CASE Client Operators Manual ver 6.5 Rev A

CE Marking Information

CE Marking Information Compliance The product CASE Client bears the CE marking CE-0459, notified body GMED, 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 acquisition module is assigned to class IIa according to Annex IX of the Council Directive 93/42/EEC. The CE marking covers only the accessories listed in the Order Information chapter. The acquisition module complies with the electromagnetic immunity requirements of standard IEC 60601-1-2 "Electromagnetic Compatibility - Medical Electrical Equipment". The radio interference emitted by the acquisition module is within the limits specified in EN 55011 - class B. 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 system comply with the relevant EMC requirements. X-ray equipment, MRI devices, radio systems, cellular telephones, etc. are possible sources of interference as they may emit higher levels of electromagnetic radiation. Keep the PC away from these devices and verify the performance of CASE Client before use. 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 Operator's Manual). The country of manufacture appears on the device label.

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Contents

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Introduction... 1-1 License Agreement... 1-3 About This Manual... 1-4 Revision History... 1-4 Manual Purpose... 1-4 Intended Audience... 1-4 Conventions... 1-5 Illustrations... 1-5 Safety Information... 1-6 Intended Use... 1-6 General Information... 1-6 Definition... 1-8 Classification... 1-12 Equipment Symbols... 1-13 Biocompatibility... 1-14 Technical Maintenance... 1-14 Legal Notice... 1-14 Service Information... 1-15 Service Requirements... 1-15 Equipment Identification... 1-15

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Product Overview... 2-1 PC / Server Setup... 2-3 Minimum PC / Server Requirements... 2-3 Peripheral Devices Connecting to the PC... 2-3 Putting the System Into Service... 2-6 Mains Connection, Power Up, Functional Test... 2-6 Initial Screen... 2-7 Using the Mouse... 2-8 Softkeys Controlling Exercise Tests... 2-10 Viewing and Printing the Operator's Manual... 2-11 Online Help... 2-11 Software Options... 2-12

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Preparing the Patient... 3-1 Applying Electrodes - The Basics... 3-3 Preparing the Patient's Skin... 3-4 Applying Electrodes... 3-5 Lead Labels on the Acquisition Modules... 3-5 Standard 12 Lead Electrode Placement... 3-6 Standard 15 Lead Electrode Placement... 3-7 Modified MASON-LIKAR Lead Electrode Placement... 3-8 FRANK X, Y, Z Lead Electrode Placement... 3-9 NEHB Lead Electrode Placement... 3-10 CM5, CC5, ML (CML) Auxiliary Lead Electrode Placement... 3-11 CM5, CC5, CH (CMH) Auxiliary Lead Electrode Placement... 3-12 Attaching the CAM 14 Acquisition Module... 3-13

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Selecting a Patient Record and Test Type... 4-1 Selecting a Patient Record from the Local Database... 4-3 Overview... 4-3 Selecting a Patient Record... 4-4 Retrieving a Patient Record from the MUSE System Database... 4-5 Entering a New Patient... 4-7 Patient Records of External Programs... 4-8

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Resting ECG... 5-1 Entering Test Information... 5-3 Overview... 5-3 Patient Information Tab... 5-3 Test / Personnel Tab... 5-4 Medications Tab... 5-5 Recording a Resting ECG... 5-6 Overview... 5-6 10-Second ECG with Analysis... 5-7 Full-Disclosure ECG... 5-10 Post Test Review... 5-11 Test Summary... 5-11 ECG Traces... 5-13 Medians... 5-16 Arrhythmia Review... 5-20 Vector Loops... 5-22

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Full Disclosure ECG... 5-23 Report Printout... 5-25 Generating the Interpretation... 5-26 Comparing Resting ECGs... 5-28

