Operators Manual
328 Pages
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GE Healthcare
CASE TM V7.0 Operator’s Manual Product Code SSF Software Version 7.0 2096198-005 EN
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NOTE: The information in this manual only applies to system software version 7.0. It does not apply to earlier software versions. NOTE: CASE V7.0 is referred as CASE across the manual. 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 1 800 558 5120 (USA only)
GE Medical Systems Information Technologies GmbH Munzinger Straße 5 79111 Freiburg Germany Tel: +49 761 45 43-0
CASE, MAC, MARS, and MUSE are trademarks owned by GE Medical Systems Information Technologies GmbH, a General Electric Company going to market as GE Healthcare. © 2018, 2020. 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. Date of the first CE mark 1999. The medical device has been assigned to class IIa as specified in Annex IX of the Directive 93/42/EEC. The medical device has a lifetime of 5 years with respect to the Council Directive 93/42/EEC essential requirement #4. 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 INTERFERENCE - Magnetic and electric fields can interfere with the system. Make sure that all peripheral components operated in the vicinity of the device comply with the relevant EMC requirements. X-ray equipment, MRI devices, radio systems (cellular phones) and so forth, are possible sources of interference because they may emit higher levels of electromagnetic radiation. Verify the performance of the system before use. 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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Contents 1
Introduction About This Manual... 1-3 Revision History... 1-3 Manual Purpose... 1-3 Intended Audience... 1-3 Illustrations... 1-3 Safety Information... 1-4 Intended Use... 1-4 General Information... 1-5 Definition... 1-6 Classification... 1-11 Equipment Symbols... 1-11 Unique Device Identifier (UDI)... 1-13 Supplies and Accessories... 1-13 Biocompatibility... 1-13 Technical Maintenance... 1-13 Legal Notice... 1-14 Security Patches... 1-14 Service Information... 1-14 Service Requirements... 1-14 Equipment Identification... 1-14
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Equipment Overview CASE System... 2-3 Front View... 2-3 Rear View... 2-4 Installing CASE... 2-4 Putting the CASE System into Service... 2-5 Connecting the System Components... 2-5 Mains Connection, Power Up, Functional Test... 2-5 Switching the System Off... 2-7 Function Keypad... 2-8 Desk Light... 2-11 Preparing the Acquisition Module... 2-11 CAM14... 2-11
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CAM CONNECT 14 (CC14)...2-12 Wireless GEH-ECG 1200...2-13 Loading Writer Paper... 2-15 Initial Screen... 2-17 Viewing and Printing the Operator’s Manual... 2-18 Online Help...2-18 Software Options... 2-19
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Preparing the Patient Applying Electrodes - The Basics... 3-3 Preparing the Patient... 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 MASON-LIKAR Lead Electrode Placement...3-8 (Modified Standard Leads for Exercise Tests)...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...3-11 Attaching the Acquisition Module... 3-12 CAM14...3-12 CAM CONNECT 14 (CC14)...3-13 Attaching the Wireless GEH-ECG 1200...3-15
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Selecting a Patient Record and Test Type Selecting a Patient Record from the Local Database... 4-3 Overview...4-3 Selecting a Patient Record...4-4 Entering a New Patient... 4-4 Retrieving a Patient Record from the MUSE System Database... 4-4 Orders from the MUSE System...4-5 Patient Records of External Programs... 4-6
