F15 Series Fetal & Maternal Monitor User Manual Product Specificaiton
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Systolic pressure, Diastolic pressure, Mean
pressure Alarm
Software Over Voltage
Protection
(297 3) mmHg [(39.6 0.4) kPa]
Hardware Over Voltage
Protection
(320 10) mmHg [(42.81.3) kPa]
* Accuracy: ±3 bpm or 3.5%, whichever is greater
*Limits of the error of the
manometer
Over the temperature range of 10 °C to 40 °C and
the relative humidity range of 15 % to
85 %(non-condensing), the maximum error for
the measurement of the CUFF pressure at any
point of the NOMINAL measurement range shall
be less than or equal to ± 3 mmHg (± 0,4 kPa) or
2 % of the reading, whichever is greater.
At 25°C ~45°C, the measurement accuracy is
0.2°C.
Other measuring range, the measurement
accuracy is 0.3°C.
The accuracy of this part consists of two parts, as
follows:
(1) Accuracy (without sensor error): ±0.1℃
(2) Sensor error: ±0.1°C at 25°C~45°C; ±0.2°C at
other measurement ranges
Traditional 510(k) of Fetal & Maternal Monitor
014_14.1_F15_Series_User_Manual