AEX™ Generator

Operator’s Manual
40-405-1
AEX™ Generator
Operator’s Manual
40-405-1
Copyright and © 2016 Medtronic. All rights reserved. Medtronic, Medtronic logo and Further, Together are
Trademarks trademarks of Medtronic. ™* Third party brands are trademarks of their respective owners. All
other brands are trademarks of a Medtronic company.
No part of this publication may be reproduced, transmitted, transcribed, stored in retrieval
systems, or translated into any form, or by any means: electronic, mechanical, magnetic,
optical, or otherwise, without the prior written permission of Medtronic Advanced Energy,
LLC, 180 International Drive, Portsmouth, NH 03801, United States of America.

Disclaimer Medtronic reserves the right to change its products and services at any time to incorporate
the latest technological developments. This guide is subject to change without notice.

Only ◆ CAUTION: Federal (USA) law restricts this device to sale by or on the order of
a physician.

Customer Service Telephone Numbers:

U.S. : China:
Tel: +1 866 777 9400 Tel: +86 21 50800998
Fax: +1 866 222 0900 Fax: +86 21 50800978/50801850

United Kingdom: Germany:
Tel: +44 1923 212213 Tel: +49 211 529 3209
Fax: +44 1923 241004 Fax: +49 211 529 3302

France: India:
Tel: +33 4 7067 9800 Tel: +91 22 26836733
Fax: +33 4 7067 9820 Fax: +91 22 26830806

Belgium-Luxemburg: Japan:
Tel: +32 2 456 0900 Tel: +81 3 6430.2011
Fax: +32 2 460 2667 Fax: +81 3 6430 7110

Canada: Netherlands:
Tel: +1 800 268 5346 Tel: +31 45 566 8000
Fax: +1 905 826 6620  Fax: +31 45 566 8042
Contents
1. Preface
About This Manual.................................................................................................................................................................................. 1-1
Conventions Used in This Manual............................................................................................................................................ 1-1
Help..................................................................................................................................................................................................... 1-1
Indications................................................................................................................................................................................................. 1-1
Contraindications................................................................................................................................................................................... 1-2
Warnings and Cautions......................................................................................................................................................................... 1-2
2. Introduction
AEX™ Generator....................................................................................................................................................................................... 2-1
Electrosurgical Modes........................................................................................................................................................................... 2-2
Controls, Displays, and Receptacles........................................................................................................................................ 2-3
3. Installation
Initial Inspection...................................................................................................................................................................................... 3-1
Installation................................................................................................................................................................................................. 3-1
Optional Wireless Footswitch............................................................................................................................................................. 3-2
Preliminary Checks................................................................................................................................................................................. 3-2
Preliminary Functional Testing........................................................................................................................................................... 3-2
4. Operation................................................................................................................................................................................................... 4-1
Using the Touch Screen........................................................................................................................................................................ 4-1
Turn on Generator.................................................................................................................................................................................. 4-2
Connect the Patient Return Electrode to Patient and Generator.......................................................................................... 4-3
Plugging in the Handpiece to the AEX™ Generator .................................................................................................................. 4-4
Loading the Pump Segment Portion of the Handpiece into the Pump Head of the AEX™ Generator.................... 4-5
Adjusting RF Power Levels................................................................................................................................................................... 4-8
Adjusting the Saline Flow Rate.......................................................................................................................................................... 4-9
Activating the Handpiece.................................................................................................................................................................... 4-9
Using an Optional Footswitch............................................................................................................................................................ 4-9
Adjusting RF Power Settings Using Memory Buttons.............................................................................................................4-10
Adjusting the Volume of the Activation Tone ............................................................................................................................4-10
After Surgery..........................................................................................................................................................................................4-11
Disposing of the Handpiece.....................................................................................................................................................4-11
Preparing the AEX™ Generator for Reuse ...........................................................................................................................4-11
Transportation and Storage of the AEX™ Generator ......................................................................................................4-12
5. Cleaning and Maintenance
Inspections Required Before Each Use............................................................................................................................................ 5-1
Required Annual Inspections............................................................................................................................................................. 5-1
Cleaning..................................................................................................................................................................................................... 5-1
Maintenance............................................................................................................................................................................................. 5-2
Service......................................................................................................................................................................................................... 5-2
Storage........................................................................................................................................................................................................ 5-2
Environmental Protection.................................................................................................................................................................... 5-2
6. Troubleshooting
Monopolar and Bipolar Errors............................................................................................................................................................ 6-1
Error Code Details................................................................................................................................................................................... 6-2
Monopolar and Bipolar Faults............................................................................................................................................................ 6-5

AEX™ Generator Operator’s Manual i

 Fault Code Details................................................................................................................................................................................... 6-6
Error Codes and Error Handling......................................................................................................................................................... 6-9
Troubleshooting Malfunctions........................................................................................................................................................6-10
7. Specifications
AEX™ Generator....................................................................................................................................................................................... 7-1
Output Characteristic Curves............................................................................................................................................................. 7-7
8. Limited Express Warranty and Disclaimers............................................................................................................................... 8-1
9. Product Accessories.............................................................................................................................................................................. 9-1
10. Glossary....................................................................................................................................................................................................10-1
11. Symbols.....................................................................................................................................................................................................11-1

List of Tables
Table 6-1 Error Codes.................................................................................................................................................................... 6-1
Table 6-2 Fault Codes................................................................................................................................................................... 6-5
Table 6-3 Troubleshooting.......................................................................................................................................................6-10
Table 7-1 Mains Input Characteristics..................................................................................................................................... 7-2
Table 7-2 Output Characteristics.............................................................................................................................................. 7-3
Table 7-3 Attached Accessory Cables..................................................................................................................................... 7-4
Table 7-4 Electromagnetic Emissions..................................................................................................................................... 7-4
Table 7-5 Electromagnetic Immunity..................................................................................................................................... 7-5
Table 11-1 Symbols........................................................................................................................................................................11-1

ii
1. Preface

About This Manual

The AEX™ Generator Operator’s Manual provides detailed information on operating and maintaining the AEX™
Generator. This manual and the equipment described within are for use only by qualified medical personnel
possessing training in the surgical procedures to be performed.
For information on accessories, refer to the appropriate Instructions For Use. The AEX™ Generator is
compatible with all Aquamantys™ and PlasmaBlade™ single use only accessories.

Conventions Used in This Manual

▲ WARNING: A warning indicates a hazardous condition that may result in injury or death, if not
corrected or avoided.

◆ CAUTION: Alerts you to the possibility of a problem with the device associated with its use or misuse
resulting in equipment damage or failure in a procedure, if not corrected or avoided.

■ IMPORTANT: Highlights important information for a particular section.

● NOTE: Points out additional information that may be helpful.

Help
Read through the section of the guide specific to the procedure you are performing. Refer to the table of
contents and index to locate information. A glossary is included to assist you with any unfamiliar terms.

1. See Troubleshooting on page 6-1 for a list of problems and suggested solutions.

2. For technical support, contact +1 866 777 9400.

Indications
The AEX™ Generator is a radio frequency (RF) electrosurgical generator capable of simultaneously powering
specified monopolar and bipolar electrosurgical instruments. It is intended to be used for delivery of RF energy
to instruments indicated for cutting and coagulation of soft tissue and for delivery of RF energy concurrent
with saline to instruments indicated for hemostatic sealing and coagulation of soft tissue and bone. It is
intended for, but not limited to, General, Plastic and Reconstructive (including but not limited to skin incisions
and development of skin flaps), ENT, Gynecologic, Orthopaedic, Arthroscopic, Spinal and Neurological,
Thoracic, and Open abdominal surgery procedures. The device is not intended for contraceptive tubal
coagulation (permanent female sterilization).

AEX™ Generator Operator’s Manual 1-1

 Contraindications
The AEX™ Generator with Aquamantys™, Transcollation™ and PlasmaBlade™ should not be used on small
appendages or body parts, as in finger surgery or circumcision.

Warnings and Cautions

Electrosurgery has been used safely in many procedures. Physicians should be familiar with the medical
literature, complications, and hazards associated with electrosurgery before beginning any electrosurgical
procedure. Electrosurgery, if misused, can pose dangers to patients or staff, as well as other equipment. Safe
and effective electrosurgery is dependent not only on equipment design, but also on factors under the control
of the user, such as surgical training and clinical decision making. The warnings and cautions presented in this
manual should be read, understood and followed for safety purposes.

▲ Warnings for Equipment Preparation

• Connect the Generator electrical cord to a properly grounded Hospital Grade receptacle. Do not use extension
cords or three-prong to two-prong adapters with the Generator. Improper grounding may result in equipment
damage, fire at the receptacle, or injury to the patient or user.

NOTE: “Use Hospital Grade receptacle for grounding reliability” statement applies to US/North America power
cords only.
• To allow for appropriate cooling, the unit should not be installed in a cabinet or similar enclosure. If mounted
on a shelf, or near a wall, allow a three-inch clearance around the unit to permit free circulation of air on all
sides of the unit. Appropriate cooling is necessary to avoid overheating of the unit.
• Do not stack equipment on top of the AEX™ Generator or place the generator on top of electrical equipment.
This may block access to the unit and not allow for proper ventilation.
• Provide as much distance as possible between the AEX™ Generator and other electronic equipment (such as
monitors). An activated electrosurgical generator may cause interference with them.
• Prior to use, inspect the AEX™ Generator and its accessories for any obvious defects or improper connections.
Do not use the Generator if it appears to be damaged, as product failure or injury may occur.
• Avoid fluid contact with the accessory cable interfaces to the AEX™ Generator receptacles, because shorting
can occur which can damage the accessory connectors and/or the AEX™ Generator receptacles.
• Use only AEX™ Compatible Footswitches.
• Do not use cords as handles as insulation damage could occur and increase the risk of burns or cause other injury.
• Do not wrap power cords around metal objects. This may induce currents that could lead to shock, fire, or
injury to the patient or surgical team. All power cords should be positioned in a way to avoid contact with the
patient or other cables.
• Nonfunction of the AEX™ Generator may cause interruption of surgery. A backup generator or alternative
surgical techniques should always be available.
• Interference from high frequency surgical equipment may adversely affect the operation of other electron-
ic medical equipment in the operating room. Interference may be resolved or reduced by rearranging the
Generator’s cables such that they do not overlap the cables from other equipment, or by using different power
outlets or extension cords for the different pieces of equipment.
• Patient monitoring systems that incorporate high-frequency current-limiting devices are recommended for
use in an electrosurgical site.

1-2 Preface
 ▲ Warnings for Accessories

• Prior to use, inspect all accessory devices, handpieces, and the AEX™ Generator for defects. Do not use if
insulation or connectors are damaged, because product failure or injury may occur.

• The AEX™ Generator is compatible with all Aquamantys™ and PlasmaBlade™ handpieces.

• The AEX™ Generator is not compatible with Aquamantys™3 handpieces.

• Do not reuse, resterilize or reprocess “Single Use Only” labeled accessory devices, because product failure or
injury may occur.

• The handpieces and Patient Return Electrodes have appropriate connectors and receptacles. Do not attempt
to connect to the improper receptacle because connector damage can occur, which may result in a failure.
Ensure all connections are secure before activating the system.

• Verify that the Patient Return Electrode is properly applied to the patient and the cable is securely connected
to the Patient Return Electrode receptacle. If there is an improper connection the AEX™ Generator may not
operate as intended.

• Do not connect wet connectors to the AEX™ Generator as this may result in equipment damage, fire at the
receptacle, or injury to the patient or user.

• Do not wrap cords around metal objects as this may induce currents that could produce system performance
changes, shocks, fires, or injury to the patient or surgical personnel.

