P3 Medical Technical Data Sheet Product Name Camera/Cable Drape ECN 150-250CAP General Description The Closed End Camera drape with HD viewing port ECN 150-250CAP is a low density polythene film tube 150mm nominal across (layflat) or 95mm diameter when fully opened. Prior to use the film is wound into a circular high density polythene housing thus shortening the length and facilitating packaging and application. The distal end of the drape is provided with a shaped optically clear window sealed to the film. This optically clear window permits a video endoscope to be connected to the outside of the drape while the video camera is isolated on the inside of the drape. The optically clear window maintains the necessary mechanical connection between the endoscope and video camera. Technical details Materials: Low density polyethylene, High density polythene, 01.mm PVC, Vivak Polyester PETG Clear, double coated adhesive tape, Length: Width: Tube diameter: Film thickness: Latex status: Latex free Intended Use This drape is intended to provide a sterile sheath for an endoscopic video camera and cable while permitting the correct connection and operation of a surgical endoscope. 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 board carton of 50 pieces Manufacturing environment Manufactured in a cleanroom constructed to comply with ISO 14644 Class 8 @ 0.5μ manned Filename: Data Sheet ECN 150-250CAP Date effective: 06/12/2012 Issue No: 1 UNCONTROLLED IF PRINTED OR EMAILED