Actocardiograph MT-610

Operation Manual

CAUTION● Read the oper ation manua l carefu lly bef ore use.
● Keep these instruct ions for future refere nce.
These are the instructions for use for MT-610 revision name Rev.6.

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.6.3EN
2023-08-18

Introduction● This operation manual describes the required method of handling and safety precautions tofollow when using the Actocardiograph MT-610.
Read this operation manual carefully before use for safe operation of the device. All users
must read “For Safe and Proper Use” even when they are already familiar with the handlingof the device. Any carelessness may result in a serious accident.
Deviation from this manual may impair the safety of patients or operators, or cause
insufficient performance of the device and damage to the device.
● The intended use of the device is to monitor the fetal heart rate and uterine contractions.
(Used from mid-pregnancy to delivery.)● This device is only to be used by doctors and health care workers (such as midwives andnurses) those who were instructed by doctors.
● In order to use the device in the proper condition, proper operation and periodic
maintenance are required.
Only qualified personnel can repair the device.
In case the device is used in a way not specified in this operation manual or repaired byunqualified personnel, we and our distributor will not have any responsibility for the
performance of the device or the safety of patients or operators.
If this manual is lost or damaged, contact us or our distributor for a new operation manual.

iHow to read this manual
In this manual, in order to avoid injury to the operator using this device, another person, or
nearby object, precautions that must be followed are categorized under "Warning" and "Caution"
as follows.
Indicates that failure to follow this instruction "may result in deathor severe personal injury."
Indicates that the use of this device beyond the performance
range, inappropriate method, or to whom other than subjects"may result in death or severe personal injury."
Indicates that failure to follow this instruction "may injure a person
or object."
Important

Indicates contents that should be followed upon operation.
Indicates useful information.

The following marks are used in order to indicate different hazards.

Electrical hazards may cause electric shock or fire.

Indicates what must be done.

Indicates what must NOT be done.

iiTable of Contents
Introduction.................................................................................................................. i
How to read this manual ............................................................................................. ii
For Safe and Proper Use .................................................................................. 1

Product Overview ........................................................................................... 12

Package Contents .......................................................................................... 16

Part Names and Functions ............................................................................. 18

Preparations before Use ................................................................................. 28

How to Use ..................................................................................................... 35
iii

Types of Alarm and Corresponding Actions .................................................... 52

Changing the Configurations .......................................................................... 57

Maintenance and Inspection ........................................................................... 65iv

Troubleshooting .............................................................................................. 73

Specifications/Parts List.................................................................................. 76

About Disposal and Warranty ......................................................................... 82

Notification to Users ................................................................................................. 83
Index ………………………………………………………………………………………...84v

（This page is blank）

vi

1. For Safe and Proper Use

For Safe and Proper Use
Safety Precautions
Below explains safety precautions those must be followed to use this device safely.

When using this device in combination with other ME devices, ground themequipotentially so that there is no potential difference between the devices.
Patients or operators may receive an electric shock if there is even a small
potential difference between chassis.
Follow the instructions in this operation manual. In case of any abnormality, stopusing the device immediately.
Be sure to inspect the device before use.
If you cannot confirm the proper condition during the inspection, turn off the power,
and remove the power plug from the outlet. Stop using the device, attach a"Failure" indication, and contact us or our distributor to repair the device
immediately.
If you use two or more of these devices connected to the delivery monitoring
cordless system in the same facility, make sure that the receivers and thetransmitters are correctly paired before use.
Failure to follow this instruction may result in mix-up of patients.
Do not disassemble or modify the device.
Failure to follow this instruction may result in failure or malfunction.
Do not apply single device to multiple patients.
Failure to follow this instruction may result in failure or malfunction.
For safety, perform electrical safety testing of other medical devices such as
cardiac pacemakers, electrical stimulators, and others applied to the patient before
using the fetal monitoring device.
Move the Doppler transducer to the position (optimal position) that provides clear,rhythmic sounds (sounds of heart wall and valves) in response to the fetal
movement.
If the ultrasound picks up the maternal blood vessel, the maternal heart rate isrecorded. Check to make sure the Doppler sound is different from the maternal
heart rate on a regular basis.
If intrauterine fetal death is suspected, perform an additional examination using
another method.
In the event of a fetal heart rate alarm, initiate the appropriate measures under the
direction of a physician.
Failure to follow this instruction may result in an accident or other deterioration of
the fetus.
1

Actocardiograph MT-610 Instructions for Use

Do not use a Doppler transducer which cannot provide the Doppler sound formeasurement.
Carefully watch the surge of the heart rate image. The heart rate can produce
incorrect signals because of the change in the number of uterine contractions. In
some cases, the displayed and recorded heart rate may be twice as much as theactual heart rate even when it is decreasing, or half as much even when it isincreasing.
Sterilize all equipment that touches the surface of the skin before every use.
Failure to follow this instruction may cause infection.
Do not place heavy objects on the power cord in such a way that the power cord iscrushed under the object. Do not damage, forcibly bend, twist, pull, or expose thepower cord to heat sources. In case of any damage to the power cord (exposure ofcore wire or breakage), contact us or our distributor for replacement.
Failure to follow this instruction may result in fire or electric shock.
Be sure to connect to a grounded wall outlet using the provided three-pin plug
power cord.
Failure to follow this instruction may result in fire or electric shock.
The accessories connected to the analog or digital interfaces of this device mustmeet the related IEC or JIS standards (ex: IEC 60950-1 for digital processing
devices, CISPR 32 EMC of maltimadia equipments, or IEC 60601-1 for medical
devices). In addition, all configurations must conform to IEC 60601-1. Therefore,
every person who connects additional devices to this device is responsible for
ensuring that the system conforms to the requirements in IEC 60601-1. If you haveany questions, contact us or our distributor.
Supply power from an isolation transformer to non-medical electronic devices
used close to expectant and nursing mothers.
Failure to follow this instruction may cause electric shock.
Do not use USB devices with their own power source unless used with anappropriate isolation device.
Failure to follow this instruction may cause electric shock.
Do not perform maintenances in a situation with patient.
Failure to follow this instruction may cause electric shock.
The device may cause radio interference with other devices in the vicinity resulting
in poor transmission. Such cases require measures to reduce the interference byusing a shield or changing the direction or installation location of the device.
Do not use this device close to or stacked on top of another device.
If the device must be used in such a way, confirm the correct operation in thearrangement to be used.
Supervise and issue instructions to not bring mobile phones, transceivers, radio
controlled toys, and other similar devices into the room where the device isinstalled or around the antenna installed in the hospital for medical devices.

2

1. For Safe and Proper Use
Do not use this device in an X-ray room, MRI room, image processing room, orwithin the strong high-frequency electromagnetic field such as from an electric
scalpel.
Failure to follow this instruction may result in a malfunction.
Do not block the heat vent of the device.
Failure to follow this instruction may cause fire and device failure.
Use of accessories, transducers and cables other than those specified or provided
by the manufacturer of this equipment could result in increased electromagnetic
emissions or decreased electromagnetic immunity of tshis equipment and result in
improper operation.
Portable RF communications equipment (including peripherals such as antennabables and external antennas) should be used no close than 30 cm (12 inches) toany part of the MT-610, including cables specified by the manufacturer. Otherwise,
degration of the performance of this equipment could result.

Do not use in the following places. Failure to follow this instruction may cause an
explosion or fire. This device is not explosion-proof.
・Using the device in the hyperbaric oxygen therapy device
・Using the device in the flammable anesthetic gas or high concentration oxygen
atmosphereThis device is not intended to be used with high frequency surgical instrument(electrical scalpel), or while defibrillation and MRI. Remove transducers, sensors,
and accessories from patient before such operations.

When a solution is spilled on the device, stop using the device and contact us or
our distributor.
Check the settings of the alarm periodically. The alarm may not be raised
depending on the setting.

3Actocardiograph MT-610 Instructions for Use

Symbols and Labels Used in this Device
The following warning label is attached to the rear of the device. Be sure to check it before
use.
Position of the warning label

The symbols used for this device are as follows.

■ Symbols defined in IEC International Standards and Japanese Industrial Standards
No.

SymbolName

No.

SymbolName(1)Stand-by(5)

Fuse rating(2)

Supply recording paper(6)

CAUTION(3)

Electrostatic sensitive
devices(7)

Type BF applied part

(4)

Alternating current■ Our own Symbols
No.

Symbol

(8)
(9)

4

Name
Revision name

I/O

Input/output

No.
(10)

SymbolName
Fuse

1. For Safe and Proper Use

Meaning of the Screen Indication Symbol Used in this Device■ Symbols defined in IEC International Standards and Japanese Industrial Standards
No.

SymbolName

No.

SymbolName

1Heart mark (heart rate)

9

Menu

2

Alarm sound off

10

Speaker3

Alarm function off

11

Picture-in
Picture selected

4

Alarm suspension

12

Patient information

5

Zero set

13

Time

6

Start action

14

Additional
information on the

7Graphic recorder

15

Zoom-in page

8

Timer

■ Our own Symbols
No.
1
2
3
4

SymbolName
Right fetal movement
markerLeft fetal movement
markerWrong measurement ofheart rate

No.

SymbolName

5

Low signal

6Timestamp

7

Time battery

Fetal stimulator

5

Actocardiograph MT-610 Instructions for Use

EMC ComplianceThis device complies with the EMC standard IEC 60601-1-2:2014/ EN 60601-1-2:2015.
Remark:CISPR11:Group 1, Class B

Essential Performance
The Essential Performance for MT-610 is as follows.

To records a fetus heart rate and labor pains curve in succession

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 Distinctive waveform distortion on recording paper The device has a complete failure

Guidance and Manufacturer’s Declaration ‐ Electromagnetic Emissions
The MT-610 is intended for use in the electromagnetic environment specified below.
The customer or the user of the MT-610 should assure that it is used in such an environment.
Emissions test

ComplianceElectromagnetic environment ‐ guidance

RF Emissions
CISPR 11

Group 1The MT-610 uses RF energy only for its internalfunction. Therefore, its RF emissions are very low andare not likely to cause any interference in nearby
electronic equipment.

RF Emissions
CISPR 11Class B

Harmonic Emissions
IEC 61000-3-2

Voltage Fluctuations/
Flicker Emissions
IEC 61000-3-3

Not applicable
NOTE

The MT-610 is suitable for use in all establishments
other than domestic and those directly connected to the
pubulic low-voltage power supply netwark that supplies
buildings used for domestic purposes.

Not applicable
NOTE

Note : This test is not applied (N/A).
Because this device is not connected to the PUBLIC AC MAINS NETWORK.

61. For Safe and Proper Use

Guidance and Manufacturer’s Declaration ‐ Electromagnetic Immunity
The MT-610 is intended for use in the electromagnetic environment specified below.
The customer or the user of the MT-610 should assure that it is used in such an environment.
IEC 60601
Test Level

ComplianceElectromagnetic environmentLevel‐ guidanceElectrostatic
Discharge (ESD)
IEC 61000-4-2±8 kV contact±2 kV, ±4 kV,±8 kV, ±15 kV air±8 kV contact±2 kV, ±4 kV,±8 kV, ±15 kV air

Floors should be wood, concrete
or ceramic tile.
If floors are covered withsynthetic material, the relative
humidity should be at least 30%.

