Technical Specifications
Synergy
RF™
System Service Guide
DFU-0276-4r0_fmt_en-US Page 18 of 50
3.5 Safety, EMC, and Regulatory Requirements
Table 13 Safety, EMC, and Regulatory Requirements
Parameter Parameter Value
System
Classification
IEC 60601-1
(protection against electric shock)
FDA Class Class II
EU Class Class IIb
Health Canada Class Class 3
Safety
Certifications
Domestic Certification ES60601-1:2005/A1:2012
Canadian Certification CAN/CSA C22.2 No. 60601-1-08
EU Certification EN 60601-1:2006/A1:2013
EMC
Certifications
CISPR 11 EMC Class Class A
CISPR 11 EMC Group Group 1
EMC Certification Certification to EN 60601-1-2
Safety
Certification
Marking
CE
Classification
93/42/EEC
Annex IX Rule 9 Class IIb
For all other accessories refer to accompanying DFUs for more information.
Refer to Section 10 Electromagnetic Emissions for further details on EMC
Certification
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