EDAN SE-2003 - Technical Specifications; Safety Compliance and Standards; Environmental Operating Conditions

SE-2003&SE-2012 Holter System Recorder User Manual
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Appendix 1 Technical Specifications
A1.1 Safety Specifications
Comply with:
IEC 60601-1:1988+A1:1991+A2:1995
EN 60601-1:1990+A1:1993+A2:1995
IEC60601-1-2:2001+A1:2004
EN 60601-1-2:2001+A1:2006
IEC/EN 60601-2-47
Anti-electric-shock type: Internal power supply
Anti-electric-shock degree: Type CF
Degree of protection against
harmful ingress of water:
Ordinary equipment (Sealed equipment without liquid
proof)
Disinfection/sterilization
method:
Refer to the user manual for details
Degree of safety of
application in the presence of
flammable gas:
Equipment not suitable for use in the presence of
flammable gas
Working mode: Continuous operation
EMC: Group 1, Class B
Patient
Leakage
Current:
NC <10μA (AC) / <10μA (DC)
SFC <50μA (AC) / <50μA (DC)
Patient
Auxiliary
Current:
NC <10μA (AC) / <10μA (DC)
SFC <50μA (AC) / <50μA (DC)
A1.2 Environment Specifications
Transport & Storage Working
Temperature:
-20 ℃ (-4 ºF) ~ +55 ℃
(+131 ºF)
+5 ºC (+41 ºF) ~ +40 ºC
(+104 ºF)
Relative Humidity:
25%~93%
Non-Condensing
25%~80%
Non-Condensing