Electrical Fast
Transient/Burst
IEC 61000-4-4±2 kV for power
supply lines±1 kV for
input/output lines±2 kV for power
supply lines±1 kV for
input/output lines

Mains power quality should bethat of a hospital environment.

Surge
IEC 61000-4-5±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

Mains power quality should bethat of a hospital environment.

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

Immunity test

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

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

Not applicable
30 A/mNOTE 2Mains power quality should bethat of a hospital environment. If
the user of the MT-610 requires
continued operation during
power mains interruptions, it isrecommended that the MT-610
be powered from anuninterruptible power supply or abattery.

Power frequency magnetic fields
should be at levels characteristicof a typical location in a typical
hospital environment.

NOTE 1: UT is the a. c. mains voltage prior to application of the test level.
NOTE 2: This test is not applied (N/A). Because this EUT is not magnetically sensitive.

7

Actocardiograph MT-610 Instructions for Use

Guidance and Manufacturer’s Declaration ‐ Electromagnetic Immunity
The MT-610 is intended for use in the electromagnetic environment specified below.
The customer or the user of the MT-610 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

ComplianceLevel‐ guidance

3V

The ISM(industrial,scientificand medical)
bands between
0.15MHz and
80MHz are6.765MHz to
6.795MHz;13.553MHz to
13.567MHz;
26.957MHz to27.283MHz; and40.66MHz to40.70MHz.
6 V in ISM bands
between 0.15 MHz
and 80 MHz

Electromagnetic environment

Field strengths from fixed RF transmitters,
as determined by an electromagnetic site
survey a , should be less than thecompliance level in each frequency
rangeb.
Interference may occur in the vicinity ofequipment marked withthe following symbol:
6V

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

Note :

3 V/m
80 MHz to 2.7 GHz
80% AM at 1 kHz

3 V/m

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 in which the equipment is used exceeds the applicable RF compliance level above, theequipment 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.
b8Over the frequency range 150 KHz to 80 MHz, field strengths should be less than 3 V/m.

1. For Safe and Proper Use

Test specifications for ENCLOSURE PORT IMMUNITY to RF Wirelesscommunications 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 MT-610,
including cable specified by the manufacturer. Otherwise, deviation of the performance of thisequipment could result.
Testfrequency

Band
(MHz)

Maximum
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

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

800-960

930
1720
1845

1700-1990

1970

2450

2400-2570

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

9

Actocardiograph MT-610 Instructions for Use

IT network connection
This device can be connected to an IT network to transmit measurement data to our central
monitor.
The IT network to which this device is connected must be securely managed with the IT security
appropriate for the medical information system.
The IT network configurations include network communication within facilities such as hospitals,
and cloud computing via the Internet.
Connecting this device and the other equipment to an IT network may create unacceptablerisks to patients, operators, or third parties.
Prior to connection, the connection details should be reviewed with the facility's IT administrator,
and risks should be identified, analyzed, evaluated, and controlled.
If the IT network fails, the following risks may occur.
- The central monitor cannot monitor the patient's condition.
- The central monitor cannot monitor the alarms of this device.
- Transmission of measurement data to the central monitor is delayed.
- Measurement data sent to the central monitor is intercepted and falsified.
Additional analysis is required for any subsequent changes to the IT network, as new risks may
arise. Examples of changes to the IT network environment are as follows.
- Change to the IT network settings.
- Adding actocardiographs,the central monitors and other equipment to the IT network.
- Removal of actocardiographs, the central monitors and other equipment from the IT
network.
- Updating actocardiographs, the central monitors and other equipment connected to the IT
network.
- Upgrading other equipment connected to the IT network.

101. For Safe and Proper Use（This page is blank）

11

Actocardiograph MT-610 Instructions for Use

Product Overview
FeaturesThis device is a fetal monitoring device intended to detect the fetal heart rate and uterine
contractions. This device can be used from mid-pregnancy to delivery. The main features are
as follows.
Easy-to-see display
7-inch color TFT LCD displays large texts and images of the recording paper.

Touch panel operation
Touch and hold operation is realized by utilizing resistive touchscreen.



CTG data storage
CTG data for up to fifteen hours can be stored in the memory on the device. This data canbe printed or stored in a USB memory (not included).

Battery operation
The device can operate for 30 minutes when it is disconnected from the power source.
(When the battery is fully charged.)
Although the recorder stops during this period, the CTG recorded (CardioTocoGram) is
printed using high-speed printing when connecting the device to the power source.

Functions
Function Name
Fetal movementmonitoring

Contraction cycle
monitoring
Twins monitoring(multi-fetuses monitoring)
Timer function(recording timer function)

Monitoring data storage
function
Recording/system
function
Display function

12

Explanation of the Function
Monitors and records the fetal movement.
(There are two monitoring methods: automatic monitoring using
ultrasound and manual recording when the mother recognizes
the fetal movement.)
Automatically monitors/displays/prints the contraction cycle.
Monitors the fetal parameters for multiple fetuses by the fetal
actocardiograph.
A function to automatically stop the recorder after a configured
time. A function to automatically start recording when theconfigured condition is met.
(For more information, see P.41 “6-4 Print the Monitoring Data”)
A function to store and play the monitoring data to the main unit
or a removable media.
A function to store the monitoring data from this device to central
monitoring equipment via an external device or communication
device.
A function to show information such as CTG patterns as animage.

2. Product Overview
Function Name
Alarm function

Explanation of the Function
A function to alert the operator via alarm sound, alarm indication,
and/or record in the case of device failure or if the configured
monitoring condition is not met.

Principle
2-3-1. Fetal heart rate
Fetal heart rate is detected by using the ultrasound Doppler method. When high-frequency
voltage is applied to the Doppler transducer, the element in it vibrates and emits ultrasound.
When this ultrasound is delivered to the heart of the fetus through the maternal abdominal
wall, it is reflected by the movement of the heart valve, bloodstream, or movement of the
fetus (fetal movement), and then returns to the transducer. The received ultrasoundundergoes signal processing, and is separated using the difference in heartbeat signal andfetal movement signal. The heartbeat signal can be heard from the speaker since it iswithin the range of human audibility.

2-3-2. Uterine contraction
A contraction (uterine contraction) signal is detected by using the strain gauge. When theexternal UC transducer containing the strain gauge is fixed to the abdominal wall at theuterine fundus, the resistance value changes when a strain is applied to the strain gauge
due to the uterine contractions. A contraction (uterine contraction) signal is detected bydetecting changes in this resistance.

13

Actocardiograph MT-610 Instructions for Use

2-3-3. Block diagram
MT-610 Chassis
Main board

LCD with touch panel

I/O 1
Y-shaped Doppler/External
UC transducer TR-687-06

RecorderI/O 2Power switch

Doppler transducer
TR-629-06

Charger board

External UC transducer
TR-619-06

Battery

Sensorconnector

Remote marker switch(single) SW-527-01
Remote marker switch(twins) SW-527-02

Sensorconnector

Speaker
Switchingpower supply

AC inlet

Switchconnector

Fetal stimulator TR-30* Remote marker switch or fetal stimulator is connected to the switch connector.
Either the remote marker switch for single or the one for twins can be connected.
* Three types of sensors can be connected to the sensor connector.
Recommended connection for each case is as follows:
What to Monitor

Connected device 1

Single monitoring
Twins monitoring

TR-687-06
TR-687-06

14

Connected device 2
TR-629-06

2. Product Overview

Usage Environment
Use the device under the following conditions.
Field
Ambient temperature
Relative humidity
Atmospheric Pressure
Other conditions

Conditions
10 to 40 °C
30 to 70% (no condensation)
700 to 1060 hPa• Room without the risk of explosion• A place where the provided power cord can be connected
to a commercial power outlet in the hospital or clinic
building• Stable, flat surface with a space of more than 40 mm at therear, 30 mm on the right side, and 70 mm on the left side
when viewed from the front

Screen Modes
There are two screen modes on this device. (See P.20 "4-2-1 Monitoring Screen”)
For switching mode, contact us or our distributor.
・ Extended mode : The mode which includes features such as the history feature.
・ Compatible mode : The mode which maintains the compatibility with the screens in therevision name Rev.4 or before.

15

Actocardiograph MT-610 Instructions for Use

Package Contents
This device consists of the main unit, accessories, and options. Check the package contents
before use. The accessories may be included with the main unit or sold separately.

Accessories
(1)

(4)
Note

No.
(1)
(2)
(3)
(4)
(5)

(6)

Name
Y-shaped Doppler/External UC
transducer
Transducer belt (pink, green)
Remote marker switch (for single
fetus)
Power cord
Note
Ultrasound gel
Note
Recording paper

(2)

(3)

(5)

(6)
Note

Function and Operation
Used for monitoring fetal heart rate andexternal contraction monitoring by ultrasound.
Used to affix the transducer to the abdominalwall.
A hand-held switch used to record maternal
perception of fetal movement.
Connects the main unit to a commercial power
supply.
Used to reduce ultrasonic attenuation between
the Doppler transducer and the abdominal
wall.
Heat-sensitive paper used to print themonitoring results.

(7)

Operation Manual(This document)* For the item number, refer to P.80 “11-2-1 Accessories supplied”.
Note: Whether Items (4) and (5) are included or not depends on the country.

16

3. Package Contents

Major Options
(1)

(2)

No.

Name

(1)

Doppler transducer(3)

Function and Operation

Used for monitoring fetal heart rate by
ultrasound in the case of twins.
(2) External UC transducer
A transducer used to monitor uterine
contraction.
(3) Remote marker switch
A hand-held switch for twin fetuses used to(for twin fetuses)
record maternal perception of fetal movement.
* Refer to P.80 “11-2-2 Options” for item codes and other optional items.

17

Actocardiograph MT-610 Instructions for UsePart Names and Functions
Body
4-1-1. Front and left side
(1)

(2)

(3)
(6)
(7)

(5)
(8)

(4)

No.

Part Name(1)

LCD screen

(2)
(3)
(4)
(5)
(6)

Power switch
Recorder cover open button
RecorderSpeaker
Sensor connectors (green)

(7)
(8)

Switch connector (white)
Heat vent

18

Function and Operation
Displays the fetal heart rate and can be operated by thetouch panel.
Turns the device ON or OFF.
Opens the recorder cover.
Prints the monitoring data and parameters.
Outputs Doppler sounds and other operating sounds.
Connects the Y-shaped Doppler/External UC
transducer, Doppler transducer, and UC transducer.
Connects the remote marker switch or fetal stimulator.
Exhausts heat from inside the device.

4. Part Names and Functions

4-1-2. Back and right side

(1)

(4)

(2)

(5)
(3)

No.

