Revision B
MAC
™
5000 resting ECG analysis system
B-7
2024917-010
Appendix B – Technical Specifications:
Technical Specifications
Safety
Item
Description
Certification
UL 60601-1 classified
UL classified for CAN/CSA C22.2 No. 601.1
CB certified for IEC 60601-1
CE marking for Council Directive 93/42/EEC concerning Medical Devices
Meets applicable AAMI EC-11 requirements
Type of Protection Against Electrical
Shock
Class 1, internally powered
Degree of Protection Against Ingress of
Liquids
Ordinary
Handling of Disposable Supplies and
Other Consumables
Use only parts and accessories manufactured or recommended by GE Medical Systems
Information
Technologies
. Follow manufacturer’s instructions for use for disposable/
consumable products. Follow local environmental guidelines concerning the disposal of
hazardous materials.
Patient Mode of Operation
Continuous
Patient Leakage Current
<10 µA
Degree of Protection Against Electrical
Shock
Type BF defibrillation protection for the patient cable (acquisition module)
Maintenance Frequency
Daily visual inspection and routine cleaning (if needed) performed by user. Use a
commercially available, industrial strength disinfectant cleaner on any part of the equipment
(other than electrodes) which comes into direct contact with the patient.
Every six months routine maintenance checks and test procedures performed by qualified
technical personnel.
Repair Guidelines
Calibration instructions, equipment descriptions, and all other information which will assist
qualified technical personnel in repairing those parts of the equipment designated as
repairable is available in the field service manual for the equipment.
We will make available upon request circuit diagrams and component parts lists for printed
circuit boards deemed repairable by qualified technical personnel.
Summary of Contents for MAC 5000
Page 9: ...Revision B MAC 5000 resting ECG analysis system 1 1 2024917 010 1 Introduction ...
Page 10: ...1 2 MAC 5000 resting ECG analysis system Revision B 2024917 010 For your notes ...
Page 21: ...Revision B MAC 5000 resting ECG analysis system 2 1 2024917 010 2 Equipment Overview ...
Page 22: ...2 2 MAC 5000 resting ECG analysis system Revision B 2024917 010 For your notes ...
Page 59: ...Revision B MAC 5000 resting ECG analysis system 3 1 2024917 010 3 Installation ...
Page 60: ...3 2 MAC 5000 resting ECG analysis system Revision B 2024917 010 For your notes ...
Page 77: ...Revision B MAC 5000 resting ECG analysis system 4 1 2024917 010 4 Maintenance ...
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Page 103: ...Revision B MAC 5000 resting ECG analysis system 5 1 2024917 010 5 Troubleshooting ...
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Page 135: ...Revision B MAC 5000 resting ECG analysis system 6 1 2024917 010 6 Parts List ...
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Page 143: ...Revision B MAC 5000 resting ECG analysis system A 1 2024917 010 A Appendix A Abbreviations ...
Page 144: ...A 2 MAC 5000 resting ECG analysis system Revision B 2024917 010 For your notes ...
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Page 164: ...C 2 MAC 5000 resting ECG analysis system Revision B 2024917 010 For your notes ...
Page 171: ...Revision B MAC 5000 resting ECG analysis system Index 1 2024917 010 Index ...
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Page 174: ...Index Index 4 MAC 5000 resting ECG analysis system Revision B 2024917 010 ...
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