文件编号:
NR-TP-0715-008
版本:
1.0
- 79 -
Appendix A Specifications
A.1
Safety Specifications
A.1.1
Product Category
In accordance with classification specified in the European Medical Device Directive
93/42/EEC, this monitor is IIb type equipment. The monitor is classified as follows in
accordance with IEC 60601-1:
Category Name
Specification
93/42/EEC ohm
Medical Devices
Directive Category
IIb
Type of electric
shock protection
Grade I, internal and external power supply equipment
When you question the integrity of the external protective earthing or
protective ground conductor parameter of the equipment, the device must
be powered by the internal power supply (battery).
Electric shock
protection grade
ECG/NIBP/SpO2/PR/TEMP/RESP: CF (defibrillation protection)
Explosion
protection grade
Common equipment, no explosion protection
Liquid inlet
protection grade
IPX1 (prevent water from entering when the water drips vertically)
Operating mode
Continuous
Movement
Portable
A.1.2
Power Specifications
Parameter
Specification
External AC power
Input voltage
100-240V~
Input current
1.5A
Frequency
50/60Hz
Internal power supply: Lithium-ion battery