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Arthrex AR-400UBC User Manual

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Universal DrillSaw Battery Charger User’s Guide
DFU-0256-1 Rev. 0 Page 14 of 35
3.2 Safety, EMC, and Regulatory Requirements
Table 9 Safety, EMC, and Regulatory Requirements
Parameter Parameter Value
System Classification
IEC 60601-1 Class I
(protection against electric
shock)
FDA class Class I medical device (non-
sterile)
EU class Class IIa
Health Canada Class Class II
Safety Certifications
Domestic Certificaton ANSI/AAMI ES60601-1
(2005+C2+A2)
Canadian Certification CSA C22.2 No 60601.1 (2008)
EU Certification EN/IEC 60601-1: 2005 +
A1:2012
EMC Certifications EMC Certification IEC 60601-1-2: 2007
Safety Certification Marking
UL
CE Classification
MDD93/42/EEC
Annex IX Rule 9 Class IIa
For all other accessories refer to accompanying DFUs for more information.Refer to Section
13.0 Electromagnetic Emissions for further details on EMC certification.

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Arthrex AR-400UBC Specifications

General IconGeneral
BrandArthrex
ModelAR-400UBC
CategoryBattery Charger
LanguageEnglish

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