SAN-Operation Manual FD-490 Ver 2.4 EU

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DOPPLER FETUS DETECTOR

FD-490(FD-491/FD-492)

O p e r a t io n M a n u a l

CAUTION
● This device can only be operated by a physician or under the direction of a
physician.
● Read this instruction manual carefully before use and operate the device
according to the instructions in the manual.
● Keep this operation manual close by for reference in the event of any
questions regarding use. Inappropriate handling may result in an accident.

Manufacturer Authorized Representative in Europe

TOITU CO., LTD. Emergo Europe


1-5-10, Ebisu-Nishi, Shibuya-Ku, Prinsessegracht 20
Tokyo 150-0021, Japan 2514 AP The Hague
Tel: +81-3-3463-6381 The Netherlands
Fax: +81-3-3463-6380 Tel: (31) (0) 70 345 8570
E-mail: [email protected] Fax: (31) (0) 70 346 7299 Ver.2.4EU
URL: http://www.toitu.co.jp/e/ 2020-09
INTRODUCTION
Thank you for purchasing the Doppler Fetus Detector FD-490. Please
read this operation manual to ensure safe, proper use of this device.
This device was inspected for confirmation of problem-free operation
before factory shipment. After opening the package, please check for
damage during transport and read this operation manual carefully to
ensure proper operation. In the event of any damage or problems with
the operation of this device, Please contact us or distributor.
● This operation manual
Describes of the handling necessary to use the Doppler Fetus
Detector FD-490 and the safety precautions must be followed.
Read this operation manual carefully before use to ensure safe,
proper operation. Any deviation from the instructions in this manual
may result in poor performance or damage to the device. All users
must read “For Safe, Proper Use” even when familiar with the
handling of this device. Carelessness may result in a serious
accident.

● The intended use of this device is as follows:


The Doppler Fetus Detector FD-490 will detect fetal heart sounds,
sounds of umbilical blood flow, or the fetal position based on
Doppler signals from the fetal heart, umbilical blood flow, and other
sounds from the early stage of pregnancy to parturition.

● To use this device in the proper condition:


Proper operation and periodic maintenance is required. Only
qualified personnel should repair this device. Toitu (hereinafter the
“Company”) and agents of the Company will assume no
responsibility for the performance of this device and the safety of
users for improper use or repair by unqualified personnel.

I
For Safe and Proper Use

In this operation manual, precautions to observe are classified as “Warning” and


“Caution” and described with pictograms. These signs are classified as follows
according to the hazard level. Read the body text and fully understand the
meaning.

WARNING
Failure to heed this precaution may result in death or serious injury.

CAUTION
Failure to heed this precaution may result in personal injury or damage to property.

II
List of Warnings
The following are all of the warnings. They may be described in the body text as needed.
Read carefully for safe, proper use.

To prevent the possibility of death or injury, breakdown, and incorrect operation


1. Follow the instructions in this operation manual. In the event of an abnormality, stop
operation immediately.
2. Be sure to check the device before use. If you cannot confirm proper operation by
inspection, turn off the power and remove the power plug from the outlet. Stop using
the device, attach a label stating “Breakdown”, and ask our office or distributor for
immediate repairs. [Failure to follow these instructions may result in an accident, false
recognition, or device malfunction.]
3. Do not disassemble or modify this device. [Failure to follow these instructions may
result in an accident or device malfunction.]
For the wireless type;
4. If two or more of these devices are used in the same facility, check the pairing of the
main unit and the wireless. Failure to follow these instructions may result in a mix-up
of patients.
5. If there is a wireless device other than this device that may cause interference, consult
us or distributor about measures to prevent such interference (e.g. installation of
partitions).

To prevent misdiagnosis
1. Do not use a probe that does not emit a Doppler sound.
2. Adjust the probe to the optimum position in response to fetal movement. If the probe
contacts a maternal blood vessel, the device will detect the maternal heart rate.
3. If intrauterine fetal death is suspected by this examination, examine using another
method.

To prevent electric shock


1. Be sure to use the provided power cord.
The use of other power cords may cause electric shock to the patient and the user.
2. Ancillary equipment to connect to the analog or digital interface of this device must be
compatible with related IEC specifications. (E.g. IEC 60950-1 for data processing
devices, CISPR 32 EMC of multimedia equipment, IEC 60601-1 for medical devices)
in addition, all configurations must be compatible with IEC 60601-1. Therefore,
anyone connecting additional equipment to this device must assume responsibility for
system compatibility with the requirements of IEC 60601-1. Please contact us or
distributor if you have any questions.

III
3. Attach or remove the battery after unplugging the power cord.
Do not operate devices when wet or with wet hands. Doing so may cause a
breakdown of the device or electric shock to the user.

To prevent infection
1. Clean and disinfect this device after every use.
2. This device is not disinfected before shipment. Be sure to disinfect and clean before
use.

To prevent explosion and fire


1. Do not use in a location where there is a risk of explosion, such as environment with
flammable anesthetic gas or oxygen.
2. Do not place heavy objects on the power cord or expose the power cord to the weight
of other objects. Do not damage, abuse, twist, pull, or heat the cord. In the event of
damage to the power cord (exposed core or breakage), ask our office or distributor for
an exchange.

To avoid electromagnetic effects


1. This device may cause poor transmission or interfere with other devices because of
radio interference. Such interference requires changing the direction or installation
location of this device or measures to reduce interference such as a shield.
2. Use of accessories, probes, and cables other than the specified ones may cause an
increase in emissions or reduce the resistance to interference of this device.
3. If this device is used close to or stacked on top of another device, check the correct
operation in the arrangement used.
4. Use a cable of 1.2 m or less in length for the earphones.
5. Attach a connector cover to a connector that is not in use. (Connector for Wired probe,
External output terminal)
6. Pins of connectors identified with ESD warning symbol should not be touched and that
connections should not be made to these connectors unless ESD precautionary
procedures are used. We recommend that all staff involved receive an explanation of
ESD warning symbol and training in ESD precautionary procedures.

Contraindication
1. Do not use microwave ovens, microwave therapy apparatuses, or devices utilizing
microwaves near this device. Failure to heed this warning may result in device
malfunction.
2. Supervise and advise people not to bring mobile phones, transceivers, radio control
toys, and other electronic devices into the room where this monitor is installed. Failure
to heed this warning may result in device malfunction.
3. Do not use in an X-ray room, MRI room, or image processing room. Failure to heed
this warning may result in device malfunction.
IV
4. This device cannot be used in conjunction with an electrosurgical knife, defibrillator, or
MRI. All probes and accessories must be removed before use of an electrosurgical
knife, defibrillator, or MRI. Failure to heed this warning may result in damage to the
device

Warning label
The following warning label is attached to the probe/gel holder to indicate an especially
important precaution. Be sure to read the label before use.

Location of label

This symbol indicates that this product comes under the provisions of
EU Directive 2002/96/EC on waste electrical and electronic equipment
(WEEE) and that this unit was placed on the market after 12 August
2005.This directive covers EOL (end-of-life) disposal.

V
Meaning of Symbols

Symbols
1. Symbols of the IEC International Standard and the Japanese Industrial Standards

Class II device Input

Functional ground I/O Connector

Attached part type B Alternate current

Device sensitive to
Fuse
static electricity

Caution Non-ionizing radiation

2. Toitu symbols

Radio wave condition Battery symbol

Abnormality indicator of
Earphone
probe

VI
Electromagnetic Compatibility (EMC)

MEDICAL ELECTRICAL EQUIPMENT needs special precautions regarding EMC and needs to be
installed and put into service according to the EMC information provided in this document.

WARNING
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 FD-490, including cable specified by the manufacturer. Otherwise, deviation of the
performance of this equipment could result.

The FD-490 should not be used adjacent to, or stacked with, other equipment. If
adjacent or stacked use is necessary, the equipment or system should be tested to
verify normal operation in the configuration in which it is being used.

This device complies with the EMC standard IEC 60601-1-2:2014/ EN 60601-1-2:2015.

Essential Performance
The Essential Performance for FD-490 is as follows.
 To examine the fetal heartbeat in early, middle and late pregnancy using Doppler technology

The following phenomena are expected when the Essential Performance is lost or degraded.
 Technical alarm
 No wafeforms and/or numeric values
 Noise is heard in the Doppler sound
 The device has a complete failure

VII
Guidance and Manufacturer’s Declaration ‐ Electromagnetic Emissions
The FD-490 is intended for use in the electromagnetic environment specified below.
The customer or the user of the FD-490 should assure that it is used in such an environment.

Emissions test Compliance Electromagnetic environment ‐ guidance

The FD-490 uses RF energy only for its internal function.


RF Emissions Therefore, its RF emissions are very low and are not
Group 1
CISPR 11 likely to cause any interference in nearby electronic
equipment.

RF Emissions
Class B
CISPR 11

The FD-490 is suitable for use in all establishments,


including domestic establishments and those directly
Harmonic Emissions
Class A connected to the public low-voltage power supply
IEC 61000-3-2
network that supplies buildings used for domestic
purposes.

Voltage Fluctuations/
Flicker Emissions Complies
IEC 61000-3-3

VIII
Guidance and Manufacturer’s Declaration ‐ Electromagnetic Immunity

The FD-490 is intended for use in the electromagnetic environment specified below.
The customer or the user of the FD-490 should assure that it is used in such an environment.

