ulrich medical uCentrum Instructions For Use Manual page 18

6. If applicable: Rinse all the lumina of the instruments five times at the beginning and/or end of the application time using a disposable syringe
(minimum volume: 50 ml).
7. Dry the instruments in suitable containers after cleaning. Ensure that liquids can run off completely. If necessary, subject the instruments to ad-
ditional drying in a clean location.
8. Inspect the instruments (see the „Instrument inspection" and „Maintenance" sections).
Instrument disinfection during manual cleaning
1. Place the disassembled and non-disassembled (see manufacturer's instructions), cleaned and inspected instruments into the disinfecting bath for
the specified application time so that the instruments are sufficiently immersed. Make sure that the instruments do not touch each other.
2. If applicable: Rinse all the lumina of the instruments five times at the beginning and/or end of the application time using a disposable syringe
(minimum volume: 50 ml).
3. Remove the instruments from the disinfecting bath and rinse them thoroughly (at least 1 minute) under running water.
4. If applicable: Rinse all the lumina of the instruments using a disposable syringe (minimum volume: 50 ml).
5. Dry the instruments in suitable containers after cleaning. Ensure that liquids can run off completely. If necessary, subject the instruments to ad-
ditional drying in a clean location.
6. Package the instruments as soon as possible after removal (see the „Packaging" section).
Instrument inspection
Inspect all the instruments, including the sterilization layers and trays, after cleaning or cleaning/disinfecting for corrosion, damaged surfaces,
chips and impurities and separate out all damaged instruments. Instruments that are still dirty must be cleaned and disinfected again.
Maintenance
Reassemble all disassembled instruments. Subject all instruments to a functional test. Apply instrument oil to all moveable parts such as
push-buttons, sliding sleeves, closures on tongs, latches, threaded spindles, etc. for maintenance purposes. Instrument oils should not be used
other than for the above purpose whenever possible. Only instrument oils (white oil) should be used which – taking into consideration the
maximum applied sterilization temperature – are approved for steam sterilization and feature proven biocompatibility.
As a rule, no oil may be applied to silicone parts.
Packaging
Sort the cleaned and disinfected instruments and place them into the proper instrument tray and package them in suitable sterilization
packaging (i.e., FDA cleared sterilization wrap).
STEAM STERILIZATION – IMPLANTS & INSTRUMENTS
The implants and instruments have been found to be thoroughly suitable for effective steam sterilization by an independent accredited
laboratory using the following parameters. Validation was performed during the half-cycle. Only the following sterilization procedure is to be
used. Other sterilization procedures are not permitted.
Cycle: Pre-Vacuum
Temperature: 270°F (132°C)
Exposure time: 4 min.
Drying time: minimum 30 min.
Testing has shown these parameters to result in a sterility assurance level (SAL) of 10-6. Do not use hot-air sterilization or radiation sterilization
procedures. Do not stack implant and/or instrument trays. Flash sterilization is not permissible under any circumstances!
Storage
After sterilization, the implants and instruments must be stored in the sterilization packaging dry and free of dust.
Material stability
When choosing the cleaning agent and disinfectant, please ensure that they do not contain the following ingredients:
ƒ Corrosion protectors/corrosion inhibitors (triethanolamine is particularly problematic)
ƒ Strong organic, mineral and oxidizing acids
ƒ Strong alkaline solutions (pH > 12 is not permissible for implants, pH > 10.5 is not permissible for aluminum trays; neutral or weakly
alkaline cleaning agents are recommended)
ƒ Solvents (alcohols, acetone), benzine
ƒ Oxidizing agents
ƒ Ammonias
ƒ Chlorine and iodine
Never clean implants, implant trays and sterilization containers with metal brushes or wire wool.
No implants, implant storage trays or sterilization containers may be exposed to temperatures higher than 141°C (286 °F).
This document is valid only on the date printed. If unsure of the print date, re-print to ensure use of the latest version of the IFU. The onus resides with
the user to ensure that the most up-to-date IFU is used.
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2019-05-06