DOPPLER FETUS DETECTOR
FD-490(FD-491/FD-492)

Operation Manual

CAUTION● This device can only be operated by a physician or under the direction of aphysician.
● 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

Distributor

TOITU CO., LTD.
1-5-10, Ebisu-Nishi, Shibuya-Ku,
Tokyo 150-0021, Japan
Tel: +81-3-3463-6381
Fax: +81-3-3463-6380
E-mail: international@toitu.co.jp
URL: http://en.toitu.co.jp/

Ver.2.6EN
2023-11-06

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 fordamage during transport and read this operation manual carefully toensure proper operation. In the event of any damage or problems withthe 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 thehandling 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 othersounds 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 ofusers for improper use or repair by unqualified personnel.
●

The following optional products for this device are no longer sold.
This instruction manual includes some operating instructions tocorrespond to the products already sold.
・Special software (FHRViewer)

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 themeaning.

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 byinspection, 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 themain 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 ofpartitions).
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 anothermethod.
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 becompatible 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 forsystem 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 abreakdown 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 beforeuse.
To prevent explosion and fire
1. Do not use in a location where there is a risk of explosion, such as environment withflammable anesthetic gas or oxygen.
2. Do not place heavy objects on the power cord or expose the power cord to the weightof other objects. Do not damage, abuse, twist, pull, or heat the cord. In the event ofdamage to the power cord (exposed core or breakage), ask our office or distributor foran exchange.
To avoid electromagnetic effects
1. This device may cause poor transmission or interfere with other devices because ofradio 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 anincrease 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 thatconnections 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 electrosurgicalknife, defibrillator, or MRI. Failure to heed this warning may result in damage to thedeviceWarning 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

Fuse

Device sensitive tostatic electricity

CautionNon-ionizing radiation

2. Toitu symbols

Radio wave condition

Battery symbol

Earphone

Abnormality indicator of
probe

VI

Electromagnetic Compatibility (EMC)
MEDICAL ELECTRICAL EQUIPMENT needs special precautions regarding EMC and needs to beinstalled 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 theperformance 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 toverify 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 failureVII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

ComplianceElectromagnetic environment ‐ guidance

RF Emissions
CISPR 11

Group 1The FD-490 uses RF energy only for its internal function.
Therefore, its RF emissions are very low and are not
likely to cause any interference in nearby electronicequipment.

RF Emissions
CISPR 11Class B

Harmonic Emissions
IEC 61000-3-2Class A

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

The FD-490 is suitable for use in all establishments,
including domestic establishments and those directly
connected to the public low-voltage power supply
network that supplies buildings used for domestic
purposes.

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.
Immunity test

Electrostatic
Discharge (ESD)
IEC 61000-4-2

Electrical Fast
Transient/Burst
IEC 61000-4-4

Surge
IEC 61000-4-5

Voltage dips, shortinterruptions andvoltage variations on
power supply inputlines
IEC 61000-4-11

Power Frequency(50/60 Hz) Magnetic
Field
IEC 61000-4-8

IEC 60601
Test Level

Compliance Level±8 kV contact±2 kV, ±4 kV,±8 kV, ±15 kV air±8 kV contact±2 kV, ±4 kV, ±8 kV,±15 kV air±2 kV for power
supply lines±2 kV for power
supply lines±1 kV for
input/output lines

Not applicable±0.5 kV, ±1 kV line(s) to line (s)±0.5 kV, ±1 kV,±2 kV line (s) toearth±0.5 kV, ±1 kV line(s) to line (s)±0.5 kV, ±1 kV,±2 kV line (s) toearth

0% UT: 0.5 cycle
At 0º, 45º, 90º,
135º, 180º, 225º,
270º and 315º

0% UT: 0.5 cycle
At 0º, 45º, 90º,
135º, 180º, 225º,
270º and 315º

0% UT: 1 cycle
and
70% UT: 25/30
cyclesSingle phase: at 0º

0% UT: 1 cycle
and
70% UT: 25/30
cyclesSingle phase: at 0º

0% UT: 250/300
cycle

0% UT: 250/300
cycle

30 A/mNot applicable
NOTE 2

Electromagnetic environment‐ guidance
Floors should be wood, concrete
or ceramic tile.
If floors are covered with synthetic
material, the relative humidity
should be at least 30%.

Mains power quality should bethat of a typical commercial or
hospital environment.

Mains power quality should bethat of a typical commercial or
hospital environment.

Mains power quality should bethat of a typical commercial or
hospital environment. If the userof the FD-490 requires continued
operation during power mains
interruptions, it is recommended
that the FD-490 be powered froman uninterruptible power supply ora battery.

Power frequency magnetic fields
should be at levels characteristicof a typical location in a typicalcommercial or hospitalenvironment.

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.
Immunity test

IEC 60601
Test Level

Conducted RF
IEC 61000-4-6

3V
0.15 MHz-80 MHz

Compliance
Level
3V

‐ guidance
Field strengths from fixed RF transmitters,
as determined by an electromagnetic site
survey a , should be less than thecompliance level in each frequency rangeb.

