Zeiss S100/OPMI pico, Instructions For Use Manual

Page: 259 / 278

Version 7.0
G-30-1781-en
Page 259
S100 / OPMI pico System Data
Regulatory information
Devices: S100 / OPMI
®
pico (Floor stand) (000000-1403-542)
S100 / OPMI
®
pico (Floor stand) (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)
Electrical safety The medical device complies with the requirements
of
– IEC 60601-1:2005 + CORR. 1 (2006) +
CORR. 2 (2007),
– IEC 601-1:1988+A1:1991+A2:1995,
– CAN/CSA-C22.2 No. 601.1
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
.
RoHS compliance The product is RoHS compliant in accordance with
Directive 2011/65/EU.