Lotus. Reprocessing instructions for reusable instrumentation. French/Swiss protocol

Transcription

1 Lotus Reprocessing instructions for reusable instrumentation French/Swiss protocol

2 Reprocessing instructions These instructions relate to the Lotus Transducers & Waveguides only. Following use remove the Single Use Handpiece from the Transducer and Waveguide assembly. Dispose of the Handpiece in an appropriate sharps bin. Reprocessing instructions have been validated by SRA Developments Ltd to be capable of preparing the Lotus system for reuse. Instruments should be sterilized prior to use using the following as guidelines. It is the responsibility of the user to ensure that reprocessing is performed in a controlled manner using validated and calibrated equipment. Any deviation by the reprocessor from these instructions should be evaluated for the effectiveness and potential adverse consequences. All Transducers & Waveguides are provided clean but not sterile. All Transducers & Waveguides have been inspected prior to shipment. Please contact SRA Developments Ltd Customer Services if further information is needed. These instructions are written in accordance with the International Standard ISO 17664:2004 Sterilization of medical devices - Information to be provided by the manufacturer for the processing of resterilizable medical devices. As required by this standard, options are given for manual OR automatic cleaning methods.

3 Warnings and guidelines Warnings Follow instructions and warnings issued by SRA Developments for cleaning and equipment use. 285ºF (140ºC) is NOT to be exceeded during the reprocessing steps. Do NOT use ULTRASONIC WASHING or CYDEX. Do NOT Sterilize Lotus generator. Scratches or dents can result in breakage or malfunction. Care should be taken to remove debris or tissue that may collect on the Lotus generator. Limitations on reprocessing End life is generally determined by wear or damage in surgical case. Carefully inspect instruments between uses to verify proper functioning. Damaged instruments should be replaced to prevent potential patient injury and loss of metal fragments into the surgical site.

4 Reprocessing guidelines Immediately after use Manual cleaning Automated cleaning Immediately after use wipe down all components (including the generator) and remove any surplus body fluids and debris. Fit the attached end cap over the free end of the Transducer cable. Push the cap until it clicks into place. Prepare enzymatic cleaning solution (e.g. Gigazyme Plus) to manufacturers instructions. Soak soiled instruments in enzymatic solution for 5 minutes. When cleaning, fully submerge the instruments in the cleaning solution. Brush with soft nonmetallic bristle brush or cloth to remove all traces of blood and debris, concentrating on any crevices, seams, or other surface discontinuities. Clean holes and recesses using an appropriate brush ensuring that the full depth of the feature is reached. Ensure instruments are visibly clean before progressing to the next step. Rinse instruments thoroughly with clean running water for 2 minutes. Ensure that blind holes and recesses are repeatedly filled and emptied with running water. Dry instruments immediately after final rinse. Do not exceed 285ºF (140 ºC) Instruments may require manually cleaning prior to automated cleaning to improve the removal of adherent soil. Brush with non-metallic bristle brush in enzymatic cleaning solution. Load instruments such that crevices, seams, surface discontinuities, holes and recesses can drain. Clean using the Instruments cycle in a validated washer disinfector and a ph neutral cleaning agent intended for use in automatic cleaning (e.g. Getinge Enzymatic Detergent). The cleaning cycle should incorporate pre-rinse (minimum 3minutes), wash (minimum 14 minutes), rinse (minimum 7 minutes), thermal rinse (minimum 4 minutes at 200ºF/93ºC), and drying steps - Do not exceed 285ºF (140 ºC).

5 Reprocessing guidelines Cleaning inspection Inspect all instruments prior to sterilization or storage to ensure the complete removal of soiled surfaces. Visually inspect instruments, if soil is still present clean instruments again. Inspect cables for wear and damage, ensuring that no cracks, tears, or other damage is found. Check to see that waveguides are free of scratches. Report any damage found to the Lotus representative. Wrapping Sterilization Double wrap in accordance with local procedures, using standard procedures wrapping techniques such as those described in ANSI/AAMI ST Label contents of wrapped tray using indelible marker or other sterilization compatible label system. Sterilization is best achieved on the day preceding the surgery, but must be at least two hours prior to use to allow the equipment to cool and stabilize. Transducers & Waveguides are NOT to be submerged in water to expedite cooling. Do NOT sterilize the generator. These components have been validated for sterilization by the following method, in a vacuum autoclave conforming to EN285. The parameters for this being 270º- 277ºF (134º - 137ºC) for a minimum of 3 and a maximum of 18 minutes. Storage Return Store sterile packaged instruments in a manner that provides protection from dust, moisture, insects, vermin, and extremes in temperature and humidity. Before returning the Lotus system or any individual components to SRA Developments Ltd, please ensure that washing and sterilization have been carried out. All equipment must have a valid cycle. Certification of decontamination must accompany the system or any individual components on their return.

6 Reprocessing guidelines The instructions provided above have been validated by SRA Developments Ltd as being CAPABLE of preparing a medical device for re-use. It remains the responsibility of the processor to ensure that the processing is actually performed using equipment, materials and personnel in the processing facility to achieve the desired result. This requires validation and routine monitoring of the process. Likewise any deviation by the processor from the instructions provided should be properly evaluated for effectiveness and potential adverse consequences.

7 Lotus SRA Developments Ltd Bremridge House Bremridge Ashburton, Devon UK TQ13 7JX