Arthrex SynergyHD3 User Manual

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4.0 Technical Information
NOTE: Technical data is subject to modification, revision and improvement without notice.
Table 3: 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 ES60601-1:2005
Canadian Certification
 CAN/CSA-C22.2 No. 601.1-M90
 CAN/CSA C22.2 No. 60601-2-18-01
 CAN/CSA-C22.2 No. 60601-1:2008
 CAN/CSA-C22.2 No. 60601-2-18:2011
EU Certification
 CAN/CSA-C22.2 No. 601.1-M90 [IEC
60601-1 2
nd
Edition with Canadian
Deviations]
 CAN/CSA C22.2 No. 60601-2-18-01 [IEC
60601-2-18 2
nd
Edition with Canadian
Deviations]
 CAN/CSA-C22.2 No. 60601-1:2008 [IEC
60601-1 3rd Edition with Canadian
Deviations]
 CAN/CSA-C22.2 No. 60601-2-18:2011
[IEC 60601-2-18 3rd Edition with
Canadian Deviations]
EMC Certifications
CISPR 11 EMC Class
Class A
CISPR 11 EMC Group
Group 1 [un-intentional radiator]
EMC Certification
Certification to IEC 60601-1-2:2014 Class A
Safety Certification
Marking
CE Marking
CE Marking for MDD 93/42/EEC

Arthrex SynergyHD3 Specifications

General

Brand	Arthrex
Model	SynergyHD3
Category	Digital Camera
Language	English