Ossur VARI-FLEX Bedienungsanleitung

Instructions for Use

VARIFLEX®MODULAR



EN | Instructions for Use 

DE | Gebrauchsanweisung 

FR | Notice d’utilisation 

ES | Instrucciones para el uso 

IT | Istruzioni per l’uso 

DA | Brugsanvisning 

SV | Bruksanvisning 

NL | Gebruiksaanwijzing 

PT | Instruções de Utilização 

JA | 取扱説明書 

Min.Size

“)

Max.











Removal

Insertion











ENGLISH

VARIFLEX®MODULAR FOOT SYSTEM Figure 

• Minimal Clearance mm (“)

• Maximum user weight  kg ( lbs)

• Available in sizes - cm

BENCH ALIGNMENT Figure +

• Fit foot with selected cover.

• Adjust to appropriate heel height (using the shoe).

• Introduce appropriate socket angles flexion/extension and abduction/

adduction.

• Divide the foot cover into  equal portions.

• The load line should fall at the junction of the posterior and the

middle third portions as shown in the diagram (the mark on the brim

of the foot cover matches the one third portion).

CUTTING FOOT MODULE Figure 

Before cutting check for enough clearance

• Measure for length and add mm (“) for T Connector, mm

( /“) when using a pyramid.

Warning: The T Connector/pyramid should only be placed where it

makes full contact with the carbon blade.

• Clamp foot module in vise. Use a sharp fine tooth hacksaw blade.

• Do not cut below the cut limit sticker line the lower cutline for

Tattachment.

• Sand away any sharp edges.

• Secure foot to pyramid or T using C-clamp

• Check height of prosthesis on patient while standing between parallel

bars.

• Cut to final length.

DRILLING FOOT MODULE ATTACHMENT HOLES

• Back-up foot module when drilling using wood block or discarded

carbon fiber section and clamp securely.

• Use drill guide template to locate holes (Figure ).

• Use sharp drill bits. Bullet nose or solid carbide tipped drill bits

suggested.

• Remove template and drill to appropriate hole size.

Drill size:

Cat - ,mm /”

Cat - mm /”

• Drill speed - RPM.

• Feed drill slowly with light intermittent pressure - do not force.

• Foot is now ready for assembly.

USING MODULAR ALIGNMENT ADAPTER

• Attach the cutting adapter to the foot module (Figure ).

• Make sure grit is between adapter and foot module.

• Connect the foot and the cutting adapter to the prosthesis.

• Adjust the cutting adapter to the correct height by sliding it on the

blade.

• Clamp the cutting adapter to the foot module by tightening the

screws to Nm.

• Disconnect the foot module, with the cutting adapter clamped on to

it, from the prosthesis.

• Drill appropriate holes according to "Drilling Foot Module

Attachment Holes" instructions above through the drill bushings

instead of the guide template. Note that the drill bushings can only

accommodate .mm drills.

• Therefore a second drilling with a . drill is required for the larger

categories.

• Mark or measure correct length of foot module.

• Detach cutting adapter from the foot module.

• Cut foot module according to "Cutting Foot Module (Figure )"

instructions above.

• Attach pyramid to foot module.

• Connect the foot module with the pyramid attached to the user.

DYNAMIC ALIGNMENT

The heel stores energy at heel strike, then slowly releasing it to assist

tibial progression to midstance. The forward momentum generated by

this action results in the toe being loaded for optimum energy release at

terminal stance. The heel to toe action can be influenced by

• A-P positioning of foot

• Dorsi-Plantarflexion

• Heel Stiffness

CATEGORY SELECTION CHART

Please refer to the selection charts below to determine the appropriate

stiffness required according to Össur recommendations.

HEEL STIFFNESS

Heel too soft

Symptoms

• Foot will come to flat position too early(amputee feels he/she is

sinking into a hole).

• Extra energy is required to climb up over the toe.

• Toe will feel too stiff.

• Knee may hyperextend.

