Product Description; Intended Use - Otto Bock 28L20 Instructions For Use Manual

9.3 CE-Konformität
Das Produkt erfüllt die Anforderungen der Verordnung (EU) 2017/745 über Medizinprodukte. Die
CE-Konformitätserklärung kann auf der Website des Herstellers heruntergeladen werden.
1 Foreword
INFORMATION
Date of last update: 2021-03-01
Please read this document carefully before using the product and observe the safety
►
notices.
Instruct the user in the safe use of the product.
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Please contact the manufacturer if you have questions about the product or in case of prob­
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lems.
Report each serious incident related to the product to the manufacturer and to the relevant
►
authority in your country. This is particularly important when there is a decline in the health
state.
Please keep this document for your records.
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These instructions for use provide you with important information about the use of the 28L20 Hip
Abduction Orthosis.

2 Product description

Scope of delivery (see fig. 1)
Item Component
1 Condyle pad
2 Saucer head screw
3 Allen wrench, 2.5 mm
4 Abduction unit
5 Rubber cuff
6 Medial condyle clasp
7 Spreader piece
8 Hexagon head screw
9 Lateral condyle clasp
10 Hook-and-loop strap with rollback loop

3 Intended use

3.1 Indications for use
The 28L20 Hip Abduction Orthosis is intended exclusively for the treatment of hip dysplasia in
children aged 6 to 18 months.
The orthosis must be used in accordance with the indications.
3.2 Indications
• Hip dysplasia up to Type IIb (as categorised by Prof. Graf)
• Residual dysplasia in children from age 6 to 18 months
• Follow-up treatment of repositioned hip joint luxation in the context of hip dysplasia
Indications must be determined by the physician.
Reference number
29L50=L/R
501Z24=M4x4.5
709S10=2.5
29L103
29L56
28L48=LI/RI
29L51=40
29Y27=M4x6
28L48=LA/RA
21Y136=38-7
English
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