UNEEG™ medical

24/7 EEG™ SubQ

User Manual for Home Use

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

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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

Body Floating type device

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TABLE OF CONTENTS SYMBOLS AND MARKINGS ....................................................................................... 3 INTRODUCTION ......................................................................................... 6

1.1 Product Overview ....................................................................................... 6 1.2 Intended Use .............................................................................................. 7 1.3 Contraindications ........................................................................................ 8 1.4 Side Effects ................................................................................................ 9 1.5 Implantation ...............................................................................................10 1.6 After the Surgery ........................................................................................10

DEVICE DESCRIPTION ............................................................................ 11 2.1 Device Parts ..............................................................................................11 2.2 Accessories ...............................................................................................11

HOW TO USE............................................................................................ 13 3.1 Turn on the Device.....................................................................................13 3.2 Mount Device on Clothes ...........................................................................14 3.3 Attach Adhesive Pads ................................................................................15 3.4 Attach the Disc ...........................................................................................16 3.5 Turn off the Device.....................................................................................17 3.6 Charge the Device .....................................................................................18 3.7 Check Status .............................................................................................20

MAINTENANCE ......................................................................................... 22 4.1 Handling ....................................................................................................22 4.2 Cleaning ....................................................................................................23 4.3 Disposal .....................................................................................................24 4.4 Malfunctioning Devices ..............................................................................24 4.5 Product Life Time .......................................................................................24 4.6 Travelling ...................................................................................................25

WARNINGS AND PRECAUTIONS ............................................................ 26 TROUBLESHOOTING ............................................................................... 29 TECHNICAL DESCRIPTION ..................................................................... 30

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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 24/7 EEG™ SubQ 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 device system, by the responsible medical professional, for the life time of the device system.

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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 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 system.

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1.5 Implantation

To use the device system, subjects need a UNEEG™ SubQ implanted first. This implant is placed behind the ear, between the skull and the skin.

The implantation procedure takes approx. 15-30 minutes and is conducted using local anaesthesia. There are always risks when having surgery done. Risks associated with the implantation are:

Bleeding during the implantation procedure.

Skin ischemia at the site of implantation due to pressure and compromised local circulation.

Infection at the site of implantation.

Pain and discomfort.

1.6 After the Surgery

For the first 24 hours after implantation, subjects should not shower or touch the operated area.

Ensure that the area of the implant is inspected for signs of infection daily. The following might be signs of infection:

Redness

Heat

Pain

Swelling

If one or more of these signs of infection occur or if in doubt that everything is as it should be, the study responsible should be contacted.

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

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DEVICE DESCRIPTION

2.1 Device Parts

The device consists of several parts (Figure B).

Figure B

Disc Receives EEG data from the implant.

Connection light Indicates if disc is connected to implant.

Attachment magnet Used for attaching device on clothes.

Power button Long press (3s): turn on/off device. Short press: check device status.

Charging light Indicates if device is charging.

Charger port Charger is inserted here.

2.2 Accessories

Besides the device and this manual, the following accessories will be found in the box:

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Charger

Cleaning cloth

Adhesive pads

WARNING

• Only items among the supplied accessories must be connected to the device.

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HOW TO USE

3.1 Turn on the Device

Figure C

Figure D

Press and hold the power button for approx. three seconds until the turning-on sound plays and the power button blinks green (Figure C).

Until attaching the disc, the connection light blinks white, and the device vibrates and plays the ‘disconnected sound’ every 10 seconds (Figure D).

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3.2 Mount Device on Clothes

Figure E

Remove the attachment magnet from the device.

Choose an appropriate place on clothes, e.g. shirt collar or bra strap.

Place the device on one side of the clothes and attach the attachment magnet from the other side (Figure E).

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3.3 Attach Adhesive Pads

Figure F

Figure G

Figure H

Wipe the skin of the implant site with a dry cloth.

Take an adhesive pad from the sheet (Figure F). Be careful to get both the adhesive pad and the protective paper. If the adhesive pad does not let go, use a fingernail or similar.

Attach the adhesive pad to either side of the disc (Figure G).

Remove the protective paper from the adhesive pad (Figure H). Make sure that the adhesive pad stays on the disc.

A single adhesive pad shall not be used for more than 24 hours.

When removing the disc from the skin, the adhesive pads may still be attached. Use a fingernail to remove the adhesive pads from the disc.

For any glue residue on the disc, see the section ‘4.2 Cleaning’.

