Little Martin’s BFD1609 User manual

Little Martin’s Fetal Sound Amplier
User Manual
For Model BFD1609

In order to ensure you and your baby’s safety, please be sure to read
this manual before using this product, and use it correctly.
• Please keep this manual in a safe place.
• When attaching the extra parts, please be sure to carefully read
manual before doing so.
• When giving this away as a gift, please be sure to include this
manual.
Contents
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.............................................................on the back cover
Before Using
About The Product
How The Product Works
Listen To The Sound Of The Fetal Heartbeat
Record The Sound Of The Fetal Heartbeat
Playback The Sound Of The Fetal Heartbeat
Transit The Fetal Heartbeat Rate
Average Fetal Heartbeat Rate
Audio Record
Safety Terms & Conditions
Safety Alert Descriptions
Name Of Parts
How To Use The Fetal Sound Amplier
Product Maintenance
Important Tips
Visual Inspection
Cleaning The Product
Disinfection
Recycling The Battery
Specications
Environmental Requipments
Symbol Descriptions
Troubleshooting
Warranty Certicate
1

Before Using
About The Product
Become familiar with the controls and how to use the product
properly before operating the product.
The product normally detects fetuses starting from 9 weeks, but can
take up to 12-14 weeks depending on each individual.
Normally there are no contraindications for use. For specic cases,
please consult your doctor.
Please consult your doctor about how to use at home.
It should not be used in life supporting or life sustaining
applications.
Caution
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.
In accordance with classication 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”.
2

Little Martin’s Fetal Sound Amplier consists of a probe (transmitter
and receiver) and signal process unit. Ultrasonic waves are transmit-
ted from one piezoelectric ceramic at the front of the probe to the
uterus of the pregnant women. Echo is received by the other
piezoelectric ceramic at the front of the probe when the ultrasonic
waves reach the fetal heart. Then it is converted into voltage.
This Doppler signal is detected and demodulated from the received
signal, and the Doppler frequency is consistent with the rhythm
of the fetal systole and diastole. Once cardiac valves vibrate and
a Doppler frequency excursion is formed. It is transmitted as an
output signal of cardiac valves vibrating, and is then sent to the
loudspeaker for getting a rhythmical sound with the fetal heartbeat.
Simultaneously, it is sent to a counter which calculates the fetal
heartbeat rate. (bpm=beat per minute)
How The Product Works
Listen To The Sound Of The Fetal Heartbeat
Record The Sound Of The Fetal Heartbeat
Playback The Sound Of The Fetal Heartbeat
The sound of the fetal heartbeat can be played through earphones
or speakers.
When the device is connected to record devices with USB cable, it
can transmit the sound of the fetal heartbeat to record devices, such
as cellphones or computers, and save it into the record devices.
Operator can playback the sound of the fetal heartbeat saved in the
record devices.
3

Average Fetal Heartbeat Rate
Transit The Fetal Heartbeat Rate
Audio Record
Safety Terms & Conditions
The detected fetal heartbeat signal will be calculated once every
ve seconds for the average FHR and the result will be displayed.
The instrument automatically displays the value according to the
fetal heartbeat detected by the probe instantly.
The sound of the fetal heartbeat can be recorded by a device which
is connected with the product.
As a safety advisement, this product can only be connected with a
recorder complaint with the safety requirements of IEC 60601-1.
The signal words shown below identify the potential hazard
categories. The denition of each category is as follows:
This alert identies hazards that will cause serious personal injury
or death.
This alert identies hazards that may cause serious personal injury
or death.
This alert identies hazards that may cause minor personal injury,
product damage, or property damage.
4
Danger
Warning
Caution

