Compliance - Zeiss S100 / OPMI pico Instructions For Use Manual

S100 / OPMI pico

Compliance

Version 9.0
G-30-1781-en
Directives and standards with which the following devices are
compliant:
S100 / OPMI pico (floor stand) (000000-1403-542)
S100 / OPMI pico (wall mount) (000000-1403-544)
S100 / OPMI pico (ceiling mount) (000000-1403-572)
S100 / OPMI pico (Centro suspension system) (000000-1403-573)
S100 / OPMI pico (support unit) (000000-1420-191)
– The devices comply with the requirements of the Medical Device Directive
93/42/EEC: Class I.
It is labeled with:
– These devices satisfy the US American and Canadian safety regulations for
medical electrical devices / systems.
It is labeled with:
– The devices comply 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 devices are classified as follows:
– Level of protection against electric shock: Class1
– Level of protection against entry of water: IPX0
– Electromagnetic compatibility (EMC): Fulfills IEC 60601-1-2, Class B
(as per CISPR 11)
– Operating mode: continuous operation
Device data
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