FM-200

Doppler Fetal Heart Rate Detector

Service Manual

V1.0 2019-05 P/N: 02111797

Shenzhen Biocare Bio-Medical Equipment Co., Ltd.
About the Service Man ual
The Manual serves for repairing this instrument only. Our company shall not be responsible
for any consequences and liabilities caused by using this manual for other purposes.
The Service Manual containing special information is under copyright protection. All rights
reserved. Copy, duplication or translation of the whole or any part of the Service Manual is
prohibited in case of no prior written consent from our company.
Information contained in the Service Manual is subject to changes without further notice.

Note:

Due to technical upgrade or special requirements from users and with the precondition
that the performance of the instrument will not be lowered, some components may vary
from the description of configuration in the Service Manual.

Caution:
Federal law restricts this device to sale by or on the order of a physician. Please read the
user manual carefully prior to use.

The CE mark is a protected conformity mark of European Community.

The products herewith comply with the requirements of the Medical Device
Directive 93/42/EEC

Shanghai International Holding Corp. GmbH(Europe)

Eiffestraße 80
20537 Hamburg
GERMANY

Shenzhen Biocare Bio-Medical Equipment Co., Ltd.

#16-1, Jinhui Road, Jinsha Community, Kengzi Sub-District, Pingshan New
District, 518122 Shenzhen, PEOPLE'S REPUBLIC OF CHINA

Tel: 86-755-33005899 Fax: 86-755-27960643

Website: http://www.biocare.com.cn
Manufacturer ’s Liability
Our company shall be responsible for safety, reliability and performance of the instrument
only assembled and maintained by authorized or approved professional, and operated
following this Service Manual.

The expected application of the instrument is for clinical observation, but not for treatment.
In case of doubt about the result of fetal heart rate detected, please immediately change to
other methods for verification, e.g. stethoscope.

Warranty Statement
Unauthorized maintenance by users is prohibited. All the maintenances are required to be
performed by authorized or approved professional by our company. Only invalid
components or malfunction caused by production process are within the scope of warranty.
With the valid warranty, all the components with fault enjoy maintenance or change at free
of charge. Damage by misuse is beyond warranty.

One year warranty for the main unit counting from the date of purchase;
Half year warranty for Probe counting from the date of purchase (Packing material, battery，
battery charger and consumptive items are beyond warranty);
Lifetime maintenance is available.

This warranty statement does not cover the products reformed, disassembled, reconstructed
or serviced with no approval from our company, and the damaged products caused by
accident, fire accident, lightning, flood, or other disasters, malicious damage, improper
installation or improper use either.

Symbol interpretation of the instrument

Power On/Off Headphone

Type B Applied part Attention! Refer to the document attached.

Refer to instruction manual/booklet

IPX0 No waterproof equipment
IPX1 Can only prevent vertical drip equipment

Note:
We are sorry but customers may not be timely notified for the changes of this Service
Manual.
 Service Manual

Contents
Safety Guidelines.............................................................................................. 1
Safety Precautions.......................................................................................... 1
Cleaning ......................................................................................................... 3
Disinfection .................................................................................................... 3
Chapter One Brief Introduction...................................................................... 5
Characteristics of the instrument ....................................................................... 5
Chapter Two Appearance and Structure .......................................................... 7
Front view ........................................................................................................... 7
Back view and side view .................................................................................... 8
Chapter Three Complete Machine Work Principle ........................................ 9
3.1 Work Principle Introduction ........................................................................ 9
3.2 Supply Principle Framework Chart ........................................................... 10
3.3 Control Board Principle Framework Chart............................................... 11
3.4 Circuit Maintenance of Power Supply and Processing Unit ................... 11
Chapter Four Removal and Installation ......................................................... 17
4.1 Physical Removal ....................................................................................... 17
4.2 Physical Installation ................................................................................... 19
Chapter Five Maintenance ............................................................................. 21
Maintenance ...................................................................................................... 21
Cleaning ............................................................................................................ 21
Disinfection ....................................................................................................... 22
Chapter Six Troubleshooting ......................................................................... 23
Appendix A Technical Index .......................................................................... 25
Appendix B Accessories .............................................................................. 29

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Safety Guidelines
The instrument is with inner power at Type B of electric shock prevention
degree.

Type B application part is with specific prevention degree for electric shock.
Type B application part indicates that the connection with patient is required to
meet the regulations on leakage current and intensity of dielectric medium
approved by IEC60601-1.

