GE Cardiolab II Plus User manual

Service Manual
2002938-002 Revision E
Cardiolab®II Plus Amplifier Manual

T-2 Cardiolab® II Plus Amplifier Manual 2002938-002E
11 December 2007
Due to continuing product innovation, specifications in this manual are subject to change without notice.
CARTO is a trademark of Biosense Webster, Inc.
Listed below are GE Medical Systems Information Technologies trademarks used in this document.
MAC-LAB®, CARDIOLAB®, CENTRICITY®, TRAM®, TRAMNET®, and TRAM-RAC®are trademarks of GE
Medical Systems Information Technologies registered in the United States Patent and Trademark Office.
All other trademarks contained herein are the property of their respective owners.
© GE Medical Systems Information Technologies, 2006. All rights reserved.

2002938-002E Cardiolab® II Plus Amplifier Manual CE-1
CE Marking Information
Compliance
The CardioLab II Plus Amplifier bears CE mark CE-0459 indicating its
conformity with the provisions of the Council Directive 93/42/EEC
concerning medical devices and fulfills the essential requirements of
Annex I of this directive.
For devices manufactured in the United States, the CE mark is applied
under the authority of Notified Body GMED (0459).
The country of manufacture and appropriate Notified Body can be found
on the equipment labeling.
The safety and effectiveness of this device has been verified against
previously distributed devices. Although all standards applicable to
presently marketed devices may not be appropriate for prior devices (i.e.
electromagnetic compatibility standards), this device will not impair the
safe and effective use of those previously distributed devices.
The CardioLab II meets the requirements of EN60601-1-2 (1993-04)
Medical Electrical Equipment, Part 1: General Requirements for Safety,
2. Collateral Standard: Electromagnetic compatibility - Requirements
and tests.
Exception
ECG Parameter
IEC601-1-2 clause 36.202.1 - Immunity: Radiated Immunity –
The level of compliance is less than 1V/m
If operating under the conditions defined in EMC Standard EN60601-1-2
(Radiated Immunity 3V/m), field strengths less than 1V/m may cause
waveform distortions and erroneous numeric data at various
electromagnetic interference (EMI) frequencies.
Recommendations: –
Review the AAMI EMC Committee technical information report (TIR-18)
titled Guidance on electromagnetic compatibility of medical devices for
clinical / biomedical engineers - Part 1: Radiated radio-frequency

CE-2 Cardiolab® II Plus Amplifier Manual 2002938-002E
electromagnetic energy. This TIR provides a means to evaluate and
manage the EMI environment in the hospital.
The following actions can be taken:
managing (increasing) distance between sources of EMI and
susceptible devices
managing (removing) devices that are highly susceptible to EMI
lower power from internal EMI sources under hospital control (i.e.
paging systems)
labeling devices susceptible to EMI
educating staff (nurses and doctors) to be aware of, and to recognize,
potential EMI related problems

2002938-002E Cardiolab® II Plus Amplifier Manual i
Contents
CE Marking Information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . CE-1
Compliance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . CE-1
Exception . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . CE-1
1 Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1-1
Introduction. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-2
Revision History . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1-2
Manual Purpose . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1-2
Intended Audience . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1-2
Intended Use . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1-3
Chapter Content . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1-3
Related Manuals . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1-3
Manual Conventions. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-4
Hardware and Software Terms . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1-4
Safety Information. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-4
Safety Messages . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1-4
Manufacturer Responsibility . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1-5
General . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1-5
Electromagnetic Interference . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-6
Equipment Symbols . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1-7
Classifications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1-8
Underwriters Laboratories Inc. (UL) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1-10
Equipment Safety . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-10
Dangers, Warnings, and Cautions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1-10
Service Information. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-14
Service Requirements . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1-14
Equipment Identification . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1-15
New Identification Tags . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1-15
Old Identification Tags . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1-16
2 Equipment Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2-1
General Description . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-2
CardioLab II Plus Amplifier Hardware. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-3
Amplifier Part Numbers . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2-3
Accessory Parts List . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .. . . . . . . . . .2-4
Required Tools and Supplies . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2-4
Front View . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-5

