GE ML_CL_INW SERVICE MANUAL_SM_2021423-022_J Centricity Cardiology INW Service Manual Instructions Version 6.5 2021423-022 Revision J

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Mac-Lab/CardioLab/ Centricity Cardiology

INW Service Manual

Instructions

Version 6.5

2021423-022 Revision J

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The information in this manual only applies to Mac-Lab/CardioLab/ Centricity CardiologyINW Service Manual software version 6.5. It does not apply to earlier software versions. Due to continuing product innovation, specifications in this manual are subject to change without notice.

CARTO is a trademark of Biosense Webster, Inc.

Listed below are GE Medical Systems Information Technologies trademarks used in this document.

MAC-LAB®, CARDIOLAB®, CENTRICITY®, TRAM®, TRAMNET®, and TRAM-RAC® are trademarks of GE Medical Systems Information Technologies registered in the United States Patent and Trademark Office.

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

T-2 Mac-Lab/CardioLab/ Centricity CardiologyINW Service Manual 2021423-022J

11 September 2013

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Contents

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

Document Information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-2

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

Purpose . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1-3

Intended Audience . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1-3

Related Manuals . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1-4

Statement of Indications for Use. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-5

Mac-Lab System . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1-5

CardioLab System . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1-6

Chapter Contents . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-7

Security Information. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-7

Non-Validated Software Applications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1-7

Policy . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1-8

Validated Third Party Software . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1-8

Service Information. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-11

Service Requirements . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1-11

Equipment Identification . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-12

Required Tools and Supplies . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1-14

Power Input Requirements . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1-14

Safety Information. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-15

Electromagnetic Compatibility and Interference . . . . . . . . . . . . . . . . . . . . . . . . . .1-15

Responsibility of the Manufacturer . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1-15

General . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1-16

Equipment Symbols . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1-18

Compliance Information. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-19

Mac-Lab/CardioLab System . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1-19

Centricity Cardiology INW . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-24

File Server EMC Immunity Performance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1-24

File Server Accessory EMC Immunity Performance . . . . . . . . . . . . . . . . . . . . . .1-24

Conventions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-25

Safety Messages . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1-25

Definitions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1-25

Hazard Statements . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-26

Dangers . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1-26

Warnings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1-26

Cautions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1-30

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

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

System Hardware . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-3

Network Components . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-3

Acquisition Workstation Configuration . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2 -9

Acquisition Workstation System Components. . . . . . . . . . . . . . . . . . . . . . . . . . . 2-10

Monitors . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2-47

Other Related Equipment . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-49

Cabling and Connections. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-54

Amplifier/Stimulator Connections . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2-55

HP/IEB Connections . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-59

Review Workstations. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-76

Software. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-79

Operating System . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2-79

Database . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2-79

Application Software . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2-79

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

Functional Checkout Procedure . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-2

Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3-2

System Initialization . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3-2

Front End Data Acquisition . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3-3

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

Planned Maintenance Form . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3-3

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

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

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

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

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

Replace Primary Video Board with Matrox M9140 Quad Video Board. . . . . . . . . 4-4

Prevent Failure of the Matrox Odyssey Driver Service . . . . . . . . . . . . . . . . . . . . 4-13

ImageCapture/CardioImage . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-14

Normal Operation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4-14

Troubleshooting . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4-14

Switching Ablation Devices . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-21

Replication. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-21

Normal Operation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4-21

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Troubleshooting . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4-21

Windows XP/2003 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-22

Normal Operation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4-22

Troubleshooting . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4-22

GEMS_TaskMonitor Service . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-24

Networking. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-25

Normal Operation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4-25

Troubleshooting . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4-25

INW Server . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-27

InSite 2.0 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-27

Normal Operation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4-27

Option Codes. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-28

Normal Operation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4-28

Troubleshooting . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4-28

CARTO™ XP System . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-29

Normal Operation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4-29

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

CVIS to Mac-Lab/CardioLab Interface. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-32

Problem Scenarios . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4-34

Test DICOM Connectivity (CVIS) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4-34

Test DICOM Connectivity (X-Ray) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4-37

HL7 Export to CVIS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4-38

Log File Locations for ML-CL System . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4-38

INNOVA CENTRAL/Touch screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-41

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

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

How to log on to the Acquisition System . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .5-2

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

INW Networked Acquisition Systems Only . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .5-7

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

Version Update Installation for 8000/8200 Acquisition Systems only. . . . . . . . . 5-26

Install Microsoft Operating System Updates . . . . . . . . . . . . . . . . . . . . . . . . . . . .5-34

Verify Computer BIOS Settings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .5-35

Switch Language . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .5-36

Restore Data to the Acquisition System . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .5-40

Set Default Baseline Phase . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .5-42

Install/Enable Software Options . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .5-43

Configure the Acquisition System. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-43

Configure the Acquisition System on the INW Network . . . . . . . . . . . . . . . . . . . 5-57

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INW Server Disaster Recovery. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-73

High-Level Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .5-73

Record Server Information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .5-76

Reimaging Procedures . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-77

G3/G4/G5 Server Setup and Data Restore. . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-93

Re-Configure Centricity Cardiology INW Network. . . . . . . . . . . . . . . . . . . . . . . 5-124

Post Configuration Procedures. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-133

Cardiovascular Information System (CVIS) Configuration . . . . . . . . . . . . . . . . 5-158

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

Centricity Cardiology INW G3 Server . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-2