Safety Precautions

For avoiding possible injury, it is required to following the safety precautions

below while operating the instrument.
 Do not use in the place with inflammable gas (e.g. anesthetic gas) to avoid
the risk of explosion.
 Do not throw the battery into fire to avoid explosion.
 Do not charge the normal dry battery to avoid fire accident caused by
current leakage, or even explosion.
 Do not contact the signal input or output connector and the patient at the
same time.
 This instrument is a portable Doppler fetal heart rate detector, and it is not
irreplaceability of standard Fetal Monitor.
 Keep battery replacement away from patient (Minimum 2meter away
from the patient).
 The maximum stretching length of probe cable is 2meter. Otherwise, the
cable may be pulled out from the instrument.
 Authorized and qualified technicians are required for performing
maintenance on this instrument.

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 The instrument is designed to be a continuous work instrument, a general

IPX1 (a closed equipment without the function of liquid-immerging-proof)
equipment. Please keep it away from splash water.
 Keep the instrument clean and free of vibration.
 High temperature disinfection or with sterilization with x-ray or γ-ray are
prohibited.
 The use environment of the instrument is required to be free of strong
electromagnetic interference.
 Before use, checking for finding obvious problems possibly causing
safety risk to patients or damages for performance of the instrument is
required. If yes, please do not use any more. It is recommended to make
regular check once a month or more frequently.
 Safety check (Including mechanical function, safety label, expected
function and compliance of safe current leakage/ intensity of dielectric
medium with the regulations prescribed in standard IEC60601-1) is
required to be implemented by personnel who are properly trained and
with sufficient experiences. Generally, check and testing is made once a
year or given by following the prescribed testing rule by the state testing
institutions.
 Chargeable battery: for ensuring lifespan, a performance of the chargeable
battery, please charge the battery full before the first time of use. It is
generally to charge it following the indications for charge on the battery.
 Short circuit or installation with reverse polarity of battery is prohibited.
 In case of long term unemployed, the battery is required to be taken out.
 The battery is required to be kept in cool and dry environment.
 Do not store the battery together with metal articles to avoid short circuit.
 The instrument cannot be used until the cover of battery pack is replaced.

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 At expiration of effective lifespan of the battery, it is required to make

proper disposal of the battery by following the local regulations
prescribed.

Cleaning

 Use of strong solvent like acetone is prohibited.

 Abrasive material is prohibited for use.
 Do not have any liquid come into the casing of the instrument; do not dip
any part of the instrument into liquid either.
 Do not pour liquid into the instrument for cleaning.
 Do not remain any cleaning residue on surface of the instrument.

Disinfection

 Disinfection with low temperature steam or other methods for the

instrument or probe is prohibited.

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Chapter One Brief Introduction

Doppler fetal heart rate detector is a portable equipment to detect the heart rate
of fetus. It is applicable for monitoring the growing index of fetus in Outpatient
Department of Obstetrics & Gynecology and delivery room.

Doppler fetal heart rate detector is composed of the parts used for ultrasonic
signal emitting and receiving, simulating signal processing, fetal heart rate
calculation and display control.

Characteristics of the instrument

 Ultrasonic Doppler probe incorporating with the special heart rate

calculation contributes to reliable measurement of fetal heart rate.
 LCD shows the real time fetal heart rate.
 Signal strength indicating function grants an easy location of ultrasonic
probe.
 Alarm function for fetal heart rate detected is convenient for judging if the
fetal heart rate exceeds the preset limit.
 The upper and lower limits are adjustable and can be saved.
 Indication for probe poor contact is convenient for user to judge the
improper use.
 Convenient and practical battery level indication and low battery alarm
 In case of fail in detecting the probe or signal within 2 minutes, it will
automatically power off to save power.
 Low power consumption design contributes to continuous measuring and
monitoring.
 Volume is adjustable.
 External headphone interface.

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Chapter Two Appearance and Structure

Front view

1
5

3
4

Figure 2-1

1. LCD Show fetal heart rate, signal level and battery level, etc.
2. Speaker (Built-in) For audio output of fetal heart beat
For power On/Off (Long press for roughly 5 seconds is
3. Power On/Off
for power-off.)
4. Probe Be used for collecting the related signals of fetus.
For connection with headphone to monitor fetal heart
5. Headphone jack
beat.