ii Cardiolab® II Plus Amplifier Manual 2002938-002E
Back View . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-8
Internal Assembly . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-9
Board Identifications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-9
Control Board (PN: 2002344-001) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2-9
ECG/Pressure/Calibration Board (P/N 2002834-004) . . . . . . . . . . . . . . . . . . . . . . 2-12
Cross-Point Amplifier Board (XPA)(PN: 2002506-004) . . . . . . . . . . . . . . . . . . . . . 2-13
Front Panel Board . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-14
Back Plane Board . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-15
Power Board (PN: 2002648-001) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .. . . . . . . . 2-16
Components . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-17
CardioLab II Plus Catheter Input Module . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2-18
Stimulator Input Cable . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2-19
ECG 10 Lead Set . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2-19
10 Lead ECG Cable . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2-20
Power Cord . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2-20
3 Operation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3-1
Getting Started . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-2
Connecting Cables to the Amplifier . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3-3
Disconnecting Cables From the Amplifier . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3-3
Installation Checkout . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3-4
A Appendix A – Maintenance and Troubleshooting . . . . . A-1
Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . A-2
Maintenance/Repair Log . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . A-2
Environmental Protection . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . A-2
Inspection and Cleaning. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . A-2
Precautions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . A-3
Cleaning . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . A-4
Amplifier Troubleshooting. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . A-4
Noise on Intracardiac Signals . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . A-5
For real-time testing during a case:. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . A-5
CardioLab Amplifier Testing . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . A-11
Storing and Transporting the Amplifier . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . A-12
Maintenance/Repair Log . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . A-13

2002938-002E Cardiolab® II Plus Amplifier Manual i-iii
B Appendix B– Technical Information . . . . . . . . . . . . . . . . .B-1
Technical Specifications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . B-2

i-iv Cardiolab® II Plus Amplifier Manual 2002938-002E

2002938-002E Cardiolab® II Plus Amplifier Manual 1-1
1Introduction

1-2 Cardiolab® II Plus Amplifier Manual 2002938-002E
Introduction
Introduction
Revision History
Each page of the document has the document part number and revision
letter at the bottom of the page. The revision letter identifies the
document’s update level.
The revision history of this document is summarized in the table below.
Manual Purpose
This manual contains the instructions necessary to service the
CardioLab II Plus Amplifier safely in accordance with its function and
intended use. These instructions include but are not limited to:
Describing fundamental controls and indicators.
Operating procedures.
Connecting and disconnecting detachable parts and accessories.
Troubleshooting and service procedures.
Intended Audience
This manual is intended for the person who maintains and troubleshoots
this equipment.
Revision History PN 2002938-002
A June 21, 2000 Initial Release of the manual.
B 15 November 2000 Release B of this manual.
C October 9, 2001 Release C with minor editorial updates.
D 21 July 2006 Revised document.
E 11 December 2007 Updated per GEHmk15561

Introduction
2002938-002E Cardiolab® II Plus Amplifier Manual 1-3
Intended Use
The CardioLab II Plus Amplifier is intended for use in an
electrophysiological catheter laboratory or catheterization laboratory
where ECG, direct cardiac, intracardiac and pressure signals need to be
recorded from a patient. This device is intended for use under the direct
supervision of a licensed health care practitioner.
Chapter Content
This manual is organized into the following chapters:
1. Introduction: Describes the manual contents and provides
general information about safety precautions, service requirements,
equipment symbols and serial number identification.
2. Equipment Overview: Gives a description of the equipment and
components.
3. Operation: Describes how to connect and disconnect cables to the
amplifier and provides a list of related user’s manuals and update
guides. Describes the stimulator bypass connections for emergency
pacing.
Appendix A: Maintenance and Troubleshooting: Describes how
to maintain the equipment and keep it in good working order with a
recommended maintenance schedule, cleaning guidelines, checkout
procedure, and safety tests.
Appendix B: Technical Information: Provides a complete table of
technical specifications for the CardioLab II Plus Amplifier.
Related Manuals
Below are a list of the related manuals.
Part Number Document
2027332-100 Mac-Lab Operator’s Manual
2027332-101 Cardiolab Operator’s Manual
2027332-102 Centricity Cardiology INW Operator’s Manual
2027332-103 Mac-Lab/Cardiolab System Security Guide

