ZiboCare SENS-AID User manual

Sens-Aid
UK: CONTENTS
DK: INDHOLD
NO: INNHOLD
SE: INNEHÂLL
DE: INHALT
NL/BE: INHOUD
FR: TABLE DES MATIÈRES
UK ................2
DK ...............10
NO ...............18
SE ................26
DE ...............34
NL/BE.............42
FR ................50
UK
DK
NO
SE
Instructions for use
Brugsanvisning
Bruksanvisning
Bruksanvisning
Gebrauchsanweisung
Gebruiksaanwijzing
Mode d’emploi
DE
NL/BE
FR

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Important safety instructions
and contraindications
WARNING!
This product may only be used for its intended purpose
as described in these instructions. The product must
not be combined, assembled or repaired with other
parts or accessories than those described in these
instructions or in other documentation from ZiboCare.
!
The product must not be used near re sources or hot
surfaces, such as a re, burning cigarette or hot lamp.
The product may be damaged if it comes in contact
with re sources or heat; you should not smoke while
using Sens-Aid.
!
We do not recommend using Sens-Aid while
standing or walking, as it has been developed for
use in a sitting position, so it is not suitable for use in
other ways than in a chair, sofa, wheelchair, armchair
or other types of chair.
!
Check Sens-Aid regularly to make sure it is not
damaged. If it is damaged, do not use it until the
damage has been repaired.
!
Always check that the product is intact before use.
!
Avoid sharp objects that can cause damage to the
Sens-Aid.
!
We do not recommend using Sens-Aid when lying
down.
!
1.1 General information
1. Introduction
1.2 Intended use
This product is a medical device and is CE marked according to EU Medical Device Regulation MDR
2017-745. According to the authorities’ regulations regarding medical devices, it is the duty of the
manufacturer and the health personnel to report accidents and incidents that involve their
products. Therefore, we request that all information about any accidents and adverse events
relating to our products are reported to ZiboCare immediately.
Sens-Aid is a weight blanket that can be used to advantage at home, at school or in institutions when
there is a need for the stimulation that Sens-Aid provides, primarily to create calm - both motor and
mental.
Sens-Aid has six heavy wings that wrap around your body and can be arranged to suit your needs,
comfort and pleasure.
When using Sens-Aid, you experience a reduction in restlessness, racing thoughts, anxiety and
insecurity, and typically experience a widespread feeling of balance and pleasure. The weight of the
wings hugs, embraces and soothes the body.
This happens because the hormone oxytocin is released and sends signals to the brain that you
can calmly “gear down”, nd peace and recharge.
Always read all the instructions before use
1.3 Typical applications
Sens-Aid is intended for children and adults of all ages with general reduced well-being, burnout or
reduced energy. The user may have a diagnosis, but Sens-Aid is also for people with dierent
challenges, even without a diagnosis. Sens-Aid is often used for:
• Motor restlessness
• Mental imbalance
• Eating disorders
• Concentration problems
• Neurological disorders
• Dementia conditions
• Brain damage
• Mental disorders, e.g., restlessness and anxiety
• Neuropsychiatric diagnoses, e.g., ADHD, ADD,
Asperger’s Syndrome, Autism and Tourette’s
Syndrome
• Spasticity
• Racing thoughts
• Involuntary movements
• Social anxiety
When packed in the transport vag, Sens-Aid does not take up much space and is easy to take with
you.
Sens-Aid is available in the following:
1.4 Additional information
People with intellectual disabilities and users who
cannot communicate their experiences with Sens-Aid
may only use Sens-Aid under supervision.
!
Sens-Aid is not suitable for adults or children who are
not able to remove Sens-Aid without diculty.
!
UK - Instructions for use
Size and weight Item no. Basis UDI-DI no. Colour
Adult, 6 kg 4237401 570000219194237401UC Grey Melange

