FD88 Fetal Doppler

User manual

0482
Version: V1.0
Date: Nov. 2016
No.: 503-020090-100
 Table of Contents
1 Safety Guide............................................................................................. 1
1.1 Important notice..................................................................................... 1
2 Brief Introduction ...................................................................................... 2
2.1 Over view .............................................................................................. 2
2.2 Function................................................................................................. 3
2.3Configurations ........................................................................................ 3
3 Product Introduction ................................................................................. 3
3.1 Appearance ........................................................................................... 3
3.2 Display ................................................................................................... 4
3.3Buttons ................................................................................................... 5
3.4 Top Port ................................................................................................. 6
3.5 External charging function .................................................................... 6
4 Operating Instructions .............................................................................. 7
4.1 Basic operation...................................................................................... 7
4.2 Put off the probe .................................................................................... 7
4.3 Replace battery ..................................................................................... 8
5 Technical Data .......................................................................................... 8
6 Maintenance ........................................................................................... 10
6.1 Maintenance ........................................................................................ 10
6.2 Cleaning ...............................................................................................11
6.3 Disinfection .......................................................................................... 12
7 Troubleshooting ...................................................................................... 12
7.1 NO display ........................................................................................... 12
7.2 FHR beyond normal range (110-160 bpm) ......................................... 12
8 Warranty ................................................................................................. 13
Appendix : Guidance and Manufacturer’s EMC Declaration .................... 15
 Fetal Doppler User manual

1 Safety Guide
This Doppler is internally powered equipment, and the degree
of protection against electric shock is Type B applied part. It is
IPX1 transducer.
Before use it, please check its lifetime. Its lifetime is 5 years
and manufacturing date is labeled at the bottom side of device.
1.1 Important notice
To avoid getting the potential harm, please make sure
operating complies with follows:
Warning: Do not dispose of batteries in fire as this can cause
them to explode.
Caution: The battery should be gotten properly treatment
according to local rules after the capability of battery run out.
Caution: This instrument must be maintained by qualified
engineers.
Caution: This instrument is designed to work continuously, and
water drop proof type, and be care to avoid to be splashed.
Caution: This instrument is in conformity with IEC60601-1-2
EMC standards. But when the electromagnetic power is very high,
it will still cause interference. Please do not use mobile phone,
portable communication devices, etc nearby it.
Caution: Before using the instrument, please check if there is
any damage of equipment that may affect the patient’s safety or
the instrument performance. The recommended check period is

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 Fetal Doppler User manual

one month or shorter. If an obvious damage is found, it should be

solved before use.
Caution: This instrument is a hand-held FHR checking device; it
can’t replace the standard fetal monitoring.
Caution: Please stop operating if this instrument is splashed or
has water drops.
Note: Applicable to the pregnant woman with over 16 gestational
weeks.

2 Brief Introduction
2.1 Over view
1. Modern medicine proves that the asphyxia, fetal distress and
umbilical cord around neck (25% of pregnant has such situation)
will affect the normal growing development of fetal, sometimes
there will be dangerous to the fetus, even to the mother, and
these symptoms will make the FHR changed abnormally, so the
FHR gives an indication of fetal well-being.
2. If condition is permitted, the pregnant should listen to the
fetal heart beating and get FHR three times per day, 1-2 minutes
per time, when abnormal FHR or abnormal fetal heart beating is
monitored, please contact your doctor immediately.
It can meet the fetal heart rate checking demand in hospital, clinic
or at home.

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 Fetal Doppler User manual

2.2 Function
 Calculating FHR with the same DSP techniques as used in
Fetal Heart monitor, ensure the FHR accuracy and reliability.
 High sensitive transducer, Low ultrasound power, more
safety to the fetus.
 Built-in speaker
 Li-polymer battery with battery status indicator
 In working mode, no FHR signal detected over 1 minute, the
device will auto power off to save battery power.
2.3Configurations
main unit ………................………..……………………1piece
Ultrasound transducer……………………..……………1piece
User Manual………...........................……………….….. 1set
Warranty Card……........................……………………... 1set