Centricity Cardiology INW G4 Server . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-3

Centricity Cardiology INW G5 Server . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-4

HP8400 Computer . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-6

HP8200 Computer . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-8

HP8000 Computer . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-10

Integrated Electronics Box (IEB) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-14

Uninterruptible Power Supply (UPS) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-15

Monitors and Printers . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-15

TRAMnet . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-17

Amplifier . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-19

Speakers & Misc. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-20

Dash Connection . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-22

Solar Connection . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-22

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

Electrical & IT Abbreviations . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . A-2

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

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

Miscellaneous Abbreviations . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . A-21

iv Mac-Lab/CardioLab/ Centricity CardiologyINW Service Manual 2021423-022J

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1 Introduction

2021423-022J Mac-Lab/CardioLab/ Centricity CardiologyINW Service Manual 1-1

Page 8

Introduction

Document Information

Revision History

A 01 October 2005 Initial release of manual. B 01 November 2005 Added INNOVA CENTRAL/Touch

C 04 November 2005 Updated per SPRs MMSmk91579,

D 02 February 2006 Updated per SPR’s MMSmk: 93782,

E 14 April 2006 Updated per SPR’s MMSmk: 78357,

Screen Information.

MMSmk93781

93704, 93799, 93806, 93637, 93981, 94543, 95886

94852, 96437, 96450, 96587, 88710, 97368

F 19 October 2006 Updated per ECR 03162-002. Updated

per SPR’s: MMSmk95352, MMSmk98580, MMSmk99502 and GEHmk00131.

G 6 June 2007 Updated per SPR: GEHmk02912,

GEHmk03343, GEHmk03491, GEHmk03772, GEHmk03912, GEHmk04773, GEHmk05983, GEHmk06122, GEHmk07646, GEHmk07733, GEHmk08228, GEHmk08525, GEHmk09209, GEHmk09210, GEHmk09258, GEHmk09409, GEHmk09648, GEHmk10366.

H 14 December 2007 Updated for 6.5.4 Update

J 11 September 2013 Updated to include installation and

troubleshooting procedures for the Matrox Quad video board.

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Purpose

Intended Audience

Introduction

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.

This manual is intended for the person who maintains and troubleshoots this equipment.

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Introduction

Related Manuals

Part Number Document

2021423-015 Mac-Lab Operator’s Manual 2021423-016 CardioLab Operator’s Manual 2021423-017 Centricity Cardiology INW Operator’s Manual 2021423-018 Mac-Lab/CardioLab Security Guide 2021423-021 Mac-Lab/CardioLab/Centricity Cardiology INW Pre-Installation Manual 2021423-023 Mac-Lab/CardioLab System Installation Manual

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Statement of Indications for Use

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.

Introduction

Mac-Lab System

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 healthcare staff members monitor patients and perform charting and administrative tasks are not considered to be Patient Vicinity areas.

The Mac-Lab system is intended for use under the direct supervision of a licensed healthcare practitioner to monitor, calculate, or record cardiovascular data from patients as they undergo cardiac catheterization. Cardiovascular data may be manually entered or acquired via interfaced GE Medical Systems Information Technologies TRAM modules, MUSE cardiovascular system, and other interfaced information systems. Data includes: ECG waveforms, heart rate, pulse oximetry (SpO2), respiration rate, valve gradients and areas, cardiac output, hemodynamic measurements, invasive and non-invasive blood

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Introduction

CardioLab System

pressure, procedural information, and optional intracardiac electrocardiogram (IECG).

This is applicable to pediatric and adult patients requiring cardiac/ circulatory system catheterization. This is intended for use in catheterization and related cardiovascular specialty laboratories.

The intended use of the CardioLab system is to acquire, filter, digitize, amplify, display, and record electrical signals obtained during electrophysiological studies and related procedures conducted in an electrophysiological laboratory. Signal types acquired include ECG signals, direct cardiac signals, and pressure recordings. 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, store the data, perform elementary caliper-type measurements of the data, and generate reports on the data. Additionally, the system may acquire, amplify, display, and record data received from other 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 physiological data or other data acquired during an EP procedure. It does not transmit alarms or arrhythmias and does not have arrhythmia detection capabilities.

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Chapter Contents

Introduction

 1 Introduction: This chapter describes the Service manual and

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

 2 Equipment Overview: This chapter describes the equipment and its

technical characteristics, connector locations, and preparation for use.

 3 Maintenance: This chapter contains a preventive maintenance

schedule and cleaning guidelines.

 4 Troubleshooting: This chapter contains troubleshooting

instructions and functional test directions.

 5 Recovery: This chapter details procedures to restore a workstation

or server in the field after failure.

 6 Parts List: This chapter contains a list of Field Replaceable parts.

 A Abbreviations: This appendix lists all abbreviations used with the

system.

Security Information

Validated configurations consist of product scenario implementations that are test 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 Invasive Cardiology monitoring products:

 GE Mac-Lab Hemodynamic Systems

 GE CardioLab Electrophysiology Systems

 GE ComboLab Hemo and EP Systems

 GE Centricity INW Server

Please remember that these products are a Class II device under the FDA regulations and should be treated as secondary monitoring medical devices.

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Introduction

Policy

Our policy is that we do not recommend installations of any other third party software applications (i.e. 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, etc. 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.

