2.2 Equipment Classifications
The following equipment classifications are applicable to the product:
Classification category Equipment classification
Protection against electric shock Class I
WARNING
TO AVOID THE RISK OF ELECTRIC
SHOCK, THIS EQUIPMENT MUST ONLY
BE CONNECTED TO A SUPPLY MAINS
WITH PROTECTIVE EARTH.
Degree of protection against electric shock
Type B applied parts
Applied parts complying with the specified requirements of the
IEC 60601-1 standard to provide protection against electric
shock, particularly regarding allowable patient leakage current
and patient auxiliary current include:
Patient support of Omega table
Degree of protection against harmful ingress of water Ordinary equipment (enclosed equipment without protection
against ingress of wat er), except :
Footswitch which is a IPX8 device (protected against the effects
of submersion).
Method(s) of sterilization or disinfection recommended by the
manufacturer
•
Sterilization: not applicable
•
Disinfection: refer to Operator Manual (Chapter Safety and
Regulatory, section Disinfection), Recommended disinfect‐
ing agents.
Degree of safety of application in the presence of a flammable
anesthetic mixture with air or with oxygen or nitrous oxide
Equipment not suitable for use in the presence of a flammable
anesthetic mixture with air or with oxygen or nitrous oxide.
Mode of operation Continuous operation with intermittent loading .
Optima IGS 320, Optima IGS 330 Pre-Installation Manual
Direction 5537562-1-1EN, Revision 3
24 2 Customer Responsibilities
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