Operator's Manual

A-1
Appendix A Technical Specifications
A.1 Safety Specifications
Standards
MDD 93/42/EEC
Medical Device Directive
IEC 60601-1:
2005+A1:2012
Medical electrical equipment - Part 1:
General requirements for basic safety
and essential performance
IEC 60601-2-25:
2011
Medical electrical equipment - Part
2-25: Particular requirements for the
safety of electrocardiographs
IEC 60601-1-2:
2014
Medical electrical equipment - Part
1-2: General requirements for basic
safety and essential performance -
Collateral Standard: Electromagnetic
disturbances - Requirements and tests
Classifications
Anti
electric-shock
type:
Device: Class II with internal power
supply
Device equipped with recorder base:
Class I with internal power supply
Anti
electric-shock
degree:
Defibrillation proof Type CF applied
part
Degree of
protection
against harmful
ingress of water:
7” device: IPX2
10.1” device: IPX0