UNEEG™ medical

24/7 EEG™ SubQ

User Manual for Professionals

Exclusively for clinical investigations

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CE-mark + authorization year

Notified body (0344)

Model

Version identifier

Date of manufacture

Address UNEEG™ medical Nymøllevej 6 3540 Lynge Denmark

Webpage www.uneeg.com

Email-address technicalsupport@uneeg.com

Telephone number +45 30 10 14 54

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SYMBOLS AND MARKINGS

Explanation of symbols found on products and on packaging:

Manufacturer

Date of manufacture

Use-by date

Batch number

Catalogue number

Serial number

CE marking: Declaration that the product meets all the safety, health, and environmental protection requirements for CE marking and can be sold throughout the EEA.

Not for general waste

Caution: Messages with this heading indicate serious adverse reactions, potential safety hazards and inadequate performance of device.

Consult instructions for use

Temperature limits

Humidity limits

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IP24 Ingress protection rating

Do not use if package is damaged

Do not resterilize

Do not re-use

Sterilized using ethylene oxide

Sterilized using irradiation

Open here

Open by hand

Body Floating type device

Explanation of markings found on products:

Implant: serial number (SN)

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Implant: X-ray readable model tag

Introducing aid: date wheel with month and year of

manufacture

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TABLE OF CONTENTS SYMBOLS AND MARKINGS ...................................................................................... 3 INTRODUCTION ........................................................................................ 7

1.1 Product Overview ....................................................................................... 7 1.2 Intended Use .............................................................................................. 8 1.3 Contraindications ........................................................................................ 9 1.4 Side Effects ...............................................................................................10 1.5 Important Subject Information ....................................................................11 1.6 Implantation ...............................................................................................12

HOW TO USE 24/7 EEG™ SubQ ..............................................................12 HOW TO USE 24/7 EEG™ Link SOFTWARE ............................................13

3.1 System Requirements ................................................................................14 3.2 Install 24/7 EEG™ Link ..............................................................................15 3.3 Connect Device to PC ................................................................................15 3.4 Connect Multiple Devices ...........................................................................17 3.5 Download Data ..........................................................................................18 3.6 Clear Memory ............................................................................................18 3.7 Device Error - Reset Device .......................................................................19 3.8 Update Device ...........................................................................................20 3.9 Demonstrate Use .......................................................................................20 3.10 System Report .......................................................................................21 3.11 Disconnect Device from PC ...................................................................21

DATA INFORMATION ...............................................................................22 4.1 Using the Data ...........................................................................................22 4.2 Metadata....................................................................................................22 4.3 Data Specifications ....................................................................................23

MAINTENANCE .........................................................................................24 5.1 Storage and Handling ................................................................................24 5.2 Product Life Time .......................................................................................24 5.3 Disposal .....................................................................................................25 5.4 Malfunctioning Devices ..............................................................................25

WARNINGS AND PRECAUTIONS ............................................................26 6.1 Sterility .......................................................................................................29

FEEDBACK PATTERNS............................................................................30

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TROUBLESHOOTING ...............................................................................31 TECHNICAL DESCRIPTION .....................................................................32

INTRODUCTION

1.1 Product Overview

Figure A

The 24/7 EEG™ SubQ (hereafter named device system) consists of implantable and non-implantable device parts (Figure A). The implantable part, the UNEEG™ SubQ (hereafter named implant), measures the subcutaneous electroencephalogram (EEG) from two bipolar channels with a common reference. It functions with a non-implantable part, the 24/7 EEG™ SubQ (hereafter named device), which supplies the implant with power, receives and stores recorded EEG. This runs through an inductive link (wireless), which requires a close transcutaneous alignment between the device and the implant to function. In addition, the device measures and stores 3D acceleration, sound pressure level and light intensity signals to support the EEG signal for different purposes. The stored data are downloaded using a dedicated computer software; the 24/7 EEG™ Link (hereafter named PC software), which parses the data to standard EDF+ file format.

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1.2 Intended Use

The device system is a medical device that continuously measures the electrical activity of the brain (EEG). The device system is intended for all subjects where ultra long-term EEG recordings are indicated. The device system is available for medical doctors and scientists who require long-term monitoring of subjects’ electroencephalogram (EEG) for research purposes.

A part of the device system is implanted subcutaneously in the tissue between the skull and the skin.

The intended users of the product are males and females above the age of 18.

IMPORTANT: The subject should receive regular follow-up related to the implant, by the responsible medical professional, for the life time of the implant.

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1.3 Contraindications

The device system is not intended in case of any of the following:

• Subjects with one or two cochlear implants.

