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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