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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.
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Please keep this document for your records.
These instructions for use contain important information for fitting and apply
ing the 50K4-1 Agilium Freestep knee osteoarthritis brace.
2 Product description
2.1 Components (see Fig. 1)
Item:
Description
Item:
Description
1
Bars
2
Foot stirrup
3
Foot component
4
Brace ankle joint
5
Allen head screws
6
Strap
Components not illustrated
Height adjuster
Allen wrench
2.2 Design
The brace consists of a foot component and a lower leg component. These
components are connected via a freely movable brace ankle joint (sagittal
plane) (4).
The foot component consists of a foot component (3) that can be cut to size
and the foot stirrup (2).
The lower leg component consists of the brace ankle joint, two adjustable
bars (1) and the strap (6). 2 Allen head screws (5) are used to adjust the
lower leg component.
3 Intended use
3.1 Indications for use
The brace is intended
exclusively
for orthotic fittings of the lower limbs and
exclusively
for contact with intact skin.
The brace must be used in accordance with the indications.
3.2 Indications
•
Unicompartmental knee osteoarthritis
•
Conditions/injuries requiring unicompartmental relief (e.g. post-operative
treatment following meniscus reconstruction or ligament injuries which
require unilateral relief)
The indication must be determined by the physician.
11
Summary of Contents for 50K4-1 Agilium Freestep 2.0
Page 3: ...Material Stahl Steel Kunststoff Plastic TPE Textilkaschierter Schaum Fabric lined foam 30 3...
Page 108: ...2 1 6 2 5 3 3 1 3 2 3 3 3 3 1 3 3 2 3 4 2 108...
Page 109: ...4 4 1 4 2 1 5 1 5 1 1 109...
Page 110: ...2 3 3 cm 3 cm 50K4 1 Agilium Freestep 2 0 50K4 Agilium Freestep Classic 5 2 1 2 2 3 3 4 110...
Page 111: ...1 2 1 4 2 6 mm 3 4 2 5 5 2 6 Nm 5 3 111...
Page 112: ...1 2 3 4 5 4 1 2 3 6 1 2 30 C 3 7 8 8 1 8 2 112...
Page 114: ...3 3 1 3 2 3 3 3 3 1 3 3 2 3 4 4 4 1 114...
Page 115: ...4 2 5 5 1 1 2 3 3 cm 3 cm Agilium Freestep 2 0 50K4 1 Agilium Freestep Classic 50K4 115...
Page 116: ...5 2 1 2 2 3 3 4 1 2 1 4 2 6 mm 3 4 2 5 5 2 6 Nm 116...
Page 117: ...5 3 1 2 3 4 5 4 1 2 3 6 117...
Page 118: ...1 2 30 C 3 7 8 8 1 20161906 24 8 2 8 3 CE 2017 745 CE 118...
Page 119: ...119...