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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

            III.   Reprocessing instructions


        To maintain instruments properly, it is important to consider the following instruction.
               1.  Flow Chart

                                                                   Remove gross soil
                                              Point of use         Rinse in running water/ tap water
                                                                   Place in pre-disinfectant bath

                                              Transport to         Avoid damage
                                            processing area        Transport in closed containers
                                                                    Minimize time before cleaning
                                                                
                                            Preparation for         Dismantle when possible
                                               cleaning         

                                                                  Remove gross soil
                                                                  Soak in cleaning solution
                                              Manual Pre-          Brush, operate moving parts
                                               Cleaning           Rinse in running water / tap water
                                                               
                                                                  Inspect, place on absorbent paper


                                                                   Load devices into automatic washer
                                                                   Avoid contact between devices
                                             Cleaning in an        Articulating devices are open
                                           automatic washer        Run  a  cycle  (T≤93°C ;  T≤200°F;
                                                                    10 minutes)
                                                                   Drying cycle


                                                        Inspection             Visual inspection
                                                                               Fonctional check
                                                                               Lubrication



                                                                            Packaging of single
       Packaging of trays         Reassemble the dismantled instruments     instruments and           Reassemble the
                                  Store devices in dedicated trays              handles           dismantled instruments
                                                                                                    
                                                                                                       Single or double
                                  Single or double wrapping
                                                                                                   packaging

                                                                            Steam autoclave :
                                                   Sterilization                o   USA: 132°C ((270°F)) during 4 min
                                                                                o   Outside  USA:  134°C  ((273°F))  during
                                                                                   18 min



                                                     Storage               Controlled environment
                                                                           Controlled shelf-life











                                                                                                      Page 9 of14
        This confidential document is the property of SpineVision Do not duplicate without authorization from SpineVision.
        Computer filename: CI_01EN.docx
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