• Do not use accessories other than the ones recommended in Product Accessories. Use of other accessories
may result in an unintended output and/or injury to patient.

• Use active accessories with rated voltage equal to or greater than that of the AEX™ Generator’s maximum
output voltage.

▲ Warnings for Patient Preparation

• Observe fire precautions at all times. An electrosurgical device may provide an ignition source due to sparking
and heating.

• Do not use in the presence of flammable anesthetics or oxidizing gases such as nitrous oxide and oxygen.
Do not activate the unit until vapors from alcohol-based skin prepping agents have dissipated. Naturally
occurring gases that accumulate in body cavities can also be an ignition source.

• Ensure that all oxygen circuit connections and endotracheal tubes are leak-free before and during
electrosurgery use. An oxygen leak could result in an airway fire.

• Inadvertent patient contact may result in burns. When not in use, place all accessory devices in a dry and
nonconductive area away from the patient.

• Position the cables for a Monopolar handpiece and the Patient Return Electrode to avoid patient contact
to protect against high frequency current paths to the patient, as such contact may result in patient or user
injury.

• Do not allow patient contact with grounded metal objects or objects that have an appreciable capacitance
to earth (e.g., operating table supports), as such contact may result in patient or user injury.

• Skin-to-skin contact (e.g., between the arms and body of the patient) should be avoided, e.g., by insertion of
dry gauze.

AEX™ Generator Operator’s Manual 1-3

 • Monopolar devices require a Patient Return Electrode. The Generator must detect proper Patient Return
Electrode impedance before output can be active. The impedance is continuously monitored and displayed
while in Monopolar Mode. The Generator presents audible and visible alarms if it detects improper impedance
with the Patient Return Electrode in Monopolar Mode and will disable Generator output. Unless a compatible
split foil Patient Return Electrode is used, loss of safe contact between the return electrode and the patient
will not result in an audible and visible alarm, and the Generator output will not be disabled. The entire area
of the Patient Return Electrode should be reliably attached to a suitably prepared and appropriate area of the
patient’s body as defined by the manufacturer. Refer to the manufacturer’s instructions for application site
and placement procedures when applying the Patient Return Electrode. Do not rely entirely on the impedance
sensing feature. It can be affected by a damaged (shorted) Patient Return Electrode. It is recommended that
the operator verify appropriate placement and contact of the Patient Return Electrode. Inadequate contact of
the Patient Return Electrode may result in patient alternate site burns or injury.
• Do not cut a Patient Return Electrode to reduce size as this could result in high current density patient burns.
• Heat applied by thermal blankets or other sources may be cumulative with heat from the Patient Return
Electrode (caused by electrosurgical currents). Choose a Patient Return Electrode site remote from other heat
sources to help minimize the risk of patient injury.
• Electrodes and probes used with monitoring, stimulating, and imaging devices can provide paths for high
frequency currents even if the electrodes or probes are insulated, battery operated, and/or isolated at
50/60 Hz. To reduce the risk of burns, place any such electrode or probe as far away as possible from the
electrosurgical site and the Patient Return Electrode.
• Needle monitoring electrodes are not recommended as burns may inadvertently result.
• The active device should not be used near electrocardiograph electrodes as it may cause interference.
• Physiological monitoring devices and their monitoring electrodes should be positioned away from the surgical
site where the AEX™ System will be utilized.
• Always use the lowest RF power setting to achieve the desired surgical effect. Pediatric applications and/
or procedures performed on small anatomic structures may require reduced power settings. The higher the
power and the longer the power is applied, the greater the possibility of unintended thermal damage to tissue.
• Adequate ventilation to reduce electrosurgical smoke by use of a smoke-plume evacuator or other means is
recommended.
• Do not attempt to alter device configurations or replace device components with nonstandard parts since this
may result in decreased device performance, device malfunction, or patient injury.
• Transcollation delivers RF energy in conjunction with saline. Do not inhibit the delivery of saline as burns may
inadvertently result.

▲ Warnings for Active Implants

• If the patient has an internal cardiac defibrillator (ICD), contact the ICD manufacturer for instructions before
performing an electrosurgical procedure. Electrosurgery may cause multiple activations of ICDs.

• Use the AEX™ System with caution in the presence of pacemakers or other active implants, as electrosurgical
equipment may cause interference with these devices or cause them to malfunction. Consult the active
implant manufacturer for further information before proceeding with the surgery.
• The use of electrosurgery in the presence of internal or external active implants is potentially hazardous.
• To minimize the possibility of active implant interference, place the Patient Return Electrode such that the
electrosurgical current path is as far as possible from the active implant lead.
• Direct contact with implanted leads can cause physical damage to the leads. Exercise caution around leads
associated with any active implant; particularly those with thin insulation.

1-4 Preface
 ▲ Warnings for Use

• It is recommended that physicians utilize pre-clinical training, review of pertinent literature, and other
appropriate educational tools before attempting newer surgical procedures, such as endoscopic, laparoscopic,
or thoracoscopic procedures.
• Read the warnings, precautions, and instructions provided with AEX™ disposable handpieces before using.
Specific instructions are not included in this manual.
• If using the optional footswitch, ensure that the footswitch is not inadvertently depressed to prevent the
device from being unintentionally activated. Place the footswitch in a location necessitating deliberate action
in order to activate the unit.
• If using the optional footswitch, only the primary surgeon using the handpiece should operate the footswitch.
Unintentional activation may occur if the footswitch is activated by a separate user, which may result in patient
or user injury.
• Ensure that the sound volume on the Generator is adequately adjusted so that the activation tones are clearly
heard. The activation tones are intended to alert the user that the device is active. This will help prevent
unintended contact with the device which could result in patient or user injury.
• Examine the handpiece before connecting it to the AEX™ Generator. After connecting the handpiece, ensure
that the handpiece and the unit are functioning as intended.
• Consult the operating and user manuals for light sources and other ancillary devices for warnings, precautions,
and instructions prior to their use with the AEX™ Generator.
• Position the AEX™ Generator away from life supporting and/or monitoring systems to reduce/avoid
interference with these systems.
• The interference produced by the operation of RF surgical equipment may adversely influence the operation
of other electronic equipment.
• DO NOT use electrosurgery in the presence of flammable anesthetics or other flammable gases, near
flammable fluids or objects, or in the presence of oxidizing agents as fire could result.
• The cable on the disposable handpieces should be positioned in a way to avoid contact with the patient or
other cables.
• Monitoring systems incorporating RF current limiting devices are recommended.
• For surgical procedures where the RF current could flow through parts of the body having a relatively small
cross sectional area, the use of bipolar techniques may be desirable in order to avoid unwanted tissue damage.
• During use, a diminished power output may indicate that the Patient Return Electrode connection has been
compromised, failure of an electrical lead, active electrode insulation failure or excessive eschar buildup on
the active electrode tip. Do not increase the power output before checking for obvious defects or improper
connections. Check for effective contact of the Patient Return Electrode to the patient any time that the
patient is moved after initial application of the Patient Return Electrode.
• If the system resets due to a power interruption or low voltage, the system will check for effective contact of
the Patient Return Electrode, however the user should verify effective contact of the Patient Return Electrode
visually prior to resuming electrosurgery.
• If power levels were increased to compensate diminished performance, it is recommended to reduce power to
the original or a lower level upon resumption of use.
• The output power selected should be as low as possible for the intended purpose.
• Failure of the high-frequency surgical equipment could result in an unintended increase of output power.

AEX™ Generator Operator’s Manual 1-5

 • Do not use Monopolar electrosurgery on small appendages, such as in finger surgery, as it can cause thrombo-
sis or other unintended injury to tissue proximal to the surgical site.
• Studies have shown that smoke generated during electrosurgery may be harmful to surgical personnel. These
studies recommend the use of a surgical mask and adequate ventilation of the smoke using a surgical smoke
evacuator or other means.
• Neuromuscular stimulation can occur causing unexpected patient movement, especially with modes pro-
ducing electrical arcs between the active device electrode and tissue. Use caution in proximity to neural
structures.
• Observe all caution and warning notices printed on the unit.
• Operating room staff should never contact the handpiece tip while the Generator is active, as injury may result.
• The tip of a recently activated handpiece may be hot enough to cause patient burns or ignite surgical drapes
or other flammable material. When not in use, store the device in an electrically insulated container or holster.
Never place or rest a handpiece on the patient.

▲ Warnings for Testing or Servicing

• Do not remove the Generator cover due to electrical shock hazard. There are no user serviceable parts inside.
• Never remove or install any parts with power ON, as this may result in potential for electrical shock or injury.
Use only Medtronic Advanced Energy approved replacement parts in order to avoid potential equipment
damage or injury.
• Avoid contact with the output leads when the Generator is activated as this may result in injury. Periodically
inspect the test leads used for the output connections for obvious defects.
• The Generator is not designed to operate for extended periods of continuous output. When testing, it is
recommended that duty cycles be limited to 25% with maximum activation times of 10 seconds into a
load greater than or equal to 600 ohms. Use for an extended period of time may result in overheating and
equipment damage.
• Periodic maintenance should be performed by a hospital qualified biomedical technician or by a qualified
Medtronic representative.
• Minimizing operating temperature and extreme thermal cycles will extend the equipment life.
• The heat dissipation capability of the Generator heat sink may be severely impaired by activating the AEX™
Generator in other than a normal operating position. Testing or using the unit in any other position should
be avoided.

1-6 Preface
2. Introduction

AEX™ Generator
The AEX™ Generator is one component of the AEX™ Surgery System. The Generator provides radio frequency
(RF) energy to disposable Monopolar and Bipolar electrosurgical handpieces. The AEX™ Generator accepts a
Patient Return Electrode for monopolar applications, and includes a rotary peristaltic pump for simultaneous
delivery of saline for a hemostatic sealing.

Figure 2-1. AEX™ Generator and AEX™ Wireless Footswitch

AEX™ Generator AEX™ Wireless Footswitch

RF Power
The AEX™ Generator delivers Bipolar RF power and saline with power settings in 5 watt increments in the
range of 20 to 100 Watts and 10 Watt increments in the range of 100 to 220 Watts. The AEX™ Generator
delivers Monopolar Cut, Coag, and Transcollation RF energy with a power output capable of up to 90 Watts.
All PlasmaBlade™ handpieces powered by the PlasmaBlade™ port contain an embedded chip dictating the
settings for that particular handpiece. Aquamantys™ handpieces do not have embedded chips. These settings
are described in the Instructions For Use accompanying the handpiece.

Simultaneous RF Power and Saline Delivery

The AEX™ Generator simultaneously delivers RF power and saline to Bipolar Handpieces and certain
Monopolar Handpieces when they are properly connected to the unit and the activation button on the
handpiece is depressed. For a list of all compatible simultaneous handpieces, please contact Medtronic
Advanced Energy Customer Service at +1 866 777 9400.

Saline Flow Rate Setting

The saline flow rate setting is determined based on the power setting and the selection of one of three
possible flow rate settings: Low, Medium, and High. The three possible saline flow rates for each power setting
are preset automatically in order to provide the optimal saline flow for a given power setting.

AEX™ Generator Operator’s Manual 2-1

 Priming
The AEX™ Generator has a convenient one touch priming function which automatically primes the
Transcollation handpiece with saline prior to use after the device has been correctly connected to the unit.
This function is activated by pressing the “PRIME” button on the unit.

Electrosurgical Modes
The AEX™ Generator operates in the following modes:

Cut Modes (Monopolar)

• Low Cut (Peak Cut) – Precision cutting with minimal hemostasis and minimal collateral damage
• Medium Cut (Pure Cut) – Precision cutting with increased hemostasis and collateral damage
• High Cut (Blend Mode) – Precision cutting with strong hemostasis

Coagulation Modes (Monopolar)

• Coagulation increases with higher settings.
• Low Coag (Pinpoint)
• High Coag (Spray)

Hemostatic Sealing Modes (Monopolar or Bipolar)

• Simultaneous delivery of RF energy with saline for hemostatic sealing of soft tissue and bone.