Safety Alert Descriptions
The following is a list of product safety alerts that appear in this
section and throughout this manual. You must read, understand,
and follow these safety alerts before attempting to operate the
product.
Recycle or dispose of the battery in accordance with all federal, state
and local laws. To avoid re and explosion hazard, do not burn or
incinerate the battery.
Do not use batteries, cables, or optional equipment other than
those approved by Little Martin’s Drawer which may cause the
product to function improperly during a rescue.
Battery Disposal
Use Only Approved Equipment
Do not operate the product in the presence of ammable gases to
avoid possible explosion or re hazard.
Fire and Explosion Hazard
Exposing the product to extreme environmental conditions outside
of its operating parameters may compromise the ability of the
product to function properly.
Temperature/Humidity/Pressure Extremes
RF susceptibility from cellular phones, CB radios and FM 2-way radio
may cause interference with the product. Do not operate wireless
radiotelephones in the vicinity of the product, if necessary, rst
turn power OFF prior to use of the radiotelephone or other similar
equipment.
Possible Radio Frequency (RF) Susceptibility
5
Danger
Caution
Caution
Caution
Warning

The product should not be used adjacent to or stacked with other
equipment. If adjacent or stacked use is necessary, the product
should be observed to verify normal operation in the conguration
in which it will be used.
Equipment connected to the product must be certied to the
respective IEC Standards (i.e. IEC 950 for data processing equipment
and IEC 601-1 for medical equipment). Furthermore, all
congurations should comply with the system standard IEC 601-1-1.
If you choose to connect additional equipment to the signal input
part or signal output part, please ensure that the system complies
with the requirements of the system standard IEC 601-1-1. The
Product Service Port is only intended for use during maintenance by
authorized service personnel.
When disinfecting the case, use a non-oxidizing disinfectant, such
as ammonium salts or a glutaraldehyde-based cleaning solution, to
avoid damage to the metal connectors.
The product is designed for indoor use. Operator must conrm that
the environment of use meets the required operating
environmental specications before using.
If the product is stored in an environment with a temperature below
the operating temperature, the unit should be allowed to warm up
to the required operating temperature before using.
6
Adjacent and/or Stacked Equipment
Systems Statement
Case Cleaning Solutions
Environment of Use
Cold Environments
Warning
Caution
Caution
Caution
Caution

Name Of Parts
Every attempt is made to ensure your accurate and complete order.
However, to ensure the correct order, please make sure to verify the
contents of the box against your packing slip.
The product is designed for simple operation and set-up, requiring
minimal assembly. The following items are included in your box:
1 x Main Unit
1 x Holder (Speaker)
1 x Audio Cable
1 x USB Cable
1 x 9V Alkaline Battery
1 x Lanyard
1 x User Manual
Carefully inspect each item as it is unpacked for any signs of
damage which may have occurred during shipment.
• Check the components according to the packing list.
• Check for any damage or defects. Do not attempt to assemble
the product if anything is damaged or defective. Contact Little
Martin’s Drawer Customer Service immediately if anything is
damaged or defective.
1
2
3
4
5
6
7
8
[Main Body Part]
7

9
10
Switch/Volume
Turn on or o the device, change the volume.
Earphone Jack
Connect to earphones to play fetal heartbeat or connect to
record devices, such as your computer or cellphone, to record
heartbeat sound and save it on the record devices.
Note: The ‘Earphone Jack’ socket can be connected to headset or
recorder. A socket for audio output can only be connected with
a recorder complied with the requirements of IEC 60601-1
USB Socket
Play the heartbeat sound through the speaker when the USB
speaker sockets on both main body and base are connected
with a USB cable.
LCD
Display heartbeat rate on it.
Probe
Detect fetal heartbeat.
1
3
4
5
2
Battery Cover Lock
Lock the Battery Cover.
Battery Cover
Hold the battery.
Label
Information about model, manufacturer, agent and so on.
Indicator
Indicate that the USB Speaker Socket is connected to USB
Socket with a USB cable.
USB Speaker Socket
Connects the USB socket in Main body with USB cable, then the
heartbeat sound can be played through the speaker in Base.
6
8
9
10
7
[Holder Part]
8

