ottobock 5R2 Lamination Ring Instruction Manual

: June 9, 2024
: ottobock

Table of Contents

PRODUCT OVERVIEW
Product description
Intended use
Safety
Scope of delivery
Preparing the product for use
Maintenance
Disposal
Legal information
Technical data
References
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ottobock 5R2 Lamination Ring

PRODUCT OVERVIEW

Product description

INFORMATION

Date of last update: 2022-07-26

Please read this document carefully before using the product and observe the safety notices.
Instruct the user in the safe use of the product.
Please contact the manufacturer if you have questions about the product or in case of problems.
Report each serious incident related to the product to the manufacturer and to the relevant authority in your country. This is particularly important when there is a decline in the health state.
Please keep this document for your records.

Construction and Function

The 5R2 lamination disc is laminated into the prosthetic socket. It serves to connect the prosthetic socket to a socket adapter.

Combination possibilities

This prosthetic component is compatible with Ottobock’s system of modular connectors. Functionality with components of other manufacturers that have compatible modular connectors has not been tested.

Intended use

Indications for use
The product is intended exclusively for lower limb exoprosthetic fittings.

Area of application
Approved for a body weight of up to 150 kg.
For use with 6A30=20
Approved for a body weight of up to 125 kg

Environmental conditions

Storage and transport

Temperature range –20 °C to +60 °C (–4 °F to +140 °F), relative

humidity 20 % to 90 %, no mechanical vibrations or impacts

Allowable environmental conditions

Temperature range: –10 °C to +45 °C (14 °F to 113 °F)
Moisture: relative humidity: 20% to 90%, non-condensing
Unacceptable environmental conditions

Chemicals/liquids: fresh water, salt water, perspiration, urine,

acids, soapsuds, chlorine water

Solids: dust, sand, highly hygroscopic particles (e. g. talcum)

Lifetime

This product was tested by the manufacturer with 3 million load cycles. Depending on the user’s activity level, this corresponds to a maximum lifetime of 5 years.

Safety

Explanation of warning symbols

CAUTION
Warning regarding possible risks of accident or injury.
NOTICE
Warning regarding possible technical damage.

General safety instructions

CAUTION

Risk of injury and risk of product damage

Comply with the product’s field of application and do not expose it to excessive strain (see page 8).
Note the combination possibilities/combination exclusions in the instructions for use of the products.
Do not expose the product to prohibited environmental conditions.
Check the product for damage if it has been exposed to prohibited environmental conditions.
Do not use the product if it is damaged or in a questionable condition. Take suitable measures (e.g. cleaning, repair, replacement, inspection by the manufacturer or a specialist workshop).
Observe the maximum lifetime of the product.
To prevent mechanical damage, use caution when working with the product.
If you suspect the product is damaged, check it for proper function and readiness for use.
Do not use the product if its functionality is restricted. Take suitable measures (e.g. cleaning, repair, replacement, inspection by the manufacturer or a specialist workshop).

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 components relative to each other and by the development of noises.

Scope of delivery

5R2 Lamination disc

Preparing the product 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 maximum product user body weight. The prosthetist assumes full responsibility for any change to the layup.

Preparing for socket fabrication

Required tools and materials: 99B81 PVA bag, 616G6 Dacron® felt, 623T3 Perlon stockinette, 616G12 carbon fibre cloth, 300 617H32 Pedilen rigid foam, 636K8 plastaband, 633F23=1 silicone grease, 617H21 Orthocryl sealing resin, 617H119 80:20 PRO Orthocryl lamination resin

Pull a soaked PVA bag over the model.
Apply one layer of Dacron felt to the model and thin out the fibres along the edge.
Pull two layers of Perlon stockinette over the model.
Place three layers of carbon fibre cloth (e.g. 15 cm x15 cm), offset on the distal end of the model.
Pull two layers of Perlon stockinette over the model.
Pull a soaked PVA bag over the model.
Perform the lamination process with Orthocryl.
Once the lamination resin has cured, remove the PVA bag.
Foam the distal end of the model with Pedilen rigid foam.
Trim the rigid foam, sand it flat in the desired position and taper it below the flat surface (see fig. 2).
Apply sealing resin to the rigid foam.
Fill the holes on the underside of the lamination disc with plastaband.
Apply silicone grease to the contact surface of the lamination dummy and put on the lamination dummy (see fig. 3).

Fabricating the prosthetic socket

Required tools and materials:
99B81 PVA bag, 623T9 Nylglass stockinette, 616G4 fibreglass mat, 616G12 carbon fibre cloth, 616G14* woven carbon fibreglass stockinette, 617H119 80:20 PRO Orthocryl lamination resin

Prepare for fabrication of the prosthetic socket (see page 10).
Stitch 2 layers of Nylglass stockinette and pull them over the model.
Pull 1 layer of fibreglass mat over the model.
Lay 1 layer of carbon fibre cloth mediolaterally over the model, up to approximately 2 cm distally of the socket brim.
Position the lamination disc on the model.
Pull 2 layers of Nylglass stockinette over the model and tie off in the groove of the lamination disc (see fig. 4).
Cut 1 piece of Nylglass stockinette (twice the length of the model). Pull the Nylglass stockinette halfway over the model.
Reinforce the area of the lamination disc and rigid foam with a 6 cm to 8 cm wide layer of carbon fibre cloth (616G12 or 616B17).
Tie off the carbon fibre cloth in the groove of the lamination disc.
Fold the second half of the Nylglass stockinette over the model.
Trim a layer of woven carbon fibreglass stockinette (1.5 times the length of the plaster model).
Pull the woven carbon fibreglass stockinette over the distal half of the model and tie it off in the groove of the lamination disc (see fig. 5). Fold the excess woven carbon fibreglass stockinette over the model.
Pull 2 layers of Nylglass stockinette over the model.
Trim a piece of woven carbon fibreglass stockinette (1.5 times the length of the plaster model) and pull it over the model. Fold the excess woven carbon fibreglass stockinette over the model.
Position a layer of carbon fibre cloth over the lamination disc.
Pull 2 layers of Nylglass stockinette over the model.
Pull a soaked PVA bag over the model.
Perform the lamination process with Orthocryl.

Final assembly

CAUTION
Improper assembly of the screw connections
Risk of injury due to breakage or loosening of the screw connections

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.
Selection chart for countersunk head screws

Chosen socket adapter| Screws to be used
4R22, 4R23, 4R54, 4R55, 4R73=A, 4R73=D, 4R74, 4R95| 501S41=M6x12_12.9
4R37, 4R51, 4R77| 501S41=M6x16
Required tools and materials:
Sanding tools, 636K13 Loctite®, 710D4 torque wrench

CAUTION! Do not sand the laminate around the edge of the product!
Sand the laminate on the distal end of the prosthetic socket down to the surface of the lamination dummy (see fig. 6).
Remove the lamination dummy.
If the 6A30=20 shuttle lock was used: Remove the 6 oval head self-tapping screws.
Select the correct countersunk head screws to connect the socket adapter to the lamination disc (see selection table).
Secure the screws with Loctite®.
CAUTION! Observe the minimum screw insertion depth of 8 mm!
Install the socket adapter with 4 countersunk head screws.
Observe the instructions and installation torque values in the socket adapter instructions for use.

Maintenance

A visual inspection and functional test of the prosthetic components should be performed after the first 30 days of use.
Inspect the entire prosthesis for wear during normal consultations.
Conduct annual safety inspections.

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.

Legal information

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

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.

CE conformity

The product meets the requirements of Regulation (EU) 2017/745 on medical devices. The CE declaration of conformity can be downloaded from the manufacturer’s website.

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.