1-4 Cardiolab® II Plus Amplifier Manual 2002938-002E
Introduction
Manual Conventions
Hardware and Software Terms
The following is a list of conventions used throughout the text of the
manual:
Hardware items shown in Bold text are keys on the keyboard.
Italicized items are software terms that identify menu items or
options in various windows.
Safety Information
Safety Messages
The terms danger, warning, and caution are used throughout this
manual to point out hazards and to designate a degree or level or
seriousness. Familiarize yourself with their definitions and significance.
Hazard is defined as a source of potential injury to a person.
DANGER
DEATH OR SERIOUS INJURY — A message which
indicates an imminent hazard which, if not avoided, will
result in death or serious personal injury or product/
property damage.
WARNING
POTENTIAL DEATH OR SERIOUS INJURY — A
message which indicates a potential hazard or unsafe
practice which, if not avoided, could result in death or
serious personal injury or product/property damage.
2027332-107 Mac-Lab/Cardiolab System Installation Manual
2027332-109 Mac-Lab/Cardiolab System Service Manual
Part Number Document

Introduction
2002938-002E Cardiolab® II Plus Amplifier Manual 1-5
CAUTION
MINOR INJURY OR DATA LOSS — A message which
indicates a potential hazard or unsafe practice which, if
not avoided, could result in minor personal injury or
product/property damage.
NOTE
A message which provides application tips or other useful
information to assure that you get the most from your equipment.
Manufacturer Responsibility
GE Medical Systems Information Technologies is responsible for the
effects of safety, reliability, and performance only if:
Installation operations, extensions, readjustments, modifications, or
repairs are carried out by persons authorized by GE Medical Systems
Information Technologies.
The equipment is used in accordance with the instructions for use.
The user attaches only accessory equipment recommended for
interaction with the amplifier.
General
The CardioLab II Plus Amplifier maintains leakage currents below
medical limits with an isolation transformer, which is incorporated into
the design of the amplifier. Amplifier power should be supplied by a
dedicated power supply on an isolated circuit for proper behavior of the
amplifier.
To ensure patient safety, use only parts and accessories manufactured or
recommended by GE Medical Systems - Information Technologies.
This equipment should only be connected as specified by GE Medical
Systems - Information Technologies. Installation of the equipment
should only be performed by qualified GE Medical Systems - Information
Technologies service representatives.
Contact GE Medical Systems - Information Technologies before
connecting any device to equipment that is not recommended in this
manual. Only cables and accessory equipment purchased from GE
Medical Systems - Information Technologies should be used in
conjunction with the amplifier.

