Marquette Mac Lab Cardiac Catheterization Equipment Manual

MAC-LAB

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Cardiac Catheterization System Equipment Manual PN 422024-006 Rev. B (11/11/98)

Marquette Medical Systems, Inc. Cardiology Group - Invasive Cardiology 100 Marquette Drive Jupiter, Florida 33468 USA Phone: (561) 575-5000 (800) 343-9341

MAC-LAB Cardiac Catheterization System Equipment Manual 422024-006 Rev. B (11/11/98)  Copyright Marquette Medical Systems, 1998. All rights reserved. Trademarked names appear throughout this document. Rather than list the names and entities that own the trademarks or insert a trademark symbol with each mention of the trademarked name, the publisher states that it is using the names only for editorial purposes and to the benefit of the trademark owner with no intention of improperly using the trademark. 900 SC, ACCUSKETCH, AccuVision, APEX , AQUA-KNOT, ARCHIVIST, Autoseq, BABY MAC, C Qwik Connect, CardioServ, CardioSmart, CardioSys, CardioWindow, CASE, CD TELEMETRY, CENTRA, CHART GUARD, CINE 35, COROLAN, CORO, COROMETRICS, Corometrics Sensor Tip, CRG PLUS, Digistore, Digital DATAQ, E for M, EAGLE, Event-Link, FMS 101B, FMS 111, HELLIGE, IMAGE STORE, INTELLIMOTION, LASER SXP, MAC, MAC-LAB, MACTRODE, MARQUETTE, MARQUETTE MAC, MARQUETTE MEDICAL SYSTEMS, MARQUETTE UNITY NETWORK, MARS, MAX, MEDITEL, MEI, MEI in the circle logo, MEMOPORT, MEMOPORT C, MINISTORE, MINNOWS, Monarch 8000, MULTI-LINK, MULTISCRIPTOR, MUSE, MUSE CV, Neo-Trak, NEUROSCRIPT, OnlineABG, OXYMONITOR, Pres-R-Cuff, PRESSURE-SCRIBE, QMI, QS, Quantitative Medicine, Quantitative Sentinel, RAMS, RSVP, SAM, SEER, SILVERTRACE, SOLAR, SOLARVIEW, Spectra 400, Spectra-Overview, Spectra-Tel, ST GUARD, TRAM, TRAM-NET, TRAM-RAC, TRAMSCOPE, TRIM KNOB, Trimline, UNITY logo, UNITY NETWORK, Vari-X, Vari-X Cardiomatic, VariCath, VARIDEX, VAS, Vision Care Filter, are trademarks of Marquette Medical Systems, Inc., registered in the United States Patent and Trademark Office. 12SL, 15SL, Access, AccuSpeak, ADVANTAGE, BAM, BODYTRODE, Cardiomatic, CardioSpeak, CD TELEMETRY®-LAN, CENTRALSCOPE, Corolation, DASH, EK-Pro, EDIC, Event-Link Cumulus, Event-Link Cirrus, Event-Link Nimbus, HI-RES, ICMMS, IMAGE VAULT, IMPACT.wf, INTERLEAD, IQA, LIFEWATCH, Managed Use, MARQUETTE PRISM, MARQUETTE® RESPONDER, MENTOR, MicroSmart, MMS, MRT, MUSE CardioWindow, NST PRO, NAUTILUS, OCTANET, O2 SENSOR, OMRS, PHi-Res, Premium, Prism, QUIK CONNECT V. QUICK CONNECT, QT Guard, RAC, SMARTLOOK, SMART-PAC, Spiral Lok, Sweetheart, UNITY, Universal, Waterfall, Walkmom are trademarks of Marquette Medical Systems, Inc.

