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Scope Cleaner S20 - G-Flex

1. www g flex com Installing the SCOPE CLEANER 20 Overview of the unit SGOPEcleaner f Firet ELEL a a a Z simple performing SCOPECICanar 20 a wrote cen atal G Flex Europe S P R L 20 Rue de l industrie 1400 Nivelles Belgium Phone 32 0 67 88 36 65 Fax 32 0 67 88 36 88 Email sales g flex com Website www g flex com US Commercial Office Only G Flex USA Inc 74 Southwood Pkwy Suite 600 Atlanta GA 30354 USA Creation Date Current Name 18 10 13 IFU ScopeCleanerS20 doc This document is only controlled in electronic format by the QM Page Version 14 of 87 7 M CLEE simple ETY E Ge T wm T S e n www g flexcom P forming Device dimensions cm D aT B ee SCORECleanenis20 Gee 1480 Setting up the unit Ensure the chosen operating environment for the SCOPE CLEANER S820 is dry and has a relative air humidity of no more than 70 and an ambient temperature between 10 C and 35 C Floor mounted unit SCOPE CLEANER S20 place the cabinet on an even floor and use the four adjustable screw feet fitted to the cabinet to ensure the unit cannot wobble G Flex Europe S P R L 20 Rue de l industrie 1400 Nivelles Belgium Phone 32 0 67 88 36 65 Fax 32 0 67 88 36 88 Email sales g flex com Website www g flex com US Commercial Office Only G Flex USA Inc 74 Southwood Pkwy Suite 600 Atlanta GA 30354
2. To sterilize the water filter for the SCOPE CLEANER 20 you will need a steam sterilizer autoclave see Chapter 5 Service and maintenance which meets the requirements of EN 13060 process cycle Type B Installation Installation must be carried out by a professional installation company When installing the equipment the following standards must be applied EN 1717 and DIN 1988 4 On site training is provided by G Flex Europe SPRL ora medical equipment consultant authorized by us G Flex Europe S P R L 20 Rue de l industrie 1400 Nivelles Belgium Phone 32 0 67 88 36 65 Fax 32 0 67 88 36 88 Email sales g flex com Website www g flex com US Commercial Office Only G Flex USA Inc 74 Southwood Pkwy Suite 600 Atlanta GA 30354 USA Creation Date 18 10 13 Page 50f 87 Current Name IF U ScopeCleanerS20 doc Version 7 This document is only controlled in electronic format by the QM Pied simple www g fiexcom performing tt Service and maintenance Safe operation of this unit can only be guaranteed it the maintenance and service instructions described in this manual are observed at all times Training On site training is provided by G Flex Europe SPRL or a medical equipment consultant authorized by us i addition the owner is responsible That only personnel uses or maintained this unit that is trained in usage and safe handling of this unit Functional test Beie use c
3. Creation Date 18 10 13 Page 10 of 87 Current Name IFU ScopeCleanerS20 doc Version 7 This document is only controlled in electronic format by the QM mple m meine ming Filling tube for connecting to the sterile water filter f spare part number 7006 350 Cold device connection cable with earthed plug Spare part number 5020 010 6 connection tubes in a connection set for SCOPE CLEANER S20 Spare part number 7600 NSO or 7600 NS1 Connection tube for leakage test The connection tube connections are adapted to the specific endoscope Detailed photo of the leakage tester cap PENTAX Spare part number 7526 PE RF SET G Flex Europe S P R L 20 Rue de l industrie 1400 Nivelles Belgium Phone 32 0 67 88 36 65 Fax 32 0 67 88 36 88 Email sales g flex com Website www g flex com US Commercial Office Only G Flex USA Inc 74 Southwood Pkwy Suite 600 Atlanta GA 30354 USA Creation Date 18 10 13 Page 11 of 87 Current Name IFU ScopeCleanerS20 doc Version 7 This document is only controlled in electronic format by the QM Detailed photo of the leakage tester cap OLYMPUS Spare part number 7526 OL SET Detailed photo of the leakage tester cap FUJINON Spare part number 7526 FU SET Optional PALL prefilter excluding holder Spare part number 11 1005 MN The maximum operating temperature of the liquid to be filtered must not exceed 40