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Exercise Test... 6-1 Patient Education... 6-3 Entering Test Information... 6-4 Overview... 6-4 Patient Information Tab... 6-4 Test / Personnel Tab... 6-6 Medications Tab... 6-7 Calculating Patient Risk... 6-7 Before the Test... 6-9 Pre-Acquisition Screen... 6-9 During the Test... 6-13 Acquisition Screen... 6-13 Pretest Phase... 6-14 Exercise Phase... 6-15 ECG Data Windows... 6-17 Recovery Phase... 6-27 Test End Phase... 6-28 Overview... 6-28 Operating Steps... 6-28 After the Test - Post Test Review... 6-30 Test Summary... 6-30 Graphic Trends... 6-33 TWA Trends... 6-34 Sample Cardiac Cycles... 6-36 Sample TWA Cycles... 6-40 ECG Strips... 6-41 Arrhythmia Review... 6-42 Full Disclosure ECG... 6-44 Waterfall... 6-48 12SL... 6-49 Report Printout... 6-51 Report Formats... 6-53 In-Test Reports with Laser Printer... 6-53 Final Reports... 6-54 Monitoring of Remote Exercise Test Workstations... 6-55

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Ambulatory Blood Pressure Measurement... 7-1 Ambulatory Blood Pressure Monitors... 7-3 Connecting the Ambulatory BP Monitor... 7-3 Setting Up the Ambulatory Blood Pressure Monitor... 7-4 Acquisition Screen... 7-4 Operating Steps... 7-5 Post Test Review... 7-7 Downloading Data... 7-7 Test Summary... 7-8 Generating or Editing the Interpretation... 7-12 Graphics... 7-13 Tabular Summary... 7-14 Hourly Averages... 7-15 Statistics Summary... 7-16 Report Printout... 7-17

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Spirometry Test... 8-1 Sensors... 8-3 Entering Test Information... 8-4 Overview... 8-4 Patient Information Tab... 8-4 Test / Personnel Tab... 8-5 Medications... 8-6 Conducting Spirometry Tests... 8-7 Overview... 8-7 Post Test Review... 8-14 Test Summary... 8-14 Generating or Editing the Interpretation... 8-16 Report Printout... 8-17 Comparing Two Spirograms... 8-18

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File Management... 9-1 Overview... 9-3 Selecting Patient Records... 9-4 Viewing, Editing, Printing Patient Records... 9-6 Viewing and Printing Patient Records from the MUSE System... 9-7 Sending, Exporting, Deleting Patient Records... 9-8

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EMR Interface... 10-1 Overview... 10-3 Performing an Examination... 10-4

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System Settings... 11-1 Resting ECG Setup... 11-3 Acquisition Tab... 11-3 Lead Sequence Tab... 11-7 Miscellaneous Tab... 11-8 Final Report Tab... 11-9 Exercise Test Setup... 11-12 Writer Tab... 11-12 Screen Tab... 11-13 Lead Sequence Tab... 11-17 Protocol Editor Tab... 11-19 Final Report Tab... 11-23 Miscellaneous 1 Tab... 11-24 Miscellaneous 2 Tab... 11-26 ST/Medians / 12SL Tab... 11-30 TWA Tab... 11-31 Ambulatory Blood Pressure Measurement Setup... 11-32 Acquisition Tab... 11-32 Miscellaneous Tab... 11-34 Spirometry Setup... 11-36 Acquisition Tab... 11-36 Miscellaneous Tab... 11-37 Custom Setups, Factory Setup... 11-39 System Configuration... 11-41 General Tab... 11-41 Devices Tab... 11-53 Modem Tab... 11-54 MUSE Tab... 11-55 Option Code Tab... 11-57 Country Settings Tab... 11-58 EMR Tab... 11-59

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Cleaning and Maintenance...A-1 Cleaning, Disinfection, and Maintenance...A-3 Equipment Surface...A-3 Cables, Electrodes...A-3 Maintenance...A-4 Before Each Use...A-4 Technical Inspections...A-4 Disposal at the End of Its Service Life...A-4

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Miscellaneous...B-1 Connecting Peripheral Devices...B-3 Bicycle Ergometers...B-3 Treadmills...B-5 Blood Pressure Monitor...B-5 SpO2 Monitor...B-7 ECG Recorder...B-7 Modem...B-7 Laser Printer...B-8 Application Tips...B-9 General Application...B-9 Recording ECGs of Pacemaker Patients...B-9 Recording ECGs During Defibrillation...B-10 Reference Value Equations, Interpretation Modes, Measurements...B-11 Reference Value Equations...B-11 Interpretation Modes...B-14 Definition of Spirometry Test Values...B-18 CardioSoft Web...B-19 Points to Note...B-19 Displaying Tests...B-20 Risk Factors...B-21 Installing the Program...B-23 Troubleshooting...B-23 Remote Service...B-25 Medical Reimbursement Program/Clinical Information System (CIS)...B-26 System Maintenance...B-27 Data Backup...B-27 Norton AntiVirus...B-27 Direct Fax Transmission of Printer Documents...B-28

