ottobock AxonSkin Natural Visual + Black Instruction Manual
- October 27, 2023
- ottobock
Table of Contents
*8S500= AxonSkin Visual + Black,
8S501=, 8S502= AxonSkin Natural**
Instructions for use (patient)
Product description
INFORMATION
Date of last update: 2021-05-25
- 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 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.
The AxonSkin prosthetic glove is used as a protective glove for a prosthetic hand.
| Designation | Reference Number |
|---|---|
| Prosthetic hand | 8E500=/8E550= Michelangelo Hand |
The PVC material is characterized by robustness and durability.
8S501=, 8S502= AxonSkin Natural
The 8S501= AxonSkin Natural is intended for men, the 8S502= AxonSkin Natural
is intended for women.
Its appearance is based on a real hand in order to achieve a high degree of
naturalness.
The prosthetic glove is cultured by hand, giving rise to possible variations
in appearance, which are not a product defect.
The fingernails can be painted with nail varnish.
8S500=-M0 AxonSkin Visual, 8S500=-M20 AxonSkin Black
The 8S500=-M0 AxonSkin Visual is translucent, making the prosthetic hand
visible. The 8S500=-M20 AxonSkin Black is completely black. Both have
specific zones on the fingertips and palms, which improve grip.
Intended use
2.1 Indications for use
The product may only be used as part of an upper limb prosthesis with
Michelangelo Hand.
2.2 Area of application
The product has been developed for use in everyday activities. It must not be
used for activities where it would be exposed to unallowable environmental
conditions or strains (e.g. extreme sports).
2.3 Environmental conditions
Allowable environmental conditions
Allowable operating temperature: -10 °C to +60 °C (+14 °F to +140 °F)
Allowable storage temperature: -20 °C to +40 °C (-4 °F to +104 °F)
Allowable transport temperature: -20 °C to +60 °C (-4 °F to +140 °F)
Allowable relative humidity: max. 80%
Cleaning agents: warm water and soap, 640F12 Special Cleaner, nail varnish
remover (acetone-free)
Unallowable environmental conditions
Mechanical vibrations or impacts, touching of sharp-edged or pointed objects
Contact with acids, unallowable cleaning agents, abrasive media (e.g. sand),
damp soil, dust, dirt, highly staining materials (e.g. printing ink, new
textiles), solvents (e.g. thinner, acetone, petrol), fire, embers and
unallowable heat (> +60 °C / > +140 °F)
2.4 Lifetime
The product is a wear part, which means it is subject to natural wear and
tear. The lifetime dimming ashes or increases depending on the individual
level of use. Only when the instructions for use are observed it is possible
to achieve the maximal lifetime, in dependence of the level of use.
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
Using the product without following the instructions for use
Injuries caused by damage to the product or malfunction of the product
- Only use the product by following the instructions for use.
Use
4.1 Information for everyday use
CAUTION
Prosthetic glove is too long and lies on the skin when wearing the prosthesis
Skin irritation due to constant contact with the prosthetic glove
- Have the qualified personnel shorten the prosthetic glove so that it does not lie on the skin when wearing the prosthesis.
CAUTION
Contact with heat, embers or fire Injuries (e.g. burns) and damage to the
product due to unallowable environmental conditions
- Keep the product away from open flames, embers and other sources of heat.
NOTICE
Non-observance of allowable environmental conditions
Damage to product and soiling due to unallowable environmental conditions
- Do not expose the product to unallowable environmental conditions (see the section “Envier omental conditions”).
- If the product has been exposed to unallowable environmental conditions, check it for soiling and damage.
- Clean the product immediately if it gets dirty, following the instructions in the section “Cleaning”, in order to prevent permanent soiling.
- If damage is apparent or in case of doubt, do not continue using the product.
NOTICE
Careless use of the product
Damage to the product due to contact with pointed or sharp-edged objects
-
Do not allow the product to come into contact with the above mentioned objects.
The sections “Area of application” and “Environmental conditions”, as well as the safety information, contain important information regarding the safe use of the product and point out how dam age to the product can be avoided.
The following points provide suggestions how problems that occur in daily use can be addressed: -
Safe handling of the product
A prosthetic glove enables the use of the prosthetic hand in everyday life. Practical exercises are required within a course of therapy to become familiar with the product, which makes it possible to use the product safely in a wide range of situations. -
Prevention of soiling and damage
A range of activities (e.g. in the house and garden) can cause soiling or damage to the pros thetic glove due to unallowable environmental conditions. It is nevertheless possible to per form these activities by taking corresponding protective measures (e.g. putting on working or safety gloves) and exhibiting due care and attention. Because it is not always possible to avoid light soiling, regular and immediate cleaning is required to keep the prosthetic glove clean. In order to reduce bleeding, strongly cultured clothing should be washed according to the manufacturer’s recommendations before being worn for the first time. Using caution when handling closured pens, printers and copiers as well as printed matter (e. g. newspapers, photocopies) is important in order to avoid pigment particles from permanently staining the material.
4.2 Cleaning
NOTICE
Non-observance of cleaning instructions
Damage to product and permanent soiling due to use of improper cleaning agents
- Only clean the product according to the cleaning instructions provided in the instructions for use.
Light soiling
Materials required: warm water, soap, cloth, lint-free cloth
- Clean the product with warm water, soap and a cloth.
- Rinse off soap residues with water.
- Dry the product with a lint-free cloth and allow it to air dry fully.
Heavy soiling
> Materials required:
640F12 Special Cleaner, 640F13 Pump Sprayer, clean, undyed cloth (e.g.
cellulose, linen), water, lint-free cloth
-
NOTICE! Clean the product promptly to avoid heavy dirt from permanently contaminating the material.
Spray the special cleaner on to the soiled area of the product and leave to take effect for a short time. -
Wipe off the dirt from the product with a clean, undyed cloth using light pressure.
-
Rinse off residual cleaner and dirt with water.
-
Dry the product with a lint-free cloth and allow it to air dry fully.
Removal of nail varnish
> Materials required:
Nail varnish remover (acetone-fee), clean, undyed cloth (e.g. cellulose,
linen), water, lint-free cloth
- Remove the nail varnish from the product with nail varnish remover and a clean, undyed cloth, using light pressure.
- Rinse off residual cleaner and dirt with water.
- Dry the product with a lint-free cloth and allow it to air dry fully.
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. bserve 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.
6.1 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.
6.2 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.
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
© Ottobock · 647H898=all_INT-14-2105