EDAN iSe Series - Technical Specifications; Safety Specifications; Environment Specifications

iSE Series Electrocardiograph User Manual Technical Specifications
Appendix 1 Technical Specifications
A1.1 Safety Specifications
IEC 60601-1:2005/A1:2012
EN 60601-1:2006/A1:2013
Comply with: IEC 60601-1-2:2014
EN 60601-1-2:2015
IEC/EN 60601-2-25
Anti-electric-shock type: Class I equipment, internally powered equipment
Anti-electric-shock degree: Type CF with defibrillation-proof
Degree of protection against Ordinary equipment (Sealed equipment without
harmful ingress of water: 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: CISPR 11, Group 1, Class B
NC <10μA (AC) / <10μA (DC)
Patient Leakage
Current:
SFC <50μA (AC) / <50μA (DC)
NC <10μA (AC) / <10μA (DC)
Patient Auxiliary
Current:
SFC <50μA (AC) / <50μA (DC)
A1.2 Environment Specifications
Transport & Storage Working
Temperature:
-20ºC (-4ºF)~+55ºC
(+131ºF)
+5ºC (+41ºF) ~ +40ºC
(+104ºF)
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