GE MAC 5000, Field Service Manual

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Revision B B-7
Appendix B: Technical Specifications: Technical Specifications
MAC 5000 resting ECG analysis system
2000657-002
Table B-10. Safety
Item Description
Certification UL 2601-1 classified
UL classified for CAN/CSA C22.2 No. 601.1
CB certified for IEC 601-1
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 Marquette
Medical Systems, Inc. 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.
GE Marquette Medical Systems, Inc. will make available upon request circuit
diagrams and component parts lists for printed circuit boards deemed repairable by
qualified technical personnel.