7
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
English
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
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.
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Please keep this document for your records.
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
Reference number
1
Condyle pad
29L50=L/R
2
Saucer head screw
501Z24=M4x4.5
3
Allen wrench, 2.5 mm
709S10=2.5
4
Abduction unit
29L103
5
Rubber cuff
29L56
6
Medial condyle clasp
28L48=LI/RI
7
Spreader piece
29L51=40
8
Hexagon head screw
29Y27=M4x6
9
Lateral condyle clasp
28L48=LA/RA
10
Hook-and-loop strap with rollback loop
21Y136=38-7
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.