4. gt Disinfectant s expiration date Hy f d J oy a DOUBTS mm dd yy HH MM SS The message indicates that the disinfectant expired Tapping the alert message the user can start the process to change the disinfectant G Flex Europe S P R L 20 Rue de l industrie 1400 Nivelles Belgium Phone 32 0 67 88 36 65 Fax 32 0 67 88 36 88 Email sales g flex com Website www g flex com US Commercial Office Only G Flex USA Inc 74 Southwood Pkwy Suite 600 Atlanta GA 30354 USA Creation Date 18 10 13 Page 67 of 87 Current Name IFU ScopeCleanerS20 doc Version 7 This document is only controlled in electronic format by the QM gt Self Disinfection KAR ets ple Wwarflex orming www g flex com v HOME PERFORM THE SELF DISINFECTION peli performing N OPTIONS CATALOG DOUBTS mm dd yy HH MM SS e The message indicates the necessity to perform the self disinfection process AB gt The Warning messages from the Main Screen will not allow the user to start any process while the warnings were not solved The exception is the Self Disinfection alert gt After the changes or corrections were solved tap the warning message to change the parameters and enable the START Button G Flex Europe S P R L 20 Rue de l industrie 1400 Nivelles Belgium Phone 32 0 67 88 36 65 Fax 32 0 67 88 36 88 Email sales g flex com
5. This document is only controlled in electronic format by the QM T EJ i GEER i amp iW wwwg flexcom P M2 ELEM simple A fresh batch of detergent solution must be prepared at least once per working day If the solution looks dirty or has been contaminated with organic waste the detergent should be replaced immediately with a fresh batch The cleaning sink must be thoroughly cleaned and disinfected daily Connecting the endoscope to the SCOPE CLEANER 20 A gt The manner in which various endoscope models are attached to the SCOPE CLEANER 920 is illustrated in Appendix I e Connect the endoscope channels via the connection tubes channel tubes to the disinfectant tank rinse adapters Observe the color coded markings on the connection tubes see table below Endoscope Channel Color of Channel Tube Color Location of Tank Connection Jet Channel White Far Left Connection Biopsy Channel Green 2nd Connection from Left Suction Channel Red 3rd Connection from Left Air Water Channel Bue Blue 4th Connection form Left Blue 5th Connection from Left G Flex Europe S P R L 20 Rue de l industrie 1400 Nivelles Belgium Phone 32 0 67 88 36 65 Fax 32 0 67 88 36 88 Email sales g flex com Website www g flex com US Commercial Office Only G Flex USA Inc 74 Southwood Pkwy Suite 600 Atlanta GA 30354 USA Creation Date 18 10 13 Page 29 of 87 Current Name IFU ScopeCleanerS20 doc V
6. i oo 5 3 Operating Instructions SCOPE CLEANER S20 E 0120 G Flex Europe S P R L 20 Rue de l industrie 1400 Nivelles Belgium Phone 32 0 67 88 36 65 Fax 32 0 67 88 36 88 Email sales g flex com Website www g flex com US Commercial Office Only G Flex USA Inc 74 Southwood Pkwy Suite 600 Atlanta GA 30354 USA Creation Date 18 10 13 Page 1 of 87 Current Name IFU ScopeCleanerS20 doc Version 7 This document is only controlled in electronic format by the QM ELISE simple n www g flexcom performing Note A The SCOPE CLEANER S20 has been designed exclusively for the disinfection of flexible endoscopes Read the Operating Instructions before using this disinfection equipment Caution A The owner is responsible for ensuring that the equipment functions are all working properly and that it meets hygiene requirements In addition the owner is responsible that only personnel use or maintain this unit that are trained in usage and safe handling of this unit G Flex Europe SPRL 20 Rue de l industrie 1400 Nivelles Belgium Telefon 32 67 88 3665 Fax 32 67 88 3688 E Mail marketing g flex com G Flex Europe S P R L 20 Rue de l industrie 1400 Nivelles Belgium Phone 32 0 67 88 36 65 Fax 32 0 67 88 36 88 Email sales g flex com Website www g flex com US Commercial Office Only G Flex USA Inc 74 Southwood Pkwy Suite 60
