HeraMED HeraBEAT User manual
Your Personal Ultrasound Fetal Doppler
By HeraMED
Your Personal Ultrasound Fetal Doppler
HeraBEAT
™US
User Manual
3
Table of Contents
1. About HeraBEATTM US Ultrasound Fetal Doppler 4
2. Who should USE (Indications) or NOT USE (Contraindications) HeraBEATTM US 4
3. HeraBEATTM US kit includes 5
4. Safety Instructions 6
5. Ultrasound Transmission Gel 9
6. HeraBEATTM US Conguration & LED Indicators 9
7. Charging HeraBEATTM US 11
8. First Time Use 12
9. Measurement of the Fetal Heart Rate 13
10. Care and Maintenance 18
11. Troubleshooting 20
12. Smartphone General Security and Privacy 22
13. HeraBEATTM US Specication 23
14. HeraBEATTM US Device Label 24
15. Warranty and Service 25
16. Wireless RF Communication 28
17. Appendices 29
Read the entire user manual thoroughly prior to use.
4
About HeraBEAT™US Ultrasound Fetal Doppler Who should USE (Indications) or NOT USE
(Contraindications) HeraBEAT™ US
Congratulations on purchasing HeraBEATTM US, your
personal Ultrasound Fetal Doppler. For the rst time ever,
a safe, eective and easy-to-use Fetal Doppler that delivers
professional results within the comfort of your home.
The HeraBEATTM US software algorithm combines
ultrasound Doppler used to measure the Fetal Heart
Rate (FHR), an optical sensor to distinguish between the
Maternal Heart Rate (MHR) and Fetal Heart Rate (FHR), and
a motion sensor used for motion detection and control.
All these enable and ensure measurement accuracy.
HeraBEATTM US will assist and guide you to locate the
optimal position for acquiring Fetal Heart Rate (FHR),
measure the Fetal Heart Rate (FHR) and store the result in
a simple and easy-to-access history le.
Indications for Use
HeraBEATTM US is intended to detect fetal heart
beats, display fetal heart rate, and play the fetal heart
sound. HeraBEATTM US is indicated for use by medical
professionals in clinical or home care settings for singleton
pregnancies from 12 weeks gestation.
During the COVID-19 it is also indicated for self-
administration.
Contra-Indications
The HeraBEATTM US device is NOT indicated for:
Fetal Heart Rate measurements in multiple pregnancy;
If you have a pacemaker or any other implanted
electronic device.
5
1. HeraBEATTM US device
2. HeraBEATTM US application (Free to download from the AppStore / Google Play.)
3. 2 Ultrasound Transmission Gel
4. Power Supply
5. Carry Case
6. User Manual
(g. 1)
HeraBEATTM US device
(g. 2)
HeraBEATTM application
(g. 3)
2 Ultrasound
Transmission Gel
Check that the box includes all items. Do not use the device if it is damaged or an item is missing.
(g. 4)
Power Supply
(g. 5)
Carry Case
(g. 6)
User Manual
HeraBEAT™ kit includes
6
Safety Instructions
HeraBEATTM US device to minimize the possibility of false-
detection or measurement errors. However, fetal Doppler
technology available today is not always able to dierentiate 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 HeraBEATTM US for any medical
diagnosis at any stage of the pregnancy.
FHR detection by the HeraBEATTM 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 suer 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.
HeraBEATTM 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.).
HeraBEATTM US was not clinically validated on severely
overweight or obese users.
The HeraBEATTM US device is for personal use. It must be
disinfected when transferred between users.
HeraBEATTM US measures the Fetal Heart Rate. Only a
trained healthcare professional can supply interpretation of
measurement results.
Do not use the HeraBEATTM US device on or near the eyes.
The device must be charged only with the supplied power
supply. (g. 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 direc tions 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 HeraBEATTM 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 conrmation by medical
professional examination.
HeraBEATTM 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
ndings, not a professional diagnosis of fetal heart rate
conditions. Interpretations should only be made by a
medical professional.
Eorts were made in the design and manufacture of the
7
Safety Instructions
3). The gel should be used only on intact, unbroken skin. Refer
to gel’s supplied leaet for its related warnings.