The ISM (industrial,
scientific andmedical) bands
between 0.15MHz
and 80MHz are
6.765MHz to
6.795MHz;13.553MHz to
13.567MHz;
26.957MHz to27.283MHz; and40.66MHz to40.70MHz.
6 V in ISM andamateur radio
bands cbetween
0.15 MHz and 80
MHzElectromagnetic environment

Interference may occur in the vicinity ofequipment marked withthe following symbol:

6V

80% AM at 1 kHz
Radiated RF
IEC 61000-4-3

10 V/m80 MHz to 2.7 GHz
80% AM at 1 kHz

10 V/mNote: These guidelines may not apply in all situations. Electromagnetic propagation is affectedby reflection from structures, objects, and people.
aField 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 inwhich 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.
bOver 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 Wirelesscommunications equipment
WARNING: Portable RF communications equipment (including peripherals such as antenna cables andexternal 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
frequency

Maximum
Band(MHz)

ServiceModulation

(MHz)

Power
(W)

Distance(m)

Immunity
Test Level
(V/m)

385

380-390TETRA 400

Pulse modulation
18 Hz

1.8

0.3

27

450

430-470

GMRS 460,
FRS 460

FM ±5 kHzdeviation
1 kHz sine

2

0.3

28

704-787

LTE Band 13,
17

Pulse modulation
217 Hz

0.2

0.3

9

800-960

GSM 800/900,
TETRA 800,
iDEN 820,CDMA 850,
LTE Band 5

Pulse modulation
18 Hz

2

0.3

28

Pulse modulation
217 Hz2

0.3

28

Pulse modulation
217 Hz2

0.3

28

Pulse modulation
217 Hz

0.2

0.3

9

710
745
780
810
870
930
1720
1845

1700-1990

1970

2450

2400-2570

GSM 1800;
CDMA 1900;
GSM 1900;
DECT;
LTE Band 1,
3, 4, 25;
UMTS
Bluetooth,
WLAN,
802.11.b/g/n,
RFID 2450,
LTE Band 7

5240
5500

5100-5800

WLAN 802.11
a/n

5785

XI

Radio Wave Information
This device uses a radio wave frequency of 2.4GHz. Many systems operate within thisfrequency 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, andamateur radio stations, (hereinafter called as “other radio stations”). This device uses thefull 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 lessmay 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
For Safe and Proper Use
List of Warnings
Meaning of Symbols
Electromagnetic Compatibility (EMC)
Radio Wave Information
1.

2.

Summary

1

1-1. Features
1-2. Principles

1
2

List of Components
2-1. Wired Type2-2. Wireless Type

3.

Part Names and Functions
3-1. Main Unit
3-2. Probe

4.

Preparations
4-1. How to attach/remove the Rechargeable Battery
4-2. Wired Type
4-3. Wireless Type5.

How to Use
5-1. Usage Environment
5-2. Charging the Main Unit
5-3. Turn on the Power5-4. Inspection before Use
5-5. Apply ultrasound gel
5-6. Measurement
5-7. After Measurement
5-8. Standby Mode
5-9. Isolation from supply mains

6.

Functions6-1. Display Function
6-2. External Output

7.

I
Ⅱ
Ⅲ
VI
VII
XII

Settings
7-1. No Signal Power Off
7-2. Automatic Power Off
7-3. Timer Setting
7-4. Buzzer Volume

3
3
3

4
4
9

11
11
12
13

18
18
19
20
21
23
24
26
27
28

29
29
31

32
33
34
34
35

7-5. Date and Time
7-6. Operation Sound
7-7. Brightness of Backlight
7-8. Languages
7-9. Sweep Rate
7-10. Wireless Off Timer (Wireless Type Only)

8.

Cleaning/Inspection/Storage
8-1. Cleaning
8-2. Inspection
8-3. Storage

9.

Troubleshooting

36
38
39
39
40
40

42
42
45
50

51

9-1. Wired Type9-2. Wireless Type52
54

10. Specifications

56

10-1. Product Specifications
10-2. Accessories
10-3. Usable service life/Warranty/Disposal
10-4. Service parts
Notification to Users

56
59
60
60
61

1. Summary
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 ofumbilical 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 toamplify Doppler sounds. There are two types of probe: wired and wireless.

● Wired type

● Wireless type1-1. 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)
Note: Special software (FHRViewer) is no longer available.
• 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 thecord during use.

• Wired type (Upright)
TR-205• Wired type(L-shape)
TR-203• Wireless type (L-shape)
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 thearea.

1-2. Principles
This device detects the fetal heart rate using ultrasound Doppler technology. When ahigh-frequency voltage is applied to the transmission element of the probe, theelement vibrates and emits ultrasound waves. When these ultrasound waves reachthe 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 thereceiving element of the probe. The received waves are processed as signals andseparated 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 speakerbecause it is in the audible range.