• Subjects involved in therapies with medical devices that deliver electrical energy to the brain.

• Subjects at high risk of surgical complications, such as active systemic infection and haemorrhagic disease.

• Subjects who are unable (i.e. mentally or physically impaired subjects) or do not have the necessary assistance, to properly operate the device system.

• Subjects who are allergic to the local anaesthetics used during implantation.

• Subjects who have an infection at the site of device implantation.

• Subjects who operate MRI scanners.

• Subjects with profession/hobby that includes activity imposing extreme pressure variations (e.g. diving or parachute jumping). NB: diving/snorkelling is allowed to 5 meter’s depth.

• Subjects with profession/hobby that includes activity imposing an unacceptable risk for trauma against the device or the site of implantation (e.g. martial art or boxing).

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1.4 Side Effects

General side effects normally associated with any surgical implantation procedure or local anaesthesia also apply to the placement of the implant.

Specifically, the following side effects may be associated with implantation and use of the device system:

Formation of haematoma or seroma near the implant site following the surgical procedure (for a period up to 3 weeks).

Temporary pain, headache, infection and discomfort (including soreness, inflammation, swelling, irritation and itching) at the implant site following the surgical procedure (for a period up to 3 weeks).

Skin ischemia potentially inducing necrosis at the implant site due to pressure and compromised local circulation

Infection, swelling, soreness, irritation or itching of the skin at the implant site.

Occasional headache or pain during long term use of the device.

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1.5 Important Subject Information

Below is a list of important information for subjects using the 24/7 EEG™ SubQ.

Inform subjects of risks, warnings and precautions for using the device as part of subject inclusion, see section ‘6 WARNINGS AND PRECAUTIONS’.

Instruct subjects in the use of the device (see User Manual for Home Use for this information). Note: The device will only collect data when it is turned on and connected to the implant. Disconnection will result in lacking data.

Demonstrate the different feedback patterns of the device to the subject, see section ‘3.9 Demonstrate Use’.

Be sure that the subjects receive the User Manual for Home Use as well as all accessories necessary for using the device system (see User Manual for Home Use for information on the accessories).

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1.6 Implantation

To use the device system, subjects need a UNEEG™ SubQ implanted first. This is implanted behind the ear, between the skull and the skin. The implantation procedure takes approx. 15-30 minutes and is conducted using local anaesthesia. The position of the implant is determined using a template, and the implant is inserted using a supplied needle called the introducing aid.

IMPORTANT: Placement of the implant requires appropriate surgical skills. The surgeon is required to hold an MD with specialisation in a surgical area relevant for the implantation and explantation procedure. The procedure is described in the “UNEEG™ SubQ Surgical Procedure” (hereafter named Surgical Procedure),

Approximately 1-2 weeks after the implantation, the stitches can be removed and the device system can be used.

HOW TO USE 24/7 EEG™ SubQ

For instructions on the daily use of the device, see the User Manual for Home Use.

For instructions on how to demonstrate the various feedback patterns of the device, see ‘3.9 Demonstrate Use’.

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HOW TO USE 24/7 EEG™ Link SOFTWARE

To extract the data from the device, the 24/7 EEG™ Link (hereafter named PC software) is required.

This section explains how to install and use the PC software.

WARNING

Never touch (physically) the subject and the computer or computer power supply simultaneously.

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3.1 System Requirements

Before installing the PC software, make sure the computer meets the requirements listed in Table 1.

Table 1: System Requirements.

Operating system Microsoft Windows 7 SP1 (32/64-bit)

Microsoft Windows 8.1 (32/64-bit)

Microsoft Windows 10 (32/64-bit)

CPU Minimum: 2 GHz (multicore)

Memory Minimum: 4 GB RAM

Disk space Minimum: 1 physical hard drive

Minimum: 30 GB available space

Graphics hardware DirectX 9 compatible graphics device with WDDM 1.0 or higher driver

Display Screen resolution minimum 1280x1024 OR 1440x900

Other

Minimum: 1 available USB 2.0 compatible port

Antivirus program should be installed

PC must be IEC 60950-1 compliant

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3.2 Install 24/7 EEG™ Link

Please be aware that the installation process will always be in English. Below is a description of how to complete the installation:

Insert the installation USB into the PC and start the installer.

Setup – 24/7 EEG™ Link

Click ‘Next’.

Select Components The installer will automatically install all necessary components.

Click ‘Next’.

Installation Folder

Select the location for the installation of the PC software.

Click ‘Next’.

License Agreement

Select ‘I accept the license’.

