GE ML_CL_INW SERVICE MANUAL_SM_2021423-503_H A7 Anesthesia System Service Manual

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GE Healthcare

Mac-Lab/CardioLab/Centricity Cardiology INW Service Manual

Version 6.5.6

Instructions

2021423-503 Revision H

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The information in this manual only applies to Mac-Lab/CardioLab/Centricity Cardiology INW Service Manual software version 6.5.6. It does not apply to earlier software versions. Due to continuing product innovation, specifications in this manual are subject to change without notice.

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, a division of General Electric Company going to market as GE Healthcare.

All other trademarks contained herein are the property of their respective owners.

T-2 Mac-Lab/CardioLab/Centricity Cardiology INW Service Manual 2021423-503H

25 August 2014

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CE Marking Information

Compliance

The Mac-Lab/CardioLab/ComboLab system 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 product complies with the requirements of standard IEC 60601-1-2.

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 (that is, electromagnetic compatibility standards), this device will not impair the safe and effective use of those previously distributed devices. Refer to the user’s information.

CE Marking Information

Recommendations

Refer to the Mac-Lab/CardioLab Service Manual for Compliance Information.

Users should be aware of known RF sources, such as radio or TV stations and hand-held or 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 Mac-Lab/CardioLab System, if operating under the conditions defined in the EMC Standard IEC 60601-1-2 (Radiated Immunity 3 V/m) and at field strengths above 3 volts per meter may cause waveform distortions at radio frequency (RF) electromagnetic interference (EMI).

MEDICAL ELECTRICAL EQUIPMENT needs special precautions regarding EMC and needs to be installed and put into service according to the EMC information provided in the ACCOMPANYING SERVICE MANUAL.

Portable and mobile RF communications equipment can affect MEDICAL ELECTRICAL EQUIPMENT.

2021423-503H Mac-Lab/CardioLab/Centricity Cardiology INW Service Manual CE-1

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CE Marking Information

The use of ACCESSORIES, transducers and cables other than those specified, with the exception of transducers and cables sold by the manufacturer of the Mac-Lab/CardioLab System as replacement parts for internal components, may result in increased EMISSIONS or decreased IMMUNITY of the Mac-Lab/CardioLab System.

The Mac-Lab/CardioLab System should not be used adjacent to or stacked with other equipment and that if adjacent to or stacked use is necessary, the Mac-Lab/CardioLab System should be observed to verify normal operation in the configuration in which it will be used.

Review the AAMI Committee Technical Information Report (TIR) 18, “Guidance on Electromagnetic Compatibility of Medical Devices for Clinical/Biomedical Engineers”. This guidance document provides a means to evaluate and manage the EMI environment in the hospital.

The following actions can be taken to reduce the risk of medical device EMI and achieve EMC:

 Assess the EMC environment of the healthcare facility (for example,

identify radio transmitters in around the facility) and identify areas where critical medical devices are used (for example, ER, ICU, CCU, NICU).

 Increase the distance between sources of EMI and susceptible

devices.

 Remove the devices that are highly susceptible to EMI.

 Lower power transmitted from electrical and electronic equipment

(EMI sources) under hospital control (that is, paging systems).

 Label devices susceptible to EMI.

 Educate healthcare facility staff (nurses and doctors) to be aware of,

and to recognize, potential EMI related problems.

Exception

ECG Parameter

IEC 60601-1-2 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 EN 60601-12 (Radiated Immunity 3V/m), field strengths less than 1V/m may cause waveform distortions and erroneous numeric data at various electromagnetic interference (EMI) frequencies.

CE-2 Mac-Lab/CardioLab/Centricity Cardiology INW Service Manual 2021423-503H

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Recommendations

CE Marking Information

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

2021423-503H Mac-Lab/CardioLab/Centricity Cardiology INW Service Manual CE-3

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CE Marking Information

CE-4 Mac-Lab/CardioLab/Centricity Cardiology INW Service Manual 2021423-503H

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Contents

1 Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1-1

Manual Information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-2

Purpose . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1-2

Intended Audience . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1-2

Revision History . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1-2

Conventions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1-3

Product References . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1-3

Related Documents . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1-3

Illustrations and Names . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1-4

Chapter Contents . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1-4

Safety Information. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-5

Safety Messages. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-5

ITE Conformance Statement . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1-12

Types of Systems . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-13

Mac-Lab System . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1-13

CardioLab EP System . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1-13

ComboLab System . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1-14

CardioLab II Plus Amplifier . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1-14

Security Information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-15

Non-Validated Software Applications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1-15

Policy . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1-15

Validated Third Party Software . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-16

Service Information. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-19

Service Requirements . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1-19

Product Identification. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-19

Required Tools and Supplies . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1-22

Power Input Requirements . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1-22

Safety Information. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-23

Electromagnetic Compatibility and Interference . . . . . . . . . . . . . . . . . . . . . . . . . .1-23

Exception . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1-23

EU Battery Directive 2006/66/EC . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1-24

Responsibility of the Manufacturer . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1-25

General . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1-25

Equipment Symbols . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1-26

Compliance Information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-29

Mac-Lab/CardioLab System . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1-29

2021423-503H Mac-Lab/CardioLab/Centricity Cardiology INW Service Manual i

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2 Equipment Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-1

Typical System Configuration . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-2

Control Room Components . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2-3

Procedure Room Components . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2-3

IT Control Room Equipment . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2-4

Network Connections . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2-4

System Hardware . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-5

Acquisition Workstation System Components. . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-5

GE Client Workstation. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-33

Mobile Workstand . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2-36

Monitors . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2-37

TRAMNet . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2-37

CardioLab II Plus Amplifier . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-39

CARTO™ System (Patient Interface Unit) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2-45

Analog Output Box . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2-47

Network Components . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-48

Cabling and Connections. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-53

HP z600 Computer I/O Backplane Connections . . . . . . . . . . . . . . . . . . . . . . . . .2-53

HP xw8400 Computer I/O Backplane Connections . . . . . . . . . . . . . . . . . . . . . . .2-54

Power Connections . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2-55

HP z600 Video Connections . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2-56

HP xw8400 Video Connections . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2-57

Communications Connections . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2-58

TRAM/Amplifier Connections . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2-59

Amplifier/Stimulator Connections . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-60

Audio . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2-64

CARTO™XP System Connections . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2-65

CARTO™ 3 System Connections . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2-66

Review Workstations. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-69

Software . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-72

Operating System . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2-72

Database . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2-72

Application Software . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2-72

3 Maintenance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-1

Mac-Lab/CardioLab Service Performance Testing . . . . . . . . . . . . . . . . . . . . . . . . . 3-2

Configuration . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3-2

FRU Checkout Procedure Table . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3-3

Tools Recommended . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3-5

Visual Inspection/Cleaning . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3-6

Electrical Safety Checks . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3-6

Functional Checkout Procedure . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-8

Mac-Lab SCOP (Standard Checkout Procedure) . . . . . . . . . . . . . . . . . . . . . . . . .3-8

CardioLab SCOP (Standard Check Out Procedure) . . . . . . . . . . . . . . . . . . . . . .3-10

TRAM Module Testing . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3-12

ii Mac-Lab/CardioLab/Centricity Cardiology INW Service Manual 2021423-503H

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CardioImage/Image Capture Testing . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3-12

IEB Testing . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3-12

Printer Testing . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3-12

CARTO Testing . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3-13

Audible Indicators Testing . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3-13

RF Ablation Testing . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3-13

Stimulator Testing . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3-14

DASH / Solar Testing . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3-14

Remote Operators Terminal Testing . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3-14

Analog Out Testing . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3-14

Centricity Cardiology INW Testing . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3-15

Remote Connection Testing . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3-16

Planned Maintenance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-16

Mobile Workstand Preventative Maintenance . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-18

Tools Required . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3-18

Adjusting Tilt and Tilt Tension . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3-18

Adjusting Swivel or Pivot Tension . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3-18

Routine Maintenance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3-18

4 Troubleshooting . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-1

Initial Inspection . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-2

Hardware . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-3

Clean Fiber Optic Cable . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4-3

Initial Check . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4-3

Troubleshooting. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-3

Matrox Parhelia Fan Alert . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4-4

Replace Main Video Board with Matrox M9140 Quad Video Board . . . . . . . . . . . 4-5

Prevent Failure of the Matrox Odyssey Driver Service . . . . . . . . . . . . . . . . . . . .4-12

CardioLab Amplifier Troubleshooting. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-13

Noise on Intracardiac Signals . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-15

Real-Time Testing During a Case. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-15

CardioImage . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-22

Normal Operation and Setup . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4-22

Troubleshooting. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-23

Switching Ablation Devices . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-29

Windows XP/2003 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-30

Normal Operation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4-30

Troubleshooting. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-30

GEMS_TaskMonitor Service . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-32

Networking. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-33

Normal Operation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4-33

2021423-503H Mac-Lab/CardioLab/Centricity Cardiology INW Service Manual iii

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Troubleshooting. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-33

Centricity Cardiology INW Server . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-36

Replication. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-37

Normal Operation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4-37

Troubleshooting . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4-37

Cleanup Database Corruption . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-37

INNOVA CENTRAL/Touch screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-39

Check Connection Status . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4-39

Determine IP Addresses . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4-39

CARTO XP/CARTO 3 System . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-40

Normal Operation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4-40

Troubleshooting . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4-40

EtCO2 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-43

EtCO2 Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4-43

Capnostat Module Setup. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-44

Capnostat Module Calibration. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-56

Calibrate the CapnoFlex LF Module (Sensor + Pump) . . . . . . . . . . . . . . . . . . . .4-58

Mac-Lab Interface . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-59

Troubleshooting. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-61

CVIS to Mac-Lab/CardioLab Interface . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-65

Problem Scenarios . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4-67

Test DICOM Connectivity (CVIS) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4-68

Test DICOM Connectivity (X-Ray) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4-70

HL7 Export to CVIS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4-71

InSite ExC . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-72

Normal Operation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4-72

GEMS Log Collector Task. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-72

List of Log Events . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4-75

List of SNMP Faults . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4-75

Application Repair . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-77

Prerequisite . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4-77

Option Codes. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-78

Normal Operation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4-78

Troubleshooting. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-78

Event Viewer . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-79

Log Files . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-80

Application Logs . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4-80

Install/Update Logs . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4-80

Install Log Files . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4-81

Upgrade Log Files . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4-82

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Maintenance Log Files . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-83

