CASE 8000 Exercise Testing System Operators Manual Sw Ver 4.0 Rev B

This manual supports software version 4.0 of the CASE 8000 system.

 2000 GE Marquette Medical Systems, Inc. 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, CORO, COROLAN, COROMETRICS, Corometrics Sensor Tip, CRG PLUS, DASH, Digistore, Digital DATAQ, E for M, EAGLE, Event-Link, FMS 101B, FMS 111, HELLIGE, IMAGE STORE, INTELLIMOTION, IQA, LASER SXP, MAC, MAC-LAB, MACTRODE, MANAGED USE, 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, RAC, RAMS, RSVP, SAM, SEER, SILVERTRACE, SOLAR, SOLARVIEW, Spectra 400, Spectra-Overview, Spectra-Tel, ST GUARD, TRAM, TRAM-NET, TRAM-RAC, TRAMSCOPE, TRIM KNOB, Trimline, UNION STATION, UNITY logo, UNITY NETWORK, Vari-X, Vari-X Cardiomatic, VariCath, VARIDEX, VAS, and Vision Care Filter are trademarks of GE 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, EDIC, EK-Pro, Event-Link Cirrus, Event-Link Cumulus, Event-Link Nimbus, HI-RES, ICMMS, IMAGE VAULT, IMPACT.wf, INTER-LEAD, LIFEWATCH, Managed Use, MARQUETTE PRISM, MARQUETTE® RESPONDER, MENTOR, MicroSmart, MMS, MRT, MUSE CardioWindow, NST PRO, NAUTILUS, O2SENSOR, Octanet, OMRS, PHi-Res, Premium, Prism, QUIK CONNECT V, QUICK CONNECT, QT Guard, SMART-PAC, SMARTLOOK, Spiral Lok, Sweetheart, UNITY, Universal, Waterfall, and Walkmom are trademarks of GE Marquette Medical Systems, Inc.

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CASE 8000 Exercise Testing System - 2000656-014, Rev.B

General Information

General Information • The product CASE 8000 system bears the CE marking 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. • Information which refers only to a specific version of the product is accompanied by the appropriate part number. The part number is shown on the nameplate of each product. • For detailed information on safety issues, please refer to the "Safety Information" section in chapter 1 "Introduction".

• The warranty does not cover damage resulting from the use of accessories and consumables from other manufacturers. • All publications are in conformity with the device specifications and standards on safety of electromedical equipment valid at the time of printing. All rights are reserved for devices, circuits, techniques, software programs, and names appearing in this manual. • Windows NT is a trademark of Microsoft Corporation. Acrobat Reader is a trademark of Adobe Systems, Inc. • The GE Marquette Medical Systems, Inc. quality management system complies with the standards DIN EN ISO 9001 and EN 46001.

• Only use accessories which have been tested in conjunction with the device. If accessories, software, and/or consumables from other manufacturers are used, GE Marquette Medical Systems cannot guarantee the safe operation or proper functioning of the device.

CASE 8000 Exercise Testing System - 2000656-014, Rev.B

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Revision History

Revision History This manual is subject to the GE Marquette Medical Systems, Inc. change order service. At the bottom of each page of the document you will find the document part number and revision letter. The revision letter identifies the document's update level and changes with every update of the manual. PN / Revision

Date

Comment

2000656-014-A

October 1999

Initial Release

2000656-014-B

1 May 2000

Added information on CDRW drive. Deleted Chapter 7 "Monitoring of Remote Test Stations". Updated windows that changed

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CASE 8000 Exercise Testing System - 2000656-014, Rev.B

Contents 1

Introduction Manual Information ... 2 Manual Purpose ... 2 Intended Audience... 2 Conventions ... 3

Safety Information ... 4 Intended Use ... 4 General Information... 5 Definition ... 7 Equipment Symbols ... 10 Biocompatibility ... 10

Service Information... 11 Service Requirements ... 11 Equipment Identification ... 11

2

The CASE 8000 System System Cart ... 2 Front View ... 2 Rear View... 3 Keyboard ... 4 Function Keypad... 5

Putting the System Into Service... 7 Installing the Monitor Support ... 7 Installing the Monitor ... 8 Routing the Cables to the Connector Panel ... 9 Installing the Keyboard and the Mouse... 10 Preparing the Acquisition Module ... 11 CASE 8000 Exercise Testing System - 2000656-014, Rev.B

Contents-1

Connecting the System Components ... 12 Loading Writer Paper... 13 Mains Connection, Power Up, Functional Test ... 14 Initial Screen... 15 Using the Program with a Mouse... 16 Viewing and Printing the Operator's Manual ... 17 Tutorial, Online Help... 18

