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Instructions for Cleaning, Sterilization, Inspection and
                                                       ®
                  Maintenance of SpineVision  medical devices
                                        English version

        Application date : 2015-12-09   Reference document: CI_01EN

               b.  Manual Pre-Cleaning
        The pre-cleaning step can be ommitted in case of direct subsequent manual cleaning and disinfection. In case of
        highly contaminated medical devices to be subjected to an automatic cleaning process, pre-cleaning in an ultrasonic
        bath is recommended.
          Remove gross soil using wipes and solution of cleaning agent.
          Immerse re-usable instruments in solution of cleaning agent.
          Ensure that all surfaces are thoroughly wet.
          Use a syringe to ensure that the cleaning solution reaches all cannulated parts.

          Ensure that air is not trapped within cannulas or voids of the device when immersed in the solution.
          Soak for minimum recommended time by the detergent manufacturer’s instructions.
          Using suitable soft bristle brush, clean the instrument thoroughly, paying particular attention to rough surfaces
            as threads, cannulated parts, joints and difficult access areas where soil may be impacted or shielded from the
            cleaning process.
          Use a bottle brush of appropriate diameter and length for cannulation. Ensure that the brush passes the whole
            length of each cannulation. Otherwise, the instrument is not conform and not re-usable; please contact your
            SpineVision representative for an exchange.
          Rinse in running water / tap water for at least 2 minutes, and until all traces of cleaning solution are removed.
          Visually inspect for any remaining soil and repeat the steps above if necessary.
          Allow to drain on absorbent paper or transfer immediately to cleaning step.


               c.  Automated Cleaning

          Load the re-usable instruments into the automatic washer.
          Avoid contact between devices as it could diminish the efficacy of cleaning process.
          Arrange re-usable instruments so that cannulations are not horizontal and blind holes inclined downwards to
            help drainage.

          Articulating devices should be opened.
          Operate the washer-disinfector cycle, using a neutral pH cleanser.  See the following table “Automatic Washing
            Cycle Steps and Parameters”

          Visually  inspect  each  device  for  remaining  soil  and  dryness.  If  soil  remains,  repeat  the  cleaning  process.
            Remaining wetness may be removed with filtered, compressed air or clean, lint-free wipes.
        Automatic Cleaning Cycle Steps and Parameters:

                        Automatic  pre- 5 min                Tap water         22°C  to  43°C  (73°F
                        cleaning                                               to 110°F
                         st
                        1  wash cycle    10 minutes          Cleaning agent    60°C (140°F)
                        Rinsing cycle    2 min               Tap water         43.3°C (110°F)
                        Thermal  Rinse  5 min                De-ionized water   90°C (194°F)
                        cycle
                        Drying cycle     30 min              N/A               98.8°C (210°F)
        Note: Purified (de-ionized) water should be used for final rinsing to eliminate mineral deposits on instruments.



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        This confidential document is the property of SpineVision Do not duplicate without authorization from SpineVision.
        Computer filename: CI_01EN.docx
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