Basic Principles: All instruments must be cleaned, disinfected and sterilised before every use; this is especially important before using for the first time after delivery as all instruments are supplied non-sterile.
Only validated procedures shown here for cleaning, disinfecting and sterilisation of the patient-specific products and instruments should be used.
Please also ensure that the equipment (ultrasonic unit and steriliser) is serviced and checked at regular intervals and that the validated parameters are adhered to for every cycle. Ensure that all regulations which apply in your country as well as the hygiene directives applicable to medical practices/hospitals are followed. This applies especially to the various instructions concerning effective deactivation of prions.
- Please ensure that all parts are separated from each other and do not touch during cleaning and sterilisation
- Always use powder-free Nitrile gloves during the cleaning process
- Use a disinfectant that is aldehyde-free with a proven efficacy and that is suitable and compatible for disinfecting instruments.
- Dilute the disinfectant with water in a container according to the supplier instructions.
- Submerge the instruments for a minimum of 5 minutes in the solution.
- Hand scrub.
- Rinse thoroughly under running water for a minimum of 60 seconds.
- Dilute the the disinfectant with warm water at 50° C in a container according to the supplier instructions.
- Add all instruments to the solution and place it into the ultrasonic bath.
- Switch the ultrasonic bath on.
- Turn the time dial to 5 minutes. (This will automatically activate the ultrasonic bath to start the cleansing process)
- Remove the container from the bath after 5 minutes and separate the contents from the solution.
- Rinse thoroughly under running water for a minimum of 60 seconds.
- Dip the instruments in medical grade alcohol and air dry.
- Store and handle as clean.
- Use a disinfectant that is aldehyde-free with a proven efficacy and that is suitable and compatible for disinfecting instruments.
- Dilute the disinfectant with water in a container according to the supplier instructions.
- Submerge the instruments for a minimum of 5 minutes in the solution.
- Hand scrub.
- Rinse thoroughly under running water for a minimum of 60 seconds.
- Dilute the the disinfectant with warm water at 50° C in a container according to the supplier instructions.
- Add all instruments to the solution and place it into the ultrasonic bath.
- Switch the ultrasonic bath on.
- Turn the time dial to 5 minutes. (This will automatically activate the ultrasonic bath to start the cleansing process)
- Remove the container from the bath after 5 minutes and separate the contents from the solution.
- Rinse thoroughly under running water for a minimum of 60 seconds.
- Dip the instruments in medical grade alcohol and air dry.
- Store and handle as clean.
Auto Cleaning
Place the instruments in the disinfectant that is aldehyde-free with a proven efficacy and that is suitable and compatible for disinfecting instruments for at least 5 minutes.
Ensure they are immersed properly. Do not allow the instruments to touch each other.
Run the cleaning cycle in accordance with ISO 15883.
Auto Cleaning Equipment and Chemicals
Disinfectant with a CE-Mark mixed with warm water
Water that is low in germs.
Auto-cleaner in accordance with ISO 15883.
- Wrap the instruments in a porous pack and place chemical indicator strips in tray and pouches, as well as on outside of pack. Write expiry date on tape. Load pack.
- Pre-condition: Vacuum pump removes air from chamber.
- Sterilisation: After air removal, steam is injected in chamber at 132°C and 240kPa for at least 4 minutes. The upper control limit being equal to sterilisation temperature plus 3°C, with no deviation exceeding 1°C, and temperature difference of any 2 points inferior to 2°C.
- Drying: The pack is dried by the vacuum pump that will draw vacuum to sufficiently remove moisture from the packs. 8 minutes of vacuum is normally enough.
- Vacuum break: Sterile air to be filtered into chamber to break the vacuum.
- Removal and cool down: Remove and place in special cooling rack. Avoid touching the hot pack by hand as hot packs can absorb moisture and bacteria from hands.
- Place pack in a sterile storage area. Please observe expiry dates and re-sterilise if necessary.
Cycle Specifications
- Hold Temperature: 132°C to 135°C
- Hold Pressure (Chamber): 225 kPa to 230 kPa
- Hold Pressure (Jacket): 240 kPa to 250 kPa
- Cycle Time: 4 minutes
