ottobock 3S124 Pre-Shaped Cored Flexed AK Cover Instruction Manual

: June 3, 2024
: ottobock

Table of Contents

3S124 Pre-Shaped Cored Flexed AK Cover
Product description
Intended use
Safety
Scope of delivery
Installing the foam cover
Cleaning
Disposal
Legal information
References
Read User Manual Online (PDF format)
Download This Manual (PDF format)

3R6, 3R24, 3R48, 3S26, 3S27,
3S106, 3S107, 3S124, 6R6, 6R7
Instructions for use
Instruction Manual

3S124 Pre-Shaped Cored Flexed AK Cover

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3R6| 3R15, 3R21, 3R23, 3R30, 3R32, 3R46, 3R49, 3R55
3R24| 3R17, 3R20, 3R33, 3R36, 3R40, 3R95
3R48| 3R38, 3R39, 3R66, 3R67
3S26| 3C60, 3C88-3, 3C98-3, 3B1-2, 3B1-3, 3B1-2=ST, 3B1-3=ST
3S27| 3C98-3, 3B1-2, 3B1-3, 3R15, 3R17, 3R20, 3R33, 3R31, 3R36, 3R60=HD, 3R60-PRO=HD, 3R78,
3R80, 7E4, 7E5, 7E7, 7E9, 7E10
3S106| 3R15, 3R21, 3R23, 3R30, 3R32, 3R46, 3R49, 3R55, 3R93
3S107| 3R31, 3R31=ST, 3R41, 3R60, 3R60=ST, 3R60=KD, 3R60-PRO, 3R60-PRO=ST, 3R60-PRO=KD,
3R62, 3R62=ST, 3R62=1, 3R62=1-ST, 3R62=KD, 3R62=1-KD, 3R78, 3R78=KD, 3R78=ST, 3R80,
3R90, 3R92, 3R93, 3R106, 3R106=ST, 3R106=KD, 3R106-PRO, 3R106-PRO=ST,
3R106-PRO=KD
3S124| 3R17, 3R20, 3R33, 3R36, 3R40, 3R95
6R6| 3R21, 3R23, 3R30, 3R32, 3R46, 3R60=KD, 3R60-PRO=KD, 3R62=KD, 3R62=1-KD, 3R78=KD,
3R106=KD, 3R106-PRO=KD, Transtibial
6R7| Transtibial (⌀ 22 mm)

Product description

INFORMATION
Date of last update: 2021-06-23

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 manu facturer and to the relevant authority in your country. This is par ticularly important when there is a decline in the health state.
Please keep this document for your records.

1.1 Construction and Function
The foam covers are suitable as cosmetic coverings for modular pros theses. They are intended to give the prosthesis a natural, inconspicu ous shape. Depending on the version, the foam covers are suitable for TT or TF prostheses. The foam covers have the following characterist ics:

TT foam covers: Suitable for both sides of the body
Continuous bore hole present. For foam covers for TF pros theses, the knee area depends on the compatible prosthetic knee joint.

These instructions for use apply to the following products:

Reference num ber:| 3R6, 3R24, 3R48, 3S26, 3S27, 3S106, 3S107, 3S124, 6R6, 6R7
---|---

1.2 Combination possibilities
The product is compatible with the specified Ottobock products. The functionality with products of other manufacturers was not tested.

The combination possibilities for the products are shown in the table at the start of the document.

Intended use

2.1 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)

2.2 Lifetime
The product is a wear part, which means it is subject to normal wear and tear.

Safety

3.1 Explanation of warning symbols
CAUTION Warning regarding possible risks of accident or injury.
NOTICE Warning regarding possible technical damage.

3.2 General safety instructions
CAUTION!
Risk of injury and risk of product damage

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 func tion and readiness for use.
Do not use the product if its functionality is restricted. Take suit able measures (e.g. cleaning, repair, replacement, inspection by the manufacturer or a specialist workshop).
Keep the product away from open flames, embers and other sources of heat.
Skin irritation, formation of eczema or infections due to contam ination with germs
Use the product for a single patient only.

NOTICE!
Risk of product damage and limited functionality

Do not allow the product to come into contact with oils, ointments or lotions containing oils or acids.
Do not clean the product.
Ensure the product is functioning reliably and check for wear and tear as well as damage before each use.
Do not continue using a product that is no longer functional or that is worn or damaged.

Scope of delivery

Quant ity	Designation	Reference number
1	Instructions for use	–
1	Foam cover	–

Installing the foam cover

Required materials: degreasing cleaner (e.g. 634A58 isopropyl alcohol), 636N9 contact adhesive or 636W17 plastic adhesive

Measure the length of the foam cover on the prosthesis and add the length allowance.
TT prostheses: Distal allowance for movement of the prosthetic foot.
TF prostheses: Allowance proximal of the knee rotation point for flexion of the prosthetic knee joint and distal allowance for move ment of the prosthetic foot.
Cut the pre-shaped foam cover to length and fit it in the proximal area on the prosthetic socket.
Pull the foam cover over the prosthesis.
Set the connecting element onto the footshell or prosthetic foot.
Depending on the version, the connecting element engages in the edge or rests on the foot adapter.
Install the prosthetic foot on the prosthesis.
Mark the outer contour of the connecting element on the distal face of the foam cover.
Disassemble the prosthetic foot and remove the connecting ele ment.
Clean the connecting element using a degreasing cleaner.
Glue the connecting element onto the distal face of the foam cov er according to the marked outer contour.
Let the glue dry (approx. 10 minutes).
Install the prosthetic foot and adapt the exterior cosmetic shape.
Take into account compression caused by cosmetic stockings or SuperSkin.

Cleaning

The product may not be cleaned.

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.

8.1 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.
8.2 CE conformity
The product meets the requirements of Regulation (EU) 2017/745 on medical devices. The CE declaration of conformity can be down loaded from the manufacturer’s website.

Ottobock SE & Co. KGaA
Max-Näder-Straße 15 · 37115 Duderstadt · Germany
T +49 5527 848-0 · F +49 5527 848-3360
healthcare@ottobock.de · www.ottobock.com