Part Name(1)

I/O-1 connector

(2)
(3)
(4)
(5)

I/O-2 connector
Heat ventBasketPower inlet

Function and Operation
Connects external devices (e.g. our specified USB
memory).
Connects our Central Monitor.
Expels heat from inside the device.
Holds the accessories.
Connects to the power cord.

19

Actocardiograph MT-610 Instructions for Use

Screen Display
The displayed content may differ depending on "Extended mode" and "Compatible mode".
These instructions are mainly based on the "Extended mode".
For switching modes, contact us or our distributor.

4-2-1. Monitoring Screen■Extended mode
(1)

(2)

(4)

(3)

(5)-1
(6)

(7)

(9)

(8)

(10)

(11)

(5)-2

(15)
(2)

(12)

(4)

(13)

(14)

(16)

■Compatible mode
(1)

(7)

20

(2)

(3)

(8)

(9)

(4)

(15)

(10)

(16)

4. Part Names and Functions
No.

Part Name

Function and Operation(1)

Monitoring value
display area

(2)

Patient ID

(3)
(4)
(5)

Free space
Date
Menu bar

(6)
(7)
(8)

Switching themenu bar
ZeroSet
Print

(9)

NST

Displays the monitoring values and alarm status.
• There are two patterns of display: number-only andnumber/waveform display.
• In number/waveform display, there are two display modes:
waveform display mode which shows the number at the left ofthe screen, and 15-minutes waveform display mode whichshows the number below the waveform.
• The waveform display mode shows the CTG for the last eightminutes from the latest measurement (on the right edge), andthe 15-minutes waveform display mode shows the CTG for thelast 15 minutes or more. Older waveform is displayed bypressing and holding the waveform. (See P.23 “4-2-3 History
screen”)• You can switch the display using the menu screen or the layout
setting screen.
Configures the patient’s data when the device is interconnectedwith our central monitor.
Displays the status of device operation or the details of alarms.
Sets the date and time.
Configures or starts various features.
Select <ZeroSet>, <Print>, <NST>, <Menu>, <Layout>,<Patient ID>, <Date>, <Parameter>, or <Full screen>.
Switch between the first ((5)-1) and second ((5)-2) pages of themenu bar.
Sets the contraction value to 12 units. Hold to set to 0 units.
Starts printing the CTG on the recording paper.
• The button changes to <Stop> while printing the CTG. Touchthe <Stop> button to stop printing.
• Note that printing the CTG is not available during battery
operation. In that case, the button turns gray and cannot beused.
Starts CTG printing which automatically stops after the configuredtime.
Displays the setting menu.
Shows/hides the volume meter. Shows the current volume level.
Adds/removes the parameter shown on the screen. (See P.24 “(1)Delete layout screen”)
Displays the setting menu for each parameter.
Displays the waveform for the last 30 minutes or more from thelatest measurement (on the right edge), not showing themonitoring value area. (See P.27 “4-2-5 Full screen”)
Sets the Doppler sound volume.
Sets the Doppler sound volume to zero.

(10) Menu(11) Speaker(12) Layout(13) Parameter(14)
Full screen(15) Volume meter(16) Mute21

Actocardiograph MT-610 Instructions for Use

4-2-2. Monitoring value display area
(4)

(1)
(2)

(5)

(3)

No.

Part Name(1)

Heartbeatsynchronization
symbol(2)(3)

Monitoring value

Function and Operation
Flashes in synchronization with the heartbeat.
The color changes to “green > yellow > red” depending on thestate of heart rate input signal. (See P.37 “6-2 (2) Decide on
the fitting position”)
Displays the monitoring values (heart rate or contraction
value).

Status of alarm setting Displays the status of alarm setting and alarm.
: Displayed when the alarm sound is turned off.
: Displayed when one or more conditions of the alarm areturned off.
: Displayed when the alarm is off.

(4)

Sensor type

Displays the monitoring sensor type.

(5)

Symbol of choosing
the heart beat sound

Displayed when the doppler is selected as speaker output.

22

4. Part Names and Functions

4-2-3. History screen
Waveform display

(2)

No.

(3)

Part Name(1)

Free space

(2)
(3)
(4)

Monitoring value
Normal Screen
Slider(1)

15 minutes waveform display

(1)

(4)

Function and Operation
Indicates how old the data is (in minutes).
Indicates the data file number when replaying the stored data.
(See P.49 “6-5-3 Replaying the stored data (only in the extendedmode)”)
Shows the current monitoring value.
Exits the history screen and return to the monitoring screen.
Change the portion of the waveform to display.

23

Actocardiograph MT-610 Instructions for Use

4-2-4. Layout setting screen
Delete layout screen

(1)

(2)

No.

Part Name(1)(Delete)

24

(2)

Add

(3)

Preset

(4)

List

(5)

OK

(6)

Cancel

(3)

(4)

(5)

(6)

Function and Operation
Deletes a parameter from monitoring/history screen.
If a parameter with display priority is deleted, anotherparameter with lower display priority may be displayed.
Displays the Add layout screen. (See P.25 "4-2-4 (2) Add
layout screen)
Stores/loads the settings for enabled/disabled displays.
Short-press: Reverts to the stored display settings.
Long-press: Stores the current display settings.
Displays the Layout summary screen. (See P.26 "4-2-4 (3)Layout summary screen")
Applies the selected settings and goes back to the monitoring
screen.
Goes back to the monitoring screen without applying settings.

4. Part Names and Functions

Add layout screen

(1)

(2)

No.

Part Name(1)- (Add)(2)

Delete(3)

Preset

(4)

List

(5)

OK

(6)

Cancel

(3)

(4)

(5)

(6)

Function and Operation
Adds a parameter to the monitoring/history screen.
Parameters that cannot be displayed at the same cannot be
selected.
Displays the Delete layout screen. (See P.24"4-2-4. (1) Delete
layout screen)
Stores/loads the settings for enabled/disabled displays.
Short-press: Reverts to the stored display settings.
Long-press: Stores the current display settings
Displays the Layout summary screen. (See P.26 "4-2-4 (3)Layout summary screen")
Applies the selected settings and goes back to the monitoring
screen.
Goes back to the monitoring screen without applying settings.

25

Actocardiograph MT-610 Instructions for Use
Layout summary screen
Important・ When a device in <OFF> status is connected, a message “A device with invalid setting
was connected” and relevant device name is displayed.
・ For the device in <OFF> status, the data is not shown on the monitoring/history screen, or
printed in the recording paper. If you want to show or print the data for the device specified
in the message, change the status of the device to <ON> in the layout setting.

(1)

(2)

No.

26

Part Name

(1)

1DOP
2DOP
E.UC

(2)

Wave

(3)

Preset(4)

Display

(5)

OK

(6)

Cancel

(3)

(4)

(5)

(6)

Function and Operation
Select either ON/OFF/Auto for each parameters.
<ON> : The data is shown on the monitoring/history screen<OFF>: The data is not shown on the monitoring/history
screen<Auto>：The data is automatically shown on themonitoring/history screen when the device isconnected
Selects the waveform display on the monitoring screen<ON> : Waveform display<OFF> : Numeric display<15min> : 15 minutes waveform display
Stores/loads the settings for enabled/disabled displays.
Short-press : Reverts to the stored display settings.
Long-press : Stores the current display settings
Displays the delete layout screen. (See P.24"4-2-4. (1) Delete
layout screen)
Applies the selected settings and goes back to the monitoring
screen.
Goes back to the monitoring screen without applying settings.

4. Part Names and Functions

4-2-5. Full screen
Displays the waveform for the last 30 minutes or more by not showing the monitoring value
area.
Important

The display will go back to the main display when an alarm occurs. Full screen is not available
during the occurrence of an alarm.
(1)

(2)

No.
(1)
(2)
(3)

Part NameFree space
SliderBack(3)

Function and Operation
Displays how old the displayed data is in minutes.
Moves the displayed position.
Ends the full screen and goes back to the monitoring screen.

27

Actocardiograph MT-610 Instructions for Use

Preparations before Use
Our company performs initial installation upon delivery. When relocating the device, disconnect
the power plug from the power outlet, and place the device in a location that meets the following
conditions. (See P.15 “2-4 Usage Environment”)
Note that the device is not sterilized before shipment. Be sure to clean and sterilize before use.
(See P.65 “9-1 Cleaning and Sterilizing”)

Do not use in the following places. Failure to follow this instruction may cause an
explosion or fire. This device is not explosion-proof.
・Using the device in the hyperbaric oxygen therapy device
・Using the device in the flammable anesthetic gas or high concentration oxygen
atmosphereThis device is not intended to be used with high frequency surgical instrument(electrical scalpel), or while defibrillation and MRI. Remove transducers, sensors,
and accessories from patient before such operations.

Setting the Recording Paper

Do not use any recording paper other than as specified.
An unspecified recording paper may cause a misdiagnosis by incorrect recordingof monitoring results.
Open the cover
Press the recorder cover open button.
The cover is unlocked and opens towards you.

Insert the new recording paper (accessory
0030-026)
1. Remove the paper from the bag andloosen them lightly.
2. Hold the paper with the cut edges facing
up, and place them on the cover, theninsert them all the way to the end.

28

Recorder cover open button

5. Preparations before Use
3. Pull the top paper out of the cover.

Close the cover
Push the cover back while holding the recording paper.
You will hear a click when it locks into place.

Connecting Plugs

Do not place heavy objects on the power cord in such a way that the power cord iscrushed under the object. Do not damage, forcibly bend, twist, pull, or expose thepower cord to heat sources. In case of any damage to the power cord (exposure ofcore or breakage), contact us or our distributor for replacement.
Failure to follow this instruction may result in fire or electric shock.
Be sure to connect to a grounded wall outlet using the provided three-pin plug
power cord.
Failure to follow this instruction may result in fire or electric shock.

Use an outlet which you can easily disconnect the power cord and do not place
any obstacles around the power outlet.
Connect the power cord
1. Connect the power connector to the power
inlet of the main unit.

2. Insert the power plug into a commercial power
outlet.

29

Actocardiograph MT-610 Instructions for Use
Check the battery charge
Charging automatically starts when the power cord is connected.
Confirm that the power switch LED flashes blue-green.
The power switch LED turns orange when the battery is fully charged.
Charging: Blinks in blue-green

Fully charged: Lights in orange

When the commercial power source is cut off, the power automatically switches to theinternal battery. When the power source is recovered, the power reverts back to thecommercial power source and continues the operation before cut off.
When the commercial power source is cut off and there is no internal power, all active
settings are recovered when the power is back based on each settings stored in the
nonvolatile memory.
Connect the transducer

Be sure to use the specified transducer.
Failure to follow this instruction may result in monitoring errors or failure.
Do not drop or excessively bump the transducer.
Do not remove the sensors while measurement. Measurement display areaof the corresponding sensor will become blank and the alarms will bedisabled.
Align the sensor connector marks (green) on the plug andon the side of the device, and then insert the plug. Fully
insert the plug until it clicks.
・ For a single fetus: the Y-shaped Doppler/External UC
transducer supplied with the device
・ For twin fetuses: the Y-shaped Doppler/External UC
transducer supplied with the device, and optional
Doppler transducer

The added Doppler transducer can be used for a single fetus. Using two Doppler transducers (double
Doppler) for a single fetus provides a wider range of monitoring since the two signals detected arecompared and the one with the highest quality is automatically selected for display and recording (single
heart). This monitoring requires a specific mode setting. (See P.62 “8-6 Measurement Setting”)

30

5. Preparations before Use
Connect the remote marker switch
Align the marks on the plug and on the switch connector(white) on the side of the device, and then insert the plug.
Fully insert the plug until it clicks.

