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System Data
KSK 150 FC
Version 7.1
Page 76
G-30-1158-en
Regulatory information
Approvals and requirements
Description
Labeling
Electrical safety
The medical device complies with the requirements
of
– IEC 60601-1:2005 + Cor. :2006 + Cor. :2007 +
A1:2012
– IEC 60601-1:2005 + A1:2012
– CAN/CSA-C22.2 No. 60601-1:2014
Protection class 1
EMC requirements
According to IEC 60601-1-2:2007, modified the
medical device is classed as Class B (according to
CISPR 11).
Product classification
The medical device is classed under Appendix IX of
the Medical Devices Directive 93/42/EEC as Class 1.
CE marking
The device meets the essential requirements stipu-
lated in Annex I to Directive 93/42/EEC governing
medical devices.
The system is marked
RoHS compliance
This product complies with the RoHS Directive
2011/65/EC.
Содержание KSK 150 FC
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Страница 37: ...Version 7 1 G 30 1158 en Page 37 KSK 150 FC Preparations for use ...
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Страница 63: ...Version 7 1 G 30 1158 en Page 63 KSK 150 FC Care and Maintenance 4 1 5 3 2 ...
Страница 66: ...Care and Maintenance KSK 150 FC Version 7 1 Page 66 G 30 1158 en ...
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Страница 90: ...Index KSK 150 FC Version 7 1 Page 90 G 30 1158 en ...
Страница 91: ...Version 7 1 G 30 1158 en Page 91 KSK 150 FC Blank page for your notes ...