ottobock 2C12 Footshell for Terion Instruction Manual

: June 4, 2024
: ottobock

ottobock 2C12 Foot shell for Terion

ottobock 2C12 Footshell for Terion LOGO

Product description

INFORMATION
Date of last update: 2021-09-15

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 2C12 foot shell is a protective cover for a prosthetic foot. The foot shell has a natural outer shape with an abducted big toe. The toenails are not paintable.

Combination possibilities

Designation	Reference number
Prosthetic foot	Terion 1C10, Terion K2 1C11

Intended use

Indications for use

The product is intended exclusively for lower limb exoprosthetic fittings.

Environmental conditions

Observe the prosthetic foot’s environmental conditions.

Other environmental conditions

UV light| Not resistant
Hydrolysis| Not resistant

Lifetime

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

Safety

Explanation of warning symbols

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

General safety instructions

CAUTION!
Risk of injury and risk of product damage

Note the combination possibilities/combination exclusions in the instructions for use of the products.
Inspect the product regularly for wear and tear. Do not continue using a worn product.
The product may only be used by one person; reuse on another person is prohibited.
Keep the product away from open flames, embers and other sources of heat.

NOTICE!
Risk of product damage and limited functionality

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).
Clean the product promptly each time after it comes into contact with salt water, chlorinated water or abrasive media (such as sand).
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 and by the development of noises.

Scope of delivery

2C12=*

Fig.| Quantity| Designation| Reference number
–| 1| Instructions for use| –
2| 1| Foot shell| –
2| 1| Connection cap| 2C13=*
–| 1| Toe insert| –

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 prosthetic foot or footshell.
Premature wear resulting from damage to the product

Do not grind the prosthetic foot or footshell.

Applying/removing the footshell

Putting on the footshell
R ecommended tools: 2C100 changing device for footshell

Pull the Spectra sock over the prosthetic foot, avoiding any wrinkles.
Slide the prosthetic foot into the footshell. Insert the carbon spring into the slot on the toe insert .
Push the prosthetic foot into the heel area of the footshell until it locks into place .
Place the connection cap on the footshell .

Removing the footshell
Recommended tools: 2C100 changing device for footshell

Push the heel area of the footshell to the rear and pull the prosthetic foot up.
Remove the prosthetic foot from the footshell.

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.

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)

Clean the product with clear fresh water and a pH neutral soap.
Rinse the soap away with clear fresh water.
Dry the product with a soft cloth.
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 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 unauthorized 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.

Technical data

Sizes [cm]| 22| 23| 24| 25| 26| 27| 28| 29| 30
---|---|---|---|---|---|---|---|---|---
Heel height [mm]| 5 ±5
Fit| slim| standard
Weight [g]| 166| 192| 204| 226| 255| 259| 300| 290| 315
Colours| beige (4), light brown (15)