SAN-Operation Manual FD-490 Ver 2.4 EU
SAN-Operation Manual FD-490 Ver 2.4 EU
SAN-Operation Manual FD-490 Ver 2.4 EU
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.
I
For Safe and Proper Use
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 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.
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.
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
Device sensitive to
Fuse
static electricity
2. Toitu symbols
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.
RF Emissions
Class B
CISPR 11
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.
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.
6 V in ISM and 6V
amateur radio
c
bands between
0.15 MHz and 80
MHz
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
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.
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.
1-1. Features
• 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.
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
1 2 TR-204
3 4 5
5 2
7 3
4
2. Back and right side
10 12
8 11
5
3. Display of heart rate
4 5 6 7 8
2 1
6
4. Waveform display
4 5 6 7 8
3
10
2 1
7
5. Symbols
The symbols displayed on the LCD screen indicate the status of the device.
・ Battery symbols
Battery abnormality or
Lighting No battery level Blinking
breakdown
8
3-2. Probe
9
3. Wireless probe (L-shape only) TR-204
1 2 3
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.
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.
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”.
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.”
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.
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(+)
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.
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
Wireless probe:
The LED on the operating switch lights in blue.
Blinking Lighting
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
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
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).
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
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.
・ Operating switch of the main unit ・ Operating switch of the wireless probe
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
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.
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.
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.
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.
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
× × ×
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
・ 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.
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
• 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.
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.
• 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.
Page display
Current page/total
number of pages
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.
Initial
Setting Details
setting
1 Min Turn off the power after 1 minute of no signal.
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
・ Timer start
Initial
Setting Details
setting
P-On Timer starts at power on.
Event Timer starts from input of event via the operating switch.
34
・ Timer
Initial
Setting Details
setting
1 Min Buzzer rings 1 minute after the set time. O
For example, in case of 1 minute (sweep rate: 30 mm) on the timer in 7-3”Timer
Setting”.
1min
・Buzzer volume
Initial
Setting Details
setting
Hi Loud volume
Touch the input box for date and time The software keyboard is displayed
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.
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.
38
Initial
Setting Details
setting
On Provides operation sounds. O
Initial
Setting Details
setting
Dim Dims 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.
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.
Examples of display: There are differences as follows if you measure for 3 minutes in
each setting.
3min 3min
3min
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.
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
1 2
Align the fixed parts of the main Allow the holder to attach to the
unit and holder. main unit.
43
Probe:
CAUTION
● Do not wipe the probe head of the probe with excessive force.
This may result in erroneous measurements or a breakdown.
Check the
× ×
connection
Wash with water with the Do not wet the connector. Do not wet the connector.
connection cord attached.
・ Wireless probe
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.
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.
46
2. Checklist of inspections
Conduct inspections in accordance with the inspection details.
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.
47
・ Inspection every six months
Serial number: Inspection date: Inspected by:
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.
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.
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.
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.
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.
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
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 consumption 30 VA
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
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℃)
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℃)
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
Cables
Type model Max. Length
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
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.
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.
● Address
● Name of facility
● Person in charge
Problem
61