Connect the fetal stimulator
You can connect an optional fetal stimulator to the switch connector (white). In this case,the remote marker switch cannot be used.
Connect the accessories
The information measured by this device can be monitored
remotely by connecting below device to the external
connectors (I/O-1 connector and I/O-2 connector).
・ Central monitor

Inspections before Use

Be sure to inspect the device before use. If you cannot confirm the propercondition by the inspection, turn off the power, and remove the power plug from theoutlet. Stop using the device, attach a "Failure" indication, and contact us or our
distributor to repair the device immediately.

When operating the LCD screen (touch panel), touch the screen using the tip ofyour finger. Do not operate it using your nails or hard objects such as ballpoint pen
or metal, and do not rub or push with excessive force.
Failure to follow these instructions may cause a failure.

31

Actocardiograph MT-610 Instructions for Use
Confirm startup
1. Press the power switch on the front of the body. The power switch LED turns
blue-green.
2. Confirm that the LCD screen displays the startup screen, and shows the charging
status on the free space.

Charging: display "Battery:Charging"
Full charge: no display

3. Confirm that there are no defective areas on the LCD screen.
Check the time
Confirm that the time is correct by comparing it with the correct time.
If there is an error proceeds to (3), be sure to correct the time.
Correct the time (or date)
1. Press and hold the area where the time and date is displayed, or touch <Date> on thesecond page of the menu bar.

The date setting screen is displayed.

2. If the time synchronization is set to <Auto>, touch <Manual>.
3. Touch <Time> (or <Date>) display area.
A software keypad appears at the right of the screen.

32

5. Preparations before Use

4. Revert back to where the correction is required by pressing <AC> or <C> and enter
the correct time (or date).
You cannot modify the seconds manually. In order to modify the seconds, enter thetime with a minute or two minutes ahead and touch <OK> when it reaches 00 secondsof the correct minute.
5. Touch <OK> to save the change.
To discard the input, touch <AC> or <C> to make the window blank, then touch <OK>.
6. Touch <Back> to go back to the measurement screen.
7. Cycle the power before using the device.
Adjust the Doppler sound volume
When both Y-shaped Doppler/External UC transducer and Doppler transducer areconnected, the Doppler sound of either Doppler 1 or Doppler 2 can be heard. You can hear
the Doppler sound of the Doppler for which
is displayed on the monitoring displayarea.
1. Touching the area of Doppler 1 or Doppler 2 switches the Doppler sound you can hear.
2. Touch the speaker at the right edge of the menu bar to open the volume meter.
3. Adjust the volume by moving the slider on the volume meter up or down.

4. Touch <Mute> to set the volume to zero. No Doppler sound can be heard. Touch again
to return to the prior level.
5. Touching the speaker again hides the volume meter.

33

Actocardiograph MT-610 Instructions for Use
Confirm the Doppler soundDo not slap the head of the Doppler transducer hard.
Failure to follow this instruction may result in monitoring errors or failure.
1. Hold the Doppler transducer in your hand so that thetransmitting and receiving surface faces out.
2. Move the palm of the other hand towards or awayfrom the transmitting and receiving surface.
3. Confirm that the Doppler sound can be heard when
the hand is close to the transducer. If it cannot beheard, increase the volume and try again.
4. After confirmation, gently place the transducer
avoiding putting pressure on the transmitting andreceiving surface.
5. If you cannot confirm the sound, connect a different
transducer and try again. If there is no Dopplertransducer with which you can confirm the Doppler
sound, do not use this device.
Confirm the contraction level

Do not exert excessive force on the pressure sensitive part of the UC
transducer.
Failure to follow this instruction may result in monitoring errors or failure.
1. Lightly press the center of the pressure sensitive
part of the UC transducer.
2. Confirm that the UC level increases inproportion to the extent of pressure applied.
3. Once complete, gently place the transducer
while avoiding putting pressure to the pressure
sensitive part.
4. If you cannot confirm the UC level change,
connect a different UC transducer and try again.
If there is no UC transducer with which you canconfirm the UC level, do not use this device.

Pressuresensitive
part

UC level34

6. How to Use

How to Use
Register the Patient Information
Patient information can be registered/displayed/recorded if the device is associated with ourcentral monitor. Use the screen to enter the patient ID.
1. Touch <ID:> at the upper-left of the screen or <Patient ID> at the second page of themenu bar.

2. Touch the <Patient ID> field.
The software keyboard is displayed.

3. Enter the ID number registered with our central monitor and touch <OK>.
4. Confirm that the data shown is what you want to register, and then touch <OK>.
Example of the patient data entry screen

35

Actocardiograph MT-610 Instructions for Use
5. Confirm that the patient ID is displayed, and then touch <Back>.
* When the data display is set to <Show>, the patient’s name is displayed on themonitoring screen.

6. Check the data displayed on the monitoring screen.

Monitor the Doppler Fetal Heart Rate

If intrauterine fetal death is suspected using this method, perform an additional
examination using another method.
It may cause a misdiagnosis.
Carefully watch the surge of heart rate image due to any artifacts. The heart rate
can be converted to incorrect signals because of the change of uterine
contractions.
In some cases, the displayed and recorded heart rate may be twice as much as theactual heart rate even when it is decreasing, or half as much even when it isincreasing.
It may cause a misdiagnosis.
Move the Doppler transmitter to the position (optimal position) that provides clear,rhythmic sounds (sounds of heart wall and valves) in response to the fetal
movement.
It may cause a misdiagnosis.

Do not use any ultrasound gel other than that specified by us.
Failure to follow this instruction may result in damage such as failure.
Confirm that the fetal heart beat is different from the maternal pulse rate.
When it is suspected the maternal pulse rate is being recorded, take the maternal
pulse and compare with the displayed heart rate.

36

6. How to Use
Apply ultrasound gel
Apply the ultrasound gel to the surface of the maternal abdomen and the transmitting andreceiving side of the Doppler transducer.
Important

The amount of the ultrasound gel should be just right and applied thoroughly so that it createsa thin layer.
Opening/closing the gel cap
Push the cap upward

Decide on the fitting position
1. Place the transmitting and receiving side of the
Doppler transducer so that it is closely attached tothe maternal abdominal wall.
2. Slowly move the Doppler transducer to detect theposition that provides clear, rhythmic sounds(sounds of heart wall and valves).
3. Check the icon for heartbeat synchronization (♥)
on the screen and hold the transducer in theposition where the green light is continuously on.
The color of the icon is defined as follows
depending on the status of the heart rate signals.

♡ Color♥ Green♥ Yellow♥ Red

Quality ofsignals

The signal isstable.

There are some noises but
the signal can be detected.

The signal isunstable

4. In the case of twins, find the position for each fetus.

37

Actocardiograph MT-610 Instructions for Use

Important・ In case of twins, position the transducer so that each fetus is measured by the Doppler
sound.
One Doppler transducer may monitor two fetuses, or two transducers may monitor one
fetus.

One transducer ismonitoring two fetuses

Two transducers aremonitoring one fetus

・ The Doppler sound switches between the selected Doppler each time you touch themonitoring display area, andis displayed on the monitoring value display area for theactive one. Regularly check the fetus with the Doppler sound and adjust the position of the
Doppler transducer as required.
Affix the transducer
1. Affix the appropriate buttonhole on one end of
the transducer belt applied to the back to thehook of the Doppler transducer while being
careful not to move the transducer.
Buttonhole
2. Affix the other buttonhole on the other end of
the transducer belt to the hook to tighten thetransducer belt.
Drop the end of the transducer belt down to theside.
3. Thoroughly wipe away any excessive ultrasound gel on the abdominal wall.

38

Hook

6. How to Use

Monitor the External UC

Do not apply ultrasound gel to the External UC transducer.
Do not fasten the transducer belt too tightly.
Failure to follow this instruction may result in excessive pressure on the abdominal
wall or cause a monitoring error.
Confirm no redness in the skin when the External UC monitoring transducer isused for a long time. If there is redness, slightly displace the contraction transducer
or stop using the monitor device.
Failure to follow this instruction may result in contact dermatitis in rare cases.
Decide on the fitting position
Place the External UC transducer slightly above the navel, the center of the abdominal wallthat provides the maximum abdominal circumference.
Position of the UC transducer

Around the bottom on the back side of
the fetus for a cephalic presentation

Around the head of the fetus
for a breech presentation

Important・ If the transducer is placed below the navel, it cannot monitor correctly due to the mother's
breathing.
・ The device has a filter to eliminate the effect of breathing.
If you do not want to use the filter, change the settings. (See P.60 “8-4 Fetal Movement/UC
Setting”）

39

Actocardiograph MT-610 Instructions for Use
Affix the transducer
1. Affix the appropriate buttonhole on one
end of the transducer belt applied tothe back hook of the External UC
transducer while being careful not tomove the transducer. Fasten thetransducer belt so that the UC level isincremented by approximately 10.
2. Drop the end of the transducer belt
down to the side.

Buttonhole

Hook

Approx.
+10

Set the contraction to zero
1. After fixing the transducer, touch <ZeroSet> while there is no contraction.
The start points of display and record are set to 12 on the scale.
Zero set and sample screen

2. To set the start point to 0, touch and hold <ZeroSet> for about 5 seconds until 0 is
displayed.
Example of zero set recording paper

When touched

40

When held

6. How to Use

Print the Monitoring Data
The data can be printed immediately or by setting a timer. The printed information can also bechanged.

6-4-1. Print immediately
1. After zero set, touch <Print>.

2. After printing the top sheet, the waveform is printed.
Printing order depends on the settings. (P.64 “8-8 Record Setting”)
The <Print> button changes to <Stop> while printing.

41

Actocardiograph MT-610 Instructions for Use

6-4-2. Print using NST timer
CTG printing starts using the timer function, which automatically stops the recorder after
the time set. If the device is in the alarm condition when it reaches the time set, it continues
printing until the alarm is released.
1. Touch <NST>.

The timer selection screen is displayed.
2. Touch the time you want to use, and then touch <Start>.

The device returns to the monitoring screen and starts recording.

