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Intelligent Counterpulsation
OPERATING Intelligent Counterpulsation
INSTRUCTIONS

Intelligent Counterpulsation
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OPERATING INSTRUCTIONS
©
Copyright 2016 Datascope Corp. Printed in U.S.A. All rights reserved. Contents of this publication may not be repro-
duced in any form without permission of Datascope Corp.

0070-10-0527-02 CS100/CS100i Operating Instructions

English - Outside of United States Only
 QUICK REFERENCE - INITIAL SET-UP

WARNING: Do not operate this system before thoroughly reading

this manual and the associated warnings and
precautions. Only use the Abbreviated Operating
Guide if you are already familiar with this product. If
not, please continue with the remainder of this
manual.

1. Establish power and verify the MAINS ON/OFF and the IABP ON/OFF switches
are on.

2. Open the Helium cylinder and verify Helium pressure.

3. Establish ECG and Pressure connections from the patient.

4. Zero the transducer.

a. Open the transducer to air.
b. Press the Zero Pressure key for 2 seconds.
c. Close the transducer.

5. Confirm that operation mode is AUTO.

6. Attach the IAB, with the appropriate catheter extender, to the safety disk
pneumatic connection labeled IAB Catheter Extender Input.

7. Fill the IAB catheter and initiate pumping.

a. Press the START key and observe the Autofilling message.
b. Once the Autofilling message clears, pumping begins.
c. If desired, IAB deflation timing can be fine-tuned using the IAB deflation
controls.

8. Verify Aug Alarm.

a. Verify that the Aug Alarm setting is approximately 10 mmHg less than the
patient’s augmented diastolic pressure.
b. Adjust, if needed, by pressing the Aug Alarm key and using the UP and
DOWN arrow keys, in the navigation circle, to change the value displayed
on the screen.

Initial Set-up is now complete.

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0070-10-0527-02 CS100/CS100i Operating Instructions

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 Table of Contents

Foreword ........................................................................................................................................................ v
Warnings, Precautions and Notes...................................................................................................................... v
Warnings ....................................................................................................................................................... vi
Precautions ..................................................................................................................................................... xi
Indications for Use ........................................................................................................................................... xiv
Contraindications............................................................................................................................................. xiv
Brief Description of Intra-Aortic Balloon Therapy .................................................................................................. xv
Overview of Clinical Features............................................................................................................................ xvi
CS100 User Interface ....................................................................................................................................... xvii
CS100i Conversion Kit ..................................................................................................................................... xvii
Physical Description of the CS100 ..................................................................................................................... xviii
Mechanical and Transport Features.................................................................................................................... xix
IABs Supported................................................................................................................................................ xix
Major Accessories ........................................................................................................................................... xix
Phone Numbers and How To Get Assistance....................................................................................................... xx
Unpacking Information ..................................................................................................................................... xx
Operator Profile............................................................................................................................................... xxi
Operator Position............................................................................................................................................. xxi
Symbols and Descriptions ................................................................................................................................. xxii
Controls and Indicators ..................................................................................................... 1 - 1
Introduction .................................................................................................................................................... 1 - 1
Operation Mode Keys ..................................................................................................................................... 1 - 2
Trigger Source Keys and Indicators ................................................................................................................... 1 - 5
IABP Control Keys ........................................................................................................................................... 1 - 8
Help Keys ...................................................................................................................................................... 1 - 12
Menu Guide................................................................................................................................................... 1 - 13
Menu Group Keys........................................................................................................................................... 1 - 14
Menu Navigation ........................................................................................................................................... 1 - 22
Opening a Submenu................................................................................................................................ 1 - 23
Changing a Setting.................................................................................................................................. 1 - 24
Changing a Numeric Parameter ................................................................................................................ 1 - 25
Immediate Action Keys .................................................................................................................................... 1 - 26
Display Screen ............................................................................................................................................... 1 - 28
Front Panel..................................................................................................................................................... 1 - 38
Rear Panel ..................................................................................................................................................... 1 - 39
Special Mode Activation.................................................................................................................................. 1 - 42
Detailed Operation ........................................................................................................... 2 - 1
Introduction .................................................................................................................................................... 2 - 1
Operation Instructions ..................................................................................................................................... 2 - 2
Safety Disk Leak Test ................................................................................................................................ 2 - 2
Power Up Procedure (Without Safety Disk Leak Test) .................................................................................... 2 - 3
Open Helium Tank Valve and Confirm Helium Pressure ................................................................................ 2 - 3
Connect IAB and IAB Catheter Extender to IABP Console.............................................................................. 2 - 4
ECG Acquisition...................................................................................................................................... 2 - 4
Arterial Pressure Acquisition...................................................................................................................... 2 - 6
Selection of Trigger Source ....................................................................................................................... 2 - 7
Selection of IAB Frequency ....................................................................................................................... 2 - 11
Timing of Intra-Aortic Balloon .................................................................................................................... 2 - 12
Verify Arterial Pressure Delay .................................................................................................................... 2 - 13
Initiation of Assist .................................................................................................................................... 2 - 14
IAB Fill / Autofill / Manual Fill .................................................................................................................. 2 - 15

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Table of Contents

Troubleshooting................................................................................................................ 3 - 1
Introduction .................................................................................................................................................... 3 - 1
ECG Troubleshooting ............................................................................................................................... 3 - 2
Trigger Troubleshooting............................................................................................................................ 3 - 2
Balloon Troubleshooting ........................................................................................................................... 3 - 3
Power-up Troubleshooting......................................................................................................................... 3 - 3
Alarms and Advisory Messages ........................................................................................................................ 3 - 4
Help Screens .................................................................................................................................................. 3 - 6
Technical Alarms ..................................................................................................................................... 3 - 7
High Priority Alarms................................................................................................................................. 3 - 9
Medium Priority Alarms ............................................................................................................................ 3 - 22
Low Priority Alarms .................................................................................................................................. 3 - 24
Informational Messages............................................................................................................................ 3 - 25
Clinical.......................................................................................................................................................... 3 - 43
Water Condensation................................................................................................................................ 3 - 43
Clinical Considerations During Operation .................................................................................................. 3 - 44
Use in Electro-surgical Environment ............................................................................................................ 3 - 45
Use During Cardiopulmonary Bypass ......................................................................................................... 3 - 46
Weaning a Patient from IABP Support........................................................................................................ 3 - 46
Doppler Information ................................................................................................................................. 3 - 47
Manual Fill Mode ........................................................................................................................................... 3 - 48
Printer .............................................................................................................................. 4 - 1
Printer Operation ............................................................................................................................................ 4 - 1
Printer Formats................................................................................................................................................ 4 - 2
Trailer Annotations.......................................................................................................................................... 4 - 4
Portable/Transport Operation........................................................................................... 5 - 1
Hospital Cart.................................................................................................................................................. 5 - 1
Portable Operation ......................................................................................................................................... 5 - 2
Battery Operation .................................................................................................................................... 5 - 2
Battery Charging ..................................................................................................................................... 5 - 3
Switching from AC to Battery Operation..................................................................................................... 5 - 3
Operation From External DC Source (CS100i only) ..................................................................................... 5 - 3
Operation from DC-to-AC Inverter.............................................................................................................. 5 - 4
Effects of Altitude Changes During Air Transportation................................................................................... 5 - 4
Portable Operation Emergency Battery Back Up Recommendations................................................................ 5 - 5
Removing Pump Console from the Cart....................................................................................................... 5 - 5
Universal Transport Systems (UTS) ..................................................................................................................... 5 - 8
Use of the Light Weight Docking Station (P/N 0436-00-0110) and Mobilizer ................................................ 5 - 9
Pediatrics.......................................................................................................................... 6 - 1
Pediatric Balloon Pumping ............................................................................................................................... 6 - 1
Pediatric Adapter Installation .................................................................................................................... 6 - 1
Safety Chamber Leak Test (Pediatric).......................................................................................................... 6 - 3
Normal Power Up Procedure .................................................................................................................... 6 - 3
Establish Fill Gas Pressure......................................................................................................................... 6 - 3
Initial Set-up for Pediatric Balloon Pumping ................................................................................................. 6 - 4
Timing of Pediatric Balloon Pumping .......................................................................................................... 6 - 4
Filling Pediatric Catheters ......................................................................................................................... 6 - 5
Initiation of Assist (Pediatric) ..................................................................................................................... 6 - 7
User Maintenance ............................................................................................................. 7 - 1
Introduction .................................................................................................................................................... 7 - 1
Chart Paper Loading ....................................................................................................................................... 7 - 2
Installation and Replacement of Helium Cylinder................................................................................................. 7 - 3

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 Table of Contents

Helium Cylinder Refilling Information................................................................................................................. 7 - 5

Safety Disk/Condensate Removal Module.......................................................................................................... 7 - 6
User Maintenance Between Pumping Procedures ................................................................................................ 7 - 8
Cleaning ................................................................................................................................................ 7 - 8
Battery Replacement ................................................................................................................................ 7 - 8
Cable and Hose Check ............................................................................................................................ 7 - 8
Lead Faults Detection Circuits .................................................................................................................... 7 - 8
Low Helium............................................................................................................................................. 7 - 9
Batteries ........................................................................................................................................................ 7 - 10
Preventive Maintenance ................................................................................................................................... 7 - 11
Warranty....................................................................................................................................................... 7 - 13
Datascope’s Responsibility ............................................................................................................................... 7 - 14
Extended Warranty......................................................................................................................................... 7 - 14
External Interfaces............................................................................................................ 8 - 1
Connecting the Modem ................................................................................................................................... 8 - 1
Connecting PC•IABP ....................................................................................................................................... 8 - 2
Data Communication....................................................................................................................................... 8 - 2
Data Output Connector (RS-232) ............................................................................................................... 8 - 2
External Monitor Interfacing ............................................................................................................................. 8 - 3
System Configuration........................................................................................................ 9 - 1
System Configuration ...................................................................................................................................... 9 - 1
Language Selection.................................................................................................................................. 9 - 2
Date Format Selection .............................................................................................................................. 9 - 3
Modem Selection..................................................................................................................................... 9 - 4
Display Software Revision......................................................................................................................... 9 - 8
50/60 Hertz Filter Selection ..................................................................................................................... 9 - 9
Accessories ..................................................................................................................... 10 - 1
Introduction .................................................................................................................................................. 10 - 1
Standard Datascope Accessories .................................................................................................................... 10 - 2
Helium Cylinders ................................................................................................................................... 10 - 3
Saline Pole ........................................................................................................................................... 10 - 5
ECG Patient Cables ............................................................................................................................... 10 - 6
Doppler (Arterial Blood Flow Monitor) ............................................................................................................. 10 - 7
Communications ........................................................................................................................................... 10 - 7
North American Modem......................................................................................................................... 10 - 7
International Modem.............................................................................................................................. 10 - 7
Data Output Connector (RS-232) ............................................................................................................. 10 - 7
Optional Accessories .................................................................................................................................... 10 - 8
Accessory Storage Bag Assembly ............................................................................................................ 10 - 8
Protective Cover .................................................................................................................................... 10 - 9
Transport Docking Station - Lightweight (for UTS) ....................................................................................... 10 - 9
System Trainer ...................................................................................................................................... 10 - 10
Specifications.................................................................................................................. 11 - 1
Triggering .................................................................................................................................................... 11 - 1
Pneumatic System ......................................................................................................................................... 11 - 2
ECG Channel............................................................................................................................................... 11 - 2
Input Characteristics............................................................................................................................... 11 - 2
Display Characteristics ........................................................................................................................... 11 - 3
ECG Waveform Output signal ................................................................................................................ 11 - 3
Pressure Channel .......................................................................................................................................... 11 - 4
Transducer Requirements ........................................................................................................................ 11 - 4
Arterial Pressure Waveforms ................................................................................................................... 11 - 4

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Table of Contents

Patient Parameters - Digital Arterial Pressure.............................................................................................. 11 - 4

Arterial Pressure Output Signal................................................................................................................ 11 - 4
Arterial Pressure Zero............................................................................................................................. 11 - 5
Heart Rate Meter .......................................................................................................................................... 11 - 6
Display ........................................................................................................................................................ 11 - 6
Printer ......................................................................................................................................................... 11 - 6
Power.......................................................................................................................................................... 11 - 7
Power Requirements............................................................................................................................... 11 - 7
Internal Battery ...................................................................................................................................... 11 - 7
External Battery Pack (CS100i only)......................................................................................................... 11 - 7
Physical Characteristics ................................................................................................................................. 11 - 8
Weight................................................................................................................................................. 11 - 8
Mechanical Dimensions.......................................................................................................................... 11 - 9
Environment (CS100) .................................................................................................................................... 11 - 10
Operating Ambient................................................................................................................................ 11 - 10
Storage Ambient ................................................................................................................................... 11 - 10
Shipping .............................................................................................................................................. 11 - 10
Vibration/Shock .................................................................................................................................... 11 - 10
Environment (CS100i) ................................................................................................................................... 11 - 13
Operating Ambient................................................................................................................................ 11 - 13
Storage Ambient ................................................................................................................................... 11 - 13
Shipping .............................................................................................................................................. 11 - 13
Vibration/Shock .................................................................................................................................... 11 - 13
Electro-Magnetic Compatibility (CS100/CS100i) ............................................................................................. 11 - 15
ESU Rejection........................................................................................................................................ 11 - 20
Safety Characteristics .................................................................................................................................... 11 - 21
Risk (Leakage) Currents .......................................................................................................................... 11 - 21
Dielectric Withstand............................................................................................................................... 11 - 21
Ground Resistance................................................................................................................................. 11 - 21
Agency Compliance...................................................................................................................................... 11 - 22
Safety Designations....................................................................................................................................... 11 - 23
Safety designations per IEC 60601-1 Standard......................................................................................... 11 - 23

iv 0070-10-0527-02 CS100/CS100i Operating Instructions

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Foreword Introduction

Foreword
This manual is intended to provide information required to properly operate the Datascope
CS100 Intra-Aortic Balloon Pump. For additional information and assistance, please contact
the Datascope Cardiac Assist Representative in your area.

General knowledge of balloon pumping and an understanding of the features and functions
of the CS100 are prerequisites for the proper use of this equipment. Therefore, DO NOT
OPERATE THE EQUIPMENT BEFORE READING THESE INSTRUCTIONS AND THE
WARNINGS, PRECAUTIONS AND NOTES WHICH FOLLOW.

Datascope maintains a policy of continual product improvement and reserves the right to
change materials and specifications without notice.

CAUTION: U.S. Federal Law restricts this device to sale by or on the

order of a physician (or properly licensed practitioner).

Warnings, Precautions and Notes

Please read and adhere to the following list of warnings, precautions and notes; some of
which are repeated in the appropriate areas throughout this manual.

A WARNING is provided if there is reasonable evidence of an association of a serious

hazard with the misuse of this device or when special attention is required for the safety of
the patient.

A PRECAUTION is provided when any special care is to be exercised by the practitioner to

avoid causing damage to this device or other property. They may also include actions to be
taken to avoid effects on patients or users that may not be potentially life threatening or result
in serious injury, but about which the user should be aware.

A NOTE is provided when extra general information is applicable. Notes appear in the
appropriate areas throughout the manual.

CS100/CS100i Operating Instructions 0070-10-0527-02 v

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Introduction Warnings

Warnings
WARNING: Do not operate this system before thoroughly reading this
manual and the associated warnings and precautions. Only
use the Abbreviated Operating Guide if you are already
familiar with this product. If not, please continue with the
remainder of this manual.

WARNING: Compressed gasses (Helium cylinders) are considered

Dangerous Goods/Hazardous Materials per I.A.T.A. and
D.O.T. regulations.

It is a violation of U.S. federal and international law to offer

any package or over pack of dangerous goods for
transportation without the package being appropriately
identified, packed, marked, classified, labeled and
documented according to D.O.T. and I.A.T.A. regulations.
Please refer to the applicable I.A.T.A. Dangerous Goods
Regulations and /or the Code of Federal Regulations 49
(Transportation, Parts 171-180) for further information.

WARNING: Possible Explosion Hazard - This instrument is not explosion

proof and must not be operated in the presence of
flammable anesthetics.

WARNING: Internal Shock Hazard - This instrument does not contain

any user-serviceable parts. DO NOT remove the instrument
covers. Refer servicing to Datascope or qualified hospital
personnel.

WARNING: Operation of the CS100 below the minimum amplitude or

value of PATIENT physiological signal may cause inaccurate
results (See sections 2.2.7, 11.1 and 11.4.1)

WARNING: Use of ACCESSORIES, transducers and cables other than

those specified in the manual may result in increased
Electromagnetic Emissions or decreased Electromagnetic
Immunity of the CS100. It can also cause delayed recovery
after the discharge of a cardiac defibrillator.

WARNING: The CS100 should not be used adjacent to or stacked with

other equipment. If adjacent or stacked use is necessary, the
CS100 should be observed to verify normal operation in the
configuration in which it will be used.

WARNING: Do not use the CS100 IABP during or near a MRI (Magnetic
Resonance Imaging) scanner.

WARNING: Safety Disk Leak Test MUST NOT be performed when the
system IAB is connected to the patient.

WARNING: The System Trainer MUST NOT be connected to a

CS100\CS100i while it is being used for patient therapy.

WARNING: Readjust or re-evaluate inflation and deflation timing after

each manual pressure trigger threshold change.

WARNING: Never leave the system set in the Internal Trigger Mode
when the patient is generating a cardiac output.

WARNING: In the manual timing mode, if the heart rate varies by more
than 10 bpm, readjustment of timing may be required.

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Warnings Introduction

WARNING: The Augmentation Alarm, which is automatically set at

power-up, provides back-up to these alarms (gas loss and
IAB catheter alarms) at higher rates. Therefore, this alarm
should not be manually disabled.

WARNING: Preventive Maintenance should not be performed when the

IABP is attached to a patient.

WARNING: System Configuration mode is not for clinical use.

WARNING: When completing a manual fill, if the contents of syringe are

not drawn into the safety disk DO NOT resume balloon
pumping. See "Manual Fill Mode" on page 3-48, Step 5 and
repeat the procedure paying careful attention to syringe fill
volume. If second attempt fails, there most likely is a leak at
one of the safety disk ports or stopcock and they should be
checked.

WARNING: Use only Datascope CS100 software datasettes and safety

disk/condensate removal assemblies in this unit.

WARNING: Do not inflate the IAB using a syringe or any other means if
a balloon leak is suspected.

WARNING: Perforation of a balloon may indicate that the patient’s

vascular condition may induce abrasion or perforation in
subsequent balloons.

WARNING: Continued pumping of an IAB which has a leak may result

in formation of a large blood clot within the balloon causing
an entrapped balloon condition which may require surgical
removal of the IAB or in a gaseous embolic injury of organs.

WARNING: The patient balloon should not remain inactive in the patient
(i.e., no inflating and deflating) for more than 30 minutes,
due to the potential for thrombus formation.

WARNING: Do not leave the patient unattended during IABP therapy.

WARNING: External bedside monitors used with the CS100 in the

operating room, must be equipped with electro-surgical
interference suppression.

WARNING: Datascope recommends the use of surgical gloves while

performing Safety Disk/Condensate Removal to avoid
contact with residual condensate or other body fluids.
Disposal of used safety disk should be in accordance with
prevailing hospital practices for medical refuse.

WARNING: Use only Manual timing when pumping the pediatric

catheters.

WARNING: Under no circumstances should an IAB patient or the CS100/

CS100i IABP ever be placed in a hyperbaric chamber.

WARNING: The CS100 may trigger on alternate ECG complexes should

a patient’s heart rate exceed 200BPM. Inflation may extend
into the next cardiac cycle should such trigger conditions
exist in either the “AUTO” or “SEMI-AUTO” operation
modes. To prevent the potential for patient harm, use only
the “MANUAL” operation mode in the unusual event that
patient heart rate remains above 200BPM.

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Introduction Warnings

WARNING: Route cables neatly. Ensure cables, hoses and wires are
away from patient's neck to avoid strangulation. Keep
floors and walkways free of cables to reduce risk to
hospital personnel, patients and visitors.

WARNING: Under certain heart rate and timing conditions catheter

alarms may be suspended. Refer to this manual for further
details.

WARNING: External monitor output signals must meet certain

requirements. See “External Monitor Interfacing” on
page 8-3.

WARNING: This unit uses a common isolation path for the ECG leads
and the Invasive Pressure Channels. Ensure that conductive
parts of the ECG electrodes do not contact other conductive
parts including earth ground. Do not connect any non-
isolated accessories to the CS100 or to the ECG or invasive
pressure channel inputs when connected to a patient. Insure
that the total chassis leakage currents of all connected units
does not exceed 300µA. Use an IEC 60601-1 approved
isolation/separation transformer if required. Do not
simultaneously touch the patient and any piece of electrical
equipment if any cover has been removed from the
equipment.

WARNING: The AC line cord and interface cables (i.e., non-patient

cables) may utilize the same ground. Therefore, removal of
the AC line cord does not necessarily isolate the CS100, if
non-patient interface cables are attached.

WARNING: Observe extreme caution when a defibrillator is used on a

patient. Do not touch any part of patient, table or CS100
when a defibrillator is in use.

WARNING: Do not put MPSO (Multiple Portable Socket Outlets i.e.,

Multiple outlet extension cords) used with the CS100 or its
accessories on the floor. Connect only CS100 accessories to
the same MPSO as the CS100. Do not overload the MPSO.

WARNING: Do not connect other equipment to the same MPSO with the
CS100, as it may increase system leakage current.

WARNING: Reliably attach Potential Equalization connector to the safety

ground when interconnecting CS100 with other medical or
non-medical electrical equipment to minimize the risk of
excessive leakage current and/or shock hazard.

WARNING: Do not reuse disposable devices.

WARNING: Pacemaker Patients: Rate meters may continue to count the

pacemaker rate during occurrences of cardiac arrest or
some arrhythmias. Keep pacemaker patients under close
surveillance. See “Selection of Trigger Source” on page 2-7,
of this manual for disclosure of the pacemaker pulse
rejection capability of this instrument.

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Warnings Introduction

WARNING: Pressure triggering is NOT recommended for use when

sustained irregular cardiac rhythms or tachyarrhythmias
are present. Remember to adjust deflation early enough so
that deflation is completed prior to systole and to provide
continuous observation while triggering in this mode. If the
“IRREGULAR TRIGGER” message appears, DO NOT attempt
to adjust the deflation control as the system will
automatically compensate by deflating earlier to avoid
interfering with systolic ejection.

WARNING: Only personnel familiar with the handling of high pressure

gas cylinders should install or replace the Helium cylinder.

WARNING: When the CS100 is operated in the Manual Fill mode, the
IAB Catheter and Gas Loss Alarms are disabled. The
message “Gas Loss and Catheter Alarms Disabled” will be
displayed in the Advisory section of the display. The IAB
status bar will not be active. Therefore, use of the Low
Augmentation Alarm is essential in pediatric IAB patient
care. By setting the Low Augmentation Alarm, the system
monitors the level of assist and alerts the user in the event
that diastolic augmentation has dropped below the alarm
limit.

WARNING: When pressure trigger is being used, balloon deflation

should always be adjusted to be complete at the upstroke
of systole. Late deflation timing causes a reduction in, and
delay in detection of, systolic pulse pressure. The system
relies on a prominent and timely systolic upstroke for
consistent, reliable pressure triggering. Any overlap of
balloon deflation and systolic ejection, while in the pressure
trigger mode, could cause triggers to be late or missed,
potentially resulting in loss of synchronization.

WARNING: The user should continually rely on visual alarm messages

during high noise transport situations. The "Flash Alarms"
option should be turned ON to improve the visibility of
alarm messages. This option can be set in the USER
PREFERENCES Menu (located in the DISPLAY PREFERENCES
submenu.)

WARNING: The Autofill mode should be used during air transport. If the
Autofill mode cannot be used and the Manual Fill mode is
required, ensure that a manual fill is performed at each
interval and altitude that an Autofill would occur.

WARNING: Replacing the internal battery, when AC mains are not

connected, will stop the therapy, (i.e., power down the
pump.)

WARNING: Continued assist of an IAB which has a leak may result in

formation of a large blood clot within the balloon. This may
cause balloon entrapment which may require surgical
removal of the IAB.

WARNING: Never connect an IAB or its extension catheter to the

Manual Fill Port. See Operating Instructions (Manual Filling
of IAB) for proper use of this function.

WARNING: Use only the Datascope approved Safety Disk/CRM (P/N's

0997-00-0344/0997-00-0380 or 0997-00-0985/0997-00-
0986) designed for use with the CS100.

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Introduction Warnings

WARNING: Gas Loss and IAB Catheter alarms are inoperative when
pumping in the Manual IAB FILL mode. Consequently, the
use of the augmentation alarm is essential when caring for
patients while operating in this mode.

WARNING: Do not remain in the internal trigger mode when the patient
is generating a cardiac output.

WARNING: When weaning by reduced IAB augmentation, do not

reduce augmentation to a point at which the IAB status
indicator moves less than 50%.

WARNING: Never use a glass syringe for the Manual Fill Procedure.
Possible injury may occur if glass breaks. Hold your hand
over the syringe plunger.

WARNING: The CS100 must be in Semi-Auto Operational mode

whenever no aortic pulse is present, and IAB assist is
desired. For example, whenever circulatory bypass or a
laminar flow, left ventricular assist device is in use.

WARNING: The Datascope IABP and accessories described or listed

herein contain chemicals known to the State of California to
cause cancer, birth defects, or other reproductive harm.

WARNING: If more than one pump is being used in close proximity,

ensure that the source of the alarm sound is correctly
identified by confirming the corresponding visual indication.

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Precautions Introduction

Precautions
CAUTION: Blood pressure transducers used with the CS100 shall meet
the standard for interchange ability and performance as
defined by AAMI Spec BP-22-1994 “Blood Pressure
Transducers”.

CAUTION: Proper operation of the automatic condensate removal

system requires proper connection of the safety disk
assembly to the console. Excessive condensate may indicate
the need to service the condensate removal module.

CAUTION: The operator is urged to routinely check the IAB extension

catheter for the formation of condensate. If excessive
condensation is allowed to accumulate it will affect system
performance. Excessive condensate may indicate a service
problem.

CAUTION: When transporting the system without the cart, be sure to

only pull the system by the handle, DO NOT PUSH.

CAUTION: The internal batteries are charging only when the AC Mains
plug is connected to an active AC Mains source, the AC
Mains switch is ON, and the battery charging status LED is
illuminated. This charging condition must be maintained
even when the system is not in use. Note that 18 hours of
charging is required to fully charge the batteries.

CAUTION: See “User Maintenance” on page 7-1, for periodic checking

and replacement of the internal battery. When the CS100 is
in storage, keep the battery pack in place and the unit
plugged in. Ensure that the battery is charging, by
confirming that the charge LED is either continuously
illuminated or flashing. If storing in extreme temperatures,
or storing for long time periods (2 weeks or longer) without
AC Mains access, remove the battery pack.

CAUTION: Use medical grade Helium only.

CAUTION: The installation and removal of the safety disk requires a

partial turning action to secure or remove. When securing,
confirm that the rib on the top surface of the safety disk
assembly is fully rotated to the 12 o’clock position.

CAUTION: When power cycling the unit, power off for a minimum of
10 seconds before powering on again.

CAUTION: It is recommended that users avoid the saline pole’s highest

setting when the CS100 is taken off its hospital cart. In this
configuration, the pump may be tilted for transport. If the
pole’s height is excessive when the pump is tilted, it may
contact the operator and possibly cause injury.

CAUTION: Prior to emergency use, when the system is to be powered

from an AC inverter, the inverter should be checked for
proper operation with the system by qualified maintenance
personnel. The message “Battery in Use” will not be
displayed during proper AC inverter operation.

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Introduction Precautions

CAUTION: The user should continually rely on the visual alarm

messages during high noise transport situations. The “Flash
Alarms” option in the Preferences Menu should be turned
on to improve the visibility of alarm messages.

CAUTION: When the optional Protective Cover is on, do not leave the
CS100 on and powered-up (i.e., with the IABP On/Off
switch in the ON position).

CAUTION: For the protection of the controls and their settings,

Datascope recommends that the display only remain open
when observing patient parameters or waveforms.

CAUTION: Conductive parts of electrodes and associated connectors for

applied parts, including the neutral electrode, should not
contact other conductive parts including earth.

CAUTION: Never place fluids on top of this unit. Make sure that the
saline container and tubing do not hang directly over the
IABP. In case of accidental spillage, wipe clean immediately
and have the unit serviced to ensure no hazard exists.

CAUTION: Do not use a damaged or broken unit or accessory.

CAUTION: Do not operate the unit with the ventilation or speaker vents
obstructed.

CAUTION: When in the Manual Fill Mode, the condensate removal

module system is disabled.

CAUTION: If the contents of the syringe are not drawn into the safety
disk DO NOT resume balloon pumping. Return to step 5 in
the Manual Fill Procedure, paying careful attention to
syringe fill volume. If second attempt fails, there most likely
is a leak at one of the safety disk ports or stopcock and they
should be checked.

CAUTION: To prevent condensation, allow the CS100 to warm up and

dry if it is moved from a cold area to a warm one.

CAUTION: The wheels (P/N 0401-00-0018 with a serial number below

2300) on this Intra-Aortic Balloon Pump contain natural
rubber latex, which may cause allergic reactions.

CAUTION: The Inflation Interval marker (highlighted) should not be

used to set timing. Timing should be set by examination of
the arterial waveform.

CAUTION: The displayed ECG signal is automatically scaled (amplified)

for optimal screen presentation. Due to the automatic
scaling, low ECG amplitudes may appear to be of normal
amplitude when displayed. Judgements concerning ECG
amplitude should be made with reference to the annotated
scale or a printed ECG output.

CAUTION: The displayed AP signal is automatically scaled (amplified)

and offset for optimal screen presentation. Because of
automatic scaling, low AP amplitudes may appear to be of
normal amplitude when displayed. Judgements should be
made with reference to the annotated scale, patient arterial
pressure parameter display or a printed AP output.

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Precautions Introduction

CAUTION: When the system is not in use, close the cylinder valve fully
clockwise to prevent a potential leak and the depletion of
the Helium supply.

CAUTION: To ensure reliable operation of the Autofill system and

proper IAB inflation pressures, it is important that the
combined total volume of the IAB’s membrane and external
tubing, plus the catheter extender tubing, is not altered.
Using IAB or catheter extender tubing of a different length
or internal diameter, from that supplied with Datascope
products, will change IAB inflation pressure levels and may
result in Autofill failures. Consequently, such practices must
be avoided.

CAUTION: Prior to transport, ensure that the Helium cylinder yoke

handle is tight and the Helium pressure gauge is a least
25% full. Approximately every 30 minutes during transport,
verify that the yoke handle is tight and that a noticeable
pressure drop has not occurred.

CAUTION: Insure that the wheels of the cart are in the locked position
when removing the pump console from the cart or returning
the pump console to the cart.

CAUTION: Lifting the IABP by the Lower Lift Handles requires two
people. While lifting, the IABP must be steadied by placing a
free hand near the top of the unit to provide stability.

CAUTION: When in Manual Fill Mode, the IAB should be re-filled every
2 hours when using adult IABs and every 45 minutes when
using pediatric IABs.

CAUTION: If the patient's pressure monitoring site is changed while

pumping, the Inflation Interval key can be quickly pressed
and released to recalculate arterial pressure transmission
delay. Reconfirm proper position. This will assure accurate
digital blood pressure indices.

CAUTION: The Condensate Removal Module (CRM) is designed to

function most efficiently when the unit is in a normal upright
(vertical) position. Transient operation of the CRM in a
horizontal position should be limited if condensate removal
functionality is required.

CAUTION: In order to ensure proper IABP performance, only

Datascope approved cables, accessories and Intra-Aortic
Balloons (IABs) should be used with the CS100.

CAUTION: Do not set the alarm volume to such a low level that it
cannot be readily heard over the ambient noise level of the
venue in which the IABP is used.

CS100/CS100i Operating Instructions 0070-10-0527-02 xiii

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Introduction Indications for Use

Indications for Use

The balloon pump is an electromechanical system used to inflate and deflate intra-aortic
balloons. It provides temporary support to the left ventricle via the principle of
counterpulsation. The intra-aortic balloon is placed in the descending aorta, just distal to the
left subclavian artery. Once the balloon is positioned, the pump is adjusted to trigger in
synchrony with the ECG or arterial pressure waveform to ensure that inflation and deflation
occur at the appropriate points during the cardiac cycle.

The target populations are adult and pediatric. The balloon pump is intended for use in the
health care facility setting.

Contraindications
• Severe aortic insufficiency
• Abdominal or aortic aneurysm
• Severe calcific aorta-iliac disease or peripheral vascular disease
• Introduction of the IAB catheter without the use of an introducer sheath is not
recommended for patients with severe obesity, scarring of the groin or other
contraindications to percutaneous insertion

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Brief Description of Intra-Aortic Balloon Therapy Introduction

Brief Description of Intra-Aortic Balloon Therapy

The CS100 Intra-Aortic Balloon Pump (IABP) is a cardiac assist device. It supports the heart's
left ventricle by increasing coronary perfusion and reducing left ventricular work.

Coronary perfusion is increased by augmenting blood pressure during the diastolic phase of
the cardiac cycle. This increase in aortic pressure forces more blood flow through the
coronary arteries.

Left ventricular work is reduced by reducing the amplitude of blood pressure during the
systolic phase of the cardiac cycle.

These beneficial effects are caused by the inflation and deflation of an intra-aortic balloon
(IAB) in the patient's descending aorta. The balloon's inflation and deflation must be properly
synchronized with the cardiac cycle. IAB inflation is initiated at the onset of diastole at the
dicrotic notch. The IAB is held inflated through diastole and is deflated at, or just prior to, the
onset of systole. The balloon is held in the deflated state throughout systole.(Hence, the
therapy is also called counter-pulsation).

See the Intra-Aortic Balloon (IAB) Catheter Instructions For Use (IFU) for detailed information
regarding the instructions for use, indications, contraindications, warnings, and precautions.

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Introduction Overview of Clinical Features

Overview of Clinical Features

The CS100 is equipped with the flexibility to aid medical staff in supporting a broad range
of patients. It is also designed to work in conditions which are unique to the operating room,
catheterization laboratory, critical care unit and transport.

The CS100 has three operation modes: AUTO, Semi Auto and Manual. The AUTO
operation mode provides simplicity and minimizes operator intervention. The Semi Auto
and Manual operation modes provide operators with flexibility for difficult clinical cases.

When the AUTO operation mode is selected, all aspects of IABP operation are automated.
The CS100 automatically selects the best available trigger source and automatically sets IAB
timing. In the event of a loss of trigger source (e.g., a lost ECG lead), the CS100 will
sequentially search for the next best available trigger source and then reset timing
accordingly. Timing is also reset on a periodic basis or if the patient's heart rate or rhythm
changes significantly.

As the name indicates, when in the Semi Auto operation mode, IABP operation is partially
automated. The operator is responsible for both selection of the trigger source and for initial
timing of the IAB. Thereafter, the IABP's timing algorithms will adjust timing in response to
changes in heart rate or rhythm. If the trigger source is lost the IABP alarms. This operation
mode provides the most flexibility for difficult clinical cases.

In the Manual operation mode, the operator is responsible for selection of a trigger source
and setting IAB timing. The operator is also responsible for maintaining correct timing in the
event of a change in patient heart rate and rhythm. This mode is used only in exceptional
cases, such as pediatrics, where a large range of timing settings must be accommodated.
Loss of trigger will result in an alarm.

In all operation modes, the processes of Helium purge and replacement, and condensate
removal are fully automatic. Operator intervention is not required for these functions.

For emergency use, the CS100 has a rapid startup feature. This feature is active at power
up. The rapid start up feature performs the following steps:

1. Selects the AUTO operation mode

2. Automatically purges and fills the IAB
3. Selects the best available trigger source
4. Starts assist and automatically sets IAB timing. It is recommended that the operator
assess the resultant timing after the process completes.

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CS100 User Interface Introduction

CS100 User Interface

The CS100 user interface was designed with ergonomics in mind. It uses a color, flat panel
display which provides high contrast and an adjustable viewing angle. The display uses both
color and layout to present information in an organized manner.

For operator convenience, and to facilitate its use in emergencies, the CS100 is highly
automated. Dedicated keys are used for functions that are frequently used or for functions
which must be accessed rapidly.

A context sensitive help system is available to assist users with alarms and common tasks. The
help system presents probable causes for alarms and recommended corrective action.

In order to provide flexibility, the CS100 operates via a menu driven system. The menu
system provides a logical and consistent method for accessing system controls and functions.

The menu system is used for:

1. Access to infrequently used modes and controls

2. Definition of User Preferences
3. Configuration and customization of the CS100

CS100i Conversion Kit

A conversion kit is available for Datascope's System 98/98XT IABPs. After installation, these
systems are labeled CS100i. The CS100i systems have essentially the same appearance and
functionality as a factory CS100, i.e. fully automatic operational mode, new user interface
with a color screen, new exterior plastic and paint.

The CS100i differs from a factory CS100 in that it retains the environmental specifications of
the original host System. Hence, a CS100i has the environmental, shock and vibration, and
external DC power specifications of a System 98/98XT. Hereafter, areas of difference in
specification or function are noted by the reference to CS100i.

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Introduction Physical Description of the CS100

Physical Description of the CS100

The CS100 consists of a hospital cart, console
and detachable control/display module.

The hospital cart is the host for the console and

display/control module. In addition, it has
storage compartments for accessories. The two
casters closest to the cart handle are multi-
functional. They can be locked in the straight
position (directional lock) or used as a brake
(total lock). The two casters on the side opposite
the handle have total lock only.

NOTE: The casters on the handle side of

the cart may or may not have a
braking feature. Refer to
markings on the casters.

The cart has a mounting bracket for the display/

FIGURE CS100 Console on a
control module. The bracket permits rotation of
Hospital Cart
the display/control module for adjustment of the
viewing angle. The display/control module can be removed from the cart and attached
directly to the console via a quick release mechanism.

The display/control module consists of a keypad which is attached to a color flat panel
display via a hinge. Therefore the display can be tilted and rotated to achieve the best
viewing angle. The module receives power and exchanges data with the console via a cable
(coil cord). Functionally, the module centralizes all key aspects of the operator interface with
the system. It integrates the functions of the patient monitor and the control panel. Remote
operation of the IABP is possible by detaching the control/display module.

The console houses the following: Patient Interface Electronics (Electrically Isolated), Patient
Pneumatic Isolator (Safety Disk), Drive Pneumatics, Shuttle Gas Supply, Condensate Removal
System, Printer, Control Electronics, Power System (Battery and AC Mains) and Data
Communications Interface.

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Mechanical and Transport Features Introduction

Mechanical and Transport Features

The CS100 console is mounted on a hospital cart for intra-hospital transport. The console
may be separated from the cart for convenient movement within a hospital room. All four
wheels of the hospital cart swivel for movement in any direction, and the two rear wheels
may be locked in the forward direction for increased maneuverability during transport. The
console has integral wheels and a handle for ease of movement.

Due to its small footprint, the CS100 can be used in ambulances, helicopters, and fixed
wing aircraft. The CS100 automatically refills the IAB on ascent and descent in order to
acclimate IAB pressure to ambient pressure changes. It is rated for an altitude of 12,000
feet.

The System can be powered from either AC Power (115/230 VAC, 50/60 Hz) or built-in
batteries. If AC power is not available, the CS100 automatically utilizes internal battery
power.

For CS100i, external DC operation from a 20.5 - 35 VDC source is available.

IABs Supported
The CS100 is designed for use with the Adult Safety Disk which interfaces with all
Datascope adult intra-aortic balloons (25, 34, 40, and 50 cc).

The CS100 is also designed for use with Pediatric IABs. Two large pediatric intra-aortic
balloon sizes (12 and 20 cc) require the use of an optional Pediatric Adapter Hose and
Adult Safety Chamber to be used in place of the Adult Safety Disk. Smaller Pediatric IABs
(2.5, 5, and 7 cc) require the use of the optional Pediatric Adapter Hose and a small
Pediatric Safety Chamber to be used in place of the Adult Safety Disk.