■ IMPORTANT:

• Each cut, coagulation, and seal mode has multiple power settings available.
• Handpiece models vary and may not utilize all modes. Available modes for each handpiece are per applicable
handpiece Instructions For Use.

Other features of the AEX™ Generator include:

• Proprietary handpieces developed by Medtronic Advanced Energy to deliver RF energy to the patient. Only
Medtronic Advanced Energy handpieces may be used with the AEX™ Generator.
• Handpiece control
• Handpiece with footswitch control
• Simultaneous activation of 2 handpieces
• Device default settings recognition
• Monopolar and Bipolar outputs
• Connection to Patient Return Electrode
• Color LCD to prompt user for input and to display informational, error, and fault messages
• Audio feedback of activation and alarm tones

2-2 Introduction
Controls, Displays, and Receptacles
This section describes each component of the AEX™ Generator and its function. The controls, displays, and
receptacles for Monopolar and Bipolar handpieces, Patient Return Electrodes, and the footswitch are located
on the front and rear panels of the Generator.

▲ WARNING: Read all warnings and instructions provided with the Generator prior to use.

Front Panel Layout Description

Refer to Figure 2-2 for a complete front panel illustration. Each display, control, or receptacle is described in
more detail below.

Figure 2-2. Front Panel Layout

6. Touch Screen Display

1. Power Switch 2. PlasmaBlade™ and 3. Patient Return 4. Aquamantys™ Receptacle 5. Rotary Peristaltic
Combo Receptacle Electrode Receptacle Pump
with Illumination of
Connection Status

1. Power Switch – A black rocker switch that toggles right to turn the AEX™ Generator
power on and toggles left to turn the power off.

2. PlasmaBlade™ and Combo Receptacle – A seven-pin circular receptacle that accepts

PlasmaBlade™ and Combo handpieces.

3. Patient Return Electrode Receptacle – A standard two-pin receptacle that accepts the
Patient Return Electrode connector used in Monopolar procedures.

AEX™ Generator Operator’s Manual 2-3

 4. Aquamantys™ Receptacle – A three-pin rectangular receptacle that accepts
Aquamantys™ handpieces.

5. Saline Pump – This is a rotary peristaltic pump. A special pump segment is attached
to the saline delivery tubing of each disposable handpiece which is designed to operate
with the pump. The pump segment is loaded into this pump head prior to operation of
the device.

6. Touch Screen Display – Screen used to prompt the user for input and to display
informational and fault messages to user.

Panel Layout Description

Refer to Figure 2-3 for a complete back panel illustration. Each control, receptacle, or panel is described in
more detail below.

Figure 2-3. Back Panel Layout

1. RS-232 Port 2. USB Port

3. Footswitch
Connector

4. Fuse Drawer

5. AC Mains Input

6. Equipotential
Ground Connector

7. Name Plate

1. RS-232 Port – Service port for use by trained personnel only.

2. USB Port – Enables uploading of software and downloading of usage data.

3. Footswitch Connector – A connector that accepts an AEX™ Wireless Footswitch

connector.

4. Fuse Drawer – This fuse drawer contains two fuses.

2-4 Introduction
 5. Power Entry / AC Mains – The power entry module combines the connector for the
3-prong, Hospital-Grade power cord with removable enclosure holding two line fuses.
Always use fuses of the rating shown in “Mains Input Characteristics” on page 7-2 of this
manual.

● NOTE: “Use Hospital Grade receptacle for grounding reliability” statement applies
to US/North America power cords only.

6. Equipotential Ground Connector – Standard connector for connecting common

grounds.

7. Name Plate – This plate specifies the model number, serial number, nominal line
voltages, frequency, current, and fuse rating information for the AEX™ Generator.

AEX™ Generator Operator’s Manual 2-5

 This page intentionally left blank.

2-6 Introduction
3. Installation

Initial Inspection
Unpack the Generator upon receipt and physically inspect it for any obvious damage that may have occurred
during shipment. A qualified biomedical engineer or personnel familiar with electrosurgical devices should
perform this inspection.
If the Generator is damaged, call +1 866 777 9400 for assistance.

Installation
The AEX™ Generator should be placed on a flat and stable surface.

▲ WARNING: The Hospital Grade power cord of the Generator should be connected to a properly polarized
and grounded power source whose voltage and frequency characteristics are compatible with those listed
on the nameplate of the AEX™ Generator (located on the rear panel of the Generator). Improper grounding
may result in equipment damage, fire at the receptacle, or injury to the patient or user.
To completely disconnect the Generator from the AC mains, the power cord needs to be unplugged from
the power source. Do not position generator such that removal of the power cord from the power source
would be difficult.

● NOTE: “Use Hospital Grade receptacle for grounding reliability” statement applies to US/North America
power cords only.

▲ WARNING: To allow for appropriate cooling, do not install the Generator in a cabinet or similar enclosure.
If mounted on a shelf or near a wall, allow a 3-inch clearance around the Generator to permit free air
circulation on all sides. Appropriate cooling is necessary to avoid overheating of the Generator.

AEX™ Generator Operator’s Manual 3-1

 Optional Wireless Footswitch
● NOTE: The optional wireless footswitch is only compatible with enabled monopolar handpieces.
Monopolar activation may be initiated either from a footswitch or a handpiece. Transcollation function
cannot be activated by the footswitch.

1. If using the optional footswitch, plug the wireless receiver into the footswitch connector of the AEX™
Generator (see Figure 2-3 on page 2-4).

2. Turn on the AEX™ Generator and ensure that the wireless receiver’s power-on LED is green, indicating that
the receiver is powered on.

Figure 3-1. Wireless Receiver

Power-On
LED Indicator

▲ WARNING: Only the primary surgeon using the handpiece should operate the footswitch. Unintentional
activation may occur if the footswitch is activated by a separate user, which may result in patient or user injury.

Refer to the Wireless Footswitch Operator’s Manual for detailed product information.

Preliminary Checks
Prior to installing and using the Generator, it is strongly recommended that a qualified maintenance technician
ensure proper and safe operation by testing the performance of the Generator. If anomalous behavior is
observed, the Generator should not be used until all issues have been resolved by a qualified technician. Call
Medtronic Advanced Energy Customer Service at +1 866 777 9400.

Preliminary Functional Testing

Preliminary functional testing should be conducted by a qualified technician or operating room personnel.
Personnel conducting functional tests should read this manual prior to testing.
1. Turn on the Generator by pressing the power switch.

2. Verify the following occurs:

• A self-test screen appears indicating that the system is performing a power-on self-test as shown in
Figure 3-2. The software version is also shown at the bottom of the screen. If the self-test screen does
not appear, cycle the power and try again. If the same problem continues, call Medtronic Advanced
Energy Customer Service at +1 866 777 9400. Do not attempt to use the Generator until the problem
has been resolved.

3-2 Installation
 Figure 3-2. Front Panel Showing Self-Test Screen.

• The Cut and Coag activation tones will sound to allow you to verify operation.
• The screen in Figure 3-2 will disappear when the self-test is complete. If the self-test is not successful, an alarm
tone will sound, a Fault Code will be displayed on the LCD screen and the Generator output will be disabled.
The alarm tone will sound until the Generator is turned off. In this case, call Medtronic Advanced Energy
Customer Service. Do not attempt to use the Generator until the problem has been resolved.
• If the self-test is successful, verify the following:
• If the Generator is powered on with no handpieces connected, the Generator displays the following operational
screen.

Figure 3-3. Front Panel Showing Operational Screen with No Devices Connected.

Figure 3-4. Front Panel Displaying the Screen with PlasmaBlade™ Handpiece Connected.

AEX™ Generator Operator’s Manual 3-3

 Figure 3-5. Front Panel Displaying the Screen with Bipolar Handpiece Connected.

Figure 3-6. Front Panel Displaying the Screen with PlasmaBlade™ and Bipolar Handpieces Connected.

Figure 3-7. Front Panel Displaying the Screen with Combo Handpiece Connected.

Figure 3-8. Front Panel Displaying the Screen with PlasmaBlade™ and Bipolar Handpieces Connected and activated.

3-4 Installation
4. Operation

Using the Touch Screen

The following are some typical examples of the touch screens and how to interact with them:

Figure 4-1. Touch screen

Sound Volume Control
Footpedal Indicator
Slide the control to the right to
It is illuminated if a footswitch is
increase the volume, slide the
connected.
control to the left to decrease
the volume.

Saline Flow Rate Indicators

Press one of the three
indicators.

Power Levels
Increase by pressing up arrow,
decrease by pressing down
arrow.

Figure 4-2. Numeric keyboard

Memory Buttons
They can be renamed by pressing and
holding the button for 1 second. Then a
keyboard will appear. Alpha and numeric
keyboards are available (see Figures 4-2 &
4-3). In order to preset the memory button
with power level preferences, the handpieces
need to be plugged in to the AEX™ Generator
display. Then change the handpiece power
Figure 4-3. Alpha keyboard
levels. Once the power levels have been
changed, press and hold the memory button
to save the preferences.

AEX™ Generator Operator’s Manual 4-1

 Turn on Generator

1. Ensure the power switch is off, and then connect the power cord to a properly grounded and polarized
mating power receptacle.

2. Set the power switch to the ON position. The color LCD on the front panel will illuminate and show a self-
test screen (Figure 4-4). The self-test will take approximately 10 seconds to complete.

Figure 4-4. Self test.

After the Generator goes through its internal self-diagnostics, the Generator should respond by:

• The self-test screen will be replaced with an operational screen (Figure 4-5), and the generator will output
a three tone sequence indicating the completion of self-test.

Figure 4-5. Operational screen.

After the power-on self-tests, the Generator is ready for use.

If the Generator fails to respond as indicated above, it has failed one of its internal tests and must not be used.
An alarm tone will sound and a Fault Code will appear on the front panel LCD. As a result, the Generator
output will be disabled. In this case, call Medtronic Advanced Energy Customer Service at +1 866 777 9400.
Do not attempt to use the Generator until the problem has been resolved.

4-2 Operation
Connect the Patient Return Electrode to Patient and Generator

● NOTE: A Patient Return Electrode is only required for RF energy delivery if the Patient Return Electrode
receptacle LED is illuminated while a handpiece is connected.

1. Select and prepare patient application site. Refer to the Instructions for Use provided with the Patient
Return Electrode. To reduce risk of patient burns, apply Patient Return Electrode to patient observing the
criteria described in Section 1 of this Operator’s Manual and the Instructions for Use provided with the
Patient Return Electrode.

2. Insert the Patient Return Electrode connector into the Patient Return Electrode receptacle in the center of
the front panel of the AEX™ Generator (Figure 4-6).

3. When the Patient Return Electrode has been properly selected and applied to the patient, and a
monopolar device has been connected, the Patient Return Electrode receptacle illumination will
change from red to green in color (Figure 4-7).

Figure 4-6. Figure 4-7.

▲ WARNING: Refer to the manufacturer’s instructions for application site and placement procedures when
applying the Patient Return Electrode.

▲ WARNING: Do not depend solely on the illumination indicator for confirmation of good Patient Return
Electrode application. Qualified personnel should make the final decision on proper Patient Return
Electrode placement.

■ IMPORTANT: Monopolar devices require a Patient Return Electrode. The Generator must detect proper
Patient Return Electrode impedance before the Generator output can be active.

