Operators Manual
364 Pages
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GE Healthcare
CASE™ Version 6.6
Operator’s Manual 2040396-001 ENG
Revision A
NOTE: The information in this manual only applies to system software version 6.6. It does not apply to earlier software versions. Due to continuing product innovation, specifications in this manual are subject to change without notice.
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
GE Medical Systems Information Technologies GmbH Munzinger Str. 5 D-79111 Freiburg, Germany Tel: +49.761.45.43.0 Fax: +49.761.45.43.233
CASE, CardioSys, MAC, MARS, and MUSE are trademarks owned by GE Medical Systems Information Technologies GmbH, a General Electric Company going to market as GE Healthcare. © 2009 General Electric Company. All rights reserved.
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CE Marking Information
CE Marking Information Compliance The product CASE 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 medical device has been assigned to class IIa as specified in Annex IX of the Directive 93/42/EEC. The CE marking only covers accessories listed in the Order Information chapter. The product complies with the electromagnetic immunity requirements of standard IEC 60601-1-2 "Electromagnetic Compatibility - Medical Electrical Equipment". The radio interference emitted by this device is within the limits specified in EN 55011 - class A. 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 cart 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 system cart away from these devices and verify the performance of CASE 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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CE Marking Information For your notes
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Contents
1
Introduction... 1-1 About This Manual... 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... 1-6 Definition... 1-8 Classification... 1-13 Equipment Symbols... 1-13 Biocompatibility... 1-14 Technical Maintenance... 1-15 Legal Notice... 1-15 Security Patches... 1-15 Service Information... 1-16 Service Requirements... 1-16 Equipment Identification... 1-16
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Equipment Overview... 2-1 CASE System... 2-3 Front View... 2-3 Rear View... 2-4 Putting the CASE System Into Service... 2-5 CASE System with CASE ES Upgrade Kit... 2-9 Mains Connection, Power Up, Functional Test... 2-11 Switching the System Off... 2-12 Function Keypad... 2-14 Desk Light... 2-17 Preparing the Acquisition Module... 2-18 Loading Writer Paper (Thermal Writer Model I)... 2-19 Loading Writer Paper (Thermal Writer Model II)... 2-21 Adjusting Brightness and Contrast... 2-23
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NEC Monitor... 2-23 CHILIN Monitor... 2-24 Initial Screen... 2-25 Viewing and Printing the Operator's Manual... 2-26 Online Help... 2-26 Software Options... 2-27
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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 Module... 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 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
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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 Full Disclosure ECG... 5-23 Report Printout... 5-26 Generating the Interpretation... 5-27 Comparing Resting ECGs... 5-29
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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... 6-15 Exercise Phase... 6-16 ECG Data Windows... 6-18 Recovery Phase... 6-28 Test End Phase... 6-29 Overview... 6-29 Operating Steps... 6-29 After the Test - Post Test Review... 6-31 Test Summary... 6-31 Graphic Trends... 6-34 TWA Trends... 6-37 Sample Cardiac Cycles... 6-39 Sample TWA Cycles... 6-43 ECG Strips... 6-44 Arrhythmia Review... 6-45 Full Disclosure ECG... 6-47 Waterfall... 6-52 12SL... 6-54 Report Printout... 6-56
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Report Formats... 6-57 In-Test Reports... 6-57 Final Reports... 6-58 Monitoring of Remote Exercise Test Workstations... 6-59
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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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Ergospirometry... 9-1 Introduction... 9-3
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Selecting the Patient and the Test... 9-4 Before the Test... 9-4 Entering Test Information... 9-4 Ergometry Configuration... 9-5 Selecting the Exercise Test Protocol... 9-5 Preparing the Patient... 9-5 Start/Stop Spirometry Button... 9-6 During the Test (Acquisition Screen)... 9-7 Post Test Review... 9-9 Report Printout... 9-11 Exporting Tests... 9-11 Starting LF8 with the Program Icon... 9-11
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File Management... 10-1 Overview... 10-3 Selecting Patient Records... 10-4 Viewing, Editing, Printing Patient Records... 10-6 Viewing and Printing Patient Records from the MUSE System... 10-7 Archiving, Exporting, Deleting Patient Records... 10-8 Working Temporarily with the Local Database... 10-12
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Operation with Administrative Tools... 11-1 Overview... 11-3 Description... 11-4
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DICOM Interface... 12-1 Overview... 12-3 Performing Procedures with the Order List (Scheduled Procedures)... 12-4 Elements of the Order List - Explanation... 12-6 Performing Procedures without the Order List (Unscheduled Procedures)... 12-6
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System Settings... 13-1 Resting ECG Setup... 13-3
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Acquisition Tab... 13-3 Lead Sequence Tab... 13-7 Miscellaneous Tab... 13-8 Final Report Tab... 13-9 Exercise Test Setup... 13-12 Writer Tab... 13-12 Screen Tab... 13-13 Lead Sequence Tab... 13-17 Protocol Editor Tab... 13-19 Final Report Tab... 13-23 Miscellaneous 1 Tab... 13-24 Miscellaneous 2 Tab... 13-26 ST/Medians / 12SL Tab... 13-29 TWA Tab... 13-30 Ambulatory Blood Pressure Measurement Setup... 13-31 Acquisition Tab... 13-31 Miscellaneous Tab... 13-33 Spirometry Setup... 13-35 Acquisition Tab... 13-35 Miscellaneous Tab... 13-36 Custom Setups, Factory Setup... 13-38 System Configuration... 13-40 General Tab... 13-40 Devices Tab... 13-54 Modem Tab... 13-55 MUSE Tab... 13-56 Option Code Tab... 13-59 Country Settings Tab... 13-60 EMR Tab... 13-61 Connectivity Server Tab... 13-62 DICOM Tab... 13-64
