SUPRASORB H Hydrocolloid Wound Dressing thin, sterile REF ...

SUPRASORB ® H Hydrocolloid Wound Dressing
thin, sterile
REF 20410 – 20414, 20424
February 2010 Translation: MI / P. Kellmann
Supplements and revision: MI / K. Ladwig
1. Composition of the product
SUPRASORB ® H Hydrocolloid wound dressings, thin, consist of:
- backing: polyurethane film
- hydrocolloid layer: chiefly carboxymethylcellulose (swelling component),
styrol isoprene styrol copolymer,
resins, mineral oil, antioxidant
- protector: paper, siliconized on one side
This product data sheet covers the following items:
REF 20424 Suprasorb ® H Hydrocolloid wound dressing, thin, sterile, 5 x 5 cm
REF 20410 Suprasorb ® H Hydrocolloid wound dressing, thin, sterile, 5 x 10 cm
REF 20411 Suprasorb ® H Hydrocolloid wound dressing, thin, sterile, 5 x 20 cm
REF 20412 Suprasorb ® H Hydrocolloid wound dressing, thin, sterile, 10 x 10 cm
REF 20413 Suprasorb ® H Hydrocolloid wound dressing, thin, sterile, 15 x 15 cm
REF 20414 Suprasorb ® H Hydrocolloid wound dressing, thin, sterile, 20 x 20 cm
2. Packaging, structure and composition
2.1 Unit container
- peel bag made of polyester and polyethylene respectively
polyester, polyethylene and cellulose (REF 20424)
2.2 Shelf container
- folding box (cellulose)
- instructions for use (cellulose)
2.3 Transit container
- corrugated cardboard box (cellulose)
PRODUCT DATA SHEET
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PDS SUPRASORB ® H Hydrocolloid Wound Dressing thin, sterile February 2010
3. Manufacture
SUPRASORB ® H Hydrocolloid wound dressings, thin, are produced according to
specification in hygienic conditions, individually sealed into peel bags and packed into
folding boxes together with their instructions for use.
The dressings are sterilized by irradiation in compliance with DIN EN ISO 11137
part 1-3.
4. Description
SUPRASORB ® H Hydrocolloid wound dressings, thin, are a homogenous cream-/to
light-brown-coloured mass with an even surface.
The product is available in various sizes.
5. Properties
SUPRASORB ® H Hydrocolloid wound dressings, thin, are self-adhesive wound
dressings with a semipermeable backing that repels fluids and microorganisms, but
allows surplus water to evaporate.
When in contact with wound exudates the dressing forms a gel, thereby creating a
wound environment for optimum healing without damaging newly-formed tissue
during a change of dressing.
SUPRASORB ® H Hydrocolloid wound dressings, thin, are hypoallergenic.
These dressings are intended for single use only and may not be re-sterilized.
The product is sterile unless the package has been opened or damaged.
6. Intended purpose / use (please see valid instructions for use)
SUPRASORB ® H Hydrocolloid wound dressings, thin, are indicated for the treatment
of superficial wounds with light exudation.
They are indicated for the following types of wounds:
• pressure sores
• arterial ulcers
• venous lower leg ulcers
• diabetic ulcers
• skin donor sites
provided the wounds are:
• lightly exuding and
• superficial
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PDS SUPRASORB ® H Hydrocolloid Wound Dressing thin, sterile February 2010
6.1 Contraindications
Infected wounds.
6.2 Precautionary measures
SUPRASORB ® H Hydrocolloid wound dressings, thin, should not be used on infected
wounds.
Where they are used for venous leg ulcers, the prescribed compression treatment
should be continued. Also when used on pressure sores normal treatment must
continue. SUPRASORB ® H Hydrocolloid wound dressings, thin, are sterile unless the
package is opened or damaged.
7. Medical device classification
As devices used principally to manage the micro-environment of wounds
SUPRASORB ® H Hydrocolloid wound dressings, thin, are in Class IIa according
to Rule 4.
(Annex IX of the Council Directive 93/42/EEC covering medical devices)
8. Biological evaluation and biocompatibility (DIN EN ISO 10993)
For wound management.
Polyurethane is known to be pharmacologically-toxicologically harmless and
indifferent. This also applies to the starting materials used for the hydrocolloid layer
as well as for the protective paper.
The starting materials used in the manufacture of SUPRASORB ® H Hydrocolloid
wound dressings, thin, are safe if the product is used appropriately and for the
purposes intended.
To date this company has received no notification of incidents involving this Lohmann
& Rauscher product, neither has there been need for a recall for reasons of quality.
The purpose of this documentation and the statements made therein is to show that
there is no risk involved in the use of the medical device SUPRASORB ® H
Hydrocolloid wound dressings, thin, and that they are designed, manufactured and
packaged in such a way that they will not compromise the clinical condition or the
safety of patients, or the safety and health of users and other persons when used
under the conditions and for the purposes intended.
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PDS SUPRASORB ® H Hydrocolloid Wound Dressing thin, sterile February 2010
9. Stability
Provided SUPRASORB ® H Hydrocolloid wound dressings, thin, are stored
appropriately – at temperatures not exceeding 25°C and in their unopened original
packaging – they have a shelf life of 5 years.
10. Disposal
The user is advised to observe current legislation, norms and guidelines, regulating
the disposal of medical refuse.
Packaging materials must also be disposed of in compliance with applicable national
requirements.
Lohmann & Rauscher International GmbH & Co. KG
D-56579 Rengsdorf
signed by
Dr. Martin Abel
(Medical & Regulatory Affairs)
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