Trial Fitting And Delivery Of Orthosis; Proper Functioning And Premature Wear; Legal Information; Liability - Otto Bock 17CF1 Instructions For Use Manual

2.4 Trial fitting and delivery of orthosis

Please cut down the subcondylar orthosis edge in accordance with the required level of stability.
We recommend shortening the orthosis edge to the height of the medial tibial plateau in cases
where the patient has a relatively stable knee joint.
INFORMATION
A condylar support may be indicated in cases of knee joint instability.
The insert does not have to be glued for the trial fitting. To make an assessment of the sagital fit-
ting, we recommend using the L.A.S.A.R Posture to check the patient with the orthosis in place.
The weight bearing line of the laser projected onto the leg should fall 15 mm in front of the com-
promise pivot point in an ideal scenario, according to Nietert (fig. 20). Appropriate modifications
to the shoe can also influence the fit. Check the fit and function of the orthosis. (Fig. 21/22)
Self-adhesive Velcro hook and loop band can be glued to the shell components for the trial
fitting. Usually a closure below the tibia head is sufficient. An additional closure can be at-
tached above the back of the foot if necessary. For closing and padding, it is possible to use
the 623Z1 Hook and Loop Closure Band, 623P5 Padding Tape, 623P5 Terry Cloth Padding
and self-adhesive 616T25 Padding Material. We recommend Ottobock 636W71 CP Quick-
Drying Rubber Cement for gluing the insert into the orthotic shell, since any discharged colors
must be avoided below the transparent plastic materials. Ottobock 636N9 Quick-Drying Rub-
ber Cement can be used for gluing in lamination shells. We recommend 620P4 Thermoplastic
Microcork for building up height and creating a flat surface on the foot part of the orthosis.
The sagittal position of the finished orthosis model should be 90° after alignment. Screw connec-
tions with Loctite 241 (636K13) secure the orthosis.
Using the orthosis in active life. (Fig. 23)

2.5 Proper functioning and premature wear

We recommend having the orthosis checked for proper functioning and premature wear every six
months. This should include an inspection of the carbon fiber spring for delamination or fractures
and a check of the screw connections. If need be, the fit should be adapted for growing patients.

3 Legal information

All legal conditions are subject to the respective national laws of the country of use and may vary
accordingly.

3.1 Liability

The manufacturer will only assume liability if the product is used in accordance with the descrip-
tions and instructions provided in this document. The manufacturer will not assume liability for
damage caused by disregard of this document, particularly due to improper use or unauthorised
modification of the product.

3.2 CE conformity

This product meets the requirements of the European Directive 93 / 42 / EEC for medical devices.
This product has been classified as a class I device according to the classification criteria outlined
in Annex IX of the directive. The declaration of conformity was therefore created by the manufac-
turer with sole responsibility according to Annex VII of the directive.
22 | Ottobock 17CF1