R1 Irrigation
Aspiration R2 Linear aspiration
Disabled R1 Irrigation Continuous
(Continuous Irrigation
Irrigation On/Off On in all
Activation in Yaw) positions
R2 Linear Aspiration Continuous
Irrigation Off
in R0 and R1
Irrigation Only Disabled R1 Irrigation
Disabled R1 Irrigation Continuous
(Continuous Irrigation
Irrigation On/Off
Activation in Yaw)
Anterior Disabled R1 Irrigation
Vitrectomy R2 Linear Aspiration Cutter
& fixed vitrectomy On/Off
when on
Aspiration on Pitch R1 Irrigation
R2 Linear Aspiration Linear
Vitrectomy
Aspiration on Yaw R1 Irrigation
R2 Linear Vitrectomy Linear
Aspiration
Posterior Disabled (Fixed R1 Linear Aspiration Cutter
Vitrectomy cut) and fixed cut On/Off
vitrectomy when
Auto On or Manual On
Infusion Disabled (Single R1 No Function Single Cut
cut) R2 Linear Aspiration Single Cut
Aspiration on Pitch R1 No Function Linear Cut
(Dual/Yaw Cut) R2 Linear Aspiration Linear Cut
Aspiration on Yaw R1 No Function Linear
(Dual/Yaw Vac) R2 Linear Cut Linear
Aspiration
Disable (co-linear) R1 Linear Aspiration Cutter
and Cut On/Off

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Phase Type Dual Linear Region Pitch Yaw Out

Control
Posterior Disabled (Fixed R1 Irrigation On Cutter
Vitrectomy Cut) R2 Linear Aspiration On/Off
and fixed cut
Infusion Auto vitrectomy when
On/Off On
Disabled (Single R1 Irrigation On Single Cut
Cut) R2 Linear Aspiration
Aspiration on Pitch R1 Irrigation On Linear Cut
(Dual/Yaw Cut) R2 Linear Aspiration
Aspiration on Yaw R1 Irrigation On Linear
(Dual/Yaw Vac) R2 Linear Cut Aspiration
Disabled R1 Irrigation On Cutter
(Co-Linear) R2 Linear Aspiration On/Off
and Cut
Extrude N/A R1 Linear Vacuum Linear
Extrude N/A R1 Irrigation On Coagulation
if
R2 Linear Vacuum
Infusion Auto Programmed
On/Off
Fragmentation Disabled (Linear R1 Linear Vacuum Toggle U/S
Frag) R2 Max Vacuum Submode

Linear U/S
Ultrasound on Yaw R1 Irrigation On Linear U/S
(Dual/Yaw US)
Fragmentation Disabled (Linear R1 Irrigation On Toggle U/S
Frag) R2 Linear Vacuum submode
Infusion Auto
R3 Max Vacuum
On/Off
Linear U/S
Ultrasound on Yaw R1 Irrigation On Linear U/S
(Dual/Yaw US) R2 Linear Vacuum

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Phase Type Dual Linear Region Pitch Yaw Out

Control
Viscous Fluid Disable (Fixed R1 Inject (Fixed), N/A
Control Inject, Linear Inject (Linear),
Inject, Fixed Extract (Fixed) or
Extract or Linear Extract (Linear)
Extract)
Aspiration on Yaw R1 No function or Linear
(Dual/Yaw Vac) Irrigation On if Vacuum
infusion type Auto
On/Off
R2 Inject (Linear)
Linear Coagulation N/A R1 Linear Coagulation N/A
Laser All Laser Modes R1 Linear Vacuum N/A
Laser All Laser Modes R1 Irrigation On N/A
R2 Linear Vacuum
Infusion Auto
On/Off

Note: I n Single Linear Phaco Phase, if the continuous irrigation activation in yaw on/off function
is enabled, the ultrasound next submode on yaw function cannot be enabled. The continuous
irrigation in yaw function must be disabled to enable the ultrasound next submode on yaw
function.

1.13. Illumination Function

Note:  he Illumination controls can be disabled through the Illuminators Tab on the Customize
T
Technique programming screen (page 3-7).

Note: Illumination is not available while in LIO mode.

General introduction to setting the correct light level

The guidelines provided in this section are based on ISO15752 and ISO15004-2.

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The Stellaris Elite™ vision enhancement system illumination system comes with a state of the art visualization
module to enhance the surgeon’s ability to see effectively during procedures. The output from the illumination
probe can attain high-lumen levels if needed; is filtered to minimize hazardous light; and is very flexible,
providing easy to access color filter options to enhance safety and tissue visibility.

As with any high-intensity illumination system used in the eye, care is needed during use to reduce potential for
damage to intraocular tissues.

WARNING: 
The light emitted from this instrument is potentially hazardous. The longer the duration
of exposure, the greater the risk of ocular damage. Exposure to light from this instrument
when operated at various output % settings is provided within the table entitled “Time to
exceed 10 J/cm2 weighted radiant exposure guideline” located on the following pages. Avoid
concentrating the illumination output on a small area of the retina for prolonged periods
of time due to the potential for photoretinitis and serious permanent patient injury. Set the
illumination level to the minimum needed to perform the surgical procedure.

There are two mechanisms by which harm can be induced:

• Photoretinitis - photochemical injury to the retina resulting from intense light exposure
• Thermal

In both cases the damage is caused by the intensity of light at a given point, normally called “irradiance” and
usually measured as power per square centimeter. This means that the risk of harm is increased when the
illumination probe is moved closer to the retina: at a distance of 5 mm from the retina the irradiance is about
twice that of the probe at 7 mm.

Figure 1.43. Irradiance as a function of distance.

For reference, the “lumens” output of an illumination probe is a measure of the total light output at the end of
a fiber. For the same lumens output, a focal probe has a higher irradiance (and hence risk of harm) than a wide
angle probe because the same total light output is concentrated into a smaller area on the retina. The lumens
measurement also takes into account the sensitivity of the human eye to different wavelengths of light.

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Figure 1.44. Irradiance as a function of probe type.

Photoretinitis

Sensitivity versus wavelength

The retina is more easily damaged by ultraviolet and violet-blue light than it is by light with longer wavelengths.
The Stellaris Elite™ vision enhancement system incorporates filters to remove ultraviolet light and violet light,
but it is not possible to eliminate more of the phototoxic influence without significantly discoloring the light
output.

Figure 1.45. Phototoxic sensitivity vs. light wavelength.

1. Phototoxic sensitivity. 2. Filtered in Stellaris Elite™. 3. Aphakic hazard weighting function. 4. UV.
5. Visible.

Note that the xenon lamp has a greater phototoxic effect than xenon-mercury for the same apparent brightness.

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Time dependency
The risk of developing photoretinitis depends not only on the intensity of light, but also on the duration of the
exposure, i.e. the total dose of intensity times duration must be limited to prevent damage. This applies to an
uninterrupted beam at a particular point on the retina. Normal surgical procedures do not involve exposure to a
single point on the retina, and movement of the light guide would be expected to extend the time before which
photoretinitis might occur.

WARNING: 
The light emitted from this instrument is potentially hazardous (see third note below). The
longer the duration of exposure, the greater the risk of ocular damage. Exposure to light from
this instrument when operated at various outputs may exceed the safety guideline after the
times listed in the table below when used with a Bausch + Lomb focal type probe:

Time to Exceed 10 J/cm² Weighted Radiant Exposure Guideline, in Minutes, at a Working Distance of 15 mm
Mercury Xenon Mercury
Lamp Filter
None Amber Green Yellow None Amber Green Yellow
Setting
100% 29 >120 >30 >30 11 >90 18 16
60% >40 >120 >70 >70 18 >120 >30 26
50% >45 >120 >90 >80 20 >120 >30 >30
Default Setting
40% >70 >120 >90 >90 27 >120 >45 >40
30% >90 >120 >120 >120 >30 >120 >60 >50
20% >120 >120 >120 >120 >50 >120 >70 >70
10% >120 >120 >120 >120 >90 >120 >120 >120

Note:  he data presented above is for 20 gauge focal illumination probes which are representative
T
worst case. Focal fibers are true worst case due to spot size, therefore midfield and widefield
probe time to phototoxicity is greater.

Note: The exposure from all light sources is cumulative and additive.

Note: I f the intensity of any of the light sources is reduced to 50% of the maximum intensity, the
exposure time for that light source to reach the exposure guideline is doubled. This linear
relationship can be used to determine the approximate time to reach the exposure guideline for
the combination of light sources at various intensity settings.

Note: The ISO 15004-2 weighted radiant exposure guideline is 10 J/cm2.

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Note:  hen using two lamps simultaneously at arbitrary settings, the formula for calculating the time
W
to reach the exposure threshold with both lamps running is:
tc = 1/[(s1 / t1,100)+(s2 / t2,100)] where:

tc = time to reach the threshold for the combination of the two lamps

s1 = (setting of Lamp 1 in %/100%)

s2 = (setting of Lamp 2 in %/100%)

t1,100 = time to reach the threshold with Lamp 1 at 100%

t2,100 = time to reach the threshold with Lamp 2 at 100%

Note:  he use of fibers with wider fields of illumination than focal probes at the same setting and
T
working distance will increase the time before the guidance threshold is exceeded.

Thermal

WARNING: 
High-intensity visible and infrared light is absorbed as heat in the retina. The
Stellaris Elite™ includes filters to remove the unwanted infrared from the light output, but
the visible light also contributes to the heat absorbed by the retina.

ISO15004-2 advises limits to the thermal power density received by the retina (in W per cm²). Unlike
photoretinitis, these limits are not time-related. With the high-intensity output of the Stellaris Elite™ vision
enhancement system, it is possible to exceed these limits with a focal probe at 100% output level with the probe
close to the retina.

Color filters
For the lamp in position 1, the user may select one of three color filters that tint the light output to give
improved visualization in certain circumstances according to surgeon preference.

The current pre-installed filter colors in the Stellaris Elite™ illumination module are green, yellow and amber.
Additional color options may become available later and at customers’ request can replace any or all of the
current colors.

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1.14. Laser Function (Stellaris Elite™ BL15455 system

only)

Note:  aser functionality may or may not be available in your region. Even if available in your region,
L
it may or may not be installed on your system.

Note: Calibration of the laser function should be performed annually, as described on page 6-3.

Note: The laser function is only available in Posterior/Combined modes.

Potential Risks

WARNING: 
A risk of fire and/or explosion exists when the laser output is used in the presence of
flammable materials, solutions or gases, or in an oxygen-enriched environment. Some
materials - for example cotton wool saturated with oxygen - may be ignited by the high
temperatures produced in normal use of the laser equipment. Flammable solutions used for
cleaning or disinfecting, or solvents of adhesives, should be allowed to evaporate before the
laser equipment is used. There is also danger of ignition of endogenous gases.

WARNING: 
Do not remove protective covers, due to shock hazard and accessible laser radiation. Refer
servicing to laser qualified personnel.

WARNING: 
Do not attempt to operate the laser if you suspect it is not working properly. Only factory
trained personnel should have access to the interior of the laser.

WARNING: 
Since the aiming beam passes down the same delivery system as the treatment beam, it
provides a good method of checking the integrity of the delivery system. If the aiming beam
spot is not present at the distal end of the delivery system, or its intensity is reduced or it looks
diffused, this is a possible indication of a damaged or not properly working delivery system. If
possible, try a different delivery device. If there is any doubt, contact Bausch + Lomb Global
Product Support. See Chapter 7 for a list of service facilities.

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WARNING: 
Inspect the moveable microscope filter periodically before use to ensure there are no
scratches or other damage, and that it is operating properly.

WARNING: 
Remove all reflective hazards near the laser before operating the laser.

WARNING: 
All support personnel who are present during laser treatment must wear appropriate laser
protective eyewear.

WARNING: 
The laser protective eyewear provided is not optimized for the aiming beam. DO NOT look
directly into the aiming beam even with laser protective eyewear.

WARNING: 
Never look directly into the fiber-optic cable which delivers the aiming or treatment laser
beam, with or without laser safety eyewear.

WARNING: 
Each delivery device has a proprietary connection that identifies its transmission
characteristics. Devices made by other manufacturers cannot be guaranteed to work properly
with this system and may result in either no operation or inaccurate laser delivery which
could result in serious permanent patient injury.

WARNING: 
The use of unapproved delivery devices may cause inaccurate laser delivery which could
result in serious permanent patient injury. Use only approved delivery devices.

WARNING: 
Careless handling of the fiber-optic cable, such as improperly inserting or securing the
connector, or sharply bending the cable and/or the delivery system, could result in serious
permanent patient or user injury.

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WARNING: 
There are potential hazards when inserting, sharply bending, or improperly securing the
fiber-optic cable. Not following the recommendations of the manufacturer may lead to
damage of the fiber or delivery system and/or harm to the patient or user.

WARNING: 
The use of controls or adjustments or performance of procedures other than those specified
herein may result in hazardous radiation exposure.

WARNING: 
Position all laser delivery devices (LIO or EndoProbes) such that laser energy is never
directed toward a door, window, or reflective surface.

CAUTION: 
The Primary (Integrated) Foot Control, EndoProbe and LIO should be used within 2 meters
of the Stellaris Elite™ vision enhancement system.

CAUTION: 
Never leave the powered laser unattended. Before leaving, turn off the Laser Key switch,
remove the Laser Key, and place it in a secure location.

CAUTION: 
Never leave the laser in Ready state when not treating a patient.

Note: A laser safety officer should be appointed to supervise the installation and use of the system.

Note:  he treating physician bears sole responsibility for determining the applicability of the laser
T
system for any patient or condition, and for the clinical effects of any treatment delivered.

Note: S ee page 1-92 for a description of room interlocks, and page 6-4 for specific wiring
instructions.

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Laser System Description

Photocoagulation in the posterior mode is accomplished with the Stellaris Elite™ (BL15455) vision
enhancement system Laser function. The treatment laser provides a visible green (532 nm CW, 2 W max.) class
4 laser for photocoagulation, and a class 2 diode aiming laser (635 nm CW < 1 mW max.). Laser energy is
delivered into the eye through a fiber-optic delivery device. The low-power, red aiming laser is used before and
(optionally) during the firing of the treatment laser.

The laser and the type of delivery device determine which clinical treatments can be performed with this
system. The Stellaris Elite™ vision enhancement system laser delivery devices are:
• Stellaris Elite™ vision enhancement system Endolaser photocoagulation probes
• Laser Indirect Ophthalmoscope (LIO) for transpupillary delivery of laser energy

Photocoagulation is available when the laser function is installed and the vision enhancement system is
operating in the posterior segment surgery mode. The laser function is accessible from the pre-programmed
Clock Menu.

The laser panel is immediately below the instrument tray, and contains the red Emergency Laser Stop button
and the Key Switch.

Figure 1.46. Front Panel with Emergency Laser Stop button, air vents and Key Switch.

A Laser Key switch prevents unauthorized use of the laser function. The laser will not operate unless the
Laser Key is inserted and in the On position. The Laser Key may be turned on when the system is powered up,
so it will be prepared for use. It will take the laser from 40 seconds to several minutes to reach its operating
temperature.

The system will sound a laser tone when the laser is firing. There is a volume control for the laser active tone,
but the tone cannot be turned off (see page 2-23).

The Emergency Laser Stop Button is a red button located on the front of the system. When pressed, laser
emission immediately stops, all related circuits are disabled, and a message is displayed. When the message is
cleared, the last status will read Emergency Laser Stop.

To re-enter Standby Mode, cycle the Laser Key off and on. The shot counter, laser total time and average power
will be reset to zero. The current laser power setting, interval and duration will maintain their prior settings and
the system will be in Standby Mode.

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The laser delivery device connects to top, left port on the front of the system, as shown below.

Figure 1.47. Laser handpiece (left) and LIO (right) connected to system.

System States
The Stellaris Elite™ vision enhancement system laser has four possible states, as described below.

Laser System Treatment Laser Aiming Beam

Off Disabled Off
Standby Disabled On or Off
Ready Ready to fire when Foot On
Pedal depressed
Treat Actively Firing On (default setting)

Note: System settings can be changed to turn the aiming beam off when laser is firing.

Operating Modes
The available surgical tools and modes are:
• Endo - Single Shot, Pulsed, and Continuous Modes
The EndoProbe consists of a blunt intraocular needle, a handle, and a fiber-optic cable.

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An Endo Submode is typically used during vitrectomy, to perform an Endophotocoagulation procedure

to seal holes during treatment of retinal detachment, or to perform a panretinal photocoagulation in
treatment of diabetic retinopathy.
• Laser Indirect Ophthalmoscope (LIO) (optional distributed product) - Single Shot and Pulsed Modes
The LIO delivery device adds the treatment option of transpupillary retinal photocoagulation to the
diagnostic indirect ophthalmoscope. It enables a physician to deliver laser energy to pathologies
in the far periphery of the retina and to treat supine patients. A LIO is typically used for retinal
photocoagulation of proliferative and nonproliferative diabetic retinopathy with pathology outside the
arcades, retinal tears, lattice degeneration, and localized retinal detachments. For detailed information
on the LIO, refer to the user manual as provided with the distributed product.

Note: Illumination is not available while in LIO mode.

Laser Foot Controls

The laser function is activated by pressing the laser firing switch on the Primary (Integrated) Foot Control or on
the Secondary (LIO) Foot Control. Bausch + Lomb recommends using the Primary (Integrated) Foot Control
with EndoProbes and the Secondary (LIO) Foot Control with the LIO. The treatment laser is activated by
depressing the predefined laser firing switch on either Foot Control. See page 1-43 for instructions on Primary
(Integrated) Foot Control use, setup and battery management.

The Secondary (LIO) Foot Control connects to the lower rear of the system. See Figure 1.2 on page 1-8.

At any given time, only one foot control can be programmed for laser firing. For Endo Submode, the default
foot control is the Primary (Integrated) Foot Control. For LIO Submode, the default foot control is the
Secondary (LIO) Foot Control.

Note:  pen and close the laser button door cover on the foot control to select and deselect the laser
O
mode automatically, if the option is enabled. The option can be enabled in Surgical More Screen
and in the programming.

Figure 1.48. Primary (Integrated) Foot Control, with laser firing switch protected by safety cover (open).

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Figure 1.49. Laser mode More Screen showing option to enabled/disabled Laser Mode with laser button door cover.

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Laser User Interface

The Laser Mode can be pre-programmed in the user file to be available in the surgical screen Clock Menu.
When Laser Mode is selected, the surgical screen will display laser settings and system status (see Figure 1.50).

Figure 1.50. Surgical Screen with Laser on, in Standby State.

The submode menu appears adjacent to the Laser segment of the Clock Menu. The Aiming setting globe and
Laser Power setting globe appear in the middle of the screen, just above and on either side of the Laser Status
window. The Laser Status window includes the laser shot counter, a button to reset the counter, and the laser
status button (toggles between Off, Standby, Ready, and Treat). There may also be a Shot Selector drop-down
menu that toggles between Single Shot and Repeat (continuous) modes, as shown in the lower right corner of
Figure 1.50.

If the surgeon’s file has been programmed to include Laser Mode, the Clock Menu will display the Laser
segment. Select the laser submode drop-down button to display list of laser submode options.

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Figure 1.51. Laser Submode Option List.

The laser function parameters (Power and Duration) can be changed through the setting globes on the right side
of the screen.

A touch button on the surgical screen, below the laser Interval setting globe, allows toggling between Single
Shot and Repeat Modes. When set to Single Shot, pressing the laser firing switch will deliver a single laser
pulse. When set to Repeat, pressing the laser firing switch will deliver a continuous series of laser pulses until
the firing button is released. Alternately, the Primary (Integrated) Foot Control side buttons can be programmed
to toggle between the two laser shot settings using the More Screen Laser Tab (page 2-23).

Note: The numeric keypad is only accessible if that surgical function is not currently in use.

The laser output power may be adjusted from 50 mW to 2000 mW for the Endo Submode, from 50 mW to
500 mW for Endo-Continuous Submode and from 50 mW to 1000 mW for LIO Submode using the up/down
arrows:

The Laser duration and interval are adjustable from 10 ms to 3000 ms in steps of:
• 10 ms from 10 ms to 100 ms
• 50 ms from 100 ms to 500 ms
• 100 ms from 500 ms to 3000 ms

Note:  hen operating the laser at high powers with a high duty cycle (ratio of the duration of each
W
pulse to the sum of the duration and interval between pulses), if the acceptable thermal limit
for laser operation is exceeded, the laser will stop firing and message LAS08 “Laser treatment
mode is unavailable - see the laser status” will be displayed. The laser will automatically return
to operating temperature. Follow the on-screen instructions to resume laser operation.

The counter increments once for each laser pulse fired during the procedure. Selecting the clear button resets the
counter to zero.

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The status button to the right of counter indicates the current status of the laser: Off, Standby, Ready, Treat.

Figure 1.52. Surgical Screen, Laser Endo Submode, Laser in Ready.

Aiming Beam
The Aiming Beam controls, including the power setting and On/Off control button, are displayed just below
and to the left of the center Clock Menu. The Aiming Beam is always on when the system is in Ready state,
and is user-programmable to be either On or Off while the system is in Standby state, and On or Off during the
treatment pulse, through the More Screen Laser Tab (page 2-23). These options can also be pre-programmed
in the surgeon file.

The intensity of the Aiming Beam Tool is displayed as a percentage of full power (0.8 mW). This percentage
may be changed using the Up/Down arrows on that control, in 5% increments. Selecting the displayed number
will bring up a numeric keypad, on which you can enter an exact percentage.

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LIO Lamp Tool

The LIO Lamp Tool settings are displayed to the left of the Aiming Beam Tool when Laser LIO Submode is
selected. The window displays the LIO Lamp status (on/off) and its current power setting. The intensity of the
LIO Lamp is displayed as a percentage of power from 5% to 100% in 5% increments. This percentage may be
changed using the up/down arrows, or selecting the number brings up a keypad where you can enter an exact
number.

The LIO Lamp Tool will be displayed if the LIO Submode is selected, even if there is no Laser Indirect
Ophthalmoscope connected to the system.

Figure 1.53. Surgical Screen, Laser LIO Submode, Laser in Standby.

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Figure 1.54. System with LIO connected.

The LIO Lamp cable connects to the port on the left side of the Stellaris Elite™ vision enhancement system,
second connector from the bottom.

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Figure 1.55. Room Interlock (7) and Microscope Filter Interlock (6) ports.
1. Fuse Holder. 2. Main Power Switch, disconnects system from mains voltage. See 60601-1,
paragraph 8.6.7. 3. Ethernet Port. 4. Secondary (LIO) Foot Control Port. 5. Primary (Integrated) Foot
Control Backup Cable Port. 6. Microscope Filter Interlock. 7. Room Interlock. 8. Potential Equalization
Connector. 9. Power Cord Input. 10. Power Cord Retention Clip.

See page 6-4 for details on use of interlocks.

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Figure 1.56. Surgical Screen showing Laser LIO selected and Laser in Standby state.
The LIO Lamp tool is displayed indicating LIO is connected.

EndoProbe

WARNING: 
Avoid unnecessary illumination of the retina using the aiming beam.

WARNING: 
Do not apply excessive stress to the EndoProbe to avoid product damage.

WARNING: 
Avoid contact of the EndoProbe tip with other instruments because of the risk of uncontrolled
scatter or damage to the EndoProbe.

CAUTION: 
All products should be stored in a clean and dry environment.

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The Laser Endo Submode allows the user to deliver laser energy inside the eye with the laser EndoProbe.
Contact your Bausch + Lomb representative for a list of available EndoProbes. Bausch + Lomb offers many
EndoProbe configurations to meet user needs, in both straight and curved versions. Illuminating EndoProbes
incorporate illumination to provide visualization and laser treatment. Aspirating EndoProbes incorporate
aspiration to provide suction and laser treatment.

Figure 1.57. System connected with Illuminating EndoProbe.

Figure 1.58. System with Aspirating EndoProbe.

EndoProbes are available in 20 gauge, 23 gauge, 25 gauge, and 27 gauge sizes.

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Endo Submode Setup and Use

These procedures assume the system is properly connected and running in the Posterior or Combined domain,
and that the system is at the Surgical Screen.

A. Ensure that the room interlock or the room interlock bypass key is connected to the system.
B. Ensure that the eye safety filter is installed in the microscope.
• If a fixed filter is in use, connect the laser filter bypass key to the system.
• If a two-position filter is in use, connect the interlock filter cable to the system.
C. Ensure all personnel in the operating room are wearing their laser protective eyewear.
D. Ensure the desired foot control is communicating with the system.
E. Remove the protective caps, and connect the EndoProbe delivery device. Tighten the connector finger
tight only.

Note:  hen attaching a delivery device to the fiber-optic port, do not overtighten the connector, or it
W
will be difficult to disconnect. Therefore, only finger tighten this connection.

F. Insert and turn the Laser Key clockwise, one quarter turn to power on the laser.
G. Select the Laser Mode from the Clock Menu.
H. Select the Laser Option List button to open the Laser Option List.
I. Select Endo or Endo-Continuous from the Laser Option List.
J. Open the laser firing switch cover, if using the Primary (Integrated) Foot Control.
K. Follow the prompts on the Laser Status window. After successfully performing all setup procedures,
the system will be in Standby state.
L. Use the up/down arrows to adjust the power, duration and interval desired. The green laser Counter
Reset command may be used to clear the pulse counter.
M. Select the Standby button to enter Ready state. When entering the Ready state, do not depress the laser
foot button. The button will blink, and in about 3 seconds will provide audio feedback that the system is
in the Ready state.
N. Press the firing button to activate the laser. Always toggle the laser to Standby state when not preparing
to deliver the laser.
O. When finished, turn the Laser Key one quarter turn counterclockwise to power down the laser. Remove
the Laser Key and secure it in a safe location.

For detailed instructions, select Show Steps Laser and a new screen will appear. Select Laser EndoProbe and a
new tabbed screen will appear, detailing the required steps and showing animations of how to perform each step.

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LIO Submode Setup and Use

These procedures assume the system is properly connected and running in the Posterior or Combined domain,
and that the system is at the Surgical Screen.

Figure 1.59. LIO Headset with Connections.

A. Ensure that the room interlock or the room interlock bypass key is connected to the system.
B. Ensure that the microscope bypass key is connected to the system.
C. Ensure all personnel in the operating room are wearing their laser protective eyewear.
D. Ensure the desired laser Foot Control is communicating with the system.
E. Remove the protective caps, and connect the LIO delivery device and lamp to the Stellaris Elite™
vision enhancement system. Tighten the connector finger tight only. Ensure that the LIO delivery device
and lamp power cable are kept out of the sterile field.

Note:  hen attaching a delivery device to the fiber-optic port, do not overtighten the connector or it
W
will be difficult to disconnect. Therefore, only finger tighten this connection.

F. Turn the Laser Key clockwise one quarter turn to power on the laser.
G. Select Laser Mode from the Clock Menu.
H. Select the Laser Option List drop-down menu to open the Laser Option List.
I. Select LIO from the Laser Option List.
J. Follow the prompts on the laser status window. After successfully performing all setup procedures, the
system will be in Standby state.
K. Use the up/down arrows to adjust the power, duration and interval desired. The green laser Counter
Reset command may be used to clear the pulse counter.
L. Select the Standby button to enter Ready state. When entering the Ready state, do not depress the laser
foot button. The Standby button will blink, and in about 3 seconds will provide audio feedback that the
system is in the Ready state.

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M. Press the firing button to activate the laser. Always toggle the laser to the Standby state when not
preparing to deliver the laser.
N. When finished, turn the Laser Key one quarter turn counterclockwise to power down the laser. Remove
the Laser Key and secure it in a safe location.

CAUTION: 
After removing a delivery device, remember to attach the protective cap to the input end (that
attaches to the system). The input end collects dirt and fingerprints, which can interfere with
transmission of light and may destroy the fiber. Make sure to attach the caps on the delivery
device and on the fiber-optic port after each treatment.

For detailed instructions, select Show Me Steps and a new screen will appear. Select Laser LIO from the
drop-down list and a tabbed screen will appear detailing the required steps and showing animations of how to
perform each step.

Laser Safety Information

General Measures
Operating room personnel must wear adequate eye protection if they work within 4 m of the delivery end of the
laser system while it is in ready or treat state. The NHZ for the EndoProbe as calculated per ANSI Z136.1 is 4 m
using a beam divergence half angle of 4.5 degrees, an average aversion reflex time of 0.25 sec., and assuming
that a (worst case) 2 W accidental boresight exposure.

All ancillary personnel who can be exposed to a laser beam directed out of the Laser Indirect Ophthalmoscope
(LIO) must wear eye protection. The NHZ for the LIO as calculated per ANSI Z136.1, Table B6, is 20 m using
an aversion reflex time of 0.25 sec., and assuming that a (worst case) 2 W accidental boresight exposure.

Protective Measures for the Green Treatment Beam

Protection for Physicians

WARNING: 
Eye safety filters protect the physician’s vision from backscattered treatment laser light.
Integral eye safety filters are permanently installed in the Laser Indirect Ophthalmoscope
(LIO) delivery device at the factory. For Endolaser applications, a separate discrete eye
safety filter assembly must be installed into each viewing path of the operating microscope.
All eye safety filters have an optical density (OD protection of a minimum of 3.0) at the laser
wavelength of 532 nm, which is sufficient to permit long-term viewing of diffuse 532 nm laser
light at Class 1 levels.

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Protection for Ancillary Personnel

WARNING: 
To adequately protect the eyes of ancillary personnel within the Nominal Hazard Zone
(NHZ) from both accidental intrabeam (boresight) viewing or long-term viewing of diffuse
reflections of the treatment beam, all personnel must wear laser protective eyewear which
offer a minimum OD protection of 3.5 or greater at the laser wavelength of 532 nm.
Appropriate laser safety eyewear is permanently identified with the protection wavelength and
OD.

Protective Measures for the Red Aiming Beam

WARNING: 
The laser system allows adjustment of the power of the red aiming laser over a continuous
range from 0 mW to a maximum power of < 1 mW. When set for maximum power, the red
aiming laser generates Class 2 radiation, and staring directly into the beam can cause retinal
damage.

Reflective Hazards

WARNING: 
Laser beams reflected from specular surfaces can harm the eyes of the physician, the patient,
or others. Any mirror or metal object which reflects the laser beam can constitute a reflection
hazard. Make sure to remove all reflection hazards near the laser, and use nonreflecting
instruments whenever possible. Be careful not to direct the laser beam at unintended objects.

For questions in the U.S. regarding laser safety requirements or training refer to ANSI
Z136.1 or contact the Laser Institute of America, http://www.lia.org or 1-800-345-2737, 13501
Ingenuity Drive, Suite 128, Orlando, FL 32826.

Compliance with FDA-Required Safety Features

The United States Food and Drug Administration (FDA), under Title 21 of the Code of Federal Regulations
(CFR) Subchapter J, Part 1040, has established that all laser products distributed in the U.S. must incorporate
specific laser safety features. This laser function complies with these regulations as follows:
• Protective Housing Safety Interlocks (21 CFR 1040.10 (f)(1))
The Laser Module’s internal housing prevents access to all unintended emission of laser radiation.
Special tools are required to open the protective housing. The laser port is electronically interlocked so
that no laser energy can be emitted without the correct connection of the delivery device.
• Safety Interlock (21 CFR 1040.10 (f)(2))
An electronic interlock prevents the Laser Module from emitting laser energy if a delivery device is
absent or incorrectly connected.

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• Remote Interlock Connector (21 CFR 1040.10 (f)(3))

A connection labeled with the Remote Interlock symbol on the power input module allows
incorporation of external interlock switches or safety circuits (for example, a switch that will disable
the laser whenever a hospital operating room door opens). The laser function will not operate unless
the two pins in the Remote Interlock jack are electrically connected. A connector will be provided that
can override this interlock.
• If external interlocks will not be used, insert the connector.
• If incorporating an external interlock, it must be connected to the system. When the external switch
circuit opens, it will open the Remote Interlock circuit and automatically shut down all laser circuits
within the module. The status display on the display will read “Room Interlock is open” to indicate
that electrical continuity must be reestablished in the interlock circuit before treatment can resume.
After the interlock circuit is closed, the system will re-initialize itself to Standby state. Power, pulse
duration, interval, and the counter will return to the most recent settings. To resume treatment,
simply press the Standby/Ready button to re-enter ready mode.
• Key Switch (21 CFR 1040.10 (f)(4))
The module will only operate when the proper Laser Key is in place. The Laser Key cannot be
removed while the Key Switch is in the “on” position.
• Laser Turn-On and Emission (21 CFR 1040.10 (f)(5))
The module has a two-step laser sequence to turn on the laser. First, insert the Laser Key into the key
switch on the front of the module and turn it clockwise to the ON position. This initiates a diagnostic
sequence and initializes the control system. When the appropriate delivery device is attached, the
Standby and status display for the specific delivery device will illuminate. During Standby state the
control system withholds power from the laser system. When ready mode is selected, there will be a
three-second delay before the ready mode is activated. The system will treat (deliver laser energy) only
when in treat mode and one of the Laser Module compatible footswitches is activated. An audible tone
is generated during delivery of laser energy. The volume of the tone can be adjusted, but it cannot be
turned off.
• Laser Beam Attenuation (21 CFR 1040.10 (f)(6))
The treatment laser does not emit continuously but is only energized when laser delivery is intended.
Power is withheld from the laser system by a fail-safe combination of electronic elements until all
requirements for emission are met and either laser Primary (Integrated) Foot Control is depressed.
The aiming beam intensity is controlled by the aiming beam adjustment. Turn off the aiming beam by
selecting the Aiming Beam tool on the user interface, and turning off the aiming beam.
• Location of Controls (21 CFR 1040.10 (f)(7))
All laser controls for the module and delivery devices are located at a safe distance from the laser
aperture.
• Viewing Optics (21 CFR 1040.10 (f)(8))
The Laser Indirect Ophthalmoscope Plus contains an integral eye safety filter which ensures that
any laser radiation returned to the physician’s eyes during clinical use does not exceed CDRH Class
1 limits. When using laser delivery devices that do not contain integral eye safety protection, the
user interface will automatically prompt for confirmation that an eye safety filter is installed before
treatment begins. If using an operating microscope with the module, an appropriate eye safety filter
must be installed in the viewing path of the microscope. An appropriate eye safety filter will be
designated with 532 nm. A list of acceptable filters is given in Chapter 6. When correctly installed,
the appropriate eye safety filter will protect from potentially unsafe laser radiation (i.e., radiation
which exceeds Class 1 limits) when looking into the microscope. Always confirm that the eye safety
filter to be used with the module is marked for use with 532 nm laser light. The moveable safety filter

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is electronically interlocked to the module via the SmartKey connector on the power input module to
prevent the selection of ready mode when a safety filter is not installed.
• Manual Restart (21 CFR 1040.10 (f)(10))
The module can tolerate minor power disruptions lasting only a few cycles without shutting down or
changing the intensity of the laser beam. However, it immediately disables all laser circuits whenever
the supply of electrical power fluctuates severely or the Remote Interlock circuit opens. To manually
restart the system, let it finish the initialization sequence, and if the fault condition is no longer
detected, the system will enter the Standby state. To begin operation of the laser, reset the power level
and re-select ready mode. The system cannot deliver laser energy without the operator making these
adjustments.
• Internal Power Monitor (21 CFR 1040.11 (1))
The system reads the output laser power emitted from the delivery device. Two power monitors
independently measure and verify the proper laser power before coupling it into the fiber-optic cable. If
the power measurements from the two monitors vary, the system automatically enters the Call Service
mode, and displays an error message. Press the button to return to the Standby state.
• Laser Safety Labels (21 CFR 1040.10 (g))
All laser safety labels included on the system are illustrated in Chapter 8.

Additional Laser Safety Features

• Laser Turn-On Sequence: Emission of laser radiation requires the user to:
(1) Insert the Laser Key and turn the lock from off to on.
(2) Press the “Standby” button to change to “Ready” on the user interface. There is a three-second
sequence in which the Primary (Integrated) Foot Control is locked out during which the module
conducts a brief diagnostic sequence and initializes the control and safety circuitry.
(3) Depress the predefined laser Foot Pedal to fire the laser. This sequence must be successfully
completed and all connection requirements must be satisfied before laser energy can be emitted.
• Laser Primary (Integrated) Foot Control: When the system is in ready mode, the physician activates the
treatment laser with either the Primary (Integrated) Foot Control or the Secondary (LIO) Foot Control.
Both are watertight and shrouded for safety. Several safety features are incorporated into the laser
Primary (Integrated) Foot Control circuit to prevent accidental emission of energy: dual signal lines to
prevent accidental contact, two separate switches that must be closed in order to obtain laser emission,
and it must be correctly installed. The system always tests for a properly connected footswitch before
entering ready mode. An error message will be displayed if there is damage or an improper connection.
Replace either Foot Control if it is damaged or if the cord becomes damaged or worn, or fails to make
the proper connection. The module will not allow adjustment of the treatment settings while either
laser firing switch is depressed.
• Emergency Laser Stop Button: The Emergency Laser Stop Button is a red button located on the front
of the module. When pressed, laser emission immediately stops, all related circuits are disabled, and
the system display reads “Emergency Laser Stop!” To re-enter Standby Mode, press the button again.
The counter, pulse duration, and interval will be restored to their prior settings and the system will be
in Standby Mode.
• Audio Tone: During laser emission, a distinct audible tone between 45 dBA and 65 dBA will sound.
The volume can be turned down, but the tone cannot be turned off.

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Compliance with FDA-Required Laser Safety Features (Summary)

• Protective Housing Safety Interlocks (21 CFR 1040.10 (f)(1))
• Safety Interlock (21 CFR 1040.10 (f)(2))
• Remote Interlock Connector (21 CFR 1040.10 (f)(3))
• Key Switch (21 CFR 1040.10 (f)(4))
• Laser Turn-On and Emission (21 CFR 1040.10 (f)(5))
• Laser Beam Attenuation (21 CFR 1040.10 (f)(6))
• Location of Controls (21 CFR 1040.10 (f)(7))
• Viewing Optics (21 CFR 1040.10 (f)(8))
• Manual Restart (21 CFR 1040.10 (f)(10))
• Internal Power Monitor (21 CFR 1040.11 (1))
• Laser Safety Labels (21 CFR 1040.10 (g))

Laser Interlocks
Two system interlocks are included in the Stellaris Elite™ vision enhancement system. The system cannot
be placed in Ready mode with an interlock open. If the system is in Ready mode or Treating (firing) and
an interlock opens, the system will be placed in Standby Mode. The status display on the display will read
“Interlock is open” to indicate that electrical continuity must be reestablished in the interlock circuit before
treatment can resume. After the interlock circuit is closed, the system will re-initialize itself to Standby state.
Power, pulse duration, interval, and the counter will return to the most recent settings. To resume treatment,
simply re-enter ready mode.

Connecting the System to the Microscope Filter

Eye safety filters protect the physician’s vision from backscattered treatment laser light. Integral eye safety
filters are permanently installed in the Laser Indirect Ophthalmoscope (LIO) delivery device. For Endolaser
applications, a separate discrete eye safety filter assembly must be installed into each viewing path of the
operating microscope. All eye safety filters have an optical density (OD protection of a minimum of 3.0) at
the laser wavelength of 532 nm sufficient to permit long-term viewing of diffuse 532 nm laser light at Class 1
levels.

The Stellaris Elite™ vision enhancement system will not allow the laser to fire unless the microscope filter
circuit is closed, either through wiring it to the filter or inserting a bypass key.