6-4-3. Print using automatic NST timer
When the automatic NST timer is set, CTG printing automatically starts when the fetal
heart rate can be stably monitored. The timer setting follows the NST timer setting. (SeeP.64 “8-8 Record Setting”)

42

6. How to Use

6-4-4. Top sheet and recording item nameBelow information is printed as a top sheet when the recording starts.
You can change the settings to skip the top sheet. (See P.64 “8-8 Record Setting”)
Printing example of the top sheet
Date and time
Patient data
Patient data is
printed by entering
the ID when thedevice isconnected to ourcentral monitor.

Prints the start time ofprinting.
The date is not printed
during monitoring.

The recording mode
Recording items are
printed depending on theaccessories used or theselected settings.
These are also printed
when the recording
conditions are changed
during monitoring.

■Recording items
1 DOP

1 DOT
1 ACT
E.UC
E.UC(HI)
2DOP-20
MARKER-RT
MARKER-LT
2 DOT
2 ACT

Y-shaped Doppler/External UC transducer connection.
In the case of double Doppler single heart, Doppler [SH] isshown.
Fetal movement dot of Doppler 1.
Fetal movement spike waveform of Doppler 1.
Y-shaped Doppler/External UC transducer connection
or external UC transducer connection.
Contraction high-sensitivity setting.
Printing example when offset -20 is selected in the setting.
Offset ±0 or +20 is printed depending on the setting.
When the right remote marker switch (twins) was operated, theright marker in "6-4-5. Example of CTG recording" is printed.
When the left remote marker switch (twins) was operated, theleft marker in "6-4-5. Example of CTG recording" is printed.
Fetal movement dot of Doppler 2.
Fetal movement spike waveform of Doppler 2.

43

Actocardiograph MT-610 Instructions for Use

6-4-5. Example of CTG recording44

6. How to Use

6-4-6. Print the fetal movement markAsk the patient wearing this device to press the remote marker switch when she
recognizes the fetal movement. A mark is printed when the switch is pressed.
Use the left and right switches when a switch for twins is used.

6-4-7. Move the position of the Doppler transducer

Move the Doppler transducer to the position (optimal position) that provides clear,rhythmic sounds (sounds of heart wall and valves) in response to the fetal
movement.
It may cause a misdiagnosis.
Adjust the Doppler transducer in response to the fetal movement.
Especially, when recording for twins, periodically check therecording paper, and if
is printed, be sure to move the positionof the Doppler transducer.

6-4-8. Stop printing
1. The recording automatically stops when the timer recording is used.
Touch <Stop> for manual recording.

Regardless of the recording speed, the paper is fed to the folding line.
2. Lightly hold the top of the folding line of the recording paper, and then cut the paper
downward.

45

Actocardiograph MT-610 Instructions for Use

Print/Restore Past Data

Use the USB memory specified by us.
Failure to follow this instruction may result in an unstable operation.
The monitoring data for the last fifteen hours is stored in the built-in non-volatile memory andcan be printed out on the recording paper and backed up to a USB memory device (soldseparately).
Old data exceeding fifteen hours is automatically deleted in chronological order. Back up thenecessary data before going over the fifteen hours.
Important

If the recorded data exceeds fifteen hours, old data is removed every minute.

6-5-1. Print the stored data

CTG files should be selected based on the start date and time.
This device will not manage CTG files using patient IDs.
1. Touch <Menu> to display the measurement setting screen.
2. Touch <Memory>.

3. Touch the Data File area.

46

6. How to Use
Start Time/Recording Time/Patient ID screen is displayed.
4. Select the data to be printed.

5. Touch <Print>.

A confirmation message is displayed.
6. Touch <Yes>.

The printing starts.

47

Actocardiograph MT-610 Instructions for Use

6-5-2. Backup
1. Insert the USB memory into the I/O-1
connector.
I/O-1 connector

2. Select the data to backup as in the samemanner as steps 1 to 4 in 6-5-1.

3. Touch <Copy>.

A confirmation message is displayed.
4. Touch <Yes>.

The data is copied to the external memory.

Important

In order to backup all data in the internal memory, touch <Copy> before selecting data in
Step2.

48

6. How to Use

6-5-3. Replaying the stored data (only in the extended mode)
1. If replaying a stored data in an USB memory, connect the USB memory.
2. Select the data to replay as in the same manner as steps 1 to 4 in 6-5-1.
3. Touch <View>.

A confirmation message is displayed.
4. Touch <OK>.

The stored data is played. (See P.23 “4-2-3 History screen”)

49Actocardiograph MT-610 Instructions for Use

6-5-4. Deleting the stored data
1. Select the data to delete as in the same manner as steps 1 to 4 in 6-5-1.
2. Touch <Delete>.

A confirmation message is displayed.
3. Touch <Yes>.

The data is deleted.
Important

In order to delete all data in the internal memory, touch <Delete> before selecting data in
Step1.

50

6. How to UseStop Monitoring
Turn off the powerPress the power switch in front of main body.
The device LCD turns off.
The LED of the power switch will flash while charging even when the power is turned off.
Remove the transducer
1. Detach the transducer belt.
Remove the transducer from the abdominal wall.
2. Wipe the ultrasound gel on the abdominal wall with tissues or a paper towel.
Sterilize the parts that have touched the surface of the skin
Sterilize the transducer and remote marker switch after each use. (See P.65 “9-1 Cleaning
and Sterilizing”)
Disconnect the plugs
Disconnect the connected plugs.

51

Actocardiograph MT-610 Instructions for Use

Types of Alarm and Corresponding Actions
When an alarm is triggered, user is notified by below. Perform actions required.
・ Alarm sound is output. (It is not output when the alarm sound is set to <Mute>.)・ Monitoring area flashes. (See below)・ A corresponding alarm message is displayed in the free space.

Pay attention to the change in the screen and recording when performing themonitoring with alarm sound off.
Failure to follow this instruction may result in the alarm being missed.
Check the settings of the alarm periodically. The alarm may not be raised
depending on the setting.

Example of alarms other thanthe heart rate alarm

Example of the heart rate alarm

The monitoring area flashes in yellow
every two seconds when an alarm otherthan the heart rate alarm is issued.

The monitoring area flashes in red
every 0.5 seconds only when the heart
rate alarm is issued.

52

7. Types of Alarm and Corresponding Actions

List of Alarms
Message

Reason for the Alarm

ActionThe heart rate was higher than theupper limit or lower than the lower
limit for more than the delay time.

See P.54 “7-2 Fetal Heart
Rate Alarm”

Signal Error

The following signal error alarm isissued.
・ Two transducers may bemonitoring the heart rate of thesame fetus.
・ The same heartbeat may be
detected for fetal heartbeat andmaternal heartbeat.

Move the position of the
Doppler transducer.

UC:Check UC
Transducer

The UC transducer is not correctly
affixed.

Move the position of the
UC transducer.
Change the way thetransducer belt isfastened.

"Recorder: Paper Out" "Printing" (displayedalternately)

The recorder cover is open or therecording paper is out.

See P.55 "7-3 Paper Out
Alarm"

Recorder:Unit Error

An error has occurred with therecorder.

Stop using the device andcontact us or our
distributor for repair.

Clock Low Battery

The voltage of the clock battery is
low.

Contact us or our
distributor for battery
replacement.
* Be sure to correct thetime when you continue
the monitoring.

Low Battery

Battery voltage of the main unit islow.

Connect the power cord to
charge the battery.

No Multiple transducers

Multiple transducers were connectedin combination which is prohibited.
Ex.: Two transducers of the same
type were connected.

Disconnect either one.

Transducer unavailable

Any abnormality with the transducer.

Use a different transducer.

Transducer
unidentifiable

A transducer other than thosespecified is connected.
A transducer which is not supportedby the device software is connected.

Connect the specified
transducer.
Update the software of thedevice.

Check Transducer

The transducer is not correctly
connected.

Reconnect the transducer.

1DOP:Heart Rate
2DOP:Heart Rate
DOP[SH]: Heart Rate

53

Actocardiograph MT-610 Instructions for Use

Fetal Heart Rate AlarmIn the event of a fetal heart rate alarm, initiate the appropriate measures under the
direction of a physician.
Failure to follow this instruction may result in an accident or other deterioration of
the fetus.
Important

If the alarm suppression feature is set to <ON>, the fetal heart rate alarm is not activated until
five minutes has passed after turning on the power or the transducer was connected, or agood heartbeat signal was monitored for over ten seconds. This is to avoid the frequent
occurrence of the fetal heart rate alarm. Pay attention to the condition of the heart rate
recorded during the time set.
When a fetal heart rate alarm is issued
Example of fetal heart rate alarm• Alarm sound is output. (It is not output when the alarm sound is set to <Mute>.)• The monitoring area flashes red every 0.5 seconds.
• "1DOP:Heart Rate" (or "2DOP:Heart Rate") appears in the free space.
Confirm the fetal heart rate alarm
1. Touch the monitoring area flashing red.
Heart rate alarm is suspended.
The alarm sound stops, the display area turns red, and the alarm suspension icon
flashes.

2. Check the fetal and maternal condition and take appropriate measures under the
direction of a physician.
54

7. Types of Alarm and Corresponding Actions
Clear the fetal heart rate alarm
The monitoring screen is redisplayed by touching the monitoring area again if themonitored value returns to the configured range while the alarm suspended mark is
flashing.
Important

The fetal heart rate alarm is not automatically cleared even if the monitored value returns to
the normal range unless the user touches the monitoring area flashing red when it is issued.

Paper Out Alarm
When a paper out alarm is issued• Alarm sound is output. (It is not output when the alarm sound is set to <Mute>.)• The monitoring area flashes yellow every two seconds.
• "Recorder: Paper Out" and "Printing" are displayed alternately in the free space.
Confirm the alarm
1. Touch the monitoring area.
The alarm is suspended, the alarm sound stops, the display area turns yellow, and thealarm suspension icon flashes.

2. Check the recorder and load new recording paper if it is empty.
Fully close the cover. (See P.28 “5-1 Setting the Recording Paper”)
The alarm is automatically cleared when recording paper is loaded and the cover isclosed.
Print the recording while printing was suspended
If the paper runs out while printing, monitored data is automatically stored in the memory.
When the new recording paper is loaded, up to 30 minutes of monitored data from the timeof paper out to when new paper was loaded is automatically printed using high-speed
printing.

55

Actocardiograph MT-610 Instructions for Use

Other Alarms
In addition to the fetal heart rate alarm or paper out alarm, there are "Low Battery Voltage","Unit Error", "Check UC Transducer", and "Signal Error" alarms.
When an alarm occurs• Alarm sound is output. (It is not output when the alarm sound is set to Mute.)• The monitoring area flashes yellow every two seconds.
• A corresponding alarm message is displayed in the free space.
Confirm the alarm
1. Touch the monitoring area.
The alarm is suspended, the alarm sound stops, the display area turns yellow, and thealarm suspension icon flashes.
2. Perform an action in response to the alarm message.
The alarm is automatically cleared when the condition is remedied.