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ECG Measurement and Interpretation Program...B-29

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Order Information...C-1 Order Information...C-3 Accessories...C-3

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Introduction: License Agreement

License Agreement Opening the envelope indicates acceptance of the license agreement. If you do not accept the terms of this agreement, please return the closed envelope including the documentation and supplied hardware to your vendor for a full refund. The object of the agreement is to grant a license for the use of the software program and product documentation. GE Medical Systems Information Technologies grants you the personal, non-exclusive and non-transferable right to use the software. The software and documentation are protected by copyright laws. The licensee agrees to observe the regulations stipulated by the copyright. The software and all rights to it remain the property of GE Medical Systems Information Technologies. Therefore, the enclosed copy of the program may be installed on one PC only. You may not transfer the software via network or other communication channels to any other PC. The program and the accompanying documentation may not be modified, copied, merged with other programs or made available to third parties. The licensee is liable for any damage to the licenser resulting from infringement of the copyright as per this license agreement. The licenser notifies all users that the present state of the art does not allow for the creation of computer programs which run trouble-free in all applications and combinations. The licenser is not liable for product malfunctions. The licenser is not obliged to make program updates available to licensees who have not signed and returned the registration card.

© GE Medical Systems Information Technologies GmbH, 2001-2006. All rights reserved. Munzinger Str. 3 D-79111 Freiburg, Germany Telephone +49 (0) 7 61 45 43 0 Fax:+49.761.45.43.233

GE Medical Systems Information Technologies, Inc. 8200 West Tower Avenue Milwaukee, WI 53223 USA Tel:+1.414.355.5000 800.558.5120 (USA only) Fax:+1.414.355.3790

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Introduction: About This Manual

About This Manual Revision History This manual is subject to the GE Medical Systems Information Technologies change order service. The revision code, a letter that follows the document part number, changes with every update of the manual. Table 1: Revision History Part No./ Revision 2027786-141-A

Date

Comment

3 February 2006

Initial release, corresponds with software version 6.5.

Manual Purpose This manual contains the instructions necessary to employ the product safely and in accordance with its function and intended use. Where necessary the manual identifies additional sources of relevant information and/or technical assistance.

Intended Audience This manual is geared for clinical professionals. Clinical professionals are expected to have working knowledge of medical procedures, practices, and terminology as required for completing these examinations.

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Introduction: About This Manual

Conventions These are the conventions used in the manual:

Styles „

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

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

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To perform an operation which appears with a plus (+) sign between the names of the 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.

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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. All names appearing in examples and illustrations are fictitious. The use of any real person's name is purely coincidental.

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Introduction: Safety Information

Safety Information Intended Use „

CASE Client is a PC-based system for electrocardiographic (resting ECGs, exercise tests) and spirometric tests as well as for ambulatory blood-pressure examinations. The program is intended for use under the direct supervision of a health-care practitioner.

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The PC with CASE Client is not intended to be used as a vital signs physiological monitor.

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The PC with CASE Client is not intended for use as an emergency device.

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The PC with CASE Client will not cause abnormal operation of a patient's cardiac pacemaker or other electronic stimulator.

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The PC with CASE Client is not intended for use with high frequency surgical units. Disconnect the patient from the CASE Client PC before using the high frequency surgical unit.

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CASE Client uses an analysis program which can be used as a tool in interpreting ECG waveforms.

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The acquisition module is not intended for intracardiac use.

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This manual is an integral part of the product. It should always be kept near the PC. Close observance of the information given in the manual is a prerequisite for proper product performance and correct operation and ensures patient and operator safety. Please read the manual once in its entirety, because information pertinent to several chapters is given only once.

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The GE Medical Systems Information Technologies quality management system complies with the standards DIN EN ISO 9001 and EN ISO 13485.

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To ensure maximum patient safety, interference-free operation and the specified measuring accuracy, we recommend using only original GE Medical Systems Information Technologies accessories. The user is responsible for application of accessories from other manufacturers.

