Lindhe Xtend Xtend Foot H100 User manual

Xtend Foot H100
Instructions for Use
Distributeur


EN
3Xtend Foot Instructions for Use
Xtend Foot van Lindhe Xtend, distributeur Loth Fabenim B.V.
Contents
1. Xtend Foot .................................................................................................................................. 4
2. Intended Use ............................................................................................................................. 5
3. Patient Indications ................................................................................................................... 6
4. General Instructions ............................................................................................................... 7
5. Patient Instructions ................................................................................................................. 8
6. Cleaning Instructions .............................................................................................................. 9
7. Installation ............................................................................................................................... 10
8. Adjustment .............................................................................................................................. 11
9. Settings and Final Fitting ...................................................................................................... 12
10. Fitting the Foot Shell ............................................................................................................. 13
11. Removing the Foot Shell ...................................................................................................... 14
12. Guarantee ............................................................................................................................... 15
13. Frequently Asked User Questions .................................................................................... 16

EN
4Xtend Foot Instructions for Use
Xtend Foot van Lindhe Xtend, distributeur Loth Fabenim B.V.
Xtend Foot
Figure 1: The foot and its dierent components
A complete foot consists of three main parts:
1) Fibre composite foot:
A) Forefoot laminate
B) Heel laminate
C) Base laminate
D) Pyramid
2) Foot shell
3) Protective sock
1
Figure 2: Size and weight guide
It is important to match the correct foot prosthesis to the right patient. The table
below must be followed when choosing a foot prosthesis. Before connecting the
foot, double check the article number in the table below with the number marked
on the foot’s attachment socket. Always check that the patient’s weight category is
correct.
D
B
C
A
Category Foot size (cm) 23 24 25 26 27 28 29
P3 Max. 60 kg/130 lbs H100-323 H100-324
P4 Max. 80 kg/175 lbs H100-423 H100-424 H100-425 H100-426 H100-427 H100-428 H100-429
P5 Max. 100 kg/220 lbs H100-523 H100-524 H100-525 H100-526 H100-527 H100-528 H100-529
P6 Max. 125 kg/275 lbs H100-625 H100-626 H100-627 H100-628 H100-629

EN
5Xtend Foot Instructions for Use
Xtend Foot van Lindhe Xtend, distributeur Loth Fabenim B.V.
Intended Use
Xtend Foot is a prosthetic foor intended to be used by below-knee or above-knee
amputees and replaces a human foot. The prosthetic foot is designed to be tted to
the remaining prosthetic leg with a pyramid connection.
2

EN
6Xtend Foot Instructions for Use
Xtend Foot van Lindhe Xtend, distributeur Loth Fabenim B.V.
Patient Indications
The prosthetic user is physically disabled and the disability can vary from amputation
of a lower lim to hip amputation.
Double amputees can also use the product. Prosthetic user can also have one or
two amputated or missing arms.
3

EN
7Xtend Foot Instructions for Use
Xtend Foot van Lindhe Xtend, distributeur Loth Fabenim B.V.
General Instructions
4
Review the care and patient instructions with the patient at the time of tting
the product.
Use Lindhe Xtend’s size and weight guide to nd the right product for the
patient.
Only authorised prosthetist may test the product op patients.
If the foot shell should become worn, have it replaced immediately by a
prosthetist.
We recommend having the foot inspected by a prosthetist every six months.
With very active use, shorter service intervals may be necessary.
The foot is water-resistant. If the foot has been exposed to water, both the foot
and foot shell must be rinsed and dried. Make sure, however, that the prosthetic
user does not detach the foot shell from the ber composite foot. This must be
done by an authorised prosthetics.
The foot prosthesis is designed for use in temperatures ranging from -30ºC to
+80ºC.
We recommend the foot is used with socks and shoes as it prolongs the service
life of the foot.
This foot is not developed for jogging, running, jumping or intensive sports
activities.
All adverse events that occurs and are related to this product should be
reported to the manufacturer and the local authority in the country of occurred
event.
After nished life cycle, the product shall be disposed in metal recycling.
If the prosthetic foot will be frequently used in water, a draining hole can be
drilled in the foot shell according to directions in the sketches below.