7. C Optional PALL prefilter cartridge packaged spare part number 11 1105 The maximum operating temperature of the liquid to be filtered must not exceed 40 C G Flex Europe S P R L 20 Rue de l industrie 1400 Nivelles Belgium Phone 32 0 67 88 36 65 Fax 32 0 67 88 36 88 Email sales g flex com Website www g flex com US Commercial Office Only G Flex USA Inc 74 Southwood Pkwy Suite 600 Atlanta GA 30354 USA Creation Date 18 10 13 Page Current Name IFU ScopeCleanerS20 doc Version This document is only controlled in electronic format by the QM 12 of 87 7 Optional Wall holder for PALL prefilter Spare part number 11 1006 Optional Gunmetal double nipple 3 4 for PALL prefilter Spare part number 11 1007 Optional Zebra printer spare part number TLP2844 Operating Instructions 2 ELE simple wwwgfiexcom performing Operating Instructions SCOPE CLEANER S20 ISGOPECleanemS20 Gres Lol G Flex Europe S P R L 20 Rue de l industrie 1400 Nivelles Belgium Phone 32 0 67 88 36 65 Fax 32 0 67 88 36 88 Email sales g flex com Website www g flex com US Commercial Office Only G Flex USA Inc 74 Southwood Pkwy Suite 600 Atlanta GA 30354 USA Creation Date 18 10 13 Page 13 of 87 Current Name IFU ScopeCleanerS20 doc Version 7 This document is only controlled in electronic format by the QM
8. actual unit Accessories Special accessories as listed in Appendix II of this manual are required to operate the SCOPE CLEANER S20 in line with its intended purpose G Flex Europe S P R L 20 Rue de l industrie 1400 Nivelles Belgium Phone 32 0 67 88 36 65 Fax 32 0 67 88 36 88 Email sales g flex com Website www g flex com US Commercial Office Only G Flex USA Inc 74 Southwood Pkwy Suite 600 Atlanta GA 30354 USA Creation Date 18 10 13 Page 30of 87 Current Name IF U ScopeCleanerS20 doc Version 7 This document is only controlled in electronic format by the QM Fired simple Ae Ge p T Bw g flex com p rfo rmin g Note Please pay particular attention to sections preceded by this symbol JN MN Instructions for avoiding injury to patients users maintenance personnel or others ZAN auton Information on the proper function and use of the unit and accessories AE Special information and recommendations for operation installation and maintenance of the unit and accessories G Flex Europe S P R L 20 Rue de l industrie 1400 Nivelles Belgium Phone 32 0 67 88 36 65 Fax 32 0 67 88 36 88 Email sales g flex com Website www g flex com US Commercial Office Only G Flex USA Inc 74 Southwood Pkwy Suite 600 Atlanta GA 30354 USA Creation Date 18 10 13 Page 4of 87 Current Name IF U ScopeCleanerS20 doc Version 7 This document is only co
9. 300 Ri a cr z am PRADE Fe fi LEAKAGE TESTE OFF dd mm yy x HH MM SS e www g flex com pe orming PROCESS PARAMETERS OE TY OF CLENANG jee DISMEFECTION TIME MIN MLL o s g ML OF ENZYMATIC PER LITER OF WATER gf i QUANTITY OF NEUTRALIZATION g OUANTITY OF PRE RISING a FINAL BLOW OUT SEG wages Sin E i T 1 f f Q dg i disinfectant solution and observe the specified concentration and exposure times affected while a long exposure time can damage the endoscope Time for Final Blow Out f2 ELE simple www g flexcom pel forming PROCESS PARAMETERS g OF CLEANING g TIME Mat Mert OUANTITY OF NEUTRALIZATION ML OF ENZYMATIC PER UTER OF WATER QUANTITY OF PRE RISING E BLOW OUT SEG Tae LEAKAGE TESTEOFF 5 L dd mm yy x 4 HH MM SS dd mm yy HH MM SS G Flex Europe S P R L 20 Rue de l industrie 1400 Nivelles Belgium Phone 32 0 67 88 36 65 Fax 32 0 67 88 36 88 Email sales g flex com Website www g flex com US Commercial Office Only G Flex USA Inc 74 Southwood Pkwy Suite 600 Atlanta GA 30354 USA Creation Date Current Name 18 10 13 IFU ScopeCleanerS20 doc This document is only controlled in electronic format by the QM Page Version 46 of 87 7 e Leakage Test Disable Leakage Test Enable Leakage Test QUANTITY OF PRE RISING QUANTITY OF NEVTRALISATION QUANTITY OF PRE RISING A QUANTITY OF NEUTRALISATION 95
10. AlI www g flex com pe rming e Dry the valves and store them in a dust free space e Do not refit the valves in the endoscope during storage Canceling process e To cancel or stop the disinfection process tap the CANCEL button The unit will ask if you want to stop the process e Choosing to stop the unit will coordinate the Cancel process opening the drain or the tank valve automatically e The drain or the tank valve will remain open waiting the user confirms if the coordinating process were finished f2 ELE simple y excom performing PROCESS STATUS EXPECTED Free sim per Being E simplo orming TOTAL TIME CLEANING PRE RISING DISINFECTION NEUTRALISATION COORDENATING THE MACHINE DRAIN VALVE OPEN LEAKAGE TEST PRESSURE 05 21 2012 mm dd yy HH MM SS mm dd yy HH MM SS gt Ifthe tank is not completely emptied It is possible to open the corresponding valve with the manual control at the Output Control in the Options menu Output control The Output control is a menu that allows the user to enable all mechanical parts of the unit e Tap the OPTIONS Button from the main screen and select the OUTPUT CONTROL Button HOME SCREEN ve ali FEEF 1 7 simple performing N OPTIONS CATALOG mMn dd yy HH MM SS dd mm yy HH MM SS G Flex Europe S P R L 20 Rue de l industrie 1400 Nivelles Belgium Phone 32 0 67 88 36 65 Fax 32 0 67 8
