24/7 EEG SUBQ Bedienungsanleitung
24/7 EEG™ SUBQ
USER MANUAL
FIGURE A
UNEEGTM SubQ
(Implant)
24/7 EEGTM SubQ
(Device)
24/7 EEG™ SubQ
2| USER MANUAL | ENGLISH
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
24/7 EEG™ SubQ
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
24/7 EEG™ SubQ
4| USER MANUAL | ENGLISH
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.
24/7 EEG™ SubQ
USER MANUAL | ENGLISH | 5
• Seek medical guidance be-
fore entering environments
that could adversely aect
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-
24/7 EEG™ SubQ
6| USER MANUAL | ENGLISH
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.
24/7 EEG™ SubQ
USER MANUAL | ENGLISH | 7
24/7 EEG™ SubQ
8| USER MANUAL | ENGLISH
CONTENTS
1. INTRODUCTION . . . . . . . . . . . . . . . . . . . . . . . . .10
1.1 Intended use. . . . . . . . . . . . . . . . . . . . . . . . . . 10
1.2 Contraindications. . . . . . . . . . . . . . . . . . . . . . . 10
1.3 Side eects . . . . . . . . . . . . . . . . . . . . . . . . . . . 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
24/7 EEG™ SubQ
USER MANUAL | ENGLISH | 9
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
24/7 EEG™ SubQ
10 | USER MANUAL | ENGLISH
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
Inhaltsverzeichnis
Beliebte Medizinische Geräte Handbücher anderer Marken
TekTone
TekTone Tek-CARE160 Bedienungsanleitung
NeuroMetrix
NeuroMetrix Quell 2.0 Bedienungsanleitung
AMT
AMT XLR8 Bedienungsanleitung
Medipost-Nutristoma
Medipost-Nutristoma MD300K2 Bedienungsanleitung
EDAN
EDAN SONOTRAX Pro Bedienungsanleitung
Restorative Therapies
Restorative Therapies RT300 Bedienungsanleitung