If you wish to incorporate the microscope filter interlock, connect the wires to your system. When your external
switch circuit opens, it will open the Remote Interlock circuit and automatically shut down all laser circuits
within the module. The status display on the Stellaris Elite™ vision enhancement system will read “Filter
Interlock is open” to remind you that you must reestablish electrical continuity in the interlock circuit before
treatment can resume. After the interlock circuit is closed, the system will re-initialize itself to Standby state.
Power, pulse duration, interval, and the counter will return to the most recent settings. To resume treatment,
simply re-enter ready mode.

Adaptor Cable (BL3242) will be needed to use these filters with the system.

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Remote Interlock Connector (21 CFR 1040.10 (f)(3))

The Stellaris Elite™ vision enhancement system will not allow the laser to fire unless the Remote Interlock
circuit is closed, either through wiring it to a facility interlock circuit or inserting a bypass key. A Remote
Interlock connection gives you the opportunity to incorporate your own external interlock switch or safety
circuit (for example, a switch that will disable the laser whenever a hospital operating room door opens).

If you wish to incorporate an external interlock, connect the wires to your own switch. When your external
switch circuit opens, it will open the Remote Interlock circuit and automatically shut down all laser circuits
within the module. The status display on the Stellaris Elite™ vision enhancement system will read “Room
Interlock is open” to remind you that you must reestablish electrical continuity in the interlock circuit before
treatment can resume. After the interlock circuit is closed, the system will re-initialize itself to Standby Mode.
Power, pulse duration, interval, and the counter will return to the most recent settings. To resume treatment,
press the Standby/Treat button to select treatment mode.

A room safety light interface can be connected on the same circuit as the room interlock, and must interface to a
24V relay.

If you choose not to use the facility interlock, you may use a room interlock bypass.

Note: Ensure both interlock bypass keys are inserted when you want to use the laser function.

Laser Probes and Cables

The following laser accessories are distributed by and compatible with the Stellaris Elite™ vision enhancement
system (BL15455). Contact your local Bausch + Lomb sales representative for the most current listing of
available laser accessories.

WARNING: 
MEDICAL DEVICE RE-USE STATEMENT
If the single-use probe accessories listed below are reprocessed and/or re-used,
Bausch + Lomb cannot guarantee the functionality, material structure, or cleanliness or
sterility of the product. Re-use could lead to illness, infection and/or injury to the patient or
user and in extreme incidents, death. The single-use probe accessories listed below are labeled
as ‘single-use’ which is defined as a device intended to be used once only for a single patient.

WARNING: 
Laser probes (also referred to as EndoProbes) and their fiber-optic cables should be handled
with care. The fiber-optic cable should not be tightly coiled, twisted or sharply bent to
preclude damage to the fiber-optic. Failure to use care may damage the fiber and/or beam
delivery system and may lead to harm of the patient or laser operator.

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1. Getting Started

SKU Description
Laser Filters
BL3236 Zeiss Fixed ESF
BL3240 Zeiss 2 Position Filter ESF
BL3245 Moeller Wedel Fixed ESF
BL3241 Leica 2 Position Filter ESF
BL3247 Leica 4-way Filter
BL3237 Leica Fixed ESF
BL3239 Laser Filter ESF Mount Topcon
BL3242 Adaptor for Fitting of 2 Position Filters
Laser Indirect Ophthalmoscopes
BL2298 TruFocus LIO Premiere™ with LED Illumination
BL2296 Auxiliary Foot Pedal for LIO Use
Standard Laser Probes
BL5290 20 gauge Standard Laser Probe Straight
BL5293 23 gauge Standard Laser Probe Straight
BL5295 25 gauge Standard Laser Probe Straight
Curved Standard Laser Probes
BL5290C 20 gauge Standard Laser Probe Curved
BL5293C 23 gauge Standard Laser Probe Curved
BL5295C 25 gauge Standard Laser Probe Curved
Illuminated Laser Probes
BL5290L 20 gauge Illuminated Laser Probe Straight
BL5293L 23 gauge Illuminated Laser Probe Straight
BL5295L 25 gauge Illuminated Laser Probe Straight
Curved Illuminated Laser Probes
BL5290LC 20 gauge Illuminated Laser Probe Curved
BL5293LC 23 gauge Illuminated Laser Probe Curved
BL5295LC 25 gauge Illuminated Laser Probe Curved
Standard Aspirating Laser Probes
BL5290ASPH 20 gauge Hard Tip Aspirating Laser Probe Straight
BL5293ASPH 23 gauge Hard Tip Aspirating Laser Probe Straight
Soft Tip Aspirating Laser Probes
BL5290ASP 20 gauge Soft Tip Aspirating Laser Probe Straight
BL5293ASP 23 gauge Soft Tip Aspirating Laser Probe Straight
Synergetics Directional Laser Probes
55.26 20 gauge Directional Laser Probe
55.26.23 23 gauge Directional Laser Probe
55.26.25, 55.26.25S 25 gauge Directional Laser Probe

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 1. Getting Started

SKU Description
55.26.27 27 gauge Directional Laser Probe
Synergetics Extendable Directional Laser Probes
55.26E 20 gauge Extendable Directional Laser Probe
55.26.23E 23 gauge Extendable Directional Laser Probe
55.26.25E 25 gauge Extendable Directional Laser Probe
Synergetics Inverted Directional Laser Probes
55.36.23E 23 gauge Inverted Directional Laser Probe
55.36.25E 25 gauge Inverted Directional Laser Probe
Synergetics Directional™ II Laser Probes
55.27 20 gauge Directional™ II Laser Probe
55.27.23 23 gauge Directional™ II Laser Probe
55.27.25 25 gauge Directional™ II Laser Probe
55.27.27 27 gauge Directional™ II Laser Probe
Synergetics Straight Laser Probes
55.21 20 gauge Straight Laser Probe
55.21.23 23 gauge Straight Laser Probe
55.21.25S 25 gauge Straight Laser Probe
55.21.27 27 gauge Straight Laser Probe
Synergetics Curved Laser Probes
*Adaptor is required for use with Stellaris Elite BL15455
55.25.23 23 gauge Flexible Tapered Laser Probe
55.25.25 25 gauge Flexible Tapered Laser Probe
55.23 20 gauge TruCurve Curved Laser Probe, 37° Curve
55.23.23 23 gauge TruCurve Curved Laser Probe, 37° Curve
55.23.25 25 gauge TruCurve Curved Laser Probe, 37° Curve
55.23.27 27 gauge TruCurve Curved Laser Probe, 37° Curve
55.12 20 gauge Curved Laser Probe*, 22° Curve
Synergetics Illuminated Laser Probes*
*Adaptor is required for use with Stellaris Elite BL15455 for the following illuminated laser probes
55.69P 20 gauge Curved Fixed Extended Illuminated Laser
Probe, 37° Curve
55.69.23P 23 gauge Curved Fixed Extended Illuminated Laser
Probe, 37° Curve
55.69.25P 25 gauge Curved Fixed Extended Illuminated Laser
Probe, 37° Curve
55.29 20 gauge Curved Maxillum™ Laser Probe, 37° Curve
55.62.23P 23 gauge Straight Fixed Extended Illuminated Laser
Probe
55.62.25P 25 gauge Straight Fixed Extended Illuminated Laser
Probe

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1. Getting Started

SKU Description
55.70.23P 23 gauge Flexible Tapered Illuminated Laser Probe
55.70.25P 25 gauge Flexible Tapered Illuminated Laser Probe
55.47.23P 23 gauge Illuminated Directional™ Laser Probe
55.47.25P 25 gauge Illuminated Directional™ Laser Probe
55.48.23P 23 gauge Illuminated Directional™ II Laser Probe
55.48.25P 25 gauge Illuminated Directional™ II Laser Probe

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2. User Interface
2. User Interface
 2. User Interface

2. User Interface
This chapter introduces you to the basic operation of the Stellaris Elite™ vision enhancement system. The
Anterior domain system allows the use of phacoemulsification, irrigation/aspiration, irrigation only and
coagulation functions. The Posterior domain allows the use of posterior vitrectomy, Fluid/Air Exchange,
coagulation, endoillumination, fragmentation, Air Forced Infusion, Viscous Fluid Control (VFC), and laser
photocoagulator. The combined domain includes all functions from both domains.

2.1. Basic Interface Controls

Setting Globe
For a single valued function, a round setting globe will display the current value. The value can be incremented
or decremented using the up and down arrows, or the value itself can be selected to activate the pop-up keypad
(see page 2-4) and enter a value.

Figure 2.1. Setting Globe.

Setting Tube
This control allows you to set the limits of a system parameter. The current value is displayed in the center of
the tube. The maximum allowed value, shown at the top of the tube, may be changed by using the increment and
decrement buttons that appear immediately above and below the value, or by selecting the value itself to activate
the pop-up keypad (see page 2-4) and enter a value. The minimum allowed value, located at the bottom of
the tube, can be changed by selecting the value itself to activate the pop-up keypad (see page 2-4) and enter a
value.

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Figure 2.2. Setting Tube.

Command Button
This is a single button control which displays a command, and initiates that action when selected. No value is
associated with this control and holding it down performs no additional function.

Figure 2.3. Command Button.

On/Off Button
This is a single round control, which is green when the associated function is on, and grey when it is off. Select
the button to toggle between the two states.

Figure 2.4. On/Off Button.

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Toggle Setting Button

This is a single button control on a labeled command button, which has a circle that is filled when the function
is on, and unfilled when the function is off. Select the button to toggle between the two states.

Figure 2.5. Toggle Settings button.

Option List
An Option List allows you to select one option from a list of available choices. Selecting the currently displayed
option will cause a list to drop down. Only one option can be selected at a given time. Selecting one option
automatically deselects others. Select close button (X) to close pop-up window without changing the current
setting.

Figure 2.6. Option Lists.

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2. User Interface

Progress Bar
This graphic shows the progress of a procedure.

Figure 2.7. Progress Bar.

Typewriter Setting Button

This is a single button control, which when selected brings up a keyboard, through which you can enter
alphanumeric text.

Figure 2.8. Typewriter Setting Button.

Numeric Keypad
Selecting a number on a setting globe brings up the numeric keypad. The keypad allows you to rapidly enter
numerical surgical settings or change settings. Numbers are entered by touching the numeral, then selecting
Enter to make the change. When a surgical function is active, the keypad is not available.

Figure 2.9. Numeric Keypad.

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 2. User Interface

Keyboard
Sometimes you will need to enter alphabetic or numeric data into the Stellaris Elite™ vision enhancement
system. A keyboard similar to that shown below will appear, and you can touch the characters in order to enter
them. Selecting the back arrow will delete the last character typed, and selecting Clear will delete all characters.
Select Enter when you are done to save the entry and return to the previous screen (or advance to next level of
programming screen).

Figure 2.10. Keyboard.

Pop-Up Message Window

This type of window appears to display informational messages. Depending on the type of message, you may
be required to take appropriate action before the system will continue. Nothing else can be done on the screen
while a pop-up window is active. The surgeon may be able to continue with the procedure once the error has
been rectified.

Figure 2.11. Pop-Up Message Window.

For some messages, suggested actions to resolve the condition appear. If more than one suggested action is
available, pressing the Next button will cycle through all possible suggested actions. For some suggested
actions, a button will appear that will initiate the suggested action.

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2.2. Surgical More Screen

The More Screen allows easy access to all system parameters. The exact More Screen options available will
depend on the current state and system settings. Select the More Screen button (shown below) to open the
More Screen.

Figure 2.12. More Screen Button.

More Screen Tabs are available for Fluidics (Vacuum and Infusion), Ultrasound, Coagulation, Vitrectomy,
Primary (Integrated) Foot Control, Laser, Audio/Visual and Messages.

Note:  hich More Screen Tabs are available at any given time depends on the current mode and
W
other system parameters.

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 2. User Interface

More Screen Vacuum Tab

The More Screen Vacuum Tab shows the vacuum settings (minimum and maximum), Primary (Integrated)
Foot Control Mapping, vacuum response setting (Global On/Off, response speed), and venting method (Global
On/Off, Air or Fluid).

Figure 2.13. More Screen Vacuum Tab.

More Screen Infusion Tab

The More Screen Infusion Tab can show the current Infusion type (Pressurized or IV Pole) and Infusion Units,
IV Pole Height (current setting and maximum allowed), Patient Eye Level, Irrigation Shut-Off Delay, Infusion
Control (Auto On, Manual, Auto On/Off), Air Port (front/back) and Pressurized Infusion pressure settings,
Irrigation Fill Time, and Balanced Salt Solution container type.

The IV Pole Height is the current distance between the aspiration port and the mid-point of the viewing port of
the Balanced Salt Solution drip chamber. The maximum IV Pole Height is the highest setting the IV Pole will
be allowed to reach, usually determined by the ceiling height and set at time of system installation. A zero-level
bottle hanger (a standard component for Stellaris Elite™ PC and PC+L configured for posterior and combined
surgeries) allows the BSS drip chamber to be level with the aspiration port.

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2. User Interface

Figure 2.14. More Screen Infusion Tab.

Note: The Air setting will only be shown on the surgical screen when Pressurized Infusion is selected.

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 2. User Interface

More Screen Ultrasound Tab

The More Screen Ultrasound Tab shows the current modulation status (Continuous, Pulsed, Single Burst,
Fixed Burst, Multiple Burst) and power level. Depending on which type of ultrasound modulation you are using,
you may also see number of pulses per second (PPS), duty cycle (DC), burst duration (BD), pulse interval (PI),
waveform type, or waveform depth. You can add or delete up to three modulation submodes, and can adjust any
of these settings.

Figure 2.15. More Screen Ultrasound Tab.

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More Screen Visc Tab

The More Screen Visc Tab shows the injection or extraction pressure (single value or min and max) and Foot
Control Mapping (Linear, Front Loaded, Back Loaded). A surgeon-level setting controls whether units are
displayed in psi or kPa (see Chapter 3).

Figure 2.16. More Screen Visc Tab.

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 2. User Interface

More Screen Coagulation Tab

The More Screen Coagulation Tab shows the current minimum and maximum power levels, and the Primary
(Integrated) Foot Control Mapping mode. You can adjust either power level setting.

Figure 2.17. More Screen Coagulation Tab.

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2. User Interface

More Screen Vitrectomy Tab

The More Screen Vitrectomy Tab allows you to change the current subphase (Fixed Cut, Co-Linear Vit,
Dual/Yaw Vac, Dual/Yaw Cut, Single Cut), the current settings for the minimum and maximum CPM (cuts per
minute), and the current Primary (Integrated) Foot Control Mapping (if applicable).

Figure 2.18. More Screen Vitrectomy Tab.

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 2. User Interface

More Screen Foot Control Tab

The More Screen Primary Foot Control Tab has three subtabs that allow you to view and edit Settings,
Regions, and the Status of the Primary (Integrated) Foot Control. These functions are described in detail in the
Primary (Integrated) Foot Control section (see page 1-43).

The Settings Subtab shows the current functions assigned to each of the Primary (Integrated) Foot Control
buttons, Next U/S (Ultrasound) Modulation on Yaw, Reflux on Yaw, Reflux Type, and Linear Coag in Setup.
You can also load up to 4 custom sets of button settings using the Custom button.

Figure 2.19. More Screen Primary (Integrated) Foot Control Tab, Settings Subtab.

The Continuous Irrigation feature available in software version 5.3 and above; (see Irrigation on page 4-43) can
be activated in the More Screen Foot Controls Tab, Settings Subtab screen for Irrigation, Single Linear Phaco,
and I/A Phases.

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2. User Interface

Figure 2.20. Continuous Irrigation On/Off Activation in Yaw Enabled.

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 2. User Interface

Figure 2.21. Continuous Irrigation On/Off Activation in Yaw Disabled.

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2. User Interface

Figure 2.22. Disabling Continuous Irrigation On/Off Activation in Yaw in the Single Linear Phaco Phase More Screen
Foot Control Tab, Settings Subtab, Allows Ultrasound Modulation on Yaw.

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 2. User Interface

The Regions Subtab shows the current settings for right or left footed operation, mode change control, the Foot
Pedal pitch regions and detent options. You can modify the starting depression position for each region.

Figure 2.23. More Screen Foot Control Tab, Regions Subtab.

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2. User Interface

The Status Subtab shows the current status of several Foot Pedal options, including communication status,
battery status, and signal strength. These are informational only and not user editable.

Figure 2.24. More Screen Primary (Integrated) Foot Control Tab, Status Subtab.

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 2. User Interface

More Screen A/V Tab

The More Screen A/V Tab and its subtabs allow you to change many aspects of the audio and video display.

The Audio Subtab controls the master volume for the system, as well as the specific tone and volume used for
Alert, Aspiration, Coagulation, Elevated Infusion, Irrigation Infusion, Key, Laser, Reflux, Occlusion, Timer,
Ultrasound, Visc Inject, Vitesse Vitrectomy, and Voice Confirmation. The selected tone will be played when that
function is active, and the frequency of the tone will change with the value of the function.

To change the tone selected for a particular function, select that function and it will appear at the top of
the screen, along with a drop-down menu of all tones currently available for use. No tone may be used
simultaneously by two functions, and some functions have a required tone.

Figure 2.25. More Screen A/V Tab, Audio Subtab.

Select the tone you want to change, then use the menu and arrows on the right side of the screen to select the
tone used for that condition, and the volume at which the tone will be played. Only tones not currently in use for
another condition will be displayed.

Voice Confirmation can also be enabled or disabled through this tab.

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2. User Interface

The Display Tab control allows you to adjust the display brightness, voice confirmation language, and to clear
the average values and elapsed times for the surgical functions for this case.

Figure 2.26. More Screen A/V Tab, Display Subtab.

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 2. User Interface

The Video Overlay Subtab allows you to select the language to be used for video overlays.

You can also set whether or not the system will display or combine the Video Overlay Format U/S Averages, or
whether or not the system will combine settings information. By default, the U/S data is shown as three separate
lines on the video overlay. If the U/S combine option is set to Yes, the display will appear on one line, which
will step through the three values. Similarly, settings are normally displayed on four lines, but if the combine
option is set to Yes, settings will appear on one line that will step through the values.

Finally, you can set the video overlay overscan in one-degree increments from 0% to 5%.

Figure 2.27. More Screen A/V Tab, Video Overlay Subtab.

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More Screen Illuminator Tab

The More Screen Illuminator Tab allows you to enable or disable the upper and lower lamps and to set the
current power and filter (none, amber, green tint, yellow tint).

The bottom section of the More Screen Illuminator Tab displays the type of bulb currently installed in each
lamp and the number of hours of lamp life remaining.

Figure 2.28. More Screen Illuminator Tab.

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More Screen Laser Tab

The More Screen Laser Tab includes the Laser Power (mW), Laser Duration (ms), Aiming Beam in Standby
(On/Off), Aiming Beam Intensity (%), Foot Pedal (Integrated Foot Pedal, Secondary Foot Pedal), Default Laser
Shot (Single, Repeat), Aiming Beam During Pulse (On/Off), LIO (On/Off, %), and Laser Foot Control Buttons
(Enabled, Disabled). Laser functionality is only available in posterior modes.

Figure 2.29. More Screen Laser Tab.

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More Screen Vitesse Tab

The More Screen Vitesse Tab includes settings for Vitesse modulation, submode, power (minimum and
maximum for linear mapping and maximum only for fixed), and foot control mapping.

Figure 2.30. More Screen Vitesse Tab.

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More Screen Messages Tab

The More Screen Messages Tab lists all system messages. You can scroll through the messages to see any
issues that have arisen during the current case.

Figure 2.31. More Screen Messages Tab.

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2.3. Surgical Screen Layout

The surgical screen is divided into four quadrants: the center of the screen displays the clock menu for
procedure selection and navigation, and different settings and functional controls are displayed in the
surrounding quadrants. The upper left corner displays the vacuum setting. The upper right corner displays the
IV Pole Height setting, air pressure setting, irrigation function status, fill function for the surgical beaker, and
Adaptive Fluidics status. The lower right corner shows the ultrasound (or coagulation) setting. The bottom of
the surgical screen displays the status bar which provides the current value for a number of system parameters.

Note:  oice confirmation (if enabled) responds to Primary (Integrated) Foot Control, remote control
V
and on-screen buttons.

Figure 2.32. Surgical Screen, Anterior Mode.

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 2. User Interface

Clock Menu
The round Clock Menu in the middle of the screen can display up to 12 phases or exceptions. The exceptions
usually appear on the left side of the Clock Menu, against a darker background. These are user-defined to be
any mode or phase type. The Setup and End are the system function keys in the Clock Menu to change from
surgical display screen to Setup and End screens.

The main Surgical Screen will have a darker background when the system is in a posterior mode and a lighter
background when it is in an anterior mode.

When the infusion type is Air Forced Infusion, the infusion pressure unit of measurement display can be toggled
between cmH2O and mmHg. Pressing the display unit button will change the displayed unit of measure.

See Chapter 3 for more details on customizing your system.

IV Pole
The upper right corner of the screen also displays the current setting for the IV Pole (in either mmHg or
cmH2O). You can use the up and down arrows to change the height, and the IV Pole will automatically move up
and down to match the setting.

The On/Off button controls the continuous irrigation function by opening or closing the irrigation pinch valve
in the fluidics system. Irrigation can be set to off, auto on, auto on/off. If the irrigation control is turned off, the
function will still be managed by the Primary (Integrated) Foot Control; when the Foot Pedal enters Region 1,
irrigation will commence.

Figure 2.33. IV Pole Controls.

Selecting the fill button opens the pinch valves in the fluidics system for a user-programmable period of time.
This function is useful for filling surgical beakers without overflow. The button shows the current state of the fill
system (On or Off), and the fill control displays the time remaining for the fill operation.

Air Pressure
The Infusion Mode (Pressurized or IV Pole) is displayed and can be changed through the More Screen. Infusion
control can be set to be manual, Auto On, or Auto On/Off.

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2. User Interface

If the Pressurized Infusion function is programmed in the surgeon file, the upper right corner of the screen
displays the current setting of air pressure when the pump is not running. When the pump is switched on, the
same area will display the actual output pressure. Below the setting display, there is an on/off button to control
the air pump operation.

Ultrasound or Coagulation
The lower right corner of the screen displays either the Ultrasound or Coagulation status, depending on which
mode is currently selected from the Clock Menu. The current setting is shown in the large setting globe, with
a green background for ultrasound, or purple background for coagulation. The actual value is displayed in the
middle of the settings tube.

When ultrasound is active, an option list control appears in the lower right corner, and selecting the button
allows you to select from a list of pre-programmed ultrasound submodes. If you select pulsed ultrasound, the
pulse per second (PPS) and duty cycle (DC) setting globes appear.

Vitrectomy and Vacuum

The upper left section of the screen shows status of the Vitrectomy and Vacuum functions, along with the setting
globes to adjust them.

Vitesse Hypersonic Vitrectomy

The Stellaris Elite™ GUI setup screen has been updated to provide one-touch Easy Prime to prime and tune
the Vitesse handpiece for surgery. A color-coded Vitesse icon has been added to the upper left-hand portion
of the screen to indicate Vitesse tune status. Detailed instructions for preparing the system and handpiece for
priming and tuning are included in Prime and Tune on page 1-23. Users may also refer to the Show Me Step
videos for animated instructions.

Once the system completes the Easy Prime cycle, the user interface controls will transition from the Setup
Screen to the Surgical Screen (Figure 2.34) in preparation for surgery.

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 2. User Interface

Figure 2.34. Surgical Screen.

The Surgical Screen user controls provide the capability to adjust the Vacuum settings from 0 mmHg to
660 mmHg, similar to the controls for the pneumatic vitrectomy cutter. The user controls also provide the
capability to control cutting power expressed as a percent of the maximum power.

Coagulation (Fixed)
If one of the Primary (Integrated) Foot Control Buttons has been programmed to control coagulation, a small
Coagulation setting globe will appear, showing the current maximum fixed setting for the coagulation function.

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2. User Interface

Status Bars
At the bottom of the screen, the status section displays the current value of a number of system parameters.
The top section includes a cassette ejection button, fluid collection device fill level indicator, the More Screen
button, as well as the Primary (Integrated) Foot Control battery level, Foot Control icon, and wireless signal
strength indicators (see page 1-52). The current pitch region is shown, and circles around the top indicate yaw
position. See page 2-13 for details on changing these settings, and the note on page 1-61.

The lower two lines in the status section show the following:
• Current Surgeon (editable)
• Current Technique (editable)
• Domain (Anterior)
• Case Number
• Timer
• U/S Average, APT, EPT
• Needle (editable)
• Grade (editable)

Figure 2.35. Surgical Screen Status Bar.

The More Screen button allows access to the More Screens for changing various system parameters.

Figure 2.36. More Screen Button.

Adaptive Fluidics™
Adaptive Fluidics is a new fluidics function for phacoemulsification surgery during lens removal and I/A only.
Adaptive Fluidics is NOT available for anterior vitrectomy and all other posterior phases. Updates to the More
Screen related to Adaptive Fluidics are detailed below.
• Enable Function
• If the system is installed with Stellaris Elite™ Software Rev 5.3 or higher, the Adaptive Fluidics
function can be enabled from either surgeon file programming or the surgical More Screen.

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 2. User Interface

To enable the Adaptive Fluidics function from the surgical More Screen:

1. Select More Screen button as shown in Figure 2.37.

2. Select the Infusion Tab on the pop-up screen to display infusion options.
3. Set Infusion Type to Pressurized, as shown in Figure 2.38.
4. Set Adaptive Fluidics to Enabled, as shown in Figure 2.38.
5. Adaptive Fluidics settings can be saved with the Save Settings command button.
6. The Adaptive Fluidics function can be turned on or off from the Surgical screen (Figure 2.39,
Figure 2.40, Figure 2.41, and Figure 2.42).

Figure 2.37. More Screen Button Located at the Lower Center Portion of the System Screen.

Figure 2.38. More Screen Infusion Tab.

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2. User Interface

Figure 2.39. Anterior Surgical Screen with More Screen Button to Turn Adaptive Fluidics Function On/Off.

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Figure 2.40. Combined Surgical Screen with More Screen Button to Turn Adaptive Fluidics Function On/Off.

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Figure 2.41. Adaptive Fluidics Turned On.

Figure 2.42. Adaptive Fluidics Turned Off (Pressurized Infusion Remains On).

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3. Customizing Your System

3. Customizing Your System
 3. Customizing Your System

3. Customizing Your System

This chapter explains how to customize your Stellaris Elite™ vision enhancement system to achieve maximum
flexibility for your operating needs.

Note: Surgical devices may not be operated during programming.

Each surgeon using the Stellaris Elite™ vision enhancement system can program the system to their own
preferred operating configuration and instrument parameters. The System Settings system profile contains all
available techniques. Several default surgeon preference files are pre-loaded on the system, and you may copy
and modify any of them through the Programming interface. You can create, modify and back up surgeon setting
preference files, as well as modify system parameters. The programming screens are organized as outlined in
the diagrams below.

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3. Customizing Your System

Figure 3.1. Programming Screen Layout.

To program system parameters, select Programming from main Clock Menu on the Surgeon Level
Programming Screen or the Setup Surgical Screen.

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 3. Customizing Your System

The Main Programming Screen will appear, from which you can perform the following functions:
• Surgeon Settings
• System Setup
• System Configuration
• System Calendar
• Remote Service

Figure 3.2. Main Programming Screen.

Each of these functions is described in more detail below.

At any time, you can select Programming to return to the Main Programming Screen, or Exit Programming
to return to the Surgeon Level Programming Screen or the Setup Surgical Screen. In either case, the
Stellaris Elite™ vision enhancement system will ask if you want to save any changes you have made. Select
Yes to save your changes and overwrite existing files, or No to discard your changes.

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3. Customizing Your System

3.1. Manage Settings

Select Surgeon Settings from the Main Programming Screen, and a new screen will appear through which
you can customize an existing surgeon’s file, create a new surgeon preference file by copying from an existing
one, back up files, restore files from a backup, or delete surgeon preference files.

A search function is available to filter the surgeon names list when selecting a surgeon file to copy.

Figure 3.3. Surgeon Settings Screen.

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 3. Customizing Your System

Customize a Settings File

To change the settings for a currently existing preference file, select Surgeon Settings on the Main
Programming Screen. A list of all surgeon preference files currently loaded on your Stellaris Elite™ vision
enhancement system will appear. Select the name of the surgeon file to be modified, then select Confirm. The
Surgeon Programming Screen appears, with the file name along the left side of the screen, and tabs across the
top (see page 3-6). These tabs are Profile, Technique, Primary (Integrated) Foot Control, Fluidics, A/V,
and Video Overlay. Each tab allows you to make global changes to system parameters, and is described in
detail below.

System parameters can be customized at different levels. Global settings take place at the Technique Level.
Technique level settings can be overridden at the phase level. See the table at the end of this chapter for details
on which options can be customized at which level.

Figure 3.4. Customize Tab on Surgeon Settings Screen.

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3. Customizing Your System

Customize Profile
To change the surgeon’s name associated with a settings file, the default screen language, Viscous Fluid
Injection Units (PSI, kPascal), enable or disable use of the remote control, or the surgeon password, select the
Profile Tab on the Surgeon Level Programming Screen.

Figure 3.5. Profile Tab on Surgeon Programming Screen.

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 3. Customizing Your System

Customize Technique
To change the techniques available for a particular surgeon or modify their settings, select the Technique Tab
on the Surgeon Level Programming Screen, and a list of currently defined techniques will appear. You can
select any technique from the current list and use the Move Up and Move Down buttons to rearrange the order
in which they appear. Select Add to add a new technique to the surgeon’s list. Select a technique, then select
Delete to remove it, or select Customize to continue programming that technique.

Figure 3.6. Technique Tab on Surgeon Level Programming Screen.

Surgeon Level Primary (Integrated) Foot Control, Fluidic, A/V and Video Overlay settings can also be
controlled from the corresponding tab. Select the right-pointing arrow to show the Video Overlay tab.

To add a new technique to the list, select Add, then select any surgeon from the list that appears, and the
techniques defined for that surgeon will appear. Select a technique and select Confirm to add that technique to
the original list.

To change the settings for a particular technique, select the technique, then select Customize. The Customize
Technique Screen will appear, with tabs for Profile, Phases, Exceptions, Primary (Integrated) Foot Control,
Fluidics, and Illuminators. Various parameters may be adjusted through these tabs, as described below.

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3. Customizing Your System

Figure 3.7. Customize Technique Screen.

• Profile Tab—Technique Name, Remote Control (Enable, Disable)
• Phases Tab—Each technique may include up to eight phases. The Phases Tab shows the name of the
phase, and the mode for that phase. Phases can be added, deleted, or re-ordered. They may also be
customized, as described below.
• Exceptions Tab—Each technique may include up to eight exceptions, for a total of no more than 12
phases and exceptions. Exceptions can be added, deleted, or re-ordered. They may also be customized,
as described below.
• Primary (Integrated) Foot Control Tab—Primary (Integrated) Foot Control Button (four standard
sets plus custom settings), enable/disable next ultrasound modulation on yaw, reflux on yaw, reflux
type, fixed coag power, linear coag setup
• Fluidics Tab—Aspiration types (Vac: Vac Modes, Flow: Vac Modes, Flow: Flow Modes, Flow: All
modes), Infusion Type (IV Pole, Pressurized), Infusion Units (mmHg or cmH2O), Infusion Mode
(Manual, Auto On, Auto On/Off), IV Pole Height, Vacuum Response, Venting Method (Air or Fluid),
Irrigation Shut-Off Delay (ms), and Pressurized Infusion Settings
• Illuminators Tab—Illumination Controls (Enabled/Disabled), Upper lamp on/off and percent on,
lower lamp on/off, percent on, and filter (none, amber, green, yellow), Display illuminator controls
(anterior technique option only)

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 3. Customizing Your System

For combined techniques, Infusion Type, Infusion Units, F/AX pressure, Infusion pressure, Elevated Infusion
pressure, and Elevated F/AX pressure settings are displayed. They are not displayed in anterior modes.

For anterior techniques, the IV Pole Height setting and Pressurized Infusion pressure setting are displayed.

Customizing Phases and Exceptions

Both Phases and Exceptions can be re-ordered and customized. Select a phase or exception from the list on the
appropriate tab, and the Customize button will appear. Select Customize, and more options specific to that
function will appear, and can be modified. These can include Phase Information, Primary (Integrated) Foot
Control settings, Fluidics (Aspiration and Infusion), Ultrasound, Vitrectomy, and Coagulation settings. When
you are done making changes, select Exit Programming. The system will ask you to confirm your changes
before exiting.

Note:  he total number of surgery phases (normal and exception) cannot exceed 12. There must be at
T
least one normal phase in each technique, and there can be no more than 8 exceptions.

Note:  hen you are in an anterior technique, and either Phaco or Irr/Asp phase, the Mode name
W
setting will have a drop-down menu with default options.

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3. Customizing Your System

Figure 3.8. Customize Phase Screen.

Select Customize, and more options specific to that function will appear, and can be modified. These can
include Profile, Primary (Integrated) Foot Control, Vacuum, Infusion, U/S Setting, U/S Waveform, Cut,
Coagulation and Visc tab.

Which tabs are displayed depends on which mode you are in, and whether Customize Settings by Case is
disabled or enabled, as detailed in the table below.

Mode Tabs Displayed on Phase Programming

Screens
Customize Setting by Case disabled
Anterior Vitrectomy Profile, Primary (Integrated) Foot Control, Vacuum,
Posterior Vitrectomy Infusion, Cut
Phaco Profile, Primary (Integrated) Foot Control, Vacuum,
Frag Infusion, U/S
I/A Profile, Primary (Integrated) Foot Control, Vacuum,
Infusion

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 3. Customizing Your System

Mode Tabs Displayed on Phase Programming

Screens
Irrigation Profile, Primary (Integrated) Foot Control, Infusion
Viscous Fluid Control Profile, Primary (Integrated) Foot Control, Visc
Viscous Fluid Control (Dual/Yaw Vac submode) Profile, Primary (Integrated) Foot Control, Visc,
Vacuum and Infusion
Extrude Profile, Primary (Integrated) Foot Control, Vacuum,
Coag (if Coag on Yaw is enabled), Infusion
Linear Coagulation Profile, Primary (Integrated) Foot Control, Coag
Customize Settings by Case enabled
Extrude Profile, Primary (Integrated) Foot Control, Case
Posterior Vitrectomy Profile, Primary (Integrated) Foot Control, Case
Phaco Profile, Primary (Integrated) Foot Control, Case
Frag Profile, Primary (Integrated) Foot Control, Case
I/A Profile, Primary (Integrated) Foot Control, Case

When you are done making changes, select Exit Programming. The system will ask you to confirm your
changes before exiting.

3.2. Surgeon Level Settings

To access the surgeon level settings, go to the Programming Screen, then select Surgeon Settings, the name of
the surgeon file to be modified, then Confirm.

Customize Primary (Integrated) Foot Control

To modify the techniques and settings for the Primary (Integrated) Foot Control, select the Primary
(Integrated) Foot Control Tab on the Surgeon Level Programming Screen. You can set the Primary
(Integrated) Foot Control for right or left foot operation.

The Mode Change Control allows you to set the Stellaris Elite™ vision enhancement system response when
the Foot Pedal is activated and you change surgical modes. Options are Allow-Limit Pedal, Allow-Remap Pedal,
Allow-No Limiting, and Not While Active.

The Detent Control determines what feedback the Stellaris Elite™ vision enhancement system will give when
changing Foot Pedal regions. This can be Disabled, Enabled for regions 1, 2 and 3 or Enabled for regions 2
and 3 only.

The Region Setting globes control at what percent depression at which each region begins.

A button is displayed that allows selection of Posterior Modes or Anterior Modes. When Posterior Modes is
selected, the Foot Pedal region 1, 2 and 3 start positions are adjustable. The posterior mode start positions are
used in the posterior domain and the posterior modes of the combined domain.

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3. Customizing Your System

When Anterior Modes is selected, the Foot Pedal region 1, 2 and 3 start positions are adjustable. The anterior
mode start positions are used in the anterior domain and the anterior modes of the combined domain.

Figure 3.9. Customize Primary (Integrated) Foot Control Screen.

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 3. Customizing Your System

Customize Fluidics
To set the parameters for Fluidics functions, select the Fluidics Tab on the Surgeon Level Programming
Screen. You can set the following options by selecting the current setting, and then selecting the new setting
from the menu.
• Container Type (500 mL bottle, 500 mL Bag, 250 mL bottle)
• Patient Eye Level (relative to the aspiration port on the fluidics system)
• Vitrectomy Gauge (Any, 20 gauge, 23 gauge, 25 gauge, 27 gauge)
• Frag Needle Gauge (Any, 20 gauge, 23 gauge)
• Extrude Gauge (Any, 20 gauge, 23 gauge, 25 gauge, 27 gauge)
• Phaco Needle (Any, Standard, MicroFlow™, MicroFlow+, Thin Tip, MICS 1.8, Vortex, MicroFlow
MICS)
• I/A Tip Type (Any, 0.3 mm, 0.5 mm)

Figure 3.10. Customize Fluidics Screen.

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3. Customizing Your System

Customize A/V (Audio/Visual)

To set the parameters for audio and visual functions, select the A/V Tab from the Surgeon Level Programming
Screen. You can adjust both Display Brightness and Master Volume by using the setting globes on this screen.
To change the tone or volume of a tone that is sounded for a particular condition, select the function from the
list at the bottom of the screen, and that condition will appear in the change section in the middle of the screen.
Select the desired tone from the option list, and use the setting globe to increase or decrease the volume.

Functions that can have a tone associated with them include:

• Alert (only volume can be adjusted)
• Aspiration
• Coagulation
• Elevated Infusion (only volume can be adjusted)
• Key (only volume can be adjusted)
• Irrigation Infusion
• Laser (only volume can be adjusted)
• Occlusion (Flow systems only)
• Reflux
• Ultrasound
• Timer
• Visc Inject
• Vitrectomy
• Voice Confirmation (Enabled or Disabled)

Note: Only tones that are not currently in use by another function will be available for selection.

Note:  levated Infusion, Key, Laser and Visc Inject are used for Posterior/Combined systems only.
E
(Stellaris Elite™ SKU BL14455 and SKU BL15455)

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 3. Customizing Your System

Figure 3.11. Customize A/V Settings Screen.

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3. Customizing Your System

Customize Video Overlay

To set the parameters for the DMS Video Overlay functions, select the Video Overlay Tab on the Surgeon
Level Programming Screen.

Through this tab you can set whether or not the system will combine Video Overlay Format information (U/S
Averages, settings). By default, the U/S data is shown as three separate lines on the video overlay. If the U/S
display option is set to Combine, the display will appear on one line, which will step through the three values,
or it may be set to Display None. Similarly, settings are normally displayed on four lines, and case information
on two lines, but if the combine option is set to Yes they will appear on one line that will step through the
values.

You can select the language to be used on the Video Overlay.

You can set the Video Overlay overscan rate from 0% to 5%.

Figure 3.12. Customize Video Overlay Screen.

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 3. Customizing Your System

3.3. Manage Surgeon Files

Create a New Settings File

The system will come pre-loaded with several system files, including System Settings, System Vitesse, and
System VFM1.

To create a new surgeon preference file, select the Create Tab from the Surgeon Settings Screen, then select
the existing surgeon file which has settings most similar to the file you are going to create. Once you have
highlighted a file, the techniques in that file will be listed on the right side of the screen. Select one or more
techniques by touching them. Select a technique a second time to deselect it.

A search function is available to filter the surgeon names list when selecting a surgeon file to load.

Figure 3.13. Create New Settings File Screen.

