Ottobock 28L10 Instructions D'utilisation page 9

6.2 CE-Konformität
Das Produkt erfüllt die Anforderungen der europäischen Richtlinie 93/42/EWG für Medizinpro­
dukte. Aufgrund der Klassifizierungskriterien nach Anhang IX dieser Richtlinie wurde das Produkt
in die Klasse I eingestuft. Die Konformitätserklärung wurde deshalb vom Hersteller in alleiniger
Verantwortung gemäß Anhang VII der Richtlinie erstellt.
6.3 Lokale Rechtliche Hinweise
Rechtliche Hinweise, die ausschließlich in einzelnen Ländern zur Anwendung kommen, befinden sich unter diesem
Kapitel in der Amtssprache des jeweiligen Verwenderlandes.
1 Foreword
INFORMATION
Last update: 2016-06-14
► Please read this document carefully before using the product.
► Follow the safety instructions to avoid injuries and damage to the product.
► Have yourself instructed by qualified personnel in the proper and safe use of the product.
Please keep this document in a safe place.
►
These instructions for use provide you with important information for properly applying and remov­
ing the Tübingen Hip Flexion and Abduction Orthosis according to Prof. Bernau and for
correctly adapting it to the patient.
2 Product Description
2.1 Components (see Fig. 1)
Item Designation
1 Shoulder harness with terry cloth covers 6
2 Hook-and-loop closure with caterpillar
graphic
3 Front closures (white)
4 Beaded cords (green/white)
5 Thigh shells
2.2 Design
The thigh shells (5) and the shoulder harness (1) are joined together by green/white beaded
cords, which are held by the white closures (3) and the red closures (8, 9). The hook-and-loop
closure (2) and the white closures (3) on the front of the shoulder harness (1) are used when put­
ting on and taking off the Tübingen Hip Flexion Orthosis.
The attending physician can change the length of the beaded cords (4) with the red closures (8,
9) on the shoulder harness (1) and on the thigh shells (5). This establishes the hip flexion position
and can be adjusted as the infant grows.
After loosening the push-pull device (6) on the spreader bar (7), the two sections of the spreader
bar (7) can be simultaneously adjusted to achieve the desired hip abduction. The numbered scale
on the bottom of the spreader bar (7) makes it easy to duplicate the setting.
Item Designation
Push-pull device for spreader bar (red)
7 Spreader bar with ratchet mechanism
8 Back closures (red)
9 Lower closures (red)
– 2 terry cloth covers and 1 hook-and-loop
closure are included as replacements
English
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