uneeg MEDICAL MYCONNECT User manual

UNEEG™ MYCONNECT
USER MANUAL – HEALTHCARE PROFESSIONAL

2| USER MANUAL FOR HEALTHCARE PROFESSIONAL | ENGLISH
UNEEG™ MyConnect
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 Setting up the system for a patient . . . . . . . . . . . . . . . . . . . . . . . . . . 9
4.3 Charging the tablet . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12
4.4 Serious incident reporting . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12
5. MAINTENANCE AND DISPOSAL OF EQUIPMENT. . . . . . . . . . . . . . . . . . .13
5.1 Handling . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13
5.2 Cleaning . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13
5.3 Return of the equipment . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13
5.4 Repairs . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13
6. TROUBLESHOOTING . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14
7. TECHNICAL SPECIFICATIONS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 17
7.1 Environmental conditions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 17
7.2 Data protection . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 17
TABLE OF CONTENTS

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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 set up UNEEG™ MyConnect for a patient.
• UNEEG™ EpiSight, minimum version 1.11 must be installed and available.
• The patient must have an inserted UNEEG implant and a UNEEG recorder.
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 NUM-
BER
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™ EpiSight Computer-assisted review system for EEG data. Avail-
able to healthcare professionals only.
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 SETTING UP THE SYSTEM FOR A PATIENT
The purpose of setting up the system for a patient is to create a wireless connection for
transfer of recorded data between UNEEG™ MyConnect and the healthcare professional.
The setup ensures that the app only recognises recorded data from the specific patient.
If recorders have already been used by the patient at home, data shall be ooaded prior
to setup.
4.2.1 BEFORE STARTING SETUP
On the tablet:
1. Select language.
2. Select Wi-Fi. A Wi-Fi connection is necessary in order to complete the setup. If the Wi-Fi
connection is interrupted, you need to restart the setup process.
3. A welcome screen is shown with the required prerequisites.
4.2.2 SETTING UP DATA TRANSFER
Setting up data transfer will require 5 Steps, which are explained below.
Step 1 of 5: Scan QR code
•
Open and create a patient profile in UNEEG™ EpiSight if one is not already available (1+2).
• Select ‘Connect’ in UNEEG™ EpiSight and a QR code is generated and displayed on the
computer screen (3).
• Scan the QR code by holding the camera on the tablet in front of the computer screen
so that the QR code is displayed in the app’s camera field, see the figure below (4).
Once the QR code has been scanned, tap ‘OK’ to continue.

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UNEEG™ MyConnect
Step 2 of 5: Patient consent
Read out the consent text for the patient or give the tablet to the patient. The patient
must accept or not accept the consent text in order to continue the setup.
The consent text is also available at www.uneeg.com.
Step 3 of 5: Record test data
In order to set up a connection between the patient and UNEEG™ EpiSight, there must
be a minimum of one minute of EEG data from the patient on the recorder. If no EEG
data exists from the patient on the recorder, record one minute of data as described in
the app, see the figure below.

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UNEEG™ MyConnect
Step 4 of 5: Transfer test data
Connect the recorder to the tablet as shown in the figure.
Once the recorder is connected, transfer will begin automatically. The app will indicate
when the transfer is complete.
Two pop-up windows 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.

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UNEEG™ MyConnect
Step 5 of 5: Complete setup
Setup of tablet and data transfer is now complete. Tap ‘OK’ to proceed to hand over
UNEEG™ MyConnect to the patient.
4.2.3 HANDOVER OF EQUIPMENT TO THE PATIENT
The setup is now complete. Hand the items listed on the screen to the patient. Tap ‘OK’ to
continue to the home page for patient use.
The patient’s daily use of UNEEG™ MyConnect is described in the user manual for user.
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.

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UNEEG™ MyConnect
5. MAINTENANCE AND DISPOSAL OF EQUIPMENT
5.1 HANDLING
Handle UNEEG™ MyConnect with care.
See environmental conditions under 7. TECHNICAL SPECIFICATIONS.
5.2 CLEANING
For information concerning the tablet, see the instructions from the manufacturer of the
tablet.
5.3 RETURN OF THE EQUIPMENT
The equipment is a single patient device and must be returned to UNEEG™ medical when
no longer in use.
5.4 REPAIRS
Modifying the equipment or using it for any purpose other than those described in this user
manual is not permitted.
If the equipment is broken or components are defective, contact UNEEG™ medical. Do not
attempt to repair the equipment. The system does not need servicing during its lifetime.