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

No.
1

2

3

2 TR-203

2 TR-205

3

4

Note

Note

Name

Quantity

No.

Name

Quantity

Main unit

1

4

SCAN(Ultrasound Gel)

1

Wired probe (Choose
TR-203 or TR-205)

1-

Operation manual1

Connecting cord

1-

Micro USB connector
cover

1

Power cord

1

-

-

-

Note: Whether Items ‘3’ and ‘4’ are included or not depends on the country.

2-2. Wireless Type
2 TR-204

1

3

4

5

Note
No.

Name

Note
Quantity

No.

Name

Quantity

1

Main unit

1

5

SCAN(Ultrasound Gel)

12

Wireless probe

1-

Operation manual13Power cord

1-

Micro USB connector
cover

1

4

Alkaline battery(for operation check)

1-

Mini-Din connector cover1

Note: Whether Items ‘3’ and ‘5’ are included or not depends on the country.
33. Part Names and Functions
3-1. Main Unit
1. Front and left side
1

4
2

5

6

3

7

№

Part names

Functions and operations
Displays heart rate and can be operated by a touch
panel.
Turns power off and on.
Used for the pairing procedure in the wireless type.

1

LCD screen

2

Operating switch

3

Speaker

Outputs Doppler sound and operation sounds.

4

External output terminal

Used to transfer measurement data saved in internal
memory to a personal computer.
Note: The device cannot be used for measurement in
the data transfer mode.
Note: Special software (FHRViewer) is no longer
available.

5

Earphone jackFor connecting of an optional earphone.

6

Reset switch

Resets the device.
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

9

№

Part names

Functions and operations

8

Connector

Connects the wired probe.

9

Battery cover

Cover for the battery box.
The special rechargeable battery is placed in the box.

10 Heat ventExhausts 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

3

2

№

1

Part names

Functions and operations

1

Display of heart rate

Displays the measured heart rate.

2

Menu

Displays the setting display.

3

Volume meter

Controls the volume of Doppler sounds.
Operation sounds and buzzer sounds are not affected.

4
5
6
7
8

Heart beatLights in response to detection of the heartbeat.
synchronization symbol
Symbol of abnormality in
Displayed in response to an abnormality in the probe.
probe
Displays the radio wave status and the pairing
Symbol for radio wave
condition.
strength
Not displayed while using the wired probe.
Displays the remaining rechargeable battery level andBattery symbol
the charging condition.
Time (hours and minutes) is displayed in 24-hourTimenotation.

64. Waveform display
4

5

6

7

8

9
3
10

2

№

1

Part names

Functions and operations

1

Display of heart rate

Displays the measured heart rate.

2

Menu

Displays setting display.

3

Volume meter

Controls the volume of Doppler sounds.
Operation sounds and buzzer sounds are not affected.

4
5
6
7
8
9

Heart beatLights in response to detection of the heartbeat.
synchronization symbol
Symbol of abnormality in
Displayed in response to an abnormality in the probe.
probe
Displays the radio wave condition and the pairing
Symbol for radio wave
condition.
strength
Not displayed while using the wired probe.
Displays the remaining battery level and the charging
Battery symbol
condition during operation of the main unit with thebattery.
Time (hours and minutes) is displayed in 24-hourTimenotation.
Waveform display

10 Event symbol

Measured heart rate is displayed in waveform.
Displayed when pushing the operating switch during
measurement.

7

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

・ Symbols for an abnormality in the transducer
Blinking

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

Lighting

Low battery level in the wireless probe

・ Symbols for radio wave strength
Lighting

Radio wave strength(excellent)Lighting

Radio wave strength(good)

Lighting

Radio wave strength(fair)

Lighting

Now checking
transmission

Lighting

・Radio wave strength(poor)
・Pairing failure

Blinking Now charging

Lighting

Battery level (high)Lighting Battery level (medium)

Lighting

Battery level (low)Lighting No battery level

Blinking

Blinking

Now pairing

・ Battery symbols

8

Battery abnormality or
breakdown3-2. Probe
1. Wired probe (L-shape) TR-203
1

2

3
№

Part names

1

Operating switch

2

Probe head3

Connecting cord

Functions and operations
Turns power off and on.
LED indicates operating status.
See section 3-2 “Probe, 4. Probe LED indications.”
Sends and receives ultrasound when touching thematernal abdominal wall.
Connects the wired probe to the main unit.

2. Wired probe (Upright) TR-205
1

2№

Functions and operations

Part names

1

Probe head

Sends and receives ultrasound when touching thematernal 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

4
№

Part names

Functions and operations

1

Operating switch

Turns power off and on.
LED indicates operating status. Used for pairing.

2

Battery cover

Cover for the battery box. Holds AA battery.

3

Probe head

Sends and receives ultrasound when touching thematernal abdominal wall.

4

Lock knob

Secures the battery cover.

