perpedes Diana D1 User manual

ES — INSTRUCCIONES DE USO— ZAPATOS PARA DIABÉTICOS
COMERCIO ESPECIALIZADO + CLIENTE FINAL
NL — GEBRUIKSAANWIJZING — DIABETISCHE SCHOENEN
VAKHANDEL + EINDGEBRUIKER
FR — INSTRUCTIONS D´UTILISATION — CHAUSSURES DIABÉTIQUES
COMMERCE SPÉCIALISÉ + CLIENT FINAL
DE — GEBRAUCHSANWEISUNG — DIABETIKER-SCHUHE
FACHHANDEL + ENDKUNDE
DIABETIC SHOES
INSTRUCTIONSFORUSE
ORTHOPEDIC/PODIATRIC RETAIL + END CONSUMER/PATIENT

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DEUTSCH FRANÇAIS NEDERLANDS ESPAÑOL ENGLISH

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CONTENTS
Introduction ......................................................................................
Product description ........................................................................
Purpose/Indications .......................................................................
Potential risks of use and contraindications .............................
Instructions for use /
Assembly instructions for retailers...............................................
Instructions for use for the patient .............................................
Safety instructions and residual risks .........................................
Cleaning and care .............................................................................
General guidelines ...........................................................................
Technical specications/Parameters ........................................
Marking ............................................................................................
Disposal/Warranty ........................................................................
For visually impaired people, this document can be
downloaded as a PDF at www.perpedes.de.
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INTRODUCTION
Dear clients,
Please read the instructions carefully before using this
product. Follow all instructions, particularly the safety
notes in this manual.
Perpedes GmbH
Haertwasen 8-14
73252 Lenningen
Germany
T: [phone]
[email protected]
www.perpedes.de
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PRODUCT DESCRIPTION
Perpedes diabetic shoes have been for diabetic patients deve-
loped. The models are available in three widths to accommo-
date feet of different shapes and sizes. The last was developed
using English half sizes for a more extensive selection of
sizes to ensure the perfect t for each patient. All models offer
sucient depth to accommodate custommade, diabetic foot
orthoses.
All diabetic shoes models have the following features:
• Closed upper
• Sucient depth for the entire foot
• Low heel height
• Low heel pitch
• Sole with incorporated rocker for forefoot relief and shock
absorption
• Padded upper edge
• Rigid / stiff sole
• Padded tongue
• Seamless forefoot area
• Cleanable textile lining
• Velcro fasteners or laces
• Available in 3 widths
• Weather-resistant upper material made of leather
• Non-slip outsole
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PURPOSE/INDICATIONS
Diabetic shoes are designed for diabetic patients. Their main
purpose is to reduce pressure points and to achieve even pres-
sure distribution on the sole of the foot.
Perpedes diabetic shoes are appropriate for the following
indications:
• Diabetic polyneuropathy (PNP) with pronounced loss of
sensitivity
• Pronounced angiopathy (circulatory disorders)
• Existing or healed plantar ulcers
• To avoid ulcer recurrence
• To prevent pressure points and chang
• Diabetes mellitus with peripheral arterial occlusive disease
(PAOD) in combination with loss of sensitivity (PNP)
• Dorsal ulcer caused by ready-made footwear with inade-
quate toe boxes, e.g. due to pronounced claw / hammer
toes
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POTENTIALRISKSOFUSEANDCONTRAINDICATIONS
• Active Charcot neuroarthropathy
• Resection of the rst metatarsal
• Extensive toe amputations and transmetatarsal
amputations
• Contralateral major amputations
• Motor function limitations / paresis of one or both legs
• Atrophy in hip/knee/ankle joint muscles or joint implant
with functional impairment / contracture
• Extreme obesity (BMI > 35)
• Renal failure requiring dialysis
• Highly unsteady gait and standing posture
• Considerable visual impairment that affecting visual
perception
• Acute lesions
• Charcot foot
• Bone necrosis
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INSTRUCTIONS FOR USE/ASSEMBLY
INSTRUCTIONS FOR RETAILERS
Before the rst use, the diabetic shoe must be adjusted to the
patient‘s needs by qualied personnel. At the time of delivery,
the qualied personnel is responsible for the correct t and
function.