Once an adhesive pad has been attached to a disc, it should not be reattached to this or any other disc.

Note: The device and supplied adhesive pads are made of non-allergenic materials. Nonetheless, in rare cases skin irritation may occur. Contact study responsible if the problem is persistent.

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3.4 Attach the Disc

Figure I

Figure J

Figure K

Hold the disc over the implant site WITHOUT attaching to skin (Figure I). When at the correct position, the connection light turns green for 10 seconds and the ‘connection sound’ plays (Figure J).

Attach disc to skin.

Make sure that you can freely move your head. If the wire is too short, try moving the device.

Note: the device is silent with no lights while recording EEG (Figure K).

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3.5 Turn off the Device

Figure L

Press and hold the power button for approx. three seconds until the device turns off. The turning-off sound plays and the power button blinks green once (Figure L).

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3.6 Charge the Device

WARNING

• Only use the supplied charger for charging the device.

To charge the device, use the provided charger.

Insert the charger into the charger port.

Insert the other end of the charger into a regular power socket.

The feedback patterns associated with charging and low battery

levels are listed in Table 1.

The device should be charged whenever it is not in use. The battery life when fully charged is minimum 24 hours.

Note: If the device is not fully charged at least every 30 days, the internal clock might become incorrect.

Note: The device will turn off while charging.

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Figure M

Figure N

Figure O

Figure P

Table 1: Charging and battery level

Charging The charging light blinks green (Figure M).

Fully charged The charging light is solid green (Figure N).

Low battery Power button and charging light blinks yellow. The low-battery sound plays every 30 minutes (Figure O).

Very low battery Power button and charging light blinks yellow. The low-battery sound plays every 5 minutes (Figure P).

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3.7 Check Status

To check that the device is correctly functioning:

Short press the power button.

Table 2: Status.

Turned on and connected to implant

The connection light is green for 4 seconds. The ‘connection sound’ plays.

Low battery The power button and charging light are yellow for 4 seconds. The ‘connection sound’ plays.

Turned off No sound or lights

Note: The device only works when it is correctly connected to the implant. Loss of connection results in missing data.

For more detailed status information, see (Figure Q) on page 21.

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Figure Q

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MAINTENANCE

The device is a valuable medical device and should be treated with care. This section contains information on how to handle it.

4.1 Handling

Make sure that the device does not get wet, and dry it thoroughly with a cloth or similar after heavy perspiration, e.g. after intense physical activity.

See environmental conditions in 7 TECHNICAL DESCRIPTION.

CAUTION

Do not wear the device in the shower or when swimming.

Avoid dropping the device.

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4.2 Cleaning

To keep the device hygienic, it is recommended to clean it at least once per week.

CAUTION

Never use water or cleaning solutions.

Never sink the device into any liquid, including alcohol.

For cleaning the device, you can use the following:

Denatured alcohol/ethanol

Hand disinfection gel

Provided cleaning cloth

The cleaning process is as follows:

Make sure that the device is turned off, that the disc has been removed from the head, and that any adhesive pads have been removed.

Apply alcohol to the cleaning cloth.

Rub all surfaces of the device, including the cable and disc.

Wait for the device to dry before next use.

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4.3 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.

4.4 Malfunctioning Devices

If the device seems to be malfunctional, contact study responsible.

CAUTION

Never try to open or repair the device.

4.5 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, 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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4.6 Travelling

It is okay to move through metal detectors and full body scanners with the implant, but the device should be unmounted and turned off before moving through metal detectors. The device should be treated as electronic hand luggage when proceeding through any security checks.

The device can be used during flight, but the airline company’s guidelines for electronic equipment should be followed. This might mean that the device should be turned off during take-off and landing. If in doubt, ask the flight staff for their policy on electronic equipment.

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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 RF communications equipment (including peripherals such as antenna cables and external antennas)

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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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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 section:

‘3.6

Charge the Device’.

The power button and connection light are red.

The device is facing an error.

Contact study responsible.

Data storage is full. Contact study responsible.

The device does not turn on.

The device is either low on battery OR facing an error.

First, try charging the battery. See section: ‘3.6 Charge the Device’. If device still does not turn on, contact study responsible.

The connection light is blinking white

The device is not properly connected to the implant.

Connect device to implant. See section: ‘3.4 Attach the Disc’

For further assistance regarding device use or unexpected events,

contact study responsible.

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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: 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