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3. Customizing Your System

Once all the desired techniques are highlighted, select Confirm and a keyboard will appear, through which
you can enter the name for the new surgeon file, then select Enter. The name of the new file will appear on the
left side of the screen, and a new set of tabs (Profile, Technique, Primary (Integrated) Foot Control, and
Fluidics) will appear across the top of the screen. These can be used to further customize the preference file (see
page 3-8).

Back Up a Settings File

To back up an existing surgeon preference file to a USB memory device, select the Backup Tab from the
Manage Settings Screen, then insert the device into one of the two USB ports behind the round sliding door
on the back of the display panel. Select the file or files to be backed up, the location to which they should
be backed up, and select Confirm. You must select the screen first, then insert device. The system will only
recognize a USB device after this screen is selected.

To move a surgeon preference file from one system to another, use Backup on the first system to move the file
to a USB drive, then Restore that file on the second machine (page 3-20).

Note:  emory devices complying with either USB 1.1 or USB 2.0 standards are supported by the
M
Stellaris Elite™ vision enhancement system. Operations with other USB devices are NOT
supported.

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 3. Customizing Your System

Figure 3.14. Backup Settings File Screen.

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3. Customizing Your System

Restore a Settings File

To restore an existing surgeon preference file from a USB memory device, select the Restore Tab from the
Manage Settings Screen, then insert the device into one of the two USB ports on the back of the system
console, behind the round sliding door. Make sure the Restore Tab is active at the top of the Manage Settings
Screen, select the file or files to be restored, and select Confirm.

To move a surgeon preference file from one system to another, use Backup on the first system to move the file
to a USB drive (page 3-18), then Restore that file on the second machine.

Note:  ou must select the Restore Settings File screen first, then insert the device. The system will only
Y
recognize a USB device after this screen is selected.

Figure 3.15. Restore Settings File Screen.

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 3. Customizing Your System

Delete a Settings File

To delete an existing surgeon preference file, select the Delete Tab from the Manage Settings Screen, select
the file or files to be deleted, and select Confirm.

Figure 3.16. Delete Settings File Screen.

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3. Customizing Your System

3.4. System Setup

Select System Setup from the Main Programming Screen, and a new screen will appear through which you
can set the Date/Time for the system, view the System IDs, and set operating room parameters. Any changes
you make here are implemented immediately.

Set Date, Time and Language

To change the system language, current date, time or format in which the time is displayed, select the Date/
Time Tab at the top of the System Setup Screen. Select from the option list menus to change the default
system language, month, day, year, clock format (12 or 24 hour), and current time in hours and minutes.
Once all changes have been made, select Confirm at the bottom of the screen to make your changes effective
immediately.

Figure 3.17. Set System Date/Time Screen.

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 3. Customizing Your System

System ID
To monitor or change the identifying names of your Stellaris Elite™ vision enhancement system, select the
System ID Tab at the top of the System Setup Screen. You can enter or update the account name and system
name that have been assigned to your Stellaris Elite™ vision enhancement system. You can view the system
catalog number as well as its installation number, but these are not editable.

Figure 3.18. System ID Screen.

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3. Customizing Your System

Rooms
To assign names to the operating rooms in which your Stellaris Elite™ vision enhancement system is used,
select the Rooms Tab at the top of the System Setup Screen, select any room button, and the keyboard will
appear, where you can enter the name for that room. Select Enter and the room name will be saved. You can
also set the Maximum IV Pole Height in centimeters, as measured from the aspiration port in the fluidics
system, using the setting globe on this screen. This setting is to allow the system to be programmed to not hit
the ceiling in a facility with ceilings lower than nine feet (2.75 meters).

Figure 3.19. Room Assignment Screen.

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 3. Customizing Your System

Primary (Integrated) Foot Control

To change the way your Stellaris Elite™ vision enhancement system connects to the Primary (Integrated) Foot
Control, select the Primary (Integrated) Foot Control Tab at the top of the System Setup Screen. Select
Enabled or Disabled to configure the connection mode.

Figure 3.20. Primary (Integrated) Foot Control Connectivity Screen.

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3. Customizing Your System

3.5. System Configuration

To see a detailed listing of the software and hardware configurations of your system, select System
Configuration from the Main Programming Screen.

Figure 3.21. System Configuration Screen.

3.6. System Calendar

To set up your system to default to certain surgeon preference files and room numbers at certain times of the
week, select System Calendar from the Main Programming Screen, and the System Calendar Screen will
appear with three or four user-editable columns.

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 3. Customizing Your System

Figure 3.22. System Calendar Screen.

The second column, next to the listing of the days of the week, determines if the default surgeon applies to the
full day, or if separate defaults will be applied to the morning and afternoon of that weekday. Select to
toggle between full day or morning and afternoon settings.

The third column contains option lists with the names of all the surgeon preference files currently available.
Select a file from the list, and that will be the default file when the Stellaris Elite™ vision enhancement system
starts up at that time.

In the fourth column, select how many rooms that surgeon operates in, and in the fifth column select in which
room number this Stellaris Elite™ vision enhancement system is located. These settings determine how the
case numbers will be incremented, to avoid duplicate case numbers for a single surgeon.

The Default Procedure menu allows selection of the default mode for the system. The Default Procedure menu
will not be displayed in posterior only configuration systems.

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3. Customizing Your System

3.7. Customization
The following tables detail which options can be customized at which level.

Audio and Visual Customization Settings

Parameter Options/Ranges/Step Sizes Level

Surgeon name Typewriter data entry (32 characters max) Surgeon
Screen/Voice language English (U.S.), English (U.K.), Français, Deutsch, Italiano, Surgeon
Español, Português, Nederlands, Norsk, Svenska, Česky,
Dansk, ελληνικά, Suomi, Magyar, 日本語, Polski,
Русский, 中文
Password Disabled and enabled Surgeon
Display backlight brightness 20% to 100%, by 10% Surgeon
System master audio volume 0% to 100%, by 5% Surgeon
Tone Selection and Volume Irrigation No Tone, By 5% Surgeon
Control Tone 1-Tone 10
Reflux
(0% to 100%)
Ultrasound
Timer
Vacuum
Viscous
Vit
Vitesse
Bipolar Tone 1-Tone 10 By 5%
(20% to 100%)

Occlusion 0% to 100% By 5%

Key
Elevated Infusion Alarm 20% to 100% By 5%
Laser
Alert - GUI Popup
Messages
Voice confirmation Disabled and Enabled, volume: 0% to 100%, by 5% Surgeon
Video overlay language English (U.S.), English (U.K.), Français, Deutsch, Italiano, Surgeon
Español, Português, Nederlands, Norsk, Svenska, Česky,
Dansk, ελληνικά, Suomi, Magyar, 日本語, Polski,
Русский, 中文

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 3. Customizing Your System

Parameter Options/Ranges/Step Sizes Level

Video overlay display format Ultrasound averages lines - Display, Display Combine, Surgeon
No Display
Combine settings lines - No, Yes
Video overlay overscan 0% to 5%, by 1% Surgeon
allowance
Remote control Disabled and Enabled Surgeon
Technique name Typewriter data entry Technique

Case Customization Settings

Parameter Options/Ranges/Step Sizes Level

Phase name Typewriter data entry (16 characters max) Phase
Mode type Phaco, irrigation/aspiration, irrigation, coagulation, anterior Phase
vitrectomy
Ultrasound Submode name Typewriter data entry (24 characters max) Phase
Customize Mode by case Disabled and Enabled Phase
(applies only to Phaco and
I/A modes)

Note:  osterior Vitrectomy, Extrude, Frag, Viscous Fluid Control and Laser may be programmed on a
P
Stellaris Elite™ (BL11145) vision enhancement system. However, these functions can only be
used on a Stellaris Elite™ (BL14455 or BL15455) vision enhancement system.

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3. Customizing Your System

Foot Control

Parameter Options/Ranges/Sizes Level

Operation Right Foot, Left Foot Surgeon
Mode change Not While Active, Allow-Limit Pedal, Allow-Remap Pedal, and Surgeon
control Allow-No Limiting
Detents Disabled, Enabled (R1/R2/R3), Enabled (R2/R3) Surgeon
Starting position Region 1: 2% to 5%<R2 start, by 5% Surgeon
Region 2: 5%>R1 start to 5%<R3 start, by 5%
Region 3: 5%>R2 start to 95%, by 5%
Linear Coagulation Disabled, Enabled Technique
in Setup Mode
Switch assignment Anterior techniques: Technique,
Unassigned, next phase, previous phase, next U/S modulation Phase
submode, confirm settings, irrigation on/off, reflux, air on/off,
vitrectomy cutting on/off, fixed coagulation, increase vacuum,
decrease vacuum, increase air pressure, decrease air pressure,
increase bottle height, decrease bottle height, increase U/S power,
decrease U/S power, increase U/S pulse rate/duration, decrease U/S
pulse rate/duration, increase U/S duty cycle/interval, decrease U/S
duty cycle/interval, increase coagulation power, decrease coagulation
power, increase vitrectomy cut rate, decrease vitrectomy cut rate

Posterior and combined techniques:

Unassigned, next phase, previous phase, next U/S / Vitesse
modulation submode, confirm settings, infusion on/off, alternate
infusion on/off, reflux, fixed coagulation, F/AX on/off, vitrectomy
cutting on/off, increase vacuum, decrease vacuum, increase infusion
pressure, decrease infusion pressure, increase F/AX pressure,
decrease F/AX pressure, increase U/S power, decrease U/S power,
increase U/S PPS/duration, decrease U/S PPS/duration, increase
U/S DC/interval, decrease U/S DC/interval, increase coagulation
power, decrease coagulation power, increase vitrectomy cut rate,
decrease vitrectomy cut rate, increase viscous fluid pressure/vacuum,
decrease viscous fluid pressure/vacuum, increase lower illuminator
power, decrease lower illuminator power, lower illuminator on/off,
increase upper illuminator power, decrease upper illuminator power,
upper illuminator on/off, next illuminator filter, increase laser power,
decrease laser power, pulse selection (Single Shot/repeat/continuous),
laser mode (Standby/ready), Vitesse power up, Vitesse power down,
Vitesse PPS duration up, Vitesse PPS duration down, Vitesse DC
interval up, Vitesse DC interval down, Vitesse ON/OFF
Reflux Type Anterior: Continuous, Single Low, Single High Technique,
Note: The Single Low and Single High settings require an Adaptive Phase
Fluidics with reflux bulb.
Posterior or Combined Domain: Continuous, Single High, Single
Low

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 3. Customizing Your System

Parameter Options/Ranges/Sizes Level

Next Ultrasound Disabled, Enabled Technique,
Modulation on Yaw Note that for single linear Foot Pedal modes, the outward yaw motion Phase
would be used for next ultrasound modulation, and for dual linear
Foot Pedal modes, the inward yaw motion would be used.
Fixed Coagulation 0% to 10% by 1% Technique,
Power Level 10% to 30% by 2% Phase
30% to 100% by 5%
Applicable if one of the Primary (Integrated) Foot Control buttons is
programmed to activate fixed coagulation.
Dual Linear Control Mode Level: Phase
U/S Modes: Disabled, Asp on Yaw, Asp on Pitch, Dual Linear U/S
I/A Modes: Disabled, Dual Linear Flow (only for AFS fluidics if flow
modes enabled)
Vit Modes: Disabled, Asp on Pitch, Asp on Yaw, Dual Linear Flow
(only for AFS fluidics if flow modes enabled)
Reflux on Yaw Disabled/Enabled Technique,
Phase
Activate Continuous Disabled and Enabled Technique,
Irrigation on Yaw Phase
Option to Auto- Disabled and Enabled Technique
Select/Deselect
Laser Mode with
Opening/Closing of
Laser Button Door

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3. Customizing Your System

Fluidics

Parameter Options/Ranges/Step Sizes Level

Max IV Pole Height 80 cm to 140 cm, by 5 cm System
Balanced Salt Solution 500 ml Bottle, 500 ml Bag, 250 ml Bottle Surgeon
Container Type
Patient Eye Level -15 cm to +15 cm, by 1 cm Surgeon
Default Ultrasound Tip Type Standard, MicroFlow™, MicroFlow+, Thin Tip, MICS 1.8, Surgeon
Vortex, MicroFlow MICS
Default I/A Tip Type 0.3 mm, 0.5 mm Surgeon
Default Vitrectomy Tip Type 20 Gauge, 23 Gauge, 25 Gauge, 27 Gauge Surgeon
Default Extrude Gauge 20 Gauge, 23 Gauge, 25 Gauge, 27 Gauge Surgeon
Default Frag Gauge 20 Gauge, 23 Gauge Surgeon
Default Vitesse™ Gauge 23 Gauge, 25 Gauge Surgeon
Default Anterior Vitrectomy 20 Gauge, 23 Gauge, 23 Gauge Bi-Blade Surgeon
Gauge
Fill Time 20 s to 120 s, by 5 s Surgeon
IV Pole bottle height 30 cmH2O to 140 cmH2O by 5 cmH2O Technique,
(Pressure) 22 mmHg to 103 mmHg by 5 mmHg Phase/Case
Irrigation Delay 100 ms to 3000 ms, steps of 50 ms. Also resolution of Technique,
50 ms even with calculator Phase/Case
Vacuum Response (1) Fastest, 2, 3, 4, (5) Slowest Technique,
Phase/Case
Vent Method Fluid Venting, Air Venting Technique,
Phase/Case
Infusion Type IV Pole, Pressurized Technique
Infusion Units cmH2O, mmHg Technique
Infusion Mode Auto On, Auto On/Off, Manual Technique

NOTE: Manual setting will operate as Auto On/Off in

Anterior techniques or phases.
Pressurized Infusion Pressure Anterior Techniques: Technique,
0 mmHg to 20 mmHg, by 2 mmHg Phase/Case
20 mmHg to 150 mmHg, by 5 mmHg

0 cmH2O to 204 cmH2O, by 5 cmH2O

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 3. Customizing Your System

Parameter Options/Ranges/Step Sizes Level

Infusion Pressure Posterior and Combined Techniques: Technique,
Infusion Type = IV Pole Phase
30 cmH2O to 140 cmH2O, by 5 cmH2O
22 mmHg to 103 mmHg, by 5 mmHg

Infusion Type = Pressurized Infusion

0 cmH2O to 204 cmH2O, by 5 cmH2O
0 mmHg to 20 mmHg by 2 mmHg, 20 mmHg to
150 mmHg by 5 mmHg
Alternate Infusion Pressure Posterior and Combined Techniques: Technique
Infusion Type = IV Pole
30 cmH2O to 140 cmH2O, by 5 cmH2O
22 mmHg to 103 mmHg, by 5 mmHg

Infusion Type = Pressurized Infusion

0 cmH2O to 204 cmH2O, by 5 cmH2O
0 mmHg to 150 mmHg, by 5 mmHg
F/AX Pressure 0 mmHg to 20 mmHg, in steps of 2 mmHg Technique,
20 mmHg to 150 mmHg, in steps of 5 mmHg Phase
Alternate F/AX Pressure 0 mmHg to 150 mmHg, in steps of 5 mmHg Technique
Air Port For use in Posterior/Combined techniques only. Technique
Front/Back
Adaptive Fluidics™ Disabled and Enabled Technique,
Phase/Case
Adaptive Fluidics™ CF 1(Lowest), 2(Low), 3(Moderate), 4(High), 5(Highest) Technique,
Phase/Case
Aspiration Type Region 2 Linear Vacuum, (applies to Phaco modes only) Phase/Case
Posterior/Combined Domain Posterior, Combined, and VFM Techniques
Disabled, Enabled
VFM
Fixed vacuum level or linear 0 mmHg to 20 mmHg by 1 mmHg Phase/Case
vacuum maximum level, for 20 mmHg to 200 mmHg by 5 mmHg
vacuum modes 200 mmHg to 660 mmHg by 10 mmHg
Minimum of 10 mmHg for U/S modes
Fixed flow level or linear 0 ml/min to 10 ml/min by 1 ml/min Phase/Case
flow maximum level, for 10 ml/min to 30 ml/min by 2 ml/min
flow modes 30 ml/min to 60 ml/min by 5 ml/min
Minimum of 5 ml/min for U/S modes
Fluidics - Fixed vacuum 0 mmHg to 20 mmHg by 1 mmHg Phase/Case
limit level or linear vacuum 20 mmHg to 200 mmHg by 5 mmHg
limit maximum level, for 200 mmHg to 650 mmHg by 10 mmHg
flow modes Minimum of 10 mmHg for U/S modes

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3. Customizing Your System

Parameter Options/Ranges/Step Sizes Level

Linear vacuum minimum 0 mmHg to 20 mmHg by 1 mmHg Phase/Case
level, for vacuum modes 20 mmHg to 200 mmHg by 5 mmHg
200 mmHg to 660 mmHg by 10 mmHg
Minimum of 10 mmHg for U/S modes
Region 2 minimum vacuum, 0 mmHg to 20 mmHg by 1 mmHg Phase/Case
for aspiration control feature 20 mmHg to 200 mmHg by 5 mmHg
vacuum modes 200 mmHg to 660 mmHg by 10 mmHg
Linear flow minimum level, 0 ml/min to 10 ml/min by 1 ml/min Phase/Case
for flow modes 10 ml/min to 30 ml/min by 2 ml/min
30 ml/min to 60 ml/min by 5 ml/min
Minimum of 5 ml/min for U/S modes
Region 2 minimum flow, for 0 ml/min to 10 ml/min by 1 ml/min Phase/Case
aspiration control feature 10 ml/min to 30 ml/min by 2 ml/min
flow modes with control on 30 ml/min to 60 ml/min by 5 ml/min
flow
Linear vacuum limit 0 mmHg to 20 mmHg by 1 mmHg Phase/Case
minimum level, for flow 20 mmHg to 200 mmHg by 5 mmHg
modes 200 mmHg to 650 mmHg by 10 mmHg
Minimum of 10 mmHg for U/S modes
Region 2 minimum vacuum 0 mmHg to 20 mmHg by 1 mmHg Phase/Case
limit, for aspiration control 20 mmHg to 200 mmHg by 5 mmHg
feature flow modes with 200 mmHg to 650 mmHg by 10 mmHg
control on vacuum limit
Primary (Integrated) Foot Linear, Front Loaded, Back Loaded Phase/Case
Control mapping (for linear
control)
Pitch function for dual linear Vacuum limit, Flow Phase/Case
flow aspiration modes
Primary (Integrated) Foot Linear, Front Loaded, Back Loaded Phase/Case
Control mapping (for yaw
function linear control in
dual linear aspiration flow
modes)

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 3. Customizing Your System

Ultrasound

Parameter Options/Ranges/Step Sizes Level

Ultrasound Modulation Type Continuous Phase/Case
Pulsed
Single burst
Fixed pulse
Multiple burst
Linear Power Linear Pulse
Linear Power Linear Duty Cycle
Dual Linear Multiple Burst
Variable Power Multiple Burst
Variable Power Linear Burst
Fixed power level or linear 0% to 10% by 1% Phase/Case
power maximum level 10% to 30% by 2%
30% to 100% by 5%
Pulse rate for pulsed modes 1 PPS to 20 PPS by 1 PPS Phase/Case
20 PPS to 50 PPS by 5 PPS
50 PPS to 250 PPS by 10 PPS
Subject to minimum on time of 2 ms and a minimum off
time of 2 ms
Duty cycle fixed or 5% to 95% by 5% Phase/Case
maximum for pulsed modes Subject to minimum on time of 2 ms and a minimum off
time of 2 ms
Burst or pulse duration for 2 ms to 20 ms by 2 ms Phase/Case
burst modes or fixed pulse 20 ms to 80 ms by 5 ms
modes 80 ms to 600 ms by 20 ms
Burst interval for fixed pulse 2 ms to 20 ms by 2 ms Phase/Case
modes 20 ms to 80 ms by 5 ms
80 ms to 600 ms by 20 ms
Maximum duty cycle for 50% to 99% by 5% Phase/Case
multiple burst modes Subject to a minimum off time of 2 ms and a maximum off
time of 1500 ms
Waveform Ultrasound Disabled, Enabled Phase/Case
Linear control power 0% to 10% by 1% Phase/Case
minimum level 10% to 30% by 2%
30% to 100% by 5%
Minimum duty cycle for 1% to 10% by 1% Phase/Case
multiple burst modes 10% to 30% by 2%
30% to 50% by 5%
Subject to a minimum off time of 2 ms and a maximum off
time of 1500 ms
Primary (Integrated) Foot Linear, Front Loaded, Back Loaded Phase/Case
Control mapping (for linear
control) - front loaded,
linear, back loaded

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3. Customizing Your System

Parameter Options/Ranges/Step Sizes Level

Waveform Depth 25% to 100% by 5% Phase/Case
Pulsed mode linear pulse rate 0 PPS to 20 PPS by 1 PPS Phase/Case
minimum 20 PPS to 50 PPS by 5 PPS
50 PPS to 250 PPS by 10 PPS
Subject to minimum on time of 2 ms and a minimum off
time of 2 ms
Pulsed mode linear duty 5% to 95% by 5% Phase/Case
cycle minimum Subject to minimum on time of 2 ms and a minimum off
time of 2 ms
Burst mode linear duration 2 ms to 20 ms by 2 ms Phase/Case
minimum 20 ms to 80 ms by 5 ms
80 ms to 600 ms by 20 ms
Primary (Integrated) Foot Linear, Front Loaded, Back Loaded, Reverse Linear, Phase/Case
Control mapping (for second Reverse Front Loaded, Reverse Back Loaded
ultrasound linear control)

Vitesse Customization Settings

Parameter Options/Ranges/Step Sizes Level

Vitesse modulation type Fixed Cut: Fixed Power, Fixed Power Fixed Pulse Phase

Co-Linear Vit, Dual/Yaw Cut, and Dual/Yaw Vac:

Continuous, Pulsed, Linear PPS, or Linear DC

Single Cut: Single

Power 0% to 10% by 1% Phase
10% to 30% by 2%
30% to 100% by 5%
Pulse Rate 1 PPS to 20 PPS, by 1 PPS Phase
20 PPS to 50 PPS, by 5 PPS
50 PPS to 250 PPS, by 10 PPS
Subject to minimum on-time of 2 ms and a minimum
off-time of 2 ms
DC for Pulsed Mode 5% to 95%, by 5%
Subject to minimum on-time of 2 ms and a minimum
off-time of 2 ms

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 3. Customizing Your System

The pulse rate can be adjusted from 1 PPS to 250 PPS. Using the up and down arrows, PPS adjustment is
made in steps of 5 PPS from 20 PPS to 50 PPS, and in steps of 10 PPS from 50 PPS to 250 PPS, subject to a
minimum on-time of 2 ms and a minimum off-time of 2 ms (for pulsed modulation, the DC setting may limit
the allowable PPS range). DC for pulsed modulation is adjustable from 5% to 95%. Using the up and down
arrows, DC adjustment is made in steps of 5%, subject to a minimum on-time of 2 ms and a minimum off-time
of 2 ms (for pulsed modulation, the PPS setting may limit the allowable DC range). Similar to other surgical
modes in the Posterior and Combined Domains, the Vitesse surgical modes have programmable reflux capability
with three setting options: Continuous, Single High, and Single Low.

Vitrectomy

Parameter Options/Ranges/Step Sizes Level

Fixed cut rate or linear cut Anterior System: Phase
rate maximum rate 30 CPM to 100 CPM by 10 CPM,
100 CPM to 1000 CPM by 50 CPM,
1000 CPM to 2500 CPM, by 100 CPM

Posterior System:
30 CPM to 100 CPM by 10 CPM,
100 CPM to 1000 CPM by 50 CPM,
1000 CPM to 2500 CPM, by 100 CPM
Linear cut rate minimum rate Anterior System: Phase
30 CPM to 100 CPM by 10 CPM,
100 CPM to 1000 CPM by 50 CPM,
1000 CPM to 2500 CPM, by 100 CPM

Posterior System:
30 CPM to 100 CPM by 10 CPM,
100 CPM to 1000 CPM by 50 CPM,
1000 CPM to 2500 CPM, by 100 CPM
Primary (Integrated) Foot Linear, Front Loaded, Back Loaded, Reverse Linear, Phase
Control mapping Reverse Front Loaded, Reverse Back Loaded

Coagulation

Parameter Options/Ranges/Step Sizes Level

Coag - Power level 0% to 10% by 1% Phase
maximum level 10% to 30% by 2%
30% to 100% by 5%
Power level minimum level 0% to 10% by 1% Phase
10% to 30% by 2%
30% to 100% by 5%
Primary (Integrated) Foot Linear, Front Loaded, Back Loaded Phase
Control mapping

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3. Customizing Your System

Illuminator Settings (For Use on Posterior/Combined Systems only - BL14455 and

BL15455)

Parameter Options/Ranges/Step Sizes Level

Display in Anterior Tech Disabled, Enabled Technique
Upper On/Off On, Off Technique
Upper Power 0% to 100% by 5% Technique
Lower On/Off On, Off Technique
Lower Power 0% to 10% by 1% Technique
10% to 40% by 2%
40% to 100% by 5%
Lower Filter None, Amber, Green Tint, Yellow Tint Technique
Set Illuminator Lower (%) Disabled, Enabled Technique
By Filter

Extrude Mode Settings (For Use on Posterior/Combined Systems only - BL14455

and BL15455)

Parameter Options/Ranges/Step Sizes Level

Coag On Yaw Enable/Disable Phase
Max Power 0% to 10% by 1% Phase
10% to 30% by 2%
30% to 100% by 5%
Min Power 0% to 10% by 1% Phase
10% to 30% by 2%
30% to 100% by 5%
Foot Control Mapping Linear, Front Loaded, Back Loaded Phase

Viscous Fluid Control Settings

Parameter Options/Ranges/Step Sizes Level

Viscous Fluid Injection 0 to 20 psi, by 1 psi Phase/Case
Pressure 20 to 70 psi, by 5 psi

0 to 140 kPA, by 10 kPA

140 to 483 kPA, by 20 kPA
Viscous Fluid Extraction 0 to 30 mmHg, by 1 mmHg Phase/Case
Vacuum 30 to 100 mmHg, by 5 mmHg
100 to 600 mmHg, by 10 mmHg
Foot Control Mapping Linear, Front-Loaded, Back-Loaded Phase/Case

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 3. Customizing Your System

Laser Mode Settings (For Use on Posterior/Combined Systems only - BL15455 only)

Parameter Options/Ranges/Step Sizes Level

Power Endo Submode Phase
50 mW to 200 mW by 10 mW
220 mW to 500 mW by 20 mW (Additional Options: 250,
350, and 450)
550 mW to 1000 mW by 50 mW
1100 mW to 2000 mW by 100 mW

Continuous Endo Submode

50 mW to 200 mW by 10 mW
220 mW to 500 mW by 20 mW (Additional Options: 250,
350, and 450)

LIO Submode
50 mW to 200 mW by 10 mW
220 mW to 500 mW by 20 mW (Additional Options: 250,
350, and 450)
500 mW to 1000 mW by 50 mW
Duration 10 ms to 100 ms by 10 ms Phase
100 ms to 500 ms by 50 ms
500 ms to 3000 ms by 100 ms
Interval Minimum is current duration setting Phase
10 ms to 100 ms by 10 ms
100 ms to 500 ms by 50 ms
500 ms to 3000 ms by 100 ms
Pulse Type Endo - Single Shot, repeat Phase
Endo-Continuous - Single Shot, continuous
LIO - Single Shot, repeat
Aiming Beam in Standby On, Off Phase
Aiming Beam in Pulse On, Off Phase
Aiming Beam Intensity 5% to 100% by 5% Phase
Selected Foot Control Primary (Integrated) or Secondary (LIO) Phase
Dedicated Foot Control Enabled, Disabled Phase
Buttons
LIO On, Off Phase
LIO Intensity 5% to 100% by 5% Phase

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 4. Detailed Reference
4. Detailed Reference
4. Detailed Reference
 4. Detailed Reference

4. Detailed Reference
This chapter provides a detailed reference for each system function and accessory.

WARNING: 
The use of flammable anaesthetics, flammable disinfectants, aerosol sprays, or oxidizing
gases such as nitrous oxide (N2O) and oxygen should be avoided unless the gaseous agents
are sucked away and the liquid agents are fully dried or evaporated. Ensure the flammable
liquids are not pooled beneath the patient drape.

WARNING: 
The use of high infusion pressure may cause damage to the eye. It is the user’s responsibility
to ensure use of appropriate infusion pressure during the surgery.

Note: Ensure tube set connection is secure when connecting to the handpiece and system.

4.1. Advanced Vacuum System Fluidics

WARNING: 
For optimum aspiration and reflux performance, the patient’s eye level must be at the same
level as (no more than 7 cm [3 in.] from) the Stellaris Elite™ vision enhancement system
aspiration port. Failure to follow this procedure may result in serious and permanent patient
injury.

The advanced vacuum fluidics creates aspiration using a venturi system driven by compressed air, which is
connected to the machine by an air hose.

With your Stellaris Elite™ vision enhancement system, the irrigation line from an inverted bottle of Balanced
Salt Solution is integrated into the tubing manifold at the top part of the vacuum cassette. The delivery pressure
of the Balanced Salt Solution is adjusted by varying the height of the bottle in relation to the patient’s eye, or
by air pressure injected into the bottle when Pressurized Infusion or AFI is used. On/off control of irrigation
is accomplished through the touch screen interface or by the Foot Pedal (for modes with infusion type Auto
On/Off).

As the cassette fills up, the system gives a Cassette Nearing Full warning. When the fluid level reaches the
maximum capacity, the system gives a Cassette Full warning. After this second warning, the aspiration function
will be disabled. You must replace the fluidics cassette with one that is either empty or nearly empty. No
re-priming is required.

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4. Detailed Reference

WARNING: 
Ensure the maximum capacity of the cassette is not exceeded as this could cause a hazardous
situation to the patient.

WARNING: 
Never intentionally modify handpieces or tips, including bending, cutting, or engraving, as
they could break or malfunction.

Note:  tellaris Elite™ vision enhancement system is designed with cassette identification feature. Use
S
only cassette type that is similar to the selected software domain. System error messages will be
displayed when wrong cassette type is inserted.

Emptying Cassette
The Stellaris Elite™ vision enhancement system’s cassette can be emptied during operation by using the
following instructions:

1. Stop operation and remove all handpieces from the eye.

2. Close both irrigation clamps (the clamp near the bottle and the clamp at the 2-way stopcock).

3. Select Eject Cassette from the surgical screen.

WARNING: 
Wear gloves before performing following instructions.

4. Remove cassette from the system.

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 4. Detailed Reference

5. Detach the aspiration tubing that connects to the cassette. Hold aspiration tubing very close to the
connector to facilitate removal (arrows).

6. Press manifold to release latch to free it from the cassette (arrows).

7. Tilt cassette backward approximately 20 to 30 degrees to drain fluids from the top compartment to the
main cassette cavity.

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4. Detailed Reference

8. Drain fluid out of the cassette. Tilt cassette to drain fluid orderly. Do not shake or flip cassette.

9. Assemble tubing manifold by first sliding the front end under the cassette retainer (R).

10. Press the manifold to engage manifold latch (arrows).

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 4. Detailed Reference

11. Connect aspiration tubing to the cassette connector.

12. Insert cassette to the system.

13. Release both irrigation clamps (the clamp near the bottle and the clamp at the 2-way stopcock).

14. Resume surgery once system passes vacuum check and surgical screen is displayed.

WARNING: 
Do not operate system with irrigation clamp closed.

Note: No re-priming is required.

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4. Detailed Reference

4.2. Posterior Functions

Posterior Vitrectomy Function

The Stellaris Elite™ vision enhancement system vitrectomy function uses an external air source to drive the
pneumatically operated guillotine type vitrectomy cutter that draws the vitreous material into the port. The
vitreous material is then cut and aspirated into a disposable collection container through the attached tubing.

Vitrectomy Cutter Modes

The Stellaris Elite™ vision enhancement system provides four vitrectomy cutter modes as described below. The
cut rate may be adjusted from 30 CPM to 7500 CPM, with increments as shown in the table below, or to any
specific value using the keypad.

Range Step Size

30 CPM to 100 CPM 10 CPM
100 CPM to 1000 CPM 50 CPM
1000 CPM to 7500 CPM 100 CPM

Note:  itrectomy cut rate derating above 915 meters (3000 feet) altitude can be compensated with
V
increased input pressure, not to exceed 6.9 bar (100 PSIG). See the Vacuum Fluidics Function
Specification table in section 8.2 for derating specifications.

Fixed Cut
Fixed cut is a single region pitch control mode, and vitreous cutting is activated the moment the Foot Pedal is
depressed. The cut rate is fixed. Vacuum is proportional to Foot Pedal depression. Each successive outward yaw
movement of the Foot Pedal toggles the cutter ON or OFF. If enabled, an audible tone will indicate cutter on
(double beep) or cutter off (single beep). By default, the vitrectomy cutter is ON.

Figure 4.1. Single region pitch control, Fixed cut, linear vacuum.

Dual Linear Cut: Dual/Yaw Cut

Dual Linear cut uses two region pitch and yaw control. Pressing the Foot Pedal downward into Region 1 is
necessary to activate cutting with outward yaw. Outward yaw while in Region 1 activates cutting without
vacuum. Linear control of the cut rate is a function of Foot Pedal yaw displacement. Further depressing the Foot
Pedal downward to Region 2 activates linear vacuum.

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 4. Detailed Reference

Figure 4.2. Diagram showing two region pitch control programmed for Dual Linear Cut.
1. Region #1 (no active function). 2. Region #2 Linear Vacuum.

The actual cut rate and vacuum level is displayed on the screen. When the Foot Pedal is released, it returns to
center and the cutter is disabled. If enabled, an audible linear tone indicates cut rate and vacuum level; the pitch
of the tone increases with increased cutter speed and vacuum level.

Figure 4.3. Primary (Integrated) Foot Control Top View to Illustrate Dual/Yaw Cut Vitrectomy
Programmed for Right Foot.
1. Pitch Movement to control linear vacuum. 2. Outward Yaw to control linear cut.

Dual Linear: Dual/Yaw Vac

This is a two region pitch and yaw control mode. Pressing the Foot Pedal downward into Region 1 activates the
vacuum with outward yaw. Outward yaw while in Region 1 activates the vacuum without cutting. Linear control
of the vacuum is a function of Foot Pedal yaw displacement. Further depressing the Foot Pedal downward into
Region 2 activates the linear cut rate.

The actual cut rate and vacuum level is displayed on the screen. When the Foot Pedal is released, it returns to
center where both vacuum and the cutter are disabled. If enabled, an audible linear tone indicates the cut rate
and vacuum level; the pitch of the tone increases with increased cutter speed and vacuum level.

Co-Linear Cut
For Co-Linear Cut mode, the Foot Pedal pitch movement simultaneously controls linear vacuum and linear
cut rate. The downward pitch movement could be programmed to increment or decrement vacuum control.

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4. Detailed Reference

Similarly, the downward pitch movement could be programmed to increment or decrement cut rate control.
The range of vacuum level and cut rate is programmable. Each successive outward yaw movement of the Foot
Pedal toggles the cutter ON or OFF. By default, the vitrectomy cutter is ON. If enabled, an audible tone will
indicate vacuum level, cut rate, cutter on (double beep) or cutter off (single beep).

Single Cut
For Single Cut mode, the Foot Pedal pitch controls linear vacuum. Single cut will be activated when the Foot
Pedal moves to 95%. Release the Foot Pedal back to at least 75% in order to have the subsequent single cut.

For all vitrectomy modes, reflux (if enabled) is activated by inward yaw movement of the Foot Pedal. The
Primary (Integrated) Foot Control side button can also be programmed to activate reflux function.

WARNING: 
Never intentionally modify handpieces or tips, including bending, cutting, or engraving, as
they could break or malfunction.

Note: Make sure the pack you are using is appropriate for the domain selected.

Posterior Vitrectomy Setup and Use

WARNING: 
For optimum aspiration and reflux performance, the patient’s eye level must be at the same
level as (no more than 7 cm [3 in.] from) the Stellaris Elite™ vision enhancement system
aspiration port. Failure to follow this procedure may result in serious and permanent patient
injury.

1. Connect the compressed air source to the connector on the lower rear of the system.
2. Turn the power on and wait until the screen displays the Primary (Integrated) Foot Control or other
system messages.
3. Acknowledge and close all messages.
4. To operate the Primary (Integrated) Foot Control wirelessly, press any button on the Primary
(Integrated) Foot Control and wait until the ready light turns solid green. This indicates that wireless
communication has been established.
5. If your system is programmed to default to either the Anterior Domain, Posterior Domain or the
Combined Domain, the Select Procedure Screen will not appear, and the system will move directly to
the Select Surgeon Screen, as shown in Figure 1.8.
6. Select Posterior Segment; the screen will transition to Select Surgeon. (Skip this step if the system is
already displaying the Select Surgeon Screen.)
7. Select Surgeon’s Name and select Confirm to transition to the Insert Cassette screen.

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 4. Detailed Reference

8. Open the posterior surgical pack with the following steps:

a. Hold the bottom of the tray with one hand placing the thumb in the thumb notch. (Circulating
Nurse)
b. Tear open the Tyvek seal with the other hand toward the body. (Circulating Nurse)
c. Transfer contents onto sterile field. (Circulating Nurse)
d. Identify loose components from the pre-connected tubing set. (Scrub Nurse)
e. Drape the system tray and screen with drapes provided. (Scrub Nurse)
f. Arrange the pre-connected tubing set with cassette, bottle spike, air tubing filter and actuation
connector toward the system front. The priming cup is placed at the other end with the tubing set
in the middle as shown in the figure below. (Scrub Nurse)

Figure 4.4. Pre-connected Tubing set arrangement to facilitate setup.

g. Remove the tape to unbind all the tubing. (Scrub Nurse)

h. Straighten the tube set and secure it, so it will not drop off the sterile surface. (Scrub Nurse)
i. Remove the tape from the cassette to release the additional tubing that is tied to the cassette.
(Scrub Nurse)
j. Connect the air tubing filter to the system (second right connector). Ensure the air pump is on.
(Scrub Nurse or Circulating Nurse)
k. Connect the vitrectomy actuation line (blue stripe) to the system. (Scrub Nurse or Circulating
Nurse)

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l. Insert the fluidics cassette all the way in and hold until it is automatically captured by the system.
The cassette housing backlight will stop blinking and remain on when the system captures the
cassette. (Scrub Nurse or Circulating Nurse)
m. Pass the bottle spike and irrigation tubing to Circulating Nurse. (Scrub Nurse)
n. Spike and hang the Balanced Salt Solution bottle on the automated IV pole or the Zero Level
hanger if using AFI. Squeeze and release the drip chamber until it is half filled with solution.
(For AFI setup, use the spiking tool provided to puncture the rubber stopper on the bottle before
inserting the metal cannula into the bottle.) (Circulating Nurse) See Figure 4.5.

Figure 4.5. AFI Setup instructions.

1. Spiking tool. 2. Remove cover. 3. Spike bottle with spiking tool. 4. Spike AFI spike into the bottle.

o. Remove the tape on the priming cup. (Scrub Nurse)

p. Place the priming cup flat on the tray as in the figure below. (Scrub Nurse)

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Figure 4.6. Priming cup with infusion cannula, left aspiration and vitrectomy cutter attached.

9. Select the first button from the Easy Prime selection menu to initiate the auto priming and vitrectomy
cutter test sequence. (Scrub Nurse or Circulating Nurse)

Note:  he system will not provide feedback as to whether or not fluid is present during priming.
T
Inspect tubing and confirm that it is filled with fluid and free of bubbles after each Prime and
Tune. Repeat the priming process if the tubing is not adequately filled with fluid.