3 Product Introduction
3.1 Appearance

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 Fetal Doppler User manual

1. LED indicator 2. LCD display screen

3. Volume decrease 4. Volume increase
5. Power on/off switch 6. Speaker
7. Label 8. Numeric/Waveform switch
9. Probe 10. Probe port
11. Earphone port 12. USB port
3.2 Display
Two FHR display modes: waveform display and numeric
display .
FHR numeric display:

Fig 3-1
See Fig 3-1, 158 is FHR value, means hear beat is 158 beat per
minute; if no heart rate identified, it shows（---）

The speaker volume, totally 8 levels, and displayed with

0~7，0 means mute, and 7 means the maximum volume, press

up/down arrow to increase or decrease the volume.

Indicating the battery capacity, there are four statuses: full, two

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 Fetal Doppler User manual

blocks, one block and empty, when the empty icon flashes, it
means the battery needs to be recharged, the FHR sound quality
get worse and the device will shut off after several minutes
automatically
FHR waveform display

Fig 3-2 FHR numeric display

158 is FHR value, means hear beat is 158 beat per minute; if no
heart rate identified, it shows (---). Vertical cursor moves from left
to right. And the light green band indicates normal range of FHR:
110-160bpm.
Note: When FHR value is beyond the normal range, green LED
turn to orange indicator; light blue FRH numeric color turn to
light-red. These are visual reminding of FHR variation.
3.3Buttons
Buttons Functions
On: Press over 2 seconds to power on the device.
Off: Press over 2 seconds to power off the device.
Change the mode of numeric display or waveform
display

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 Fetal Doppler User manual
▲ Press once, volume increase by one level

▼ Press once, volume decrease by one level

3.4 Top Port

: Earphone port for audio output. It can connect with

sound-loaded recorder. Earphone is not included with this

device.
: External power charging port.
3.5 External charging function
Charging method:
If the battery runs out, do not take the battery out; just connect
one end of the charging cable to power charger and the other end
to fetal Doppler. See below pictures:

After connected with power charger, the device will shut off
automatically and display charging status. If charging is not
finished, battery charging rolling bar will display at the bottom of
display screen. If charging is finished, full power battery icon will
display at the bottom of the display screen. Please plug off the
charging cable. For this device, charging cable is included while
charging adapter is not included.
Caution: The device does not work when it is charging. When
use the device, user need to plug off the charging cable first. For
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 Fetal Doppler User manual

the charging adapter, it must be CE certified. For this device,

charging cable is included while charging adapter is not included.
Caution: If device is not put into use for a long time, it is a must to
charge the device every month to ensure battery lifetime.

4 Operating Instructions
4.1 Basic operation
Power on: Press on/off switch over 2 seconds, the device is on.
Find position where heart beats is strong by touch; Put
appropriate gel on the surface of ultrasound probe and put it near
the fetal heart, adjust the probe to get good fetal heart signal (the
sound is clear and less noise). User can adjust the sound volume
as per clinical requirement. Usually, for the earlier gestational
weeks, the fetal heart position is always at 1/3 between navel and
pubis, as the fetus grows up, the position will move up, and will be
at left or right slightly due to different fetus position. When using
the probe, please make sure it touch the skin completely. When
regular fetal heart sound is heard, the FHR value will be on
display simultaneously.
4.2 Put off the probe
Hold the fetal Doppler by left hand and hold head of probe
with right hand(see Fig 4-1), take off the probe gently. Use the
contrary way to put the probe back.
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 Fetal Doppler User manual

Take off the probe

Fig 4-1
4.3 Replace battery
Only authorized or trained technicians can replace the
battery.
Battery spec: 3.7V, 500mAh Li-polymer battery.

