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

2 Intended use
2.1 Indications for use
The product is to be used solely for lower limb prosthetic fittings.
2.2 Area of application
5R1=1, 5R1=2, 5R1=6: Approved for a body weight of up to
•
125 kg.
5R1=6-H: Approved for a body weight of up to 150 kg.
•
2.3 Environmental conditions
Allowable environmental conditions
Temperature range for use: -10 °C to +60°C
Allowable relative humidity 0 % to 90 %, non-condensing
Unallowable environmental conditions
Mechanical vibrations or impacts
Perspiration, urine, fresh water, salt water, acids
Dust, sand, highly hygroscopic particles (e.g. talcum)
2.4 Service Life
This prosthetic component has been tested by the manufacturer for 3
million load cycles according to ISO 10328. Depending on the
patient's activity level, this corresponds to a service life of 3 to 5
years.
3 Safety
3.1 Explanation of warning symbols
Warning regarding possible risks of accident or
CAUTION
injury.
3.2 General safety instructions
CAUTION
Excessive strain on the product
Risk of injury due to breakage of load-bearing components
► Use the product according to the specified area of application
(see Page 5).
CAUTION
Unallowable combination of prosthetic components
Risk of injury due to breakage or deformation of the product
► Only combine the product with prosthetic components that are
approved for that purpose.
► Based on the instructions for use of the prosthetic components,
verify that they may be combined with each other.
CAUTION
Use under unallowable environmental conditions
Risk of injury due to damage to the product
► Do not expose the product to unallowable environmental condi­
tions.
► If the product has been exposed to unallowable environmental
conditions, check it for damage.
► If damage is apparent or in case of doubt, do not continue using
the product.
► Take suitable measures if required (e.g. cleaning, repair,
replacement, inspection by the manufacturer or a specialist
workshop etc.).
CAUTION
Exceeding the service life
Risk of injury due to change in or loss of functionality and damage to
the product
► Ensure that the approved service life is not exceeded.
CAUTION
Mechanical damage to the product
Risk of injury due to change in or loss of functionality
► Use caution when working with the product.
► If the product is damaged, check it for proper function and readi­
ness for use.
► In case of changes in or loss of functionality, do not continue
using the product (see "Signs of changes in or loss of functional­
ity during use" in this section).
► Take any necessary measures (e.g. repair, replacement, inspec­
tion by the manufacturer's customer service, etc.).
Signs of changes in or loss of functionality during use
Among other factors, changes in functionality can be indicated by an
altered gait pattern, a change in the positioning of the prosthetic com­
ponents relative to each other and by the development of noises.
4 Scope of delivery
see fig. 1, item Quant­
ity
– 1
1 1
2
3
6
4 1
5 4
5 Preparation for use
CAUTION
Incorrect alignment or assembly
Risk of injury due to damaged prosthetic components
► Observe the alignment and assembly instructions.
INFORMATION
The layup described in this document was approved for the maxim­
um product user body weight. The prosthetist assumes full respons­
ibility for any change to the layup.
5.1 Fabricating the prosthetic socket
First lamination process
Required materials: 99B81 PVA bag, 616G6 Dacron® felt,
>
623T3 Perlon stockinette, 616G12 carbon fibre cloth, 617H119
Orthocryl lamination resin 80:20 PRO
1) Pull a soaked PVA bag over the model.
2) Place a layer of Dacron® felt over the entire model.
3) Place a layer of Dacron® felt around the proximal edge of the
model.
4) Pull 2 layers of Perlon stockinette over the model.
5) Place 3 layers of carbon fibre cloth (e.g. 15 cm x 15 cm) on the
distal end of the model, offsetting the fibre alignment.
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.
Foaming and fastening the socket attachment block
Required materials: 617H32 Pedilen rigid foam 300, 617H21
>
Orthocryl sealing resin
1) Sand down the surplus lamination resin on the distal end of the
model.
2) Foam the distal end of the model with rigid foam.
3) Trim the rigid foam to the maximum possible extent and sand it
smooth in the desired position.
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).
Designation Reference
number

Instructions for use

Socket attachment 5R1=1
block
5R1=2
5R1=6-H
5R1=6
Lamination dummy
Countersunk head 501S41=M6x­
screw
–
4X6
25
5