3

Preparing the Patient Patient Information... 2 CAM-14 Acquisition Module... 3 Preparing the Patient's Skin... 4 Applying Electrodes... 5 Standard 12 Lead Placement ... 5 Standard 15 Lead Placement ... 6 Modified MASON-LIKAR Placement... 7 FRANK X, Y, Z Placement ... 8 NEHB Placement ... 9 CM5, CC5, ML Auxiliary Lead Placement ... 10 CM5, CC5, CH Auxiliary Lead Placement... 11 Attaching the CAM-14 Acquisition Module ... 12

4

Entering Patient Information Selecting a Patient Record ... 2 Overview ... 2 Retrieving a Patient Record from the CASE 8000 System Database... 3 Retrieving a Patient Record from a MUSE CV System Database ... 4 Retrieving an Order from the MUSE CV System Database ... 5 Retrieving a Patient Record from an Archived Data Database (Option) ... 6

Entering a New Patient ... 7 Test Information ... 8 Overview ... 8 Entering Patient Information ... 8 Entering Information on the Test and Personnel... 9

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CASE 8000 Exercise Testing System - 2000656-014, Rev.B

Entering Medications Information ... 10 Calculating Patient Risk Factors... 11

5

Running an Exercise Test Before the Test ... 2 Pre-Acquisition Screen (Overview) ... 2 Pre-Acquisition Screen (Function Icons)... 3 Pre-Acquisition Screen (Operating Steps) ... 4

During the Test ... 5 Acquisition Screen (Overview)... 5 Pretest Phase (Overview)... 6 Pretest Phase (Operating Steps) ... 6 Exercise Phase (Overview)... 7 Exercise Phase (Operating Steps / Manual Control)... 8 Comparing Previous Test Data... 18 Recovery Phase (Overview) ... 19 Test End Phase (Overview) ... 19 Test End Phase (Operating Steps) ... 20

After the Test-Post-Test Review ... 22 Test Summary... 22 Tabular Summary... 23 Trend Graph ... 24 Sample Cardiac Cycles ... 25 ECG Strips ... 28 Arrhythmia Review ... 29 Full Disclosure ECG ... 31 Waterfall Display ... 34 12SL... 35 Vector Loop ... 36 Printing the Final Report ... 37

Report Formats... 38

CASE 8000 Exercise Testing System - 2000656-014, Rev.B

Contents-3

6

File Management Overview ... 2 Selecting Patient Records ... 2 Viewing, Editing, Printing Patient Records... 4 Saving (storage device/MUSE), Deleting Patient Records ... 5 Retrieving, Viewing, Printing Patient Records from the MUSE CV System ... 6

7

System Settings Exercise Test Setting ... 2 Writer ... 2 Screen... 3 Lead Sequence ...7 Protocol Editor... 8 Final Reports ... 12 Miscellaneous... 14 12SL Program Settings ... 17 Load, Save, and Delete Custom Setups/Factory Settings ... 18

System Configuration ... 19 General ... 19 Devices ... 24 MUSE... 25 Option Code ... 27 Country Settings ... 28

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CASE 8000 Exercise Testing System - 2000656-014, Rev.B

A Cleaning and Maintenance Cleaning ... 2 Maintenance ... 3 Changing the System's Time and Date ... 4

B Technical Specifications C Miscellaneous Connecting Peripheral Devices ... 2 Bicycle Ergometer ... 2 Treadmill ... 2 Blood Pressure Monitor ... 5 SpO2 Monitor... 7 Laser Printer... 7

Application Tips ... 9 Duke Treadmill Score... 11 Risk Factors... 13

D Formatting Blank CDs ... 2

CASE 8000 Exercise Testing System - 2000656-014, Rev.B

Contents-5

Contents-6

CASE 8000 Exercise Testing System - 2000656-014, Rev.B

Introduction

1

Manual Information... 1-2 Manual Purpose... 1-2 Intended Audience ... 1-2 Conventions... 1-3

Safety Information ... 1-4 Intended Use ... 1-4 General Information ... 1-5 Definition... 1-7 Equipment Symbols... 1-10 Biocompatibility... 1-10

Service Information ... 1-11 Service Requirements... 1-11 Equipment Identification... 1-11

CASE 8000 Exercise Testing System - 2000656-014, Rev.B

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Introduction: Manual Information

Manual Information Manual Purpose

Intended Audience

This manual contains the instructions necessary to operate the

This manual is designed for use by the person who uses,

equipment safely in accordance with its function and intended

maintains, or troubleshoots this equipment.

use. These instructions include but are not limited to: • an explanation of the function of controls and indicators • the sequence of operation • connection and disconnection of detachable parts and accessories, and • instructions for functional tests, cleaning, preventive inspection and maintenance. Where necessary the manual identifies additional sources of relevant information and/or technical assistance.

