ottobock 453A2 Derma Protection Knee Comfort Instructions
- June 3, 2024
- ottobock
Table of Contents
ottobock 453A2 Derma Protection Knee Comfort
Product description
INFORMATION
Date of last update: 2021-08-05
- 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.
Function
Sealing sleeves improve the adhesion of lower limb prostheses and create an
airtight seal on the prosthetic socket. The airtight seal makes it possible to
produce a vacuum in the prosthetic socket.
- Series (reference number)
Derma Protection (453A2), ProFlex (453A3, 453A4), ProFlex Plus (453A30, 453A40)
The sealing sleeves are coated with a copolymer gel on the inside. This gel contains medical-grade white oil. The sealing sleeves can be used on their own or with vacuum pumps.
Intended use
Indications for use
The product is intended exclusively for exoprosthetic fittings after a
transtibial amputation.
Lifetime
The product is a wear part, which means it is subject to normal wear and tear.
Safety
Explanation of warning symbols
WARNING Warning regarding possible serious risks of accident or injury.
CAUTION Warning regarding possible risks of accident or injury.
NOTICE **** Warning regarding possible technical damage.
General safety instructions
WARNING!
Risk of severe injuries
Store the product out of reach of children. There is a risk of suffocation
if the product is pulled over the mouth and nose.
CAUTION!
Risk of injury and risk of product damage
- Keep the product away from open flames, embers and other sources of heat.
- Do not expose the product to temperatures above +80 °C or below –20 °C.
- Make sure the product is applied properly and fits correctly. Improper or excessively tight application can cause pressure points and constriction of blood vessels and nerves.
- Do not continue to use the product if it does not fit properly. Skin irritation, formation of eczema or infections due to contamination with germs
- The product may only be used by one person; reuse on another person is prohibited.
- Observe the cleaning instructions.
- Only use the product on intact skin.
Scope of delivery
Quantity| Designation| Reference
number
---|---|---
1| Instructions for use| –
1| Sealing sleeve| –
Spare parts/accessories (not included in the scope of deliv
ery)
Designation
| Reference
number
Gaiter| 454A11
Preparing the product for use
Size selection
- Determine the circumference at the height of the medial tibial plateau.
- If required for the sealing sleeve: Determine the circumference 20 cm above the medial tibial plateau.
- Select the sealing sleeve size that corresponds to the resulting measurement. The next smaller size can be chosen as an alternative.
- Check the fit of the sealing sleeve.
Assembling
Sealing sleeve
- Turn the gel side in the lower half of the sealing sleeve inside out.
- Apply the sealing sleeve to the socket brim and unroll the half that was turned inside out over the prosthetic socket.
Use
CAUTION
Use of powder (e.g. baby powder or talcum)
Skin irritation on the residual limb and loss of function of prosthetic
components due to clogging with particles or deprivation of lubricant
- Keep the product away from powders.
NOTICE
Mechanical overload
Impaired functionality due to mechanical damage
- Check the product for damage prior to each use.
- Do not use the product if its functionality has been impaired.
- Take any necessary measures (e.g. repair, replacement, inspec tion by the manufacturer’s customer service, etc.).
Donning the prosthesis
- Prerequisite: The liner (and, if necessary, a residual limb sock) has been applied.
- Roll the upper half of the sealing sleeve down to the prosthetic socket.
- If a gaiter is being used: Roll the gaiter down over the socket brim.
- Slide the residual limb into the prosthetic socket.
- If a gaiter is being used: Roll the gaiter up, avoiding wrinkles wherever possible.
- Roll the sealing sleeve up over the knee. Avoid wrinkles, air pock ets and soft tissue displacement as you do so.
Cleaning and Care
NOTICE
Use of improper cleaning agents
Damage to the product due to use of improper cleaning agents
- Only clean the product with the approved cleaning agents.
-
Unroll the sealing sleeve from the prosthetic socket.
-
Hand wash the sealing sleeve in warm water (30 °C) using neutral detergent (e.g. 453H10=1 Ottobock Derma Clean).
NOTICE! Do not wring out the sealing sleeve, as this could damage it. -
Rinse the sealing sleeve thoroughly with clear water until all detergent residues have been removed.
-
Put a hand towel into the sealing sleeve and leave the sealing sleeve to dry lying flat on a drying rack.
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 fitting. 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.