Zeiss 000000-1080-349, Instructions For Use Manual

Page: 260 / 278

System Data S100 / OPMI pico
Version 7.0
Page 260 G-30-1781-en
Devices S100 / OPMI
®
pico (Carrier unit for external lighting) (000000-1095-094)
S100 / OPMI
®
pico (Atmos support unit) (000000-1080-349)
Electrical safety The medical device complies with the requirements
according to
– IEC 60601-1:2005 + CORR. 1 (2006) +
CORR. 2 (2007),
– IEC 601-1:1988+A1:1991+A2:1995
Classification according to the level of protection
against electrical shock: Protection class I
Protection type (according to IEC 60529): IP X0
Electromagnetic com-
patibility According to IEC 60601-1-2:2007 the medical de-
vice is classed as Class B (according to CISPR 11).
Classification The medical device is classed under Appendix IX of
the Medical Devices Directive 93/42/EEC as Class 1.
CE marking The medical device complies with the essential re-
quirements stipulated in Appendix I of the Medical
Device Directive 93/42/EEC.
In line with appendix XII of the Medical Device Di-
rective 93/42/EEC the medical device is labeled
with
.