Therapy Equipment Ltd
Comfort Range Demand Valve Cleaning Instructions Ver 7 June 2013
Cleaning Instructions
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Comfort Range Demand Valve Cleaning/Sterilising Instructions The following procedures should only be undertaken by trained decontamination personnel. A special Y Spanner (Part No. 6005-80) may be required in connection with the disassembly of the product (available from Therapy Equipment Ltd). 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.
Using the specified Y Spanner (or similar) remove the Demand Valve Cap (Part No. 600513), to expose the Demand Valve Diaphragm (Part No. 6005-14) and Skid Ring (Part No. 6005-12).
2.
Disconnect the Gas Supply Hose.
3.
Remove the Wrist Strip (Part No. 6005-33)
Version 7
June 2013
Therapy Equipment Ltd Comfort Range Demand Valve Cleaning/Sterilising Instructions Page 2 of 3
Cleaning & Disinfection: 1.
If a PVC Hose is used, then this cannot be cleaned/sterilised, and can only be wiped externally with an alcohol wipe.
2.
Where a Silicone Hose is used, this may be cleaned/sterilised with the Demand Valve Head components.
3.
The Demand Valve parts (Demand Valve Cap, Skid Ring, Demand Valve Head, and Silicone Hose Assembly) should be cleaned using an automated disinfector validated to the requirements of BS EN ISO 15883-1:2006. The parts should be cleaned using pH Neutral detergents. If alternative non-pH Neutral detergents are proposed, please contact the Manufacturer prior to use.
4.
The Demand Valve 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.
5.
Following autoclaving, the unit should be fully dried, re-assembled (see re-assembly procedures) and suitably packaged.
6.
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 Demand Valve requires workshop inspection after 1000 cleaning/disinfection cycles. The Demand Valve/Hose requires strip down maintenance (reconditioning) every 3 years. Facemask The Facemask is not sterilisable, and is considered to be for single patient use. We recommend that the Facemask should be replaced for every new patient. Mouthpiece The Mouthpiece is not sterilisable, and is considered to be for single patient use. We recommend that the Mouthpiece 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.
Version 7 th 24 June 2013 www.therapyequipment.co.uk
Therapy Equipment Ltd Comfort Range Demand Valve Cleaning/Sterilising Instructions Page 3 of 3
1.
The Demand Valve Head should be dismantled as much as possible, by removal of the Demand Valve Cap, Diaphragm, Skid Ring, Wrist Strap and Hose Assembly.
2.
The Demand Valve 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.
Re-Assembling the Unit after Cleaning: 1.
Place the Demand Valve Diaphragm (Part No. 6005-14) into the Demand Valve head (inverted outwards to cover the internal chamber)
2.
Place Skid Ring (6005-12) around the circumference of the Diaphragm
3.
Screw Demand Valve Cap over the Diaphragm/Skid Ring, and tighten into place using special tool.
4.
Re-connect Wrist Strap, by sliding O Ring into place on Demand Valve Handle
5.
Re-connect Hose Assembly and tighten using a spanner.
6.
Before use, re-connect to suitable Gas Supply and both purge the unit in accordance with Instructions for use.
Use of Breathing/Microbiological Filters Any filter used with the Demand Valve should be considered single use, and discarded after each patient use, together with the Facemask or Mouthpiece. Any decision to use filters as primary Infection Control, should be taken after a suitable Risk Assessment has been carried out and in accordance with local Hospital Policies.
Version 7 th 24 June 2013 www.therapyequipment.co.uk