Replication Log Files . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-84

Device Log Files . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4-85

Log File Locations for Mac-Lab/CardioLab System . . . . . . . . . . . . . . . . . . . . . . . 4-86

5 Recovery Procedures . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-1

Acquisition System Disaster Recovery . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-2

High-Level Overview. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-2

Log On to the Acquisition System . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-3

Save Acquisition System Information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-3

INW Networked Acquisition Systems Only . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-8

Restore System Software . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-10

Set Default Baseline Phase . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-31

Install/Enable Software Options . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-32

Configure the Acquisition System. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-32

Configure the Acquisition System on the INW Network . . . . . . . . . . . . . . . . . . . 5-40

Initialize Applications. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-48

Confirm File Paths and Network Storage Settings . . . . . . . . . . . . . . . . . . . . . . . . 5-51

Additional Installation for Purchased Options . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-51

Reconfigure Printer . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-52

Reconfigure Mapped Drives . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .5-52

Configure Data Export . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-52

Reload CVIS Client . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-54

Update Operator Manuals . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-54

Review System Disaster Recovery . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-55

High-Level Overview. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-55

Log On to the Review System . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .5-56

Save Review System Information. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-56

Gather Information from INW Server . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-60

Configure New Hardware . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-61

Configure the Review System. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-63

Configure the Review System on the INW Network . . . . . . . . . . . . . . . . . . . . . . 5-75

Initialize Applications. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-81

Confirm Windows XP is Activated . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-84

Confirm File Paths and Network Storage Settings . . . . . . . . . . . . . . . . . . . . . . . . 5-84

Additional Installation for Purchased Options . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-84

Reconfigure Printer . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-84

Reconfigure Mapped Drives . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .5-85

Configure Data Export . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .5-85

Reload CVIS Client . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-85

Update Operator Manuals . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-86

Perform Necessary Software Updates . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-86

System Checkout . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-87

Review Workstation Test . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-87

INW Server Disaster Recovery . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-88

High-Level Overview. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-88

Record Server Information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-90

Reimaging Procedures . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-91

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G4/G5/G6 Server Setup and Data Restore . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-98

Reconfigure Centricity Cardiology INW Network . . . . . . . . . . . . . . . . . . . . . . . 5-119

Post Configuration Procedures. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-128

Cardiovascular Information System (CVIS) Configuration . . . . . . . . . . . . . . . . 5-148

Perform On Demand Backup . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-155

Verify Backups Ran Successfully . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .5-156

Update Operator Manuals . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-157

System Checkout . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-158

Verify Functionality . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-158

6 Parts List . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-1

HP z600 Computer with ADA Drive . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-2

HP z600 Computer with DVD-RAM Drive . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-4

HP xw8400 Computer . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-6

GE Client Workstation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-8

DASH Connection . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-9

Solar Connection . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-9

Centricity Cardiology INW G6 Server . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-9

Centricity Cardiology INW G5 Server . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-10

Centricity Cardiology INW G4 Server . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-11

Integrated Electronics Box (IEB) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-12

Uninterrupted Power Source (UPS) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-13

Monitors and Printers . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-14

TRAMNet . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-15

Amplifier . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-17

MicroPace . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-18

RMOT . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-19

Speakers and Miscellaneous . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-19

vi Mac-Lab/CardioLab/Centricity Cardiology INW Service Manual 2021423-503H

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A Abbreviations . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .A-1

Electrical and IT Abbreviations . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . A-2

Hospital Staff . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . A-4

Medical Abbreviations . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . A-5

Miscellaneous Abbreviations . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . A-18

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viii Mac-Lab/CardioLab/Centricity Cardiology INW Service Manual 2021423-503H

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1 Introduction

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Introduction

Manual Information

Purpose

This manual contains the instructions necessary to operate and service the Mac-Lab/CardioLab system 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

Revision Date Comment

A 6 November 2009 Initial release of the manual.

B 21 April 2010 Updated with serviceability

improvements.

C 1 August 2011 Updated to address new hardware.

D 8 November 2011 Added power cords.

E 28 February 2012 Updated Hard Drive, Memory and RMOT

parts.

F 7 May 2013 Updated to include installation and

troubleshooting procedures for the Matrox Quad video board.

G 18 November

2013

H 24 March 2014 Updated to include information for EIZO

Updated to include information for new speakers.

monitors.

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Conventions

Introduction

The following conventions are used throughout this manual.

Bold Indicates keys on the keyboard, text to be entered, or hardware items

such as buttons or switches on the equipment.

Italics Indicates software terms that identify menu items, buttons, or

options in various windows.

[Key1] + [Key2] Indicates a keyboard operation. A (+) sign between the names of two

keys indicates that you must press and hold the first key while pressing the second key once.

For example, “Press Ctrl + Esc” means to press and hold down the

Ctrl key while pressing the Esc key.

<Space> Indicates you must press the spacebar on the keyboard when typing a

precise text string with one or more spaces. The point where the spacebar must be pressed is indicated as: <Space>. The purpose of the < > brackets is to ensure you press the spacebar when required.

Product References

Illustrations and Names

All illustrations in this manual are provided as examples only. They may not necessarily reflect your system’s configuration or the data on your system.

In this manual, all names appearing in examples and illustrations are fictitious. The use of any real person’s name is purely coincidental.

Chapter Contents

 Chapter 1, Introduction: This chapter describes the Service

 Chapter 2, Equipment Overview: This chapter describes the

 Chapter 3, Maintenance: This chapter contains preventive

 Chapter 4, Troubleshooting: This chapter contains

 Chapter 5, Recovery Procedures: This chapter details procedures

 Chapter 6, Parts List: This chapter contains a list of Field

 Appendix A, Abbreviations: This appendix lists all abbreviations

manual and chapter contents. Also included are general safety requirements, service requirements, equipment symbols, and serial number identification information.

equipment and its technical characteristics, connector locations, and preparation for use.

maintenance information and cleaning guidelines.

troubleshooting instructions and functional test directions.

to restore a workstation or server in the field after failure.

Replaceable parts.

used with the system.

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Safety Information

Safety Messages

Definitions

Introduction

DANGER

— Safety messages which indicate an imminently hazardous situation which, if not avoided, WILL result in death or serious injury.

WARNING

— Safety messages which indicate a potentially hazardous situation which, if not avoided, COULD result in death or serious injury.

Applicable Messages

CAUTION

— Safety messages which indicate a potentially hazardous situation which, if not avoided may result in minor or moderate injury, loss of data or system failure.

NOTE

Messages which provide additional user information.

DANGER

EXPLOSION HAZARD — Using this equipment in the presences of flammable gasses (including anesthetics and oxygen) may cause an explosion or fire.

Always use this equipment in a well ventilated area away from the presence of potentially flammable gasses

WARNING

SYSTEM STABILITY — All systems should be installed and maintained according to installation instructions and manufacturers specifications. Any alterations may affect the stability of the system.

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Introduction

WARNING

PATIENT MONITORING — The system is intended to be used as a recording system for catheterization, electrophysiology and related specialty laboratories. A defibrillator or ECG monitor should be attached for patients in need of uninterrupted ECG display. An additional means to display SPO

patients in need of uninterrupted SPO

should be available for

display. A

temporary pacemaker needs to be available for patients in need of uninterrupted delivery of pacing.

WARNING

SUPERVISED USE — This device is intended for use under the direct supervision of a licensed health care practitioner.

WARNING

ACCESSORIES — All system components sold by GE Healthcare for use with this system are tested to meet IEC 60601-1 when used with the system. All other components used with the system must meet IEC 60601-1.

WARNING

IEC — All equipment not complying with IEC 60601-1 should be placed outside the patient environment.

WARNING

SHOCK HAZARD — 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.

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Introduction

WARNING

SHOCK HAZARD — Keep the conductive parts of lead electrodes and associated parts away from other conducting parts, including earth.

WARNING

SHOCK HAZARD — Total system earth leakage current must not exceed 500 microamperes.

Voltages between the three power outlet connections must be accurate BEFORE measuring power outlet ground-toneutral loop resistance.

Electrostatic discharge (ESD) can damage electronic components. Be sure you are properly grounded when using or servicing the system.

WARNING

SHOCK HAZARD — To reduce the risk of electric shock or damage to the equipment, do not disable the power cord grounding feature. This equipment is designed for connection to a grounded (earthed) power outlet.

WARNING

SHOCK HAZARD — Use appropriate Lock Out/Tag Out procedures whenever an energy hazard exists, such as disconnecting equipment to perform maintenance.

WARNING

SHOCK HAZARD — Electrical shock hazard 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 grounded (earthed) power outlet. The grounding plug is an important safety feature.

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Page 22

Introduction

WARNING

SHOCK HAZARD — High voltages exist in the unit. Use insulated tools. Remove jewelry and use only one hand when possible.

Always disconnect power from the equipment before attempting service.

WARNING

SHOCK HAZARD — Only connect IEC 60601-1 certified medical equipment. If fluid of any kind should leak into the system, discontinue use of the equipment and contact GE Healthcare immediately.

WARNING

SHOCK HAZARD — 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

SHOCK HAZARD — 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 nonisolated 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 60601-1 certified product Ablation operations should NOT be executed when a stimulator unit is connected.

WARNING

SHOCK HAZARD — Do not allow any foreign materials such as fluids to come in contact with the CardioLab II Plus Amplifier. If fluid of any kind should leak into the CardioLab II Plus Amplifier, discontinue using the amplifier and contact GE Healthcare. DO NOT allow hydraulic fluid from any device to contact any conductive surface. Hydraulic fluid is electrically conductive.

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Introduction

WARNING

SHOCK HAZARD — Use appropriate Lock Out/Tag Out procedures before performing any service on potentially energized equipment.

WARNING

SHOCK HAZARD — Remote speakers must be powered by a 60601-1 certified power supply.

WARNING

CONDUCTION HAZARD — Do not leave conductive parts of lead electrodes open. This condition could leave the patient or user more susceptible to shock.

WARNING

GROUNDING — Electrostatic discharge (ESD) can damage electronic components. Be sure you are properly grounded before opening any equipment.

WARNING

POWER SUPPLY — The supply line must be fused and capable of delivering 16A.

Route the AC power cable away from moving parts.

Connect only to a properly earth grounded outlet.

WARNING

DEFIBRILLATOR PRECAUTIONS — DO NOT contact the amplifier or patient during defibrillation.

Defibrillation equipment is required in the event that the patient needs to be cardioverted or defibrillated.

WARNING

INTERNAL DEFIBRILLATION — Prior to internal defibrillation, disconnect the intercardiac catheters from the system to prevent damage to the amplifier.