■ IMPORTANT: The AEX™ Generator accepts both single foil and split foil Patient Return Electrodes up to
power levels of 50 watts. If a hand piece with monopolar capability exceeding 50 Watts is connected to
the generator, a split foil Patient Return Electrode is required.

AEX™ Generator Operator’s Manual 4-3

 Plugging in the Handpiece to the AEX™ Generator

PlasmaBlade™
1. Insert the handpiece connector into the gray PlasmaBlade™ receptacle on the front panel of the AEX™
Generator.

■ IMPORTANT: Upon connection, the Generator will alarm if the device is not recognize the handpiece,
if it fails a unit test, or if it is expired.

2. The screen will display default output levels for Cut and Coag (Figure 4-8).

Figure 4-8. Default Cut and Coag output levels

▲ WARNING: Always stow unused devices in an electrically insulated location such as a safety holster
in sterile field.

Aquamantys™ Handpiece
1. Insert the handpiece connector into the yellow Aquamantys™ receptacle on the front panel of the AEX™
Generator.
2. The touchscreen will display the default output level for Bipolar power and a glow around the "Prime"
button to prompt saline setup (Figure 4-9).

Figure 4-9. Default Bipolar output level

▲ WARNING: Always stow unused devices in an electrically insulated location such as a safety holster in sterile
field.

4-4 Operation
Combo Handpiece
1. Insert the handpiece connector into the gray PlasmaBlade™ 7-pin receptacle on the front panel of the
AEX™ Generator.

■ IMPORTANT: Upon connection, the Generator will alarm if the device is not recognized as a Combo
handpiece, if it fails a unit test, or if it is expired.

2. The screen will display default output levels and a glow around the "Prime" button to prompt saline setup
(Figure 4-10).

Figure 4-10. Default output levels

● NOTE: If two handpieces with transcollation technology are connected to the generator, the generator
will only permit use of transcollation on the 3-Pin receptacle powered handpiece. Only the 3-Pin
handpiece saline tubing should be loaded in this instance.

Handpiece use requires compatible generator software. If the generator software is not compatible with
its connected handpiece, the handpiece will not function.

▲ WARNING: Always stow unused devices in an electrically insulated location such as a safety holster
in sterile field.

Loading the Pump Segment Portion of the Handpiece into the Pump Head
of the AEX™ Generator
1. Raise the upper part of the pump head by flipping open the pump lid as shown in Figure 4-11.

Figure 4-11. Open pump lid

AEX™ Generator Operator’s Manual 4-5

 2. On the handpiece saline tubing, locate the pump segment portion (between black and white tubing
connectors), place the pump segment portion of the saline delivery tubing into the pump head with
the black tubing connector positioned to the left side of the pump head (i.e., closest to the front panel
of the AEX™ Generator). The white tubing connector should then be positioned to the right side of the
pump head (i.e., closest to the back panel of the AEX™ Generator). A label on the front of the pump
indicates the position of the black and white connectors.

Figure 4-12 Open pump lid

■ IMPORTANT: Ensure that the pump segment portion of the saline delivery tubing is properly aligned in
the center of guide slots (upside down “v”) where it enters and exits the pump head.

3. Close the pump head.

The pump segment tubing must be centered in the guide slot of both tubing guides, with no pinching
of the tubing (see Figure 4-13).

Figure 4-13 Closed pump

▲ WARNING: Always close the pump head prior to priming or device activation. Always allow the pump
head rotor to come to a complete stop prior to opening the pump head. Do not attempt to load or
adjust the positioning of the pump segment of the disposable bipolar device in the pump head while
the pump head rotor is turning. Fingers or loose clothing could be caught in the pump rollers.

4-6 Operation
Spiking the Saline Bag
1. Hang a bag of sterile saline (0.9% NaCl) solution on the AEX™ Generator Cart I.V. pole or another I.V.
support that is in close proximity to the AEX™ Generator.
2. Remove the protective cover over the spike of the drip chamber at the end of the handpiece’s saline
delivery tubing.
3. Using aseptic technique, spike the bag of sterile saline (0.9% NaCl) solution.
4. Squeeze the drip chamber once or twice to fill the drip chamber to a level of at least one-third full.

Priming the Handpiece

1. Press the “PRIME” button as shown in Figure 4-14. This initiates priming of the handpiece with saline.

• The pump will operate for a preset time period to prime the device. The pump head speed is
accelerated during the priming cycle compared to normal use.
• The device is primed when saline drips from both device electrodes of the handpiece. After the prim-
ing cycle is complete, the pump shuts off automatically.

Figure 4-14. Prime Button Screen

2. The “PRIME” indicator will change to “STOP” when priming is activated. If priming needs to be stopped
after priming has been initiated, press the “STOP” button as shown in Figure 4-15.

Figure 4-15. Stop Button Screen

AEX™ Generator Operator’s Manual 4-7

 3. After the initial priming of the handpiece, the button is renamed “REPRIME” as shown in Figure 4-16.

Figure 4-16. Reprime Button Screen

▲ WARNING: Always place the handpiece into a holster or over a container to collect the saline that
exits the device electrodes as a result of the priming process. If excess saline is not collected, saline
could drip on the patient, patient drapes, surgical instruments, or operating room surfaces.

▲ WARNING: Lack of saline flow from both of the device electrodes can result in a lack of tissue effect
and may damage the device electrodes during device activation. Use caution to avoid conditions
that can result in lack of adequate saline flow from the device.

Adjusting RF Power Levels

▲ WARNING: Set the RF power to the lowest setting for desired tissue effect to avoid overtreatment,
which could result in swelling, fluid, seroma or unintended tissue necrosis. Setting the RF power too
low may produce insufficient tissue effect.

1. Set the RF power output for the desired tissue effect by pressing the button to increase, or the
button to decrease, RF power.

2. Release the button when the desired RF power setting is displayed. The final RF power settings will be
shown on the screen.

■ IMPORTANT: The RF power setting cannot be adjusted while the handpiece is being activated.

3. The default power setting and the range of possible power adjustments will depend upon which
disposable handpiece is inserted into the AEX™ Generator. The range of power settings for each
handpiece have been selected to optimize its performance.

4-8 Operation
Adjusting the Saline Flow Rate
1. The saline flow rate may be adjusted by pressing the desired flow rate button. The three flow rate
buttons are:

• High Flow ( )
• Medium Flow ( )

• Low Flow ( )

2. The three possible saline flow adjustments are preset for each given RF power setting.

● NOTE: The saline flow rate setting cannot be adjusted while the disposable hand piece is activated.

3. If a flow rate setting is not manually selected, the medium setting is selected as the default setting.

Activating the Handpiece

1. Press the activation button on the handpiece to simultaneously activate RF power and saline flow (if
applicable) from the handpiece. The appropriate indicator on the touch screen will illuminate and the
appropriate activation tone will sound.

2. Release the activation button on the handpiece to shut off both RF power and saline flow from the
handpiece.

At maximum output settings and rated load conditions, the generator may be safely operated at duty cycles of
33% for bipolar Transcollation (40 seconds on, 80 seconds off ), and 25% for monopolar RF delivery (10 seconds
on, 30 seconds off ).

Using an Optional Footswitch

An optional footswitch may be used. If a footswitch will be used, plug the wireless receiver into the footswitch
connector on the back of the generator (see Figure 2-3 on page 2-4). While using a footswitch, RF power will
be delivered via the handpiece.

AEX™ Generator Operator’s Manual 4-9

 Figure 4-17. Footswitch Connected

▲ WARNING: Ensure that the footswitch is not inadvertently depressed to prevent the device from
being unintentionally activated. Place the footswitch in a location that requires deliberate action
in order to activate the unit.

■ IMPORTANT: Use only the AEX™ Wireless Footswitch.

Adjusting RF Power Settings Using Memory Buttons

Once a Memory Button has been set up with appropriate settings, a user can select a memory button and the
settings that have been preset will automatically become active for the hand pieces that are plugged into the
AEX™ Generator.

Adjusting the Volume of the Activation Tone

▲ WARNING: Do not turn the activation tone down to an inaudible level. The activation tone alerts
the surgical team when a device is active.

• To increase the volume of the RF power activation tone, slide the button to the right.
• To decrease the volume of the RF power activation tone, slide the button to the left.
• The AEX™ Generator prevents this tone from being silenced.

4-10 Operation
After Surgery

Disposing of the Handpiece

1. Turn the Generator off by pressing the left half of the power switch.
2. If the handpiece has saline tubing, firmly knot the saline tubing between the drip chamber and the
pump segment.

• Open the pump head and remove the pump segment portion of the saline delivery tubing.
• Remove the used saline bag from I.V. pole.

3. Unplug the handpiece from the AEX™ Generator.

4. Dispose of the handpiece and used saline bag according to the procedures
for your institution.

■ IMPORTANT: Some handpieces and the saline bags will contain unused saline following use of the
handpiece. Take precautions to prevent the unused saline from flowing onto operating room surfaces
by placing handpiece into waste receptacle prior to opening pump head and removing device pump
segment.

Preparing the AEX™ Generator for Reuse

▲ WARNING: Electric Shock Hazard. Always turn off and unplug the unit before cleaning.

■ IMPORTANT: Do not clean the unit with abrasive cleaning or disinfectant compounds, solvents, or other
materials that could scratch the panels or damage the unit.

1. Turn the AEX™ Generator off by pressing the left hand portion of the power switch.
2. Unplug the main power cord from the wall outlet and receptacle on the AEX™ Generator.
3. Thoroughly wipe all surfaces of the unit and power cord with a damp cloth using a mild cleaning solution
or disinfectant. Follow the procedures approved by your institution or use a validated infection control
procedure. Do not allow fluids to enter the chassis. The unit should not be sterilized.

AEX™ Generator Operator’s Manual 4-11

 Transportation and Storage of the AEX™ Generator
Care should be taken when transporting the AEX™ Generator prior to and after use to prevent impact damage
to the unit. The unit should be transported on the AEX™ Generator Cart or a suitable alternative. Consult the
procedures for your institution and applicable regulations.
If the unit is stored at a temperature outside its normal operating range of 50 °F to 104 °F (10 °C to 40 °C),
allow it to stabilize at room temperature prior to use.
The unit can be stored indefinitely. However, if you store it longer than one year, you must perform specific
checkout procedures, including functional verification before use. Refer to section 10 of this guide.
Do not store the AEX™ Generator on its side or end. This may cause damage to the unit.

■ IMPORTANT: Do not discard in trash. Electronic equipment should be disposed of in an appropriate

manner by a certified disposal company.

4-12 Operation
5. Cleaning and Maintenance

This section contains information for ordinary cleaning and maintenance of the AEX™ Generator. While
the Generator has been designed and manufactured to high industry standards, periodic inspection and
performance testing must be performed by a qualified biomedical technician for safe and effective operation.

● NOTE: Refer to the AEX™ Preventive Maintenance Guide for more detailed information and instructions.

Inspections Required Before Each Use

1. Visually inspect the Generator for physical damage. Report damage to Medtronic Advanced Energy or
your biomedical department. Do not use the Generator if it is damaged.

2. Visually inspect the power cord and plug for physical damage. Replace the cord if the insulation has been
breached. Do not use the Generator if the cord or plug has been damaged and has not yet been replaced.

Required Annual Inspections

1. Inspect the tightness of the power plug. If this component is loose, it must be replaced with a Medtronic
Advanced Energy approved component.

2. Inspect the mating, cleanliness, and absence of damage to the patient connectors. Do not use the
Generator if the connectors are damaged.

3. Inspect for accumulation of lint or debris on the Generator or fan vents. Do not use the Generator if lint or
debris has accumulated and has not been cleared.

