Etac Flex Manual Del Usuario página 9

Demontering Lim ....................................
I1. Limbrickan vrids loss ifrån väggen med hjälp
av en polygrip.
I2. Limrester kan skrapas bort med glasskrapa.
I3. Limrester kan tvättas bort med
silikon borttagare.
Underhåll
Rengöring: Rengör produkten med rengörings-
medel utan lösningsmedel och med pH-värde
5-9 eller med 70% desinfektionssprit.
Dekontaminering: Kan vid behov dekontamine-
ras i max 85º C i 3 minuter.
Ingående material är korrosionsbeständiga.
5 års garanti mot fel i material och tillverkning.
För villkor, se www.etac.com.
Förvaring
Produkten ska förvaras inomhus på en torr
plats med en temperatur över 5°C. Om pro-
dukten har lagrats en längre tid (mer än fyra
månader) ska dess funktion kontrolleras.
en
English
General information
Thank you for choosing an Etac product.
In order to avoid damage during assembly,
handling and use, it is important to read this
manual and save it for future reference. You
can also find it at www.etac.com. You can
select your language via the "International"
and "Local websites" link. Here you will also
find other product documentation, such as
prescriber information, pre purchase guide,
and reconditioning instructions.
In the manual, the user is the person sitting
in the chair. The carer is the person helping
the user.
Device description
Flex is a wall-mounted grab rail with a stable
and secure grip for the hand. The design
makes it possible to add on as many sections
as needed and in angles/positions that suit
each individual need.
Intended purpose
Flex (hereafter also referred to as "the device"
or "the product"), is an assistive device
intended for alleviation of or compensation for
a physical impairment due to an injury or dis-
ability. The device is designed to give a stable
and secure grip when standing or making a
transfer when using the shower, toilet or bath.
Intended user group
The user group for the device is based on
the individual's functional ability and not on
a specific diagnosis, health condition or age.
It is intended for individuals with a height of
146 cm or more, or a mass of 40 kg or more.
Secondary users of the device are caregivers
providing assistance and clinicians/techni-
cians who set up the device.
Intended environment
The device is intended for indoor use at home
environments or institutions and is suitable for
use in bathrooms, but not swimming pools or
similar corrosive environments.
Intended application
The device is intended for short-term and long-
term use and can be applied several times
per day. The device is intended to be used in
contact with intact skin.
The device is intended for refurbishment and
reuse.
Expected service life
The expected service life is 10 years. For com-
plete information regarding the service life of
the device, see www.etac.com.
Figur I Indications
Indication for use is disability, including, but
not limited to, an individual with fluctuating
balance issues, physiological and/or func-
tional impairment, and/or a history of falls.
Contraindications
There are no known contraindications.
Warnings
Warnings describing a risk element for
a specific action or setting of the device
can be found in the relevant section.
A defective or incorrectly mounted device
should not be used. In the event of a fault,
contact your prescriber or retailer.
Heated device can cause burns.
Ignoring installation or assembly instruc-
tions may result in injury.
Declaration of conformity
The device meets the requirements of the
Medical Device Regulation (EU) 2017/745.
The device is tested and meets the require-
ments of the EN ISO 10993-1, SS EN 12182.
Pre-purchase information
Pre-purchase information can be found at
www.etac.com.
Adverse event
In case of an adverse event occurred in
relation to use of the device, it should be
reported to your local dealer and the national
competent authority in a timely manner.
The local dealer will forward information
to the manufacturer.
Customization
is everything that goes beyond the manual's
instructions and settings. Device specially
adapted by the customer must not retain
Etac's CE marking. Etac's warranty expires.
If there is any uncertainty regarding the execu-
tion of the customization, consult Etac. Device
coupled with another device may not retain
either device's CE mark unless combination
agreements exist. Contact Etac for current
information.
Device description, content
of the delivery.......................................
1. Content of the delivery 2. Handle
3. Extension
Symbols ................................................Figure B
Symbols in the manual and on the device:
1. Warning, precaution or limitation. 2. Useful
advice and tips. 3. Material for recycling.
4. Product weight 5. Surface must be dry
6. Maximum tightening torque
7. Electric screwdriver must not be used
8. Maximum user weight (see technical data)
9-10. Cleaning (see maintenance)
Explanation item no label:
1. Product name 2. Product description
3. Serial number 4. Item number 5. Date
of manufacture 6. Barcode acc. to
GS1-128 GTIN-14 and serial number*
*The device's date of manufacture can be
read from the barcode on the device. The
number 11 is shown below the barcode in
brackets. The number combination after these
brackets is the date of manufacture.
Technical data ......................................Figure D
Positioning, installation ......................
Etac Flex can be mounted in different posi-
tions. The additional handle can be mounted
at angles of 22.5° between 0 and 90°. Etac
Flex can be extended by an unlimited number
of additional handles.
Mounting options
Etac Flex has been designed to withstand a
maximum user weight of 100 kg (220 lbs)
and should only be mounted onto a wall with
sufficient load-bearing capacity.
Glue: The glue kit can be used to mount the
handle on tiles, glass, stone or metal walls.
Inspect the surface to be sure it is completely
flat at all fastening points. The bar should not
rock or have gaps between the base and the
wall.
If in doubt about the wall's load-bearing
capacity or the suitability of mounting with
glue, an assessment should be carried out by
a qualified person.
Cleaning prior to mounting ................
F1-F5. Cleaning: Ensure that limescale deposits
F1. Use a sanding sponge with sandpaper sur-
face (80). Clean the mounting surface using
the sponge and a detergent (PH 5-9) suitable
for the surface. Ensure that the surface
is completely free of limestone residues
and dirt. Note! Start by testing the sanding
sponge with detergent on a less visible area
to ensure that the surface is not scratched.
F2. Wipe off and dry the surface.
F3. Wash the surface with the wet wipe supplied
to remove any residues from the detergent
(the alcohol cleaning cloth should only be
used for its intended purpose. It can only
work adequately if opened directly before
Figure A
use).
F4. Wipe the surface with a clean, lint-free cloth.
F5. Wait until the surface is completely dry and
has had time to adapt to room temperature.
If you are not sure, wait for 15 minutes.
Other cleaning methods may be required to
ensure that the mounting surface is clean.
Mounting
Flex 30 .................................................
.................Figure C
Flex 60 .................................................
Etac Flex must be mounted on a dry surface.
G/H1. Place the glue plate(s) in the handle with
G/H2. Remove the protective tape.
G/H3. Press the glue plate(s) into place against
Figure E
9
Etac / Flex / www.etac.com
Mounting on a wall with insufficient
load-bearing capacity poses a danger
to the user!
Do not glue the device onto concrete,
plaster, wallpaper, veneer or any other
covering.
Tubes with hardened glue should not be
used.
and other dirt is removed by cleaning
the mounting surfaces. The following
cleaning method is recommended:
The surface must be dry
The glue's adhesive effect cannot be
guaranteed if the mounting surface has not
been fully cleaned.
the protective tape outwards.
the wall where the handle is to be
positioned.
Figure F
Figure G
Figure H