F9, F9 Express Fetal & Maternal Monitor User Manual Safety Guidance
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Chapter 1 Safety Guidance
CAUTION
Federal (U.S.) Law restricts this device to sale by or on the order of a physician.
NOTE:
1 In order to ensure the operator and patient’s safety, read through this chapter before
using this monitor.
2 This user manual is written to cover the maximum configuration. Therefore, your
model may not have some of the parameters and functions described, depending on
what you have ordered.
3 The functions frequently used are marked with an asterisk *, for example 4.10
*Reviewing Alarms.
The monitor mainly consists of the main unit, FTS-3 fetal telemetry system (including the base
station, wireless US-T transducers, wireless TOCO-T transducer or TOCO-E transducer, DECG
cable and MECG cable), built-in recorder, recorder paper, US transducer, TOCO transducer, ECG
lead, NIBP cuff, SpO
2
sensor, TEMP sensor, event remote marker, fetal stimulator, IUP cable and
catheter and other accessories.
The monitor is intended to monitor FHR, DECG, fetal movement, TOCO, ECG, PR, IUP, NIBP,
SpO
2
, TEMP.
1.1 Intended Use/Indications for Use
F9 Fetal & Maternal Monitor (hereinafter called F9):
The F9 Fetal & Maternal Monitor is intended for non-invasive and invasive monitoring of fetus
during antepartum examination, labor and delivery. It is intended to be used only by trained and
qualified personnel in antepartum examination rooms, labor and delivery rooms.
F9 Fetal & Maternal Monitor provides Non-Stress testing for pregnant women. It can externally
monitor the FHRs using ultrasound and uterine activity via a TOCO transducer. Alternatively, it
can internally monitor one of the FHRs with DECG and uterine activity with an IUPC.
F9 Express Fetal & Maternal Monitor (hereinafter called F9 Express):
F9 Express Fetal & Maternal Monitor is intended for monitoring physiological parameters of
pregnant women during antepartum examination, labor and delivery. It is intended to be used
only by trained and qualified personnel in antepartum examination rooms, labor and delivery
rooms.
F9 Express Fetal & Maternal Monitor is intended for providing Non-Stress testing or fetal
monitoring for pregnant women. In addition, it provides a solution for maternal vital signs
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