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Resting ECG Entering Test Information... 5-3 Overview... 5-3 Entering Patient Information... 5-3 Entering Test/Personnel Information... 5-4 Entering Medications... 5-5 Recording a Resting ECG... 5-6 Overview... 5-6 Conducting a 10-Second ECG with Analysis... 5-7 Conducting a Full Disclosure ECG... 5-8 Printing Rhythm Report... 5-8 Post Test Review... 5-9 Test Summary... 5-9 ECG Traces... 5-11 Zoom Mode... 5-12 Measuring the ECG... 5-12 Medians... 5-13 Reanalysis... 5-13 Performing Reanalysis... 5-15 Arrhythmia Review... 5-15 Determining the Heart Rate... 5-16 Vector Loops... 5-17 Full Disclosure ECG... 5-18 Printing the Full Disclosure ECG... 5-19 Enabling the Zoom Mode... 5-19 Analyzing Full Disclosure ECG Segments, Save as Resting ECGs 519 Report Printout... 5-19 Generating the Interpretation... 5-20 Copying Diagnostic Statements Using Acronyms... 5-21 Comparing Resting ECGs... 5-21 Comparing Two Resting ECGs... 5-21 Comparing Median Complexes from Multiple Resting ECGs... 5-23
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Exercise Test Patient Education... 6-3 Entering Test Information... 6-3 Entering Patient Information... 6-3 Test/Personnel Tab... 6-4 Entering Medications Information... 6-5 Calculating Patient Risk... 6-5
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Before the Test... 6-6 Pre-Acquisition Screen...6-6 Starting the Test...6-7 Acquisition Screen...6-8 Pretest Phase...6-9 Running a Pretest...6-9 Exercise Phase...6-10 Starting a Treadmill Test...6-10 Manual Control...6-11 ECG Data Windows...6-12 ST/Arrhy...6-12 Medians...6-13 Waterfall...6-13 Tabular Summary...6-14 METS Formula (Metabolic Equivalents)...6-15 Trends...6-15 ECG Strips...6-16 12SL...6-16 Interpretation...6-17 Full-Disclosure ECG...6-17 Comparing Previous Test Data...6-18 Recovery Phase... 6-18 Test End Phase... 6-19 Ending the Phase...6-19 After the Test - Post Test Review...6-20 Test Summary...6-20 Tabular Summary...6-21 METS Formula...6-22 Graphic Trends...6-22 Viewing Medians, Replacing max. ST Changes...6-23 Viewing TWA Medians, Replacing max. TWA Values...6-23 Sample Cardiac Cycles...6-24 Reanalysis...6-25 Performing Reanalysis...6-26 Performing Measurements on the Median Complex...6-26 Sample TWA Cycles...6-26 ECG Strips...6-27 Arrhythmia Review...6-28 Full Disclosure ECG...6-30 Printing the Full Disclosure ECG...6-32 Enabling the Zoom Mode...6-32 Audio ECG...6-32 Waterfall...6-33 3D Graph...6-34 12SL Report...6-35 Vector Loops...6-36 Report Printout...6-37
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Report Formats... 6-38 In-Test Reports... 6-38 Final Reports... 6-39 Monitoring Remote Exercise Test Workstations... 6-40
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Ambulatory Blood Pressure Measurement Ambulatory Blood Pressure Monitors... 7-3 Connecting the Ambulatory BP Monitor... 7-4 Setting Up the Ambulatory Blood Pressure Monitor... 7-5 Acquisition Screen... 7-5 Operating Steps... 7-6 Post Test Review... 7-8 Downloading Data... 7-8 Test Summary... 7-9 Patient Information... 7-10 Test Information... 7-10 Measurement Results... 7-12 Generating or Editing the Interpretation... 7-13 Graphics... 7-15 Tabular Summary... 7-16 Hourly Averages... 7-16 Statistics Summary... 7-17 Compare... 7-18 Printing the Report... 7-20
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Spirometry Test ... 8-3 Spirometry Test... 8-5 Test Types... 8-5 Forced Vital Capacity (FVC)/Flow Volume Loop (FVL)... 8-6 Maximal Voluntary Ventilation (MVV)... 8-6 Slow Vital Capacity (SVC)... 8-7 Preparing the Spiro-SP TrueFlow™ Sensor... 8-7 Configuring the System for the TrueFlow Sensor... 8-7 Entering Test Information... 8-8 Entering Patient Information... 8-9 Entering Test/Personnel Information... 8-10 Entering Medications Information... 8-11 Pulmonary Factors... 8-11
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Conducting a Spirometry Test... 8-12 Preparations...8-13 Performing the Measurement Test...8-13 %Pred Graph...8-18 Ambient Conditions...8-19 Bronchodilator (Test)...8-19 Conducting a Bronchodilator Test...8-20 Delete Test...8-22 Children’s Animation Program...8-22 Post Test Review... 8-24 Test Summary...8-24 Store / Review...8-25 Interpretation Screen...8-25 Quality Messages/Grades...8-26 FVC/FVL Quality Messages...8-26 FVC/FVL Quality Grades:...8-27 SVC Quality Messages:...8-27 SVC Quality Grades:...8-28 Print the Report...8-28 Comparing the Test Results...8-28 System Evaluation...8-31 Changing Trial Status...8-31 Changing Display Settings...8-32 Parameters Definition...8-34 Troubleshooting... 8-35