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UNEEG™ MyConnect
6. TROUBLESHOOTING
This table provides information on how to react in various situations. Please note the error
message number together with the version number of the app and email it to UNEEG™
medical at [email protected]om. Troubleshooting during daily use is described in the user
manual for users.
PROBLEM POSSIBLE CAUSE POSSIBLE SOLUTION
The tablet shows a black
screen.
The tablet is turned o.
Turn on the tablet, see
section 2.
The screen on the tablet
has turned o. The screen
turns o automatically af-
ter 2 minutes if the tablet
has not been used.
Turn on the tablet, see
section 2.
No power to the tablet.
Connect the tablet to a
power outlet, see sec-
tion 2.
QR code cannot scan.
There is too much backlight
on the screen where the QR
code is displayed.
Avoid the backlight and
try again.
The cursor on the screen is
placed over the QR code.
Move the cursor away
from the QR code and
try again.
Other error.
Contact UNEEG™ medical.
The tablet informs you that
the tablet cannot connect to
Wi-Fi.
The password you entered
for the Wi-Fi is incorrect.
Enter the correct pass-
word.
The tablet informs you that
the recorder is connected to
the tablet.
The recorder can only be
connected when the tablet
asks you to connect it. This
only applies during the set-
up process.
Disconnect the record-
er until you are asked to
connect it in step 4 of 5.

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UNEEG™ MyConnect
PROBLEM POSSIBLE CAUSE POSSIBLE SOLUTION
The tablet informs you that
data was not transferred.
The recorder is discon-
nected.
Connect the recorder to
the tablet. Make sure the
recorder is connected
to the tablet during the
transfer of data.
No data was found on the
recorder.
Go back to step 3 of 5 in
the setup and repeat the
process .
Wi-Fi connection is lost.
Reconnect the recorder
to Wi-Fi and repeat the
process.
Connection to UNEEG™
Cloud could not be estab-
lished.
Try again later.
The recorder contains
data from more than one
implant.
Use an empty recorder
and repeat the setup.
The recorder has encoun-
tered an error.
Contact UNEEG™
medical.
Other error. Try again later.
The tablet informs you that
the battery level of the tablet
is below 25%.
Data transfer requires a
battery level of at least 25%.
Connect the tablet to a
power outlet.
The tablet informs you that
the data upload was not con-
firmed in UNEEG™ EpiSight.
Data was received in
UNEEG™ EpiSight but no
confirmation could be sent
to the tablet.
Verify manually that
data has been received
in UNEEG™ EpiSight.
If data has been received
in UNEEG™ EpiSight, tap
‘Data is received’.
Data has not been received
in UNEEG™ EpiSight.
Verify manually that
data has been received
in UNEEG™ EpiSight.
If data has not been
received in UNEEG™
EpiSight, contact
UNEEG™ medical.

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UNEEG™ MyConnect
If anything suspicious occurs on the tablet, other than already described in the table, please
shut down the tablet by long pressing the power button and contact UNEEG™ medical.
PROBLEM POSSIBLE CAUSE POSSIBLE SOLUTION
The tablet informs you that
something went wrong.
An error has occurred in
the app.
Try again later. If the er-
ror persists, please restart
the tablet.
The data transfer does not
start.
The two pop-up
notifications were
cancelled.
Disconnect the recorder,
connect again and press
‘OK’ to the two pop-up
notifications.

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UNEEG™ MyConnect
7. TECHNICAL SPECIFICATIONS
UNEEG™ MYCONNECT
Tablet For information concerning the tablet, see the instructions from the
manufacturer of the tablet.
Power supply For information concerning the power supply, see the instructions
from the manufacturer of the power supply.
Connector cable Length: 200 mm
Junction 1: USB A port
Junction 2: Micro USB port (8 mm)
7.1 ENVIRONMENTAL CONDITIONS
Avoid subjecting the equipment to temperatures of below 5 °C or above 35 °C.
7.2 DATA PROTECTION
All data saved on UNEEG™ MyConnect is protected in a safe format.
To ensure there is no misuse of data on the tablet, the tablet will become inactive if it is not
used as intended for a period of 90 days. If this situation occurs, please contact UNEEG™
medical.
If any breach related to data security is detected, UNEEG™ medical will inform you of how
to act to ensure that data protection is restored.
Read more about UNEEG™ medical’s data policy at www.uneeg.com.

UNEEG medical A/S
Borupvang 2
DK-3450 Allerød
www.uneeg.com
© 2021 UNEEG medical
2022/01
Rev. LTX10081-3