5 Technical Data
Product Name: Fetal Doppler
Model:FD88
Classify:
Protection against electric shock: internal power supply,

type B: ;

Protection against liquid: normal device, (Probe IPX1), do

not have waterproof ability;
Protection against flammable gas: not suitable for using in
the environment with flammable gas;
Working mode: continuous;
Electromagnetic compatibility: Class I Type B.
Physical Characteristics

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 Fetal Doppler User manual

Size: 25 mm (Length)*75 mm (width)*128 mm (height)

Weight: 190g ± 20g (include battery)
Working environment:
Temperature: +5℃ - +40℃
Humidity: ≤ 80％
Atmospheric pressure: 86kPa - 106kPa
Transport and storage:
Temperature: -10℃ - +55℃
Humidity: < 93％
Atmospheric pressure: 86kPa - 106kPa
Without corrosive gas and good ventilation.
Note: Allow transporting by air, ship, truck and rail, during
transportation, it should avoid impact, violent vibration and
damp.
Capability of fetal heart rate:
Total sensitivity: ≥ 90 dB
Measurement range: 50 ~ 210bpm
Accuracy: ±2bpm
Speaker power:0.5W
Ultrasonic probe:
Working style: Continuous Doppler
Acoustic-Working frequency: 2.5MHz ±15％

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 Fetal Doppler User manual

Ultrasonic output power：< 20 mW

Effective ultrasound sending area: 245 mm2 ±15％
This product is exempted from publishing the following acoustic
parameters:
P_：< 1MPa
Iob< 20mW/cm2
Ispta<100mW/ cm2
Note: This device is applied to the mother who gestational
week is over 16 weeks.

6 Maintenance
6.1 Maintenance
The acoustics of ultrasonic probe is a precise instrument that
we should handle them gently. Washing the Gel left on
transducer after using is very useful for extending the service life
of this instrument.
Before using, ensure the device has no obvious damage of
device function and which may be harmful to patient.
Recommended checking period is one month or shorter. Once
there is obvious damage, please replace it.
The equipment should undergo periodic safety testing to
insure proper patient isolation from leakage currents. This should
include leakage current measurement. The recommended testing
interval is once every two years or as specified in the institution’s
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 Fetal Doppler User manual

test and inspection protocol.

The accuracy of FHR is decided by machine itself and can
not be adjusted. If you are suspicious of accuracy of result, you
can verify it through other devices like a stethoscope; also you
can contact local distributors or manufacturers for help.
Only qualified technicians who are certificated by our
company can repair machine, anyone can't repair machine
without special permit. Accessories needed are offered by our
company only.
6.2 Cleaning
Please power off the instrument, and remove the battery
before the cleaning.
Keep the instrument clean without dust, use a dry and soft
cloth to mop outside (include screen). If necessary, only a cloth
wet with clean water or soapy water can be used.
Do not use strong solvents such as acetone
Caution: Forbid to use friction material (such as steel wool
and silver polishing agent)
Caution: Do not immerse instrument in any liquid
Caution: Do not splash any liquid into the instrument when
cleaning
Caution: Do not leave any cleaning liquid on the surface

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 Fetal Doppler User manual

Note: The probe surface may be use 70% alcohol or

Isopropyl alcohol to wipe, dry it in natural air or clean it by a clean,
soft cloth.
6.3 Disinfection
As above described way to clean the instrument appearance
and transducer, then use the alcohol which density is 70% or
isopropyl alcohol to clean the transducer surface. Then use a dry
and soft cloth to clean the liquid left on the instrument.

7 Troubleshooting
7.1 NO display
If the instrument can’ be powered on, please open the
battery cover to check whether the battery is installed well, or
whether the metal electrodes of the battery is contacted with
spring metal in the battery case, if so, reinstall the battery.
7.2 FHR beyond normal range (110-160 bpm)
1. When no fetal heartbeat sound is heard, it is most possible
that the probe is not at a good detective position or the pregnant
moves, adjust the probe to a better detective position.
2. It should not switch off the volume during the monitoring, no
fetal heartbeat sound can be heard when the fetal heart is out of
the ultrasound field due to movement, so care the FHR displayed
on the screen may be meaningless.
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 Fetal Doppler User manual

