Infusion. 1 evercare inline

Transcription

1 Infusion 1 evercare inline

2 The evercare inline series of infusion therapy products is a result of years of product development with high quality materials and latest technology. Special attention has been paid to adaptation to Nordic requirements. Every product is delivered with a high degree of knowledge about its proper use in the therapy. The evercare inline infusion assortment includes: Standared gravity sets TIVA sets Monosets 3-way stopcocks 3-way stopcocks with extension lines Extension lines Urology irrigation sets Certifications: evercare inline products are CE marked and manufactured according to EN ISO product and quality standards. CE 0434 The product complies with legal requirements for medical devices. Notified body Det Norske Veritas. 2 evercare inline

3 Materials The main raw materials of evercare inline infusion products are polyolefine plastic material and DEPH- both specifically designed for medical devices. None of the materials used in evercare inline products contains carcinogenic, mutagenic or toxic substances, including any of the Substances of Very High Concern (SVHC) as listed in the latest available version of the Candidate List published by European Chemicals Agency (ECHA). Phthalate no plasticizer diffusion Excellent kink resistant, soft and flexible Highly resistant to chemicals -> low drug absorption With excellent optical properties, highly transparent State-of-the-art roller clamp All infusion sets with -, easy-to-fill, X-large and safe drip chamber 3 evercare inline

4 OneMed's Infusion Systems OneMed offers a wide range of infusion sets containing quality components adapted to the customers demands and requirements. Tested and safe, complies with highest standards Future-oriented Adopting environmentally friendly materials Environmentally friendly manufacturing process of - material, no harmful substances as in other - materials 2 raw material options, DEHP- and - Universal spike, fits all types of containers Air-vent with bacteria retention filter Extra large, transparent and easy-to-fill drip chamber Easy to detect drips from distance 20 drips/ml 15 μm fluid filter protect the patient from particles 3 tube lengths Kink-resistant clear tubing Easy detection of air bubbles Sophisticated state-of-the art roller clamp High precision and accurate flow rate Safe, user friendly tube dock All sets with rotating luer lock Safe and easy connection without twisting the tube All sets with hydrophobic filter Easy, time saving and safe priming Protects against contamination Hydrophobic filter ensures that the line fills automatically Gravity sets can stand pressure up to 2 bars Optional in standard gravity sets Pre-mounted lipid resistant stop-cock, can be used up to 72 hours for lipid containing drugs Needle- connector. Halkey Roberts Can be wiped up to 300 times Luer lock Back-check valve Tolerates up to 6 bar pressure Coloured back-check valves for easy detection 4 evercare inline

5 Standard Gravity sets REF Infusion sets length DEHP Gravity set, vented 180 cm x 1/20/ Gravity set, vented 220 cm x 1/20/ Gravity set, vented 320 cm x 1/15/ Gravity set, vented, 3-way stopcock 195 cm x 1/20/ Gravity set, vented, 3-way stopcock 235 cm x 1/20/ Gravity set, vented, needle connector 180 cm x 1/20/ Gravity set, vented, backcheck valve 180 cm x 1/20/ Gravity set, vented, backcheck valve 320 cm x 1/15/ Gravity set, vented, 3-way stopcock, backcheck valve 195 cm x 1/20/ Gravity set, vented, 3-way stopcock, backcheck valve 335 cm x 1/15/ Gravity set, non-vented 180 cm x 1/20/ Gravity set, non-vented 220 cm x 1/20/ Gravity set, non-vented 320 cm x 1/15/ Gravity set, non-vented, 3-way stopcock 180 cm x 1/20/ Gravity set, non-vented, needle connector 180 cm x 1/20/ Gravity set, vented 180 cm x 1/20/ Gravity set, vented 220 cm x 1/20/ Gravity set, vented 320 cm x 1/15/ Gravity set, vented, backcheck valve 180 cm x 1/20/ Gravity set, vented, backcheck valve 320 cm x 1/15/ Gravity set, vented, 3-way stopcock 195 cm x 1/20/ Gravity set, vented, 3-way stopcock 235 cm x 1/20/ Gravity set, vented, 3-way stopcock 335 cm x 1/15/ Gravity set, vented, needle connector 180 cm x 1/20/ Gravity set, non-vented 180 cm x 1/20/ Gravity set, non-vented 220 cm x 1/20/ Gravity set, non-vented 320 cm x 1/15/ Gravity set, non-vented, 3-way stopcock 195 cm x 1/20/ Gravity set, non-vented, 3-way stopcock glued 195 cm x 1/20/ Gravity set, non-vented, 3-way stopcock 235 cm x 1/20/ Gravity set, non-vented, needle connector 180 cm x 1/20/ Gravity set, non-vented, 3-way stopcock, backcheck valve 195 cm x 1/20/80 5 evercare inline