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Cleaning and Maintenance...A-1 Cleaning, Disinfection, and Maintenance...A-3 Equipment Surface...A-3 Cables, Electrodes...A-3 Monitor...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-4 Blood Pressure Monitor...B-4 SpO2 Monitor...B-6 ECG Recorder...B-6 Modem...B-6 Laser Printer...B-6 Application Tips...B-8 General Application...B-8 Recording ECGs of Pacemaker Patients...B-8 Recording ECGs During Defibrillation...B-8 Reference Value Equations, Interpretation Modes, Measurements...B-10 Reference Value Equations...B-10 Interpretation Modes...B-13 Definition of Spirometry Test Values...B-17 Duke Treadmill Score...B-18 References...B-18 Risk Factors...B-20 Installing the Program in a Network Environment...B-22 Troubleshooting...B-23 Remote Service...B-25 Virus Protection...B-26 Norton AntiVirus...B-26 McAfee VirusScan...B-26 Direct Fax Transmission of Printer Documents...B-27 ECG Measurement and Interpretation Program...B-28
C
Order Information...C-1 Order Information...C-3 Accessories...C-3
D
Formatting CDs...D-1 Blank CDs...D-3
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For your notes
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1
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Introduction
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For your notes
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Introduction: About This Manual
About This Manual Revision History This manual is subject to the GE Healthcare 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 2040396-001-A
Date
Comment
8 September 2009
Initial release, corresponds with software version 6.6.
Manual Purpose This manual contains the instructions necessary to operate the equipment 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.
Italicized text indicates software terms that identify menu items, onscreen controls, buttons or options in various windows.
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.
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
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CASE is intended to be used by trained operators under direct supervision of a licensed health care practitioner on adult and pediatric patients.
CASE is designed to acquire, process, record, archive, analyze and output ECG data (12 and 15 leads) during a period of physiologic stress or during a resting ECG test and acquire data from ancillary devices, such as spirometry and ambulatory blood pressure devices. Furthermore, it provides median morphology recordings and records ECG in real-time with and without arrhythmia detection.
The arrhythmia detection algorithm of CASE is provided to the user for the convenience of automatic detection of arrhythmias but does not provide alarms.
CASE provides the control of external devices. These are typically treadmills and bicycle ergometers. Additionally, CASE communicates with centralized electronic/digital storage systems via data networks.
CASE provides a user-selectable option for printouts of prognostic scores on selected reports. Vector loops are also available.
CASE can be configured in a network environment for multiple CASE and CardioSoft/CS stations allowing the user to create a central database of patient demographics and collected patient physiological data.
CASE is intended to be used primarily in the hospital. However, it can also be used in clinics, physician offices, outreach centers or wherever exercise stress testing, ECG, spirometry or ambulatory blood pressure testing is performed.
CASE offers no diagnostic opinion to the user. Instead is provides interpretive statements of morphology, rhythm, and conduction for which the physician renders his/her own medical opinion.
CASE is not intended to be used as a transport device or for home use.
CASE is not intended for use as a vital signs physiological monitor.
CASE is not intended for intracardiac use.
CASE is not intended for use as an emergency device.
CASE will not cause abnormal operation of a patient's cardiac pacemaker or other electronic stimulators.
CASE is not intended for use with high frequency surgical units. Disconnect the patient from CASE before using the high frequency surgical unit.
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Introduction: Safety Information
Use with the CASE ES Upgrade Kit
The system is intended for ergospirometric tests in adult patients and in adolescents from 13 to 21 years of age.
Users should note that the environmental operating conditions of the HP Color LaserJet CP1515n differ to the environmental operating conditions of the CASE system. Operate the printer between 15°C (59°F) to 32.5°C (90.5°F) and 10% to 80% Relative Humidity (non condensing) only. Usage outside of these conditions can result in a loss of print quality.
This manual is an integral part of the device. It should always be kept near the device. 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. Please read the manual once in its entirety, because information pertinent to several chapters is given only once.
To ensure maximum patient safety, interference-free operation and the specified measuring accuracy, we recommend using only original GE Healthcare accessories. The user is responsible for application of accessories from other manufacturers.
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
GE Healthcare is responsible for the effects on safety, reliability, and performance of the device, only if:
assembly operations, extensions, readjustments, modifications, or repairs are carried out by GE Healthcare or by persons authorized by GE Healthcare.
the electrical installation of the relevant room complies with the requirements of the appropriate regulations, and
the device is used in accordance with the instructions given in this 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. The maximum overall system error is ± 5%.
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 GE Healthcare 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 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
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 equipment 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 device 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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