Prior to use, verify that the Ultrasound Transmission Gel (g. 3)
has not exceeded its expiration date (located on the tube). The
gel is valid for 5 years from the month of manufacture.
For any Doppler examination, it is essential that an adequate
supply of Ultrasound Transmission Gel is used to transmit the
ultrasound energy from HeraBEATTM US to the surface of the
skin. Re-apply more gel if it starts to dry out or spread so thinly
that an air gap occurs between the skin and the bottom of the
device. Applying too much gel may impede the Maternal Heart
Rate measurement.
Incorrect placement of the device on the abdomen can lead to
inaccurate measurement results.
Follow the on-screen and voice instructions to locate the
optimal position for the Fetal Heart Rate (FHR) measurement.
Do not expose HeraBEATTM US to temperatures outside
the storage or operating range (Refer to HeraBEATTM US
Specications chapter)
Do not expose HeraBEATTM US to direct sunlight for extended
periods of time.
Long term storage outside of acceptable conditions may
permanently reduce the battery capacity or lead to failure of
the device and inaccurate measurement results.
Wash hands before the measurement procedure to avoid
contamination.
HeraBEATTM US is MR unsafe and should not enter the MRI
scanner room.
Do not use the device if the smartphone being used to collect
the data is damaged such that the app does not function
properly.
Portable RF communications equipment (including peripherals
such as antenna cables and external antennas) should be used
no closer than 30 cm (12 inches) to any part of the HeraBEATTM
US. Otherwise, degradation of the performance of this
equipment could result.
Use of this equipment adjacent to or stacked with other
equipment should be avoided because it could result in
Use the device and its accessories only on intact skin.
Do not leave the HeraBEATTM US device unattended. Store the
device and its accessories in secured place to prevent access
and use of the device by unintended individuals who cannot
express their consent to use and especially by children.
Do not allow water or any liquids to enter the HeraBEATTM US
device or its charging connector. Do not use/store the device
near any sources of water or liquids. Do not use the device if
any liquids entered it or its charging connector.
This device is not re-resistant and cannot be used after
exposure to re or high temperatures.
Although there are no conrmed biological eects on patients
caused by exposure to ultrasound, the possibility exists that
such biological eects may be identied in the future. Use
ultrasound only to the extent needed to provide medical
benet.
Do not drop the device. Do not use if cracked or broken, or in
case of any visible malfunction. Do not touch the inner parts of
the device.
Do not disassemble, modify, remanufacture, puncture
or damage the device. The device has no consumable or
replaceable parts or pieces which can be replaced by the user
(including batteries).
Check that the device is intact before use. Discontinue use of
the device if there are any signs of damage or loss of cover
integrity.
Should the device require service, it must be serviced only by
authorized and trained personnel by HeraMED Ltd. to maintain
safety, and reliability.
Do not use the device close to explosive or highly ammable
materials like alcohol, methanol, acetone, etc. Do not clean the
device with alcoholic materials.
Use device only with the supplied gel (g. 3). Using ultrasound
transmission gel that is not approved by HeraMED may reduce
signal qualit y and can lead to absence of Fetal Heart Rate (FHR)
measurement or inaccurate measurement results.
The Ultrasound Transmission Gel is for external use only (g.
8
Safety Instructions
Reorient or relocate the receiving antenna.
Increase the separation between the equipment and
receiver.
Connect the equipment into an outlet on a circuit dierent
from that to which the receiver is connected.
Consult the dealer or an experienced radio/TV technician
for help.
Do not move the smartphone away from the room where
the HeraBEATTM US Device is in use. This assures proper
pairing of the HeraBEATTM US and smartphone and minimizes
potential disruptions in wireless data transfer.
Notes
Notes are intended to draw your attention and aid with the use
of this medical device.
For successful measurement please verify that the gel is
applied and the device is gently pressed against the skin and
held steady without any movement.
If the displayed Fetal Heart Rate (FHR) value becomes briey
irregular, and then returns to a regular rhythm, do not
reposition the HeraBEATTM US device. The irregularity might
be caused by fetal or maternal movement.