IEC 60601 Electromagnetic environment


Immunity test Compliance Level
Test Level ‐ guidance

Floors should be wood, concrete


Electrostatic ±8 kV contact ±8 kV contact or ceramic tile.
Discharge (ESD) ±2 kV, ±4 kV, ±2 kV, ±4 kV, ±8 kV, If floors are covered with synthetic
IEC 61000-4-2 ±8 kV, ±15 kV air ±15 kV air material, the relative humidity
should be at least 30%.

±2 kV for power ±2 kV for power


Electrical Fast supply lines supply lines Mains power quality should be
Transient/Burst that of a typical commercial or
IEC 61000-4-4 ±1 kV for Not applicable hospital environment.
input/output lines

±0.5 kV, ±1 kV line ±0.5 kV, ±1 kV line


(s) to line (s) (s) to line (s) Mains power quality should be
Surge
±0.5 kV, ±1 kV, ±0.5 kV, ±1 kV, that of a typical commercial or
IEC 61000-4-5
±2 kV line (s) to ±2 kV line (s) to hospital environment.
earth earth
0% UT: 0.5 cycle 0% UT: 0.5 cycle
At 0º, 45º, 90º, At 0º, 45º, 90º,
135º, 180º, 225º, 135º, 180º, 225º, Mains power quality should be
270º and 315º 270º and 315º that of a typical commercial or
Voltage dips, short
hospital environment. If the user
interruptions and
0% UT: 1 cycle 0% UT: 1 cycle of the FD-490 requires continued
voltage variations on
and and operation during power mains
power supply input
70% UT: 25/30 70% UT: 25/30 interruptions, it is recommended
lines
cycles cycles that the FD-490 be powered from
IEC 61000-4-11
Single phase: at 0º Single phase: at 0º an uninterruptible power supply or
a battery.
0% UT: 250/300 0% UT: 250/300
cycle cycle
Power frequency magnetic fields
Power Frequency
Not applicable should be at levels characteristic
(50/60 Hz) Magnetic
30 A/m of a typical location in a typical
Field NOTE 2 commercial or hospital
IEC 61000-4-8
environment.
NOTE 1: UT is the a. c. mains voltage prior to application of the test level.
NOTE 2: This test is not applied (N/A). Because this EUT is not magnetically sensitive.

IX
Guidance and Manufacturer’s Declaration ‐ Electromagnetic Immunity

The FD-490 is intended for use in the electromagnetic environment specified below.
The customer or the user of the FD-490 should assure that it is used in such an environment.

IEC 60601 Compliance Electromagnetic environment


Immunity test
Test Level Level ‐ guidance
Conducted RF 3V 3V Field strengths from fixed RF transmitters,
IEC 61000-4-6 0.15 MHz-80 MHz as determined by an electromagnetic site
a
survey , should be less than the
b
The ISM (industrial, compliance level in each frequency range .
scientific and
medical) bands Interference may occur in the vicinity of
between 0.15MHz equipment marked with
and 80MHz are the following symbol:
6.765MHz to
6.795MHz;
13.553MHz to
13.567MHz;
26.957MHz to
27.283MHz; and
40.66MHz to
40.70MHz.

6 V in ISM and 6V
amateur radio
c
bands between
0.15 MHz and 80
MHz

80% AM at 1 kHz

Radiated RF 10 V/m 10 V/m


IEC 61000-4-3 80 MHz to 2.7 GHz
80% AM at 1 kHz

Note: These guidelines may not apply in all situations. Electromagnetic propagation is affected
by reflection from structures, objects, and people.

a
Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless) telephones
and land mobile 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 equipment is used exceeds the applicable RF compliance level above, the equipment
should be observed to verify normal operation. If abnormal performance is observed, additional
measures may be necessary, such as re-orienting or relocating the equipment.
b
Over the frequency range 150 KHz to 80 MHz, field strengths should be less than 3 V/m.
c
The ISM (industrial, scientific and medical) bands between 0.15MHz and 80MHz are 6.765MHz to
6.795MHz; 13.553MHz to 13.567MHz; 26.957MHz to 27.283MHz; and 40.66MHz to 40.70MHz.
The amateur radio bands between 0.15MHz and 80MHz are 1.8MHz to 2.0MHz, 3.5MHz to 4.0MHz,
5.3MHz to 5.4MHz, 7MHz to 7.3MHz, 10.1MHz to 10.15MHz, 14MHz to 14.2MHz,18.07MHz to
18.17MHz, 21.0MHz to 21.4MHz, 24.89MHz to 24.99MHz, 28.0MHz to 29.7MHz and 50.0MHz to
54.0MHz.

X
Test specifications for ENCLOSURE PORT IMMUNITY to RF Wireless
communications equipment
WARNING: 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 FD-490, including
cable specified by the manufacturer. Otherwise, deviation of the performance of this equipment could
result.
Test Maximum Immunity
Band Distance
frequency Service Modulation Power Test Level
(MHz) (m)
(MHz) (W) (V/m)

Pulse modulation
385 380-390 TETRA 400 1.8 0.3 27
18 Hz
FM ±5 kHz
GMRS 460,
450 430-470 deviation 2 0.3 28
FRS 460
1 kHz sine
710
LTE Band 13, Pulse modulation
745 704-787 0.2 0.3 9
17 217 Hz
780

810 GSM 800/900,


TETRA 800,
Pulse modulation
870 800-960 iDEN 820, 2 0.3 28
18 Hz
CDMA 850,
930 LTE Band 5
GSM 1800;
1720
CDMA 1900;
GSM 1900;
1845 Pulse modulation
1700-1990 DECT; 2 0.3 28
217 Hz
LTE Band 1,
1970 3, 4, 25;
UMTS
Bluetooth,
WLAN,
Pulse modulation
2450 2400-2570 802.11.b/g/n, 2 0.3 28
217 Hz
RFID 2450,
LTE Band 7
5240
WLAN 802.11 Pulse modulation
5500 5100-5800 0.2 0.3 9
a/n 217 Hz
5785

XI
Radio Wave Information
This device uses a radio wave frequency of 2.4GHz. Many systems operate within this
frequency band industrial, scientific, or medical devices; microwave ovens; and on
premises radio stations for mobile identification on the manufacturing lines in factories
that require a license, specified low power radio stations that require no license, and
amateur radio stations, (hereinafter called as “other radio stations”). This device uses the
full band of 2.4GHz and cannot avoid the band of systems for mobile identification. The
FH-SS system is employed as the method of modulation, and a distance of 10 m or less
may cause interference.

Remarks: Precautions for use of common wireless devices


1. Make sure that no other radio stations are near the device before use.
2. If there is any harmful radio wave interference between other radio stations,
immediately change the frequency of this device, change the location, or stop
operation (stop transmission of radio waves).
3. Contact us or distributor in the event of any problems, such as radio wave
interference.

XII
Table of Contents
Introduction I
For Safe and Proper Use Ⅱ
List of Warnings Ⅲ
Meaning of Symbols VI
Electromagnetic Compatibility (EMC) VII
Radio Wave Information XII

1. Summary 1
1-1. Features 1
1-2. Principles 2
2. List of Components 3
2-1. Wired Type 3
2-2. Wireless Type 3
3. Part Names and Functions 4
3-1. Main Unit 4
3-2. Probe 9
4. Preparations 11
4-1. How to attach/remove the Rechargeable Battery 11
4-2. Wired Type 12
4-3. Wireless Type 13
5. How to Use 18
5-1. Usage Environment 18
5-2. Charging the Main Unit 19
5-3. Turn on the Power 20
5-4. Inspection before Use 21
5-5. Apply ultrasound gel 23
5-6. Measurement 24
5-7. After Measurement 26
5-8. Standby Mode 27
5-9. Isolation from supply mains 28

6. Functions 29
6-1. Display Function 29
6-2. External Output 31
7. Settings 32
7-1. No Signal Power Off 33
7-2. Automatic Power Off 34
7-3. Timer Setting 34
7-4. Buzzer Volume 35
7-5. Date and Time 36
7-6. Operation Sound 38
7-7. Brightness of Backlight 39
7-8. Languages 39
7-9. Sweep Rate 40
7-10. Wireless Off Timer (Wireless Type Only) 40
8. Cleaning/Inspection/Storage 42
8-1. Cleaning 42
8-2. Inspection 45
8-3. Storage 50
9. Troubleshooting 51
9-1. Wired Type 52
9-2. Wireless Type 54
10. Specifications 56
10-1. Product Specifications 56
10-2. Accessories 59
10-3. Usable service life/Warranty/Disposal 60
10-4. Service parts 60

Notification to Users 61
1 . S um ma r y
The FD-490 is a handheld Doppler fetus detector used by physicians or medical
professionals under the direction of a physician to examine fetal heart sounds, sounds of
umbilical blood flow, or fetal position. This device consists of the main unit and the probe.
The main unit incorporates an LCD screen to display fetal heart rates and a speaker to
amplify Doppler sounds. There are two types of probe: wired and wireless.

● Wired type ● Wireless type

1-1. Features

• User friendly display


Heart rate display was enlarged.
(Length and width are twice as large as
the conventional Doppler fetus detector.)
Changes in heart rates can be identified in the
waveform display by switching the screen.

• Storage of measurement data


The internal memory can hold 160 items.
(one item: 10 minutes after power on)

• Touch panel operation


Control the volume and configure the settings simply by touching the screen.

• Waterproof probe
The probe is waterproof (IPx7).
The probe can be washed, allowing more hygienic use.