There are three settings to control infusion On/Off in Posterior modes of surgery: “Manual”, “Auto On/Off”,
“Auto On”.
• In Manual Infusion Mode, infusion is activated and deactivated by using the button on the GUI screen
or one of the Primary (Integrated) Foot Control switches assigned to this function. Pressing the Foot
Pedal into Region 1 will NOT start infusion.

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Note:  hen the system is in Manual Infusion Mode, pressing the Foot Pedal will not activate
W
aspiration.

Note: When in an Anterior phase, manual infusion will operate as auto on/off.
• In Auto On/Off Infusion Mode, infusion will be activated when the Foot Pedal is depressed into
region 1 or beyond and will be deactivated when the Foot Pedal is released to region 0 for all aspirating
modes. The GUI screen and a Primary (Integrated) Foot Control switch assigned to this function will
toggle between “infusion always on” and “infusion On/Off” with the Foot Pedal. This infusion option
is identical to the infusion control in all anterior modes.
• In Auto On Infusion Mode, infusion control is the same as in Manual Infusion Mode except that
infusion will be activated as soon as the Foot Pedal is depressed into region 1 or beyond and will
remain active when the Primary (Integrated) Foot Control pedal is released to region 0.

For all infusion control modes: Infusion, once started, cannot be turned off using either the GUI or the foot
control switch while the Primary (Integrated) Foot Control pedal is in region 1 or beyond.

CAUTION: 
Make sure to remove vitrectomy cutter by pulling it away from the priming cup, without
allowing the cutter needle to touch the priming tray.

Note: In all circumstances, the stopcock and tubing clamp may be used to stop infusion.

Note:  he system will prime the left aspiration line, right aspiration line, cutter test, infusion line and
T
the infusion cannula. Irrigation will be shut off and some Balanced Salt Solution will be left
in the priming cup at the end of priming cycle. The system will transition to Surgical screen.
Inspect the infusion line to ensure it is free of air bubbles. If there are bubbles in the infusion
line, toggle Irrigation On from the screen and tap the line to purge it of the air bubbles. To turn
irrigation off, use the tubing clamp or toggle Irrigation Off from the screen.

ESA Use
The Entry Site Alignment (ESA) system is designed for posterior segment ophthalmic surgery. The system
consists of the following components (see Figure 4.7A):
• Trocar Handle (1) with ESA Cannula Hub Assembly (2) preloaded
• Protective Tip Guard (3)
1. Use the “marker” end of the Trocar handle (1) to mark the eye in the surgeon’s preferred location. (see
Figure 4.7B).

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2. Carefully remove the cap (3) covering the ESA Cannula. (see Figure 4.7C).

Note:  old the ESA with tip pointing up while removing the cap to prevent the ESA Cannula from
H
sliding off.

3. At the desired location, insert the Trocar until the cannula hub rests against the conjunctiva. Twist the
handle, if necessary, to ease insertion. (see Figure 4.7D).

WARNING: 
Misplacement or over manipulation of the trocar during this step could result in serious
patient injury.

4. Slide the handle out of the ESA cannula, allowing the cannula to remain in place. (see Figure 4.7E). For
the cannula to remain in place as the handle is withdrawn, it may be necessary to apply a counter force
to the cannula hub.
5. Once the cannula is in place, the ESA cannulas may be used to insert an infusion line, insert a plug, or
introduce instruments or other devices for surgical procedures.
6. Replace the protective tip guard (3) over the trocar needle.
7. At the end of the procedure, grasp each ESA cannula individually with forceps and gently remove.
8. Follow proper disposal procedures to discard the ESA components upon surgery completion.

Figure 4.7. ESA Usage.

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Vitesse™ Hypersonic Vitrectomy

WARNING: 
Do not place fingers on the needle during use.

WARNING: 
Exercise great care when operating near the retina or other sensitive structures within the
eye. When operating near the retina, begin with minimum effective Power and Vacuum
settings and increase settings cautiously as needed. The Vitesse Low surgical phase setting
may be used to assist.

WARNING: 
Exercise care when using the Single High reflux setting near the retina to minimize the risk
of retinal damage.

WARNING: 
Use only the Entry Site Alignment (ESA) devices provided with the Vitesse™ handpiece pack
(yellow trocar caps). Do not use any ESA with metal components to avoid particulate in
the eye.

WARNING: 
This product should only be used by a trained and registered physician.

WARNING: 
Only use this product with Bausch + Lomb products and Bausch + Lomb vision enhancement
systems. Use of this product with non-Bausch + Lomb products may affect system
performance and create hazards.

WARNING: 
Use of accessories manufactured or distributed by Bausch + Lomb on systems for which they
are not designated may affect system performance and create hazards.

WARNING: 
Contact with an implanted intraocular lens (IOL) while Vitesse™ ultrasound energy is
activated may result in abrasion of the surface of the IOL. Physicians should use care when
using Vitesse™ on patients with implanted IOLs.

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WARNING: 
Do not excessively flex the needle during use.

WARNING: 
Bending of the needle can lead to needle damage and/or handpiece performance degradation.

WARNING: 
Do not use any item in this pack if received in an unsatisfactory manner. Customer inquiries
or concerns should be promptly directed to a Bausch + Lomb representative.

WARNING: 
If needle port obstruction is suspected during use, use the reflux function (directed away from
the retina or other eye structures) per the owner’s manual to attempt to clear material that
may be blocking the port.

WARNING: 
If air bubbles are seen while using Vitesse™, it is recommended that you reduce the power
and/or vacuum.

WARNING: 
If the handpiece fails to operate at the commanded power settings or loses efficiency during
use, retune the handpiece. To retune, hold the handpiece with the needle tip submerged in
Balanced Salt Solution. Return to the Setup Screen and press the Tune Vitesse button to
initiate the tuning sequence. Hold the handpiece until tuning completes. Do not allow the
needle to contact any hard surface during priming and tuning.

CAUTION: 
Failure to follow priming, tuning, and retuning instructions may result in a reduction in
handpiece effectiveness.

CAUTION: 
To avoid damage to handpiece internal components, do not submerge the front end of the
handpiece body during priming and tuning.

CAUTION: 
Do not allow the needle to contact any hard surfaces during priming and tuning.

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CAUTION: 
When using the Dual-Yaw mode, commanding power before activating vacuum may result in
reduced performance of the handpiece.

CAUTION: 
Only energize the Vitesse™ handpiece with the needle partially submerged in BSS, vitreous,
or other liquids and maintain fluid flow or you may experience reduced performance of the
handpiece.

CAUTION: 
Using Vitesse™ at high power and low vacuum may reduce flow and result in reduced
performance of the handpiece.

The Vitesse™ handpiece is an accessory that is used on the Stellaris Elite™ vision enhancement system to
remove vitreous humor, lens tissue and other material from the posterior segment of the eye using ultrasound
energy and aspiration during a typical or atypical surgery. The Vitesse™ handpiece pack is designed to be
used with an appropriate Posterior or Combined Vitrectomy Pack, or Posterior or Combined Basic Pack, and
appropriate accessories for posterior vitrectomy.

The Vitesse™ handpiece (Figure 4.8) is a vitreous cutting and aspiration device for the removal of vitreous
humor, lens tissue and other material from the posterior segment of the eye during a typical or atypical surgery.
Vitesse™ uses ultrasonic, harmonic (U/H) needle movement to generate vitreous cutting. Similar to the
pneumatically operated, guillotine type vitrectomy cutter, the device draws vitreous to the port, then cuts and
aspirates the vitreous out of the eye into a disposable fluid collection cassette through the attached tubing.

Figure 4.8. Vitesse Handpiece.

The Vitesse™ connector is the bottom port on the front left side of the Stellaris Elite™, and is labeled as shown
in Figure 4.9.

The Vitesse™ handpiece electrical plug connects to the connector port (Figure 4.9). The handpiece aspiration
tubing (yellow stripe) connects to the right-hand aspiration connector on the fluid collection cassette.

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Figure 4.9. Vitesse™ handpiece plug and aspiration tubing connected to the
Stellaris Elite™ vision enhancement system.

The Stellaris Elite™ vision enhancement system GUI Setup Screen provides one-touch EASY PRIME
functionality to prime and tune the Vitesse™ handpiece for surgery (Figure 4.10). A color-coded Vitesse™ icon
on the upper left portion of the screen indicates the Vitesse™ tune status. Detailed instructions for preparing the
system and handpiece for priming and tuning are included in the Vitesse™ Posterior Vitrectomy Setup and
Use section below. Users may also refer to the Show Me Steps videos for animated instructions.

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Figure 4.10. Setup Screen.

Once the system completes the EASY PRIME cycle, the user interface controls will transition from the Setup
Screen to the Surgical Screen (Figure 4.11) in preparation for surgery.

Figure 4.11. Surgical Screen, Combined Procedure.

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Figure 4.12. Surgical Screen, Posterior Procedure.

To adjust the numerical settings on the Surgical Screen, use the up and down arrows on the setting globe or
setting tube to increase or decrease the setting or use the pop-up keypad to enter settings directly. (Refer to the
Operator’s Manual Section 2.1 for additional instructions for using the basic interface controls.)

Five surgical modes are included on the Surgical Screen for Vitesse™ operation: Vitesse Core, Vitesse Vac,
Vitesse Low, Vitesse Pulse, and Vitesse Medium. These modes serve as a baseline to facilitate changing
power and vacuum levels based on surgeon needs. The Vitesse Core mode provides starting default settings for
vitreoretinal surgeries which may be adjusted further by the surgeon prior to each case. The Vitesse Low mode
provides lower power and lower vacuum. The Vitesse Vac mode provides higher vacuum and a broad range of
power. The Vitesse Medium mode provides default settings that are intermediate to the low and core settings.
Vitesse Pulse adjusts the number of cycles of ultrasound power that occur during a one-second time interval. In
Pulsed Mode, the handpiece is energized for the portion of each time interval as programmed by the Duty Cycle
setting.

The user interface controls also provide surgical sub-modes for Vitesse™, similar to those for the pneumatic
vitrectomy cutter: Fixed Cut, Co-Linear, Dual/Yaw Cut, Dual/Yaw Vac, and Single Cut. (Refer to the
Operator’s Manual Section 4.2 for a detailed explanation of vitrectomy sub-modes.)

The Surgical Screen user controls provide the capability to adjust Vacuum settings from 0 to 600 mmHg
(a maximum of 660 mmHg is available as an option dependent on local registration of the product), similar
to the controls for the pneumatic vitrectomy cutter. The user controls also provide the capability to control
handpiece power expressed as Vitesse Power in percent (%). Vitesse Power can be adjusted from 0 to 100% of
the full ultrasonic power of the handpiece. Using the up and down arrows, power adjustment is made in steps
of 1% from 0-10%, steps of 2% from 10-30%, and in steps of 5% from 30-100%.

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The Vitesse™ user controls incorporate ultrasound modulation, pulse rate (pulses per second [PPS]), and duty
cycle (DC) controls similar to those for the phacoemulsification and fragmentation ultrasound handpieces.

The ultrasound modulation types available for the Vitesse™ surgical sub-modes are as follows:

Surgical Sub-Modes Available Modulation Types

Fixed Cut Fixed Power, Fixed Power Fixed Pulse
Co-Linear, Dual/Yaw Cut, Dual/Yaw Vac Continuous, Pulsed, Linear PPS, Linear DC
Single Cut Single Burst

The pulse rate can be adjusted from 1 to 250 PPS. Using the up and down arrows, PPS adjustment is made in
steps of 1 PPS from 1 to 20 PPS, in steps of 5 PPS from 20 to 50 PPS, and in steps of 10 PPS from 50 to 250
PPS, subject to a minimum on-time of 2 ms and a minimum off-time of 2 ms (for pulsed modulation, the DC
setting may limit the allowable PPS range).

The DC for pulsed modulation is adjustable from 5% to 95%. Using the up and down arrows, DC adjustment
is made in steps of 5%, subject to a minimum on-time of 2 ms and a minimum off-time of 2 ms (for pulsed
modulation, the PPS setting may limit the allowable DC range).

Similar to the other surgical modes in the Posterior and Combined domains, the Vitesse™ surgical modes have
programmable reflux capability with three setting options: Continuous, Single High, and Single Low.

Vitesse Posterior Vitrectomy Setup and Use

1. Connect the compressed air source to the connector on the lower rear of the system.
2. Turn the power on and wait until the screen displays the Primary (Integrated) Foot Control or other
system messages.
3. Acknowledge and close all messages.
4. To operate the Primary (Integrated) Foot Control wirelessly, press any button on the Primary
(Integrated) Foot Control and wait until the ready light turns solid green. This indicates that wireless
communication has been established.
5. The screen will display Select Procedure. (If your system is programmed to default to either the
Anterior Domain or the Posterior/Combined Domain, the Select Procedure Screen will not appear, and
the system will move directly to the Select Surgeon Screen, as shown in Figure 1.8 in the Operator’s
Manual.)
6. Select Posterior Segment; the screen will transition to Select Surgeon. (Skip this step if the system is
already displaying the Select Surgeon screen.)
7. Select Surgeon’s Name and select Confirm to transition to the Insert Cassette screen.
8. Open the posterior or combined surgical pack with the following steps:
a. Hold the bottom of the tray with one hand. (Circulating Nurse)
b. Tear open the Tyvek seal with the other hand toward the body. (Circulating Nurse)
c. Pour contents onto sterile surface. (Circulating Nurse)

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d. Identify loose components from the pre-connected tubing set. (Scrub Nurse)
e. Drape the system tray and screen with the provided drapes. (Scrub Nurse)
f. Arrange the pre-connected tubing set with cassette, bottle spike, air tubing filter, and actuation
connector toward the system front. In a later step, the Vitesse™ priming tray will be placed at the
other end with the tubing set in the middle as shown in Figure 4.13. (Scrub Nurse)

Figure 4.13. Complete Vitesse™ tubing connections and setup.

g. Remove the tape to unbind all the tubing. (Scrub Nurse)

h. Straighten the tube set and secure it, so it will not drop off the sterile surface. (Scrub Nurse)
i. Remove the tape from the cassette to release the additional tubing that is tied to the cassette.
(Scrub Nurse)
j. Connect the air tubing filter to the system (second right connector). Ensure the air pump is on.
(Scrub Nurse or Circulating Nurse)
k. If the surgical pack contains a pneumatic vitrectomy cutter, disconnect it from the cassette and set
it aside. (Scrub Nurse)
l. If the surgical pack contains Entry Site Alignment (ESA) devices, remove and set aside. Only use
the ESA devices provided with the Vitesse™ handpiece pack (yellow trocar caps) while using
Vitesse™.
m. Insert the fluidics cassette all the way in and hold until it is automatically captured by the system.
The cassette housing backlight will stop blinking and remain on when the system captures the
cassette. (Scrub Nurse or Circulating Nurse)
n. Pass the bottle spike and irrigation tubing to the Circulating Nurse. (Scrub Nurse)
o. Spike and hang the Balanced Salt Solution (BSS) bottle on the automated I/V pole or the Zero
Level hanger if using Air Forced Infusion (AFI). Squeeze and release the drip chamber until it
is half filled with solution. (For AFI setup, use the spiking tool provided to puncture the rubber
stopper on the bottle before inserting the metal cannula into the bottle.) (Circulating Nurse) See
Figure 4.5 of the Operator’s Manual.
p. If the surgical pack contains a priming cup, remove it and set it aside. (Scrub Nurse)
9. Open the Vitesse™ handpiece pack and perform the following setup steps:

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a. Hold the bottom of the tray with one hand. (Circulating Nurse)
b. Tear open the Tyvek seal with the other hand toward the body. (Circulating Nurse)
c. Remove the enclosed tray insert containing the handpiece and accessories and place on a sterile
surface, with the clear top section facing up. The tray insert can be removed from the tray either by
pouring out or by lifting out, while ensuring no contact is made with the non-sterile top edge of the
tray. (Circulating and Scrub Nurse)
d. Unfasten the handpiece electrical cable and plug from the outside top of the tray insert, remove
tape, and connect the plug to the U/H VIT handpiece connector port on the left side of the
Stellaris Elite™ vision enhancement system (bottom port). (Scrub Nurse)
e. Remove clear top section of the tray insert by removing any tape, unfastening the tab holding the
top and bottom sections together, and then lifting off the top section. Discard the top section after
removal. (Scrub Nurse)
f. Remove the package containing the ESA devices, and any other accessories from the bottom of the
tray insert. Set aside for later use. (Scrub Nurse)
g. Carefully remove aspiration tubing coil (yellow stripe) from the bottom of the tray insert, without
disturbing the handpiece. Remove any tape on the tubing coil. (Scrub Nurse)
h. Connect the aspiration tubing to the connector located on the right side of the fluid collection
cassette. (Scrub Nurse)
i. Remove any remaining tape holding the handpiece in the tray insert. (Scrub Nurse)
j. To ensure effective system priming, tuning, and Vitesse™ operation, verify all tubing connections
are made in accordance with Figure 4.13. For use of the EASY PRIME function, it is important
that the infusion cannula and second aspiration line are positioned in the bottom of the tray insert,
as shown in Figure 4.14. (Scrub Nurse)

Figure 4.14. Proper positioning of infusion and aspiration lines for effective Easy Prime operation.

To prepare for priming and tuning, position the tray insert on the system mayo tray such that the handpiece
needle is pointing away from the system. (Scrub Nurse)

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10. Prime and tune the system and handpiece. For hands-free priming and tuning with the handpiece in the
tray insert, select EASY PRIME on the Setup Screen or hold the handpiece with needle tip submerged
in BSS. If the handpiece is held while priming and tuning, ensure the needle does not contact any hard
surface during this process or the handpiece may fail to tune. Press the EASY PRIME button to initiate
the auto priming and tuning sequence. Hold the handpiece until prime/tune completes. (Scrub Nurse)
11. (Optional) Installation and removal of the snap-on finger guard.

Note:  n optional snap-on finger guard may be included in the Vitesse™ handpiece pack to assist
A
surgeons with avoiding inadvertent finger contact with the handpiece needle during Vitesse™
operation. Finger contact with the needle during use can lead to a frictional heating effect that
may result in minor discomfort to the surgeon. The finger guard may help to reduce the chance
of inadvertent needle contact and the resulting frictional heating.

Figure 4.15. Vitesse™ snap-on finger guard.

a. The finger guard can be installed on the front of the handpiece, as shown in Figure 4.16. To ensure
safe, effective installation, attach the finger guard with the needle pointed away from the hand,
while avoiding finger contact with the needle. (Scrub Nurse)

Figure 4.16. Left: Safe, effective method for installing the finger guard; Right: Incorrect method.

b. The finger guard can be removed from the handpiece, as shown in Figure 4.17. Carefully pull the
finger guard off the front of the handpiece and rotate it such that the needle passes through the
open slot on the finger guard. (Scrub Nurse)

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Figure 4.17. Removal of the finger guard.

Illumination Function

WARNING: 
Care should be taken to avoid concentrating the illumination output on a small area of the
retina for unnecessarily prolonged periods of time, due to the potential for phototoxicity and
serious permanent injury.

CAUTION: 
Do not use lamps in damp locations, in areas of high humidity, or if condensation is likely to
have formed; for example, immediately after moving from a cold location to a warm location.

CAUTION: 
Do not block air vents.

Note: The surgeon should use the minimum illumination necessary to undertake the desired procedure.

Fiber-optic illumination for intraocular viewing is accomplished with the Stellaris Elite™ illumination
function. The system contains two individually controlled light outputs, each with its own lamp. The standard
configuration is a xenon lamp in the lower position (Lamp 1) and xenon-mercury lamp in the upper position
(Lamp 2), but the instrument can be configured with either type of lamp in either position. The probe connector
contains a shutter mechanism to prevent light leakage when the probe is not connected.

The light transmitted to the patient will have a spectral content between 435 nm and 650 nm.

Each lamp provides slightly different illumination, and the choice of which to use will be dependent on both
surgeon preference and procedure type. The xenon lamp has a whiter light with a full spectrum. The xenon-
mercury lamp has a greener light that has less blue light content than the xenon spectrum at the same perceived
light level.

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If a xenon lamp is installed in the lower position, the user may select one of three color filters (green, yellow,
amber) to tint the light output to give improved visualization in certain circumstances.

The Primary (Integrated) Foot Control side button may be programmed to turn Lamp 1 or Lamp 2 on and off.
There are three ways to map the illuminator settings to the Primary (Integrated) Foot Control:

1. Using the More Screen Foot Control Tab .

2. Programming the technique level Primary (Integrated) Foot Control settings.
3. Also in programming, overriding the technique level settings on the phase level Primary (Integrated)
Foot Control settings screen.

Illumination Setup and Use

1. Connect the fiber-optic illuminator to the desired port (see Figure 1.24 Posterior). Push the connector
into the port until the groove on the connector is aligned with the front surface of the port receptacle.
See Figure 4.18. (Scrub Nurse or Circulating Nurse)

Figure 4.18. Connecting Fiber-Optic Connector to the Illumination Port.

1. Connector groove. 2. Connector groove align with port receptacle when it is properly connected.

2. To turn illumination on, select the On/Off button from the screen as shown in the figure below. (Scrub
Nurse or Circulating Nurse)

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Figure 4.19. Illumination Control.

Illumination control showing a green ring around the On/Off button, which indicates the
lower illumination port (right) is turned on. The filter button is below the On/Off button for
the lower (right) lamp.

3. Use the on-screen control to adjust the intensity.

CAUTION: 
Never turn the illumination on and off rapidly.

Note:  amp may take several minutes to complete the warm up, but can be used once the required
L
intensity has been reached.

4. Set the illumination output with the Up/Down buttons in the display tube. Click on the arrow to increase
or decrease the output level, or click and hold to make larger changes.

Note: S hould the light source fail during use, the operator must switch the fiber-optic illuminator to
the other lamp port. The burned-out lamp should be replaced before the next surgery.

Illumination Filter Control

The lower lamp has three optional filters that can be used.

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You can change the current filter using the touch screen display and Primary (Integrated) Foot Control
(if programmed appropriately), or use the filter button on the surgical screen to toggle filter selection (none,
amber, green, yellow). You can also select the filter from the More Screen Illumination Tab.

By default, the filter is set to None. To change this, edit your surgeon preferences file (see page 3-11).

The output level should be set in accordance to the guidance shown in the detail section on page 4-20.

Lamp Life Cycle

As the lamp ages, its operating voltage will naturally increase. In some cases, it may increase beyond an
acceptable level before the normal number of operating hours have elapsed. In this case the Stellaris Elite™
will prevent further use of the lamp to avoid the possibility of lamp rupture.

If the lamp takes longer than usual to strike, or fails to strike, this indicates the lamp is nearing the end of its life
and a warning message may appear on the screen.

Each lamp has a maximum number of hours of life, and the system will provide a warning when that limit is
near, and again once the limit has been reached. Once the limit has been reached, the lamp will remain on for
the current surgery but once turned off will not turn on again and must be replaced.

The amount of lamp life remaining for each lamp is displayed in the Illumination More Screen. The display
represents the remaining hours of lamp life. The Green area represents the amount of hours of life remaining
prior to the user notification. The Yellow area represents the point that the user notification has been given,
meaning that the lamp has a specific number of hours (15) until the indicated light bulb must be replaced.

Lamp Life
Xenon—400 hours, notification is at 15 remaining hours of lamp life.
Xenon-Mercury—500 hours, notification is at 15 remaining hours of lamp life.

Figure 4.20. Lamp Life Indicator.

Lamp Replacement Procedure

WARNING: 
Always turn off the power supply before attempting to replace the lamps to avoid danger of
burns, electric shock and eye damage from arc light.

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WARNING: 
Wear eye protection when installing or removing lamps.

WARNING: 
Do not touch the glass lamp or the circuit board. Hold the assembly only by the outer metal
housing.

WARNING: 
Do not drop, scratch, or apply force to lamp, as the high pressure inside may cause the lamp
to rupture.

Note:  he Stellaris Elite™ will not work unless both lamps are fitted in place. If you remove a lamp
T
you must replace it with another lamp or the system will not function.

1. TURN OFF THE SYSTEM. Wait 20 minutes for the system to cool before attempting lamp
replacement.
2. Open the lamp replacement access door on the side of the unit by placing a coin or flat head screwdriver
into the slot and turning it counter-clockwise. The dot should be on the right, and the door should then
lift off.

Figure 4.21. System Side with Lamp Access Door Open.

3. Identify the lamp that requires replacement: lower lamp = Lamp 1; upper lamp = Lamp 2.
4. Undo the two lamp fasteners by turning the two thumbscrews counterclockwise.

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5. Carefully pull the lamp housing from the unit and dispose of according to applicable regulations.

Note:  ake sure to dispose of the old lamp properly. Lamps are filled with high pressure xenon gas
M
or xenon and mercury gases. When disposing of the used lamp, take appropriate measures
in compliance with applicable regulations regarding waste disposal, or entrust disposal to a
licensed industrial waste disposal company. Be sure to comply with the regulations in your
country, state, region or province to ensure the used lamp is disposed of legally and correctly.

6. If the bulb is shattered and glass fragments are found, contact Bausch + Lomb service to remove them to
prevent damage to the unit.

Figure 4.22. Side of Unit with Lamps Removed, with Lamp Location and Orientation Shown.

7. DON’T TOUCH THE LENS, LAMP CONNECTORS OR OTHER PARTS INSIDE THE SYSTEM.
8. Open the packaging for the replacement lamp (holding only the metal housing). BE CAREFUL NOT
TO TOUCH ANY PART OF THE GLASS BULB OR CIRCUIT BOARD.

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Figure 4.23. Lamp Housing Exterior.

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Figure 4.24. Lamp Housing Interior.

9. Align the replacement lamp housing with the hole, taking care to align the connectors on the top-right
and bottom-left corners.
10. Push the replacement lamp housing firmly into place.
11. Screw the two lamp fasteners clockwise until tight (thumbscrews).

WARNING: 
RISK OF ARC EXPOSURE.

12. Prior to restoring power to the system, replace the access door on the side of the unit, and turn the slot
clockwise. Make sure the dot is pointing down, indicating that the door is locked.
13. Turn on the system.
14. Check that the new lamp is recognized.

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Note:  ake sure to dispose of the old lamp properly. Lamps are filled with high pressure xenon gas
M
or xenon and mercury gases. When disposing of the used lamp, take appropriate measures
in compliance with applicable regulations regarding waste disposal, or entrust disposal to a
licensed industrial waste disposal company. Be sure to comply with the regulations in your
country, state, region or province to ensure the used lamp is disposed of legally and correctly.

Fluid/Air Exchange (F/AX) Function

The Fluid/Air Exchange function provides continuous air flow from a pneumatic pump located in the
compressor. The air output connector must be used in the posterior mode for Fluid/Air Exchange. Air is filtered
through a disposable filter. The Primary (Integrated) Foot Control side button may be programmed to turn
Fluid/Air Exchange On or Off.

Fluid/Air Exchange Operation

The Fluid/Air Exchange mode is a posterior feature which provides the surgeon with the ability to instill a
preset air pressure into the eye for Fluid/Air Exchange. It supports pressures up to 150 mmHg at flow rates up
to 3.5 standard cubic feet (99 liters) per hour. The air pressure from the pump may be adjusted from 0 mmHg to
150 mmHg in 1 mmHg increments.

Fluid/Air Exchange Setup and Use

The Fluid/Air Exchange tubing is an integrated part of the pre-connected tubing set of the Stellaris Elite™
procedure pack. The function shares the same air source as AFI. In the event the air pump is already on for AFI,
all you need to do to activate Fluid/Air Exchange is switch the 2-way stopcock that is attached to the infusion
cannula.

1. Set up the system for posterior vitrectomy (see page 4-8) or combined surgery (see page 4-67).
2. Select the On/Off button to turn on air pump. (Scrub Nurse or Circulating Nurse)

Note:  hen the pump is turned on, the air pressure numeric display will transition to show actual
W
pressure. When the pump is off, the display indicates the preset air pressure.

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Figure 4.25. A Green Ring on the On/Off Switch Indicates Air Pump Has Been Turned On.

3. Select the up/down arrows to change the air pressure output. (Scrub Nurse or Circulating Nurse)
4. Turn the valve of the stopcock to stop the flow of irrigating solution and start the flow of air as shown in
Figure 4.26 (top). (Scrub Nurse)

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Figure 4.26. The 2-way stopcock control of Fluid/Air Exchange.

Top: On - Air flows into the eye.
Bottom: Off - Fluid flows into the eye.
1. Air. 2. BSS.

Tamponade

Air Tamponade
Air Tamponade is a function where the air pressure is temporarily elevated to a pre-programmed level during a
Fluid/Air Exchange procedure. The pressure level for Air Tamponade is higher than pressure use during normal
operation. The temporary increase of pressure is normally used to stop intraocular bleeding.

The Air Tamponade function may be enabled by the Alt Inf On/Off button on the display (see Figure 4.27),
or the Primary (Integrated) Foot Control switch if it is programmed to control Alternate Infusion. Adjusting
the air pressure above 59 mmHg will also enable Elevated Infusion. The tamponade pressure is displayed in
the surgical screen and may be adjusted by selecting the numeric pressure display or using the touch screen
Up/Down arrows. Air Tamponade would also be enabled whenever the Fluid/Air Exchange pressure level is
raised above the programmed tamponade level.

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When the function is enabled, a two bell auditory notification will sound every 30 seconds and an Elevated
Infusion indicator on a yellow background is displayed, with an elapsed time counter, on the surgical screen to
indicate the low priority alarm condition for elevated infusion.

An optional voice indication if enabled will state “Elevated Infusion On” at one minute intervals.

When Alt Inf is disabled or the Fluid/Air Exchange level is reduced below the tamponade level, the alarm
condition is immediately ended when the infusion pressure is set below the tamponade level of 60 mmHg or
81 cmH2O.

When Alt Inf is toggled Off, the Fluid/Air Exchange function status and pressure will return to the value it
had prior to turning Alt Inf On, and the timer will be cleared from the screen if the pressure setting is reduced
below 60 mmHg (81 cmH2O).

Figure 4.27. Surgical Screen Displays Elevated Infusion Controls (Status On) and Timer.

Fluid Tamponade
Similar to the Air Tamponade, Fluid Tamponade is a function where the fluid infusion pressure is temporarily
elevated to a pre-programmed level. The Fluid Tamponade can be driven by pressurized air or gravity infusion.

The Fluid Tamponade function may be enabled by the Alt Inf On/Off button on the display, or the Primary
(Integrated) Foot Control switch if it is programmed to control the Elevated Infusion. Adjusting IV Pole above
80 cm or pressurized infusion above 59 mmHg, will also enable Elevated Infusion. The tamponade pressure
is displayed in the surgical screen and may be adjusted by selecting the numeric pressure display or using the
touch screen Up/Down arrows. Fluid Tamponade would also be enabled whenever the Fluid/Air Exchange
pressure level is raised or the IV Pole is adjusted above the programmed tamponade level.

When the function is enabled, a two bell auditory notification will sound every 30 seconds and an Elevated
Infusion indicator on a yellow background is displayed, with an elapsed time counter, on the surgical screen to
indicate the low priority alarm condition for elevated infusion.

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An optional voice indication if enabled will state “Elevated Infusion On” at one minute intervals.

When Alt Inf is disabled or the Fluid/Air Exchange level is reduced below the tamponade level, the alarm
condition is immediately ended when the infusion pressure is set below the tamponade level of 60 mmHg or
81 cmH2O.

When Alt Inf is toggled Off, the air pressure and IV Pole will be set to the value it had prior to turning
Alt Inf On, and the timer will be cleared from the screen if the pressure setting is reduced below 60 mmHg
(81 cmH2O).

The visual and auditory indicators provided when elevated infusion pressure is set above the stated limits
constitutes a low priority alarm as prolonged use has the potential to induce blindness in the patient. It is
triggered as soon as the feature is activated and will turn off immediately after the feature is deactivated. While
the volume level can be adjusted, it cannot be turned off, see Section 3.

To program the Elevated Infusion pressure for Air Tamponade and Fluid Tamponade, go to the Technique Level
Programming Fluidics tab to set desired pressure (see page 3-7). By default, the pressure is set at 80 mmHg
and 100 cm.

Figure 4.28. Technique Programming Level Fluidics Screen with Air and Fluid Tamponade Settings.

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Viscous Fluid Control (VFC) Function

WARNING: 
The VFC is not intended for aspiration of BSS.

The Stellaris Elite™’s VFC function generates the required injection pressures and aspiration vacuums for
injecting viscous fluids to, and aspirating viscous fluids from, the eye during posterior segment surgery.
The Viscous Fluid function will deliver up to 72.5 psig (500 kPa, 5.0 bar) of pneumatic pressure to the
disposable tube set. All other posterior system functions except fragmentation and vitrectomy may be operated
simultaneously or in conjunction with this function.

Silicone Oil: When used in the injection mode, the system can inject up to 5 cc of 1000 centistoke to
7500 centistoke silicone oil at 24°C (75°F) in less than 6.25 minutes.

Viscous Fluid Injection: Setup and Use

1. Open a viscous fluid injection disposable pack and place contents on a sterile surface.
2. Connect the locking air connector on the tubing set to the Stellaris Elite™ system (top-right connector,
Figure 1.24).
3. Connect the syringe coupler of the Viscous Fluid tubing to the syringe filled with silicone oil. Twist the
coupler to lock it securely to the syringe (see Figure 4.29).

WARNING: 
Ensure a black piston is in the syringe before connecting the syringe coupler to the syringe
filled with silicone oil. Failure to do so will cause patient injury.

4. Slowly turn the syringe upward so that the tip points toward the ceiling, allowing any air to move to the
tip in one cohesive bubble.
5. While holding the syringe in the upright position, remove the syringe cap from the syringe and attach
the 19 gauge Teflon cannula. (Teflon cannula is recommended for injection.)
6. Select Visc Inject from the Surgical Screen Clock Menu to perform the VFC injection procedure.
7. To evacuate air from the syringe, hold the syringe in the upright position and activate low injection
pressure to force air out the tip of the cannula.
8. Remove the cannula cover before use.

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Figure 4.29. Viscous Fluid Injection Setup.

1. Viscous Fluid Port. 2. Air Tubing Connector. 3. Coupler. 4. Piston. 5. Syringe with Silicone Oil.
6. Syringe Cap. 7. 19 gauge Injection Cannula (for injection). 8. 19 gauge Extraction Cannula.

Viscous Fluid Injection: Operation Modes

Fixed Fluid Injection
The Foot Pedal is used to control the injection with a pre-programmed fixed pressure. The pressure level is set
using the setting globes on the touch screen.

Linear Fluid Injection

Control of linear fluid injection is via the Foot Pedal. The injection pressure increases proportional to Foot
Pedal travel from the minimum programmed setting to the maximum programmed setting. The minimum and
maximum pressure levels are set using the touch screen.

Dual/Yaw Vac (Linear Fluid Injection, Linear Vacuum)

Linear fluid injection is actuated by depressing the Foot Pedal. Linear aspiration through the left aspiration line
is actuated by an outward yaw movement of the center Foot Pedal. The minimum and maximum pressure levels
are set using the touch screen.

Viscous Fluid Extraction: Setup and Use

1. Open a viscous fluid extraction disposable pack and place contents on a sterile surface.

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2. Connect the locking air connector on the tubing set to the Stellaris Elite™ system (top-right connector,
Figure 1.24).
3. Remove the syringe cap (item 6 of Figure 4.29). (Must be completed before step 4)
4. Place the black piston into the syringe barrel and use the plunger to push the piston all the way down to
the tip of the syringe. (Refer to Figure 4.30 and Figure 4.31.)

CAUTION: 
Ensure a black piston is in the syringe before connecting the syringe coupler to the syringe.
Failure to do so will cause fluid to be aspirated into the system’s electronic components.

5. Connect the syringe coupler of the Viscous Fluid tubing to the empty syringe. Twist the coupler to lock
it securely to the syringe. (Refer to Figure 4.32.)
6. Connect the extraction needle to the syringe. The 19-gauge steel needle is suitable for this application.
7. Remove the cannula cover (8) before use.
8. Select Visc from the Surgical Screen Clock Menu to perform the VFC extraction procedure. A
drop-down menu will appear with different inject or extract submode options.

Figure 4.30. Viscous Fluid Extraction Setup.

Inserting Piston (4) into the Empty Syringe (5).

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Figure 4.31. Viscous Fluid Extraction Setup.

Use Plunger (9) to Push Piston (4) to the End of the Empty Syringe (5).

Figure 4.32. Viscous Fluid Extraction Setup.

1. Viscous Fluid Port. 2. Air Tubing Connector. 3. Coupler. 4. Piston. 5. Empty Syringe. 6. Syringe Cap.
7. 19 gauge Teflon Cannula. 8. 19 gauge Extraction Cannula. 9. Plunger.

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Viscous Fluid Extraction: Operation Modes

Fixed Extract
Extraction is activated when the Foot Pedal is depressed. Aspiration pressure is fixed and pre-programmed
through the touch screen user interface.

Linear Extract
Extraction is controlled via the center Foot Pedal. The extraction vacuum increases proportional to Foot
Pedal travel from the minimum programmed setting to the maximum programmed setting. The minimum and
maximum vacuum are set using the touch screen.

Fragmentation
The Stellaris Elite™ Fragmentation function provides ultrasound emulsification and vacuum for lens removal
from the posterior segment of the eye.

WARNING: 
During any ultrasonic procedure, metal particles may result from inadvertent touching of the
ultrasonic tip with a second instrument. Another potential source of metal particles resulting
from any ultrasonic handpiece may be the result of ultrasonic energy causing micro abrasion
of the ultrasonic tip.

Fragmentation Setup and Use

WARNING: 
A loose needle may lead to improper tuning and could cause shedding of metal fragments into
the eye, which can result in serious permanent patient injury.

Note:  ragmentation uses the same power connection as the ultrasound handpiece. Only one function
F
can be used at a time.

Note:  rior to setting up Fragmentation, the Stellaris Elite™ has to be set up for Posterior Vitrectomy
P
or Combined surgery.

Note: S pecific instructions for cleaning and sterilization included with a handpiece or accessory take
precedence over these instructions.

1. Set up the system for posterior vitrectomy (page 4-8) or combined surgery (page 4-67).
2. Ensure the screen is displaying the Prime and Tune Setup screen.

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3. Connect the handpiece electrical connector to the connector on the machine. (Scrub or Circulating
Nurse)
4. Thread and firmly secure the single-use fragmentation needle onto the fragmentation handpiece using a
needle wrench. (Scrub Nurse)
5. Connect the clear aspiration line to the fragmentation handpiece. (Scrub Nurse)
6. Hold the handpiece with tip submerged into BSS. (Scrub Nurse)

Figure 4.33. Hold Frag Piece with Tip Submerged into Water During Priming and Tuning.

7. Select Prime/Test U/S to initiate the autopriming and tune ultrasound sequence. Hold the handpiece
until prime and tune completes and the system transitions to the Surgical Screen. (Scrub or Circulating
Nurse)
8. Select Frag mode from the Clock Menu to perform the fragmentation procedure. (Scrub or Circulating
Nurse)

Fragmentation Modes
The Stellaris Elite™ provides two Fragmentation modes with adjustable ultrasound power and vacuum control.
Refer to the table on page 3-35 on ultrasound customization for information on the available vacuum range and
options on ultrasound modulations. Detailed description of Ultrasound modulations such as Pulse, Burst and
Duty Cycle are provided in the Ultrasound Functions section in the Anterior Domain Section, page 4-43.

Linear Frag
Linear Frag submode provides linear vacuum in Foot Pedal Region 1 and fixed maximum vacuum and linear
ultrasound in Foot Pedal Region 2. The outward yaw in any Foot Pedal region controls ultrasound On/Off.