Cleaning
▲ WARNING: Electric shock hazard. Always unplug the Generator from the wall outlet prior to cleaning.

The Generator does not require sterilization.

1. Clean the front display, cover, and cord with a mild detergent or mild disinfecting solution and damp
cloth.

It is recommended that non-flammable agents be used for cleaning and disinfection whenever possible.
If flammable agents are used for cleaning, disinfecting, or as solvents, they should be allowed to dry
before surgery.
◆ CAUTION: Do not allow fluids to enter the chassis. Do not use alcohol, caustic, corrosive, or abrasive
materials on the front display, cover, and cord, as they may cause damage to the equipment. Medtronic
Advanced Energy recommends following hospital procedures for cleaning the outside of the Generator
after each procedure.

Refer to the AEX™ Wireless Footswitch Operator’s Manual for detailed cleaning instructions for the footswitch
and receiver.

AEX™ Generator Operator’s Manual 5-1

 Maintenance
The AEX™ Generator must be performance tested by a hospital qualified biomedical technician at least every
year. Follow your hospital’s procedures for periodic performance verification of electrosurgical generators.
Medtronic Advanced Energy recommends the following checks:
• Power Output verification for each mode of operation
• RF Leakage
• AC Leakage
• AC Ground Integrity

Service
The RS-232 port provided on the rear panel is used for the following service features, which can be performed
by a qualified Medtronic Advanced Energy technician only:
• To reprogram set-up parameters.
• To download the event history log containing information on errors and faults.

Storage
The Generator must be thoroughly checked by a qualified biomedical engineer if it has been stored for longer
than 6 months.
Allow the Generator to remain at room temperature for at least 1 hour if it has been stored at extreme
temperatures. Refer to “Storage Parameters” on page 7-1 for the limits for storing the AEX™ Generator.

Environmental Protection
Retain the shipping container and packing material in the event that the Generator needs to be returned for
repair or service. At the end of the equipment’s life, dispose of it in accordance with your local regulations.
The materials in the generator include aluminum, steel, copper, thermoplastics, and electronic components.

5-2 Cleaning and Maintenance

6. Troubleshooting

This section identifies the possible error and fault conditions and offers common solutions for correcting
malfunctions and responding to alarms.
The AEX™ Generator has been designed and manufactured for reliable operation. In the event that the
Generator fails, it has several self-diagnostic routines to aid in troubleshooting the problem. If the software
detects a problem, an error code or fault code is displayed on the screen, and the Generator is disabled. The
Generator will remain disabled until the detected problem is corrected. The self-diagnostic routines are only an
aid for qualified technicians, and are not a substitute for evaluation of a problem by a qualified technician.

▲ WARNING: Electric shock hazard. Always unplug the Generator from the wall outlet prior to opening the
cover for servicing. There are no user-serviceable parts inside the Generator. The AEX™ Generator should
only be serviced by a Medtronic Advanced Energy trained technician.

Monopolar and Bipolar Errors

The AEX™ Generator includes automatic self-diagnostics. If the diagnostics detect a condition that can be
corrected by the operator, the system displays an error code, sounds an alarm tone, and deactivates the
Generator’s output. Correcting the error will enable the Generator’s output.
Most error codes result from conditions in accessories attached to the Generator. The following table lists the
error codes and describes the condition.

Table 6-1. Error Codes

Error Code Description

E1 Switch on handpiece may be stuck in the ON position.

E2 Footpedal switch may be stuck in the ON position.

E3 Patient Return Electrode has poor connection.

E4 Generator monopolar output error.

E5 Handpiece has reached end of life.

E6 Handpiece is not recognized as a Medtronic Advanced Energy device or failed test.

E7 Generator bipolar output.

E8 Monopolar output circuitry has exceeded a normal temperature.

E9 Patient Return Electrode is not supported by current handpiece.

E10 Handpiece must be Primed before performing Transcollation.

AEX™ Generator Operator’s Manual 6-1

 Error Code Details
A detailed description of the cause of each error is provided below, along with steps to follow. Figure 6-1
shows an example of an Error screen.

Figure 6-1. Error Code E1

Error Code E1
Switch on handpiece may be stuck in the ON position.

Cause Solution

Handpiece button stuck in the 1. Ensure that the handpiece is not in contact with the patient.
ON position when the device 2. Disconnect and reconnect the handpiece.
is connected. The Error Code
is displayed and the alarm will 3. If the Error Code reappears, turn the Generator power OFF and then turn the
sound once. power ON again.
4. If the problem persists, replace the handpiece and repeat this procedure.
5. If the Error Code reappears, record the number and contact Medtronic Advanced
Energy Customer Service. Do not use the Generator.

Error Code E2
Foot pedal switch may be stuck in the ON position.

Cause Solution

Footswitch has pedal switch 1. Ensure that the handpiece is not in contact with the patient.
stuck in the ON position when 2. Disconnect and reconnect the footswitch.
the footswitch is connected.
The Error Code is displayed 3. If the Error Code reappears, turn the Generator power OFF and then turn the
and the alarm will sound once. power ON again.
4. If the problem persists, replace the footswitch and repeat this procedure.
5. If the Error Code reappears, record the number and contact Medtronic Advanced
Energy Customer Service. Do not use the Generator.

6-2 Troubleshooting
Error Code E3 with Red LED Illumination
Patient Return Electrode has poor connection or no connection.

Cause Solution

The Error Code is displayed when 1. Follow the manufacturer’s instructions for Patient Return Electrode placement.
the impedance is out of range. 2. Verify that a Split Foil Patient Return Electrode is used for handpieces with power
The Error Code is displayed and levels greater than 50 watts.
the alarm will sound once. The
error/alarm will only display/ 3. Verify that the Patient Return Electrode is connected to the Generator.
sound if the handpiece is 4. Verify the Patient Return Electrode is making proper contact with the patient.
activated. The Patient Return
Electrode receptacle LED 5. Disconnect and reconnect the Patient Return Electrode and Generator.
Illumination will turn red and stay If the Error Code reappears, record the number and contact Medtronic Advanced
red as long as the impedance Energy Customer Service. Do not use the Generator.
is out of range. The Patient
Return Electrode impedance is
continuously checked.

Error Code E4
Generator monopolar output error.

Cause Solution

Measurements of the monopolar 1. If the Error Code reappears, replace the handpiece.
output voltage and current are 2. If the Error Code reappears, disconnect the handpiece and the Patient Return
being made while the Generator Electrode. Turn the Generator power OFF and then turn the power ON again.
has active output. If these Reconnect the handpiece and Patient Return Electrode and try again.
measurements are outside the
normal range, the output will 3. If the Error Code reappears, record the number and contact Medtronic Advanced
be disabled. The Error Code is Energy Customer Service. Do not use the Generator.
displayed and the alarm will
sound once.

Error Code E5
Handpiece has reached end of life.

Cause Solution

For safety reasons, each device 1. Replace the handpiece.

has a limited active life span. If the 2. The Error Code screen will disappear if the device is recognized, tested, and has
time is exceeded, then the Error a life expectancy.
Code is displayed and the alarm
will sound once. 3. If the Error Code reappears, record the number and contact Medtronic Advanced
Energy Customer Service. Do not use the Generator.

Error Code E6
Handpiece is not recognized as compatible.

Cause Solution

The handpiece is connected to the 1. Replace the handpiece. The Error Code screen will disappear if the device is
Generator and it is not recognized as recognized, tested, and has a life expectancy.
an AEX™ device, a generator software 2. If the Error Code reappears, record the number and contact Medtronic Advanced
update is needed, or it has failed Energy Customer Service. Do not use the Generator.
testing. The Error Code is displayed
and the alarm will sound once.

AEX™ Generator Operator’s Manual 6-3

 Error Code E7
Generator bipolar output error.

Cause Solution

Measurements of the bipolar 1. If the Error Code reappears, replace the handpiece.
output voltage and current are 2. If the Error Code reappears, disconnect the handpiece and the Patient Return
being made while the Generator Electrode. Turn the Generator power OFF and then turn the power ON again.
has active output. If these Reconnect the handpiece and Patient Return Electrode and try again.
measurements are outside the
normal range, the output will 3. If the Error Code reappears, record the number and contact Medtronic Advanced
be disabled. The Error Code is Energy Customer Service. Do not use the Generator.
displayed and the alarm will
sound once.

Error Code E8
Monopolar output circuitry has exceeded a normal temperature.

Cause Solution

Intensive use of high power 1. Release the transcollation button on the handpiece.
output can cause significant 2. Cut and Coag use may be continued.
increase in the generator circuit
temperature. If the temperature 3. The error code will remain on the screen until the generator circuit temperature
is determined to exceed a normal has returned to a normal level. While the error code is displayed, monopolar
level, the monopolar transcollation transcollation will be deactivated.
output will be disabled. The error
code is displayed and the alarm
will sound once.

Error Code E9
Patient Return Electrode is not supported by current handpiece.

Cause Solution

The connected handpiece has 1. Substitute a Split foil Patient Return Electrode for the Patient Return Electrode
the capability of delivering currently connected to the receptacle on the front of the generator.
greater than 50 Watts of 2. If the Error Code reappears, disconnect the handpiece and the Patient Return
monopolar RF power. A device Electrode. Turn the Generator power OFF and then turn the power ON again.
with this capacity can only be Reconnect the handpiece and Patient Return Electrode and try again.
used with a split foil Patient
Return Electrode. The output will 3. If the Error Code reappears, record the number and contact Medtronic Advanced
be disabled if the unlocked NE Energy Customer Service. Do not use the Generator.
Impedance measures less than 18
Ohms while such a handpiece is
connected.
The Error Code will be displayed
and the alarm will sound once.

6-4 Troubleshooting
Error Code E10
Handpiece needs to be primed before performing Transcollation.

Cause Solution

The generator requires that 1. Press the Prime button on the display.
all connected handpieces are 2. Allow the priming sequence to complete or press the Stop button to end priming.
primed before they can perform
Transcollation. The Error Code 3. Attempt Transcollation activation again.
is displayed and the alarm will 4. If the Error Code reappears, record the number and contact Medtronic Advanced
sound once upon un-primed Energy Customer Service. Do not use the Generator.
Transcollation activation attempt.

Monopolar and Bipolar Faults

The AEX™ Generator includes automatic self-diagnostics. If the diagnostics detect a fault, the system displays
a fault code, sounds an audible tone, and deactivates the Generator’s output. All faults indicate a possible
problem with the equipment. Power must be turned off and then back on before operation can continue. If
the self-test does not successfully complete, refer the equipment to Service Personnel.

Table 6-2. Fault Codes

Non-Recoverable
Description
Fault Code

F1 Internal temperature of the Generator has exceeded the limit.

F2 CRC self-test fault.

F3 RF Module not calibrated or calibration was lost.

F4 Real Time Clock self-test fault.

F5 Watchdog Monitor has detected a Watchdog Processor failure.

F6 Controller Processor communication with the Display has failed.

F7 Pump Communications fault.

F8 Pump Control Overheating.

F9 ADC Reference fault.

F10 RAM self-test fault.

AEX™ Generator Operator’s Manual 6-5

 Fault Code Details
A detailed description of the cause of each fault code is provided below, along with steps to follow. Figure 6-2
shows an example of a Fault screen.

Figure 6-2. Fault Code

Fault Code F1
Internal temperature of the Generator has exceeded the limit.

Cause Solution

Internal temperature exceeded 1. Turn off Generator and turn back on after the Generator has cooled sufficiently.
limit while turned ON. The Fault 2. If the Fault Code reappears, record the number and contact Medtronic Advanced
Code is displayed and the alarm Energy Customer Service. Do not use the Generator.
will sound once.

Fault Code F2
CRC self-test fault.

