EDAN F6 User manual - Chapter 1 Safety Guide
F Series 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.
3 The functions frequently used are marked with an asterisk
*
, for example 4.9
*
Reviewing Alarms.
1.1
Indications for Use/ Intended Use
F6/F9 Fetal & Maternal Monitor (hereinafter called F6/F9):
F6/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.
F6/F9 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/F9 Express Fetal & Maternal Monitor (hereinafter called F6 Express/F9
Express):
F6 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.
F6 Express/F9 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.