HeraMED HeraBEAT, User Manual, Page: 6 / 36

6
Safety Instructions
HeraBEAT TM US device to minimize the possibility of false-
detection or measurement errors. However, fetal Doppler
technology available today is not always able to differentiate a
fetal heart rate (FHR) signal source from a maternal heart rate
(MHR) source or other signal interferences in all situations.
False detection of fetal heart rate may occur.
Fetal heart rate measurements may lead to false reassurance,
therefore do not rely solely on HeraBEAT TM US for any medical
diagnosis at any stage of the pregnancy.
FHR detection by the HeraBEAT
TM
US device may not always
indicate that the fetus is alive.
Assume there may be measurement errors, and do not rely
exclusively on measurement results.
Recorded FHR segments of only a few seconds may be less
reliable. The longer the recorded FHR segment, the more
reliable it is.
Recorded FHR with no or little change in the FHR values may be
less reliable or may indicate fetal distress.
If you suffer from an irregular heartbeat, measurements taken
with this device should be evaluated with your physician.
The sound recording is a synthesis of measured data and not
the actual sound of your fetal heartbeat. Do not rely on the
sound as an indication of the fetal heart rate existence.
HeraBEAT TM US does not measure fetal movements. No results
can be referred to as an indication of fetal movements.
Do not use the device while not in static situations (For
example, do not use in a car, plane etc.).
HeraBEAT TM US was not clinically validated on severely
overweight or obese users.
The HeraBEAT
TM
US device is for personal use. It must be
disinfected when transferred between users.
HeraBEAT TM US measures the Fetal Heart Rate. Only a
trained healthcare professional can supply interpretation of
measurement results.
Do not use the HeraBEAT TM US device on or near the eyes.
The device must be charged only with the supplied power
supply. (fig. 4)
Do not charge the device under direct sun light.
Always adhere to all warnings and cautions.
As with any electrical device, you must observe certain
precautions to ensure safety
Warnings
Warnings are directions which if not followed could cause fatal or
severe injury to a user, or other person, or could lead to clinical
misdiagnosis, and/or loss/damage of patient-related data.
Do not use the device if you are under 18 years of age.
This device may only be used for the purposes described in
this User Manual. HeraMED cannot be held liable for damage
or injury caused by incorrect use. Always follow the operating
procedures described in this User Manual. Use this device for
its intended purpose only, as described in this user manual.
Your pregnancy must be carefully followed by your treating
physician.
Use of HeraBEAT TM US is not intended to replace medical
advice.
Self-diagnosis and treatment is dangerous. In case of
any doubt or concern, we recommend seeking medical
assistance.
This device is not designed or intended for the complete
assessment of the fetal wellbeing or conditions. This device
should never be used as a basis for starting or modifying
treatment without independent confirmation by medical
professional examination.
HeraBEAT TM US is not intended to diagnose, cure, or prevent
any pregnancy related medical condition, and is not intended
to be used as a life saving or life preserving device.
If you have any doubt about the fetal health status after
using this device, please seek medical advice.
Measurements made by this device are potential
findings, not a professional diagnosis of fetal heart rate
conditions. Interpretations should only be made by a
medical professional.
Efforts were made in the design and manufacture of the