4. Probe LED indications (L-shape only)
Common in wired/wireless types

Wireless type only

Power onBlinking(blue)

Now pairing

No lighting Power off

Blinking(red)

Battery level (low)Blinking(red andblue)

Blinking
every 5seconds(blue)

Standby

Lighting(blue)

Transmission
abnormality

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 ina 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 holderin 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 ora screwdriver.

3. Connect the connector in the battery boxof 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 themain unit.
11

・ Removal of the battery
Pull the connector on the rechargeable battery
while pushing the lock on the connector for therechargeable battery from the upper side toremove the rechargeable battery.

4-2. Wired TypeCAUTION● 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 thatthe 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 theconnection cord

Insert the connector so the

The wired probe connectedconnection 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 todisplay 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 theBattery 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.

Click2) When sliding the lock knob to the end, the battery cover will lift slightly to make aspace.

・ 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
the indication in the battery
compartment.

Insert the battery from theminus (-) end and then push
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 thepairing 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 causeinterference, consult us or distributor about measures to prevent suchinterference (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 samefacility.
Pairing is a procedure to identify the combination of the main unit and the wirelessprobe.
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
in blue)

・ LED on the operating switch (blinks
In blue)

・ Check pairing

When pairing is complete, the symbol and the LED stop blinking, and thedisplays 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.

Lighting

Blinking

・ Pairing completed

・ Pairing started

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

Blinking

・ 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 theMenubutton in the lower left of the LCD screen to display thesetting 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 asenvironment 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 thedirection 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 thecorrect 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 isinstalled.
● 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 useof 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 withthe 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 UnitWARNINGTo 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 (exposedcore 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 thestart 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
switches

The LCD screen of the main unit and the
LED of probe light when the power is on20

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 theoperation switches
・ Operating switch of the wireless probe

・ Operating switch of the main unit

The LCD screen of the main unit and the LEDof 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 metergo up and down as the finger slides.
Reference:
If you set the volume to “00,” the Doppler sound is not output but there is nochange in the volume of the operation sound and buzzer sound. To change thevolume of these sounds, see 7-4 “Buzzer Volume” and 7-6 “Operation Sound.”Volume up

Volume down

Slide your finger while touching thevolume meter

2. Check of signal detection

WARNINGTo 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. (Except
TR-205)23

5-6. Measurement

WARNINGTo prevent misdiagnosis● Adjust the probe to the optimum position in response to the movements ofthe fetus. If the unit firmly touches a maternal blood vessel, the probe willdetect 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 thisdevice 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 systemcompatibility 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 wirelessprobe. When determining the fixing point, hold the transducer so as not tocover 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 themain unit too high.
● The wireless range of this device is within 10 m.
Measurements using the wireless probe may be less reliable than with thewired probe depending on the conditions, such as setting point andsurrounding environment. Place the probe closer to the body of thisdevice 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 sound1) 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 responseto 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 thesymphysis 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 thenavel-spine line of the fetal back side. If you cannot detect the heart rate,
search three fingerbreadths from the superior margin of the symphysis pubisin 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 detectionof 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 theprobe (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 withtissues 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. Doingso may damage the device. For the wireless probe, do not place it from the sideof the battery box. If you do, the device may fall when carried.

○
×

○

○

・ Correct storage of the probe

××・ Improper storage of the probe26

Ultrasound gel:
You can store the ultrasound gel in the probe/gel holder on the back of the mainunit.
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 fiveseconds.

・ Display of standby of the main unit
(Display of the symbol for radio wave
strength)

27・ Display of standby of the wireless probe(LED of the operating switch blinking inblue)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 bytouching each displayarea3) 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 thevertical 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 displayedmeasurement 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

Setting: 10mm

4 min 30 sec

3 min

Setting: 20mm

29

Setting: 30mm

• 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: 30mm), 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
Heart rate range: 30-240bpm
Measurement time: 3 min, 4 min 30
sec, 9 min

Enlarged display
Heart rate range: 100-170bpm
Measurement time: 1 min, 1 min 30
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 bytimely 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 event symbol is displayed

The displayed event symbol is no longer
displayed, and a new one is displayed on
the right in the display area30

6-2. External Output

WARNINGTo 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 dataprocessing devices, CISPR 32 EMC of multimedia equipment, IEC60601-1 formedical 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 (oneitem: 10 minutes after the power was turned on). The saved data can be transferred toa personal computer for reference.
* Special software (FHRViewer) is needed to see the previous saved data. See theattachment “FHRViewer Instruction Manual” about data transfer via external output
and the special software.
Note: Special software (FHRViewer) is no longer available.

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 bechanged. The setting display can be displayed by touching the Menu button in thelower left area on the LCD screen of the main unit.

・ Touch theMenubutton 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 theadjustment to return to the measurement screen. When changing several settings, moveto 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.

Setting

Details

1 Min

Turn off the power after 1 minute of no signal.

2 Min

Turn off the power after 2 minutes of no signal.