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Dual/Yaw U.S. Frag

This submode provides linear vacuum control on Foot Pedal pitch, and linear ultrasound on outward yaw in
Foot Pedal Region 1.

4.3. Anterior Functions

Irrigation
Irrigation is part of the fluidics system, providing continuous fluid flow to compensate for fluid aspirated out of
the eye. Irrigation on/off is controlled by the pinch valve, which is opened when the Foot Pedal is pressed and
closed when the Foot Pedal is released.

An Irrigation-only mode is available, in which the Foot Pedal controls irrigation on/off. The Fill Button on the
Surgical Screen opens the irrigation control valve for 20 seconds to facilitate collection of irrigation solution
into a surgical container.

Irrigation/Aspiration (I/A) Function

Note:  o not pull the tubing taut — it must be allowed to have a droop or sag between the cassette
D
and the handpiece.

Note:  henever the cassette is ejected from the system console, keep the handpiece above the level of
W
the cassette port.

The Advanced Vacuum Function provides vacuum levels from 0 mmHg to 660 mmHg in 1 mmHg increments
depending upon the mode of operation. Aspiration limits are set via the touch screen, the remote control, or the
Primary (Integrated) Foot Control buttons (if programmed).

In I/A mode, irrigation is activated in Region 1 of Foot Pedal travel, and both irrigation and aspiration are
activated in Region 2 of Foot Pedal travel.

Capsule Polish
The capsule polish function is typically accomplished with a lower vacuum setting than standard settings. These
settings may be customized to allow quick entry into a lower vacuum level as explained in Chapter 3.

Viscoelastic Removal
The viscoelastic removal function provides different settings for the doctor’s convenience. These settings may
be customized to allow quick entry into a specific vacuum level as explained in Chapter 3.

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Venting
The Vacuum Flow Fluidics system provides the surgeon with either air or fluid venting options to free an
occluded tip when the Foot Pedal is released. When air venting is selected, the residual vacuum is vented to
atmospheric pressure, and when fluid venting is selected, it is vented to a positive pressure equal to the bottle
height head pressure. Venting automatically occurs every time the Foot Pedal travels back to region 1.

Reflux
Aspiration of fluid to the collection cassette occurs via the handpiece and a tube set. Reflux applies a
momentary reverse pressure through the aspiration line to clear the aspiration port of lodged material.

The Stellaris Elite™ vision enhancement system is designed for use with continuous reflux or pulse reflux. If
enabled, the reflux feature is activated by inward movement of the Foot Pedal in all aspiration modes.

Continuous Reflux
Reflux pressure is based on irrigation pressure.

Pulse Reflux
Reflux is created by the momentary activation of a plunger on the reflux bulb.

Pulse reflux is only available with Adaptive Fluidics built with reflux bulb and combined procedure cassette.

Vacuum Response
Vacuum response refers to the amount of time required to obtain the desired aspiration level. A fast response
value instructs the system to achieve the desired aspiration level in the shortest amount of time; similarly,
slow indicates that the time to achieve the desired aspiration will be significantly longer. The response can
be changed through the programming interface (see Chapter 3) or the More Screen (see page 2-7). The
Advanced Vacuum System has five levels of vacuum response setting, with one being the fastest response and
five being the slowest response.

Primary (Integrated) Foot Control of Irrigation/Aspiration

As the Foot Pedal is initially pressed, the irrigation control valve will open to allow irrigation into the eye.

Once irrigation has been initiated and the Foot Pedal has been depressed approximately five degrees (or as
programmed), a momentary increase in Foot Pedal resistance will be noted, signifying the transition from
Region 1 to Region 2 and the start of aspiration. Aspiration increases proportional to Foot Pedal travel, with the
maximum level being set via the Max Vacuum input on the touch screen. You can program Region 2 to provide
either fixed or linear vacuum control. The Actual Vacuum display will indicate the current aspiration level.

If enabled, an audible linear tone will indicate aspiration. The pitch of the tone increases with increased
aspiration.

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Irrigation/Aspiration Setup

WARNING: 
For optimum aspiration and reflux performance, the patient’s eye level must be at the same
level as (no more than 7 cm [3 in.] from) the Stellaris Elite™ vision enhancement system’s
aspiration port. Failure to follow this procedure may result in serious and permanent patient
injury.

WARNING: 
Ensure the handpiece and accessories are sterilized before use as specified.

Note: S pecific instructions for cleaning and sterilization included with the handpiece or accessory
take precedence over these instructions.

1. Turn Power on.

2. Press any button on the Primary (Integrated) Foot Control and wait until the ready light turns solid
green, indicating wireless communication has been established.
3. Select Surgeon’s Name and select Confirm.
4. Open the disposable package and insert the fluidics cassette all the way in and hold until it is
automatically captured by the system. The cassette housing backlight will stop blinking and remain on
when the system captures the cassette.
5. After the vacuum test completes, the Setup Screen will display with Prime and Tune as the highlighted
function.
6. Spike the Balanced Salt Solution container and hang it at the desired height.
Additional step if pressurized infusion is used:
Connect the Air Tubing Line to the vent port at the bottle spike and the other end with air filter to the
Stellaris Elite™ air output connector. Switch on the air pump from the system setup screen (use the
control in the upper right-hand corner of the screen). The output connector will remain lit when it is at
commanded pressure, and blink on and off when it is not at the commanded pressure.
7. Connect tubing to the I/A handpieces. Select Show Me Steps for animated setup guide, if necessary.
8. Ensure the irrigation clamp is open and toggle Irrigation Off to turn the flow on and allow irrigation to
fill the tubing up to the handpieces.
9. Fill the test chamber with irrigating solution, then slide over the tip of the handpiece.
10. Select Prime Only. A vacuum test is part of the priming cycle.
11. After successful priming and tuning, the Main Surgical Screen will be displayed.

The external components of your system are now ready. Continue to set the operating parameters.

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4. Detailed Reference

Note:  old the handpiece tip towards the ceiling while priming the irrigation line to ensure all air has
H
been removed.

I/A Use
1. Select the I/A mode on the Clock Menu.
2. Use the setting globes to set the desired aspiration vacuum.
3. The system is now ready for Irrigation/Aspiration.

Note: See Chapter 5 for cleaning and sterilization requirements when surgery is completed.

Ultrasound Function
Phacoemulsification refers to the process of ultrasonic disintegration of the lens using a vibrating needle
operating at a frequency above the audible range, in the anterior chamber of the eye.

Ultrasound Power
The ultrasound display allows you to adjust maximum ultrasound power pulses per second (PPS), duty cycle
(DC), pulse duration, and pulse interval. Both the current setting and the actual value are shown on the Surgical
Screen display. The status bar (see page 2-30), visible at the top center of the surgical screen, might display
the average ultrasound power (AVE), actual phaco time (APT), and effective phaco time (EPT), depending on
system settings.

The AVE display is internally calculated as the arithmetic average of all phaco power used since last reset. The
APT display indicates the time in minutes and seconds that phaco power has been energized since last reset. The
EPT is derived from multiplication of AVE and APT. Use the More Screen A/V Tab (see page 2-19) to reset
the phaco timer and average. The timer is also reset when you select Next Patient on the End of Case Screen.

Pulse Mode Ultrasound

Pulse mode ultrasound power may be adjusted from 0% to 10% in 1% increments, 10% to 30% in 2%
increments, and 30% to 100% in 5% increments using the up/down setting globes, Primary (Integrated) Foot
Control buttons, or remote, and in 1% increments using the keypad. Pulse output control is programmable from
1 to 250 pulses per second in 1 PPS increments.

The pulse rate control does not adjust the ultrasound power. The control adjusts the number of cycles of
ultrasound power that occurs during a one second time interval. In Pulsed Ultrasound Mode, the ultrasound
handpiece is energized for the portion of each time interval as programmed by the Duty Cycle setting.

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Burst Mode Ultrasound

Burst mode ultrasound is an anterior only mode to provide minimal ultrasound energy. Ultrasound is applied in
either single or multiple bursts using a fixed power or in fixed bursts using a linear control of power. The burst
duration can range from 2 ms to 600 ms.

When single burst mode is selected, a burst of ultrasound energy is emitted when the Primary (Integrated) Foot
Control is pressed to 90% of the linear control position, and is reset when the pedal is released to less than 90%
of the linear control position.

Figure 4.34. Burst Mode Ultrasound.

1. Single Burst. 2. Pedal Position. 3. Power.

When fixed pulse mode is selected, the pulse duration and interval may be selected with the screen settings.

Figure 4.35. Fixed Pulse Ultrasound.

1. Fixed Pulse. 2. Pedal Position. 3. Power.

The ultrasound power is controlled by the linear control position of the Foot Pedal.

When multiple burst mode is selected, a sequence of bursts of ultrasound energy is emitted. The time interval
between bursts is controlled by the linear control position of the Foot Pedal. When the pedal reaches full travel
in the linear control, the ultrasound energy is limited by the Max Duty Cycle setting.

Figure 4.36. Multiple Burst Mode Ultrasound.

1. Multiple Burst. 2. Pedal Position. 3. Power.

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Ultrasound Submode
Up to three sets of ultrasound modulation settings may be stored with each ultrasound mode. Primary
(Integrated) Foot Control activation of the submode sequence may be enabled or disabled. Submodes can
be toggled with the Primary (Integrated) Foot Control heel switch or by Foot Pedal outward yaw motion in
Region 2 or 3, depending on how the system has been programmed.

The options to change submodes with the Primary (Integrated) Foot Control are:
• Either the left side button pair or the right side button pair may be grouped to change submodes to the
next submode (toe) or previous submode (heel)
• Any of the four Primary (Integrated) Foot Control buttons may be assigned to advance to the next
submode (when ungrouped)
• The outward yaw switch may be enabled to advance to the next submode (in any region) (for single
linear modes)
• The inward yaw switch may be enabled to advance to the next submode (in any region) (for dual linear
modes with reflux disabled)
• The inward yaw switch may be enabled to advance to the next submode (in Region 2/3) (for dual linear
modes with reflux enabled)

Ultrasound Tuning
The ultrasound handpiece must be tuned with the needle installed before using. Select Prime and Tune on the
Setup Screen.

Description of Ultrasound Modes

The application of ultrasound power may be fixed or linear. Linear power is proportionally controlled by the
Foot Pedal between zero and the maximum limit set on the console.

Ultrasound power may be adjusted from 0% to 10% in 1% increments, 10% to 30% in 2% increments, and
30% to 100% in 5% increments using the up/down setting globes, Primary (Integrated) Foot Control buttons,
or remote, and in 1% increments using the keypad. The ultrasound output will be activated at the minimum
programmed power level as the Foot Pedal moves into the active ultrasound region, and will increase to the
maximum programmed output as a function of linear Foot Pedal travel.

Single Linear Ultrasound Mode with Fixed Aspiration

Once irrigation has been initiated and the Foot Pedal has been depressed approximately five degrees (or as
programmed), an increase in Foot Pedal resistance will be noted, signifying the transition from Region 1 to
Region 2 and the start of aspiration. Fixed aspiration will be developed at the selected aspiration level. The
screen will display the actual amount of aspiration at any given time.

Ultrasound power is activated in Region 3 of Foot Pedal travel. Another momentary increase in Foot Pedal
resistance will be noted (if detents are enabled) signifying the transition from one Region to the next and the

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start of ultrasound power. Ultrasound power will be initiated and controlled as a function of Foot Pedal travel in
Region 3. The next ultrasound submode may be selected (if enabled) by moving the Foot Pedal in the outward
yaw direction.

Single Linear Ultrasound Mode with Linear Aspiration

Once irrigation has been initiated and the Foot Pedal has been depressed approximately five degrees (or as
programmed), an increase in Foot Pedal resistance will be noted, signifying the transition from Region 1 to
Region 2 and the start of aspiration. Aspiration will increase from 0 to the fixed level in proportion to Foot Pedal
travel in Region 2. The screen will display the actual amount of aspiration. Aspiration will remain at the fixed
level in Region 3.

Ultrasound power is activated in Region 3 of Foot Pedal travel. Another momentary increase in Foot Pedal
resistance will be noted, signifying the transition from one region to the next and the start of ultrasound power.
Linear ultrasound power will be initiated and controlled as a linear function of Foot Pedal travel in Region 3.
Pulsed ultrasound may be toggled on/off by moving the Foot Pedal in the outward yaw direction.

Note: I f single or multiple burst mode is selected, position 3 (or outward yaw movement) does not
control ultrasound power, but rather the burst interval (for multiple burst) or nearly full travel
initiates and resets the single burst (see page 4-50).

Dual Linear Ultrasound Mode with Aspiration in Yaw (Fixed Minimum

Vacuum in Region 2)
Once irrigation has been initiated and the Foot Pedal has been depressed approximately five degrees (or as
programmed), an increase in Foot Pedal resistance will be noted, signifying the transition from Region 1
to Region 2 and the start of aspiration. The minimum set aspiration will be developed in Region 2. Linear
aspiration to the maximum setting will be controlled by outward yaw Foot Pedal travel. The screen will display
the actual amount of aspiration.

Ultrasound power is activated in Region 3 of Foot Pedal travel. Another momentary increase in Foot Pedal
resistance will be noted, signifying the transition from one region to the next and the start of ultrasound power.
Linear ultrasound power will be initiated and controlled as a linear function of Foot Pedal travel in Region 3
(see note).

Dual Linear Ultrasound Mode with Aspiration in Yaw and Linear

Aspiration (Linear Vacuum in Region 2)
Once irrigation has been initiated and the Foot Pedal has been depressed approximately five degrees (or as
programmed), an increase in Foot Pedal resistance will be noted, signifying the transition from Region 1 to
Region 2 and the start of aspiration. Aspiration will increase from zero to the minimum level in proportion to
Foot Pedal travel in Region 2. Linear aspiration to the maximum setting will be controlled by outward yaw Foot
Pedal travel. The screen will display the actual amount of aspiration.

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Ultrasound power is activated in Region 3 of Foot Pedal travel. Another momentary increase in Foot Pedal
resistance will be noted, signifying the transition from one region to the next and the start of ultrasound power.
Linear ultrasound power will be initiated and controlled as a linear function of Foot Pedal travel in Region 3.

Note: I f single or multiple burst mode is selected, position 3 (or outward yaw movement) does not
control ultrasound power, but rather the burst interval (for multiple burst) or nearly full travel
initiates and resets the single burst.

Dual Linear Ultrasound Mode with Aspiration in Pitch

Irrigation is activated by Region 1 of Foot Pedal travel. As the Foot Pedal travels through Region 1, the
irrigation pinch valve will open to apply irrigation to the eye.

Aspiration is activated by Region 2 of Foot Pedal travel. A momentary increase in Foot Pedal resistance will
be noted, signifying the transition from Region 1 to Region 2 and the start of aspiration. In Region 2, linear
aspiration will be developed at the selected aspiration level. The screen will display the actual amount of
aspiration.

Linear ultrasound power will be initiated and controlled as a linear function of outward yaw Foot Pedal travel in
position 2.

Dual Linear Ultrasound

Dual Linear Ultrasound mode allows control of two ultrasound parameters, one on pitch and one on yaw.
In these modes, position 1 provides irrigation, position 2 provides fixed aspiration or fixed aspiration with
aspiration control feature enabled, and position 3 pitch and yaw movements provide linear control of two
ultrasound parameters. Modes are available for controlling power and pulse rate (pulsed), power and duty cycle
(pulsed), duration and duty cycle (multiple burst), power and duration (multiple burst), and power and duty
cycle (multiple burst).

Phacoemulsification Setup

WARNING: 
Never intentionally modify handpieces or tips, including bending, cutting, or engraving, as
they could break or malfunction.

WARNING: 
Do not touch an activated ultrasonic handpiece tip, as injuries could occur.

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WARNING: 
A loose needle may lead to improper tuning and could cause shedding of metal fragments into
the eye, which can result in serious permanent patient injury.

WARNING: 
For optimum aspiration and reflux performance, the patient’s eye level must be at the same
level as (no more than 7 cm [3 in.] from) the Stellaris Elite™ vision enhancement system
aspiration port. Failure to follow this procedure may result in serious and permanent patient
injury.

WARNING: 
The ultrasound handpiece, needle, and irrigation sleeve must be sterilized before performing
these steps.

Note: S pecific instructions for cleaning and sterilization included with the handpiece or accessory
take precedence over these instructions.

1. Turn Power on.

2. Press any button on the Primary (Integrated) Foot Control and wait until the ready light turns solid
green, indicating wireless communication has been established.
3. Select Surgeon’s Name and select Confirm.
4. Open disposable package and insert the cassette all the way in and hold until it is automatically captured
by the system. The cassette housing backlight will stop blinking and remain on when the system
captures the cassette. The vacuum test starts automatically.
5. After vacuum test completes, the Setup Screen will appear with Prime and Tune as the highlighted
function.
6. Spike the Balanced Salt Solution container and hang it at the desired height.
Additional step if pressurized infusion is used:
Connect the Air Tubing Line to the vent port at the bottle spike and the other end with air filter to the
Stellaris Elite™ vision enhancement system air output connector. Switch on the air pump from the system
setup screen; the control is at the upper right-hand of the screen. The output connector will remain lit
when it is at commanded pressure, and blink on and off when it is not at the commanded pressure.
7. Connect tubing to ultrasound handpiece. Select Show Me Steps for animated setup guide if necessary.
8. Plug the handpiece connector to the machine (second connector from the top on the left side).
9. Thread and firmly secure the ultrasound needle onto the ultrasound handpiece using a needle wrench.
10. Thread the irrigation sleeve over the ultrasound needle so that the holes in the irrigation sleeve are
placed approximately 1 mm from and perpendicular to the bevel of the ultrasound needle (increase to
approximately 1.5 mm for denser cataracts). For MICS needles, assemble sleeve as shown. Balanced

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Salt Solution wetting of the sleeve prior to assembly is advised to assist assembling the irrigation sleeve
to the needle.

Figure 4.37. Irrigation Sleeve and Needle (Left: Needle without ramp, Right: Needle with ramp)
1. Irrigation Sleeve. 2. Needle.

WARNING: 
When installing irrigation sleeve on phaco handpiece, avoid scratching the inner surface of
the sleeve with the needle tip. Inadvertent scratching of the sleeve’s inner surface may create
silicone particulate that may appear during surgery.

11. Ensure the irrigation clamp is open and toggle Irrigation Off to turn flow on, and allow the flow to
fill the irrigation tubing up to the handpieces. (See page 2-27 for details on the irrigation flow button.)
Activate the Fill button to turn flow on for 20 to 120 seconds. The duration is user-defined.
12. Fill the test chamber with irrigating solution, then slide over the tip of the handpiece.
13. Select Prime and Tune. A vacuum test is part of the priming cycle.
14. After successful priming and tuning, the Main Surgical Screen will appear.

The external components of your system are now ready. Continue to set the operating parameters.

Note:  he system will not provide feedback as to whether or not fluid is present during priming.
T
Inspect tubing and confirm that it is filled with fluid and free of bubbles after each Prime and
Tune. Repeat the priming process if the tubing is not adequately filled with fluid.

Phacoemulsification Use

WARNING: 
During any ultrasonic procedure, metal particles may result from inadvertent touching of the
ultrasonic tip with a second instrument. Another potential source of metal particles resulting
from any ultrasonic handpiece may be the result of ultrasonic energy causing micro abrasion
of the ultrasonic tip.

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WARNING: 
The ultrasound needle must be properly installed and not defective, and the irrigation and
aspiration lines must be properly connected.

Note:  old the handpiece tip towards the ceiling while priming the irrigation line to ensure all air has
H
been removed.

You have connected the external components of your Stellaris Elite™ vision enhancement system. Now you are
ready to set the operating parameters.

1. From the Main Surgical Screen, select the desired surgical mode from the Clock Menu.
2. Use the setting globes to set the desired aspiration level and the ultrasound maximum power. Set the
desired number of PPS for pulsed ultrasound.

Note:  nsure all air bubbles are cleared from lines during priming. Once the system has been primed,
E
ultrasound tuning will begin automatically, and ultrasound tone will sound. When complete, the
Main Surgical Screen will appear.

Note:  s a matter of operator convenience, priming is automatically canceled when tuning has been
A
completed or canceled. Re-tune if either the handpiece or ultrasound needle is changed.

3. Press the Foot Pedal to begin ultrasound operation. Aspiration and ultrasound power will be applied as
the Foot Pedal enters their pre-programmed regions (as described in page 1-43).
4. The Actual Vacuum displays the vacuum being used in relation to the maximum setting. The Actual
U/S progress bar displays amount of ultrasound power being used in relation to the maximum setting.
The Elapsed Time display indicates the time in minutes and seconds that ultrasound power has been
energized.

Note: See Chapter 5 for cleaning and sterilization requirements when surgery is completed.

Adaptive Fluidics
Features
If the system is installed with Stellaris Elite™ Software Rev 5.3 or higher, the Adaptive Fluidics function can
be enabled from either surgeon file programming or the surgical More Screen. Please refer to page 2-30 for
additional details related to the GUI for Adaptive Fluidics.

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• New Fluidics Function

• Adaptive Fluidics is a fluidics function for phacoemulsification surgery during lens removal and I/A
only.
• It is not available for anterior vitrectomy.
• Surgical Packs
• The new function is to be used with Adaptive Fluidics surgical packs.
• Fluidic Stability
• Adaptive Fluidics maintains fluidic stability inside the eye by linking variable infusion pressure
to the real-time surgeon-commanded vacuum level. The variable infusion pressure is generated by
pressurized air in the BSS bottle.

Adaptive Fluidics Setup (with Anterior Adaptive Fluidics Packs)

1. Turn Power on.

2. Press any button on the Foot Control. Wait until the ready light changes to solid green, indicating
wireless communication has been established.
3. Select Anterior Segment.
4. Select Surgeon’s Name, and then select Confirm.
5. Open disposables pack and insert fluid collection system as follows:
a. Insert the fluidics cassette completely.
b. Hold the fluidics cassette until it is automatically captured by the system.
c. The cassette housing backlight will stop blinking and turn solid when the system captures the
cassette.
6. Insert the spike into the BSS bottle, following the steps listed in Figure 4.38.

Figure 4.38. Steps for Inserting Spike into BSS Bottle.

1. Spiking tool. 2. Remove cover. 3. Spike bottle with spiking tool. 4. Insert spike into the bottle.

7. Squeeze and release the drip chamber until it is half filled with solution.
8. Hang the bottle at the desired BH.

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9. Connect the air tubing with filter to the air output connector at the back of the system (Figure 4.39).

Figure 4.39. Air Tubing Connected to the Back of the System.

10. Ensure Adaptive Fluidics and Pressurized Air are switched on.
a. The output connector LED ring will remain lit when it is at the commanded pressure, and blink
when it is not at the commanded pressure.
11. Ensure the irrigation clamp is open, connect the irrigation and aspiration lines to the handpiece, and
select Prime and Tune. Select Show Me Steps for animated setup guide.
12. After successful prime and tune, the system will transition to the surgical screen.

Note: Adaptive Fluidics is not available for anterior vitrectomy procedures.

Baseline Infusion Pressure (BIP) Settings

The use of Adaptive Fluidics does not require changes to the vacuum settings, needle/sleeve, tubing types, or
surgical techniques. Changes are only required to BIP settings for Adaptive Fluidics use. The BIP is the starting
infusion pressure when vacuum is 0 mmHg. During surgery, the infusion pressure will increase proportionally
to the commanded vacuum level.

It is the user’s prerogative to determine the appropriate BIP setting to optimize the surgical outcome. The
following calculation method is a guide to determine the BIP when transitioning to Adaptive Fluidics:

9:;..7 01))'*+
!"# = %&'()'*+ "*-.('/* 01))'*+ − !/))31 41'+ℎ) ( 774+ ) − ( )
11

WARNING: 
Turning Adaptive Fluidics ON or OFF requires the user to check and adjust the infusion
settings in each surgical phase throughout the user file.

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Compensation Factor (CF) Settings

There are five levels of CF settings for Adaptive Fluidics. The default CF setting is level three. Higher CF
settings provide higher intraocular pressure (IOP) compensation when the vacuum is activated. A higher CF
setting could be used to sustain anterior chamber stability in the event of abnormal/unexpected substantial fluid
leakage through the incision.

Reflux with Adaptive Fluidics Surgical Packs

When operating Adaptive Fluidics using surgical packs which have a built-in reflux bulb on the cassette,
the user has access to more Reflux options. The options can be selected from the Foot Control More Screen
(Figure 4.40).

Figure 4.40. Reflux Options Selection from More Screen.

Reflux Types
• Continuous: Reflux pressure is based on irrigation pressure.
• Single High: Reflux is created by the momentary activation of a plunger on the reflux bulb.
• Single Low: Similar to Single High reflux with lower pressure.

Reflux activation can be programmed with Inward Yaw of the Foot Pedal and also on any of the Foot Control
buttons.

Anterior Vitrectomy Function

The Stellaris Elite™ vision enhancement system supports a pneumatic vitrectomy cutter, which uses
pressurized air to drive the guillotine-type vitrectomy cutter. The Advanced Vacuum System provides aspiration
to draw the vitreous material into the port, where it is then cut and aspirated through the flexible tubing into the
disposable collection container.

Anterior Vitrectomy Cutter Modes

The Advanced Vacuum System provides two vitrectomy cutter modes:

Fixed Cut
Pneumatic cutter: The control may be adjusted to provide a fixed cutting speed from 30 cuts per minute (CPM)
to 7500 CPM.

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Dual Linear Cut

Pneumatic cutter: The control may be adjusted to provide a linear cutting speed from 30 CPM to 7500 CPM.
The Foot Pedal yaw is used to achieve dual linear function.

The cut rate may be adjusted from 30 CPM to 7500 CPM, with increments as shown in the table below, or to
any specific value using the keypad.

Range Step Size

30 CPM to 100 CPM 10 CPM
100 CPM to 1000 CPM 50 CPM
1000 CPM to 7500 CPM 100 CPM

Planned Anterior Vitrectomy Setup

WARNING: 
For optimum aspiration and reflux performance, the patient’s eye level must be at the same
level as (no more than 7 cm [3 in.] from) the Stellaris Elite™ vision enhancement system
aspiration port. Failure to follow this procedure may result in serious and permanent patient
injury.

1. Turn Power on.

2. Press any button on the Primary (Integrated) Foot Control and wait until the ready light turns solid
green, indicating wireless communication has been established.
3. Select Surgeon’s Name and select Confirm.
4. Open the disposable phaco package and insert the fluidics cassette all the way in and hold until it is
automatically captured by the system. The cassette housing backlight will stop blinking and remain on
when the system captures the cassette.
5. Spike the Balanced Salt Solution container and hang it at the desired height.
If pressurized infusion is used:
Connect the Air Tubing Line to the vent port at the bottle spike and the other end with air filter to the
Stellaris Elite™ vision enhancement system air output connector. Switch on the air pump from the system
setup screen; the control is at the upper right-hand of the screen. The output connector will remain lit
when it is at commanded pressure, and blink on and off when it is not at the commanded pressure.
6. Ensure the irrigation clamp is open, connect the irrigation and aspiration lines together, and select
Prime. Select Show Me Steps for animated setup guide if needed.
7. Open the vitrectomy cutter pack; connect the tubing and the actuation line to the pneumatic port on the
Stellaris Elite™ vision enhancement system.
8. Apply a pinch clamp (not supplied) at the end of the irrigation line to shut off irrigation flow when using
the vitrectomy cutter without irrigation. Do not close the clamp on the irrigation line.
9. Ensure the irrigation clamp is opened and the tip is immersed in irrigation solution, then select Vit Test.

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10. After successful test, select Advance to Surgery and the Main Surgical Screen will appear.

Planned Anterior Vitrectomy Use

1. Select Vit from the Clock Menu. The Show Me Steps animated setup guide will appear.
2. Use the setting globes to set the desired vacuum level and cut rate.
3. For Fixed cut vitrectomy, yaw the Foot Pedal outward to toggle the cutter on and off, and depress the
Foot Pedal for aspiration. An audio tone will signify cutter operation (if enabled). Fixed cut rate is
activated in Foot Pedal Region 2.
4. For Linear cut vitrectomy, activate the cutter by outward yaw travel of the Foot Pedal in Region 2.
5. For Reflux (if enabled), rotate the Foot Pedal inward.

Unplanned Anterior Vitrectomy Setup

In the event anterior vitrectomy is needed during phaco surgery:

1. Select the Vitrectomy mode from the Clock Menu. The Show Me Steps animated setup guide will
appear. Select Close to close the animated setup guide.
2. Open the appropriate vitrectomy cutter pack.
For the pneumatic cutter, connect tubing and the actuation line to the pneumatic port on the
Stellaris Elite™ vision enhancement system.
3. Ensure that the irrigation clamp is open and the tip is immersed in irrigation solution. Select Setup, then
Pneumatic Vit Test. Select Show Me Steps for animated setup guide if needed.
4. After a successful test, select Advance to Surgery and select the Vit phase from the Clock Menu.

Primary (Integrated) Foot Control of Anterior Vitrectomy Mode

As the Foot Pedal is initially pressed, the irrigation control valve will open to allow irrigation into the eye.

Once irrigation has been initiated and the Foot Pedal has been depressed approximately five degrees (or as
programmed), a momentary increase in Foot Pedal resistance will be noted, signifying the transition from
Region 1 to Region 2 and the start of aspiration. Aspiration increases proportional to Foot Pedal travel, with the
maximum level being set via the Max Vacuum input on the touch screen. Region 2 will provide linear control
of aspiration. The Actual Vacuum display will indicate the current aspiration level.

If enabled, an audible linear tone will indicate aspiration. The pitch of the tone increases with increased
aspiration.

For Fixed Cut vitrectomy mode, vitreous cutting is activated in Region 2. The cut rate is fixed. Each successive
outward yaw movement toggles the cutter ON or OFF. If enabled, an audible tone will indicate cutter on (double
beep) or cutter off (single beep).

For Dual Linear Cut mode, outward yaw movement provides linear control of the cut rate as a function of Foot
Pedal displacement once it is within Region 2. The actual cut rate is displayed on the screen. When the Foot

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Pedal is released, it returns to center and the cutter is disabled. If enabled, an audible linear tone indicates cut
rate, and the pitch of the tone increases with increased cutter speed.

Reflux (if enabled) is activated by inward yaw movement of the Foot Pedal.

By default, the vitrectomy cutter is On.

Pressurized Infusion

WARNING: 
When using Pressurized Infusion with Balanced Salt Solution bottle hung on the system
automated IV pole, the actual intraocular pressure will be higher than the air pressure
displayed in the machine. The actual intraocular pressure would be equal to air pressure
combined with hydrostatic pressure created from the gravity force.

WARNING: 
When using air pressured infusion, hang the bottle so that the drip chamber is close to patient
eye level.

Note: S pecific instructions for cleaning and sterilization included with the handpiece or accessory
take precedence over these instructions.

The Pressurized Infusion function infuses a preset air pressure to pressurize the Balanced Salt Solution bottle.
The pressure generated would force Balanced Salt Solution into the eye to maintain a preset intraocular pressure
(IOP). The air pressure is generated by a compressor in the system and air is infused into the bottle through
air tubing. The use of Pressurized Infusion function would replace the gravity infusion that depends on bottle
height. The preset air pressure may be adjusted from the system screen display.

Enable Pressurized Infusion Function

To enable Pressurized Infusion function from Surgical More Screen:

1. Select the More Screen button.

2. Select the Infusion Tab of the pop-up screen.
3. Select Infusion type of Pressurized Infusion.
4. The Pressurized Infusion settings and function can be saved through Save Settings command button.

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Figure 4.41. More Screen, Infusion Tab (Anterior Domain).

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Figure 4.42. More Screen, Infusion Tab (Combined Domain).

Pressurized Infusion Setup

1. Remove the filter cap (A) from the bottle spike venting port that comes with the system disposable pack
in Figure 4.43.
2. Connect the Air Tubing Line male connector to the bottle spike venting port (A) in Figure 4.43.
3. Connect the Air Tubing Line filter to the vision enhancement system air source (B) in Figure 4.43.
4. Spike and hang the bottle on the hanger at the desired bottle height.
5. Use the up and down arrows to select the desired air pressure.
6. Turn On the air pump by selecting the Off button below the setting display. Selecting the same button
again will turn off the pump.

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Figure 4.43. Pressurized Infusion Setup.

Note: I f the infusion type is set to “Pressurized Infusion”, the pump will come on when a cassette is
captured and the vacuum check completes.

4.4. Coagulation Function (Posterior & Anterior Modes)

WARNING: 
Check the coagulation power level when changing between extraocular and intraocular
cauterization.

WARNING: 
Use only bipolar handpieces and cables designed and manufactured or distributed by
Bausch + Lomb that are designated for use with this system. Failure to do so may affect
system performance and create hazards. Use of accessories manufactured or distributed by
Bausch + Lomb on systems for which they are not designated may affect system performance
and create hazards.

WARNING: 
Failure of HF surgical equipment could result in an unintended power output increase.

WARNING: 
The patient leads should be positioned in such a way that contact with the patient or other
leads is avoided. Temporarily unused bipolar handpieces should be stored in a location that is
isolated from the patient.

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WARNING: 
When the device and physiological monitoring equipment are used simultaneously on the
same patient, any monitoring electrodes should be placed as far as possible from the surgical
electrodes. Needle monitoring electrodes are not recommended. In all cases, monitoring
systems incorporating high-frequency current limiting devices are recommended.

CAUTION: 
All bipolar accessories must be rated for an operating voltage of at least 120V.

Note: I f Linear Coagulation is enabled or a Primary (Integrated) Foot Control button is programmed
for coagulation, begin by plugging in the coagulation cord.

Note: No neutral electrode is required for use of the bipolar function.

Note: The output power selected should be as low as possible for the intended purpose.

Note: For explanation of Dual Linear Primary (Integrated) Foot Control see page 1-57.

Bipolar coagulation is accomplished with the Stellaris Elite™ vision enhancement system Coagulation
Function. Bipolar forceps or pencil handpieces are used as electrodes. Coagulation power may be adjusted from
0% to 100% of the output power using the up/down arrow keys. The available coagulation modes are:

Fixed coagulation mode

Provides an adjustable output between 0% and 100%. Power levels are set via setting globe control. Fixed
coagulation may be actuated by any Primary (Integrated) Foot Control button, if programmed. Fixed
coagulation remains activated as long as the button remains depressed.

Linear coagulation mode

Provides an adjustable output between 0% and 100%. Power levels are set via setting globe control. Linear
Coagulation is selected from the Clock Menu on the Main Surgical Screen. Linear coagulation is actuated
by depressing the Foot Pedal, if it has been programmed to provide linear control as a function of angular Foot
Pedal displacement.

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Fixed Coagulation Setup and Use

WARNING: 
Ensure the handpiece and accessories are sterilized before use.

WARNING: 
Cables to the surgical electrodes should be positioned such that contact with the patient or
other leads are avoided.

Note: S ee Chapter 5 for cleaning and sterilization requirements when surgery is completed.
Specific instructions for cleaning and sterilization included with the handpiece or accessory
take precedence over these instructions.

Figure 4.44. Fixed Coagulation Handpiece setup.

1. Adaptor CX9404. 2. To system coagulation connector.
3. 2-pin connector style. 4. Lemo connector style.

1. Connect the desired bipolar forceps or pencil to its cable. You may need to use an adapter.
2. Connect the bipolar cable to the coagulation connector.

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3. Use the setting globes to adjust the percentage of coagulation power desired.
4. The fixed coagulation function is activated by pressing the programmed Primary (Integrated) Foot
Control switch. When the switch is released, the function will deactivate. Fixed coagulation mode is
accessible during the system setup.
5. If programmed, a tone will signify bipolar coagulation operation.

Linear Coagulation Setup and Use

WARNING: 
Ensure the handpiece and accessories are sterilized before use as specified.

Note: S pecific instructions for cleaning and sterilization included with the handpiece or accessory
take precedence over these instructions.

Note: See Chapter 5 for cleaning and sterilization requirements when surgery is completed.

Note:  ue to compliance with 60601-2-2, position 1 will not start until approximately 35% of pedal
D
travel is attained in the linear coagulation mode.

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Figure 4.45. Linear Coagulation Handpiece Setup.

1. Adaptor CX9404. 2. To system coagulation connector.
3. 2-pin connector style. 4. Lemo connector style.

1. Connect the desired bipolar forceps or pencil to its cable. The use of an adapter may be necessary.
2. Connect the bipolar cable to the coagulation electrical connector, if required.
3. Select Coag from the Clock Menu.
4. Use the setting globes to adjust the Max Coagulation power desired.
5. The linear coagulation function is actuated by the Foot Pedal, if programmed. The Actual Coagulation
progress bar will display the amount of coagulation power being used in relation to the maximum
setting.
6. A tone will signify bipolar coagulation operation if programmed.

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4.5. Combined Domain

The Stellaris Elite™ PC and PC with Laser systems that are configured to support combined procedures allow
users to perform both posterior and anterior segment surgeries with the dedicated software interface and packs.
Select Posterior/Anterior Segment in the Select Procedure startup screen to begin. The Posterior/Anterior
Domain user interface allows the user to perform all the posterior and anterior functions from a single surgical
screen and cassette pack.

Note: Make sure the pack you are using is appropriate for the domain selected.

Combined Procedure Setup and Use

WARNING: 
For optimum aspiration and reflux performance, the patient’s eye level must be at the same
level as (no more than 7 cm [3 in.] from) the Stellaris Elite™ vision enhancement system
aspiration port. Failure to follow this procedure may result in serious and permanent patient
injury.

Note: S pecific instructions for cleaning and sterilization included with any handpiece or accessory
take precedence over these instructions.

1. Connect the compressed air source to the connector on the lower rear of the system.
2. Turn the power on and wait until the screen displays the Primary (Integrated) Foot Control or other
system messages.
3. Acknowledge and close all messages.
4. To operate the Primary (Integrated) Foot Control wirelessly, press any button on the Primary
(Integrated) Foot Control and wait until the ready light turns solid green. This indicates that wireless
communication has been established.
5. The screen will display Select Procedure. (If your system is programmed to default to either the
Anterior Domain or the Posterior/Combined Domain, the Select Procedure Screen will not appear, and
the system will move directly to the Select Surgeon Screen, as shown in Figure 1.8.)
6. Select Posterior/Anterior Segment, and the screen will transition to the Select Surgeon Screen. (Skip
this step if the system is already displaying the Select Surgeon Screen.)
7. Select Surgeon’s Name and then Confirm to transition to the Insert Cassette screen.
8. Open the combined surgical pack with the following steps:
a. Hold the bottom of the tray with one hand with the thumb placed in the thumb notch. (Circulating
Nurse)
b. Tear open the Tyvek seal with the other hand toward the body. (Circulating Nurse)

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c. Transfer contents onto sterile field. (Circulating Nurse)

d. Identify loose components from the pre-connected tubing set. (Scrub Nurse)
e. Drape the system tray and screen with drapes provided. (Scrub Nurse)
f. Arrange the pre-connected tubing set with cassette, bottle spike, air tubing filter and actuation
connector toward the system front. The priming cup is placed at the other end with the tubing set
in the middle as shown in the figure below. (Scrub Nurse)

Figure 4.46. Pre-connected tubing set.

g. Remove the tape to unbind all the tubing. (Scrub Nurse)

h. Straighten the tube set and secure it so it will not drop off the sterile surface. (Scrub Nurse)
i. Insert the fluidics cassette all the way in and hold until it is automatically captured by the system.
The cassette housing backlight will stop blinking and remain on when the system captures the
cassette. (Scrub Nurse or Circulating Nurse)
j. Connect the air tubing filter to the system (second connector down, on the right side of the
machine). Ensure the air pump is on. (Scrub Nurse or Circulating Nurse)
k. Connect the vitrectomy actuation line (blue stripe) to the system. (Scrub Nurse or Circulating
Nurse)
l. Pass the bottle spike and irrigation tubing to Circulating Nurse. (Scrub Nurse)
m. Spike and hang the Balanced Salt Solution container on the automated IV pole or the Zero Level
hanger if using AFI. Squeeze and release the drip chamber until it is half filled with solution.
(For AFI setup, use the spiking tool provided to puncture the rubber stopper on the bottle before
inserting the metal cannula into the bottle.) (Circulating Nurse). See Figure 4.5.
n. Remove the tape on the priming cup. (Scrub Nurse)
o. Place the priming cup flat on the tray as in the figure below. (Scrub Nurse)

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Figure 4.47. Priming cup with infusion cannula, left aspiration and vitrectomy cutter attached.

