Produktdatablad. Euroderm

Transkript

1 Tilbudsoversigt Sår Pos Produktdatablad Euroderm 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: Fax nr [email protected] Website: Kvalitetsstyringssystemer: Producent: ja Forhandler: nej 2. Produktet EURODERM. transparent sterile PU film Semipermiabel film 2.1 Handelsnavn EURODERM 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: Latex: nej Bomuld: Økologisk: Andet: transparent film of polyurethane with high permeability. 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 EURODERM side 1/2 dato og version

2 4. Emballagens bestanddele (Ved sterile produkter eksklusiv enkeltemballagen/sterilbarrieren) Pap: X Papir: x Glas: Metal: Latex: Bomuld: Økologisk: Andet: 4.2. Plast: Plast-typer: evt plastspole: polystyren polymer 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: I 6. Miljøoplysninger 6.1. Eksisterer et anerkendt miljømærke for produktområdet? Ja: Nej: x 6.2. Er produktet miljømærket? Nej: x Ja: Mærke: 6.3. Miljøstyringssystemer: (Angiv eventuelle godkendte miljøstyringssystemer) Producent: Lokale / Nationale lovkrav Forhandler: Lokale / Nationale lovkrav 7. Holdbarhed Holdbarhedstid efter produktionsdato / sterilisationsdato: 5 år 8. Opbevaring og håndteringsanbefalinger (Angiv anbefalinger) Opbevares tørt og væk fra varmegivere med en temp. på over 30 o C for sterile produkter i.h.t. 'Kvalitetshåndbog for Sterilcentraler' /1.udg Anbefalinger vedr. affaldshåndtering Anbefaling = X Forbrænding Deponi Genanvendelse Produkt x Enkeltemballage x x Inderemballage x x Transportemballage x x x Mærke f. genanvend. Produktdatablad Eurofarm EURODERM side 2/2 dato og version

3 KOH I NOOR Euroderm Sortimentsoversigt Producent Forhandler Beskrivelse Størrelse Pakn. Enh. Steril Vare Nr. Vare Nr. Stk./Pk. * Vare Nr. Vare Nr. Str. Pakning (kartoner x stk..) EURODERM transparent sterile film á PU Euroderm 4 x 5 cm 42 x 100 * Euroderm 6 x 7 cm 36 x 100 * Euroderm 10 x 12 cm 26 x 50 * Euroderm 15 x 20 cm 50 x 10 * Euroderm 10x 25 cm 90 x10 * EURODERM I.V. transparent sterile PU film for canula fixation x 7 cm 36 x 100 * EURODERM ROLL Polyurethane rulle Euroderm 10 m x 2,5 cm 408 stk. * Euroderm 10 m x 5 cm 204 stk. * Euroderm 10 m x 10 cm 102 stk. * Euroderm 10 m x 15 cm 72 stk. * Euroderm 10 m x 20 cm 52 stk. *

4 EURODERM i.v. plaster eller film sådan bruges det. 1. Først fjernes det hvide papir 2. Herefter det trykte papir 3. Plastret placeres på huden 4. Papirrammen fjernes 5. Den løse strip kan fjernes nu, eller senere for at lette aftagningen af plastret.

5 Produktdatablad Eurofarm EURODERM KOH I NOOR Laboratorio Controllo Qualità TECHNICAL FILE Product: EURODERM DESCRIPTION OF PRODUCT: Euroderm is a transparent film of polyurethane with high permeability. Its transparency enables the observation of the wound or puncture site without having to remove it. The thin film is flexible, conforms to all body contours and guarantees an excellent moisture vapour transmission rate, creating an ideal environment for wound healing and reduces the risk of skin maceration. Due to its capacity to protect the wound from external contaminations Euroderm can be used in hospitals as fixation for cannula or catheters or as treatment for minor skin abrasions and burns, allowing the patient to wash himself. ART. N, SIZES AND PACKING: cm x 5cm 100 pcs per box - 42 boxes per case cm x 7cm 100 pcs per box - 36 boxes per case cm x 12cm 50 pcs per box - 26 boxes per case cm x 20cm 10 pcs per box - 50 boxes per case cm x 25 cm 10 pcs per box - 90 boxes per case PHYSICAL CHARACTERISTICS: COMPOSITION: Ultra-thin polyurethane film coated with pressure-sensitive adhesive, between two protective liners. 1. Silicone release paper 1: Thickness: 105 ± 10 Weight: g/m² 2. Polyurethane film: Thickness: Silicone release paper 2: Thickness: 70 ± 5 Weight: 90 5 g/m² ADHESIVE: Polyacrylic, dry weight: 30 5 g/m² Laboratory tests on guinea pigs found it skin-friendly, non-sensitising. FILM DEPOSIT: g / m² MVTR: g/m² in 24 h ADHESION TO STEEL: 800 g/2,5cm LOAD TO PRODUCE 20% ELONGATION: g/2,5cm and sandwiched The above-mentioned data and tolerances are tested in compliance with the requirements of Official Italian Pharmacopoeia F.U.I, 9th Ed., PSTC Norms and the Medical Device Directive 93/42 CEE. Eurofarm ISO 9002 Quality Handbook Revision 1 n E ST of IDENTIFICATION OF RISKS: Injurious effects on health: not determinable Injurious effects on the environment: Does not represent risks for the Environment provided that the national laws for the refuses are respected. Ways of fire extinguishing: Suitable: Foam, Powder, and CO2. Contra-indicated: none of our knowledge, next to fire suitable ways of fire extinguishing have to be used. Special packaging conditions: None. Ydl. Oplysninger Side 2 af 2

6 Produktdatablad Eurofarm EURODERM KOH I NOOR CAUTIONS: Single use. Do not use if the package is damaged because its barrier properties may be compromised. Do not use the product after the expiration date. Clean and disinfect the wound before applying the dressing. When changing dressing care should be taken not to dislodge a device such as a catheter. If dressing adheres to the wound gentle soaking will aid the removal. Observe the site frequently for changes, which can indicate infection such as redness, swelling, pain, discharge or fever. If any of these conditions develop, seek appropriate medical advise and if necessary, discontinue or change the dressing more frequently. INSTRUCTIONS FOR USE: 1. Wash and dry hands thoroughly. 2. Prepare the skin for application. 3. Open and remove the sterile dressing. 4. Remove central window section of dressing from white side of the product. 5. Turn over to printed side. Remove central section, leave tab ends, exposing adhesive surface. 6. Holding both tabs, position and apply dressing adhesive side down. Smooth and seal the dressing from the centre to the edges. If placing over catheter, seal the dressing securely around the catheter hub. 7. Firmly smooth the edge before removing the paper frame. 8. Snap off the removable tabs if desired or leave on for easy removal. 9. To remove dressing, grasp the tab if still in place and carefully pull the dressing from the skin in the direction of hair growth. If the tabs have been removed, then peel up and grasp the edge of the product. Removal is best attained by gently pulling the dressing straight out to stretch and release the product from the skin. To assist in removal an adhesive solvent can be wiped on the exposed adhesive as it is gently peeled back. Eurofarm ISO 9002 Quality Handbook Revision 1 n E ST of MANUFACTURING OF THE PRODUCT: Euroderm is manufactured in a clean room (Class ) under following conditions: Temperature: C Relative humidity: 30% - 70% STORAGE: Keep dry and far from heating sources at a temperature exceeding 30 C/86 F. Ydl. Oplysninger Side 2 af 2