Major Accessories
An ultrasonic doppler is included in the top compartment of the hospital cart. The doppler
is used to verify arterial blood flow in a non-invasive manner.

A patient simulator is available for system training. It demonstrates various ventricular

rhythms, four rates of sinus rhythm, A-fib, pacer stimulus and atmospheric venting of the
transducer.

A two compartment accessory case allows storage of a trainer, a manual and IAB
supplies. A protective cover is also available for the system. A remote monitor mount and
extension cable are available for mounting the monitor/keypad module in the operating
room.

See "Accessories" on page 10-1.

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Introduction Phone Numbers and How To Get Assistance

Phone Numbers and How To Get Assistance

Datascope maintains a network of service representatives and factory-trained distributors.
Prior to requesting service, perform a complete operational check of the instrument to verify
proper control settings. If operational problems continue to exist, contact the Datascope
Service Department at (800) 777-4222 for assistance in determining the nearest field service
location.

Please include the instrument model number, the serial number, and a description of the
problem with all requests for service.

Any questions regarding the warranty should be directed to the nearest Datascope location.
A list of international offices, along with their phone numbers, is provided at the end of this
manual.

Unpacking Information
The IABP is shipped as a complete unit in a single shipping container, to be unpacked only by
an authorized Datascope service representative.

Accessories and gas cylinders are shipped separately. Please contact an authorized
Datascope representative prior to placing the IABP into service.

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Operator Profile Introduction

Operator Profile
The primary intended users of the intra-aortic balloon pump are Critical Care Nurses,
Catheterization Lab Technicians and Perfusionists who have been trained in the theoretical,
technical and clinical aspects of counterpulsation therapy. Other potential users include
Paramedics involved in transporting patients (e.g. flying patients from a rescue site to a
hospital). Note that these other potential users are less likely to receive thorough training in
the device use, are likely to use the device only for a portion of the therapy and are likely to
be dependent on the Primary users at various points to assure proper therapy.

The user of the system needs to understand the concepts of cardiovascular anatomy and
physiology in order to integrate the effects of counterpulsation with the other therapies being
used to provide cardiac support. The user should not operate the IABP before reading the
operating instructions, including the warnings and cautions. The user needs to be able to
read and understand English or the other translated languages used to label the controls and
features of the system. The user needs to have the visual acuity to clearly view the waveforms
on the monitor screen. The color-coded waveforms are also labeled to indicate the source of
the waveform so a user with color vision deficiency will be able to identify the source of the
waveform source based on the labeling. The primary user must possess the manual dexterity
to make the necessary patient connections to the console and to be able to use the touch
controls of the user interface. Since the device may also be used for inter-hospital transport,
in addition to the above requirements, the user needs to be able to lift/load the device into
the transport vehicle with the assistance of other transport personnel using appropriate body
mechanics.

Datascope Corp. recommends that medical professionals be properly trained prior to

operation of CS100. Training can be provided on-site by contacting the local Sales and/or
Clinical representative. Additional information, education and training can be provided by
accessing the MAQUET* website at: http://ca.maquet.com. In addition, MAQUET/
Datascope Corp. provides 24/7 emergency clinical support by calling 1-800-777-4222.

Operator Position
The user may operate CS100 in either a seated or standing position. The System’s monitor
can be rotated to accommodate a variety of operator positions. The monitor should be
adjusted so that it is easily visible to the operator.

CS100/CS100i Operating Instructions 0070-10-0527-02 xxi

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Introduction Symbols and Descriptions

Symbols and Descriptions

SYMBOL DESCRIPTION SYMBOL DESCRIPTION

Attention, Consult Accompanying

Protective Earth (Ground)
Documents/Refer to Manual

ON (power connection to the AC

Equipotentiality
mains)

OFF (power disconnection to the

Dangerous Voltage
AC mains)

Defibrillator Proof Type CF

ON (IABP functions are active)
Applied Part

OFF (IABP functions are inactive) Type CF Applied Part

Indicates Approximate Battery

Standby Battery Charge Level

Start (Assist) Battery Charging LED

Direct Current (DC) IAB Status

Alternating Current (AC)

!!! High Priority Alarm

Helium
Indicates Approximate Level Of
Helium Left In Tank !! Medium Priority Alarm

Non-ionizing electromagnetic
radiation ! Low Priority Alarm

Fuse Replacement Symbol - Alarm Mute

2 x F10A 250V CS100

Replace Fuse as Marked - Alarm Inhibited

F10A / 250V
CS100i

Earth (Ground) Do Not Discard

Consult Instructions for Use CE Mark

0086

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 1.0 Controls and Indicators

1.1 Introduction
This section of the Operating Instructions identifies and describes each feature and control of
the CS100. See “Detailed Operation” on page 2-1, for more specific instructions.

CS100/CS100i Operating Instructions 0070-10-0527-02 1-1

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Operation Mode Keys Controls and Indicators

1.2 Operation Mode Keys

1 2 3

OPERATION MODE

Semi Zero
AUTO Manual Pressure START STANDBY
Auto
Hold 2 Sec.
Pediatric Only

TRIGGER SOURCE IAB FREQUENCY AUGMENTATION IAB INFLATION IAB DEFLATION

MAX Earlier Later Earlier Later

ECG 1:1
Pressure
1:2
Pacer V / AV
Pacer A 1:3
Internal OFF

Ref ECG / AP Inflation

Alarm
Help Line Sources Interval
Mute

IAB Pump Freeze

Aug Open Display
Fill Alarm Options
Menu
Hold 2 Sec.

User Print
Preferences Strip
Hold for continuous

Back

FIGURE 1-1 Operation Mode Keys

The CS100 has three operating modes, AUTO, Semi Auto and Manual. The AUTO
operation mode provides simplicity, and the Semi Auto and Manual operation modes
provide versatility. The default operation mode is AUTO.

The choice of operation mode strongly effects the system’s behavior and the user interface.
For example, when the system is in AUTO, many of its controls are not required and are
therefore disabled. Conversely, when in the Semi Auto or Manual operation mode, these
controls are enabled.

AUTO SEMI AUTO MANUAL

Trigger Source Auto Manual selection Manual selection
IAB Timing Auto Initial timing manual, Manual selection
then automatic
Lost Trigger Source Auto detect new IABP alarms IABP alarms
source
Applications Adult Adult Pediatric

Each operation mode key has an LED indicator which illuminates to indicate that the mode is
selected. Operation mode keys are used to select the automation and control used by the
IABP in its application of therapy to the patient. Selection of any operation mode key cancels
the previous selection. Any transition between operation modes stops assist and places the
system in STANDBY mode. Assist may be resumed by pressing the START key.

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Controls and Indicators Operation Mode Keys

Each of the keys/modes is described below:

1. AUTO Key
Pressing this key places IABP operation in the AUTO operation mode. When the IABP is
operating in AUTO operation mode, operation is completely automatic. The IABP
automatically selects the most appropriate Trigger Source. Then the IABP automatically
sets inflate and deflate timing. No operator intervention is required. For flexibility, deflation
timing can be fine tuned via use of the IAB DEFLATION keys.

In this fully automatic mode, there is no operator selection or override of the trigger source. In
the event that the trigger source is lost, the IABP automatically selects the next best available
trigger and re-times the IABP, if appropriate. Similarly, if a superior trigger source is made
available, it is automatically selected and timing is reset.

The system's software algorithms automatically track changes in patient heart rate or rhythm
and adjust the inflation and deflation points accordingly. When the patient's rhythm is not
adequately predictable, and a valid ECG trigger is available, R-Wave deflation is
automatically selected. This surveillance is continuous. It continually monitors the patient's
rhythm and selects R-Wave deflation when it is the most appropriate. This is indicated via the
Deflation Timing Indicator and the Auto R-wave Deflate advisory message on the
display.

Assist is automatically suspended when making the transition to AUTO operation mode from
another operation mode. Resume assist by pressing the START key.

WARNING: The CS100 must be in Semi-Auto Operational mode

whenever no aortic pulse is present, and IAB assist is
desired. For example, whenever circulatory bypass or a
laminar flow, left ventricular assist device is in use.

2. Semi Auto Key

Pressing this key places IABP operation in the Semi Auto operation mode. Selection of this
key cancels the previous operation mode.

In this operation mode, the operator selects the most appropriate TRIGGER SOURCE. Then
the operator sets IAB INFLATION and DEFLATION (See Figure 1-3). Software algorithms
automatically track changes in patient heart rate or rhythm and adjust the inflation and
deflation points accordingly.

When the patient's rhythm is not adequately predictable, and a valid ECG trigger is
available, R-Wave deflation is automatically selected. This surveillance is continuous. It
continually monitors the patient's rhythm and selects R-Wave deflation when it is the most
appropriate. On the display, the status message Auto R-Wave Deflate is shown when R-
Wave Deflation has been selected.

In this operation mode, loss of the trigger source will result in a No Trigger alarm. Trigger
source selection is not automated, it is the responsibility of the operator.

CS100/CS100i Operating Instructions 0070-10-0527-02 1-3

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Operation Mode Keys Controls and Indicators

When this timing mode is selected, the system will immediately stop assist and enter
STANDBY mode. This is done to emphasize the need for operator intervention when
entering this operation mode. The operator should re-assess timing when the trigger source is
changed. Assist may be resumed by pressing the START key.

Similarly, when a new trigger source is selected, and timing has not been set by the operator,
the system will immediately stop assist and enter STANDBY mode. This is done to
emphasize the need for initial operator intervention when changing trigger sources. The
operator should re-assess timing when trigger sources are changed. Assist may be resumed
by pressing the START key.

3. Manual Key
When the Manual operation mode is selected, the timing of IAB Deflation and Inflation
is exclusively determined by operator selection, using the IAB INFLATION and IAB
DEFLATION timing keys.

In this mode, the inflate and deflate points do NOT automatically change to match changes
in patient rate or rhythm. Consequently, increased operator vigilance is required to assure
that the proper timing is maintained. Typically, this mode is used for pediatric cases or other
cases where additional timing range is needed. See “Pediatric Balloon Pumping” on page 6-
1, for a detailed description of the Manual operation mode.

When this timing mode is selected, the system will immediately stop assist and enter
STANDBY mode. This is done to emphasize the need for operator intervention when
entering this operation mode. Assist may be resumed by pressing the START key.

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Controls and Indicators Trigger Source Keys and Indicators

1.3 Trigger Source Keys and Indicators

OPERATION MODE

Semi Zero
START STANDBY
AUTO Manual Pressure
4 Auto
Hold 2 Sec.
Pediatric Only

5
TRIGGER SOURCE IAB FREQUENCY AUGMENTATION IAB INFLATION IAB DEFLATION

6 ECG 1:1
MAX Earlier Later Earlier Later

Pressure
1:2
7 Pacer V / AV
Pacer A 1:3
Internal OFF
8

9
Ref ECG / AP Inflation
Alarm
Help Line Interval
Mute Sources

IAB Pump Freeze

Aug Open Display
Fill Options
Alarm Menu
Hold 2 Sec.

User Print
Preferences Strip

Hold for continuous

Back

FIGURE 1-2 Trigger Source Keys

NOTE: In Semi Auto or Manual operation mode, assist is

automatically suspended when making the transition from
one trigger source to another. This is done to remind the
operator to adjust the Inflate and Deflate timing controls
prior to resuming assist. Resume assist by pressing the
START key.

The trigger signal source selections are ECG, Pressure, Pacer V/AV, Pacer A and
Internal.

Irrespective of the operation mode, the active trigger source is indicated by illumination of
the appropriate LED on the keypad. The active trigger source is also shown in the in the
upper right hand corner of the display in the Trigger Source field.

Therefore, when the CS100 is in the AUTO operation mode:

• The trigger source keys are inoperative

• The source chosen by the CS100 is indicated on the keypad LEDs and on the screen
4. UP Arrow and DOWN Arrow Keys (for Trigger Source Selection)
The UP and DOWN arrow keys are used to select the desired trigger source. The keys are
active when the IABP is in Semi Auto or Manual operation mode, and inactive when in
AUTO operation mode, where trigger source selection is automatic.

5. ECG Trigger
This indicates that the patient's ECG is currently selected as the active trigger source for the
IABP. The system will trigger on the patient's R-Wave. The ECG signal source can be from
either patient electrodes or an external ECG signal from a patient monitor.

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Trigger Source Keys and Indicators Controls and Indicators

If a pacemaker is detected while in ECG trigger mode, it will be ignored and the system will
trigger on the patient's QRS complex. Detected pacer pulse signals are enhanced on the
display. They are shown as spikes.

In the AUTO operation mode, the best available skin lead (I, II, III) or External ECG
source is automatically selected. If these sources are exhausted, then Pressure Trigger
mode may be automatically selected. An automatic change in trigger source can be
provoked by electro-surgical noise, motion artifact or loss of electrodes.

In the Semi Auto and Manual operation modes, the operator can change the ECG trigger
source (I, II, III, aVR, aVL, aVF, V or External) via the ECG/AP Source menu.

In all cases, the Trigger field on display shows the currently active ECG source and lead.
Similarly, the ECG waveform on the display reflects the currently active ECG trigger source.

6. Pressure Trigger
This indicates that the patient's arterial blood pressure is currently selected as the trigger
source for the IABP. The system will trigger on the systolic upstroke of the patient's arterial
pressure waveform. The signal source can be either the direct pressure transducer (e.g., IAB
inner lumen) or an external pressure signal.

To facilitate rapid startup while in Pressure Trigger, assist can be initiated without zeroing
the transducer. However, zeroing is necessary to support the numeric display of patient
parameters.

In the AUTO operation mode, the best available source for arterial pressure is selected.
Preference is given to the IAB's pressure transducer. If it is unavailable, then the external
arterial pressure source is automatically selected. If all potential valid signal sources are lost,
then a No Trigger alarm will sound. An automatic change to this trigger mode can be
provoked by electro-surgical noise, motion artifact or loss of electrodes.

In the AUTO operation mode, the operator can manually change the pressure source. If
however the pressure source, selected by the operator, becomes unavailable or its trigger
was lost, the CS100 will automatically select the alternate pressure source, if available.

In the Semi Auto and Manual operation modes, the operator selects the source for arterial
pressure trigger (Direct vs. External) via the ECG/AP Source menu.

7. Pacer V/AV Trigger

This trigger mode is available in the Semi Auto and Manual operation modes and must
be selected by the operator.

In this trigger mode, the system automatically determines if a Ventricular or Atrio-Ventricular

pacemaker is present. In either case, the system triggers on the pacer's ventricular pulse. It
ignores the patient's QRS and arterial pulse if applicable. The type of pacer is displayed in
the Trigger field on the display.

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Controls and Indicators Trigger Source Keys and Indicators

Use of this mode requires that the patient is 100% paced and captured (i.e., no demand
pacing). The ECG signal source can be from patient skin electrodes or an external ECG
signal from a patient monitor.

This trigger mode is often selected when the patient is paced and the resultant QRS response
is too weak to be a reliable trigger source (e.g., operating room usage.)

8. Pacer A Trigger
This trigger mode is available in the Semi Auto and Manual operation modes and must
be selected by the operator.

This mode is recommended for use only when the tails of an atrial pacer interfere with
R-Wave detection. Either fixed or demand atrial pacers can be used in this trigger mode.

In this trigger mode, patient's ECG is used as the trigger source for the IABP. The system will
trigger on the patient's R-Wave and reject interference from atrial pacer artifact. The ECG
signal source can be either patient electrodes or an external ECG signal.

9. Internal Trigger
This trigger mode is available in the Semi Auto and Manual operation modes and must
be selected by the operator.

This indicates that the IABP's Internal trigger source is selected as the trigger source for the
IABP. The system will trigger at a fixed rate, as defined by internal rate in the PUMP
OPTIONS menu.

This trigger mode should not be used when a viable QRS is present. When in this mode, the
system automatically deflates the IAB when an R-Wave is detected, to prevent asynchronous
assist. Also, an alert message that reads ECG Detected and a tone, are generated.

This mode is typically used in the OR during CABG procedures. It is used when the patient is
on bypass and no QRS is present. Assist is recommended when in full bypass to prevent clot
formation on the IAB membrane.

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IABP Control Keys Controls and Indicators

1.4 IABP Control Keys

10 11 12 13 14

OPERATION MODE

Semi Zero
AUTO Manual START STANDBY
Pressure
Auto 15
Hold 2 Sec.
Pediatric Only

TRIGGER SOURCE IAB FREQUENCY AUGMENTATION IAB INFLATION IAB DEFLATION

MAX Earlier Later Earlier Later

ECG 1:1
Pressure
1:2
Pacer V / AV
Pacer A 1:3
Internal OFF

Alarm
Mute
Help
Ref
Line
ECG / AP
Sources Inflation 16
Interval

IAB Aug Pump Freeze

Open
Fill Alarm Options Display
Menu
Hold 2 Sec.

User Print
Preferences Strip
17
Hold for continuous

Back

FIGURE 1-3 IAB Control Keys

10. IAB FREQUENCY Keys and Indicators

The UP and DOWN arrow keys are used to select the ratio of augmented cardiac cycles to
actual cardiac cycles.

Available selections are:

• Every beat assisted (1:1)

• Every other beat assisted (1:2)
• Every third beat assisted (1:3)

The selected IAB frequency is indicated by an illuminated LED. When either 1:2 or 1:3 is
selected, both the assisted and unassisted systolic and diastolic pressures are numerically
displayed and may be printed. They are labeled accordingly.

Changes in IAB FREQUENCY are commonly made by operators to assess timing or reduce
assist (wean patients from IAB therapy).

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Controls and Indicators IABP Control Keys

11. IAB AUGMENTATION Keys and Indicators

Pressing the UP and DOWN arrow keys will adjust the time interval during which drive
pressure, from OFF to MAX, is applied to the safety disk. This interval determines the gas
volume displaced from the safety disk into the patient balloon. The relative selected level of
augmentation is indicated by the illuminated number of segments on the LED indicator bar.

This control is often used during the weaning process, where the amount of augmentation is
reduced over a course of time to wean the patient from IAB therapy.

12. Zero Pressure Key

This key is applicable only for the direct pressure signal.

Press and hold this key for two (2) seconds to zero the direct pressure transducer. (The
zeroing function accommodates pressure transducers with offsets of up to ±120 mmHg.)

The displayed patient blood pressure parameters are only valid if the transducer has been
properly zeroed. If the transducer has not been zeroed or if the process is unsuccessful, then
the message NO ZERO is displayed in the systolic field of the patient’s blood pressure
parameter on the display.

If the offset of the transducer exceeds the valid limit of ±120 mmHg then the advisory
message NO ZERO will be posted in the systolic field of the display. (This might occur in
cases where the transducer is defective or if the transducer is not vented to atmosphere when
Zero Pressure is pressed.)

To prevent zeroing at inappropriate times, this key is disabled when:

• Pulsatility is detected on the AP waveform

• The transducer is disconnected
• The Pressure Source is set to External

13. START Key and Indicator

Press START to initiate assist. The associated LED indicator flashes during the inflation
period, while assisting. The LED is not illuminated during STANDBY.

Pressing the START key at power-up automatically initiates the IABP's rapid start feature. This
feature expedites the start of IAB assist. The rapid start feature automatically performs the
following steps:

• Selects the AUTO operation mode

• Automatically purges and fills the IAB
• Selects the best available trigger source
• Starts assist and automatically sets IAB timing. It is recommended that the operator assess
the resultant timing after the process completes.
When assist is active, the START key has an additional function. If the key is momentarily
pressed while in the pressure trigger mode, it initiates an instantaneous re-synchronization of
timing. During this process, two consecutive beats are un-assisted.

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IABP Control Keys Controls and Indicators

14. STANDBY Key and Indicator

Press STANDBY to stop or suspend balloon pumping. The associated LED indicator is
illuminated while in STANDBY. The LED is not illuminated while assisting.

15. IAB INFLATION Timing Controls: EARLIER and LATER Keys

The IAB INFLATION keys, EARLIER and LATER, are active only in the Semi Auto and
Manual operation modes. They are disabled in AUTO operation mode, where inflate
timing is automatically set.

These keys are used to adjust the time duration between the trigger event and the beginning
of the IAB inflation. Each time a key is pressed, the inflation point is moved one increment.
The keys repeat their function if held.

The inflation timing indicator (displayed directly under the Blood Pressure Waveform) moves
in response to inflation changes. Also, the highlighted area on the blood pressure waveform
will move in response to changes in the inflate setting.

16. IAB DEFLATION Timing Controls: EARLIER and LATER Keys

The IAB DEFLATION keys, EARLIER and LATER, are active in the Semi Auto and
Manual operation modes. These keys are used to adjust the time at which the start of IAB
deflation occurs.

Deflation is automatically set in the AUTO operation mode. The IAB DEFLATION keys are
disabled in AUTO operation mode, except when ECG triggering is active. In this case, user
modification of the automatically established deflation point is permitted but NOT required.
Unlike inflation, deflation timing practices can vary considerably and this option allows users
the flexibility to tailor deflation to personal or institutional preference.

Detecting the early occurrence of a cardiac cycle will produce an immediate start to
deflation, overriding the scheduled deflation point.

Each time a key is pressed, the deflation point is moved one increment. The keys repeat their
function if held.

The deflation timing indicator (displayed directly under the Blood Pressure Waveform) moves
in response to deflation changes. Also, the highlighted area on the blood pressure waveform
will move in response to changes in the deflate setting.

The LATER key can be used to manually select R-Wave Deflation mode. In this mode, IAB
deflation is initiated upon detection of the R-Wave. This mode is only active when the trigger
source is ECG or PACER A. To select this deflation mode, the LATER key must be held down
until the IAB deflation indicator moves to the extreme right (this movement is facilitated by the
repeating action of the key). The deflation indicator should now display “4.0” and this
timing selection will be confirmed by the advisory message R-Wave Deflate.

17. IAB Fill Key

Press and hold this key for two (2) seconds to initiate a purge and fill of the IAB shuttle gas.
The autofill process suspends assist for approximately eight (8) seconds. The IAB Fill process
completely purges and replaces the shuttle gas with pure Helium.

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Controls and Indicators IABP Control Keys

Since the CS100 automatically purges and replaces the shuttle gas every two hours,
operator intervention is not normally required. Consequently, this key is used infrequently.
Typically, it is used in conjunction with an alarm. The help screens suggest corrective action
for alarms. In some cases, a manually initiated fill process is suggested.

This key has a secondary function which is active solely at power-up. It can be used to select
the Safety Disk Leak Test. This is done by pressing and holding the key while simultaneously
turning the power switch to ON. A prompt on the display will confirm that the test has been
selected. See “Safety Disk Leak Test” on page 2-2, for additional information.

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Help Keys Controls and Indicators

1.5 Help Keys

OPERATION MODE

Zero
Semi START STANDBY
AUTO Manual Pressure
Auto
Hold 2 Sec.
Pediatric Only

TRIGGER SOURCE IAB FREQUENCY AUGMENTATION IAB INFLATION IAB DEFLATION

MAX Earlier Later Earlier Later

ECG 1:1
Pressure
1:2
Pacer V / AV
Pacer A 1:3
Internal OFF

18

Ref ECG / AP Inflation

Alarm
Help Line Sources Interval
Mute

IAB Pump Freeze

Aug Open Display
Fill Alarm Options
Menu
Hold 2 Sec.

User Print
Preferences Strip
19
Hold for continuous

Back

FIGURE 1-4 Help Keys

18. Help Key and Indicator

The help text information is accessed via the Help key. This provides operators with a list of
probable causes and corrective action for alarm and advisory conditions. It is context
sensitive, displaying the recommended corrective action for the active alarm. If more than
one alarm or advisory is active, then the help text associated with the highest priority
message is displayed first, followed by the help text with the next highest priority.

Help text information is available upon initial setup and during alarm conditions. A message
on the display states either Help available for initial setup upon power-up or Help
available for Alarm/Advisory during assist.

To cancel the help display, press the Help key again.

19. Next Page and Previous Page Keys

Press the appropriate key to page through the available help screens. These keys are only
enabled when help is selected and a help screen is displayed.

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Controls and Indicators Menu Guide

1.6 Menu Guide

The CS100 uses menus to provide rapid access to infrequently used functions. The menu
guide, below, is also located on the top of the CS100 console.
.

Ref. ECG/AP
Line Sources

ECG Lead Source*

Pressure Source

Pump
Options

ECG Gain*
Aug. Pressure Threshold*
Alarm
Internal Rate*
Slow Gas Alarm
IAB Fill Mode*
Arterial Pressure Delay*
R-Trac

User
Preferences
*Not available in "AUTO"
operation mode.
Display Preferences
Sweep Speed
Balloon Waveform
Brightness
ECG Inflation Markers
Flash Alarms
Audio Preferences
Alarm Volume
Standby Advisory Tone
Beep Volume
Printer Preferences
First Waveform
Second Waveform
Menu Guide Strip Length
Timed Print
24hr. Emergency Helpline Print on Alarm
1.800.777.4222
Print Trigger &
Alarm Log
Set Time and Date
0334-00-2651-01 R1

FIGURE 1-5 Menu Guide

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Menu Group Keys Controls and Indicators

1.7 Menu Group Keys

OPERATION MODE

Zero
Semi START STANDBY
AUTO Manual Pressure
Auto
Hold 2 Sec.
Pediatric Only

TRIGGER SOURCE IAB FREQUENCY AUGMENTATION IAB INFLATION IAB DEFLATION

MAX
21
ECG 1:1 Earlier Later Earlier Later

Pressure
1:2
Pacer V / AV
Pacer A 1:3
Internal OFF

26 23

Alarm ECG / AP Inflation

Mute
Help
Ref
Line Sources Interval 24

IAB Pump Freeze

Fill Aug Open
Options Display
Hold 2 Sec.
Alarm Menu 25
User Print
Preferences Strip
27
Hold for continuous

Back

22 20

FIGURE 1-6 Menu Group Keys

Default Settings: If the system is switched OFF for less than 15 minutes, trend data and
the user settings, accessible via the Menu Group keys, are retained. If the system is OFF for
more than 15 minutes, default settings are restored. Default settings are listed in the tables in
this section. To adopt default settings without waiting for 15 minutes of power OFF, press and
hold the Open Menu key while switching the system ON.

20. Navigation Circle Arrow Keys

These keys are used in association with the Ref Line, Aug Alarm, ECG/AP Sources,
Pump Options and User Preferences keys. The arrow keys are only active when the
LED for one of the listed keys is illuminated.

21. Navigation Circle Open Menu Key

This key is active only when used in conjunction with the PUMP OPTIONS or USER
PREFERENCES menu. Press this key to open a submenu, if available, for the current selected
menu item. This key is disabled if all menu windows are closed.

22. Back Key

Press this key to close the current menu and move back one level in the menu tree. This key
will completely close the menu window and restore the balloon waveform, if the top level
menu is displayed. This key has no effect if all menu windows are closed.

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Controls and Indicators Menu Group Keys

23. ECG/AP Sources Menu Key

NOTE: The signal selected for triggering is automatically used for

the waveform display. For example, if the ECG Lead II is
selected as the triggering source, then it is used as the ECG
waveform on the display. Similarly, if the pressure source is
EXTERNAL, then it is used as the source for waveform
display and the source for the numeric readouts of patient
blood pressure on the display.

The menu items in ECG/AP Sources are effected by the operation mode and are described
in the following table.

ITEM
NAME DESCRIPTION MENU OPTIONS COMMENTS
ECG Lead Defines ECG lead used No Operator Automation will seek to use
Source for triggering and Selectable Items ECG trigger when possible
waveform display (Lead I,II, III or Ext.
Loss of ECG Lead will
are selected by
result in search for an
Automation) alternative ECG Lead
If no skin ECG is valid, Ext.
will be used, if available
Pressure Defines source of Direct, External Pressure trigger will be
Source pressure signal used for used if no valid ECG is
triggering and available
AUTO OPERATION MODE

waveform display
Automation will seek best
available pressure source
if no ECG and both
pressure sources are
present. If both Direct and
External pressure sources
are available, and both the
ECG and preferred
pressure sources are lost,
then the system will ignore
the selected preference
and trigger on the
alternative pressure source
(if valid). If all trigger
sources are found to be
invalid, it will alarm "NO
TRIGGER." Restoration of a
valid ECG source will
result in a return to ECG
trigger

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Menu Group Keys Controls and Indicators

ITEM
NAME DESCRIPTION MENU OPTIONS COMMENTS
ECG Lead Defines ECG lead used I, II, III, aVR, aVL, If the selected ECG Lead is

SEMI AUTO AND MANUAL OPERATION MODES

Source for triggering and aVF, V, Ext. lost, a No Trigger Alarm
waveform display will occur.
Default: II
If 3 Lead ECG cables are
used, then valid selections
are: I,II,II and Ext. Other
selections will cause a
Lead Fault alarm.
Pressure Defines source of Direct, External If selected source is lost, a
Source pressure signal used for No Trigger Alarm will
triggering and Default: Direct occur.
waveform display

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Controls and Indicators Menu Group Keys

24. Pump Options Menu Key

The menu items in Pump Options are effected by the operation mode.

The tables below summarize the operation modes:

ITEM
NAME DESCRIPTION OPTIONS COMMENTS
ECG Gain Defines the gain applied No operator Manual Gain settings are
to ECG signal used for selectable items unavailable
triggering and
ECG Gain is automatically
waveform display set
Pressure Defines trigger threshold No operator Manual Threshold settings
Threshold on systolic upstroke. selectable items are unavailable
Triggering occurs when
Pressure threshold is
the systolic pulse height automatically set
(Height = Peak systole -
End Diastole) exceeds
the trigger threshold.
Internal Sets rate used when No operator This function is unavailable
AUTO OPERATION MODE

Rate Internal trigger is selectable items

selected
SLOW Enables or disables the On, Off Unaffected by operation
GAS Slow Gas Loss alarm. mode
ALARM This alarm is used to
detect the slow loss of
shuttle gas from the
IAB's pneumatic circuit.
IAB FILL Defines if the IAB's No operator MANUAL fill mode is
MODE shuttle gas is purged selectable items unavailable
and filled automatically
Automatically fills IAB
by the CS100 every 2 every 2 hours
hrs., or manually by the
operator
Arterial Displays the currently No operator Manual setting of APD not
Pressure measured APD selectable items permitted
Delay
See “Verify Arterial
Pressure Delay” on
page 2-13, for a
discussion of APD
R-Trac Enables or disables the On, Off
automatic activation of
R-Wave Deflation for Default: On
tracking unpredictable
rhythm patterns.

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Menu Group Keys Controls and Indicators

ITEM
NAME DESCRIPTION OPTIONS COMMENTS
ECG Gain Defines the gain applied Normal (1X), Manual Trigger Source must be:
to ECG signal used for (0.15X to 3.0X) ECG, Pacer V/AV or
triggering and Pacer A to access
waveform display Default: 1X Manual Gain Settings
Pressure Defines trigger threshold Automatic, Manual Trigger Source must be
Threshold on systolic upstroke. (7 to 30 mmHg) Pressure to access
Triggering occurs when Manual Threshold Settings
the systolic pulse height Default: Automatic
(Height = Peak systole -
End Diastole) exceeds
the trigger threshold.
SEMI AUTO AND MANUAL OPERATION MODES

Internal Sets rate used when Internal Rate = Trigger Source must be
Rate Internal trigger is 40 to 120 bpm Internal to access
selected Manual Rate Settings
Default: 80
The advisory ECG
Detected will be displayed
if ECG is detected while in
this mode
SLOW Enables or Disables the On, Off Unaffected by operation
GAS Slow Gas Loss Alarm. mode
ALARM This alarm is used to Default: On
detect the slow loss of
shuttle gas from the
IAB's pneumatic circuit.
IAB FILL Defines if the IAB's AUTO, Manual Autofill mode is preferred
MODE shuttle gas is purged Manual fill mode is
and filled Automatically Default: AUTO
typically used for pediatric
by the CS100 every 2
cases, or in the event of a
hrs., or manually by the failure of the automatic fill
Operator
system.
Arterial Displays the currently Automatic, Manual Automatic measurement of
Pressure measured APD and Manual adjustment APD occurs as needed
Delay provides for manual range is 0 to 180 An additional
setting
measurement of APD can
Default: 40 ms, then
be initiated by pressing the
automatic adjustment Inflation Interval key
while assisting
Manual entry of APD is
used in pediatric cases
R-Trac Enables or disables the On, Off R-Trac is not available in
automatic activation of Manual operation mode.
R-Wave Deflation for Default:
tracking unpredictable On (Semi-Auto)
rhythm patterns. Off (Manual)

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Controls and Indicators Menu Group Keys

25. User Preferences Menu Key

The User Preferences menu and the submenus associated with it allow the user to
customize the display, audio and printer, set time and date.

The following tables detail the contents of each submenu:

ITEM
NAME DESCRIPTION MENU OPTIONS COMMENTS
Sweep Sets the sweep speed of 25 mm/sec, 50 mm/
Speed the display's waveforms sec
and printer
Default: 25 mm/sec
DISPLAY PREFERENCES SUBMENU

Brightness Sets Display Brightness Low, Medium, High

Default: High
Balloon Enables or disables On, Off See “Display Screen” on
Waveform display of the Balloon page 1-28, for information
Pressure Waveform Default: As Last Set on the Balloon Pressure
Waveform
ECG Enable or disables On, Off See “Display Screen” on
Inflation display of the ECG page 1-28, for information
Markers markers Default: As Last Set on the ECG Inflation
Markers
Flash Enables or disables On, Off In noisy environments, it
Alarms flashing of the display may be helpful to flash
when an alarm Default: Off alarm messages. If this is
condition is active. the case, set to ON

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Menu Group Keys Controls and Indicators

ITEM
NAME DESCRIPTION MENU OPTIONS COMMENTS
Alarm Adjustment of Alarm 1 to 8 When this option is

AUDIO PREFERENCES SUBMENU

Volume Volume (Lowest to Loudest) selected, a sample tone is
generated for operator
Default: 4 feedback
Standby Enables or disables the On, Off Set to Off at the factory.
Advisory Prolonged Time in
Tone Standby Advisory Tone Default: As Last Set
Beep Enable or Disables the On, Off
Volume QRS Trigger Beep
Default: Off

ITEM
NAME DESCRIPTION MENU OPTIONS COMMENTS
First Defines which waveform ECG, Arterial, See “Printer” on page 4-1,
Waveform at the top of printout Balloon for a discussion of printer
formats
Default: ECG
Second Defines which waveform Off, ECG, Arterial, See “Printer” on page 4-1,
Waveform is printed at the bottom Balloon for a discussion of printer
of the printout, or formats
disables printout of a Default: Arterial
second waveform
Strip Defines the length of a 6, 8,15,30,
PRINTER PREFERENCES SUBMENU

Length printed strip 60 seconds

Default: As Last Set

Timed Print Set interval for Off, 15 min, 30 min,
automatically printed 1 hr, 2 hr, 4 hr
strips
Default: Off
Print On Enables/Disables the Off, On Automatically prints a strip
Alarm print on alarm feature on an alarm: If a trigger
Default: As Last Set alarm, then ECG and
arterial pressure are
printed. If a pneumatic
alarm, then arterial and
balloon pressure are
printed. All other events
print the user specified
waveform(s).
Print Initiates immediate Press the Open
Trigger printout of a time Menu key to print
and Alarm stamped history of now
Log trigger settings and
alarms Default: N/A

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Controls and Indicators Menu Group Keys

ITEM
NAME DESCRIPTION MENU OPTIONS COMMENTS
Set Time Sets Time and Date used Set Time and Date via

SET TIME AND DATE SUBMENU

and Date to annotate printouts the Navigation keys
and events
Default: 0

26. Ref Line Function Key

The reference line is an operator controlled cursor for the measurement of pressure data on
the arterial pressure waveform. It appears as a horizontal line with an associated numeric
readout of pressure in mmHg.

Press the Ref Line key to activate the reference line. When activated, this function closes
any open menu. The reference line position becomes controlled by the UP and DOWN
arrow keys located in the Navigation Circle.

27. Aug Alarm Function Key

This key is used to set the alarm limit for the Augmentation Alarm. It activates when, for
assisted beats, the patient's diastolic blood pressure drops below the augmentation alarm
limit.

The Augmentation Alarm limit is automatically set at the initiation of assist (the pressure
transducer must be zeroed). The automatic augmentation alarm limit is determined by an
adaptive process which sets the alarm to 10 mmHg below the patient's augmented diastolic
pressure.

To reset or change the augmentation alarm limit, press the Aug Alarm key. Once activated,
this function closes any open menu. The augmentation alarm limit becomes controlled by the
UP and DOWN arrow keys in the Navigation Circle. These keys increment/decrement the
augmentation alarm limit by 2 mmHg. The alarm limit is displayed in the Aug. Alarm field of
the CS100 Display. The available alarm settings range from 60 to 200 mmHg.

To disable (turn off) the Augmentation alarm, use the UP or DOWN arrow keys to set the
alarm limit to OFF.

Pressing either the Aug Alarm key (while active), or any other function/menu key will
cause the indicator to be extinguished, indicating that the Navigation Circle arrow keys no
longer control the augmentation alarm limit.

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Menu Navigation Controls and Indicators

1.8 Menu Navigation

The first step in menu navigation is to open the desired menu by pressing the associated key.
The system responds by opening the menu. As a convention, the first entry in the list is
selected. This is indicated by a highlighted bar.

The highlighted bar is always used as a pointer (cursor) to select menu entries. Only one item
can be selected at a time. Where applicable, the highlighted bar is also used to identify the
current setting associated with a selected item.

The arrow keys in the menu navigation circle control the movement of the highlighted bar.
Therefore, they define which item in a list is selected.

To select an alternative item, use the UP and DOWN arrow keys, located in the navigation
circle, to move vertically within the list.

A menu may contain a list of functions, submenus or both.

When a function in a menu is highlighted:

• The name is highlighted

• The current setting is highlighted
• The text associated with the function is expanded horizontally to show the alternative
settings available for the function.
To change the setting of the selected function, use the LEFT and RIGHT arrow keys, located
in the navigation circle, to move horizontally through the list.

As each new setting is selected, it is made effective and retained immediately.

To reverse the effect of a setting selection, use the navigation keys to re-select the original
setting.

In cases where numeric entries are needed (e.g., setting the date or time) the navigation
circle's LEFT or RIGHT arrow keys are used to select the digit of interest, and the UP and
DOWN arrow keys are used to increment or decrement the value.

Submenus are shown as a single string of text. They do not expand when highlighted. To
open a submenu, use the navigation circle's UP and DOWN arrow keys to highlight the
name of the menu. Then press the Open Menu key to open the submenu.

To close a menu or submenu, press the Back key. This will move back to the parent menu. If
a parent menu does not exist, then the menu is closed and the display is returned to its
normal state. Therefore, successive depressions of the Back key will result in a quick exit
from the menu system.

Menus can also be exited by a second press of the active menu key or by selecting a
different menu family key.

The following examples illustrate menu navigation sequences.

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Controls and Indicators Menu Navigation

1.8.1 Opening a Submenu

USER MENU Key Depression

PREFERENCES

USER PREFERENCES
 By default when opened the first menu
DISPLAY PREFERENCES item is selected.
AUDIO PREFERENCES  To close this menu, press either the Back
key in the menu navigation circle, or press
PRINTER PREFERENCES any menu key, (e.g., ECG/AP, Pump
SET TIME AND DATE Options or User Preferences.)

