Compliance - Zeiss OPMI Lumera i Instructions For Use Manual

OPMI Lumera i

Compliance

Version 8.0
G-30-1720-en
Directives and standards with which the device complies:
– The device complies with Medical Device Directive 93/42/EEC: Class I
It is labeled with:
– This device satisfies the US American and Canadian safety regulations for
medical electrical devices/systems.
It is labeled with:
– The device complies with Directive 2011/65/EU on the restriction of the use
of certain hazardous substances in electrical and electronic equipment.
Classification of the device according to IEC 60601-1
The device is classified as follows:
– Level of protection against electric shock: Class 1
– Level of protection against entry of water: IP X0
– Electromagnetic compatibility (EMC): Fulfills IEC 60601-1-2, Class B (as per
CISPR 11)
– Operating mode: continuous operation
Device data
Page 171