Cause Solution

Self-test diagnostics are run 1. Turn the Generator power OFF and then turn the power ON again. Do not press
when the Generator is powered buttons or activate handpieces during the self-test.
ON. This Fault Code indicates that 2. If the Fault Code reappears, disconnect the handpiece and Patient Return
one or more of the self-tests have Electrode. Turn the Generator power OFF and then turn the power ON again.
failed. The Fault Code is displayed
and the alarm will sound 3. If the Fault Code reappears, record the number and contact Medtronic Advanced
continuously. Energy Customer Service. Do not use the Generator.

6-6 Troubleshooting
Fault Code F3
RF Module not calibrated or calibration was lost.

Cause Solution

The RF Module has detected that 1. Turn the Generator power OFF and then turn the power ON again. Reconnect the
it is not calibrated or calibration handpiece and Patient Return Electrode and re-attempt use of the handpiece.
values have been lost. The Fault 2. If the Fault Code reappears, record the number and contact Medtronic Advanced
Code is displayed until the Energy Customer Service. Do not use the Generator.
Generator is turned off and the
alarm will sound once.

Fault Code F4
Real Time Clock self-test fault.

Cause Solution

Self-test diagnostics are run 1. Turn the Generator power OFF and then turn the power ON again. Reconnect the
when the Generator is powered handpiece and Patient Return Electrode and re-attempt use of the handpiece.
ON. 2. If the Fault Code reappears, record the number and contact Medtronic Advanced
This Fault Code indicates that Energy Customer Service. Do not use the Generator.
one or more of the self-tests
have failed. The individual self-
test that failed will be recorded
in the Generator’s data flash for
retrieval during maintenance. The
Fault Code is displayed until the
Generator is turned off and the
alarm will sound once.

Fault Code F5
Watchdog Monitor has detected a Watchdog Processor failure.

Cause Solution

The Watchdog Monitor has 1. Turn the Generator power OFF and then turn the power ON again. Reconnect the
detected that the Processor handpiece and Patient Return Electrode and re-attempt use of the handpiece.
Watchdog has engaged. The 2. If the Fault Code reappears, record the number and contact Medtronic Advanced
Fault Code is displayed until the Energy Customer Service. Do not use the Generator.
Generator is turned off and the
alarm will sound once.

AEX™ Generator Operator’s Manual 6-7

 Fault Code F6
Controller Processor communication with the Display has failed.

Cause Solution

The Controller processor has 1. Turn the Generator power OFF and then turn the power ON again. Reconnect the
detected that the display handpiece and Patient Return Electrode and re-attempt use of the handpiece.
communication is not 2. If the Fault Code reappears, record the number and contact Medtronic Advanced
functioning properly. The Fault Energy Customer Service. Do not use the Generator.
Code is displayed until the
Generator is turned off and the
alarm will sound once.

Fault Code F7
Pump Communications fault.

Cause Solution

The Pump motor controller 1. Turn the Generator power OFF and then turn the power ON again. Reconnect the
communications have failed. The handpiece and Patient Return Electrode and re-attempt use of the handpiece.
Fault Code is displayed and the 2. If the Fault Code reappears, record the number and contact Medtronic Advanced
alarm will sound once. Energy Customer Service. Do not use the Generator.

Fault Code F8
Pump Overheating.

Cause Solution

The temperature of the pump’s 1. Turn off Generator and turn back on after the Generator has cooled sufficiently.
motor controller exceeded limit 2. If the Fault Code reappears, record the number and contact Medtronic Advanced
while turned ON. The Fault Code Energy Customer Service. Do not use the Generator.
is displayed and the alarm will
sound once.

Fault Code F9
ADC Reference fault.

Cause Solution

This Fault Code indicates that 1. Turn the Generator power OFF and then turn the power ON again. Reconnect the
the Generator’s analog to handpiece and Patient Return Electrode and re-attempt use of the handpiece.
digital conversion circuitry has 2. If the Fault Code reappears, record the number and contact Medtronic Advanced
experienced a fault while turned Energy Customer Service. Do not use the Generator.
ON. The Fault Code is displayed
and the alarm will sound once.

6-8 Troubleshooting
Fault Code F10
RAM self-test fault.

Cause Solution

Self-test diagnostics are run when 1. Turn the Generator power OFF and then turn the power ON again. Reconnect the
the Generator is powered ON. handpiece and Patient Return Electrode and re-attempt use of the handpiece.
This Fault Code indicates that 2. If the Fault Code reappears, record the number and contact Medtronic Advanced
one or more of the self-tests have Energy Customer Service. Do not use the Generator.
failed. The Fault Code is displayed
until the Generator is turned off
and the alarm will sound once.

Error Codes and Error Handling

The AEX™ Generator self-test, which is executed immediately following power up, comprises several phases.
The first phase covers the internal RAM and the MPU0 watchdog test. The second phase tests the major
computer hardware components (microcontroller). The third phase tests the NV-RAM and the separate RFGEN
modules for potential errors. Portions of this self-test are repeated in the background during normal use.
If an error is detected, the respective test is repeated at least once in order to exclude sporadic deviations.
If the deviation remains, the self-test aborts, an error message is generated, and the unit enters the safe state.
The safe state disables functions of the pump generator until the error condition is cleared.

AEX™ Generator Operator’s Manual 6-9

 Troubleshooting Malfunctions
If a solution is not readily apparent, use the table below to help identify and correct specific malfunctions.
After you troubleshoot the malfunction, verify that the unit completes the self-test as described in
Section 4, Operation.

Table 6-3. Troubleshooting

Situation Possible Cause Solution

No power No power cord. Use power cord shipped with AEX™ Generator or
contact Medtronic Advanced Energy Customer Service
to obtain new power cord.
Wrong power cord utilized. Use power cord shipped with AEX™ Generator or
contact Medtronic Advanced Energy Customer Service
to obtain new power cord.
Faulty wall outlet. Insert power cord into a functioning wall outlet.

Fuse drawer is open or fuses are blown. Close the fuse drawer. Replace the blown fuse(s).

Wrong fuse. Use fuse listed in Section 7, Specifications. Correct fuse

is also listed on back panel of the unit.

Unit not turned on. Switch unit on using the power switch located on the
front panel of the unit.
Insufficient insertion of device plug into receptacle. Ensure disposable handpiece is fully inserted into
receptacle.
Insufficient insertion of power cord into unit or wall Ensure power cord is fully inserted into back of unit and
jack. wall jack.
Damaged AEX™ Generator power cord. Contact Medtronic Advanced Energy Customer Service
to obtain a new power cord.
Damaged disposable handpiece power cord. Do not use device. Return the device to Medtronic
Advanced Energy and use new device.
No saline when device Pump tubing segment not inserted correctly into Remove pump tubing segment from pump head and
activated pump head. reinsert correctly as indicated in User Guide.

Saline bag positioned on side or upside down. Ensure saline bag is positioned right side up.
Pump head not closed. Close the pump head prior to use.
No saline source. Ensure spike at end of device tubing set is correctly
inserted into a 250 ml or larger I.V. bag of sodium
chloride solution (0.9%NaCI).
Priming cycle not completed. Press “PRIME” button once and ensure priming cycle
completes and saline drips from both device electrodes.

Priming button on unit pressed before the saline bag Press “PRIME” button once and ensure priming cycle
was spiked. completes and saline drips from both device electrodes.

Inadequate supply of saline. Replace used bag of sodium chloride solution

(0.9%NaCI) with a new bag.

6-10 Troubleshooting
 Table 6-3. Troubleshooting (continued)

Situation Possible Cause Solution

No saline when device Pump tubing segment inserted in reverse Ensure black connector on the tubing segment is
activated (continued) orientation. oriented to the left side of the pump head and the
white connector to the right side of the pump head
when pump tubing segment is inserted.

Saline line kinked/compressed/occluded. Ensure disposable handpiece pump segment is

properly aligned in the pump head. Ensure saline line is
not kinked, compressed, or occluded by operating room
equipment, instruments, or personnel.

Non-AEX™ handpieces connected to AEX™ Generator. Ensure device connected to AEX™ Generator is an
handpiece. If incorrect handpiece is being utilized,
discard and utilize correct disposable handpiece.

All saline slots in either of the device electrodes Clean device electrodes with gauze. Ensure precautions
of the handpiece clogged by tissue or coagulated are taken to avoid inadvertent device activation when
blood. cleaning device electrodes. If this does not correct
the problem, discontinue use and return device to
Medtronic Advanced Energy and use new device.

Pump is jammed by pump segment connector which Ensure pump segment is aligned in the center of guide
has inadvertently entered into pump head. slots (upside down “v”) where it enters and exits the
pump head.
Source of normal saline is a non-vented glass bottle. Open vent cap on handpiece drip chamber.

Incorrect saline flow Pump tubing segment not inserted correctly into Remove pump tubing segment from pump head and
when device activated pump head. reinsert correctly as indicated in User Guide.

Saline bag height below pump head. Ensure saline bag is positioned at a height above the
pump head.

Saline delivery tubing inserted into pump head Ensure black connector on the tubing segment is
instead of pump tubing segment. oriented to the left side of the pump head and the
white connector to the right side of the pump head
when pump tubing segment is inserted.

Air bubbles in line due to incorrect priming Press “PRIME” button once to reprime the device in
technique. order to remove air bubbles.

Saline line kinked or compressed. Ensure pump segment is properly aligned in the pump
head. Ensure saline line is not kinked, compressed, or
occluded by OR equipment, instruments, or personnel.

Incorrect (non-AEX™) disposable handpiece utilized. Ensure device connected to AEX™ Generator is an AEX™
handpiece. If incorrect handpiece is being utilized,
discard and utilize correct AEX™ disposable handpiece.

One or more of the saline slots in either of the device Clean device electrodes with gauze. Ensure precautions
electrodes of the handpiece clogged by tissue or are taken to avoid inadvertent device activation when
coagulated blood. cleaning device electrode.
If this does not correct the problem, return device to
Medtronic Advanced Energy and use new device.
Handpiece pump segment is not inserted into pump Insert pump tubing segment into pump head as shown
head. in User Guide.

AEX™ Generator Operator’s Manual 6-11

 Table 6-3. Troubleshooting (continued)

Situation Possible Cause Solution

Generator doesn’t AEX™ Generator damaged. Contact Biomedical Engineering Department or
work a Medtronic Advanced Energy representative for
assistance. Use a backup AEX™ Generator or traditional
techniques to complete the surgical procedure if
repairs cannot be made prior to the scheduled surgical
procedure.
AEX™ Generator did not receive a scheduled safety Contact Biomedical Engineering Department or
check. a Medtronic Advanced Energy representative for
assistance. Use a backup AEX™ Generator or traditional
techniques to complete the surgical procedure if
repairs cannot be made prior to the scheduled surgical
procedure. See Section 5, Cleaning and Maintenance, for
maintenance schedule.
AEX™ Generator plugged into an inappropriate wall Plug AEX™ Generator into an appropriate wall outlet
outlet (e.g. not protected against ground fault, etc.). prior to use.

Unit is on, but did not Software or internal component malfunction. Turn off, and then turn on the unit. If the fault code
complete self-test reappears:
• Record the error code number and refer to Fault Code
Details in this section.
• Use a backup AEX™ Generator or traditional
techniques to complete the surgical procedure.

Unit is on and Power setting is too low. Increase the power. Refer to Section 4, Operation,
disposable handpiece Adjusting the RF Power Setting. Use the lowest possible
is activated, but unit power setting needed to obtain the desired surgical
does not deliver effect.
output

Malfunctioning handpiece or improper handpiece Turn off the unit. Check the device connection. If
connection. device continues to malfunction, replace device and
contact Medtronic Advanced Energy to report device
malfunction.