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:

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Enterprise Backup Software

Introduction

Mac-Lab/ CardioLab/ ComboLab

Tivoli Storage Manager

ARCserv v. 6.5 v. 11.0 v. 11.5 Veritas v. 8.6 v. 9.1 v. 10.0 Legato Networker - - v. 7.4 Symantec - - v. 11D

5.x IT (v. 6.0 & v. 6.1) IT (Version 6.5)

N\A v. 5.2.2 v. 5.4

Anti-Virus Software

Mac-Lab/ CardioLab/ ComboLab

Symantec v. 8.0 v. 8.1 v. 10.2 McAfee v. 4.5.1 v. 7.x v. 8.5i with

5.x IT (v. 6.0 & v. 6.1) IT (Version 6.5)

Protection Pilot 1.5 Norton Professional v. 8.0 v. 8.1 2007 Trend Micro - - Corporate v. 8.0

(English)

v.7.3 (Except

English and

Swedish)

eTrust - - EZ Antivirus 2005

v. 7.1

CA Antivirus - - r8.1

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Introduction

Archival: Storage Area Network (SAN) (equal to a mapped network drive)

3rd Party: PedCath

Language PedCath Version

English v. 7.6.5

French v. 7.5.5

Italian v. 7.5.5

Spanish v. 7.5.5

Japanese v. 7.4.3J

NOTE

Chinese systems will use the Japanese version of PedCath. Swedish/ 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 Medical Systems

 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

Information Technologies authorized service personnel only.

that warranty.

Medical Systems Information Technologies 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.

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Page 18

Introduction

XXXXXXXXXXXXXX

XXXXXXXXXXXXXXXXXX

XXXXXXXXX

XXXXXXXXXXX

XXXXXXXXXXXXX

AA5 XX XX XXXX X X

A B

Equipment 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, front and back of the Integrated Electronics Box (IEB), right side of the RAC 4A, back of the TRAM and back of the Amplifier.

Identification Tags

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 Misc.

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Old Identification Tags

[NAME OF DEVICE]

GE MEDICAL SYSTEMS

MILWAUKEE

MADE IN USA

A2PX1808F

A 2 PX 1808 XX

A B

D E

Introduction

Identification Tag

Item Name Description

A Name of Device Cathlab Computer, CLABII Plus Amplifier or Cath Lab IEB Box B Manufacturer GE Medical Systems Information Technologies C Serial Number Unique Identifier D Facility Code F or G = Milwaukee, P = Bangalore, S = Border Ops (Juarez/El Paso) E Product Sequence

Manufacturing number of total units manufactured

Number F Product Code Two character product descriptor G Year Manufactured 9 = 1999, 0 = 2000 (and so on) H Month Manufactured A = January, B = February (and so on)

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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

 Signal generator 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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Safety Information

Follow all of the instructions and warnings marked 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 Medical Systems Information Technologies offers optional ECG patient cables with electrosurgical noise filtering, which reduces the level of interference on ECG traces.

Introduction

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.

Responsibility of the Manufacturer

GE Medical Systems Information Technologies is responsible for the effects of safety, reliability, and performance only if:

 Installation operations, extensions, readjustments, modifications, or

repairs are performed by persons authorized by GE Medical Systems Information Technologies.

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

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Introduction

General

 The user attaches only accessory equipment recommended for

interaction with the amplifier.

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

The Mac-Lab/CardioLab system 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.

To ensure patient safety, use only parts and accessories manufactured or recommended by GE Medical Systems Information Technologies. 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 Medical Systems Information Technologies 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 Medical Systems Information Technologies.

This equipment should only be connected as specified by GE Medical Systems Information Technologies. Installation of the equipment should only be performed by qualified GE Medical Systems Information Technologies service representatives. Connection of the system to the equipment is not recommended in this manual.

Contact GE Medical Systems Information Technologies for information before connecting any device to this equipment that is not recommended in this manual. Only cables and accessory equipment purchased form GE Medical Systems Information Technologies 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 Medical Systems Information Technologies authorized service personnel. Any attempt to repair equipment under warranty will void that warranty.

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Introduction

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.

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Introduction

Equipment Symbols

Equipment Symbols Descriptions

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, if required, IEC 60601-2-27, IEC 60601-2-30, IEC 60601-2-34, IEC 60601-1-1.

Power Ratings Chart:

V~ = Voltage I = Current

Fuse =

Equipotentiality

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

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.

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Equipment Symbols Descriptions

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.

Attention

Pay attention to the documents delivered with the equipment.

Input Symbol

Introduction

Compliance Information

Mac-Lab/CardioLab System

Table 1. 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.

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Introduction

Table 2. Declaration - Electromagnetic Immunity

Immunity Test IEC 60601 Test Level Compliance Level Electromagnetic Environment -

Guidance

Electrostatic discharge (ESD)

± 6 kV contact ± 8 kV air ± 6 kV contact ±8 kV air Floors should be wood, concrete or

IEC 61000-4-2

Electrical fast transient/burst IEC 61000-4-4

± 2kV for power supply lines ± 1 kV for input/ output lines

Surge IEC 61000-4-5 ± 1kV differential mode

± 2kV common mode

Voltage dips, short interruptions and voltage variations on power supply

<5% 100-120Vac <5% 200-240Vac (>95% dip) for 0,5 cycle

input lines IEC 61000-4-11

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

± 2kV for power supply lines ±1 kV for input/output lines

± 1kV differential mode ±2kV common mode

<5% 100-120Vac <5% 200-240Vac (>95% dip) for 0,5 cycle

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

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.

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.