There are several physiological conditions that may impair the
ability to locate the Fetal Heart Rate:
Detection of Fetal Heart Rate in the early weeks of
pregnancy can be challenging since the size of the fetus’
heart may be very small and might be missed.
Excessive or prolonged fetal, maternal or device
movements can degrade the ability to locate and measure
the Fetal Heart Rate (FHR). If you are experiencing frequent
fetal movements during the measurement, stop the
measurement and try again once fetal movements have
subsided.
Placenta position: In cases of frontal placenta, it may take
longer to detect the pulse and will require your patience
during the search.
improper operation. If such use is necessary, this equipment
and the other equipment should be observed to verify that
they are operating normally.
Use of accessories, transducers and cables other than those
specied or provided by the manufacturer of this equipment
could result in increased electromagnetic emissions or
decreased electromagnetic immunity of this equipment and
result in improper operation.
Cautions
Cautions are directions which if not followed could cause
damage to the equipment on which the software of the medical
device is installed and/or other equipment or goods, and/or
cause environmental pollution.
Dispose the device only according to electrical device’s
federal, state, local, and household regulations, as applicable.
If the wireless connection is unstable, try to change your
position, make sure any other wireless devices in the vicinity
are turned o or are kept at least 1.5 feet away from the
HeraBEATTM US Device and smartphone during operation, and
make sure the smartphone is within 10 feet of the HeraBEATTM
US Device.
This equipment has been tested and found to comply
with the limits for a class B digital device, pursuant to part
15 of the FCC Rules. These limits are designed to provide
reasonable protection against harmful interference in a
residential installation. This equipment generates, uses and
can radiate radiation frequency energy and if not installed and
used in accordance with the instructions, may cause harmful
interference to radio communications. However, there is no
guarantee that interferences will not occur in a particular
installation. If this equipment does cause harmful interference
to radio or television reception, which can be determined by
turning the equipment o and on, the user is encouraged to
try to correct the interference by one or more of the following
measures:
9
Ultrasound Transmission Gel HeraBEAT™ US Configuration & LED Indicators
Use device only with the supplied gel (g. 3). Using ultrasound
transmission gel that is not approved by HeraMED may
reduce signal quality and can lead to absence of Fetal Heart
Rate (FHR) measurement or inaccurate measurement results.
The Ultrasound Transmission Gel (g. 3) is for external use
only. Gel can be used on intact, unbroken skin and on all
patients in facilities where cross contamination is of minimal
concern.
Prior to use, verify that the Ultrasound Transmission Gel (g.
3) has not exceeded its expiry date (located on the tube). The
gel is valid for 5 years from month of manufacture.
Refer to the gel’s Leaet for further guidelines.
The HeraBEATTM US measures the Fetal Heart Rate,
processes the data and transmits the information
wirelessly to the HeraBEATTM US smartphone application
(the HeraBEATTM App) using BLE communication channel.
The HeraBEATTM App receives the digital information and
displays the data to the user.
The HeraBEATTM App guides the user step by step, to
easily locate the Fetal Heart Rate (FHR), displays the Fetal
Heart Rate values, stores the Fetal Heart Rate in the
smartphone's memory, provides access to results history,
and indicates the status of battery and connection with
HeraBEATTM US.
HeraBEATTM US LED Indicators
The device provides you with the following status
indicators:
Device turned OFF - light is OFF
Device turned ON (waiting to be connected to the App)
– constant white light
Device is connected to the App – fast ashing of white
light
Device in measurement state – Ultrasound is ON– slow
ashing of white light
Device requires charging – device is ashing a white light
3 times and turns OFF
Device is charging – orange light ON
Device is fully charged – green light ON
Review the device lights in the following two illustrations.
10
HeraBEAT™ US configuration and LED indicators
White light App Home
Screen
Orange / Green
charging lights
Measurements History
HeraBEATTM US Measurement
Tap on the Home Screen to start
measurement session.
