Arthrex NanoScope User Manual

Technical Specifications
NanoScope Manual
DFU-0298-1, Revision 0 Page 18 of 38
3.5 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 II
EU Class
Class I Console/ Class IIa Handpiece
Health Canada Class Class 2
Safety Certifications
Domestic Certification IEC60601-1:2005/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 IEC 60601-1-2:2014
Safety Certification
Marking
Per IEC 60601-1 3
rd
Ed.
UL
cUL
FCC
Safety
Classifications
According to protection
against electric shock
Class 1 (grounded)
According to degree of
protection against
electrical shock
Applied part is Type BF Isolated
According to degree of
protection against
harmful ingress of water
NanoScope Console is IP20
NanoScope Handpiece is IPX4
(protected against water splash)
According to the degree of
safety in the presence
Flammable Anesthetics
Equipment is NOT suitable for use in
the presence of flammable
anesthetics

Arthrex NanoScope Specifications

General

Brand	Arthrex
Model	NanoScope
Category	Medical Equipment
Language	English