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

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

Table 3. Declaration - Electromagnetic Immunity

Immunity Test IEC 60601 Test Level Compliance Level Electromagnetic Environment -

Guidance

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Introduction

Table 3. Declaration - Electromagnetic Immunity

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) Conducted RF emissions IEC 61000-4-6

Radiated RF emissions IEC 61000-4-3

3 Vrms 105kHz to 80 MHz

3V/m80 MHz to 2,5 GHz

3 Vrms

d = 1.17 P

3 V/m

d = 2.33 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 a,

should be less than the compliance

level in each frequency range b.

Interference may occur in the

vicinity of equipment marked with

the following symbol:

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Introduction

Table 3. Declaration - Electromagnetic Immunity

NOTE 1: At 80 MHz and 800 MHz, the higher frequency range applies. NOTE 2: These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflected from

structures, objects and people. a 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. b Over the frequency range 150 kHz to 80 MHz. Field strengths should be less than 3 V/m.

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Introduction

Centricity Cardiology INW

File Server EMC Immunity Performance

The Centricity Cardiology INW information system file server was subjected to:

 Electrical Fast Transient (EFT) bursts applied to the AC power

mains, per CISPR 24GemsFT bursts on the AC power mains may temporarily reduce network performance/bandwidth. Operator intervention is not required and normal performance returns upon cessation of the EFT event.

 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 device or system.

File Server Accessory EMC Immunity Performance

The Sony CRT monitor was subjected to:

Fast Transient Surges (FTS) of 2 KV applied to the AC power lines common mode (line to earth), per CISPR24. FTSs of 2 KV or greater may cause the Sony CRT monitor to experience unrecoverable hardware failure.

NOTE

The Sony CRT monitor meets/passes the IEC61000-4-5 ITE requirement of 1 KV.

The UPS was subjected to:

Fast Transient Surges (FTS) of 2 KV applied to the AC power lines common mode (line to earth), per CISPR24. FITSs of 2 KV or greater may cause the UPS to go into bypass mode and require a manual reset for normal operation.

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Conventions

Safety Messages

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.

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.

Definitions

NOTE

Messages which provide additional user information.

 Items shown in Black text are keys on the keyboard, text to be

entered, or hardware items such as buttons or switches on the equipment.

 Items shown in Italicized text are software terms which identify

menu items, buttons, or options in various windows.

 To perform an operation which appears with a plus (+)sign between

the names of two keys, you press and hold the first key while pressing the second key once. This is called a keystroke combination.

For example, Press Ctrl+Esc means to press and hold down the Ctrl key while pressing the Esc key.

 When instructions are given for 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.

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Introduction

 Enter means to press the Enter or Return key on the keyboard. Do

Hazard Statements

Dangers

Warnings

not type enter.

DANGER

EXPLOSION/FIRE 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

PATIENT SHOCK HAZARD — Only connect UL/IEC 60601-1 certified medical equipment.

WARNING

EQUIPMENT DAMAGE — DO NOT allow hydraulic fluid from any device to contact any conductive surface. Hydraulic fluid is electrically conductive.

If fluid of any kind should leak into the system, discontinue use of the equipment and contact GE Medical Systems Information Technologies immediately.

WARNING

MISINTERPRETATION OF DATA — The system may report erroneous heart rate values when pacemaker spikes or arrhythmias are present. Reported values should be verified by a qualified physician.

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Introduction

WARNING

PATIENT SHOCK/EQUIPMENT DAMAGE — Keep the conductive parts of lead electrodes and associated parts away from other conducting parts, including earth.

WARNING

PATIENT SHOCK/EQUIPMENT DAMAGE — DO NOT contact the amplifier or patient during defibrillation.

Standby defibrillation equipment is required in the event that the patient needs to be cardioverted or defibrillated. Disconnect leadwires from patient before defibrillating. Otherwise, serious injury, death, or damage to the equipment could result.

WARNING

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

WARNING

POWER SUPPLY SAFETY — 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

POWER SUPPLY/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.

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Introduction

WARNING

MISINTERPRETATION OF DATA — 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

LEAKAGE CURRENT SAFETY — The system should be tested yearly for adequate grounding on patient leakage current.

Keep leakage current within acceptable limits when connecting auxiliary equipment to the system.

When more than two electrical devices are interconnected, the summation of leakage currents must be checked yearly.

WARNING

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

WARNING

MAINTENANCE/SERVICE — 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.

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Introduction

WARNING

PERSONAL/PATIENT SAFETY — 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

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

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

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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Introduction

Cautions

CAUTION

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

CAUTION

INACCURACY OF DATA — DO NOT display any channels which are based on unused catheter input modules. Otherwise, erroneous values may occur.

ECG signal quality should only be checked by qualified medical personnel.

CAUTION

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

CAUTION

EQUIPMENT USE —

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

EQUIPMENT DAMAGE — Exit the software application properly before turning off the system. Failure to do so may damage the optical disk.

Remove the optical disk before moving the system. Failure to do so may result in damage to the drive or the disk.

DO NOT reuse single use devices.

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Introduction

CAUTION

TRANSDUCER — Remove air that is trapped in the transducer or associated tubing by flushing the system according to Cath lab procedures.

CAUTION

REMOTE MONITOR — Always power the system through separate isolation transformers which are independently connected to a wall outlet. You can power the laser printer through the IEB/Workstation power supply. Otherwise, the printer may draw enough current away from the system and cause it to reboot.

