GE HEALTHCARE MAC 2000, Operator'S Manual

Page: 13 / 226

Introduction
WARNING:
ELECTRIC SHOCK — Improper connection of this equipment may cause electric
shock.
To avoid risk of electric shock, this equipment must only be connected to a supply
mains with protective earth.
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
Classification
Type of protection against electrical
shock Class I internally powered equipment
Degree of protection against electrical
shock Type CF defibrillation-proof applied part
Degree of protection against solids 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.
Degree of protection against harmful
ingress of liquids (IP20) The IP code for this device is IP20.
Non-protected
This device is ordinary equipment (enclosed
equipment without protection against ingress
of liquids)
Degree of safety of application in the
presence of flammable anesthetic
mixture with air or with oxygen or with
nitrous oxide Equipment is not suitable for use in the presence
of a flammable anesthetic mixture with air or
with oxygen or with nitrous oxide
Method(s) of sterilization or disinfection
recommended by the manufacturer Not applicable
Mode of operation Continuous operation
Certification Information
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.
2053535-002K MAC™ 2000 13