Tap to start Fetal Heart Rate Search
in every new position
Tap to end the Fetal Heart
Rate measurement
Bluetooth Low Energy (BLE) connection
indicates that HeraBEATTM US is
connected to your smartphone. (BLE
connected).
indicates that HeraBEATTM US is NOT
connected to your smartphone. (BLE
NOT connected).
GO
END
START
Tap on the Home Screen to access the
Measurements History.
Recorded measurements will be displayed by
pregnancy week.
App Settings Menu App Settings Menu
Tutorial
Support
About
Change Language
Advanced Settings
Measurement History
Tap on the Home Screen to access
the in-app settings menu
Tap to access the Tutorial.
Tap for Support contact details
Tap to view the App version
Tap to change the App language
Tap to access the Advanced Settings.
You can edit your Personal Information, reset all
App information or Unpair Device.
Warning! Reset will permanently erase
all App private information and all
measurements history from the App.
Device Unpairing will separate the connection
between the HeraBEATTM US device and the app
and will allow to connect a new device to the
app. Your information and all measurements
history is kept within the App.
We recommend resetting when you want to use
the device for a new pregnancy.
i
11
Charging HeraBEAT™ US
1. Use only supplied Power Supply for charging. (g. 4)
2. Remove the charging connector cover.
3. Connect the Power Supply Cord to the HeraBEATTM US device
4. Plug the Power Supply into an electrical outlet.
5. During charging orange light illuminates. Once fully charged, the orange light turns green.
6. Unplug the Power Supply from the electrical outlet and then disconnect its cord from the HeraBEATTM US device.
Before you turn ON and start using the device, fully charge it.
When the HeraBEATTM US device lights ash 3 times and the device turns OFF, it’s time to charge it.
The device cannot be used during charging.
Do not charge the device under direct sun light.
Full charge time is approximately 4 hours.
It is recommended not to over-charge the device.
When device is not in frequent use, it is recommended to periodically charge it every 3 months.
12
First Time Use
All measurement results are recorded according to your
pregnancy week.
Please make sure that you ll in your personal
information accurately!
HeraBEATTM US
device pairing with the smartphone:
The app will automatically search for and attempt to
connect to a
HeraBEATTM US
device.
Once connected, the
HeraBEATTM US
device is ashing
a white light.
This is only for rst use, next time the app nds the
same unique
HeraBEATTM US
device, it will automatically
connect to it.
If the app was unable to connect to a device, use the
smartphone operating system’s Bluetooth menu to
connect to a HeraMED device. (For details, please refer
to the user guide of the Smartphone).
If the connection to
HeraBEATTM US
has not been
established, verify that the
HeraBEATTM US
device is
turned ON (a constant white light will show), then stop
the app and re-launch it.
Turn
HeraBEATTM US
ON by giving it a
little shake, or by unplugging it from
the power supply (g. 4). A White light
will quickly turn on.
Note: The device will turn itself o
automatically 2 minutes after it is not in
use and disconnected from the App.
Note: The device must be operated using the smartphone
application. Visit our website for a list of supported devices.
Make sure you fully charge the HeraBEATTM US prior to rst use.
Install the HeraBEATTM App on your smartphone: Go to AppStore
/ Google-Play on your smartphone. Search for ‘HeraBEATTM app
in the AppStore/Google-Play and install it on your smartphone.
When the App starts for the rst time, the Tutorial will guide
you how to use the device.
Fill in your personal information: Last
Menstrual Period date or Estimated Due
Date (according to the app ), Maternal
date of birth & Number of previous
pregnancies.
HeraBEATTM US will optimize the guided
search based on the gestational age
providing 3 pre-dened search areas
that consist of a number of search
positions:
Week 12-18, Week 19-24, Week 25-42.
The search will recommend the lower
abdomen area for pregnancy weeks 12
to 18.
13
Measurement of the Fetal Heart Rate
1. Before starting a Measurement session
2.1 HeraBEATTM US preparation
Turn the HeraBEATTM US device ON by
giving it a little shake, or by unplugging
it from the power supply (g. 4).
A White light will quickly turn on.
Note: The device will turn itself o
automatically after 2 minutes if not
used and disconnected from the App.
