Handling, Cleaning and Sterilization of the Medistim QuickFit
Contents
1. NG11 7EP Phone 44 0 115 981 0871 medistim medistim com www medistim com MED STIM Handling Cleaning and Sterilization of the Medistim QuickFit TTFM Probes PS101011 PS101012 PS100021 PS100022 PS100031 PS100032 PS100041 PS100042 PS100051 PS100052 PS100071 PS100072 Probe Manual PS499001 Rev G MED STIM Explanation of symbols on probe and package labeling Conformit Europ enne European C 0470 Conformity This symbol means that the device fully complies with European Directive 93 42 EEC Follow instructions for use Protected against the effects of temporary immersion in water IPX7 Quantity Date of Manufacture Manufacturer address EGE this device to sale by or on the order R Caution Federal Law USA restricts onl y of a physician Shipped NON STERILE Serial Number J R E F Catalogue number Probe Manual PS499001 Rev G Handling Cleaning and Sterilization of the Medistim QuickFit TTFM Probes To guarantee that the probe performance is in accordance with the specifications during the entire lifecycle of the probe Medistim has limit ed the number of sterilization cycles to 50 The probes are warranted against manufacturing defects for one year limited to a maximum of 50 sterilization cycles 1 HANDLING The Medistim probes are delicate instruments made with very high precision and should be handled with care Damage to the probe can cause me2. EANING Wear protective gloves when removing the probe from the sterile field and when cleaning as it may be stained with blood Automatic washing machine The PS probes can be cleaned in an automatic washing machine at a maximum temperature of 95 C using non aggressive detergents and at a drying temperature of maximum 100 C for up to 20min Manual cleaning After use immerse the probe and soak for a minimum of five 5 minutes in a fresh pH neu tral enzymatic cleaning solution per manufac turer s instructions Use a soft bristled brush moistened with clean ing solution to remove all traces of debris being particularly thorough in the area of the probe head and locking slide Thoroughly rinse the probe under warm running 30 43 C tap water for a minimum of one 1 minute and until visibly clean Wipe the probe with 70 isopropyl alcohol IPA and allow to air dry Repeat this cleaning procedure if any remaining debris is observed on the probe 4 DISINFECTION Subsequent to the cleaning procedure de scribed in section 3 the probe must be sterilized according to the method described in section 5 Sterilization in the user manual Additional disinfection is not required and may ultimately damage the probe If nonetheless disinfection is performed ensure that the disinfection solution used is listed by Medistim for use with the PS probe models MED STIM covered by this manual For an updated list
3. MED STIM er s loading instructions and close the chamber door Start preprogrammed sterilization cycle per manufacturer s instructions The probe is ready for use after the sterilization cycle is complete including a minimum drying time of 30 minutes 5 2 Sterrad Sterilization A Johnson amp Johnson Process The Medistim PS probes can be sterilized using Sterrad a rapid low temperature and low moisture technology designed for delicate instrument sterilization The following models can be used to sterilize the probe e Sterrad NX e Sterrad 100S e Sterrad 100NX e Sterrad 200 The sterilization cycle involves the following steps 1 Follow instructions for use for the Johnson amp Johnson sterilization process to protect the probe from accidental damage during handling 2 Clean the probe as described in Section 3 Cleaning and dry thoroughly Place the dry probe in the probe box delivered with the probe or a Sterrad instrument tray Double wrap tray or box in CSR wrap 3 Place the instrument tray s in the sterilization chamber according to manufacturer s loading instructions and close the chamber door Start preprogrammed sterilization cycle per manufacturer s instructions 4 The probe is ready for use after the sterilization cycle is complete Normal cycle time is 28 75 minutes depending upon the model Probe Manual PS499001 Rev G 5 3 Renosem plasma Sterilizaton The follow