11. Belgium Phone 32 0 67 88 36 65 Fax 32 0 67 88 36 88 Email sales g flex com Website www g flex com US Commercial Office Only G Flex USA Inc 74 Southwood Pkwy Suite 600 Atlanta GA 30354 USA Creation Date 18 10 13 Page 71 of 87 Current Name IFU ScopeCleanerS20 doc Version 7 This document is only controlled in electronic format by the QM Ey a J PaA mz T 1 D www g flex ccom P nl 7 Troubleshooting simple forming Problem Error Cause Troubleshooting Filling pump Blocked filter in the tank section no or too low filling power Coupling of the suction tube is not locked snapped into place Suction tube to the tank is buckled Suction filter in disinfection tank is pulluted Rinsing pumps no or too low rinsing power Complete blackout of one rinsing pump Foam formation in the disinfection tank O ring black rubber ring on the coupling connector of the suction tube tank absent or defective Tank is not filled with disinfection solution gt pump takes air Wrong filter inlay in suction filter to tank Overflow of the disinfections tank Foreign substance blocks the vent for the return line fluid rinse through the return tube in the disinfection tank Neutralization solution does not drain fast enough water stands in the disinfection tak and the filling pump is already filling the disinfection tank with disinfection solution T
12. LIFE TIME 12 12 MACHINE CYCLES 12345 HH MM SS MACHINE 0000 mm dd yy G Flex Europe S P R L 20 Rue de l industrie 1400 Nivelles Belgium Phone 32 0 67 88 36 65 Fax 32 0 67 88 36 88 Email sales g flex com Website www g flex com US Commercial Office Only G Flex USA Inc 74 Southwood Pkwy Suite 600 Atlanta GA 30354 USA Creation Date 18 10 13 Page 50 of 87 Current Name IFU ScopeCleanerS20 doc Version 7 This document is only controlled in electronic format by the QM ELISE simple n www g flexcom performing gt gt To remove the endoscope from the SCOPE CLEANER S20 it is essential to use new disposable gloves to prevent recontamination of the endoscope through e g germs from the user s skin We would urge you to ensure thorough disinfection of the hands e Remove the connection tubes from the endoscope e Remove the endoscope from the tank gt gt During the course of the day it is perfectly sufficient to blast with air to clear the liquids from the channels However at the end of the day the endoscope and all its channels must be thoroughly dried gt gt Because the endoscope control head contains cavities depending on the model there may be residual fluid in the suction and air water valve e Hold the endoscope control head with the valves facing down Remove the valve covers and shake out the remaining fluid e Finally blow out all the channels carefully
13. NUMBER OF DISINFECTION CYCLES AAKI EXPIRATION DATE OF DISINFECTANT dd mm yy HH MM SS dd mm yy x HH MM SS Status of the SCOPE CLEANER S20 and unit information s To see the status of the unit tap the MACHINE STATUS Button from the Optional Menu At the Machine Status screen there are information about the expiration date of disinfectant the next date to replace the pre filter and the sterile water filter the date to autoclave the sterile water filter quantity of disinfectant cycle and machine cycles and the work hours of the unit 8 le wwwgfexcom performing MACHINE S STATUS a rT _ a e _ i fo ta DISINFECTANT TIME Tn PI fo jora Tj STERILE WATER FILTER DISINFECTANT CYCLE MACHINE CYCLES m a a er a 2 NF NT N p Vv STATU b ee ee s z Pam a at AR fi A a CLA S Te Ej STERILE WATER FILTER Jernerers 7 A nD ATIO hd I ERN EEN CALI Zaid E E _ oo WORK HOURS E fo pe a zi PRE FILTER dd mm yy x J HH MM SS 05 22 2012 K 14 41 01 G Flex Europe S P R L 20 Rue de l industrie 1400 Nivelles Belgium Phone 32 0 67 88 36 65 Fax 32 0 67 88 36 88 Email sales g flex com Website www g flex com US Commercial Office Only G Flex USA Inc 74 Southwood Pkwy Suite 600 Atlanta GA 30354 USA Creation Date 18 10 13 Page 550f 87 Current Name IFU ScopeCleanerS20 doc Version 7 This document is only contro