EN
8Xtend Foot Instructions for Use
Xtend Foot van Lindhe Xtend, distributeur Loth Fabenim B.V.
Patient Instructions
5
If the foot emits any noises, contact a prosthetist as soon as possible to inspect
the foot. This also applies if the foot does not work properly.
Note any change in or loss of function. This includes diminished shock
absorptions or lateral exibility and loss of forward elasticity. Contact your
prosthetist if this occurs, and do not use the product until its function has been
examined.
Remember that it can take up to 14 days to get used to a new foot prosthesis.
Because the foot stimulates a natural pattern of movement, you may
occasionally experience some muscle soreness in the amputated leg when you
begin using it.
If you dramatically gain or lose weight, contact your prosthetist to ensure that
the foot prosthesis ts you.
You should also avoid heavy lifting e.g. heavy rucksacks, as this aects the total
load on the foot. If you often carry heavy loads, it is better to use a foot in a
higher weight class. In this case, talk to your prosthetist about it.

EN
9Xtend Foot Instructions for Use
Xtend Foot van Lindhe Xtend, distributeur Loth Fabenim B.V.
Cleaning Instructions
6
The prosthetic user should clean the outside of the foot shell at least once a
week. We recommend using warm water and a gentle cleaning agent.
If the foot has been exposed to sand or dirt on the inside of the cosmetic cover,
contact your prosthetist as soon as possible for cleaning and inspection.

EN
10 Xtend Foot Instructions for Use
Xtend Foot van Lindhe Xtend, distributeur Loth Fabenim B.V.
Installation
Xtend Foot has three dierent laminates that interact during use to reproduce
sucient energy while the foot compensates for uneven surfaces. The pyramid
ensures correct tting on a connecting leg prosthesis/tublar structure. Thread
locker e.g. Loctite 275 is nedded for the installation.
7
WARNING Only trained personnel such as an prosthetist may install, carry
out maintenance on and t the product on prosthetic users.
WARNING Do not remove the pyramid or modify the foot’s construction.
Any modications made to the product will invalidate the product guarantee.

EN
11Xtend Foot Instructions for Use
Xtend Foot van Lindhe Xtend, distributeur Loth Fabenim B.V.
Adjustment
The foot must be adjusted and adapted to
the patient for the greatest possible comfort.
Observe the following tting instructions to
ensure a proper t.
Dynamic adjustment
Place the foot so the vertical goes through the
back third portion of the foot, as seen from
the side.
Seen from the front, place the foot so the
centre of the knee and the center of the
pyramid are in line between the rst and
second toe.
Xtend Foot is exible on uneven surfaces and
requires no extra adjustment for dierent
surfaces. This is managed by the construction
in the foot itself.
8
Static adjustment
The foot prosthesis is designed for a 10 mm high heel. The foot prosthesis must be
tted in the foot shell when tested on the patient. The unit must be either tted in a
shoe or alternatively a heel wedge can be used to adjust the height correctly when
tting. Centre the pyramid straight ahead and tighten the screws.

EN
12 Xtend Foot Instructions for Use
Xtend Foot van Lindhe Xtend, distributeur Loth Fabenim B.V.
Settings and Final Fitting
The four adjustment screws for the tubular socket adapter must be tightened
evenly using 15 Nm of nominal torque. Secure the adjustment screws when the
right position is achieved using e.g. Loctite 275.
9

EN
13Xtend Foot Instructions for Use
Xtend Foot van Lindhe Xtend, distributeur Loth Fabenim B.V.
Fitting the Foot Shell
Careful handling while tting will extend the function and service life of the foot shell
Never use sharp tools such as screwdrivers to t or remove the foot shell. We also
recommend not to t the foot shell when the patient is wearing the foot prosthesis
10
Do as follows:
Pull the protective sock on over the bre composite foot.
Put the forefoot in the foot shell as far as you can and place a shoe horn
between the end of the heel and inside the foot shell. Assure that the foot shell
is touching the inner bottom surface.
Gently push the heel into position. Make sure the foot ends up straight and in
the appropriate notches on the inside of the foot shell.
Pull away the shoe horn and check that the composite foot’s heel laminate
snaps into the heel lock in the foot shell (See gure A).
Only a Lindhe Xtend foot shell may be used with the bre composite foot.