9. Select the first button from the Easy Prime selection menu to initiate the auto priming and vitrectomy
cutter test sequence. (Scrub Nurse or Circulating Nurse)

Note:  he system will not provide feedback as to whether or not fluid is present during priming.
T
Inspect tubing and confirm that it is filled with fluid and free of bubbles after each Prime and
Tune. Repeat the priming process if the tubing is not adequately filled with fluid.

The posterior section setup is now complete.

Anterior Segment Setup

1. Remove the second aspiration line from the priming cup and connect to the phaco handpiece.
2. Remove the irrigation line from the 2-way stopcock and connect it to the phaco handpiece. See Show
Me Steps for animated setup guide if necessary.

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Figure 4.48. Connecting tubing to the phaco handpiece.

1. Phaco Handpiece. 2. Phaco Needle. 3. Irrigation sleeve. 4. Test Chamber. 5. Connect to U/S
connector. 6. Connect to Vit actuation port. 7. Connect to air pressure port.

3. Plug the handpiece connector to the machine (second connector from the top, U/S port).
4. Thread and firmly secure the ultrasound needle onto the ultrasound handpiece using a needle wrench.
5. Slide the irrigation sleeve over the ultrasound needle so that the holes in the irrigation sleeve are
placed approximately 1 mm from and perpendicular to the bevel of the ultrasound needle (increase
to approximately 1.5 mm for denser cataracts). For MICS needles, assemble sleeve as shown in
Figure 4.37. Balanced salt solution of the sleeve prior to assembly is advised to assist assembling the
irrigation sleeve to the needle.

WARNING: 
When installing irrigation sleeve on phaco handpiece, avoid scratching the inner surface of
the sleeve with the needle tip. Inadvertent scratching of the sleeve’s inner surface may create
silicone particulate that may appear during surgery.

6. Toggle the Irrigation Off button to turn flow on, and allow the flow to fill the irrigation tubing up to
the handpieces. See page 2-27 for details on the irrigation flow button. Activate the Fill button with turn
flow on for 20 to 120 seconds. The duration is user-defined.
7. Fill the test chamber with irrigating solution, then slide over the tip of the handpiece.
8. Select Prime and Tune. A vacuum test is part of the priming cycle.

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After successful priming and tuning, the Main Surgical Screen will appear.

Adaptive Fluidics is a fluidics function for phacoemulsification surgery during lens removal and I/A only. It is
not available for anterior vitrectomy and all posterior phases. The function is to be used with Adaptive Fluidics
surgical packs. This function is also available for combined procedure using combined surgical packs that come
with a vented BSS spike (AFI packs). Please see page 4-53 for detailed information on Adaptive Fluidics, and
page 2-30 for Adaptive Fluidics changes to the GUI.

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4. Detailed Reference

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5. Cleaning and Sterilization

5. Cleaning and Sterilization

5. Cleaning and Sterilization
 5. Cleaning and Sterilization Requirements

5. Cleaning and Sterilization Requirements

This chapter provides instructions for cleaning the Stellaris Elite™ vision enhancement system, and for
cleaning and sterilization of the reusable accessories.

WARNING: 
Do not reprocess single-use instruments.

WARNING: 
Do not use this procedure for any items other than those described within this manual.

CAUTION: 
Preventative scheduled maintenance is recommended once a year to ensure that the
Stellaris Elite™ vision enhancement system meets its optimum performance, reliability
and safety standards set by the manufacturer. The maintenance shall be done by a
Bausch + Lomb certified individual only.

5.1. Routine Cleaning

WARNING: 
Do not reprocess single-use instruments.

WARNING: 
Disconnect AC power before cleaning the system.

CAUTION: 
To preserve the surface finish, avoid the use of abrasive cleaners. If possible, clean spots
before they dry.

Bausch + Lomb tested the following products, and found that they can be used on all external surfaces of the
Stellaris Elite™ vision enhancement system. Use of any substance not listed is at the user’s own risk.
• Isopropyl alcohol (70%)
• Mild soap and water

You should wipe the external surfaces of the Stellaris Elite™ vision enhancement system, Primary (Integrated)
Foot Control and remote control with a soft cloth moistened with cleaning solution on a weekly basis while
the Stellaris Elite™ vision enhancement system is disconnected from any power supply. Avoid applying any

4135904EN Operator’s Manual 5-1

5. Cleaning and Sterilization Requirements

cleaner directly to the display (apply to cloth sparingly). Remove all traces of the cleaning solution with a cloth
dampened with clean water, and dry the surfaces with a lint-free cloth.

You should clean the fluid level detection lens (Figure 5.1) every three months with a 4 x 4 in. gauze pad and
isopropyl alcohol.

Figure 5.1. Fluid Level Detection Lens.

Gently swab the electrical connectors with an alcohol swab weekly, taking care to avoid excessive quantities of
cleaning solution around the ports. Do not reconnect to power until the ports have completely dried.

5.2. Reusable Accessories

All Stellaris Elite™ vision enhancement system requirements for cleaning and sterilization of reusable
accessories are located within the accessory Reprocessing Instructions. Accessories may include bipolar
coagulation accessories, irrigation and irrigation/aspiration handpieces, ultrasound handpieces and accessories.

5.3. Laser Protective Eyewear

Use isopropyl alcohol, or soap and water to clean the lenses of the goggles. Rinse with warm water and air-dry.
DO NOT USE ANY OTHER CLEANING SOLVENTS. Laser protective eyewear should be stored at room
temperature.

5-2 Operator’s Manual 4135904EN

6. Troubleshooting

6. Troubleshooting
6. Troubleshooting
 6. Troubleshooting

6. Troubleshooting
This chapter contains procedures for identifying and resolving problems that may occur with your
Stellaris Elite™ vision enhancement system.

CAUTION: 
Preventative scheduled maintenance is recommended once a year to ensure that the
Stellaris Elite™ vision enhancement system meets optimum performance, reliability
and safety standards set by the manufacturer. The maintenance shall be done by a
Bausch + Lomb certified individual only.

Note:  ther than main fuses, power cords, and lamps (PC systems only), this system contains no parts
O
that are serviceable by the user. All maintenance shall be done by a Bausch + Lomb certified
individual only.

6.1. User Troubleshooting

• If possible, try a known good handpiece or connector to isolate the issue.
• If the aspiration line becomes clogged, and it cannot be cleared using reflux, remove the handpiece
from the eye and clear the aspiration port of lodged material.
• If ultrasound calibration fails, check connections and needle, then attempt calibration a second time. If
calibration fails twice, change to a known good handpiece and attempt to calibrate again. If a known
good handpiece fails calibration, or if assistance is needed to determine if the original handpiece is
defective, contact the Global Product Support (see Chapter 7).

6.2. Power Issues

WARNING: 
For continued protection of operators and patients from electrical and other hazards, replace
fuses only with the same type and rating as defined in the service instructions.

WARNING: 
For continued protection of operators and patients from electrical hazards, only replace the
mains power cord with a Bausch + Lomb-specified replacement.

If you flip the main power switch and no power is sent to the system (i.e., the Standby power switch does not
light up, there is no faint fan noise from the lower rear of the system, etc.) there may be a bad fuse. First check

4135904EN Operator’s Manual 6-1

6. Troubleshooting

that the rest of the operating suite has power, the cord is still plugged in, and the wall outlet is still supplying
proper power.

If the power supply chain appears to be intact, you may have a blown fuse. A blown fuse is usually noticeable
after removal from the system by obvious discoloration within the fuse and/or an obviously broken fuse-wire
within the fuse.

Fuse Replacement
The Stellaris Elite™ vision enhancement system has 2 user-replaceable fuses. If an over-current condition
should occur which opens these fuses, they must be replaced with fuses of the same type and rating as the
original fuses (see specifications table in Chapter 8).

A blown fuse may be indicated when you are using a known good outlet, and no power is sent to the system
when you flip the main power switch to on (i.e., the Standby power switch is not lit up, no faint fan noise from
the lower rear of the system, etc.).

A blown fuse is usually noticeable after removal from the system by obvious discoloration within the fuse and/
or an obviously broken fuse-wire within the fuse.

Note: If damage is apparent to either fuse, both should be replaced to ensure proper operation.

a. Remove the power cord from the Stellaris Elite™ vision enhancement system. The presence of the
power cord will physically prevent the removal of the fuse drawer.
b. Using a flat-blade screwdriver, turn the fuse holder counter-clockwise, and pull outward. One style of
fuse holder will come partially out and the fuse will drop out. On the other style, the fuse is retained by
clips on the back.
c. Replace the fuses, reinstall the fuse holder and lock it by turning clockwise.
d. Snap the fuse drawer back into place.
e. Replace the cord and the system should be ready to run again.

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 6. Troubleshooting

Fuse Holder Location

Figure 6.1. Fuse Holder Location.

6.3. Laser Calibration Verification (Stellaris Elite™

BL15455 only)
The Stellaris Elite™ vision enhancement system Laser function should have its output verified annually. An
external power meter is used to measure the actual power delivered through the delivery devices. The
Stellaris Elite™ vision enhancement system also displays the power delivered from the selected delivery
device. Bausch + Lomb recommends using an annually calibrated laser power meter system (e.g. Thorlabs
S142C laser power sensor and compatible meter head) with a previously unused EndoProbe.

To measure the power:

A. Wear appropriate eye protection.

B. Connect a known good EndoProbe to the laser port.
C. Prepare the Stellaris Elite™ vision enhancement system and enter the laser Endo mode.
D. Select laser power to the value on the chart below.
E. Select 50 ms exposure Duration and 50 ms Repeat Interval (50% duty cycle).
F. Select Treat mode and turn the aiming beam on.
G. Direct the end of the EndoProbe into the power meter so that the aiming beam diameter is 2 mm to
4 mm in diameter and centered in the meter.
H. Depress the footswitch, measure the delivered power, and record this value. Make sure to select the
correct wavelength (532 nm) and range as needed on the power meter.
I. Repeat steps D through H for each value on the chart.
J. If a reading falls outside the minimum/maximum value shown (+/-20%), recheck the test setup, the
power meter, the placement of the device into the meter, and the delivery device. If possible, test with
another delivery EndoProbe. If the system is still out of calibration, it must be returned for service (see
7.1. Service Information on page 7-1).

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6. Troubleshooting

Display Meter Reading Date Minimum @ Maximum @

50% duty cycle 50% duty cycle
50 20 30
350 140 210
2000 800 1200

6.4. Laser Interlocks (Stellaris Elite™ BL15455 only)

Room Interlock & Safety Light Instructions

The Stellaris Elite™ vision enhancement system includes a 3M, 37104-B122-00E MB, 4-pin yellow insulation
displacement plug for user termination of a room interlock and/or a room laser safety light. This connector
accepts 22 and 24 AWG wire with outer diameters from 1.0 mm to 2.0 mm. Bausch + Lomb recommends Alpha
79052 if additional wire is needed.

The door interlock circuit is in pins 1 and 2 of the connector. A normally open mechanical switch should be
used in the door frame, with a closed circuit when the door is closed and an open circuit when the door is open.
Connect one side of the switch to pin 1 and the other side of the switch to pin 2.

CAUTION: 
Do not interface this circuit to any external power.

If you are not installing a door interlock but will use a Laser Safety Light, use a short piece of 22 AWG wire to
connect pins 1 and 2.

The Room Laser Safety Light circuit is in pins 3 and 4 of the connector. It is a normally open relay contact that
is closed when the laser is enabled. The circuit will support any lamp that uses less than 2A at 24 VDC. If the
lamp is less than 50W DC, connect pin 3 of the connector to the lamp source voltage, and pin 4 of the connector
to the high side of their lamp. An additional wire will be needed from the low side of the lamp to the ground
side (or return) of the power supply.

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 6. Troubleshooting

Figure 6.2. Wiring Diagram for Room Interlock.

If your lamp uses more power (is greater than 50W DC or AC power), a dry contact relay and DC Power supply
must be installed with the lamp. In this case, the higher voltage or circuit that powers the lamp must go through
the switching contact of the relay, and the lower voltage power supply must be used as the source voltage for pin
3, as shown below.

Figure 6.3. Wiring Diagram for Room Interlock with Dry Connection.

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6. Troubleshooting

After inserting all the wires into the connector, use pliers to press the yellow block into the black body mating
the insulation displacement blades. Insert the plug into the 4-pin port on the Power Input Module of the
Stellaris Elite™ vision enhancement system.

Microscope Filter Interlocks

The Stellaris Elite™ vision enhancement system includes a 3M, 37103-A124-00E MB, and a 3-pin green
insulation displacement plug for user termination of a Removable Microscope Filter (RMF). This connector
accepts 22 and 24 AWG wire with outer diameters from 1.0 mm to 2.0 mm. Bausch + Lomb recommends
Belden 9533 if additional wire is needed. To terminate this plug, you will need the wiring definition of your
RMF.

Figure 6.4. Interlock Connector.

Note:  sers with a microscope equipped with a 2-position laser safety filter for use with a Millennium
U
Microsurgical System should call Bausch + Lomb for a BL3242 adapter.

1. If your RMF is only 2 wires with a mechanical switch between them, trim the two wires to a matched
length and insert into the back of the connector body into pins 2 and 3.

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 6. Troubleshooting

Figure 6.5. Interlock Switch with Two Wires.

2. If your RMF is 3 wires (identified as power, switch, and ground), trim the wires to a matched length and
insert into the back of the connector body with power in pin 1, switch in pin 2, and ground in pin 3.
3. If your RMF is 4 wires (identified as power, switch 1 and switch 2 or switch ground, and ground), use a
multimeter to verify 4 ohms or less between the 2 grounds. Once verified, follow step 2 above, leaving
one of the two ground wires unconnected. If the voltage cannot be verified, cut off 2 inches from the 2
grounds, strip a ¼" off three of the wires and create a Y by soldering them together, then continue with
step 2 above.
4. For any other RMF configuration call Bausch + Lomb for assistance (see page 7-1).
5. After inserting the wires into the connector, use a standard set of pliers to press the green block into the
black body, mating the insulation displacement blades.

Figure 6.6. Interlock Closure.

6. Finally, insert the plug into the 3-pin port on the Power Input Module of the Stellaris Elite™ vision
enhancement system.

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6. Troubleshooting

6.5. System Messages

All system messages displayed by the user interface are uniform in their appearance. However, the message box
will have a red border if a safety-related condition is present. When an event occurs, the system will sound a
tone and display a pop-up window with the appropriate message displayed. The pop-up window may provide a
choice of options for proceeding, but no other action may be taken while a message box is active.

Messages and suggested corrective actions are shown in the following tables.

Message Prefix Trouble Area

BPS Power supply module, refer to page 6-9.
CPX Compressor module, refer to page 6-10.
EIV IV Pole module, refer to page 6-12.
LAS Laser module, refer to page 6-35.
LM Light module, refer to page 6-31.
RCR Remote control receiver module, refer to page 6-13.
UIC/PRT User interface computer module, refer to page 6-14.
USM Ultrasound module, refer to page 6-17.
VFM Vacuum fluidics module, refer to page 6-21.
WFC Wireless Primary (Integrated) Foot Control module, refer to page 6-27.
WFR Wireless Primary (Integrated) Foot Control Receiver module, refer to page 6-31.

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 6. Troubleshooting

Power Supply Module Messages

ID Type Message Suggested Action

BPS02 Caution The power supply was not detected Call your product service
in the system. Surgical mode is not representative.
available.
BPS03 Caution The power supply software version Call your product service
is not compatible with this software representative. A compatible software
version. Surgical mode is not available. version must be installed.
BPS04 Caution The power supply has failed to respond Call your product service representative
to a settings command. The module if this problem persists.
settings have been re-sent to the
module.
BPS05 Caution The power supply has reset. The Call your product service representative
module settings have been re-sent to if this problem persists.
the module.
BPS07 Informational The power module temperature is Confirm that the bottom and lower rear
higher than expected. areas of the system are not blocked
from free air flow.
Call your product service representative
if this problem persists.
BPS08 Caution The power module is at an over Confirm that the bottom and lower rear
temperature condition. System areas of the system are not blocked
shutdown is imminent. from free air flow.
Call your product service representative
if this problem persists.
BPS09 Caution The power module output is low. Call your product service representative
System functions may not be available. if this problem persists.
BPS12 Informational A back-up battery was detected in Call your product service representative
the power supply. This feature is no if this problem persists.
longer supported. Surgical mode is not
available.

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6. Troubleshooting

Compressor Module Messages

ID Type Message Suggested Action

CPX01 Caution The compressor module was not Call your product service
detected in the system. Surgical mode representative.
is not available.
CPX02 Caution The compressor module software Call your product service
version is not compatible with the representative. A compatible software
system software version. Surgical mode version must be installed.
is not available.
CPX03 Caution The compressor module has failed to Call your product service representative
respond to a settings command. The if this problem persists.
module settings have been re-sent to
the module.
CPX04 Caution The compressor module has reset. The Call your product service representative
module settings have been re-sent to if this problem persists.
the module.
CPX05 Caution The air pressure output is lower than Check that the air line tubing is
commanded. connected tightly to the system.
Check that there are no leaks in the
air line and that the air line tubing
is connected tightly to the pack
components.
Call your product service representative
if this problem persists.
CPX06 Caution The air pressure output is higher than P/C Domains:
commanded. Disconnect the air tubing from the
system and switch to gravity infusion
setup.

Anterior Domain:
Change the bottle and switch to gravity
infusion setup.

Call your product service representative

if this problem persists.
CPX07 Caution The internal air pressure system cannot PC Systems BL14455 and BL15455
reach the full pressure expected. Only:
Increase input pressure to nominal
pressure of 85 psi (5.9 bars). Call your
product service representative if this
problem persists.
CPX08 Caution The internal vacuum pump has failed. Call your product service representative
if this problem persists.

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 6. Troubleshooting

ID Type Message Suggested Action

CPX09 Caution The internal vitrectomy air pressure is PC Systems BL14455 and BL15455
low. Only:
Increase input pressure to nominal
pressure of 85 psi (5.9 bars). Call your
product service representative if this
problem persists.
CPX10 Caution Viscous fluid injection pressure is low. PC Systems BL14455 and BL15455
Only:
Check that the VFI tubing is connected
tightly to the system and to the other
pack systems. Call your product service
representative if this problem persists.
CPX11 Caution Viscous fluid injection pressure is high. Call your product service representative
if this problem persists.
CPX12 Caution Viscous fluid extraction vacuum is low. PC Systems BL14455 and BL15455
Only:
Check that the VFI tubing is connected
tightly to the system and to the other
pack systems. Call your product service
representative if this problem persists.
CPX13 Caution Viscous fluid extraction vacuum is Call your product service representative
high. if this problem persists.
CPX14 Informational External supply pressure is low. PC Systems BL14455 and BL15455
Only:
Increase input pressure to nominal
pressure of 85 psi (5.9 bars).
CPX15 Caution The internal air pressure supply to PC Systems BL14455 and BL15455
the vacuum fluidics module is low. Only:
The vacuum fluidics module may not Increase input pressure to nominal
function properly. pressure of 85 psi (5.9 bars).
Call your product service representative
if this problem persists.
CPX19 Caution The vitrectomy cutter input pressure is Call your product service representative
high. The vitrectomy cutter function is if this problem persists.
not available.
CPX20 Caution The internal air pressure supply to Call your product service representative
the vacuum fluidics module is high. if this problem persists.
The vacuum fluidics module may not
function properly.
CPX22 Caution The internal air pressure system Call your product service representative
pressure is higher than expected. if this problem persists.
CPX23 Informational External supply pressure is high. PC Systems BL14455 and BL15455
Only:
Decrease input pressure to 85 psi (5.9
bars).

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6. Troubleshooting

ID Type Message Suggested Action

CPX24 Informational The compressor module has failed the Ensure that the front and back air ports
pressure sensors power up test. are not connected to tubing and shut
down the system by selecting the ‘End’
icon, confirming any prompts, and then
selecting the ‘Shutdown System’ button
on the End screen. Following system
shut down, restart the system. Close
this message and then complete this
action or use the ‘Shut Down System’
button on this message.

Call your product service representative

if this problem persists.

IV Pole Module Messages

ID Type Message Suggested Action

EIV01 Caution The IV Pole controller was not detected Call your product service
in the system. Surgical mode is not representative.
available.
EIV02 Caution The IV Pole controller software version Call your product service
is not compatible with the system representative. A compatible software
software version. Surgical mode is not version must be installed.
available.
EIV03 Caution The IV Pole controller has failed to Call your product service representative
respond to a settings command. The if this problem persists.
module settings have been re-sent to
the module.
EIV04 Caution The IV Pole controller has reset. The Call your product service representative
module settings have been re-sent to if this problem persists.
the module.
EIV05 Caution The IV Pole position cannot be Command the IV Pole to the minimum
determined. bottle height position using the down
arrow or the numeric keypad for the
IV Pole bottle height setting on the
surgical screen. Close this message
and then complete this action or use
the ‘Lower IV Pole’ button on this
message.

Call your product service representative

if this problem persists.

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 6. Troubleshooting

ID Type Message Suggested Action

EIV07 Caution The IV Pole is not detecting the home Call your product service representative
position switch or the IV Pole motor if this problem persists.
may have failed.
EIV08 Caution The IV Pole panel button sensors Ensure that the IV Pole back panel
have failed or the buttons have been buttons are not activated.
activated continuously since being Confirm proper operation of the IV
powered on. Pole back panel buttons.
Call your product service representative
if this problem persists.

Remote Control Receiver Module Messages

ID Type Message Suggested Action

RCR01 Caution The remote control receiver was not Call your product service
detected in the system. Surgical mode representative.
is not available.
RCR02 Caution The remote control receiver software Call your product service
version is not compatible with the representative. A compatible software
system software version. Surgical mode version must be installed.
is not available.
RCR03 Caution The remote control receiver has failed Call your product service representative
to respond to a settings command. The if this problem persists.
module settings have been re-sent to
the module.
RCR04 Caution The remote control receiver has reset. Call your product service representative
The module settings have been re-sent if this problem persists.
to the module.
RCR05 Informational Possible interference with remote Turn off or dim room lights. Certain
control receivers. Remote control types of room lighting may cause this
function may not be available. type of interference.
Call your product service representative
if this problem persists.
RCR06 Informational The remote control battery level is low. Replace the remote control battery at
Remote control function may not be your earliest convenience.
available shortly. Call your product service representative
if this problem persists.

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6. Troubleshooting

User Interface Computer (UIC) Module Messages

ID Type Message Suggested Action

UIC01 Informational The IV Pole height has been limited to Go to Infusion More screen or
the maximum ceiling height. The IV programming function to reset max
Pole height range is {X}-{Y} {cm | IV Pole Height. Close this message
mmHg}. to complete this action or use the ‘Set
Max IV Pole Height’ button on this
message.
UIC03 Informational Phase/Mode change not allowed while Change Phase/Mode while surgical
surgical functions are in use. functions are not in use.
UIC04 Caution Initialization of surgical system failed. Power down the system by selecting the
Surgical mode not available. ‘End’ icon, confirming any prompts,
and then selecting the ‘Shutdown
System’ button on the End screen.
Following system shut down, restart the
system. Close this message and then
complete this action or use the ‘Shut
Down System’ button on this message.

Call your product service representative

if this problem persists.
UIC06 Informational Cassette type does not match procedure Press Yes for a {anterior, posterior,
type. Do you want to change to the combined} procedure, or Press No to
matching procedure type? eject the cassette.
UIC07 Informational Cassette type does not match procedure Please insert a posterior cassette.
type.
UIC08 Informational Incorrect ultrasound handpiece Please plug in a {Phaco, Frag}
connected. handpiece, or try a different ultrasound
handpiece.
UIC09 Informational Priming/Tuning/Vitrectomy cutter Please wait for Priming/Tuning/
testing is in progress. Vitrectomy cutter testing to complete.
UIC13 Informational Surgeon File Is Not Usable due to loss None
of database integrity. Try a system
default setting file.
UIC14 Informational Posterior and Combined Techniques None
Only: The IV Pole and AFI are both
engaged. Please confirm that the AFI
bottle is at patient eye level.
UIC15 Informational A laser endoprobe is not connected. Connect an EndoProbe.
UIC16 Informational A laser Laser Indirect Ophthalmoscope Connect an LIO.
(LIO) is not connected.
UIC17 Informational A laser module is not installed; laser Call your product service
functions will not be available. representative.

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 6. Troubleshooting

ID Type Message Suggested Action

UIC18 Informational The laser foot control is programmed Change the laser Foot Control to
for primary (integrated) but the primary secondary (LIO) via the info screen.
(integrated) foot control is not found.
Connect the Primary (Integrated) Foot
Control.
UIC19 Informational The laser foot control is programmed Connect the secondary (LIO) Foot
for secondary (LIO) but the secondary Control.
(LIO) foot control is not connected.
Change the laser Foot Control to
primary (integrated) via the info screen.
UIC20 Caution A loss of audio feedback processing Power down the system by selecting the
has been detected. System may not be ‘End’ icon, confirming any prompts,
providing audio feedback. and then selecting the ‘Shutdown
System’ button on the End screen.
Following system shut down, restart the
system. Close this message and then
complete this action or use the ‘Shut
Down System’ button on this message.

Call your product service representative

if this problem persists.
UIC21 Caution The system requires restarting due to None
an internal error, Please perform the
following

1. Select “Shutdown” to initiate system

shutdown.

2. If system does not shut down in

30 seconds, power off the system by
pressing and holding the power button
at the front panel

3. Restart system after 1 minute.

Call your product service representative

if this problem persists.
UIC22 Informational Anterior module installed is not Call your product service
compatible with Vitesse; Vitesse representative.
functions will not be available.

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6. Troubleshooting

ID Type Message Suggested Action

UIC23 Informational This technique was programmed with Call your product service
the Adaptive Fluidics feature enabled, representative. A compatible software
but this feature is not available with version must be installed.
the current system hardware and/or
software options configuration. Check
and adjust the infusion settings in each
surgical phase during this procedure.
UIC24 Informational This technique was programmed with Turn Adaptive Fluidics off. Check and
the Adaptive Fluidics feature enabled. adjust the infusion settings in each
When this feature is used with the surgical phase during this procedure.
anterior cassette, confirm that the
vented long bottle spike is inserted.
Select Yes to confirm the vented bottle
spike is in use, or select No to turn
Adaptive Fluidics off.
UIC27 Caution Exercise care when using the Single Set Reflux Type to Single Low. Close
reflux types near the retina with the the message and then complete this
Vitesse handpiece. Position the Vitesse action or use the Single Select Low
handpiece at a distance to the retina Reflux Button on the message. Select
that is equal to or greater than the size Continue to continue with Single High
of the optic disc when using the Single Reflux selected.
reflux types, especially the Single High
reflux type.
User Interface Prompt Messages
PRT1 Prompt Press Yes to confirm turning off N/A
pressurized infusion.
PRT2 Prompt Please allow setup functions to N/A
complete and turn off all surgical
functions before entering the
Programming mode.
PRT3 Prompt This mode change will turn N/A
off/on surgical functions and load new
settings!
(i.e. Alternate Infusion, Fluid Air
Exchange, Air, Illuminators)
Are you sure you want to change
modes?
PRT4 Prompt 1) Close the Irrigation Clamp. N/A
2) Press yes to end case.
PRT5 Prompt This mode change will turn off N/A
Alternate Infusion. Are you sure you
want to change modes?
PRT10 Prompt Are you sure you want to Shut Down N/A
the System?

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 6. Troubleshooting

ID Type Message Suggested Action

PRT11 Prompt Clamp the irrigation line, then Press N/A
Yes to eject the cassette.
PRT12 Prompt Press Yes to confirm turning on or off N/A
Adaptive Fluidics. Check and adjust
infusion settings in each surgical phase
throughout this procedure.

Ultrasound Module Messages

ID Type Message Suggested Action

USM01 Caution The ultrasound module was not Call your product service
detected in the system. Surgical mode representative.
is not available.
USM02 Caution The ultrasound module software Call your product service
version is not compatible with the representative. A compatible software
system software version. Surgical mode version must be installed.
is not available.
USM03 Caution The ultrasound module has failed to Call your product service representative
respond to a settings command. The if this problem persists.
module settings have been re-sent to
the module.
USM04 Caution The ultrasound module has reset. The Call your product service representative
module settings have been re-sent to if this problem persists.
the module.
USM05 Informational The ultrasound handpiece is not Please plug in the {Phaco, Frag}
connected or detected. handpiece. The ultrasound connector
indicator light is flashing.
If the handpiece is not detected, unplug
the handpiece and try another {Phaco,
Frag} handpiece.
Call your product service representative
if this problem persists.
USM06 Informational The ultrasound handpiece has not been Select ‘Setup’, then select ‘Prime/
tuned. Tune’ or ‘Tune Only’ button. Close this
message and then complete this action
or select the ‘Prime/Tune’ button on
this message.

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6. Troubleshooting

ID Type Message Suggested Action

USM08 Informational The ultrasound handpiece has failed the Ensure ultrasound needle is properly
tuning process. tightened, the handpiece is sufficiently
cooled, and the connector is dry. Select
the ‘Prime/Tune’ or ‘Tune Only’ button
again to repeat the handpiece tuning
process. Close this message and then
complete this action or use the ‘Prime
and Tune’ button on this message.

Unplug the handpiece and try another

ultrasound handpiece. Select the
‘Prime/Tune’ or ‘Tune Only’ button
again to repeat the handpiece tuning
process. Close this message and then
complete this action or use the ‘Prime
and Tune’ button on this message.

Call your product service representative

if this problem persists.
USM09 Informational The ultrasound handpiece may have Unplug the handpiece and try another
failed or may be failing. ultrasound handpiece. Select the
‘Prime/Tune’ or ‘Tune Only’ button
again to repeat the handpiece tuning
process. Close this message and then
complete this action or use the ‘Prime
and Tune’ button on this message.

Call your product service representative

if this problem persists.
USM10 Caution Coagulation circuit may have failed, Unplug the bipolar handpiece and cord
potential coagulation output over- and try another bipolar handpiece and
voltage condition. cord.

Call your product service representative

if this problem persists.
USM11 Caution Coagulation circuit may have failed, Unplug the bipolar handpiece and cord
potential uncommanded or incorrect and try another bipolar handpiece and
coagulation output. cord.

Call your product service representative

if this problem persists.

6-18 Operator’s Manual 4135904EN

 6. Troubleshooting

ID Type Message Suggested Action

USM15 Informational Unable to read ultrasound handpiece Ensure ultrasound needle is properly
data. Attempt to tune the handpiece to tightened, the handpiece is sufficiently
confirm proper operation. cooled, and the connector is dry. Select
the ‘Prime/Tune’ or ‘Tune Only’ button
again to repeat the handpiece tuning
process. Close this message and then
complete this action or use the ‘Prime
and Tune’ button on this message.

Unplug the handpiece and try another

ultrasound handpiece. Select the
‘Prime/Tune’ or ‘Tune Only’ button
again to repeat the handpiece tuning
process. Close this message and then
complete this action or use the ‘Prime
and Tune’ button on this message.

Call your product service representative

if this problem persists.
USM16 Informational The ultrasound module fan has failed. Power down the system by selecting the
The ultrasound handpiece cannot be ‘End’ icon, confirming any prompts,
tuned or operated. and then selecting the ‘Shutdown
System’ button on the End screen.
Following system shut down, restart the
system. Close this message and then
complete this action or use the ‘Shut
Down System’ button on this message.

Call your product service representative

if this problem persists.
USM17 Informational The Vitesse handpiece is not connected Plug in the Vitesse handpiece. The
or detected. ultrasound connector indicator light is
flashing.

If the handpiece is not detected, unplug

the handpiece and try another Vitesse
handpiece.

Call your product service representative

if this problem persists.
USM18 Informational The Vitesse handpiece has not been Select the ‘Setup’ icon, and then select
tuned. the ‘Easy Prime’ or ‘Tune Vitesse’
button. Close this message and then
complete this action or select the
‘Prime / Tune’ button on this message.

4135904EN Operator’s Manual 6-19

6. Troubleshooting

ID Type Message Suggested Action

USM19 Informational The Vitesse handpiece has failed the Unplug the handpiece and try
tuning process. another Vitesse handpiece. Select the
Prime/Tune Vitesse or Tune Vitesse
button again to repeat the handpiece
tuning process. Close this message
and then complete this action or use
the Prime/Tune Vitesse button on this
message.

Call your product service representative

if this problem persists.
USM20 Informational The Vitesse handpiece may have failed Unplug the handpiece and try
or may be failing. another Vitesse handpiece. Select the
Prime/Tune Vitesse or Tune Vitesse
button again to repeat the handpiece
tuning process. Close this message
and then complete this action or use
the Prime/Tune Vitesse button on this
message.

Call your product service representative

if this problem persists.

6-20 Operator’s Manual 4135904EN

 6. Troubleshooting

Vacuum Fluidics Module Messages

ID Type Message Suggested Action

VFM01 Caution The vacuum fluidics module was not Call your product service
detected in the system. Surgical mode representative.
is not available.
VFM02 Caution The vacuum fluidics module software Call your product service
version is not compatible with the representative. A compatible software
system software version. Surgical mode version must be installed.
is not available.
VFM03 Caution The vacuum fluidics module has failed Call your product service representative
to respond to a settings command. The if this problem persists.
module settings have been re-sent to
the module.
VFM04 Caution The vacuum fluidics module has reset. Call your product service representative
The module settings have been re-sent if this problem persists.
to the module.
VFM05 Caution The vacuum fluidics module does not Call your product service representative
have valid factory calibration data. to replace or calibrate the vacuum
Surgical mode is not available. fluidics module.
VFM07 Informational The cassette vacuum check is in Please wait for the cassette vacuum
progress. check to complete.
VFM08 Informational The cassette vacuum check has failed. Eject the cassette using the ‘Eject
Cassette’ icon button in the status
display and then re-insert the cassette to
retry the cassette vacuum check. Close
this message and then complete this
action or use the ‘Eject Cassette’ button
on this message.

Eject the cassette using the ‘Eject

Cassette’ icon button in the status
display and then replace the cassette
with a new cassette. Close this message
and then complete this action or use the
‘Eject Cassette’ button on this message.

Call your product service representative

if this problem persists.
VFM09 Informational System priming has not been Select the ‘Setup’ icon, then select the
completed. ‘Prime’ or ‘Prime and Tune’ button to
complete the system priming. Close
this message and then complete this
action or use the ‘Prime’ or ‘Prime and
Tune’ button on this message.

4135904EN Operator’s Manual 6-21

6. Troubleshooting

ID Type Message Suggested Action

VFM11 Informational System priming has failed. Check irrigation and aspiration tubing
connections for leaks. Check that
the test chamber is forming a tight
seal around the handpiece. Select the
‘Setup’ icon, then select the ‘Prime’ or
‘Prime and Tune’ button to complete
the system priming. Close this message
and then complete this action or use the
‘Prime’ or ‘Prime and Tune’ button on
this message.

Eject the cassette using the ‘Eject

Cassette’ icon button in the status
display and then load a new pack.
Close this message and then complete
this action or use the ‘Eject Cassette’
button on this message.

Call your product service representative

if this problem persists.

6-22 Operator’s Manual 4135904EN

 6. Troubleshooting

ID Type Message Suggested Action

VFM13 Informational The cassette is nearly full. P/C Domains:
At the soonest convenient time, empty
the cassette. To empty the cassette:
1. Clamp the infusion line. 2. Select
the eject cassette icon. 3. Empty the
cassette. 4. Re-insert the cassette.
5. Open the infusion clamp. Refer
to operator’s manual for detailed
instructions to detach tubing manifold
from the cassette.

Anterior Domain:
At the soonest convenient time, empty
the cassette. To empty the cassette:
1. Clamp the irrigation line. 2. Replace
the test chamber on the handpiece.
3. Select the eject cassette icon.
4. Empty the cassette. 5. Re-insert the
cassette. 6. Open the irrigation clamp
7. Remove the test chamber from the
handpiece. Refer to operator’s manual
for detailed instructions to detach
tubing manifold from the cassette.

Eject the cassette using the ‘Eject

Cassette’ icon button in the status
display and then load a new pack.
Close this message and then complete
this action or use the ‘Eject Cassette’
button on this message.

Call your product service representative

if the cassette is not nearly full and this
message persists.

4135904EN Operator’s Manual 6-23

6. Troubleshooting

ID Type Message Suggested Action

VFM14 Caution The cassette is full. P/C Domains:
Empty the cassette. To empty the
cassette: 1. Clamp the infusion line.
2. Select the eject cassette icon.
3. Empty the cassette. 4. Re-insert the
cassette. 5. Open the infusion clamp.
Refer to operator’s manual for detailed
instructions to detach tubing manifold
from the cassette.

Anterior Domain:
Empty the cassette. To empty the
cassette: 1. Clamp the irrigation line.
2. Replace the test chamber on the
handpiece. 3. Select the eject cassette
icon. 4. Empty the cassette. 5. Re-insert
the cassette. 6. Open the irrigation
clamp 7. Remove the test chamber
from the handpiece. Refer to operator’s
manual for detailed instructions to
detach tubing manifold from the
cassette.

Eject the cassette using the ‘Eject

Cassette’ icon button in the status
display and then load a new pack.
Close this message and then complete
this action or use the ‘Eject Cassette’
button on this message.

Call your product service representative

if the cassette is not full and this
problem persists.

6-24 Operator’s Manual 4135904EN

 6. Troubleshooting

ID Type Message Suggested Action

VFM15 Caution The vitrectomy cutter output pressure Check that the vitrectomy cutter tubing
is low. Vitrectomy cutter may not be is connected tightly. Select the ‘Setup’
cutting. icon, then select the ‘Vit Test’ button.
Close this message and then complete
this action or select the ‘Vit Test’ button
on this message.

Replace the vitrectomy cutter. Select

the ‘Setup’ icon and then select the ‘Vit
Test’ button. Close this message and
then complete this action or select the
‘Vit Test’ button on this message.

Call your product service representative

if this problem persists.
VFM17 Informational Please insert the cassette. None
VFM18 Informational Unrecognized cassette. Please re-insert the cassette or try a
different cassette.

Call your product service representative

if this problem persists.
VFM19 Caution A Vacuum Fault has occurred. Eject the cassette using the ‘Eject
Cassette’ icon button in the status
display and then load a new pack.
Close this message and then complete
this action or use the ‘Eject Cassette’
button on this message.

