EDAN F15 Series User Manual page 153

Traditional 510(k) of Fetal & Maternal Monitor
F15 Series Fetal & Maternal Monitor User Manual
*Alarm
Software Over Voltage
Protection
Hardware Over Voltage
Protection
Unit
Measurement Methods
PR Measurement
*
Limits of the error of the
manometer
Channel
*Measurement Range
Resolution
*Accuracy
TEMP
Unit
Refresh Time
Alarm Limits
*Alarm
Position
Transient Response Time
Measuring Mode
eFHR
FECG
014_14.1_F15_Series_User_Manual
(2.7kPa~31.3 kPa)
Systolic pressure, Diastolic pressure, Mean
pressure Alarm
(297  3) mmHg [(39.6  0.4) kPa]
(320  10) mmHg [(42.81.3) kPa]
mmHg, kPa
Auto, Manual
*
Range:40bpm ~ 240bpm
* Accuracy: ± 3 bpm or 3.5%, whichever is greater
Resolution: 1bpm
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.
1
0° C ~ +50° C
0.1° C
At 25° C ~45° C, the measurement accuracy is
0.2° C.
Other measuring
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
° C, ℉
1 ~ 2s
0.0℃ ~ +50.0℃
TEMP Alarm
Axilla
≤30 s
Direct Mode
- 137 -
Product Specificaiton
range, the measurement
153／202