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Introduction

WARNING

INTERPRETATION HAZARD — A qualified physician must overread all computer-generated measurements and tracings. Computerized interpretation is only significant when used in conjunction with clinical findings.

Signal quality should be checked only by a licensed health care practitioner.

All computer assisted measurement functions must be verified by a licensed health care practitioner.

WARNING

ANNUAL EQUIPMENT MAINTENANCE — The system should be checked yearly to ensure compliance with medical device standards.

WARNING

PINCH POINT HAZARD — Keep hands, hair, jewelry and loose clothing away from moving parts. Otherwise, serious injury could result.

WARNING

REPLACEMENT PARTS — Replace only with the same type and rating of fuse.

WARNING

SOFTWARE — DO NOT add unauthorized software to the system. Doing so may make the software unstable.

WARNING

REMOVABLE MEDIA — Exit the software application properly before turning off the system. Failure to do so may result in loss of ability to store the data properly.

Follow recommended instructions when exiting the application or turning off the system to ensure data integrity.

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Introduction

CAUTION

ELECTROSTATIC SHOCK — Working on electronic devices while not properly grounded my cause damage to the equipment.

Always use a wrist grounding strap and grounding pad when working on electronic equipment.

CAUTION

SALE OF DEVICE — Federal (USA) law restricts this device to sale by or on the order of a physician.

CAUTION

EQUIPMENT CABLING DAMAGE — Route optical cables thorough conduit in the ceiling or floor to avoid damage to the cables or cable connectors.

CAUTION

EQUIPMENT USE —

DO NOT reuse single use devices.

CAUTION

EMC — No known electromagnetic or other interference between the system exists. However, precautions should be taken to avoid the use of cellular telephones, pagers, or other transmitters.

CAUTION

TRANSDUCER — All air must be removed from the transducer or associated tubing before calibration for accuracy.

Pressure channels should be calibrated to a known pressure value if the pressure value is in question.

CAUTION

REMOTE MONITOR — Always power the system through separate isolation transformers which are independently connected to a wall outlet.

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Introduction

ITE Conformance Statement

 The Mac-Lab/CardioLab/Centricity Cardiology INW Server software

applications are intended to be installed and run on an applicable ITE compliant hardware platforms (minimum Hardware Essential Performance be ITE compliant) which may not meet leakage and/or EMC requirements of patient care area equipment. This means but is not limited to the following (unless the medical electrical standard [EN60601-1-1 and EN60601-1-2] is followed):

 The Mac-Lab/CardioLab/Centricity Cardiology INW Server

hardware does not directly deliver energy to the Patient.

 The Mac-Lab/CardioLab/Centricity Cardiology INW Server

hardware does not indirectly control energy delivered to the Patient.

 The Mac-Lab/CardioLab/Centricity Cardiology INW Server

hardware is not directly connected to the Patient.

 The Mac-Lab/CardioLab/Centricity Cardiology INW Server

hardware is not installed or used in the Patient vicinity.

 Patient Vicinity summarized as follows:

 A space, within a location intended for the examination and

treatment of patients, extending 6 ft (1.83 m) beyond the normal location of the bed, chair, table, treadmill, or other device that supports the patient during examination and treatment and extending vertically to 8 ft 2.4 in. (2.5 m) above the floor.

 Areas where health care staff members monitor patients and

perform charting and administrative tasks are not considered to be Patient Vicinity areas.

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Types of Systems

Mac-Lab System

Introduction

The Mac-Lab System is intended for use in a catheterization and related cardiovascular specialty laboratories under the direct supervision of a licensed healthcare practitioner. It is intended to monitor, calculate and/ or record cardiovascular data from adult and pediatric patients undergoing cardiac catheterization procedures. The data may be manually entered or acquired via interfaced devices. Data includes: ECG, heart rate, pulse oximetry (SpO

temperature, valve gradients and areas, cardiac output, hemodynamic measurements, invasive and noninvasive blood pressure and procedural information and optional intracardiac electrocardiogram (IECG). Physiological parameters such as diastolic, systolic, and mean blood pressure, heart rate, and cycle length may be derived from the signal data, displayed and recorded. The system allows the user to monitor the acquisition of data, review the data, and generate reports on the data. Additionally, the system may acquire, amplify, display and record data received from other interfaced medical devices typically used during these procedures, such as imaging devices. The Mac-Lab System does not control the delivery of energy, administer drugs, perform any lifesupporting or life-sustaining functions, or analyze data acquired during the procedure. The Mac-Lab System does not transmit alarms or arrhythmias and does not have arrhythmia detection capabilities.

), respiration rate, EtCO2,

CardioLab EP System

The CardioLab EP System is intended for use in an electrophysiological laboratory and related specialty laboratories under the direct supervision of a licensed healthcare practitioner. It is intended to monitor, calculate and/or record electrophysiological data from adult and pediatric patients undergoing electrophysiological studies. Data includes: ECG, pressure, and intracardiac electrocardiogram (IECG) waveforms, heart rate, pulse oximetry (SpO

temperature, invasive and noninvasive blood pressure, and procedural information. Physiological parameters such as diastolic, systolic, and mean blood pressure, heart rate, and cycle length may be derived from the signal data, displayed and recorded. The system allows the user to monitor the acquisition of data, review the data, and generate reports on the data. Additionally, the system may acquire, amplify, display and record data received from other interfaced medical devices typically used during these procedures, such as imaging devices and RF generators. The CardioLab EP System does not control the delivery of energy, administer drugs, perform any life-supporting or life-sustaining functions, or analyze data acquired during the procedure. The CardioLab EP System does not transmit alarms or arrhythmias and does not have arrhythmia detection capabilities.

), respiration rate, EtCO2,

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Introduction

ComboLab System

The ComboLab System is the combination of the both the Mac-Lab and CardioLab EP systems. The ComboLab System is intended for use in either a catheterization laboratory or electrophysiological laboratory and related speciality laboratories under the direct supervision of a licensed healthcare practitioner. The ComboLab System allows the user to run either the Mac-Lab System or the CardioLab EP System, although only one may be used at a time.

CardioLab II Plus Amplifier

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.

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Security Information

Validated configurations consist of product scenario implementations that are tested against GE product failure and sample cases run to simulate a real environment while conducting testing. GE provides service and support based on validated configurations only and bears responsibility for GE products only.

Non-Validated Software Applications

This is to detail the policy for non-validated software applications applied to the following products:

 Mac-Lab Hemodynamic Systems

 CardioLab Electrophysiology Systems

 ComboLab Hemodynamic and Electrophysiology Systems

 Centricity Cardiology INW Server

Introduction

Policy

Our policy is that we do not recommend installations of any other third party software applications (that is, not mentioned above) on the products above as they could affect performance, warranty and serviceability. Examples of such might include other Anti-Virus programs, print servers, interface engines, anti-spyware, anti-adware, viruses, malware, and so on. GE does not support the use or installation of these non-validated applications or tools. If such programs are installed the customer bears the risk of the product not functioning properly and any risks that are introduced for patient safety. GE will not guarantee support for an environment that is different than a validated implementation. In cases where this is found and technical assistance is requested, GE will provide support, by first eliminating the third party software on the product and bringing it back to a known and validated configuration. If it is found that the third party software is the cause of product failure, any costs associated with this will be the responsibility of the hospital.

At GE Healthcare we understand the uniqueness of our customers and pride ourselves in the personalized solutions we provide to help you in your quest to care for patients. We hope this section will help you to better understand our policy on non-validated software applications and we hope you can work with us as we proceed in further developing our products for your future benefit.

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Introduction

Validated Third Party Software

Currently validated and allowed third party software such as Enterprise Back-up, Archival, Anti-virus and other applications to run on the same computer are:

Enterprise Backup Software

IBM Tivoli Storage Manager v6.1

Symantec Backup Exec for Windows Server v12.5

CA ARCserv Backup for Windows r12.5

EMC Networker v7.5 + SP1

Validated Anti-Virus Software

Mac-Lab/CardioLab/ComboLab IT (Version 6.5.6)

The Mac-Lab/CardioLab 6.5.6 system has been validated to run with the software listed below. Except where noted, the software below supports English, French, German, Italian, Spanish, Swedish, Chinese, and Japanese:

Supported Anti-Virus Software Supported Anti-Virus Software Version

CA eTrust Antivirus r8.1

McAfee® VirusScan® (with McAfee ePolicy Orchestrator v4.0, Patch 5)

Norton Antivirus™ 2009

Symantec EndPoint Protection 11.0.5 (English, French, German, Italian,

Trend Micro OfficeScan Client/Server Edition

The Antivirus Server software can be installed at a hospital domain level and the Centricity Cardiology INW server can be a client for the Antivirus software.

8.7i, Patch 2

Spanish, Chinese)

11.0.4 MR4 + MP2 (Japanese)

10.0

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Previously Validated Anti-Virus Software

The Mac-Lab/CardioLab system has previously been validated to run with the software listed below. It is recommended that systems run with one of the currently validated Anti-Virus software packages to avoid any unforeseen issues. Please refer to “Validated Anti-Virus Software” on page 1-16.

Supported Anti-Virus Software Supported Anti-Virus Software Version

Introduction

CA eTrust™ AntiVirus Enterprise (for a single Acquisition, Review, or Server)

McAfee® VirusScan® (with McAfee ePolicy Orchestrator v4.0, Patch 3)

McAfee Active VirusScan SMB Edition (for Acquisition, Review, or Server).

McAfee ProtectionPilot™ 1.0.1, 1.5

McAfee ViruScan Enterprise 8.5i

Norton AntiVirus Edition (for Acquisition and Review) (Norton AntiVirus software must be the boxed copy. Do not download the software from internet.)

Norton Antivirus™ (Norton AntiVirus software must be the boxed copy. Do not download the software from internet.)

Symantec EndPoint Protection 11.0.4

Symantec AntiVirus (for Acquisition, Review, or Server)

Symantec AntiVirus Corporate Edition (for Acquisition, Review, or Server)

r8.1

8.7i

8.0

2005

2007

9.0

10.2

Trend Micro OfficeScan Client/Server Edition

Trend Micro OfficeScan Client/Server Edition (for Acquisition, Review, or Server)

2021423-503H Mac-Lab/CardioLab/Centricity Cardiology INW Service Manual 1-17

8.0 + SP1

8.0 (English)

7.3 (non-English and non-Swedish)

Page 32

Introduction

3rd Party: PedCath

Language PedCath Version

English v7.6.7

French v7.5.5

Swedish/German (see note) v7.6.5

Italian v7.5.5

Spanish v7.5.5

Japanese v7.4.3J

Chinese (see note) v7.4.3J

NOTE

Chinese systems will use the Japanese version of PedCath. Swedish and German systems will use the English version of PedCath.