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File Management Overview... 9-3 Selecting Patient Records... 9-3 Viewing, Editing, Printing Patient Records... 9-4 Printing a Combined Report...9-4 Viewing and Printing Patient Records from the MUSE System...9-5 Archiving, Exporting, Deleting Patient Records... 9-5 Save to Archive...9-5 Transfer to MUSE...9-5 Send...9-6 Exporting a Patient Record...9-6 Working Temporarily with the Local Database... 9-8
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Operation with Administrative Tools Overview... 10-3 Description... 10-3
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DICOM and DCP Interfaces About DICOM... 11-3 About DCP... 11-3 DCP Port Configure... 11-3 DICOM /DCP Functions... 11-4 Performing Procedures with the Order List... 11-4 Elements of the Order List - Explanation... 11-6 Performing Procedures without the Order List... 11-7
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System Settings Resting ECG Setup... 12-3 Acquisition Tab... 12-3 Editing the Reason for Test Library... 12-4 Editing the Interpretation Library... 12-4 Editing Medication Groups, Assigning Drug Names... 12-4 Lead Sequence Tab... 12-4 Modifying the Lead Sequence... 12-4 Miscellaneous Tab... 12-5 Run the Final Report... 12-6 Report Editor... 12-6 System Evaluation Tab... 12-7 Exercise Test Setup... 12-8 Writer Tab... 12-8 Screen Tab... 12-9 Configuring the Tabular Summary... 12-9 Configuring Trends... 12-10 Configuring the Vital Signs... 12-10 Lead Sequence Tab... 12-11 Modifying the Lead Sequence... 12-11 Protocol Editor Tab... 12-12 Selecting the Default Protocol... 12-12 Protocol Editor Screen... 12-13 Creating a New Phase... 12-14 Editing Stage or Phase Information... 12-14
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Run the Final Report...12-14 Miscellaneous 1 Tab...12-15 Miscellaneous 2 Tab...12-16 Editing the Comments, Test Types, Reason for Test, Reasons for Termination, Medications Library...12-16 Configuring the Measurement Results...12-16 Editing the Interpretation Library...12-17 Entering Extra Questions...12-17 Assigning Functions to the Function Keys...12-17 ST/Medians / 12SL Tab...12-18 TWA Tab...12-18 Ambulatory Blood Pressure Measurement Setup... 12-20 Acquisition Tab...12-20 Editing the BP Protocol...12-21 Miscellaneous Tab...12-22 Editing the Interpretation Library...12-23 Spirometry Setup... 12-23 Acquisition Tab...12-24 Parameter Selection...12-25 Miscellaneous Tab...12-26 Editing the Interpretation Library...12-28 Calibration Check Tab...12-29 Custom Setups, Factory Setup... 12-33 Save...12-33 Load or Delete...12-33 Load the Factory Setup...12-34 System Configuration... 12-35 General Tab...12-35 Adjusting the Screen Size for Widescreen Monitors...12-37 User Administration...12-37 Receiving Resting ECGs from Other ECG Devices...12-38 Copying Patient Records...12-40 Archiving Patient Records...12-41 Changing System Date and Time...12-41 Procedure Statistics...12-41 Printer Settings...12-42 Devices Tab...12-42 Modem Tab...12-43 MUSE Tab...12-44 Option Code Tab...12-45 Country Settings Tab...12-46 EMR Tab...12-47 DCP Tab...12-48 Connectivity Server Tab...12-49 Add Inbound Connections Window...12-50 Configure DCP Server...12-51
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DICOM Tab... 12-51
A
Cleaning and Maintenance Equipment Cleaning, Disinfection, and Maintenance... A-3 Equipment Surface...A-3 Cleaning/Disinfecting...A-3 Cautions...A-4 Storage...A-4 Improper Cleaning Products and Processes Impact/Results...A-4 Cleaning Products to Avoid...A-5 Monitor...A-5 Maintenance... A-6 Before Each Use...A-6 Technical Inspections...A-6 Disposal at the End of Its Service Life...A-6 TrueFlow™ Sensor Cleaning, Maintenance, and Disposal... A-7 CAM14 Maintenance, Cleaning and Disinfecting... A-7 Wireless GEH-ECG 1200 Maintenance, Cleaning and Disinfecting... A-7 CC14 - Cleaning, Visual Inspection, and Disinfecting... A-7 Other Cleaning and Disinfection Agents...A-7 Cleaning and Disinfecting Guidelines...A-7 Visual Inspection, Cleaning, and Disinfecting Frequency...A-8 Visual Inspection...A-8 Cleaning and Disinfecting the CC14 Acquisition Module...A-9 Cables and Electrodes Cleaning... A-10 Tonoport... A-11