Alarm Specifications
Intended position of the operator
The alarms of this device are intended to notify the situation to the personnel in the area
where they can see the monitor or the recording paper.
Information delay
There are delays to the alarm signal of this device caused by below processes.
・ Delay caused by the heart rate detection algorithm.
・ Delay caused by internal communication.
Method and timing for verifying alarm system function
Check periodically that the alarm function of this device operates normally.
・ Verification timing: every six months
・ Verification method: refer to P.67 “9-2 Inspections to be Conducted by Users”

56

8. Changing the Configurations

Changing the Configurations
In the setting screen, you can configure the settings of this device or parameters for measuring
devices such as a transducer.

Setting Items List
There are two types of setting items. Settings that are set by displaying the settings screen
from the measurement screen, and those that are set by displaying the setting screen from
<Menu>.
ScreenSetting Items

Refer toItems shown from the measurement screen
Heart rate 1 or heart
rate 2 setting

FHR Alarm/Upper Limit/Lower Limit/Delay Time/
HR1Color/HR1Dot/HR2Color/HR2Dot

Fetal movement/UC
setting

FM Spike/Dot of FM/UC Sensitivity/UC Filter/UC Color

Date and time setting Date/Time/Clock Sync

P.59
P.60
P.61

Items shown from <Menu>
Measurement setting

Dop Focus Range/Display Mode/Recording
Range/FHR2 Waveform Offset/Single Heart
Mode/Bed ID/Signal Error Alarm

P.62

System setting

Alarm Volume/Suspend Time/Alarm Restraint/Key
Sound/Print Settings/Brightness/Clock Battery/Initial
Settings/Night Mode

P.63

Record setting

REC Speed/Top Sheet/Auto Feed/Auto Print/Auto
NST Timer

P.64

57

Actocardiograph MT-610 Instructions for Use

Display Setting Screen
8-2-1. Opening the setting screen from the monitoring screen
Display the settings screen by either holding the display area of the desired item in themeasurement screen, or selecting <Parameter> in the menu bar. Three items, "Heart ratesetting", "Fetal movement/UC setting", and "Date and time setting" can be set with thismethod.

1DOP, 2DOP
Uterine ContractionDate

8-2-2. Opening the setting screen from the <Menu>
Display the settings screen by selecting <Menu> in the menu bar. Three items,"Measurement setting", "System setting", "Record setting" can be set with this method.

58

8. Changing the Configurations

Heart Rate 1 or Heart Rate 2 Setting
Press and hold the Doppler 1 (Doppler 2) area to open the heart rate 1 (heart rate 2) setting
screen. (When the Doppler transducer is connected.)

From the monitoring screen, you can also touch <▼>, then <Parameter> to open the heart rate 1 setting
screen.

Field

FunctionsDefaultValue

FHR Alarm

Sets whether the fetal heart rate alarm ON or OFF.

ON

Upper Limit

Sets the upper limit of the fetal heart rate alarm.

180

Lower Limit

Sets the lower limit of the fetal heart rate alarm.

100

Delay Time

Sets how long the selected heart rate must remain
outside the threshold before the fetal heart rate alarm isissued.
Sets the color of waveforms displayed on the CTG
screen.
Sets the line weight of waveforms for CTG printing.

20 sec.

Sets the color of waveforms displayed on the CTG
screen.
Sets the line weight of waveforms for CTG printing.

OrangeHR1Color
HR1DotHR2Color
HR2DotBlue
32* Only the display color and the line weight can be set separately for heart rate 1 and 2.
The fetal heart rate alarm criteria can be set from both, but the setting is common.
Therefore, if one setting is set and then the other, the first setting is disabled.
Example: Upper limit of heart rate is set to 180 for heart rate 1, and then 190 for heart rate2.
In this case, 190 are applied for both.

59

Actocardiograph MT-610 Instructions for Use

Fetal Movement/UC Setting
Touch and hold the External Uterine Contraction (EUC) monitoring area to open the fetal
movement/contraction setting screen.

The Fetal movement/UC setting screen can also be shown by touching <▼>, <Parameter>, then
<FM/UC> from the monitoring screen.

Field
FM Spike

Functions

Dot of FM

Sets whether or not to record spike waveforms for fetal
movement.
Sets the threshold for recording fetal movement dots.

UC Sensitivity

Sets the sensitivity of contraction monitoring.

UC Filter

Default
Value
ON
25
NormalSets the filter function to eliminate the breathingON
components.
UC Color
Sets the color of waveforms displayed on the CTG
Greenscreen.
* Set to <OFF> if fetal movement spike waveform recording is not used.
* Fetal movement dot threshold
In fetal movement dot recording, dots are displayed and printed when the monitored fetal
movement level is higher than the setting.
Touch <▲> or <▼> to change the setting.

60

8. Changing the Configurations

Date and Time Setting
The date and time setting screen is displayed by holding the date and time display area. The
software keyboard is displayed by touching the date or time area.

・ The date and time setting screen can also be shown by touching <▼>, <Parameter>, then <Date>from the monitoring screen.
・ Refer to “(3) Correct the time (or date)” in P.31 “5-3 Inspections before Use” for the method of
operation.

Field

FunctionsDefault
Value

Date

Sets the date separated by a hyphen.

-

Time

Sets the time separated by a colon (24-hour notation).

-

Clock Sync

When set to <Manual> the date and time can be manuallyentered from the LCD of the device.
When set to <Auto>, automatic time synchronization is
performed with our central monitor.

Manual61

Actocardiograph MT-610 Instructions for Use

Measurement Setting
The measurement settings screen is displayed when <Menu> in the menu bar is selected.

Field

FunctionsDefault
Value

Dop Focus Range

Sets the range of depth monitored by ultrasound.

Shallow

Display Mode

Sets the display manner of the monitoring results.

Num

Recording Range

Sets the recording paper to be used.

50-210

FHR2 Waveform
OffsetSingle Heart Mode

Sets the offset of waveform display/printing of heart
rate 2.
Sets monitoring of a wide range using two Dopplertransducers for one fetus.
Used for device identification when it is connected toour central monitor.
The Signal Error Alarm is issued when both dopplertransducers are detecting only either heart rate, one of
the twins in case of twin fetus, and one of mother's or
the fetus' in case of a single fetus.

Bed ID
Signal Error Alarm0
OFF
Not setON

8-6-1. Double Doppler single heart setting
1. Touch <ON> for the Double Doppler Single Heart Mode.
2. Touch <Back> to return to the monitoring screen. DOP [SH] is displayed on the spacefor fetal heart rate mode.
Sample double Doppler single heart screen62

8. Changing the Configurations
3. Touch <Print> to start printing on the recording paper.
DOP [SH] is printed on the header of the recording paper.
4. During monitoring, better signals from the two Doppler transducers are automaticallyselected and recorded.
Important

In order to use the double Doppler single heart setting, you must connect the optional Dopplertransducer. (See P.17 “3-2 Major Options”)

System Setting
The system settings screen is displayed when <Menu>-<System> in the menu bar is selected.

Field
Alarm Volume
Suspend Time
Alarm Restraint
Key Sound
Print Settings
Brightness
Clock Battery
Initial Settings
Night Mode

Functions
Sets the volume of the alarm.
Sets the length of alarm suspension period after alarm
check.
Sets if the biological alarm is suppressed at startup.
Sets the operation sounds to ON or OFF.
Prints the list of settings of the device.
Sets the brightness of the LCD screen.
Displays the voltage of the battery for the clock.
Restores the settings to the factory defaults.
When set to <ON>, sets the brightness of the LCD to 20.

Default
Value
Medium
5 min
OFF
ON
100
OFF

* Contact us or our distributor when you want to set the alarm volume to <MUTE>.

63

Actocardiograph MT-610 Instructions for Use

Record Setting
The record settings screen is displayed when <Menu>-<Recorder> in the menu bar isselected.

Field
REC Speed
Top Sheet
Auto Feed
Auto Print
Auto NST Timer

64

Functions
Sets the speed of CTG printing.
Sets whether the top sheet is printed or not.
Feeds the recording paper to its fold line at the end ofrecording.
Automatically starts CTG printing when the device isturned on.
Enables or disables the function to automaticallystart/stop the printing.

Default
Value
30
ON
ON
OFF
OFF

9. Maintenance and Inspection

Maintenance and Inspection
Cleaning and Sterilizing

Sterilize all equipment that touches the surface of the skin before every use.
Failure to follow this instruction may cause infection.
Do not insert or remove the plugs with wet hands.
Failure to follow this instruction may result in electric shock.

The device is not sterilized before shipment. Be sure to sterilize and clean beforeuse.
For safety reasons, remove the power cord before wiping for safety.
Do not use chemicals such as sodium hypochlorite, alcohol (ethanol, methanol),thinner, benzine, peracetic acid formulation (Acecide), sodium hydroxide, volatilesolvents, or cleanser.
Failure to follow these instructions may degrade the material.
Do not use chemicals other than those specified by us for disinfection or
sterilization.
Do not excessively wipe the head of the transducer.
Failure to follow this instruction may damage the sensor or remove the surface
coating, preventing smooth movement on the abdominal wall, resulting in theredness in the skin.
Do not use water to clean, wipe, or disinfect the power cord plug.
Failure to follow this instruction may result in corrosion.
Do not apply or spray disinfectant to the electrical part.
Some disinfectants are conductive. Residual liquid may become more conductive
by absorbing dust or dirt.
Perform an inspection using the checklist in Section P.68 "9-2-2 Inspection
checklist”after cleaning.
Do not use the following methods of disinfection or sterilization.
・Disinfection or sterilization at more than 70°C, such as autoclave
・Sterilization by EOG (ethylene oxide gas) or ultraviolet light
The device body is not waterproof. Do not allow water to get inside the device.
Although the Doppler transducer and the External UC transducer are IPX7
waterproof, their waterproofness may decrease by immersing into chemicals.
Immerse only the applying surface into disinfectants.

65

Actocardiograph MT-610 Instructions for Use
Periodically clean the device to keep it clean.
Failure to follow this instruction may spread bacteria that cause a rash.

9-1-1. Sterilizing the accessories which touch the surface of the skin
■ Chemicals that can be used・ Glutaral (STERIHYDE)・ Benzalkonium chloride solution (Osvan)
・ Amphoteric surfactant (TEGO 51)■ Before sterilization
Before sterilization, wipe the ultrasound gel from the Doppler transducer carefully withtissues or a soft cloth.

■ Sterilization
Bacterial sensitivity differs depending on the chemicals being used. Follow the instructionsin the documents supplied with each chemical such as the indications, usage, andprecautions.

9-1-2. Cleaning the device
Wipe the device with a soft cloth on a regular basis.
Clean tough stains in the following manner.
1. Put a soft cloth in neutral detergent diluted with warm or cold water.
Wring out the cloth before wiping so that the water does not drip.
2. Wipe the device with the damp cloth.
3. Finally, wipe with a soft dry cloth.