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Back view and side view

1 2

-
3

UP
4

DOWN
5

MODE
6

Figure 2-2
Item Function

AA Ni-MH rechargeable batteries or AA alk alin e

1. Battery Cabinet
batteries is already placed in.
2. Belt clamp For clamping/fastening the instrument.

3. Volume switch For adjusting the volume of fetal heart beat.

4. UP button For setting upper limit of alarm.

Start and stop of counting when the instrument works on

5. DOWN button
mode 3, and setting lower limit of alarm.
For switch over of modes. The instrument is with three
work modes:
 Real time fetal heart rate display mode
6.MODE button  Average fetal heart rate display mode
 Manual counting mode
 Setting mode (mode 0)

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Chapter Three Complete Machine Work Principle

3.1 Work Principle Introduction

The fetal heart beat signal can be obtained through the acoustic-electric energy
conversion device (ultrasound chip), and then form voltage electrical signals
after frequency discrimination, filtration and amplification. One signal is
amplified by amplifier circuit and goes to the speaker to get the heart rate
sound, and the other is transformed into digital signal through the A / D and
sent to the arithmetic unit to extract the accurate value of fetal heart rate with
the auto-correlation algorithm; and then the heart rate value is displayed on the
LCD screen. FM-200 LCD screen is a pen-segment large font screen, with
clear display of every function. For ease of use, the power can adopt No.5
rechargeable batteries or ordinary dry batteries, and two reliable voltage
conversion devices are adopted inside to feed the CPU and the amplifier circuit,
which achieves more stable performance for the whole machine.

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3.2 Supply Principle Framework Chart

Battery

Voltage regulator Voltage regulator

Voltage stabilizer

Voltage stabilizer

Figure 3-1
The battery voltage input passes through the voltage regulator to output the
5.2V, and then through two voltage stabilizers with regulated voltage of 5V and
3.3V separately. The other circuit directly passes through the voltage regulator
to output voltage of 3V directly.
Wherein:
5V is the main power supply for the analog processing section and the probe;
3.3V is the main power supply for the CPU and its peripheral circuits;
3V is the main power supply for amplifier circuit of heart rate sound;

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3.3 Control Board Principle Framework Chart

After getting into the motherboard, the signals from the probe of fetal heart rate
are divided into two signals for processing: the first signal is amplified by the
precision rectifier and limiter circuit, and then gets into the CPU for A / D
conversion before digital signal processing, and finally the processed data will
be displayed; the second signal does not require digital processing, but will be
sent to the speaker after direct rectification and amplification. The speaker
volume will be adjusted via potentiometer.

probe of
fetal heart Rectifier amplifier speaker
rate

Volume
Rectifier display
adjustment

press key display drive

Figure 3-2

3.4 Circuit Maintenance of Power Supply and Processing Unit

Maintenance of power supply:

In case of unable power-on, no display, stillness and other faults, please firstly
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consider whether it is caused by abnormal power. Prior to testing, visually

observe whether there are obvious phenomenon such as cylindrical ladle of
capacitor and burned IC. If there is no abnormal appearance on the
motherboard, please confirm that the battery is fully charged, and in good
contact. Then you can use the multimeter to measure the tenth pin of DC-DC
converter U7. Under normal circumstances, there should be 5.2V output
voltage. Then measure the fifth pin of voltage regulator U8, where should be
3.3V output voltage. Likewise, measure the fifth pin of voltage regulator U10,
where should be 5V output voltage. If U7 has no voltage output, neither U8 nor
U10 has any output. You can determine faulty point according to the following
circuit diagram. Note that the 5V and 3.3V voltage outputs in the circuit shown
in the following figure are main power supply for analog amplifier, probe, and
CPU peripheral circuit. During maintenance, you can make a judgment to
repair the circuit that may be affected by the power failure. The circuit of
power amplifier part of heart rate sound adopts a separate power supply.

Hard
power-off Power off

Soft power-off due to low battery

Figure 3-3 Circuit diagram of analog amplifier, probe and CPU power supply

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Because the amplifier module of heart rate sound consumes more consumption,
a separate DC-DC converter U14 is adopted for power supply. This separate
design is conducive to stability of the system, reducing the interference caused
by voltage fluctuations.In case of abnormal heart rate sound, or no display of
heart rate sound, etc., please first determine the faulty point by measuring the
circuit as follows. The specific method is to use the multimeter to measure the
tenth pin of DC-DC converter U14. Under normal circumstances, there should
be a 3V output voltage. If no voltage output, the DC-DC converter may have
been damaged.