Actions

• Add polyurethane heel wedge.

• Shift socket anterior (or foot posterior).

Heel too hard

Symptoms

• Rapid heel to toe movement.

• At initial contact the amputee has poor control of his prosthesis.

WEIGHT KG - - - - - - - - - -

WEIGHT LBS - - - - - - - - - -

Low Impact Level          

Moderate

Impact Level Special

Order

High Impact Level         Special

Order

Special

Order

• Minimal energy return feeling.

• Knee may become unstable.

Actions

• Replace heel wedge with a smaller one.

• Shift socket posterior (or foot anterior).

Heel Wedges

The wedge can influence the heel to toe function. Start altering the heel

resistance to improve foot response by adding a heel wedge. The small,

medium and large wedges can be interchanged to customize the

stiffness

and achieve the desired functional characteristics. The wedges can

be trimmed using sharp scissors to customize stiffness.

Temporary Wedge Placement

• Cut the wedge to the width of the foot module.

• Roughen the upper and lower surface of the wedge with abrasive

paper.

• Place the wedge in the angle of heel and foot module with the curved

surface of wedge towards the foot module.

• Secure in position with tape wrapped around the foot module

(Figure ).

Permanent Wedge Placement (Figure )

• Apply adhesive on the lower side of the wedge only ().

• Locate in the foot/heel junction and position before adhesive sets.

• For split toe feet install the heel wedge then remove a thin slice in the

middle by cutting with a sharp knife through the split in the carbon

foot module (Figure ).

Instant adhesive is necessary to bond the urethane heel wedge. The

adhesive cures in - seconds. For removal the adhesive may be

softened by soaking in acetone or cyanoacrylate adhesive remover.

Heel Assembly

If it is necessary to replace the heel the heel component use Loctite 

and torque to following specifications:

Category Bolt Size Heel Bolt Torque

- /“  Nm (ft-lbs)

- /“  Nm (ft-lbs)

Heel Divider

The heel divider should be placed in the last third of the splitted heel

part. To secure its position a drop of instant adhesive can be used on one

side.

FLEXFOOT SOCK

The toe end of the sock is divided by a thread and fits within the toe split.

Upon fitting the sock, hold the top of the toe thread and slide the sock

into the toe split. The thread of the sock should rest on top of foot

module and not underneath the toe split. The sock should be loose from

the heel area and secured proximally with the cable tie provided.

SHOE HORN Figure 

When removing and installing the cover use shoehorn to avoid damage

to foot or cover.

ENVIRONMENTAL CONDITIONS

• Operating temperature: - °C (+ °F) to  °C ( °F).

• Operating humidity: -% relative humidity

• Shipping and storage temperature: - °C (- °F) to  °C ( °F).

Note: The device should always be used with spectra socks and foot

covers to minimize dust and dirt from entering between carbon blades. It

is important to fix the spectra sock around pyramid location in order to

prevent noise issues coming from sand entering between the plates.

WATERPROOF IF USED WITH CARBON TUBE/DIRECTLY LAMINATED

ONTO THE SOCKET

A waterproof device allows use in a wet and/or humid environment and

temporary (< mins.) submersion of up to m in fresh water. Exposure

to fresh water under these circumstances shall have no harmful effect.

Dry thoroughly after contact with fresh water. Fresh water: Includes tap

water. Excludes salt and chlorinated water.

The components used with the foot need to be waterproof as well.

WEATHERPROOF IF USED WITH PYRAMID/T CONNECTOR

A weatherproof device allows use in a wet and/or humid environment

but does not allow submersion. Fresh water splashing against the

enclosure from any direction shall have no harmful effect. Dry thoroughly

after contact with fresh water. Fresh water: Includes tap water. Excludes

salt and chlorinated water.

LIABILITY

The manufacturer recommends using the device only under the specified

conditions and for the intended purposes. The device must be

maintained according to the instructions for use. The manufacturer is

not liable for damage caused by component combinations that were not

authorized by the manufacturer.

