► Report each serious incident in connection with the product, in particu
lar a worsening of the state of health, to the manufacturer and to the
relevant authority in your country.
► Please keep this document for your records.
These instructions for use provide important information on the fitting and
application of the 50S8 Malleo Tristep immobilising orthosis.
2 Product description
2.1 Product overview
The product is delivered ready for trial fitting in phase 1 (see fig. 1).
Item
Component
1
Foot shell
2
Stabilisation strap
3
Orthosis
4
Padding set
2.2 Design
The individually adjustable hook and loop closures are arranged to close in
opposite directions to prevent the orthosis from twisting.
3 Intended use
3.1 Indications for use
The orthosis is intended exclusively for orthotic fittings of the lower limbs
and exclusively for contact with intact skin.
The orthosis must be used in accordance with the indications.
3.2 Indications
•
Acute ankle injuries
•
Acute and chronic capsular ligament instability
•
Inflammatory joint diseases
•
Degenerative ankle diseases
•
Rehabilitation after ankle surgery
•
Medial ligament ruptures
Indications must be determined by the physician.
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