Otto Bock 5R1-6 Instructions For Use Manual page 6

Second lamination process
Required materials: 99B81 PVA bag, 623T3 Perlon stockinette,
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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, 710D1 torque wrench
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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
This product may not be disposed of with regular domestic waste in
all jurisdictions. Disposal that is not in accordance with the regula­
tions of the country where the product is used may have a detrimental
impact on health and the environment. Please observe the information
provided by the responsible authorities in the country of use regarding
return, collection and disposal procedures.
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.
6
9.2 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 manufacturer with sole responsibility according to Annex VII of the
directive.
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 : 2017-05-22
► Veuillez lire attentivement l'intégralité de ce document avant
d'utiliser le produit.
► Respectez les consignes de sécurité afin d'éviter toute blessure
et endommagement du produit.
► Apprenez à l'utilisateur à bien utiliser son produit et informez-le
des consignes de sécurité.
► 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 prothétique 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.
2.3 Conditions d'environnement
Conditions d'environnement autorisées
Plage de température de fonctionnement -10°C à +60°C
Humidité relative de l'air admise 0 % à 90 %, sans condensation
Conditions d'environnement non autorisées
Vibrations mécaniques ou chocs
Sueur, urine, eau douce, eau salée, acides
Poussières, grains de sable, particules hygroscopiques (talc par
ex.)
5R1=1 5R1=2 5R1=6 5R1=6-­
Wood
147 120
445 355 155
Min. 46, max. 30
64
125
H
240
33
150
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