T-2

Revision B

11 November 1998

CE Marking Information Compliance

The MAC-LAB Cardiac Catheterization System bears the 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. The product is in radio-interference protection class A in accordance with EN 55011. For devices manufactured in the United States, the CE mark is applied under the authority of Notified Body GMED (0459). For devices manufactured in Germany, the CE mark is applied under the authority of Notified Body VDE (0366). The country of manufacture and appropriate Notified Body can be found on the equipment labeling. The product complies with the requirements of standard EN 60601-1-2 "Electromagnetic Compatibility - Medical Electrical Equipment." The CE marking prescribed above is only found on the equipment labeling of the 230V European equipment. Only applicable equipment will bear the CE marking. The safety and effectiveness of this device has been verified against previously distributed devices. Although all standards applicable to presently marketed devices may not be appropriate for prior devices (i.e., electromagnetic compatibility standards), this device will not impair the safe and effective use of those previously distributed devices. See user’s information.

Exceptions

The MAC-LAB Cardiac Catheterization System EMC Immunity Performance: There are no exceptions.

General 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 EMC performance. Consult with qualified personnel regarding changes to the system configuration. This manual is an integral part of the product and describes its intended use. It should always be kept close to the equipment. Observance of the manual is a prerequisite for proper product performance and correct operation, and ensures patient and operator safety. All publications are in conformity with the product specifications and IEC publications on safety of electromedical equipment, as well as with UL requirements valid at the time of printing. All rights are reserved for products, circuits, techniques, software programs, and names appearing in the manual. The warranty does not cover damages resulting from the use of accessories and consumables from other manufacturers. The Marquette Medical Systems quality management system complies with the international standards EN/ISO 9001 and EN 46001, and the Council Directive on Medical Devices 93/42/ EEC.

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CE-1

This product is not likely to cause abnormal operation of other patient-connected equipment, such as a cardiac pacemaker or other electrical stimulators. This product is protected against the effects of cardiac defibrillator discharges to ensure proper recovery, as required by test standards. Periodically, and whenever the integrity of the monitor is in doubt, connect a patient simulator and test all functions.

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How to Reach Us… Following are telephone numbers and addresses for contacting various Service, Supplies and Sales personnel.

Service calls Supply products and service parts

To open a service call with Marquette Service, call: 1-800-558-7044.

Order supplies (leadwires, ECG electrodes, thermal paper, etc.) from Marquette Supplies, P.O. Box 9100, 100 Marquette Drive, Jupiter, FL, 33468-9100, Attn: Supplies. Telephone 1-800-558-5102. Order service parts (circuit boards, cables, software, etc.) and manuals from Marquette Service, P.O. Box 9100, 100 Marquette Drive, Jupiter, FL, 334689100, Attn: Service Parts. Telephone: 1-800-558-5102. Have the following handy: ■

part number of the replacement part, or

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model and serial number of the equipment,

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part number/name of the assembly where the item is used,

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item name, and

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where applicable, reference designation (e.g. R13, S12).

When ordering additional operator manuals, remember to get the software version from either the back of the title page or a printed report.

Tech Support

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Tech Support has the most current information about your equipment, and can provide assistance with any technical questions or problems. ■

MAC-LAB ...1-800-552-3244

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E for M System ...1-800-334-7272

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Resting ECG analysis systems...1-800-558-7072

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Exercise testing systems ...1-800-558-7072

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Ambulatory ECG analysis and editing systems...1-800-558-6802

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MARS unity workstation ...1-800-282-6297

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MUSE cardiology management systems: ■

D-Series ...1-800-558-7070

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Network systems and Buffer Server...1-800-645-9309

MAC-LAB Cardiac Catheterization System Manual

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How to Reach Us…

Applications (“How to…” questions)

MAC-LAB, E for M System...1-800-343-9341

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All diagnostic cardiology products - except MARS CRS (full disclosure) software ...1-800-531-5613

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MARS clinical review station (full disclosure) software: ■

USA ...1-800-992-0344

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Canada ...1-800-874-4357

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United Kingdom ... 0800-89-1645

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Other countries ... 414-255-9831

48-hour turnaround repair

Some Marquette products (MAC PC resting ECG analysis systems, acquisition modules, and Holter recorders) are repaired on a 48-hour turnaround basis. Send items for 48-hour repair to Marquette Service, 100 Marquette Drive, Jupiter, FL, 33468-9100, Attn: 48-Hour Turnaround Repair. Telephone: 1-800-552-3426 (Holter recorders) or 1-800-558-7072 (MAC PC systems and acquisition modules).

