User's Manual

SE-1200 Pro&SE-1201 Pro Electrocardiograph 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 60601-1-2:2014
EN 60601-1-2:2015
IEC/EN 60601-2-25
Anti-electric-shock type
Class І with internal power supply
Anti-electric-shock degree
CF type 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
Degree of safety of application in
the presence of flammable gas
Equipment not suitable for use in the presence of
combustible 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)
Essential Performance
The main performance features are defined as:
⚫ Defibrillation protection as specified in IEC60601-2-25;
⚫ Amplitude and interval measurements as specified in IEC60601-2-25;
⚫ Filters (including line frequency interference filters) as specified in IEC60601-2-25