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10. TECHNICAL SPECIFICATIONS
9. REFERENCE TO STANDARDS
Device Standard:
Device corresponds to the requirements of the European
standard for
Standard
IEC60601-1-6:2010+A1:2013/ EN60601-1-6:2010+A1:2015
IEC60601-1:2005+A1:2012/EN60601-1:2006+A11:2011+A1:2013+A12:2014
IEC60601-1-2:2014/ EN60601-1-2:2015
IEC/EN60601-1-11:2015
IEC80601-2-30:2009+A1:2013/EN80601-2-30:2010+A1:2015
The stipulations of the EU-Guidelines 93/42/EEC for Medical Products Class IIa
have been fulfilled.
Measurement Procedure
Oscillometric , corresponding to
Korotkoff method: Phase I :
systolic , Phase V : diastolic
Display
Digital display
Measuring range
Pressure: 30 to 280 mmHg (in 1 mmHg
increment)
Pulse: 40 to 199 beat/minute
Measuring resolution
1mmHg
Inflation
Automatic inflation by internal pump
Memory function
2 x 120 memories for 2 users (SYS, DIA, Pulse)
Decompression
Constant exhaust valve system
Power Source
4- size “AA” alkaline Batteries
Operation Temperature
5~40°C/41~104°F
Operation Humidity
15%~85%RH maximum
Storage Temperature
-20~+55°C/~4~+131°F
Storage Humidity
10%~95%RH maximum
Dimensions
113×90×56±1.0 mm
Static accuracy
Pressure: ±3mmHg / Pulse: ±5% of reading
