Comen N10 - Appendix II Product Specifications

II-1
Appendix II Product Specifications
1) Monitor Type
Classified by
Type
Protection against electric
shock
Class I; defibrillation-proof devices with internal power supply;
Degree of protection against
electrical shock
Defibrillation-proof type CF: ECG/RESP, TEMP, SpO
2
, NIBP, IBP, C.O.;
Defibrillation-proof type BF: CO
2
.
Operation mode
Continuous operation equipment.
Protection against ingress of
liquid
Main Unit：IPX1
SpO
2
：IPX2
The degree of application in
the presence of a flammable
anesthetic mixture with air
or with oxygen or nitrous
oxide or within an oxygen-
rich environment
Equipment is not suitable for use in the presence of a flammable anesthetic
mixture with air or oxygen or nitrous oxide or within an oxygen-rich environment.
2) Environmental Specifications
Item
Specification
Operating condition
Ambient temperature
5°C -40°C
Relative humidity
5% -95%, non-condensing
Barometric pressure
700hPa-1060hPa
Transportation
Protect the device against violent impact, vibration, rain and snow during
transportation.
Storage
The packaged monitor shall be kept in a well-ventilated environment free of
corrosive gas with certain ambient temperature (-20°C -55°C), barometric
pressure (700hPa~1060hPa), and relative humidity (5%-93%), non-condensing.,
Shock & Vibration
(robustness)
Conform to standards of IEC 80601-2-30:2018, ISO 80601-2-55:2018, ISO80601-2-
61:2017
3) Power Supply
Item
Specification
AC input voltage
100-240V~