Ottobock 2c3-1 Footshell Trias Instruction Manual

2C3-1, 2C15
Instructions for use

Product Description

INFORMATION
Date of last update: 2021-05-26
► Please read this document carefully before using the product and observe the safety notices.
► Instruct the user on 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 particularly important when there is a decline in the health state.
► Please keep this document for your records.
1.1 Construction and Function
Foothills are pulled over compatible prosthetic feet. They are required for using the prosthetic feet and give them their natural exter­ior shape. This document applies to the following foot shells: 2C3-1, and 2C15.
The toenails are not paintable.
1.2 Combination possibilities

• Observe the prosthetic foot instructions for use.

Intended use

2.1 Indications for use
The product is intended exclusively for lower limb endoprosthetic fit­tings.
2.2 Environmental conditions
Observe the prosthetic foot’s environmental conditions.

2.3 Lifetime
The product is a worn part, which means it is subject to normal wear and tears.

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
Improper 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 of a worn product and reuse on another patient
Risk of injury due to loss of functionality as well as damage to the product
► Inspect the product regularly for wear. Do not continue using a worn product.
► Only use the product for a single patient.
CAUTION
Contact with heat, embers, or fire
Risk of injury (such as burns) and risk of product damage.
► Keep the product away from open flames, embers, and other sources of heat.
NOTICE
Use under unallowable environmental conditions
Damage to the product due to unallowable environmental conditions
► Do not expose the product to unallowable environmental condi­tions.
► 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.).
NOTICE
Contact with salt water or water containing chlorine as well as abrasive substances (e.g. sand)
Damage and premature product wear and tear
► Promptly clean the product following any contact with the sub­ stances identified above.
NOTICE
Mechanical damage to the product
Change in or loss of functionality due to damage
► Use caution when working with the product.
► If the product is damaged, check it for proper function and readi­ness 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 functional­ity during use” in this section).
► Take any necessary measures (e.g. repair, replacement, inspection 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 and by the development of noises.

Scope of delivery

Preparing the product for use

CAUTION
Incorrect alignment or assembly
Risk of injury due to damaged prosthetic components
► Observe the alignment and assembly instructions.
NOTICE
Grinding the foot shell
Premature wear resulting from damage to the foot shell
► Do not grind the foot shell.
► Inform the patient.
5.1 Applying/removing the foot shell
Putting on the foot shell
> Recommended tools: 2C100 changing device

1. Slide the prosthetic foot into the foot shell.
2. Press the heel of the prosthetic foot into the foot shell until it engages.

Removing the foot shell
> Recommended tools: 2C100 changing device

1. Push the lock of the foot shell to the rear and pull up the heel of the prosthetic foot.
2. Remove the prosthetic foot from the foot shell.

Use

CAUTION
Use of the product without shoes
Risk of injury due to slipping on slippery surfaces
► Do not use the product on slippery surfaces.
6.1 Cleaning
CAUTION
Use of unsuitable cleaning agents or disinfectants
Impairment of functionality and damage due to incorrect cleaning agents or disinfectants
► Only clean the product with the approved cleaning agents.
► Only disinfect the product with the approved disinfectants.
► Observe the instructions for cleaning and care.
> Recommended cleaning agent: pH neutral soap (e.g. 453H10 Derma Clean)

1. Clean the product with clear fresh water and pH-neutral soap.
2. Rinse the soap away with clear fresh water.
3. Dry the product with a soft cloth.
4. Allow to air dry in order to remove residual moisture.

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 a 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 unauthorized 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.

Technical data

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Ottobock SE & Co. KGaA
Max-Näder-Straße 15 · 37115 Duderstadt · Germany
T +49 5527 848-0 · F +49 5527 848-3360
[email protected] · www.ottobock.com
Otto Bock HealthCare LP
3820 West Great Lakes Drive
Salt Lake City, UT 84120 · USA
T +1 800 328 4058 · F +1 800 655 4963
© Ottobock · 647G1740=all_INT-01-2105

References

• Welcome to Ottobock. We help people regain their movement.