CASE Exercise Testing System Operators Manual Sw Ver 4.1 Rev A

127(The information in this manual only applies to CASE Exercise Testing System software version 4.1. It does not apply to earlier software versions. Due to continuing product innovation, specifications in this manual are subject to change without notice.

Listed below are GE Medical Systems Information Technologies trademarks. All other trademarks contained herein are the property of their respective owners. 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 Medical Systems Information Technologies 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, IQA, LIFEWATCH, Managed Use, MARQUETTE PRISM, MARQUETTE® RESPONDER, MENTOR, MicroSmart, MMS, MRT, MUSE CardioWindow, NST PRO, NAUTILUS, O2SENSOR, Octanet, OMRS, PHiRes, Premium, Prism, QUIK CONNECT V, QUICK CONNECT, QT Guard, SMART-PAC, SMARTLOOK, Spiral Lok, Sweetheart, UNITY, Universal, Waterfall, and Walkmom are trademarks of GE Medical Systems Information Technologies. © GE Medical Systems Information Technologies, 2001. All rights reserved.

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CE Marking Information

CE Marking Information Compliance The CASE Exercise Testing System bears CE mark CE-0459 indicating its conformity with the provisions of the Council Directive 93/42/EEC concerning medical devices and fulfills the essential requirements of Annex I of this directive. The product is in radio-interference protection class A in accordance with EN 55011. 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 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 Users should be aware of known RF sources, such as radio or TV stations and hand-held or mobile two-way radios, and consider them when installing a medical device or system. Be aware that adding accessories or components, or modifying the medical device or system may degrade the EMI performance. Consult with qualified personnel regarding changes to the system configuration.

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Contents

1

Introduction... 1-1 Manual Information... 1-3 Revision History... 1-3 Manual Purpose... 1-3 Intended Audience... 1-3 Conventions... 1-4 Illustrations... 1-4 Safety Information... 1-5 Intended Use... 1-5 General Information... 1-5 Definition... 1-7 Notes... 1-10 Equipment Symbols... 1-11 Biocompatibility... 1-12 Technical Maintenance... 1-12 Service Information... 1-13 Service Requirements... 1-13 Equipment Identification... 1-13

2

Equipment Overview... 2-1 System Cart... 2-3 Front View... 2-3 Rear View... 2-4 Keyboard... 2-5 Function Keypad... 2-6 Desk Light... 2-9 Putting the System Into Service... 2-10 Installing the Monitor Support... 2-10 Installing the Monitor... 2-11 Routing the Cables to the Connector Panel... 2-12 Installing the Keyboard and the Mouse... 2-13 Preparing the Acquisition Module... 2-14 Connecting the System Components... 2-15 Loading Writer Paper... 2-16 Mains Connection, Power Up, Functional Test... 2-18 Initial Screen Icons... 2-19 Using the Program with a Mouse... 2-21 Viewing and Printing the Operator’s Manual... 2-23

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Online Help... 2-24 Software Features... 2-25

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Preparing the Patient... 3-1 Patient Information... 3-3 CAM-14 Acquisition Module... 3-4 Preparing the Patient’s Skin... 3-5 Applying Electrodes... 3-7 Standard 12 Lead Electrode Placement... 3-7 Standard 15 Lead Electrode Placement... 3-8 Modified MASON-LIKAR Lead Electrode Placement... 3-9 FRANK X, Y, Z Lead Electrode Placement... 3-10 NEHB Lead Electrode Placement... 3-12 CM5, CC5, ML Auxiliary Lead Electrode Placement... 3-13 CM5, CC5, CH Auxiliary Lead Electrode Placement... 3-14 Attaching the Acquisition Module... 3-15

4

Entering Patient Data... 4-1 Selecting a Patient Record... 4-3 Overview... 4-3 Retrieving a Patient Record from the CASE Exercise Testing System Database . 4-4 Retrieving a Patient Record from a MUSE CV System Database... 4-5 Retrieving a Patient Record from a CD Database... 4-7 Entering a New Patient... 4-8 Test Information... 4-9 Overview... 4-9 Entering Patient Information... 4-9 Entering Information on the Test and Personnel... 4-10 Entering Medications Information... 4-11 Calculating Patient Risk Factors... 4-11

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Recording an ECG... 5-1 Before the Test... 5-3 Pre-Acquisition Screen... 5-3 Pre-Acquisition Screen... 5-5 Pre-Acquisition Screen... 5-6

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During the Test... 5-7 Acquisition Screen... 5-7 Pretest Phase... 5-9 Overview... 5-9 Exercise Phase... 5-10 ECG Data Windows... 5-13 Recovery Phase... 5-23 Test End Phase... 5-24 Overview... 5-24 Operating Steps... 5-25 After the Test - Post Test Review... 5-27 Test Summary... 5-27 Tabular Summary... 5-28 Sample Cardiac Cycles... 5-32 ECG Strips... 5-36 Arrhythmia Review... 5-37 Full Disclosure ECG... 5-39 Overview... 5-39 Waterfall Display... 5-43 12SL... 5-44 Vector Loop... 5-45 Printing the Final Report... 5-46 Report Formats... 5-48 In-Test Reports... 5-48 Final Reports... 5-49