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Service Information

Service Requirements

Follow the service requirements listed below:

 Equipment servicing should be performed by GE Healthcare

 Any unauthorized attempt to repair equipment under warranty voids

 It is the user’s responsibility to report the need for service to GE

 Failure on the part of the responsible individual, hospital, or

 Regular maintenance, irrespective of usage, is essential to ensure

Introduction

authorized service personnel only.

that warranty.

Healthcare or one of their authorized agents.

institution using this equipment to implement a satisfactory maintenance schedule may cause undue equipment failure and possible health hazards.

that the system is always functional when required.

Product Identification

Every system has a unique serial number for identification. The serial number appears on the product labels which are located on the top of the CPU, the back of the Integrated Electronics Box (IEB), the right side of the RAC 4A, the back of the TRAM and the back of the Amplifier.

Identification Tag

Item Name Description

1 Manufacture Date Date of manufacture in YYYY-MM format.

2 Part Number of Product GE Healthcare part number for product.

3 Product Code Description Identifier for type of product.

4 Serial Number Unique serial number for identification.

Encoded as barcode below displayed number.

5 Manufacturer Information Name and address of device

manufacturer.

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Introduction

XXXXXXXXXXXXXX

XXXXXXXXXXXXXXXXXX

XXXXXXXXX

XXXXXXXXXXX

XXXXXXXXXXXXX

AA5 XX XXXX XXX X

Old Identification Tags

Systems manufactured earlier may have one of the two following styles of identification labels instead.

Identification Tag

Item Name

A Name of Device

B Manufacturer

C Serial Number

D 3-digit Product Code

E Year Manufactured

F Fiscal Week

G Product Sequence Number

H Manufacturing Site

I Miscellaneous

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Identification Tag

XXXXXXXXXXXXXXX

XXXXXXXXXXXXXXXXXX

XXXXXXXXX

XXXXXXXXXXX

XXXXXXXXX

D E

A X XX XXXX XX

Item Name

Introduction

A Name of Device

B Manufacturer

C Serial Number

D Facility Code

E Product Sequence Number

F Product Code

G Year Manufactured

H Month Manufactured

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Introduction

Required Tools and Supplies

The following is a list of tools needed to service the Mac-Lab/CardioLab system:

 Adjustable wrench with a 1-inch capacity

 Phillips screwdriver

 Needle nose pliers

 Pliers

 Socket wrench (3/16 inch to 1 inch size bits)

 Phillips head screwdriver (small and large sizes)

 Flat head screwdriver (small and large sizes)

 Cutting pliers

 Power outlet ground tester

 Grounding strap

 Simulator with ECG, pressure, cardiac output, and temperature

outputs

 Cables to connect simulator to ECG inputs of amplifier and TRAM

 Cables to connect the simulator to the catheter input modules (2 mm

shielded)

 Adapter cable to connect the simulator to the amplifier and TRAM

pressure inputs

 Cables to connect the simulator to the TRAM, cardiac output, and

temperature inputs

Power Input Requirements

If the equipment is installed in the USA and uses 240V rather than 120V, the source must be a center-tapped, 240V single phase circuit (120V, 20A; 240V, 10A).

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Page 37

Safety Information

Follow all of the instructions and warnings included in this manual and save these instructions for later use. However, these instructions in no way supersede current medical practices regarding patient care and safety.

Electromagnetic Compatibility and Interference

This catheterization system meets the requirements of the European Medical Device Directive, and by reference, the requirements for electromagnetic compatibility specified by EN 60601-1-2. This equipment is not likely to interfere with other equipment, except with certain types of rate adaptive pacemakers that rely on bioelectric impedance measurement (BIM) technology. Also, interference with the operation of this equipment is not likely to result from proximity to general equipment.

This equipment meets or exceeds Class A immunity levels. However, avoid the use of strong intentional radio transmitters in the immediate vicinity, including cellular telephones. The use of strong unintentional radiators, such as electrosurgical equipment, may cause some level of interference. GE Healthcare offers optional ECG patient cables with electrosurgical noise filtering, which reduces the level of interference on ECG traces.

Introduction

Exception

The Mac-Lab/CardioLab system and CardioLab Plus II Amplifier meets the requirements of IEC 60601-1-2 Medical Electrical Equipment, Part 1: General Requirements for Safety, 2. Collateral Standard: Electromagnetic compatibility - Requirements and tests.

If using electrosurgical or RF ablation equipment in conjunction with this equipment, select an ESU filtered cable. For more information about management of the equipment in the clinical environment (from an electromagnetic compatibility perspective) consult the Association for the Advancement of Medical Instrumentation's technical information report

Guidance on Electromagnetic Compatibility of Medical Devices for Clinical/Biomedical Engineers.

ECG Parameter

IEC 60601-1-2 clause 36.202.1 - Immunity: Radiated Immunity –

The level of compliance is less than 1V/m

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Page 38

Introduction

Recommendations:

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

EU Battery Directive 2006/66/EC

The Mac-Lab/CardioLab product conforms to the EU Battery Directive 2006/66/EC.

The Uninterruptable Power Supply (UPS) supplied with the IEB of the Mac-Lab/CardioLab contains lead/acid storage batteries. These batteries are a permanent part of the UPS assembly and are not intended to be removed or changed. Attempting to remove or change these batteries may result in an unsafe condition.

The separate collection symbol is affixed to a battery, or its packaging, to advise you that the battery must be recycled or disposed of in accordance with local or country laws. The letters below the separate collection symbol indicate whether certain elements (Pb=Lead, Cd=Cadmium, Hg=Mercury) are contained in the battery. To minimize potential effects on the environment and human health, it is important that all marked batteries that you remove from the product are properly recycled or disposed. Information on the potential effects on the environment and human health of the substances used in batteries is available at the urls below:

http://www.gehealthcare.com/euen/weee-recycling/index.html

http://www.epa.gov/mercury/about.htm

http://www.cdc.gov/niosh/npg/npgd0383.html

http://www.epa.gov/lead/

http://www.cdc.gov/niosh/npg/npgd0368.html

http://www.cdc.gov/niosh/npg/npgd0087.html

http://www.epa.gov/waste/hazard/wastemin/minimize/factshts/ cadmium.pdf

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Page 39

Responsibility of the Manufacturer

GE Healthcare is responsible for the effects of safety, reliability, and performance only if:

 Installation operations, extensions, readjustments, modifications, or

repairs are performed by persons authorized by GE Healthcare.

 The equipment is used in accordance with the instructions provided.

 The user attaches only accessory equipment recommended for

interaction with the amplifier.

General

This system is intended for use under the direct supervision of a licensed health care practitioner.

The Mac-Lab/CardioLab system, including the CardioLab Plus II Amplifier, maintains leakage currents below medical limits with an isolation transformer which is incorporated into the design of the integrated electronics box (IEB). The system power is supplied by a dedicated power supply on an isolated circuit for proper behavior of the system.

Introduction

To ensure patient safety, use only parts and accessories manufactured or recommended by GE Healthcare. Parts and accessories used must meet the requirements for the applicable EN 60601 series safety standards, and the system configuration must meet the requirements of the EN 60601-1 medical electrical systems standard. Contact GE Healthcare before connecting any device to this system that is not recommended for use in this manual.

If the equipment is installed in the USA and uses 240V rather than 120V, the source must be a center-tapped, 240V single-phase circuit.

To ensure patient safety, use only parts and accessories manufactured or recommended by GE Healthcare.

This equipment should only be connected as specified by GE Healthcare. Installation of the equipment should only be performed by qualified GE Healthcare service representatives.

Contact GE Healthcare for information before connecting any device to this equipment that is not recommended in this manual. Only cables and accessory equipment purchased from GE Healthcare should be used in conjunction with the system.

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.

Refer servicing of the equipment to GE Healthcare authorized service personnel. Any attempt to repair equipment under warranty will void that warranty.

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Page 40

Introduction

Equipment Symbols

Equipment Symbols Descriptions

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 includes:

 Use of the accessory in the Patient Vicinity.

 Evidence that the safety certification of the Accessory is performed in

accordance with the appropriate EN 60601-1 and EN 60601-1 harmonized national standard.

The CardioLab II Plus Amplifier is a component/accessory of a Class II medical device.

CE Marking

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 IEC 60601-1-1.

Power Ratings Chart:

V~ = V = Voltage, ~ = Alternating Current

I = Current

Fuse =

Equipotential Ground Point

A nonessential electrical connection which may be used to connect the chassis to other equipment to achieve the same potential.

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Page 41

Equipment Symbols Descriptions

Type CF Equipment that is Defibrillator Proof

Type CF Applied Part: Isolated (floating) applied part suitable for intentional external and internal application to the patient excluding direct cardiac application. The “paddles” outside the box indicate that the 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 provide a higher degree of protection against electric shock than that provided by Type B applied parts.

Type CF Equipment

Type CF Applied Part: Isolated (floating) applied part suitable for intentional external and internal application to the patient excluding direct cardiac application.

Type BF Equipment that is Defibrillator Proof

Introduction

Type BF Applied Part that is defibrillator proof: Isolated (floating) applied part suitable for intentional external and internal application to the patient excluding direct cardiac application. “Paddles outside the box indicate the applied part is defibrillator proof.

Atmospheric Pressure Limits

Temperature Limits

Humidity Limits

Attention

Pay attention to the documents delivered with the equipment.

Input Symbol

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Page 42

Introduction

Equipment Symbols Descriptions

General Warning

Manufacturer

Date of Manufacture

Consult Instructions for Use

WARNING: SHOCK HAZARD

Remove power cord from the mains source by grasping the plug. Do not pull on the cable. This may cause cable damage, which could result in loss of protective earthing or exposure to mains voltage.

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Page 43

Introduction

Compliance Information

Mac-Lab/CardioLab System

Declaration - Electromagnetic Emissions

The Mac-Lab / CardioLab System is intended for use in the electromagnetic environment specified below. The customer or the user of the Mac-Lab / CardioLab System should assure that it is used in such an environment.

Emissions Tests Compliance Electromagnetic environment guidance

RF emissions CISPR 11 Group 1 The Mac-Lab / CardioLab System uses RF

energy only for its internal function. Therefore, its RF emissions are very low and are not likely to cause any interference in nearby electronic equipment.