1
•Probes
Three types of probes are available as follows:
Use each type depending on the intended purpose.
• The wired type features a curled cord offering better maneuverability than previous
models.
• The wireless type frees the operator and patient from having to worry about the
cord during use.

• Wired type (Upright) • Wired type(L-shape) • Wireless type (L-shape)


TR-205 TR-203 TR-204
• Light and compact
The unit is light, compact, and easy to carry.
• Convenient power supply in two ways
The unit can be used the internal battery when there is no electrical outlet in the
area.

1-2. Principles
This device detects the fetal heart rate using ultrasound Doppler technology. When a
high-frequency voltage is applied to the transmission element of the probe, the
element vibrates and emits ultrasound waves. When these ultrasound waves reach
the fetal heart through the maternal abdominal wall, the waves are reflected by the
movement of the heart valves, blood flow, and fetal movement and return to the
receiving element of the probe. The received waves are processed as signals and
separated by differences between the heart-rate signal and the fetal movement signal.
The Doppler sound caused by the fetal heart rate can be heard through the speaker
because it is in the audible range.

2
2. List of Components
2-1. Wired Type

1 2 TR-203 2 TR-205

3 4

No. Name Quantity No. Name Quantity


1 Main unit 1 4 SCAN(Ultrasound Gel) 1
Wired probe (Choose
1 - Operation manual 1
TR-203 or TR-205)
2
Micro USB connector
Connecting cord 1 - 1
cover
3 Power cord 1 - - -

2-2. Wireless Type

1 2 TR-204

3 4 5

No. Name Quantity No. Name Quantity


1 Main unit 1 5 SCAN(Ultrasound Gel) 1
2 Wireless probe 1 - Operation manual 1
Micro USB connector
3 Power cord 1 - 1
cover
Alkaline battery
4 1 - Mini-Din connector cover 1
(for operation check)
3
3. Part Names and Functions
3-1. Main Unit
1. Front and left side

5 2

7 3

№ Part names Functions and operations


Displays heart rate and can be operated by a touch
1 LCD screen
panel.
Turns power off and on.
2 Operating switch
Used for the pairing procedure in the wireless type.
3 Speaker Outputs Doppler sound and operation sounds.
Used to transfer measurement data saved in internal
memory to a personal computer.
4 External output terminal
Note: The device cannot be used for measurement in
the data transfer mode.
5 Earphone jack For connecting of an optional earphone.
Resets the device.
6 Reset switch
See section 9 “Troubleshooting, Reset procedure.”
7 Power inlet / fuse holder Connects the power cord. Fuse is inside.

4
2. Back and right side

10 12

8 11

№ Part names Functions and operations

8 Connector Connects the wired probe.


Cover for the battery box.
9 Battery cover
The special rechargeable battery is placed in the box.
10 Heat vent Exhausts heat from inside the main unit.
11 Probe/gel holder Holds the probe and SCAN(Ultrasound Gel).
12 Spare fuse holder Holds the spare fuse.

5
3. Display of heart rate

4 5 6 7 8

2 1

№ Part names Functions and operations

1 Display of heart rate Displays the measured heart rate.


2 Menu Displays the setting display.
Controls the volume of Doppler sounds.
3 Volume meter
Operation sounds and buzzer sounds are not affected.
Heart beat
4 Lights in response to detection of the heartbeat.
synchronization symbol
Symbol of abnormality in
5 Displayed in response to an abnormality in the probe.
probe
Displays the radio wave status and the pairing
Symbol for radio wave
6 condition.
strength
Not displayed while using the wired probe.
Displays the remaining rechargeable battery level and
7 Battery symbol
the charging condition.
Time (hours and minutes) is displayed in 24-hour
8 Time
notation.

6
4. Waveform display

4 5 6 7 8

3
10

2 1

№ Part names Functions and operations

1 Display of heart rate Displays the measured heart rate.


2 Menu Displays setting display.
Controls the volume of Doppler sounds.
3 Volume meter
Operation sounds and buzzer sounds are not affected.
Heart beat
4 Lights in response to detection of the heartbeat.
synchronization symbol
Symbol of abnormality in
5 Displayed in response to an abnormality in the probe.
probe
Displays the radio wave condition and the pairing
Symbol for radio wave
6 condition.
strength
Not displayed while using the wired probe.
Displays the remaining battery level and the charging
7 Battery symbol condition during operation of the main unit with the
battery.
Time (hours and minutes) is displayed in 24-hour
8 Time
notation.
9 Waveform display Measured heart rate is displayed in waveform.
Displayed when pushing the operating switch during
10 Event symbol
measurement.

7
5. Symbols
The symbols displayed on the LCD screen indicate the status of the device.

・ Symbols for an abnormality in the transducer


Abnormality in transmission
Blinking
* E.g., the connection cord is unplugged

Lighting Low battery level in the wireless probe

・ Symbols for radio wave strength


Radio wave strength Radio wave strength
Lighting Lighting
(excellent) (good)

Radio wave strength Now checking


Lighting Lighting
(fair) transmission
・Radio wave strength
Blinking Now pairing Lighting (poor)
・Pairing failure

・ Battery symbols

Blinking Now charging Lighting Battery level (high)

Lighting Battery level (medium) Lighting Battery level (low)

Battery abnormality or
Lighting No battery level Blinking
breakdown

8
3-2. Probe

1. Wired probe (L-shape) TR-203


1 2

№ Part names Functions and operations


Turns power off and on.
1 Operating switch LED indicates operating status.
See section 3-2 “Probe, 4. Probe LED indications.”
Sends and receives ultrasound when touching the
2 Probe head
maternal abdominal wall.
3 Connecting cord Connects the wired probe to the main unit.

2. Wired probe (Upright) TR-205


1 2

№ Part names Functions and operations


Sends and receives ultrasound when touching the
1 Probe head
maternal abdominal wall.
2 Connecting cord Connects the wired probe to the main unit.

9
3. Wireless probe (L-shape only) TR-204
1 2 3

№ Part names Functions and operations


Turns power off and on.
1 Operating switch
LED indicates operating status. Used for pairing.
2 Battery cover Cover for the battery box. Holds AA battery.
Sends and receives ultrasound when touching the
3 Probe head
maternal abdominal wall.
4 Lock knob Secures the battery cover.

4. Probe LED indications (L-shape only)

Common in wired/wireless types Wireless type only

Lighting Blinking
Power on Now pairing
(blue) (blue)

Blinking
No lighting Power off Battery level (low)
(red)

Blinking
Blinking
Transmission every 5
(red and Standby
abnormality seconds
blue)
(blue)

10
4. Preparations

WARNING
● Attach or remove the battery after unplugging the power cord. Do not operate
devices when wet or with wet hands. Failure to heed this warning may result in
a breakdown of the device or electric shock.

4-1. How to attach/remove the Rechargeable Battery


・ Attach the battery
1. Slip the probe/gel holder to the upper side
for removal from the main unit.
You can see how to remove the holder
in 8-1 “Cleaning: how to remove the holder.”

2. Remove the screw of the battery cover on


the back of the main unit using a coin or
a screwdriver.

3. Connect the connector in the battery box


of the body and the rechargeable battery
until they lock.

4. Push the connector and the rechargeable


battery into the battery box.

5. Secure the battery cover with the screw and attach the probe/gel holder to the
main unit.

11
・ Removal of the battery
Pull the connector on the rechargeable battery
while pushing the lock on the connector for the
rechargeable battery from the upper side to
remove the rechargeable battery.

4-2. Wired Type

CAUTION
● Connect the wired probe while the power is turned off.

Note1:The wired probe and the wireless probe cannot be used at the same time.
(The wired probe has priority.) When using the wireless probe, check that
the wired probe is not connected to the main unit.
Note2: In normal use, attach a Micro USB connector cover to the external output
terminal (See 3-1 Main Unit 1. Front and left sides). Otherwise, see
“6-2.External Output”.

1. Connection of wired probe


When using the wired probe, connect the cord to the connector of the main unit.
Insert the connector so that direction of the cord is upward.
Direction of the
connection cord

Insert the connector so the The wired probe connected


connection cord is upward. to the main unit.

12
2. Setting the time of the main unit
Set the time after attaching the rechargeable battery to the main unit.

1) Connect the power cord and turn on the power to the main unit according to
5-2 “Charging the Main unit” and 5-3 “Turn on the Power.”
2) Touch the Menu button in the lower left of the LCD screen of the main unit to
display the setting display.

3) Set the time according to the procedures in 7-5 “Date and Time.”

4-3. Wireless Type


1. How to insert the battery
Insert the battery according to the following procedures.
The wireless probe requires an AA battery. Use an alkaline battery or an AA nickel
metal-hydride rechargeable battery.

Note1: In normal use, attach a Micro USB connector cover to the external output
terminal (See 3-1 Main Unit 1. Front and left sides). Otherwise, see “6-2.
External Output”.
Note2: Attach a Mini-Din connector cover to the connector (See 3-1 Main Unit
2. Back and right sides) .
Note3: The battery can be replaced using the same procedures. Remove the
Battery cover by pushing in the direction of the arrow as in the following
picture. Do not press the battery cover while sliding the lock knob.

13
1) Release the lock to the battery cover. Slide the lock knob in the opposite
direction from LOCK until it clicks.

Click

2) When sliding the lock knob to the end, the battery cover will lift slightly to make a
space.

・ Be careful not to press the battery cover with your fingers.


* If the lock knob will not slide easily, place the side of probe head on a flat
surface and push down on the lock knob.