Click ‘Next’.

Start Menu Shortcut

Select a name for the start menu shortcut for the PC software.

Click ‘Next’.

Select Startup Language

Select preferred language.

Click ‘Next’.

Ready to Install

Click ‘Next’.

Installing 24/7 EEG™ Link Please wait while the PC software is installed.

Completing the 24/7 EEG™ Link Wizard

Click ‘Finish’.

3.3 Connect Device to PC

Apart from the accessories for the subject, which are described in the User Manual for Home Use, the device system also comes with a

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special USB cable. The USB cable is needed to connect the device to the PC.

WARNING

Only use the supplied USB cable to connect the device to the PC.

Start the PC software.

Insert the USB cable into the PC and into the device.

Note: When the device is connected to the PC, the internal clock of the device is synchronized with the PC. To make sure that data are correctly time stamped, the clock shall be synchronized within 30 days prior to data collection start.

Note: The device cannot record data while it is connected to the PC.

The feedback patterns of the device when connected to the PC is

illustrated in 7 FEEDBACK PATTERNS.

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3.4 Connect Multiple Devices

To handle data from several devices at the same time, it is possible to connect up to five different devices while using the PC software.

See Figure B for an example of multiple connected devices. The device with the serial number (SN) 0000525 is currently selected. The devices with serial numbers 0000771, 0000124, 0001050, and 0000341 are all connected but inactive.

To select another device, click the corresponding serial number.

Figure B

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3.5 Download Data

When the device has collected data from a subject, it can be downloaded to the PC.

Connect device to PC (see section ‘3.3 Connect Device to PC‘).

Click ‘Download data’.

Select the destination folder and file name for the data.

Click ‘Start data download’ and wait for the data to download.

Note: Do NOT disconnect the device or turn off PC while downloading data.

When data are downloaded, select whether to clear the memory of the device. To do this at another time, see section ‘3.6 Clear Memory‘.

To go directly to the downloaded data, click ‘Open Folder’.

3.6 Clear Memory

The memory storage size allows for minimum 30 days of recording.

To clear the memory of the device, follow these steps:

Connect device to PC (see section ‘3.3 Connect Device to PC’).

Click ‘Clear memory’. The PC software will inform about the last data download time.

Note: Make sure that all data are downloaded before clearing memory of device.

Click ‘Clear memory’ and wait for the device to clear memory.

Note: Do NOT disconnect the device or turn off PC while clearing the memory of the device.

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When the device has finished clearing the memory, it is safe to disconnect the device.

3.7 Device Error - Reset Device

If the device has entered the ‘Error & Data storage full’ state (Figure C) it might be necessary to use the PC software to reset the device.

Figure C

Connect device to PC (see section ‘3.3 Connect Device to PC’).

If the device has encountered an error, the PC software will state “An error has occurred”.

Download data from the device to the PC (see section ‘3.5 Download Data‘).

Note: It is not possible to reset the device before data has been downloaded.

When download has finished, click ‘Reset device’.

Note: Do not disconnect the device or turn off PC while device is resetting.

When reset has finished, click ‘OK’.

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Click ‘Open folder’.

Find the system report (“…Systemreport.zip”) in the folder and send it to UNEEG™ medical by the following email address: technicalsupport@uneeg.com

Note: A system report must be sent to UNEEG™ medical every time

the device has faced an error.

3.8 Update Device

The PC software will automatically detect any available firmware updates for the device.

Before updating the device, the memory will need to be cleared. Either download data (see section ‘3.5 Download Data’) or clear memory of device (see section ‘3.6 Clear Memory’).

After the memory has been cleared, the PC software will prompt whether to update the firmware of the device. Click ‘Yes’.

Wait for the device to update.

Note: Do not disconnect the device or turn off PC while device is updating.

When update is finished, click ‘Continue’.

3.9 Demonstrate Use

To demonstrate the sounds and lights of the device, use the demonstration mode of the PC software.

Connect device to PC (see section ‘3.3 Connect Device to PC’).

Click ‘Demonstrate use’. The power button of the device will blink white twice to show that demo mode is activated.

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To demonstrate the sounds and lights of one of the scenarios, click the corresponding button (e.g. “Low battery”).

3.10 System Report

A system report (…Systemreport.zip) is automatically generated every time data is downloaded from the device (see section ‘3.5 Download Data’).

In case the device has faced an error (see section ‘3.7 Device Error - Reset Device’), please send the system report to UNEEG™ medical.

For information regarding implant model and year of manufacture, send system report to UNEEG™ medical and request the details.