RF emissions CISPR 11 Class A The Mac-Lab / CardioLab System is suitable

Harmonic emissions IEC 61000-3-2 Class A

Voltage fluctuations/Flicker emissions IEC 61000-3-3

Complies

for use in all establishments other than domestic and those directly connected to the public low-voltage power supply network that supplies buildings used for domestic purposes.

Declaration - Electromagnetic Immunity

Immunity Test

Electrostatic discharge (ESD) IEC 61000-4-2

Electrical fast transient/burst IEC 61000-4-4

Surge IEC 61000-4-5

IEC 60601

Test Level

± 6 kV contact ± 8 kV air

± 2kV for power supply lines (signal lines exempt from testing, length is less than 3 m)

± 1kV differential mode ± 2kV common mode

Compliance

Level

± 6 kV contact ±8 kV air

± 2kV for power supply lines

± 1kV differential mode ±2kV common mode

Electromagnetic Environment - Guidance

Floors should be wood, concrete or ceramic tile. If floors are covered with synthetic material, the relative humidity should be at least 30%.

Mains power quality should be that of a typical commercial or hospital environment.

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Page 44

Introduction

Declaration - Electromagnetic Immunity

Immunity Test

Voltage dips, short interruptions and voltage variations on power supply input lines IEC 61000-4-11

Power frequency (50/60 Hz) magnetic field IEC 61000-4-8

IEC 60601 Test Level

<5% 100-120Vac <5% 200-240Vac (>95% dip) for

0.5 cycle

Compliance

Level

<5% 100-120Vac <5% 200-240Vac (>95% dip) for

0.5 cycle

Electromagnetic Environment - Guidance

Mains power quality should be that of a typical commercial or hospital environment. If the user of the Mac-Lab / CardioLab System requires continued operation during power mains interruptions, it is recommended that the Mac-Lab / CardioLab System be powered from an Uninterruptable

power supply or a battery. 40% 100-120Vac 40% 200-240Vac (>60% dip) for 5 cycles

70% 100-120Vac 70% 200-240Vac (>30% dip) for 25 cycles

<5% 100-120Vac <5% 200-240Vac (>95% dip) for 5 seconds

40% 100-120Vac 40% 200-240Vac (>60% dip) for 5 cycles

70% 100-120Vac 70% 200-240Vac (>30% dip) for 25 cycles

<5% 100-120Vac <5% 200-240Vac (>95% dip) for 5 seconds

3 A/m 3 A/m Power frequency magnetic fields should be at levels characteristic of a

typical location typical commercial or hospital environment.

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Introduction

Declaration - Electromagnetic Immunity

Immunity Test

Conducted RF emissions IEC 61000-4-6

Radiated RF emissions IEC 61000-4-3

IEC 60601 Test Level

3 Vrms 105kHz to 80 MHz with 2 Hz modulation

3V/m80 MHz to

2.5 GHz

Compliance

Level

Portable and mobile RF communications equipment should be used no

closer to any part of the Mac-Lab / CardioLab System, including cables,

than the recommended separation distance calculated from the equation

applicable to the frequency of the transmitter.

Recommended separation distance (d)

3 Vrms d = 1.2 P

3 V/m d = 1.2 P

d = 2.3 P

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).Field Strengths from fixed RF

transmitters, as determined by a electromagnetic site survey

less than the compliance level in each frequency range

occur in the vicinity of equipment marked with the following symbol:

Electromagnetic Environment - Guidance

. Interference may

, should be

NOTE

At 80 MHz and 800 MHz, the higher frequency range applies.

These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflected from structures, objects and people.

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 Mac-Lab / CardioLab System is used exceeds the applicable RF compliance level above the Mac-Lab / CardioLab System should be observed to verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as re-orienting or relocating the Mac-Lab / CardioLab System.

Over the frequency range 150 kHz to 80 MHz. Field strengths should be less than 3 V/m

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Page 46

Introduction

d 1.2 P=

d 2.3 P=

Recommended Separation Distances Between

Portable and Mobile RF Communications Equipment and the Mac-Lab/CardioLab system

The Mac-Lab/CardioLab system is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The customer or the user of the Mac-Lab/CardioLab system can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and the Mac-Lab/CardioLab system as recommended below, according to the maximum output power of the communications equipment.

Rated Maximum Output

Power of Transmitter

Separation Distance According to Frequency of Transmitter

150 kHz to 80 MHz 80 MHz to 800 MHz 800 MHz to 2.5 GHz

0.01 0.12 0.12 0.23

0.1 0.38 0.38 0.73

1 1.2 1.2 2.3

10 3.8 3.8 7.3

100 12 12 23

For transmitters rated at a maximum output power not listed above, the recommended separation distance d in meters (m) can be estimated 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, separation distance for the higher frequency range applies.

These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflected from structures, objects and people.

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2 Equipment Overview

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Equipment Overview

Typical System Configuration

NOTE

For configuration, component and connection information for HP xw8200 and HP xw8000 computers, refer to the Mac-Lab/CardioLab/ Centricity Cardiology INW Service Manual v6.5 (PN 2021423-022).

This system may consist of either Mac-Lab (hemodynamic), CardioLab (electrophysiologic), or ComboLab (both systems).

The system may be standalone or connected to a network. Network installations include a Centricity Cardiology INW server. In this manual, INW refers to Centricity Cardiology INW. It may be connected to an optional CVIS server.

The system may also include a CardioLab II Plus Amplifier, also referred to as CLab II Plus.

The following block diagram shows a typical setup.

Dashed lines indicate CardioLab/ComboLab only

Stimulator

Keyboard

Workstation

Control Room

Speakers

Mouse

Real-Time

Monitor

CPU

UPS

Printer

Review

Monitor

IEB

Image

Monitor

3" Floor Conduit

3" Ceiling Conduit

Amplifier

CIM

Monitor Boom

Catheter

Personality

Module

Generator

Remote

Real-Time

Monitor

TRAM

RAC4A

Remote

Review

Monitor

Bed

Procedure Room

INW

Server

IT Control Room

Network

Switch

CVIS

To Hospital Network

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Page 49

Control Room Components

 Acquisition Computer

 USB Mouse

 Keyboard

 Barcode scanner

 Integrated Electronics Box (IEB): The IEB provides power to

local system components, signal pass through video and communications.

 Uninterruptible Power Supply (UPS): The UPS provides

emergency power to the HP computer.

 Monitors: Two monitors (Real-Time and Review) are standard. A

third Image monitor is optional.

 Local speakers: Provide output for ECG QRS tone and optional

audible indicators.

 Laser Printer: Prints images or reports.

 Cardiac Stimulator: Provides direct cardiac stimulation to assist

the physician during an EP case.

Equipment Overview

Procedure Room Components

 Monitors: One remote monitor is standard (and is software

switchable between Real-Time and Review windows). A second monitor is optional.

 Remote speakers: Provide output for ECG QRS tone and optional

audible indicators in the procedure room.

 TRAMNet: The TRAMNet gathers patient data for the Mac-Lab

system. The TRAMNet consists of a Remote Acquisition Case (RAC4A) and a Transport Remote Acquisition Module (TRAM).

 CardioLab II Plus Amplifier: The Amplifier gathers data for both

the ComboLab and CardioLab systems.

 CARTO™ System (Patient Interface Unit): Provides 3D

electroanatomical cardiac maps to the CardioLab.

 Analog Output Box: Distributes Heart rate and blood pressure

signals from the TRAMNet and Amplifier to other equipment.

 Review Workstation: Client installed in physician office or outside

lab. Provides post-procedure analysis capabilities such as generating reports.

 Nurses Workstation: Client used during the study. Provides the

operator with the ability to participate in an active study and perform actions such as document administered medications and supplies consumed.

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Page 50

Equipment Overview

DMS Express Server

(Interface Server)

INW Server

Review

Workstation

Mac-Lab CardioLab

Hospital

Enterprise

IT Control Room Equipment

 Network Switch

 Centricity Cardiology INW Server

 CVIS Server

Network Connections

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Page 51

System Hardware

WARNING

SHOCK HAZARD — Use appropriate Lock Out/Tag Out procedures before performing any service on potentially energized equipment.

Acquisition Workstation System Components

HP Computer

The HP computer is used for either Acquisition systems or Review workstations and has the following components:

 Primary Hard Drive with two partitions:

 C: Application partition

 D: Data partition

 Optional Magneto-Optical drive (Drive E:).

NOTE

The optional Magneto-Optical drive is only available on HP xw8400 computers.

Equipment Overview

 DVD-RAM drive (Drive F:).

NOTE

The drive used to store application studies is determined by the file paths set in under System Settings in the main application menu.

 Secondary Hard Drive (Drive G:).

 Four standard expansion cards (plus optional cards):

 HP xw8400: Matrox Parhelia video board provides video out for

the Real-Time (Video 1) and Review (Video 2) monitors.

 HP z600: Matrox M9140 video board provides video out for the

Real-Time (Video 1), Review (Video 2), and optional (Video 3) monitors.

 TRAMNet to Ethernet Adapter board for communication with

the TRAM in the RAC 4A.

 PCI Communication board to provides Amplifier

Communication, Analog and Digital I/O, and Switched video (video out from the IEB).

 Dual NIC Adapter board provides Network connection.

 Optional on HP xw8400: Adaptec Ultra320 SCSI PCIe board for

supporting MO drive.

 Optional on HP xw8400: Matrox Odyssey XA board used to

capture images from an X-Ray or other imaging system.

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Equipment Overview

 Optional on HP xw8400: ATI FIREGL V5200 256MB PCI-E or

ATI FIREGL V3350 256MB PCI-E Video board. Provides video out for optional (video 3) monitor.

 Optional on HP z600: Matrox Odyssey EA board used to capture

images from an X-Ray or other imaging system.

External Components and Connections for the HP z600

Label Part Number Description

1 2028599-002 DVD-RAM Drive

2 N/A Power Switch

3 N/A LEDs, USB, Firewire, and Audio connections

4 N/A Backplane I/O panel

5 N/A Board Slots

6 N/A AC Power

Not Shown 2026539-001 HP USB 2-Button Optical Mouse with Wheel

Not Shown Various Keyboard (dependent on language)

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Page 53

Equipment Overview

External Components and Connections for the HP xw8400

Label Part Number Description

1 2028599-002 DVD-RAM Drive

2 N/A Power Switch, LEDs, USB, Firewire, and Audio

connections

3 N/A AC Power

4 N/A Backplane I/O panel

5 N/A Board Slots

Not Shown 2003340-001 Magneto-Optical Drive (optional)

Not Shown 2026539-001 HP USB 2-Button Optical Mouse with Wheel

Not Shown Various Keyboard (dependent on language)

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Page 54

Equipment Overview

Disassembly

WARNING

GROUNDING HAZARD — Electrostatic discharge (ESD) can damage electronic components. Be sure you are properly grounded before opening any equipment.