Navigation Reminders

DOWN ARROW Key - Menu Navigation

USER PREFERENCES
 Vertical movement has selected this sub-
DISPLAY PREFERENCES menu. To open it, press the Open Menu.
AUDIO PREFERENCES  To close this menu, press the Back key
or any menu key.
PRINTER PREFERENCES
SET TIME AND DATE

Navigation Reminders

Open
Menu
OPEN MENU Key - Menu Navigation

AUDIO PREFERENCES
 The sub-menu is now open. Functions
ALARM VOLUME 1/2/3/4/5/6/7/8 and the current settings are listed.
 By default, the first function is selected.
STANDBY ADVISORY TONE Off The listing expands to show the current
BEEP VOLUME Off setting and alternatives.
 The remaining functions are listed with
their current settings.
Navigation Reminders  To completely exit this menu system,
either:
- Press the BACK key twice or
- Press the parent MENU key
(User Preferences) to toggle it Off

FIGURE 1-7 Opening a submenu

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Menu Navigation Controls and Indicators

1.8.2 Changing a Setting

AUDIO PREFERENCES
 By default, the first listed function is
ALARM VOLUME 1/2/3/4/5/6/7/8 selected when the menu opens.
STANDBY ADVISORY TONE Off  Its listing is expanded to show available
settings and current setting.
BEEP VOLUME Off

Navigation Reminders

DOWN ARROW Key - Menu Navigation

AUDIO PREFERENCES
 Moving down the list collapses the
ALARM VOLUME 8 de-selected function’s listing.
STANDBY ADVISORY TONE Off/On  The new selected function listing expands
to show its alternative choices and active
BEEP VOLUME Off setting.

Navigation Reminders

LEFT ARROW Key - Menu Navigation

AUDIO PREFERENCES

ALARM VOLUME 8  Horizontal movement of the highlighting

changes the function’s setting. The new
STANDBY ADVISORY TONE Off setting is active immediately.
BEEP VOLUME Off/Low/Medium/High  To exit this sub-menu, press the BACK
key.
 To exit this menu system, press the BACK
Navigation Reminders key twice, or press any menu key.

FIGURE 1-8 Changing a Setting

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Controls and Indicators Menu Navigation

1.8.3 Changing a Numeric Parameter

PUMP Menu Key Depression

OPTIONS

PUMP OPTIONS
Manual
 Pressing the Menu Key (PUMP OPTIONS)
ECG Gain Normal
opens the menu.
Pressure Threshold *  The first menu item is highlighted, and its
Internal Rate * listing is expanded.
Slow Gas Alarm ON
IAB Fill Mode AUTO  Unavailable selections are marked with an
Arterial Pressure Delay asterisk (*).
R-Trac ON
Navigation Reminders

UP ARROW Key - Menu Navigation

 Pressing the UP ARROW key causes
PUMP OPTIONS the cursor to wrap, i.e. go to the bottom
ECG Gain Normal of the list.
Pressure Threshold *  When an adjustable parameter is
Internal Rate * highlighted, the directive, Press OPEN
Slow Gas Alarm ON MENU to Adjust key is displayed. To
IAB Fill Mode AUTO accept the change, press the key as
Arterial Pressure Delay Press OPEN MENU to Adjust directed.
R-Trac ON
 To leave the parameter untouched,
Navigation Reminders move vertically or use the BACK key to
close the menu.
OPEN
MENU OPEN MENU Key - Menu Navigation

ARTERIAL PRESSURE DELAY

Arterial Pressure Delay 22 MSec  Pressing the OPEN MENU key

opens this adjustment menu.
Initial Value on Opening = 22 MSec

Adjustment Reminders
 Pressing the OPEN MENU key opens
this adjustment menu.
UP ARROW Key - Menu Navigation
 To change the parameter, Arterial
ARTERIAL PRESSURE DELAY Pressure Delay, use the menu
navigation UP and DOWN arrow keys.
Each activation increments or
decrements the parameter’s value.
Arterial Pressure 26 MSec When the desired value is reached,
Delay press the BACK key to close the
Initial Value on Opening = 22 MSec
menu and retain the setting.
 For reference, the initial value of the
Adjustment Reminders parameter is recorded in the lower left
corner of the menu. This is done so
that it can be re-entered, if desired.

FIGURE 1-9 Changing a Numeric Parameter

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Immediate Action Keys Controls and Indicators

1.9 Immediate Action Keys

OPERATION MODE

Semi Zero
AUTO Manual START STANDBY
Auto Pressure

Hold 2 Sec.
Pediatric Only

TRIGGER SOURCE IAB FREQUENCY AUGMENTATION IAB INFLATION IAB DEFLATION

MAX Earlier Later Earlier Later

ECG 1:1
Pressure
1:2
Pacer V / AV
Pacer A 1:3
Internal OFF

28 Alarm Help
Ref ECG / AP Inflation
Interval
29
Mute Line Sources

IAB
Fill Aug Open
Pump
Options
Freeze
Display
30
Alarm Menu
Hold 2 Sec.

User
Print
Preferences
Strip 31
Hold for continuous

Back

FIGURE 1-10 Immediate Action Keys

28. Alarm Mute Key

Press the Alarm Mute key to disable an active audible alarm for 60 seconds. This control
does not override the alarm. If an alarm condition is not corrected within 60 seconds the
audible alarm is enabled again. Alarm messages will remain displayed while the associated
audible tone is temporarily disabled. In the event that a new alarm condition occurs, while
audible alarms are muted, the alarm tone will be immediately reactivated.

NOTE: Use of the Help key is recommended in the troubleshooting

of alarm conditions.

29. Inflation Interval Key

This key has two functions.While in the Assist Mode, press and hold this key, to view the
period of diastolic augmentation on the arterial pressure waveform. The marked and
highlighted portion identifies the approximate balloon inflation period.

CAUTION: The Inflation Interval marker (highlighted) should not be

used to set timing. Timing should be set by examination of
the arterial waveform.

In Semi Auto and Manual Operation Mode, when the key is quickly pressed and released,
the arterial pressure delay (APD) is recalculated.

30. Freeze Display Key

Press the Freeze Display key to freeze all traces on the display. Press again to unfreeze the
traces. This key is disabled when the recorder is activated.

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Controls and Indicators Immediate Action Keys

31. Print Strip Key

Press the Print Strip key briefly to initiate printing. See “Printer” on page 4-1, for
information about defining the format of the printout.

To print continuously, press and hold the key for two (2) seconds.

To stop printing, press the key again. Printing will stop after the strip has been annotated.

NOTE: Pressing the PRINT STRIP key will unfreeze the display, if
frozen.

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Display Screen Controls and Indicators

1.10 Display Screen

Intelligent Counterpulsation

ALARM !!! Check IAB Catheter Pressure TRIGGER

MESSAGES
0.5 mV 19 mm Auto
Threshold
32
ADVISORIES !! Low Battery
Battery In Use H E A R T R AT E

Function Not Available

120
80 bpm

ECG
33 • LEAD
II SYSTOLIC
• GAIN
Normal
80
94
9499 mmHg

34 Unassisted

DIASTOLIC

35
PRESSURE
SOURCE
External
40
4051
Unassisted
mmHg

AU T O
0.0
IAB FILL MODE Infl. Defl.
Auto MEAN

36 72 mmHg

SLOW GAS
On AUG.
37
ALARM
115 mmHg

O P E R AT I O N
MODE
Auto Off AUG. ALARM
38 mmHg

22 min in
Standby
39 I A B S TAT U S
HELP Available for Alarm/Advisory Helium Battery

FIGURE 1-11 Display Screen

NOTE: The display shown is for illustrative purposes and does not
represent actual clinical conditions.

32. ALARM AND ADVISORY MESSAGES

This section of the screen displays alarm and advisory messages. The top-most line is
reserved for high priority alarms. The lower three (3) lines are shared to display any
medium/low level alarms or informational messages. If more than one message is displayed,
they are posted in priority order. See “Alarms and Advisory Messages” on page 3-4, for
more information regarding priority. As conditions are corrected, the corresponding message
is cleared and the next highest priority alarm or informational message is displayed. Pressing
the HELP key will access the appropriate help screen for the displayed condition. See “Help
Screens” on page 3-6 for more information.

33. ECG LEAD

This field displays the selected (active) ECG signal source and its status. Selections are skin
leads (I, II, III, aVR, aVL, aVF, V) or EXTERNAL.

When skin leads are selected and a lead fault occurs, then the selected lead is alternately
displayed with the text Lead Fault.

When an External source is selected and a cable is not present, then the text No Cable is
displayed.

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Controls and Indicators Display Screen

34. ECG GAIN

This field indicates the gain factor (multiplier) applied to the ECG signal. When normal gain
is applied, Normal will be displayed in this field. When using a variable ECG gain, the
selected multiplier is displayed. The multiplier range is 0.15 to 3.0. When Normal is
displayed the multiplier is 1.0.

35. PRESSURE SOURCE

Pressure Source displays the source of the blood pressure signal and the status. The word
Direct is displayed when a direct transducer input is selected. The word EXTERNAL is
displayed when an external signal source is selected. In cases where the selected source is
not present, No Cable is displayed.

36. IAB FILL MODE

This display text indicates the current IAB FILL MODE, selections are: Auto or Manual.
Auto is the default mode.

In the AUTOFILL mode, the CS100 will provide rapid start of IAB assist following a power-
up. See “Initiation of Assist” on page 2-14. Thereafter, it will automatically purge and refill
the IAB's shuttle gas at two (2) hour intervals or upon activation of the IAB Fill key.

The Manual Fill mode must be selected for Pediatric IABs. The selection of the fill mode is
made in the PUMP OPTIONS menu.

When Manual Fill is selected, automation of the fill process is inhibited. See “Manual Fill
Mode” on page 3-48. The IAB must be purged and filled manually. See “Filling Pediatric
Catheters” on page 6-5. Similarly, the automated sequence of steps, affiliated with the rapid
start feature, is not supported.

37. SLOW GAS ALARM Status

This display text indicates the status of the slow gas alarm. When the displayed text is On
and a slow gas loss is detected, assist will be suspended, a continuous alarm tone will sound,
and the alarm message Leak in IAB Circuit is displayed.

When the displayed text is Off, the advisory message Slow Gas Alarm Off is displayed
in the Advisory area. If a slow gas loss is detected while in this override state, the IABP will
continue to assist and the gas loss alarm message will be displayed without an associated
alarm tone.

WARNING: Continued assist of an IAB which has a leak may result in

formation of a large blood clot within the balloon. This may
cause balloon entrapment which may require surgical
removal of the IAB.

NOTE: When in the Manual Fill Mode, the Slow Gas Alarm status
display is OFF and all catheter and leak detect alarms are
suspended.

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Display Screen Controls and Indicators

38. OPERATION MODE

This display area indicates the operation mode (AUTO, Semi Auto, or Manual) selected
by the operator. See “Operation Mode Keys” on page 1-2, for more information.

39. IAB STATUS Indicator

The IAB status indicator is a segmented bar graph, in the shape of an IAB, that depicts
movement of the safety disk diaphragm as sensed by the system's internal pressure
transducers. No quantitative measurement should be inferred or intended.

Intelligent Counterpulsation

ALARM !!! Check IAB Catheter Pressure TRIGGER

MESSAGES
0.5 mV 19 mm Auto
Threshold
40
ADVISORIES !! Low Battery
Battery In Use H E A R T R AT E

Function Not Available

120
80 bpm

ECG
• LEAD
41
II SYSTOLIC
• GAIN
Normal
80
94
9499
Unassisted
mmHg

DIASTOLIC
42
PRESSURE
SOURCE
External
40
4051
Unassisted
mmHg

0.0
IAB FILL MODE Infl.
AU T O
Defl. 43
Auto MEAN
72 mmHg

SLOW GAS 44
On AUG.
ALARM
115 mmHg

O P E R AT I O N
Auto AUG. ALARM
45
MODE Off mmHg

22 min in
Standby 46
I A B S TAT U S
HELP Available for Alarm/Advisory Helium Battery

48 47

FIGURE 1-12 Display Screen

NOTE: The display shown is for illustrative purposes and does not
represent actual clinical conditions.

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Controls and Indicators Display Screen

40. TRIGGER
Trigger displays the selected trigger source used for both IABP synchronization and Heart
Rate determination. The possible display items for this field include: ECG, Pacer V, Pacer
A, Internal or Pressure. When a pressure trigger is selected, the pressure trigger
threshold (in mmHg) and threshold adjustment mode (Auto or Manual) will be displayed
along with the trigger source.

41. HEART RATE

This field is a numeric display of the current average heart rate in beats per minute (bpm).
The CS100 displays a zero (0) when the heart rate drops below 15 BPM. See “Heart Rate
Meter” on page 11-6 for more information.

42. SYSTOLIC
Indicates peak systolic pressure in mmHg. When 1:2 or 1:3 is selected as the IAB
Frequency both the assisted and unassisted systolic pressures are displayed. They are
labeled accordingly. NO ZERO is displayed if the transducer requires zeroing. The display
is blanked if a pressure transducer is not connected or if an external source is selected and
the external cable plug is not inserted.

43. DIASTOLIC
Indicates end diastolic pressure in mmHg. When 1:2 or 1:3 is selected as the IAB
Frequency, both the assisted and unassisted diastolic pressures are displayed. They are
labeled accordingly. The display is blanked if the zero process has not been performed, if a
pressure transducer is not connected or if external source is selected and the external cable
plug is not inserted.

TRIGGER
Pressure
19 mm Auto
Threshold

Assisted Systolic
H E A R T R AT E

80 bpm
Pressure

Unassisted
SYSTOLIC
9499
Unassisted
mmHg Systolic Pressure

DIASTOLIC
4051
Unassisted
mmHg

Assisted End
0.0 Diastolic Pressure
Defl.
MEAN
72 mmHg
Unassisted End
Diastolic Pressure
AUG.
115 mmHg

AUG. ALARM
Off mmHg
Augmented Diastolic
Pressure

HELP Available for Alarm/Advisory Helium Battery

FIGURE 1-13 Display Showing Assisted and Unassisted Pressure

NOTE: The display shown is for illustrative purposes and does not
represent actual clinical conditions.

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Display Screen Controls and Indicators

44. MEAN
Indicates mean pressure in mmHg. The display is blanked if the zero process has not been
performed, if a pressure transducer is not connected or if External source is selected and
external cable plug is not inserted.

45. AUG. (Diastolic Augmentation)

Indicates peak augmented diastolic pressure in mmHg. The display is blanked when:

• IABP is in STANDBY
• The zero process for the transducer has not been performed
• A pressure transducer is not connected
• External source is selected and external cable plug is not inserted

46. AUG. ALARM

Indicates diastolic augmentation alarm limit in mmHg. This value is always displayed. If the
alarm is not enabled OFF is displayed.

NOTE: While the AUG. alarm adjustment is active, the

augmentation alarm limit number is displayed in reverse
video.

47. Battery Indicator

This icon indicates the approximate charge remaining in the internal batteries. This indicator
is displayed only when the system is powered by the internal batteries.

NOTE: The advisory message Low Battery is displayed when less

than 30 minutes (approximately) of internal battery life
remains. When this message appears, the battery symbol is
displayed as empty and starts flashing. See page 3-23 in
the “Troubleshooting” section for corrective actions for this
condition.

NOTE: The advisory message Low Battery (EXT) (CS100i only) is

displayed when less than 30 minutes (approximately) of
external battery life remains. See page 3-23 in the
“Troubleshooting” section for corrective actions for this
condition.

NOTE: The advisory message Battery In Use is displayed when the

internal battery pack is connected and AC power is not
present.

NOTE: The advisory message Battery In Use (EXT) (CS100i only) is

displayed when the external battery pack or external DC
supply is connected and AC power is not present.

48. Helium Indicator

Indicates the approximate amount of Helium remaining in the tank.

NOTE: A Low Helium advisory message will be displayed when the

tank needs to be replaced.

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Controls and Indicators Display Screen

51 52 53

Intelligent Counterpulsation

ALARM !!! Check IAB Catheter Pressure TRIGGER

49 MESSAGES
19 mm Auto
0.5 mV
Threshold

ADVISORIES !! Low Battery

Battery In Use H E A R T R AT E

Function Not Available

120
80 bpm

ECG
50 • LEAD
II SYSTOLIC
• GAIN
Normal
80
94
9499
Unassisted
mmHg

DIASTOLIC
51 PRESSURE
SOURCE
External
40
4051
Unassisted
mmHg

AU T O
0.0
IAB FILL MODE Infl. Defl.
Auto MEAN
72 mmHg

SLOW GAS
51 On AUG.
ALARM
115 mmHg

O P E R AT I O N
MODE
Auto Off AUG. ALARM
mmHg

22 min in
Standby
54 I A B S TAT U S
HELP Available for Alarm/Advisory Helium Battery

FIGURE 1-14 Display Screen

NOTE: The display shown is for illustrative purposes and does not
represent actual clinical conditions.

49. ECG Scale

The ECG Scale is located immediately to the left of the displayed ECG waveform. It is
provided to facilitate determination of ECG amplitude. The scale is one centimeter high. The
annotation indicates the current scale factor for the displayed ECG waveform.

CAUTION: The displayed ECG signal is automatically scaled (amplified)

for optimal screen presentation. Due to the automatic
scaling, low ECG amplitudes may appear to be of normal
amplitude when displayed. Judgements concerning ECG
amplitude should be made with reference to the annotated
scale or a printed ECG output.

50. Arterial Pressure (AP) Scale

The AP Scale is located immediately to the left of the displayed AP waveform. The scale is a
vertical line with annotated tick marks. The numeric units of the annotation are mmHg. The
scale is provided to facilitate determination of AP amplitude.

CAUTION: The displayed AP signal is automatically scaled (amplified)

and offset for optimal screen presentation. Because of
automatic scaling, low AP amplitudes may appear to be of
normal amplitude when displayed. Judgements should be
made with reference to the annotated scale, patient arterial
pressure parameter display or a printed AP output.

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Display Screen Controls and Indicators

51. Waveforms (ECG, AP, shuttle gas)

Depending upon the current USER PREFERENCE Menu setting, the system displays either
two waveforms (ECG and AP) or three waveforms (ECG, AP, Balloon Pressure). ECG, AP and
Balloon Pressure are displayed in order from top to bottom.

Waveforms are plotted from left to right. The oldest data is erased and is replaced by new
data. To facilitate identification of the newest data a vertical erase bar is drawn. The newest
data is to the left of the bar and the oldest is to the right. Visually, the traces appear fixed as
a moving vertical bar moves through the traces and updates their appearance.

Inflation Interval Highlighting and Annotation

(Arterial Pressure Highlighting)

This is used to highlight the arterial pressure waveform.

When in STANDBY mode, the approximate interval of assist is continuously estimated, and
shown on the display by highlighting the appropriate interval on the arterial pressure
waveform.

The assist interval is also displayed as a horizontal bar, with vertical dashed lines. The length
and placement of the horizontal line indicates the approximate timing of assist. The vertical
lines extend the interval upward, to the arterial pressure waveform.

During assist, display of Inflation Interval Highlighting is stopped. To view these markers
while assisting, continuously press the Inflation Interval key. (These markers are visible
only while the key is pressed).

Dicrotic Notch

Inflation Marker

FIGURE 1-15 Highlighted Inflation Marker

CAUTION: The Inflation Interval marker (highlighted) should not be

used to set timing. Timing should be set by examination of
the arterial waveform.

52. ECG Inflation Interval Markers (User Preferences)

As a user preference, the ECG waveform can be annotated to show the estimated inflation
(assist) interval. This mark is a horizontal line that is drawn below the ECG waveform. The
length and placement of the line indicate the approximate timing of assist.

Display of these markers is a user preference. Enable or disable display on the ECG
waveform via the USER PREFERENCES submenu.

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Controls and Indicators Display Screen

53. Trigger Indicator

A graphic trigger indicator is located at the top right of the screen. It has a diamond shape.
It blinks on and off each time a trigger event is detected.

54. Time In Standby

A Time In Standby alert is provided as a reminder that a risk of thrombosis is incurred if
the IAB is not inflated for long periods of time.

Time in Standby (in minutes) is numerically displayed on the left side of the screen. This
display is active only when the system is in STANDBY. The timer display starts when the
system enters STANDBY mode for any reason. The timer display is cleared when assist is re-
initiated.

After an elapsed time of 10 minutes, an alert message is continuously displayed in the

advisory field of the screen and an optional tone will sound. This tone can be enabled or
disabled via the AUDIO PREFERENCES submenu in the USER PREFERENCES menu.

The audio tone affiliated with the alert will sound a double beep for 30 seconds. This audio
tone will be repeated at 15 to 20 minute intervals, and again at 2 minute intervals after the
20 minute mark (i.e., 22 minutes, 24 minutes, etc.) This will continue until the pump is
returned to assisting or the power is cycled.

60

59 Intelligent Counterpulsation

ALARM !!! Check IAB Catheter Pressure TRIGGER

MESSAGES
0.5 mV 19 mm Auto
Threshold

ADVISORIES !! Low Battery

Battery In Use H E A R T R AT E

Function Not Available

120
80 bpm

ECG
LEAD
56 •
II SYSTOLIC
• GAIN
Normal
80
94
9499
Unassisted
mmHg

DIASTOLIC
55 PRESSURE
SOURCE
External
40
4051
Unassisted
mmHg

AU T O
0.0
IAB FILL MODE Infl. Defl.
Auto MEAN
72 mmHg

57 SLOW GAS
On AUG.
ALARM
115 mmHg

O P E R AT I O N
Auto Off AUG. ALARM
58 MODE mmHg

22 min in
Standby
I A B S TAT U S
HELP Available for Alarm/Advisory Helium Battery

FIGURE 1-16 Display Screen

NOTE: The display shown is for illustrative purposes and does not
represent actual clinical conditions.

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Display Screen Controls and Indicators

55. AP Waveform Trigger Event Marks

In the Arterial Pressure Trigger mode small horizontal lines are added to the arterial pressure
waveform. These AP Trigger Event Markers provide a visual indication of the current arterial
pressure trigger threshold on the upstroke of the systole. These markers do not indicate the
exact moment of the trigger event, they are slightly delayed in time.

56. Reference Line with Numeric Pressure Readout

The reference line is a user controlled, horizontal cursor. It is used to measure the amplitude
of any point on the pressure waveform. The numeric value of the pressure corresponding to
the reference line position is shown at extreme left side of the line. When the monitor is
initially turned on the reference line is automatically set to 0 mmHg. If this pressure level is
below the current display window, the reference line will appear at the bottom of the window
upon the first press of either arrow key.

To activate the line press the Ref Line key. Once activated, it will appear at the bottom of the
arterial pressure waveform. Use the Navigation Circle’s UP and DOWN arrow keys to
move the reference line to the desired measurement point on the waveform.

NOTE: The reference line may also be moved into the Balloon
Waveform Area. When used in the Balloon Waveform area,
the reference line color is blue and there is no pressure
annotation.

57. Inflation Timing Indicator

This graphical indicator provides visual feedback for the selected time duration between the
trigger event and the start of inflation.

When in Semi Auto or Manual operation mode, the indicator is controlled by the IAB
INFLATION EARLIER and LATER keys. The Inflation Timing Indicator ranges from 0
to 5 for Manual operation mode, and from -4 to +4 for the Semi Auto operation mode.

When in the AUTO operational mode, the word AUTO appears at the center of the
indicator. This indicates that inflation timing is being automatically set and no operator
intervention is required.

58. Deflation Timing Indicator

This graphical indicator provides visual feedback for the selected time at which deflation
occurs. The IAB DEFLATION timing control keys are active in all operation modes with the
exception of Pressure trigger while in AUTO Operation Mode. When in Pressure trigger
while in AUTO operational mode, the word AUTO appears at the center of the indicator.
This indicates that deflation timing is being automatically set and no operator intervention is
permitted.

In ECG trigger, while in the AUTO operational mode, user modification of the automatically
established deflation point is permitted but NOT required. Unlike inflation, deflation timing
practices can vary considerably and this option allows users to tailor deflation to personal or
institutional preference. The indicator is controlled by the IAB DEFLATION Earlier and
Later keys. The Deflation Timing Indicator ranges from 0 to 5 for Manual operation
mode and from -4 to +4 for the Semi Auto and AUTO operation modes.

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Controls and Indicators Display Screen

The Deflation Timing Indicator also aids in distinguishing when the pump is operating in
R-Wave Deflation mode. This mode may be automatically activated by the pump
whenever atrial fibrillation or other unpredictable rhythm patterns are detected. Or, the
operator can manually activate R-Wave Deflation.

Automatic R-Wave Deflation is indicated by the Deflation Timing Indicator

repositioning itself to the far right (late) position and displaying “R-Trac” instead of a
deflation timing value. The advisory message Auto R-Wave Deflate is also displayed.
Any manual movement of the deflation timing indicator or the resumption of a predictable
rhythm when in automatic R-Wave Deflation, will return the timing indicator and the
deflation timing to its previous value. The pump then continues monitoring for unpredictable
rhythms.

Manual R-Wave Deflation mode is activated by the operator moving the Deflation
Timing Indicator to its extreme right (late) position. The indicator will display “4.0” and
the advisory message R-Wave Deflate will also display. Manual activation of R-Wave
Deflation mode will always override automatic control of R-Wave Deflation.

59. Alarms Muted Icon

This icon, a bell with an X, appears when the operator has muted the alarm tones with the
Alarm Mute key. Visual indicators of the alarm condition remain active.

60. Alarm Inhibited Icon

This icon, a triangle with a solid “X”, appears when an operator inhibits a specific alarm or
group of alarms. It will appear under any of the following conditions:

• Slow Gas Alarm switched OFF.

• IAB Fill mode switched to MANUAL.

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Front Panel Controls and Indicators

1.11 Front Panel

61

CS100
Intelligent Counterpulsation
63

62

FIGURE 1-17 Front Panel

61. IABP ON/OFF

This is the ON/OFF switch for the IABP console and monitor module. Operation of this
switch does not affect the status of the internal battery charger.

62. Battery Charging LED

This indicator has three states:

• It illuminates continuously when the internal batteries are fully charged

• The LED indicator flashes when the internal batteries are charging
• It is not illuminated when system is using the battery as a power source

CAUTION: The internal batteries are charging only when the AC Mains
plug is connected to an active AC Mains source, the AC
Mains switch is ON, and the battery charging status LED is
illuminated. This charging condition must be maintained
even when the system is not in use. Note that 18 hours of
charging is required to fully charge the batteries.

63. Printer
See “Printer” on page 4-1, for detailed printing information.

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Controls and Indicators Rear Panel

1.12 Rear Panel

NOTE: All signal input and signal output ports are intended only
for connection to specified equipment.

64 81

80

79

65 78

66
77

67 76

75

68

74

69

73

72

82
CS100i
71
only

70

FIGURE 1-18 Rear Panel

64. IAB CATHETER EXTENDER INPUT

Used for connection of the IAB catheter extender.

65. Trainer Input

A mini-jack provides the appropriate timing signal required to synchronize the System
Trainer.

66. D.C. Output (Condensate Removal Module Connection)

A six-pin connector which provides power to the condensate removal module.

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Rear Panel Controls and Indicators

67. ECG Input

A six-pin connector used for attaching patient cables. This connection is electrically isolated
for patient safety.

68. Pressure Input

A six-pin male connector used for attaching Datascope specified physiologic pressure
transducers. This connection is electrically isolated for patient safety.

69. Mains ON/OFF

A fuse holder, AC mains switch and AC line cord receptacle.

CAUTION: The internal batteries are charging only when the AC Mains
plug is connected to an active AC Mains source, the AC
Mains switch is ON, and the battery charging status LED is
illuminated. This charging condition must be maintained
even when the system is not in use. Note that 18 hours of
charging is required to fully charge the batteries.

70. Diagnostic Output

Reserved for Datascope use only.

71. RS-232
A 9-pin D-type connector provided for RS-232 serial data communication lines.

72. Phone Line

A standard RJ11 modular telephone jack for connecting the internal modem to a standard
analog phone line.

73. System Timer (Hours)

Displays elapsed system operating time in hours. This is used to determine preventive
maintenance intervals. The elapsed time cannot be reset. See “Preventive Maintenance” on
page 7-11.

74. Equipotential Lug

A connector used to equalize the voltage potential which may exist between the CS100 and
earth ground or other hospital equipment.

75. Pres. (Monitor Input)

A 1/4" phone jack which permits the CS100 to display and trigger from a pressure signal
acquired from an external monitor. See “External Monitor Interfacing” on page 8-3, for
additional information. The assumed scale factor of the incoming signal is 1V/100 mmHg.

76. ECG (Monitor Input)

A 1/4" phone jack which permits the CS100 to display and trigger from an ECG signal
acquired from an external monitor. See “External Monitor Interfacing” on page 8-3, The
assumed scale factor of the incoming signal is 1V/1mV.

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Controls and Indicators Rear Panel

77. ECG/Pressure Output

This 1/4" jack provides analog patient information to external equipment. The ECG signal is
connected to the tip, and the AP signal is connected to the ring. The sleeve is connected to
the ground. The scale factor of the ECG signal is1v/millivolt. The scale factor of the AP signal
is 1V/100 mmHg.

78. Manual Fill Port

This pneumatic fitting is used to extract Helium when a syringe is attached and the Helium
cylinder is open. This pneumatic port can also be used to fill non-standard balloon volumes
such as pediatric IAB sizes. This port is used ONLY for manual filling.

WARNING: Never connect an IAB or its extension catheter to the

Manual Fill Port. See Operating Instructions (Manual Filling
of IAB) for proper use of this function.

79. DRAIN PORT

This pneumatic port connects to the Safety Disk/Condensate Removal Module (CRM)
assembly. This port is used to automatically remove excess water (condensate) from the
system.

80. IAB FILL PORT

This pneumatic port connects to the Safety Disk/Condensate Removal Module (CRM)
assembly.

81. Helium Pressure Gauge

This mechanical pressure gauge indicates the gas pressure in the Helium cylinder. The
cylinder's valve must be open to check pressure.

82. External DC Input (CS100i only)

An input connector for external DC voltage power to the system.

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Special Mode Activation Controls and Indicators

1.13 Special Mode Activation

During the power-up sequence of the CS100, certain functions or modes can be enabled by
pressing assigned keys. The following table describes these functions and the key(s) required
to enable that function.

Press and hold the following key(s) while activating the power switch until the function or
mode is enabled.

KEY(S) TO PRESS AND

HOLD WHILE
FUNCTION POWERING UP HOW TO EXIT
User To enter the Safety Disk IAB Fill When the test is
Functions Leak Test complete the system will
automatically enter the
normal operating mode.
To enter the Pediatric IAB Fill and HELP When the test is
Safety Disk Leak Test PREVIOUS PAGE complete the system will
automatically enter the
normal operating mode.
Service To enter the System User Preferences From the Main Menu
Functions Configuration Mode.(See press the Back key
“System Configuration” twice to exit this mode
on page 9-1, for details and enter the normal
on using this mode.) operating mode.
To restore System default Open Menu The system powers up in
settings (See “Menu the normal operating
Group Keys” on page 1- mode with all default
14, for details.) settings restored.
To print software revisions Print Strip The system powers up in
the normal operating
mode and the software
revisions are printed
from the recorder.
To enter Service Inflation Interval and Power OFF
Diagnostics Freeze Display

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 2.0 Detailed Operation

2.1 Introduction
This section of the manual provides step-by-step instructions for properly operating the
CS100.

Prior to operating the equipment, the user must be familiar with the controls and functions of
the CS100 (See “Controls and Indicators” on page 1-1.) and have a thorough knowledge of
intra-aortic balloon pumping.

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Operation Instructions Detailed Operation

2.2 Operation Instructions

2.2.1 Safety Disk Leak Test
This optional test measures the pneumatic leak rate(s) of the Safety Disk. The test requires
multiple interactions with the operator. Specifically during the course of the test, the operator
is requested to plug and unplug the outlet of the safety disk. The CS100 prompts the user at
the appropriate times for this action.

WARNING: Safety Disk Leak Test MUST NOT be performed when the
system IAB is connected to the patient.

1. Press and hold the IAB Fill key while switching IABP ON/OFF to ON. This switch is
located on the top right of console's front panel. Release the IAB Fill key when the
message LEAK TESTING SAFETY DISK appears in the advisory section of the screen.

NOTE: If the IAB Catheter Extender Input is not vented to air at the
start of the Safety Disk Leak Test, a double beep alarm tone
will sound and the message UNPLUG DISK OUTLET will be
displayed.

After approximately 10 seconds, a tone sounds and the message PLUG DISK OUTLET
is displayed in the advisory section of the screen.

2. Plug the IAB Catheter Extender Input on the safety disk with a dead end Luer plug
(supplied).
3. A double beep will sound at the end of the safety disk test. If the system passes the test,
the message SYSTEM TEST OK is displayed in the advisory section of the screen.
Remove dead end Luer plug.

NOTE: If the message on the display is “SAFETY DISK TEST FAILS”,

inspect all pneumatic connections and Luer locks. Switch the
IABP On/Off to the OFF position and repeat from Step 1.

If in doubt about the integrity of the safety disk, replace it. See “Safety Disk/Condensate
Removal Module” on page 7-6.

If the safety disk has been replaced and no leak is evident, but the screen still flashes the
message SAFETY DISK TEST FAILS, the IAB Autofill system may be malfunctioning and the
Manual fill procedure should be performed until a Service Representative can be contacted.

WARNING: Use only the Datascope approved Safety Disk/CRM (P/N's

0997-00-0344/0997-00-0380 or 0997-00-0985/0997-00-
0986) designed for use with the CS100.

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2.2.2 Power Up Procedure (Without Safety Disk Leak Test)

If the CS100 is not already on, press the IABP ON/OFF switch to turn ON.

1. Attach the line cord, appropriate for the country of use, securely into the MAINS power
receptacle on the IABP console.
2. Plug the system line cord into a compatible grounded AC receptacle. In the U.S. use
only receptacles marked Hospital Grade. Do not use an adapter to eliminate the
plug's connection to ground. If auxiliary equipment is used with the CS100, insure that
the equipment is also properly grounded.

3. Verify the MAINS On/Off switch, located on the rear panel next to the receptacle, is
On. This switch may be left in the On position between IABP usages. This switch
enables power flow to system's power supply and battery charger circuitry.
4. Confirm AC operation by checking that the battery charging indicator is illuminated or
flashing.
See “Safety Disk Leak Test” on page 2-2, if a Safety Disk Leak Test is desired.

At power up, the system performs an electrical and pneumatic self test. When the self-check
is successful the SYSTEM TEST OK message appears in the advisory field of the display. In
the event that any electrical or pneumatic test fails, the message ELECTRICAL TEST FAILS
CODE #____ is displayed on the screen. The code number indicates which test has failed in
the system. Power cycle the system (power down for a minimum of 10 seconds) and if
message repeats, record the code # and call a Datascope Service Representative. See
“Troubleshooting” on page 3-1, for probable causes and recommended actions.

2.2.3 Open Helium Tank Valve and Confirm Helium Pressure

1. Slowly open the Helium cylinder valve fully counter-clockwise.
2. Make sure that the Helium indicator on the display indicates that an adequate volume of
gas exists in the Helium tank. A mechanical Helium pressure gauge directly above the
Helium tank provides an alternate check of the Helium supply. Ensure the Helium supply
reading on the gauge is within the operating range (within the white area).

CAUTION: When the system is not in use, close the cylinder valve fully
clockwise to prevent a potential leak and the depletion of
the Helium supply.

3. Check that the message LOW HELIUM advisory is not displayed. If the LOW HELIUM
message is displayed, check Helium cylinder icon or gauge for adequate gas capacity
and check Helium cylinder attachment for leaks. Replace the cylinder if necessary. See
“Installation and Replacement of Helium Cylinder” on page 7-3.

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2.2.4 Connect IAB and IAB Catheter Extender to IABP Console

1. Remove any plug from IAB catheter extender input connector. Visually inspect that the
safety disk is properly seated and that all pneumatic fittings are sound.
2. At the patient end, connect the IAB to its extension catheter. Next, connect the extension
catheter to the IAB Catheter Extender Input Luer fitting located on the Safety Disk.

CAUTION: To ensure reliable operation of the Autofill system and

proper IAB inflation pressures, it is important that the
combined total volume of the IAB’s membrane and external
tubing, plus the catheter extender tubing, is not altered.
Using IAB or catheter extender tubing of a different length
or internal diameter, from that supplied with Datascope
products, will change IAB inflation pressure levels and may
result in Autofill failures. Consequently, such practices must
be avoided.

In the case of pediatric IABs, the safety disk must be removed and replaced with an adapter.
In addition, other measures must be taken. See “Pediatrics” on page 6-1.

2.2.5 ECG Acquisition

A high quality ECG signal is desirable to ensure optimal triggering. An ECG signal can be
acquired either directly from skin electrodes or indirectly as a high level output from an
external monitor. See “External Monitor Interfacing” on page 8-3, for additional information
on interfacing requirements when using external monitor sources.

Direct ECG signal acquisition requires an ECG patient cable, lead wires and skin electrodes.
Use only the Datascope supplied patient cable and leads to minimize noise.

The type of skin electrode and application technique are major factors in determining the
quality of the signal obtained. Use of high quality electrodes is recommended. These are
designed to acquire an ECG with excellent baseline stability, recovery from defibrillation and
minimum artifact from patient movement.

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2.2.5.1 Use of ECG Skin Electrodes

1. When acquiring an ECG directly from skin electrodes:
a. Insure that the patient lead wires are securely inserted into the yoke of the Datascope
supplied ECG patient cable. Connect each patient lead wire to a skin electrode. The
following table shows the number of ECG Electrodes vs. Leads available. The
recommended minimum number of electrodes is 4 to provide optimal lead selection
triggering options.

(#) PATIENT ELECTRODES IN USE (#) ECG LEADS AVAILABLE

RA, LA, LL I, II, III
RA, LA, LL, RL I, II, III, aVR, aVL, aVF
RA, LA, LL, RL, V (C) I, II, III, aVR, aVL, aVF, V (C)

b. Attach electrodes to the patient at the appropriate locations, as shown.

Electrode Placement Electrode Placement

Surgical Electrode Placement Surgical Electrode Placement

RA LA RA LA
White Black Red Yellow
RA LA RA LA

(Chest) (Chest)
V C
Brown White

RL LL RL LL

RL LL RL LL
Green Red Black Green

FIGURE 2-1 Electrode Placement AHA FIGURE 2-2 Electrode Placement IEC

c. Plug ECG patient cable into the rear panel ECG INPUT connector.
d. Check that an ECG waveform is present on the system's display screen and that the
ECG field on the display indicates the desired lead and gain. Also confirm
triggering and that the heart rate read-out is now functional.
2. To change the ECG lead:
a. Confirm that the operation mode is either Semi Auto or Manual and confirm that
the trigger source is ECG.
b. Access the ECG/AP menu by pressing the ECG/AP Sources key. When the menu
is open, select the desired LEAD, then close the menu.

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Use of an External ECG Source

1. When using a high level ECG output from an external monitor, plug the interface cable
into the ECG monitor input jack.
2. Select desired lead setting for direct skin electrode acquisition or the external monitor
input by accessing the ECG/AP menu and pressing the ECG/AP Sources key. When
the menu is open, select the desired LEAD, then close the menu.
3. Check that an ECG waveform is now present on the system screen and that the heart
rate read-out is now functional.

2.2.6 Arterial Pressure Acquisition

An arterial pressure signal can be acquired either directly from a physiologic pressure
transducer or indirectly as a high level output from a compatible external monitor. See
“External Monitor Interfacing” on page 8-3, for additional information on interfacing
requirements when using external monitor sources.

1. When acquiring the arterial pressure directly from a transducer, plug the pressure
transducer adapter cable into the rear panel pressure input connector. Verify that
DIRECT is indicated in the Pressure Source display field.
2. When using a high level pressure output from an external monitor, plug the interface
cable into the pressure monitor input jack and set the PRESSURE SOURCE to
EXTERNAL by pressing the ECG/AP Sources key. Verify pressure waveform display
and source display field.
3. To establish a monitoring site, utilize the inner lumen of the intra-aortic balloon or
introduce an arterial pressure catheter into the patient's radial artery in accordance with
standard hospital procedures. Aortic pressure monitoring is recommended for managing
patients on IABP therapy.
4. Connect catheter line, with a flushing device, to the pressure transducer.