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The warranty does not cover damage resulting from the use of unsuitable accessories and consumables from other manufacturers.

General Information

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Introduction: Safety Information

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

assembly operations, extensions, readjustments, modifications, or repairs are carried out by GE Medical Systems Information Technologies or by persons authorized by GE Medical Systems Information Technologies.

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the electrical installation of the relevant room complies with the requirements of the appropriate regulations, and

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the product is used in accordance with the instructions given in this manual.

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The acquisition module is protected against the effects of cardiac defibrillator discharge to ensure recovery as required by standards.

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Accuracy of the Input Signal Reproduction

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Overall System Error is tested using the method described in AAMI EC11 3.2.7.1. The maximum overall system error is ± 5%.

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Frequency Response is tested according to AAMI EC11 3.2.7.2, methods A and D.

Modulating Effects in the Digital System This device uses digital sampling techniques that may produce some variation in amplitude of Q, R, and/or S waves. This effect 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.

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Contact General Electric Company for information before connecting any devices to this system that are not recommended in this manual.

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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.

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The use of accessories 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

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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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Introduction: Safety Information

Definition The terms Danger, Warning, and Caution are used throughout this manual to point out hazards and to designate a degree or level of 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 product in general. The order in which safety statements are presented in no way implies order of importance. Danger - indicates an imminent hazard which, if not avoided, will result in death or serious injury. Warning - indicates a potential hazard or unsafe practice which, if not avoided, could result in death or serious injury. Caution - indicates a potential hazard or unsafe practice which, if not avoided, may result in minor personal injury or product/property damage. Danger Explosion Hazard - The acquisition module is not designed for use in areas of medical locations where an explosion hazard may occur. An explosion hazard may result from the use of flammable anesthetics, skin cleansing agents and disinfectants. Furthermore, the device is suitable for application in an oxygen-enriched atmosphere only with certain restrictions. The atmosphere is considered to be oxygen-enriched when the room air contains more than 25% of oxygen or nitrous oxide.

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Introduction: Safety Information

Warning Shock Hazard - Observe the following warnings. Failure to do so endangers the lives of the patient, the user, and other persons present.

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Before putting the device into operation, the operator is required to ascertain that it is in correct working order and operating condition. The cables, in particular, must be checked for damage. Damaged cables and connectors must be replaced immediately.

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When disconnecting the device from the power line, remove the plug from the wall outlet, before disconnecting the cable from the device. Otherwise there is a risk of coming in contact with line voltage by inadvertently introducing metal parts in the socket of the power cord.

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Do not use extension cables with multiple portable socket outlet (MPSO).

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All devices of a system must be connected to the same power supply circuit. Devices that are not connected to the same circuit must be electrically isolated for operation (electrically isolated RS 232 interface); this requirement does not apply in the USA.

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The PC must be installed outside the patient vicinity, if it does not meet the requirements of EN 60601-1.

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The acquisition module is not intended for intracardiac use.

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All bicycle ergometers and treadmills connected to the system must meet the requirements of IEC 60601-1. The CASE Client PC and the connected bicycle ergometer or treadmill must be connected to the same electric circuit via separate wall outlets; this requirement does not apply in the USA.

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Introduction: Safety Information

Warning Shock Hazard - Observe the following warnings. Failure to do so endangers the lives of the patient, the user, and other persons present.

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All modems connected to the system must meet the requirements of IEC 60950 or UL1950. The specific regulations valid in your country must also be observed.

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The modem must be installed within the medical location, but not in the patient vicinity.

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Disconnect the patient from the PC while sending data via the modem.

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Devices may only be connected to each other or to parts of systems when it has been made certain that there is no danger to the patient, the operator, or the environment as a result. In those instances where there is any element of doubt concerning the safety of connected devices, the user must contact the manufacturers concerned or other informed experts as to whether there is any possible danger to the patient, the operator, or the environment as a result of the proposed combination of devices. Standards IEC 60601-1-1/EN 60601-1-1 must be complied with in all cases.

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Liquids must not be allowed to enter the devices. If liquids have entered the devices, notify service to have them inspected for damage before using them again.

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Use only the original GE Medical Systems Information Technologies patient cable.

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