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

USER MANUAL FOR HEALTHCARE PROFESSIONAL | ENGLISH | 3
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.

4| USER MANUAL FOR HEALTHCARE PROFESSIONAL | ENGLISH
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

USER MANUAL FOR HEALTHCARE PROFESSIONAL | ENGLISH | 5
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

6| USER MANUAL FOR HEALTHCARE PROFESSIONAL | ENGLISH
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.

USER MANUAL FOR HEALTHCARE PROFESSIONAL | ENGLISH | 7
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

8| USER MANUAL FOR HEALTHCARE PROFESSIONAL | ENGLISH
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.

USER MANUAL FOR HEALTHCARE PROFESSIONAL | ENGLISH | 9
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.

10 | USER MANUAL FOR HEALTHCARE PROFESSIONAL | ENGLISH
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.