Off

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

33

InitialsettingO

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.

Setting

Details

5 Min

Turn off the power automatically 5 minutes after power on.

10 MinTurn off the power automatically 10 minutes after power on.

Off

InitialsettingO

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
Setting

Details

P-On

Timer starts at power on.

Event

Timer starts from input of event via the operating switch.

No useNo timer function is used.

InitialsettingO34

・ Timer
Setting

Initialsetting

Details

1 Min

Buzzer rings 1 minute after the set time.

2 Min

Buzzer rings 2 minutes after the set time.

3 Min

Buzzer rings 3 minutes after the set time.

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

1min

The event symbol “▲” is displayedby pushing the operating switch

Buzzer rings 1 minute after
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 theEndbutton・Buzzer volume
Setting

Details

Hi

Loud volume

Mid

Medium volume

Low

Low volume

InitialsettingO

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.

The software keyboard is displayed

Touch the input box for date and time

1. Setting the date (e.g. June 23, 2012)
1) Touch the input box for "year". The software keyboard appears.

The software keyboard is displayed

Touch the input box for “year"2) Type "12" and touchSetbutton. 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

Returnbutton after changing the setting to return to themeasurement display.
2. Setting the time (e.g. 12:23:00)
1) Touch the input box for “hour.” The software keyboard is displayed.

The software keyboard screen is opened

Touch the input box for “hour”

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

Type "12" then touch Set button

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 themeasurement 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Setting

Details

On

Provides operation sounds.

Off

Provides no operation sounds.

InitialsettingO

7-7. Brightness of Backlight
Set the brightness of the LCD screen.
Select Dim for a darker screen, Bright for a brighter screen.

Setting

Details

Dim

Dims the backlight brightness.

Mid

Sets backlight brightness to the middle level.

BrightBrightens the backlight brightness.

InitialsettingO

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

Setting

Details

Initialsetting

Japanese Displays in Japanese.
EnglishDisplays in English

O39

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

Setting

Initialsetting

Details

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 ineach setting.

3min

Setting: 10mm

3min

Setting: 20mm

3min

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

Setting
0 Min
30 MinCont.

Details
No standby mode.

Initialsetting
O

Switches to standby mode.
The power is turned off by standby for 30 minutes.
Switches to standby mode.
Standby continues until the battery level drops to zero.
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 setting41

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

21

Holderstopper

Pull to the backside to remove
the holder.

Support the main unit with one
hand.

42

3

4

Pull holder upward from 2) state
and remove it from main unit.

Slide the tray to remove.

・ How to attach the holder

12

Align the fixed parts of the main
unit and holder.

Allow the holder to attach to themain unit.

3

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 theunit is exposed to water, wipe the water off thoroughly and dry before use.
Check theconnection

× ×

Wash with water with theconnection cord attached.

Do not wet the connector.

Do not wet the connector.

・ Wireless probe

Wash with water while thebattery cover closed.

Check the locks.

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, orother material.
3) Sterilization
Sensitivity to microorganisms differs by chemical. Follow the efficacy, usage,
precautions, and other instructions specified in the package insert for eachchemical.

8-2. Inspection

WARNING● Follow the instructions in this manual. In the event of an abnormality, stopusing 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 fromthe 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 themain 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 toheed 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 abreakdown.

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 beforeuse

Be sure to conduct before
every use of this device.

See "Inspection before
use"

Inspection afteruse

Be sure to conduct after every See "Inspection after
use of this device
use"

Inspection in
every 6 months

Conduct an inspect offunctions in every 6 months

See "inspection every six
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:

No.

Inspected by:Inspection details

Results1

No damage to the device.

Pass / Fail2

The power is turned on by pushing the operating switch.

Pass / Fail3

No missing display on the LCD screen.

Pass / Fail4

The power level of the device remains sufficient.

Pass / Fail

5

Correct date and time are displayed.

Pass / Fail6

The touch panel of the LCD screen reacts correctly.

Pass / Fail

7

When tapping the probe head with the palm of the hand, a sound isemitted from the speaker.

Pass / Fail

8

Sounds with appropriate volume are emitted from the speaker bycontrolling the volume meter.

Pass / Fail・ Inspection after use
Serial number:

Inspection date:Inspected by:No.

Inspection details

Results

1

Remove remaining ultrasound gel and extraneous matter from thedevice.

Pass / Fail2

Disinfect the used probe.

Pass / Fail3

No damage to the device.

Pass / Fail47

・ Inspection every six months
Serial number:

Inspection date:

No.

Inspected by:Inspection details

Results1

No damage to the device.

Pass / Fail2

No damage to the power cord.

Pass / Fail

3

When you connect the device (the power off) to the power outlet, therechargeable battery symbol is displayed on the LCD screen.

Pass / Fail

4

When you turn the power on by pushing the operating switch, the
LCD screen and the LED of the probe light.

Pass / Fail5

No missing display on the LCD screen.

Pass / Fail

6

Correct date and time are displayed.

