24/7 EEG SUBQ User manual

24/7 EEG™ SUBQ
USER MANUAL

FIGURE A
UNEEGTM SubQ
(Implant)
24/7 EEGTM SubQ
(Device)
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The 24/7 EEG™ SubQ (here-
after named system) consists
of implantable and non-im-
plantable parts (FIGURE A).
The implantable part, the
UNEEG™ SubQ (hereafter
named implant) is implanted
under the skin and measures
PRODUCT OVERVIEW
the electroencephalogram
(EEG).
It communicates with a
non-implantable part, the
24/7 EEG™ SubQ (hereafter
named device), which sup-
plies the implant with power,
and receives and stores the

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USER MANUAL | ENGLISH | 3
recorded EEG data. The data
are sent through a wireless
link.
The device exists in two
variants; one with a magnet
inside (M1) and one with-
out (C1). Please be aware
of which variant you have
been supplied with. The M1
variant is marked with a mag-
net-symbol (FIGURE B).
Subjects with other active
implantable devices must
consult their responsible
medical professional before
using the M1 variant.
The M1 variant is attached to
clothing using the supplied
attachment magnet, while
the C1 variant is attached to
clothing using a plastic clip.
In addition to EEG, the device
measures and stores 3D ac-
celeration to support future
product development. These
data are encrypted and are
only readable if sent to
UNEEG™ medical.
FIGURE B

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WARNINGS AND PRECAUTIONS
IMPORTANT: Additional
warnings and precautions
may appear in this user
manual.
WARNINGS
• The implant is not com-
pliant with the following
medical procedures. The
implant must be explanted
before receiving any of the
following treatments:
- MRI scan. The implant is
MR unsafe.
- Therapeutic ionizing
radiation induced close to
the implant (e.g. radiation
therapy for cancer).
- Therapeutic ultrasound
induced close to the
implant.
- Electrical current induced
close to the implant (e.g.
electro knife, electrocon-
vulsive therapy).
• The following medical pro-
cedures are safe to use with
the implant:
- Diagnostic ionizing radia-
tion (e.g. x-ray, CT).
- Diagnostic ultrasound.

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• Seek medical guidance be-
fore entering environments
that could adversely aect
the implant. This includes,
but is not limited to:
- Hospital areas with
restricted access for
patients.
- High-power, radio-fre-
quency transmitters (e.g.
military radar installations,
radio/TV transmitters).
• Usage of the device closer
than 30 cm to other elec-
tronic equipment (including
radio-frequency communi-
cations equipment) might
result in improper opera-
tion. If such use is neces-
sary, check that the device
is functioning.
• Only supplied accessories
may be connected to the
device.
• Keep device and accesso-
ries out of reach of children.
PRECAUTIONS
When you use the device,
take note of the following:
• The implant can be da-
maged if exposed to
physical impact. Do not
take part in combat sports
such as boxing, and wear a
helmet in activities such as
skiing, mountain bike riding
or horseback riding.
• The implant can be dam-

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aged if exposed to extreme
pressure variations. Do not
take part in extreme sport
activities such as parachute
jumping or diving deeper
than 5 metres.
• If the implant site has been
exposed to physical injury,
contact the responsible
medical professional.
• Hold mobile phone to the
opposite ear from the
implant site.
• The device contains personal
data. Take precautions not
to lose the device.
• Do not wear the device in
the shower or when swim-
ming.
• Avoid dropping the device.
• Do not use water or clean-
ing solutions to clean the
device. See ‘4.2 CLEANING’.
• Do not sink the device into
any liquid, including alcohol.
• Do not try to open or repair
the device.

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CONTENTS
1. INTRODUCTION . . . . . . . . . . . . . . . . . . . . . . . . .10
1.1 Intended use. . . . . . . . . . . . . . . . . . . . . . . . . . 10
1.2 Contraindications. . . . . . . . . . . . . . . . . . . . . . . 10
1.3 Side eects . . . . . . . . . . . . . . . . . . . . . . . . . . . 11
2. DEVICE DESCRIPTION . . . . . . . . . . . . . . . . . . . . .14
2.1 Device parts. . . . . . . . . . . . . . . . . . . . . . . . . . .14
2.2 Accessories . . . . . . . . . . . . . . . . . . . . . . . . . . .16
3. HOW TO USE . . . . . . . . . . . . . . . . . . . . . . . . . . 18
3.1 Turn on the device . . . . . . . . . . . . . . . . . . . . . . .18
3.2 Mount device on clothes . . . . . . . . . . . . . . . . . . .19
3.3 Attach adhesive pads. . . . . . . . . . . . . . . . . . . . 22
3.4 Attach and connect the disc. . . . . . . . . . . . . . . . 24
3.5 Turn o the device . . . . . . . . . . . . . . . . . . . . . 25

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3.6 Charge the device . . . . . . . . . . . . . . . . . . . . . . 26
3.7 Check status . . . . . . . . . . . . . . . . . . . . . . . . . 28
3.8 Diary check mark . . . . . . . . . . . . . . . . . . . . . . 30
4. MAINTENANCE . . . . . . . . . . . . . . . . . . . . . . . . .32
4.1 Handling . . . . . . . . . . . . . . . . . . . . . . . . . . . 32
4.2 Cleaning . . . . . . . . . . . . . . . . . . . . . . . . . . . 33
4.3 Disposal. . . . . . . . . . . . . . . . . . . . . . . . . . . . 34
4.4 Malfunctioning devices . . . . . . . . . . . . . . . . . . . 34
4.5 Lifetime of implant . . . . . . . . . . . . . . . . . . . . . 35
4.6 Maintenance of device . . . . . . . . . . . . . . . . . . . 35
4.7 Travelling . . . . . . . . . . . . . . . . . . . . . . . . . . . 35
5. TROUBLESHOOTING. . . . . . . . . . . . . . . . . . . . . .36
6. TECHNICAL DESCRIPTION . . . . . . . . . . . . . . . . . .37
7. SYMBOLS AND MARKINGS . . . . . . . . . . . . . . . . . 46

