EDAN SE-1515 - Appendix 1 Technical Specifications; A1.1 Safety Specifications; A1.2 Environment Specifications

SE-1515 PC ECG User Manual Technical Specifications
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Appendix 1 Technical Specifications
A1.1 Safety Specifications
Comply with:
IEC 60601-1:2005/A1:2012
EN 60601-1:2006/A1:2013
IEC 60601-1-2:2007
EN 60601-1-2:2007/AC:2010
IEC 60601-2-25:2011
Anti-electric-shock type:
Class ІI
Anti-electric-shock
degree:
Type CF with defibrillation-proof
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 (Please see Chapter 10,
"Cleaning, Care and Maintenance")
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 A
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:
DP12/DE15/DE18 ECG
sampling box:
-40ºC (-8ºF) ~ +55ºC (+131ºF)
+5ºC (+41ºF) ~ +40ºC (+104ºF)