Produktdatablad HYDROMED

Transkript

1 Tilbudsoversigt Sår Pos. 1-4 og Pos Produktdatablad HYDROMED 1. Virksomhedsdata 1.1. Producent: 1.2. Forhandler: Navn Eurofarm S.p.A Navn KOH I NOOR Adresse Zona Industriale Piano Tavola (CT) Adresse Toldvejen 27 Land Italien Tlf. nr Website: Fa nr [email protected] Website: Kvalitetsstyringssystemer: Producent: ja Forhandler: nej 2. Produktet HYDROMED steril 2.1 Handelsnavn HYDROMED 2.2. Sortimentsoversigt: Se "Sortiment" 2.3. Yderligere oplysninger om produktet Se "Ydl. oplysninger" 3. Produktets bestanddele (Ved sterile produkter inklusiv enkeltemballagen/sterilbarrieren) Pap: Papir: Glas: Metal: Late: nej Bomuld: Økologisk: Andet: se venligst ydl. oplysninger 3.2. Plast: Plast-typer: PVC: Hvis PVC, angiv blødgører: % af PVC: 3.3. Tungmetaller, Klor m.m.: Tungmetal: nej Typer: Klorbleget materiale: nej Genbrugsmaterialer: nej Indgår stoffer fra Miljøstyrelsens liste over uønskede stoffer? : Angiv stoffer: Produktdatablad Eurofarm HYDROMED side 1/2 dato og version

2 4. Emballagens bestanddele (Ved sterile produkter eksklusiv enkeltemballagen/sterilbarrieren) Pap: X Papir: Glas: Metal: Late: Bomuld: Økologisk: Andet: 4.2. Plast: Plast-typer: PVC: Hvis PVC, angiv blødgører: % af PVC: 4.3. Tungmetaller, Klor m.m.: Tungmetal: nej Typer: Klorbleget materiale: nej Genbrugsmaterialer: Angiv eventuelle stoffer fra Miljøstyrelsens liste over uønskede stoffer: 5. CE-mærkning 5.1. CE-mærke: Nej: Ja: Ja Klasse: II b 6. Miljøoplysninger 6.1. Eksisterer et anerkendt miljømærke for produktområdet? Ja: Nej: 6.2. Er produktet miljømærket? Nej: Ja: Mærke: 6.3. Miljøstyringssystemer: (Angiv eventuelle godkendte miljøstyringssystemer) Producent: Lokale / Nationale lovkrav Forhandler Lokale / Nationale lovkrav 7. Holdbarhed Holdbarhedstid efter produktionsdato / sterilisationsdato: 3 år 8. Opbevaring og håndteringsanbefalinger (Angiv anbefalinger) tørt og ved temp o C. for sterile produkter i.h.t. 'Kvalitetshåndbog for Sterilcentraler' /1.udg Anbefalinger vedr. affaldshåndtering Anbefaling = X Forbrænding Deponi Genanvendelse Produkt Enkeltemballage Inderemballage Transportemballage Mærke f. genanvend. Underskrift på original Produktdatablad Eurofarm HYDROMED side 2/2 dato og version

3 KOH I NOOR Hydromed Sortimentsoversigt Producent Forhandler Beskrivelse Størrelse Pakn. Enh. Steril Vare Nr. Vare Nr. Stk./Pk. * Vare Nr. Vare Nr. Str. Pakning (kartoner stk..) HYDROMED hydrogel sterile dressing ,5 5 cm * cm 60 5 * cm 32 5 * cm 3 stk./ æske * Vare Nr. Vare Nr. Str. Pakning (kartoner stk..) HYDROMED PLUS hydrogel sterile dressing bordered with PU overlay cm 60 5 * cm 32 5 * HYDROMED THIN PU overlay coated with hidrogel, sterile cm 60 5 *

4 Produktdatablad Eurofarm HYDROMED KOH I NOOR Laboratorio Controllo Qualità TECHNICAL FILE Product: HYDROMED DESCRIPTION OF PRODUCT: Hydromed is a non adhesive hydrogel dressing with an high water content. It is two sided, clear, transparent Hydrogels formed around a supporting blue polyethylene matri. It contains approimately 75% water with the remaining 25% consisting of a swollen acrylic polymer based on a polyacrylamide derivative with phenoyethanol as a preservative. The dressing is permeable to water vapour, gases and small protein molecules but impermeable to bacteria. Hydromed provides a moist environment at the surface of the wound. Provided that the gel is not allowed to dry out, it will not adhere to the underlying tissue upon removal. Sterile dressings for medical use are class IIb sterile products according to the MDD 93/42 EEC of INDICATIONS: It may be used a wound contact layer, providing cooling and soothing as well as eudates absorption and retention. Hydromed is especially suitable for burns, scalds, radiation therapy damages and for the treatment of chronic, eudating and slow-healing wounds. ART. N, SIZES AND PACKING: ,5 cm 5cm 1 bo 5 pcs cm 10cm 1 bo 5 pcs cm 15cm 1 bo 5 pcs cm 20cm 1 bo 3 pcs. PHYSICAL CHARACTERISTICS: Water content (%): >65% Water activity (% ERH): 90% Saline uptake (%): 1000% MVTR (g/m²/24hrs): (gel only) BIOBURDEN: The maimum bioburden allowable for Hydromed is set at 100 cfu s for a device having a contact surface area of 225cm². PROCESS OF STERILIZATION: The products are terminally sterilized using Gamma Irradiation. The process is carried out in accordance with EN 552 Medical devices Validation and routine control of radiation sterilization. The products are sterilized with a dose of kgy. The products are labelled as STERILE R, in accordance with EN 980:1997 Graphical symbols for use in the labelling of medical devices and it belongs to class IIb Sterile according to the MDD 93/42 EEC of (Anne IX, chapter II, Rule 4). Ydl. Oplysninger Side 1 af 2

5 Produktdatablad Eurofarm HYDROMED KOH I NOOR IDENTIFICATION OF RISKS: Injurious effects on health: None determined Injurious effects on the environment: Does not represent any risk to the environment provided that the national laws for refuse disposal are respected. Ways of fire etinguishing: Use of water, Foam, Powder and CO2 are acceptable. To our knowledge there are no contra-indications. Special packaging conditions: None INSTRUCTIONS FOR USE: 1. Select a dressing that will allow the gel to cover the wound and etend onto healthy tissue. (Approimately 25mm) 2. Prepare the wound site by cleansing as needed. 3. Remove the sterile dressing from the package. 4. To apply the dressing, first remove one of the overlaid white plastic liners. Position and smooth into place whilst removing the second folded white plastic liner. (Take care not to remove the clear dressing cover from the other side, as this is required to position the dressing.) 5. Finally, once in position, remove the clear plastic liner from the top of the product. 6. Check the wound regularly. Single use. Do not use if packaging damaged or compromised in any way. Do not use after epiry date. In the case of an intolerance to the dressing, remove and clean the area carefully. FREQUENCY OF CHANGE: Hydromed should be changed as often as the condition of the wound dictates, but as a general rule, the dressing should be replaced after 3 4 days, or when it becomes cloudy or opaque owing to the absorption of wound eudates. In the treatment of an infected wound, it may be necessary to change the dressing more frequently. MANUFACTURING OF THE PRODUCT: Hydromed is manufactured in a Class clean room under the following conditions: Temperature: 15-25ºC Relative humidity: 55 65% STORAGE: Keep dry and within the temperature range of 0ºC - 40ºC Shelf life of three (3) years Ydl. Oplysninger Side 2 af 2