Reference only

Melody i SeriesSpecifications only in Japan● Ultrasound FHR Transducer● Uterine Contraction TOCO Transducer● iCTG app for control

111

Can be measured anywhere

Melody i

Cloud server

Anytime, Anywhere● AC adapter for charging● Carry bag● Pulse oxymeter● Fetal movement Marker Switch● Controlling tablet and App

Internet

Small and Smart Mobile Fetal Monitor
1. Sending data after
measurement done
2. Real-time sending

Melody i Sereies

Fet al Monitor

iCTG

Central i ( in-hospital / regional) usage example
Regional use

A. By iCTG Viewer app for iOS3G/LTE connection or Wi-Fi connectionin the hospital.
Real-time viewing is possible.
Notification when start measurement.
*iOS notification function.
History viewing function.
*listed by measurement time and bypatient ID.
Multiple iCTGs can be registered to asingle device.
*Internet connection required.

PC / Smart devices

Fetal Monitor iCTG

Accessories / Options● Remote monitoring features

Made in Japan

Single Usage example of Fetal Monitor iCTG

Fetal Monitor iCTG standard equipment

In-hospital Use

Central i(Central monitoring)
Staff station

Smart device

Out-of-hospitalviewing

Hospital server
VPNVPN

Participating clinic,
midwife center

Hospital Wifi

Fetal Monitor
iCTG

Emergency transfer
Ward, L&D room, Outpatient

B. By e-mail link
Send link to registered e-mail addresswhen measurement starts.
*unlimited number of registered e-mailaddresses.
Real-time viewing is possible.
Only the data linked in the e-mail canbe viewed.
*Internet connection required

C. By web browser
SSO: Login ID / Password Security*Unlimited number of IDs registered.
Real-time viewing is possible.
CTG graph printing function
CTG graph PDF conversion function(A4/A3)
Patient ID list history viewing function*Internet connection required● Central I (central monitoring system)
Connect as many Mobile Fetal
Monitors as you want and monitor
them all in real-time on a web browser.
Wide-area CTG monitoring connecting
multiple medical institutions.
Reduce initial costs with Cloud CentralMonitor. It can also be deployed on
on-premises servers.
【 Manufacturer 】

Melody International Ltd.
Registered Medical Device Manufacturer / Class 2 medical devices marketing license /Licensed Medical Device Retail/Rental Service

304 NEXT Kagawa 2217-44, Hayashi, Takamatsu,Kagawa 761-0301, JAPAN
Email: e-support@melody.international【 Manufacturer 】 Melody International Ltd.
Phytronix Ltd. Takamatsu Factory■ Specificiation
Product Name :Fetal Monitor iCTG

Model Name :MI1001A

Medical Device Approval Number :230AFBZX00024000 - JAPANNonproprietary Name :Fetal Monitor JMDN 37796000

Group :

Machinery and Equipment 21, device forvisceral organ function examination
Controlled Medical Device Class 2, Specially designatedClassification Class :maintenance control required medical devices
Device Classification
Forms of protection against electric shock:The degree of protection against electric shock on applied part:The degree of protection against invasion of water:

Internally Powered
Type BF
IPX2

Communication Method / Operating Hour / Weight / Size

Electrical Rating Charging AC Adapter

Communication Method

Bluetooth 4.1 LE

Recommended Distanceapprox. 20m

Input Voltage

AC100-240V

Operating Hour

approx. 6 hours (with Max Volume)

Input Rating

0.29A-0.16A

Charging Timeapprox. 1 hour

WeightUltrasound Transducer / 166 gram
Uterus Contraction Transducer / 137 gram

Size

96mm x 93mm x 29.5mm (L x W x H, ±1mm)

Electrical Rating: Transducer
Power-Supply Voltage - Internal PowerDC 3.7V

Battery Type

Lithium Ion Battery

Power-Supply Voltage - Charge

DC 5.0V - AC Adapter

Frequency

50/60Hz

Output Voltage

DC5V

Output Rating

2A

Operating Environment
Temperature

15~35°C

Relative Humidity

20~80% (no dewing)