Figure 3-4 Circuit diagram of amplifier power supply of heart rate sound

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Maintenance of amplifier circuit of detector:

Detector amplifier

Figure 3-5 Circuit diagram of amplifier of heart rate sound

After determining that the probe of fetal heart rate is intact and the power
supply circuit of amplifier of heart rate sound keeps at normal voltage, please
consider that the fault may appear in the amplifier circuit of detector if there is
no heart rate sound or there is heart rate sound but no heart display.
This kind of faults is more difficult to be determined, which normally needs
Depot Repair. However, if applicable, users can adopt the oscilloscope to
perform simple detection and judgment for all levels of amplifier circuits.If
there is no heart rate display, hand rub the probe, and use an oscilloscope to
detect the first pin, seventh pin, eighth pin, fourteenth pin of operational
amplifier U1, and the first pin and seventh pin of U2 level by level. Observe
whether there is signal in the oscilloscope during every detection and
determine the faulty point. If there is no heart rate sound, the maintenance
method is the same as above, test the eighth pin and fourteenth pin of
operational amplifier U2 level by level. Of particular note is that no heart rate
sound may sometimes caused by bad contact of the volume control
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potentiometer or accidental adjustment to the minimum volume.

Local Maintenance of CPU circuit:

For this part of the circuit, users cannot do maintenance by themselves. Even if
they have determined that the CPU was damaged, they cannot repair it by
self-replacement, because the CPU shall be burned with the process. Therefore,
if any CPU fault is detected, please contact the factory for maintenance.

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Chapter Four Removal and Installation

4.1 Physical Removal

Removal of outer casing

1.Turn over the machine, and

remove six screws from the bottom
of the machine with a screwdriver.
Note that the screw at the left down
corner can be seen only after the
batteries are removed.

Figure 4-1

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Removal of motherboard

Unplug speaker
connection
cable

After removing the

back casing, remove
two screws that fix the
motherboard with a
screwdriver, and then
remove the
motherboard.
Figure 4-2
Description of the front of the motherboard:
Earphone
socket

LCD screen
Volume
control
switch

Function P ower-on b utton

key

Figure 4-3
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Description of the back of the motherboard:

Earphone Volume
socket control
switch

Function
key
Battery
insert

P robe
socket
Figure 4-4

4.2 Physical Installation

Machine installation is the reverse process of removal.

During installation, route the cables according to the original cable routing (to
avoid interference); ensure good contact of sockets, correct connection of
cables, secure screws of the motherboard, and in-place installation. After
installation, power on and check once to ensure correctness; do one-hour aging
test to ensure correctness before delivery.

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Chapter Five Maintenance

Maintenance

The probe is precise ultrasonic equipment, and therefore great care is required
to use and save it. After use, the excessive coupling gel should be removed.
The maintenance will prolong the lifespan of the monitor.

Before use, checking for finding obvious problems possibly causing safety risk
to patients or damages for performance of the instrument is required. It is
recommended to make regular check once a month or more frequently.

Regular safety test for the instrument is required. It is recommended to make a

test once for every year or to perform the test following the instructions of
public institutions and test procedures.

The accuracy of fetal heart rate is controlled by the instrument. Unauthorized

adjustment is prohibited. In case of unreliable result for fetal heart rate, please
use other methods, e.g. make verification with stethoscope, or contact local
distributor for help.

Cleaning

1. Before start cleaning, please disconnect power to the instrument, and take
the battery out.
2. Keep the surface of the instrument clean and free of dust. Clean the surface
of instrument (Including the digital display part) with a piece of dry and soft
cloth. If necessary, clean the surface with a piece of cloth soaked with suds or
water.

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3. Probe cleaning: Remove the excessive coupling gel with a piece of soft cloth.
The probe can be cleaned only with suds or water.
4. Use of strong solvent like acetone is prohibited.
5. Abrasive material (e.g. steel wool) is prohibited for use.
6. During cleaning, do not have any liquid come into the casing of the
instrument, and do not dip any part of the instrument into liquid either.
7. Do not pour liquid on to the instrument while cleaning.
8. Do not remain any cleaning residue on surface of the instrument.

Note:
The surface of probe can be wiped with 70% alcohol or isopropyl alcohol, dry
it naturally or clean it with clean and dry cloth.

Disinfection

Clean the surface of the instrument and probe with methods mentioned above.

Note:
Disinfection with low temperature stream, solution and other methods for the
instrument and probe is prohibited.

