Zeiss EXTARO 300, Инструкция по эксплуатации

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Technical specification Instructions for Use
Ordering data
Only operate the system with the accessories included in the delivery package and proved by ZEISS.
You will find the contact responsible for orders in your country on this website:
www.zeiss.com/meditec
The product configurations, accessories and spare part that are applicable for authorized ZEISS partners
are stipulated by contract.
For more information, please contact your authorized ZEISS partner.
Regulatory information
Electrical safety
The medical device meets the requirements according to IEC
60601-1:2012 and ANSI/AAMI ES60601-1:2005+A2 (R2012)
+A1.
Classification according to level of protection against electrical
shock: Protection class I.
Electromagnetic compatibility
The medical device is allocated to class A (acc. To IEC 61000-3-
2) in line with IEC 60601-1-2:2014.
Classification
The medical device is allocated to class I in line with appendix
IX of the Medical Device Directive 93/42/ EEC.
CE marking
The medical device meets the essential requirements stipulated
in Appendix I of the Medical Device Directive 93/42/EEC.
In line with Appendix XII of the Medical Device Directive
93/42/EEC the medical device is labeled with
RoHS compliance
The product is RoHS compliant in accordance with Directive
2011/65/EU.
55 / 59 305935-3500-000 – 2.1 – 2017-12-15