6 TIVA sets TIVA sets are devloped to be used for Total IntraVenous Anaesthesia Therapy The sets provide: A quick set up Safe connections Less disposables and waste Cost saving 100% leakage and block tested Stand pressure up to 2 bars Suitable for pumps Fixation secured by gluing Extension lines in polyethylene Backcheck-valves Coloured for easy identification Stand pressure up to 6 bar 3-way stopcocks Lipid resistant Colour coded Backcheck-valves REF TIVA sets DEHP Stop cocks Backcheck valves Extension lines Needle connector TIVA set, 3-way, 1 backcheck valve x /5/ TIVA set, 2-way, ext.lines, 3 backcheck valves x /5/ TIVA set, 3-way, ext.lines, 4 backcheck valves x /5/ TIVA set, 2-way, 1 backcheck valve x /5/ TIVA set, 3-way, 1 backcheck valve x /5/ TIVA set, 2-way, ext.lines, 3 backcheck valves x /5/ TIVA set, 2-way, ext.lines, 4 backcheck valves x /5/ TIVA set, 3-way, ext.lines, 4 backcheck valves x /5/ TIVA set, 3-way, ext.lines, 5 backcheck valves x /5/ TIVA set, 2-way, ext.lines, needle connector, 3 backcheck valves x /5/35 6 evercare inline

7 Monoset A safe system for preparation and administration of antibiotics. By using the system the users avoid spillage and aerosols from hazardous drugs. Various configurations Aerosol filter for antibiotics Hydrophobic filter prevents leakage and exposure to hazardous substances Needle connector Easy identification of the prepared drug, vial connected to the set during administration REF MONO sets length DEHP Monoset, 1-way 180 cm x 1/15/ Monoset, 1-way, backcheck valve 180 cm x 1/15/ Monoset 1-way, needle- connector 180 cm x 1/15/ Monoset, 1-way 180 cm x 1/15/ Monoset, 1-way, needle connector 180 cm x 1/15/ Monoset, 1-way, 3-way stopcock, needle connector Monoset, 1-way, 3-way stopcock, needle connector, backcheck valve 195 cm x 1/15/ cm x 1/15/60 Urology sets The Urology sets can be used for irrigation and for cystoscopy, T.U.R., general, and other arthroscopic surgical procedures. Large bore set, large diameter tubing Large drip chamber for safe high flow rate Universal connector + separate single packed luer lock connector Y-connection with 2 spikes, 2-way Available in - or DEHP- materials REF Urological sets length DEHP Urological set, 2-way 215 cm x 1/5/ Urological set, 1-way 215 cm x 1/5/ Urological set, 2-way 215 cm x 1/5/ Urological set, 1-way 215 cm x 1/5/20 7 evercare inline

8 3-way stopcock REF 3-way stopcocks Colour way stopcock White 1/50/ way stopcock, needle connector 3-way stopcock, 2 needle connectors White 1/25/100 White 1/25/100 Lipid-resistant for 72 hours Rotating luer lock Large wings for easy handling Extension lines with stopcock Lipid-resistant for 72 hours Large wings for easy handling Rotating luer lock Hydrophobic filter Can stand pressure up to 2 bar REF Extension line, 3-way stopcock Colour diameter length DEHP Extension line, 3-way stopcock White 3x4,1 mm 7 cm x 1/25/ Extension line, 3-way stopcock White 3x4,1 mm 10 cm x 1/25/ Extension line, 3-way stopcock White 3x4,1 mm 15 cm x 1/25/ Extension line, 3-way stopcock White 3x4,1 mm 25 cm x 1/25/ Extension line, 3-way stopcock White 3x4,1 mm 30 cm x 1/25/ Extension line, 3-way stopcock White 3x4,1 mm 50 cm x 1/25/ Extension line, 3-way stopcock White 3x4,1 mm 60 cm x 1/25/ Extension line, 3-way stopcock White 3x4,1 mm 90 cm x 1/25/ Extension line, 3-way stopcock White 3x4,1 mm 100 cm x 1/25/ Extension line, 3-way stopcock White 3x4,1 mm 120 cm x 1/25/ Extension line, 3-way stopcock White 3x4,1 mm 150 cm x 1/25/ Extension line, 3-way stopcock White 3x4,1 mm 10 cm x 1/25/ Extension line, 3-way stopcock, needle connector Extension line, 3-way stopcock, 2 needle connectors White 3x4,1 mm 10 cm x 1/25/100 White 3x4,1 mm 10 cm x 1/25/ Extension line, 3-way stopcock White 3x4,1 mm 30 cm x 1/25/ Extension line, 3-way stopcock White 3x4,1 mm 50 cm x 1/25/ Extension line, 3-way stopcock White 3x4,1 mm 60 cm x 1/25/ Extension line, 3-way stopcock White 3x4,1 mm 90 cm x 1/25/ Extension line, 3-way stopcock White 3x4,1 mm 100 cm x 1/25/100 8 evercare inline