Important!
Before performing any
measurement, switch your
smartphone to Airplane Mode
(Airplane Mode ON).
The HeraBEATTM US device
communicates with your smartphone
via Bluetooth Low Energy, therefore
please ensure that your smartphone’s
Bluetooth is turned ON (Bluetooth ON).
Before begining a search, please
make sure you have available with
you: HeraBEATTM US (g. 1), your
smartphone (g. 2), the supplied
ultrasound transmission gel tube
(g. 3) and a clean paper tissue/
towel.
It is recommended that you nd a
comfortable position before starting
any measurement session. Lean back
on a pillow in bed or on a couch.
2. HeraBEATTM US Measurement preparations
2.2 HeraBEATTM US smartphone preparation
2.3 HeraBEATTM US APP preparation
Start the HeraBEATTM App.
Wait for HeraBEATTM US to connect.
The App will automatically create
a Bluetooth connection which will
be indicated on the screen. Once
connection with HeraBEATTM US is
obtained, it will rapidly ash a white
light.
Please verify the device is turned ON,
otherwise turn it on by giving it a
little shake.
14
Measurement of the Fetal Heart Rate
3. Applying the Ultrasound Transmission Gel:
4. Fetal Heart Rate Search
3.2
Place HeraBEATTM US bottom side on your abdomen area and position over the bellybutton.
3.3
Hold the device in the palm of your hand and press it gently against your abdomen. Perform a circular motion
to ensure a thin and even layer of gel between HeraBEATTM US and the skin.
3.4
Re-position the device over the bellybutton and make sure the bottom surface is fully touching your skin during
the entire measurement.
4.1
Tap the ‘START’ button.
To assist you with the Fetal Heart Rate Search, you can select either the Guided
Search or the Manual Search.
In Guided search the app will guide you through several positions on your
abdomen, based on the your pregnancy week, while it is searching for the Fetal
Heart Rate. After placing the device on the recommended position, tap the ‘GO’
button and keep the device steady while waiting for the app to detect the Fetal
Heart Rate. If the Fetal Heart Rate is not detected, the app will recommend moving
to the next search position.
In Manual search, you select where to position the device and tap the ‘GO’ button.
The device will search for the Fetal Heart Rate in the position chosen. If the Fetal
Heart Rate is not detected, the app will recommend moving to another search
position.
3.1 Apply a drop of supplied ultrasound
transmission gel (g. 3), about the
size of your little nger, to the bottom
surface of the HeraBEATTM US device.
Bottom Surface
15
Measurement of the Fetal Heart Rate
4.2 Follow the on-screen instructions, while
maintaining the following:
3.
Hold HeraBEATTM US steady while
it is searching and measuring.
1.
Make sure there is always a thin
and even layer of gel between
HeraBEATTM US and your skin.
Note that the gel will dry after
several minutes. Add gel as
required to maintain a thin, moist
layer.
2.
Apply a small amount of pressure
on HeraBEATTM US against your
skin. Verify full contact during the
entire measurement.
4.3 During the search
Note: The measurement is sensitive to noises which occur due
to talking, eating, heavy breathing or moving. Please refrain from
these actions during the measurement.
Abdominal activity or fetal movements detected may prolong the
search duration, you may be requested to wait in your current
position to allow the device to locate the fetal heart rate.
At the bottom of the screen a running graph will indicate
device activity.
Next to the graph, a level bar displays the signal level.
Understanding the running graph and signal level:
If you detect a “repetitive waves
pattern” as below, it may be a fetal
heart rate. Wait in this position to
allow for the signal level to rise until
the fetal heart rate is located:
If the running graph displays a
“repetitive spike pattern” as below,
it may be maternal heart rate. Move
the device to search in a dierent
position:
A momentary “irregular pattern”
followed by a at line may be caused
by abdominal or other activity. Wait
in this position to allow the data to
stabilize.
16
Measurement of the Fetal Heart Rate
5. Fetal Heart Rate Measurement
The HeraBEATTM app will inform
you audibly and visually when the
Fetal Heart Rate is detected. The app
will then move to the measuring
screen.