A malfunction condition exists. Check the power display for an error code. Note the
code number and refer to Error Code Details in this
section.
Interference with Metal-to-metal sparking. Check all connections to the unit and handpiece.
other device only
when the unit is Electrically inconsistent ground wires in the Verify that all ground wires are as short as possible and
activated operating room. go to the same grounded metal.
Continuous monitor Faulty chassis-to-ground connections. Check and correct the chassis ground connections for
interference the monitor and for the unit.

Monitor responding to radiated frequencies. Check other electrical equipment in the room for
defective grounds. If not resolved, contact Biomedical
Engineering Department to check with the monitor
manufacturer.

Abnormal Metal-to-metal sparking. Check all connections to the unit and device.
neuromuscular
stimulation (Stop
surgery immediately)

6-12 Troubleshooting
 Table 6-3. Troubleshooting (continued)
Situation Possible Cause Solution
Ineffective hemostasis Power setting too low. Increase the power. Refer to Section 4, Operation,
Adjusting RF Power Settings. Use the lowest possible
power setting needed to obtain the desired surgical
effect.
Tissue under-treated. Tissue not treated long See disposable handpiece Instructions For Use
enough to result in a reduction in intraoperative or and/or device treatment guides for treatment
postoperative blood loss. recommendations.
Wrong fluid used for device irrigation. Only utilize sterile bag of sodium chloride solution
(0.9%NaCI) with the AEX™ System.
Device electrode(s) of disposable handpiece clogged Clean device electrodes with gauze. Ensure precautions
by tissue or coagulated blood. are taken to avoid inadvertent device activation when
cleaning device electrodes. If this does not correct the
problem, return device to Medtronic Advanced Energy
and use new device.
Excessive blood, fluid or saline in surgical field where Utilize appropriate suction to remove blood, fluid and/
device is being utilized. or saline. See disposable handpiece Instructions For
Use and/or handpiece treatment guides for treatment
recommendations.
Unintended tissue Power setting too high. Decrease the power. Refer to Section 4, Operation,
effect Adjusting RF Power Settings.
Tissue over-treated. See disposable handpiece Instructions For Use
and/or device treatment guides for treatment
recommendations.
Non-AEX™ handpieces utilized. Ensure device connected to AEX™ Generator is an AEX™
handpiece. If incorrect handpiece is being utilized,
discard and utilize correct disposable handpiece.
Excessive saline Saline flow rate setting too high. Decrease saline flow rate. Refer to Section 4, Operation,
Adjusting the Saline Flow Rate.
Excess saline resulting from priming cycle. Place the device into a holster or over a container to
collect the saline that will exit the device electrodes as a
result of the priming process.
2nd (or more) activation of priming cycle. Place the device into a holster or over a container to
collect the saline that will exit the device electrodes as a
result of the priming process.
Off tissue handpiece activation. Only activate the disposable handpiece on/over
tissue intended to be treated. Activation over
another location may result in hot saline run-off onto
unintended tissue, patient, patient drapes, hospital
staff, and operating room surfaces.
Saline delivery tubing inserted into pump head Ensure black connector on the disposable pump
instead of pump tubing segment. segment is oriented to the left side of the pump head
and the white connector to the right side of the pump
head when pump tubing segment is inserted.
Pump head disengaged following procedure prior to The disposable handpiece and the saline bag will
firmly knotting the saline delivery tubing between contain unused saline following use of the device.
the drip chamber and the pump segment on the Firmly knot the saline delivery tubing between the drip
handpiece. chamber and the pump segment on the device prior to
opening the pump head.
Error codes Error codes appear. Turn power off for a minimum of 10 seconds, turn
power back on. If error code still displays, contact
Medtronic Advanced Energy.
If problem persists after applying the appropriate solution indicated in this table, use a backup AEX™ Generator or traditional techniques
to complete the surgical procedure. Contact Medtronic Advanced Energy Customer Service for assistance, refer to section 10 of this guide
(Returning the AEX™ Generator for Service).

AEX™ Generator Operator’s Manual 6-13

 This page intentionally left blank.

6-14 Troubleshooting
7. Specifications

AEX™ Generator
All specifications are nominal and are within ±20% of a stated value at room temperature (77 °F/25 °C) and
a nominal input power voltage. All specifications are subject to change without notice.

General
Classification: IEC 60601-1, Class I

Type: CF

Internal Design: Solid state

Output Configuration: Isolated (RF Floating)

Cooling: Forced air (fan)

Designed to Meet: ES60601-1; IEC 60601-1, 60601-1-4, 60601-1-2, 60601-2-2;

CAN/CSA C22.2 NO. 601.1.

Dimensions and Weight

Width: 14.5 in (36.8 cm)

Length: 17 in (43.2 cm)

Height: 6.5 in (16.5 cm)

Weight: <20 lb (9 kg)

Operating Parameters
Temperature: 10 °C to 40 °C

Humidity: 15% to 85% relative humidity, non-condensing

Storage Parameters
Temperature: –20 °C to 65 °C

Humidity: 0% to 85% Non-condensing relative humidity

Shipping Conditions for

Packaged Unit: –20 °C to 65 °C; 15–85% relative humidity, non-condensing

Atmospheric Pressure: 600 to 795 mmHg (800-1060 hPa)

AEX™ Generator Operator’s Manual 7-1

 Audio Specifications
The audio levels stated below are for activation tones (Cut, Coag, and Seal) and error indicator tones
(Patient Return Electrode and system alarms) at a distance of one meter. Error indicator tones meet
the requirements for IEC 60601-2-2.

Activation Tone Error Indicator Tone

Volume: >43 to 65 dBa, adjustable >65 dBa, not adjustable

Frequency: Mono Cut: 1109 Hz An 8 note sequence alternating between

1865Hz and 1480Hz
Mono Coag: 554 Hz

Bipolar Seal: 932 Hz

Simultaneous Mono Cut and

Bipolar Seal: 330 Hz

Simultaneous Mono Coag and

Bipolar Seal: 415 Hz

Duration: Continuous while the ¼ second duration for each note,

Generator is activated total sequence duration of 2 seconds.

Table 7-1. Mains Input Characteristics

Mains Input Characteristics

Frequency Mains Voltage (V) Mains Current (A)
Fuses
Hz Nominal Minimum Maximum Maximum

50/60 115/230 100 240 8A - 4A 10A

Low Frequency (50/60Hz) Leakage Current

• Earth leakage current in normal condition <5 mA

• Earth leakage current in single-fault condition <10 mA

• Enclosure (touch) leakage current in normal condition <100 µA

• Enclosure (touch) leakage current in single fault condition <500 µA

• Patient leakage current in normal condition <10 µA

• Patient leakage current in single fault condition <50 µA

7-2 Specifications
High Frequency (RF) Leakage Current
• Monopolar RF leakage current <150 mA
• Bipolar RF Leakage Current <100 mA

Table 7-2. Output Characteristics

Output Characteristics
Power Rated Maximum Operating
Duty Cycle
Mode (watts Load Open Circuit Frequency
(% Typical )
Typical) (ohms) Voltage (Vpk) (kHz Typical)
Low Cut 0.5 to 20 100 1365 469 0.17 to 4.3

Medium Cut 0 to 90 500 585 469 100

High Cut 10 to 50 500 1300 469 37.8 to 66.78

Low Coag 0 to 50 500 1500 469 23.8

High Coag 10 to 50 1000 2600 469 16

Bipolar 20 to 220 100 175 (nom) 469 100

User Duty Cycle

• Cut Mode: 10 seconds ON, 30 seconds OFF
• Coag Mode: 10 seconds ON, 30 seconds OFF
• Bipolar Mode: 40 seconds ON, 80 seconds OFF

Patient Return Electrode Contact Quality Monitor

The system continuously monitors the impedance across the Patient Return Electrode. The system
presents audible and visible error indication when it senses a loss of contact quality for the Patient
Return Electrode. When the error condition exists, the system deactivates output power.

Single Foil: Once the system establishes the single foil Patient Return Electrode
impedance (>18 Ω), an increase of 10 Ω or more will cause a Patient
Return Electrode has poor or no connection “E3” error indication.
Using a combo device with a monopolar power capability above 50
Watts will cause a Patient Return Electrode Incompatible “E9” error
indication.
Split Foil: Once the system establishes the split foil Patient Return Electrode
impedance (18 to 135 Ω), an increase greater than 30% or
above 135 Ω will cause a Patient Return Electrode has poor or no
connection “E3“ error indication.

AEX™ Generator Operator’s Manual 7-3

 Electromagnetic Compatibility

The AEX™ Generator conforms to electromagnetic compatibility standard EN/IEC 60601-1-2.

Compliance was verified with the following accessories connected to the AEX™ Generator:

Table 7-3. Attached Accessory Cables

Accessory Cable Description Cable Length (meters)

AC mains power cord 4.6
PlasmaBlade™ device 3.0
Aquamantys™ device 3.2
Patient Return Electrode 2.75
Footswitch receiver 1.2
RS-232 cable 1.8
USB cable 1.8

■ IMPORTANT: Medical Electrical Equipment needs special precautions regarding EMC and needs to
be installed and put into service according to the EMC information provided in this section.

Portable and Mobile RF Communications can affect Medical Electrical Equipment.

Table 7-4. Electromagnetic Emissions

The AEX™ Generator is intended for use in the electromagnetic environment specified below.
The customer or user of the AEX™ Generator should assure that it is used in such an environment.

Emissions Test Compliance Electromagnetic Environment – Guidance

RF emissions Group 1 The AEX™ Generator uses RF energy only for its internal
CISPR11 function. Therefore, its RF emissions are very low and are
not likely to cause any interference in nearby electronic
equipment.

RF emissions Class A The AEX™ Generator is suitable for use in all establishments,
CISPR11 other than domestic, and those directly connected to the
public low-voltage power supply network that supplies
buildings used for domestic purposes.
Harmonics Class A
▲ WARNING: This equipment/system is intended for use
IEC 61000-3-2 by healthcare professionals only. This equipment/system
may cause radio interference or may disrupt the operation
Flicker Complies of nearby equipment. It may be necessary to take mitigation
IEC 61000-3-3 measures, such as re-orienting or relocating the AEX™
Generator or shielding the location.

7-4 Specifications
 Table 7-5. Electromagnetic Immunity

The AEX™ Generator is intended for use in the electromagnetic environment specified below.
The customer or user of the AEX™ Generator should assure that it is used in such an environment.

Electromagnetic Environment
Immunity Test IEC 60601 Test Level Compliance Level
Guidance
ESD ±6 kV contact ±6 kV contact Floors should be wood, concrete, or
EN 61000-4-2 ±8 kV air ±8 kV air ceramic tile. If floors are synthetic, the
relative humidity should be at least
30%.

EFT ±2kV Mains ±2kV Mains Mains power quality should be that
IEC 61000-4-4 ±1kV I/Os ±1kV I/Os of a typical commercial or hospital
environment.

Surge ±1 kV Differential ±1 kV Differential Mains power quality should be that

IEC 61000-4-5 ±2 kV Common ±2 kV Common of a typical commercial or hospital
environment.

Voltage Dips/ >95% Dip for 0.5 Cycle >95% Dip for 0.5 Cycle Mains power quality should be that
Dropout 60% Dip for 5 Cycles 60% Dip for 5 Cycles of a typical commercial or hospital
IEC 61000-4-11 environment. If the user of the
30% Dip for 25 Cycles 30% Dip for 25 Cycles AEX™ Generator requires continued
>95% Dip for 5 sec. Note 1 operation during power mains
interruptions, it is recommended that
the AEX™ Generator be powered from
an uninterruptible power supply or a
battery.

