YDA Optima Molliter User manual

INSTRUCTIONS
FOR USE

1. WARNINGS
THE PRODUCT
Optima Molliter S.r.l. declares that YDA footwear is a medical device if used for
personalised or customised insoles made and controlled applying standard
tests by licensed healthcare professionals to treat changes to foot morphology.
Conceived and designed in accordance with the state of the art, YDA footwear
has been tested and made compliant to Directive 93/42 GEE, as amended.
Nevertheless, it should be considered that inappropriate use of the product or
underestimation of resulting hazards can cause injuries or harm.
2. THERAPEUTIC INDICATIONS
A doctor prescription is always necessary if YDA footwear must be used for the
following therapeutic uses:
• Treatment of the most common forefoot pains.
• Biomechanical movement problems.
• Rehabilitation after minor forefoot surgery (such as bunion, hammer toes,
Morton's neuroma) after using post-surgery orthosis until stabilisation.
• Metatarsalgia, only if used together with a personalised insole on the patient's
foot, made and controlled applying standard tests by a licensed healthcare
professional.
• Polyarthritis, only if used with a personalised or customised insole on the
patient's foot, made and controlled applying standard tests by a licensed
healthcare professional.
• Morton's neuroma, only if used with a personalised or customised insole on
the patient's foot, made and controlled applying standard tests by a licensed
healthcare professional.
• Arthrosis, only if used with a personalised or customised insole on the patient's
foot, made and controlled applying standard tests by a licensed healthcare
professional.
• Primary prevention of diabetic foot: foot not at risk (no neuropathy, vascular
disease, or deformity), foot at risk (neuropathy and/or vasculopathy), foot at
high risk (neuropathy and/or vasculopathy and/or mild deformity and/or pre-
ulcerative signs). For a foot at risk, footwear must ALWAYS be used together with
personalised insoles made and controlled applying standard tests by licensed
healthcare professionals. For a foot at high risk, footwear must ALWAYS be used
together with customised insoles made and controlled applying standard tests
by licensed healthcare professionals.
2.1 LIMITATIONS
The product has limitations that derive from the specic use of the product and
the materials used.
3. LIMITS OF LIABILITY
Optima Molliter S.r.l. shall not be held liable if the product is used under the
conditions listed below as improper use.
3.1 IMPROPER USE
Improper use means using the product in the following conditions:
• Failure to comply with the rules and instructions of the manufacturer.
• Non-compliance with or use contrary to current safety standards.
• For healing purposes without medical indications.
• For healing purposes without a personalised or customised insole made by a
licensed healthcare professional who has checked the efciency of the product
applying standard tests.
• Change to size.
• Alteration of the structure by changing/adding items.
• Adaptation of footwear by altering the rule.
• Use of unsuitable cleaning products.
• Unsuitable storage.
• People with plantar lesions.
• People allergic to components and/or treatments of components and/or
materials used to make the footwear.
• Wearing the product when there are osteo-structural alterations of the foot and/
or concomitant metabolic and/or neurological and/or vascular disorders without
medical written prescription/indication.
• Wearing the product on slippery/oily oors or substances.
3.2 PRECAUTIONS
• Strictly follow the cleaning instructions.
• Do not expose the product to open ames or heat sources in general.
• Do not use tools, blades and tools that can pierce, scratch and/or permanently
damage the product.
• Do not soak the product with water, solvents and liquids in general.
• Pay utmost care when walking if there are liquid substances on the oor; do not
walk on slippery/oily oors or substances.
• Do not store the product in a damp place.
• Do not let the product come in contact with water.
• It is expressly prohibited to use the product for any purpose other than as
footwear. In particular, it is expressly prohibited to use the product as a weapon,
tool or toy.

4. INSTRUCTIONS FOR USE
4.1 OVERVIEW
The product keeps its characteristics unchanged if used and adequately
maintained throughout its useful life (one season/6 months on average)
depending on environmental characteristics and its use.
Please pay particular attention when wearing YDA footwear, make sure you open
it by gently moving the elastic drawstring slider outward and sliding your foot in
without putting pressure on the back of your heel. We recommend always using
a shoehorn. The product can be used directly, or can accommodate a suitable
orthopaedic insole made by a licensed healthcare professional, replacing the one
supplied as standard with the footwear. It is important not to change the structure
and the expected support points so as not to alter the product performance.
We point out that the lining is made exclusively with materials that have not been
chemically treated and not with prohibited products. In any case, discolouration
and/or stains caused by normal foot transpiration must be regarded as natural.
We recommend wearing socks with both winter and summer footwear.
4.2 PRODUCT CLEANING
Do not use alcoholic and corrosive liquids, detergents, alcohol, laundry detergents,
bleach, ammonia, and solvents.
Do not use abrasive materials and/or products, brushes, steel wool, glass paper,
blades or similar, to remove stains or residues.
Do not machine wash.
Do not soak the product.
If the product gets accidentally wet, let it dry away from heat sources and in a dry
environment.
4.3 WASHING INSTRUCTIONS
YDA footwear MUST NOT be machine-washed or washed by being immersed in or
put under water.
To clean the lower lateral surface of the sole, use a soft sponge dampened in
warm water (not exceeding 30°C) and neutral soap.
Do not use abrasive or aggressive degreasers; preferably use detergents with a
high degree of biodegradability.
Do not dry the wet or soaked product in front of heat sources; this may irreparably
damage the footwear, and the warranty will be void. Optima Molliter S.r.l shall
NOT be held liable for damages caused by abrasive products, by products that
attack the materials, by direct exposure to heat sources and by improper use/
maintenance.
5. DISPOSAL OF THE PRODUCT
The materials used in YDA footwear are partially environmentally friendly and,
therefore, must be disposed of following specic recommendations.
Dispose of product responsibly.
Refer to the Italian and local regulations on the disposal of inert products.
6. WARRANTY
The warranty, which refers only to defects of materials used and manufacturing
defects, protects the footwear pursuant to the law, only if recognized as defective
by the Company, after application of the proof of purchase of the product on the
back of the booklet.