Remove Case Side Panel

1. Lift the tab near the top.

2. Swing the side panel out.

Remove Front Panel - HP xw8400 only

1. Lift tabs indicated.

2. Swing the front panel out.

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Equipment Overview

Remove Hard Drive - HP xw8400 only

1. Press tabs as indicated.

2. Slide drive out.

Remove Hard Drive - HP z600 only

1. Press tab to release handle.

2. Pull drive out.

Remove the AGP/PCI Card Support Assembly - HP xw8400 only:

1. Squeeze in the tabs, where indicated. Gently push in, then pull out.

2. Lift off the clamp.

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Page 56

Equipment Overview

Remove PCI Boards

1. Open the PCI retainer by pressing down on the green tabs and moving the retainer

away.

2. Matrox M9140 only: Carefully hold the board release tab toward the top of the case.

3. Gently pull the board out of the computer case.

Remove DVD-RAM Drive

1 2

1. Remove screw, if present.

2. Lift tab indicated.

3. Slide drive out.

Remove Power Supply - HP z600 only

1. Pull green handle to release power supply.

2. Slide power supply out.

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Page 57

Equipment Overview

DVD-RAM Drive

The DVD-RAM drive can also read/write to CDs. The recommended disks have a capacity of approximately 4.7 GB per side.

NOTE

The drive used to store application studies is determined by the file paths set in under System Settings in the main application menu.

12 3

 1: DVD-RAM Drive Jumpers

 2: IDE Connector

 3: Power Connector

SATA-to-IDE Converter - HP z600 Only

The DVD-RAM drive is connected using a SATA-to-IDE converter.

Label Description

1 SATA Connection

2 4-pin Power Connection

Not Shown IDE Connection (on back of device)

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Page 58

Equipment Overview

Optical Drive

The optical drive is an optional upgrade to HP Computers.

NOTE

The optional Magneto-Optical drive is not available on HP z600 computers.

NOTE

Drive use is determined by the file paths set in under System Settings in the main application menu.

 1: Optical Drive Jumpers

 2: SCSI Adapter (PN 2012522-002)

NOTE

Two sets of DIP switches are located on the top optical drive. These are factory preset and must not be changed.

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Page 59

HP z600 Installed Boards

HP z600 Custom Dual NIC Adapter Board

Equipment Overview

 Part Number: 2047766-001

 Location: Slot 1

 Function: Network connection card, ablation connection card.

 I/O: Two network connection jacks, one serial port (for connection to

ablation devices)

Uses internal serial connection from motherboard:

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Page 60

Equipment Overview

HP z600 Matrox Quad Board M9140 LP Video Board

 Part Number: 2049434-001

 Location: Slot 2

 Function: Video out for Monitor 1, Monitor 2 and Monitor 3 (optional)

 I/O: One proprietary connector. Provides four DVI/VGA output ports

through a custom connector.

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Page 61

Equipment Overview

HP z600 Matrox Odyssey eA Board (Optional)

 Part Number: 2049435-001

 Location: Slot 3

 Function: Image capture for X-Ray or other imaging systems

 I/O: Two DVI connectors

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Page 62

Equipment Overview

HP z600 TRAMNet to Ethernet Adapter board

 Part Number: 2009937-003

 Location: Slot 5

 Function: Provides communication with the TRAM in the RAC 4A,

and converts signals from the TRAM to the ethernet.

 I/O: Network Interface Port and 9-Pin D connector

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Page 63

Equipment Overview

HP z600 PCI Communication Board

 Part Number: 2014935-002

 Location: Slot 6

 Functions:

 Communicates with the CardioLab II Plus Amplifier via the fiber

optic connectors

 Analog and Digital communication with the IEB via the D-

Connector

 Provides the video switching signal for the Switched Video

output on the IEB via the D-Connector

 I/O: D-Connector to IEB, Fiber Optic Jacks to the Amplifier

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Page 64

Equipment Overview

HP xw8400 Installed Boards

HP xw8400 PCI Communication Board

 Part Number: 2014935-002

 Location: Slot 1

 Functions:

 Communicates with the CardioLab II Plus Amplifier via the fiber

optic connectors

 Analog and Digital communication with the IEB via the D-

Connector

 Provides the video switching signal for the Switched Video

output on the IEB via the D-Connector

 I/O: D-Connector to IEB, Fiber Optic Jacks to the Amplifier

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Page 65

Equipment Overview

HP xw8400 ATI FIREGL V5200 256MB PCI-E Video Board (Optional)

 Part Number: 2026189-002

 Location: Slot 2

 Function: Video out for optional (video 3) monitor

 I/O: Two DVI connectors (only the left one is used)

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Page 66

Equipment Overview

HP xw8400 Dual NIC Adapter Board

 Part Number: 2017795-002

 Location: Slot 3

 Function: Network connection card

 I/O: Two network connection jacks

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Page 67

Equipment Overview

HP xw8400 PCIX 2 SCSI Card

NOTE

This board is optional with the MO upgrade kit (available only for 2034493-002 – 2034493-004 Acquisition configurations).

 Part Number: 2038632-001

 Location: Slot 4

 Function: Provides SCSI cable connection internally to an optional

MO Drive.

 I/O: Two SCSI connectors (only internal SCSI is used)

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Page 68

Equipment Overview

HP xw8400 Matrox Parhelia PCI 256 MB Video Card

 Part Number: 2026188-001

 Location: Slot 5 (PCI slot)

 Function: Provides video out for the Real-Time (Video 1) and Review

(Video 2) monitors. This board supports resolutions of 1280x1024 for Mac-Lab, 1600x1200 for CardioLab.

 I/O: Two DVI connectors

 Included adaptors: DVI to HD15 Video Adapter (2021697-001).

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Page 69

HP xw8400 Matrox Odyssey XA Board (Optional)

Equipment Overview

 Part Number: 2030688-001

 Location: Slot 6

 Function: Image capture for X-Ray or other imaging systems

 I/O: Two DVI connectors

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Page 70

Equipment Overview

HP xw8400 TRAMNet to Ethernet Adapter board

 Part Number: 2009937-002

 Location: Slot 7

 Function: Provides communication with the TRAM in the RAC 4A,

and converts signals from the TRAM to the ethernet.

 I/O: Network Interface Port and 9-Pin D connector

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Page 71

Integrated Electronics Box (IEB)

The IEB provides power to local system components and signal pass through video and communications. Three versions of the IEB are available to handle different line voltages: 100, 120, and 240 VAC.

The IEB consists of the following components:

 Video Multiplexer (VID MUX) board to distribute video signals from

the video cards in the HP computer to the monitors.

 I/O board to provide signal pass through for other system

components.

 Isolation transformer:

 Conforms to IEC 60601-1

 2.0 kVA medical grade high-isolation transformation

 Provides either 120 VAC (for 100 and 120 VAC systems) or 240

Equipment Overview

VAC. The primary and secondary windings are wired in parallel for 120 VAC and in series for 240 VAC.

CAUTION

CONNECTIONS — If the transformer must be disconnected for any reason, ensure the connections are correct.

 UPS (either 100, 120, or 240 VAC) and Power Distribution panel

provide conditioned power to local system components.

NOTE

The UPS is external to the IEB and provides uninterrupted power to the HP computer. The monitors and other peripherials will not remain on if power is lost.

Depending on which IEB is installed, a modem and modem power supply for dial-up communication may be present. The power supply accepts any line voltage and converts it into 9 VDC.

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Page 72

Equipment Overview

External Components and Connections

Label Part Number Description

1 2003681-003 VID MUX board

2 2003680-001 I/O Board

3 N/A Power Connections. The bottom right connector is for the HP

computer and the four vertical connectors on the right and left are for peripheral equipment.

4 N/A Thermal Overcurrent Circuit Breaker. This breaker protects all

internal components and external devices connected to the IEB.

5 N/A Main Power Switch. This switch controls power to all internal

components and external devices except the HP computer.

Both the Main Power switch on the front of the IEB and the Thermal Overload circuit breaker on the back must be on for the system to power up.

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Page 73

Video Multiplexer (VID/MUX) Board

Label Description

Equipment Overview

1 Switched video out (Video 1 or 2). This is used when the facility has only

one remote monitor. To switch monitors:

 Mac-Lab: Go to the main menu and select Windows > Physician Video

 CardioLab: Use the dropdown box just under the main menu.

2 Video 1 (Real-time) out to local monitor (bottom) and remote monitor (top)

3 Video 2 (Review) out to local monitor (bottom) and remote (top)

4 Video 3 (CardioImage) out to local monitor (bottom) and remote (top)

5(L to R) Video 1, Video 2, Video 3 in from HP Computer Matrox AGP Video

board (Vid 1 and Vid 2) and the Matrox PCI Video board (Vid 3)

The VID/MUX board amplifies (±5V 1.25A from the internal IEB DC power supply. See “Internal Components and Connections” on page 2-31) and distributes the video signals from the HP Computer (See“HP xw8400

Video Connections” on page 2-57 or “HP z600 Video Connections” on

page 2-56).

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Equipment Overview

I/O Board

Label Description

1 Analog I/0 Communications. Connects to the HP Computer PCI

Comms board.

2 Analog in from another system (Fluoro, and so on).

3 Connection to the Analog Output Box.

4 Analog out (Stimulator, and so on).

5 I/O TRAM (includes 16.5VDC power).

6 Output to HP Computer TRAMNet to Ethernet to Adapter board.

Refer to the following cabling diagrams:

 “Communications Connections” on page 2-58.

 “TRAM/Amplifier Connections” on page 2-59.

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Page 75

Equipment Overview

Power Connections

Label Description

1 and 5 AC out to local equipment (6A @ 120 VAC max.; 3A @ 240 VAC max.)

2 Thermal Overcurrent circuit breaker. Protects all internal components

and external devices connected to the IEB.

3 AC main power in (15A @ 120 VAC max; 7A, @ 240 VAC max.)

4 AC power out to UPS (2A @ 120 VAC max; 1A, @ 240 VAC max.)

Refer to the cabling diagram, “Power Connections” on page 2-55.

