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Cleaning, Disinfection and Sterilization
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       7.2     Disinfection and Sterilization Procedure for Lip Clip,                                    Operation       Operating mode               Warning
               Connection Hook and Fork
                                                                                                                      •  Inspect devices and   •  Dirty instruments must be
               Foreword                                                                                                  sort out those with   cleaned and disinfected
                                                                                                                         defects.              again.
               For hygiene and sanitary safety purposes, the lip clip, the connection                                 •  Assemble the devices   •  Discard instruments which
               hook and the fork must be cleaned, disinfected and sterilized before                                      (stops).              show any deformations
               each usage to prevent any cross-contamination between patients. This                                                            (bent, twisted), damages
               concerns the first use as well as the subsequent uses.                                                                          (broken, corroded) or defects
                                                                                                   7   Inspection
               General recommendations                                                                                                         (loss of colour coding or
               •  Use only a disinfecting solution which is approved for its efficacy                                                          marking) affecting the
                  (VAH/DGHM-listing, CE marking, FDA approval) and in accordance                                                               resistance, the safety or the
                                                                                                                                               performance of the
                  with the DFU of the disinfecting solution manufacturer. For all metal                                                        instrument.
                  instruments, it is recommended to use anticorrosion disinfecting                                                          •  Do not use instrument
                  and cleaning agents;                                                                                                         lubricants.
               •  For your own safety, please wear personal protective equipment                                      •  Place the devices in a   •  Avoid any contact between
                  (gloves, glasses, mask).                                                                               support or container   instruments during
               •  The user is responsible for the sterility of the product for the first                                 to avoid any contact   sterilization. Use supports or
                  cycle and each further usage as well as for the usage of damaged                                       between instruments   containers.
                  or dirty instruments where applicable after sterility.                                                 or posts and pack the   •  Check the validity period of
               •  Limitations and restrictions on reprocessing:                                                          devices in            the pouch given by the
                  the appearance of defects such as cracks, deformations (bent,                    8   Packaging         “Sterilization        manufacturer to determine
                  twisted), corrosion, loss of colour coding or marking, are indications                                 pouches”.             the shelf life.
                  that the devices are not able to fulfil the intended use with the                                                         •  Use packaging which are
                                                                                                                                               resistant up to a temperature
                  required safety level.                                                                                                       of 141°C (286°F) and in
               •  Use only clean water in all cleaning and rinsing steps.                                                                      accordance with
                                                                                                                                               EN ISO 11607.
               Step-by-step procedure


               Operation       Operating mode               Warning
                            •  Disassemble the
        1   Disassembling
                               device.













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