Technical Data; Description Du Produit - Ottobock 5R1-1 Instrucciones De Uso

4) Fasten the socket attachment block to the rigid foam with sealing
resin.
5) Mill a transition between the socket attachment block and the
rigid foam (see fig. 2). While doing this, do not sand the shape or
size of the adapter connection surface, which is determined by
the socket attachment block.
6) Insert the lamination dummy in the threaded holes of the socket
attachment block (see fig. 3).
7) Apply sealing resin to the outside of the prosthetic socket and to
the lamination dummy (see fig. 4).
Second lamination process
> Required materials: 99B81 PVA bag, 623T3 Perlon stockinette,
616B1=50 carbon fibre cloth strap, 616G12 carbon fibre cloth,
616G15 woven carbon fibre stockinette, 617H119 Orthocryl lam­
ination resin 80:20 PRO
1) Pull a Perlon stockinette over the model.
2) Apply 2 strips of carbon fibre cloth strap in a cross over the sock­
et attachment block up to the middle of the model.
3) Place 2 layers of carbon fibre cloth (e.g. 15 cm x 15 cm) on the
distal end of the model, offsetting the fibre alignment.
4) Pull a Perlon stockinette over the model.
5) Pull 2 layers of woven carbon fibre stockinette over the model. Do
not allow the stockinette to protrude beyond the socket edge.
6) Pull 2 layers of Perlon stockinette over the model.
7) Pull a soaked PVA bag over the model.
8) Complete the lamination process with lamination resin.
9) Once the lamination resin has cured, remove the PVA bag.
5.2 Final assembly
CAUTION
Improper assembly of the screw connections
Risk of injury due to breakage or loosening of the screw connec­
tions
► Clean the threads before every installation.
► Apply the specified torque values.
► Follow the instructions regarding the length of the screws and
about how to secure the screws.
Required materials: sanding tool, 710D20 torque wrench
>
1) NOTICE! Do not sand down the laminate around the edge of
the product.
Sand down the laminate on the distal end of the prosthetic socket
to the surface of the lamination dummy and remove the lamination
dummy.
2) CAUTION! Do not use thread lock (e.g. Loctite®) to mount
the socket adapter. Chemical thread locks damage the lam­
inate.
Fasten the socket adapter to the socket attachment block using
the countersunk head screws (see fig. 5):
Screw in 2 countersunk head screws on the posterior side
(12 Nm).
Screw in 2 countersunk head screws on the anterior side
(12 Nm).
6 Cleaning
1) Clean the product with a damp, soft cloth.
2) Dry the product with a soft cloth.
3) Allow to air dry in order to remove residual moisture.
7 Maintenance
► A visual inspection and functional test of the prosthetic compon­
ents should be performed after the first 30 days of use.
► Inspect the entire prosthesis for wear during normal consulta­
tions.
► Conduct annual safety inspections.
8 Disposal
In some jurisdictions it is not permissible to dispose of the product
with unsorted household waste. Improper disposal can be harmful to
health and the environment. Observe the information provided by the
responsible authorities in your country regarding return, collection
and disposal procedures.
6
9 Legal information
All legal conditions are subject to the respective national laws of the
country of use and may vary accordingly.
9.1 Liability
The manufacturer will only assume liability if the product is used in
accordance with the descriptions and instructions provided in this
document. The manufacturer will not assume liability for damage
caused by disregarding the information in this document, particularly
due to improper use or unauthorised modification of the product.
9.2 CE conformity
The product meets the requirements of Regulation (EU) 2017/745on
medical devices. The CE declaration of conformity can be down­
loaded from the manufacturer's website.
9.3 Warranty
The manufacturer warrants this device from the date of purchase. The
warranty covers defects that can be proven to be a direct result of
flaws in the material, production or construction and that are reported
to the manufacturer within the warranty period.
Further information on the warranty terms and conditions can be
obtained from the competent manufacturer distribution company.

10 Technical data

Reference number
Material
Wood connection diameter
[mm]
Weight [g]
System height [mm]
Max. body weight [kg]

1 Description du produit

INFORMATION
Date de la dernière mise à jour : 2020-03-23
► Veuillez lire attentivement l'intégralité de ce document avant
d'utiliser le produit ainsi que respecter les consignes de sécuri­
té.
► Apprenez à l'utilisateur comment utiliser son produit en toute sé­
curité.
► Adressez-vous au fabricant si vous avez des questions concer­
nant le produit ou en cas de problèmes.
► Signalez tout incident grave survenu en rapport avec le produit,
notamment une aggravation de l'état de santé, au fabricant et à
l'autorité compétente de votre pays.
► Conservez ce document.
1.1 Conception et fonctionnement
Les admissions d'emboîture 5R1=1, 5R1=2, 5R1=6 et 5R1=6-H se
montent par collage puis par stratification sur l'extrémité distale de
l'emboîture de prothèse. Elles permettent de relier l'emboîture de la
prothèse avec un adaptateur d'emboîture.
1.2 Combinaisons possibles
Ce composant prothétique est compatible avec le système modulaire
Ottobock. Le fonctionnement avec des composants d'autres fabri­
cants disposant de connecteurs modulaires compatibles n'a pas été
testé.
2 Utilisation conforme
2.1 Usage prévu
Le produit est exclusivement destiné à l'appareillage exoprothétique
des membres inférieurs.
2.2 Domaine d'application
5R1=1, 5R1=2, 5R1=6 : admis pour les patients d'un poids de
•
125 kg maximum.
5R1=6-H : admis pour les patients d'un poids de 150 kg maxi­
•
mum.
5R1=1 5R1=2 5R1=6 5R1=6-­
Wood
147 120
445 305 155
Min. 46, max. 30
64
125
H
155
33
150
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