12. Reference to standards
Device standard:
Device corresponds to the requirements of
the European standard for non-invasive
blood- pressure monitor
EN1060-1
EN1060-3
EN1060-4 – clinical investigation
IEC/EN
60601-1-11
ANSI / AAMI SP10, NIBP,
IEC80601-2-30:2009 + corrigendum 2010
Electrical compatibility:
Device fulfils the stipulations of the
IEC/EN
60601-1,
EN
60601-1-2
The stipulations of the EU-Guidelines 93/42/EEC for Medical Products Class IIa have been fulfilled.
13. Technical specifications
Measurement Procedure:
Oscillometric , corresponding to Korotkoff method:
Phase I : systolic , Phase V : diastolic
Display:
Digital display
Measuring range: SYS/DIA: 30 to 280 mmHg (in 1 mmHg increment)
Pulse: 40 to 200 beat/minute
Static accuracy: SYS/DIA:
±3mmHg
Pulse: ±5% of reading
Measuring resolution:
1mmHg
Inflation:
Automatic inflation by internal pump
Memory function:
120 memory × 2 users(SYS, DIA, Pulse)
Decompression:
Constant exhaust valve system
Power source:
2- size “AAA” alkaline Batteries
Rated voltage:
DC 3V 1.5W (direct current)
Operation temperature:
5~40
℃
/41~104
℉
Operation humidity: 15%~85%RH maximum
Storage temperature:
-10~55
℃
/14~131
℉
Cuff size:
12.5- 21.5cm
Storage humidity:
10%~95%RH maximum
Dimensions:
74 x 64 x32 ±1.0 mm
Device weight:
135g±5g (including batteries and cuff)
Batteries weight
:
23g±1.0g
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Summary of Contents for PM-B51 PLUS
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