5. Zero pressure transducer as follows:

Initially, the message NO ZERO is displayed in place of the systolic digital display
value, indicating the need to zero the transducer.

a. Open transducer vent to atmosphere.

b. Press the Zero Pressure key and hold for a minimum of two seconds.
Two audible clicks will sound and the automatic zero process is performed.

All of the numeric pressure values at the right side of the display will show zero (±2
mmHg) when zeroing is successful.

NOTE: If the transducer offset exceeds ±120 mmHg, it will not be

possible to automatically zero the transducer. A NO ZERO
message indicates this is a fault condition. If this occurs, the
transducer should be considered incompatible or defective
and should not be used.

6. Close pressure transducer vent to atmosphere. Check that the pressure waveform is
displayed and SYSTOLIC/DIASTOLIC and MEAN digital displays are functional at
this time.

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2.2.7 Selection of Trigger Source

Trigger sources may not be selected in the AUTO operation mode. In all other modes the
triggering source must be selected manually by the operator. A No Trigger alarm will sound
if a missing or invalid trigger source is selected.

See “Trigger” on page 1-31, for more information.

2.2.7.1 ECG Trigger

In the ECG TRIGGER, the system triggers on the QRS. This is indicated by a flashing
diamond in the upper right corner of the screen. The trigger circuitry adapts to changes in
QRS amplitude and suppresses motion artifact. Pacemaker pulses are rejected in this trigger
mode.

ECG: Normal Gain Mode

This is the default setting for ECG GAIN. To prevent false positive triggers, trigger sensitivity
is limited to 120µV when the system is in the normal ECG GAIN setting. The minimum QRS
trigger threshold of 120µV will be increased automatically if a pacer spike is present, to
avoid detection of pacer artifact.

ECG: Variable Gain Mode

At the users discretion the variable gain mode may be selected. In some clinical settings or
circumstances, higher or lower ECG sensitivity may be needed to achieve proper triggering.
The variable gain control is accessed via the PUMP OPTIONS menu.

NOTE: ECG gain can only be changed when the TRIGGER SOURCE is
set to ECG. In the menu, ECG gain is expressed as a
multiplier. It can be varied from 0.15 to 3.0, where 1.0 is
NORMAL.

For example, the 3.0 setting increases the trigger's sensitivity from its normal value of 120µV
to 40µV. When making changes to ECG GAIN, make sure QRS detection operates properly
by observing the flashing diamond and the Heart Rate display.

NOTE: Normal gain will handle most cases. Gain alteration should
be used ONLY if required.

See “Pump Options Menu Key” on page 1-17, for more information.

2.2.7.2 Pressure Trigger

In the Pressure Trigger mode, the CS100 uses the arterial blood pressure waveform as its
trigger source. This is a less preferred trigger source.When possible, ECG trigger should be
used.

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Pressure Trigger: Automatic Trigger Threshold

The IABP identifies and triggers on the upstroke of the systolic pressure pulse. This upstroke is
identified as a positive upturn in arterial pressure. The CS100 continuously optimizes and
adapts the trigger threshold to changes in the systolic pulse height, (i.e., pressure trigger
threshold is automatic.) The approximate trigger level is indicated on the arterial pressure
waveform by a horizontal tick mark beside the arterial pressure upstroke.

Pressure Trigger: Manual Trigger Threshold

In some clinical settings or circumstances, additional sensitivity may be necessary. It may be
helpful to fix the pressure threshold at a constant value. Manual threshold mode is provided
for greater triggering flexibility. The threshold level may be varied from 7 to 30 mmHg in 1
mmHg increments.

The threshold level and mode, Manual or Automatic, are posted just below the pressure
trigger source indication in the trigger source field of the display screen.

WARNING: Readjust or re-evaluate inflation and deflation timing after

each manual pressure trigger threshold change.

See “Pump Options Menu Key” on page 1-17, for more information.

2.2.7.3 Use of Pressure Trigger

The CS100 is designed to trigger on the upstroke of systole and ignore rises in arterial
pressure attributed to the augmenting action of the IAB. This protective refractory mechanism
is very useful in blocking false diastolic trigger events, but it can mask very premature pulses
associated with instantaneous rises in heart rate. The CS100 can detect and adapt to rises
in rate. However, extreme changes, such as rate doubling, can result in every other systole
remaining invisible to detection. Alternate beat triggering is apparent when the displayed
heart rate is half the patient’s actual rate. This condition is rare, but if observed can be
immediately corrected by pressing the START key. This will suspend assist for a single beat
and restore proper trigger detection. If no user action is taken, proper triggering will be
restored at the 60 second automatic synchronization check point. See details in the following
paragraph.

Suspended assist is
indicated by the
intensified portion of
the displayed
waveform.

FIGURE 2-3 Suspended Assist Waveform

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Automatic Synchronization Checks in Pressure Trigger

An important feature of the CS100 is the pressure trigger's 60 second periodic
synchronization check. Every minute, when in 1:1 assist mode, pumping is suspended for a
single beat. (See Figure 2-3 on page 2-8) This permits the patient's natural systolic pulse and
interval parameters, unaltered by the action of the IAB, to be checked. This check
periodically ensures that the refractory and IAB timing intervals are being properly
determined and if necessary, corrects these intervals.

This automatic synchronization check can also be user initiated at any time by momentarily
pressing the START key while assist is active. This provides the capability to immediately re-
synchronize triggering and timing in the rare event that a loss of synchronization is observed.
When a synchronization check is initiated by pressing the START key, the timer for the next
check is automatically reset to 60 seconds.

Dysrhythmias While in Pressure Trigger

The CS100 will automatically adapt to sustained random dysrhythmias, such as atrial
fibrillation. Such rhythms lack a predictable pattern and will produce early systolic ejections
that can unavoidably overlap with balloon deflation, impairing stable and consistent systolic
pulse detection. The CS100 automatically detects such rhythms and minimizes the
probability of overlap.

An Irregular Trigger message is posted in the Advisory display field (upper left corner of
the screen) and an alert tone is briefly activated. This message indicates to users that the
system is compensating for an irregular rhythm by deflating somewhat earlier to avoid
interfering with systolic ejection. Consequently, users should NOT attempt to adjust the
deflation control if the patient is dysrhythmic and the Irregular Trigger advisory message
is posted. Adjustments to deflation timing could compromise trigger performance when the
patient finally resumes a regular rhythm and the system automatically reverts back to
standard timing.

WARNING: When pressure trigger is being used, balloon deflation

should always be adjusted to be complete at the upstroke
of systole. Late deflation timing causes a reduction in, and
delay in detection of, systolic pulse pressure. The system
relies on a prominent and timely systolic upstroke for
consistent, reliable pressure triggering. Any overlap of
balloon deflation and systolic ejection, while in the pressure
trigger mode, could cause triggers to be late or missed,
potentially resulting in loss of synchronization.

WARNING: Pressure triggering is NOT recommended for use when

sustained irregular cardiac rhythms or tachyarrhythmias
are present. Remember to adjust deflation early enough so
that deflation is completed prior to systole and to provide
continuous observation while triggering in this mode. If the
“IRREGULAR TRIGGER” message appears, DO NOT attempt
to adjust the deflation control as the system will
automatically compensate by deflating earlier to avoid
interfering with systolic ejection.

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2.2.7.4 Pacer V/A-V

In this setting, the QRS is ignored, and the CS100 triggers on the ventricular spike of the
pacemaker. It is typically used when ECG triggering is unsuccessful and a ventricular or
atrial-ventricular sequential pacemaker is in use.

If an AV sequential pacer is used, then the atrial pacing spike is ignored and the CS100
triggers on the Ventricular Spike. Subject to a heart rate limitation, the system automatically
recognizes and discriminates between V and AV pacer types. The trigger field on the display
screen will show V or AV as appropriate.

Pacer Discrimination Criteria

PACER V: The system recognizes the presence of a ventricular pacer provided the
ventricular pacing interval is fixed and the rate is less than 185 bpm.

PACER A-V: The system recognizes the presence of an atrial-ventricular sequential

pacer provided the A-V interval is between 80 - 224 msec. and the rate is
less than 125 bpm.

When using this setting, insure that the CS100 is reliably recognizing the pacemaker spikes.
If a ventricular pacer is used, be sure an enhanced ventricular pacer pulse is observed on
each cardiac cycle.

Enhanced Ventricular Pacer

FIGURE 2-4 Pacer V

If an atrial-ventricular sequential pacer (AV Pacer) is in use, then two enhanced pacer pulses
must be observed. If this is not the case, select a different ECG Lead or increase ECG GAIN
until reliable detection is achieved.

Enhanced Atrial Enhanced

Pacer Ventricular Pacer

A-V Interval

FIGURE 2-5 Pacer A-V

The system triggers on the ventricular pulse for either type of pacer, provided there is 100%
paced rhythm (i.e., no demand pacing). If the conditions for either pacer type are not met, a
trigger alarm occurs and the message CHECK PACER TIMING is displayed.

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NOTE: Pacer V/A-V trigger will not function in the presence of ESU
Interference. Assist will be suspended temporarily and will
resume automatically when interference disappears. The
"TRIGGER INTERFERENCE" status message is displayed when
ESU interference is detected in the Pacer V/A-V trigger
mode.

2.2.7.5 Pacer A
This mode is only applicable to patient with an atrial pacer. In Pacer A trigger, the CS100
triggers on the patient's QRS. This trigger is recommended only if atrial pacer tails interfere
with R-Wave detection when using the ECG trigger. Fixed or demand atrial pacing can be
used in this trigger.

2.2.7.6 Internal Trigger

Internal trigger is used when there is no mechanical cardiac cycle, (i.e., cardio-pulmonary
bypass or asystole.)

The internal trigger rate can be adjusted from 40 to 120 bpm, in increments of 5 bpm. The
rate is adjusted by opening the PUMP OPTIONS menu, selecting Internal Rate, and then
using the UP and DOWN arrow keys to set the desired rate.

When using this trigger source, the system will display INTERNAL in the upper right corner
of the screen. When Internal Trigger is selected, the system continues to monitor for
R-Wave activity via the ECG patient cable. If valid R-Wave activity is detected, then the
system displays the message ECG DETECTED and sounds a double beep alarm. The system
deflates the IAB when an R-Wave is detected to prevent competitively pumping with the
patient. If reliable R-Wave activity has resumed then the system should be switched back to
the ECG Trigger mode for proper timing.

WARNING: Do not remain in the internal trigger mode when the patient
is generating a cardiac output.

NOTE: Internal trigger rate can only be changed when the trigger
source is set to internal.

2.2.8 Selection of IAB Frequency

The selection of IAB Frequency determines the ratio of heart beats that are assisted by the
IAB. The selections are: 1:1, every beat is assisted; 1:2, one out of two beats are assisted;
or 1:3, one out of three beats are assisted. Press the UP and DOWN IAB FREQUENCY
arrow keys to make a selection.

The choice of IAB frequency determines the manner in which the arterial pressure indices are
computed and displayed. In 1:1 mode all beats are assisted and a single assisted value is
displayed for each pressure index.

When either 1:2 or 1:3 is selected, the CS100 will separately display the peak assisted
and unassisted systolic and diastolic pressures. Figure 2-6 on page 2-12, illustrates these
pressure indices.

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Augmented
Unassisted Diastolic Pressure
Systolic Pressure Assisted Systolic
Pressure

Unassisted End Assisted End

Diastolic Pressure Diastolic Pressure

FIGURE 2-6 Detail of Waveform Showing Assisted and Unassisted Pressure

If the recorder is activated during 1:2 or 1:3 frequency, the assisted and unassisted systolic
and diastolic pressure will also be annotated on the strip.

2.2.9 Timing of Intra-Aortic Balloon

2.2.9.1 Initial Timing Adjustments - Use of the Inflation Marker
In the STANDBY mode an inflation marker appears as a highlighted interval on the Arterial
Pressure Waveform. To supplement the marker, a horizontal bar is drawn beneath the
Arterial Pressure Waveform. Appropriate movement of the inflate and deflate timing control
will shift the duration and position of the marker.

NOTE: The Inflation Marker is only visible when the CS100 is in

STANDBY (not assisting). When assisting, the markers are
removed. This is done to assure that the operator sets inflate
and deflate timing solely by viewing the patient's
hemodynamic response.

To Set Initial Inflate Timing (not applicable in AUTO operation mode):

• Use the IAB Inflation arrows until the highlighted segment of the arterial pressure trace
begins at the dicrotic notch.
To Set Initial Deflate Timing (optional in AUTO operation mode):

• Use the IAB Deflation arrows to adjust the end of the highlighted segment prior to
ventricular ejection.

Dicrotic Notch

Inflation Marker

FIGURE 2-7 Highlighted Inflation Marker

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2.2.10 Verify Arterial Pressure Delay

Arterial Pressure Delay (APD) is the time delay between the time when Arterial Pressure
changes occur at the heart and when they are observed at the IABP. APD will vary with the
pressure monitoring site used (typically inner lumen or radial) and with the physiology of the
patient.

APD is a value used by the IABP to adjust the time position of the intensified segment of the
Arterial Pressure Waveform.

In Semi Auto and Manual operation modes, the APD only effects the position of the
intensified segment of the waveform. It does not effect timing.

NOTE: In the AUTO operation mode, APD is determined

automatically and is not user adjustable.

The initial power-up APD default setting is 40 msec. After the first few assisted beats, the
value is recomputed and updated.

To Verify the APD current setting: While pumping, press and hold the Inflation
Interval key and confirm that the intensified segment of the arterial pressure trace begins
approximately at the dicrotic notch.

To Recompute APD: If the APD requires recomputation, then it can be automatically

recalculated by quickly pressing and releasing the Inflation Interval key while assisting.
Re-confirm proper intensification position.

NOTE: If the patient's pressure monitoring site is changed while

pumping, the Inflation Interval key can be quickly pressed
and released to recalculate arterial pressure transmission
delay. Reconfirm proper position. This will assure accurate
digital pressure displays.

Manually Entering a Value for APD: If still incorrect, APD can be manually adjusted
via the PUMP OPTIONS menu.

1. Access the Arterial Pressure Delay submenu.

2. The delay may be adjusted from 0 to 180 msec. in 4 msec increments using the UP and
DOWN arrow keys in the navigation circle. The marked and intensified segment of the
arterial pressure waveform will consequently move later on the trace.
3. If this is still incorrect, this delay can be adjusted to approximate the start of
intensification at the dicrotic notch.

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2.2.11 Initiation of Assist

1. Connect the IAB, with appropriate catheter extender, to the safety disk pneumatic
connection labeled IAB Catheter Extender Input.
2. Press the START key to initiate assist. Confirm that an IAB Autofill is in progress,
indicated by the Autofilling message posted in the advisory field of the display. The
balloon catheter circuit will be purged and filled with a calibrated volume of Helium.
This fill process will then be repeated.
3. Assist will begin following the successful completion of Autofill, indicated by the
Autofilling message clearing and the START key indicators flashing with each
inflation cycle.
4. The CS100 will begin pumping with its augmentation set at maximum.
The automatic augmentation feature may be disabled at any time by pressing either the
UP or DOWN IAB AUGMENTATION key. Subsequent presses of the UP or DOWN
keys will incrementally increase or decrease augmentation.

5. Verify that after one minute of assist, the Aug Alarm Limit determination on the
display panel is approximately 10 mmHg below the patient's diastolic augmentation
pressure.
6. If adjustment to the alarm limit is desired, press the Aug Alarm key. Then press the
adjacent UP or DOWN arrow keys in the navigation circle to adjust the alarm limit.

WARNING: Gas Loss and IAB Catheter alarms are inoperative when
pumping in the Manual IAB Fill mode. Consequently, the use
of the augmentation alarm is essential when caring for
patients while operating in this mode.

NOTE: The augmentation alarm, when used properly, serves as an

important backup to internal monitoring alarms. Due to the
dynamic nature of the shuttle gas system, Gas Loss and IAB
Catheter alarms do not operate under severe patient
conditions (See “Troubleshooting” on page 3-1, for more
details). By setting the augmentation alarm, the system
monitors the level of assist and will alert the user in the
event of a decrease in augmentation pressure.

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Detailed Operation Operation Instructions

2.2.12 IAB Fill / Autofill / Manual Fill

In almost all circumstances, the CS100 will be in the Autofill (as opposed to Manual Fill)
mode, and will automatically purge and refill the balloon catheter circuit with Helium every
two hours. This fill cycle will complete in approximately eight (8) seconds, after which assist
will automatically resume. An Autofill can be initiated, at any time, by pressing the IAB Fill
key. This resets the two (2) hour Autofill timer. Should a two (2) hour Autofill time-out occur
while in the STANDBY mode, an Autofill will be performed one minute after returning to
the ASSIST mode.

An Autofill will also occur if local atmospheric pressure decreases or increases by 25 or 50

mmHg respectively, as may occur during air transport. These pressure changes will initiate
Autofills approximately every 1,000 feet of rise or 2,000 feet of drop in altitude to keep
the balloon pressure acclimated to local conditions.

NOTE: If the Autofill procedure fails to purge and fill the safety disk
properly, the message “Autofill Failure” will be displayed
and an audible alarm will be activated. Corrective action
can be obtained by pressing the HELP key. Manual Fill help
screens, as well as detailed fill illustrations are provided
should Manual Fill become necessary. See “Manual Fill
Mode” on page 3-48.

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 3.0 Troubleshooting

3.1 Introduction
The tables below list a number of operational symptoms and provide guidelines for the
necessary corrective action.

In the event that service is required, please contact a Datascope Service Representative.
Internal servicing should only be performed by qualified personnel.

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Introduction Troubleshooting

3.1.1 ECG Troubleshooting

RECOMMENDED
SYMPTOM POSSIBLE CAUSES CORRECTIVE ACTION
Interference on ECG Faulty electrodes/electrode Check electrode contact;
leads replace electrodes
Interference on ECG Baseline Unit not configured for proper Call service representative
line frequency
Intermittent ECG Faulty electrodes/electrode Check electrode contact;
leads/patient cable. replace electrodes. Check or
replace patient cable
Lead Fault message on the ECG patient lead fault Check electrode contact;
display replace electrodes. Check or
replace patient cable
Motion Artifact Faulty electrodes Check electrode contact;
replace electrodes
Weak ECG signal Electrode position or poor Try alternate lead
quality configurations (Lead II
generally provides the largest
R-wave). Adjust ECG GAIN
to increase the size of the
ECG
ESU interference Poor electrode placement, poor See “Use of ECG Skin
ECG cable orientation or wrong Electrodes” on page 2-5.
ECG cable Use shielded ECG cable for
OR use. See “Operating
Room Leadwire Set” on
page 10-6.
Interfaced to monitor without Use direct ECG electrodes
ESU suppression

3.1.2 Trigger Troubleshooting

RECOMMENDED
SYMPTOM POSSIBLE CAUSES CORRECTIVE ACTION
System does not trigger ECG signal too small Increase ECG Gain
System triggers erratically Interfaced to external monitor See “External Monitor
with limited bandwidth Interfacing” on page 8-3.
Large A-pacer tails in ECG Select A Pacer trigger
trigger
Demand pacer in Pacer V/A-V Select ECG or pressure
mode trigger
Pacer spike coincident with See “Pacer V/A-V” on
R-wave page 2-10.
System triggers every other Pressure trigger needs Quickly depress the START
cardiac cycle in pressure resynchronization key for re-synchronization.
trigger See “Use of Pressure Trigger”
on page 2-8.
System skips assist cycles in Deflation time is set too late. Quickly depress the START
pressure trigger key for re-synchronization

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Troubleshooting Introduction

3.1.3 Balloon Troubleshooting

RECOMMENDED
SYMPTOM POSSIBLE CAUSES CORRECTIVE ACTION
Balloon requires frequent pre- Leak in safety disk Check and replace
loading
Loose attachment of patient Check and tighten
balloon or fill hose
Leak in balloon Replace if necessary
Poor augmentation, low Leak in balloon Replace if necessary
augmentation alarm Leak in Safety Disk Check and replace
Clogged pump filter Call service representative
Faulty pressure regulator Call service representative
Leaky 9 psi relief valve Call service representative
Clogged mufflers Call service representative
Cannot auto-fill, auto-fill failure Wrong length catheter extender Must use Datascope supplied
extender with Datascope IABs
No Helium Replace Helium cylinder
Malfunction in auto-fill Use Manual Fill

3.1.4 Power-up Troubleshooting

General
RECOMMENDED
SYMPTOM POSSIBLE CAUSES CORRECTIVE ACTION
Cannot pump in portable mode Low battery charge Recharge battery to full

Messages
RECOMMENDED
SYMPTOM (MESSAGE) POSSIBLE CAUSES CORRECTIVE ACTION
SYSTEM FAILURE System computer failure Contact Datascope Service
LOW VACUUM Insufficient vacuum Make sure safety disk is leak
tight. Restart System
ELECTRICAL TEST FAILS Major system failure Turn the IABP off. After 10
CODE#__ seconds power back up. If
condition persists, note the
Code number displayed and
contact Datascope Service
MAINTENANCE REQUIRED System maintenance may be Note the code number
CODE#__ required displayed and contact
Datascope Service

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Alarms and Advisory Messages Troubleshooting

3.2 Alarms and Advisory Messages

The IABP utilizes both auditory and visual alarm signals to communicate the need for
attention or awareness by the pump operator. Auditory alarm signals (tone sequences) are
primarily intended to attract the attention of the operator. They were carefully developed to
communicate the urgency of the response, as well as the pump's location. Auditory signals
are effective over a relatively broad range of operator positions.

CAUTION: Do not set the alarm volume to such a low level that it
cannot be readily heard over the ambient noise level of the
venue in which the IABP is used.

Visual alarm signals consist of both display panel symbols and text. The displayed
information further reinforces the urgency of the alarm (symbol shape, color & flashing
property) and also identifies the alarm via a specific text message. Textual information is
legible at the operator's position, up to 1meter from the front of the display panel.

Additionally, alarms are further complimented by an option to display context sensitive help
information to aid in the understanding and guide in the resolution of the alarm condition.

Alarm and advisory messages are grouped into the following categories in order to facilitate
operator awareness and understanding: Technical Alarms, High, Medium and Low Priority
Alarms, and Informational Messages. These messages are displayed based upon the priority
of the condition(s) that prompted them.

Technical Alarms and High Priority Alarm messages are displayed in the top line of the Alarm
and Advisory Messages section of the display. These alarms require the operator's
immediate response. Technical Alarms initiate a continuous alarm tone and suspend
pumping. High Priority Alarms initiate the High Priority Alarm Tone, and, in a majority of
cases, suspend pumping. If more than one alarm condition is present, then the highest
priority alarm is displayed. When the first alarm condition has been corrected, then the next
highest priority alarm is displayed. The "Help Screens" section that follows is organized to
reflect the order of priority.

When Medium Priority Alarms are displayed, IAB assist is not suspended and the Medium
Priority Alarm tone is sounded. Medium Priority Alarms require the Operator’s prompt
response.

When Low Priority Alarms are displayed, IAB assist is not suspended and the Low Priority
Alarm tone is sounded. Low Priority Alarms require the Operator’s awareness.

Informational messages typically provide awareness of conditions that do not require

immediate action and may persist for longer periods. These messages may also be
accompanied by an infrequently repeated audio reminder tone. Informational Messages may
also be displayed in the bottom right corner of the screen when initial Setup or Help screens
are available.

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Troubleshooting Alarms and Advisory Messages

Medium and Low Priority Alarms and Informational Messages are displayed in the lower
three (3) lines of the Alarm and Advisory Messages section of the display. If more than three
messages are sent, the three highest priority messages are displayed. When one Medium
Priority Alarm, Low Priority Alarm or Informational Message condition is corrected or
eliminated, then the next highest priority message is displayed.

Gas loss alarms provide surveillance for leaks which can result in gas leaving or entering the
IAB circuit. IAB Catheter Alarms detect an occlusion of the IAB catheter or extender. Gas can
be trapped in the IAB and/or safety disk depending on the timing of the occlusion with
respect to the pump cycle.

Gas Loss and IAB Catheter alarm operation is maintained at heart rates up to 140 BPM*.
However, one component of the IAB Catheter Alarms, detection of gas trapped in the safety
disk, is suspended at 112 BPM to minimize nuisance alarms.

WARNING: The Augmentation Alarm, which is automatically set at

power-up, provides back-up to these alarms (gas loss and
IAB catheter alarms) at higher rates. Therefore, this alarm
should not be manually disabled.

WARNING: Gas Loss and IAB Catheter alarms are inoperative when
pumping in the Manual IAB Fill mode. Consequently, the use
of the augmentation alarm is essential when caring for
patients while operating in this mode.

WARNING: If more than one pump is being used in close proximity,

ensure that the source of the alarm sound is correctly
identified by confirming the corresponding visual indication.

* The cited heart rates assume that the timing controls are at nominal mid-position.

NOTE: The CS100 maintains a non-volatile event log which is

accessible in Service Diagnostics Mode. For more
information, see the Service Manual.

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Help Screens Troubleshooting

3.3 Help Screens

Help screens are provided to guide the user through set-up procedures and for consultation
regarding alarm or informational message descriptions and alarm configuration. Help
Screens are context sensitive and available based on the information displayed on the
screen. For example: The help screens for initial set-up are only available at power-up and
cleared once pumping is initiated. Similarly, the help screens for alarm messages are only
available while an alarm condition or informational message exists.

To display the Help Screens:

1. Press the HELP key on the keypad. The key's LED illuminates. The HELP screen window
replaces the balloon waveform.
2. In the HELP window, use the NEXT PAGE or PREVIOUS PAGE keys to page through
the available screens. Pressing the NEXT PAGE key displays the next available page of
help screen information. Pressing the PREVIOUS PAGE key displays the previous page
of information. If the NEXT PAGE or PREVIOUS PAGE keys are pressed, and
additional pages are not available, then the same page is displayed again.
3. Press the HELP key again or the BACK key to return the screen to the normal waveform
display.

TITLE PAGE NO. TOTAL PAGES

FIGURE 3-1 Example of Help Screen

For reference, the following pages show all of the available alarm and set-up help screens.

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Troubleshooting Help Screens

3.3.1 Technical Alarms

Technical Alarms are indications that an IABP electrical hardware failure has occurred.
Technical Alarms are the highest priority alarms and sound a continuous tone. In all cases of
Technical Alarms, pumping is suspended.

Electrical Test Fails Code # _____

ASSOCIATED HELP SCREEN:

PROBABLE CAUSE CORRECTIVE ACTIONS

There is a start-up failure in a major subsystem of the 1 Turn the IABP off by setting the IABP (SYSTEM POWER)
IABP. switch, located on the front panel, to the OFF position.
2 Wait 10 seconds.
3 Turn the IABP on by setting the IABP (SYSTEM POWER)
switch, located on the front panel, to the ON position.
4 If the condition persists, note the code number
displayed and contact Datascope Service.

CAUSE AND RESPONSE:

OPERATION TRIGGER
MODE SOURCE DETAILED CAUSE SYSTEM RESPONSE RESET
All All Failure of one or more System is held in VENT mode/ Attempt to clear by cycling
electrical sub-system IAB deflated. power OFF and ON.
tests during system
power-up diagnostics.

System Failure
ASSOCIATED HELP SCREEN:

PROBABLE CAUSE CORRECTIVE ACTIONS

There is a malfunction of the microprocessor. 1 Turn the IABP off by setting the IABP (SYSTEM POWER)
switch, located on the front panel, to the OFF position.
2 Wait 10 seconds.
3 Turn the IABP on by setting the IABP (SYSTEM POWER)
switch, located on the front panel, to the ON position.
4 If the condition repeats, contact Datascope Service.

CAUSE AND RESPONSE:

OPERATION TRIGGER
MODE SOURCE DETAILED CAUSE SYSTEM RESPONSE RESET
All All Solenoid driver System disabled and safety Attempt to clear by cycling
watchdog detected disk is vented to atmosphere/ power OFF and ON.
vacuum and/or pressure IAB deflated.
solenoid energized for
approx. 2 seconds or
vacuum valve is not
activated within 2
seconds of pressure
valve or IABP processor
failure.

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Help Screens Troubleshooting

No Patient Status Available

ASSOCIATED HELP SCREEN:

PROBABLE CAUSE CORRECTIVE ACTIONS

There was an internal communications failure. 1 Turn the IABP off by setting the IABP (SYSTEM POWER)
switch, located on the front panel, to the OFF position.
2 Wait 10 seconds.
3 Turn the IABP on by setting the IABP (SYSTEM POWER)
switch, located on the front panel, to the ON position.
4 If the condition persists, contact Datascope Service.

CAUSE AND RESPONSE:

OPERATION TRIGGER
MODE SOURCE DETAILED CAUSE SYSTEM RESPONSE RESET
All All Internal electronics System is disabled, IAB Attempt to clear by cycling
communication failure. deflated. power OFF and ON.

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Troubleshooting Help Screens

3.3.2 High Priority Alarms

High Priority Alarms indicate situations that require immediate Operator response. Pumping
is suspended for the majority of High Priority Alarms (See the “SYSTEM RESPONSE”column
of the CAUSE AND RESPONSE tables). A red flashing alarm icon with three (3) exclamation
points denotes High Priority Alarms. All High Priority Alarms have a uniform audio tone. The
combination of five notes for High Priority Alarms is played in the following sequence: five
notes a short pause, five notes a long pause and then this cycle repeats.

!!!
FIGURE 3-2 High Priority Alarm Icon

Safety Disk Test Fails

ASSOCIATED HELP SCREEN:

PROBABLE CAUSE CORRECTIVE ACTIONS

There is a leak in the drive system or its fittings. 1 Check that the fittings are leak tight and that the Safety
Disk is properly installed.
2 Repeat the leak test. If the test fails again, replace the
Safety Disk.
3 Repeat the leak test.

CAUSE AND RESPONSE:

OPERATION TRIGGER
MODE SOURCE DETAILED CAUSE SYSTEM RESPONSE RESET
N/A - Diagnostic Test Leak detected in Safety Safety Disk Diagnostic Mode/ To restart the test, hold the
Disk/Autofill Assembly IAB is not connected. IAB Fill key down for 2
during Safety Disk seconds. Attempt to clear
diagnostic test or test by cycling power OFF
prompts not executed and ON.
properly.

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Help Screens Troubleshooting

Leak in IAB Circuit

ASSOCIATED HELP SCREEN:

PROBABLE CAUSE CORRECTIVE ACTIONS

A gas gain has been detected in the IAB circuit. 1 Verify all connections are leak free.
2 Press the START key to refill the IAB and resume
pumping.
3 If alarm persists, contact Datascope Service.

CAUSE AND RESPONSE:

OPERATION TRIGGER
MODE SOURCE DETAILED CAUSE SYSTEM RESPONSE RESET
All All Cumulative shuttle gas Vent / IAB deflated Message and Tone
gain exceeds 5 cc, cleared when: the START
relative to last autofill key is pressed, Autofill has
volume. Active ONLY in been initiated and
AUTOFILL mode with pumping resumes or the
IAB inflation period 80 IAB Fill key is pressed for
mSec and deflation 2 seconds and START is
period 250 mSec. pressed to resume
pumping.

Autofill Failure - No Helium

ASSOCIATED HELP SCREEN:

PROBABLE CAUSE CORRECTIVE ACTIONS

The Helium tank is closed. 1 Open the Helium tank.
The Helium tank is empty. 1 Replace the Helium tank.

CAUSE AND RESPONSE:

OPERATION TRIGGER
MODE SOURCE DETAILED CAUSE SYSTEM RESPONSE RESET
All All Balloon could not be Vent / IAB deflated Replace the Helium Tank
automatically filled then retry the autofill by
because of inadequate pressing the START key,
Helium gas or by pressing the IAB Fill
supply. key for 2 seconds.

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Blood Detected
ASSOCIATED HELP SCREEN:

PROBABLE CAUSE CORRECTIVE ACTIONS

Blood is detected in the IAB catheter. 1 Check for traces of blood in the IAB catheter and/or
Drain Port tubing.
2 If blood is present, notify the physician. Disconnect the
IAB catheter from the console as soon as this can be
done without endangering the patient.
3 Refer to the IAB catheter manufacturer's instructions for
IAB removal.
4 Contact Datascope Service.
5 If blood is not present, then turn the IABP off by setting
the IABP (SYSTEM POWER) switch, located on the front
panel, to the OFF position.
6 Wait 10 seconds.
7 Turn the IABP on by setting the IABP (SYSTEM POWER)
switch, located on the front panel, to the ON position.
8 Press the START key to refill the IAB and resume
pumping.
9 If “BLOOD DETECTED” message repeats, then the IAB
must be manually filled before pumping can continue:
Set the operation mode to SEMI AUTO. Then, in the
PUMP OPTIONS menu, set the IAB FILL MODE to
MANUAL.
10 See the Help screen, MANUAL FILL IAB, for
instructions on how to perform the Manual Fill
procedure.
11 Contact Datascope Service.

CAUSE AND RESPONSE:

OPERATION TRIGGER
MODE SOURCE DETAILED CAUSE SYSTEM RESPONSE RESET
All All While the system was Vent / IAB deflated/Purge Attempt to clear by cycling
autofilling, a leak in the valves closed. power OFF and ON.* If
IAB resulted in blood alarm persists and no
migration back to the blood is present, switch to
system. MANUAL FILL MODE.

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Help Screens Troubleshooting

Autofill Failure
ASSOCIATED HELP SCREEN:

PROBABLE CAUSE CORRECTIVE ACTIONS

The IABP cannot fill the IAB catheter system 1 Verify that the correct size IAB catheter and extender
automatically. are attached.
2 Verify that the autofill tubing is connected to the IAB Fill
Port, and the drain tubing is connected to the Drain
Port, on the Safety Disk.
3 Check for traces of blood in the IAB catheter and/or
Drain Port tubing.
4 If blood is present, notify the physician. Disconnect the
IAB catheter from the console as soon as this can be
done without endangering the patient.
5 Refer to the IAB catheter manufacturer's instructions for
IAB removal.
6 Contact Datascope Service.
7 If blood is not present, then press START to refill the IAB
and resume pumping.
8 If the autofill fails again then refill the IAB manually by
setting OPERATION MODE to SEMI AUTO. Then, in
the PUMP OPTIONS menu, set the IAB FILL MODE
to MANUAL.
9 Follow the step by step instructions in the help screen for
“Manual Fill IAB”.
10 Contact Datascope Service.

CAUSE AND RESPONSE:

OPERATION TRIGGER
MODE SOURCE DETAILED CAUSE SYSTEM RESPONSE RESET
All All Balloon could not be Vent / IAB deflated Retry the autofill by
automatically filled as pressing the START key,
defined in performance or by pressing the IAB Fill
section but, Helium key for 2 seconds, or
supply is adequate. select MANUAL Fill
MODE.

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Troubleshooting Help Screens

Rapid Gas Loss

ASSOCIATED HELP SCREEN:

PROBABLE CAUSE CORRECTIVE ACTIONS

A large leak has been detected in the IAB pneumatic 1 Check for blood in the tubing. If found, stop pumping
circuit. and notify physician. Refer to IAB manufacturer's
instructions for IAB removal.
2 If blood is not found in the tubing, verify the connections
are leak free. Refill the IAB and closely observe the
tubing to verify no blood is present. Press the START
key to resume pumping.

CAUSE AND RESPONSE:

OPERATION TRIGGER
MODE SOURCE DETAILED CAUSE SYSTEM RESPONSE RESET
All All 5 cc's loss over 2 Vent / IAB deflated Message and Tone
consecutive cycles (i.e., cleared when: the START
2.5 cc's loss beat to key is pressed, Autofill
beat). has been initiated and
pumping resumes or the
IAB Fill key is pressed for
2 seconds and START is
pressed to resume
pumping.

IAB Disconnected
ASSOCIATED HELP SCREEN:

PROBABLE CAUSE CORRECTIVE ACTIONS

The IAB catheter or extension tubing is disconnected. 1 Reattach the IAB catheter and extension tubing.
2 Press the START key to refill the IAB and resume
pumping.

CAUSE AND RESPONSE:

OPERATION TRIGGER
MODE SOURCE DETAILED CAUSE SYSTEM RESPONSE RESET
All All Disconnection at IAB or Vent / IAB deflated Message and Tone
extension catheter while cleared when: the START
in the assist mode. key is pressed, Autofill
has been initiated and
pumping resumes or the
IAB Fill key is pressed for
2 seconds and START is
pressed to resume
pumping.

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Help Screens Troubleshooting

High Drive Pressure

ASSOCIATED HELP SCREEN:

PROBABLE CAUSE CORRECTIVE ACTIONS

There is a component failure in the pneumatic system. 1 Attempt to resume pumping by pressing the START key.
2 If the message persists, contact Datascope Service.

CAUSE AND RESPONSE:

OPERATION TRIGGER
MODE SOURCE DETAILED CAUSE SYSTEM RESPONSE RESET
All All Regulated pressure from Standby / IAB deflated Resume assist by pressing
compressor exceeds the START key.
acceptable operating
range.

Autofill Required
ASSOCIATED HELP SCREEN:

PROBABLE CAUSE CORRECTIVE ACTIONS

The IAB FILL mode has been changed from MANUAL 1 If appropriate, return the IAB FILL MODE to MANUAL
to AUTO without an autofill. by using the PUMP OPTIONS menu. Press the START
key to resume pumping.
2 If the autofill MODE is desired, refill the IAB by pressing
and holding the IAB FILL key for 2 seconds, then press
the START key to resume pumping.

CAUSE AND RESPONSE:

OPERATION TRIGGER
MODE SOURCE DETAILED CAUSE SYSTEM RESPONSE RESET
Semi Auto or All Prompts the user to Standby / IAB deflated Message and Tone
Manual Autofill the IAB. This cleared when:
prompt occurs while The IAB Fill key is
assisting and when the pressed for 2 seconds and
current IAB Fill is the START key is pressed
Manual and the user to resume pumping, or the
has switched to the IAB FILL MODE is
Autofill mode. returned to MANUAL.

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Check IAB Catheter

ASSOCIATED HELP SCREEN:

PROBABLE CAUSE CORRECTIVE ACTIONS

The IAB remains in the sheath immediately after 1 Check the markings on the IAB catheter to assure the
insertion. balloon has exited the sheath. If not, pull sheath back to
the appropriate position.
2 Press the START key to resume pumping.

The IAB membrane is not completely unfolded. 1 Aspirate to assure blood is not returned through the
extracorporeal tubing.
2 If using a 34, 40 or 50 cc IAB, manually inflate and
deflate the IAB with 60 cc of gas through the male Luer
of the IAB.
3 If using a 25 cc IAB, manually inflate and deflate the
IAB with 50 cc of gas through the male Luer of the IAB.
4 Refill the IAB. Press the START key to resume pumping.

There is a kink in the IAB catheter or tubing. 1 Check the catheter tubing and relieve kink if possible.
2 Press the START key to resume pumping.

CAUSE AND RESPONSE:

OPERATION TRIGGER
MODE SOURCE DETAILED CAUSE SYSTEM RESPONSE RESET
All All Occlusion of IAB/ Standby / IAB deflated Reset by resuming assist
extension catheter or via the START key. If un-
unwrapped balloon. wrapped IAB is suspected,
use syringe to inflate
manually, see IAB's
manual.

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Help Screens Troubleshooting

Leak in IAB Circuit

ASSOCIATED HELP SCREEN:

PROBABLE CAUSE CORRECTIVE ACTIONS

There is a small leak in the IAB circuit, a loose 1 Check for blood in the tubing. If found, stop pumping
connection, or a high rate of Helium diffusion, possibly and notify physician. Refer to IAB manufacturer's
due to the patient being febrile or tachycardiac. instructions for IAB removal.
2 If blood is not found in the tubing, verify the connections
are leak free. Refill the IAB by pressing and holding the
IAB Fill key for 2 seconds and closely observe the
tubing to verify no blood is present. Press the START
key to resume pumping.
3 If the alarm persists and there is no evidence of a leak
in the IAB catheter, consider setting the Slow Gas Loss
Alarm to the OFF position.