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Page 76

Equipment Overview

Disassembly

Open Case

1. Remove 7 side-panel screws.

2. Lift the side panel out.

Remove Connection Boards

1. Open the case.

2. Remove the board screws.

3. Disconnect interior cables.

WARNING

GROUNDING HAZARD — Electrostatic discharge (ESD) can damage electronic components. Be sure you are properly grounded before opening any equipment.

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Page 77

Internal Components and Connections

Equipment Overview

Label Part Number Description

1 2003681-003

2003680-001

2 2013535-001 Power Supply: Provides ±5 VDC 1.25A for the Vid/

VID/MUX Board Assembly

I/O DB Connect Board Assembly

MUX board and +16.5 VDC for the RAC-4A.

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Page 78

Equipment Overview

Uninterruptible Power Supply (UPS)

The UPS is designed to maintain power to the computer during a power outage.

NOTE

The UPS is external to the IEB and provides uninterrupted power to the HP computer. The monitors and other peripherials will not remain on if power is lost.

Part Number Description

2034077-001 UPS Powercom, 120V, 50/60 Hz, 1500 VA, BNT

2034078-001 UPS Powercom, 230V, 50/60 Hz, 1500 VA, BNT

2034079-001 UPS Powercom, 100V, 50/60 Hz, 1500 VA, BNT

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Page 79

GE Client Workstation

Equipment Overview

There are several configuration options for use of the Review workstations in a networked system environment.

 Nursing Workstation software allows the user to join a Mac-Lab or

CardioLab case in progress to chart and to document within the case log.

 Remote Review Workstation software allows the user to review a

Mac-Lab or CardioLab case in full disclosure in order to compose or complete reports or coronary diagrams or to review patient waveforms and measurements.

 Pre/Post Procedure Workstation software allows the user to start

or continue a Mac-Lab or CardioLab case in order to chart and to document within the case log.

NOTE

Automatic vitals logging is also available with the optional DASH and Solar monitor interface.

NOTE

When used in a patient care area, the hardware must meet IEC60601-1. This can be achieved through the use of a medical grade computer, separate isolation transformer or other means as determined by appropriate hospital personal.

The GE Client Review computer has the following components:

 Primary Hard Drive with two partitions:

 C: Application partition

 D: Data partition

 DVD-RAM drive (Drive E:).

NOTE

The drive used to store application studies is determined by the file paths set in under System Settings in the main application menu.

 Secondary Hard Drive (Drive G:).

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Page 80

Equipment Overview

External Components and Connections for the GE Client Workstation

Label Part Number Description

1 N/A Power and Reset Switches

2 N/A DVD Drive

3 N/A USB and Audio connections (behind cover)

4 N/A AC Power

5 Various Keyboard (dependent on language)

6 N/A Com Port for DASH/Solar connection

7 N/A Video Input

8 N/A USB 2-Button Optical Mouse with Wheel

9 N/A RJ-45 Port to Network

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Page 81

Disassembly

Equipment Overview

WARNING

GROUNDING HAZARD — Electrostatic discharge (ESD) can damage electronic components. Be sure you are properly grounded before opening any equipment.

Remove Case Side Panel

1. Loosen thumbscrews.

2. Pull side panel off.

Remove Hard Drive

1. Remove screws for hard

drive.

2. Slide drive out and disconnect cables.

Remove DVD Drive

1. Disconnect cables from DVD drive.

2. Remove DVD drive cage

screws.

3. Remove DVD drive cage from case.

4. Remove screws for DVD drive.

5. Remove DVD drive from cage.

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Page 82

Equipment Overview

Mobile Workstand

Refer to the instructions included with the mobile workstand for details on how to place the GE hardware on an assembled GE mobile workstand (PN 2008203-001).

Label Part Number Description

1 N/A DASH Monitor

2 N/A Mouse or Barcode Scanner location

3 N/A Keyboard location

4 2017588-001, 2021331-001, 2026192-001,

2037934-001 or 2048966-001

5 2004195-001 Isolation Transformer 120/220V 50/60HZ 600VA

6 2079070-002 LCD Monitor

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Review Workstation Computer

Page 83

Monitors

TRAMNet

Equipment Overview

The standard workstation comes with two monitors and may have a third optional monitor. The monitors include:

 A Real-Time monitor to display current patient information. It is

usually located on the left.

 A Review monitor to display past patient information.

 An optional Image monitor (used with the CardioImage option)

displays live or frozen video images.

A single remote monitor is standard and receives input from the switched video out (Video 1 or 2) jack on the IEB (see “External

Components and Connections” on page 2-26).

 To switch video for the Mac-Lab go to the main menu and select

Windows > Physician Video.

 To switch video for the CardioLab use the drop-down box just under

the main menu.

Label Description

1 TRAM Module

2 To Analog Out Box

3 To IEB TRAM Connector

The TRAMNet consists of a Remote Acquisition Case (RAC-4A) and one or more TRAM modules. The TRAMNet is located in the procedure room near the procedure table.

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Page 84

Equipment Overview

The TRAM module receives patient inputs and then transmits signal data to the IEB and other equipment through the Analog Output Box (refer to the cabling diagrams in “TRAM/Amplifier Connections” on page 2-59.

TRAM Module Inputs:

 Electrocardiogram (ECG) - green connector (5 or 10 leads)

 Thermal Dilution Cardiac Output (TDCO) - brown connector

 Invasive Blood Pressure (IBP) - 3 red connectors

 Non-Invasive Blood Pressure (NIBP) - black connector

 Pulse Oximetry (SpO

) - blue connector

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Page 85

Outputs: Analog output connector.

The following TRAM modules are supported by the Mac-Lab system:

 200SL

 400/450SL (Ohmeda, Nellcor)

 451/451N/451M (Ohmeda, Nellcor, Massimo)

 600/650SL (Ohmeda, Nellcor)

The following software versions are supported by the Mac-Lab system:

 7A, 7B, 7C, 7D, 7E, 7F, 7H

 8A, 8B, 8C, 8D

 9A, 9B

 10A, 10B

 11A, 11B, 11C

CardioLab II Plus Amplifier

The CardioLab II Plus Amplifier is designed to amplify various types of cardiac signals that are acquired from a patient and transmit them back to the CardioLab system. These signals include 12 Lead ECG, intracardiac and pressure signals.

Equipment Overview

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Equipment Overview

Front View

Front View 64/32 Channels- CardioLab II Plus Amplifier

Name Description

Pressure Inputs Four pressure inputs will each accept a pressure transducer that is calibrated to 5uV/V/mmHg. See the Accessory

Parts List for GE Healthcare Systems Information Technologies recommended pressure transducers.

ECG Input The ECG input connector will accept a 10 lead ECG input cable.

Stimulator Input The stimulator input will accept a stimulator input cable. Use the 3 ft, 15 ft or 30 ft Touchproof Stimulator Cables

(part numbers, 301-00204-03, 301-00204-15, 301-00204-30, respectively) with the CardioLab II Plus Amplifier.

Catheter Inputs Up to three catheter inputs will each accept a 32 pole catheter input module. Use the CardioLab II Plus Catheter

Input Modules (part number 301-00202-08) with the CardioLab II Plus Amplifier.

Auxiliary Inputs The auxiliary input will accept the Auxiliary Input Cable (part number 301-00205-08).

Power Indicator The power indicator is on as long as the CardioLab II Plus Amplifier is turned on.

Communication Indicators

Three communication indicators show the status of the communication between the acquisition computer and the CardioLab II Plus Amplifier.

 When the XMT indicator is on, the CardioLab II Plus Amplifier is transmitting data to the acquisition computer.

The XMT indicator should remain on as long as the power indicator is on.

 When the RCV CMD indicator is on, the CardioLab II Plus Amplifier is receiving data from the acquisition

computer. The RCV CMD indicator will turn on as long as an instruction is being received by the amplifier.

 When the RCV ERR indictor is on, the CardioLab II Plus Amplifier may not be receiving data from the

acquisition computer in a valid format or there may be a problem with the fiber optic cable.

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Page 87

Front View 128/96 Channels- CardioLab II Plus Amplifier

Equipment Overview

Name Description

Pressure Inputs Four pressure inputs will each accept a pressure transducer that is calibrated to 5uV/V/mmHg. See the Accessory

Parts List for GE Healthcare Systems Information Technologies recommended pressure transducers.

ECG Input The ECG input connector will accept a 10 lead ECG input cable.

Stimulator Input The stimulator input will accept a stimulator input cable. Use the 3 ft, 15 ft or 30 ft Touchproof Stimulator Cables

(part numbers, 301-00204-03, 301-00204-15, 301-00204-30, respectively) with the CardioLab II Plus Amplifier.

Catheter Inputs Up to seven catheter inputs will each accept a 32 pole catheter input module. Use the CardioLab II Plus Catheter

Input Modules (part number 301-00202-08) with the CardioLab II Plus Amplifier.

Auxiliary Inputs The auxiliary input will accept the Auxiliary Input Cable (part number 301-00205-08).

Power Indicator The power indicator is on as long as the CardioLab II Plus Amplifier is turned on.

Communication Indicators

Three communication indicators show the status of the communication between the acquisition computer and the CardioLab II Plus Amplifier.

 When the XMT indicator is on, the CardioLab II Plus Amplifier is transmitting data to the acquisition computer.

The XMT indicator should remain on as long as the power indicator is on.

 When the RCV CMD indicator is on, the CardioLab II Plus Amplifier is receiving data from the acquisition

computer. The RCV CMD indicator will turn on as long as an instruction is being received by the amplifier.

 When the RCV ERR indictor is on, the CardioLab II Plus Amplifier may not be receiving data from the

acquisition computer in a valid format or there may be a problem with the fiber optic cable.

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Equipment Overview

Back View

Back View - CardioLab II Plus Amplifier

Name Description

FDDI Connection to Computer

Power Input The GE-supplied power cord connects to the Power Input.

Equipotentiality Terminal

This connector will accept a FDDI type fiber optic cable. The fiber optic cable allows for two-way communication between the amplifier and the CardioLab system.

The Equipotentiality Terminal is connected to earth ground.

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Page 89

CardioLab II Plus Catheter Input Module

Equipment Overview

The equivalent to the Stimulus Inputs 1-4 on the Stimulator Input Cable are labelled on the CardioLab II Plus Amplifier as Stimulus Inputs A1, A2, B1 and B2.

The four stimulus inputs on the Stimulator Input Cable connect to the stimulator.