14. Page Version IFU ScopeCleanerS20 doc Current Name This document is only controlled in electronic format by the QM owen area arenuaouoo emoenuey owen yuey wasasa UO PSHUBYD UOINIOS UOlIsjUISIg UO Psde Ceal 137 1 UONONS UO payau 137 1 187JEM sjLiajs TWANVW SONVNSALNIVIN US Commercial Office Only G Flex USA Inc 74 Southwood Pkwy Suite 600 Atlanta GA 30354 USA Phone 32 0 67 88 36 65 Fax 32 0 67 88 36 88 Email sales g flex com Website www g flex com 18 10 13 G Flex Europe S P R L 20 Rue de l industrie 1400 Nivelles Belgium wl Creation Date 82 of 87 7 Page Version IFU ScopeCleanerS20 doc Current Name This document is only controlled in electronic format by the QM wen area arenueou09 semoeynuey owen yuey wasasa UO PSHUBYD UOINIOS UOljIsjUISIg UO Psde Ceal 137 1 UONONS UO PexHISYD 137 1 JSJEM sjLa s TWANVW SONVNALNIVIN US Commercial Office Only G Flex USA Inc 74 Southwood Pkwy Suite 600 Atlanta GA 30354 USA Phone 32 0 67 88 36 65 Fax 32 0 67 88 36 88 Email sales g flex com Website www g flex com 18 10 13 G Flex Europe S P R L 20 Rue de l industrie 1400 Nivelles Belgium wl Creation Date 83 of 87 7 Page Version IFU ScopeCleanerS20 doc Current Name This document is only controlled in electronic format by the QM UO PSHUBYD UOINIOS UOlIBjUISIg UO
15. Psde Ceal 137 1 UONONS UO Pex Jazip JSJEM sjLa s TWANVW SONVNSALNIVIN Phone 32 0 67 88 36 65 Fax 32 0 67 88 36 88 Email sales g flex com Website www g flex com G Flex Europe S P R L 20 Rue de l industrie 1400 Nivelles Belgium wl Creation Date US Commercial Office Only G Flex USA Inc 74 Southwood Pkwy Suite 600 Atlanta GA 30354 USA 18 10 13 84 of 87 7 Page Version IFU ScopeCleanerS20 doc Current Name This document is only controlled in electronic format by the QM UO PSHUBYD UOINIOS UOlIBjUISIg UO Psde Ceal 137 1 UONONS UO Pex Jazip JSJEM sjLa s TWANVW SONVNSALNIVIN Phone 32 0 67 88 36 65 Fax 32 0 67 88 36 88 Email sales g flex com Website www g flex com G Flex Europe S P R L 20 Rue de l industrie 1400 Nivelles Belgium wl Creation Date US Commercial Office Only G Flex USA Inc 74 Southwood Pkwy Suite 600 Atlanta GA 30354 USA 18 10 13 85 of 87 7 Page Version IFU ScopeCleanerS20 doc Current Name This document is only controlled in electronic format by the QM CO CC SC T T T UO PSNUBYD UOINIOS UO IsjuIsig UO Psde Ceal 1373 1 UONONS UO PexIsY9 Jazip JBJEM UAS IWANVW SONVNALNIVA US Commercial Office Only G Flex USA Inc 74 Southwood Pkwy Suite 600 Atlanta GA 30354 USA Phone 32 0 67 88 36 65 Fax 32 0 67 88 36 88 Email sales g flex com Website www g fle
16. air water channel irrespective of whether they have been used DRYING Note Wipe off the outer mantle with a disposable lint free cloth At the end of the day check to see whether all the endoscopes have completely dried and if necessary dry the channels with compressed air STORAGE Store endoscopes by hanging them in a completely dry dust free environment Follow the manufacturer s instructions to ensure the water bottle is baid G Flex Europe S P R L 20 Rue de l industrie 1400 Nivelles Belgium Phone 32 0 67 88 36 65 Fax 32 0 67 88 36 88 Email sales g flex com Website www g flex com US Commercial Office Only G Flex USA Inc 74 Southwood Pkwy Suite 600 Atlanta GA 30354 USA Creation Date Current Name 18 10 13 Page IF U ScopeCleanerS20 doc Version This document is only controlled in electronic format by the QM 87 of 87 7
17. also connected to the normal sewage system for your building The drain leading to the building s sewers must not be higher than 450 mm from the floor gt The drain tube must have a uniform slope to ensure liquid can drain completely with no sagging in the tube which would cause liquid to remain in the tube Electrical connection The SCOPE CLEANER 20 is connected to the mains power supply via the cold device connection cable supplied A emo gt Check the label on the back of the unit to ensure that the mains voltage is appropriate If the mains voltage is incorrect the unit may not function properly or could be damaged gt The maximum power consumption of the SCOPE CLEANER