B
Miscellaneous Connecting Peripheral Devices... B-3 Bicycle Ergometers...B-3 Treadmills...B-3 Blood Pressure Monitor...B-3 SpO2 Monitor...B-4 ECG Recorder...B-4 Modem...B-4 Laser Printer...B-4 Printers in a Network Environment...B-4 Application Tips... B-5
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General Application... B-5 Recording ECGs of Pacemaker Patients... B-5 Recording ECGs During Defibrillation... B-5 Exercise Test Interpretation (XTI)... B-6 Duke Treadmill Score... B-7 References... B-7 Risk Factors... B-8 Spirometry Reference Value Equations, Interpretation Modes, Measurements B-10 Reference Value Equations... B-10 Interpretation Modes... B-11 Europe... B-11 CHS... B-13 System Interpretation... B-13 GOLD-Hardie Interpretation 2003/2008... B-13 NLHEP Interpretation... B-14 NICE Interpretation... B-15 Definition of Spirometry Test Values... B-17 Installing the Program in a Network Environment... B-18 Troubleshooting... B-19 Remote Service... B-21 Data Backup... B-21 Virus Protection... B-21 Direct Fax Transmission of Printer Documents... B-22 Related Physician’s Guides... B-23
C
Order Information Order Information... C-3
D
Technical Description Technical Specifications – CASE System... D-3 Spirometry Technical Specification... D-9 Ambulatory Blood Pressure (ABP) - TONOPORT Technical Specifications... D-9 Wireless GEH-ECG 1200... D-9
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Introduction
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For your notes
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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
Date
A
2018-03-12
Initial release.
B
2018-03-12
Initial release.
C
2018-12-18
Initial release.
D
2018-12-18
Customer release.
E
2020-04-07
Revision upgrade to match the MyWorkshop revision number.
F
2020-04-07
Updated Initial Screen image. Added treadmill speed compatibility.
G
2020-07-28
Updated InSite Information
Comment
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.
Illustrations All illustrations in this manual are provided as examples only. They may not necessarily reflect your equipment setup or data displayed.
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About 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
Safety Information Intended Use
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. WARNING Patient Hazard-Do not use the digital or analog outputs to control therapeutic devices such as defibrillators.
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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 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 it 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.
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Safety Information
CASE is not intended for use with high frequency surgical units. Disconnect the patient from CASE before using the high frequency surgical unit.
This manual is an integral part of the product. It should always be kept near the product. 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. 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.
GE Healthcare is responsible for the effects on safety, reliability, and performance of the product, only if:
General Information
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 product 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:
Recording speed accuracy is tested using the method described in IEC 60601-2-25and the maximum error is ± 5 %.
Frequency Response is tested according to IEC 60601-2-25 and IEC 60601-2-51 sub-clause 51.107.1 conforming to the specifications of sub-clause 51.107.1.1.
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
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