Rotate the battery cover locker(6) in the proper
direction before using it for the rst time, take o battery
cover(7), and insert 9V battery.
Rotate Switch/Volume to power on the device, the LCD
(4) displays“- - -”at this moment. Put on the earphones,
adjust the volume to desired level.
Plug earphones into Earphone Jack(2) (Using unmatched
earphones may reduce sound quality).
Locate the position of the fetus rst by touching gently
with hands to nd out the best direction to the fetal
heart. Place the faceplate of the probe at the best
position for detecting fetal heartbeat. Adjust the probe
to obtain an optimum audio signal ideally by angling
the probe around. Generally, fetus’ heart is 1/3 below
the navel line at its earlier stage, it then moves upward
with increasing of gestational period, and from there,
will deviate slightly to the left or right depending on the
fetus. Please make sure that the surface of the probe is in
full contact with the skin. After the sound becomes clear
and stable for a few seconds, the FHR value will appear
on the LCD in real time. If coupling gel is not available,
water can be used.
STEP 1.
STEP 3.
STEP 2.
STEP 4.
Remove the battery if the device is not likely to be used for some
time.
Irregular treatment of batteries may result in hazards to health and
environment.
How To Use The Fetal Sound Amplier
9
Caution
Warning

Rotate the Switch/Volume to power o the device.
Connect the USB Socket(3) of the main body to the USB
Speaker Socket(10) with the Base with a USB cable if you
want to use the speaker in the Base, then the Indicator(9)
will turn on after you power on the device.
Note: abnormal FHR values may appear while searching
for the fetal heart.
Plug one end of the record cable into Earphone Jack (2),
the other end into the record device, the computer, in
order to record the fetal heart beat. Move the Probe (5) to
the user’s left breast to record the heart beat, replaying it
can calm down the baby after the fetus is born.
STEP 6.
STEP 7.
STEP 5.
Product Maintenance
Gestation
Ante Partum
Parturition
Proper maintenance of the product is very simple, yet it is an
important factor of its reliability. This section describes the
maintenance and service required for the product and its
accessories.
The transducer acoustic surface is frangible and must be handled
with care. These precautions will prolong the life of the unit.
The user must check that the equipment does not have visible
evidence of damage that may aect patient safety or product’s
capability before use. The recommended inspection interval is once
per month or less. If damage is evident, replacement is
recommended before use.
10
[Positions of fetus heart in dierent periods]

To ensure the product is always functional when required, the
following maintenance should be performed:
• Visual Inspection
• Cleaning the product and its accessories
• Checking the battery
• Testing product performance
Correction: manually calculate the FHR with hearing fetal heartbeat
sound for qualification.
• It is important that the product is stored at the operating
temperature range if it is expected to be used. Optimal battery
life will be obtained if stored and operated at room temperature.
• The product requires no calibration.
The product and its accessories should be carefully inspected prior
to installation once every 12 months thereafter and each time the
equipment is serviced.
• Carefully inspect the equipment for physical damage.
• Inspect all external connections for loose connectors or frayed
cables.
• Inspect the graphics display for marks, scratches, or other
damage.
• Verify that the safety label on back of the product is clearly
legible.
11
Important Tips
Visual Inspection

INSTRUCTION
Examine the case
connectors and
accessories
Examine accessory
cables
INSPECT FOR
Foreign substances
Damage or cracks
Foreign substances
Broken parts, cracks, damage,
or extreme wear, broken or
bent connectors and pins, after
bending and exing the cable
RECOMMENDED
REMEDY
Clean the product
and its accessories as
described.
Contact our customer
service.
Clean the cables
Replace cable if any
abnormalities are found.
After the visual inspection, if the product and/or its accessories are
damaged please contact our Customer Service. The product will
need to be returned for repair. The accessories should be disposed
of appropriately and replacement parts shall be ordered.
The following cleaning products may be used to clean the exterior
surfaces of the product as well as the batteries.
• Isopropyl alcohol (70% solution in water)
• Mild soap and water
• Sodium hypochlorite (chlorine bleach) (3% solution in water)
• Quaternary ammonium compounds (such as Lysol)
(10% solution in water)
12
When you clean the product,
• Do not use abrasive cleaners or strong solvents such as acetone
or acetone-based cleaners.
• Do not use mixing disinfecting solutions (such as bleach and
ammonia) as hazardous gases may result.
• Do not clean electrical contacts or connectors with bleach.
Warning
Cleaning The Product

