Please read the instruction for use and safety information before using VACOankle..
You will find readable instructions for use on our OPED homepage.
Purpose/function
Orthosis for stabilisation of the ankle joint with limitation of pro- and supination.
Safety instructions
The product is intended for use by one patient only.
Never apply the product to open wounds and only use under prior medical
instruction.
The patient may only adjust the setting in consultation with his/her treating doctor.
Should you experience excessive pain, swelling, numbness or sensitivity changes,
unusual reactions or an uncomfortable sensation while wearing the project,
please contact your doctor or orthopaedic technician immediately.
This medical product was developed for the indications stated and may be
damaged through unusual and non-intended use or through activities such as
sport, falls or other accidents, as well as liquids.
Please consult your treating doctor before using it in conjunction with another
medical device.
Please observe the road transport law of your country.
Avoid fastening the orthosis too tight at first.
VACOankle is not made from natural rubber latex.
Only replacement parts approved by OPED GmbH may be used.
Fitting process (instruction video can be found at app.oped.de or app.oped.ch)
1.
Open and unthread all three Velcro fasteners.
(Fig. 1)
2. Push the yellow clasp backwards until it stops.
(Fig. 2+3)
3. Unfold the side shells
(Fig. 4)
and put on the orthosis from behind.
(Fig. 5)
Note: Position the foot at a 90° angle.
4. The lower edge should rest on the floor or be flush with the sole of the foot.
(Fig. 6)
5. Fasten the middle strap tight.
(Fig. 7)
If necessary, move the side shells so that a
comfortable fit is achieved.
6. Fasten the top strap loosely. Press the lower ends of the side shells together and fix
the sole tape.
(Fig. 8)
Note: VACOankle should be worn with a long sock and in a lace-up shoe.
(Fig. 9)
Avoid wearing the orthosis too tight. If you feel pressure, please loosen the straps.
Product characteristics
VACOankle is available in two sizes, one each for the left and right.
Small, left/right
Standard, left/right
EUR
≤ 42
≥ 42
UK
≤ 8
≥ 8
US (M) ≤ 9
≥ 9
US (F)
≤ 10
≥ 10
Indications
●
Ligament ruptures
●
Sprains
●
Stable ankle fractures
Contraindications
None known
Information regarding care/cleaning/disinfection/sterilisation
You are receiving this medical product in a hygienically perfect condition.
Washing: Hand wash at 30°C with commercially available detergent
Drying: Leave to dry naturally. Do not dry in a tumble dryer.
Disinfection/sterilisation: This medical product
is not suitable for disinfection/sterilisation.
Technical data/parameters
Materials used: Shell and clasp (POM/PA), inner parts and straps (PES/PA/PU/EPS)
Storage conditions/disposal
Storage: Store in a dry and hygienic place and protect from direct sunlight.
Disposal: Please dispose of the medical device in residual or household waste.
There are no specific criteria for destruction.
Warranty
The warranty is provided in line with statutory regulations. In addition to these,
the terms and conditions of business of OPED GmbH also apply, where permissible.
Data protection
Information about the processing of your personal data can be found under:
http://oped.de/support/ihre-daten/
.
Information about the processing of your personal data can be found
http://oped.ch/kontakt/ihre-daten/
.
In the event of complaints relating to the product, such as damage or problems with
the fit, please contact the manufacturer directly. Only serious events which can lead to
a significant deterioration in health or death should be reported to the manufacturer
and the responsible authorities of the member state. Serious events are defined in
Article 2 (65) of Directive (EU) 2017/745 (MDR).
Your OPED Team
30° C
English
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