3) When the battery cover lifts up, remove the cover from the unit.

14
4) How to insert the battery
Pay attention to the direction of the AA battery and insert the minus (-) end first.

Minus(-) Minus(-)

Plus(+) Plus(+)

Match the battery polarity to Insert the battery from the


the indication in the battery minus (-) end and then push
compartment. the plus (+) end.

5) Attach the battery cover


When replacing the battery cover, push firmly until there is no space.
Slide the lock knob until clicks.

Click

2. Pairing

WARNING
● If two or more of these device are used in the same facility, check the
pairing of the main unit and wireless probe. Failure to follow these
instructions may result in a mix-up of patients.
● If there is a wireless device other than this device that may cause
interference, consult us or distributor about measures to prevent such
interference (e.g. installation of partitions).

15
CAUTION
● Place the main unit close to the wireless probe while pairing.
● Do not pair simultaneously when two or more devices are used in the same
facility.

Pairing is a procedure to identify the combination of the main unit and the wireless
probe.
Pair the device according to the following procedures.
Note:
Once you pair the device, you do not need to pair it again.

・ Pairing procedures
Push the operating switches on the main unit and the wireless probe until the
LCD screen on the main unit and the LED on the wireless probe light.

Push the operation


switches until the LCD
screen and the LED light.
・ Operating switch on the main unit ・ Operating switch on the wireless probe

When pairing starts, the symbol for radio wave strength in the upper area of the
LCD screen blinks in blue. The LED of the operating switch on the wireless probe
also blinks in blue. Lift your finger off the operating switches when pairing starts.

・ Symbol for radio wave strength (blinks ・ LED on the operating switch (blinks
in blue) In blue)

・ Check pairing
When pairing is complete, the symbol and the LED stop blinking, and the
displays on the main unit and the wireless probe change.

16
Main unit:
Symbol for radio wave strength on the LCD screen is displayed in black.

Blinking Lighting

・ Pairing started ・ Pairing completed

Wireless probe:
The LED on the operating switch lights in blue.

Blinking Lighting

・ Pairing started ・ Pairing completed

3. Setting time of the main unit


Set the time after attachment of the rechargeable battery onto the main unit.

1) Touch the Menu button in the lower left of the LCD screen to display the
setting display.

2) Set the time according to the procedures in 7-5 “Date and Time.”

17
5. How to Use
5-1. Usage Environment

WARNING
● Do not use in a location where there is a risk of explosion, such as
environment with flammable anesthetic gas or oxygen.
● This device may cause poor transmission or interfere with other devices
because of radio interference. Such interference requires changing the
direction or installation location of this device or measures to reduce
interference such as a shield.
● Use of accessories, probe, or cables other than the specified ones may
cause an increase in emissions or reduce the resistance to interference of
this device.
● If this device is used close to or stacked on top of another device, check the
correct operation in the arrangement used.

Contraindication

● Do not use microwave ovens, microwave therapy apparatuses of devices


utilizing microwaves near this device.
● Supervise and advise people not to bring mobile phones, transceivers, radio
control toys, and other electronic devices into the room where this device is
installed.
● Do not use in x-ray imaging rooms, MRI rooms, or image processing rooms.
● This device cannot be used in conjunction with an electrosurgical knife,
defibrillator, or MRI. All probes and accessories must be removed before use
of an electrosurgical knife, defibrillator, or MRI.

CAUTION
● Do not block the heat vent of this device.
● If a liquid is spilled on this device, stop using.
● Do not use this device in the strong high-frequency electromagnetic field,
such as while using an electrosurgical knife.

18
CAUTION
Please do not use in the following locations as they may lead to problems with
the device (e.g., malfunction, discoloration, stains.)
● Direct sunlight
● Moisture or dust
● Hot areas (over 40 °C)
● Cold areas (under 10 °C)
● Exposure to vibrations or unstable locations

Use this device under the following conditions:


・Temperature: 10-40 °C
・Relative humidity: 30-70% (No condensation)
・Atmospheric pressure: 700-1060hPa
・A room without the risk of an explosion
・Stable, flat location

5-2. Charging the Main Unit

WARNING
To avoid fire and electric shock
● Do not place heavy objects on the power cord. Do not damage, abuse, twist,
pull, or heat the cord. In the event of damage to the power cord (exposed
core or breakage), ask our office or distributor for an exchange.
(core wire exposed, broken).

To avoid electric shock


● Be sure to use the provided power cord. Other power cords may cause
electric shock to the patient and the user.

The main unit incorporates a rechargeable battery. Check the battery level and charge
regularly.
Note:
Low battery levels may result in the display of the wrong date and time.

19
1. Connection of the power cord
1) Connect the power cord to the power inlet of the main unit.
2) Insert the power plug into an AC outlet.

2. Charge
Charging starts automatically after connection of the power cord.
The Battery symbol starts blinking in the upper part of the LCD screen after the start
of charging.
The Battery symbol changes from blinking to lighting after the device is fully
charged.

Battery symbol

5-3. Turn on the Power

1. Wired type
Push the operating switch on either the main unit or the wired probe until the LCD
screen of the main unit and the LED of the wired probe light and then lift your finger
off.

Push either of the operation The LCD screen of the main unit and the
switches LED of probe light when the power is on

20
2. Wireless type
Push the operating switches on both the main unit and the wireless probe until the
LCD screen of the main unit and the LED of the wireless probe light and then lift
your finger off.

Push both of the


operation switches

・ Operating switch of the main unit ・ Operating switch of the wireless probe

The LCD screen of the main unit and the LED


of probe light when the power is on

5-4. Inspection before Use

1. Volume control

CAUTION
● Pay attention to the following points when operating the LCD screen
(touch panel) of the main unit. Failure to heed this warning may result in a
breakdown.
・ Do not dig fingernails into the screen. Do not operate with solid metal
objects, such as a ballpoint pen.
・ Do not rub or push with excessive force.

21
The volume of this device can be controlled by touching the volume meter
displayed in the left of the LCD screen. Slide your finger “up” to increase the volume
and “down” to decrease the volume. The value for the volume and the yellow meter
go up and down as the finger slides.

Reference:
If you set the volume to “00,” the Doppler sound is not output but there is no
change in the volume of the operation sound and buzzer sound. To change the
volume of these sounds, see 7-4 “Buzzer Volume” and 7-6 “Operation Sound.”

Volume up

Volume down

Slide your finger while touching the


volume meter

2. Check of signal detection

WARNING
To prevent misdiagnosis
● Do not use a probe that does not emit a Doppler sound.

CAUTION
● Do not expose the probe head of the probe to impacts or shocks.
Doing so may result in an incorrect measurement or breakdown.

22
Check this device to detect signals and produce sounds from the speaker.
1) Tap the palm of the hand several times with the probe head.
2) Confirm that the speaker emits Doppler sounds.

5-5. Apply ultrasound gel


Apply the ultrasound gel to the surface of the maternal abdomen and the probe head.
Too much or too little gel will not work well. Apply evenly in a thin layer.

Note :
This device incorporates a mute function. The mute prevents loud sounds when
applying the gel to the probe head or moving across the abdominal wall.

23
5-6. Measurement

WARNING
To prevent misdiagnosis
● Adjust the probe to the optimum position in response to the movements of
the fetus. If the unit firmly touches a maternal blood vessel, the probe will
detect the maternal heart rate.
● If intrauterine fetal death is suspected by this test method, examine using
another method.

To prevent electric shock


● Ancillary equipment to connect to the analog or digital interface of this
device must be compatible with related IEC specification. (E.g. IEC
60950-1 for data processing devices, CISPR 32 EMC of multimedia
equipment, IEC 60601-1 for medical devices) In addition, all compositions
must be compatible with IEC 60601-1. Therefore, anyone connecting an
additional device to this device must take responsibility for system
compatibility with the requirements of IEC 60601-1. Please contact us or
distributor if you have any questions.

CAUTION
● Poor reception of radio waves may interrupt the sound from the wireless
probe. When determining the fixing point, hold the transducer so as not to
cover the operation switch with the palm of the hand and adjust the angle.
● Check that the USB cable is not connected.
You cannot measure in the data transfer mode.
● When using an earphone, pay attention to avoid raising the volume of the
main unit too high.
● The wireless range of this device is within 10 m.
Measurements using the wireless probe may be less reliable than with the
wired probe depending on the conditions, such as setting point and
surrounding environment. Place the probe closer to the body of this
device during use in such cases.
● The measurement time should be within 10 minutes and avoid keeping
the probe in the same position for a long time.

24
1. Doppler sound
1) Touch the probe head firmly to the maternal abdominal wall.
Control the volume to the appropriate level.
2) Move slowly while touching firmly to detect the position that provides clear-cut
rhythmic sounds (sounds of heart wall and valves).
3) The Doppler sound may be faint in the early pregnancy period.
You can hear more easily by using the optional earphone in such cases.

2. Display of heart rates


1) Detected heart rates are displayed on the LCD screen of the main unit.
2) The display becomes unstable after detection of the placenta and blood flow.
Search the optimal position that provides clear-cut rhythmic sounds in response
to the movements of the fetus.

・ Display of heart rates

3. If you cannot measure successfully


During the early pregnancy period:
• Start searching from a position two fingerbreadths from the superior margin of the
symphysis pubis in the middle of abdomen.
• Detection is easier by checking the position of the uterus on palpation before
starting.
During mid to late pregnancy period:
• Utilize the knowledge of the Traube stethoscope as is.
E.g. In the vertex position, search the position 1/3 of the distance from the
navel-spine line of the fetal back side. If you cannot detect the heart rate,
search three fingerbreadths from the superior margin of the symphysis pubis
in the middle of the abdomen.

