1 (one) Operator’s manual
The product is mainly used to detect 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
gynecology and obstetrics and clinic daily.
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”.
The product is powered by an internal battery
