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 Mattress.
Degree of protection against harmful ingress of water
Ordinary equipment (enclosed equipment without protection
against ingress of water), except footswitch which is a watertight
device (protected against the effects of submersion, IPX8).
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
NOTICE
The system can only be installed in an anesthetizing location if that location is
classified as Other Than Hazardous as per NFPA 70 clause 517.60
NOTICE
The product is not classified as AP, APG (Equipment not suitable for use in the
presence of a flammable anaesthetic mixture with air or with oxygen or nitrous
oxide).
Innova
TM
IGS 620, Innova
TM
IGS 630 Preinstallation Manual
Direction 5694389-1-1EN, Revision 2
24
2 Customer Responsibilities
Содержание Innova IGS 620
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