• Before cleaning the product, turn the device off and disconnect
the power cord.
• Before cleaning, remove all adherent soil (tissue, fluids, etc.) and
wipe thoroughly with a cloth dampened with water before
applying the cleaning solution.
• When cleaning, do not immerse. Keep the exterior surface of
the device clean and free of dust and dirt, clean exterior surface
of the unit with a dry, soft cloth. If necessary, clean it with a soft
cloth soaked in a solution of soap and wipe dry with a clean
cloth immediately.
• Avoid pouring fluids on the device, and do not allow fluids to
penetrate the exterior surfaces of the device.
• To prevent scratching the display, the use of a soft cloth is
recommended.
• To prevent damage to equipment, do not clean any part of
the product or accessories with phenol compounds. Do not use
abrasive or flammable cleaning agents. Do not steam,
autoclave, or gas-sterilize the product or accessories.
• Cleaning liquids: Do not submerge the device in liquids or pour
cleaning liquids over, into or onto the device.
• Do not use strong solvents such as acetone.
• Never use an abrasive cleaning tool such as steel wool or metal
polish.
• Do not allow any liquid to enter the product, and do not
immerse any parts of the device into and liquids.
• Avoid pouring liquids on the device while cleaning.
• Do not leave any cleaning solution on the surface of the device.
• Wipe the surface of the sensor of transducer with 70% ethanol
or alcohol, self-air dry or clean with a clean, dry cloth.
13
Caution

Clean the unit surface and the transducer according to the method
mentioned above, then wipe the surface of transducer with 70%
ethanol or alcohol. Clean the transducer surface with a dry, soft
cloth.
The battery is recyclable. Remove the old battery from the product
and follow your local recycling guidelines or refer to local
regulations.
• Do not use low temperature steam sterilization or other
sterilization methods.
• Do not use high temperature sterilizing process.
14
Irregular treatment of batteries may be cause hazards to health and
environment.
Warning
Disinfection
Recycling The Battery

The following specications are subject to change and are only
noted as a point of reference.
DISPLAY
ULTRASOUND
FHR PERFORMANCE
AUDIO OUTPUT
BATTERY
LCD Size 34mm X 16mm
Ultrasonic emitting frequency:
Overall sensitivity at distances 200mm from
the face of the probe (Doppler frequency:
300±50Hz,Targe velocity: 10cm/s~40cm/s)
Spatial-peak temporal-peak acoustic pressure
Output power
Eective area of the ultrasonic transducer
active element
The acoustic coupling medium for normal use:
FHR Test Range:
Resolution:
Accuracy:
Audio Output Power:
Audio Out Socket:
Battery Voltage:
Type:
2.5MHz±3%
≥90dB
<8.6kPa
<20mW
1.57cm2
30 bpm ~240 bpm (Beat/Minute)
1 bpm
± 1% ± 1 bpm
<0.5 W
Φ3.5mm
9V
9V Alkaline
ph: 5.5~8, Acoustic
impedance:
≤1.7×105g/cm2.s
Specications
Storage and Shipping
-10°C to 60°C
10% - 95% RH,
non-condensing
50kPa to 106kPa
Operating
5°C to 40°C
<80% RH,
non-condensing
86kPa to 106kPa
Conditions
Temperature:
Humidity:
Atmospheric pressure:
15
Environmental Requipments