1-6 Cardiolab® II Plus Amplifier Manual 2002938-002E
Introduction
It is important that all of the instructions in this manual be followed,
however, these instructions in no way supersede current medical
practices regarding patient care and safety.
Parts and accessories used must meet the requirements of the applicable
IEC 601 series safety standards, and/or the system configuration must
meet the requirements of the IEC 601-1-1 medical electrical systems
standard.
Refer servicing of amplifiers under warranty to GE Medical Systems -
Information Technologies authorized service personnel. Any attempt to
repair equipment under warranty will void that warranty. It is the
responsibility of users of systems needing service to contact GE Medical
Systems - Information Technologies for servicing of the equipment.
Failure on the part of responsible individuals or institutions to
implement a satisfactory equipment maintenance schedule may lead to
undue equipment failure and possible health hazards.
The use of ACCESSORY equipment not complying with the equivalent
safety requirements of this equipment may lead to a reduced level of
safety of the resulting system. Consideration relating to the choice shall
include:
use of the accessory in the PATIENT VICINITY; and
evidence that the safety certification of the ACCESSORY has been
performed in accordance to the appropriate IEC 601-1 and/or IEC
601-1-1 harmonized national standard.
The CardioLab II Plus Amplifier is a component/accessory of a Class II
medical device.
Electromagnetic Interference
Interference with the operation or signal integrity of this equipment is
unlikely as a result of proximity to general equipment. The user should
understand that the use of some electrosurgical equipment and medical
generators may cause some level of interference of the amplifier.
Users should be aware of known RF sources, such as radio or TV stations
and hand-held mobile two-way radios, and consider them when installing
a medical device or system.
Be aware that adding accessories or components, or modifying the
medical device or system, may degrade the EMI performance. Consult
with qualified personnel regarding changes to the system configuration.
The CardioLab II meets the requirements of EN60601-1-2 (1993-04)
Medical Electrical Equipment, Part 1: General Requirements for Safety,

Introduction
2002938-002E Cardiolab® II Plus Amplifier Manual 1-7
2. Collateral Standard: Electromagnetic compatibility - Requirements
and tests.
Exception
ECG Parameter
IEC601-1-2 clause 36.202.1 - Immunity: Radiated Immunity –
The level of compliance is less than 1V/m
If operating under the conditions defined in EMC Standard EN60601-1-2
(Radiated Immunity 3V/m), field strengths less than 1V/m may cause
waveform distortions and erroneous numeric data at various
electromagnetic interference (EMI) frequencies.
Recommendations:
Review the AAMI EMC Committee technical information report (TIR-18)
titled Guidance on electromagnetic compatibility of medical devices for
clinical / biomedical engineers - Part 1: Radiated radio-frequency
electromagnetic energy. This TIR provides a means to evaluate and
manage the EMI environment in the hospital.
The following actions can be taken:
managing (increasing) distance between sources of EMI and
susceptible devices
managing (removing) devices that are highly susceptible to EMI
lower power from internal EMI sources under hospital control (i.e.
paging systems)
labeling devices susceptible to EMI
educating staff (nurses and doctors) to be aware of, and to recognize,
potential EMI related problems
Equipment Symbols
The following symbols appear on the equipment.
Attention:
Pay attention to the documents delivered with the equipment.
Type CF Equipment

1-8 Cardiolab® II Plus Amplifier Manual 2002938-002E
Introduction
Type CF equipment is specifically designed for applications where a
conductive connection to the heart is directly established.
Type CF Equipment
Type CF equipment that is defibrillator proof.
Isolated (floating) applied part suitable for intentional external and
internal application to the patient including direct cardiac application.
“Paddles” outside the box indicate the applied part is defibrillator proof.
[Medical Standard Definition:] F-type applied part (floating/isolated)
complying with the specified requirements of IEC 60601-1/UL 2601-1/
CSA 601.1. Medical Standards to provide a higher degree of protection
against electric shock than that provided by BF applied parts.
Equipotentiality
A nonessential electrical connection which may be used to connect the
chassis to other equipment to achieve the same potential.
Classifications
The CardioLab II Plus Amplifier is classified, according to IEC-60601-1,
as:
Type of protection against electrical shock I
Degree of protection against electrical
shock CF—ECG, BP, CIM, Auxiliary Inputs
Degree of protection against harmful
ingress of water Ordinary
Degree of safety of application in the
presence of a flammable anesthetic
mixture with air or with oxygen or nitrous
oxide
Not suitable
Method(s) of sterilization or disinfection
recommended by the manufacturer Not Applicable
Mode of operation Continuous operation