CAUSE AND RESPONSE:

OPERATION TRIGGER
MODE SOURCE DETAILED CAUSE SYSTEM RESPONSE RESET
All All Cumulative shuttle gas Vent / IAB deflated Message and Tone
loss exceeds the 5 cc/ cleared when: the START
hr. dynamic limit, or key is pressed, Autofill has
total loss exceeds 12.5 been initiated and
cc, relative to last pumping resumes or the
Autofill volume. Active IAB Fill key is pressed for
only in Autofill mode 2 seconds and START is
with IAB inflation period pressed to resume
80 mSec and deflation pumping.
period 250 mSec.

Low Vacuum
ASSOCIATED HELP SCREEN:

PROBABLE CAUSE CORRECTIVE ACTIONS

The patient is tachycardiac. 1 Change IAB frequency to 1:2 by using the IAB
- or - FREQUENCY arrow keys.
There is insufficient vacuum in the drive system. 2 If the message persists contact Datascope Service.

CAUSE AND RESPONSE:

OPERATION TRIGGER
MODE SOURCE DETAILED CAUSE SYSTEM RESPONSE RESET
All All Insufficient or no Waiting to pump / IAB Automatically, when
compressor vacuum. deflated. vacuum is restored.

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Trigger Interference
ASSOCIATED HELP SCREEN:

PROBABLE CAUSE CORRECTIVE ACTIONS

The system is detecting electro-surgical interference while 1 Pumping automatically resumes when interference
in a pacer trigger mode. clears.
2 If the condition persists, then select PRESSURE trigger
using the TRIGGER SOURCE arrow keys.
3 Verify timing and press the START key to resume
pumping.

CAUSE AND RESPONSE:

OPERATION TRIGGER
MODE SOURCE DETAILED CAUSE SYSTEM RESPONSE RESET
Semi Auto or Pacer V/ Electro-Surgical Noise Waiting to pump / IAB Automatically, when ESU
Manual AV (ESU) detected while the deflated. interference stops. Or
Pacer Trigger Source Manually, by de-selection
is selected. A nominal 10 Sec. alarm of the Pacer Trigger
delay is incorporated to Source.
reduce false-positive nuisance
alarms due to transient
violations.

Check Pacer Timing

ASSOCIATED HELP SCREEN:

PROBABLE CAUSE CORRECTIVE ACTIONS

The patient is not 100% paced. 1 Select ECG trigger source, using the TRIGGER
SOURCE arrow keys, when demand pacing a patient.
2 Press the START key to resume pumping.

The patient's A-V paced rate is above 125 BPM. 1 Reduce the pacer rate.
or
The patient's V paced rate is above 185 BPM.

The system is unable to identify the A-V interval. 1 Adjust the A-V time interval to between 80 and 224
mSec.

CAUSE AND RESPONSE:

OPERATION TRIGGER
MODE SOURCE DETAILED CAUSE SYSTEM RESPONSE RESET
Semi Auto or Pacer V/ V/A-V pacer trigger Waiting to pump / IAB Automatically, if pacer
Manual AV interval varies >25% or deflated. timing conditions are met.
an A-V pacer rate is Or manually, by de-
>125 bpm. A nominal 10 Sec. alarm selecting Pacer Trigger
delay is incorporated to Source.
reduce false-positive nuisance
alarms due to transient
violations.

CS100/CS100i Operating Instructions 0070-10-0527-02 3 - 17

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Help Screens Troubleshooting

No Trigger
ASSOCIATED HELP SCREEN:

PROBABLE CAUSE CORRECTIVE ACTIONS

No ECG signal due to detached electrode(s) or poor 1 Attach or reposition the electrode(s) and check the
cable/lead connection. integrity of all cable/lead connections.
There is no arterial pressure waveform present. 1 Verify that the transducer was not left vented; check all
transducer cable connections.
The patient's pulse pressure is inadequate for pressure 1 Attempt to restore A.P. pulse height by flushing the fluid
triggering. circuit.
R-wave voltage is very low. 1 Switch operation mode to SEMI AUTO and increase
ECG Gain setting in the PUMP OPTIONS menu.
2 Use IAB Inflation and IAB Deflation controls to adjust
timing and resume pumping by pressing the START key.

CAUSE AND RESPONSE:

OPERATION TRIGGER
MODE SOURCE DETAILED CAUSE SYSTEM RESPONSE RESET
AUTO ECG or Valid ECG and Waiting to pump / IAB Automatically, when trigger
Pressure Arterial Pressure deflated. returns.
trigger do not exist or
are lost while in A nominal 10 Sec. alarm
AUTO operation delay is incorporated to
mode. reduce false-positive
nuisance alarms due to
transient violations.

No Trigger
ASSOCIATED HELP SCREEN:

PROBABLE CAUSE CORRECTIVE ACTIONS

An electrode is detached or malpositioned. 1 Reattach or reposition the electrodes.
An incorrect trigger source has been selected. 1 Select a different trigger source using the TRIGGER
SOURCE arrow keys. Resume pumping by pressing the
START key.
There is inadequate signal acquisition. 1 Try ECG lead selections via the ECG/AP SOURCES
menu, or select EXT. ECG, if appropriate.
2 Adjust the ECG GAIN by accessing the PUMP
OPTIONS menu.

CAUSE AND RESPONSE:

OPERATION TRIGGER
MODE SOURCE DETAILED CAUSE SYSTEM RESPONSE RESET
Semi Auto or ECG, Valid trigger is Waiting to pump / IAB Automatically, when trigger
Manual Pacer A or unavailable or lost deflated. returns.
Pacer V/ when either the ECG
AV or Pacer Trigger A nominal 10 Sec. alarm
modes are selected delay is incorporated to
(Not applicable to reduce false-positive
AUTO Operation nuisance alarms due to
Mode). transient violations.

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Troubleshooting Help Screens

Poor Signals Persist

ASSOCIATED HELP SCREEN:

PROBABLE CAUSE CORRECTIVE ACTIONS

No source of reliable triggering is available in AUTO 1 If A.P. signal is absent or flat, verify transducer was not
Operation Mode. left vented and check integrity of all cable connections.
If pulse height is unusually low or over damped, flush
fluid circuit. If ringing or noisy, find and correct source.
2 Attempt to improve ECG signal by ensuring electrode
contact and optimal placement; check integrity of all
cable/lead connections.
3 If signal problems persist, switch operation mode to
SEMI AUTO. Verify trigger source. Use IAB Inflation
and IAB Deflation controls to adjust timing and resume
pumping by pressing the START key.

CAUSE AND RESPONSE:

OPERATION TRIGGER
MODE SOURCE DETAILED CAUSE SYSTEM RESPONSE RESET
AUTO ECG or Both ECG and Arterial Waiting to pump / IAB Automatically, upon
Pressure Pressure signal quality deflated. detection of a good input
have been poor for a signal.
sustained period of time.

CS100/CS100i Operating Instructions 0070-10-0527-02 3 - 19

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Help Screens Troubleshooting

No Pressure Trigger
ASSOCIATED HELP SCREEN:

PROBABLE CAUSE CORRECTIVE ACTIONS

The patient's pulse pressure is inadequate for pressure 1 If appropriate, select a different trigger source using the
triggering. TRIGGER SOURCE arrow keys. Resume pumping by
pressing the START key.
2 If pressure trigger is required and manual threshold is
selected, reduce the pressure trigger threshold by using
the PRESSURE THRESHOLD sub menu from the
PUMP OPTIONS menu.
There is no arterial pressure waveform present. 1 Verify that the desired Pressure Source, DIRECT/
EXTERNAL, is selected. Use the ECG/AP Sources menu
to select the Pressure Source.
2 Verify that a properly wired transducer or monitor cable
is connected.
3 Verify that the transducer has not inadvertently been left
vented to atmosphere following zeroing.
4 Re-zero transducer, while vented, and reapply arterial
pressure to transducer.

CAUSE AND RESPONSE:

OPERATION TRIGGER
MODE SOURCE DETAILED CAUSE SYSTEM RESPONSE RESET
Semi Auto or Pressure Valid trigger is Waiting to pump / IAB Automatically, when
Manual unavailable or is lost deflated. trigger occurs.
while in Pressure trigger.
A nominal 10 Sec. alarm
delay is incorporated to
reduce false-positive nuisance
alarms due to transient
violations.

ECG Detected
ASSOCIATED HELP SCREEN:

PROBABLE CAUSE CORRECTIVE ACTIONS

A valid ECG is now detected with the INTERNAL trigger 1 Select ECG as the trigger source using the TRIGGER
selected as the trigger source. SOURCE arrow keys.
2 Verify proper timing. Resume pumping by pressing the
START key.

CAUSE AND RESPONSE:

OPERATION TRIGGER
MODE SOURCE DETAILED CAUSE SYSTEM RESPONSE RESET
Semi Auto or Internal ECG activity is detected Assisting / IAB is immediately Automatically, when ECG
Manual persistently for 4-6 deflated on each R-wave. activity ceases. Manually,
seconds while in the by de-selecting Internal
Internal Trigger Trigger mode.
mode.

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Troubleshooting Help Screens

Augmentation Below Limit Set

ASSOCIATED HELP SCREEN:

PROBABLE CAUSE CORRECTIVE ACTIONS

There is a change in the patient's hemodynamic status. 1 Assess the patient.
The Augmentation Alarm limit is set too high. 1 Reset the Aug Alarm limit to 8 - 10 mmHg below the
patient's augmented diastolic pressure by pressing the
AUG ALARM key and using the navigation arrow
keys. Press AUG ALARM to exit.
Augmentation is set too low. 1 If appropriate, increase augmentation by pressing the
AUGMENTATION UP ARROW key.
The Helium concentration is low. 1 Refill the IAB by pressing and holding the IAB FILL key
for 2 seconds.
2 Press the START key to resume pumping.

CAUSE AND RESPONSE:

OPERATION TRIGGER
MODE SOURCE DETAILED CAUSE SYSTEM RESPONSE RESET
All All Diastolic augmentation Unaffected Automatically, when
has dropped below the augmentation rises above
user-selected limit. A nominal 10 Sec. alarm alarm limit.
delay is incorporated to
reduce false-positive nuisance
alarms due to transient
violations.

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Help Screens Troubleshooting

3.3.3 Medium Priority Alarms

Medium Priority Alarms indicate situations in which a prompt Operator response is required.
This class of alarm does not suspend pumping, but may indicate a need for corrective action.
A yellow flashing alarm icon with two (2) exclamation points denotes Medium Priority Alarms
(See Figure 3-3). All Medium Priority Alarms have a uniform audio tone. The combination of
three (3) notes for Medium Priority Alarms is played in the following sequence: three notes a
pause and then this cycle repeats.

!!
FIGURE 3-3 Medium Priority Alarm Icon

Poor Signal Quality

ASSOCIATED HELP SCREEN:

PROBABLE CAUSE CORRECTIVE ACTIONS

Both ECG and A.P. signal quality are poor. 1 Attempt to improve ECG signal by ensuring electrode
contact and optimal placement: Checking all cable/
lead connections.
2 If A.P. signal is absent or flat, verify transducer was not
left vented and check integrity of all cable connections.If
pulse height is unusually low or over damped, flush fluid
circuit.

CAUSE AND RESPONSE:

OPERATION TRIGGER
MODE SOURCE DETAILED CAUSE SYSTEM RESPONSE RESET
AUTO ECG Both ECG and Arterial System automatically bases Automatic upon detection
Pressure signal quality is inflation on shorter cardiac of a good input signal.
poor while in ECG intervals.
trigger.

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Troubleshooting Help Screens

No Pressure Source Available

ASSOCIATED HELP SCREEN:

PROBABLE CAUSE CORRECTIVE ACTIONS

No DIRECT or EXTERNAL blood pressure source was 1 Connect transducer cable or A.P. slave cable from an
detected. external monitor to the IABP.
2 Verify that the cable is wired correctly.
3 If advisory persists and A.P. is viewable on an external
monitor, switch operation mode to SEMI AUTO. Verify
trigger source, adjust timing with the IAB Inflation and
IAB Deflation controls and resume pumping by pressing
the START key.

CAUSE AND RESPONSE:

OPERATION TRIGGER
MODE SOURCE DETAILED CAUSE SYSTEM RESPONSE RESET
AUTO ECG or Neither a direct or System automatically bases Automatically, upon
Pressure external blood pressure inflation on a shorter cardiac connection of a
source was detected. intervals. viable pressure source.

Low Battery (EXT) (CS100i only)

ASSOCIATED HELP SCREEN:

PROBABLE CAUSE CORRECTIVE ACTIONS

There is less than 30 minutes of battery operating time 1 The system will switch to internal batteries when the
remaining on external battery. external batteries are depleted.

CAUSE AND RESPONSE:

OPERATION TRIGGER
MODE SOURCE DETAILED CAUSE SYSTEM RESPONSE RESET
All All The external source falls Unaffected Automatically removes
below 30 minutes of message, turns off tone,
operating time. transfer to internal battery
occurs.

Low Battery
ASSOCIATED HELP SCREEN:

PROBABLE CAUSE CORRECTIVE ACTIONS

There is less than 30 minutes of battery operating time 1 Verify MAINS power switch, located above the AC
remaining. power cord connector, is ON.
2 Connect system to an AC power outlet.

CAUSE AND RESPONSE:

OPERATION TRIGGER
MODE SOURCE DETAILED CAUSE SYSTEM RESPONSE RESET
All All Battery reserve falls Unaffected Automatically removes
below 30 minutes of message and turns off
operating time. tone when AC is restored.

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Help Screens Troubleshooting

3.3.4 Low Priority Alarms

Low Priority Alarms are indications that Operator awareness is required. A yellow flashing
alarm icon with one exclamation point denotes Low Priority Alarms (See Figure 3-4). All Low
Priority Alarms have a uniform audio tone. The combination of two (2) notes for Low Priority
Alarms is played in the following sequence: two notes a pause and then this cycle repeats.

!
FIGURE 3-4 Low Priority Alarm Icon

Unable to Update Timing

ASSOCIATED HELP SCREEN:

PROBABLE CAUSE CORRECTIVE ACTIONS

Poor waveform quality. 1 If A.P. signal is absent or flat, verify the transducer was
not left vented and check the integrity of all cable
connections. If the pulse height is unusually low or over
damped, flush the fluid circuit. If ringing or noisy, find
and correct the source.
2 If not properly triggering or signal problems persist,
switch operation mode to SEMI AUTO. Verify trigger
source, adjust timing with the IAB Inflation and IAB
Deflation controls, and resume pumping by pressing the
START key.
The sustained heart rate is less than 30 BPM or greater 1 Switch the OPERATION MODE to SEMI AUTO if heart
than 150 BPM. rate is sustained between 30 BPM and 150 BPM. Verify
trigger source, adjust timing with IAB Inflation and IAB
Deflation controls, and resume pumping by pressing the
START key.
Poor diastolic augmentation. 1 Verify that the augmentation control is set to MAX. Then
check for catheter restriction and press the START key
to resume pumping.

CAUSE AND RESPONSE:

OPERATION TRIGGER
MODE SOURCE DETAILED CAUSE SYSTEM RESPONSE RESET
AUTO ECG or Waveform quality is poor. System increases Automatic upon
Pressure 1 One or more frequency of attempts to completion of a
waveform features update. successful update.
needed to update.
Timing can not be
identified.
2 The sustained heart
rate is less than 30
BPM or greater
than150 BPM.
3 Poor Augmentation.

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Troubleshooting Help Screens

3.3.5 Informational Messages

Informational Messages provide system information to the Operator. Informational Messages
display textual messages and, in some cases, are accompanied by an infrequently-repeating
audio reminder tone.

Install Safety Disk

ASSOCIATED HELP SCREEN:

PROBABLE CAUSE CORRECTIVE ACTIONS

(No Associated Help Screen) (No Associated Help Screen)

CAUSE AND RESPONSE:

OPERATION TRIGGER
MODE SOURCE DETAILED CAUSE SYSTEM RESPONSE RESET
N/A - Diagnostic Test There is no Safety Disk Safety Disk Diagnostic Mode / Automatically when Safety
attached to the system. IAB is NOT connected. Disk is attached to the
system.

Unplug Disk Outlet

ASSOCIATED HELP SCREEN:

PROBABLE CAUSE CORRECTIVE ACTIONS

(No Associated Help Screen) (No Associated Help Screen)

CAUSE AND RESPONSE:

OPERATION TRIGGER
MODE SOURCE DETAILED CAUSE SYSTEM RESPONSE RESET
N/A - Diagnostic Test Prompts user at start of Safety Disk Diagnostic Mode / Manual; Press the IAB Fill
Safety Disk Leak IAB is NOT connected. key for 2 seconds to
Diagnostics to open the resume testing.
safety disk's catheter
connector so that
atmospheric pressure
may be sampled. The
diagnostic will remain
paused until the prompt
is cleared.

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Help Screens Troubleshooting

Plug Disk Outlet

ASSOCIATED HELP SCREEN:

PROBABLE CAUSE CORRECTIVE ACTIONS

(No Associated Help Screen) (No Associated Help Screen)

CAUSE AND RESPONSE:

OPERATION TRIGGER
MODE SOURCE DETAILED CAUSE SYSTEM RESPONSE RESET
N/A - Diagnostic Test Prompts user at start of Safety Disk Diagnostic Mode / Automatic, after ten
Safety Disk Leak IAB is NOT connected. second delay interval.
Diagnostics, to cap the
safety disk's catheter
connector. The user is
given 10 seconds to
plug the connector
before the prompt is
cleared and the
diagnostic resumes.

Irregular Pressure Trigger

ASSOCIATED HELP SCREEN:

PROBABLE CAUSE CORRECTIVE ACTIONS

The patient's rhythm is too variable to accurately predict 1 The System has automatically compensated by deflating
the next systolic pressure trigger event. earlier to avoid interfering with systolic ejection.
Consequently, do NOT attempt to adjust the IAB
DEFLATION control.
2 Confirm that the patient's ECG also indicates
irregularity. If rhythm disturbance persists, consider
using ECG trigger mode for more reliable triggering.

The patient's rhythm is regular however IAB deflation is 1 Confirm that the patient's ECG rhythm is regular. If so,
set too late, interfering with systolic detection. then adjust the IAB DEFLATION control earlier to
improve consistency of the PRESSURE trigger.

CAUSE AND RESPONSE:

OPERATION TRIGGER
MODE SOURCE DETAILED CAUSE SYSTEM RESPONSE RESET
Semi Auto Pressure Erratic Pressure System automatically bases Automatically, when
Triggering due to either: deflation on shorter cardiac trigger interval is regular.
- Patient arrhythmias, or intervals. This earlier deflation
- Late deflation which avoids interference with
inhibits pressure pulse premature beats.
detection.

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Troubleshooting Help Screens

Maintenance Required Code # _____

ASSOCIATED HELP SCREEN:

PROBABLE CAUSE CORRECTIVE ACTIONS

The internal microprocessor has determined that system 1 Note the code number displayed and contact
maintenance may be required. Datascope Service.
2 Continue assist as appropriate.

CAUSE AND RESPONSE:

OPERATION TRIGGER
MODE SOURCE DETAILED CAUSE SYSTEM RESPONSE RESET
All All System maintenance Unaffected See corrective actions
may be required. above.

Low Helium
ASSOCIATED HELP SCREEN:

PROBABLE CAUSE CORRECTIVE ACTIONS

The Helium tank is closed. 1 Open the Helium tank.
There are fewer than 24 fills of Helium remaining in the 1 Replace the Helium tank.
tank.

CAUSE AND RESPONSE:

OPERATION TRIGGER
MODE SOURCE DETAILED CAUSE SYSTEM RESPONSE RESET
All All Helium supply is below Unaffected Automatically when a full
a preset reserve as Helium tank is connected.
determined by tank
pressure.

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Help Screens Troubleshooting

Leak in IAB Circuit (Overridden)

ASSOCIATED HELP SCREEN:

PROBABLE CAUSE CORRECTIVE ACTIONS

There is a small leak in the IAB circuit, a loose 1 Check for blood in the tubing. If found, stop pumping
connection, or a high rate of Helium diffusion, possibly and notify physician. Refer to IAB manufacturer's
due to the patient being febrile or tachycardiac. instructions for IAB removal.
2 If blood is not found in the tubing, verify the connections
are leak free. Refill the IAB by pressing and holding the
IAB Fill key for 2 seconds and closely observe the
tubing to verify no blood is present. Press the START
key to resume pumping.
3 If the alarm persists and there is no evidence of a leak
in the IAB catheter, consider setting the Slow Gas Loss
Alarm to the OFF position.

CAUSE AND RESPONSE:

OPERATION TRIGGER
MODE SOURCE DETAILED CAUSE SYSTEM RESPONSE RESET
All All Cumulative shuttle gas Unaffected since the alarm is Message cleared when:
loss exceeds the 5 cc/ overridden. the IAB FILL key is
hr. dynamic limit, or pressed for 2 seconds,
total loss exceeds 12.5 followed by the START
cc, relative to last key, to resume pumping.
Autofill volume. Active
only in Autofill mode
with IAB inflation period
80 mSec and deflation
period 250 mSec.

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Troubleshooting Help Screens

Blood Detected (Overridden)

ASSOCIATED HELP SCREEN:

PROBABLE CAUSE CORRECTIVE ACTIONS

Blood is detected in the IAB 1 Check for traces of blood in the IAB catheter and/or
catheter. Drain Port tubing.
2 If blood is present, notify the physician. Disconnect the
IAB catheter from the console as soon as this can be
done without endangering the patient.
3 Refer to the IAB catheter manufacturer's instructions for
IAB removal.
4 Contact Datascope Service.
5 If blood is not present, then turn the IABP off by setting
the IABP (SYSTEM POWER) switch, located on the front
panel, to the OFF position.
6 Wait 10 seconds.
7 Turn the IABP on by setting the IABP (SYSTEM POWER)
switch, located on the front panel, to the ON position.
8 Press the START key to refill the IAB and resume
pumping.
9 If Blood Detected message repeats, then the IAB must be
manually filled before pumping can continue: Set the
OPERATION MODE to SEMI AUTO. Then, in the
PUMP OPTIONS menu, set the IAB FILL MODE to
MANUAL.
10 See the Help screen, Manual Fill IAB, for instructions on
how to perform the Manual Fill procedure.
11 Contact Datascope Service.

CAUSE AND RESPONSE:

OPERATION TRIGGER
MODE SOURCE DETAILED CAUSE SYSTEM RESPONSE RESET
All All While the system was Vent / IAB deflated / Purge Attempt to clear by cycling
autofilling, a leak in the valves closed. power OFF and ON.
IAB resulting in blood
migration back to
System. The Operator
switched the IAB FILL
MODE to MANUAL to
override the alarm.

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Help Screens Troubleshooting

No Trigger (on Start-Up)

ASSOCIATED HELP SCREEN:

PROBABLE CAUSE CORRECTIVE ACTIONS

No ECG signal due to detached electrode(s) or poor 1 Attach or reposition the electrode(s) and check the
cable/lead connection. integrity of all cable/lead connections.
There is no arterial pressure waveform present. 1 Verify that the transducer was not left vented; check all
transducer cable connections.
The patient's pulse pressure is inadequate for pressure 1 Attempt to restore A.P. pulse height by flushing the fluid
triggering. circuit.
R-wave voltage is very low. 1 Switch operation mode to SEMI AUTO and increase
ECG Gain setting in the PUMP OPTIONS menu.
2 Use IAB Inflation and IAB Deflation controls to adjust
timing and resume pumping by pressing the START key.

CAUSE AND RESPONSE:

OPERATION TRIGGER
MODE SOURCE DETAILED CAUSE SYSTEM RESPONSE RESET
AUTO ECG or Valid ECG and Waiting to pump / IAB Automatically, when trigger
Pressure Arterial Pressure deflated. returns.
trigger do not exist or
are lost while in A nominal 10 Sec. alarm
AUTO operation delay is incorporated to
mode. reduce false-positive
nuisance alarms due to
transient violations.

No Trigger (on Start-Up)

ASSOCIATED HELP SCREEN:

PROBABLE CAUSE CORRECTIVE ACTIONS

An electrode is detached or 1 Reattach or reposition the electrodes.
malpositioned.
An incorrect trigger source has been selected. 1 Select a different trigger source using the TRIGGER
SOURCE arrow keys. Resume pumping by pressing the
START key.
There is inadequate signal acquisition. 1 Try ECG lead selections via the ECG/AP Sources
menu, or select EXT. ECG, if appropriate.
2 Adjust the ECG Gain by accessing the PUMP
OPTIONS menu.

CAUSE AND RESPONSE:

OPERATION TRIGGER
MODE SOURCE DETAILED CAUSE SYSTEM RESPONSE RESET
Semi Auto or ECG, No valid trigger has Standby / IAB is deflated. Automatically, when a
Manual Pacer A, existed since the IABP Audible alarm is inhibited. valid trigger is detected.
or Pacer was powered up in
V/AV SEMI AUTO or
MANUAL OPERATION
MODE.

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Troubleshooting Help Screens

Prolonged Time in Standby

ASSOCIATED HELP SCREEN:

PROBABLE CAUSE CORRECTIVE ACTIONS

The IABP has been in STANDBY mode for an extended 1 Verify whether it is appropriate to resume pumping.
period of time.
2 Press the START key to resume pumping.

CAUSE AND RESPONSE:

OPERATION TRIGGER
MODE SOURCE DETAILED CAUSE SYSTEM RESPONSE RESET
All All Pump has been in Unaffected Message cleared by
Standby for at least 10 pressing the START key.
minutes.

Manual Timing Selected - See Help

ASSOCIATED HELP SCREEN:

PROBABLE CAUSE CORRECTIVE ACTIONS

The operator has selected MANUAL OPERATION 1 MANUAL OPERATION MODE is recommended for
MODE. pediatric therapy.
2 Refer to the operating instructions for pediatric use.

CAUSE AND RESPONSE:

OPERATION TRIGGER
MODE SOURCE DETAILED CAUSE SYSTEM RESPONSE RESET
Manual All The operator selected Standby/IAB deflated Automatically when the
MANUAL OPERATION operator selects another
MODE. OPERATION MODE or
presses the START key.

Verify Proper Timing

ASSOCIATED HELP SCREEN:

PROBABLE CAUSE CORRECTIVE ACTIONS

The operator has selected SEMI AUTO OPERATION 1 Press the START key to resume pumping.
MODE.
2 Verify proper timing and adjust using IAB INFLATION
and IAB DEFLATION controls if necessary.

CAUSE AND RESPONSE:

OPERATION TRIGGER
MODE SOURCE DETAILED CAUSE SYSTEM RESPONSE RESET
Semi Auto All The operator selected Standby / IAB deflated Automatically when the
SEMI AUTO operator selects another
OPERATION MODE. OPERATION MODE or
presses the START key.

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Help Screens Troubleshooting

IAB Not Filled

ASSOCIATED HELP SCREEN:

PROBABLE CAUSE CORRECTIVE ACTIONS

(No Associated Help Screen) (No Associated Help Screen)

CAUSE AND RESPONSE:

OPERATION TRIGGER
MODE SOURCE DETAILED CAUSE SYSTEM RESPONSE RESET
Semi Auto or All System is in Manual Fill Vent / IAB deflated. Perform a Manual Fill or
Manual and user pressed the switch to Autofill.
START key when no fill
had been performed.

Verify Proper Timing

ASSOCIATED HELP SCREEN:

PROBABLE CAUSE CORRECTIVE ACTIONS

(No Associated Help Screen) (No Associated Help Screen)

CAUSE AND RESPONSE:

OPERATION TRIGGER
MODE SOURCE DETAILED CAUSE SYSTEM RESPONSE RESET
Semi Auto or All Operator has changed Standby / IAB deflated Automatically when the
Manual the trigger source. operator presses the
START key or an
OPERATION MODE key.

Manual Fill IAB

ASSOCIATED HELP SCREEN:

PROBABLE CAUSE CORRECTIVE ACTIONS

(See the following Manual Fill IAB - Adult Size IAB Catheters
and Manual Fill IAB - Pediatric IAB Catheters tables for
corrective actions.)

CAUSE AND RESPONSE:

OPERATION TRIGGER
MODE SOURCE DETAILED CAUSE SYSTEM RESPONSE RESET
Semi Auto or All Notifies the operator when Fill Mode (Safety Disk Drive Press the IAB Fill key for
Manual to manually fill the IAB Vented) / IAB deflated. 2 seconds.
catheter with shuttle gas.
Displayed in MANUAL
FILL mode when the IAB
Fill key is activated,
venting the safety disk.

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Troubleshooting Help Screens

Manual Fill IAB - Adult Size IAB Catheters

1. Remove the autofill tubing from the IAB Fill Port on the Safety Disk.

2. Attach a 3-way stopcock to the IAB Fill Port on the Safety Disk.

3. Attach a 60 cc syringe to the stopcock.

4. If the IAB FILL LED is not illuminated then press and hold the IAB Fill key for 2 seconds to activate it and
relieve vacuum.

5. Open the stopcock between the disk and syringe. Evacuate the disk by pulling back on the syringe
plunger.

6. Close the stopcock to the disk. Evacuate the syringe.

7. Repeat steps 5 and 6 until strong resistance is noted. A strong resistance should be noted within 3
attempts. If a strong resistance is noted, proceed to step 9.

8. If a strong resistance is not noted within 3 attempts, remove the Drain port tubing and attach the Drain
port plug, located in the manual fill accessory kit, to the Drain port. Repeat steps 5 through 7.

NOTE: All Datascope adult size IAB Catheters have a manual fill pre-load of 80 cc.
When using catheters from another manufacturer consult manufacturer for
guidelines.

9. Attach the syringe to the manual fill port located below the Safety Disk.

10. Fill the syringe and discard the contents.

11. Fill the syringe with 40 cc of Helium.

12. Holding the syringe tip DOWN, attach the syringe to the stopcock on the Safety Disk, and open the
stopcock to the disk.

13. Press the IAB Fill key for 2 seconds to allow the syringe contents to be drawn into the disk.

14. Close the stopcock to the disk.

15. Refill the syringe with the remaining 40 cc pre-load of Helium from the manual fill port.

16. Holding the syringe tip down, attach the syringe to the stopcock on the Safety Disk.

17. Open the stopcock to the Safety Disk. The remaining 40 cc of gas is drawn into the disk.

18. Close the stopcock and remove the syringe.

19. Press the START key to begin pumping.

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Manual Fill IAB - Pediatric IAB Catheters

1. Set the OPERATION MODE to MANUAL and then set IAB FILL MODE to MANUAL via the PUMP
OPTIONS menu.

2. Refer to the pediatric balloon catheter instructions for the correct Safety Chamber size, pre-load volume
and extender.

3. On the Safety Disk, remove the autofill tubing from the IAB Fill Port, the drain tubing from the Drain Port,
and the D.C. output cable.

4. Remove the Adult Safety Disk from the IABP. Install the pediatric adapter, drive hose and the appropriate
size Safety Chamber as directed in the Operator manual.

5. Attach a 3 way stopcock to the IAB Fill Port on the Safety Chamber.

6. Attach the patient balloon and extender to the Safety Chamber.

7. Attach a 20 cc syringe to the stopcock.

8. If the IAB FILL LED is not illuminated then press and hold the IAB Fill key for 2 seconds to activate it and
relieve vacuum.

9. Open the stopcock between the chamber and syringe. Evacuate the chamber by pulling back on the
syringe plunger.

10. Close the stopcock to the chamber. Evacuate the syringe.

11. Repeat steps 9 and 10 until strong resistance is noted.

12. Attach a 20 cc syringe to the manual fill port located below the Safety Disk.

13. Fill the syringe and discard the contents.

14. Fill the syringe with the correct pre-load volume of Helium as outlined in the catheter instructions. If the
pre-load volume exceeds 20 cc, fill the syringe with half of the appropriate pre-load volume.

15. Holding the syringe tip DOWN, attach the syringe to the stopcock on the Safety Chamber, and open the
stopcock to the chamber.

16. Press the IAB Fill key for 2 seconds to allow the syringe contents to be drawn into the chamber. Close
the stopcock and remove the syringe.

17. If the pre-load volume exceeded 20 cc, add the remaining pre-load volume by repeating steps 14
through 15.

18. Close the stopcock and remove the syringe.

19. Press the START key to begin pumping.

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Troubleshooting Help Screens

Leak Testing Safety Disk

ASSOCIATED HELP SCREEN:

PROBABLE CAUSE CORRECTIVE ACTIONS

(No Associated Help Screen) (No Associated Help Screen)

CAUSE AND RESPONSE:

OPERATION TRIGGER
MODE SOURCE DETAILED CAUSE SYSTEM RESPONSE RESET
N/A - Diagnostic Test Displayed during the Safety Disk Diagnostic Mode / Message clears when leak
safety Disk Leak IAB is not connected. test completes.
Diagnostic to indicate
that testing is still in
progress.

Autofilling
ASSOCIATED HELP SCREEN:

PROBABLE CAUSE CORRECTIVE ACTIONS

(No Associated Help Screen) (No Associated Help Screen)

CAUSE AND RESPONSE:

OPERATION TRIGGER
MODE SOURCE DETAILED CAUSE SYSTEM RESPONSE RESET
All All The System is in the Autofill Mode / IAB deflated Message clears when
process of Automatically autofill completes.
purging and refilling the
IAB with Helium.

Autofilling and Clearing IAB Circuit

ASSOCIATED HELP SCREEN:

PROBABLE CAUSE CORRECTIVE ACTIONS

The IABP is performing an extended Autofill process to 1 Check for traces of blood in the IAB catheter and/or
clear the IAB circuit of condensate. Drain Port tubing.
2 If blood is present, notify the physician. Disconnect the
IAB catheter from the console.
3 If blood is not present, continue therapy as appropriate.

CAUSE AND RESPONSE:

OPERATION TRIGGER
MODE SOURCE DETAILED CAUSE SYSTEM RESPONSE RESET
All All The IABP has detected Continue autofill. Message cleared when
the potential presence of autofill process is
condensation in the IAB completed.
circuit.

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Help Screens Troubleshooting

Function Not Available

ASSOCIATED HELP SCREEN:

PROBABLE CAUSE CORRECTIVE ACTIONS

(No Associated Help Screen) (No Associated Help Screen)

CAUSE AND RESPONSE:

OPERATION TRIGGER
MODE SOURCE DETAILED CAUSE SYSTEM RESPONSE RESET
All All Displayed when the Unaffected. No action in Message automatically
operator presses an response to pressing clears after 3 seconds.
unavailable key. unavailable keys.

AUTO OPERATION MODE is Disabled

ASSOCIATED HELP SCREEN:

PROBABLE CAUSE CORRECTIVE ACTIONS

AUTO operation mode requires that IAB FILL mode be 1 Open PUMP OPTIONS menu, and set the IAB FILL
set to Auto. mode to AUTO.
2 If the AUTOFILL mode is desired, then, press the
START key to refill the IAB and resume pumping.

CAUSE AND RESPONSE:

OPERATION TRIGGER
MODE SOURCE DETAILED CAUSE SYSTEM RESPONSE RESET
Semi Auto or All System is set to Manual Unaffected. AUTO operation Message clears after 30
Manual Fill mode and the mode is disabled. seconds or upon user
operator tries to select selection of Autofill mode.
AUTO operation mode.

Gas Loss and Catheter Alarms Disabled

ASSOCIATED HELP SCREEN:

PROBABLE CAUSE CORRECTIVE ACTIONS

IAB FILL mode is set to MANUAL. 1 If appropriate, set IAB FILL mode to AUTO via the
PUMP OPTIONS menu. The system must now be
autofilled to activate the gas loss and catheter alarms.

NOTE: The autofill system cannot be used with

pediatric size catheters.

CAUSE AND RESPONSE:

OPERATION TRIGGER
MODE SOURCE DETAILED CAUSE SYSTEM RESPONSE RESET
Semi Auto or All All leak and catheter Unaffected Message clears when not
Manual alarms are disabled in MANUAL FILL mode.
when manual fill mode
is selected (IAB catheter
is manually filled).

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Troubleshooting Help Screens

Slow Gas Loss Alarm is OFF

ASSOCIATED HELP SCREEN:

PROBABLE CAUSE CORRECTIVE ACTIONS

The SLOW GAS LOSS ALARM is set to OFF. 1 If appropriate, set the SLOW GAS LOSS ALARM to ON
via the PUMP OPTIONS menu.

CAUSE AND RESPONSE:

OPERATION TRIGGER
MODE SOURCE DETAILED CAUSE SYSTEM RESPONSE RESET
All All Slow gas loss alarm has Unaffected Message clears when
been disabled by the slow gas loss alarm is re-
user. Note: Rapid enabled.
loss function is still
active.

Function Unavailable in AUTO OPERATION MODE

ASSOCIATED HELP SCREEN:

PROBABLE CAUSE CORRECTIVE ACTIONS

(No Associated Help Screen) (No Associated Help Screen)

CAUSE AND RESPONSE:

OPERATION TRIGGER
MODE SOURCE DETAILED CAUSE SYSTEM RESPONSE RESET
AUTO ECG or Displayed when the Unaffected. No action in Message automatically
Pressure operator presses an response to pressing clears after 3 seconds.
unavailable key while in unavailable keys.
the AUTO operation
mode.

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Help Screens Troubleshooting

Battery In Use
ASSOCIATED HELP SCREEN:

PROBABLE CAUSE CORRECTIVE ACTIONS

The IABP is being powered from the internal batteries. 1 Verify that it is necessary to operate from the internal
battery. If appropriate, switch to the AC power source.
2 Verify MAINS power switch, located above the AC
power cord connector, is ON.

CAUSE AND RESPONSE:

OPERATION TRIGGER
MODE SOURCE DETAILED CAUSE SYSTEM RESPONSE RESET
All All Indicates System is Unaffected. Message clears when
operating from an power is received from
internal battery. AC power source.

SYSTEM TEST OK
ASSOCIATED HELP SCREEN:

PROBABLE CAUSE CORRECTIVE ACTIONS

(No Associated Help Screen) (No Associated Help Screen)

CAUSE AND RESPONSE:

OPERATION TRIGGER
MODE SOURCE DETAILED CAUSE SYSTEM RESPONSE RESET
All All All systems passed Vent / IAB deflated Message automatically
power-up diagnostics. clears 10 seconds after
completion of the tests.

System Trainer
ASSOCIATED HELP SCREEN:

PROBABLE CAUSE CORRECTIVE ACTIONS

(No Associated Help Screen) (No Associated Help Screen)

CAUSE AND RESPONSE:

OPERATION TRIGGER
MODE SOURCE DETAILED CAUSE SYSTEM RESPONSE RESET
All All Displayed when the Unaffected Message clears when
System Trainer is being System Trainer is removed.
used as ECG and
Pressure source.

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Troubleshooting Help Screens

Auto R-Wave Deflate

ASSOCIATED HELP SCREEN:

PROBABLE CAUSE CORRECTIVE ACTIONS

The patient's rhythm is too random to predict the next 1 DO NOT adjust the deflation setting. The System will
beat. The System is now using R-wave deflation instead return to that setting once the rhythm becomes
of the current deflation setting. predictable.
2 If you do not want the System to override the deflation
setting, set R-TRAC to OFF via the PUMP OPTIONS
menu.

CAUSE AND RESPONSE:

OPERATION TRIGGER
MODE SOURCE DETAILED CAUSE SYSTEM RESPONSE RESET
AUTO or Semi ECG in R-TRAC is ON and the Pumping Unaffected - The Status automatically clears
Auto AUTO patient's rhythm is too system is now using R-wave when patient rhythm
or random to predict the deflation instead of the current becomes predictable.
ECG or A occurrence of the next deflation setting.
Pacer in beat. Disabled by setting R-Trac
Semi Auto In response, the system to OFF in the PUMP
has automatically OPTIONS menu.
selected R-Wave
Deflation Mode.

