1.8 Litre Receiver Jar Cleaning/Sterilising Instructions The following procedures should only be undertaken by trained decontamination personnel. All cleaning instructions should be carried out after the Unit has been disconnected from the Gas Supply. It is recommended that safety procedures should be followed, including the wearing of personal protective equipment including aprons, gloves etc. Always wash your hands thoroughly, clean down the work area and dispose of cleaning materials and protective clothing after you have completed the procedure. Cleaning Instructions: In accordance with the requirements of the Medical Devices Directive (93/42/EEC), it is recommended that the valve should be cleaned/sterilised after each patient use. The following reprocessing procedure is recommended: Disinfecting/Sterilising Stripping the unit down ready for cleaning: 1. Remove the Vacuum and Patient Tubing and discard 2. Remove Jar Lid by twisting it anti-clockwise from the Jar 3. Remove Float Assembly by pulling downwards 4. Remove the Blue Jar Seal and Blue Swirl Tube from Lid Assembly Therapy Equipment Ltd 1.8 Litre Receiver Jar Cleaning/Sterilising Instructions Page 2 of 3 Cleaning & Disinfection: 1. The Receiver Jar Parts (Jar, Jar Lid, Float Assembly, Seal and Swirl Tube) should be cleaned using an automated disinfector validated to the requirements of BS EN ISO 158831:2006. The parts should be cleaned using pH Neutral detergents. If alternative non-pH Neutral detergents are proposed, please contact the Manufacturer prior to use. 2. The Receiver Jar Parts should then be autoclaved at 134ºC - 137ºC @ 2.2 Bar Pressure for a minimum of 3 minutes (per BS EN ISO 285:2006). The unit will not emit any noncondensable gases during the autoclaving process. Again we would remind users that only the Silicone Hose is autoclavable. 3. Following autoclaving, the unit should be fully dried, re-assembled (see re-assembly procedures) and suitably packaged. 4. Prior to use on a patient, the unit should be fully purged with gas. All cleaning/decontamination processes must be carried out to the requirements of BS EN ISO 17665-1:2006, BS EN ISO 15883-1:2006, and BS EN ISO 285:2006. The Receiver Jar Assembly requires workshop inspection after 1000 cleaning/disinfection cycles. Tubing The Suction Tubing is not sterilisable, and is considered to be single patient use. We recommend that the Tubing should be replaced for every new patient. Manual Cleaning Manual immersion cleaning is not a disinfection/sterilising process and should only be undertaken when other mechanical methods are unavailable. 1. The Receiver Jar Assembly should be dismantled as much as possible, by removal of the Jar Lid, Float Assembly, Jar Seal, and Swirl Tube. 2. The Receiver Jar parts should be immersed fully in warm water i.e. not greater than 35ºC for 1 minute into a pH neutral cleaning solution, taking care to dilute the cleaning fluid in accordance with the solution manufacturer’s instructions. 3. Whilst immersed brush, or jet wash the unit to dislodge and remove all visible soiling. 4. Rinse the item fully with clean water, again ensuring the item is fully immersed. 5. Dry either manually using a Non-Linting cloth, or a hot air drier, or allow to drain 6. Once dried, reassemble the Valve (see re-assembly instructions). 7. Suitably package and store in clean dry environment. Version 3 th 25 February 2014 www.therapyequipment.co.uk Therapy Equipment Ltd 1.8 Litre Receiver Jar Cleaning/Sterilising Instructions Page 3 of 3 Re-Assembling the Jar Assembly after Cleaning: 1. Re-connect the Jar Seal around the lip on the underside of the Jar Lid 2. Push the cylindrical Swirl Tube ontothe Patient Connector which protrudes from the underside of the Jar Lid. The side of the swirl tube which has been cut away must be angled towards the outside of the Jar. 3. Push and Twist the complete Float Assembly onto the central port on the underside of the Jar Lid. 4. Re-connect the complete Lid Assembly to the Jar. This is done by slotting the two bayonet latches into the relevant gaps on the lip on the Jar, and turning the lid clockwise until the handle on the Lid is in line with the handle on the Jar. Version 3 th 25 February 2014 www.therapyequipment.co.uk
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