Hold the device steady while
HeraBEATTM US is measuring the
Fetal Heart Rate.
The App will present and record the measurement. The
measured Fetal Heart Rate is displayed in the center of
For ever y search position, whether using guided or manual
search mode, the HeraBEATTM US device will make sure
that the maternal heart rate is not being regarded as the
fetal heart rate. In such a case, it will guide you audibly and
visually to move to the next search position.
The search duration of every search position is indicated
by a depleting ring.
If the Fetal Heart Rate is not detected at a certain position,
you will be asked audibly to move HeraBEATTM US to the
next position (the new position will be displayed on the
screen).
The distance betwee
search points is about
2 ngers wide.
The app will remind you to
add more gel, if necessary,
every 5 search positions.
the screen and a Fetal Heart Rate sound is played.
Results are presented in Beats Per Minute (BPM)
A timer displays the measuring duration at the top of
the screen.
Note: Measurement results of only a few seconds may
be unreliable. Hold device steady in order to allow the
measurement results to stabilize as much as possible.
The longer and more continuous the measurement,
the more reliable and accurate it is.
If fetal heart rate tracking is lost during
measurement, the App will display
‘Wait’ instead of the fetal heart rate
value. Keep the device steady until
the fetal heart rate is located again.
If the fetal heart rate is not located
again after 20 consecutive seconds,
the App will move back to the Searc
Screen in order to guide you to
locate the fetal heart rate.
6. END Measurement Session
Tap the ‘END’ button to end the measurement. You can
end the measurement at any time by tapping the ‘END’
button, or by closing the App or by Switching to another
App.
The HeraBEATTM US device switches o automatically if
no operation is performed for 2 minutes and the device
is not connected to the smartphone.
Turn o the Airplane Mode on the smartphone.
17
7. Measurement Results
Once the measurement has nished, the measurement
results screen is shown.
The measurement results screen includes:
A test name at the top including pregnancy week,
date and time.
An average Fetal Heart Rate.
Measurement duration (total time from search start to
measurement end).
Use the Share key to share a
screenshot of the measurement
result screen and the sound
recording.
Measurement of the Fetal Heart Rate
8. Measurements History
All recorded measurements are kept and organized in
accordance with your pregnancy week in the history
screen.
Tap any week to see its measurements as shown below.
Tap a specic measurement to see its results screen.
Note: All Measurement history data saved within the
HeraBEATTM App. will be deleted should you uninstall the
app or upgrade to a new smartphone.
Share is done using the mobile device operating system
available option. Make sure to switch OFF airplane
mode in order to share measurements.
If following the measurement Fetal Heart Rate was not
located, the application will display a ‘Fetal Heart Rate
not found’ message.
18
Care and Maintenance
Proper care, cleaning and handling are essential to the operation of
the HeraBEATTM US device. The HeraBEATTM US device must always
be thoroughly cleaned at the point of care following each use and
disinfected prior to a transfer to another user.
Follow the instructions below for cleaning and disinfection of the
HeraBEATTM US device.
WARNING
The HeraBEATTM US device must be cleaned after each use, with
particular attention to the transducer plate on the bottom
of the device. Thorough cleaning is an essential step before
eective disinfection.
WARNING
Use only the cleaning and disinfection solutions stated in the
instructions. Use of any other solutions may result in damage
to the device.
WARNING
Never submerge the device in liquids. Do not allow any liquid to
enter the device especially at the charging connector.
CAUTION
Do not use paper or abrasive wipes or brushes when cleaning or
disinfecting the bottom transducer plate as these may damage
the transducer lens window.
CAUTION
When handling the device, be careful not to bump the device on
any hard surfaces.
CAUTION
When not in use, always store the device in its carry case and
locate it with its accessories in a safe cool and dry place, away
from direct sunlight. Follow the temperature and humidity
guidelines as specied in this Instructions for Use.
CAUTION
The device is not intended to be sterilized.
19
Disinfection
The HeraBEATTM US device is classied as noncritical for disinfection
as it only comes into contact with intact skin. Therefore, only low
level disinfection is recommended according to the instructions
below:
1. First follow the cleaning steps above to thoroughly remove all
ultrasound gel and any other visible soil from the device.