3.11 Disconnect Device from PC

Make sure that the device is not downloading data (See

section ‘3.5 Download Data’), clearing memory (See section

‘3.6 Clear Memory’), resetting (see section ‘3.7 Device Error

- Reset Device’) , or updating (see section ‘3.8 Update

Device’).

Pull out the USB cable of the device.

It is not necessary to ‘eject device’ like it would be for a flash drive.

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DATA INFORMATION

4.1 Using the Data

Be aware that the supplied PC Software is only capable of downloading the data from the device to the PC. To utilize the data, a third-party software capable of handling EDF+ files must be installed.

Note: By any suspicion that the data are wrong/bad, verify the data with another measuring system.

4.2 Metadata

Metadata are contained in the filename of the downloaded data. To make sure that the correct data are being analysed, it might be necessary to look at the metadata – e.g. to determine the serial number of the implant, from which the data have been collected.

After data download (see section ‘3.5 Download Data’), open the folder containing the data.

The EDF+ file(s) containing the EEG data will be named after this pattern:

[Filename]_XXXXXX_ZZZZ_YYYYMMDD_FN_EEGdata.edf

Where:

[Filename]: Filename selected when downloading data

XXXXXX: External device serial number

ZZZZ: Implant serial number

YYYYMMDD: Year, month, and date when file session (FN)

started recording

FN: File session number

o FN starts at 01 after memory has been cleared.

o Data is separated into new file sessions (FN) when:

There is more than 6 hours of data.

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Another implant has been connected to the

device.

The device has been disconnected for more

than 2 minutes during use.

A3D: 3-Dimensional accelerometer data.

EEG: electroencephalogram data.

LIL: light intensity level data.

SPL: sound pressure level data.

4.3 Data Specifications

Specifications for the data are found in Table 2.

Table 2: Data specifications. EEG A3D SPL LIL

Sampling frequency

207 Hz 12.5 Hz 10 Hz 10 Hz

Bandwidth 0.5 – 40 Hz XX XX XX

Resolution < 1µV XX XX XX

Dynamic range ±350 µV ±4 g XX XX

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MAINTENANCE

See User Manual for Home Use for information on cleaning.

5.1 Storage and Handling

Store the device within a temperature range of +5°C to +30°C.

Make sure that the device does not get wet, and dry it thoroughly with a cloth or similar in case it is necessary.

CAUTION

Do not expose the device to water or other liquids.

Avoid dropping the device.

5.2 Product Life Time

The implant has a product life time of 5 years. Before product life time expiration, the implant must be explanted.

The device, charger, USB cable, and attachment magnet all have a product life time of 2 years from first day of use.

During product life time, the device and implant do not need service or calibration.

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5.3 Disposal

After product life time expiration, the device and all electronic accessories must be disposed of according to the (WEEE) EU directive 212/19/EC.

This means that the device and all electronic accessories should be handed in for recycling rather than discarded with the household waste.

5.4 Malfunctioning Devices

If a device is malfunctional, first try resetting the device, see section ‘3.7 Device Error - Reset Device’. If this does not work, the malfunctioning device shall be returned to UNEEG™ medical.

In case an implant is not performing as expected, it is recommended that UNEEG™ medical is consulted before explanting the implant. The malfunctioning implant shall be returned to UNEEG™ medical.

CAUTION

Never try to open or repair the device.

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WARNINGS AND PRECAUTIONS IMPORTANT: additional warnings and precautions may appear in

the preceding sections.

WARNING

Seek medical guidance before entering protected areas, which could adversely affect the implant, including hospital areas with restricted access for patients.

The implant is not compliant with the following medical equipment. Note that the implant must be explanted before receiving any of the following treatments:

MRI scan. The implant is MR Unsafe.

Therapeutic ionizing radiation (e.g. x-ray, CT)

Any treatment where an electrical current is conducted or induced into the body (e.g. electro knife, electroconvulsive therapy)

Any procedure involving therapeutic levels of ultrasound.

Keep away from high power RF transmitters (e.g. military radar installations, base stations for radio telephones and land mobile radios, amateur radio, AM and FM radio broadcast, and TV broadcast).

Avoid usage of the device adjacent to or stacked with other equipment since it can result in improper operation. If such use is necessary, the device system and the other equipment should be observed to verify that they are operating normally.

Do not use portable Radio Frequency (RF) communications equipment (including peripherals such as antenna cables and

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external antennas) closer than 30 cm to any part of the device system, including the supplied USB cable.

Do not use accessories, transducers and cables other than those provided. This could result in increased electromagnetic emissions or decreased electromagnetic immunity and result in improper device system operation.