9 Extension lines REF Extension lines diameter length DEHP 2 different diameters 2 raw material options, DEHP- and - 1 x 2 mm Ø high pressure infusion lines for pumps Hydrophobic filter for safety and easy handling Can stand pressure up to 2 bar Coiled, especially suitable for children wards and MRI (magnetic resonance imaging) Extension line 1x2 mm 150 cm x 1/25/ Extension line 1x2 mm 200 cm x 1/25/ Extension line 1x2 mm 300 cm x 1/25/ Extension line 3x4,1 mm 10 cm x 1/25/ Extension line 3x4,1 mm 30 cm x 1/25/ Extension line 3x4,1 mm 50 cm x 1/25/ Extension line 3x4,1 mm 90 cm x 1/25/ Extension line 3x4,1 mm 100 cm x 1/25/ Extension line 3x4,1 mm 120 cm x 1/25/ Extension line 3x4,1 mm 150 cm x 1/25/ Extension line 3x4,1 mm 200 cm x 1/25/ Extension line 3x4,1 mm 300 cm x 1/25/ Extension line, Taxol filter 3x4,1 mm 15 cm x 1/25/ Extension line 1x2 mm 50 cm x 1/25/ Extension line 1x2 mm 150 cm x 1/25/ Extension line 1x2 mm 200 cm x 1/25/ Extension line 1x2 mm 300 cm x 1/25/ Extension line 3x4,1 mm 10 cm x 1/25/ Extension line 3x4,1 mm 30 cm x 1/25/ Extension line 3x4,1 mm 50 cm x 1/25/ Extension line 3x4,1 mm 90 cm x 1/25/ Extension line 3x4,1 mm 100 cm x 1/25/ Extension line 3x4,1 mm 120 cm x 1/25/ Extension line 3x4,1 mm 150 cm x 1/25/ Extension line 3x4,1 mm 200 cm x 1/25/ Extension line 3x4,1 mm 300 cm x 1/25/ Extension line, Taxol filter 3x4,1 mm 15 cm x 1/25/ Extension line, Taxol filter, 1 backcheck valve 3x4,1 mm 15 cm x 1/25/100 REF Extension lines, coiled diameter length Extension line, coiled 1x2 mm 150 cm x 1/25/ Extension line, coiled 1x2 mm 200 cm x 1/25/ Extension line, coiled 1x2 mm 300 cm x 1/25/ Extension line, coiled 1x2 mm 400 cm x 1/25/ Extension line, coiled 2x3 mm 150 cm x 1/25/ Extension line, coiled 2x3 mm 300 cm x 1/25/100 9 evercare inline

10 Environmentally friendly materials (vinyl plastic) is used throughout health care in a wide variety of applications, from IV bags and disposable gloves, to curtains and flooring. Today it is the most commonly used plastic in medical devices. However, the use of creates a number of environmental and health risks including dioxin pollution and patient exposure to hazardous chemicals such as the plasticizer phthalate DEHP, which may leach from vinyl medical devices. In the European Union, the use of Di(2-ethylhexyl)phthalate (DEHP) in medical devices has been under serious pressure. DEHP is classified as a category 2 reproductive toxin, thus it is a CMR (Carcinogenic, Mutagenic or Toxic for Reproduction) substance. With effect from March 2010, all medical devices containing phthalates must be labelled as such for use in the European Union. This is in accordance with the consolidated Medical Devices Directive 93/42/EEC, as amended by Directive 2007/47/EC. Due to these concerns, many health care facilities around the world are switching to safer, cost-effective medical devices that do not contain vinyl plastic or phthalate plasticizer OneMed s choice for evercare inline is a polyolefin based thermoplastic elastomer (TPE) that is specially developed for medical applications. From health point of view the main benefits with TPE are: Low migration -> no plasticizer migration Low drug absorption -> due to high chemical resistance Does not contain latex, BPA (bisphenol A), phthalates, or Substances of Very High Concern as listed in the REACH Regulation. Environmentally TPE offers following advantages: - -> chlorine -> dioxin Lower density -> lower material consumption-> reduced waste Better environmental profile (vs (polyvinyl chlorine) and TPU/PUR (thermoplastic polyurethane/polyurethane). All evercare inline products are - or DEHP-. The plasticizer in evercare DEHP- products is a non-phthalate plasticizer. aging & labeling ed in high quality/high grammage medical grade paper and strong multilayer plastic film 3 layers of packaging throughout the range Labeling in accordance with ISO , EN980 and EN1041 and respective product standard 10 evercare inline

11 aging Symbols Explained Catalogue number Product does not contain LOT Batch Code Use by date Sterilized using Ethylene Oxide length Do not use if package is damaged Do not re-use Keep away from sunlight Date of manufacture Keep dry Manufacturer Liquid filter with pore size LATEX Product does not contain latex 20 ml Drops per millilitre Non-pyrogenic CE mark + identity code of the notified body Fluid path Safe for use with pressure infusion equipment Luer-lock Gravity feed only Needle- connector 3-way stopcock One-way valve Consult instructions for use 11 evercare inline

12 OneMed Group Oy P.O.Box 10 (Metsäläntie 20), FI Helsinki Phone OneMed Group 5/2014 Rev 2. evercare inline is a registered trademark of OneMed Group Oy 12 evercare inline