S20 is 3 15A It is recommended that the SCOPE CLEANER 820 is connected on a separate fuse to the mains MN gt The unit must be connected to the mains via an earthed contact gt The unit is not explosion proof Do not operate the unit in an environment which may contain explosive gases The SCOPE CLEANER S20 may be used as soon as it has been installed correctly The procedures outlined below should be carried out the first time the unit is used and then at regular intervals during normal operation G Flex Europe S P R L 20 Rue de l industrie 1400 Nivelles Belgium Phone 32 0 67 88 36 65 Fax 32 0 67 88 36 88 Email sales g flex com Website www g flex com US Commercial Office Only G Flex USA Inc 74 Southwood Pkw
18. button at the main screen e Tap the Output Control button e To check the pumps and valves tap the corresponding button FLEE simple wwwgfiexcom performing i fexcom performing HOME SCREEN Gree ay t simp zii ip portarmi DNI i 13 12 48 gt The access to Output Control could be protected by password gt DO NOT use the unit for purging or disinfecting endoscopes if the functional test has NOT been successfully completed If in doubt please contact G Flex Europe SPRL or a service engineer authorized by us G Flex Europe S P R L 20 Rue de l industrie 1400 Nivelles Belgium Phone 32 0 67 88 36 65 Fax 32 0 67 88 36 88 Email sales g flex com Website www g flex com US Commercial Office Only G Flex USA Inc 74 Southwood Pkwy Suite 600 Atlanta GA 30354 USA Creation Date 18 10 13 Page 22 of 87 Current Name IFU ScopeCleanerS20 doc Version 7 This document is only controlled in electronic format by the QM 4 Operating the SCOPE CLEANER 20 Functional tests amp routine checks to be performed on every working day For the functional test proceed as follows gt Check all connections to the drinking water electrical supplies and the drains Ensure they are firm Check if the strainer has been autoclaved and correctly connected Open the drinking water stopcock According to the supplier recommendation verify the disinfection and enzymatic solution validity by in
19. sales g flex com Website www g flex com US Commercial Office Only G Flex USA Inc 74 Southwood Pkwy Suite 600 Atlanta GA 30354 USA Creation Date 18 10 13 Page 26o0f87 Current Name IF U ScopeCleanerS20 doc Version 7 This document is only controlled in electronic format by the QM M ELEF simple q www g flex com perfo ming Endoscope reprocessing in accordance with the reprocessing plan refer to Appendix VI Precleaning the endoscope directly after an endoscopic examination The prewash will be performed directly on the light source in subsequent to the examination The outer coating of the insertion tube has to be cleaned as described by the endoscope supplier with a lint free fabric saturated with cleaning solution starting on the control element to the distal end G Flex Europe SPRL has specially developed cleaning sponges soaked in a special enzymatic cleaning agent Further details are available from the main GFlex catalogue or your authorized supplier Sufficiently enzymatic cleaning solution has to be sucked through the channel system by actuating the suction vent All accessible channels has to be rinsed multiple times to prevent any incrustation or pharmacological debris building up inside the channels which may not be removable later Separate the endoscope from the processor light source optical rinsing system and suction pump Contact safety caps to the contacts o the supply jack and ve
20. the main switch VVV WV Leakage test 2 min Prerinsing 4 5 min including 1 min blow out Disinfection cycle freely selectable 4 min filling and emptying including 1min blow out Neutralization 7 min including 2 min blow out Total time 18 min disinfection time including 2 min blow out G Flex Europe S P R L 20 Rue de l industrie 1400 Nivelles Belgium Phone 32 0 67 88 36 65 Fax 32 0 67 88 36 88 Email sales g flex com Website www g flex com US Commercial Office Only G Flex USA Inc 74 Southwood Pkwy Suite 600 Atlanta GA 30354 USA Creation Date 18 10 13 Page 430f87 Current Name IF U ScopeCleanerS20 doc Version 7 This document is only controlled in electronic format by the QM CLIE simple Ae Ge Mm www g flexcom performing Additional enzymatic precleaning with the SCOPE CLEANER 20 A e For particularly heavily contaminated endoscopes the SCOPE CLEANER 20 offers the option of extending the process by adding an enzymatic precleaning followed by a flushing stage before disinfection e This extends the recommended standard procedure by 3 5 minutes 1 minute blow out Leakage test 2 min Cleaning 4 5 min including 1 min blow out Prerinsing 4 5 min including 1 min blow out Disinfection cycle freely selectable 4 min filling and emptying including 1min blow out Neutralization 7 min including 2 min blow out Total time 22 5 mi