CAUTION

SOFTWARE — DO NOT add unauthorized software to the Mac-Lab/CardioLab system. Doing so may make the Mac-Lab/CardioLab software unstable.

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Introduction

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2 Equipment Overview

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Page 40

Equipment Overview

IEB

Amplifier

CIM

TRAM

RAC4A

Bed

Generator

Catheter

Personality

Module

Mouse

Printer

Speakers

Stimulator

Real-Time

Monitor

Review Monitor

Remote

Real-Time

Monitor

3" Ceiling Conduit

3" Floor Conduit

Remote

Review

Monitor

Image

Monitor

INW

Server

CVIS

Network

Switch

To Hospital Network

Keyboard

Workstation

Dashed lines indicate CardioLab/ComboLab only

Procedure Room

Control Room

IT Control Room

Monitor Boom

CPU

UPS

Typical System Configuration

This system is used to assess the cardiac condition of patients and 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 an INW and an optional CVIS server.

The block diagram below shows a typical setup.

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001

Page 41

System Hardware

Network Components

Equipment Overview

WARNING

— LOCK OUT/TAG OUT

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

 INW Server provides

 Network repository for patient studies

 Acquisition and review workstation access to patient studies

 CVIS Server provides

 Central list management for staff, supplies, etc.

 Patient scheduling

 Patient information

 Inventory Management

 Statistical Reports

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Equipment Overview

Servers

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 chart below):

 The C: drive is RAID 1 mirrored

 The D: drive is RAID 5 mirrored

012

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Equipment Overview

308

Picture Name Description

 Part Number: 2036800-038

HP SMART ARRAY P/400

HP BBWC ENABLE - MEM - 1 GB DIMM

 Function: Hard drive RAID controller  Location: Slot 4, 5

 Part Number: 2036798-017  Function: Improves server performance and decreases

data loss potential if power is lost

 Location: Slots 1, 5

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Equipment Overview

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 chart below):

 The C: drive is RAID 1 mirrored

 The D: drive is RAID 5 mirrored

010

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Picture Name Description

 Part Number: 2026881-001  Function: Provides reliable network connection

NOTE

HP PCI GIGABIT NIC

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

Equipment Overview

402

HP SMART ARRAY 641

HP BBWC ENABLE - MEM 128 MB DDR

 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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Equipment Overview

INW G3 Server

The G3 server has the following specifications:

 2.8 GHz Xeon processor with 512 MB RAM

 Three tiers:

 Low: One 72 GB drives

 Mid: Three 146 GB drives (RAID 5 mirrored)

 High: Six 146 GB drives (RAID 5 mirrored)

401

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Acquisition Workstation Configuration

Control Room Components

 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.

 HP Acquisition computer

 USB Mouse

 Keyboard

 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.

 A laser printer: Prints images or reports.

 Barcode scanner

Equipment Overview

Remote 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.

Other Related System Equipment

 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).

 CLab II Plus Amplifier: The Amplifier gathers data for both the

ComboLab and CardioLab systems.

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

electroanatomical cardiac maps to the CardioLab.

 Analog Output Box: Distributes HR and BP signals from the

TRAMnet and Amplifier to other equipment.

 Review or Nurses workstation

 Video Printer

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Equipment Overview

Acquisition Workstation System Components

Integrated Electronics Box (IEB)

The IEB provides power to local system components, signal pass through video and communications. A modem for dial-up communications may be present, depending on which IEB is installed. 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

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

CAUTION

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

 Power Distribution panel provides conditioned power to local system

components.

 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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External Components and Connections

Equipment Overview

190b

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.

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Equipment Overview

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.

Video Multiplexer (VID MUX) Board

Label Description

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)

197c

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Equipment Overview

The VID MUX board amplifies (±5V 1.25A from the internal IEB DC power supply. See “Internal Components and Connections” on page 2-17) and distributes the video signals from the HP Computer (See“HP8400

Video Connections” on page 2-61, “HP8200 Video Connections” on

page 2-62 or “HP8000 Video Connections” on page 2-63).

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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, etc.). 3 Connection to the Analog Output Box. 4 Analog out (Stimulator, etc.). 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:

 “HP8400 Communications Connections” on page 2-65

 “HP8200 Communications Connections” on page 2-66

 “HP8000 Communications Connections” on page 2-67

 “HP8400 TRAM/Amplifier Connections” on page 2-68

 “HP8200 TRAM/Amplifier Connections” on page 2-69

196c

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Equipment Overview

 “HP8000 TRAM/Amplifier Connections” on page 2-70

Power Connections

Label Description

198c

1 & 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.)

See the cabling diagram, “Power Connections” on page 2-60.

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Equipment Overview

Disassembly

Open Case

191

1. Remove 7 side-panel screws.

2. Lift the side panel out.

Remove Connection Boards

193

1. Open the case.

2. Remove the board screws.

3. Disconnect interior cables.

WARNING

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

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Internal Components and Connections

Equipment Overview

195c

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Equipment Overview

Label Part Number Description

1 2003681-003

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

3 2003263-001 Terminal Strip

Uninterruptible Power Supply (UPS)

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

NOTE

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

2003680-001

Video and I/O boards (rear view)

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

199

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Equipment Overview

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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Equipment Overview

HP Computer

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

 Floppy drive (Drive A:) - On 8000/8200 only.

 Primary Hard Drive with two partitions

 C: Application partition

 D: Data partition

 Magneto-Optical drive (Drive E:)- Optional on 8200/8400.

