uneeg MEDICAL MYCONNECT User manual

UNEEG™ MYCONNECT
USER MANUAL – USER

2| USER MANUAL FOR USER | ENGLISH
UNEEG™ MyConnect
TABLE OF CONTENTS
1. INTRODUCTION . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3
1.1 Intended use . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3
1.2 Indications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3
1.3 Intended user and population . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3
1.4 Contraindications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3
1.5 Warnings and precautions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3
1.6 Side eects. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3
2. PRODUCT DESCRIPTION . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4
2.1 Requirements for using UNEEG™ MyConnect. . . . . . . . . . . . . . . . . . . . . . . 4
2.2 UNEEG™ MyConnect device description . . . . . . . . . . . . . . . . . . . . . . . . . 4
2.3 Compatible products. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6
3. SYMBOLS AND LABELLING. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7
4. USING THE SYSTEM . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8
4.1 How to assemble your equipment . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8
4.2 Daily use . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9
4.3 Charging the tablet . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10
4.4 Serious incident reporting . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10
5. MAINTENANCE AND DISPOSAL OF EQUIPMENT . . . . . . . . . . . . . . . . . . . . . 11
5.1 Handling . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11
5.2 Cleaning . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11
5.3 Return of the equipment . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11
5.4 Repairs . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11
6. TROUBLESHOOTING. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .12
7. TECHNICAL DESCRIPTION . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15
7.1 Environmental conditions. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .15
7.2 Data protection . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15

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UNEEG™ MyConnect
1. INTRODUCTION
1.1 INTENDED USE
The intended use of UNEEG™ MyConnect is to transfer data from a UNEEG recorder to the
UNEEG™ Cloud.
1.2 INDICATIONS
Not applicable for this product.
1.3 INTENDED USER AND POPULATION
UNEEG™ MyConnect is aimed to be used by lay persons and healthcare professionals.
1.4 CONTRAINDICATIONS
There are no known contraindications with the use of UNEEG™ MyConnect.
1.5 WARNINGS AND PRECAUTIONS
No warnings or precautions have been identified.
1.6 SIDE EFFECTS
There are no known side eects related to the use of UNEEG™ MyConnect.

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UNEEG™ MyConnect
2. PRODUCT DESCRIPTION
UNEEG™ MyConnect ensures that recorded data from a recorder is transferred via a cloud-
based solution to the healthcare professional.
2.1 REQUIREMENTS FOR USING UNEEG™ MYCONNECT
To use UNEEG™ MyConnect the following criteria must be met:
•
Wi-Fi must be available to transfer data from UNEEG™ MyConnect to the healthcare
professional.
• A UNEEG recorder and an inserted UNEEG implant must be available.
2.2 UNEEG™ MYCONNECT DEVICE DESCRIPTION
The figure shows the assembled UNEEG™ MyConnect with a UNEEG recorder and power
supply.
1
2
3
4

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UNEEG™ MyConnect
The components included in UNEEG™ MyConnect are described in the table below.
NO. ITEM
NUMBER
NAME DESCRIPTION
A
B
C
20002 Tablet Device for using the
UNEEG™ MyConnect app.
The tablet can only be used
with the preinstalled app.
Power button (A) Button to turn the tablet
on and o.
Connection port
(B)
To connect the USB hub.
Holder (C) Enables the tablet to be
placed in an upright position.
Camera (D) For scanning the QR code
when setting up a patient.
20021 USB hub Connects tablet to connector
cable and power supply.
USB A port (E) To connect the recorder.
Micro USB
port (F)
To connect the power
supply.
20002 Power supply
For charging the tablet.
Consist of a power adaptor
and a cable.
20020 Connector cable Connects the recorder to the
USB hub.
D
F
E
1
2
3
4

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UNEEG™ MyConnect
2.3 COMPATIBLE PRODUCTS
PRODUCT PART DESCRIPTION
24/7 EEG™ SubQ Records EEG data. Referred to as ‘recorder’ in this
user manual.
UNEEG™ Cloud Transfers data from UNEEG™ MyConnect to the health-
care professional.

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UNEEG™ MyConnect
3. SYMBOLS AND LABELLING
Key to symbols on equipment and packaging:
SYMBOL EXPLANATION
Manufacturer
Date of manufacture
Batch code
Catalogue number
Serial number
Temperature limit
Consult instructions for use
Not for general waste
CE marking
Medical device
Wi-Fi
Battery power level

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UNEEG™ MyConnect
4. USING THE SYSTEM
4.1 HOW TO ASSEMBLE YOUR EQUIPMENT
1. Place the tablet in the holder (optional).
2. Connect the USB hub to the tablet.
3. Connect the power supply to the USB hub.
4. Connect the connector cable (20 cm) to the USB hub.
5. Turn on the tablet and follow the on-screen instructions. The tablet is ready to be connected
with the recorder.

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UNEEG™ MyConnect
4.2 DAILY USE
4.2.1 HOME PAGE
The tablet starts up on the home page. The home page shows:
The time stamp for the latest data transferred from the recorder to the tablet.
An overview of recorded data for the past 7 days.
An overview of recorded data for the past 30 days.
Button to begin the transfer of data from recorder to tablet.
1
2
3
4
4.2.2 MENU
The menu in the top right provides the following options:
• Instruction for use
• Select language
• Select Wi-Fi
• About the app
1
2 3
4

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UNEEG™ MyConnect
4.2.3 SELECTION OF WI-FI
To transfer recorded data to your healthcare professional, the tablet must be connected to
Wi-Fi. To select Wi-Fi use the menu on the top right. Tab the Wi-Fi you want to connect to.
Once connected a Wi-Fi icon will appear next to the menu.
If there is no Wi-Fi connection available, data will be transferred to the tablet when the
recorder is connected. The stored data is transferred to the healthcare professional once
the tablet is connected to Wi-Fi and new data is transferred to the tablet.
4.2.4 TRANSFER EEG DATA
To transfer the data, you can do one of the following:
• Tap ‘Transfer data’ on the home page and follow the instructions for connecting the recorder
to the tablet. Once the recorder has been connected correctly, transfer will begin automatically.
• Alternatively, connect the recorder to the tablet, and the data transfer will begin automatically.
Two pop-up windows may appear the first time you connect the recorder to the tablet. Tick
the checkbox to avoid these pop-ups in the future. Tap ‘OK’ to continue. If you tab ‘Cancel’
data will not transfer.
You will receive a notification if the tablet is not connected to Wi-Fi. You must then select
whether you wish to continue data transfer to the tablet or connect to Wi-Fi in order to transfer
data to the healthcare professional.
4.2.5 CHARGING THE RECORDER
The recorder charges when it is connected to the tablet. Leave the recorder connected to
the tablet after data transfer has been completed to finish charging.
4.3 CHARGING THE TABLET
Charge the tablet by connecting the power supply to a power outlet. The equipment may
only be charged using the power supply provided with UNEEG™ MyConnect.
4.4 SERIOUS INCIDENT REPORTING
Per European Regulations: Report any serious incident that has occurred in relation to this
device to the manufacturer and the competent authority of the EU Member State where
the device was used.