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CASE 8000 Exercise Testing System - 2000656-014, Rev.B

Introduction: Manual Information

Conventions These are the conventions used in the manual

Styles

• Bold text indicates keys on the keyboard, text to be enSymbols

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

a message providing additional user information. start treadmill

Modify...

keys on the function keypad

(labeling in italics) controls on the monitor screen

• Italicized text indicates software terms that 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. 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 is to ensure you press the spacebar when required.

CASE 8000 Exercise Testing System - 2000656-014, Rev.B

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Introduction: Safety Information

Safety Information Intended Use • The CASE 8000 system is intended for use under the direct

• This device uses a computerized analysis program which

supervision of a licensed healthcare practitioner. It is a di-

can be used as a tool in ECG tracing interpretation.

agnostic device intended to monitor and record electrocardiographic data from the patient during exercise, as well as perform resting ECG analysis. • The CASE 8000 system is not intended to be used as a vital signs physiological monitor. • This equipment will not cause abnormal operation of a patient's cardiac pacemaker or other electronic stimulator. • This device is not intended for use with high frequency surgical units. Disconnect the patient from the device before using the high frequency surgical unit.

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CASE 8000 Exercise Testing System - 2000656-014, Rev.B

Introduction: Safety Information

General Information • The product complies with the electromagnetic immunity requirements of standard IEC 60601-1-2 / EN 60601-1-2 "Electromagnetic Compatibility - Medical Electrical Equipment". • The radio interference emitted by this device is within the limits specified in EN 55011/CISPR 11, class A. • The CE marking covers only the accessories that are included in the CASE 8000 system Accessory List. • Close observance of the information given in the manual is a prerequisite for proper device performance and correct operation and ensures patient and operator safety. • GE Marquette is responsible for the effects on safety, reliability, and performance of the device, only if − assembly operations, extensions, readjustments, modifi-

− the device is used in accordance with the instructions given in this operator's manual. • This equipment is protected against the effects of cardiac defibrillator discharge to ensure recovery as required by test standards. • Accuracy of the Input Signal Reproduction − Overall System Error is tested using the method described in AAMI EC11 3.2.7.1. Overall System Error is ±5%. − Frequency Response is tested using the method described in AAMI EC11 3.2.7.2 methods A and D. • Modulating Effects in Digital System − This device uses digital sampling techniques that may

cations, or repairs are carried out by GE Marquette or

produce some variation in amplitudes of Q, R, and/or S

by persons authorized by GE Marquette,

waves from one heart beat to the next, which may be

− the electrical installation of the relevant room complies

particularly noticeable in pediatric recordings. If this

with the requirements of the appropriate regulations;

phenomenon is observed, the clinician should be aware

and

that the origin of amplitude variations is not entirely

CASE 8000 Exercise Testing System - 2000656-014, Rev.B

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Introduction: Safety Information

physiologic. For measuring voltages of Q, R, and S waves, it is advisable to use the QRS complexes with the largest deflection of the particular waves. • Contact GE Marquette for information before connecting any devices to this system that are not recommended in this manual. • Parts and accessories used must meet the requirements of the applicable IEC 60601 series safety standards, and/or the system configuration must meet the requirements of the IEC 60601-1-1 medical electrical systems standard. • 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. Considerations relating to the choice shall include: − use of the accessory in the PATIENT VICINITY; and − evidence that the safety certification of the ACCESSORY has been performed in accordance to the appropriate IEC 60601-1 and/or IEC 60601-1-1 harmonized national standard. 1-6

CASE 8000 Exercise Testing System - 2000656-014, Rev.B

Introduction: Safety Information

Definition The terms Danger, Warning, and Caution are used throughout

Caution-indicates a potential hazard or unsafe practice

this manual to point out hazards and to designate a degree or

which, if not avoided, may result in minor personal injury or

level or seriousness. Familiarize yourself with their definitions

product/property damage.

and significance. Note-provides application tips or other useful information to Hazard is defined as a source of potential injury to a person. The safety statements presented in this chapter refer to the

assure that you get the most from your equipment. DANGERS

equipment in general and, in most cases, apply to all aspects of the device. There are additional safety statements in the other

Explosion Hazard-Do NOT use in the presence of flammable

chapters which are specific to the topic described.

anesthetics.

The order in which safety statements are presented in no way

WARNINGS

implies order of importance.

Shock Hazard-This is Class I equipment. The mains plug

Danger-indicates an imminent hazard which, if not avoided,

must be connected to an appropriate power supply.

will result in death or serious injury.