 DVD-RAM drive or CD-RW 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 two optional cards):

 Video board provides video out for the Real-Time (Video 1) and

Review (Video 2) monitors. (Matrox Parhelia PCI for 8400 and 8200, Matrox AGP Parhelia for 8000)

 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 8400): Adaptec Ultra320 SCSI PCIe board for

supporting MO drive.

 (optional on 8200 and 8400): Matrox Odyssey XA board used to

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

 (optional on 8200 and 8000): Matrox Odyssey XPro board used to

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

 (optional on 8400): ATI FIREGL V5200 256MB PCI-E Video

board. Provides video out for optional (video 3) monitor.

 (optional on 8200): ATI FIREGL V5100 128MB PCI-E Video

board. Provides video out for optional (video 3) monitor

 (optional on 8000): Matrox PCI Parhelia Video board provides

video out for the optional (video 3) monitor.

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Equipment Overview

External Components and Connections for the HP8400

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)

306

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Equipment Overview

External Components and Connections for the HP8200

200a

Label Part Number Description

1 2028599-001 DVD-RAM Drive 2 2026804-001 Floppy Drive 3 N/A Power Switch, LEDs, USB, Firewire, and Audio

connections 4 N/A AC Power 5 N/A Backplane I/O panel 6 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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Equipment Overview

External Components and Connections for the HP8000

Label Part Number Description

1 2003340-001 Magneto-Optical Drive 2 2028599-001 DVD-RAM Drive 3 2026541-001 Floppy Drive 4 N/A Power Switch & LEDs 5 N/A USB, Firewire, and Audio connections 6 N/A AC Power 7 N/A Backplane I/O panel 8 N/A Board Slots.

Not Shown 2026539-001 HP USB 2-Button Optical Mouse with Wheel Not Shown Various Keyboard (dependent on language)

090b

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Page 62

Equipment Overview

Disassembly

WARNING

— 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

1. Lift tabs indicated.

2. Swing the front panel out.

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Page 63

Equipment Overview

Remove Hard Drive

1. Press tabs as indicated.

2. Slide drive out.

Remove Floppy Drive

1. Remove screw.

2. Lift tab indicated.

3. Slide drive out.

Remove Clamps

1. Lift the clamp fingers.

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

3. Lift off the clamp.

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Equipment Overview

Remove the ATI FIREGL V5100/V5200 128MB/256MB PCI-E Video Board (HP8200/

8400 only)

1. Lift up the lock arm as shown.

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

3. Lift off the clamp.

Remove DVD-RAM Drive

1. Remove screw.

2. Lift tab indicated.

3. Slide drive out.

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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.

092b

 1: DVD-RAM Drive Jumpers

 2: IDE Connector

Optical Drive

The optical drive is optional upgrade to HP 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 (p/n 2012522-002)

NOTE

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

093b

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Equipment Overview

HP8400 Installed Boards

8400 PCI Communication Board

309

 Part Number: 2014935-002

 Location: Slot 1

 Functions:

 Communicates with the C-Lab 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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Equipment Overview

8400 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)

304

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Page 68

Equipment Overview

8400 Dual NIC Adapter Board

 Part Number: 2017795-002

 Location: Slot 3

 Function: Network connection card

 I/O: Two network connection jacks

307

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Page 69

8400 PCIX 2 SCSI Card

NOTE

This board is optional with the MO upgrade kit.

Equipment Overview

 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)

310

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Equipment Overview

8400 MATROX PARHELIA PCI 256 MB Video Card

305

 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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8400Matrox 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

311

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Equipment Overview

8400 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

312

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HP8200 Installed Boards

NOTE

Slot 4 is not used.

8200 Dual NIC Adapter Board

Equipment Overview

 Part Number: 2017795-001

 Location: Slot 1

 Function: Network connection card

 I/O: Two network connection jacks

201a

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Page 74

Equipment Overview

8200 ATI FIREGL V5100 128MB PCI-E Video Board (Optional)

 Part Number: 2026189-001

 Location: Slot 2

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

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

202a

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Equipment Overview

8200 PCI Communication Board

 Part Number: 2014935-002

 Location: Slot 3

 Functions:

 Communicates with the C-Lab 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

203a

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Page 76

Equipment Overview

8200 MATROX PARHELIA PCI 256 MB Video Card

205a

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

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8200 Matrox Odyssey XA Board (Optional)

Equipment Overview

 Part Number: 2030688-001 (replaces initially released part number

2017708-001, Matrox Odyssey XPro board, which is obsolete)

 Location: Slot 6

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

 I/O: Two DVI connectors

206a

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Page 78

Equipment Overview

8200 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

207a

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HP8000 Installed Boards

NOTE

Slot 1 is not used.

8000 Matrox AGP Parhelia Video board

Equipment Overview

102a

 Part Number: 2017707-001

 Location: Slot 2 (AGP 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 adaptor: DVI to HD15 Video Adapter (2021697-001).

