OPED VACOpedes Diabetic Manual De Instrucciones página 9

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VACOpedes Diabetic
Indications
• Ulcerations on the foot
• Diabetic foot wounds
• Post-operative care following toe and forefoot amputations
Contraindications
None known
Accessories
To support treatment, the following accessories, if not included in the scope of delivery,
can be ordered from OPED GmbH:
• Strap lock (VERS-16-4-41): The strap lock can be used to lock the orthosis and ensure
it cannot be removed. It is locked and unlocked using a special key and can therefore be
repeatedly locked and unlocked.
• Locking key (VERS-11-3): The locking key can be used to prevent the unwanted removal
of the orthosis.
Information regarding care / cleaning / disinfection / sterilisation
You are receiving this medical product in a hygienically perfect condition.
Cleaning instructions for patients:
• Lower shell: Dishwasher at 60 °C
• Strap: Washing machine at 40° C
• PA velour covers: Wash with similar colours in a washing machine at 60°C.
Please remove the vacuum cushion before washing. Close the zip and Velcro fasteners again.
• Drying: Air dry, do not dry in a tumble dryer.
• Disinfection: Wipe disinfection with plastic-compatible disinfectant.
• Sterilisation: This medical product is not suitable for sterilisation.
Technical data / parameters
Materials used:
Hard lower shells (PP); Covers (cotton/PA velour/PU foam); Cushion sleeve (PVC); Filler
material (EPS spheres); Strap (PP fabric); Sole (EVA); Insole (PU); Upper shell (EVA/PP);
Upper shell clasp (POM). Note: Not made from natural rubber latex.
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Transport conditions / storage conditions / disposal
Storage: Store in a dry and hygienic place and protect from direct sunlight.
Germany/Switzerland: The medical device is a rental product and
must be returned to OPED!
Other countries: Please dispose of the medical device in residual or household waste.
Warranty
The warranty complies with statutory regulations. The terms and conditions of
business of OPED GmbH also apply, where permissible.
Data protection
Germany: Information about the processing of your personal data can be
found under: http://oped.ch/kontakt/your-data/.
Switzerland: Information about the processing of your personal data can be
found under: http://oped.ch/kontakt/your-data/.
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
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