The following symbols may appear in this manual, on the product,
or on its accessories. Some of the symbols represent standards and
compliances associated with the product and its use.
Product is designed for indoor use. Operator must conrm that the
environment of use meets the required operating environmental
specications before using.
If the product is stored in an environment with a temperature below
the operating temperature, the unit should be allowed to warm up
to the required operating temperature prior to use.
16
Environment of Use
Cold Environments
Caution
Caution
Consult instructions for
use of the product and
its accessories
Serial number of the
product
Warning information LOT Number
Ingress Protection. IPX4
oers protection from
dust 1mm or larger from
entering the casing.
Authorized representative
in the European Community
It indicates that the equipment
should be sent to the special
agencies according to local
regulation for separate
collection after its useful life.
CE Mark: The product
system conforms to
essential requirements of
the Medical Device Directive
93/42/EEC.
100% Recycleable
Symbol Descriptions

Common
problems
There is no
reaction after
pressing power
on button or
product powers
off too soon.
There are values
on LCD but no
sound.
Too much noise
while using the
device.
There is sound
but no values on
LCD, difficult to
find the position
of the fetal heart.
Random values
appear frequent-
ly on the LCD
when using the
device.
Possible causes
1. Battery is low.
2. Batter is in bad
contact.
3. Placement of the
battery is incorrect.
4. Device failures.
1.Volume is at the
minimum.
2. Earphones of speaker
incorrectly inserted.
1. There is no coupling
agent.
2. Moving the probe on
the skin of abdomen
causes noise.
3. Probe is not placed at
the optimal position.
1. There is no coupling
agent between probe
facet and abdomen skin.
2. Gestation period is
the short, fetal heartbeat
is weak.
1. The friction between
the probe and abdomen
skin causes. the wrong
random values during
looking for right position
of fetal heart.
2. There is
electromagnetic
interference around,
such as high frequency
generator machines
which create electrical
spark, and cellphones.
3. There is fetal
movement, which means
the position of fetal heart
may have changed.
Solutions
1. Change battery.
2. Ensure battery is in good
contact.
3. Insert the battery correctly.
4. Send the device back to
manufacturer for repair.
1.Adjust the volume to the
proper lever.
2. Plug the earphones or
speaker correctly.
1.Use coupling agent.
2. Do not allow the probe
to come in contact with the
skin while searching for the
fetal heart. Find the right angle
between probe facet and skin of
the abdomen to get the clearest
fetal heartbeat sound.
3. Look for the right position of
the fetal heart again.
1. Make sure that there is
enough coupling agent
between the probe facet and
abdomen skin.
2. Use the device after longer
gestation period, fetus is bigger.
1. Find the position where the
fetal heartbeat sound is the
loudest, keep the probe static
for 10 seconds, then the values
on LCD are real instant fetal
heart rate.
2. Use the device in a place
without interferences.
3. Adjust the position of the
probe, making sure that the
probe is where the fetal
heartbeat sound is the loudest.
17
Troubleshooting

This certicate promises our customers that they will receive free
repair. If you notice any problems listed below within the warranty
period, please contact our customer service with this certicate.
1. Once you have used this product, we basically will not oer
exchangement.
2. When the product is damaged (after proper use) within the
warranty period which is a year from the purchase date, we will
repair it for free. Contact us via email
[e-mail], and send the product over to our
customer center.
3. Even within the warranty period, in the following situation the
repair process will come with a fee.
a. Natural discoloration of the plastic area.
b. Damage due to misuse of the product.
c. Damage due to re, water, earthquake and other natural
disasters.
d. Damage due to commercial or business usage.
e. The shipping fee for paid repair.
4. This service will apply only inside United States.
5. Once the product is out of production and certain parts are out
of stock, we will not be able to oer certain repairs.
Warranty Certicate
BATCH CODE
SEE THE LOT NUMBER ON THE BACK
OF THE MOTOR UNIT
CONSULT INSTRUCTIONS FOR USE
100% RECYCLEABLE
WASTE FROM
ELECTRICAL AND
ELECTRONIC
EQUIPMENT (WEEE)