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CAUTION

Subjects using the device system should take note of the following;

Hold mobile phone to the opposite ear from the implantation site.

Do not take part in combat sports such as boxing or martial arts, where the implant can be exposed to injuries.

Do not take part in extreme sport activities such as parachute jumping, bungee jumping, or diving, where the implant can be exposed to extreme pressure variations.

Wear a helmet in activities such as skiing, mountain bike riding, or horseback riding, since these activities entail an increased risk of falling and suffering a head injury.

The implant can be damaged if exposed to shocks or extreme pressure variations. In case the site of implantation has been exposed to physical injury, contact study responsible.

The device contains personal data that may be abused in the wrong hands. Take precautions not to lose the device.

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6.1 Sterility

The implant has been sterilized using ethylene oxide.

The introducing aid (IA, see Surgical Procedure) has been sterilized using irradiation.

WARNING

After use, implant and IA are not to be re-sterilized or re-used. Single-use only.

In event of damage to the sterile packaging, content must not be used.

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FEEDBACK PATTERNS

Feedback patterns of the device when connected to the PC are shown in Figure D.

Figure D

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TROUBLESHOOTING

See Table 3 for information on how to react in different situations.

Table 3: Troubleshooting.

Problem Possible cause Possible solution

The power button and charging light are blinking yellow.

The device is low on battery.

Charge the battery.

See User Manual for

Home Use.

The power button and connection light are red.

The device is facing an error.

Reset the device. See section ‘3.7 Device Error - Reset Device’.

Data storage is full. Clear memory of device. See section: ‘3.6 Clear Memory’.

The device does not turn on.

The device is facing an error.

Reset the device. See section ‘3.7 Device Error - Reset Device’.

The device is low on battery.

Charge the battery. See User Manual for Home Use.

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TECHNICAL DESCRIPTION

Intended Performance The 24/7 EEG™ SubQ records EEG.

Power Source The device may only be charged by an IEC 60950-1 compliant power source. Only use the charger or USB Cable to charge the device. The charger is considered as an accessory to the medical device.

Mains Isolation Device is categorized as an F-type device as according to IEC 60601. The following have been done to ensure mains isolation: - Means of isolation is integrated into the device - The equipment is inactive when connected to a power source or computer - Device is only to be recharged by a 60950-1 compliant USB power source

Modification No modification of the equipment is allowed.

Repairs The device contains no replaceable or repairable parts. Defective equipment should be disposed of according to (WEEE) EU directive 212/19/EC.

Environmental Conditions The following are the allowed environmental conditions for the device and accessories: Pressure: 70 kPa (3000 m above sea level) to 150kPa (5 m below sea level) Relative Humidity: 10% to 95% Temperature (transport): -10 °C to +55 °C (max 2 weeks) Temperature (storage): +5 °C to +30 °C Temperature (use): 0 °C to +40 °C Ingress: Device is IP24 water and dust resistant

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Specifications & Characteristics

The device system consists of the following parts:

24/7 EEG™ SubQ

Device Length: 89.9 mm. Width: 37.5 mm. Thickness (without Attachment Magnet): 6.4 mm. Thickness (with Attachment Magnet): 10.9 mm. Polycarbonate/Acrylonitrile Butadiene Styrene (PC ABS). Material grade: Sabic CYCOLOY HC1204HF. Weight (without Attachment Magnet and wire): 37.1 g.

Disc Diameters: 15.9x20.4 mm. Thickness: 3 mm. Moulded in epoxy Weight (with wire): 2.9 g.

Wire Length: 360 mm. Outer diameter: 1.4 mm Cable: silicone. Bend reliefs: Polyamide (PA).

UNEEG™ SubQ (implant) House 23.9x17x3.3 mm.

Ceramic, titanium, silicone, tungsten, gold and ruby feed through overload.

Lead 104 mm. Silicone. 3 contact points.

Contact points Outer diameter: 1.06 mm. Length: 10 mm. Pt-Ir.

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Emissions & Immunity Emissions test apparent from the following table.

Emissions test Compliance Electromagnetic environment guidance

RF emissions CISPR 11

Group 1 XX

RF emissions CISPR 11

Class B XX

Harmonic emissions IEC 61000-3-2

XX

Voltage fluctuations/ Flicker emissions IEC

XX

Device RF reception specifications:

Fc 1.0606MHz

RBW 30kHz

Device RF transmission specifications:

Fc 1.0606MHz

Modulation Load modulation (ASK)

Data 8,3k bit/s Manchester encoded

OBW 30kHz (TBD)

ERP TBD