Diagnostic hardware repair

Send all items except 48-hour turnaround repair items to Marquette Service and Supplies, 100 Marquette Drive, Jupiter, FL, 33468-9100, Attn: Diagnostic Hardware Repair. Telephone: 1-800-552-3248.

Service agreements

Sales offices

ii

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For information about service agreements, call: 1-800-552-3248.

For all sales-related inquiries, contact the offices listed on these pages.

United States Region

Marquette Medical Systems, US Regional Office, 8200 West Tower Avenue, Milwaukee, WI, 53223. Telephone: (800) 558-5544. FAX: (414) 355-3790.

Canada Region

Source Medical, 20 Bond Avenue, Don Mills, Ontario, M3B 1L9 CANADA. Telephone: (416) 444-7381. FAX: (416) 510-0949.

Latin America Region

Marquette Medical Systems, Latin America Region Office, P.O. Box 77-10, Santiago, 8965 CHILE. Telephone: (562) 242-8574. FAX: (562) 242-9148.

Europe/Middle East/Africa Department

Marquette Hellige Medical Systems, Continental Square, Batiment Uranus, 3 place de Londres, B.P. 10772, 95727, Roissy Cedex FRANCE. Telephone: (33) (1) 48-64-4642. FAX: (33) (1) 48-64-4640.

Central and Eastern Europe

Marquette Hellige (Austria), Wilhelminenstrase 91, 1160 Vienna AUSTRIA. Telephone: (43) (1) 48 01 61 10. FAX: (43) (1) 48 01 61 145.

France

Marquette France, Continental Square, Batiment Uranus, B.P. 10772, Place de Londres, 95727 Roissy Cedex FRANCE. Telephone: (33) (1) 48 16 17 60/1. FAX: (33) (1) 48 16 17 75.

Belgium Region

General De Wittelaan 9/9, B-2800 Mechelen BELGIUM. Telephone: (32) (15) 20-88-18. FAX: (32) (15) 20 41 42.

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How to Reach Us… Netherlands Region

Marquette Hellige (Benelux), Leyensehof Leyenseweg 111B, 3721 BC Bilthoven NETHERLANDS. Telephone: (31) (30) 228-9090. FAX: (31) (30) 228-2877.

Germany

Marquette Hellige Germany, Regional Office, Munzinger Strase 3, 79111 Freiburg im Breisgau GERMANY. Telephone: (49) (761) 4543 230. FAX: (49) (761) 4543 411.

Italy

Marquette Hellige Italy, Strada Padana Superiore 2/B, 20063 Cernusco Sul Naviglio, Milano ITALY. Telephone: (39) (2) 921-41982. FAX: (39) (2) 92141985.

Middle East/Africa Region

Marquette Medical Systems, Themis tower, Olympion Street, Limassol CYPRUS. Telephone: (357) (5) 355-516. FAX: (357) (5) 361-288.

Scandinavia/CIS/ Poland Region

Marquette Medical Systems, Raseborgsgaten 9, Box 49, 164 93 Kista SWEDEN. Telephone: (46) (8) 703-0360. FAX: (46) (8) 703-9240.

Spain/Portugal Region

Marquette Hellige Spain, Edificio Vertice, Antonio Lopez, nr. 249 - Planta 3, Zona A, Of. 6, 28041 Madrid SPAIN. Telephone: (34) (1) 500-3090. FAX: (34) (1) 500-1877.

United Kingdom/Ireland Region

Marquette Hellige UK Limited, Montagu Court, Kettering Parkway, Kettering, Northants, NN15 6XR UNITED KINGDOM. Telephone: (44)(1536) 316-200. FAX: (44)(1536) 316-205.

Northeast Asia Region

Marquette Medical Systems, Waseda Hirai Building 7th Floor, 1-18-9, NishiWaseda, Shinjyuku-Ku, Tokyo 169 JAPAN. Telephone: (81) (3) 3203-1631. FAX: (81) (3) 3203-1626.

Central Asia Region

Marquette Medical Systems, Room 3404 Citicorp Centre, 18 Whitfield Rd., Causeway Bay HONG KONG. Telephone: (852) 2804-2320. FAX: (852) 28041776.

