Technical specification Instructions for Use305935-9900-000–1.3 –2020-08-25-for USA 61 / 65Ordering dataOnly 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/meditecThe product configurations, accessories and spare part that are applicable for authorized ZEISS partnersare stipulated by contract.For more information, please contact your authorized ZEISS partner.Regulatory informationElectrical safetyThe medical device meets the requirements according to IEC60601-1:2012 and ANSI/AAMI ES60601-1:2005+A2 (R2012)+A1.Classification according to level of protection against electricalshock: 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.ClassificationThe medical device is allocated to class I in line with Annex VIIIof the Medical Device Regulation (EU) 2017/745. and fulfil theMDR (EU) 2017/745: Class I. It is marked with CE.CE markingThe medical device meets the General safety and performancerequirements stipulated in Annex I of the Medical DeviceRegulation 2017/745.In line with Annex V of the Medical Device Regulation2017/745 the medical device is labeled withRadio frequency approvallabellingThe medical device contains radio modules and fulfills therequirements of 2014/53/EU.The medical device is labeled withRoHS compliance The product is RoHS compliant in accordance with Directive2011/65/EU.