Safety - GE MAC 5000 Service Manual

Item
Certification
Type of Protection Against Electrical
Shock
Degree of Protection Against Ingress of
Liquids
Handling of Disposable Supplies and
Other Consumables
Patient Mode of Operation
Patient Leakage Current
Degree of Protection Against Electrical
Shock
Maintenance Frequency
Repair Guidelines
Revision B
Appendix B – Technical Specifications: Technical Specifications
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
Class 1, internally powered
Ordinary
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.
Continuous
<10 µA
Type BF defibrillation protection for the patient cable (acquisition module)
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.
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.
MAC™ 5000 resting ECG analysis system
2024917-010

Safety

Description
B-7