Shock Hazard-Do not use multiple portable socket outlets

Warning-indicates a potential hazard or unsafe practice which, if not avoided, could result in death or serious injury.

(MPSO) to connect the device to the power line. Shock Hazard-Before putting the device into operation, visually check all connecting cables and electrodes for signs of damage. Damaged cables and electrodes must be replaced immediately.

CASE 8000 Exercise Testing System - 2000656-014, Rev.B

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Introduction: Safety Information

Shock Hazard -To avoid electric shock or device malfunction

tem to crash or fail. Loss of previous or current test results

liquids must not be allowed to enter the device. If liquids have

could also occur.

entered a device, take it out of service and have it checked by a service technician before it is used again.

Interpretation Hazard-A qualified physician must overread all computer-generated tracings. Computerized interpretation

Shock Hazard-Extreme care must be exercised when using

is only significant when used in conjunction with clinical

medical electrical equipment. Many parts of the man/machine

findings.

circuit are conductive, such as the patient, connectors, elec-

CAUTIONS

trodes, and transducers. It is very important that these conductive parts do not come into contact with other grounded, con-

Equipment Damage-The device may be connected to the

ductive parts when connected to the isolated patient input of

power line only if the voltage and frequency ratings are the

the device. Such contact would bridge the patient's isolation

same as those indicated on the nameplate.

and cancel the protection provided by the isolated input. In

U. S. Federal law restricts this device to sale by or on the order

particular, there must be no contact of the neutral electrode and

of a physician.

ground. NOTES Shock Hazard-Keep leakage current within acceptable limits when connecting auxiliary equipment to this device.

• The device is designed to comply with IEC 60601 / EN 60601/UL 2601 requirements. It is a protection class I

System Failure-Only run GE Marquette approved applica-

device. It is MDD class IIb equipment and is designed for

tions while the CASE 8000 system application is active. Use of

continuous operation. The device is not suitable for intra-

unapproved software programs could cause the operating sys-

cardiac application.

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CASE 8000 Exercise Testing System - 2000656-014, Rev.B

Introduction: Safety Information

• Set up the device in a location which affords sufficient

• Chemicals required for the application or maintenance of

ventilation. The ventilation openings of the device must not

the devices must under all circumstances be stored, pre-

be obstructed. The ambient conditions specified in the

pared and kept at hand in the containers provided by the

"Technical Specifications" chapter must be ensured at all

manufacturer. Failure to observe this instruction may result

times.

in severe consequences for the patient.

• As an additional safety precaution the device can be con-

• Medical technical equipment must only be used by persons

nected to the room's potential equalization system by

who have sufficient knowledge, who have received ade-

means of a separate potential equalization cable (connector

quate training in the use of such equipment and who are

O, Figure 2-2). If the protective earth conductor fails, the

capable of applying it properly.

potential equalization system acts as the protective earth conductor. • Magnetic and electrical fields are capable of interfering

• Before using the system, the operator must verify that it is in correct working order and operating condition. Also, the system performance must be checked once a month on

with the proper performance of the device. For this reason

systems that are not in use. The Technical Inspections

make sure that all external devices operated in the vicinity

should be carried out on an annual basis.

of the CASE 8000 system comply with the relevant EMC

• Dispose of the packaging material, observing the applica-

requirements. X-ray equipment, MRI devices and radio

ble waste-control regulations and keeping it out of chil-

systems are a possible source of interference as they may

dren's reach.

emit higher levels of electromagnetic radiation. • During exercise tests, a defibrillator and a pacemaker, both checked for proper functioning, should be kept at hand.

• At the end of its service life, the system and its accessories must be disposed of in compliance with the special waste control regulations for electronic parts. If you have any questions in this matter, please contact GE Marquette.

CASE 8000 Exercise Testing System - 2000656-014, Rev.B

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Introduction: Safety Information

Equipment Symbols Consult accompanying documents Type BF signal input, defibrillation-proof Mains power switch (ON-OFF) Potential equalization pin

Biocompatibility All parts of the product and all accessories that come in contact with the patient during the intended use of the product, fulfill the biocompatibility requirements of the applicable standards. If you have questions in this matter, please contact GE Marquette Medical Systems, Inc. or its representatives.

Caution! High Voltage! Signal input Signal output Fuse (replace with T8.0 A, 250 V fuses) ASSIFIED CL

C

R

US

MEDICAL EQUIPMENT UL 2601-1 CAN/CSA 601.1 4P41

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Classified 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, CAN/CSA C22.2 No. 601-2-25 EN 60601-225, EN 60601-1-1.

CASE 8000 Exercise Testing System - 2000656-014, Rev.B