4. Detection for locations of the placenta and umbilical cord


Audible sounds differ by blood flow. Compare the Doppler sounds during detection
of blood flow.

25
• Blood flow sound of Placenta
The sound is emitted as a continuous sound “GOH”.
When the position of placenta is on back wall, possibility for detection is lower
than the case on anterior wall.
• Blood flow sound of umbilical cord:
The sound “HYUH” “HYUH” is emitted from the blood flow of umbilical cord in
Synchronization with fetal heart beats.

5-7. After Measurement


1. Turn off the power
Turn off the power by pushing the operating switch on either of the main unit or the
probe (L-shape) until the LCD screen of the main unit goes out.

2. Wipe off the ultrasound gel


Wipe the ultrasound gel from the maternal abdominal wall and the probe with
tissues or a soft cloth. The probe is waterproof and can be washed with water. See
8-1 “Cleaning” for washing with water.
* The main unit is not waterproof.

3. Storage
Place the used probe and the ultrasound gel in the probe/gel holder on the back of
the main unit.
Probe:
Place the probe from the side of probe head as shown in the following pictures.
Do not push the probe head in the direction of the back of the main unit. Doing
so may damage the device. For the wireless probe, do not place it from the side
of the battery box. If you do, the device may fall when carried.

○ ○ ○
・ Correct storage of the probe

× × ×

・ Improper storage of the probe

26
Ultrasound gel:
You can store the ultrasound gel in the probe/gel holder on the back of the main
unit.
The gel can be stored on both the upper or lower side.

Probe holder
Gel holder

Storage of the ultrasound gel

5-8. Standby Mode


You can change the power on and the standby mode of the device with the operating
switch of the wireless probe with setting of the “7-10. Wireless Timer Off”.

・ How to use the standby mode


1. Turn on the power
Push the operating switches of the main unit and the wireless probe.
See 5-3 “Turn on the Power ; 2. Wireless type” for instructions on how to turn on
the power.

2. Set the standby mode


Push the operating switch of the wireless probe until the indicator goes out.
The radio wave strength symbol is displayed on the LCD screen during standby.
The LED of the operating switch of the wireless probe blinks in blue every five
seconds.

・ Display of standby of the main unit ・ Display of standby of the wireless probe
(Display of the symbol for radio wave (LED of the operating switch blinking in
strength) blue)

27
3. Turn on the power during standby
Push the operating switch of the wireless probe until the LED lights.

4. Turn off the power


Push the operating switch of the main unit the display goes out.

5-9. Isolation from supply mains


1. Remove the power plug from an AC outlet.
2. Remove the power cord from the power inlet of the main unit.

28
6. Functions
6-1. Display Function
1. Display switching
When touching the following areas on the LCD screen of the main unit, the display
switches to 1) Heart rate display, 2) Waveform display and 3) Waveform display
(enlarged) in turn.
1) Heart rate display 2) Waveform display

Display switches by
touching each display
area

3) Waveform display (enlarged)

2. Heart rate display


Measured heart rates are displayed in numbers.

3. Waveform display
• Display area
Measured heart rates are displayed in a waveform. The heart rate is on the
vertical ordinate and the measurement time is on the horizontal ordinate. The
display changes in intervals of 10 mm/min, 20 mm/min, or 30 mm/min according
to the setting for the sweep rate and transits from right to left. The displayed
measurement time is 9 minutes, 4 minutes and 30 seconds, and 3 minutes,
respectively. See 7-9 “Sweep Rate” for details on the setting.

9 min 4 min 30 sec 3 min

Setting: 10mm Setting: 20mm Setting: 30mm

29
• Enlarged display
The waveform for measured heartbeats is enlarged. The enlarged display shows
the heart rates of 100–170bpm and the measured time of 1 minute (setting: 30
mm), 1 minute and 30 seconds (setting: 20 mm), or 3 minutes (setting: 10 mm)
depending on the setting of the sweep rate. See 7-9 “Sweep Rate” for details
about the setting.

Enlarged display area

Normal display Enlarged display


Heart rate range: 30-240bpm Heart rate range: 100-170bpm
Measurement time: 3 min, 4 min 30 Measurement time: 1 min, 1 min 30
sec, 9 min sec, 3 min

• Events
Push the operating switch of the main unit or the probe during the Waveform
display and lift your finger immediately. The event symbol “▲” is displayed in the
waveform display area. You can easily follow up the event such as labor pains by
timely display of the event symbols.
Only one event symbol can be displayed on the waveform display area. If you
push the operating switch again after an event symbol is displayed, the symbol is
no longer displayed, and a new one is displayed on the right in the display area.

Push the operating switch while The displayed event symbol is no longer
the event symbol is displayed displayed, and a new one is displayed on
the right in the display area

30
6-2. External Output

WARNING
To prevent electric shock:
● Ancillary equipment to connect to the analog or digital interface of this device
must be compatible with related IEC specifications. (E.g., IEC60950-1 for data
processing devices, CISPR 32 EMC of multimedia equipment, IEC60601-1 for
medical devices) In addition, all configurations must be compatible with
IEC60601-1. Therefore, anyone connecting an additional device to this device
must assume responsibility for system compatibility with the requirements of
IEC60601-1. Please contact us or distributor if you have any questions.

CAUTION
● Connection of the FD-490 to an IT-network that included other equipment
could result in previously unidentified risks to patients, operators or third
parties
● The user should identify, analyze, evaluate and control these risks
● Subsequent changes to the IT-network could introduce new risks and require
additional analysis
● Changes to the IT-network include:
 Changes in the IT-network configuration
 Connection of additional items to the IT-network
 Disconnecting items from the IT-network
 Update of equipment connected to the IT-network
 Upgrade of equipment connected to the IT-network

A total of 160 items of previously measured data can be saved on the device (one
item: 10 minutes after the power was turned on). The saved data can be transferred to
a personal computer for reference.
* Special software (FHRViewer) is needed to see the previous saved data. See the
attachment “FHRViewer Instruction Manual” about data transfer via external output
and the special software.

31
7. Settings

CAUTION
● Pay attention to the following points in operation of the LCD screen (touch
panel) of the main unit. Failure to follow these operations may result in a
breakdown.
・ Do not dig fingernails into the screen. Do not operate with solid metal
objects, such as a ballpoint pen.
・ Do not rub or push with excessive force.

The settings for power-saving function, operation sounds, and date and time can be
changed. The setting display can be displayed by touching the Menu button in the
lower left area on the LCD screen of the main unit.

・ Touch the Menu button to display the setting display

Page display
Current page/total
number of pages

Various setting buttons


Selected button turns
into blue

Previous page Next page Exit button

・ Display and operating buttons for the setting display

Touch the setting button to make changes on the menu screen. The selected item turns
blue and the setting change is reflected. Touch the Return button after making the
adjustment to return to the measurement screen. When changing several settings, move
to the other pages using the < and > buttons in the lower area without touching the
Return button.
32
The menu consists of seven screens in total.
Move to the following screens to change the appropriate setting.

Menu screen: Table of contents


7-1. No Signal Power Off ________________________________________ (1/7)
7-2. Automatic Power Off ________________________________________ (1/7)
7-3. Timer Settings _____________________________________________ (2/7)
7-4. Buzzer Volume _____________________________________________ (3/7)
7-5. Date and Time _____________________________________________ (4/7)
7-6. Operation Sound ___________________________________________ (5/7)
7-7. Brightness of Backlight______________________________________ (5/7)
7-8. Languages ________________________________________________ (6/7)
7-9. Sweep Rate________________________________________________ (6/7)
7-10. Wireless Off Timer __________________________________________ (7/7)

*(x/7) is the displayed on the upper right on the LCD screen

7-1. No Signal Power Off


This function turns the power off when there is no signal (the heart rate display is “--“)
after a predetermine amount of time. The initial (default) setting is to turn off the power
after 2 minutes of no signal for the heart rate.

Initial
Setting Details
setting
1 Min Turn off the power after 1 minute of no signal.

2 Min Turn off the power after 2 minutes of no signal. O


The power is not turned off even in the continuous no signal
Off
condition.

33
7-2. Automatic Power Off
This function turns off the power at the set time during operation of the monitor. The
power will turn off even in the middle of a measurement. The initial setting is 10
minutes.
* The setting is canceled in the standby mode.

Initial
Setting Details
setting
5 Min Turn off the power automatically 5 minutes after power on.

10 Min Turn off the power automatically 10 minutes after power on. O

Off The power is not turned off automatically.

7-3. Timer Setting


When the set time has passed after the start of the timer, the device informs the user
with a buzzer sound.

・ Timer start
Initial
Setting Details
setting
P-On Timer starts at power on.

Event Timer starts from input of event via the operating switch.

No use No timer function is used. O

34
・ Timer
Initial
Setting Details
setting
1 Min Buzzer rings 1 minute after the set time. O

2 Min Buzzer rings 2 minutes after the set time.

3 Min Buzzer rings 3 minutes after the set time.

・ Timer start – event


Timer starts by pushing the operating switch during a measurement.
In the trend display, the event symbol “▲” is displayed in the waveform display
area.

For example, in case of 1 minute (sweep rate: 30 mm) on the timer in 7-3”Timer
Setting”.