Power frequency 3 A/m 3 A/m Power frequency magnetic fields

(50/60 Hz) should be that of a typical commercial
Magnetic Field or hospital environment.
IEC 61000-4-8

NOTE 1: The EUT powers down during a 5 second loss of AC Mains power, but recovers into Standby Mode as soon as
power is restored. This meets the manufacturer’s requirements for maintaining Basic Safety and Risk Management.

AEX™ Generator Operator’s Manual 7-5

 Table 7-5. Electromagnetic Immunity (continued)

Immunity Electromagnetic Environment -

Test IEC 60601-1-2 Test Level Compliance Level Guidance

Conducted RF 3 V/m (V1)=3 Vrms Portable and mobile communications

IEC 61000-4-6 150 kHz – 80 MHz equipment should be separated from
the AEX™ Generator by no less than the
distances calculated/listed below:

D=(3.5/V1)(Sqrt P)
150kHz to 80MHz
Radiated RF IEC 3 V/m (E1)=3 V/m
61000-4-3 80 MHz – 2.5 GHz D=(3.5/E1)(Sqrt P)
80 to 800 MHz

D=(7/E1)(Sqrt P)
800 MHz to 2.5 GHz

where P is the max power in watts and D

is the recommended separation distance
in meters.

Field strengths from fixed transmitters,

as determined by an electromagnetic
site survey, should be less than the
compliance levels (V1 and E1).

Interference may occur in the vicinity of

equipment containing a transmitter.

Other Specifications
Power Cord: Generators have a power entry connector to allow connection with a US Hospital
Grade power cord or an EU plug power cord. Units accept 100–240 VAC at a
frequency of 50/60 Hz, fused at 10 amps.

Display Size: 7 in diagonal (3.5 in tall x 6 in wide)

7-6 Specifications
Output Characteristic Curves

Figure 7-1. Output Power vs Impedance for Low Cut

25 AEX™ Low Cut

20 Power, MID
Power, MAX
Output Power, W
15

10

0
0 500 1000 1500 2000
Ohms

Figure 7-2. Output Power vs Impedance for Medium Cut

AEX™ Medium Cut

100.00
Power, MID
90.00
Power, MAX
80.00
Output Power, W

70.00
60.00
50.00
40.00
30.00
20.00
10.00
0.00
0 500 1000 1500 2000
Ohms

Figure 7-3. Output Power vs Impedance for High Cut

60 AEX™ High Cut

Power, MID
50
Power, MAX
Output Power, W

40

30

20

10

0
0 500 1000 1500 2000
Ohms

AEX™ Generator Operator’s Manual 7-7

 Figure 7-4. Output Power vs Impedance for Low Coag

40 AEX™ Low COAG

Power, MID
35 Power, MAX
30

Output Power, W
25
20
15
10
5
0
0 500 1000 1500 2000
Ohms

Figure 7-5 Output Power vs Impedance for High Coag

60 AEX™ High COAG Power, MID

Power, MAX
50
Output Power, W

40

30

20

10

0
0 500 1000 1500 2000
Ohms

Figure 7-6. Output Power vs Impedance for Bipolar

250 AEX™ Bipolar

Power, MID
200 Power, MAX
Output Power, W

150

100

50

0
0 200 400 600 800 1000
Ohms

7-8 Limited Warranty

 Figure 7-7. Output Power vs Impedance for Monopolar

AEX™ Monopolar

Power, MID

Output Power, W
Power, MAX

Ohms

AEX™ Generator Operator’s Manual 7-9

 This page intentionally left blank.

7-10 Specifications
8. Limited Express Warranty and Disclaimers

Limited Express Warranty

Medtronic Advanced Energy LLC warrants the AEX™ Generator against defects in materials or workmanship
under normal use and preventive maintenance for the respective warranty periods shown below. Medtronic
Advanced Energy will repair or replace the unit without charge, at its option, of any product, or part thereof,
which has been returned to Medtronic Advanced Energy LLC or its Distributor within the applicable time
period shown below. This warranty does not apply to any product or part that has been adversely affected
due to use with devices manufactured or distributed by parties not authorized by Medtronic Advanced
Energy LLC; repaired or altered outside Medtronic Advanced Energy’s factory; subjected to improper use,
negligence or accident or not used in accordance with the instructions provided in this manual. Standard
hospital preventive maintenance procedures should be followed and performed by qualified biomedical
service personnel and are not covered in the warranty.

• Medtronic Advanced Energy’s products are warranted for the following periods after delivery to the
original purchaser:
• AEX™ Generator - One (1) Year, Parts and Labor
• AEX™ Wireless Footswitch - One (1) Year, Parts and Labor

Disclaimer of Implied Warranties and Consequential Damages

MEDTRONIC ADVANCED ENERGY LLC MAKES NO OTHER WARRANTIES WITH RESPECT
TO THE PRODUCT AND EXPRESSLY DISCLAIMS ALL OTHER WARRANTIES, EXPRESS OR
IMPLIED, AS TO MERCHANTABILITY, FITNESS FOR A PARTICULAR PURPOSE OR ANY
OTHER MATTER. IN NO EVENT SHALL MEDTRONIC ADVANCED ENERGY LLC BE LIABLE FOR
ANY CONSEQUENTIAL DAMAGES. THE REMEDIES SET FORTH IN THE LIMITED EXPRESS
WARRANTY ARE THE EXCLUSIVE REMEDIES AVAILABLE TO CUSTOMER.

AEX™ Generator Operator’s Manual 8-1

 This page intentionally left blank.

8-2 Limited Warranty

9. Product Accessories

The following accessories are compatible for use with the AEX™ Generator. Only Medtronic Advanced Energy
recommended accessories should be used with the Generator.

• PlasmaBlade™ Monopolar devices

• Aquamantys™ Bipolar Disposable handpieces
• PlasmaBlade™ and Aquamantys™ Combination handpieces
• AEX™ Wireless Footswitch
• Standard Patient Return Electrode
• Single Foil – Valleylab™ Standard PolyHesive™ II E7506 and E7508
• Split Foil – Adult REM Valleylab™ PolyHesive™ II E7507 and E7509
- 3M1179 corded adult REM™ pads
• Compatible with Aquamantys™ and AEX™ Carts

AEX™ Generator Operator’s Manual 9-1

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9-2 Product Accessories

10. Glossary

This section provides definitions of terms relating to electrosurgery. The information below is provided as a
convenience and should not be interpreted as an authoritative discussion of the subject.

active electrode The device electrode or electrode assembly at which the electrosurgical effect is
intended. It usually has a small contact surface area and provides a high current
density to achieve the desired surgical effect.

blend A modified cut waveform incorporating some off-time, thus allowing tissue to cool, and
providing varying degrees of hemostasis.

coagulation The clotting of blood or dehydration of tissue with no cutting effect. Electrosurgical
coagulation often incorporates intermittent bursts of high-voltage, low-current
electricity.

cutting Occurs when intense sparks focus the energy and vaporize the tissue. It results from high
current density in the tissue causing cellular fluid to burst into steam and disrupt the
structure. Voltage is low and current flow is high. In order to induce a cutting effect in
human tissue, voltage must exceed 200 Vp.

desiccation A procedure where a small amount of surface tissue is dried out by placing the active
electrode in contact with the tissue. Desiccation differs from fulguration in that peak
voltage is lower resulting in the inability of the current to arc through air to tissue. Direct
contact between electrode and tissue is required. See fulguration.

disposable accessory An electrosurgical accessory, such as active electrodes, handles, dispersive electrodes, etc.
It is not intended to be used more than once.

duty cycle The proportion of time (expressed in percentage) that a current or device is on versus
off. Duty cycle may be used when referring to current waveforms that are repetitive. Thus
high-frequency current would be on using a shorter period of time than a low-frequency
current. Duty cycle is also used in reference to electrical components or equipment. For
example, some equipment is designed to be used continuously, that is, with a duty cycle
rating of 100%, while other equipment may be rated for intermittent use, that is less than
100% duty cycle. Most ESU’s are designed to be used intermittently. Typically, they are
rated for 25% duty cycles. Use of any equipment beyond its duty cycle rating may result
in premature failure.

electrosurgery (surgical The generation and delivery of radio frequency current between an active electrode and
diathermy) a Patient Return Electrode for the purposes of dehydration of tissue. Electrosurgery also
includes cutting or vaporizing (tissue explosion). In contrast to electrocautery, the electric
current actually passes through the patient.

AEX™ Generator Operator’s Manual 10-1

 electrosurgical accessory Equipment used in conjunction with the electrosurgical generator to accomplish
electrosurgery. These include, but are not limited to footswitch, cable, Patient Return
Electrode, and active electrode.

fulguration Coagulating tissue or blood by means of radio frequency electric arcs. In contrast to
(spray technique) desiccation, the active electrode is not in good electrical contact with the tissue, and arcs
jump from the active electrode to the tissue.

impedance (measured in Total opposition, both resistive and reactive, a circuit offers to the flow of alternating
ohms) current at a given frequency.

mode Each of the distinct ways in which the electrosurgical unit can be operated with
(operating) electrosurgical output, for example, monopolar cutting, monopolar coagulation,
monopolar blended, monopolar spray (fulguration).

monopolar The traditional form of electrosurgical circuit, which uses an active electrode to apply
the therapeutic current to the surgical site, and a Patient Return Electrode to return the
current to the ESU.

Patient Return Electrode The electrode at which no electrosurgical effect is intended or desired. It is usually large
in area in order to provide a low current density so that no electrosurgical effect occurs
at that site. It is also known as a patient plate, patient pad, return pad, plate electrode,
return electrode, neutral electrode, dispersive electrode or inactive electrode. It is
sometimes (inaccurately) referred to as a grounding plate.

power The rate at which energy is produced or consumed. Power is equal to voltage multiplied
by current, or resistance multiplied by current squared. The unit of measure of power is
the watt.

Transcollation The effect of RF energy applied concurrently with saline resulting in hemostatic sealing
and coagulation of soft tissue and bone without charring.

10-2 Glossary
11. Symbols
The following symbols are used on the product and/or packaging.

Table 11-1. Symbols

Symbol Description

Defibrillation-proof type CF equipment

RF Isolated - Patient connections are isolated from earth at high frequency

Warning: Dangerous voltage

Power ON - To indicate connection to voltage mains

Power OFF - To indicate disconnection from voltage mains

UP button - To increase the output level

DOWN button - To decrease the output level

Speaker volume control

Footswitch

Caution: Pinch Hazard - Keep fingers clear of rollers

To reduce the risk of electric shock, do not remove the cover. Refer servicing to qualified personnel.

Consult instructions for use

Model number

Serial number

Date of manufacture

AEX™ Generator Operator’s Manual 11-1

 Table 11-1. Symbols (continued)

Symbol Description

Equipotential ground

Caution: Consult accompanying documents

Non-ionizing radiation

Explosion risk if used in the presence of flammable anesthetics

Separate collection of waste at end of life as required by European Directives.

Dispose of in accordance with the applicable country regulation.

..
TUV Rheinland In accordance with IEC 60601-1, ES 60601-1, and IEC 60601-2-2; CAN/CSA C22.2 NO. 601.1.
C US

Manufacturer

Do not operate in oxygen enriched environments

Caution: Federal law (USA) restricts this device to sale by or on the order of a physician.

Affixed in accordance with European Council Directive 93/42/EEC.

Authorized European Representative

Fragile, Handle with Care

Keep Dry

Temperature Limitation

Humidity Limitation

Atmospheric Pressure Limitation

This Way Up

11-2 Symbols
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© Copyright 2016
Medtronic Advanced Energy LLC
70-10-1455 Rev F
2016/09