Eu Authorized Representative; Safety Design In Wireless Link; Declaration Of Conformity (For Red) - GE Optima XR646 Operator's Manual

The wireless parts come with the following software versions:
Table 2-2
Item
1 UWB Host Dongle
2 URP Wireless Detector

EU Authorized Representative:

GE Medical Systems SCS
283 rue de la Minière
78530 BUC, FRANCE

Safety Design in Wireless Link

System will inhibit the x-ray exposure during exam if the wireless image link is poor or broken
due to low signal quality or unintended radio frequency (RF) interference. System will recover
the wireless link and lift the inhibit when the signal quality exceeds the threshold or the inter-
ference stops. Wired connection (tether mode) is provided as a backup option when the RF
environment cannot support a reliable wireless link.

Declaration of Conformity (for RED)

The wireless parts listed above are CE marked according to the provisions of the RED Directive
(2014/53/EU). GE Medical Systems LLC., here by declares that these parts are in compliance with
the essential requirements and other relevant provisions of Directive 2014/53/EU.
The Declarations of Conformity made under Directive 2014/53/EU are available on the website.
Please refer to the section How to access the electronic version of a manual on website under
chapter 1.
5495975-1EN Rev.9
© 2013-2017 General Electric Company. All rights reserved.
Name
Chapter 2: Safety and Regulatory
Software / Firmware Version
5398846-4 Rev. 2
5420645 Rev. 1
2-8