Arthrex Synergy UHD4 Series User Manual

950-0073-00 B SM, English, Arthrex Synergy UHD4 System 61 of 74
6.0 Technical Information
NOTE: Technical data is subject to modification, revision and improvement without notice.
Safety, EMC and Regulatory Requirements
Parameter
Parameter Value
System Classification
FDA Class
Class II
EU Class
Class I
Health Canada Class
Class II
Safety Certifications
Domestic Certification
 UL 60601-1:2003
 ANSI/AAMI ES60601-1/A1:2012
Canadian Certification
 CAN/CSA-C22.2 No. 601.1-M90
 CAN/CSA-C22.2 No. 60601-1:2014
EU Certification
 ANSI/AAMI ES60601-1/A1:2012
 IEC 60601-1:2005 + Corrigendum 1:2006
+ Corrigendum 2:2007 + AM1:2012 [IEC
60601-1:2012]
EMC Certifications
CISPR 11 EMC Class
Class A
CISPR 11 EMC Group
Group 1 [RF internally generated for the
operation of the device]
EMC Certification
Certification to EN 60601-1-2 Class A
Safety Certification Marking
CE Marking
CE Marking for MDD 93/42/EEC, RoHS 2011/65/EU, and R&TTE
1999/5/EC

Arthrex Synergy UHD4 Series Specifications

General

Brand	Arthrex
Model	Synergy UHD4 Series
Category	Camera Accessories
Language	English