Atmospheric Pressure

700~1060hPA

Storing Environment
Temperature-10~45°C

Relative Humidity

10~90%

Atmospheric Pressure

700~1060hPA

CautionPlease charge transducers and tablet every day. Please check the Bluetooth connection before measurement. *Tablet is notincluded in Fetal Monitor iCTG. Please install included controlling software into specified tablet to use. ※Tablets can bechosen from a list of designated devices.
【Mesurement Tablet System Requirement】only for designated devices. iOS, Android OS (Support planned). Has Bluetooth
chip from Cypress Inc. (ex.Broadcom Inc.) Certified as IEC62368-1 or IEC60601-1*iOS® is a registered trademark of Cisco in the US and is used by Apple under license. Android is a trademark of Google LLC.

Melody i Approved Japan PMDA / ISO13485 certified
Channel Registerd Thai FDA

US FDA will be obtained by mid of 2022
CE mark and Saudi Arabia FDA are preparing
Nov. 2021_ver.2.0e

We are seeking
DISTRIBUTORMelody i Series

Anytime, Anywhere

Measured data is stored in a data server
Data will be securely saved in a data server(either in-hospital or cloud), providing safe place
for medical data. Our cloud server will guarantee
10 years of data storage. You don’t have to think
about managing data recording sheets anymore.
In case you need to print out, use data viewing PC
to print out desired section of a graph and attach
it to medical record.

It’s a small and smart Mobile Fetal Monitor
that comprises of two transducers.

Easy to find a fetal heart rate

You can monitor health condition of anHeart shaped fetal heart monitor will
emit heart beat sound, enabling users
to locate fetal heart location naturally.

expectant mother and her fetus at any time,from anywhere.
6 “S” will help ease busy medical scenes.

*PatentedSends Data to your smartphone
Achieves paperless work with tablet display
A tablet device will be used for controllingmeasurement and displaying CTG graph.
IPad, Windows 10 device, and Android device
can be used depending on a hospital system.
Tablet screen can be scrolled to see a full viewof a graph, assisting doctor’s quick decision making.

ActualFetal Heart Rate
Ultrasound Transducer

Uterine Contraction
Toco transducer

Small, lightweight, wireless= reduces stress of an expectant motherTransducers only have a weight of an averagesmartphone. It is completely cable-free,
so expectant mothers can walk freely when
the device is connected to the Wi-Fi network.
(please carry with you a display tablet)

Size

After measurement is done, results can besent to devices like doctor’s smartphone andtablet, as well as to PC in the doctor’s officeor staff room through internet / Wi-Fi. Data
can be checked by opening internet browser.
Doctors can utilize their available timeeffectively. Real-time monitoring is possible
with Central i (central monitoring, optional)
and real-time cloud (optional).

Actual Screenshot

Up to 6 to 10 hours use
1 hour battery charging will allow up to 6 to 10
hours of continuous measuring. You can use it
for long time without a hassle to charge.
(check the battery level before use)

High quality and multifunction, packed in a small body; it can be used in various medical situations.

Doctors can use any devices to view results.

It enables straight forward usability and versatility like never before.

Remote monitoring

Using a waiting timeefficiently

Real-time transmission during emergency transfer

Same attachment style as conventional devices

Fits on expectant mother’s body perfectly

Control from tablet after putting it on

High risk expectant mother’s condition can bemonitored remotely. Screening in advance canbe done, reducing high risk emergency delivery.
Reducing the Risk of COVID-19 Incidence.

Because Fetal Monitor iCTG is battery operated
and cable-free, it can be used during an outpatient
waiting time, reducing total time of checkup andresults in reduction of maternal stress.

By loading Fetal Monitor iCTG on an ambulance, areal-time transmission of measured data becomes
possible, enabling accepting hospital to better
prepare before arrival. (real-time cloud is optional)

There is no difference in how to put it on than theconventional CTG device. Place FHR on a proper
location for an optimal fetal heart sound, and TOCOon a location were stable pressure is applicable.

Because it is completely cable-free, there is
no problem in moving around after thetransducers are placed on an expectant
mother’s abdomen.

Once transducers are connected to a tablet
via Bluetooth, you can control everythingfrom a tablet with a good usability.