Introduction
2002938-002E Cardiolab® II Plus Amplifier Manual 1-9
I: Class I equipment
CF: Type CF applied part
Ordinary: Ordinary equipment (enclosed equipment without protection
against ingress of water)
Not Suitable: Equipment not suitable for use in the presence of a
flammable anesthetic mixture with air or with oxygen or nitrous oxide

1-10 Cardiolab® II Plus Amplifier Manual 2002938-002E
Introduction
Underwriters Laboratories Inc. (UL)
Underwriters Laboratories, Inc.
Classified by Underwriters Laboratories Inc. with respect to electric
shock, fire, mechanical and other specified hazards, only in accordance
with UL 2601-1, CAN/CSA C22.2 No. 601.1, IEC 60601-1, and, if
required, IEC 60601-2-27, IEC 60601-2-30, IEC 60601-2-34, IEC 60601-
1-1.
Equipment Safety
The safety statements presented in this chapter refer to the equipment
in general and, in most cases, apply to all aspects of the product.
The order in which safety statements are presented in no way implies
order of importance.
Dangers, Warnings, and Cautions
There are no dangers that refer to the equipment in general. Specific
Danger statements may be given in the respective sections of this
manual.
DANGER
EXPLOSION — Do not use in the presence of flammable
anesthetics or other flammable gases.
WARNING
EQUIPMENT DAMAGE — Only connect UL 544 or UL
2601-1 listed or IEC certified medical equipment.
If fluid of any kind that should leak into the system,
discontinue use of the equipment and contact GE Medical
Systems Information Technologies immediately.
Do not allow any foreign materials such as fluids to come
in contact with the CardioLab II Plus Amplifier.

Introduction
2002938-002E Cardiolab® II Plus Amplifier Manual 1-11
WARNING
ELECTRICAL SHOCK — DO NOT allow hydraulic fluid
from any device to contact any conductive surface.
Hydraulic fluid is electrically conductive.
An electrical shock hazard exists between chassis ground
and isolated (floating) ground when power is applied.
Unplug the unit from the power source before proceeding.
To reduce the risk of electric shock or damage to your
equipment, do not disable the power cord grounding
feature. This equipment is designed for connection to a
earth grounded power outlet. The grounding plug is an
important safety feature.
WARNING
ELECTRICAL SHOCK — To reduce the risk of electric
shock, DO NOT remove cover or back. This equipment
contains no user serviceable parts. Refer servicing to
qualified service personnel.
WARNING
BACK-UP MONITORING — Back-up patient monitors
should always be available when using the equipment.
WARNING
CONDUCTION HAZARD — Keep the conductive parts
of lead electrodes and associated parts away from other
conducting parts, including earth.

1-12 Cardiolab® II Plus Amplifier Manual 2002938-002E
Introduction
WARNING
CONDUCTIVE CONNECTIONS — Proper connections
to the patient are critical for the proper operation of the
CardioLab II Plus Amplifier and patient safety. Use
extreme caution when making patient connections.
Do NOT connect non-isolated equipment to the amplifier.
Proper connections to the stimulator are critical for the
proper operation of the CardioLab II Plus Amplifier and
patient safety. Use extreme caution when making
stimulator connections. The stimulator must be a IEC
601-1 certified product
Ablation operations should NOT be executed when a
stimulator unit is connected.
WARNING
DEFIBRILLATOR PRECAUTIONS — DO NOT contact
the system or patient during defibrillation.
Standby defibrillation equipment is required in the event
that the patient needs to be cardioverted or defibrillated.
WARNING
PATIENT/EQUIPMENT SAFETY — The system should
be tested yearly for adequate grounding on patient
leakage current.
Total system earth leakage current must not exceed 50
microamperes.
When more than two electrical devices are interconnected,
the summation of leakage currents must be checked
before use and rechecked yearly.
WARNING
IEC — All equipment not complying with IEC 601-1
should be placed outside the patient environment.