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Sit in the seat of the Sens-Aid. Placement: Place the Sens-Aid
folded in the chair, with the an-
ti-slip back surface facing down
before sitting down. Spread the
wings over the chair. The upper
wings may be folded over the
back of the chair, the middle
and lower wings folded out over
the sides of the chair and any
armrests.
Wrap the middle wings around
your stomach. Here, you can also
use the pockets for your hands
and arms and feel the calm when
your hands are in the pockets and
you “embrace your body”.
Place the lower wings over your
thighs. The pockets can be used
if you need to rest your arms and
hands.
Place the upper wings over
your shoulders so that you feel
the weight on your shoulders
and chest. This will make your
breathing deeper, and calm both
your body and mind.
1
4
2
5
3
Once you are sitting down in the seat of your Sens-Aid, you can place the wings over your body
to suit your needs, comfort and pleasure. You can either do it yourself or have someone else help
you.
What to do:
2. Features and positions
3. Unpacking Sens-Aid
Sens-Aid comes wrapped in recyclable plastic.
1. Start by checking that the packaging is undamaged.
2. Remove the plastic bag and any protective material. Avoid using a knife when opening the
packaging, as this may damage the Sens-Aid and bag.
3. Try folding the Sens-Aid out on a chair, and follow the instructions in point 2.
4. Be sure to save this user manual, as well as the cleaning information.
ACCESSORIES
Sens-Aid comes in a practical and smart bag with a shoulder strap that makes it easy to take
Sens-Aid with you to where you need it most. At the same time, the bag protects the Sens-Aid
from dirt and grime.
How to easily fold Sens-Aid to t in the included bag:

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5. Miscellaneous
5.8 Symbol explanation
5.1 Storage
Keep Sens-Aid in the transport bag, in a chair or folded in a place where no one risks tripping over it.
Sens-Aid should always be stored indoors in a dry place.
5.2 Labelling
Sens-Aid is labelled according to current EU guidelines in the eld of Medical Devices with the
product name, production date, item number, size/weight and CE mark. Instructions for use
and washing are enclosed.
Sens-Aid comes with a 2-year warranty covering manufacturing defects. The warranty does not
cover normal wear and tear, deterioration of the product or damage resulting from careless
handling or care of the product.
5.3 Warranty
Sens-Aid requires no service or maintenance other than cleaning as described in these instructions.
5.4 Service and maintenance
If the surface of the Sens-Aid is damaged and torn so that the lling comes out, the device can no
longer be used. Contact the supplier for more information about a possible repair.
5.5 Repair
5.6 Recycling
Sens-Aid’s fabric covers are fully recyclable and should be recycled as “combustible waste”.
5.7 Returns and complaints
In the event of a return or complaint, please contact the shop where the Sens-Aid was purchased.
Here, they will help with the further handling of the case according to applicable terms and
conditions.
See the instructions
Warning, see important safety instructions
Do not tumble dry
Do not bleach
Do not heat , e.g., in a
microwave
Do not iron
Manufacturer
The production date as
indicated on the label
Lot no.
Medical device
!
LOT
The product is CE marked
Do not wash
Sens-Aid cannot be washed, but with light supercial dirt and grime it can be wiped o with a well
wrung-out cloth. For heavier dirt and grime, Sens-Aid can be dry cleaned.
• Always check before dry cleaning that the Sens-Aid is intact and that there is no damage or tears in
the fabric or seams.
• If there is a tear in the fabric or seams, the Sens-Aid cannot be cleaned.
TECHNICAL SPECIFICATIONS
Weight:
Filling:
Cover:
Standards:
6 kg
70% plastic beads, 30% polyester fiber
100% polyester Oeko-Tex, Standard 100
EU Medical Device Regulation MDR 2017-745
4. Cleaning
It is important to follow the instructions below when cleaning the product; for example, before using
Sens-Aid with a new user.
Dry clean only

