Tilbudsoversigt.plaster Pos. 48-49 Produktdatablad Euroderm Plus 1. Virksomhedsdata 1.1. Producent: 1.2. Forhandler: Navn Eurofarm S.p.A Navn KOH I NOOR Adresse Zona Industriale - 95040 Piano Tavola (CT) Adresse Toldvejen 27 Land Italien Tlf. nr. 8655 7066 Website: http://www.eurofarm-spa.com/ Fax nr. 8655 7061 E-mail: hospitaler@kohinoor.dk Website: http://www.kohinoor-medica.com/ 1.3. Kvalitetsstyringssystemer: Producent: ja Forhandler: nej 2. Produktet EURODERM Plus transparent sterile PU film m. central pude 2.1 Handelsnavn EURODERM Plus transparent sterile PU film m. central pude 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: 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 Plus side 1/2 dato og version
4. Emballagens bestanddele (Ved sterile produkter eksklusiv enkeltemballagen/sterilbarrieren) Pap: X Papir: x Glas: Metal: Latex: 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: I & II a 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: 3 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. 2000 9. 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 Plus side 2/2 dato og version
KOH I NOOR 8655 7066 Euroderm Plus Sortimentsoversigt Producent Forhandler Beskrivelse Størrelse Pakn. Enh. stk Kart. Steril Vare Nr. Vare Nr. Stk./Pk. * 717600 717600 Polyuretanfilm 5 x 7 cm 100 3.000 * 717601 717601 m. pude 7 x 6 cm 100 3.000 * 717602 717602-9 x 6 cm 50 1.500 * 717603 717603-10 x 10 cm 50 1.500 * 717604 717604-12 x 7 cm 50 1.200 * 717605 717605-15 x 8 cm 50 1.200 * 717606 717606-20 x 10 cm 50 600 * 717607 717607-25 x 10 cm 50 600 * 717608 717608-30 x 10 cm 50 400 * 717609 717609-35 x 10 cm 50 400 *
Produktdatablad Eurofarm EURODERM Plus KOH I NOOR Laboratorio Controllo Qualità TECHNICAL FILE Product: EURODERM PLUS DESCRIPTION OF PRODUCT: Euroderm Plus is a post-operative island dressing with support in polyurethane film with central pad. The absorbent and non-adherent pad absorbs exudates, minimizing the risk of skin maceration, and allows a painless removal of the dressing. The film transparency enables the observation of the exudates in the pad without having to remove the dressing. 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. Moreover, the film protects the wound from external contaminations. Ref. Size Packaging (boxes x pcs) 717600 5 x 7 cm 30 x 100 717601 6 x 7 cm 30 x 100 717602 6 x 9 cm 30 x 50 717603 10 x 10 cm 30 x 50 717604 12 x 7 cm 24 x 50 717605 15 x 8 cm 24 x 50 717606 10 x 20 cm 12 x 50 717607 10 x 25 cm 12 x 50 717608 10 x 30 cm 12 x 50 Sterile dressings for medical use are Class I sterile products according to the MDD 93/42 EEC of 14.06.1993 (Annex IX, chapter III, Rule 4). PHYSICAL CHARACTERISTICS: COMPOSITION 1. Silicone release paper 1 : Weight: 120 10 g/m² Thickness: 105 2. Silicone release paper 2 : Weight: 90 5 g/m² 3. Polyurethane film: Thickness: 30 Weight: 33 35 g/m² Peel strength: 800 50 g / 2,5cm MVTR : 1.200 g/m² in 24 h WOUND PAD: It is made of two layers: a) Non-adherent perforated 100% polyethylene layer Weight of non-adherent layer: 15 g/m² 10 % b) Absorption layer: 90% viscose and 10% polypropylene Weight of absorbent layer: 180 g/m² 10 % Weight of pad: 195 g/m² 10 % Thickness of pad: 1,87 mm 10 % Absorption capacity and time: 15,2 gr in 4,3 s Eurofarm ISO 9002 Quality Handbook Revision 0 n E 0 0602 ST of 12.01.04 Ydl. Oplysninger Side 1 af 3
Produktdatablad Eurofarm EURODERM Plus KOH I NOOR FILM DEPOSIT: 33-35 g / m² ADHESION TO STEEL: 800 g/2,5cm LOAD TO PRODUCE 20% ELONGATION: 210-230 g/2,5cm ADHESIVE: Polyacrylic, dry weight: 30 5 g/m² Laboratory tests on guinea pigs found it skin-friendly, non-sensitising. 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. BIOBURDEN: The microbe burden of adhesive plasters for post-operative use must be inferior to 500 CFU/cm². The culture exam of Euroderm Plus has shown the following: The bioburden is tested every month in specialized laboratories. The bioburden is tested before sterilisation according to the following procedure of control: 1st week: Control of one sample of every batch. 2nd week: Control of one sample of every two batches. 3rd week: Control of one sample of every three batches. 4th week: Control of one sample of every four batches. The control is currently made on one sample every 4 batches. If negative, one sample will be tested every 3 batches and so on. If positive, the sample will be passed on to sterilization. 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. Eurofarm ISO 9002 Quality Handbook Revision 0 n E 0 0602 ST of 12.01.04 CAUTIONS: Single use. Do not use if the package is damaged or opened. Do not use the product after the expiration date. Clean and disinfect the wound before applying the dressing. Ydl. Oplysninger Side 2 af 3
Produktdatablad Eurofarm EURODERM Plus KOH I NOOR INSTRUCTIONS FOR USE: 1. Wash and dry hands thoroughly. 2. Disinfect the wound before applying Euroderm Plus. 3. Open and remove the sterile dressing. 4. Remove the protective paper and apply the dressing 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. Removal is best attained by gently pulling the dressing straight out to stretch and release the product from the skin. MANUFACTURING OF THE PRODUCT: Euroderm Plus is manufactured in a clean room (Class 100.000) under following conditions: Temperature: 18-25 C Relative humidity: 30% - 80% STORAGE: Keep dry and far from heating sources at a temperature exceeding 30 C/86 F. Ydl. Oplysninger Side 3 af 3