Syringe Extension
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Technical form SYRINGE EXTENSION FOR TREATMENT OF THE HAEMORRHOIDS THE PACKAGING The ISO Med syringe extensions are disposable sterile devices used for haemorrhoids sclerotherapy. It is an ambulatory treatment according to which we inject the sub-mucous membrane above the haemorrhoidal site with a sclerosing product. The advantages are the laziness and the ease of practice in external consultation. This treatment is thus an instrumental method which is made through an anuscope. THE CANNULA : The cannula is designed to insure the position of the hand of the operator when this one moves downstream (from top to bottom) of the direct line of aim, making if possible to see better the nodule to be sclerosed through the body of the anuscope. The choice of the material concerned to some stainless steel 304L because it is the material which is very resistant and which possesses a good medicinal compatibility and a chemical inertia. THE PEEL AWAY SACHET The ISO Med syringe extensions are packaged in individual sachets. They are composed of two sheets, which are glued: - the transparent upper sheet is made of medical quality component. It permits a quick identification of the contents. - the PGL opaque lower sheet is very resistant and adapted to the ethylene oxide sterilisation. It mentions the necessary indications of contents identification: designation, item code, manufacture date … GENERAL TECHNICAL INFORMATION 1 – The products quality is guaranteed by inspections at all levels of manufacture. All our products are manufactured in a clean room quoted class 100000. The final control is made at the level of packaging. THE HUBS: The ISO Med syringe extensions are also constituted by an hub in every extremity to be able to link instruments necessary for the operation. It is a female hub 6 % Luer Lock for an extremity and a male hub 6 % Luer for the other extremity. These connections allow the use of accessories Luer and/or Luer Lock insuring a better waterproofness and preventing the disconnection. These hubs are made of MABS polymer that is a very rigid material, transparent and also has a good biocompatibility and medicinal compatibility. 2 – The packaged syringe extensions sterilization is made by ethylene oxide according to a validated method in the physical and microbiological field. The shelf life is 5 years from the sterilisation date. ISO Med conforms to 93/42/CEE European Directive requirements and maintains a quality insurance system according to ISO 9001 ISO 13485 SPECIFICATIONS REFERENCE TOTAL LENGTH(MM) CANNULA OUTER DIAMETER (MM) CANNULA LENGTH (MM) 12351 120 2 73 FT/12351/A – Ind 1 – P 1/1