ECN 150-250TK
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P3 Medical Technical Data Sheet Product Name Camera/Cable Drape ECN 150-250TK General Description The camera drape ECN 150-250TK is a polythene film tube. The distal end of the drape is terminated with an elasticated section which facilitates the secure attachment of the film to a video camera. Prior to use the film is formed over a plastic ring into a compact assembly thus shortening the length and facilitating packaging and use. Two lengths of self-adhesive polythene tape are supplied with each drape. These lengths of tape may be used to secure the tube in use. In use the item to be covered is passed through the centre of the ring. The tube then unfolds quickly and easily throughout the length of the film. Technical details Materials: Low density polyethylene, High density polythene, Low density polythene film 163µ with repositionable acrylic adhesive, Siliconised paper, TPE Length: Width: Tube diameter: Film thickness: Latex status: Latex free Intended Use This device is intended to provide a sterile sheath over cables or other long thin flexible items in order to isolate them from their surroundings. The presentation is intended to allow the simple insertion of the object to be sheathed and for the controlled extension of the length of the film. Packaging Unit pack: Shelf pack: Regulatory compliance Meets the essential requirements of directive 93/42/EEC as amended 2007/47/EC for Class I Sterile medical Devices. Single packed: film front fully peel-able pouch. Corrugated cardboard box of 50 pieces. Manufacturing environment Manufactured in a cleanroom constructed to comply with ISO 14644 Class 8 @ 0.5μ manned Sterilisation Terminally sterilised by EtO Filename: Data Sheet ECN 150-250TK Date effective: 20/11/2012 Issue No: 1 UNCONTROLLED IF PRINTED OR EMAILED