66

9. Maintenance and Inspection

Inspections to be Conducted by Users

Follow this operation manual. In case of any abnormality, stop using immediately.
Be sure to inspect the device before use.
If you cannot confirm the proper condition by the inspection, turn off the power, andremove the power plug from the outlet. Stop using the device, attach a "Failure"indication, and contact us or our distributor for immediate repairs.
Do not disassemble or modify the device.
Failure to follow this instruction may result in failure or malfunction.
Do not perform maintenances in a situation with patient.
Failure to follow this instruction may cause electric shock.

9-2-1. About inspections
Inspections are required to maintain the function of this device. Some inspections shouldbe performed by the user and some inspections should be performed by our service
personnel. The hospital or clinic is responsible for these inspections.
Users should conduct the following inspections.
Inspection

Refer toInspection before use

Be sure to conduct before every use.

P.68

Inspection after use

Be sure to conduct after every use.

P.68

Six-month inspection

Conduct a functional inspection every six month.

P.69

Annual inspection

Conduct every year.

P.69

If you cannot confirm the proper action, the device has failed.
Turn off the power, unplug the power cord, and attach a label stating “Failure", and contact
us or our distributor to request repairs.

67

Actocardiograph MT-610 Instructions for Use

9-2-2. Inspection checklist
Perform the inspection according to the check items. Copy the checklist for yourconvenience.

■ Inspection before use
Perform before use and after the power is turned on.
Body No.

Date of inspection
Year

No.

Month

Day

Inspected by

Details of inspection

Results

1

The body is correctly installed without the risk of a falling hazard.

Y/N2

No damage or deformation on the body and power cords.

Y/N

3

No defective areas on the screen.

Y/N

4

The touch panel can be operated.

Y/N

5

The date and time are correct.

Y/N

6

The recording paper is set.

Y/N

7

The volume level is appropriate.

Y/N

8

The top sheet is correctly printed.

Y/N

9

The Doppler transducer correctly operates and the Doppler sound can beheard.

Y/N

10

The display of contraction level changes by pressing the pressure sensitive
part of the External UC transducer.

Y/N■ Inspection after use
Turn off the power before inspection.
Body No.

No.

68

Date of inspection
Year

Month

Day

Inspected by

Details of inspection

Results

1

Accessories which touch the surface of the skin are sterilized.

Y/N

2

No damage or deformation found on the body and the transducers.

Y/N

3

No dirt or foreign matter is found on the body and transducers.

Y/N9. Maintenance and Inspection■ Six-month inspection
Connect the transducers to the device and set the recording paper before inspection.
Date of inspection

Body No.

Year

No.

Month

Inspected by

Day

Details of inspection

Results1

No loose or missing screws in the body and the stand.

Y/N2

No damage or deformation on the body and power cords.

Y/N

3

The touch panel can be operated.

Y/N

4

No missing accessories.

Y/N

5

No defective areas on the screen.

Y/N

6

The date and time are correct.

Y/N

7

The volume level is appropriate.

Y/N

8

The Doppler transducer correctly operates and the Doppler sound can beheard.

Y/N

9

The display of contraction level changes by pressing the pressure sensitive partof the External UC transducer.

Y/N

10

The remote marker switch operates correctly.

Y/N

11

The fetal heart rate alarm can be correctly activated.

Y/N■ Annual inspection
Conduct the six-month inspection at the same time.
Body No.

No.

Date of inspection
Year

Month

Day

Inspected by

Details of inspection

Results1

No abnormality is found with the six-month inspection.

Y/N

2

No abnormality in the recorder. No dirt on the thermal head.

Y/N

69

Actocardiograph MT-610 Instructions for Use

9-2-3. How to inspect the fetal heart rate alarm
1. Press the power switch to turn on the device, and connect the Doppler transducer.
2. Set <Alarm Restraint> to <OFF>, <Lower limit of heart rate> to 120, and <Delay time>to 10 seconds so that the heart rate alarm can be easily issued.
3. Turn the transmitting and receiving surface up to prevent signal input (“---" is displayedon the screen).
4. Confirm that the alarm is issued after the set delay time.
5. Restore the setting after confirming the alarm.

9-2-4. Inspection of the thermal head

Thermal head (brown part)

1. Annually check the thermal head of therecorder for dirt.
2. .If it is dirty, clean using thermal headcleaner(commercially available products).

Inspection by our Service Personnel
In general, contact our service personnel to request inspection once a year.
The service personnel will check that the electronic parts inside the device are operatingcorrectly by using various measurement devices. He/she will visit your site based on the
periodic inspection contract. If you need details of the inspection or the service manual,contact our sales representative.
Failure to conduct a periodic inspection may degrade the function of the device, delay thedetection of loss, or prevent correct monitoring.
Record the results of these periodic inspections.

70

9. Maintenance and Inspection

Storage Precautions

Do not store the device in the following conditions.
Failure to follow this instruction may result in failure.
• A place with direct sunlight• Moist (95% or above) or dusty place• Hot place (60°C or above), cold place (-10°C or below)• Unstable place such as under vibration

9-4-1. Storage or transport conditions
・ Ambient temperature: -10 to +60°C (excluding freezers)
・ Relative humidity: 30-95% (no condensation)
・ Atmospheric Pressure: 700-1060 hPa

9-4-2. If the device is not going to be used for a long time
1. Disconnect the power cord from the power outlet.
2. Do not store in a location in which the device could come into contact with water.
Important

・ Avoid direct sunlight, high temperature and humidity, slopes, vibrations, and shocks.
・ The battery in the device runs out even if the device is not being used. Charge the battery
at least once every three months. The battery may become unchargeable if the device is
not used for more than three months. We recommend removing the battery when storing
the device. Contact us or our distributor to request battery removal.

9-4-3. Storing recording paper
Note the following points when handling and storing under the following conditions. They
may cause discoloration.
・ Storing in locations subject to high temperature, high humidity, or direct sunlight・ Contact with alcohol or adhesive materials of adhesive tape・ Storing the recording paper in PVC files
Use water-soluble glue to stick the recording paper to medical records.
The recording paper will gradually discolor over time even under optimum storage
conditions. In the optimal environment (ambient temperature of 23°C, relative humidity of50%), the recording paper is readable for approximately five years.

9-4-4. Storing transducer
Avoid subjecting the transmitting and receiving surface of the Doppler transducer and thepressure receiving surface of the External UC transducer to shocks.

71

Actocardiograph MT-610 Instructions for Use

How to Replace the Fuse
The device incorporates a fuse to prevent damage from transient overcurrent. When the plugs
are correctly connected but the power does not turn on, the fuse may have blown. Pull out thefuse holder, check the fuse, and replace it with a new one if the fuse is blown.
Specified fuse: AC250V 3.15A, Time-lag, Low-breaking capacity, ø5.2×20 mm(ET3.15A made by SOC)

Turn off the power
1. Press the power switch to turn off the power.
2. Unplug the power cord connector from the power inlet.
Remove the fuse holder
Pull out the fuse holder from the upper side using yourfingernail or a flat screwdriver.

Replace the fuse
1. Push the blown fuse laterally and pull it out.
2. Insert a new fuse.

Return the fuse holder
Turn the fuse holder guide upwards and return the holder
to the power inlet.

72

10. Troubleshooting

Troubleshooting

Follow this operation manual. In case of any abnormality, stop using immediately.
Do not disassemble or modify the device.
Failure to follow this instruction may result in failure or malfunction.
This section describes the procedures for users to address problems. If there is no improvement
after completing the procedures, contact us or our distributor to request repairs since theproblem may be caused by a failure or a bad electrical contact. Also, contact us or our distributor
if it is necessary to replace the battery for the clock or the lithium-ion battery.

Errors Displayed in the Free Space
Examples of failure

Possible causes

ActionClock Low Battery

The voltage of the battery forclock memory is low.

Contact us or our distributor to
replace the battery.

Recorder: Paper Out

No recording paper.

Insert new recording paper.

The recorder cover is open.

Close the cover.

The recorder failed.

Contact us or our distributor torequest repairs.

Recorder:Unit Error

UC:Check UC Transducer The input signal deviates due to Check the UC transducer.
a sensor abnormality or forother reasons.

Problems Not Displayed in the Free Space
Examples of failure

Possible causes

ActionThe power light does notturn on after switching on
the power.

The power cord is unplugged.

Insert the power cord firmly.

The power fuse is blown.

Replace the fuse.
(See P.72 “9-5 How to Replace
the Fuse”)

The date and time is notcorrect

The time setting is incorrect.

Open the date and time setting
screen and set them again(See P.32 “(3) Correct the time(or date)”)

The clock is not correct
The battery of the clock has run Contact us or our distributor toeven after setting the time. out.
replace the battery.

73

Actocardiograph MT-610 Instructions for Use

Examples of failure

Possible causes

ActionNo Doppler sound isheard

The volume setting is too low.

Adjust the volume.

The Doppler does notwork normally

The transducer is not connected Connect the transducer firmly
correctly to the device.
to the device.

The transducer is not connected Connect the transducer firmly
correctly to the device.
to the device.

The transducer is applied to the Adjust the Doppler transducer
inappropriate position.
to the position that provides
clear, rhythmic sounds.
Too small amount of ultrasound Apply a thin, even layer.
gel was applied to thetransducer.
The fetus has an irregularheartbeat or hiccups.

Continue careful monitoring.
Use another method ofmonitoring which does not use
this device.

The transducer failed.

Use a different transducer.

The fetus or mother frequently
moves.

Use another method ofmonitoring which does not use
this device.

The mother is severely obese.

Use another method ofmonitoring which does not use
this device.

No signals.

Auscultate the fetal heartbeat.

Static noise in the Doppler The fetus frequently moves.

を表 was displayed orprinted74

Move the position of thetransducer.

Affected by environmental
noise.

Keep the sheet and gown awayfrom the transducer.
Do not hold the transducer.

The mother frequently moves.

Stop the mother moving.

The transducer failed.

Use a different transducer.

Two transducers may bemonitoring the heart rate of asingle fetus.

Check the fetal position andadjust the transducer.

10. Troubleshooting

Examples of failure

Possible causes

ActionThe external UC
transducer records nocontraction

The transducer isinappropriately applied.

Affix the transducer to theuterine fundus of the mother.

The zero-setting switch ispressed at the time ofcontraction.

Press the <ZeroSet> switch
during a break in contractions.

The transducer is not connected Connect the transducer firmly
correctly to the device.
to the device.
The transducer failed.

Use a different transducer.

No Uterine contraction.

Wait for a contraction andmonitor for a while.

The contraction exceeds thereference range.

Loosen the belt.
Remove the transducer and fix
it again making sure it is not too
tight.

CTG is not printed.
Device is not connected to the
The <Print> button color is power source.
gray(See P.12 “Battery operation”)

Insert the power cord to thepower source.