Qualied personnel means any user who is a qualied medical
product advisor or any other person authorized under national
law to provide and supply this medical product. Product liability
cannot be guaranteed if this step is omitted.
The following steps must be carried out by qualied personnel
before the rst use:
• Determination of the correct shoe length using customary
measuring equipment (blue print as well as measuring inst-
ruments), as well as the length and width chart provided
• Measurement of the ball girth by means of a measuring
tape. Determination of the correct width using the deter-
mined values and the sizing chart
• Determination of the area of application in comparison
with the clinical picture
• Removal of the shoe llers and tting the shoes to the
patient’s feet
• Adding diabetic foot beds to compensate for swelling or
soft cushioned soles. Pay attention to the correct t
• If necessary, adjustment of the upper material, e.g. of the
pressure-distributing, custom made Velcro straps
• If necessary, adjustment of the shoe sole, e.g. compen-
sation of leg length discrepancies, wedges to inuence
eversion or inversion
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• Carrying out a gait and motion analysis
• Providing the patient with instructions for handling and
care (laces / Velcro fasteners, daily inspection of the inner
shoe for foreign objects)
• Depending on the clinical picture, it is recommended to
perform in-shoe pressure measurements with diabetic foot
orthoses at regular intervals, if applicable
• Point out that the shoes should only be worn for a few
hours at a time at rst to get used to them
• The shoes may only be worn with socks
INSTRUCTIONS FOR USE
Perform the following steps to correctly put on the diabetic
footwear; this procedure has to be followed every time. The
qualied personnel is required to teach the patient how to
handle the product correctly:
1. Open the shoes wide and fold the tongue forward.
2. Check the shoe for foreign objects and remove them
before putting on the shoe. Check all parts of the shoe daily
for damages.
3. Step into the open shoe.
4. Ensure that the foot is positioned securely / correctly in
the shoe, i.e. the heel must be positioned as far back in
the shoe as possible. The foot must t completely into the
shoe with a diabetic foot orthosis.
5. Please make sure that the tongue is correctly positioned to
prevent pressure and friction.
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6. Close the shoe with Velcro straps or laces, depending on
the model. The foot needs to be well secured and the shoe
shouldn’t be too loose or too tight.
7. The therapeutic benet, the condition of the footwear with
regard to possible signs of wear and tear as well as the
t must be regularly checked and assessed by qualied
personnel.
8. Get a gait analysis by qualied personnel.
9. Slowly break the shoes in by walking on even surfaces,
starting with a few minutes and gradually increase wearing
time
10. After taking off the shoe, inspect the feet for possible skin
irritations, lesions or other signs of ill-tting or worn mate-
rials. Use a mirror to check the soles of the feet, if needed.
11. The shoes may only be worn with socks.
SAFETY INSTRUCTIONS AND RESIDUAL RISKS
Fitting, adjustment and instructions on the diabetic
protective footwear must be carried out by qualied
personnel only.
The product is intended for use by one patient only.
If you experience pain, swelling, redness, numbness
or changes in sensitivity, unusual reactions or
discomfort while wearing the shoe, please contact your
treating physician or orthotist, pedorthist or similar
immediately.
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If the product is damaged, please replace it
immediately or have it repaired by qualied personnel.
Depending on the country and its health insurance
system, diabetic protective footwear may require a
physician‘s prescription and should be worn under
medical supervision. It may only be used in accordance
with the instructions in this manual and for the intended
purpose.
Icy surfaces or a damp outsole can increase the risk of
slipping. Be particularly careful when using the product
for the rst time and get used to it on even and rm
ground.
After processing the diabetic foot bed, internal pressure
measurements must be carried out on a regular basis
(follow-up check).
Footwear materials are subject to natural aging and
the mechanical stress of daily use, which can lead to
material fatigue or damage. Therefore, check the shoes
and foot orthoses daily for signs of wear.
The product must not be used in water and must be
protected from moisture (impaired function).
The product must be protected from heat and direct
sunlight as this may affect the color and function of the
shoes.
The product must be kept away from re and heat
sources as this may cause material damages.