South Pacific Region

Marquette Medical Systems (Australia) Pty Ltd, Forest Corporate Centre, Suite 7, 19 Rodborough road, Frenchs Forest NSW 2086 AUSTRALIA. Telephone: (61) (2) 9975-5501. FAX: (61) (2) 9975-5503.

Southeast Asia Region

Marquette Electronics (SEA) Pte., #2 Leng Kee Road, 04-04A Thye Hong Centre, 0315 SINGAPORE. Telephone: (65) 471-2133. FAX: (65) 471-1540.

Other questions or problems

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For any other questions or problems, contact the main switchboard operator in Milwaukee, Wisconsin at 1-800-558-5120 or (414) 355-5000. The operator will direct your call to the person most able to assist you.

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How to Reach Us…

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CONTENTS

CE Marking Information... CE-1 Compliance ... CE-1 Exceptions ... CE-1 General Information ... CE-1 How to Reach Us… ... i Service calls ...i Supply products and service parts ...i Tech Support ...i Applications (“How to…” questions) ...ii 48-hour turnaround repair ...ii Sales offices ...ii Other questions or problems ... iii

1

INTRODUCTION ...1-1 Manual Information ... 1-3 Manual Purpose ... 1-3 Chapter Content ... 1-3 1 Introduction ... 1-3 2 Equipment Overview ... 1-3 3 Printing ... 1-3 Appendices ... 1-3 Related Manuals ... 1-4 Safety Information ... 1-5 Responsibility of the Manufacturer ... 1-5 General ... 1-5 Equipment Symbols ... 1-6 Warnings and Cautions ... 1-7 Service Information ... 1-9 Service Requirements ... 1-9 Equipment Identification ... 1-9

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2

EQUIPMENT OVERVIEW ...2-1 Introduction ... 2-3 Console ... 2-4 System Power ... 2-4 QRS Tone Volume Adjustment ... 2-5 Data Retention During Power Failure ... 2-5 Hard Disk Drive Recording ... 2-7 Using Diskettes ... 2-8 Erasing Patient Cases ... 2-9 Backing Up Patient Cases Onto Diskettes ... 2-9 Backing Up Protocols Onto a Diskette ... 2-9 Display Monitors ... 2-10 Remote Acquisition Unit ... 2-11 TRAM Modules ... 2-12 TRAM A.R. Module ... 2-13 TRAM X00 Series ... 2-14 TRAM X00A and TRAM X00SL ... 2-14 TRAM X50 ... 2-14 TRAM 200 Module ... 2-14 TRAM 400 Module ... 2-15 TRAM 500 Module ... 2-16 TRAM 600 Module ... 2-16

3

PRINTING ...3-1 Thermal Printer ... 3-3 Thermal Printer Description ... 3-3 Real-Time Waveform Printing ... 3-3 Playback Waveform Printing ... 3-5 Print Screen ... 3-5 Form Feeding ... 3-5 Printer Paper ... 3-6 Thermal Printer Paper Replacement ... 3-6 Care for Thermal Printer Paper ... 3-7 Archivist Thermal Paper ... 3-7

A

APPENDIX A: MAINTENANCE ... A-1 General Maintenance ...A-3 Cleaning the Chassis Exterior ...A-3 Cleaning the Monitor Screens ...A-3 Cleaning EP Cables ...A-4 Monthly Maintenance ...A-5 Cleaning the Print Head ...A-5

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Annual Maintenance ... A-6 Fan Filter Inspection and Replacement ...A-6 Inspect All Cables, Plugs and Connectors ...A-6 Electrical Safety Tests ...A-6 Error Log ...A-8 Inspecting the Equipment ...A-8

B

APPENDIX B: TROUBLESHOOTING ... B-1 ECG Waveforms ... B-3 Cardiac Output Waveforms ... B-4 Pressure Waveforms ... B-5

C

APPENDIX C: ERROR MESSAGES & INDICATORS ... C-1 MAC-LAB Cardiac Catheterization System ... C-3 TRAM Module ... C-8

D

APPENDIX D: TECHNICAL DESCRIPTION ... D-1 Specifications ... D-3 Environmental ... D-5