6

File Management... 6-1 Overview... 6-3 Selecting Patient Records... 6-4 Viewing, Editing, Printing Patient Records... 6-6 Saving (storage device/MUSE), Deleting Patient Records... 6-7 Retrieving, Viewing, Printing Patient Records from the MUSE CV System... 6-8 Exporting Patient Records... 6-9

7

System Settings... 7-1 Exercise Test Settings... 7-3 Writer... 7-3 Screen... 7-4

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Lead Sequence... 7-8 Protocol Editor... 7-10 Final Reports... 7-14 Miscellaneous... 7-16 ST/Medians/12SL Program Settings... 7-19 Load, Save, and Delete Custom Setups... 7-20 System Configuration... 7-22 General... 7-22 Devices... 7-26 MUSE... 7-27 Option Code... 7-29 Country Settings... 7-30

Cleaning and Maintenance...A-1 Cleaning, Disinfection... A-3 External Surfaces...A-3 Electrodes...A-3 Maintenance... A-4 Checks Before Each Use...A-4 Technical Inspections...A-4 Changing the System’s Time and Date...A-5

Miscellaneous...B-1 Connecting Peripheral Devices... B-3 Ergometer...B-3 Treadmill...B-4 Blood Pressure Monitor...B-6 SpO2 Monitor...B-8 Laser Printer...B-8 Application Tips... B-11 General Application...B-11 Recording ECGs of Pacemaker Patients...B-11 Recording ECGs During Defibrillation...B-11 Duke Treadmill Score... B-13 References...B-14 Risk Factors... B-15

Formatting CDs...C-1 Blank CDs... C-3

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Introduction: Manual Information

Manual Information Revision History Each page of the document has the document part number followed by a revision letter at the bottom of the page. The revision letter identifies the documents update level.

Table 1. Revision History PN 2002213-041 Revision

Date

A

18 May 2001

Comment Initial release of this document.

Manual Purpose This manual contains the instructions necessary to operate the equipment safely in accordance with its function and intended use. These instructions include but are not limited to:

n n n

An explanation of the function of controls and indicators

n

Instructions for functional tests, cleaning, preventive inspection and maintenance.

The sequence of operation Connection and disconnection of detachable parts and accessories, and

Where necessary the manual identifies additional sources of relevant information and/or technical assistance.

Intended Audience This manual is designed for use by the person who uses, maintains, or troubleshoots this equipment.

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Conventions These are the conventions used in the manual:

Styles n

Bold text indicates keys on the function keypad, the keyboard, text to be entered, or hardware items such as buttons or switches on the equipment.

n

Italicized text indicates software terms that identify menu items, onscreen controls, buttons, or options in various windows.

n

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.

n

When instructions are given for typing a precise text string with one or more spaces, the point where the space bar must be pressed is indicated as Space. The purpose is to ensure you press the spacebar when required.

Illustrations All illustrations in this manual are provided as examples only. They may not necessarily reflect your equipment setup or data displayed. In this manual, all names appearing in examples and illustrations are fictitious. The use of any real person’s name is purely coincidental.

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Safety Information Intended Use n

The CASE Exercise Testing System is intended for use under the direct supervision of a licensed health care practitioner. It is a diagnostic device intended to monitor and record electrocardiographic data from the patient during exercise, as well as perform resting ECG analysis.

n

The CASE Exercise Testing System is not intended to be used as a vital signs physiological monitor.

n

This equipment will not cause abnormal operation of a patient’s cardiac pacemaker or other electronic stimulator.

n

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.

n

This device uses a computerized analysis program which can be used as a tool in ECG tracing interpretation.

n

The product complies with the electromagnetic immunity requirements of standard IEC 60601-1-2 / EN 60601-1-2 “Electromagnetic Compatibility-Medical Electrical Equipment.”

n

The radio interference emitted by this device is within the limits specified in EN 55011/CISPR 11, class A.

n

The CE marking covers only the accessories that are included in the CASE Exercise Testing System Accessory List.

n

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.

n

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

General Information

u Assembly operations, extensions, readjustments, modifications, or repairs are carried out by GE or by persons authorized by GE,

u The electrical installation of the relevant room complies with the requirements of the appropriate regulations; and

u The device is used in accordance with the instructions given in this Operator’s Manual.

