4) Ein Handtuch in die Kniekappe stecken und die Kniekappe flach
liegend auf einem Wäscheständer trocknen.
7 Entsorgung
Das Produkt darf nicht überall mit unsortiertem Hausmüll entsorgt
werden. Eine unsachgemäße Entsorgung kann sich schädlich auf die
Umwelt und die Gesundheit auswirken. Beachten Sie die Angaben
der zuständigen Behörde Ihres Landes zu Rückgabe, Sammel- und
Entsorgungsverfahren.
8 Rechtliche Hinweise
Alle rechtlichen Bedingungen unterliegen dem jeweiligen Landesrecht
des Verwenderlandes und können dementsprechend variieren.
8.1 Haftung
Der Hersteller haftet, wenn das Produkt gemäß den Beschreibungen
und Anweisungen in diesem Dokument verwendet wird. Für Schäden,
die durch Nichtbeachtung dieses Dokuments, insbesondere durch
unsachgemäße Verwendung oder unerlaubte Veränderung des Pro
dukts verursacht werden, haftet der Hersteller nicht.
8.2 CE-Konformität
Das Produkt erfüllt die Anforderungen der Verordnung (EU) 2017/745
über Medizinprodukte. Die CE-Konformitätserklärung kann auf der
Website des Herstellers heruntergeladen werden.
8.3 Garantie
Der Hersteller gewährt auf das Produkt eine Garantie ab Versor
gungsdatum. Von der Garantie sind Mängel umfasst, die nachweislich
auf Material-, Fertigungs- oder Konstruktionsfehlern beruhen und in
nerhalb des Garantiezeitraums dem Hersteller gegenüber geltend ge
macht werden.
Nähere Informationen zu den Garantiebedingungen erteilt die zustän
dige Vertriebsgesellschaft des Herstellers.
1 Product description
English
INFORMATION
Date of last update: 2021-08-18
►
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 manu
facturer and to the relevant authority in your country. This is par
ticularly important when there is a decline in the health state.
►
Please keep this document for your records.
1.1 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)
Harmony (454A7, 454A8, 454A9)
The sealing sleeves are coated with a polyurethane gel on the inside.
This gel stands out for its viscoelasticity. The sealing sleeves are
intended for use in combination with outlet valves or vacuum pumps.
The gaiter included in the scope of delivery protects the sealing sleeve
against direct contact with the socket brim.
2 Intended use
2.1 Indications for use
The product is intended exclusively for exoprosthetic fittings after a
transtibial amputation.
2.2 Lifetime
The product is a wear part, which means it is subject to normal wear
and tear.
3 Safety
3.1 Explanation of warning symbols
WARNING
Warning regarding possible serious risks of accident
or injury.
CAUTION
Warning regarding possible risks of accident or
injury.
3
NOTICE
Warning regarding possible technical damage.
3.2 General safety instructions
WARNING!
Risk of severe injuries
►
Store the product out of reach of children. There is a risk of suf
focation 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 contam
ination 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.
4 Scope of delivery
Quantity
Designation
Reference
number
1
Instructions for use
–
1
Sealing sleeve
–
1
Gaiter
454A11
5 Preparing the product for use
5.1 Size selection
1) Determine the circumference at the height of the medial tibial plat
eau.
2)
If required for the sealing sleeve:
Determine the circumference
20 cm above the medial tibial plateau.
3) Select the sealing sleeve size that corresponds to the resulting
measurement. The next smaller size can be chosen as an alternat
ive.
4) Check the fit of the sealing sleeve.
5.2 Assembling
Gaiter
1) Pull the gaiter over the prosthetic socket with the Lycra side
facing in. Position the lower edge of the gaiter about
2.5 cm
below the socket brim.
2) Secure the gaiter on the prosthetic socket with vinyl or polyethyl
ene adhesive tape.
Sealing sleeve
1) Turn the gel side in the lower half of the sealing sleeve inside out.
2) Apply the sealing sleeve to the socket brim and unroll the half that
was turned inside out over the prosthetic socket.
6 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 lubric
ant
►
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.