Each Catheter Input Module is broken down into two groups of 16 poles each. For example, Block A is broken into A (1-16) and A (17-32).

Each pacing channel, requires one positive and one negative pole. In order to maximize the number of pacing channels, only one positive and one negative designation should be made for each group.

For detailed instructions on how to designate pacing channels and enable pacing for particular sites, refer to the on-line help in the software application.

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Equipment Overview

Accessory Parts List

GE Healthcare Systems Information Technologies recommends the following accessory parts be used with the CardioLab II Plus Amplifier:

Accessory Parts List

Accessory Name Part Number

Abbott Transpac IV Disposable Transducer with 4 ft extension Cable*

Abbott Transpac Reusable Cable* Abbott #42661-04-42

3M Disposable Electrode for ECG Monitoring*

* This accessory is not stocked by GE Healthcare Systems Information Technologies.

Abbott #42582-08

3M Red Dot #2256

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Page 91

CARTO™ System (Patient Interface Unit)

Label Description

1 CARTO XP PIU Output to Amplifier

Equipment Overview

CAUTION

EXCESSIVE SIGNAL NOISE — Using a CARTO XP PIU earlier than version 10 with a crossover cable may cause excessive signal noise.

If this excessive signal noise occurs, then discontinue using the crossover cable until the PIU is replaced with a later version. (The new PIU must be purchased from Biosense Webster).

2021423-503H Mac-Lab/CardioLab/Centricity Cardiology INW Service Manual 2-45

Label Description

1 CARTO 3 PIU Output to Amplifier

Page 92

Equipment Overview

NOTE

For specific information related to the operation, troubleshooting, or repair of the CARTO System, refer to the OEM documentation. For information about the CardioLab/CARTO System interface, refer to the CardioLab Operator manual.

The CARTO System acquires and displays electroanatomical 3D images of heart chambers. This information is displayed on the CARTO System and can be exported into the CardioLab application.

Two connections are required: one from the CARTO System Patient Interface Unit to the CardioLab II Plus Amplifier and another from the CARTO System computer to the HP computer. Refer to the cabling diagram in “CARTO™XP System Connections” on page 2-65 or

“CARTO™ 3 System Connections” on page 2-66 for specific information.

To quickly view the status of the interface, check the CARTO System icon at the bottom-right of the Real-Time window (a heart against a grid). The color changes, depending on the system state:

 Gray: Disconnected

 Blue: Standby

 Green: Passive Interface

 Yellow: Active Interface

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Page 93

Analog Output Box

Equipment Overview

Label Description

1 Input from TRAMNet

2 Input from Amplifier through the IEB

 The analog output box distributes heart rate and blood pressure

signals to multiple outputs (refer to the connection diagram in

“TRAM/Amplifier Connections” on page 2-59. This may be done to

synch auxiliary equipment or display the information on a scope or other device.

Patient information comes from either the TRAMNet or the Amplifier (through the IEB) and is output through the output jacks on the top of the box:

 Channels 2-4 and 13-16 are switchable between the TRAMNet (Mac-

Lab) and CardioLab II Plus Amplifier (CardioLab).

 The remaining channels are used exclusively by CardioLab.

 Channels 1-12 may be distributed to up to 4 other devices using the

selector switch.

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Equipment Overview

(

Network Components

Servers

 Centricity Cardiology INW Server provides

 Network repository for patient studies

 Acquisition system and Review workstation access to patient

studies

 CVIS Server provides

 Central list management for staff, supplies, and so on.

 Patient scheduling

 Patient information

 Inventory Management

 Statistical Reports

Centricity Cardiology INW G6 Server

The G6 server has the following specifications:

 Intel Xeon E5504, Quad-Core, 2.00 GHz, 4MB L3 Cache, 80W

 Two tiers:

 Low: Three 146GB Drives

 High: Six 300GB Drives

 Separate C: and D: drives (see the following chart):

 The C: drive is RAID 1

 The D: drive is RAID 5

DDiisskk1

6GB

11446

RRAAIIDD11++0

(CC––DDrriivvee))

DDiisskk2

6GB

11446

DDiisskk3 33000

Parity

0GB

DDiissk 33000

Parity

0GB

DDiisskk5

0GB

33000

Parity

DDiisskk6 33000

Parity

0GB

DDiisskk7

0GB

33000

Parity

DDiisskk8

0GB

33000

Parity

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Equipment Overview

Label Description

1 CD/DVD Drive

2 Tape Drive

3 Power Switch, USB Connectors, External Monitor Connection

4 Hard Drives

Picture Name Description

 Part Number: 2050659-001

HP Network Interface Card

HP Tape Drive Controller

 Function: Network Interface Card

 Location: Slot 4, 5

 Part Number: 2050328-001

 Function: Tape Drive Controller Card

 Location: Slot 4, 5

Centricity Cardiology INW G5 Server

The G5 server has the following specifications:

 Intel Dual-Core Xeon 5120/1.86 GHz (1066 MHz) with 4MB Level 2

cache (2MB per core)

 Three tiers:

 Low: Three 72 GB drives

 Mid: Three 146 GB drives

 High: Eight 146 GB drives

 Separate C: and D: drives (see the following chart):

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Equipment Overview

 The C: drive is RAID 1 mirrored

 The D: drive is RAID 5 mirrored

1 2

Label Description

1 Hard Drives

2 CD/DVD Drive

3 Floppy Disk Drive

4 Tape Drive

Picture Name Description

 Part Number: 2036800-038

HP SMART ARRAY P/400

2-50 Mac-Lab/CardioLab/Centricity Cardiology INW Service Manual 2021423-503H

 Function: Hard drive RAID controller

 Location: Slot 4, 5

Page 97

Centricity Cardiology INW G4 Server

The G4 server has the following specifications:

 3.2 GHz Xeon processor with 1 GB RAM

 Three tiers:

 Low: Three 72 GB drives

 Mid: Three 146 GB drives

 High: Four 300 GB drives

 Separate C: and D: drives (see the following chart):

 The C: drive is RAID 1 mirrored

 The D: drive is RAID 5 mirrored

Equipment Overview

Label Description

1 Hard Drives

2 AIT Drive

3 CD/DVD Drive

4 Floppy Drive (behind cover)

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Equipment Overview

Picture Name Description

HP PCI GIGABIT NIC

HP SMART ARRAY 641

HP BBWC ENABLE - MEM 128 MB DDR

 Part Number: 2026881-001

 Function: Provides reliable network connection

NOTE

On G4 servers, connect the ethernet cable to the NIC card. Do not use the motherboard network port.

 Location: Slot 5

 Part Number: 2016993-001

 Function: Hard drive RAID controller

 Location: Slot 2

 Part Number: 2026817-001

 Function: Improves server performance and decreases

data loss potential if power is lost

 Location: Connected to the SMART ARRAY card in Slot 2

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Page 99

Cabling and Connections

z600 Computer

I/O Backplane

WARNING

SHOCK HAZARD — Use appropriate Lock Out/Tag Out procedures before performing any service on potentially energized equipment.

HP z600 Computer I/O Backplane Connections

Equipment Overview

Label Part Number Description

1 N/A PS2 Connection for Keyboard

2 2020280-001

(Note: This number is

for the cable only)

3 HP 237241-001 USB Port for Mouse (Must use this port)

4 N/A RJ-45 Port to Network

5 N/A To Speakers

6 2025965-002 USB Port for Printer (cable to use depends on the printer)

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PS2 connection for Barcode Scanner Y-Cable (other side connects to Keyboard)

Page 100

Equipment Overview

HP xw8400 Computer I/O Backplane Connections

Label Part Number Description

1 N/A PS2 Connection for Keyboard

2 2020280-001

(Note: This number is

for the cable only)

3 6119-101

2031697-001

4 HP 237241-001 USB Port for Mouse (Must use this port)

5 N/A To Speakers

6N/AHP xw8400 only: To Ablation Interface

7 N/A RJ-45 Port to Network

8 2025965-002 USB Port for Printer (cable to use depends on the printer)

PS2 connection for Barcode Scanner Y-Cable (other side connects to Keyboard)

HP xw8400 only: To Local Printer (cable to use depends on the printer).

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GE ML_CL_INW SERVICE MANUAL_SM_2021423-503_H A7 Anesthesia System Service Manual

Specifications and Main Features

Frequently Asked Questions

User Manual

1 Introduction

Manual Information

Purpose

Intended Audience

Revision History

Conventions

Product References

Related Documents

Illustrations and Names

Chapter Contents

Safety Information

Safety Messages

Definitions

Applicable Messages

ITE Conformance Statement

Types of Systems

Mac-Lab System

CardioLab EP System

ComboLab System

CardioLab II Plus Amplifier

Security Information

Non-Validated Software Applications

Policy

Validated Third Party Software

Enterprise Backup Software

Validated Anti-Virus Software

Previously Validated Anti-Virus Software

3rd Party: PedCath

Service Information

Service Requirements

Product Identification

Old Identification Tags

Required Tools and Supplies

Power Input Requirements

Safety Information

Electromagnetic Compatibility and Interference

Exception

EU Battery Directive 2006/66/EC

Responsibility of the Manufacturer

General

Equipment Symbols

Compliance Information

Mac-Lab/CardioLab System

2 Equipment Overview

Typical System Configuration

Control Room Components

Procedure Room Components

IT Control Room Equipment

Network Connections

System Hardware

Acquisition Workstation System Components

HP Computer

External Components and Connections for the HP z600

External Components and Connections for the HP xw8400

Disassembly

DVD-RAM Drive

SATA-to-IDE Converter - HP z600 Only

Optical Drive

HP z600 Installed Boards

HP z600 Custom Dual NIC Adapter Board

HP z600 Matrox Quad Board M9140 LP Video Board

HP z600 Matrox Odyssey eA Board (Optional)

HP z600 TRAMNet to Ethernet Adapter board

HP z600 PCI Communication Board

HP xw8400 Installed Boards

HP xw8400 PCI Communication Board

HP xw8400 ATI FIREGL V5200 256MB PCI-E Video Board (Optional)

HP xw8400 Dual NIC Adapter Board

HP xw8400 PCIX 2 SCSI Card

HP xw8400 Matrox Parhelia PCI 256 MB Video Card

HP xw8400 Matrox Odyssey XA Board (Optional)

HP xw8400 TRAMNet to Ethernet Adapter board

Integrated Electronics Box (IEB)

External Components and Connections

Video Multiplexer (VID/MUX) Board

I/O Board