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CLEANING AND CARE
To prolong the life of the product, dirt should be removed after
each use by means of a soft, at most slightly damp brush.
Do not use any cleaning agents or solvents.
If the inner lining is soiled, it can be wiped off with a damp
cloth or mild disinfectant. Please note that the treatment
can change the appearance of the shoe. The function and
properties will not be impaired. Please test disinfectants on an
inconspicuous area rst!
Never clean shoes in a washing machine.
Air dry the shoes at room temperature with good ventilation,
away from a heat source or direct sunlight.
Sand and salt water can damage the diabetic footwear. Clean
the shoes thoroughly if they have been exposed to such condi-
tions.
LEATHER
Leather is a natural product. To prevent the aging of leather,
we recommend using good quality leather cleaners and
conditioners.
Please note that the treatment can change the appearance
of the shoe. The function and properties will not be impaired.
Please test care products on an inconspicuous area rst. The
color of the leather may bleed.
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SHOE LINING
It is recommended that the lining and the inside of the shoe
are cleaned regularly and disinfected with a mild
disinfectant.
SHOELACES
Shoelaces and other fasteners are used daily and are therefore
prone to wear out. If necessary, they should be replaced to
ensure that the footwear functions and ts properly.
VELCRO FASTENERS
Velcro fasteners must be kept clean to work properly. Clean
them regularly and seek replacements for worn fasteners if
necessary.
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GENERAL GUIDELINES
Check the diabetic footwear for foreign objects, creases,
wear and tear and damage before each use. The functional
properties may deteriorate with repeated use (wear and tear).
It is therefore impossible to predict the product’s lifespan and
period of use. The shoes should be replaced or repaired when
worn out.
In view of the indication-related selection, the individual adap-
tations and for hygienic reasons, diabetic shoes may be used
by one patient only. It is not possible to reuse the shoes for
another patient.
The diabetic shoes can be used in combination with other
medical products. However, a combination is only permitted
with diabetic foot orthoses that have been selected and
adjusted by qualied personnel in accordance with the
indication. Modied shoes are regarded as custom-made
products.
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TECHNICAL SPECIFICATIONS/PARAMETERS
Materials may vary depending on the shoe style and type:
• Upper leather tested for harmful substances
• Upper material made of microber or polyacrylic
• Lining made of a combination of polyamide and
polyurethane
• Inner soles made of polypropylene nonwoven fabric with
an acrylic berglass reinforcement
• Outsoles made of ethylene vinyl acetate (EVA),
polyurethane (PUR), thermoplastic rubber (TR) or
thermoplastic polyurethane (TPU)
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MARKING
Important information and safety-relevant markings can
be found on the nameplate on the shoe box. All signs and
symbols are explained in the following table.
Diana D1 UK 5,0
D1AB1050
20-380-000005
MADE IN EU
Perpedes GmbH
Haertwasen 8-14
D-73252 Lenningen
Illustrations similar
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1Diana Model designation
2D1 Width specication
3UK 5.0 Size indication (UK sizes)
4Item number
5Batch designation
6CE marking
7Medical device
8Materials used for upper
9Materials used for outer sole
10 Materials used for lining & sock
11 Perpedes GmbH
Haertwasen 8-14
D-73252 Lenningen Manufacturer
12 MADE IN EU Country of manufacture
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2020-01
Date of manufacture
The size and width of each model is displayed on the inside of
the tongue.
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DISPOSAL
Product and packaging can be disposed of in
accordance with the legal requirements of the corresponding
country of use.
WARRANTY
The currently valid legal regulations apply. Non-compliance
with the instructions for use, improperly performed cleaning,
unauthorized technical alterations and additions to the product
lead to the expiration of the warranty and the product liability
in general.
The CE marking conrms conformity with the relevant
requirements of the medical device regulations in
accordance with the declaration of conformity. The
valid declaration of conformity can be found in the
download area on our homepage.
All serious incidents relating to the product shall be
reported immediately to the manufacturer and the
competent authority.
Perpedes GmbH
Haertwasen 8-14
73252 Lenningen
Germany
T: [phone]
[email protected]
www.perpedes.de
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