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SECTION 1: INTRODUCTION
1.1 OVERVIEW
Become familiar with the controls and how to use the product properly
before operating the product.
CAUTION:
It should not be used in life supporting or life
sustaining applications
CAUTION:
It cannot replace the professional fetal monitor,
when the fetal heart rate is abnormal, or can not find the fetal
heart, can not feel the fetal movement, pregnant woman's
should immediately go to the hospital to seek the doctor's help.
Intended Use
The Fetal Doppler JPD-100S4 is a hand-held, battery powered
audio Doppler device used for detecting fetal heart heats.
1.2 PRODUCT DESCRIPTION
The product is a lightweight, portable, detector. It is designed to meet
your detecting and hearing needs by providing advanced detecting
functions and a full range of sound of the fetal heartbeat.
The product is mainly used to detect the fetal heartbeat rate (FHR) and
the sound of the fetal heartbeat (SFH).
The growth and development of a fetus can be found out through
examination of these indices. It is applicable for department of
gynaecology and obstetrics and clinic daily
It is a hand-held, battery powered audio Doppler device integrated with
3MHz probe, used for detecting fetal heart beats. And the device is
normally applied to pregnancy for more than twelve weeks.
In accordance with classification criteria in Annex IX on “Medical Device
Directive 93/42/EEC”, the product is class IIa based on rule 10, “Devices
for Direct Diagnosis or Detection on physiological process”.