Pass / Fail7

The touch panel of the LCD screen reacts correctly.

Pass / Fail

8

When tapping the probe head with the palm of the hand, a sound isemitted from the speaker.

Pass / Fail

9Sounds with appropriate volume are emitted from the speaker bycontrolling the volume meter.

Pass / Fail

10

When tapping the probe head with the palm of the hand, the heart
rate is displayed on the LCD screen.

Pass / Fail11

No abnormal sound after shaking the device.

Pass / Fail48

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 ifnecessary.
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 andapply a screwdriver to thedepressed area.

Pull out the fuse holder
with the edge of thescrewdriver.

Do not pull the fuseholder too far.

3) Remove the burned out fuse
Hold both edges of the fuse with the fingers and push out from upper side of thefuse holder to remove.
Push out from upper side with aforefinger. Support with the thumbto 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.

Proper position

Wrong position

5) Return the fuse holder
Push the fuse holder into the inlet.
49

Adjust properly

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 longtime.
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 longtime.
・ 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 threemonths 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, stopusing 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 holeO 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 thedevice.
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 switch51

9-1. Wired Type
Example ofmalfunctioning

Possible causes

Solutions

No AC power
The power of the main
unit cannot be turned on.

Low battery level

The power cannot be
turned on by theoperating switch of thewired probe (TR-203).

The battery cannot becharged.
No battery symbol isdisplayed on the LCD
screen.

Incomplete connection of
the cord
Abnormality in theconnection cord

No AC power

Breakdown/degradation of
the rechargeable battery
Breakdown of the LCD
screenThe battery level
decreases rapidly.
The battery symbol isblinking in red.
"P" symbol is blinking on
the LCD screen and thepower is turned off.

The display of the LCD
screen is disturbed

Breakdown/degradation of
the rechargeable battery
Breakdown of the main unitor the rechargeable battery
Incomplete connection of
the cord
Abnormality in theconnection cordInternal error in the mainunit.
Breakdown of the LCD
screen52

Check the following items:
1. Check the power cord connection. If it is noconnected, connect completely. See 5-2“Charging the main unit, 2. Connectionof the power cord.”
2. Check for any damage to the power cord. If
it is damaged, exchange for a new powercord.
3. Check the fuse to the power inlet. If it is
disconnected, exchange for new one.
See 8-2 “Inspection, 3. Exchange of thefuse.”
Check the rechargeable battery level of themain unit. If the battery level has decrease,charge it. See 5-2 “Charging the main unit.”
Check the connection cord to the main unit
and the wired probe. If it is not connected,
connect completely. See 4-2 “Wired Type.”
Check for any damage to the connection cord.
If it is damager, exchange for a newconnection cord.
Check the following items:
1. Check the power cord connection. If it is notconnected, connect completely.
2. Check for any damage to the power cord. If
it is damaged, exchange for a new powercord.
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.”
Ask our office or distributor to repair.
Ask our office or distributor to repair.
Ask our office or distributor to repair.
Ask our office or distributor to repair.
Check the connection cord to the main unit
and the wired probe. If it is not connected,
connect completely. See 4-1 “Wired Type.”
Check for any damage to the connection cord.
If it is damaged, exchange for a newconnection cord.
Reset by pushing the reset switch.
See 9 “Troubleshooting, Reset procedure.”
Ask our office or distributor to repair.

Example ofmalfunctioning
The touch panel showsno reaction.

The heart rate is not
displayed.
There are noises in theheartbeat.

Possible causes

SolutionsInternal error in the mainunit.
Breakdown of the LCD
screenInappropriate position of theprobe
Too little gel applied to theprobe
Incomplete connection of
the cord
Abnormality in theconnection cord
Low volume setting

No heartbeat can beheard.

Incomplete connection of
the cord
Abnormality in theconnection cord

The power is suddenly
turned off.

The function of no signal
power off or automatic
power off worked.

The power cannot be
turned off.
Abnormal sounds are
emitted from the
speaker.

Internal error in the device

53

Reset by pushing the reset switch.
See 9 “Troubleshooting, Reset procedure.”
Ask our office or distributor to repair.
Search the appropriate position that provides
clear-cut rhythmic sounds.
Apply the gel evenly.
Check the connection cord to the body and thewired probe. If it is not connected, connect
completely. See 4-2 “Wired Type.”
Check for any damage to the connection cord.
If it is damaged, exchange for a newconnection cord.
Check the volume meter of the LCD screen. If
it is low, turn up. See 5-4 “Inspection before
Use 1. Volume control.”Check the connection cord to the body and thewired probe. If it is not connected, connect
completely. See 4-2 “Wired Type.”
Check for any damage to the connection cord.
If it is damaged, exchange for a newconnection cord.
The no signal condition for 2 minutes or at 10
minutes after the power on leads to power off.
Change the settings as needed. See 7-1 “No
Signal Power Off” and 7-2 “Automatic Power
Off.”
Reset by pushing the reset switch.
See 9 “Troubleshooting, Reset procedure.”9-2. Wireless Type
Example ofmalfunctioning

Pairing cannot be
conducted.