Call your product service representative

if this problem persists.
VFM20 Informational Reflux is not available – Reflux cannot To activate reflux, release the Foot
be activated when aspiration is active. Pedal to a non-aspirating position
and activate the inward yaw reflux
command or the button programmed
for reflux.
VFM21 Informational Reflux is not available – too many Press the Foot Pedal to activate a short
reflux pulses have been activated, period of aspiration before re-activating
aspiration must be commanded again to reflux.
reset the reflux function.
VFM22 Informational Aspiration is not available – the Foot Release the Foot Pedal to home
Pedal started in the inward yaw position position and ensure the Primary
when pressed to activate aspiration or (Integrated) Foot Control button
the foot control button programmed for programmed for reflux is not activated.
reflux is activated. Press the Foot Pedal into the aspiration
region again to obtain aspiration.

4135904EN Operator’s Manual 6-25

6. Troubleshooting

ID Type Message Suggested Action

VFM23 Informational Aspiration is not available – in Manual Set Manual mode infusion to ON.
infusion mode, infusion is set to OFF. Close this message and then complete
this action or use the ‘Infusion On’
button on this message.
VFM24 Informational The cassette was not captured – the Clean and dry the fluid level detection
fluid level sensor could not be read. lens inside the cassette capture slot
on the right side (red blinking light)
as recommended in the Operator’s
Manual, and insert the cassette again.

Call your product service representative

if this problem persists.
VFM26 Informational The fluid level sensor could not be Without ejecting the cassette, gently
read. push it back into the module. This
message will clear automatically once
the fluid level sensor can be read
successfully.

Clean and dry the fluid level detection

lens inside the cassette capture slot
on the right side (red blinking light)
as recommended in the Operator’s
Manual, and insert the cassette again.

Eject the cassette using the ‘Eject

Cassette’ icon button in the status
display and then replace the cassette
with a new cassette. Close this message
and then complete this action or use the
‘Eject Cassette’ button on this message.

Call your product service representative

if this problem persists.
VFM27 Informational Aspiration is not available - Pressurized Set pressurized infusion to ON. Close
infusion is commanded OFF. this message and then complete this
action or use the ‘Infusion On’ button
on this message.

6-26 Operator’s Manual 4135904EN

 6. Troubleshooting

Primary (Integrated) Foot Control Module Message

ID Type Message Suggested Action

WFC01 Informational The foot control battery has exceeded If the battery does not provide power
300 charge cycles. The foot control for the full day, replace the battery.
battery may not provide power for the Use the Primary (Integrated) Foot
entire day. Control cable to connect the Primary
(Integrated) Foot Control to the system.
Replace the Primary (Integrated)
Foot Control with another Primary
(Integrated) Foot Control. Use the
wired cable connection to initially
pair the new Primary (Integrated) Foot
Control with the system.
WFC02 Caution The foot control does not have valid Replace the Primary (Integrated)
factory calibration data. Surgical mode Foot Control with another Primary
is not available. (Integrated) Foot Control. Use the
wired cable connection to initially
pair the new Primary (Integrated) Foot
Control with the system.
Call your product service representative
to have the Primary (Integrated) Foot
Control calibrated.
WFC03 Informational The foot control is programmed for Change the Primary (Integrated) Foot
right footed operation, but is set up for Control home position switch selector
left footed operation. located underneath the pedal to the
center position or left-side biased for
right footed operation or to the center
position or right-side biased for left
footed operation.
Confirm the correct surgeons’ settings
file is loaded. If incorrect, return to the
Setup Select Surgeon screen to select
the correct settings file. Close this
message and then complete this action
or select the ‘Select Surgeon’ button on
this message.

4135904EN Operator’s Manual 6-27

6. Troubleshooting

ID Type Message Suggested Action

WFC04 Informational The foot control is programmed for left Change the Primary (Integrated) Foot
footed operation, but is set up for right Control home position switch selector
footed operation. located underneath the pedal to the
center position or left-side biased for
right footed operation or to the center
position or right-side biased for left
footed operation.
Confirm the correct surgeons’ settings
file is loaded. If incorrect, return to the
Setup Select Surgeon screen to select
the correct settings file. Close this
message and then complete this action
or select the ‘Select Surgeon’ button on
this message.
WFC05 Caution The foot control center pedal or button Reposition the Primary (Integrated)
sensors have failed or the foot control Foot Control and ensure that the center
has been activated continuously since pedal and buttons are not activated.
being powered on. Replace the Primary (Integrated)
Foot Control with another Primary
(Integrated) Foot Control. Use the
wired cable connection to initially
pair the new Primary (Integrated) Foot
Control with the system.
Change the Primary (Integrated) Foot
Control home position switch selector
located underneath the pedal to the
center position or left-side biased for
right footed operation or to the center
position or right-side biased for left
footed operation.
Call your product service representative
if this problem persists.

6-28 Operator’s Manual 4135904EN

 6. Troubleshooting

ID Type Message Suggested Action

WFC08 Informational The system is not detecting the wireless Initiate wireless Primary (Integrated)
foot control. Foot Control connectivity by pressing
one of the Primary (Integrated) Foot
Control buttons momentarily, the left
LED will light up.
Use the Primary (Integrated) Foot
Control cable to connect the Primary
(Integrated) Foot Control to the system.
Replace the Primary (Integrated)
Foot Control with another Primary
(Integrated) Foot Control. Use the
wired cable connection to initially
pair the new Primary (Integrated) Foot
Control with the system.
Call your product service representative
if this problem persists.
WFC09 Caution The foot control software version is not Replace the Primary (Integrated)
compatible with the system software Foot Control with another Primary
version. Surgical mode is not available. (Integrated) Foot Control. Use the
wired cable connection to initially
pair the new Primary (Integrated) Foot
Control with the system.
Call your product service
representative. A compatible software
version must be installed.
WFC10 Informational Foot control detected on wired cable Please wait while the Primary
connection. (Integrated) Foot Control configuration
completes.
WFC11 Informational Foot control configuration on wired You may disconnect the Primary
cable connection has completed (Integrated) Foot Control cable and
successfully. operate the Primary (Integrated) Foot
Control wirelessly.
WFC12 Informational Foot control configuration on the wired Replace the Primary (Integrated)
cable connection has failed. Foot Control with another Primary
(Integrated) Foot Control. Use the
wired cable connection to initially
pair the new Primary (Integrated) Foot
Control with the system.
Call your product service representative
if this problem persists.
WFC13 Caution The foot control battery charge level is Use the Primary (Integrated) Foot
low. Control cable to connect the Primary
(Integrated) Foot Control to the system.
If the battery does not provide power
for the full day, replace the battery.

4135904EN Operator’s Manual 6-29

6. Troubleshooting

ID Type Message Suggested Action

WFC14 Caution The foot control battery is nearly Use the Primary (Integrated) Foot
discharged and may be insufficient to Control cable to connect the Primary
complete the case. (Integrated) Foot Control to the system.
If the battery does not provide power
for the full day, replace the battery.
WFC16 Caution The foot control spring has failed; the Replace the Primary (Integrated)
foot control center pedal is disabled. Foot Control with another Primary
(Integrated) Foot Control. Use the
wired cable connection to initially
pair the new Primary (Integrated) Foot
Control with the system.
Call your product service representative
if this problem persists.
WFC17 Caution The foot control battery has exceeded Immediately replace the battery to
300 charge cycles and the battery is ensure Primary (Integrated) Foot
nearly discharged. The foot control Control functionality.
may stop functioning unless the battery Replace the Primary (Integrated)
is replaced immediately. Foot Control with another Primary
(Integrated) Foot Control. Use the
wired cable connection to initially
pair the new Primary (Integrated) Foot
Control with the system.
WFC18 Informational The system is not detecting the wired Use the Primary (Integrated) Foot
foot control. Control cable to connect the Primary
(Integrated) Foot Control to the system.
Replace the Primary (Integrated)
Foot Control with another Primary
(Integrated) Foot Control. Use the
wired cable connection to initially
pair the new Primary (Integrated) Foot
Control with the system.
Call your product service representative
if this problem persists.
WFC19 Caution The system has lost communications Go to the programming function to
with the wireless foot control, wireless re-enable wireless communication.
function is disabled. Close this message and then complete
this action or use the ‘Re-enable
Wireless’ button on this message.

Connect the Primary (Integrated) Foot

Control cable to continue surgery.

6-30 Operator’s Manual 4135904EN

 6. Troubleshooting

ID Type Message Suggested Action

WFC20 Caution The system has lost communications Check the Primary (Integrated) Foot
with the wired foot control. Control cable connection.
Replace the Primary (Integrated)
Foot Control with another Primary
(Integrated) Foot Control. Use the
wired cable connection to initially
pair the new Primary (Integrated) Foot
Control with the system.
Call your product service representative
if this problem persists.
WFC21 Informational Charge the foot control battery before Charge the Primary (Integrated) Foot
next use. Control battery before next use.

Primary (Integrated) Foot Control Receiver Module Messages

ID Type Message Suggested Action

WFR01 Caution The foot control receiver was not Call your product service
detected in the system. Surgical mode representative.
is not available.
WFR02 Caution The foot control receiver software Call your product service
version is not compatible with the representative. A compatible software
system software version. Surgical mode version must be installed.
is not available.
WFR03 Caution The foot control receiver has failed to Call your product service representative
respond to a settings command. The if this problem persists.
module settings have been re-sent to
the module.
WFR04 Caution The foot control receiver has reset. The Call your product service representative
module settings have been re-sent to if this problem persists.
the module.

Illumination Module Messages

ID Type Message Suggested Action

LM01 Caution The light module was not detected Call your product service
in the system. Surgical mode is not representative.
available.
LM02 Caution The light module software version Call your product service
is not compatible with the system representative. A compatible software
software version. Surgical mode is not version must be installed.
available.

4135904EN Operator’s Manual 6-31

6. Troubleshooting

ID Type Message Suggested Action

LM03 Caution The light module has failed to respond Call your product service representative
to a settings command. The module if this problem persists.
settings have been re-sent to the
module.
LM04 Caution The light module has reset. The module Call your product service representative
settings have been re-sent to the if this problem persists.
module.
LM05 Caution The upper illuminator bulb is near end PC Systems BL14455 and BL15455
of life. Only:
Use the lower illumination source.
Replace the upper illuminator bulb at
your earliest convenience (requires
system shutdown).
LM06 Caution The lower illuminator bulb is near end PC Systems BL14455 and BL15455
of life. Only:
Use the upper illumination source.
Replace the lower illuminator bulb at
your earliest convenience (requires
system shutdown).
LM07 Caution The illuminator temperature is too high. Call your product service representative
The illuminators have been turned off. if this problem persists.
LM09 Caution The upper illuminator bulb has failed. PC Systems BL14455 and BL15455
Only:
Use the lower illumination source.
Replace the upper illuminator bulb at
your earliest convenience (requires
system shutdown).
LM10 Caution The lower illuminator bulb has failed. PC Systems BL14455 and BL15455
Only:
Use the upper illumination source.
Replace the lower illuminator bulb at
your earliest convenience (requires
system shutdown).
LM11 Caution The illuminator filter control has failed. Call your product service representative
if this problem persists.
LM12 Caution The upper illuminator brightness Call your product service representative
control has failed. if this problem persists.
LM13 Caution The lower illuminator brightness Call your product service representative
control has failed. if this problem persists.

6-32 Operator’s Manual 4135904EN

 6. Troubleshooting

ID Type Message Suggested Action

LM14 Caution The upper illuminator bulb type is not PC Systems BL14455 and BL15455
valid. Only:
Use the lower illumination source.
Replace the upper illuminator bulb at
your earliest convenience (requires
system shutdown).
Call your product service representative
if this problem persists.
LM15 Caution The lower illuminator bulb type is not PC Systems BL14455 and BL15455
valid. Only:
Use the upper illumination source.
Replace the lower illuminator bulb at
your earliest convenience (requires
system shutdown).
Call your product service representative
if this problem persists.
LM16 Caution The upper illuminator fan has failed. Call your product service representative
Illuminators will be turned off in 5 if this problem persists.
minutes if the fan failure persists.
LM17 Caution The lower illuminator fan has failed. Call your product service representative
Illuminators will be turned off in 5 if this problem persists.
minutes if the fan failure persists.
LM18 Caution The upper illuminator has a bulb ballast Call your product service
error and cannot be used. It will be representative.
turned off in 30 seconds.
LM19 Caution The lower illuminator has a bulb ballast Call your product service
error and cannot be used. It will be representative.
turned off in 30 seconds.
LM20 Caution The upper illuminator bulb voltage is PC Systems BL14455 and BL15455
high. Only:
Use the lower illumination source.
Replace the upper illuminator bulb at
your earliest convenience (requires
system shutdown).
LM21 Caution The lower illuminator bulb voltage is PC Systems BL14455 and BL15455
high. Only:
Use the upper illumination source.
Replace the lower illuminator bulb at
your earliest convenience (requires
system shutdown).
LM23 Caution The illuminator ballast fan has failed. Call your product service representative
The illuminators will be turned off in if this problem persists.
30 seconds.

4135904EN Operator’s Manual 6-33

6. Troubleshooting

ID Type Message Suggested Action

LM24 Caution The upper illuminator bulb is at end of PC Systems BL14455 and BL15455
life. Lamp will be disabled when turned Only:
off. Use the lower illumination source.
Replace the upper illuminator bulb at
your earliest convenience (requires
system shutdown).
LM25 Caution The lower illuminator bulb is at end of PC Systems BL14455 and BL15455
life. Lamp will be disabled when turned Only:
off. Use the lower illumination source.
Replace the upper illuminator bulb at
your earliest convenience (requires
system shutdown).
LM26 Caution The illuminator temperature is too high. Call your product service representative
The illuminators will be turned off in if this problem persists.
2.5 minutes if the fan failure persists.
LM27 Informational Note that the level of light output None
being requested should be used with
And awareness of exposure time and
proximity to the retina.
LM28
Limiting exposure to less than a
guideline value of 10 J/cm2 helps
maintain the retinal tissue. At the
requested setting, this dose level may
be exceeded in less than 30 minutes
with the Bausch & Lomb focal light
probe positioned 15mm from the retina.

Do you want to continue?

6-34 Operator’s Manual 4135904EN

 6. Troubleshooting

ID Type Message Suggested Action

LM27 Informational The time to reach the exposure None
Page 2 guidelines will vary with:

And 1) Filter selection - Value reached

within the 30 minutes with the
LM28 following settings:
Page 2
a) White - 60%

b) Green - 68%

c) Yellow - 88%

d) Amber - 100%

2) Distance from the retina

3) Light dispersing probes

Consult the User Manual for additional

information.

Do you want to continue?

Laser Module Messages

ID Type Message Suggested Action

LAS01 Caution The laser module was not detected Call your product service
in the system. Surgical mode is not representative.
available.
LAS02 Caution The laser module software version Call your product service
is not compatible with the system representative. A compatible software
software version. Surgical mode is not version must be installed.
available.
LAS03 Caution The laser module has failed to respond Call your product service representative
to a settings command. The module if this problem persists.
settings have been re-sent to the
module.
LAS04 Caution The laser module has reset. The module Call your product service representative
settings have been re-sent to the if this problem persists.
module.
LAS05 Caution The laser module emergency stop has Cycle the Laser Key switch to
been pressed. deactivate emergency stop.

4135904EN Operator’s Manual 6-35

6. Troubleshooting

ID Type Message Suggested Action

LAS06 Caution A laser module malfunction has Cycle the Laser Key off and then on.
occurred, malfunction code XX (where
XX is the code). Call your product service representative
if this problem persists.
LAS07 Caution Ensure that the eye safety filter is None
installed (Endo mode) and operating
room personnel have proper eye
protection.
LAS08 Informational Laser treatment mode is unavailable – None
see the laser status.
LAS09 Informational Laser not in treatment mode. Select the laser mode button to enter
ready mode.
LAS10 Caution Laser has failed to deliver the Cycle the Laser Key off and then on.
commanded power. Call your product service representative
if this problem persists.

Internal Application Messages

The system requires restarting due to an internal error, please perform the following:

1. Select Shut Down System to initiate system shutdown.

2. If system does not shut down after 30 seconds, power off the system by pressing and holding the power
button on the front panel.
3. Restart system after one minute.

Call your product service representative if this problem persists.

6-36 Operator’s Manual 4135904EN

 6. Troubleshooting

Additional Troubleshooting Guide

Symptom Potential Cause Corrective Action

1 Primary (Integrated) Foot The Foot Pedal Offset switch not properly Check Offset switch at the
Control lost Pitch control engaged. System not detecting if Foot Pedal back of the Foot Pedal,
of Region 2, 3 and Yaw. is offset to Left, Right or Center. See page 1-50. ensure switch is fully
Pitch could only control engaged to the Left, Right
Irrigation On/Off. or Center.
The four side buttons
function normally.

1. Pitch Tension Adjustment. 2. Battery Door.

3. Offset Adjustment.
2 Primary (Integrated) The Primary (Integrated) Foot Control does Following the
Foot Control does not not automatically transition to wireless disconnection of backup
automatically transition operation every time the backup cable is cable, initiate wireless
to wireless operation after disconnected. Primary (Integrated) Foot
disconnecting the Primary Control connectivity
(Integrated) Foot Control by pressing one of the
backup cable. Primary (Integrated) Foot
Control buttons. The right
LED light would light
up within 10 seconds;
indicating wireless
connection is ready.
3 System not reading cassette The cassette was not fully inserted. This Eject cassette and reinsert.
fluid level correctly. can occur if the cassette is inserted slowly
and captured in a position that affects the To ensure cassette is
performance of the fluid level sensor. properly positioned in the
system, firmly insert the
This may also occur if the cassette is inserted cassette until it snaps in
too fast and released before the capture place.
mechanism captures the cassette at the
optimum position.

4135904EN Operator’s Manual 6-37

6. Troubleshooting

Symptom Potential Cause Corrective Action

4 No or low infusion with System displays actual pressure correctly and 1. Air tubing or irrigation
Pressurized Infusion air is coming out of the air output connector. tubing may be kinked.
function. Check air tubing and
If problem persists with the all of the above irrigation tubing for kink
corrective actions, stop using Pressurized or pinch.
Infusion and call service. 2. The air tubing pathway
may be obstructed.
Ensure new air tubing is
used. Otherwise, replace
with new tubing.
3. Preset pressure may be
set too low.
Increase air pressure
setting to desired level.
5 System shutdown, cassette Power supply cut off from the source or 1. Stop surgery and
ejected and irrigation power cable is accidentally unplugged from remove handpiece from
running into cassette/ the wall. the eye.
cartridge and handpiece. 2. Close irrigation clamp
to stop fluid flow into
the cassette/cartridge and
handpiece.
3. Replace test chamber
to the handpiece that is
connected to the tubing.
4. Reboot system, prime
and tune handpiece when
power supply resumes
(make sure to open
irrigation clamp before
starting to re-prime and
tune system).
6 Remote Control not Remote firmware not responding to key Corrective action: Reset
working with good or new inputs. the device by removing the
batteries. batteries and waiting for
at least one minute before
re-installing the batteries.

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 6. Troubleshooting

6.6. System Configurations, Replacement Parts, and

Medical Device Accessories

WARNING: 
No modification of this equipment is allowed.

Use of non-approved medical device accessories including procedure packs or replacement parts may affect
system performance. The unauthorized modification or alteration of the equipment, or the use of non-approved
medical device accessories, or replacement parts with the equipment shall relieve Bausch + Lomb from any
warranty, service obligation or other liability for damages to, or failure of, the equipment caused by such
unauthorized acts.

Approved medical device accessories will be appropriately labeled as Manufactured By, Manufactured For, or
Distributed By Bausch & Lomb Incorporated. For a complete list of approved accessories please consult your
local Bausch + Lomb catalog or contact your local Bausch + Lomb representative.

Applied Parts (non-energized) include: vitrectomy cutters, illumination probe, I/A handpieces, and various
ophthalmic surgical items such as needles, entry site alignment, laser probes etc.

Applied Parts (energized) include: reusable phaco or fragmentation handpiece or fragmentation handpiece,
bipolar forceps, Vitesse handpiece.

Stellaris Elite™ System List

Category SKU Description

System BL11145 Stellaris Elite™ Anterior System
System BL14455 Stellaris Elite™ Posterior/Combined System
System BL15455 Stellaris Elite™ Posterior/Combined System with Laser

Anterior Device Accessories

Category SKU Description

Accessory BL3170 Ultrasound Phaco Handpiece
Accessory BL3379 Stellaris™ Ultrasound Handpiece Tray

Posterior Device Accessories

Category SKU Description

Miscellaneous BL4360 Alternate Mayo Tray - Metal Bracket
Miscellaneous BL4364 Alternate Mayo Tray - Plastic Bracket
Miscellaneous BL4363 Stellaris™ PC Zero Level Bottle Hanger

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6. Troubleshooting

Category SKU Description

Miscellaneous BL5280 Dual Infusion Kit
Accessory BL3270 Fragmentation Handpiece
Accessory BL2295 Primary (Integrated) System Foot Control
Accessory BL2296 Secondary (LIO) Foot Control
Accessory BL2394 Elite Primary (Integrated) System Foot Control

Replacement Parts

Category SKU Description

Miscellaneous BL4351US System Power Cord, United States
Miscellaneous BL4351EUR System Power Cord, Europe
Miscellaneous BL4351UK System Power Cord, United Kingdom
Miscellaneous BL4351ITL System Power Cord, Italy
Miscellaneous BL4351SWI System Power Cord, Switzerland
Miscellaneous BL4351CHI System Power Cord, China
Miscellaneous BL4352 Fuses, AC Input, User Replaceable
Miscellaneous BL4361 Dust Cover
Miscellaneous BL4390 Primary (Integrated) Foot Control Battery
Miscellaneous BL4391 Primary (Integrated) Foot Control Wall Charger (without adapter)
Miscellaneous BL4393 Primary (Integrated) Foot Control Charging Cradle
Miscellaneous BL4394 Primary (Integrated) Foot Control Backup Cable
Miscellaneous CX7120 Universal Maintenance Kit
Module BL2271 532 nm Laser module
Accessory BL3320 Xenon Lamp Assembly
Accessory BL3321 Xenon-Mercury lamp assembly
Accessory BL2273 Anterior module with laser connection ports
Accessory BL3234 Laser On/Off keys
Accessory BL3235 532 Laser safety glasses
Accessory BL3244 Kit, Interlock Bypass Connectors
Accessory BL3246 LIO Lamp Replacement

Refer to Laser Function Section 1.14 of manual for listing of medical device laser accessories.

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 6. Troubleshooting

Table of Cables

Cable Maximum Length

BL3170 Ultrasound handpiece 84"
BL4351US, Power Cable United States 180"
BL4351UK, Power Cable Great Britain 180"
BL4351EUR, Power Cable General Europe 180"
BL4351ITL, Power Cable Italy 180"
BL4351SWI, Power Cable Switzerland 180"
BL4351CHI, Power Cable China 98"
BL4394 Primary (Integrated) Foot Control Backup Cable 144"
BL2296 Secondary (LIO) Foot Control Cable 192"
BL3270 Frag Handpiece 84"
S2050B Autoclavable Bipolar Cord 144"
CX9400 Bipolar Cord 144"
CX9430 Bipolar Cord with Lemo 144"
CX9404 Bipolar Cord 144"
BL4394 Primary (Integrated) Foot Control Power Cable 144"

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6. Troubleshooting

6-42 Operator’s Manual 4135904EN

7. Service and Warranty

7. Service and Warranty

7. Service and Warranty
 7. Service and Warranty

7. Service and Warranty

This chapter contains instructions on how to contact Bausch + Lomb to obtain service on your
Stellaris Elite™ vision enhancement system, as well as warranty and environmental information.

CAUTION: 
Preventive scheduled maintenance is recommended once a year to ensure that the
Stellaris Elite™ vision enhancement system meets its optimum performance, reliability
and safety standards set by the manufacturer. The maintenance shall be done by a
Bausch + Lomb certified individual only.

Note:  ther than main fuses, power cords, and lamps (PC systems only), this system contains no parts
O
that are serviceable by the user. All maintenance shall be done by a Bausch + Lomb certified
individual only.

7.1. Service Information

Technical Assistance
Assistance for Stellaris Elite™ vision enhancement system is available from Global Product Support:

Bausch & Lomb Incorporated

3365 Tree Court Industrial Blvd.
St. Louis, MO 63122 USA
Attention: Global Product Support Department

https://www.bausch.com/ecp/for-your-practice/surgical-support/surgical-product-support
• For product support within the USA call the 24-hour telephone line 1-800-338-2020 or fax
1-636-226-3070.
• For product support from outside the USA either call 1-636-226-3535, send a fax to 1-636-226-3070,
or contact your local Bausch + Lomb Product Support Representative (listing of local offices starts on
page 7-3).

Please organize your material before calling or writing for technical support. Please have the following
information ready:
• Customer account number
• Name of function, handpiece, etc. that needs service
• Model number (REF #) and serial number (SN#) of Stellaris Elite™ vision enhancement system,
located on the label on the back panel
• Date of purchase

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7. Service and Warranty

• Date of awareness
• Date of event
• Occurrence stage
• Medical intervention Yes/No. If Yes, please describe.
• Description of problem, listing all observable symptoms and characteristics, and details of occurrence.
Was patient involved at time of occurrence?

Returns
To return a Stellaris Elite™ vision enhancement system and/or system assembly or component to
Bausch + Lomb for service, a return authorization number must be obtained from your local Product
Support team prior to returning any unit for repair or calibration. The following information must accompany all
returned units:
• Customer account number
• Customer name, address, and telephone number
• Name of function, handpiece, etc. that needs service
• Model number (REF #) and serial number (SN#) of Stellaris Elite™ vision enhancement system,
located on the label on the back panel
• Date of purchase
• Description of the problem or service desired. List all observable symptoms and characteristics, and
details of occurrence. Was patient involved at time of occurrence?
• Return authorization number assigned by our Global Product Support specialist
• Contact name and phone number if additional information is required
• Date of awareness
• Date of event
• Occurrence stage
• Medical intervention Yes/No. If Yes, please describe.

Ship or otherwise return the part, transportation and insurance prepaid, to your local Bausch + Lomb
International Facility unless otherwise instructed.

For accessories and disposable handpieces, contact your local Bausch + Lomb representative to determine
applicable return policies for your local market.

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 7. Service and Warranty

Bausch + Lomb International Facilities

* Indicates Global Product Support Numbers

Argentina
Bausch & Lomb Argentina S.R.L.
Avenida Del Libertador 174 piso 12
B1638BEN- Vicente López.
Provincia de Bs As. Argentina
Teléfonos
(54911) 4718-4200

Australia
Bausch + Lomb Australia Pty Ltd
Level 2, 12 Help Street
Chatswood, NSW 2067 Australia
Tel: 1800 251 150
eMail: [email protected]

Austria
Bausch + Lomb GesmbH
SURGICAL
Hintzerstraße 5 / Top 2
1300 Wien
Austria
Tel: 0800 / 241015
+49 (0) 800 2233331
Fax: 0800 / 241016

Belgium
Bausch & Lomb Pharma S.A
Avenue du Haras, 156
1150 Woluwe-Saint-Pierre
Belgium
Tel : +32 3 280 82 71
*Tel: +33 4 67 12 30 68
*Fax: +33 4 67 12 30 66

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7. Service and Warranty

Bermuda
Bausch & Lomb Bermuda Office
Gibbons Bldg.
P.O. Box 1154
Hamilton, HM EX Bermuda
Tel: 441‑295‑1044
Fax: 441‑292‑6140

Brazil
BL Industria Otica LTDA.
Rua Dona Alzira, 139
91110‑010, Porto Alegre, RS, Brazil
Tel: 55‑51‑3393‑2000
Fax: 55‑51‑3393‑2100

BL Industria Otica LTDA.

Av Eng° Luiz Carlos Berrini, 1700 -15°andar
04571‑000- Sao Paulo - Brazil
Tel: 55‑11‑3238‑2900
Fax: 55‑11‑5506‑5528

Canada
Bausch & Lomb Canada
520 Applewood Crescent
Vaughan, Ontario L4K 4B4
Canada
Tel: 905‑695‑7695
Fax: 905‑695‑7656
Customer service 1‑800‑387‑3284

China
Bausch + Lomb Shanghai Corporate Office
27F, One ICC Plaza,
No. 999 Huaihai Middle Road
Shanghai, 200031, P.R.China
Tel: 86(0)21 6032-7188
Fax: 86(0)21 6032-7100

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 7. Service and Warranty

France
Bausch & Lomb France SAS
416 rue Samuel Morse
Le Millenaire
CS79005
34967 Montpellier Cedex 2
France
Tel: 33‑4‑67‑12‑30‑30
Fax: 33‑4‑67‑12‑30‑31 (General)
*Tel: 33‑4‑67‑12‑30‑68
*Fax: 33‑4‑67‑12‑30‑66

Bausch & Lomb France SAS (DistOps Office)

Tel: 33‑4‑37‑48‑83‑83 Reception
Fax: 33‑4‑37‑48‑83‑84 Reception

Germany
Bausch + Lomb GmbH – Surgical
Brunsbütteler Damm 165/173
13581 Berlin Germany
Field Service Hotline (within Germany) Phone 0800 2233331
Fax 0180 / 5 90 94 90 94

Greece
Bausch & Lomb Greece
Bausch + Lomb BV
59B Apostolopoulou str
152 31 K. Halandri
Athens, Greece
Phone: +30 210 67 48220

Hong Kong
Bausch & Lomb (Hong Kong) Ltd
Suites 3901 & 3912-14, 39/F,
Tower 6, the Gateway.
9 Canton Road, Tsim Sha Tsui,
Kowloon, Hong Kong
Tel: +852 2213 3333
Fax: +852 2213 3612 / 2213 3773

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7. Service and Warranty

India
Bausch & Lomb India Private Limited.
4th Floor, Tower–B,
Unitech Business Park South City – 1,
Gurgaon – 122001 Haryana, India.
Tel: 91-124-4152100

Indonesia
Bausch & Lomb (Indonesia)
c/o address in Singapore, see Singapore

Italy
Bausch & Lomb‑IOM S.p.a.
Ind: V.le Martesana 12
20090 Vimodrone (MI)
Tel: 02.27407300
Fax: 02.2650784/79
SERVIZIO CLIENTI CHIRURGIA
Tel: 02.91483851
Fax: 800.173931

Japan
Bausch & Lomb Japan Ltd.
Tower B, Omori Bellport
6‑26‑2 Minami‑Oi, Shinagawa‑ku
Tokyo 140‑0013 Japan
Phone: +81‑3‑5763‑4003
Fax: +81‑3‑5763‑4003

Korea
Bausch & Lomb Surgical
13F, KT&G Kosmo Daechi-Tower,
8, Teheran-ro 98-gil, Gangnam-gu Seoul, 06181, Korea
Tel: +8280-080-3378
Fax: +822-6442-1352

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 7. Service and Warranty

Malaysia
Bausch & Lomb (M) Sdn. Bhd.
6F-1, 6th Floor
Tower 4 @ The PFCC
Jalan Puteri ½, Bandar Puteri
47100 Puchong, Selangor, MALAYSIA.
Tel: +603-86017000
Fax: +603-86017001

Mexico
Bausch & Lomb Mexico
Calzada de Tlalpan 2021
Parque San Andres
Coyoacán, CDMX
C.P. 04040
Tel: +52‑55‑50‑62‑4000
Customer Service: Tel: + 52‑55‑50-62-4101

Netherlands
Bausch & Lomb B.V.
Koolhovenlaan 110
1119 NH Schiphol‑Rijk
The Netherlands
Tel: 31‑20‑65‑54‑500
Fax: 31‑20‑65‑37‑871
*Tel: 31‑20‑65‑54‑555
*Fax: 31‑20‑65‑37‑873

New Zealand
Bausch+Lomb Australia Pty, Ltd.
Level 2, 12 Help Street
Chatswood, NSW 2067
Australia
Tel: + 61 2 9390 1800
eMail: [email protected]

Philippines
Bausch & Lomb Philippines, Inc.
Unit 1806 Finance Centre,
26th Street cor 9th Avenue
Bonifacio Global City, Taguig City
Philippines.
Tel/Fax: +63-83967470

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7. Service and Warranty

Portugal
Bausch & Lomb, SA (Suc. em Portugal)
Av. Da República, n° 25 - 6° A
1050-186 Lisboa
Portugal

Recepção de Lisboa: +351-214-24-1425 *Tel: +351-214-24-1510

*Fax: +351-214-24-1519
SURGICAL CLIENTS NUMBERS:
Tel. +351808203178
Fax +351808203179

Singapore
Bausch & Lomb (Singapore) Private Limited
3 Harbourfront Place
Harbourfront Tower Two #09-04
Singapore 099254.
Tel: +65-68349112
Fax: +65-62860448

South Africa
(includes Botswana, Kenya, Lesotho, Mauritius/Maurice, Namibia, Zimbabwe)
Soflens (Pty) Ltd. trading as Bausch & Lomb
254 Hall Street
Centurion
South Africa
0157

PO Box 11418
Die Hoewes
0163
Tel: +27 (10) 025 2100

Spain
Bausch & Lomb S.A.
Avda. Valdelaparra 4
28108 Alcobendas (Madrid) Spain
Tel: 34‑91‑657‑6300
Fax: 34‑91‑661‑4266
*Tel: 34‑902‑381‑010
*Fax: 34‑902‑250‑310

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 7. Service and Warranty

Sweden
(Denmark, Finland, Norway and Sweden)
Bausch & Lomb Nordic AB
Söder Mälarstrand, 45
P.O. Box 15070
S‑104 65 Stockholm, Sweden
Tel: 46‑8‑616‑9500
Fax: 46‑8‑669‑8623
*Tel: 46‑8‑616‑9585
*Fax: 46‑8‑658‑2541

Switzerland
Bausch & Lomb Swiss AG
Industriestr. 15a
CH - 6300 Zug
Tel +41 (0) 848 / 22 87 24
+41 (0) 848 / 22 87 26
Fax +41 (0) 848 / 22 87 25

Taiwan
Bausch & Lomb Taiwan Ltd.
16F, No. 95, Sec. 2, Dunhua S. Rd, Da’an
Dist, Taipei City 10682, Taiwan (R.O.C.)
Tel: +886 2 8161 9200
Fax: +886 2 8161 9290

Thailand
Bausch & Lomb (Thailand) Ltd.
98 Sathorn square Office Tower,
19th Floor, Unit 1909-12,
North Sathorn Road,
Silom, Bangrak, Bangkok 10500
Tel: 662-6437888

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7. Service and Warranty

Turkey
Bausch & Lomb Saglik ve Optik Urunleritic A.S.
Metrocity Is Merkezi
Buyukdere Cad. Kirgulu Sok.
No:4 Kat: 3
34742
Turkey
Esentepe, Sisli, Istanbul
Phone: +90212 3718200
Fax: +90212 2830330

United Kingdom
Bausch & Lomb U.K., Ltd.
106‑114 London Road
Kingston‑upon‑Thames
Surrey KT2 6TN, England
Tel: 44‑20‑8781‑2900
Fax: 44‑20‑8781‑2901
*Tel: 44‑208‑781‑0000
*Fax: 44‑208‑781‑0001
Europe, Middle East & African Division
European Headquarters

Vietnam
c/o address is Singapore, see Singapore

7.2. Environmental Protection

Accessories such as disposable packs, handpieces, and tubing will be contaminated with human tissue
fragments and bodily fluids during the surgical process. These should be handled and disposed of in accordance
with current biomedical procedures.

The system and accessories and Primary (Integrated) Foot Control may, in use, become contaminated with
fluids from the operating field and should be treated as biohazards and therefore need to be decontaminated.

When discarding any major component of the system, use local market techniques for disposal of standard
electronic components and equipment.

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 7. Service and Warranty

7.3. Warranty Information

Stellaris Elite™ vision enhancement system Warranty

Bausch & Lomb Incorporated warrants, for the benefit of the purchaser only, that the
Stellaris Elite™ vision enhancement system, when delivered, will conform to the manufacturer’s then current
version of the published specifications for the device in all material respects and shall be free from defects in
material or workmanship for a period of twelve (12) months from the date of delivery when properly installed,
maintained and used for its intended purpose and in accordance with all manufacturer’s instructions.

The exclusive remedy for any breach of this Warranty, and Bausch + Lomb’s only responsibility therefore,
shall be, at Bausch + Lomb’s option, the repair or replacement of the non-conforming defective equipment or
component thereof. Non-conforming or defective parts may be either repaired or replaced with new, refurbished,
or remanufactured parts at Bausch + Lomb’s sole discretion. Any such non-conforming or defective parts, which
are replaced by Bausch + Lomb, will become the property of Bausch + Lomb. Any service or replacement
part provided under this Warranty may be supplied by Bausch + Lomb or any of its affiliates or authorized
service providers, at Bausch + Lomb’s sole discretion. Any claim based on this Warranty must be submitted
to Bausch + Lomb, in writing, within the twelve (12) month warranty period which commences on the date of
delivery.

Bausch + Lomb reserves the right to deny warranty coverage, and shall have no responsibility to repair or
replace any non-conforming or defective equipment or component under this warranty if (a) the
Stellaris Elite™ vision enhancement system is not maintained and operated in accordance with all
manufacturer’s instructions, (b) the non-conformity or defect arises from, or is related to, any service or
maintenance of the equipment, or component(s) thereof, provided by persons other than Bausch + Lomb or its
authorized service representatives, (c) the non-conformity or defect arises from, or is related to, any spare or
replacement part(s) or component(s) or any consumable or disposable products or parts which are used in the
operation of the equipment or its components other than those purchased from, installed by or approved for
use by Bausch + Lomb or its authorized service representatives, (d) the Stellaris Elite™ vision enhancement
system has been altered, neglected, abused or misused, (e) the Stellaris Elite™ vision enhancement system
has been relocated, reinstalled or taken apart by any person other than Bausch + Lomb or its authorized service
representative, (f) the non-conformity or defect arises from, or results from, any damage to the Stellaris Elite™
vision enhancement system or its components occurring subsequent to delivery, or (g) the non-conformity or
defect is not reported to Bausch + Lomb in writing within the twelve (12) month warranty period. This Warranty
does not apply to normal wear and tear or disposable components used in connection with the Stellaris Elite™
vision enhancement system.

BAUSCH + LOMB EXCLUDES AND DISCLAIMS ALL OTHER WARRANTIES OR

REPRESENTATIONS RELATING TO THE Stellaris Elite™ vision enhancement system WHETHER
EXPRESS, IMPLIED OR ARISING BY OPERATION OF LAW, INCLUDING, BUT NOT LIMITED
TO, ANY WARRANTIES OF MERCHANTABILITY OR FITNESS FOR A PARTICULAR PURPOSE.
IN NO EVENT SHALL BAUSCH + LOMB BE LIABLE FOR, AND IT SPECIFICALLY DISCLAIMS
RESPONSIBILITY FOR, ANY INCIDENTAL, CONSEQUENTIAL, SPECIAL OR EXEMPLARY
DAMAGES OR EXPENSES ARISING OUT OF THE PURCHASE OR USE OF THE
Stellaris Elite™ vision enhancement system OR THIS WARRANTY, EVEN IF BAUSCH + LOMB
HAS BEEN ADVISED OF THE POSSIBILITY OF SUCH LOSS, DAMAGE OR EXPENSE. THE
LIABILITY OF BAUSCH + LOMB TO THE PURCHASER OR ANY USER FOR ANY CLAIM

4135904EN Operator’s Manual 7-11

7. Service and Warranty

RELATED TO THE Stellaris Elite™ vision enhancement system OR THIS WARRANTY, WHETHER
IN CONTRACT, TORT, STRICT LIABILITY OR OTHERWISE, SHALL NOT EXCEED THE
PURCHASE PRICE OF THE Stellaris Elite™ vision enhancement system PAID TO BAUSCH + LOMB.

