Biolight Meditech P1 - Appendix A Product Specifications; Safety Specifications

P1 Patient Monitor User’s Manual
1
Appendix A Product Specifications
A.1 Safety Specifications
According to the MDD 93/42/EEC, the monitor is Type IIb equipment. Classified
according to the IEC60601-1 is as follows:
Parts
Classifica
tion of
protectio
n against
electric
shock
Degree of
protectio
n against
electric
shock
Degree of
protectio
n against
ingress of
liquid
Degree of
protection
against
hazards of
explosion
Recommen
ded
disinfection
and
sterilization
methods
Mode of
operation
Mainframe I No mark
IP44 (P1)
IP21 (P1
with
Docking
station)
Not suitable
See Chapter
19
Maintenanc
e and
Cleaning of
this manual
for details.
Continuou
s
Fixed
parameter
(ECG,
TEMP,
RESP, NIBP,
SpO
2
)
NA
CF
IBP
CO
2
BF
Note:
I: Class I, internally and externally powered equipment.
When you doubt about the protecting earth integrality or protecting earth lead of the
equipment, you’d better change the equipment to internally powered equipment.
CF: Type CF applied part.
BF: Type BF applied part.
NA: Not applicable
Not suitable: Equipment is not suitable for use in the presence of flammable
anesthetic mixture with air or with oxygen or nitrous oxide.