EDAN INSTRUMENTS SE-2003 Series

SE-2003&SE-2012 Series Holter System Recorder User Manual
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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 60601-1-2:2014
EN 60601-1-2:2015
IEC/EN 60601-2-47
IEC 60601-1-11
Anti-electric-shock type:
Internal power supply
Anti-electric-shock degree:
Type CF
Degree of protection against
solid foreign objects and
harmful ingress of water:
SE-2003 & SE-2012: IP27
SE-2003A & SE-2012A: IP22
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
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)