Handpiece Warranty
Bausch + Lomb warrants ultrasonic handpieces against defects in materials and workmanship under normal
use for the minimum period of twelve (12) months from the date of delivery unless otherwise specified on
your sales tender or contract. If any such defect occurs within the warranty period, contact Bausch + Lomb
to return the handpiece for replacement. Bausch + Lomb will, as its sole obligation under this warranty, and
at its sole discretion, replace the defective handpiece with either a new or repaired/refurbished handpiece.
All replacement handpieces are covered for the balance of the warranty period remaining on the original
handpiece. Bausch + Lomb will arrange for replacement at no charge. Loss or damage in return shipment to
Bausch + Lomb shall be at purchaser’s risk.

The warranty shall not apply to, and Bausch + Lomb shall not be responsible for, any loss arising in
connection with the purchase or use of any handpiece which has been repaired or altered in any way so as, in
Bausch + Lomb’s judgment, to affect its reliability or which has been subject to misuse, negligence or accident,
or which has had the serial or lot number altered, defaced or removed, or which has been used otherwise than in
accordance with the instructions furnished by Bausch + Lomb. Bausch + Lomb neither assumes nor authorizes
any representative or other person to assume for it any other liability in connection with the sale of such
handpieces.

BAUSCH + LOMB DISCLAIMS ALL OTHER WARRANTIES, EXPRESS OR IMPLIED, INCLUDING

ANY IMPLIED WARRANTY OF MERCHANTABILITY OR FITNESS FOR A PARTICULAR
PURPOSE OR APPLICATION OTHER THAN THOSE EXPRESSLY SET FORTH IN THE
APPROPRIATE PRODUCT LABELING OR USER INFORMATION MANUAL. IN NO EVENT
WILL BAUSCH + LOMB BE LIABLE FOR ANY INCIDENTAL, INDIRECT OR CONSEQUENTIAL
DAMAGES IN CONNECTION WITH THE PURCHASE OR USE OF ITS PRODUCTS.

Code Project Open License (CPOL)

Use of the Stellaris Elite™ vision enhancement system constitutes the user’s acceptance and agreement to the
terms of The Code Project Open License (CPOL) 1.02, a copy of which is available at
http://www.codeproject.com/info/cpol10.aspx, for certain Executable Files and Source Code embedded in
the Stellaris Elite™ vision enhancement system, specifically with respect to an Advanced WPF Localization
Library, written by Jecho Jekov.

Post-Warranty Information:
When the Manufacturer’s Warranty expires, Bausch + Lomb is pleased to offer Service Agreements that provide
the assurance that customers are seeking in managing equipment performance and budgeted service expense.
Contact your local Bausch + Lomb sales or service representative for service agreement programs.

7-12 Operator’s Manual 4135904EN

 7. Service and Warranty

CAUTION: 
Bausch + Lomb is the only authorized service organization for Bausch + Lomb ultrasonic
handpieces. Bausch + Lomb does not recommend having your ultrasonic handpiece repaired
by third-party service organizations and assumes no responsibility or liability for the
function, safety or operation of any handpiece repaired or serviced by anyone other than the
Bausch + Lomb service organization.

Return Policy:
Bausch + Lomb will, within the return period as specified on your invoice, from the date of invoice, accept
return of this product for a full refund less any handling and shipping charges incurred by Bausch + Lomb.
Customer must call their local Bausch + Lomb customer service representative to request a Return Good
Authorization prior to expiration of the return period. It is the Customer’s responsibility to properly pack all
items being returned. A restocking charge of 15% of the purchase price listed on the invoice for the product, in
addition to any refurbishment, handling and shipping charges, may be assessed for any return received after the
return period but not greater than 180 days of the invoice date.

Handpiece Disclaimer
Bausch + Lomb is the only authorized service organization for the Bausch + Lomb handpiece. Bausch + Lomb
does not recommend having your handpiece repaired by third-party service organizations and assumes no
responsibility or liability for the function or safety of operation of any handpiece repaired or serviced by anyone
other than the Bausch + Lomb service organization.

4135904EN Operator’s Manual 7-13

7. Service and Warranty

7-14 Operator’s Manual 4135904EN

8. Specifications

8. Specifications
8. Specifications
 8. Specifications

8. Specifications

8.1. Environmental and Physical Specifications

Note:  his device contains items which may be classified as waste electrical or electronic equipment.
T
Please dispose of the equipment according to local requirements.

This symbol indicates that the product must be disposed of separately and safely. Therefore, it is your
responsibility to dispose of this waste equipment by handing it over to a designated collection point or
organization that specializes in the recycling of waste electrical and electronic equipment. The separate
collection and recycling of your waste equipment at the time of disposal will help conserve natural resources
and ensure that it is recycled in a manner that protects human health and the environment. For more information
about where you can drop off your waste equipment for recycling, please contact your local recycling office or
electronic waste hauler.

Essential Performance: Maintenance of static irrigation pressure in the eye is considered essential performance
of the system. Other surgical functions (Aspiration pressure, Diathermy power, Diathermy frequency,
Illumination output, Ultrasonic velocity of Tip, Vitrectomy probe cut rate, and Laser output of the working
beam) are considered critical functions that are tested similarly and guaranteed to have their output free from:
incorrect numeric values, production of excessive output, unintended transient or permanent changes to assigned
values, unintended activation of function or laser firing, and unwanted output in the event of power loss or
system reset but are not essential performance as non-function does not create an immediate hazardous situation
for the patient or operator.

Note: I n the context of essential performance, any EMC related impact could lead to a delay of
surgery with the system continuous irrigation to maintain inner ocular pressure based on
the current bottle height. After the EMC disturbance has passed, the system will need to be
restarted, the cassette re-inserted, the handpieces primed and tuned prior to continuing surgery.

4135904EN Operator’s Manual 8-1

8. Specifications

Environmental Specifications

Parameter Specifications
Electrical Input Detachable international power cord
Universal Input (100-240 VAC, 50/60 Hz, 1000 VA)
Equipotential grounding stud
Fuse Set BL4352—includes (2)T 10AL, 250V slow-blow (5 mm x 20 mm) fuses
Temperature Ambient Operating Temperature:
10°C to 40°C (50°F to 104°F)
Ambient Storage/Transport Temperature:
-20°C to 60°C (-4°F to 140°F)
Humidity Operating Humidity:
30% to 70% Relative
Storage/Transport Humidity:
10% to 98% Non-Condensing
Altitude Operates as rated up to 3,000 feet above sea level. See the Vacuum Fluidics
Function Specification table in section 8.2 for derating specifications.
Shock/Vibration Passes ISTA 3A and 3H
Air Input Filtered medical grade air or medical grade nitrogen, at 72.5 psig to 100 psig
(500 kPa to 690 kPa or 5.0 bar to 6.9 bar) and a flow rate of 2.25 SCFM
(63.7 SLPM).

Physical Specifications

Parameter Specifications
Stellaris Elite™ vision enhancement system 122 cm (H) x 45.7 cm (W) x 45.7 cm (D)
(excluding IV Pole and handle) 48 in. (H) x 18 in. (W) x 18 in. (D)
162.5 cm (64 in.) from floor to top of IV Pole
Approximate Weight: 230 lbs. (114 kg)
Recommended Tray Capacity: 12 lbs. (5.4 kg)

Equipment Classifications
Type of Protection Against Electrical Shock Class I
Degree of Protection Against Electrical Shock Type BF
Degree of Protection Against Water Ingress Ordinary
Mode of Operation Continuous
Electromagnetic Compatibility (EMC) Class A

Electromagnetic Compatibility
For Electromagnetic Compatibility (EMC) details please refer to document 41539XX.

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 8. Specifications

A complete line of accessories for the Stellaris Elite™ vision enhancement system and other surgical
instruments are available from Bausch + Lomb. Contact your Bausch + Lomb sales representative for detailed
information.

WARNING: 
The use of accessories and cables other than those specified by Bausch + Lomb in the table
below may result in increased electromagnetic emissions or decreased immunity to external
electromagnetic radiation, resulting in decreased patient safety.

WARNING: 
Use of this equipment adjacent to or stacked with other equipment should be avoided because
it could result in improper operation. If such use is necessary, this equipment and the other
equipment should be observed to verify that they are operating normally.

Note:  he Stellaris Elite™ vision enhancement system includes functions that use high-frequency
T
signals for treatment, including bipolar coagulation and pulsed phaco. As with all systems using
high-frequency signals, interference may occur between the bipolar function or the pulsed phaco
function and other equipment. If any physiological patient sensors are to be used in conjunction
with the Stellaris Elite™ vision enhancement system, the phaco and bipolar circuits should be
activated briefly prior to contact with the patient while the sensor operator is monitoring the
output of the sensor. If there is noise observed on the sensor, the operator may adjust the sensor
according to the instructions of the sensor manufacturer.

When phaco or bipolar functions and physiological monitoring equipment are used
simultaneously on the same patient, any monitoring electrodes should be placed as far as
possible from the surgical electrodes. Needle monitoring electrodes are not recommended.

In all cases, monitoring systems incorporating high-frequency current limiting devices are
recommended. Properly equipped monitors are usually identified as having “electrosurgery
interference suppression” or “ESIS” options.

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8. Specifications

8.2. Primary System Specifications

Computer Unit Specifications

Parameter Specification
Display Assembly Display Technology: Flat Panel, Liquid crystal display (TFT
LCD) full color
Size: 19" diagonal
Pixels: 1280 x 1024
Physical Adjustment:
Tilt: +15° up and -10° down
Swivel: 90° left and 90° right
Brightness: Controlled via touch screen
Touch Screen Technology: Resistive Analog
Size: Approximately 19" diagonal active area
Environmental:
Chemical resistant to cleaning solutions
Drip proof bezel
Motherboard Technology: IBM Compatible, Pentium or better
Computer Hard Drive or Solid State Drive
Computer Assembly hardware Two Audio Speakers
Two USB ports
Ethernet port

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 8. Specifications

Primary (Integrated) Foot Control Specifications

Parameter Specification
General External components and housing are corrosion resistant
Watertight housing
Wireless control (10 m standard range)
Corded, low voltage connection to system
Non-skid base
4 gray-colored function switches
Wall Charger
3.6v battery (lithium)
Battery charging cradle
Physical 13.8 cm, 5.44 in. (H)
30.1 cm, 11.83 in. (W)
34.8 cm, 13.72 in. (L)
Weight 3.9 kg, 8.6 lbs.
Center pedal: Pitch Linear on/off
Center pedal: Yaw Left On/Off (simulated)
Right On/Off (simulated)
Left Linear
Right Linear
Function switches Increase/decrease
On/Off
Function
Center pedal: Pitch Motion: Pitch (up/down)
Automatic return to up position
Detent: (2) programmable as to position, may be enabled or
disabled
Control: Provides primary linear function or on/off
Center pedal: Yaw Motion: Yaw (Left/Right)
Automatic return to center
Detent: (1) center detent
Non-programmable control: Provides secondary linear function
in primary yaw direction and on/off control in secondary yaw
direction, may be physically set for greater linear movement
Function switches Motion: Momentary Push-button
Control: Provides programmable increment/decrement or on/off
control of assigned function
Laser Flip Up Door Open (enables firing button)/Closed (disables firing button)
See Laser Module Specifications Table
Laser Firing Button On/Off
See Laser Module Specifications Table

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8. Specifications

Remote Control Unit Specifications (Anterior Only)

Parameter Specification
Wireless pointing device providing line of sight operation using
an IR transmitter
Provides operation up to 15 feet from display console
Powered from standard AA battery (batteries)
General
Low battery indicator
Transmit indicator
Splash-proof (IPX2)
Illuminated keys
Vacuum Level Increase/Decrease
Aspiration (ASP)
Air consumption Increase/Decrease
Up
IV Pole
Down
Next Phase
Phase
Previous Phase
Ultrasound Power Increment
(U/S), Vitrectomy, Decrement
Coagulation (shared button)
Tab Future Use
Enter Activate selected type
Parameter increment/
Select Prime and tune/test type
decrement

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 8. Specifications

IV Pole Specification

Parameter Specification
Automated
General
Provides two (2) bottle hooks
Capable of lifting two 500 ml glass bottles of
Capacity
Balanced Salt Solution
Range of 110 cm (43.3 in.)
Travel (30 cm to 140 cm, 13.8 in. to 55 in. from
aspiration port)
Operation Parameters
Speed 10.6 cm/sec. (4 in./sec.)
Controlled via touch screen entry, remote
Control control, Primary (Integrated) Foot Control, or
directly via buttons on the back of the system
Positioning Relative from home sensed position

Coagulation Function Specifications

Parameter Specification
Single, Floating BF Connection
Connector
Coaxial connector
Coagulation Connections United States—Banana Jack Cord, Banana
Cords Jack to Coaxial adapter
International—Reusable Coaxial Cord
Modes of Operation
Maximum Output Range: 7.5 Watts, 0.274 A
Nominal @ 100 ohms
Frequency: 1 MHz nominal
Maximum Peak Open Circuit Voltage = 120V
Linear Mode
Range: Programmable from 0% to 100% in
1% increments
Control: Linear control of coagulation power
Operating Parameters via the Foot Pedal
Maximum Output Range: 7.5 Watts, 0.274 A
Nominal @ 100 ohms
Frequency: 1 MHz nominal
Fixed
Maximum Peak Open Circuit Voltage = 120V
Control
Range: Programmable from 0% to 100% in
1% increments
Control: On/Off control via the Foot Pedal

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8. Specifications

Linear coagulation output vs. target impedance

7 8
100% 7 6
4 5
75% 6 5
50%
5
25%
4
1
2 3
2
1
0
100 200 300 400 500 600 700 800 900 1000
3

Coagulation output voltage vs. linear coagulation power level

11

9 8

10

Figure 8.1.
1. Bipolar Power vs. Load. 2. Power (watts). 3. Load (ohms). 4. Power out. 5. Load. 6. Setting.
7. Settings. 8. Maximum Possible Peak Coagulation Output Voltage at all Output Control Settings and
Both Modes. 9. Peak Output (V). 10. Output Control Setting (%). 11. Linear and Fixed Control.

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 8. Specifications

Ultrasound Function Specifications

Parameter Specification
Ultrasound Time: System records and displays
ultrasound time in 0.01 second increments
Tuning: System provides one step tuning.
Special Features Self-adjusts to resonant frequency of handpiece
Probe Present: System provides a probe present
detection system
Wave form ultrasound available
Connection Type: Floating BF Connection
Continuous ultrasound
Pulsed ultrasound
Fixed pulse ultrasound
Single burst ultrasound
Multiple burst ultrasound
Modes of Operation
Dual Linear Ultrasound
Linear Power, Linear Pulse ultrasound
Linear Power, Linear Duty Cycle ultrasound
Dual Linear Multiple Burst ultrasound
Variable Power Multiple Burst ultrasound
Variable Power Linear Burst ultrasound

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8. Specifications

Ultrasound Mode Specifications

Parameter Specification
Maximum Power: 35 Watts @ approx. 900 ohms
Frequency: 28.5 kHz nominal
Range: 0% to 100% power in 1% increments
Ultrasound Waveform: Disabled/Enabled (throughout)
Continuous Ultrasound Mode
Control: Linear power control via the Foot Pedal
Nominal phaco handpiece tip stroke at 100% power
setting with DP8230 Microflow™ needle is 130 um at
28.5 kHz.
Maximum Power: 35 Watts @ approx. 900 ohms
Frequency: 28.5 kHz nominal
Pulsed Ultrasound Mode
Range: 1 to 250 pulses per second
Duty Cycle: 5% to 95% in 1% increments
Maximum Power: 35 Watts @ approx. 900 ohms
Frequency: 28.5 kHz nominal
Single Burst Ultrasound Mode
Range: 80 ms to 600 ms. burst width
Control: Single burst at end of pitch or yaw travel
Maximum Power: 35 Watts @ approx. 900 ohms
Frequency: 28.5 kHz nominal
Duration: 2 ms to 600 ms
Fixed Pulse Ultrasound Mode
Interval: 2 ms to 600 ms
Control: Linear power control via the Foot Pedal. Burst
duration and interval as selected.
Maximum Power: 35 Watts @ approx. 900 ohms
Frequency: 28.5 kHz nominal
Range: 2 ms to 600 ms. burst width
Maximum Duty Cycle*: 50% to 99% in 1% increments
Minimum Duty Cycle*: 1 - 50% in 1% increments
Waveform: Enabled (Rise Time 2), Disabled (Rise
Multiple Burst Ultrasound Mode
Time 1)
Control: 1 burst at minimum duty cycle at start of linear
control region. Interval decreases until maximum duty
cycle is commanded at end of linear control region.
*Actual Duty Cycle Range is limited by the Burst Width
Setting

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 8. Specifications

Vacuum Fluidics Function Specifications

Parameter Specification
Provides Cassette Full, Near-Full and Continuous Fluid Level
General Sensing
Programmable vacuum response curves
Linear control of vacuum
Modes of
Fixed, On/Off control of vacuum
Operation
Aspiration Dual Linear Modes: Pitch or Yaw
I/A mode: 0 mmHg to 660 mmHg
Phaco: 10 mmHg to 660 mmHg
Operating
Vitrectomy: 0 mmHg to 660 mmHg
Parameters
Extrude: 0 mmHg to 660 mmHg
Vacuum Control: 1 mmHg increments
Gravity feed from I/V bottle with pinch valve On/Off control via
Irrigation
Foot Pedal
Gravity feed from I/V bottle
Reflux Control Modes: Continuous, Pulsed
Activated via the Primary (Integrated) Foot Control
Linear Cut
Rate Mode Range: 30 to 7500 cuts per minute
Operating Control: Linear control of cut rate via the Foot Pedal
Parameters
Vitrectomy
Fixed Cut Range: 30 to 7500 cuts per minute
Rate Mode Cut rate is derated no more than 20% above 3000 feet
Operating (915 meters) altitude
Parameters Control: On/Off control of cut via the Foot Pedal
The system will provide minimum aspiration of 660 mmHg at sea level. A derating of 24.3 mmHg
per 1000 feet up to 9000 feet (2745 m). The vacuum rise time, with an empty cassette, shall not
increase more than 25% above 1.6 seconds per 1000 feet up to 9000 feet (2745 m).

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8. Specifications

Viscous Fluid Control Specifications

Parameter Specification
Injection Mode Pressure: 70 psi (482.6 kPa, 4.8 bar)
Extraction Mode Vacuum: Between 5 mmHg to 660 mmHg in
10 mmHg increments

Fluid/Air Exchange, Pressurized Infusion and Air Forced Infusion Specifications

Parameter Specification
Output 0.1 micron hydrophobic filtered air
Pressure 150 mmHg or 203 cmH2O maximum air pressure
Flow Rate Up to 4.8 standard cubic feet per hour (2.25 L/min)
System includes pneumatic shut-off valve in case of power
Safety
loss

Illumination Specifications

Parameter Specification
Modes of Operation Independent Illumination and control of either port
Lamp Type Xenon and Xenon-Mercury
Light output from a single port is minimum 25 lumens using standard
Output
20 gauge probe
Both ports incorporate permanent filtration to reduce ultraviolet, violet,
Safety Filter
deep red and infrared light
Control 0-100% control range, 1% resolution
None, Green, Yellow, Amber
Color Filtration
(only available on Port 1 when a xenon lamp is installed)

Laser Module Specifications

Parameter Specification
Connector Single, Floating BF
Connector
Connection
Laser Connections Ground Leakage Current < 200 μA 115V 60 Hz
< 300 μA 230V 50 Hz
< 500 μA 250V 60 Hz
Low Power 150 W
Electrical Power
Standby 250 W
Consumption
Treat 300 W

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 8. Specifications

Parameter Specification
Safety Interlocks Room Interlock, Key Switch, Laser
Turn-On and Emission Indicator,
Emergency Off, Microscope eye safety
filter interlock
Cooling Internal whisper fans, operating on
demand
Temperature Range Operating: 10°C to 35°C (50°F to 95°F)
Storage: -20°C to 60°C (-4°F to 140°F)
Relative Humidity Operating: 30%-70%, noncondensing
Storage: 10%-98%
Shock/Vibration Passes IEC601-1, MIL-STD-810D, and
ISTA Procedure 2A
Surgical Submodes LIO Mode, EndoProbe Mode, Continuous
Endo Mode
Laser Operating Modes Disabled, Stabilization, Reduced Cooling,
Standby, Treatment, Deliver Pulse

Feature Description
Treatment Laser Fixed 532 nm +/- 3 nm

Treatment Laser: Diode-pumped, frequency-doubled, solid-state laser

Laser delivery device connector Industry standard SMA 905 connection with delivery device detection
via a resistor in the delivery device connector

Connection located above the sterile field

Connector backlit to make it visible in a darkened room

Back light will be on when in a Laser Mode or when the key is turned
on, and will blink to indicate no or incorrect delivery device is connected
Endo Single Shot mode Single Shot 10 ms to 3000 ms

50 mW to 2000 mW
Endo Pulsed mode Duration 10 ms to 3000 ms

Interval 10 ms to 3000 ms

50 mW to 2000 mW
Endo Continuous (paint mode) Continuous mode for up to 1 minute of firing

50 mW to 500 mW

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8. Specifications

Feature Description
LIO Single Shot Single Shot 10 ms to 3000 ms

50 mW to 1000 mW
LIO pulsed mode Duration 10 ms to 3000 ms

Interval 10 ms to 3000 ms

50 mW to 1000 mW
Aiming beam 635 nm +/- 5 nm Red diode laser adjustable from 0 mW to 0.8 mW

Coincidental with treatment laser to ensure accurate targeting

Aiming beam modes Standby Mode - Aiming Beam On/off

Ready mode - Aiming Beam On

Treatment Mode - Continuous On or On/Off during pulse treatment

Laser fire tone 2 kHz, 45 dBA to 65 dBA adjustable
Primary (Integrated) Foot Control Laser firing button integrated into Stellaris Elite™ vision enhancement
system Primary (Integrated) Foot Control, with wired and wireless
modes of operation

All system functionality accessible from the integrated Primary

(Integrated) Foot Control

Laser firing button is located under a flip up door

General purpose toe and heel buttons can be assigned laser functions

Laser power up, power down, Standby/Ready toggle, Single/Repeat

toggle, in addition to standard functions

IPX7 rating (water and dust proof)

Secondary (LIO) Foot Control Dedicated Secondary (LIO) Foot Control (wired) for laser functions only

Designed to be easily moved when using a LIO headset, but remain in

place and stable when firing the laser

Can be used in all Laser Modes (Endo and LIO)

Laser power adjustment via side buttons, which can be programmed for
Standby/Ready toggle or Single/Repeat toggle. Default setting is for
buttons to adjust laser power - right is increase, left is decrease. Side
buttons can be disabled via the GUI.

IPX7 rating (water and dust proof)

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 8. Specifications

Feature Description
GUI integration Laser control, Aspiration control, Infusion control, Illumination control,
all accessible in Endo and Continuous Submodes

Illumination is not available while in LIO mode

Laser setting Preset increment and decrement values for up and down buttons (power
duration and interval) or the ability to enter an exact setting
User presets Laser default settings power, interval and duration by mode can be
stored by the user in Stellaris Elite™ vision enhancement system
surgeon preference file
Audio feedback Active Laser Mode (Endo, LIO)

Active laser state (Laser Standby or Ready mode)

Current laser settings

Laser setting changes via either Primary (Integrated) Foot Control

Language of voice selectable

Movable filter interface System interlock interface to a 2-position microscope filter

Connector available to adapt existing 2-position filters to system

Adapter available for backwards compatibility to Millennium 2-position

filters. (BL3242)
• Bausch + Lomb part number CX5996 IRIDEX 30494 WILD
• Bausch + Lomb part number CX5595 IRIDEX 30493 ZEISS

Key included with each system to be used when a fixed filter is in use
Room interlock System room interlock

Smart key included when used in a room without a room interlock

connection

Connector available to adapt existing room interlock

Room safety light System interface to control a room laser safety light

Light will be commanded on when Laser Key is on

Connector available to adapt existing safety interlock

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8. Specifications

Feature Description
Laser Key Conveniently located on front of system for easy access

Two Laser Keys supplied

Key On initiates system warm up

Key On illuminates EndoProbe connection back light (blinks until probe

is connected)
Emergency stop button Conveniently located on front of system

Backlit to be clearly visible in a darkened room

Off when the Laser Key is off

On when the Laser Key is on

Blinking if the emergency stop function is active. (Cycling the Laser

Key will clear emergency stop.)
LIO LIO lamp power connector conveniently located on front of system

Connector backlit to be clearly visible in a darkened room

System will automatically detect if an LIO device is connected

LIO power output for a 6.3V 10W bulb

EndoProbes Full line of EndoProbes in 20, 23, 25 gauge

Proprietary illuminating probe connects directly with Stellaris Elite™

vision enhancement system illumination module
Microscope safety filter > 3.0 OD at 532 nm required
Eye protection 1 set of user goggles supplied > 3.5 OD at 532 nm
System LIO compatibility Industry standard SMA 905 connection with LIO device detection
requirements resistor

fiber ≥ 150 micron

532 nm, 50 mW to 1000 mW

Laser light input 100 micron spot size with a NA of 0.08

RCA Style Illumination power connector

Illumination Power output 6.3V 10W user variable

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 8. Specifications

8.3. System Labels

Main System Label Primary (Integrated) Foot Control Label

Large Remote Control Label

Small Remote Control Label System Power and Fuse Label

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8. Specifications

Primary (Integrated) Foot Control Battery Label Primary (Integrated) Foot Control Battery
Compartment Label

Xenon Lamp Label Xenon-Mercury Lamp Label

Interlock Connections

Compliance Label

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 8. Specifications

Pressurized Air Input Label

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8. Specifications

8-20 Operator’s Manual 4135904EN

9. Glossary

9. Glossary
9. Glossary
 9. Glossary

9. Glossary
Adaptive Fluidics
Adaptive Fluidics is a new fluidics function for phacoemulsification surgery during lens removal and I/A only.
Adaptive Fluidics is NOT available for anterior vitrectomy and all other posterior phases. Adaptive Fluidics
maintains fluidics stability inside the eye by linking variable infusion pressure to the real-time surgeon-
commanded vacuum level.

AFI
Air Forced Infusion. Refers to the use of pressurized air to create necessary pressure for infusion of fluid into
the eye. The Stellaris Elite™ vision enhancement system AFI requires the use of the bottle spike with metal
tube to supply air pressure and venting.

A/V
Audio/Visual settings that include screen display, tone, volume and video display.

Burst Mode Ultrasound

An intermittent ultrasound modulation with ultrasound duration and rest-time controlled linearly with Primary
(Integrated) Foot Control. Ultrasound power is fixed.

Case
Settings relating to instrument gauge, needle type, cataract hardness or pathology.

Detent
Tactile feedback in Stellaris Elite™ vision enhancement system Primary (Integrated) Foot Control to alert user
when Foot Pedal is moved from one region to another.

DMS
Digital Media System provides video overlay where real time system settings are displayed simultaneously on
the surgical screen and/or projected on external monitors or video recording devices.

Domain
System functionality and setup that provides a group of functions related to either anterior, posterior or
combined surgery.

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9. Glossary

Dual Linear
Primary (Integrated) Foot Control feature that controls various surgical functions with two axes of Foot Pedal
movement. Both axes allow linear control of surgical functions relative to the pitch and yaw movement of the
Foot Pedal.

Elevated Infusion
Refers to temporary use of higher than normal infusion pressure during posterior surgery. In Stellaris Elite™
vision enhancement system, Elevated Infusion is defined as pressure above 60 mmHg for air infusion or above
81 cmH2O for fluid infusion.

End Case
Describes the conclusion of surgery. A touch screen button in the Stellaris Elite™ vision enhancement system
graphical user interface would conclude a surgery and transition system to the End of Case screen.

Extrude
A surgical mode that aspirates fluid out of the eye. Selecting the Extrude mode activates vacuum from the left
aspiration line to be used during the procedure.

Fluid/Air Exchange
F/AX. A surgical procedure to replace fluid in the eye with atmospheric air. The process involves injecting air
with a specific pressure and an extrusion cannula to evacuate the fluid.

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 9. Glossary

Foot Control Mapping

The correspondence between Foot Pedal linear movement and surgical function activation. Primary (Integrated)
Foot Control mapping options are linear (1), front loaded (2), back loaded (3) or reverse linear (4). X = Foot
Pedal movement from home position and Y = Surgical function energy level. (see diagram below)

Foot Control Switches

Four active pressable areas surrounding the Stellaris Elite™ vision enhancement system Foot Pedal. The two
upper switches are referred to as toe switches and the two lower switches are referred to as heel switches.

Gravity Infusion
Infusion derived from pressure created by hanging the fluid bottle at a certain height above the patient’s eye
level.

Infusion
Similar to irrigation, particularly referring to fluid use for posterior segment surgery. In addition to fluid,
atmospheric air infusion can also be used in posterior surgery.

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9. Glossary

Irrigation
Refers to flow of fluid use in the surgery. Irrigation flows out of surgical handpieces into the eye through tubing
to maintain intraocular pressure.

Mode/Phase
It is a subset of the Technique level setting. It describes the surgical phase that provides a specific function.
Example 1: Vitrectomy mode provides vitreous removal functions derived from vitreous cutting and aspiration.
Example 2: Phaco mode provides lens removal functions derived from lens emulsification and aspiration.
Stellaris Elite™ allows up to 12 different modes to be programmed in each Technique setting.

Modulation
Ultrasound settings with a unique characteristic, such as pulsed, burst, or waveform.

More Screen
Secondary menu-driven graphical user interface screen that allows the user to adjust surgical settings. The More
Screen is hidden during normal operation and can be accessed from the main screen when needed.

Patient Eye Level

The vertical distance from patient eye level to the aspiration ports of the Stellaris Elite™ vision enhancement
system. Stellaris Elite™ system has a feature to adjust patient eye level offset if the patient eye level is not at
the same level as the aspiration port. The offset range is -15 cm to +15 cm.

Phase
See Mode.

Pitch
Up and down movement of Foot Pedal.

Pressurized Infusion
Similar to AFI, pressurized air is used to drive irrigation into the eye for anterior surgery.

Programming Level
Describes the Stellaris Elite™ vision enhancement system system settings hierarchy. The hierarchy is System,
Surgeon, Technique, Mode/Phase, Sub-mode and Case levels.

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 9. Glossary

Pulse Mode Ultrasound

An intermittent ultrasound pulse modulation with fixed rate. Ultrasound power is linearly controlled with the
Primary (Integrated) Foot Control.

Reflux
Momentary reversal of fluid flow towards the handpiece. Reflux pressure is generated from the irrigation bottle
or mechanical plunger.

Rise Time
Speed with which system generates commanded ultrasound level. The Stellaris Elite™ vision enhancement
system has ultrasound rise times 1 and 2. Rise time 1 is traditional power control where ultrasound is ramped up
to demanded level instantaneously. Rise time 2 ramps up phaco power gradually.

Sub-mode
Different Primary (Integrated) Foot Control options or settings within a surgical mode/phase. Examples of
Vitrectomy sub-modes are Fixed Cut, Co-Linear Vit and Single Cut.

Surgeon Level
It is the second highest programming level, after the System level setting, in the Stellaris Elite™ vision
enhancement system system hierarchy. Typical Surgeon level settings are language, Primary (Integrated) Foot
Control settings, audio-visual feedback and units of measurement.

Technique Level
Refers to surgical settings within the Surgeon level programmed either for anterior, posterior or combined
surgery. It is a subset of the Surgeon level setting. The Stellaris Elite™ vision enhancement system includes a
list of default techniques settings, and individual users can create new techniques using the default techniques as
a template.

Tone
System audio feedback specific to surgical functions and energy level.

Vacuum Response
Speed with which system generates commanded vacuum level. The Stellaris Elite™ vision enhancement system
has a vacuum response range of 1 to 5 (1 = fastest).

Video Overlay
Feature that simultaneously projects system settings on the surgical video screen.

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9. Glossary

Viscous fluid
Refers to high viscosity fluids. Normally refers to silicone oil use in posterior segment surgery.

Vitesse Handpiece
The Vitesse handpiece is an accessory that is used on the Stellaris Elite™ PC configuration to perform
hypersonic vitrectomy in the posterior segment of the eye.

Volume
System audio feedback output level.

Waveform
Ultrasound modulation where power delivery is software controlled to simulate a sinusoidal wave pattern.

Xenon lamp
A type of lamp used in the Stellaris Elite™ vision enhancement system to provide endoillumination. It contains
pure xenon gas and emits whiter light with a full spectrum.

Xenon-Mercury lamp
A type of lamp used in the Stellaris Elite™ vision enhancement system to provide endoillumination. It contains
xenon gas and small amounts of mercury metal, and emits greener light.

Yaw
Side to side movement of Foot Pedal.

9-6 Operator’s Manual 4135904EN

Index

Index
Index
 Index

Index
A
Adaptive Fluidics 2-30, 4-53
AFI (Air Forced Infusion) 1-6, 1-22, 1-24, 1-39, 4-1, 4-10, 4-32, 4-68
Alternate Infusion 4-34
Anterior Vitrectomy 4-56
APT (Actual Phaco Time) 2-30, 4-46
Aspiration Setup, Vacuum Fluidics 4-45
Aspiration, Ultrasound 4-50
Assistance 7-1
Audio Tab 2-19
A/V (Audio/Visual) Settings 2-19, 3-7, 3-14
AVE (Average Ultrasound Power) 4-46

B
Backup, Cable 1-8, 1-9, 1-48, 1-54, 1-56, 1-83
Backup, Settings 3-18
Batteries, Remote Control 1-42
Burst Mode, Ultrasound 4-47

C
Cables 6-41
Calibration
Laser 1-71, 6-3
U/S 4-51, 6-1
Capsule Polish 4-43
Cassette
Full 4-1, 6-24
Nearing Full 4-1, 6-23
Cleaning
Accessories 5-2
Laser Protective Eyewear 5-2
Routine Cleaning 5-1
Clock Menu 2-27
Coagulation
Display 2-28
Function 4-62, 8-7
More Screen 2-11
Settings Globe 2-28
Computer Unit, Specifications 8-4
Connections
Compressed Air 1-9
Electrical 1-7, 1-37
Foot Control, Primary (Integrated) 1-9, 1-43, 1-47, 1-53
Foot Control, Secondary (LIO) 1-62
Handpieces 1-38, 1-39
LIO 1-87

4135904EN Operator’s Manual

Index

D
Date
Format 3-22
Setting 3-22
DC (Duty Cycle) 2-9, 2-28, 3-35, 4-20, 4-46, 4-50, 8-10
Delete Settings File 3-21
Display Tab 2-21
Disposables, End of Case 1-32
DMS (Digital Media System) 1-43

E
Elevated Infusion 1-6, 4-34, 4-35, 4-36
EPT (Effective Phaco Time) 2-30, 4-46
Equipment Classifications 8-2
Error Messages 6-8
Essential Performance 8-1
Ethernet Cable 1-9
Exceptions
Clock Menu 2-27
Customization 3-9

F
Fluid/Air Exchange 4-32
Fluidics, Vacuum 4-1
Foot Control
Button 1-58
Customization 1-63, 1-64, 1-65, 1-66, 3-11
Description 1-9, 1-40, 1-43
Laser Functions 1-61, 1-62
Operation
Aspiration 4-44
General 1-57, 1-58
Irrigation 4-44
Vitrectomy 4-58
Setup 1-51
Specifications 8-5
Foot Pedal
Control Combinations 1-59, 1-60, 1-61
Description 1-58
Fragmentation 4-41
Fuse, Replacement 6-2

G
Globe, Setting 2-1

Operator’s Manual 4135904EN

 Index

I
Illumination
Function 4-24
More Screen 2-22
Setup and Use 4-25
Infusion
Display 2-27, 2-28
More Screen 2-7, 2-8
Irrigation
Description 4-43
Setup 4-45
IV Pole
Display 2-27
Function 1-41
Height 2-7, 3-32
Specifications 8-7

K
Keyboard 2-5

L
Language 2-21, 3-6, 3-16, 3-22, 3-28
Laser
Function 1-71, 1-74
Safety 1-88, 1-89, 1-90, 1-91
Setup and Use
Endo Submode 1-86
LIO Submode 1-87
States 1-75
User Interface 1-78
Layout, Screen 2-26

M
Module
Messages 6-8
More Screen
A/V 2-19
Button 2-6
Coagulation 2-11
Foot Control 2-13
Illuminator 2-22
Infusion 2-7
Laser 2-23
Messages 2-25
Ultrasound 2-9
Vacuum 2-7
Visc 2-10
Vitrectomy 2-12

4135904EN Operator’s Manual

Index

O
Option List 2-3

P
PD (Pulse Duration) 4-46
Phacoemulsification
Function 4-46
Setup and Use 4-50, 4-52
PI (Pulse Interval) 2-9, 4-46
PPS (Pulses Per Second) 2-9, 2-28, 4-46
Pressurized Infusion 2-7, 2-28, 3-8, 3-32, 4-59
Prime and Tune 1-23

R
Reflux 1-57, 1-61, 4-44, 4-56
Remote Control
Batteries 1-42
Specifications 8-6
Replacement
Foot Control Battery 1-45
Fuse 6-2
Lamp 4-27
Parts 6-39
Restore Preference File 3-20
Rise Time (U/S) 8-10

S
Screen Layout 2-26
Setting Globe 2-1
Setup
Anterior Segment 4-69
Anterior Vitrectomy
Planned 4-57
Unplanned 4-58
Coagulation
Fixed 4-64
Linear 4-65
Combined Procedure 4-67
Fluid/Air Exchange 4-32
Fragmentation 4-41
Illumination 4-25
Irrigation/Aspiration 4-45
Phacoemulsification 4-50
Posterior Vitrectomy 4-8
Pressurized Infusion 4-61
Viscous Fluid Extraction 4-38
Viscous Fluid Injection 4-37
Vitesse Hypersonic Vitrectomy 4-20

Operator’s Manual 4135904EN

 Index

Wireless Foot Control 1-51

Specifications
Coagulation 8-7
Computer Unit 8-4
Foot Control 8-5
I/A Vitrectomy 8-11
IV Pole 8-7
Physical 8-2
Remote Control 8-6
Ultrasound 8-9
Vacuum Fluidics 8-11
Surgeon Settings 3-4, 3-5, 3-11, 3-17
System Settings 2-6, 3-1
System Setup 3-22

T
Technical Assistance 7-1
Time 3-22
Troubleshooting 6-1

U
Ultrasound
Customization 3-35
Display 2-28
Function 4-46
More Screen 2-9
Specifications 8-9
Unpacking 1-3
Unplanned Anterior Vitrectomy 4-58

V
Vacuum Limit Settings 2-28
Vacuum Response 4-44
Venting 4-44
VFC (Viscous Fluid Control)
Function 4-37
Specifications 8-12
Video Overlay Tab 2-21
Viscoelastic Removal 4-43
Viscous Fluid Extraction 4-38, 4-41
Viscous Fluid Injection 4-37, 4-38
Vitrectomy
Customization 3-37
Function 4-6
More Screen 2-12
Setup and Use 4-20
Voice Confirmation 2-19, 2-26, 3-14, 3-28

4135904EN Operator’s Manual

Index

Y
Yaw
Aspiration 1-60

Operator’s Manual 4135904EN

LEMO is a trademark owned by Interlemo Holding S.A. and NEUTRAWASH is a trademark owned by Getinge USA, Inc.; these references are used for information only, no endorsement or sponsorship by the owners is implied.

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4135904EN