75

Actocardiograph MT-610 Instructions for Use

Specifications/Parts List
Product Specifications
11-1-1. Material of the parts which touch the surface of the skinName
Y-shaped
Doppler/External UC
transducer
Transducer belt
Remote marker switch
Doppler transducer
Ultrasound gel

Material
PC/ABS resin, silicone rubber

Polyurethane rubber, polyester
PC/ABS resin, elastomer material
PC/ABS resin
Propylene glycol/carboxypolymethylene
sodium/cellulose derivative/purified water

11-1-2. Device category
Category
Classification by protection
type to electric shock
Classification of appliedpart by protection level toelectric shock
Classification by protectionlevel to hazardous entry ofwaterClassification by actuation(operation) mode

Description
Class I
Y-shaped Doppler/External UC transducer:
Type BF applied part
Doppler transducer: BF applied part
Main unit: IPX0
Transducer: IPX7 (excluding the connector to the mainunit)
Remote marker switch: IPX7 (excluding the connector
to the main unit)
Continuous actuation (operation) device

11-1-3. Electrical rating
Category
Alternating current/direct
current
Rated voltage
Frequency

76

Description
Alternating current
100-240 V 47 VA (momentary 66 VA)
50 Hz /60 Hz

11. Specifications/Parts List

11-1-4. Dimension/weight
Category

Description

Main unit

250±25 mm(W)×265±27 mm(H)×205±21 mm(D)/4.0±0.4 kg(excluding accessories)

Y-shaped Doppler/External
UC transducer

66±7 mm(W)×18±2 mm(H)×80±9 mm(D)/240±24 g
Length: 2.85±0.1 m

Doppler transducer

66±7 mm(W)×18±2 mm(H)×80±9 mm(D)/170±17 g
Length: 2.85±0.1 m

Remote marker switch

73±7 mm(W)×45±5 mm(H)×28±3 mm(D)/100±10 g
Length: 2.5±0.3 m

11-1-5. Technical specifications
Category

Details

Description

Fetal heart ratemeasurement by
ultrasounddoppler

Ultrasound driving
methodPulse Doppler with autocorrelation processing

Oscillating
frequency

1.108 MHz±10%

Ultrasound powerNot more than 10 mW/cm2

Heart ratemeasuring range

50-240 bpm

Heart ratemeasuringaccuracy

Within ±3 bpm

UC input

Strain gauge

Measuring range

0-100 UNIT

Contraction
sensitive mode

1.33 times the normal mode

Recordingsensitivity

30 mm on the recording paper for 100 g load

Double Doppler
Single HeartTwo Doppler transducers are used for a single
pregnancy to monitor across a wide range.

NST timer

The function to automatically stop the recorder
after the time set.

Automatic NST

The function to automatically start recording at
the beginning of heart rate monitoring andautomatically stop after the time set.

Contraction cycle
monitoring

The intervals of contraction peaks are monitored,
displayed, and printed.

MethodThermal headFeeding speed

10, 20, 30 mm/minute

Range of recording

Heart rate 50-210 bpm/80 mm, or 30-240
bpm/70 mm
UC 0-100[UNIT]/40 mm

External UC

Measurement
function

Print function

Tl, Ml<1.077

Actocardiograph MT-610 Instructions for Use
Category

Alarm function

Details

Description

Simultaneousrecordings

Heart rate area 4 channels, UC area 3 areas,
Remote marker switch area 2 channels.

Applicable
recording paper

0030-026(50-210bpm/color)
0030-027(50-210bpm/black and white)
0030-031(30-240bpm/color)

Heart rate andpulse rate alarm

Alarm setting with user-selectable high and low
FHR and delay time.

Wrong heart ratemeasurement
alarm

Alarm of two sensors measuring the same heartrate.

Device alarm

Alarm regarding the state of the device such asout of paper and low battery.

Alarm soundpressure level

45 dBA~85 dBA

Category
Fetal movement

Description
Auto measurement of fetal movement spike waveform by
Doppler ultrasound system (2 channels).
Fetal movement spike waveforms and dot recording by
thresholds.
Monitoring of maternal perception by the Remote marker.

FHR sound monitor

Doppler sound.

Display

7-inch TFT LCD panel, resolution: 800 x 480 (WVGA).

External I/O

IO-1: For connecting accessories.
IO-2: For connecting our central monitor.

78

11. Specifications/Parts List

11-1-6. Classification by sterilization methods
Dipping method. The following chemicals are used for IEC 60601-1 test.
Name of chemicals

Usage/AmountDippingtime

STERIHYDE
20 W/V% solution

Carefully measure 100 mL, add it to 900 mL of purified
water to make 1 L of 2 W/V% solution, add 5.7 g ofbuffer agent (powder) to this to make the rattan red
solution.

30
minutesOsvan disinfectant
10%

Used by diluting with purified water. 100 times solution(0.1% solution).

10
minutes

TEGO 51 disinfectant
10%

Used by diluting with purified water. 50 times solution(0.2% solution).

15
minutes

11-1-7. Wiping test
Use undiluted natural detergent for IEC 60601-1 test.

79

Actocardiograph MT-610 Instructions for Use

Accessories/Options List
11-2-1. Accessories supplied
Name

Item
code

Cable
lengthQuantity

Y-shaped Doppler/External UC
transducer

GA0128TR-687-06

2.9 m

1

Remote marker switch (single)

GA1264SW-527-01

2.9 m

1

Transducer belt

GA0115

Personal belt, 2pcs/set(each 1 pc for Doppler&UC)-

1

JA2222

10A 250VAC, CEE7/7,
With ferrite cores

2.9m

1

JA1885

7A 125VAC, Type B,
With ferrite cores

2.4m

1

Ultrasound gel
Note2

GA0132Aquasonic 100 gel,
250ml/bottle-

1

Recording paper

GA10510030-026(50-210bpm/color)-

1Power cord
Note1Standard or Model Name

Operation Manual
GZ1153 (This document)
Note1: Either Cord JA2222, JA1885, or no cord is included depending on the country.
Note2: Whether it is included or not depends on the country.

111-2-2. Options
Name

Item
code

Standard or Model Name

Cable
lengthDoppler transducer

GA0129TR-629-06

2.9 m

External UC transducer

GA0130TR-619-06

2.9 m

Remote marker switch (twins)

GA1265SW-527-02

2.9 m

Twins set

GA1770Recording paper

GA10510030-026(50-210bpm/color)-

Recording paper

GA10480030-027(50-210bpm/black and white)-

Recording paper

GA10550030-031(30-240bpm/color)-

Remote marker connection
cable

HA1810For connection of Fetal Stimulator
TR-30

USB memory

VB0865

Standard cart

AA0174JC-174-Multi-cart

AA0175

JC-175

-

80

-

2.9 m
-

11. Specifications/Parts List

Service Parts
The usable life of this device is six years after sale. However, the following components aresupplied for maintenance since they have shorter usable lives than that of the device.
We will store the parts necessary for repairs for six years after the device is sold. The timing of
the replacement will depend on the frequency and the environment of use of the device.
Replace components that fail inspections.
If you have any questions, contact us or our distributor.
Names of the major components

Usable life

Reasons of usable life

Power cord

4 years

Power switch
Doppler transducer

5 years
5 years

Consumable, degradation of
external covering of the cord
Degradation with use
Degradation with use

External UC transducer

4 years

Degradation with use

Battery for clock

3 years

Consumption

Lithium ion battery

2 years

Degradation by charge anddischarge
Degradation with use

Remote marker switch (single/twins)

3 - 4 years* The table does not show components that can normally function after the usable life of thedevice.

81

Actocardiograph MT-610 Instructions for Use

About Disposal and Warranty
Usable Life and Disposal
12-1-1. Usable life
The usable life of this device is six years after sale. (Based on our self-certification using
in-house data. This applies only when the specified service inspection has been
conducted.)
Some components may degrade with age within the usable life. It is necessary to regularly
replace the components to maintain the performance of the device during the usable life.
Conduct repairs or overhauls depending on the results of inspections as needed.

12-1-2. Disposal
The device is classified as industrial waste. Contact the local authority for disposal. The
device has a built-in battery. For disposal of the body, recycle or dispose in accordancewith your local authority rules and regulations.
Not complying with regulations may cause environmental pollution.
Contact us or our distributor if disassembly (such as removing the battery) or other support
is necessary.

Warranty
We will repair the device free of charge within the warranty period based on the terms andconditions described in the warranty.
For repairs after the warranty period, we will repair only devices that can be normally used
after the repair but the cost is born by the user. We will store the parts necessary for repairs
for six years after the device is sold.

82How to read this manual

Notification to Users
Pursuant to the provisions of the Pharmaceuticals and Medical Devices Etc. Act, we must
provide users with information related to the effectiveness and safety of the device andinformation necessary for proper use of the device. Also, it is required by law that users mustcooperate in the collection of information necessary for proper use.
If you encounter any problems, contact us and provide the following information.
(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● Facility name● Contact person
Device name: Actocardiograph MT-610 Serial number:

Problem description

The contents of this document are subject to change without notice.

83

Actocardiograph MT-610 Instructions for Use

Index
A
About inspections .....................................................67
Accessories ........................................................16, 80
Adjust the Doppler sound volume ............................33

high-speed printing ............................................ 12, 55
History screen ......................................................... 23
How to inspect the fetal heart rate alarm ................. 70

I

Alarm Volume ...........................................................63

Initial Settings .......................................................... 63

automatic NST timer.................................................42

Inspection checklist ................................................. 68

B
Backup .....................................................................48
Battery operation ......................................................12C
Check the battery charge .........................................30

Inspection of the thermal head ................................ 70

L
List of Alarms ........................................................... 53

M
Material of the parts which touch the surface of the

Cleaning the device ..................................................66

skin ..................................................................... 76

Clear the fetal heart rate alarm.................................55

Monitoring Screen ................................................... 20

Clock Sync ...............................................................61

Monitoring Setting ................................................... 62

Confirm the contraction level ....................................34

Move the position of the Doppler transducer ........... 45

Confirm the Doppler sound ......................................34

Mute ........................................................................ 21

Connect the remote marker switch...........................31
Connect the transducer ............................................30
Correct the time............................................32, 61, 73

D
Decide on the fitting position ....................................37
Decide on the fitting position of the external UC
transducer ............................................................39N
NST timer ................................................................ 42

O
Options .............................................................. 17, 80

P

Device category .......................................................76

print past data ......................................................... 46

Display setting screen ..............................................58

Print the fetal movement mark ................................ 45

double Doppler .........................................................30
Double Doppler single heart setting .........................62

E
Electrical rating.........................................................76
Example of CTG recording .......................................44

F

R
Record setting ......................................................... 64S
set date ........................................................32, 61, 73
Set the contraction to zero ...................................... 40
Sterilizing the accessories which touch the surface of

Fetal movement/UC setting ......................................60

the skin ............................................................... 66

Full screen................................................................27

System setting ......................................................... 63

HHeart rate 1 or heart rate 2 setting ...........................59

84

T
the device is not going to be used for a long time ... 71

Indexthe recording while printing was suspended ............ 55
timer function ........................................................... 42
Top sheet and recording item name ........................ 43
Turn off the power.................................................... 51

Uultrasound gel .......................................................... 37

W
When a fetal heart rate alarm is issued ................... 5485

Manufacturer 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/