4. asurements to be inaccurate or even impossible To ensure optimal performance and longevity of the probe please note the following handling guidelines e Do not bend the steel reflector e Do not stretch the cable e Do not rotate the flexible distal portion of the probe around the probe center axis e Use care when coiling the probe cable the cable should be wound in large loose loops not tightly wrapped e Use care when cleaning the probe e Clean the probe immediately after use Do not let blood dry on the probe e Use care not to cut the cable with sharp tools or in any way crush the cable It is highly recommended that the probe s original packaging be used during ship ment handling and storage Probes that have been damaged due to care less handling are not covered under warranty 2 CHECKING MECHANICAL INTEGRITY Prior to use and during the cleaning process check each probe for mechanical integrity The probes are delicate medical devices that may experience mechanical abrasion which could damage them Probes that show external signs of abrasion visible cracks small cuts in the probe cable etc should be checked for mechanical integrity In particular carefully examine the section between the flexible part of the probe and the probe handle Probes with major mechanical malfunctions should not be used and should be replaced Please contact your local representative or Medistim directly 3 CL
5. cifically warranted by the steam autoclave sterilization manufacturer or in the probe box delivered with the probe Place the pouch or probe container in the steam sterilization chamber according to manufactur Probe Manual PS499001 Rev G
6. ing Renosem models can be used to sterilize the probe Reno S20 Reno S30 Reno D50 e Reno S130 Reno S130D The sterilization cycle involves the following steps 1 Follow instructions for use for the Renosem sterilization process to protect the probe from accidental damage during handling 2 Clean the probe as described in Section 3 Cleaning and dry thoroughly Place the dry probe in the probe box and double wrap box in CSR wrap 3 Place the instrument tray s in the sterilization chamber according to manufacturer s loading instructions and close the chamber door Start preprogrammed sterilization cycle per manufacturer s instructions 4 The probe is ready for use after the sterilization cycle is complete Normal cycle time is 28 62 minutes depending upon the model WARNING NEVER INSERT A WET CONNECTOR TO THE SYSTEM AS THIS COULD CAUSE THE SYSTEM TO MALFUNCTION Medistim ASA Head office kernveien 94 0579 Oslo Norway Phone 47 23 05 96 60 Medistim Norge AS kernveien 94 0579 Oslo Norway Phone 47 23 03 52 50 Medistim USA Inc 14000 25th Ave N Ste 108 Plymouth MN 55447 USA Phone 1 763 208 9852 Medistim Danmark ApS Gengetoften 13 2950 Vedb k Denmark Phone 45 2276 5669 Medistim Deutschland GmbH Bahnhofstr 32 82041 Deisenhofen Germany Phone 49 0 89 62 81 90 33 Medistim UK Limited 34 Nottingham South Ind Est Ruddington Lane Wilford NOTTINGHAM
7. of disinfection solutions visit the Medistim homepage www medistim com Note The connector must not be left to soak in disinfection solution When disinfection is performed follow the manufacturers instructions applicable to the disinfection solution Please note that the cleaning procedure see Section 3 must be administered prior to disin fection and or final sterilization see Section 5 WARNING damages due to use of disinfection solutions NOT LISTED BY MEDISTIM are not covered by the warranty 5 STERILIZATION 5 1 Steam Autoclave The PS series probes can be sterilized us ing steam autoclave for full cycles of four 4 minutes at 132 C or three 3 minutes at 134 C using prevacuum air removal in double pouched or double wrapped probe box up to three 3 Bar pressure and a duration of up to thirteen 13 minutes Medistim guarantees that the PS probe series can be re sterilized 50 times when handled in accordance with this procedure WARNING CLEANING SHALL ALWAYS BE PERFORMED PRIOR TO STERILIZATION The steam sterilization cycle involves the follow ing steps Follow instructions for use for the autoclave sterilization process to protect the probe from accidental damage during handling When sterilizing multiple devices do not exceed the maximum load as indicated in the manufactur er s instructions Clean the probe as described in Section 3 Cleaning and dry thoroughly Place the dry probe in a pouch spe
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