1min

The event symbol “▲” is displayed Buzzer rings 1 minute after


by pushing the operating switch pushing the operation switch

7-4. Buzzer Volume


Check the setting of the buzzer volume and set the volume as per user preference.

Stop the buzzer sound test


via the End button

・Buzzer volume
Initial
Setting Details
setting
Hi Loud volume

Mid Medium volume O

Low Low volume


35
・ Buzzer sound test
Buzzer rings at the set volume after touching the Start button.
The buzzer sound stops after touching the End button for the buzzer sound test.

7-5. Date and Time


Set the date and time.
The software keyboard is displayed by touching the input box for date and time. Enter
the appropriate date and time.

Touch the input box for date and time The software keyboard is displayed

1. Setting the date (e.g. June 23, 2012)


1) Touch the input box for "year". The software keyboard appears.

Touch the input box for “year" The software keyboard is displayed

2) Type "12" and touch Set button. The change is reflected in the setting display.
* Enter only the last two digits of the year.
Years from “00 to 99 (2000 to 2099)” can be entered.

Type "12" and touch Set button "2012" is reflected in the setting display

36
3) Set “month” and “day” using the same procedure.
* Enter “1-12” in the input box for “month.”
* Enter “1-31” in the input box of “day.”
You can enter up to 30 for a month of 30 days, up to 28 for February, and up to
29 in a leap year.

4) Touch the Return button after changing the setting to return to the
measurement display.

2. Setting the time (e.g. 12:23:00)


1) Touch the input box for “hour.” The software keyboard is displayed.

Touch the input box for “hour” The software keyboard screen is opened

2) Type "12" and touch Set . The change is reflected in the setting display.
* Type “0-23” in the input box for “hour.”

Type "12" then touch Set button "12" is reflected in the setting display

37
3) Set “minutes” using the same procedure.
* Enter 0-59” in the input box for “minutes.”

4) When you touch the box for “seconds,” the displayed value is reset to “00.”
* The software keyboard is not displayed by touching the input box for “seconds”
in contrast to other boxes.

Touch the box for "seconds" displaying “26” "26" is reset to "00"

5) Touch the Return button after changing the setting to return to the
measurement display.
* The setting is reflected by touching the Return button or the < or >.
button.

7-6. Operation Sound


Operation sounds can be turned on or off. Select On to activate operation sounds
and Off to mute operation sounds.

38
Initial
Setting Details
setting
On Provides operation sounds. O

Off Provides no operation sounds.

7-7. Brightness of Backlight


Set the brightness of the LCD screen.
Select Dim for a darker screen, Bright for a brighter screen.

Initial
Setting Details
setting
Dim Dims the backlight brightness.

Mid Sets backlight brightness to the middle level. O

Bright Brightens the backlight brightness.

7-8. Languages
Select the language on the LCD screen. The options are Japanese and English.

Initial
Setting Details
setting
Japanese Displays in Japanese.

English Displays in English O

39
7-9. Sweep Rate
Set the sweep rate in the waveform display for the heart rate. When changing the
sweep rate, the data is reset during measurement.

Initial
Setting Details
setting
10mm Display corresponds to 10mm/min.

20mm Display corresponds to 20mm/min.

30mm Display corresponds to 30mm/min. O

Examples of display: There are differences as follows if you measure for 3 minutes in
each setting.

3min 3min
3min

Setting: 10mm Setting: 20mm Setting 30mm

7-10. Wireless Off Timer (Wireless Type Only)


Set the time for activating the standby mode. Switch the power on and standby modes
using the operating switch of the wireless probe during standby mode.

40
Initial
Setting Details
setting
0 Min No standby mode. O
Switches to standby mode.
30 Min
The power is turned off by standby for 30 minutes.
Switches to standby mode.
Standby continues until the battery level drops to zero.
Cont. Remains standby condition approximately 24 hours when you
use a brand-new battery (alkaline battery).
Switch of the operating switch of the main unit after use.

・ Behaviors after pushing the operating switch for each setting

41
8. Cleaning/Inspection/Storage
8-1. Cleaning

WARNING
● This device is not disinfected before shipment. Be sure to disinfect and clean
before use.
● Clean and disinfect this device after every use.

CAUTION
● Unplug the power plug before cleaning for safety.
● Conduct an inspection using the checklist in section 8-2 after cleaning.
● Do not insert or remove plug with wet hands. Failure to heed this warning may
result in electric shook.

1. Wipe
Main unit:
Wipe periodically with a soft, dry cloth. If it is difficult to remove the stain, clean in
the following manner:
1) Dip a soft cloth in neutral detergent diluted by warm water (or cold water).
Squeeze the cloth thoroughly and wipe a little more firmly.
2) Then wipe with the cloth moistened with water that has been squeezed
thoroughly.
3) Finally, wipe with a soft, dry cloth.

Probe/gel holder:
The probe/gel holder can be removed for washing with water.
・ How to remove the holder

1 2

Holder
stopper

Support the main unit with one Pull to the backside to remove
hand. the holder.

42
3 4

Pull holder upward from 2) state Slide the tray to remove.


and remove it from main unit.

・ How to attach the holder

1 2

Align the fixed parts of the main Allow the holder to attach to the
unit and holder. main unit.

Slide downward to attach.

43
Probe:

CAUTION
● Do not wipe the probe head of the probe with excessive force.
This may result in erroneous measurements or a breakdown.

The probe is waterproof and can be washed with water.


・ Wired probe
Remove from the main unit and wash with water the connection cord is
attached to the wired probe. Check the connection cord to the connector of
the wired probe. Pay attention not to expose the connector to liquids. If the
unit is exposed to water, wipe the water off thoroughly and dry before use.

Check the

× ×
connection

Wash with water with the Do not wet the connector. Do not wet the connector.
connection cord attached.

・ Wireless probe

Wash with water while the Check the locks.


battery cover closed.

44
2. Disinfection
1) Acceptable chemicals:
・ Glutaraldehyde (Cidex, Sterihyde, etc.)
・ Benzalkonium chloride (Osvan, Diamir, etc.)
・ Amphoteric surfactant (Tego 51, Hypal, Anon, etc.)
2) Before disinfection
Wipe the ultrasound gel from the probe carefully with tissues, a soft cloth, or
other material.
3) Sterilization
Sensitivity to microorganisms differs by chemical. Follow the efficacy, usage,
precautions, and other instructions specified in the package insert for each
chemical.

8-2. Inspection

WARNING
● Follow the instructions in this manual. In the event of an abnormality, stop
using the device immediately.
● Be sure to check the monitor before use. If you cannot confirm proper
operation by inspection, turn off the power and remove the power plug from
the outlet. Stop using the device, attach label displaying “Breakdown,” and ask
our office or distributor for repairs.
● Do not disassemble or modify this device.

CAUTION
● Do not block the heat vent of this device. Failure to heed this warning may
result in a breakdown.
● Do not provide a strong shock such as dropping the probe or bumping the
main unit. Failure to heed this caution may result in a breakdown.
● Do not use objects that generate electromagnetic waves such as mobile
phone near this device. Failure to heed this caution may result in incorrect
measurements.
● Do not use gel other than as specified [SCAN(Ultrasound Gel)]. Failure to
heed this caution may result in signal degradation or damage to the probe.
● Do not use batteries other than as specified because doing so may cause a
breakdown.

45
1. Inspection
Inspections are required to maintain the functions of this device.
Hospitals or clinics should take responsibility for inspections.
If hospitals or clinics outsource the inspections, they should also assume
responsibility for the outsourcing.

Users should conduct the following inspections:

Inspections Inspection details

Inspection before Be sure to conduct before See "Inspection before


use every use of this device. use"
Inspection after Be sure to conduct after every See "Inspection after
use use of this device use"
Inspection in Conduct an inspect of See "inspection every six
every 6 months functions in every 6 months months"

Failure to confirm proper operation means a breakdown in the monitor. Turn the
power off, unplug the power cord, attach a label stating “breakdown; do not use,”
and ask our office or distributor for repairs.

・ Rechargeable battery of the main unit


The performance of the rechargeable battery gradually degrades depending on
the conditions of use, environment, and aging. The rechargeable battery must
be exchanged after degradation as needed. Ask our office or distributor for an
exchange.

46
2. Checklist of inspections
Conduct inspections in accordance with the inspection details.

・ Inspection before use


Serial number: Inspection date: Inspected by:

No. Inspection details Results

1 No damage to the device. Pass / Fail

2 The power is turned on by pushing the operating switch. Pass / Fail

3 No missing display on the LCD screen. Pass / Fail

4 The power level of the device remains sufficient. Pass / Fail

5 Correct date and time are displayed. Pass / Fail

6 The touch panel of the LCD screen reacts correctly. Pass / Fail

When tapping the probe head with the palm of the hand, a sound is
7 Pass / Fail
emitted from the speaker.
Sounds with appropriate volume are emitted from the speaker by
8 Pass / Fail
controlling the volume meter.

・ Inspection after use


Serial number: Inspection date: Inspected by:

No. Inspection details Results

Remove remaining ultrasound gel and extraneous matter from the


1 Pass / Fail
device.

2 Disinfect the used probe. Pass / Fail

3 No damage to the device. Pass / Fail

47
・ Inspection every six months
Serial number: Inspection date: Inspected by:

No. Inspection details Results

1 No damage to the device. Pass / Fail

2 No damage to the power cord. Pass / Fail

When you connect the device (the power off) to the power outlet, the
3 Pass / Fail
rechargeable battery symbol is displayed on the LCD screen.
When you turn the power on by pushing the operating switch, the
4 Pass / Fail
LCD screen and the LED of the probe light.

