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Strictly comply with your healthcare professional's prescription and recommendations for use.
Check the condition of the affected limb and the state of the skin daily (with particular attention for patients
with sensory deficit).
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CAUTION. For diabetics, the device should only be used with a minimum of 3 mm ( 1 1/8") padding
protection. Seek advice from a healthcare professional.
In the event of discomfort, significant hindrance, pain, variation in limb volume, abnormal sensations or change
in colour of the extremities, remove the device and consult a healthcare professional.
For hygiene, security and performance reasons, do not re-use the product for another patient.
In the event of any modification in the product's performance, remove it and consult a healthcare professional.
Do not use the device in case of application of certain products on the skin (creams, ointments, oils, gels, patches...).
Do not wear the device in a medical imaging machine.
The ability to drive a vehicle with the device must be assessed by a healthcare professional and according to
local regulations.
The systematic use of a sock and a soft insole for protection is recommended when wearing the device.
Do not expose the product to extreme temperatures.
Do not heat, this device cannot be thermomolded.
Do not kneel with the device. Ⓐ
Undesirable side-effect
This device can cause skin reactions (redness, itching, burns, blisters, etc.) or wounds of various degrees of
severity.
Any serious incidents occurring related to the device should be reported to the manufacturer and to the
competent authority of the Member State in which the user and/or patient is resident.
Instructions for use/Application
The device must be worn in shoes with the following features:
• Stiff posterior heel cup sufficiently high to fully encapsulate the foot and the orthosis: recommended height
7 - 7.5 cm (2 3/4 - 3") Ⓑ ;
• Low heel height (< 2 cm (3/4"), 1.1 - 1.3 cm (≈ 1/2") higher than the forefoot area) Ⓒ ;
• Shoe closure system: self-fastening tabs or laces.
Pediatric version:
• Stiff posterior heel cup sufficiently high to fully encapsulate the foot and the orthosis;
• Low heel height;
• Shoe closure system: self-fastening tabs or laces.
Trainers or athletic shoes are the best type of shoes to use with the device.
Preparation of the device by a healthcare professional:
Ensure that the size and the model (right or left) are appropriate for the patient's needs.
Measure the foot length from the heel to the longest toe and/or ask the patient's shoe size.
Choose the appropriate size to fit the patient, referring to the size chart.
If the patient is between 2 sizes, choose the bigger product.
Make sure that the patient's footwear complies with the recommendations.
Sole pattern and trimming:
Note: only the blue translucent area can be cut.
Note: we recommend to wear personal protective equipment during device adjustment.
Make sure when you trim the footplate so that it matches the full template of the shoe, to avoid leaving an edge
under the plantar surface.
If the shoe has a removable inner sole, use it to draw the cutting outline on the device's sole. ❶
If there is no removable inner sole, position the patient's foot to draw the cutting outline on the device's sole. ❷
Use scissors to cut out the device sole along the traced outline. ❸
Recommendation: If scissors are used to alter the device, we recommend that the edges be lightly sanded to
remove any rough edges.
Use a buffing cone or fine grade sandpaper to create a smooth finish on trimmed area(s).
Mortons extension and/or reverse Mortons extension is possible but must be modified by a healthcare
professional.
Fitting the footplate:
Take the inlay out of the shoe, if removable.
Place the device into the shoe ❹ and then the removable insole removed previously. ❺
Ensure the device's foot plate sits flat on the sole of the shoe.
Loosen the shoe laces and slide the foot inside the shoe. ❻
You may use a shoe horn if required.
Check the fit:
Ensure laces or other tightening mechanisms are firmly fastened.
Ensure comfort of foot, with no impingements, prior to use.
Ask the patient to walk.
Care/Maintenance
Product can be washed in accordance with the instructions shown on this leaflet and on the label.
Wash the rigid part with a moist cloth.
If the device is exposed to seawater or chlorinated water, make sure to rinse it in clear water and dry it.
Storage
Store at room temperature, preferably in the original packaging.
Disposal
Dispose of in accordance with local regulations.
COMMERCIAL WARRANTY AGREEMENT AND WARRANTY LIMITATIONS
Thuasne offers a free, limited commercial warranty to the user, in the territory where the device was purchased,
against defects in manufacturing and workmanship for a period of:
- one year for the rigid components.
The limited warranty is effective from the date of purchase of the product by the end-user.
The limited commercial warranty does not apply to any defects in manufacturing and workmanship in case of:
- any damage occurred by a usage outside the normal and intended use of the product as mentioned in the
instructions for use,
- damages occurred as part of attempts to modify the product.
Any deterioration or improper trimming of the product during its modification or adjustment process by the
healthcare professional when fitting device is expressly excluded from this warranty.
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