Huntleigh Sonicaid FM800 Series, Инструкция по эксплуатации, Страница: 98 / 130

Sonicaid FM800 Encore Series Instructions for Use
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Sonicaid CARE Antepartum
Analysis
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Intended use
The intended use of Sonicaid CARE analysis is to analyse antepartum CTGs in
pregnancies from 26 weeks gestation onwards. It can be used on women who are
experiencing Braxton-Hicks contractions, but it is not intended for use in established
labour as the fetus is then exposed to additional factors such as labour contractions,
pharmacological agents, and epidural anaesthesia.
The analysis provided by the Sonicaid CARE is intended to
assist, not to replace, the physician's visual assessment of
a trace.
As such, Sonicaid CARE is not a diagnosis, but an aid to clinical management. Diagnosis
remains the responsibility of an appropriately qualified physician. Indeed, both the
physician's visual assessment of the trace and the analysis provided by Sonicaid CARE
should be considered within the context of a full clinical assessment before decisions are
made regarding management. Such a clinical assessment may include further tests such
as umbilical blood flow velocity waveforms or biophysical profiling.
Note : Sonicaid CARE analysis is not approved for sale in the USA and Canada.
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Overview
Sonicaid CARE antepartum analysis is a software option available with all FM800E series
monitors. The software tests fetal heart rate parameters against the criteria which define a
normal record. Abnormalities are highlighted.
IMPORTANT
The analysis describes fetal heart rate, toco and fetal movements. Interpretation and
diagnosis of the CTG record remain the responsibility of the appropriately qualified medical
staff.
The Sonicaid CARE analysis is valid for admission testing,
but is not valid during labour.