5 No missing display on the LCD screen. Pass / Fail

6 Correct date and time are displayed. Pass / Fail

7 The touch panel of the LCD screen reacts correctly. Pass / Fail

When tapping the probe head with the palm of the hand, a sound is
8 Pass / Fail
emitted from the speaker.
Sounds with appropriate volume are emitted from the speaker by
9 Pass / Fail
controlling the volume meter.
When tapping the probe head with the palm of the hand, the heart
10 Pass / Fail
rate is displayed on the LCD screen.

11 No abnormal sound after shaking the device. Pass / Fail

48
3. Exchange of the fuse
The device has a fuse to prevent damage from transient overcurrent.
When the power fails to turn on despite the correct connection of the plugs, the fuse
may have burned out. Check the fuse by removing the fuse holder and exchange if
necessary.
1) Unplug the power cord from the power inlet
2) Pull out the fuse holder using a screwdriver.
The fuse holder cannot be removed from the inlet. Do not pull out too far.

Unplug the power cord and Pull out the fuse holder Do not pull the fuse
apply a screwdriver to the with the edge of the holder too far.
depressed area. screwdriver.

3) Remove the burned out fuse


Hold both edges of the fuse with the fingers and push out from upper side of the
fuse holder to remove.

Push out from upper side with a


forefinger. Support with the thumb
to prevent breaking the removed fuse.

4) Insert a new fuse


Insert a new fuse in the proper position (See the pics below).
Adjust the centers of the fuse and fuse holder.
Use fuse EMG-S250V0.5APBF as specified.

Wrong position Adjust properly


Proper position

5) Return the fuse holder


Push the fuse holder into the inlet.
49
8-3. Storage

CAUTION
● Do not place in the following conditions:
・ Direct sunlight
・ Moisture (95% or more) or dust
・ Heat (at 60°C or more)
・ Coldness (at -10°C or less)
・ Vibrated or unstable places
● Remove the battery of the wireless probe if it will remain unused for a long
time.

1. Storage or transport condition:


Ambient temperature: -10°C to +60°C (except of freezing)
Relative humidity: 30 to 95% (no condensation)
Atmospheric pressure: 700-1060hPa

2. If it will remain unused for a long time


・ Remove the power cord from the power outlet if it will remain unused for a long
time.
・ Do not store in locations where the monitor will be exposed to water or moisture.
・ Avoid direct sunlight and high temperature and humidity and store in a location
where the surface is level without vibration and shock.
・ Charge the rechargeable battery every three months because the power level
naturally decreases without use. If the monitor will remain unused for three
months or longer, remove the rechargeable battery from the device after
charging because it may not hold a charge after a long period of disuse.

3. Probe
Remove the battery of the wireless probe to prevent liquid leakage.

50
9. Troubleshooting

WARNING
● Follow the instructions in this manual. In the event of an abnormality, stop
using the device immediately.
● Do not disassemble or modify this device.

This section describes the procedures to address problems for users. If there is no
improvement after completing the procedures, ask our office or distributor for repairs
since the problem may be caused by a bad internal connection.

・ If the connection cord (the side of wired probe) is unplugged:


Connect using the following procedures.

How to connect:
Adjust the O mark on the connector and the position of the strap hole for the
L-shape probe (△mark for the upright probe) and insert straight without twisting.

△mark
Strap hole

O mark on the connector

O mark on the connector

L-shape (TR-203,204) Upright (TR-205)


・ Reset procedure
If the operation of the main unit is unstable or the unit does not operate, reset the
device.
Push the reset switch on the side of the main unit with a paper clip or similar object
until there is a discernible click.

Reset switch

51
9-1. Wired Type
Example of
Possible causes Solutions
malfunctioning
Check the following items:
1. Check the power cord connection. If it is no
connected, connect completely. See 5-2
“Charging the main unit, 2. Connection
of the power cord.”
2. Check for any damage to the power cord. If
No AC power
it is damaged, exchange for a new power
The power of the main
cord.
unit cannot be turned on.
3. Check the fuse to the power inlet. If it is
disconnected, exchange for new one.
See 8-2 “Inspection, 3. Exchange of the
fuse.”
Check the rechargeable battery level of the
Low battery level main unit. If the battery level has decrease,
charge it. See 5-2 “Charging the main unit.”
Check the connection cord to the main unit
Incomplete connection of
The power cannot be and the wired probe. If it is not connected,
the cord
turned on by the connect completely. See 4-2 “Wired Type.”
operating switch of the Check for any damage to the connection cord.
Abnormality in the
wired probe (TR-203). If it is damager, exchange for a new
connection cord
connection cord.
Check the following items:
1. Check the power cord connection. If it is not
connected, connect completely.
2. Check for any damage to the power cord. If
The battery cannot be No AC power it is damaged, exchange for a new power
charged. cord.
No battery symbol is 3. Check the fuse to the power inlet. If it is
displayed on the LCD disconnected, exchange for new one. See
screen. 8-2 “Inspection, 3. Exchange of the fuse.”
Breakdown/degradation of
Ask our office or distributor to repair.
the rechargeable battery
Breakdown of the LCD
Ask our office or distributor to repair.
screen
The battery level Breakdown/degradation of
Ask our office or distributor to repair.
decreases rapidly. the rechargeable battery
The battery symbol is Breakdown of the main unit
Ask our office or distributor to repair.
blinking in red. or the rechargeable battery
Check the connection cord to the main unit
Incomplete connection of
and the wired probe. If it is not connected,
"P" symbol is blinking on the cord
connect completely. See 4-1 “Wired Type.”
the LCD screen and the
Check for any damage to the connection cord.
power is turned off. Abnormality in the
If it is damaged, exchange for a new
connection cord
connection cord.
Internal error in the main Reset by pushing the reset switch.
The display of the LCD unit. See 9 “Troubleshooting, Reset procedure.”
screen is disturbed Breakdown of the LCD
Ask our office or distributor to repair.
screen

52
Example of
Possible causes Solutions
malfunctioning
Internal error in the main Reset by pushing the reset switch.
The touch panel shows unit. See 9 “Troubleshooting, Reset procedure.”
no reaction. Breakdown of the LCD
Ask our office or distributor to repair.
screen
Inappropriate position of the Search the appropriate position that provides
probe clear-cut rhythmic sounds.
Too little gel applied to the
Apply the gel evenly.
The heart rate is not probe
displayed. Check the connection cord to the body and the
There are noises in the Incomplete connection of
wired probe. If it is not connected, connect
heartbeat. the cord
completely. See 4-2 “Wired Type.”
Check for any damage to the connection cord.
Abnormality in the
If it is damaged, exchange for a new
connection cord
connection cord.
Check the volume meter of the LCD screen. If
Low volume setting it is low, turn up. See 5-4 “Inspection before
Use 1. Volume control.”
Check the connection cord to the body and the
No heartbeat can be Incomplete connection of
wired probe. If it is not connected, connect
heard. the cord
completely. See 4-2 “Wired Type.”
Check for any damage to the connection cord.
Abnormality in the
If it is damaged, exchange for a new
connection cord
connection cord.
The no signal condition for 2 minutes or at 10
The function of no signal minutes after the power on leads to power off.
The power is suddenly
power down or automatic Change the settings as needed. See 7-1 “No
turned off.
power down worked. Signal Power Off” and 7-2 “Automatic Power
Off.”
The power cannot be
turned off.
Reset by pushing the reset switch.
Abnormal sounds are Internal error in the device
See 9 “Troubleshooting, Reset procedure.”
emitted from the
speaker.

53
9-2. Wireless Type
Example of
Possible causes Solutions
malfunctioning
Too far between the
Allow the body and the wireless probe to move
wireless probe and the main
closer to conduct pairing.
unit
Check the LED of the wireless probe and the
Pairing cannot be
Abnormal beginning of symbol for radio wave strength. If symbols are
conducted.
pairing not blinking start from the first procedure again.
See 4-3 “Wireless Type, 2. Pairing.”
Other wireless devices used Stop other wireless device or keep it far from this
close device to conduct pairing.
Check the following items:
1. Check the power cord. If it is not connected,
connect completely. See 5-2 “Charging the
Main Unit, 1. Connection of the power cord.”
No AC power 2. Check for any damage to the power cord. If it
The power of the main is damaged, exchange for a new power cord.
unit cannot be turned on. 3. Check the fuse to the power inlet. If it is
disconnected, exchange for new one. See
8-2 “Inspection, 3. Exchange of the fuse.”
Check the rechargeable battery level of the main
Low battery level unit. If the battery level has decreased, charge it.
See 5-2 “Charging the Main Unit.”
The power of the wireless
Change the battery of the wireless probe. See
probe cannot be turned Low battery level
4-3 “Wireless Type 1. How to insert the battery.”
on.
Check the following items:
1. Check the power cord. If it is not connected,
connect completely. See 5-2 “Charging the
Main Unit, 1. Connection of the power cord.”
The battery cannot be No AC power 2. Check for any damage to the power cord. If it
charged or start to be is damaged, exchange for a new power cord.
charged. 3. Check the fuse to the power inlet. If it is
No battery symbol is disconnected, exchange for new one. See
displayed on the LCD 8-2 “Inspection, 3. Exchange of the fuse.”
screen.
Breakdown/degradation of
Ask our office or distributor to repair.
the rechargeable battery
Breakdown of the LCD
Ask our office or distributor to repair.
screen
The battery level
decreases rapidly despite Breakdown/degradation of
Ask our office or distributor to repair.
charging with no the rechargeable battery
problems.
The battery symbol is Breakdown of the main unit
Ask our office or distributor to repair.
blinking in red. or the rechargeable battery
Too far between the
Allow the main unit and the wireless probe to
wireless probe and the main
move closer.
"P" symbol is blinking on unit.
the LCD screen and the Other wireless device is too Stop other wireless device or keep it far from this
power is turned off. close device to conduct pairing.
Change the battery of the wireless prob. See 4-3
Low battery level
“Wireless Type 1. How to insert the battery.”