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1. INTRODUCTION
1.1 INTENDED USE
Measuring and recording of
electrical activity of the brain
(EEG) through electrodes
implanted subcutaneously
in the tissue between the
skull and the skin. Intended
for subjects where single
location, continuous, ultra
long-term (more than two
weeks) EEG recordings are
indicated to aid in monitoring
and diagnosis of diseases or
conditions that alter the EEG.
The intended users of the
product are males and
females, age 18 and above.
IMPORTANT: You should
receive regular follow-up
related to the system from
the responsible medical
professional.
1.2 CONTRAINDICATIONS
The system should not be
used in the following cases:
• If you have cochlear im-
plant(s).
• If you receive therapy with
medical devices that deliver
electrical energy in the area
around the implant.
• If you are at high risk of
surgical complications, such
as active systemic infection

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and hemorrhagic disease.
• If you, for mental or phy-
sical reasons, cannot or
do not have the necessary
assistance, to properly
operate the system.
• If you have an infection
where the implant should
be placed.
• If you operate MRI scanners.
• If you have a profession/
hobby that includes activity
imposing extreme pressure
variations (e.g. diving or
parachute jumping).
NB: diving/snorkelling is
allowed to 5 metres depth.
• If you have a profession/
hobby that includes activity
imposing a high risk of trau-
ma against the device or
the site of implantation (e.g.
martial art or boxing).

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1.3 SIDE EFFECTS
General side eects normally
associated with any surgical
implantation procedure or lo-
cal anaesthesia also apply to
the placement of the implant.
Specifically, you may ex-
perience the following side
eects with the implantation
and use of the system:
• Up to 3 weeks after the
surgical procedure, haema-
toma or seroma may
appear near the implant.
• Temporary pain, headache,
infection and discomfort
(including soreness, inflam-
mation, swelling, irritation
and itching) may appear
around the implant up to
3 weeks after the surgical
procedure.
• Damaged blood circulation
and pressure to the skin
around the implant may
result in damaged tissue.
• Infection, swelling, soreness,
irritation or itching of the
skin around the implant.
• Occasional headache or
pain during long-term use
of the system.

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1.4 AFTER THE SURGERY
Do not shower or touch the
operated area the first 24
hours after the implantation.
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 appear, or if
you are in doubt whether
everything is as it should be,
please contact the responsi-
ble medical professional.
Approximately 1-2 weeks
after the implantation, the
stitches can be removed, and
the device can be used.

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2. DEVICE DESCRIPTION
2.1 DEVICE PARTS
The device consists of several parts (FIGURE C).
Disc Receives EEG data from the implant.
Connection light Indicates if the disc is connected to
the implant.
Power button
Long press (3 sec): turn on/o de-
vice. Double press: diary check mark.
Short press: check device status.
Charging light Indicates if the device is charging.
Charger port Insert the charger here.
Attachment clip
(only for C1)
Used for attaching the C1 device
on the clothes.
Attachment
magnet (only for M1)
Used for attaching the M1 device
on the clothes.
1
2
3
4
5
6
7

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2. DEVICE DESCRIPTION
2.1 DEVICE PARTS
The device consists of several parts (FIGURE C).
FIGURE C
1
2
3
4
5
67

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2.2 ACCESSORIES
Besides the device and this
manual, the following acces-
sories are supplied:
• Charger, consisting of
- Wall adapter
- USB cable, 150 cm, with
long-tip (8 mm) micro
USB connector
• Cleaning cloth
• Adhesive pads
WARNING
• Only connect the
supplied accessories
to the device.

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3. HOW TO USE
3.1 TURN ON THE DEVICE
1. Press and hold the power
button for approx. 3 seconds
until the ‘turning-on sound’
plays and the power button
blinks green (FIGURE D).
Until you have attached
the disc, the connection
light blinks white, and the
device vibrates and plays the
‘disconnected sound’ every
10seconds (FIGURE E).FIGURE D FIGURE E
Turning on/o Disconnected
Error or
Data storage full
Fully chargedChargingVery low batteryLow battery
DisconnectedTurning on/o
Sound
Signature
Vibration Turns off
after 3 min
Every
30 min
Every
5 min Once
Turns off
after 30
seconds
Error or
Data storage full
Fully chargedChargingVery low batteryLow battery
DisconnectedTurning on/o
Sound
Signature
Vibration
Turns off
after 3 min
Every
30 min
Every
5 min Once
Turns off
after 30
seconds

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• The device exists in two
variants; M1 and C1.
• M1 contains a magnet
inside and is marked with a
symbol (FIGURE F).
• C1 does not contain a
magnet.
• M1 is attached to clothing
using a second magnet,
while C1 is attached to
clothing using a plastic clip.
WARNING
• The magnetic field from
the M1 device might
disturb other active
implantable devices (e.g.
pacemakers). If you have
another active implanta-
ble device, consult your
responsible medical pro-
fessional before use.
3.2 MOUNT DEVICE ON CLOTHES
FIGURE F

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3.2.1 MOUNT WITH ATTACHMENT CLIP
(only applicable for the C1 variant)
1. Choose an appropriate
place on your clothes, e.g.
shirt collar or bra strap.
2. Slide the device onto your
clothes using the clip-arms
(FIGURE G).
Note: The clip version is
non-magnetic and is safe
to mount near implantable
devices.
FIGURE G