INDEX

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INTRODUCTION Manual Information ... 1-3 Manual Purpose ... 1-3 Chapter Content ... 1-3 1 Introduction ... 1-3 2 Equipment Overview ... 1-3 3 Printing ... 1-3 Appendices ... 1-3 Related Manuals ... 1-4 Safety Information ... 1-5 Responsibility of the Manufacturer ... 1-5 General ... 1-5 Equipment Symbols ... 1-6 Warnings and Cautions ... 1-7 Service Information ... 1-9 Service Requirements ... 1-9 Equipment Identification ... 1-9

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MAC-LAB Cardiac Catheterization System Manual

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INTRODUCTION: Manual Information

Manual Information Manual Purpose

This manual describes the operational features of the Marquette MAC-LAB Cardiac Catheterization System. We strongly recommend that the manual be read completely and used as a reference guide after gaining a working knowledge of the system. If possible, have a patient simulator hooked up to simulate physiological conditions. Be sure to read all safety notices. Each chapter is designed to provide operational procedures, and when applicable, indicators, error messages and troubleshooting information. Chapters within the manual can quickly and easily be located using the tabs. Chapter titles are displayed along the top of each page. In addition, appendices and an index have been included for quick references.

Chapter Content

This manual is organized into chapters, summarized as follows:

1 Introduction

Describes the manual contents and provides general information about safety precautions and service requirements.

2 Equipment Overview

Describes the hardware provided with the MAC-LAB Cardiac Catheterization System.

3 Printing Appendices

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Describes how to print reports. Includes basic equipment maintenance information, basic steps for troubleshooting malfunctions, error messages, and a quick reference.

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INTRODUCTION: Manual Information

Related Manuals

The following documents provide information for the MAC-LAB Cardiac Catheterization System. Table 1-1. Related Manuals

Part Number

1-4

Name

422024-001

MAC-LAB & MAC-LAB System 3000EX/5000EX Cardiac Catheterization System Operator’s Manual

422024-002

MAC-LAB System 1000/1000 EX Catheterization System Operator’s Manual

422024-003

MAC-LAB & MAC-LAB System 3000EX/5000EX Cardiac Catheterization System Quick Reference Guide

422024-004

MAC-LAB System 1000/1000 EX Catheterization System Quick Reference Guide

422024-005

MAC-LAB System EX Cardiac Catheterization System Equipment Manual

422024-006

MAC-LAB Cardiac Catheterization System Equipment Manual

422024-007

MAC-LAB System EX Cardiac Catheterization System Installation Guide

417301-001

MAC-LAB System EX Cardiac Catheterization System Service Manual

MAC-LAB Cardiac Catheterization System Manual

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INTRODUCTION: Safety Information

Safety Information Responsibility of the Manufacturer

General

Marquette Medical Systems is responsible for the effects of safety, reliability, and performance only if: ■

Assembly operations, extensions, readjustments, modifications, or repairs are carried out by persons authorized by Marquette.

■

The electrical installation of the relevant room complies with the requirements of the appropriate regulations.

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The equipment is used in accordance with the instructions for use.

This device is intended for use under the direct supervision of a licensed health care practitioner. All computer generated measurements must be checked by qualified personnel for accuracy using the equipment’s review and edit functions. To ensure patient safety, use only parts and accessories manufactured or recommended by Marquette Medical Systems. Contact Marquette Medical Systems for information before connecting any devices to this equipment that are not recommended in this manual. If the installation of this equipment in the USA requires 240V rather than 120V power, the source must be a center-tapped, 240V single-phase circuit. 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 system. For continued safe use of this equipment, it is necessary that the listed instructions are followed. However, instructions listed in this manual in no way supersede established medical procedures concerning patient care. Disposable devices are intended for single use only and should not be reused.

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INTRODUCTION: Safety Information

Equipment Symbols

The following symbols appear on the equipment.

Defibrillator-proof Type CF equipment

Consult accompanying documents

~

Alternating current.

Protective earth (ground)

Equipotential (rear console ground lug).

Type B equipment.

Defibrillator-proof Type BF equipment.

To reduce the risk of electric shock, do NOT remove cover (or back). Refer

CAUTION servicing to qualified personnel.

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