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Help Screens Troubleshooting

R-Wave Deflate
ASSOCIATED HELP SCREEN:

PROBABLE CAUSE CORRECTIVE ACTIONS

(No Associated Help Screen) (No Associated Help Screen)

CAUSE AND RESPONSE:

OPERATION TRIGGER
MODE SOURCE DETAILED CAUSE SYSTEM RESPONSE RESET
AUTO or Semi ECG in Operator has enabled Unaffected - Deflation occurs Move deflation slider
Auto AUTO R-wave deflation by upon detection of the R-wave. away from extreme right
or moving deflate slider to position.
ECG or A extreme right position.
Pacer in
Semi Auto

Battery Maintenance Required

ASSOCIATED HELP SCREEN:

PROBABLE CAUSE CORRECTIVE ACTIONS

The IABP internal battery requires maintenance. 1 Contact Getinge Service.
2 Continue operation on AC power.
3 If battery operation is necessary, battery run time may
be reduced. Monitor the system for a Low Battery
alarm.

NOTE: If a Low Battery alarm occurs, immediately

connect the system to AC power.

CAUSE AND RESPONSE:

OPERATION TRIGGER
MODE SOURCE DETAILED CAUSE SYSTEM RESPONSE RESET
All All The Battery Test Due None At startup the message is
Date or Battery cleared when the START
Replacement Date key is pressed. During
predate the current operation the message is
system date at startup or removed after 30 seconds.
the internal battery has
a total accumulated
discharge time in excess
of 100 total discharge
cycles.

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Troubleshooting Help Screens

Battery Maintenance Required

ASSOCIATED HELP SCREEN:

PROBABLE CAUSE CORRECTIVE ACTIONS

The internal battery has become unreliable. 1 Contact Getinge Service. Battery replacement may be
required.
2 Continue operation on AC power.
3 If battery operation is necessary, battery run time may
be reduced. Monitor the system for a Low Battery
alarm.

NOTE: If a Low Battery alarm occurs, immediately

connect the system to AC power.

CAUSE AND RESPONSE:

OPERATION TRIGGER
MODE SOURCE DETAILED CAUSE SYSTEM RESPONSE RESET
All All The internal battery None At startup the message is
failed to reach a cleared when the START
satisfactory level of key is pressed. During
charge within 10 hours. operation the message is
removed after 1 minute.

Help Available for Initial Setup

ASSOCIATED HELP SCREEN:

PROBABLE CAUSE CORRECTIVE ACTIONS

(See the following table for corrective actions)

CAUSE AND RESPONSE:

OPERATION TRIGGER
MODE SOURCE DETAILED CAUSE SYSTEM RESPONSE RESET
All All Displayed at power-up Unaffected Automatically, message
until the first pump cycle. clears with first pump
cycle.

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Help Screens Troubleshooting

Help Available for Initial Set Up

1. Verify MAINS power switch is ON.

2. Open the Helium Tank.

3. Establish ECG and Pressure.

4. If using a Sensor IAB, ensure that the IAB sensor cable (orange) has been connected. Otherwise, zero
the transducer:

• Open the transducer to air

• Press the ZERO PRESSURE key for 2 seconds
• Close the transducer
5. Confirm that the operation mode is AUTO.

6. Attach the IAB catheter and the appropriate extender to the safety disk.

7. To initiate pumping, press the START key. In response the IABP will Autofill and then begin pumping. If
desired, IAB DEFLATION timing can be fine-tuned using the IAB DEFLATION controls.

8. Verify the setting of the AUG. ALARM:

• Verify that the AUG. ALARM setting is approximately 10 mmHg less than the patient's diastolic
augmented pressure.

• If needed, adjust by pressing the AUG ALARM key and using the NAVIGATION ARROW keys to
change the value displayed on the screen.

9. Initial setup is now complete.

Help Available for Manual Fill

ASSOCIATED HELP SCREEN:

PROBABLE CAUSE CORRECTIVE ACTIONS

(See text for “Manual Fill IAB” Help Screen) (See text for “Manual Fill IAB” Help Screen)

CAUSE AND RESPONSE:

OPERATION TRIGGER
MODE SOURCE DETAILED CAUSE SYSTEM RESPONSE RESET
Semi Auto or All Displayed when the user Unaffected Automatically, message
Manual selects Manual Fill. clears when autofill is
There is no advisory selected.
message displayed.
Only an auxiliary
message on the bottom
of the screen.

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Troubleshooting Clinical

3.4 Clinical
3.4.1 Water Condensation
During balloon pumping, a fine mist or small droplets of water may occasionally be
observed within the IAB extension catheter and/or fill and drain tubing. This mist is
condensed water. The CS100 has a condensate removal module which automatically
collects and removes condensate without operator intervention.

If desired, the following procedure may be used to manually check and purge any
condensate which may have collected in the IAB extension catheter.

1. In the Semi Auto operation mode, set the IAB FILL MODE to Manual, via the
PUMP OPTIONS menu.
2. Disconnect patient balloon catheter extender from patient IAB. Tip the catheter extender
downward.
3. Press the START key.
4. Pump for approximately 20 to 30 seconds. Water will be expelled.
5. Stop assist by pressing the STANDBY key. Reconnect the IAB catheter extender to
patient IAB.
6. Via the PUMP OPTIONS menu, set the IAB FILL MODE to Auto.
7. Return to AUTO operation, if appropriate.
8. Press the START key to autofill the IAB and resume assist.

NOTE: If large water droplets remain in 6 foot extender (P/N

0684-00-0182), it may be attached to suction to remove
them. Be sure extension is disconnected from IAB and safety
disk. See “User Maintenance” on page 7-1.

NOTE: When in the Manual Fill mode or when the battery is low,
the condensate removal module is disabled to conserve
power.

NOTE: When transferring a patient from another IABP system

without a condensate removal feature, ensure that all
droplets of condensate are removed from the extension
catheter tubing before connecting to the CS100. To remove
condensate, see the procedure above or follow the IABP
manufacturer's recommendations.

CAUTION: Proper operation of the automatic condensate removal

system requires proper connection of the safety disk
assembly to the console. Excessive condensate may indicate
the need to service the condensate removal module.

CAUTION: The Condensate Removal Module (CRM) is designed to

function most efficiently when the unit is in a normal upright
(vertical) position. Transient operation of the CRM in a
horizontal position should be limited if condensate removal
functionality is required.

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Clinical Troubleshooting

3.4.2 Clinical Considerations During Operation

ECG: There are several methods to correct conditions which alter or hamper
the acquisition of a reliable ECG. Reposition or replace ECG elec-
trodes and check that the patient cable is properly connected. In Semi
Auto operation mode, choose an alternate lead selection or change
ECG Gain setting.

Pressure: Flush arterial line at regular intervals per standard hospital procedure.
Adequate flushing to maintain pressure line patency and alignment of
stopcock in the proper position will prevent the majority of possible
pressure trace problems.

Atrial Ensure that the R-Trac option is not disabled. In AUTO operation mode,
Fibrillation: there are no special pump considerations for handling atrial fibrillation.
In Semi Auto operation mode, use ECG Trigger. This will track ran-
dom rhythm most consistently, by automatically holding the IAB inflated
until the detection of the next R-Wave. Pressure triggering is not recom-
mended in atrial fibrillation.

Triggering on Ectopics: The CS100 automatically deflates on and assists the ectopic beat, if
the ectopic R-wave is sensed. In Semi Auto operation mode, if the
ectopic beat is of small amplitude, reliable triggering can be maxi-
mized if an ECG Lead is selected which minimizes the amplitude differ-
ence between the normal QRS complex and that of the ectopic beat.
No special adjustments are necessary.

Cardiac Arrest- When defibrillating the patient, the CS100 has protection and is com-
Ventricular Fibrillation: pletely isolated from the patient and the defibrillator's electrodes. How-
ever, the operator should stand clear of the pump during defibrillation.
This is particularly important when the CS100 is operated while dis-
connected from an earth grounding point, such as the A.C. power
receptacle.

Ventricular Standstill If possible, use ECG or Arterial Pressure trigger during CPR. This
or Prolonged Cardiac facilitates synchronization of the assist to the rate and rhythm of chest
Arrest: compressions.

In AUTO operation mode, the ECG (R-wave) or Arterial Pressure

signal will automatically be selected as the Trigger Source. Choice is
dependent upon relative signal quality.

If neither the ECG nor the Arterial Pressure signals produce ade-
quate trigger reliability to allow for AUTO Operation, the IABP may be
triggered by its own internal clock. Select the Semi Auto operation
mode and set the Trigger Source to Internal. The default internal
rate is 80 bpm but can be varied between 40 and 120 bpm by access-
ing the PUMP OPTIONS menu and setting the Internal Rate.

Prolonged Time in If the CS100 is inadvertently placed in STANDBY, the time in

Standby and STANDBY will appear on the left side of the monitor screen. After 10
Thrombus on the IAB minutes an alert message will appear. The audible alert is user select-
membrane: able. Verify whether it is appropriate to resume assist. If so, press the
START key to resume assist.

WARNING: The patient balloon should not remain

inactive in the patient (i.e., no inflating and
deflating) for more than 30 minutes, due to
the potential for thrombus formation.

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Troubleshooting Clinical

Change in Pressure If patient's pressure monitoring site is changed while assisting in Semi
Monitoring Site: Auto or Manual operation mode, the Inflation Interval key can
be quickly pressed and released to recalculate arterial pressure trans-
mission delay (APD). This will assure accurate digital pressure display
values and arterial pressure trace inflation interval markers.

Patient Risk Currents: Simultaneous connection of several medical devices to the patient may
cause summation of leakage currents which can exceed the values
allowed by the Safety Agency Standards. See “Agency Compliance”
on page 11-22.

3.4.3 Use in Electro-surgical Environment

The CS100 IABP has built in electro-surgical interference suppression which minimizes
electro-surgical unit (ESU) noise from disturbing system performance. While the system will
suppress ESU noise, it cannot eliminate it all together. Sparking to tissue occurs when an ESU
is operated. This generates noise that extends into the ECG frequency range. Since the
system must pass these frequencies, some ESU noise may interfere with the ECG signal,
particularly with high ESU power settings.

Limiting the power of this noise energy is desirable. The magnitude of interference is directly
related to the power setting of the ESU, which should be as low as possible for the intended
effect. Successful ECG triggering in the presence of ESU noise depends, to a large extent, on
proper patient preparation and ESU use.

Following the guidelines listed will minimize the amount of energy coupled from the ESU to
the ECG input of the CS100, generally resulting in stable ECG triggering. When the CS100
is in AUTO operation mode, it will automatically select Pressure Trigger when ESU
interference is detected and return to ECG a short interval after interference ceases. If the
clinician prefers to stay in Pressure Trigger during the operating room procedure, this can
be accomplished by selecting Semi Auto operation mode. Then select Pressure Trigger
Source. Return to AUTO operation mode when appropriate.

When the CS100 is used in an electrosurgical environment, the following techniques are
recommended to minimize interference from electrosurgical devices:

• Always use supplied Datascope Operating Room ECG patient cable and lead wire
option. See “ECG Patient Cables” on page 10-6, for more information. These cables are
shielded and incorporate ESU suppression components
• Keep the ECG cables at right angles to the electrosurgical cables to the greatest extent
possible
• Locate the ECG electrodes as far away from the surgical site as possible
• Locate the ECG electrodes approximately equidistant from the surgical site to minimize
any difference in potential between electrodes
• Place all ECG electrodes on the same plane (either anterior or posterior) to minimize any
difference in potential between electrodes
• Place the electrosurgical return plate directly under the surgical site
• Use the minimum required electrosurgical setting

CS100/CS100i Operating Instructions 0070-10-0527-02 3 - 45

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Clinical Troubleshooting

WARNING: External bedside monitors used with the CS100 in the

operating room, must be equipped with electro-surgical
interference suppression.

3.4.4 Use During Cardiopulmonary Bypass

During full cardiopulmonary bypass, the CS100 can be used to inflate and deflate an IAB
by selecting Semi Auto Operation Mode and using the Internal Trigger source. The
internal rate can be adjusted by accessing the PUMP OPTIONS menu and then adjusting
the Internal Rate. The Inflation and Deflation controls should be set to their default mid
position.

While the patient is on full bypass, either Semi Auto or Manual operation mode can be
used. The Inflation and Deflation controls should be set to mid position.

If ECG activity is detected while in the internal trigger mode, the IAB will be immediately
deflated to avoid asynchronous pumping and resultant interference with systole.

WARNING: Do not remain in the internal trigger mode when the patient
is generating a cardiac output.

When weaning a patient from cardiopulmonary bypass, the IABP can be used to assist
cardiac function. If ECG is established it can be used to trigger the system. Check to see if a
reliable ECG trigger is present by noting a flashing diamond in the upper right corner of the
display. The diamond should flash one time for each R-Wave.

If the patient's ECG amplitude is insufficient to cause triggering, select the Semi Auto or
Manual operation mode. Then adjust ECG Gain to increase its amplitude, via the PUMP
OPTIONS menu. If a pacer is present, the appropriate pacer trigger mode can also be
used. Pressure triggering is also available if a 7 mmHg minimum pulse pressure is present.

As bypass flow rate is decreased and the heart begins to generate a cardiac output, check
that timing is correct. Frequent reassessment may be necessary as changes in patient
condition may alter the relationships between electromechanical events.

3.4.5 Weaning a Patient from IABP Support

Weaning may be accomplished by a gradual and progressive reduction in IAB frequency or
IAB volume displacement (augmentation), or a combination of both.

When weaning, frequent assessment of hemodynamic parameters and patient condition is

recommended.

WARNING: When weaning by reduced IAB augmentation, do not

reduce augmentation to a point at which the IAB status
indicator moves less than 50%.

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Troubleshooting Clinical

3.4.6 Doppler Information

The doppler used with the CS100 is the Huntleigh* Mini Dopplex*. This doppler uses
ultrasound techniques to detect vascular blood flow.

To Use the Doppler

Waveform Headphone
1. Open the top storage bin. The doppler is Socket Socket
located inside the door panel. LCD Display
Probe
Loudspeaker Holder
2. Remove the doppler from the storage bin.
Probe
3. Press the button on the tether reel to retract
the doppler. On/Off Button

4. If battery replacement is necessary, remove

Probe
the cover of the battery compartment, and lift Probe Cable Connector
out the old battery. Install a new 6LR61,
6LF22, or equivalent 9V alkaline battery. FIGURE 3-5 Front View
5. Replace cover.

6. Place a liberal amount of coupling gel on the

transducer or on the patient's skin.
Pocket Clip
7. Turn the unit on and position the probe over Attachment
Volume
the artery to be examined. Control

8. Hold the probe at a 45° angle to the surface Cal Button

of the skin. Battery
Compartment
9. Adjust the position and angle of the probe to
obtain the optimum audio signal.

NOTE: Refer to the Huntleigh Operators

FIGURE 3-6 Rear View
Manual for more detailed
instructions.

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Manual Fill Mode Troubleshooting

3.5 Manual Fill Mode

If an Autofill failure remains unresolved after following the associated help screen
instructions, the IAB may be manually filled. Step-by-step help screen instructions for manual
fill are also provided for display at the bedside. These help screens become available
following a press and hold of the IAB Fill key in the Manual Fill mode. The step-by-step
manual fill instructions, with illustrations, are included below for Adult IABs:

WARNING: Gas Loss and IAB Catheter alarms are inoperative when
pumping in the Manual IAB Fill mode. Consequently, the use
of the augmentation alarm is essential when caring for
patients while operating in this mode.

CAUTION: When in the Manual Fill Mode, the condensate removal

module system is disabled.

1. Via the PUMP OPTIONS menu, set the IAB

FILL MODE to Manual.

FIGURE 3-7 Press the Manual

Key
2. Remove the Autofill tubing from the IAB Fill Port
on the safety disk.

FIGURE 3-8 Remove Autofill

Tubing

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Troubleshooting Manual Fill Mode

3. Attach a three way stopcock to the IAB Fill Port

on the safety disk.

FIGURE 3-9 Attach 3-way

Stopcock

4. Attach a plastic 60 cc syringe to the stopcock.

FIGURE 3-10 Attach Syringe

5. Press the IAB Fill key for 2 seconds to relieve

vacuum. Verify that the Advisory Manual fill is
displayed.

NOTE: All Datascope adult size IAB

catheters (plus extenders) have a
Manual fill volume of 80 cc. When
using catheters from another
manufacturer consult that
manufacturer for guidelines.

6. Open the stopcock between the disk and syringe.

Evacuate the disk by pulling back on the syringe
plunger.
FIGURE 3-11 Press the IAB Fill
7. Close the stopcock to the disk. Evacuate the key
syringe.

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Manual Fill Mode Troubleshooting

8. Repeat steps 6 and 7 until a strong resistance is

noted. A strong resistance should be noted within

OFF
three attempts. If a strong resistance is noted,
proceed to step 10. OFF

OPENED CLOSED

FIGURE 3-12 Open and Close

Stopcock

9. If a strong resistance is not noted within three

attempts, remove the Drain port tubing and
attach the Drain port plug, located in the Manual
fill accessory kit, to the Drain port.
Repeat steps 6 - 8.

10. Attach the syringe to the Manual Fill Port located

on the rear panel. Hold hand over syringe
plunger.

WARNING: Never use a glass syringe for the

Manual Fill Procedure. Possible
injury may occur if glass breaks.
Hold your hand over the syringe
plunger. FIGURE 3-13 Pull Back on the
Plunger to
11. Fill the syringe and discard the contents. Evacuate the
Syringe

12. Refill the syringe with 40 cc of Helium.

FIGURE 3-14 Attaching

Syringe to
Manual Fill Port

13. Quickly move and attach the syringe to the

stopcock on the safety disk, and open the
stopcock to the disk.

FIGURE 3-15 Attach syringe to

Stopcock

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Troubleshooting Manual Fill Mode

14. Press the IAB Fill key for 2 seconds to allow the
syringe contents to be drawn into the disk.

15. Close the stopcock to the disk.

16. Fill the syringe with the remaining 40 cc fill
volume of Helium from the Manual Fill Port.
17. Quickly move and attach the syringe to the
stopcock on the safety disk.
18. Open the stopcock to the safety disk. The
remaining 40 cc of gas will be drawn into the
disk.

FIGURE 3-16 Press the IAB Fill

key
19. Close the stopcock and remove the syringe.

CAUTION: If the contents of the syringe are not

drawn into the safety disk DO NOT
resume balloon pumping. Return to
step 5 in the Manual Fill Procedure,
paying careful attention to syringe
fill volume. If second attempt fails,
there most likely is a leak at one of
the safety disk ports or stopcock and
they should be checked.

FIGURE 3-17 Syringe Contents

Drawn into Disk
20. Press the START key to begin assisting.

NOTE: Due to diffusion of gas, the Manual

fill procedure should be repeated
every 2 hours or as needed.

FIGURE 3-18 Press the START

key

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 4.0 Printer

4.1 Printer Operation

To initiate a printout, press the Print Strip key. To start a continuous printout, hold the Print
Strip key for two (2) seconds. The associated LED lamp will blink as printing continues. To
stop the continuous printout, press the Print Strip key again.

If desired, printing can be initiated automatically due to an alarm event or at a fixed interval
selected by the user. The initiation, format and length of the printout will adhere to the
settings in the PRINTER PREFERENCES submenu of the USER PREFERENCES menu.

The speed of printing (25 or 50 mm/sec) is controlled by the Sweep Speed setting in the
DISPLAY PREFERENCES submenu of the USER PREFERENCES menu. See “Menu Group
Keys” on page 1-14.

CS100/CS100i Operating Instructions 0070-10-0527-02 4-1

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Printer Formats Printer

4.2 Printer Formats

(Recording Waveforms)

The dual trace chart recorder provides a hard copy record of patient waveforms. Printouts
follow the format defined by the settings in the PRINTER PREFERENCES submenu, located
in the USER PREFERENCES menu. Dual or single trace formats may be selected. Waveform
choices are: ECG, Arterial Pressure and Balloon Pressure Waveforms.

ECG: A delayed ECG waveform will be recorded for the length specified in the
printer configuration menu. Numeric information for Lead selection and
Size is printed at the beginning of the trace. If either are changed the
numeric information is reprinted.

Trigger
Markers

Inflation
Interval

FIGURE 4-1 ECG Sample

Arterial Pressure: A delayed invasive arterial pressure waveform will be recorded for the
length specified in the printer configuration menu. Scale information is
annotated at the beginning of the trace. If the pressure scale changes the
annotation is automatically repeated.

Shows
Indica the
que la end of Congelar
función the graphpantalla se ha cancelado

FIGURE 4-2 Arterial Pressure Sample

Balloon Waveform: A delayed balloon pressure waveform will be recorded for the length
specified in the printer configuration menu.

NOTE: There is no scale information printed for balloon pressure

waveform.

FIGURE 4-3 Balloon Waveform Sample

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Printer Printer Formats

Dual Waveforms: Two of the three possible waveforms, ECG, Arterial Pressure and Balloon
Waveform may be recorded simultaneously for the length specified in the
printer configuration menu. Waveforms will be printed as in the exam-
ples below. Annotations will be as described previously for single wave-
form recordings.

13

FIGURE 4-4 ECG and Arterial Pressure Sample

FIGURE 4-5 ECG and Balloon Waveform Sample

13

FIGURE 4-6 Arterial Pressure and Balloon Waveform Sample

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Trailer Annotations Printer

4.3 Trailer Annotations

At the completion of the recording, an annotated trailer is appended to the print. The
annotation describes patient and system status. The format of the annotation depends upon
the IAB Assist Frequency selection. Specifically, it determines how the systolic and
diastolic pressures are presented. When 1:2 or 1:3 is selected as the IAB frequency, the
recorder will print both assisted and unassisted systolic and diastolic pressure information.

See FIGURE 4-7, for samples of these trailer formats. The date and time of the recording is
automatically printed by the CS100. The Patient I.D. is left blank and can be filled in
manually.

Sample Printer Formats for Waveforms

Patient I.D.__________ Patient I.D.__________ Patient I.D.__________

Date: 20/06/98 Date: 20/06/98 Date: 20/06/98

Time: 11:3 Time: 11:33 Time: 11:33

Alarm and Advisory Messages Alarm and Advisory Messages Alarm and Advisory Messages

Alarm and Advisory Messages Alarm and Advisory Messages Alarm and Advisory Messages

Alarm and Advisory Messages Alarm and Advisory Messages Alarm and Advisory Messages

OPERATION MODE: Auto OPERATION MODE: Semi Auto OPERATION MODE: Manual

TRIGGER: ECG TRIGGER: ECG TRIGGER: ECG

HEART RATE: 80 HEART RATE: 80 HEART RATE: 80

ASSIST FREQ.: 1:1 ASSIST FREQ.: Standby ASSIST FREQ.: 1:3

SYST/DIAS: 113/46 SYST/DIAS: 117/52 ASSISTED

AUG: 125 MEAN: 69 Syst/Dias: 104/47

MEAN: 91 Aug: 126

UNASSISTED
Printout for IAB Frequency 1:1 Printout for Standby Mode
Syst/Dias: 117/52

MEAN: 79

Printout for IAB Frequency 1:3

FIGURE 4-7 Trailer Formats

NOTE: 1:2 uses the same format as 1:3

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 5.0 Portable/Transport Operation

5.1 Hospital Cart

The CS100 console is mounted on a hospital cart
for intra-hospital transport. The console may be
separated from the cart to accommodate very
tight spaces within a hospital room/venue.

All four casters on the hospital cart swivel to

facilitate movement in any direction. The two
casters closest to the cart handle are multi-
functional. They can be locked in the straight
position (directional lock) or used as a brake
(total lock). The two casters on the side opposite
the handle have total lock only.

NOTE: The casters on the handle side of

the cart may or may not have a
braking feature. Refer to
markings on the casters.

It is recommended that all four casters are locked FIGURE 5-1 CS100 Console on
a Hospital Cart
for use on uneven surfaces or in transport
vehicles.

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Portable Operation Portable/Transport Operation

5.2 Portable Operation

Datascope recommends the following during portable operation:

1. Battery fully charged

2. Altitude changes are compensated for automatically in the Autofill mode or manually
in the Manual Fill mode
3. The system is secure and stable when used on an ambulance, helicopter or fixed wing
aircraft.
The CS100 is available in two versions with identical clinical functionality. A console version
with a hospital cart or the CS100 Universal Transport System (UTS). The UTS is specifically
designed for air and vehicular transport. The UTS version mechanically attaches to a docking
station for high strength mounting.

WARNING: The user should continually rely on visual alarm messages

during high noise transport situations. The "Flash Alarms"
option should be turned ON to improve the visibility of
alarm messages. This option can be set in the User
Preferences Menu (located in the Display Preferences
submenu.)

CAUTION: Prior to transport, ensure that the Helium cylinder yoke

handle is tight and the Helium pressure gauge is a least
25% full. Approximately every 30 minutes during transport,
verify that the yoke handle is tight and that a noticeable
pressure drop has not occurred.

CAUTION: The Condensate Removal Module (CRM) is designed to

function most efficiently when the unit is in a normal upright
(vertical) position. Transient operation of the CRM in a
horizontal position should be limited if condensate removal
functionality is required.

NOTE: For information on outfitting an aircraft for IABP transport

contact your local Datascope sales representative. See
“Accessories” on page 10-1, for information on the
Transport Docking Station.

5.2.1 Battery Operation

During portable operation, the CS100 is powered by a rechargeable battery. Prior to
portable operation the battery should be fully charged. A fully charged battery is indicated
by a continuously illuminated battery charging LED. This LED is located on the front panel.

The Battery In Use status message and the Battery Indicator are displayed when the
CS100 is operating from the internal rechargeable battery. When the battery has
approximately 30 minutes of operating time remaining, the following occurs:

• An audible double beep alarm is activated for 30 seconds

• The Low Battery or Low Battery (EXT) (CS100i only) alert messages are displayed
on the screen continuously
• The Battery Indicator is displayed as empty and it starts flashing
• The condensate removal module will not operate

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Portable/Transport Operation Portable Operation

5.2.2 Battery Charging

To charge the internal battery:

1. Leave the system power cord plugged in and set the MAINS On/Off to ON.
2. Check that the Battery Charging LED is illuminated (continuously or flashing depending
on state).
3. Allow a minimum of 18 hours to fully charge a low battery. Allow 8 hours to achieve at
least 90 percent charge (typically).
4. A fully-charged new internal battery will provide at least 135 minutes of portable
operation.

NOTE: A reduction in run time will occur over a battery's life due to
age, storage temperature and discharge depth. Batteries
which are continually subjected to complete discharge cycles
without the recommended immediate recharging, can incur
permanent damage. See “User Maintenance” on page 7-1,
for additional information.

5.2.3 Switching from AC to Battery Operation

1. The system automatically switches to battery power if AC power is removed
(intentionally or due to power loss).
2. If necessary, charge the battery as described in accordance with previous instructions.
3. Verify that the BATTERY IN USE advisory message and the Battery Indicator are
displayed.

NOTE: Battery charging is not active in this state.

4. When AC power is restored the system automatically reverts from internal battery
operation to AC Mains usage. The internal battery pack will resume charging while the
system operates from AC Mains power. Always verify that the Battery Charging LED is
continuously illuminated or flashing.

5.2.4 Operation From External DC Source (CS100i only)

In this case, the System is to be powered from an external DC source such as may be
available from an ambulance, helicopter, or external battery pack.

1. Connect a voltage-compatible* external source to the External DC Input connector.

2. Internal battery will not be charged in this mode.
3. The IABP ON/OFF switch will activate the system.
4. Interruption of the external DC source power will result in portable internal battery
operation, as described in section 5.2.1.
5. The internal BATTERY INDICATOR will not be displayed during external DC operation
* See section 11.8 “Power” for compatibility issues.

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Portable Operation Portable/Transport Operation

5.2.5 Operation from DC-to-AC Inverter

The CS100 can be powered from a DC-to-AC inverter if the DC source and the inverter meet
the specifications defined below. The DC source and inverter should be checked for proper
operation by qualified maintenance personnel prior to emergency use. The message
Battery in Use will not be displayed during proper AC inverter operation.

Specifications for DC Source and Inverter For Use with the CS100
Voltage Output: 100-120/220-240 VAC ±10%

Frequency: 50 Hz ±2 Hz, 60 Hz ±2 Hz

Overshoots: Does not continuously generate overshoots greater than 375.

Volts peak with widths greater than 10 msec. when powering the
system.

Waveform: Sine wave or modified sine wave

Output Capability: Minimum of 500 watts continuous power; 1000 watts surge power

Safety Compliance: Meets or exceeds safety standards per IEC 60601-1.

See “Operation Instructions” on page 2-2. The operating sequence is the same as described
in this section, except that AC power is obtained from the inverter output connector.

5.2.6 Effects of Altitude Changes During Air Transportation

NOTE: Before using the system in air transportation, check for
sufficient supply of Helium since the balloon will be filled
several times.

For proper operation during air transport, the CS100 balloon pressure must adapt to local
atmospheric pressure. In the Autofill mode the system will automatically purge and fill the
IAB when local atmospheric pressure decreases or increases by 25 or 50 mmHg,
respectively. These pressure changes occur approximately every 1,000 feet of rise or 2,000
feet of drop in altitude.

WARNING: The Autofill mode should be used during air transport. If the
Autofill mode cannot be used and the Manual Fill mode is
required, ensure that a manual fill is performed at each
interval and altitude that an Autofill would occur.

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Portable/Transport Operation Portable Operation

5.2.7 Portable Operation Emergency Battery Back Up Recommendations

Datascope recommends that a back-up to the internal battery always be available.

WARNING: Replacing the internal battery, when AC mains are not

connected, will stop the therapy, (i.e., power down the
pump.)

5.2.8 Removing Pump Console from the Cart

The console can be removed from the cart with or without the battery pack attached.
Removing the console without the battery pack attached reduces the lift weight by
approximately 35 lbs.

CAUTION: Insure that the wheels of the cart are in the locked position
when removing the pump console from the cart or returning
the pump console to the cart.

1. Lock the wheels on the cart. Pivot the cart handle

out of the way. The cart handle swivel release is
located on the inside surface of the vertical
support column near the top (see figure 5-2). To
release, push knob down and pivot the handle
counter-clockwise approximately 180°. Follow
the same procedure when returning the handle to
its normal locked position.

To remove console with battery pack attached,

continue with step 2. To remove console by
detaching battery pack, skip to step 3. Push down
to release

FIGURE 5-2 Release Handle

2. To remove with the battery pack attached keep

the release levers on the console in the locked
position. Pull the console release handle on the CS100
Intelligent Counterpulsation

cart base by pressing the tab to the right of the

handle and pulling straight out (see figure 5-3).
Lift pump console (to lift, grab the pump console
along the top edge of the front and rear panel)
straight up, off the cart and place down near the
cart. Skip to step 5.

FIGURE 5-3 Console Release

Handle

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Portable Operation Portable/Transport Operation

3. To remove by detaching battery pack, while the

console is attached to the cart, lift both battery
release levers up to the unlocked position (see
figure 5-4). Lift the console (to lift, grab the pump
console along the top edge of the front and rear
panel, (see figure 5-5) straight up, off the cart
and place down near the cart. The battery pack
remains on the cart.

Levers

FIGURE 5-4 Lift Levers to Unlock

Battery

4. To release the battery pack from the cart, pull the Lift from here
console release handle located just below the
battery pack (see figure 5-3). Use both hands to IABP OFF

CS100
ON

PUSH HERE
TO OPEN

Pump Intelligent Counterpulsation

pick up the battery pack. Place the battery pack Console

on a dry, flat surface. Lift the release levers up to
the unlocked position. To reconnect the battery
pack to the console, lift the pump console (to lift,
grab the pump console along the top edge of the
Release
front and rear panels) and carefully lower it Levers
straight down onto the battery pack. When firmly
seated, push the release levers into the locked
Connector
position. Test the electrical integrity by turning the Block
IABP On/Off switch ON. If system does not turn
on, lift the release levers, lift up pump console
Battery
and lower again. Repeat until proper connection Pack
is made.
FIGURE 5-5 Placement of System
over the Battery

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Portable/Transport Operation Portable Operation

5. Push the button on the rear of the monitor to

detach it from the cart handle (see figure 5-6).
6. Attach monitor on top of the pump console. Make
sure that the monitor is securely attached before
transporting the system.

Release
button

FIGURE 5-6 Push Button to

Detach Monitor

7. Pull up the console handle and tilt the system to

pull for transport (see figure 5-7).

CAUTION: When transporting the system

without the cart, be sure to only pull
the system by the handle, DO NOT
PUSH.
IABP
OFF
CS ON
100
Inte
llige
nt Cou
nterpu
lsat
ion

PUS
TO H HERE
OPEN

FIGURE 5-7 Pull Up Handle

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Universal Transport Systems (UTS) Portable/Transport Operation

5.3 Universal Transport Systems (UTS)

The CS100 is available in a transport specific version designated as UTS.

• The UTS IABP features larger wheels than the cart-configured IABP. This allows for ease of
movement over rough, uneven surfaces.
• The UTS IABP has a retractable handle, used for pulling the IABP while in transport

NOTE: The UTS should never be pushed by this handle.

• The UTS IABP includes a soft-sided storage bag for accessories such as the Doppler, ECG
cables and lead wires.
• The UTS IABP has pockets and handles to ease lifting into vehicles, helicopters or fixed
wing aircraft.

Upper Lift Pockets

Handles

FIGURE 5-8 Universal Transport System - Lift Locations

CAUTION: Lifting the IABP by the Lower Lift Handles requires two
people. While lifting, the IABP must be steadied by placing a
free hand near the top of the unit to provide stability.

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Portable/Transport Operation Universal Transport Systems (UTS)

5.3.1 Use of the Light Weight Docking Station (P/N 0436-00-0110) and
Mobilizer
The UTS IABP mounts onto a docking station (Datascope accessory) for transport use in an
emergency vehicle, helicopter or fixed wing aircraft.

Ensure that the docking station has been properly secured to the transport vehicle deck. (see
instruction sheet enclosed with the docking station).

1. Position swing bolts as shown in figure below and red knobs are fully backed out (turn
the red knobs counter-clockwise).

Transport Vehicle Deck

Transport
Mount
Swing Bolt Red Knobs

Swing Bolt Swing Bolt

FRONT VIEW

FIGURE 5-9

2. Place the System in front of the docking station and center it. Roll the System into place
using the sides of the docking station as guides.

CS10
Intellig 0
ent Co
unterp
ulsatio
n

Handle

SIDE VIEW

FIGURE 5-10 CS100 UTS and Docking Station

The UTS IABP mounts onto a docking station (Datascope accessory) for transport use in an
emergency vehicle, helicopter or fixed wing aircraft.

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Universal Transport Systems (UTS) Portable/Transport Operation

3. Without tilting the System, ensure the conical pins have been fully engaged by the
conical holes on the mobilizer.

IABP OFF ON

CS100 PUSH HERE

TO OPEN

Intra-Aortic Balloon Pump

Mobilizer Conical Pin

Gap
SIDE VIEW (PARTIAL CUT AWAY)

FIGURE 5-11

4. Move the swing bolts into position as shown in FIGURE 5-9. Turn the red knobs
clockwise until gaps are fully closed and a sudden increase in resistance is felt.

Red
Knobs

No Gap FRONT VIEW No Gap

FIGURE 5-12

5. Check the function of the docking station by rocking the top of the System in all
directions. No motion between the mobilizer and the docking station should be
apparent.

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 6.0 Pediatrics

6.1 Pediatric Balloon Pumping

The following is an abbreviated version of the normal set up instructions. See “Detailed
Operation” on page 2-1, for more information regarding procedures.

The drive system of the CS100 is modified for pediatric use by replacing the safety disk with
the pediatric adapter assembly (P/N 0998-00-0110-01). This adapter extends the drive
pressure line allowing remote placement of the safety chamber isolator by the patient's side.
This is required to keep pediatric IAB catheter length short. Note that the 4 and 6 ft.
extension catheters are used only with adult balloons.

6.1.1 Pediatric Adapter Installation

1. Disengage all pneumatic and electrical
connections (IAB Fill Port, Drain Port, IAB Catheter
Extender) and DC Input.

FIGURE 6-1 Connections

CS100/CS100i Operating Instructions 0070-10-0527-02 6-1

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Pediatric Balloon Pumping Pediatrics

2. Turn the adult safety disk approximately 30°

counter-clockwise and pull straight out.

FIGURE 6-2 Safety Disk

3. Install pediatric adapter assembly into the
pneumatic drive and turn the adapter
approximately 30° clockwise.
4. Verify an o-ring is installed at the end of the
adapter assembly.

FIGURE 6-3 Pediatric Adapter

Assembly
5. Hand-tighten the appropriate size pediatric safety
chamber onto the other end of the adapter hose.
(See table below for the correct safety chamber
selection.)

FIGURE 6-4 Pediatric Safety

Chamber

DATASCOPE PEDIATRIC IAB APPROPRIATE SAFETY CHAMBER

2.5, 5, 7 cc Pediatric (15 cc) Safety Chamber
12, 20 cc Adult (72 cc) Safety Chamber

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Pediatrics Pediatric Balloon Pumping

6.1.2 Safety Chamber Leak Test (Pediatric)

Perform a safety chamber leak test using the following procedure:

1. Unplug the safety chamber fill port.

2. Move the safety chamber close to the CS100 and attach the Autofill tube to the safety
chamber fill port.
3. Obtain a dead end Luer plug for later use in capping the end of the safety chamber.
4. Press and hold the IAB Fill key and the PREVIOUS PAGE key (located under the
HELP key) while pressing the system Power On/Off switch to ON.
5. Release both keys when the message Safety Disk Leak Test appears adjacent to the
Advisories on the display.
6. See “Safety Disk Leak Test” on page 2-2, for a detailed description of the leak test.
7. At the completion of the leak test, remove the Autofill tube.
8. Remove any plug from the patient balloon connector on the safety chamber.

6.1.3 Normal Power Up Procedure

If the CS100 is not already on, press the IABP ON/OFF switch to turn it ON.

6.1.4 Establish Fill Gas Pressure

1. Slowly open the Helium cylinder valve fully counter-clockwise.
2. Make sure that the Helium pressure gauge shows that the Helium supply is in the
operating range (within the white area).

CAUTION: When the system is not in use, close the cylinder valve fully
clockwise to prevent a potential leak and the depletion of
the Helium supply.

3. Check that the message Low Helium is not displayed.

4. If the Low Helium message is displayed, check Helium display icon or Helium cylinder
gauge for adequate gas capacity and check Helium cylinder attachment for leaks.
5. Replace the cylinder if necessary.

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Pediatric Balloon Pumping Pediatrics

6.1.5 Initial Set-up for Pediatric Balloon Pumping

1. Set the pump controls as follows:
• Operation Mode Manual
• Trigger Source ECG
• IAB Frequency 1:1
• IAB Augmentation Off
• IAB Inflation Midpoint
• IAB Deflation Midpoint

Using the PUMP OPTIONS menu, set the following conditions:

• IAB FILL MODE Manual

• ECG Gain Normal

2. Attach Pediatric IAB catheter to the safety chamber now or after acquisition of ECG and
pressure signals.

See the following sections for more detailed information:

• See “ECG Acquisition” on page 2-4.

• See “Arterial Pressure Acquisition” on page 2-6.
• See “Selection of Trigger Source” on page 2-7.

6.1.6 Timing of Pediatric Balloon Pumping

Manual Timing
On the keypad, check that the operation mode is set to Manual. Use the IAB inflation
controls to move the highlighted segment of the arterial pressure trace so that it begins at the
dicrotic notch. Adjust the IAB Deflation control so that the highlighted portion ends slightly
before systole.

On the inflate control scale, 0 represents inflation at the trigger event with each increment
representing a 125 msec delay. On the deflate control scale, 0 represents deflation
immediately after inflation with each increment representing a 125 msec delay.