21. with compressed air until they are dry We recommend using compressed air up to a maximum of 0 5bar gt gt We recommend using a compressor to generate exactly the correct compressed air pressure The individual steps for final drying of the endoscopes with compressed air can be found in the instructions issued by the manufacturer of the endoscope or the Operating Instructions supplied with the compressor e Wipe dry the outer mantle of the endoscope using a disposable cloth e Carry out a functional test of the endoscope e After this step the endoscope can be used for examining patients again e For storage purposes the endoscope must be completely dry protected from dust preferably stored hanging in a special endoscope cabinet gt After the process were finished and any of the Parameters Disinfection need reconfiguration Just tap the START button to initialize a new process AN ato gt Only thorough drying can guard against recontamination during storage G Flex Europe S P R L 20 Rue de l industrie 1400 Nivelles Belgium Phone 32 0 67 88 36 65 Fax 32 0 67 88 36 88 Email sales g flex com Website www g flex com US Commercial Office Only G Flex USA Inc 74 Southwood Pkwy Suite 600 Atlanta GA 30354 USA Creation Date 18 10 13 Page 51 of 87 Current Name IF U ScopeCleanerS20 doc Version 7 This document is only controlled in electronic format by the QM CLIE simple e
22. 0 Rue de l industrie 1400 Nivelles Belgium Phone 32 0 67 88 36 65 Fax 32 0 67 88 36 88 Email sales g flex com Website www g flex com US Commercial Office Only G Flex USA Inc 74 Southwood Pkwy Suite 600 Atlanta GA 30354 USA Creation Date 18 10 13 Page 730f 87 Current Name IFU ScopeCleanerS20 doc Version 7 This document is only controlled in electronic format by the QM 8 Technical specifications Main supply nominal 230 V or optional 230 V 115 V Fuses T 3 15 IEC 127 2 pieces Max power consumption 3 715 A 2 5A Dimensions incl floor cabinet 770mm x 520mm x 1100mm width x depth x height Weight incl floor cabinet approx 42 kg PLC Programmable Logic Controller 32K OEM Max Pressure water connection 5 bar Operating conditions ambient temperature 10 C to 35 C Il b 15 EG RL 93 42 EEC Appendix Classification according to 93 42 EEC IX m MC complies with EN IEC 61010 1 2 15 liters and external to the unit O a making it easier to regular cleaning Scavenging channels 5 additional channels with individual pumps each Without contact with the tray Inlet water avoiding contamination of the water supply Print label or storage data in the USB Traceability flash drive Self disinfection time configured by Self disinfection cycle the user min 1 hour max 12 hours increasing pressure obstruction in the air water or s
23. 0 Atlanta GA 30354 USA Creation Date 18 10 13 Page 2of 87 Current Name IF U ScopeCleanerS20 doc Version 7 This document is only controlled in electronic format by the QM ELISE simple n www g flexcom performing Contents 1 Safety Instructions 2 Intended use and purpose 3 Using the equipment for the first time 4 Operating the SCOPE CLEANER 20 5 Service and maintenance 6 Error and warning messages 7 Troubleshooting 8 Technical specifications Appendix l Connecting an endoscope Appendix II Accessories Appendix III Replacement parts Appendix IV Maintenance and cleaning requirements Appendix V Service Logbook Appendix VI Reprocessing instructions Read the operating instructions Read the operating instructions before using the SCOPE CLEANER S20 for the first time and familiarize yourself with the functions and mode of operation of the unit and accessories Failure to comply with these operating instructions may result in injury to patients users and maintenance personnel and may also result in damage to the unit or endoscope or the unit and endoscope may stop working completely Store the operating instructions near the unit so that all users have access to the instructions at all times Technical modifications G Flex Europe SPRL reserves the right to modify and upgrade the unit without prior notice Illustrations and descriptions in this manual therefore may differ from the