8 Warranty
All maintenances of this instrument should be operated by
professional technical persons. The warranty period of the PCB
boards is 2 years (from the purchased date), the warranty
periods of the screen and probe is 1 year. All the failures caused
by the material failure or production problem are within the
warranty range. And all the failed parts are free replaced and
repaired. The warranty does not apply if the product:
● has been damaged from improper operation (misuse).
● has been damaged because of improper connection to
other equipment.
● has been damaged by accident.
● has been modified without written authorization of the
Company.
NOTE: The information contained in this publication is carefully
checked and is believed to be correct. Our company assumes no
responsibility for errors contained herein or for any damage to the
user resulting from accidents or any other reasons during
operation of the user’s unit according to this material.
Specifications are subject to change without prior notice.
Warning: This instrument is used for clinic application, not use
for treatment. if you are suspicious of accuracy of result ,you can
verify it through other devices like a stethoscope .
Explaining the label:

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 Fetal Doppler User manual

Warning: you should know the information to avoid the potential

hurt to the patient and doctor.
Caution: you should know this information about how to protect
the instrument.
Note: you should know this important information.
IPX1: closed instrument with water drop proof function.
Manufacturer

Manufacturer’s serial number.

Authorised representative in the european
community
B type applied part .

Refer the files attached with this doppler.

Waste Electrical and Electronic Equipment Directive
2002/96/EC (WEEE Directive).

0482 Declaration of Conformity “The product complies

with the requirements of the MDD 93/42/EEC”.

Manufacturer : ShenZhen LuckCome Technology INC,.Ltd

Factory address: 201, 2F,NO.1 ZhongJian Industrial Building,
NO.18 Yanshan Road, SheKou, Nanshan District,
Shenzhen.Guangdong, China Post: 518067
Tel.: +86-755-26853526 Fax: +86-755-26833076
E-mail:info@ luckcome.com http://www.luckcome.com
European Representative: MEQUIPEX
Addr: Feldstrasse 39, 4813 Altmuenster Austria
Tel: 0043-650 735 2000
Registration No.: AT/CA01/RC001145-00

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 Appendix

Appendix : Guidance and Manufacturer’s EMC Declaration

Table1 Guidance and manufacture's declaration - electromagnetic
emission - for all EQUIPMENT AND SYSTEMS
Guidance and manufacturer’s declaration - electromagnetic
emission
The model FD88 is intended for use in the electromagnetic
environment specified below. The customer or the user of the model
FD88 should assure that it is used in such an environment.
Emission Test Compliance Electromagnetic
Environment
Guidance
RF emissions Group 1 The Model FD88
CISPR11 uses RF energy only
for its internal
function. Therefore,
its RF emissions are
very low and are not
likely to cause any
interference in
nearby electronic
equipment
RF emissions Class B The Model FD88 is
suitable for use in all
CISPR11 establishments
including domestic
establishments
and those directly
connected to the
public Iow-voltage
power supply
network that
supplies buildings
used for domestic
purposes.
Harmonic emissions N/A
IEC 616000-3-2
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 Appendix

Voltage fluctuations / N/A

flicker emissions
IEC 61000-3-3

Table2 Guidance and manufacture's declaration - electromagnetic

immunity - for all EQUIPMENT AND SYSTEMS
Guidance and manufacturer’s declaration - electromagnetic
immunity
The model FD88 is intended for use in the electromagnetic environment
specified below. The customer or the user of the model FD88 should
assure that it is used in such an environment.
EN 60601 Compliance Electromagnetic
Immunity Test
test level Level Environment-Guidance
Floors should be wood,
concrete or ceramic tile.
Electrostatic
±6KV contact ±6KV contact If floors are covered
discharge(ESD)
±8KV air ±8KV air with synthetic material,
IEC61000-4-2
the relative humidity
should be at least 30%.
±2KV for power
Electrostatic supply lines
transient/burst ±1KV for N/A
IEC 61000-4-4 input/output
lines
±1KV
differential
Surge
mode N/A
IEC 61000-4-5
±2KV common
mode
Voltage dips, short <5% UT
interruptions and (>95% dip in N/A
voltage variations UT)

16
 Appendix

on power supply for 0.5 cycle

input lines
IEC 61000-4-11 40% UT
(60% dip in UT)
for 5 cycles

70% UT
(30% dip in UT)
for 25 cycles

<5% UT
(>95% dip in
UT)
for 5 sec
Power frequency
magnetic fields should
Power
be at levels
frequency(50/60Hz)
3A/m 3A/m characteristic of a
magnetic field
typical location in a
IEC 61000-4-8
typical commercial or
hospital environment.