54
Example of
Possible causes Solutions
malfunctioning
Too far between the
Allow the main unit and the wireless probe to
wireless probe and the main
move closer.
unit
Wrong pair of wireless probe
Turn the power on individually to check the
The main unit and the and the main unit
pair.
wireless probe cannot * When using multiple pairs
connect wirelessly. If you turned on the power immediately after
power off, it may be difficult to connect
Wireless communication
wirelessly.
error
Turn on the power 5 seconds or more after
power off.
Reset by pushing the reset switch.
Internal error
The display of the LCD See 9 “Troubleshooting, Reset procedure.”
screen is disturbed. Breakdown of the LCD
Ask our office or distributor to repair.
screen
Reset by pushing the reset switch.
Internal error
The touch panel shows See 9 “Troubleshooting, Reset procedure.”
no reaction. Breakdown of the LCD
Ask our office or distributor to repair.
screen
Inappropriate position of the Search the appropriate position that provides
probe clear-cut rhythmic sounds.
Too little gel applied to the
The heart rate is not Apply the gel evenly.
probe
stably displayed.
There are noises in the Too far between the
Allow the body and the wireless probe to move
heartbeat. wireless probe and the main
closer.
unit
Other wireless devices used Stop other wireless device or keep it far from
close this device to conduct pairing.
Check the volume meter of the LCD screen. If it
Low volume setting
is lower, turn up.
Too far between the
No heartbeat can be Allow the main unit and the wireless probe to
wireless probe and the main
heard. move closer.
unit
Other wireless devices used Stop other wireless device or keep it far from
close this device to conduct pairing.
The no signal condition for 2 minutes or at 10
The function of no signal minutes after the power on leads to power off.
The power is suddenly
power off or automatic Change the settings as needed. See 7-1 “No
turned off.
power off was worked Signal Power Off” and 7-2 “Automatic power
off.”
The power of the wireless
Reinsert the battery of the wireless probe. See
probe cannot be turned Internal error of the probe
4-3 “Wireless Type 1. How to set the battery.”
off.
The power cannot be
turned off. Reset by pushing the reset switch.
Internal error of the device
Abnormal sounds are See 9 “Troubleshooting, Reset procedure.”
emitted from the speaker.

55
10. Specifications
10-1. Product Specifications

Main unit
Power-supply voltage AC 100 – 240 V

Power-supply frequency 50/60 Hz

Power consumption 30 VA

Rated voltage (internal power supply) 7.2 V


Power consumption (internal power
15 VA
source)
Continuous operating time (internal
160 min
power source)
Charging time 70 min

Dimensions: width × height × depth 200 × 195 × 125 mm

Weight 1.5 kg
Outer protection level against ingress
IPx0
of water
LCD screen: Displays operating conditions,
Display function
settings, battery level and abnormal conditions
Operating function Settings and maintenance

External output External output terminal, earphone jack


Type:
2.4GHz upgrade low power data communication
system
Wireless communication
Type of radio wave,, frequency and aerial power:
F1D, 2441 MHz, 0.0000121-0.0000475 W/MHz
G1D, 2441 MHz, 0.0000052-0.0000206 W/MHz

Wired probe TR-203(L-shape)


AC power Class II device
Protection type to electric shock
Battery Internally-powered device
Classification of attached area by
Attached part type B
protection level
Dimensions: width × height × depth 46 ×130 × 50 mm

Weight 0.1 kg
Outer protection level against ingress
IPx7
of water
Materials of parts which contact to
PC, ABS/PC, Elastomer
human body
Applied part (Maximum temperature) Probe head (43℃)

Display function LED indicator: indicates operation status


56
Wired probe TR-205(Upright)
AC power Class II device
Protection type to electric shock
Battery N/A
Classification of attached area by
Attached part type B
protection level
Dimensions: width × height × depth 35 × 122 mm

Weight 0.05 kg
Outer protection level against ingress
IPx7
of water
Materials of parts which contact to
ABS/PC
human body
Applied part (Maximum temperature) Probe head (43℃)

Wireless probe TR-204


Rated voltage 1.2 V

Power source AA battery

Power consumption 0.57 VA


180 min (Alkaline battery/new/at 28℃*)
Continuous operating time 250 min (Nickel metal-hydride battery/new/full
charge)
Protection type to electric shock Internally-powered device
Classification of attached area by
Attached part type B
protection level
Dimensions: width × height × depth 46 × 130 × 50 mm

Weight 0.1 kg
Outer protection level against ingress
IPx7
of water
Materials of parts which contact to
PC, ABS/PC, Elastomer
human body
Applied part (Maximum temperature) Probe head (43℃)
LED indicator: indicates operation status, remaining
Display function
battery, abnormal conditions
Operating function Settings
Type:
2.4GHz upgrade low power data communication
system
Wireless communication
Type of radio wave, frequency and aerial power:
F1D, 2441 MHz, 0.0000121-0.0000475 W/MHz
G1D, 2441 MHz, 0.0000052-0.0000206 W/MHz

57
Measurement specifications (fetal heart rate by Doppler ultrasound)
Ultrasound drive method Continuous wave

Oscillating frequency 2.5 MHz +/-10%

Ultrasound output 10mW/cm2 or less


Peak sound pressure in peak time of
21.2kPa
space
Effective region of ultrasonic
119 mm2
transducer
Heart rate measuring range 50-240bpm

Accuracy of heart rate measurement Within ± 3bpm


The thermal index and mechanical index are not more than 1.0 in all setting conditions.

Cables
Type model Max. Length

Power cord 2.9 m

Curl cord YC01014 2.5 m

Earphone cord 1.3 m


Use of cables other than the specified above may cause an increase in emissions or reduce
the resistance to interference of this device.

58
10-2. Accessories

Cable
Names Item code Quantity Remarks
length
Wired probe TR-203 JA1693 1 - Wired type FD-491 only

Curl cord for TR-203 YC0104 1 2.5 m Wired type FD-491 only
Wireless probe
JA1706 1 - Wireless type FD-492 only
TR-204
Wired probe TR-205 JA1913 1 - Wired type FD-491 only

Curl cord for TR-205 YC0104 1 2.5 m Wired type FD-491 only

Ultrasound gel GA0133 1 - SCAN(Ultrasound Gel)


EGM-S250V0.5APBF
Fuse SA0058 2 -
One in the inlet, one spare
Power cord YA0014 1 2.9 m 10A 250VAC

Operation manual GZ1268 1 -

Package insert 1 -
Alkaline battery (for
SG0028 1 - Wireless type FD-492 only
performance check)
Mini-DIN connector When using a wireless probe
SD0731 1 -
cover TR-204
Micro USB Connector
SD0730 1 -
cover

59
10-3. Usable service life/Warranty/Disposal
Usable service life
The usable service life of this device is 6 years after shipment. Service life is
based on the self-certification (our data). Some components may degrade with
age within the usable service life. Regularly exchange the components to maintain
the performance of this device during the usable service life. Repair or overhaul
depending on the results of inspections as needed.
Warranty
We will repair the device free of cost within the warranty period according to the
provisions of the warranty. In the event of a breakdown after the warranty period,
we will repair only devices that can returned to normal operation, and you must
bear the cost. The repair parts necessary for repair will be stored for 6 years after
the device is sold.
Disposal
This device is categorized an industrial waste. Contact to the local government
about disposal.

10-4. Service parts


The usable service life of this device is 6 years. However, the following components
are supplied for maintenance since they have a shorter usable service life than that
of the device. Repair parts necessary for repair will be stored for 6 years after the
device is sold. Exchange timing depends on the frequency and environment of
usage of the device. Exchange the components if you find it necessary during
inspections. Ask any questions to our office or distributor.

Usable
Names of major components Reason of usable service life
service life
Rechargeable battery for the
2 years Aged degradation
main unit (nickel metal-hydride)
Degradation of ceramic adhesion
Probe 5 years
Degradation of movable connection of cord
Degradation of movable connection and
Curl cord 3-4 years
coating
Consumable, deterioration of coating of
Power cord 3-4 years
cord

60
Notification to Users

We must provide information about efficacy and safety, and other necessary information for
proper use of the device to all users according to the provisions of the Pharmaceutical
Affairs Act. It is established by law that all users must help to collect information necessary
for proper use. Please take a few minutes and inform us about the following information if
any negative problem was caused by use of the device.

(Inform) Toitu Co., Ltd. International Department


1-5-10, Ebisu-Nishi, Shibuya-Ku, Tokyo,
150-0021 Japan
Tel: +81-3-3463-6381 Fax: +81-3-3463-6380

● Address

● Name of facility

● Person in charge

Device name: Doppler Fetus Detector FD-490 (□FD-491, □FD-492)


Serial number:

Problem

61

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