COMPLIANCE

This component has been tested according to ISO  standard to two

million load cycles. Depending on the amputee’s activity this

corresponds to a duration of use of two to three years. We recommend

carrying out regular yearly safety checks

ISO 10328 - “P” - “m”kg *)

*) Body mass limit not to be exceeded!

For specic conditions and limitations of use see

manufacturer’s written instructions on intended use!

In the standard mentioned,

test levels (P) are assigned

to a certain maximal body

masses (m in kg). In some

cases, which are marked

with, no test level is

assigned to the product

related maximal body mass.

In these cases, the test loads have been adapted adequately on the basis

of the specified load level.

Category Össur high activity

Category Weight (Kg) Lable text

  P ISO  - P  kg

  P ISO  - P  kg

  P ISO  - P  kg

  P ISO  - P  kg

  P ISO  - P  kg

  P ISO  - P  kg

  P ISO  - P  kg

  P ISO  - P  kg

  P ISO  - P  kg

• This manual is intended for use by a certified prosthetist.

DEUTSCH

VARIFLEX®MODULAR FUSSSYSTEM Abbildung 

• Mindestbauhöhe mm

• Maximales Anwendergewicht: kg

• Erhältlich in den Größen -cm

STATISCHER AUFBAU Abbildung +

• Passen Sie dem Fuß die gewählte Fußkosmetik an.

• Stellen Sie die entsprechende Absatzhöhe ein(mit. Hilfe des Schuhs).

• Wenden Sie die passende Schaftflexion und Absatzhöhe an.

• Teilen Sie den Fuß der Länge nach in  gleiche Abschnitte ein.

• Die Belastungslinie sollte, wie in der Ab- bildung dargestellt, auf die

Trennlinie zwischen dem hinteren und mittleren Abschnitt fallen.

ZUSCHNITT DES FUSSMODULS Abbildung 

• Messen Sie die Länge und fügen Sie den Maßen  mm für Carbon-T,

 mm für Pyramide hinzu.

Achtung: Die T-Befestigung/Pyramide sollte nur dort platziert werden,

wo voller Kontakt zur Karbonplatte besteht.

• Klemmen Sie das Fußmodul in eine Schraub-zwinge. Benutzen Sie

eine feine Metallsäge.

• Nicht unterhalb der Markierung schneiden die untere Linie ist für

Carbon-T.

• Falls notwendig, feilen Sie die Kanten glatt.

• Sichern Sie den Fuß an der Pyramide oder dem T mit Hilfe einer

C-Klemme

• Überprüfen Sie die Höhe der Prothese am Patienten, der dabei am

besten in einem Parallelbarren stehen sollte.

• Kürzen Sie auf entgültige Länge.

BOHREN DER BEFESTIGUNGSLÖCHER FÜR FUSSMODUL

• Stützen Sie das Fußmodul während des Bohrens mit Hilfe eines

Holzblocks oder einem ausgesonderten Karbonfaseranschnitt ab und

klemmen Sie es sicher fest.

• Benutzen Sie eine Bohrlehre um die Positionen der Bohrlöcher

festzulegen (Abbildung ).

• Benutzen Sie einen scharfen Kugelkopfbohrer oder einen Bohrer mit

Karbidbohrspitze.

• Entfernen Sie die Bohrschablone und bohren Sie auf angegebene

Bohrgröße.

Bohrgröße:

Kat - ,mm /”

Kat - mm /”

• Bohrgeschwindigkeit - U/Min.

• Führen Sie den Bohrer mit leichtem, periodischem Druck ein -

wenden Sie keinen starken Druck an.

• Der Fuß ist jetzt bereit für die Verbindung zum T oder zur Pyramide.

ANWENDUNG DES MODULAREN AUSRICHTUNGSADAPTERS

• Befestigen Sie den Schneideadapter am Fußmodul (Abbildung ).

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