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Vigtige sikkerhedsregler
og kontraindikationer
ADVARSEL!
Dette produkt må kun anvendes til det tiltænkte
formål som beskrevet i denne vejledning. Produktet
må ikke kombineres, samles eller repareres med andre
dele, andet tilbehør eller andre reservedele end dem,
der er beskrevet i denne vejledning eller i anden
dokumentation fra ZiboCare.
!
Produktet må ikke anvendes i nærheden af eller i
forbindelse med brandkilder/varme overader som
f.eks. ild, brændende cigaretter eller varme lamper.
Produktet kan beskadiges, hvis det kommer i kontakt
med brandkilder. Det frarådes derfor at ryge ved brug
af Sens-Aid.
!
Vi fraråder anvendelse i stående/gående stilling,
idet Sens-Aid er udviklet til anvendelse i den sidden-
de stilling, og dermed ikke egner sig til brug på andre
måder end i en stol, sofa, kørestol, hvilestol eller
andre stoleformer.
!
Undersøg jævnligt Sens-Aid for at sikre, den ikke er
beskadiget. Hvis Sens-Aid er beskadiget, må den ikke
bruges, før skaden er udbedret.
!
Kontrollér altid, at produktet er intakt før anvendelse.
!
Undgå skarpe genstande, der kan beskadige
Sens-Aid.
!
Vi fraråder at anvende Sens-Aid i liggende stilling.
!
Læs altid hele brugsanvisningen inden brug
Psykisk handicappede og brugere, der ikke kan
kommunikere deres oplevelser med Sens-Aid, må kun
anvende Sens-Aid under opsyn.
!
Sens-Aid er ikke egnet til voksne eller børn, som ikke er
i stand til selv at tage Sens-Aid af uden besvær.
!
DK - Brugsanvisning
1.1 Generelle oplysninger
1. Indledning
1.2 Tiltænkt brug
Dette produkt er medicinsk udstyr og er CE-mærket i henhold til EU Medical Device Regulation MDR
2017-745. I henhold til myndighedernes bestemmelser vedrørende medicinsk udstyr er det
producentens og sundhedspersonalets pligt at indberette ulykker og utilsigtede hændelser, som
involverer deres produkter. Vi beder derfor om, at alle oplysninger om eventuelle ulykker og
utilsigtede hændelser, som vedrører vores produkter, omgående indberettes til ZiboCare.
Sens-Aid er et tyngdetæppe, der med fordel kan anvendes i hjemmet, i skolen eller på institutioner, når
der er behov for den stimulering, Sens-Aid giver, primært for at skabe ro – både motorisk og mentalt.
Sens-Aid har 6 tunge vinger, der pakker kroppen ind efter behov, ønske og behag.
Ved brug af Sens-Aid opleves reducering af uro, tankemylder, angst og utryghed, ligesom en udbredt
følelse af balance og velbehag typisk indtræer. Tyngden i vingerne krammer, samler og beroliger
kroppen.
Dette sker, fordi hormonet oxytocin frigives og sender signaler til hjernen om, at man roligt kan
”geare ned”, nde ro og lade op.
Sens-Aid anvendes i en stol; f.eks. hvilestol, skolestol, kørestol, under transport eller i en sofa – ude
såvel som inde.
1.3 Typiske anvendelsesområder
Sens-Aid er tiltænkt børn og voksne i alle aldre ved generel nedsat trivsel, udbrændthed og nedsat
overskud. Brugeren kan have en diagnose, men Sens-Aid henvender sig også til personer med
forskelligartede udfordringer uden diagnose. Sens-Aid bruges ofte ved:
• Motorisk uro
• Psykisk ubalance
• Spiseforstyrrelser
• Koncentrationsproblemer
• Neurologiske lidelser
• Demenstilstande
• Hjerneskade
• Psykiske lidelser, f.eks. uro og angst
• Neuropsykiatriske diagnoser, f.eks. ADHD,
ADD, Aspergers syndrom, Autisme og Touret-
tes syndrom
• Spasticitet
• ”Tankemylder”
• Ufrivillige bevægelser
• Social angst
Sens-Aid pakket sammen fylder ikke meget og er let at tage med i transporttasken.
Sens-Aid fås i følgende udgave:
1.4 Tillægsinformation
Størrelse og vægt Varenr. Basis UDI-DI nr. Farve
Voksen, 6 kg 4237401 570000219194237401UC Gråmeleret