Product Manual

F6 and F6 Express Fetal & Maternal Monitor User Manual Safety Guide
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Chapter 1 Safety Guide
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.
1.1 Intended Use
F6 Fetal & Maternal Monitor (hereinafter called F6):
The F6 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.
F6 Fetal & Maternal Monitor provides Non-Stress testing for pregnant women from the 28
th
week
of gestation. 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.
F6 Express Fetal & Maternal Monitor (hereinafter called F6 Express):
F6 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.
F6 Express Fetal & Maternal Monitor is intended for providing Non-Stress testing or fetal
monitoring for pregnant women from the 28
th
week of gestation. In addition, it provides a
solution for maternal vital signs monitoring.
Contraindications:
They are not intended for use in intensive care units, operating rooms or for home use.