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HOW TO DISPOSE OF THE PRODUCT AT END-OF-LIFE
Once the device has been withdrawn from service, the medical device can be disposed of as normal
municipal waste.
NOTES:
In the event of a device-related „serious incident" that directly or indirectly led to, could have led to, or is likely
to lead to any of the following:
(a) death of a patient, user or other person, or
(b) temporary or permanent deterioration of the health of a patient, user or other person, or
(c) a serious risk to public health
the above ‚serious incident' must be notifi ed to the manufacturer and to the competent authority of the
Member State in which the user or patient is resident. In the case of Poland, the competent authority is the
Offi ce for Registration of Medicinal Products, Medical Devices and Biocidal Products.
NOTES:
In the event of pain, allergic reactions or other disturbing symptoms unclear to the user related to the use of
the medical device, a healthcare professional should be consulted.
DIAGRAM OF HOW TO PUT ON THE ORTHOSIS:
REMOVAL
Remove the orthosis by following all the above steps in reverse order.
SIZING TABLE (To fi t the correct size, measure the circumference above the ankle):
- S (19-22cm),
- M (22-26cm),
- L (26-30cm)
TARGET PATIENT GROUP
The healthcare professional indicates the use of the device to adults and children at his own risk, taking
into account the available variants/sizes/necessary functions/sizes and indications, bearing in mind the
information provided by the manufacturer.
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2023-05-28 23:13:44
2023-05-28 23:13:44
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