Appendix D – Technical Specifications: Safety
MAC 5000 System — 2000657-057, Revision B D-7
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 Medical Systems Information Technologies. Follow
manufacturer’s instructions for use for disposable/consumable products. Follow local environmental guidelines concerning
the disposal of hazardous materials.
Mode of Operation Continuous
Patient Leakage Current <10 µ A
Degree of protection against
electric shock
Type BF defibrillation protection for the patient cable (acquisition module)