Diabeticus + Rheumaticus

Instructions for use

Diabeticus + Rheumaticus®

for patients and orthopaedic staff

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Dear customers,

With these shoes you have acquired a high-quality class I medical device as defined in the Medical Devices Regulation (MDR) EU 2017/745. Since you should take care of your shoes just as much as you take care of your feet, we will give you some tips here on how to care for them and handle them.

Before using our medical product, please read carefully through the instructions for use and note the following information:

Intended purpose / indication:

  • Diabetes mellitus with pronounced neuropathy (loss of sensation) and/or pronounced angiopathy (circulatory disorders) polyneuropathy / peripheral arterial occlusive disease
  • Diabetes mellitus with healed ulceration and/or other mechanical irritations leading to regional pressure peaks
  • Diabetes mellitus with partial foot amputation
  • Minimising the risk of threatened dorsal ulceration
  • Place of use / conditions for use:

  • The street shoes are for outdoor use only and the indoor shoes for indoor use only.
  • These special shoes are wearable in various different temperature and weather conditions. However, they do not protect against cold or heat. Dry the shoes after use in the rain. (See care instructions).
  • Caution: There is an increased risk of slipping on wet or slippery surfaces and ice or snow. The outsoles do not provide sufficient grip here.
  • Instructions for use:

  • Always wear socks to prevent skin irritations.
  • Always use a shoehorn to put your shoes on.
  • Always close the fasteners well so that the function of the shoes is fully guaranteed.
  • To avoid pressure marks and circulatory problems, do not fasten or lace the shoes too tightly.
    Check the fastening right away and adjust it if necessary.
  • We recommend changing shoes after one day’s wear.
  • Your doctor will decide how long and how frequently the shoes should be worn.
  • Discuss with your doctor whether there are any impediments on particiaption in road traffic that need to be taken into account.
  • The shoes are a medical product which is always intended for one particular patient only. They should not be used by any other person.
  • Safety notice for patients:

    Please read our instructions before wearing Diabeticus + Rheumaticus shoes, and especially before wearing them for the first time:

  • Feel inside the shoes each time before you wear them and remove any foreign objects.
  • Never wear the shoes without Thanner insoles or special insoles from your orthopaedic shoe supplier.
  • New shoes should only be worn for a short while to begin with. Check your feet for pressure marks after 20 minutes. The time and duration of daily use will be decided by your doctor.
  • If any pressure marks, pain or other negative phenomena arise, consult your doctor or orthopaedic shoe supplier immediately.
  • Possible risks and contraindications, possible requirements for higher-level care:

  • Major amputation
  • Arthropathy in hip / knee / upper leg or joint implant with functional impairment / contracture
  • Amputation of big toe / resection of metatarsus
  • Paresis of one or both legs
  • High degree of insecurity when walking and standing
  • Extreme obesity (BMI ≥ 35)
  • Renal failure requiring dialysis
  • Significant visual impairment
  • Acute lesion (ulcer or ongoing florid DNOAP)
  • If you suffer from a skin allergy to any of the materials used, consult your doctor before use.
  • Material information:

  • Upper leather made of calf nappa, calf nubuck or cowhide tested for harmful substances
  • Microfibre or synthetic upperk
  • Lining: Diasoft-3D biocompatible microfibre with spacer fabric
  • Insole made of polyester fleece or polyester fleece with polypropylene
  • Outsole made of EVA, PU, LTPU or EVA rubber
  • No intentional use of latex or DEHP
  • Cleaning, care, storage and disinfection instructions:

    Cleaning:

  • Shoes made of suede or microfibre should be treated with the impregnation spray and cleaned with a fine crepe or wire brush.
  • Smooth leather shoes should also be treated with suitable impregnation sprays and cleaned with an appropriate brush.
  • The lining can be cleaned out with a damp cloth if it is very dirty.
  • Disinfection:

  • For diabetics, we recommend using a suitable disinfectant to clean the lining of the shoes (This can be obtained from a chemist, for example).
  • Do not use disinfectant on the leather uppers.
  • The shoes are not sterile and not suitable for sterilisation.
  • Drying:

  • Never put wet or damp shoes directly next to a heat source.
  • Avoid radiators and direct sunlight for drying the shoes.
  • Stuff wet or damp shoes with newspaper or use a suitable shoe tree.
  • Give your shoes time to dry. This can take a day or two depending on how much moisture the shoes have absorbed.
  • Leather care:

  • To keep the leather supple, the shoes should be treated regularly with nutrients. Different types of leather should be treated with the appropriate shoe care products.
  • Protect from sunlight.
  • Keep and store the shoes in a dry place.
  • Do not wash the shoes in the washing machine. Do not bleach them or iron them.
  • General tips / maintenance:

  • The shoes should be changed after one day of wearing.
  • If there is a loss of function or excess wear and tear or damage, you should stop wearing the shoes and consult your doctor or orthopaedic shoe supplier.
  • Disposal:

  • The disposal of the product and its packaging should comply with the legal regulations.
  • Storage:

  • Store the shoes at room temperature in a dry cupboard.
  • Guarantee:

  • We guarantee the statutory warranty provided that the shoes are worn as intended.
  • No liability for improper handling.
  • The service life and durability of the shoes is three years given intended use and normal care.
  • Instructions for use for orthopaedic staff:

  • Determine the length of the shoe (by creating a blueprint of the foot or using a measuring device) with the aid of the insole contour sheet supplied and add at least 1.5 cm. Important: sandals must be chosen at least 1 size smaller (except Grandessa models, for which there is a separate last 935/945).
  • Take the ball measurement (using a tape measure) to determine the correct width. Compare with the measurement table.
    For a cushioned footbed with a thickness of 1 cm, 2 cm must be added to the patient's measurement. Select the correct width.
  • Remove the filling material (e.g. paper) from the shoes and have the patient try them on.
  • Change the inserts or instal therapeutic elements depending on the purpose and indication.
  • If necessary, adapt the upper material (e.g. cut out sections, widen, correct the length of the Velcro).
  • If necessary, adapt the sole (e.g. modify the position, correct the roll, compensate for shortening).
  • Instruct the patient in the handling of the shoe (laces; Velcro closures; checking for foreign objects that may cause injury) and shoe care.
  • After a given period of wear, check the therapeutic benefits.
  • Construction and assembly instructions:

  • Remove the filling material (e.g. paper) from the shoes and have the patient try them on.
  • Change the inserts or instal therapeutic elements depending on the purpose and indication. .
  • If necessary, adapt the upper material (e.g. cut out sections, widen, correct the length of the Velcro).
  • If necessary, adapt the sole (e.g. modify the position, correct the roll, shortening compensation).
  • With individual alterations to the product, we point out that the accessory must be marked permanently as 'custom-made'.
  • Type plate

    • Pictograms can be found in the shoe as follows:
      • Obermaterial Upper material
      • Obermaterial Lining + footbed liner
      • Obermaterial Outsole
      • Obermaterial Leather
      • Obermaterial Textile
      • Obermaterial Other
    • The size and width are stamped on the insole:
      • e.g. 41
      • SS or XS
      • =
      • extra narrow
      • S
      • =
      • narrow
      • M
      • =
      • medium
      • W
      • =
      • wide
      • WW
      • =
      • extra wide
    • The name of the model, the size, width, material and colour are listed on the shoe box and the following are also designated:
      • BATCH/LOT: e.g. 1644609 = production lot number, batch (manufacturer's number enabling the batch / lot to be identified).
      • Medical Device
      • Manufacturer of the product
      • CE Marking = confirmation of compliance with EU requirements

    Notice for blind and visually impaired persons

    You can have the instructions for use read out to you on our website under the following link:

    https://www.thanner-gmbh.com/gebrauchsanweisung/dia_en.php


    Basis-UDI: 42518308DiabeticusschuhZP

    Pursuant to Section 86 of the German Medical Devices Act (MPDG), the product group "Diabeticus + Rheumaticus®" is listed in the information system for medical devices at the Federal Institute for Drugs and Medical Devices (BfArM) under the registration number DE/CA61/RvS-SG53-2697.2-26/1-8.

    Please inform THANNER GmbH of any issues, problems or shoe deficiencies.

    We wish you much pleasure
    while wearing our shoes.

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