Table3 Guidance and manufacture's declaration - electromagnetic

immunity - for EQUIPMENT AND SYSTEMS that are not
LIFE-SUPPORTING
Guidance and manufacturer’s declaration - electromagnetic
immunity
The model FD88 is intended for use in the electromagnetic environment
specified below. The customer or the user of the model FD88 should
assure that it is used in such an environment.
Immunity Test EN 60601 Test Compliance Electromagnetic
Level Level Environment-Guidance

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 Appendix

Conducted 3Vrms N/A Portable and mobile RF

RF 150k to 80MHz communications equipment
IEC61000-4-6 should be used no closer to
any part of the model FD88,
including cables, than the
Radiated RF 3V/m 3V/m
recommended separation
IEC61000-4-3 80MHz to
distance calculated from the
2.5GHz
equation applicable to the
frequency of the transmitter.
Recommended separation
distance

80MHz to
800MHz

800MHz to
2.5GHz
Where P is the maximum
output power rating of the
transmitter in watts (W)
according to the transmitter
manufacturer and d is the
recommended separation
distance in meters (m).
Field strengths from fixed RF
transmitters, as determined
by an electromagnetic site
survey, a should be less than
the compliance level in each
frequency range. b

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 Appendix

Interference may occur in the

vicinity of equipment marked
with the following symbol:

NOTE 1 At 80 MHz and 800MHz, the higher frequency range applies.

NOTE 2 These guidelines may not apply in all situations.
Electromagnetic is affected by absorption and reflection from structures,
objects and people.
a. Field strengths from fixed transmitters, such as base stations for radio
(cellular/cordless) telephones and land mobile radios, amateur radio, AM
and FM radio broadcast and TV broadcast cannot be predicted theoretically
with accuracy. To assess the electromagnetic environment due to fixed RF
transmitters, an electromagnetic site survey should be considered. If the
measured field strength in the location in which the model FD88 is used
exceeds the applicable RF compliance level above, the model FD88 should
be observed to verify normal operation. If abnormal performance is
observed, additional measures may be necessary, such as reorienting or
relocating the model FD88.
b. Over the frequency range 150 kHz to 80 MHz, field strengths should be
less than 3 V/m.

Table4 Recommended separation distances between portable and

mobile RF communications equipment and the EQUIPMENT or
SYSTEMS - EQUIPMENT and SYSTEMS that are not
LIFE-SUPPORTING
Recommended separation distances between portable and mobile
RF communications equipment and the model FD88
The model FD88 is intended for use in an electromagnetic environment in
which radiated RF disturbances are controlled. The customer or the user
of the model FD88 can help prevent electromagnetic interference by
maintaining a minimum distance between portable and mobile RF

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 Appendix

communications equipment (transmitters) and the model FD88 as

recommended below, according to the maximum output power of the
communications equipment.
Rated Maximum Separation Distance According to Frequency of
Output of Transmitter(m)
Transmitter 80MHz to 800MHz 800MHz to 2.5GHz
(W)

0.01 0.12 0.23

0.1 0.38 0.73
1 1.2 2.3
10 3.8 7.3
100 12 23
For transmitters rated at a maximum output power not listed above the
recommended separation distance d in metres (m) can be estimated
using the equation applicable to the frequency of the transmitter, where P
is the maximum output power rating of the transmitter in watts (W)
according to the transmitter manufacturer.
NOTE 1 At 80 MHz and 800 MHz, the separation distance for the higher
frequency range applies.
NOTE 2 These guidelines may not apply in all situations. Electromagnetic
propagation is affected by absorption and reflection from structures,
objects and people.

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In order to protect your right for repair service, please take a few
moments to fill out the warranty card below:

Warranty Card
Product

Model
SN：

Date of purchase

Warranty period
Customer Name
Tel.
Fax

Add.
Information source □ Internet

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