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n

This equipment is protected against the effects of cardiac defibrillator discharge to ensure recovery as required by test standards.

n

Accuracy of the Input Signal Reproduction

u Overall System Error is tested using the method described in AAMI EC11 3.2.7.1. Overall System Error is ±5%.

u Frequency Response is tested using the method described in AAMI EC11 3.2.7.2 methods A and D.

n

Modulating Effects in Digital System

u This device uses digital sampling techniques that may produce some variation in amplitudes of Q, R, and/or S waves from one heart beat to the next, which may be particularly noticeable in pediatric recordings. If this phenomenon is observed, the clinician should be aware that the origin of amplitude variations is not entirely 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.

n

Contact GE Medical Systems Information Technologies for information before connecting any devices to this system that are not recommended in this manual.

n

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.

n

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:

u Use of the accessory in the PATIENT VICINITY; and u 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.

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Definition The terms Danger, Warning, and Caution are used throughout this manual to point out hazards and to designate a degree or level or seriousness. Familiarize yourself with their definitions and significance. Hazard is defined as a source of potential injury to a person. The safety statements presented in this chapter refer to the equipment in general and, in most cases, apply to all aspects of the device. There are additional safety statements in the other chapters which are specific to the topic described. The order in which safety statements are presented in no way implies order of importance. 'DQJHU-indicates an imminent hazard which, if not avoided, will result in death or serious injury. :DUQLQJ-indicates a potential hazard or unsafe practice which, if not avoided, could result in death or serious injury. &DXWLRQ-indicates a potential hazard or unsafe practice which, if not avoided, may result in minor personal injury or product/property damage. 1RWH-provides application tips or other useful information to assure that you get the most from your equipment.

'$1*(5 Explosion Hazard-Do NOT use in the presence of flammable anesthetics.

:$51,1*6 Shock Hazard-This is Class I equipment. The mains plug must be connected to an appropriate power supply. Shock Hazard-Do not use multiple portable socket outlets (MPSO) to connect the device to the power line.

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:$51,1*6 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. Shock Hazard -To avoid electric shock or device malfunction liquids must not be allowed to enter the device. If liquids have entered a device, take it out of service and have it checked by a service technician before it is used again. Shock Hazard-Extreme care must be exercised when using medical electrical equipment. Many parts of the man/machine circuit are conductive, such as the patient, connectors, electrodes, and transducers. It is very important that these conductive parts do not come into contact with other grounded, conductive parts when connected to the isolated patient input of the device. Such contact would bridge the patient's isolation and cancel the protection provided by the isolated input. In particular, there must be no contact of the neutral electrode and ground. Shock Hazard-Keep leakage current within acceptable limits when connecting auxiliary equipment to this device. System Failure-Only run GE Medical Systems Information Technologies approved applications while the CASE Exercise Testing System application is active. Use of unapproved software programs could cause the operating system to crash or fail. Loss of previous or current test results could also occur. Interpretation Hazard-A qualified physician must overread all computer-generated tracings. Computerized interpretation is only significant when used in conjunction with clinical findings.

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&$87,216 Equipment Damage-The device may be connected to the power line only if the voltage and frequency ratings are the same as those indicated on the nameplate. Restricted Sale-U. S. Federal law restricts this device to sale by or on the order of a physician.

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Notes The device is designed to comply with IEC 60601 / EN 60601/UL 2601 requirements. It is a protection class I device. It is MDD class IIb equipment and is designed for continuous operation. The device is not suitable for intracardiac application. Set up the device in a location which affords sufficient ventilation. The ventilation openings of the device must not be obstructed. The ambient conditions specified in the “Technical Specifications” chapter must be ensured at all times. As an additional safety precaution the device can be connected to the room's potential equalization system by means of a separate potential equalization cable. If the protective earth conductor fails, the potential equalization system acts as the protective earth conductor. Magnetic and electrical fields are capable of interfering with the proper performance of the device. For this reason make sure that all external devices operated in the vicinity of the CASE Exercise Testing System comply with the relevant EMC requirements. X-ray equipment, MRI devices and radio systems are a possible source of interference as they may emit higher levels of electromagnetic radiation. During exercise tests, a defibrillator and a pacemaker, both checked for proper functioning, should be kept at hand. Chemicals required for the application or maintenance of the devices must under all circumstances be stored, prepared and kept at hand in the containers provided by the manufacturer. Failure to observe this instruction may result in severe consequences for the patient. Medical technical equipment must only be used by persons who have sufficient knowledge, who have received adequate training in the use of such equipment and who are capable of applying it properly. 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 systems that are not in use. The Technical Inspections should be carried out on an annual basis. Dispose of the packaging material, observing the applicable wastecontrol regulations and keeping it out of children's reach.

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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 Medical Systems Information Technologies.

Equipment Symbols Consult accompanying documents

Type BF signal input, defibrillation-proof

Mains power switch (ON-OFF)

Potential equalization pin

Caution! High Voltage!

Signal input Signal output

Fuse (replace with T8.0 A, 250 V fuses) 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 60601-2-25, EN 60601-1-1.

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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 Medical Systems Information Technologies or its representatives.

Technical Maintenance Schematic diagrams, specifications, and other relevant technical information can be found in the service manuals supplied with this equipment. Comply with the policies of your institution’s Biomedical Department, or the recommendations made within the Preventive Maintenance section of the product’s service manual.

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