ottobock 647H1658 Derma Protection ArmComfort Instruction Manual

: June 4, 2024
: ottobock

Table of Contents

Description
Indications
Safety
- Explanation of warning symbols
Use and care
Material and Sizes
Disposal
Legal information
Support
Read User Manual Online (PDF format)
Download This Manual (PDF format)

ottobock 647H1658 Derma Protection ArmComfort Instruction Manual

INFORMATION

Last update: 2021-07-01

Please read this document carefully before using the product and observe the safety notices.
Obtain instruction from the qualified personnel in the safe use of the product.
Please contact the qualified personnel if you have questions about the product or in case of problems.
Report each serious incident in connection with the product, in particular a worsening of the state of health, to the manufacturer and to the relevant authority in your country.
Please keep this document for your records.

Description

Derma Protection ArmComfort improves the suspension of the arm prosthesis while offering increased wearing comfort. Derma Protection ArmComfort protects the upper arm from the upper edge of the socket. It is made of a flexible, knitted polyamide fabric and is lined with a coating of polymer gel. The polymer gel is extruded with a medical grade mineral oil that is especially gentle to the skin. This mineral oil is released during wearing and, thus, lubricates the skin.

Indications

For below elbow amputations.

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
Product is pulled over mouth and nose
Danger of suffocation due to lack of oxygen supply

Store the product away from the reach of children.

CAUTION
Reuse on other patients and improper cleaning
Skin irritation, formation of eczema or infections due to contamination with germs

Only use the product for a single patient.
Clean the product regularly

CAUTION
Incorrect or excessively tight application of the product to the body
Risk of pressure points and constriction of blood vessels and nerves due to improper application

Ensure that the product is applied properly and fits correctly.
Do not continue to use the product if there are problems with the correct fit.

CAUTION
Use of the product on damaged skin
Skin irritation, formation of eczema or infections due to contamination with germs

Only use the product on healthy skin.

CAUTION
Contact with heat, embers or fire
Injuries (e.g. burns) caused by melting of the material

Keep the product away from open flame, embers and other sources of heat.

Use and care

NOTICE

Damage due to incorrect environmental conditions. Do not expose your product to temperatures above 40 °C/104 °F (e.g. thermal impact caused by hot water, drying on a radiator).

This would destroy or damage the product.

Roll the Derma Protection ArmComfort inside out to the foam base then roll this section onto your residual limb. (Illus.1 and 2).
Roll the bottom end inside out. (Illus.3)
Pull on the prosthesis and roll the Derma Arm-Comfort down over the prosthetic socket. (Illus.4).
The polymer gel must not be in contact with the cosmetic glove. If necessary shorten the cosmetic glove accordingly.
Before removing the prosthesis, roll the upper edge of the Derma Protection ArmComfort down and onto the prosthetic socket (Illus.5 and 6). When later donning the prosthesis, simply roll it back onto the upper arm.

Derma Protection ArmComfort may be washed as needed in warm water (approx. 30 °C/86 °F using a mild detergent. Do not wring.
Rinse thoroughly with clear water. Drying time may be longer for the polymer layer.
Drying time may be shortened by drying it with a hand towel. Lay to dry flat either on a rack of towel.

Do not wear your Derma Protection ArmComfort until fully dry!
We recommend that you have two Derma ArmComforts on hand so you will always have one to wear that is clean and dry.
If the suspension of the polymer gel should diminish, lightly powder the inside of your Derma ArmComfort
For hygienic reasons, and to allow air to reach the skin, we recommend that you not wear the Derma Protection ArmComfort for at least a few hours per day.

INFORMATION
To avoid folds and creases in the inner polymer-gel lining, your Derma Protection ArmComfort should always be stored rolled on its foam bed.

Material and Sizes

Flexible, knitted polyamide fabric and polymer-gel-coated lining.

Article no.

| For|

Size

---|---|---
453A1| Adults| Universal size
453A1=1| Children| Universal size

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 disregard of this document, particularly due to improper use or unauthorised modification of the product.

CE conformity

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