MAC ® 1200 Operations Manual - Jaken Medical...

Putting the Device into Operation and Performance Test
NOTES
- The MAC 1200 is designed to comply with IEC
60601/ EN 60601 requirements. It is Class I
equipment/equipment with a built-in rechargeable
electrical power source. The device is not suitable
for intracardiac use. The device is suitable
for continuous operation.
- Choose a location which affords an unobstructed
view of the display screen and easy access to the
operating controls.
- The MAC 1200 has no additional protection
against ingress of water.
- Medical technical equipment such as the MAC
1200 must only be used by persons who have received
adequate training in the use of such
equipment and who are capable of applying it
properly.
- At the end of its service life; the MAC 1200 and
its accessories must be disposed of in compliance
with the special waste control regulations for
electronic parts. If you have any questions in this
matter, please contact GE Medical Systems Information
Technologies.
Literature
Medical Device Directive 93/42/EEC
EN 60601-1/1990 + A1: 1993 + A2: 1995: Medical
electrical equipment. General requirements for
safety
EN 60601-1-1/9.1994 + A1 12.95: General requirements
for safety. Requirements for the safety of
medical electrical systems. Requirements for the
safety of medical electrical systems.
EN 60601-2-25/1993: Medical electrical equipment.
Part 2: Special requirements for the safety of electrocardiographs.
IEC Publication 513/1994: Fundamental aspects of
safety standards for medical equipment.
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