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Chapter Six Troubleshooting

Part Phenomena Possible Causes Solutions

Low volume Adjust the volume
upward
Poor contact of fetal Connect the probe
heart rate probe again.
There is a gap Apply some coupling
Weak or
between the probe and gel and force the air
shriveled fetal
skin. bubble between the
heart beat
probe and skin out.
Fetal The probe does not Gently move the
heart aim at fetal heart. probe for the best
beat position.
Damaged equipment * Servicing
The scrambled signal After having the
Fetal hear beat is caused by large pregnant woman
can be heard, but motion of the repose, gently move
is scrambled and pregnant woman or the probe till the clear
no heart rate fail for the probe in fetal heart beat is
displayed. the best position. heard for detecting the
best position.

Note:
The item marked with * is required to be maintained by the professionals
from our company or professionals approved by our company.

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Appendix A Technical Index

Product name Doppler Fetal Heart Rate Detector

Model FM-200
Safety Standard EN 60601-1, IEC 60601-2-37

Classification
Electric shock resistance type Internally powered equipment
Electric shock resistance gradeType B applied part
Ultrasonic Doppler fetal heart rate
Function detector with the function of fetal heart
rate detecting
The type of ultrasonic Doppler Continuous ultrasonic Doppler fetal
sensor heart rate detector
Hazardous liquid immerging
Main unit is IPX0 while probe is IPX1
resistance grade
Safety grade when used in the An equipment can not used in the
condition with mixed gas of condition with mixed gas of flammable
flammable anesthetic gas with air anesthetic gas with air or/with Nitrous
or/with Nitrous oxide oxide
Work type Continuous work
Electromagnetic compatibility Group I, Class B

Probe
Work mode Continuous ultrasonic Doppler
Ultrasonic work frequency 2MHz or 3MHz, tolerance: ±5％；
≥90dB
Synthetical sensibility(At position (Measured in the state with rated work
200mm far from the probe frequency of 2 MHz and reflecting
surface) target speed of 140bpm); (3MHz is
optional, error: ±5%);
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Maximum ultrasonic power

<18mW
output
Peak sound pressure at space
≤0.2MPa
peak and time peak
Output beam intensity Iob＜20 mW/cm2
Peak-negative acoustic pressure P-＜1MPa
Spatial-peak temporal-average
Ispta＜100mW/cm2
derived intensity
Effective ultrasonic emitting area 3.14cm2 ±10％

Fetal heart rate (FHR)

Measuring range of fetal heart
50bpm～240bpm
rate
Resolution 1bpm
Precision ±2bpm

LCD (Can be turned on and off the

Display backlight)
adjustable
Adjustable lower limit range: 50bpm～
Fetal heart rate
120bpm
alarm limit
Adjustable upper limit range:
160bpm～240bpm
Alarm triggering time ＜3s
0.5W/8Ωspeaker can be connected
Audio output with headphone, and the volume is
adjustable
it will automatically power off in case
Automatic power-off
of no signal for 2 minutes

Battery
Storage temperature -10℃～+40℃

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3.0V, 2 x 1.5V Alkaline Battery (AA)

DC (non-rechargeable), and the continuous
monitoring time is over 5 hours.
Power 500mW

Overall dimensions/weight
Overall dimensions 130mm×89mm×34mm
Net Weight 405g (Including battery)

Environment requirement
Ambient temperature +0℃～+40℃
≤95% (No
Relative humidity
Work environment condensation)
70kPa ～
Atmospheric pressure
106kPa
-20 ℃ ～
Ambient temperature
+55℃
≤95% (No
Relative humidity
Transportation and storage condensation)
70kPa ～
Atmospheric pressure
106kPa
Without corrosive gas, good ventilation

Statement of acoustic output:

Acoustic output parameters of this device are in accordance with relevant
requirements of IEC 61157:1992. When the fawf is 2.0MHz or 3.0MHz, its peak
negative acoustic pressure is: p_<1MPa, output beam intensity is:
Iob<20mW/cm2, and space peak time average sound intensity is:
Ispta<100mW/cm2.

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Appendix B Accessories

Fetal Doppler Main Unit 1 PC

Ultrasound Doppler Probe 1 PC
Ultrasound Coupling Gel 1 PC
AA Alkaline Battery 2 PCS
Qualified Certificate 1 PC
Packing List 1 PC
User Manual 1 PC

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Shenzhen Biocare Bio-Medical Equipment Co., Ltd.

Address: #16-1, Jinhui Road, Jinsha Community, Kengzi Sub-District, Pingshan New
District, 518122 Shenzhen, PEOPLE'S REPUBLIC OF CHINA
Tel: +86-755-33005899 Fax: +86-755-27960643
E-mail：sales@biocare.com.cn support@biocare.com.cn
Website: http://www.biocare.com.cn