Revision E MAC 5500 resting ECG analysis system B-7
2020299-020
Appendix B – Technical Specifications: Technical Specifications
Safety
Item Description
Certification UL 60602-1 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.
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