PRODUCTDATASHEETSUPRA SORB ® X + PHMB Antimicrobial ...

P R O D U C T D A T A S H E E T
S U P R A S O R B ® X + PHMB
Antimicrobial HydroBalance Wound Dressings
sterile
REF: 20540 - 20543
April 2007 Translation: P.Kellmann/MI
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1. Composition of the product
Suprasorb® X + PHMB Antimicrobial HydroBalance Wound Dressings, sterile
consist of:
- cellulose (3 – 5%)
- water (95 – 97%)
- 0.3% polyhexamethylene biguanide (PHMB)
- polyester (backing sheets of wound dressing on both sides)
This product data sheet covers the following items:
REF 20540 Suprasorb® X + PHMB Antimicrobial Hydrobalance Wound Dressing, sterile 5 x 5 cm
REF 20541 Suprasorb® X + PHMB Antimicrobial HydroBalance Wound Dressing, sterile 9 x 9 cm
REF 20542 Suprasorb® X + PHMB Antimicrobial HydroBalance Wound Dressing, sterile 14 x 20 cm
REF 20543 Suprasorb® X + PHMB Antimicrobial HydroBalance Packing Rope, sterile 2 x 21 cm
2. Packaging, structure and composition
2.1 Unit Container
- a peel pouch of polyester, polyethylene and aluminium
2.2 Shelf Container
- a cellulose folding box
- instructions for use (cellulose)
2.3 Transit Container
- a corrugated cardboard case (cellulose)

PDS Suprasorb® X + PHMB Antimicrobial HydroBalance Wound Dressings, sterile,
April 2007
3. Manufacture
Suprasorb® X + PHMB Antimicrobial HydroBalance Wound Dressings are produced
to specification under hygienic conditions. They are individually wrapped in wellsealed
peel pouches and placed in boxes and cases for transportation. Suprasorb®
X + PHMB Antimicrobial HydroBalance Wound Dressings are sterilized by gamma
irradiation in compliance with DIN EN ISO 11137 parts 1-3.
4. Description
Suprasorb® X + PHMB Antimicrobial HydroBalance Wound Dressings are white and
have a smooth surface. They are presented covered on both sides with PET backing
sheets. The wound pad is available in various sizes.
5. Properties
Suprasorb® X + PHMB Antimicrobial HydroBalance Wound Dressings, sterile act
against a broad spectrum of pathogens. In addition, depending on the state the
wound is in, Suprasorb® X + PHMB Antimicrobial HydroBalance Wound Dressings,
sterile can either provide the wound with moisture or absorb excess exudate, thereby
creating a moist wound environment. The dressing material allows the dressings to
be adapted without problem to individual shapes and depths of wounds.
This product range is therefore particularly suitable for managing wounds in difficult
places of the body. The dressings do not adhere to either wound or secondary
wound dressing. They have a cooling effect which is agreeable and which gives the
patient the sensation of pain being alleviated.
Suprasorb® X + PHMB Antimicrobial HydroBalance Wound Dressings, sterile are
indicated for single use only and must not be re-sterilized.
6. Intended purpose/use
Suprasorb® X + PHMB Antimicrobial HydroBalance Wound Dressings, sterile can
be used managing infected or critically colonized wounds if they show slight or
medium exudation; they may be superficial or deep wounds e.g. arterial or venous
ulcers, diabetic ulcers, pressure ulcers, superficial second degree burns, postoperative
surgical wounds, skin grafts, skin donor sites, abrasions and lacerations.
7. Medical device classification
Suprasorb® X + PHMB Antimicrobial HydroBalance Wound Dressings, sterile are in
Class III according to Rule 13, Annex IX of the Council Directive 93/42/EEC of
14.06.1993 concerning medical devices.

PDS Suprasorb® X + PHMB Antimicrobial HydroBalance Wound Dressings, sterile,
April 2007
8. Biological evaluation and biocompatibility (DIN EN ISO 10993)
Indicated for the care and management of wounds.
The starting materials used to produce Suprasorb® X + PHMB Antimicrobial
HydroBalance Wound Dressings, sterile, are of such purity that the correct use of
this product range for the purposes intended is completely safe.
To date this company has received no notification of incidents involving this
Lohmann & Rauscher product range, neither has there been a need for a recall for
reasons of quality.
The purpose of this documentation and of the statements made therein is to show
that there is no risk involved in the use of Suprasorb® X + PHMB Antimicrobial
HydroBalance Wound Dressings, sterile, and that - as it says in the Essential
Requirements of the Council Directive 93/42/EEC concerning Medical Devices -
Suprasorb® X + PHMB Antimicrobial HydroBalance Wound Dressings, sterile "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 or
other persons when used under the conditions and for the purposes intended".
9. Stability
Appropriately stored at between 5° and 30°C and with the original packaging intact,
Suprasorb® X + PHMB Antimicrobial HydroBalance Wound Dressings, sterile have
a shelf life of 3 years.
10. Disposal
Incineration or landfill disposal of the product itself will generate CO2 and H2O,
of the packaging CO2, H2O and Al2O3.
The user is advised to observe current legislation, norms and guidelines, regulating
the disposal of medical refuse.
Lohmann & Rauscher International GmbH & Co. KG
D-56579 Rengsdorf
signed by
Dr. Martin Abel
(Medical & Regulatory Affairs)