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Traditional 510(k) of Fetal & Maternal Monitor
F15 Series Fetal & Maternal Monitor User Manual
FHR scaling
TOCO printout width
TOCO scaling
Printing speed
Standard Speed(Real-Time Traces)
Fast Print Speed(Stored Traces)
Accuracy of data
Accuracy of data
Resolution
Record Information
A1.5
Rechargeable Lithium-ion Battery
Monitor Battery:
Type
Continual Working Time
Necessary charge time from
"out
of
power"
to
charged"
Necessary charge time from
"out
of
power"
to
charged"
Nominal Capacity
Nominal Voltage
Cycle Life
Transducer Battery:
014_14.1_F15_Series_User_Manual
30bpm/cm (American Standard)
20bpm/cm (International Standard)
40mm
25%/cm
1 cm/min, 2 cm/min, 3 cm/min
Up to 15mm/sec
± 5% (X axis)
± 1% (Y axis)
8 dots/mm
FHR1/DFHR
trace/mark, TOCO/IUP trace, AFM trace/black mark, fetal
movement
AUTO-zero symbol, alarm indicator, SOV alarm indicator,
US signal weak alarm indicator, transducer wireless
signal weak indicator, date, time, printing speed, ID,
name, FHR2 Offset, FHR3 Offset, HR, SpO
MAP, PR, TEMP, CTG analysis results etc.
Rechargeable Lithium-ion Battery
≥ 2 hours (use new fully charged battery, in environmental
temperature 20~30℃, access fetal transducer, TOCO transducer,
MECG lead wire, blood pressure sleeve, finger blood oxygen
transducer and temperature transducer to simulate monitoring,
and open the real-time print and automatic blood pressure
measurement functions, with paper speed 1cm/min, and automatic
blood pressure measurement interval 15 min.)
≤7 hours (stand by or power off status)
"fully
≤5 hours (stand by or power off status)
"90%
5100 mAh(± 10%)
10.8V
≥300 times
- 139 -
Product Specificaiton
trace/mark,
FHR2
mark,
event
mark
trace/mark,
FHR3
(and
annotation),
, SYS, DIA,
2
155／202
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