Classification Of Medical Device; Certification Information; Recording Ecgs During Defibrillation - GE MAC 2000 Service Manual

NOTE:
Follow the instructions provided. Do not position equipment in a way that makes it
difficult to disconnect the device when using an appliance coupler, mains plug, or
other separable plug as a means of isolation.

Classification of Medical Device

The device is classified as follows, according to IEC 60601-1:
Medical Device Classifications
Category
Type of protection against electrical
shock
Degree of protection against electrical
shock
Degree of protection against solids
Degree of protection against harmful
ingress of liquids (IP20)
Degree of safety of application in the
presence of flammable anesthetic
mixture with air or with oxygen or with
nitrous oxide
Method(s) of sterilization or disinfection
recommended by the manufacturer
Mode of operation

Certification Information

Recording ECGs During Defibrillation

This equipment is protected against the effects of cardiac defibrillator discharge
to ensure recovery, as required by test standards. The patient signal input of the
acquisition module is defibrillation-proof. Therefore, it is not necessary to remove
the ECG electrodes prior to defibrillation.
2053535-003C
Classification
Class I internally powered equipment
Type CF defibrillation-proof applied part
The IP code for this device is IP20.
Protected against solid foreign objects with a
diameter of 12.5 mm and greater
The object probe, a sphere 12.5 mm diameter,
shall not fully penetrate. The jointed test finger
12 mm diameter, 80 mm length, shall have
adequate clearance from hazardous parts.
The IP code for this device is IP20.
Non-protected
This device is ordinary equipment (enclosed
equipment without protection against ingress
of liquids)
Equipment is not suitable for use in the presence
of a flammable anesthetic mixture with air or
with oxygen or with nitrous oxide
Not applicable
Continuous operation
Medical Equipment
With respect to electric shock, fire, and mechanical hazards only in
accordance with UL 60601–1, and CAN/CSA C22.2 NO. 601.1.
MAC™ 2000 ECG Analysis System
Introduction
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