2. Then use a soft cloth, moistened with 70% medical grade alcohol,
to disinfect the device for at least 1 minute. Be sure that the
alcohol is in contact with all surfaces of the device for at least 1
minute. Do not use a spray or immersion method for disinfection
as this may result in liquids entering the device housing and
damaging the device,
3. Air dry or use a soft, dry cloth to thoroughly dry the device.
4. Verify the device is intact. Discontinue use with any signs
of damage such as cracking or any other damage that may
jeopardize the integrity of the device. Report all damage to
HeraMED and discontinue use of the device.
5. Once thoroughly clean and dry, store the device in its carry case
and locate it with its accessories in a safe cool and dry place,
away from direct sunlight.
Cleaning
1. The device should be cleaned immediately following the end of
each use to remove all ultrasound gel and any other soil from all
device surfaces. Delay in cleaning may result in the ultrasound
gel drying on the device and being more dicult to remove.
2. Before cleaning the HeraBEATTM US device, be sure that it is
unplugged from the power supply.
3. Thoroughly remove all ultrasound gel and any other visible soil
from the device with a soft dry cloth or tissue, using a gentle
wiping or blotting motion. If necessary, moisten the cloth
with a mild soap solution. Pay close attention to the LED and
photodiode windows and avoid aggressive wiping or scrubbing in
these areas as this may damage the lens surfaces.
4. Use a soft cloth, moistened with water, to remove any soap
residuals.
5. After visually verifying that all ultrasound gel has been removed
and the device is clean, thoroughly dry the device with a soft dry
cloth.
6. Inspect the device to verify that the product is intact. Discontinue
use if there are any signs of damage such as cracking or any other
damage that may jeopardize the integrity of the device. Report
any damage to HeraMED and discontinue use of the device.
7. If any ultrasound gel or other soil remains on the device, repeat
the cleaning steps 3 through 6 above as necessary.
8. Once thoroughly clean and dry, the device may be disinfected.,
Follow the disinfection instructions below.
Care and Maintenance
20
Troubleshooting
Problem: The device failed to detect the Fetal Heart Rate, or
measured rate is inconsistent.
Details: The device failed to detect the Fetal Heart Rate at all
recommended locations.
Solution:
1. Measurement is fully eective when:
a. There is always a thin and even layer of gel
between HeraBEATTM US and your skin. Note that the
gel might dry after several minutes. Add gel as
required to maintain a thin, moist layer.
b. Apply a small amount of pressure on HeraBEATTM US
against your skin. Verify full contact during the
entire measurement.
c. Hold HeraBEATTM US steady while it is searching and
measuring.
d. Carefully follow the step-by-step guidance as the
App suggests.
2. Excessive or prolonged fetal, maternal or device
movements can degrade the ability to locate and
measure the Fetal Heart Rate (FHR). If you’re
experiencing frequent fetal movements during the
measurement, stop the measurement and try again
once fetal movements have stopped.
3.
Detection of Fetal Heart Rate in early weeks of
pregnancy can be challenging in some cases. The size of
the fetus’ heart can be very small and it might be missed.
4. It is recommended to perform measurements at
least 1 hour after major meals as these may cause
abdominal noises that may interrupt the measurement.
5. Consult with your physician.
Problem: The HeraBEATTM US device is not connected
or the app and device frequently disconnect.
Details: The ‘No connection’ message or icon is displayed.
Solution:
1. Verify that HeraBEATTM US is located within 3 meters
from your smartphone.
2.
Ensure that Bluetooth on the smartphone is turned ON.
3. Ensure that HeraBEATTM US is ON.
Turn HeraBEATTM US ON by giving it a little shake, or by
plugging and unplugging it from the power
supply after charging (g. 4).
The white light ring on the top part of the device will
quickly turn on.
Note: The device will turn itself o automatically after
2 minutes if not in use and disconnected from the App.
4. Close the HeraBEATTM app and restart it.
Other manuals for HeraBEAT
1
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