If inflation is adjusted, deflation is directly effected and will also require re-adjusting. If a
trigger event is detected prior to the IAB deflation point, a safeguard will automatically
deflate the IAB at the trigger event.

WARNING: Use only Manual timing when pumping the pediatric

catheters.

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Pediatrics Pediatric Balloon Pumping

NOTE: The CS100 is designed to recognize heart rates up to 200

bpm. At rates in excess of 200 bpm, the ECG trigger
refractory period causes the CS100 to automatically assist
every other beat. In manual timing mode, IAB timing will
NOT be adversely effected when this occurs. The system will
automatically resume assisting every beat when the heart
rate falls below 200 bpm.

6.1.7 Filling Pediatric Catheters

NOTE: Autofill is not calibrated to fill pediatric catheters. Follow
this procedure and use the exact filling volume specified on
the balloon package.

NOTE: The installation of the pediatric adapter assembly must be

completed, as detailed in “Pediatric Adapter Installation” on
page 6-1, before proceeding.

1. On the display, verify the IAB FILL MODE is set to Manual.

NOTE: If this is not the case, set the IAB FILL MODE to Manual via
the PUMP OPTIONS menu.

NOTE: Manual Fill is not available when in AUTO operation mode.

2. Attach a 3-way stopcock to the side port Luer fitting on the chamber.
3. Press the IAB FILL key for 2 seconds. Screen will display Manual Fill IAB message.
4. Check that the Helium gauge indicates sufficient gas pressure.

5. Attach an empty 20 cc plastic syringe to the 3-way

stopcock.
6. Open the stopcock between the syringe and the
safety chamber.
7. Evacuate the safety chamber by pulling up on the
plunger of the syringe.
OFF

8. Close the stopcock to the safety chamber and press

the plunger down to empty the syringe.
9. Repeat this until a strong resistance is felt. Safety FIGURE 6-5 Attaching Syringe
chamber balloon should be tightly collapsed after to Stopcock
this procedure.
10. Close the stopcock to the safety chamber and
remove the syringe.
OFF
OFF

OPENED CLOSED

FIGURE 6-6 Opened and

Closed Stopcock

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Pediatric Balloon Pumping Pediatrics

11. Attach a 20 cc syringe to the Manual Fill Port.

12. Fill the syringe and discard the contents.
13. Fill the syringe a second time with the amount of fill
(preload) volume specified on the balloon
package.

WARNING: Never use a glass syringe for the

Manual Fill Procedure. Possible injury FIGURE 6-7 Attaching Syringe
may occur if glass breaks. Hold your
to Manual Fill Port
hand over the syringe plunger.

14. Hold the syringe tip down and/or cover with your
finger. Attach the filled syringe to the stopcock on
the safety chamber and open the stopcock
between the safety chamber and the syringe. OFF

FIGURE 6-8 Attaching filled

Syringe to
Stopcock

15. Press the IAB Fill key for 2 seconds. Contents of

the syringe will be pulled into the safety chamber.
16. Close the stopcock and remove the syringe.
17. If the contents of the syringe are not drawn into the
safety chamber, DO NOT resume balloon
pumping.
18. Return to step 3 and repeat the procedure paying
careful attention to the syringe fill volume.
19. If the second attempt fails, there most likely is a
leak at one of the safety chamber ports or stopcock
and they should be checked.
FIGURE 6-9 Pressing the IAB
Fill key

CAUTION: When in Manual Fill Mode, the IAB should be re-filled every
2 hours when using adult IABs and every 45 minutes when
using pediatric IABs.

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Pediatrics Pediatric Balloon Pumping

6.1.8 Initiation of Assist (Pediatric)

1. Check that IAB AUGMENTATION is OFF.
2. To initiate assist, press the START key. The associated indicator will begin to flash and
continue flashing with each inflation.

NOTE: A short full inflation cycle is initiated to facilitate Arterial

pressure transmission delay (APD) measurements for the
first initiation of assist only.

3. Use the IAB AUGMENTATION UP arrow key to slowly increase the level until IAB
augmentation is at maximum.
4. If necessary, adjust the IAB INFLATION and IAB DEFLATION controls to achieve
proper timing. Augmentation should begin at the dicrotic notch.
5. While pumping, press and hold the Inflation Interval key to confirm that the marked
and intensified segment of the arterial pressure trace begins approximately at the
dicrotic notch.
6. If not, the Arterial Pressure transmission delay (APD) can be automatically recalculated
by quickly pressing and releasing the Inflation Interval key.
7. Confirm proper intensification position on the AP waveform.
8. If still incorrect, APD can be manually adjusted by accessing the Arterial Pressure
Delay submenu in the PUMP OPTIONS menu.
9. Once APD is selected, the delay may be adjusted from 0 to 180 msec. in 4 msec.
increments using the UP and DOWN arrow keys. The marked and intensified segment
of the arterial pressure waveform will consequently move later on the trace. This delay is
adjusted to approximate the start of intensification at the dicrotic notch.

CAUTION: If the patient's pressure monitoring site is changed while

pumping, the Inflation Interval key can be quickly pressed
and released to recalculate arterial pressure transmission
delay. Reconfirm proper position. This will assure accurate
digital blood pressure indices.

10. Confirm that the Aug Alarm is ON and the limit is set approximately 10 mmHg below
diastolic augmentation.

WARNING: When the CS100 is operated in the Manual Fill mode, the
IAB Catheter and Gas Loss Alarms are disabled. The
message “Gas Loss and Catheter Alarms Disabled” will be
displayed in the Advisory section of the display. The IAB
status bar will not be active. Therefore, use of the Low
Augmentation Alarm is essential in pediatric IAB patient
care. By setting the Low Augmentation Alarm, the system
monitors the level of assist and alerts the user in the event
that diastolic augmentation has dropped below the alarm
limit.

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Pediatric Balloon Pumping Pediatrics

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 7.0 User Maintenance

7.1 Introduction
This section of the manual outlines routine maintenance which should be performed by the
user or qualified personnel. Guidelines for correcting certain problems are also provided.
Some system problems may require the user to contact a Datascope Service Representative.

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Chart Paper Loading User Maintenance

7.2 Chart Paper Loading

Instructions are provided below to describe the periodic
replacement of chart paper. In order to obtain
satisfactory recordings it is important that the correct CS100
Intelligent Counterpulsation

type of paper be used (P/N 0683-00-0422-02).

Paper can be replaced as follows:

1. Open paper compartment by pressing the release

bar.
2. Remove depleted paper spindle.

FIGURE 7-1 Recorder Door

3. Place new paper inside paper compartment,

leaving enough paper exposed to exit the door.
4. Close the recorder door. CS100
Intelligent Counterpulsation

5. Press the Print Strip key to confirm correct paper

roll insertion.

FIGURE 7-2 Recorder

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User Maintenance Installation and Replacement of Helium Cylinder

7.3 Installation and Replacement of Helium Cylinder

WARNING: Only personnel familiar with the handling of high pressure
gas cylinders should install or replace the Helium cylinder.

CAUTION: Use medical grade Helium only.

The Helium cylinder should be replaced when pressure drops below a preset level. This is
indicated when the LOW HELIUM message is displayed during operation and/or when the
Helium pressure gauge shows that the Helium supply is in the red zone. There is no need to
interrupt IABP. However, the cylinder should be replaced as soon as possible to avoid a
potential Autofill failure which can delay pumping.

To replace cylinder:

1. Close Helium cylinder valve fully clockwise.

2. Slowly loosen the yoke T handle.
3. Remove the cylinder.
4. Check that the washer is present and in good condition on the yoke.
5. Install a fresh Helium cylinder.
6. Tighten the yoke T handle.
7. Slowly open the Helium cylinder valve (turn counter-clockwise).
8. Using the mechanical Helium gauge, verify Helium pressure is within acceptable limits.

NOTE: See “Helium Cylinders” on page 10-3, for additional

information regarding Helium cylinder specifications.

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Installation and Replacement of Helium Cylinder User Maintenance

Cylinder
Valve

Cylinder
Yoke

Cylinder

FIGURE 7-3 Helium Cylinder

NOTE: Disposal of used Helium cylinders should be in accordance

with prevailing local statues and in conformance with
recycling requirements.

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User Maintenance Helium Cylinder Refilling Information

7.4 Helium Cylinder Refilling Information

Operation of the system with Helium as the shuttle gas requires using one of three custom
size medical gas cylinders available only through Datascope (See “Accessories” on
page 10-1.) These cylinders incorporate a standard post-style valve and may be refilled by
suppliers who normally refill D size cylinders. Cylinders filled by any medical gas supply
company may be used if they meet DOT, CGA, and USP requirements. Additional local
requirements may apply depending on specific locale. Datascope recommends using only
medical grade USP Helium with the system.

If your usual medical supplier cannot refill cylinders with medical grade Helium, consult the
following suggested sources. Any phone or fax numbers that have been provided may have
changed. Please check your local directory for current phone numbers. Also, the Customer
Service Representative at the Regional Sales Office nearest your location can supply the
name of a local distributor who can provide this cylinder gas product.

Puritan Bennett Gas - U.S.

Phone: (800) 234-5456

Use the following extensions to reach the Regional Sales Office:

Atlanta 46
Baltimore 47
Boston 48
Chicago 21
Kansas City 20
Miami 50
Ontario, CA 74
San Francisco 70
St. Louis 30

BOC Gases - Domestic and International

Phone: (800) 262-4273 or (908) 464-8100
Fax: (888) 262-3298
Website: www.boc.com

Praxair, Inc. - Domestic and International

Phone: (800) 772-9247 or (716) 879-4077
Fax: (716) 879-2015
Website: www.praxair.com

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Safety Disk/Condensate Removal Module User Maintenance

7.5 Safety Disk/Condensate Removal Module

WARNING: Datascope recommends the use of surgical gloves while
performing Safety Disk/Condensate Removal to avoid
contact with residual condensate or other body fluids.
Disposal of used safety disk should be in accordance with
prevailing hospital practices for medical refuse.

CAUTION: The installation and removal of the safety disk requires a

partial turning action to secure or remove. When securing,
confirm that the rib on the top surface of the safety disk
assembly is fully rotated to the 12 o’clock position.

The safety disk and condensate removal module are combined into one assembly. The
assembly is located on the rear of the CS100.

Removal of the assembly:

1. Disconnect assembly's pneumatic connections:

• Luer fitting, labeled IAB Fill Port.
• Condensate drain line, located on the rear panel, labeled Drain Port.
2. Disconnect assembly's electrical connector labeled DC Input.
3. Turn the safety disk approximately 30° counter-
clockwise.

FIGURE 7-4 Turn the

Safety Disk

4. Pull straight out. Narrow

Pin
Curved Slot

FIGURE 7-5 Aligning the

Safety Disk

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User Maintenance Safety Disk/Condensate Removal Module

Disassembly/Reassembly of Condensate Removal Module

1. Remove the condensate removal module from
the disk by removing the two screws and
peeling back the label.
2. Assemble the CRM to the new safety disk. Be
sure the safety disk label lines up between the
ribs on the CRM (see figure 7-6).
3. Replace and tighten screws and adhere label.
4. Fill in installation hours/date and planned
replacement hours/date on label.
FIGURE 7-6 Safety Disk/CRM
Assembly

Installation of the Assembly

1. To install the assembly, reverse the above removal procedure (“Disassembly/Reassembly
of Condensate Removal Module”) aligning the narrow curved slot with the pin (see
figure 7-5).

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User Maintenance Between Pumping Procedures User Maintenance

7.6 User Maintenance Between Pumping Procedures

7.6.1 Cleaning
7.6.1.1 Clean System
Clean the unit with a damp sponge and a mild soap solution or ammoniated cleaner. DO
NOT USE organic solvents or abrasive cleansers. Patient contact parts, such as ECG leads
and blood pressure transducers, should be kept clean and disinfected. Standard hospital
operating procedures regarding cleaning and infection control should always be observed.
The supplied ECG leads can be sterilized using the ETO Gas Sterilization Method. If
appropriate, contact the pressure transducer manufacturer for the recommended sterilization
procedures.

7.6.1.2 Clean Display Area

Clean display screen carefully to prevent scratches. Dust and dirt particles can be blown off
or brushed off using a soft cloth. Fingerprints and stains may be removed by using a liquid
cleaner applied to a soft cloth. DO NOT USE alcohol or solvents containing chlorinated
hydrocarbon. DO NOT apply cleaner directly to the screen.

7.6.2 Battery Replacement

Replace batteries as required. Battery life corresponds with the number of discharge cycles.
Batteries should be replaced after 100 full discharge cycles, at no more than 3 year
intervals, or if run time is less than 135 minutes.

See “Batteries” on page 7-10.

See “Preventive Maintenance” on page 7-11.

NOTE: The sealed lead-acid batteries used in the system are

maintenance free. They will perform reliably provided that
they are kept in the charged state. Leave system plugged
into an AC outlet with the MAINS switch On, even when the
system is not in use. This MUST be done after each portable
operating mode. Disposal of batteries should be conducted
in accordance with local recycling statues and labeling
shown on the battery pack.

7.6.3 Cable and Hose Check

Replace any cables, hoses and cords which appear to be damaged.

7.6.4 Lead Faults Detection Circuits

Periodically test the lead fault detection circuits when the system is not in use.

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User Maintenance User Maintenance Between Pumping Procedures

7.6.5 Low Helium

Periodically test the Low Helium Sensor and indicator.

NOTE: This test should be performed when the system is not in use.
It may be necessary to fill the system more than once before
the “LOW HELIUM” message is displayed.

1. Turn gas supply off.

2. Loosen cylinder yoke slightly. This is to release any residual pressure in the system.
3. Low Helium message will appear.

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Batteries User Maintenance

7.7 Batteries
This section of the manual provides information about the batteries used in the CS100. The
CS100 includes a battery pack which contains two sealed lead acid batteries. A basic
understanding of the proper care and handling of these batteries is essential for safe and
effective battery operation of the CS100.

The batteries are maintenance free. There is no need to add water or electrolyte. The
batteries are sealed to prevent leakage from the terminals or case. Batteries should be
replaced after 100 full discharge cycles, at no more than three (3) year intervals, or if run
time is less than 135 minutes. This recommendation is based upon general experience,
consideration of the typical number of charge/discharge cycles an average battery will be
subjected to over the period, and the number of charge/discharge cycles available from the
battery as well as its application.

This battery type may be subject to local regulations regarding disposal. At the end of the
battery life, dispose of the battery in accordance with any local regulations.

To obtain optimum battery performance and expected battery life the following guidelines
should be observed.

1. The batteries should be maintained at full charge when the CS100 is not in use. It is
required that the CS100 be plugged into an AC outlet when the system is not in use.
Verify the battery is charging by observing the charge indicator on the pump module. If
the unit must be stored for an extended time period (2 months or longer) and AC power
is not available to maintain the internal battery, disconnect the system battery pack from
the system console. Due to battery self-discharge the disconnected batteries must be fully
recharged at least every four months.
2. The battery contains a safety vent that will allow gases to be released should its rating
be exceeded. If this vent is actuated do not operate the unit and contact a qualified
service representative.
3. Over discharging, or draining the battery beyond its capacity, is generally not practical
and will shorten battery life or damage the battery. Therefore, when the IABP is not in
use and the system is not plugged into an AC source, avoid attachment of the battery
pack to the system console.
4. Do not short circuit the battery or battery pack terminals. Keep battery pack covers on at
all times to avoid objects or liquids falling on batteries. Excessive heat is very
detrimental to battery life. Avoid placing the battery or instrument containing the battery
in close proximity to heat sources of any kind.
5. DO NOT attempt to repair the battery. If the case is cracked or terminal leads are
broken replace with the same rate battery.
6. DO NOT disassemble battery. The battery contains an electrolyte which can injure skin
or damage clothing. In the event that electrolyte gets on skin or in eyes, immediately
flush with water for 15 minutes and get prompt medical attention.
7. Batteries must be replaced as pairs, (i.e., same lot/date code.)
8. When a Low Battery message is displayed after any system operation, the battery
should be recharged within several hours to minimize any further drain and to prevent
battery damage.

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User Maintenance Preventive Maintenance

7.8 Preventive Maintenance

Two preventive maintenance schedules have been provided.

Schedule A indicates which actions should be taken by either the Clinical User or by a
Biomedical Technician (BMET). These steps do not require the use of tools and may be
performed in a clinical setting.

Schedule B indicates the actions which should be performed only by a BMET or other
qualified service personnel. Tools are required and in some cases the instrument covers must
be removed.

WARNING: Preventive Maintenance should not be performed when the

IABP is attached to a patient.

Schedule A
To be performed by the clinical user or the BMET.

INTERVAL

BEFORE OR EVERY 1000

AFTER EVERY EVERY 6 HRS. OF USE OR
REQUIRED ACTION EACH USE MONTH MONTHS 2 YRS.*
1 Clean system if necessary.
Check cables, Autofill
tubing, safety disk Luer •
fittings, and line cord.**
2 Perform Safety Disk Leak
Test (See “Safety Disk Leak
Test” on page 2-2.)
•
3 Check Autofill operation
and Helium supply. •
4 Check lead fault,
transducer operation, low
Helium.
•
5 Check battery system (See
“Batteries” on page 7-10.)
Check Battery Indicator
(See “Front Panel” on
•
page 1-38.)
6 Replace safety disk (See
“Safety Disk/Condensate
Removal Module” on •
page 7-6.)
7 Check battery run time.
Replace batteries when
operating time is marginal.
(See “User Maintenance
Between Pumping •
Procedures” on page 7-8.
See “Batteries” on page 7-
10.)
* Whichever comes first.
** Patient contact parts, such as ECG leads and blood pressure transducers, should be kept clean and disin-
fected. Standard hospital operating procedures regarding cleaning and infection control should always
be observed.

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Preventive Maintenance User Maintenance

Schedule B
To be performed by the BMET.

INTERVAL

REQUIRED ACTION (REFER TO EVERY 6 EVERY 2500 EVERY 5000

SERVICE MANUAL) MONTHS HOURS HOURS
1 Perform visual inspection
check list. •
2 Calibrate system and perform
functional test. •
3 Check battery for rated
voltage and check battery run
time. Replace batteries when
operating time is marginal or
•
after three (3) years.*
4 Replace the muffler, the
pneumatic filter and
diaphragms located on the
pump assembly. Confirm
operation of the power
•
supply and compressor
housing fans.
5 Clean the pump
compartment. Inspect hoses
and pump shock mounts.
•
6 Replace the vacuum and
pressure heads on the pump. •
7 Replace the pneumatic filter
located on the purge line. •
8 Vacuum inside of front cover
and power supply intake. •
* This does not imply a three year warranty. The supplied ECG leads can be sterilized using the ETO Gas
Sterilization Method. If appropriate, contact the pressure transducer manufacturer for the recommended
sterilization procedures.

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User Maintenance Warranty

7.9 Warranty
Datascope Corp. warrants that its products will be free from defects in workmanship and
materials for a period of one year from the date of purchase except that (1) disposable or
one-use products are warranted to be free from defects in workmanship and materials up to
a date one year from the date of purchase or the date of first use, whichever is sooner (2)
compressor pump heads, diaphragms, mufflers, motor brushes, and pneumatic filters are
consumed in the course of normal use and are not warranted.

The sealed lead-acid battery is also warranted to be free from defects in materials and
workmanship for a period of one year from the date of purchase.

Safety disks that are initially shipped with the IABP are warranted for one year from the date
of installation, 1000 hours of use or expiration date, whichever comes first.

Recommended preventive maintenance is the responsibility of the user, for which parts and
labor are not included under this warranty.

Datascope Corp. shall not be liable for any incidental, special, or consequential loss,
damage or expense directly or indirectly arising from the use of its products, liability under
this warranty and the buyer’s exclusive remedy under this warranty is limited to servicing or
replacing at Datascope Corp’s option at the factory or at an authorized Datascope
distributor, any product which shall under normal use and service appear to the Company to
have been defective in material or workmanship.

No agent, employee, or representative of Datascope Corp. has any authority to bind

Datascope Corp. to any affirmation, representation, or warranty concerning its products,
and any affirmation, representation, or warranty made by any agent, employee, or
representative shall not be enforceable by the buyer.

This warranty is expressly in lieu of any other express or implied warranties, including any
implied warranty of merchantability or fitness, and of any other obligation on the part of the
seller.

Damage to any product or parts through misuse, neglect, accident or by affixing any non-
standard accessory attachments or by any customer modification voids this warranty.
Datascope Corp. makes no warranty whatever in regard to trade accessories, such being
subject to the warranty of their respective manufacturers.

A condition of this warranty is that this equipment or any accessories which are claimed to
be defective be returned when authorized by Datascope, freight prepaid to Datascope
Corp., Mahwah, New Jersey. Datascope Corp. shall not have any responsibility in the event
of loss or damage in transit.

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Datascope’s Responsibility User Maintenance

7.10 Datascope’s Responsibility

Datascope is responsible for the effects on safety, reliability and performance of the
equipment only if:

A. Assembly operations, extensions, readjustments, modifications or repairs are carried out

by persons authorized by Datascope; and
B. The electrical installation of the relevant room complies with IEC requirements (VDE
0107); and
C. The equipment is used in accordance with the Instructions for Use.

7.11 Extended Warranty

Datascope Corp. warrants that components within the Intra Aortic Balloon Pump units will be
free from defects in workmanship and materials for the number of years shown on the
Datascope invoice. Under this extended warranty, Datascope Corp. will repair any defective
component other than consumables, at no charge for labor and/or materials. Consumable
items are identified as, but not limited to batteries, all external cables, displays, lead wires,
interface cables, and safety disks and/or chambers.

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 8.0 External Interfaces

8.1 Connecting the Modem

The CS100 has an internal modem. The modem is
used for connection to phone lines which can link the
CS100 to a remote PC, with PC•IABP remote clinical
support software installed.

The connection to the CS100 internal modem is

achieved by connecting a standard analog telephone
line to the RJ11, modular phone line jack, on the Rear
Panel.

NOTE: The telephone line should connect

directly to an analog phone line, not
through a company/hospital FIGURE 8-1 Connecting the
switching system. Modem

1. Connect a standard analog phone line into the

phone line connector.
2. Ensure that the telephone line is connected to the telephone jack.

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Connecting PC•IABP External Interfaces

8.2 Connecting PC•IABP

PC•IABP is a personal computer (PC) software application program that is designed for
clinicians to assist in monitoring an Intra-Aortic Balloon Pump (IABP) supported patient from a
remote location. PC•IABP will not affect operator settings on the IABP. It does not have the
capability of altering patient parameters. PC•IABP displays patient and system information
from the CS100 on a remote PC screen.

1. Connect the modem as shown. See “Connecting the Modem” on page 8-1.
2. All other work is performed through the PC. See the PC•IABP Operating Instructions for
complete details.

8.3 Data Communication

The CS100 can transmit data that is requested by a host through the RS-232 port and the
phone line. The following is an overview of the scope of information available via the data
communications port in the standard operating mode. For more information, refer to the
CS100 Communication Specification.

• Pump Control and Alarm Surveillance Settings

• ECG, Arterial Pressure, and Balloon Pressure Waveforms and Markings
• Physiologic Indices
• Alarms, Prompts, Alerts, and Status Messages
• Alarm, Fault, Trigger Modes and Trend Histories

8.3.1 Data Output Connector (RS-232)

Connector: 9 pin, D-type, female

Transmit (TXD) Pin 3

Receive (RXD) Pin 2
Signal Ground Pin 5

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External Interfaces External Monitor Interfacing

8.4 External Monitor Interfacing

The CS100 can use patient ECG and Arterial Pressure signals provided by an external
monitor. External connections are supported by two 1/4” female phone jacks located on the
rear panel.

WARNING: External monitor output signals must meet certain

requirements. See “External Monitor Interfacing” on
page 8-3.

External ECG Monitor Requirements

Bandwidth* 0.5 Hz maximum to 100 Hz minimum
(-3 dB referenced to 10 Hz): (Set monitor to Diagnostic Quality bandwidth)

NOTE: Direct patient leads are preferred for optimum Ventricular

Pacer Triggering due to the system's integral 100 Hz low
pass filter.

Propagation Delay* 25 msec. maximum

(Delay of QRS complex):

Scale Factor* 1 V/mV ±10%

(referenced to 10 Hz):

Pacer Enhancement Enabled for Ventricular Pacer Triggering if

feature is available on the monitor.

NOTE: Digital pacer pulse summed in.

External Arterial Blood Pressure Monitor Requirements

Bandwidth*
(-3 dB referenced to DC): DC to 15 Hz minimum

Propagation Delay*: 25 msec. maximum

(Delay of AC coupled zero-crossings when a 1 Hz sine
wave is applied to the external monitor input)

Scale Factor*: 1 V/100 mmHg ±2%

Datascope supplies interface cables which can be custom wired for compatibility with any
monitor which meets the minimum requirements above. Wiring instructions for both ECG and
Arterial Pressure interface cables are provided (see figure 8-2).

*Required for proper IABP triggering and pressure accuracy.

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External Monitor Interfacing External Interfaces

ECG with Standard Accessory External Signal Cable

(P/N 0012-00-0323*)

1. The cable is supplied with a stereo phone plug to be connected to the CS100 rear
panel ECG Monitor Input jack.
2. The other end should be terminated with the appropriate connector for the external
monitor.
3. The following connections should be made to the external monitor connector:

Brown To 1 Volt/1mV ECG signal

output of external monitor

Black To signal ground

White

FIGURE 8-2 External ECG Signal Cable

Pressure with Standard Accessory External Interface Cable

(P/N 0012-00-0323*)

1. The cable is supplied with a stereo phone plug to be connected to the CS100 rear
panel Pressure Monitor Input jack.
2. The other end should be terminated with the appropriate connector for the external
monitor.
3. The following connection should be made to the external monitor connector.

Brown To 1 Volt / 100 mmHg

PRESSURE signal output of
external monitor
Black
White To signal ground

FIGURE 8-3 External Pressure Interface Cable

WARNING: External bedside monitors used with the CS100 in the

operating room, must be equipped with electro-surgical
interference suppression.

CAUTION: In order to ensure proper IABP performance, only

Datascope approved cables, accessories and Intra-Aortic
Balloons (IABs) should be used with the CS100.

For assistance in interfacing the CS100 with external monitors, contact the Datascope
Technical Support Department.

* Datascope does not recommend the use of the P/N 0012-00-0467 cable with the CS100.

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 9.0 System Configuration

9.1 System Configuration

1. To enter the System Configuration mode press and hold the USER PREFERENCES
menu key while turning the IABP On/Off switch to On.

NOTE: The key must be pressed until the System Configuration

screen appears.

System Configuration WARNING: System Configuration

mode is not for clinical use!

Language Selection
Date Format Selection
Modem Selection
Display Software Revision
50/60 Hertz Filter Selection

To Navigate OPEN MENU To Change BACK BACK To Exit

FIGURE 9-1 System Configuration Screen

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System Configuration System Configuration

9.1.1 Language Selection

1. To enter the Language Selection menu item, use the Navigation Circle's UP and
DOWN arrow keys to highlight the submenu choice LANGUAGE SELECTION.
2. Press the Open Menu key to open the highlighted LANGUAGE SELECTION menu
item.
3. Use the Navigation Circle's UP and DOWN arrow keys to highlight the desired choice
for language (e.g., English.)

WARNING: System Configuration

System Configuration mode is not for clinical use!

Language Selection
Current Selection English
Deutsch
Français
Español
Japanese
Italiano
Português

To Navigate OPEN MENU To Change BACK To Exit

FIGURE 9-2 Language Selection Screen

4. To retain the highlighted choice, press the Open Menu key.

5. To exit this submenu, press the BACK key.

NOTE: The list of languages will always be shown in the native

language while all other text will be in the selected
language.

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System Configuration System Configuration

9.1.2 Date Format Selection

The CS100 allows the date to be set as DD/MM/YY or MM/DD/YY.

1. To enter the date format menu item, use the Navigation Circle's UP and DOWN arrow
keys to highlight the Date Format Selection submenu and then press the Open
Menu key
2. Use the UP and DOWN arrow keys to select the desired format.
3. To retain the selected format, press the Open Menu key.
4. Once the desired format is selected, press the BACK key to move up one menu. The
system restarts and returns to the normal monitoring mode.

WARNING: System Configuration

System Configuration mode is not for clinical use!

Date Format Selection

DD/MM/YY
Current Selection MM/DD/YY

To Navigate OPEN MENU To Change BACK To Exit

FIGURE 9-3 Date Format Selection Screen

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System Configuration System Configuration

9.1.3 Modem Selection

The CS100 is equipped with an internal modem which requires configuration before it can
be used.

1. To enter the modem selection menu item, use the Navigation Circle's UP and DOWN
arrow keys to highlight the Modem Selection submenu.
2. Press the Open Menu key to open the modem selection screen.
3. Use the UP and DOWN arrow keys to highlight the desired modem.
4. To retain the selected modem (e.g., United Kingdom) press the Open Menu key.

System Configuration WARNING: System Configuration

mode is not for clinical use!

Modem Selection
North America
Central/South America, Asia, Far East
Japan
France
Germany
Current Selection United Kingdom
Netherlands
Australia
South Africa
New Zealand
Singapore
Taiwan
User Define/Country

To Navigate OPEN MENU To Change BACK To Exit

Refer to Modem: Cermetek 1794, or TDK DF 2814, or DF 5660 or MultiTech 5600

FIGURE 9-4 Modem Selection Screen

5. Press the BACK key to exit and move up one menu. The system restarts and returns to
the normal monitoring mode.

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System Configuration System Configuration

User Define/Country Selection

This selection permits customization of the modem attributes associated with a country. To
select this choice, open the Modem Selection menu, then via the Navigation Circle’s UP
and DOWN keys, highlight the submenu User Define/Country. Select the submenu by
pressing the Open Menu key.

When the User Define/Country submenu is opened, the following screen is displayed.

NOTE: Contact Datascope Service Personnel for assistance in

setting up a User defined modem.

WARNING: System Configuration

System Configuration mode is not for clinical use!

User Define/Country
Modem ID String TDK-Germany
InitializationString AT&F-I17Z
Reset String AT&F
Default DTE Baud Rate 9600
Override DTE Default Off

to highlight item CHANGE setting DONE Main Menu

FIGURE 9-5 User Define/Country Modem Selection Screen

WARNING: System Configuration

System Configuration mode is not for clinical use!

User Define/Country
Modem ID String MultiTech-Germany
InitializationString AT&GCI=FD
Reset String AT&F
Default DTE Baud Rate 9600
Override DTE Default Off

to highlight item CHANGE setting DONE Main Menu

FIGURE 9-6 User Define/Country Modem Selection Screen (MultiTech 5600)

1. To set or modify the modem ID string, initialization the string or reset the string use the
Navigation Circle’s UP and DOWN arrow keys to highlight selection and press the
Open Menu key to open the submenu.
Key Input is displayed at the bottom of the menu screen along with the string to be
modified in square brackets [ ].

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System Configuration System Configuration

WARNING: System Configuration

System Configuration mode is not for clinical use!

User Define/Country
Modem ID String TDK-Germany
InitializationString AT&F-I17Z
Reset String AT&F
Default DTE Baud Rate 9600
Override DTE Default Off

Key Input:
&/%\$-+=ABCDEFGHIJKLMNOPQRSTUVWXYZ
0123456789 SPACE - - SAVE
[ TDK - Germany ]

To Navigate OPEN MENU To Change BACK To Exit

FIGURE 9-7 User Define/Country Modem Selection with Key Input

2. A highlighted cursor is placed on the first character within the square brackets. To
change that character, use the UP and DOWN arrow keys to highlight the desired
character in the key Input section and press the Open Menu key.
The cursor now moves over to the next character within the square brackets. To skip a
character or to go back to a character, highlight either the <- or -> in the Key Input
field and press the Open Menu key. Each time this is done the cursor will move one
space to the left or right.

3. The Initialization string must be set properly for the selected modem to function. The
string for the TDK is AT&F-I (country code) Z where the country code is replaced
with the appropriate number from the following table. The string for the MultiTech 5600
AT+GCI = (country code).
For example, in Austria, the string for the MultiTech modem will be: AT&GCI = FD and
in Brazil the string will be AT&GCI = 16.

COUNTRY COUNTRY CODE

Austria 22
Belgium 23
Czech Republic 18
Denmark 10
Egypt 3
Finland 9
Ireland 24
Israel 15
Italy 3
New Zealand 11
Norway 8
Poland 3
Spain 6
Sweden 7
Switzerland 14
Turkey 3
UAE 2
All Other Countries 1

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System Configuration System Configuration

MultiTech 5600

COUNTRY COUNTRY
COUNTRY CODE COUNTRY CODE
Argentina 07 Hungary FD
Austria FD Iceland FD
Belgium FD Italy FD
Brazil 16 Korea B5
Canada 99 Liechtenstein FD
Chile FD Luxembourg FD
China FD Malaysia 6C
Cyprus FD Mexico B5
Czech Republic FD Norway FD
Denmark FD Philippines B5
Estonia FD Poland 99
Finland FD Portugal FD
Greece FD Slovak Republic FD
Ireland FD Spain FD
Indonesia 99 Sweden FD
Israel B5 Switzerland FD
Hong Kong 99 Turkey FD

4. The modem selection list allows the TDK DF5660 to be configured for use in many
additional countries. Refer to the following table to find the selection corresponding to
the desired country setting.

COUNTRY SELECTION
Algeria France
Cameroon France
Central African Republic France
Congo France
Ghana United Kingdom
Ivory Coast France
Mali France
Niger France
Nigeria United Kingdom
Pakistan United Kingdom
Senegal France
Togo France
Tunisia France
Yemen United Kingdom
Zambia United Kingdom
European Countries Germany
(not previously listed)
All Other Countries North America

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System Configuration System Configuration

5. Press the BACK key when all initialization information has been entered.
6. Verify the Reset String is set to AT&F.
7. To change the Default DTE Baud Rate use the Navigation Circle’s UP and DOWN
arrows keys to highlight the submenu Default DTE Baud Rate, and then press the
Open Menu key. The open menu displays the available choices for baud rates.
8. To select a new rate, use the Navigation Circle’s LEFT and RIGHT arrow keys, and then
press the Open Menu key to retain the selected rate.

WARNING: System Configuration

System Configuration mode is not for clinical use!

User Define/Country
Modem ID String TDK-Germany
InitializationString AT&F-I17Z
Reset String AT&F
Default DTE Baud Rate 1200 / 2400 / 4800 / 9600
Override DTE Default Off

To Navigate OPEN MENU To Change BACK To Exit

FIGURE 9-8 Default DTE Baud Rate

9. To change the Override DTE Default, highlight that line and press the Open Menu key.
The choices of On and Off display on that line. Choose Off and press the Open
Menu key.

10. Press the BACK key to exit.

11. At the Modem Selection screen, press the BACK key.
12. At the System Configuration screen, press the BACK key. The system should now
return to regular operation, configured and ready for use.

9.1.4 Display Software Revision

1. To enter the Display Software Revision submenu, use the Navigation Circle's UP
and DOWN arrow keys to highlight Display Software Revision.
2. Press the Open Menu key to open the Display Software Revision information.
3. Press the BACK key to close this menu and move up the menu tree.

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System Configuration System Configuration

WARNING: System Configuration

System Configuration mode is not for clinical use!

Display Software Revision

FRONT END: 300F

COMM PROC: 500C
MONITOR KEYPAD: 400K
DSS: XXXD
IABP: 500I

BACK To Exit

FIGURE 9-9 Display Software Revision Screen

9.1.5 50/60 Hertz Filter Selection

The CS100 allows the selection either a 50 or 60 Hertz Notch Filter for ECG noise
reduction. The filter selection should match the local AC MAINS frequency.

1. To enter the 50/60 Hertz Filter Selection submenu, use the Navigation Circle's UP
and DOWN arrow keys to highlight the 50/60 Hertz Filter Selection submenu,
and then press the Open Menu key.
2. Press the UP and DOWN arrow keys to select the desired format, and then press the
Open Menu key to retain it.
3. When the desired format is selected, press the BACK key to move up one menu. The
system restarts and returns to the normal monitoring mode.

WARNING: System Configuration

System Configuration mode is not for clinical use!

50/60 Hertz Filter Selection

Current Selection 50 Hertz Filter
60 Hertz Filter

NOTE: Power must be cycled to take effect.

To Navigate OPEN MENU To Change BACK To Exit

FIGURE 9-10 50/60 Hertz Filter Selection Screen

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 10.0 Accessories

10.1 Introduction
This section of the manual lists accessories used with the CS100. Please refer to the
appropriate sections of this manual for detailed instructions on how the accessories are used
in conjunction with the system.

NOTE: Datascope accessories are recommend for use with the

CS100.

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Standard Datascope Accessories Accessories

10.2 Standard Datascope Accessories

ACCESSORY KITS 0020-00-0463-XX(a)
COUNTRY/LANGUAGE SPECIFIC PARTS
5 Lead Shielded ECG Trunk Cable 0012-00-1155-XX(b)
5 Lead Shielded 50" Leadwire Set for 1155 Trunk Cable 0012-00-1156-XX(b)
5 Lead ESIS 50" Leadwire Set for 1155 Trunk Cable 0012-00-1157-XX(b)
Safety Disk, Adult 0997-00-0985-XX(c)
Condensate Removal Module 0997-00-0986-XX(c)
Manual Fill Kit (Qty. 2) 0020-00-0418-XX(c)
CS100/CS100i Operating Instructions Manual 0070-00-0527-XX(c)
COMMON PARTS
Chart Paper (4 roll pack) 0683-00-0422-04
External Monitor Signal Cable (Qty. 2) 0012-00-0323
60 cc Syringe 0103-00-0026
Washer, Helium Cylinder (Qty. 10) 0348-00-0185
Cable, 4 Wire RJ-11 (modem connection for PC-IABP) 0012-00-0752-02
CS100/CS100i Service Manual CD 0070-CD-0528-01
(a) Accessory Kit - XX tailcodes:
01 English North America
02 English International
03 German
04 French
05 Spanish
06 Japanese
07 Italian
08 Portuguese
09 Swedish
11 Danish
15 Chinese

(b) ECG Trunk/leadwire tailcodes:

- 01 AHA markings for English North America.
- 02 IEC markings for all other countries/languages.
(c) Translated/labeled in multiple languages.

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Accessories Standard Datascope Accessories

10.2.1 Helium Cylinders

Helium cylinders are a standard accessory with the CS100, but they are shipped separately
from the standard accessory kit.

Five different Helium cylinders are available. When either of the 90 liter refillable cylinders
or 99 liter refillable cylinders are ordered, a quantity of three (3) is shipped. When the 140
liter disposable cylinder is ordered, a quantity of one (1) is shipped.

DESCRIPTION PART NUMBER

90 Liter Refillable Helium Cylinder (Qty. 3) 0075-02-0001-03 or 0075-02-0002-03*
99 Liter Refillable Helium Cylinder (Qty. 3) 0075-00-0024-03
140 Liter Disposable Helium Cylinder (Qty. 1) 0202-00-0104
99 Liter Empty Helium Cylinder (Qty. 3) 0075-00-0034-03

* P/N 0075-02-0001-XX is BSI and APPAVE approved. P/N 0075-02-0002-XX is TUV approved.

10.2.1.1 90 Liter Refillable Helium Cylinder

(P/N 0075-02-0001 (BSI, APPAVE approved))
(P/N 0075-02-0002 (TUV approved))

Capacity: 0.5 liters (30.5 in3) @ 2900 psi (equivalent to

approx. 90 std. liters @ 1 Bar (14.7 psi).

Weight (Full): 1.02 kg (2.25 lbs) nominal.

Endurance (Nominal): 1.8 months (125 cc Standard Temperature and

Pressure per fill @ fill every 2 hrs. pumping
continuously 24 hrs. per day).