Possible causes

SolutionsToo far between thewireless probe and the mainunit

Allow the body and the wireless probe to movecloser to conduct pairing.

Abnormal beginning of
pairing
Other wireless devices used
close

No AC power
The power of the main
unit cannot be turned on.

Low battery level
The power of the wirelessprobe cannot be turned
Low battery levelon.

The battery cannot becharged or start to be
charged.
No battery symbol isdisplayed on the LCD
screen.

The battery level
decreases rapidly despite
charging with noproblems.
The battery symbol isblinking in red.

"P" symbol is blinking on
the LCD screen and thepower is turned off.

Check the LED of the wireless probe and thesymbol for radio wave strength. If symbols are
not blinking start from the first procedure again.
See 4-3 “Wireless Type, 2. Pairing.”
Stop other wireless device or keep it far from thisdevice to conduct pairing.
Check the following items:
1. Check the power cord. If it is not connected,
connect completely. See 5-2 “Charging theMain Unit, 1. Connection of the power cord.”
2. Check for any damage to the power cord. If it
is damaged, exchange for a new power cord.
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
unit. If the battery level has decreased, charge it.
See 5-2 “Charging the Main Unit.”
Change the battery of the wireless probe. See
4-3 “Wireless Type 1. How to insert the battery.”No AC power

Check the following items:
1. Check the power cord. If it is not connected,
connect completely. See 5-2 “Charging theMain Unit, 1. Connection of the power cord.”
2. Check for any damage to the power cord. If it
is damaged, exchange for a new power cord.
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.”

Breakdown/degradation of
the rechargeable battery

Ask our office or distributor to repair.

Breakdown of the LCD
screenAsk our office or distributor to repair.

Breakdown/degradation of
the rechargeable battery

Ask our office or distributor to repair.

Breakdown of the main unitor the rechargeable battery
Too far between thewireless probe and the main
unit.
Other wireless device is too
close
Low battery level54

Ask our office or distributor to repair.
Allow the main unit and the wireless probe tomove closer.
Stop other wireless device or keep it far from thisdevice to conduct pairing.
Change the battery of the wireless prob. See 4-3“Wireless Type 1. How to insert the battery.”Example ofmalfunctioning

The main unit and thewireless probe cannot
connect wirelessly.

Possible causes

SolutionsToo far between thewireless probe and the mainunit
Wrong pair of wireless probe
and the main unit
* When using multiple pairs
Wireless communication
error

The display of the LCD
screen is disturbed.

The touch panel showsno reaction.

The heart rate is notstably displayed.
There are noises in theheartbeat.

Internal error

The power is suddenly
turned off.

Turn the power on individually to check thepair.
If you turned on the power immediately after
power off, it may be difficult to connect
wirelessly.
Turn on the power 5 seconds or more after
power off.
Reset by pushing the reset switch.
See 9 “Troubleshooting, Reset procedure.”

Breakdown of the LCD
screenAsk our office or distributor to repair.

Internal error

Reset by pushing the reset switch.
See 9 “Troubleshooting, Reset procedure.”

Breakdown of the LCD
screenInappropriate position of theprobe
Too little gel applied to theprobe
Too far between thewireless probe and the main
unit
Other wireless devices usedclose
Low volume setting

No heartbeat can beheard.

Allow the main unit and the wireless probe tomove closer.

Too far between thewireless probe and the main
unit
Other wireless devices usedclose
The function of no signal
power off or automatic
power off was worked

The power of the wirelessprobe cannot be turnedInternal error of the probe
off.
The power cannot be
turned off.
Internal error of the device
Abnormal sounds are
emitted from the speaker.

55

Ask our office or distributor to repair.
Search the appropriate position that provides
clear-cut rhythmic sounds.
Apply the gel evenly.
Allow the body and the wireless probe to movecloser.
Stop other wireless device or keep it far fromthis device to conduct pairing.
Check the volume meter of the LCD screen. If it
is lower, turn up.
Allow the main unit and the wireless probe tomove closer.
Stop other wireless device or keep it far fromthis device to conduct pairing.
The no signal condition for 2 minutes or at 10
minutes after the power on leads to power off.
Change the settings as needed. See 7-1 “No
Signal Power Off” and 7-2 “Automatic power
off.”
Reinsert the battery of the wireless probe. See
4-3 “Wireless Type 1. How to set the battery.”Reset by pushing the reset switch.
See 9 “Troubleshooting, Reset procedure.”10. Specifications
10-1. Product Specifications
Main unit
Power-supply voltage

AC 100 – 240 V

Power-supply frequency

50/60 HzPower consumption

30 VA

Rated voltage (internal power supply)

7.2 V

Power consumption (internal powersource)Continuous operating time (internal
power source)