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Page 80

Equipment Overview

8000 TRAMnet to Ethernet Adapter board

 Part Number: 2009937-002

 Location: Slot 3

 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

103a

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8000 PCI Communication board

Equipment Overview

 Part Number: 2014935-002

 Location: Slot 4

 Functions:

 Communicates with the C-Lab 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

104a

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Equipment Overview

8000 Dual NIC Adapter Board

 Part Number: 2017795-001

 Location: Slot 5

 Function: Network connection card

 I/O: Two network connection jacks

105a

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8000 Matrox Odyssey XPro Board (Optional)

Equipment Overview

 Part Number: 2017708-001

 Location: Slot 6

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

 I/O: Two DVI connectors

106a

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Equipment Overview

8000 Matrox PCI Parhelia Video Board (Optional)

 Part Number: 2017709-001

 Location: Slot 7

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

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

107a

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Monitors

Equipment Overview

120b

Label Description

1 DVI Jacks. Note: the video cable may be plugged into either jack--the

monitor automatically switches to the correct jack.

2 USB and Firewire ports. (Not Used) 3 AC power connection

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 2-11).

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Equipment Overview

 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 dropdown box just under

the main menu.

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Page 87

Other Related Equipment

TRAMnet

Equipment Overview

029b

Label Description

1 TRAM Module 2 To Analog Out Connector 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.

The TRAMnet receives power (+16.4 VDC) from the IEB DC power supply via the serial cable.

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 on page“HP8400 TRAM/Amplifier

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Equipment Overview

Connections” on page 2-68, “HP8200 TRAM/Amplifier Connections” on

page 2-69 and “HP8000 TRAM/Amplifier Connections” on page 2-70).

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 (SpO2) - blue connector

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

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CARTO™ XP System (Patient Interface Unit)

Label Description

Equipment Overview

160c

1 Output to Amplifier

CAUTION

EXCESSIVE SIGNAL NOISE — Using a 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).

NOTE

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

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

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Equipment Overview

Two connections are required: one from the CARTO™ XP System Patient Interface Unit to the Clab II Plus Amplifier and another from the CARTO™ XP System computer to the HP computer. Refer to the cabling diagram on page“HP8400 CARTO™XP System Connections” on page 273, “HP8200 CARTO™XP System Connections” on page 2-74 and

“HP8000 CARTO™ XP System Connections” on page 2-75 for specific

information.

To quickly view the status of the interface, check the CARTO™ XP 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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Analog Output Box

Equipment Overview

050b

Label Description

1 Input from TRAMnet 2 Input from Amplifier through the IEB

The analog output box distributes HR and BP signals to multiple outputs (refer to the connection diagram on page “HP8400 TRAM/Amplifier

Connections” on page 2-68, “HP8200 TRAM/Amplifier Connections” on

page 2-69 and “HP8000 TRAM/Amplifier Connections” on page 2-70). 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 Clab 2 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

Cabling and Connections

WARNING

LOCK OUT/TAG OUT — Use appropriate Lock Out/Tag Out procedures before performing any service on potentially energized equipment.

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Amplifier/Stimulator Connections

IEB

Computer

MicroPace Stimulator

MicroPace

CPU

Amplifier

Generator

Catheter

Connection

Box

External

ECG

Auxiliary Reference

Catheter

Input

Module

Personality

Module

Typical Setup (with MicroPace)

Equipment Overview

004

Label Part Number Description

1 2003411-001 BNC Cable (50’). Connects back of MicroPace (ECG 1

Input) to back of IEB (Analog Out 1).

2N/ALarge Cable with D-Connectors. Connects back of

MicroPace (Auxiliary Port) to side of Catheter Connection Box.

3N/ASmall Cable. Connects front of MicroPace (Green

Connection Port or in emergencies Red Connection Port) to side of Catheter Connection Box.

4 301-00204-03 Red or Black leads connect to front of Catheter

Connection Box to Amplifier Stimulator Input. 5 2003434-001 Fiber Optic Cable (75’) 6 2003587-001 DB44 Connect Cable 7 2003408-002 50’ Serial Cable 8 301-00202-08 Catheter Input Module

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Equipment Overview

IEB

Computer

Bloom

Patient

Isolation

Box

Amplifier

Generator

Battery Battery

Catheter

Connection

Box

External

ECG

Auxiliary Reference

Catheter

Input

Module

Personality

Module

Typical Setup (with Bloom)

003

Label Part Number Description

1 2003410-001 BNC Cable (30’). Connects Bloom and IEB. 2N/ALarge Cable with Square Connectors. Connects

back of Bloom to back of Patient Isolation Box. 3N/ASmall Cable. Connects front of Patient Isolation Box to

side of Catheter Connection Box. 4 301-00204-03 Red or Black leads connect to front of Catheter

Connection Box to Amplifier Stimulator Input. 5 2003434-001 Fiber Optic Cable (75’) 6 2003587-001 DB44 Connect Cable 7 2003408-002 50’ Serial Cable 8 301-00202-08 Catheter Input Module

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Equipment Setup

Label Part Number Description

C and C1 N/A Bloom (This is a typical example.Specific equipment may vary by location).

Equipment Overview

002a

Connects to the IEB (not shown) via the External Input BNC jack on the back (C1) and the Patient Isolation Box (D) via a large cable with square connectors. (See next section for detail.)

DN/APatient Isolation Box Rear connection to Bloom (C1) via large cable with square

connectors. Front connection to Catheter Connection Box (E). Front panel provides access to internal batteries.

EN/ACatheter Connection Box Side connection to the Patient Isolation Box (D) front

connector. Red and Black leads connect from the front to the Amplifier (F) Stim Input.

F 301-00088-10 Amplifier Connected to:

 (1) External ECG connection  (2) Catheter Input Module  (3) Auxiliary Reference Cable  (6) Catheter Connection Box

G 301-00202-08 Catheter Input Module Catheter leads (not shown) plug into the block end.