Approvals: BSI, APPAVE, TUV, EEC per 84/526/EEC,

BAM (Valve)

Container
Specification: 7.06 cm x 23.19 cm (2.78" x 9.13") Overall Height
31.55 cm (12.42") aluminum cylinder pin-indexed
yoke-type Medical Valve connection per ISO 407:
1991 (E) para. 7.2.7/CGAV-1-1994 connection
No. 930.

10.2.1.2 99 Liter Refillable Helium Cylinder

(P/N 0075-00-0024-01)

Capacity: 698 cc (42.6 in3) @ 2216 psi (equivalent to

approx. 99 std. liters @ 1 Bar (14.7 psi)

Weight (Full): 1.13 kg (2.49 lbs) nominal

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Standard Datascope Accessories Accessories

Endurance (Nominal): 2.0 months (125 cc standard Temperature and

Pressure per fill @ fill every 2 hrs. pumping
continuously 24 hrs. per day).

Compliance/Approvals: U.S. DOT 3AL, Post Type Medical Valve

U.S. CGA S-1.1-1994
U.S. CGA V-1-1994
U.S. CGA V-9-1991

Container Specification: 8.23 cm x 23.01 cm (3.24" x 9.06")

Overall Height 31.39 cm (12.36") Service pressure of
153 Bar (2216 PSIG) aluminum cylinder
pin-indexed yoke-type Medical Valve connection per
ISO 407: 1991 (E) para. 7.2.7/CGAV-1-1994
connection NO. 930.

10.2.1.3 140 Liter Disposable Helium Cylinder

(P/N 0202-00-0104)

Capacity: 0.95 liters (58 in3) @ 2200 psi (equivalent to

approx. 140 std. liters @ 1 Bar (14.7 psi).

Weight (Full): 1.82 kg (4 lbs) nominal.

Endurance (Nominal): 2.9 months (125 cc standard Temperature and

Pressure per fill @ fill every 2 hrs. pumping
continuously 24 hrs. per day).

Compliance/Approvals: U.S. DOT E8990, Post Type Medical Valve

U.S. CGA S-1.1-1994.

Container Specification: 8.26 cm x 23.88 cm (3.25" x 9.40") Overall Height

31.37 cm (12.35"). Service pressure of 152 Bar (2200
psig) steel cylinder pin-indexed yoke-type
Medical Valve connection per ISO 407: 1991 (E)
para. 7.2.7/CGAV-1-1994 connection NO. 930.

10.2.1.4 Empty 99 Liter Helium Cylinder, Refillable

P/N 0075-00-0034

Volume: 42.6 cubic inches (698 cc) nominal.

Service Pressure: 153 Bar (2216 PSIG) nominal.

Weight: 2.49 lbs. (when full).

Endurance: 2.0 months when full (125 cc standard Temperature

and Pressure) per fill @ fill every 2 hours pumping
continuously 24 hours per day.

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Accessories Standard Datascope Accessories

Compliance/Approvals: CGA V-9, Standard for Compressed Gas

Cylinder Valve.

CGA S-1.1, Pressure Relief Device Standard.

CGA V-1, Standard for Compressed Gas Cylinder

Valve Outlet & Inlet Connections.

Container Specification: 8.23 cm x 23.01 cm (3.24" x 9.06")

Overall height 31.5 cm (12.4")

Aluminum cylinder pin-indexed yoke-type Medical

Valve connection per ISO 407: 1991 (E)
para. 7.2.7 / CGAV-1-1994 connection No. 930.

10.2.2 Saline Pole

The Saline Pole is included with the CS100. It provides a convenient location to place the
saline container and tubing when needed.

CAUTION: Never place fluids on top of this unit. Make sure that the
saline container and tubing do not hang directly over the
IABP. In case of accidental spillage, wipe clean immediately
and have the unit serviced to ensure no hazard exists.

CAUTION: It is recommended that users avoid the saline pole’s highest

setting when the CS100 is taken off its hospital cart. In this
configuration, the pump may be tilted for transport. If the
pole’s height is excessive when the pump is tilted, it may
contact the operator and possibly cause injury.

FIGURE 10-1 CS100 with Saline Pole

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Standard Datascope Accessories Accessories

10.2.3 ECG Patient Cables

P/N 0012-00-1155-XX

Different leadwire options are provided depending upon the environment in which the IABP
is used. (See below).

NOTE: It is recommended to replace ECG leadwire sets once a year.

Caution should be exercised when individual leadwires are
replaced within a leadwire set. Improper alignment of the
individual leadwires within the combiner may result in
improper connection with the ECG trunk cable. The
technique to properly align the leadwires requires that the
unlocked leadwire combiner first be inserted into the trunk
cable yoke. Next the individual leadwires should be
completely plugged into the yoke observing that the colors
are properly matched. Finally, the combiner is locked to
secure all the leadwires as a set.

10.2.3.1 General Non-Operating Room Leadwire Set

P/N 0012-00-1156-XX

High performance (low noise), fully shielded ECG patient trunk cables and leadwires sets are
recommended for general non-operating room use. The fully shielded, low triboelectric effect
cables minimize the level of noise pick-up due to coupled noise sources and motion-induced
ECG artifact which can occur during patient transport and movement.

10.2.3.2 Operating Room Leadwire Set

P/N 0012-00-1157-XX

High performance (low noise), fully shielded ESIS (Electro-Surgical Interference Suppression)
ECG patient trunk cables and leadwire sets are recommended for operating room use. The
fully shielded ESIS leadwire set contains RF chokes to minimize the pick-up of interference
and the risk of ESU-induced patient burns at electrode sites.

The available trunk cable and shielded leadwire sets are as follows (Note that the trunk cable
indicated is the same for either leadwire set).

DESCRIPTION PART NUMBER

5-Lead Fully Shielded ECG Patient Trunk Cable 0012-00-1155-XX*
5-Lead Fully Shielded Leadwire Set (50") for general use 0012-00-1156-XX*
5-Lead ESIS Fully Shielded Leadwire Set (50") for operating room use 0012-00-1157-XX*
* -01 AHA marking
-02 IEC marking

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Accessories Doppler (Arterial Blood Flow Monitor)

10.3 Doppler (Arterial Blood Flow Monitor)

Type: 8 MHz, ultrasonic, non-directional, hand-held probe

Audible Output: Integral speaker (with volume control) or

removable headset

Display: LCD display of On/Off, battery status

Power: 9V battery

10.4 Communications
For additional information refer to the CS100 Communications Specification.

10.4.1 North American Modem

Compatibility: CCITT V.32 bis with automatic fall-back to
CCITT V.22 bis and Bell 212A or CCITT V.22 bis

Registration: FCC registered for direct connection to telephone

system in North America.

10.4.2 International Modem

Compatibility: CCITT V.34 and lower speed protocols

10.4.3 Data Output Connector (RS-232)

Connector: 9 pin, D-type, female

Transmit (TXD) Pin 3

Receive (RXD) Pin 2
Signal Ground Pin 7
Chassis Ground Pin 1

Data Rate: 9600 bps

Compatibility: EIA RS-232

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Optional Accessories Accessories

10.5 Optional Accessories

DESCRIPTION PART NUMBER
System Trainer 0998-00-0308
Remote Monitor Mount (for pole attachment) 0997-00-0417-01
Monitor Extension Cable 0012-00-1212
Accessory Storage Bag Assembly 0997-00-0428
Protective Cover (for standard unit on hospital cart) 0198-00-0023
Transport Docking Station - Lightweight (for UTS) 0436-00-0110

10.5.1 Accessory Storage Bag Assembly

An optional storage case (P/N 0997-00-0428) is available for attachment to the unit.
Instructions for attachment are included with the storage case.

FIGURE 10-2 CS100 with Accessory Storage Case

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Accessories Optional Accessories

10.5.2 Protective Cover

An optional protective cover (P/N 0198-00-0023) is available for the CS100. This cover is
to be used when the system is not in use. (The IABP ON/OFF switch must be in the OFF
position.)

The cover is placed on the system with the clear window panel over the battery charge
indicator. A velcro strap is provided to secure the cover.

FIGURE 10-3 CS100 with Protective Cover

10.5.3 Transport Docking Station - Lightweight (for UTS)

The docking station (P/N 0436-00-0110) is used to mount the IABP - UTS for use while in
transport in a vehicle or by air.

FIGURE 10-4 Docking Station

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Optional Accessories Accessories

10.5.4 System Trainer

An optional System Trainer (P/N 0998-00-0308) is a compact patient simulator that
generates ECG and Arterial Pressure waveforms. The Trainer plugs onto the patient-direct
ECG and Pressure Input connectors on the Rear Panel. The short phone plug cable, attached
to the Trainer, plugs into the Trainer Input jack on the rear panel.

FIGURE 10-5 System Trainer

WARNING: The System Trainer MUST NOT be connected to a

CS100\CS100i while it is being used for patient therapy.

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 11.0 Specifications

11.1 Triggering
Trigger Threshold: In all operation modes (AUTO, Semi Auto, and
Manual) both the ECG and Pressure trigger thresholds
are automatically and dynamically adjusted by the
system to compensate for variations in trigger
signal amplitude.

ECG Trigger Threshold: 120 ±20 V (default setting in all Operation Modes)

40 µV (at maximum gain – user adjustable in Semi Auto

or Manual Operation Modes)

Pressure Trigger Threshold: User adjustable between 7 and 30 mmHg (±3 mmHg)
in Semi Auto or Manual Operation Modes

Pacer Blanking: 40 ms if ECG trigger source is selected

100 ms if Pacer A trigger source is selected by the user

in the Semi Auto or Manual Operation Modes

Pacer V / A-V: (This Trigger Source is user selectable in the Semi Auto
or Manual Operation Modes)

V Pacer: fixed rate up to 185 bpm (no demand pacing)

A-V Pacer: fixed rate up to 125 bpm (no demand

pacing) with A-V intervals between 80 and 224 ms

Tall T-Wave Rejection: Rejects all T-Waves where Q-T interval is <300 ms
(ECG and Pacer A and the amplitude is <70% of QRS input amplitude.
Trigger Mode)

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Pneumatic System Specifications

Pacer Rejection: Rejects all pacer pulses of amplitude ±2.0 mV to ±700

(ECG and Pacer A mV and durations between 0.1 ms to 2.0 ms with:
Trigger Mode) 1. No tail,
2.100 ms time constant tail <1 mV, or
3. 25 ms time constant tail <1 mV, or
4. 4 ms time constant tail <2 mV

NOTE: Pacer tail peak amplitudes shall not exceed 25% of the
pacer pulse amplitude per AAMI EC13-2002 paragraph
4.1.4.2. (Pacer and tail rejection performance may be
degraded in Manual timing and Variable ECG gain modes.)

Electro-Surgical Interference
Suppression (ESIS): The operation of an Electro-Surgical Unit in the
proximity of the IABP does not cause any
unrecoverable malfunction or require user
intervention.

Internal Trigger: 80 ±1 bpm default setting

(Semi Auto and Manual Adjustable from 40 -120 bpm
operation modes only)

11.2 Pneumatic System

Auto-Fill Time: 14 seconds maximum

11.3 ECG Channel

11.3.1 Input Characteristics
Leads: I, II, III, aVR, aVL, aVF, V, or External

Input Linear DC Offset:

Range: ±300 mV minimum

Linear Input Range: ±5.0 mV minimum (ECG Gain = NORMAL)

Input Impedance: >5 M Ohm differential, at 10 Hz for Leads I, II, III

Defibrillator Overload
Protection: Withstands up to 360 Joules for damped sinusoidal
(per IEC 60601-2-27:1994) and trapezoidal
(per AAMI DF2:1996) waveforms applied to
100 Ohm load and 50 Ohm electrode impedance
at 20 second intervals

Defibrillator Recovery
Time: 5 seconds maximum for trace to return to screen
from a defibrillator mono pulse

NOTE: Complies with AAMI EC13:2002 and IEC 60601-2-27:1994

requirements)

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Specifications ECG Channel

Lead Fault Detection: Guaranteed Lead fault detection when any active
electrode wire becomes open. Guarantee no lead
fault with electrode impedance 51 k Ohms and
with DC offsets ranging from -300 mV to +300 mV.

Noise: < 25 V p-p referred to input (r.t.i) with 51 k Ohm in

parallel with 47 nF on each leg over ECG bandwidth.

Common Mode
Rejection Ratio: 80 dB minimum, at 50/60 Hz with an imbalance
of up to 51 k Ohm in parallel with 47 nF and up
to ±300 mV DC offset.

11.3.2 Display Characteristics

Autoscaling of waveform Automatically scaled to occupy the majority of the
amplitude in “Normal” gain: waveform amplitude ECG display window. Inhibited
from adapting to transient artifacts such as caused by:
Electro Surgical Unit, lead fault/change of lead,
pacemaker pulse heights; A/D over-ranging caused by
changes in electrode offset potentials, large ectopic
beats, or defibrillator discharges. Does not rescale
when ECG peak amplitudes are less than 120 V.

11.3.3 ECG Waveform Output signal

(Phone Jack)

Frequency Response
to ECG output 0.5 to 135 Hz, -3 dB maximum (with ESU
connector: detection disabled).

Output Impedance: <120 Ohm

ECG gain at External

ECG Output: 1 V output per mV input ±5%

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Pressure Channel Specifications

11.4 Pressure Channel

11.4.1 Transducer Requirements
Input Sensitivity: 5.0 V/V/mmHg (nominal)

Transducer Excitation: +5 VDC ±5% (capable of supplying up to 130 mA)

11.4.2 Arterial Pressure Waveforms

Autoscaling: The waveform is automatically scaled and displayed
in the Arterial Pressure Waveform display window. Its
associated pressure scale is annotated with numeric
values at the lowest, middle and highest range covering
the vertical span of the scaled waveform.

Trace Accuracy 3 mmHg or 3%, whichever is greater

(two trace mode
excluding Transducer):

Reference Line: 0-300 mmHg

11.4.3 Patient Parameters - Digital Arterial Pressure

(Systolic, Diastolic, Mean and Augmented Diastolic Pressures)

Resolution: 1 mmHg (all scale factors)

Accuracy: 2 mmHg or 2% whichever is greater

Range: 0 to 250 mmHg minimum

Update Rate: 2 seconds (nominal)

11.4.4 Arterial Pressure Output Signal

(Phone Jack)

Pressure Range: 0 to +300 mmHg

Accuracy: 2 mmHg or 2% whichever is greater (excluding

transducer)

Scale: 10.0 mV/mmHg ± 2%

Frequency Response: DC to 15 Hz ± 15% (+0 to -3 dB) for IAB direct

pressure inputs

DC to 22 Hz ± 15% (+0 to -3 dB) for external

(monitor) pressure inputs

Output Impedance: < 5 Ohms up to 22 Hz

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Specifications Pressure Channel

Noise: 5 mV p-p max. (0 to 1 kHz bandwidth), which

equates to 1/2 mmHg p-p max r.t.i.
(0 to 1 kHz bandwidth)

11.4.5 Arterial Pressure Zero

Zero Accuracy: ±1 mmHg at pressure output, +1.0 mm deviation
from zero line at maximum deflection range
(0-200 mmHg) on the display.

Zero Drift: 0.15 mmHg/°C, (excluding transducer drift)

Zero Range: ±120 mmHg minimum

Auto-Zero Time: <3 seconds

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Heart Rate Meter Specifications

11.5 Heart Rate Meter

Usable Range: 15-200 bpm

Resolution (Display): 1 bpm

Accuracy (Display): 15-200 bpm, ±3 bpm or ±3%, whichever is greater.

Step Change Response 7 seconds (including 2 second max. digital display

Time: update) to indicate new rate to within 15 bpm for
a 40 bpm step change in a rate tested between 80
to 120 bpm. Tested to ANSI/AAMI Std. EC13-2002.

11.6 Display
Type: Color TFT Liquid Crystal Display (LCD)

Resolution: 640 Horizontal x 480 Vertical

Viewing Area: 21.12 cm x 15.84 cm (8.3" x 6.2")

(Typical) 26.4 cm (10.4") diagonal

Viewing Angle: Up 45°, Down 55°, Right 70°, Left 70°

(Typical)

11.7 Printer
Print Mechanism: Thermal Array

Chart Paper Width: 50 mm

Chart Speeds: 25 mm/sec or 50 mm/sec (both ±5%)

Print Resolution: Vertical: 8 dots/mm (200 dots/inch)

Horizontal: 31.5 dots/mm (800 dots/inch)
(at 25 mm/sec)

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Specifications Power

11.8 Power
11.8.1 Power Requirements
AC Mains Source: 100 - 120 VAC ± 10%, 50/60 Hz ±3 Hz
220 - 240 VAC ± 10%, 50/60 Hz ±3 Hz
(automatic range switching)

Power Consumption (AC Mains) 180 VA Nominal (90 bpm, low rate battery charge)

400 VA Maximum (120 bpm, high rate battery charge)

Power Factor Correction: 0.95 Power Factor at nominal line

(meets current Harmonic limits defined in
EN61000-3-2: 1995)

11.8.2 Internal Battery

Type: 24 VDC (nominal), 17.2 Amp-hours
Sealed lead acid, maintenance free

Run Time: 2.25 hours minimum (from full charge,

120 bpm, 22 ± 5 °C)
Approximately 3.0 hours typical with new battery
(from full charge, 90 bpm, 22 ± 5 °C)

NOTE: A reduction in run time can occur over a battery’s life for
reasons such as age, storage temperature and discharge
depth.

Recharge Time: 18 hours maximum (from complete discharge to

full charge, 22 ± 5 °C), 8 hours to achieve at least 90
percent charge (typically)

11.8.3 External Battery Pack (CS100i only)

Type: 24 VDC (nominal), 17.2 amp hours sealed lead acid,
maintenance free

Run Time: 1.8 hours minimum* (from full charge at room

temperature, at 120 bpm)

Recharge Time: 18 hours maximum (from complete discharge to

full charge)

“Battery Low” Threshold: 23.0 Volts, ±0.5 Volts

“Battery Cutoff” Threshold: 20.0 Volts, ±0.5 Volts

* NOTE: A reduction in run time can occur over a battery’s life for
various reasons such as age, storage temperature and
discharge depth.

CS100/CS100i Operating Instructions 0070-10-0527-02 11 - 7

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Physical Characteristics Specifications

11.9 Physical Characteristics

11.9.1 Weight *
kg lbs
Standard Console (w/o monitor): 34.8 76.8
Monitor: 4.3 9.5
Internal Battery Pack (P/N 0146-00-0047) 15.4 34.0
Safety Disk and CRM: 1.6 3.5
Helium Tank (99 liter, full): 1.1 2.5
Total - Console with Monitor, Battery, SD/CRM, 57.2 126.3
and Helium Tank:
Cart (including storage bin, doppler and doppler holder): 29.1 64.0
UTS Console (w/o monitor, includes integral wheelbase): 39.8 87.8
Internal Battery Pack (P/N 0146-00-0051) 13.6 30.0
Monitor: 4.3 9.5
Safety Disk and CRM: 1.6 3.5
Helium Tank (99 liter, full): 1.1 2.5
Total -UTS Console with all above: 60.4 133.2
Optional Accessories:
Storage Bag: 1.7 3.6
Transport Docking Station-Lightweight (for UTS) 7.4 16.3
* All weights ± 5%

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Specifications Physical Characteristics

11.9.2 Mechanical Dimensions *

Console and Display
Display Closed: 26.9" H x 20.5" D x 10.8" W
68.3 cm H x 52.1 cm D x 27.4 cm W

Display Open 90°: 34.3" H

87.1 cm H

Console Mounted on Cart

Display Closed: 43.1" H x 22.3" D x 16.8" W
109 cm H x 56.6 cm D x 42.7 cm W

Display Open 90°: 51.0" H

129.5 cm H

Universal Transport System Model (UTS)

Display Closed: 30.0" H x 22.5" D x 13.2" W
76.2 cm H x 57.2 cm D x 33.5 cm W

Display Open 90°: 37.4" H

95.0 cm H

* All dimensions ± 5%. Dimensions include the safety disk/CRM.

CS100/CS100i Operating Instructions 0070-10-0527-02 11 - 9

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Environment (CS100) Specifications

11.10 Environment (CS100)

11.10.1 Operating Ambient
Operating Temperature: 10 °C to 40 °C

Operating Humidity: 5% to 95% R.H. non-condensing

NOTE: The range of humidity specified is not found at all specified

temperatures. Performance verified at discrete temperature
and humidity combinations per “ECRI - PB-296892” Section
AIII.1.7c Class 2 guidelines.

Operating Altitude: Sea Level to 12,000 feet

1013 hPa to 644 hPa nominal

WARNING: Under no circumstances should an IAB patient or the CS100/

CS100i IABP ever be placed in a hyperbaric chamber.

11.10.2 Storage Ambient

Storage Temperature: -20 °C to 70 °C

Storage Humidity: 5% to 95%, R.H. non-condensing

Storage Altitude: Sea level to 12,000 feet

1013 hPa to 644 hPa nominal

NOTE: The range of humidity specified is not found at all specified

temperatures. Performance verified at discrete temperature
and humidity combinations per “ECRI - PB-296892” Section
AIII.1.7c Class 2 guidelines.

11.10.3 Shipping
International Safe Transit Association (ISTA) Pre-shipment Test Procedure, Procedure 1B,
June 1998

11.10.4 Vibration/Shock
Sinusoidal Vibration EN 1789:1999 “Medical vehicles and their equipment
-Road ambulances”. FDA “Reviewer Guidance for
Pre-Market Notification Submissions” section n.4 (ii)
specifies sinusoidal vibration test per IEC 68-2-6,
frequency range 10 to 500 Hz, with acceleration
amplitude 1g, 10 cycles in each axis. Non-
operational.

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Specifications Environment (CS100)

Random Vibration EN 1789:1999 “Medical vehicles and their equipment

- Road ambulances”

MIL-STD-810F “Military Standard. Environmental Test

Methods and Engineering Guidelines”, Method 514.5:
Aircraft. Category 14 Helicopter. Installed material.
Ground: Category 20. Ground vehicle.

RTCA/DO-160D "Environmental Conditions and Test

Procedures for Airborne Equipment," Section 8,
Vibration. Category U - Helicopter with unknown
frequencies.

FDA “Reviewer Guidance for Pre-Market Notification

Submissions” section n.4 (iii) specified random
vibration test per IEC 68-2-34, frequency range 20 to
500 Hz, ASD 0.02g2/Hz, duration 9 min. Non-
operational.

Bump Test EN 1789:1999 "Medical vehicles and their equipment

- Road ambulances".

Rough Handling Test IEC 601-1 (1988), sub-clause 21.6, with Amendment 1
(1991) and Amendment 2 (1995)”.

Shock - Operational RTCA/DO-160D “Environmental Conditions and Test

Procedures for Airborne Equipment,” Section 7,
“Operational Shocks and Crash Safety,” Category B

MIL-STD-810F “Military Standard. Environmental Test

Methods and Engineering Guidelines,” Method 516.5

Shock - Non-Operational FDA “Reviewer Guidance for Pre-market Notification

Submission”, November 1993, section n, paragraph
4I, which recommends non-operational shock per IEC
68-2-27 with 100 g, duration 6 ms, half sine, 3 times in
each orientation.

Crash Test EN 1789:1999 “Medical vehicles and their equipment

- Road ambulances“

RTCA/DO-160D “Environmental Conditions and Test

Procedures for Airborne Equipment“

MIL-STD-810F “Military Standard. Environmental Test

Methods and Engineering Guidelines” Method 516.5,
Procedure V- Crash Hazard.

Elevator Threshold Test: ECRI* (AIII.3.1)

CS100/CS100i Operating Instructions 0070-10-0527-02 11 - 11

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Environment (CS100) Specifications

Barrier Impact Test: ECRI* (AIII.3.2.2)

Drop Test:
Steel Sphere Impact Test: ECRI* (AIII.3.3)

Tip-over Test: IEC 60601-1, 1988 (plus Amendment 1:1991,

Amendment 2: 1995, and Corrigendum, June 1995)
Section 4, Clause 24

* U.S. Department of Commerce, National Technical Information Service, PB-296 892 “Development of Envi-
ronmental Test Methods for Non-Implantable Devices” by Emergency Care Research Institute (ECRI), Pre-
pared for Food and Drug Administration, April,1979.

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Specifications Environment (CS100i)

11.11 Environment (CS100i)

11.11.1 Operating Ambient
Operating Temperature: 10 °C to 40 °C

Operating Humidity: 5% to 95% R.H. non-condensing

NOTE: The range of humidity specified is not found at all specified

temperatures. Performance shall be verified at discrete
temperature and humidity combinations per “ECRI - PB-
296892” Section AIII.1.7c Class 2 guidelines.

Operating Altitude: Sea Level to 12,000 feet (1,000 ft./minute maximum

rate of change)

WARNING: Under no circumstances should an IAB patient or the CS100/

CS100i IABP ever be placed in a hyperbaric chamber.

11.11.2 Storage Ambient

Storage Temperature: -20 °C to 70 °C

Storage Humidity: 5% to 95%, R.H. non-condensing

Storage Altitude: Sea level to 12,000 feet

NOTE: The range of humidity specified is not found at all specified

temperatures. Performance shall be verified at discrete
temperature and humidity combinations per “ECRI - PB-
296892” Section AIII.1.7c Class 2 guidelines.

11.11.3 Shipping
International Safe Transit Association (ISTA) Pre-shipment Test Procedures:, Test Procedure 1,
April 1996.

11.11.4 Vibration/Shock
Operational:
Random Vibration: MIL-STD 810E (Vibration method 514.4, using
Category 1 vibration amplitude for common
carrier transport).

Sinusoidal Vibration: RTCA/DO-160C, December 1989, (Vibrations Section

8, using Curve N vibration amplitude profile for
helicopter mounted equipment).

Elevator Threshold Test: ECRI* (AIII.3.1)

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Environment (CS100i) Specifications

Barrier Impact Test: ECRI* (AIII.3.2.2)

Drop Test:
Steel Sphere Impact Test: ECRI* (AIII.3.3)
Tip-over Test: ECRI* (AIII.3.4)

* U.S. Department of Commerce, National Technical Information Service, PB-296 892 “Development of Envi-
ronmental Test Methods for Non-Implantable Devices” by Emergency Care Research Institute (ECRI), Pre-
pared for Food and Drug Administration, April,1979.

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Specifications Electro-Magnetic Compatibility (CS100/CS100i)

11.12 Electro-Magnetic Compatibility (CS100/CS100i)

The CS100/CS100i meets the requirements of EN 60601-1-2:2001.

NOTE: The CS100/CS100i needs special precautions regarding EMC

and needs to be installed and put into service according to
the EMC information provided below.

NOTE: Portable and mobile RF communications equipment can

affect the CS100/CS100i. See tables 1, 2, 3 and 4, below.

Table 1

GUIDANCE AND DATASCOPE CORP. DECLARATION – ELECTROMAGNETIC EMISSIONS

The CS100/CS100i is intended for use in the electromagnetic environment specified below. The
customer or the user of the CS100/CS100i should assure that it is used in such an environment.

EMISSIONS ELECTROMAGNETIC ENVIRONMENT –

TEST COMPLIANCE GUIDANCE
RF emissions Group 1 The CS100/CS100i uses RF energy only for its internal
CISPR 11 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 CS100/CS100i is suitable for use in all
CISPR 11 establishments other than domestic and those directly
Harmonic Class A connected to the public low-voltage power supply
network that supplies buildings used for domestic
emissions
purposes
IEC 61000-3-2
Voltage Complies
fluctuations/
Flicker emissions
IEC 61000-3-3

CS100/CS100i Operating Instructions 0070-10-0527-02 11 - 15

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Electro-Magnetic Compatibility (CS100/CS100i) Specifications

Table 2

GUIDANCE AND DATASCOPE CORP. DECLARATION – ELECTROMAGNETIC IMMUNITY

The CS100/CS100i is intended for use in the electromagnetic environment specified below. The
customer or the user of the CS100/CS100i should assure that it is used in such an environment.

IMMUNITY IEC 60601 TEST COMPLIANCE ELECTROMAGNETIC

TEST LEVEL LEVEL ENVIRONMENT – GUIDANCE
Electrostatic 6 kV contact 8 kV contact Floors should be wood, concrete or
discharge (ESD) 8 kV air 15 kV air ceramic tile. If floors are covered
IEC 61000-4-2 with synthetic material, the relative
humidity should be at least 30%.
Electrical fast 2 kV for power 2 kV for power Mains power quality should be that
transient/burst supply lines supply lines of a typical commercial or hospital
IEC 61000-4-4 1 kV for input/ 1 kV for input/ environment.
output output
lines lines
Surge 1 kV differential 1 kV differential Mains power quality should be that
IEC 61000-4-5 mode mode of a typical commercial or hospital
2 kV common 2 kV common environment.
mode mode
Voltage dips, <5% UT <5% UT Mains power quality should be that
short (>95% dip in UT) (>95% dip in UT) of a typical commercial or hospital
interruptions and for 0,5 cycle for 0,5 cycle environment. If the user of the
voltage CS100/CS100i requires continued
variations 40% UT 40% UT operation during power mains
on power supply (60% dip in UT) (60% dip in UT) interruptions, it is recommended that
input lines for 5 cycles for 5 cycles the CS100/CS100i be powered
IEC 61000-4-11 from an uninterruptible power
70% UT 70% UT supply or a battery.
(30% dip in UT) (30% dip in UT)
for 25 cycles for 25 cycles

<5% UT <5% UT
(>95% dip in UT) (>95% dip in UT)
for 5 sec for 5 sec
Power frequency 3 A/m 3 A/m Power frequency magnetic fields
(50/60 Hz) should be at levels characteristic of a
magnetic field typical location in a typical
IEC 61000-4-8 commercial or hospital environment.
NOTE: UT is the a.c. mains voltage prior to application of the test
level.

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Specifications Electro-Magnetic Compatibility (CS100/CS100i)

Table 3

GUIDANCE AND DATASCOPE CORP. DECLARATION – ELECTROMAGNETIC IMMUNITY

The CS100/CS100i is intended for use in the electromagnetic environment specified below. The
customer or the user of the CS100/CS100i should assure that it is used in such an environment.

ELECTROMAGNETIC
IEC 60601 TEST COMPLIANCE ENVIRONMENT –
IMMUNITY TEST LEVEL LEVEL GUIDANCE
Portable and mobile RF
communications equipment
should be used no closer to any
part of the CS100/CS100i,
including cables, than the
recommended separation
distance calculated from the
equation applicable to the
Conducted RF 3 Vrms 3 Vrms frequency of the transmitter.
IEC 61000-4-6 150 kHz to 80 MHz
outside ISM bands a Recommended separation
distance
10 Vrms 10 Vrms d = 1.2 x P
150 kHz to 80 MHz
in ISM bands a d = 1.2 x P

Radiated RF 10 V/m 20 V/m

IEC 61000-4-3 80 MHz to 2.5 GHz d = 0.6 x P 80 MHz to 800
MHz

d = 1.2 x P 800 MHz to 2.5

GHz

where P is the maximum output

power rating of the transmitter
in watts (W) according to the
transmitter manufacturer and d
is the recommended separation
distance in meters (m). b

Field strengths from fixed RF

transmitters, as determined by
an electromagnetic site survey, c
should be less than the
compliance level in each
frequency range.

Interference may occur in the

vicinity of equipment marked
with the following symbol:

CS100/CS100i Operating Instructions 0070-10-0527-02 11 - 17

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Electro-Magnetic Compatibility (CS100/CS100i) Specifications

Table 3
NOTE: At 80 MHz and 800 MHz, the higher frequency range
applies.

NOTE: These guidelines may not apply in all situations.

Electromagnetic propagation is affected by absorption
and reflection from structures, objects and people.
a. The ISM (industrial, scientific and medical) bands between 150 kHz and 80
MHz are 6.765 MHz to 6.795 MHz; 13.553 MHz to 13.567 MHz; 26.957
MHz to 27.283 MHz; and 40.66 MHz to 40.70 MHz.
b. The compliance levels in the ISM frequency bands between 150 kHz and 80
MHz and in the frequency range 80 MHz to 2.5 GHz are intended to decrease
the likelihood that mobile/portable communications equipment could cause
interference if it is inadvertently brought into patient areas. For this reason, an
additional factor of 10/3 is used in calculating the recommended separation
distance for transmitters in these frequency ranges.
c. Field strengths from fixed transmitters, such as base stations for radio (cellular/
cordless) telephones and land mobile radios, amateur radio, AM and FM radio
broadcast and TV broadcast cannot be predicted theoretically with accuracy. To
assess the electromagnetic environment due to fixed RF transmitters, an
electromagnetic site survey should be considered. If the measured field strength in
the location in which the CS100/CS100i is used exceeds the applicable RF
compliance level above, the CS100/CS100i should be observed to verify
normal operation. If abnormal performance is observed, additional measures
may be necessary, such as reorienting or relocating the CS100/CS100i.

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Specifications Electro-Magnetic Compatibility (CS100/CS100i)

Table 4

RECOMMENDED SEPARATION DISTANCES BETWEEN PORTABLE AND MOBILE RF

COMMUNICATIONS EQUIPMENT AND THE CS100/CS100i
The CS100/CS100i is intended for use in an electromagnetic environment in which radiated RF
disturbances are controlled. The customer or the user of the CS100/CS100i can help prevent
electromagnetic interference by maintaining a minimum distance between portable and mobile RF
communications equipment (transmitters) and the CS100/CS100i as recommended below,
according to the maximum output power of the communications equipment.

SEPARATION DISTANCE ACCORDING TO FREQUENCY OF

TRANSMITTER M (METERS)
RATED 150 kHz to 80 150 kHz to 80 80 MHz to 800 MHz to
MAXIMUM MHz MHz 800 MHz 2.5 GHz
OUTPUT
POWER OF outside ISM in ISM bands
TRANSMITTER bands
W (WATTS) d = 1.2 x P d = 1.2 x P d = 0.6 x P d = 1.2 x P
0.01 0.12 0.12 0.06 0.12
0.1 0.38 0.38 0.19 0.38
1 1.2 1.2 0.6 1.2
10 3.8 3.8 1.9 3.8
100 12 12 6 12
For transmitters rated at a maximum output power not listed above, the recommended separation
distance d in meters (m) can be determined using the equation applicable to the frequency of the
transmitter, where P is the maximum output power rating of the transmitter in watts (W) according to
the transmitter manufacturer.

NOTE: At 80 MHz and 800 MHz, the separation distance for the
higher frequency range applies.

NOTE: The ISM (industrial, scientific and medical) bands

between 150 kHz and 80 MHz are 6.765 MHz to 6.795
MHz; 13.553 MHz to 13.567 MHz; 26.957 MHz to 27.283
MHz; and 40.66 MHz to 40.70 MHz.

NOTE: An additional factor of 10/3 is used in calculating the

recommended separation distance for transmitters in the
ISM frequency bands between 150 kHz and 80 MHz and
in the frequency range 80 MHz to 2.5 GHz to decrease
the likelihood that mobile/portable communications
equipment could cause interference if it is inadvertently
brought into patient areas.

NOTE: These guidelines may not apply in all situations.

Electromagnetic propagation is affected by absorption
and reflection from structures, objects and people.

The CS100/CS100i meets the following requirements of RTCA/DO- 160D.

Radiated Emissions: RTCA/DO- 160D, 2 MHz - 6 GHz

Sec.21, Category B

Radiated Susceptibility: RTCA/DO- 160D, Sec.20, 100 MHz to 8 GHz 5V/m, >90%
Category T AM at 1 kHz

CS100/CS100i Operating Instructions 0070-10-0527-02 11 - 19

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Electro-Magnetic Compatibility (CS100/CS100i) Specifications

The CS100/CS100i meets the following requirements of Reviewer Guidance for Pre-Market
Notification Submissions, November 1993, Division of Cardiovascular, Respiratory, and
Neurological Devices; Anesthesiology and Respiratory Devices Branch, U.S. Food and Drug
Administration (related to EMC).

Quasi-Static Field
Susceptibility: FDA 11/93 7. ii.f 2 kV/m electric field modulated @
0.5 Hz

Magnetic Emissions: MIL-STD-461/2D, RE101 30 Hz to 100 kHz @ 7 cm

Magnetic Susceptibility: MIL-STD-461/2D, RS101 30 Hz to 100 kHz

Steady- State Voltage: FDA 11/93 Sec.m.ii.c1 Tests 95-132V operation and
seamless AC / battery switching
below 95Vrms

Dropout: FDA 11/93 Sec.m.ii.c.2 AC line dropout < 10 ms

Slow Sags and Surges: FDA 11/93 Sec.m.ii.c.3 AC line slow sags to 90 Vrms and
surges to 150Vrms for 500 ms
duration

11.12.1 ESU Rejection

Performance During The operation of an Electro-Surgical Unit in the
proximity of the IABP does not cause any
unrecoverable malfunction or require user
intervention.

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Specifications Safety Characteristics

11.13 Safety Characteristics

11.13.1 Risk (Leakage) Currents
When measured with the AAMI standard test load:

Enclosure Risk Current:  100 A Normal Condition

 300 A Single Fault Condition

Patient Source Current:  10 A Normal Condition

 50 A for Single Fault Condition

Patient Sink Current:  50 A

11.13.2 Dielectric Withstand

System: 1500 VAC at 50/60 Hz from AC Mains hot or
neutral to chassis for one minute

1500 VAC at 50/60 Hz from any lead or combination

of patient leads to chassis for one minute

11.13.3 Ground Resistance

< 0.1 Ohm from the MAINS power inlet module’s
ground contact pin to any exposed metal parts,
which can become energized, as measured per
IEC 60601-1, 1988 (< 0.2 Ohm when measured
from the U-blade of the supplied line cord.)

CS100/CS100i Operating Instructions 0070-10-0527-02 11 - 21

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Agency Compliance Specifications

11.14 Agency Compliance

The CS100/CS100i is designed to comply with the following agency standards:

• IEC 60601-1: 1988/EN60601-1: 1990

• IEC 60601-1-2: 2001/EN60601-1-2: 2001
• IEC 60601-2-27: 1994/EN60601-2-27:1994 1
• IEC 60601-2-34: 2000/EN 60601-2-34:2000 2 (CS100 only)
• IEC 601-2-34: 1994 (CS100i only)
• UL 2601-1: 1997
• CSA C22.2 - No. 601.1 - M90
• CSA C22.2 - No. 601.1S1 - 94
• EC Medical Device Directive 93/42/EEC
• WEEE Compliance: this system is in compliance with European Community Directive,
2002/96/EC with regard to waste management.

1
When tested with P/N 0681-00-0098-XX and 0681-00-0100-XX ECG electrodes.

2
When tested with Baxter, Model PX 600 or Abbot, Model 42582-05 disposable pressure transducers.

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Specifications Safety Designations

11.15 Safety Designations

11.15.1 Safety designations per IEC 60601-1 Standard
Type of protection against
electric shock: Class 1 and Internal Electric Power Source.
Where the integrity of the external protective
earth conductor arrangement is in doubt,
equipment operates from its
internal electric power source.

Degree of protection against

electric shock: ECG, Type CF defibrillation protected
Balloon, Type CF defibrillation protected
Pressure Transducer, Type CF defibrillator
protected (CS100)
Pressure Transducer, Type CF (CS100i)

Supply Connection: AC Operation:

100 - 120 VAC/220-240 VAC (nominal)
50/60 Hz; 4.2/2.1 A

Internal Battery Operation:

24 VDC Internal Battery

Mode of Operation: Continuous

Protection Against Hazards

of Explosion: Not protected (Ordinary)

Protection Against Ingress of

Liquids: Not protected (Ordinary)

Degree of Electrical Connection

Between Equipment and Patient: Equipment designed for direct electrical and
non-electrical connection to the patient

Degree of Mobility: Mobile

CS100/CS100i Operating Instructions 0070-10-0527-02 11 - 23

English - Outside of United States Only
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Printed in U.S.A 0070-10-0527-02 Rev B 5.2017

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physician. Refer to Instructions for Use for current indications, warnings, contraindications, and precautions.

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Phone: 1 800 777 4222 or within healthcare and life sciences. We operate under the three brands
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