15 VA
160 min

Charging time

70 minDimensions: width × height × depth

200 × 195 × 125 mm

Weight

1.5 kgOuter protection level against ingressof water

IPx0

Display function

LCD screen: Displays operating conditions,settings, battery level and abnormal conditions

Operating function

Settings and maintenance

External output

External output terminal, earphone jack

Wireless communication

Type:
2.4GHz upgrade low power data communication
systemType 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)
Protection type to electric shock

AC power

Class II device

Battery

Internally-powered device

Classification of attached area byprotection level

Attached part type B

Dimensions: width × height × depth

46 ×130 × 50 mm

Weight0.1 kgOuter protection level against ingressof waterMaterials of parts which contact tohuman body

IPx7
PC, ABS/PC, Elastomer

Applied part (Maximum temperature)

Probe head (43℃)

Display function

LED indicator: indicates operation status56

Wired probe TR-205(Upright)
Protection type to electric shock

AC power

Class II device

Battery

N/AClassification of attached area byprotection level

Attached part type B

Dimensions: width × height × depth

35 × 122 mm

Weight0.05 kg

Outer protection level against ingressof waterMaterials of parts which contact tohuman body
Applied part (Maximum temperature)

IPx7
ABS/PC
Probe head (43℃)

Wireless probe TR-204
Rated voltage

1.2 V

Power source

AA battery

Power consumption

0.57 VA

Continuous operating time

180 min (Alkaline battery/new/at 28℃*)
250 min (Nickel metal-hydride battery/new/fullcharge)Protection type to electric shock

Internally-powered device

Classification of attached area byprotection level

Attached part type B

Dimensions: width × height × depth

46 × 130 × 50 mm

Weight0.1 kgOuter protection level against ingressof waterMaterials of parts which contact tohuman body

IPx7
PC, ABS/PC, Elastomer

Applied part (Maximum temperature)

Probe head (43℃)

Display function

LED indicator: indicates operation status, remaining
battery, abnormal conditions

Operating function

Settings

Wireless communication

Type:
2.4GHz upgrade low power data communication
systemType 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 ofspace
Effective region of ultrasonictransducer

21.2kPa
119 mm2

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.

CablesType

Item code

Power cordCurl cord

Max. Length
2.9 m

YC01042.5 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
Names

Item
code

QuantityCable
lengthWired probe TR-203

JA1693

1-

Wired type FD-491 only

Curl cord for TR-203

YC01041

2.5 m

Wired type FD-491 only

Wireless probe
TR-204

JA17061-

Wireless type FD-492 only

Wired probe TR-205

JA1983

1-

Wired type FD-491 only

Curl cord for TR-205

YC01041

2.5 m

Wired type FD-491 only

Ultrasound gel
Note1

GA0133

1-

SCAN(Ultrasound Gel)

Fuse

SA00582-

EGM-S250V0.5APBF
One in the inlet, one spare

YA00731

2.9 m

10A 250VAC, CEE7/7

YA00701

2.4m

7A 125VAC, Type B

GZ1271

1-

1-SG00281-

Wireless type FD-492 only

SD0731

1-

When using a wireless probe
TR-204SD0730

1-

Power cord
Note2
Operation manual
Package insert
Alkaline battery (forperformance check)
Mini-DIN connector
cover
Micro USB Connector
cover

Remarks

Note1: Whether it is included or not depends on the country.
Note2: Either Cord YA0073, YA0070, or no cord is included depending on the country.

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 isbased on the self-certification (our data). Some components may degrade withage within the usable service life. Regularly exchange the components tomaintain the performance of this device during the usable service life. Repair oroverhaul depending on the results of inspections as needed.
Warranty
We will repair the device free of cost within the warranty period according to theprovisions 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 mustbear the cost. The repair parts necessary for repair will be stored for 6 years after
the device is sold.
DisposalThis 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 thatof the device. Repair parts necessary for repair will be stored for 6 years after thedevice is sold. Exchange timing depends on the frequency and environment ofusage of the device. Exchange the components if you find it necessary during
inspections. Ask any questions to our office or distributor.
Names of major components

Usableservice life

Rechargeable battery for themain unit (nickel metal-hydride)

2 yearsProbe

5 years

Curl cord

3-4 years

Power cord

3-4 years

60

Reason of usable service life
Aged degradation
Degradation of ceramic adhesion
Degradation of movable connection of cord
Degradation of movable connection andcoating
Consumable, deterioration of coating ofcord

Notification to Users
We must provide information about efficacy and safety, and other necessary information forproper 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:
Problem61

This page is blank. Please use it as a memo.

This page is blank. Please use it as a memo.

This page is blank. Please use it as a memo.

TOITU CO., LTD.
1-5-10, Ebisu-Nishi, Shibuya-Ku,
Tokyo 150-0021, Japan
Tel: +81-3-3463-6381
Fax: +81-3-3463-6380
E-mail: international@toitu.co.jp
URL: http://en.toitu.co.jp/