Connector on other end plugs into the Amplifier (4) Cardiac Input (Labeled A, B,

C, etc.) 1 N/A Bloom connection to IEB (BNC cable not shown). 2 N/A Bloom connection to Patient Isolation Box. 3 N/A Patient Isolation box to Catheter Input Module cable.

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Equipment Overview

1 2

Label Part Number Description

4 301-00204-03 Catheter Connection Box to Amplifier cable. 5 301-00038-00 External ECG Connections. Colored leads connect to patient. Connector on

6 301-00205-08 Auxiliary Reference Cable. Plugs into the Amplifier (4) Auxiliary Input.

Bloom (Connection Detail)

other end connects into the Amplifier(4) ECG Input.

Connector Description

1 External Input. BNC connection to the IEB (cable not shown). 2 J20. Connection to Patient Isolation Box (large square

connector)

001

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HP/IEB Connections

HP8000 Computer

I/O Backplane

HP8200/8400 Computer

I/O Backplane

HP Computer I/O Backplane Connections

Equipment Overview

025

Label Part Number Description

1 N/A PS2 Connection for Y-cable to keyboard (if

connecting with PS2 version Barcode Scanner)

2 2020280-001

(Note: This number is

PS2 connection for Y-Cable to PS2 version Barcode Scanner

for the cable only)

3 6119-101

To Local Printer (cable to use depends on printer)

2031697-001

4 N/A USB Ports for Mouse (Must use right-most port), and

for USB version Barcode Scanner 5 N/A To Speakers 6 N/A To Ablation Interface 7 N/A To Network

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Equipment Overview

3 3

HP Computer

IEB

UPS

Power Connections

Label Part Number Description Length

1 700775-001

700774-001

2 405535-013

80274-006

2003927-001

3 2003927-001

403689-010

120 VAC main power in 250 VAC main power in

AC power to HP CPU (100V) AC power to HP CPU (120V) AC power to HP CPU (230V) AC to Local Equipment--Monitors, Printers, etc.

AC to Remote Monitors

100'

4 2003927-001 AC power to UPS 8'

018

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HP8400 Video Connections

HP8400

Computer

IEB

Equipment Overview

Label Part Number Description Length

1 2003928-001 Real-time display (Video 1) in to IEB 5' 2 2003928-001 Review display (Video 2) in to IEB 5' 3 2003928-001 Cardio Image display (Video 3) in to IEB 5' 4 2003928-001 Out to Local Cardio Image Monitor (Video 3) 5' 5 2003928-001 Out to Local Review Monitor (Video 2) 5' 6 2003928-001 Out to local Real-time monitor (Video 1) 5' 7 2003442-001 Out to remote monitor (switched Video 1 or Video 2) 100' 8 2003442-001 Out to optional remote monitors (Video 1, 2, or 3) 100'

421

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Equipment Overview

HP8200

Computer

IEB

Label Part Number Description Length

9a 2018060-001 Image capture. DVI to 5-BNC female connector cable

9b 2003411-001 BNC Cable to optional imaging system 50'

HP8200 Video Connections

plugs into either DVI plug. Only one BNC connection is used to connect to the image input from another system (9b)

419

Label Part Number Description Length

1 2003928-001 Real-time display (Video 1) in to IEB 5' 2 2003928-001 Review display (Video 2) in to IEB 5' 3 2003928-001 Cardio Image display (Video 3) in to IEB 5'

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4 2003928-001 Out to Local Cardio Image Monitor (Video 3) 5'

GE ML_CL_INW SERVICE MANUAL_SM_2021423-022_J Centricity Cardiology INW Service Manual Instructions Version 6.5 2021423-022 Revision J

Specifications and Main Features

Frequently Asked Questions

User Manual

1 Introduction

Document Information

Revision History

Purpose

Intended Audience

Related Manuals

Statement of Indications for Use

Mac-Lab System

CardioLab System

Chapter Contents

Security Information

Non-Validated Software Applications

Policy

Validated Third Party Software

Service Information

Service Requirements

Equipment Identification

Identification Tags

Old Identification Tags

Required Tools and Supplies

Power Input Requirements

Safety Information

Electromagnetic Compatibility and Interference

Responsibility of the Manufacturer

General

Equipment Symbols

Compliance Information

Mac-Lab/CardioLab System

Centricity Cardiology INW

File Server EMC Immunity Performance

File Server Accessory EMC Immunity Performance

Conventions

Safety Messages

Definitions

Hazard Statements

Dangers

Warnings

Cautions

2 Equipment Overview

Typical System Configuration

System Hardware

Network Components

Servers

INW G5 Server

INW G4 Server

INW G3 Server

Acquisition Workstation Configuration

Acquisition Workstation System Components

Integrated Electronics Box (IEB)

Uninterruptible Power Supply (UPS)

HP Computer

External Components and Connections for the HP8400

External Components and Connections for the HP8200

External Components and Connections for the HP8000

Disassembly

DVD-RAM Drive

Optical Drive

HP8400 Installed Boards

HP8200 Installed Boards

HP8000 Installed Boards

Monitors

Other Related Equipment

TRAMnet

CARTO™ XP System (Patient Interface Unit)

Analog Output Box

Cabling and Connections

Amplifier/Stimulator Connections

HP/IEB Connections

HP Computer I/O Backplane Connections

Power Connections

HP8400 Video Connections

HP8200 Video Connections