EN
14 Xtend Foot Instructions for Use
Xtend Foot van Lindhe Xtend, distributeur Loth Fabenim B.V.
Removing the Foot Shell
11
Place the foot on a bench so the heel is sticking out over the edge of the bench.
Press down with your hand on the foot shell heel’s upper, so it snaps out of the
heel retainer. If needed, carefully use a shoe horn to press down on the heel
lock on the inside
The product is not designed for jogging, running, intense exercise such as ball
sports, gym or similar activities. This also applies for jumping and heavy dancing.
This can lead to unacceptable risks.
Do not use the foot without a foot shell. This can lead to unacceptable risk.
Avoid using very acidic and alkaline cleaning agents when cleaning the foot
prosthesis components.
Do not re-use a foot that has been used by another patient. It’s a single user only
device.
Lindhe Xtends foot prostheses are designed with a common pyramid interface.
It is the prosthetist’s responsibility to correctly adapt this interface to other
prosthesis components.
The user may be exposed to new environmental risks if not used to exible foot.
The prosthetic foot is NOT to be altered or modied outside the specications of
the product by the user or orthopedic engineer.
It is not allowed to use a prosthetic foot intended for a lower weight class, this
can lead to unacceptable risks.
A
WARNING:

EN
15Xtend Foot Instructions for Use
Xtend Foot van Lindhe Xtend, distributeur Loth Fabenim B.V.
Guarantee
36-month guarantee from the delivery date applies for the foot structure and
6-month guarantee applies for the foot shell. Failure to follow the user instructions
will invalidate the guarantee. For full details on the guarantee please consult our
General Terms and Conditions for Product Sales.
The orange material is an active material in bre-composite, designed to allow
full lateral exibility. This can cause supercial cracks in the laminate, which is
completely normal, and the foot will maintain its function. Please contact Lindhe
Xtend if you have any questions.
Customer Satisfaction Guarantee
We oer a 30-day money-back guarantee from the consignment date. If you are not
satised, you are entitled to return the item for a full refund.
12

EN
16 Xtend Foot Instructions for Use
Xtend Foot van Lindhe Xtend, distributeur Loth Fabenim B.V.
Frequently Asked User Questions
Q: What is the maximum weight for Xtend Foot?
A: The maximum weight for using the Xtend Foot is 125 kg / 275 lbs (Category P6).
Though there is a maximum weight for each category of the foot, ensuring that
the foot is safe, functional and durable. See the Size and weight guide on page 2.
Q: Which other components, e.g. knee joints, t with Xtend Foot?
A: The interface between Xtend Foot and other systems is a commonly used pyramid
which can be adapted to those systems which are compatible with the pyramid.
Q: The foot is making a noise. How can I correct it?
A: The cause of the noise has to be analysed. Contact your prosthetist. The prosthetist
can remove the foot shell and clean both the bre composite foot and the foot
shell using compressed air or a soft cloth. Inspect the foot for visible damage or
dirt. Also make sure the protective sock is intact and not damaged. Then mount
the foot shell as described above, and re-t it on the patient. If the noise remains,
contact Lindhe Xtend.
Q: Can I run with the Xtend Foot?
A: This foot is not developed for running or other sports activities, so for safety and
durability of the foot we don’t recommend running with Xtend Foot.
13

EN
17Xtend Foot Instructions for Use
Xtend Foot van Lindhe Xtend, distributeur Loth Fabenim B.V.

Contact Loth Fabenim B.V.
De Liesbosch 14-G
3439 LC Nieuwegein, THE NETHERLANDS
Tel: +31 30 27 32 506
Fax: +31 30 27 11 045
Email: [email protected]
www.lothfabenim.nl
Lindhe Xtend AB
Olofsdalsvägen 40B
302 41 Halmstad, Zweden
Tel: +46 (0) 35 262 92 00
Email: [email protected]
www.lindhextend.com
Please contact us if you nd any page missing or disordered.
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