Huntleigh SONICAID FREEDOM SF1-EUR, Инструкция по эксплуатации

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4
Intr
oduction
1. Introduction
1.1 Indications of Use
The Sonicaid™ Freedom (‘Freedom’) is a wireless fetal monitoring system
for the monitoring of fetal heart movement and maternal contractions
during intrapartum and antepartum periods of pregnancy.
It is an optional accessory for use with Huntleigh Healthcare Limited’s
approved Fetal Monitors such as Sonicaid FM820, FM830 Encore Fetal
Monitors (‘FM800E Monitors’) and Team Monitors
(Excluding TeamIP)
as
an alternative to their wired transducers. When connected to a suitably
approved Monitor, the system monitors:
•
Uterine activity by using an external, pressure-sensitive TOCO
transducer, and
• Fetal heart rate (FHR) by pulsed Doppler ultrasound using an external
Ultrasound transducer.
Freedom is suitable for use in clinical and hospital facilities for use on
pregnant woman. The transducers are water tight allowing pregnant
women to be monitored while they are mobile, stationary or in a bath or
shower environment.
This system should only be used by, or under the supervision of, a
licensed physician or other health practitioner who is trained in the use of
FHR monitors.
1.2 Contraindications
Sonicaid™ Freedom is not intended for use with patients fi tted
with cardiac pacemakers, during defi brillation, while undergoing
surgery, or while MRI scanning is taking place.
Sonicaid™ Freedom must not be used in intensive care units or
operating rooms.