24. 21 2013 15 51 51 EATE 15 49 39 Starting Process e After all the parameters were configured correctly and all the Users and Devices were registered tap the START Button to initialize the process simple com pe rforming performing OPTIONS CATALOG mm dd yy e Tap the button next to the text box to select an user e Choose the User and press the return button ee simple SELECT USER SELECT USER wg fiexcom performing 3 o yal m ee z J SELECT DEVICE 5E POSITION INSERT NAME PATIENT CODE wo w oa w da w N co e To the same steps to select the Device G Flex Europe S P R L 20 Rue de l industrie 1400 Nivelles Belgium Phone 32 0 67 88 36 65 Fax 32 0 67 88 36 88 Email sales g flex com Website www g flex com US Commercial Office Only G Flex USA Inc 74 Southwood Pkwy Suite 600 Atlanta GA 30354 USA Creation Date 18 10 13 Page 47 of 87 Current Name IFU ScopeCleanerS20 doc Version 7 This document is only controlled in electronic format by the QM ELIZE le www g flex com Simple e e Insert the name or patient code and tap the button D to start the procedures that were already configured a 5 le PF SELECT DEVICE www g flex com performing 3j SELECT USER C eaen E SELECT USER ami BBBBBB a E a m POSITION OSITION SELECT DEVICE 2 SS POSITION 0 SELECT DEVICE M POSITION INSERT NAME PATIENT CODE e 77 INSERT NA
25. 300 Concentrated disinfectant agent ml 1700 gt After the disinfectant reservoir has been filled make a note of the date when the disinfection solution was mixed in a clearly visible suitable place and in the service manual service manual table refer to the Appendix The disinfectant should be changed according to the manufacturer s instructions or sooner if there is visible contamination We recommend replacing the disinfectant after one week at the latest Where colonoscopes are to be processed the disinfectant solution must be changed daily or at the latest every second day gt When the disinfection solution is replaced the disinfectant reservoir itself must be thoroughly cleaned and disinfected manually using suitable cloths and surface disinfectant gt The suction filter in the disinfectant reservoir must be replaced at least every 14 days gt The date of the last filter change must be noted in a clearly visible position and in the User Information Pack Service Manual Table see Appendix v G Flex Europe S P R L 20 Rue de l industrie 1400 Nivelles Belgium Phone 32 0 67 88 36 65 Fax 32 0 67 88 36 88 Email sales g flex com Website www g flex com US Commercial Office Only G Flex USA Inc 74 Southwood Pkwy Suite 600 Atlanta GA 30354 USA Creation Date 18 10 13 Page 250f 87 Current Name IF U ScopeCleanerS20 doc Version 7 This document is only controlled in electronic
26. 4 USA 18 10 13 Page 38 of 87 IF U ScopeCleanerS20 doc Version 7 This document is only controlled in electronic format by the QM CLIE simple Qe Ge A L eo Mm 1 SET emme A gfiexcom performing Configure Date Time gt Tap the configuration button from the main screen and select DATE amp TIME Button dZ ELEME simple wwwgfiexcom performing HOME SCREEN f ELE simple www g fiexcom performing CONFIGURATIONS PROCESS SELF DISINFECTION DATE amp TIME FILTERS PASSWORDS MACHINE INFORMATIONS dd mm yy f 4 A N G ELES A simple performing A CATALOG mm dd yy HH MM SS HH MM SS gt Select the icon and set the date and time f ELE simple f ELE simple __ wwwgfiexcom performing y ADJUSTE DATE amp TIME www gfiexcom performing Er rs mm dd yy HH MM SS 05 20 2013 13 29 25 Configure Disinfection s parameters expiration date gt At the Configuration Screen tap the Disinfectant Button to set the parameter e Enter the Maximum quantity of cycles and the Expiration date of Disinfectant f2 FLE simple 2 FLE simple wwwgflexcom performing www fiexcom performing a _ _ _ _ CONFIGURATIONS DISINFECTANT PARAMETER PROCESS SELF DISINFECTION MAXIMUM NUMBER OF DISINFECTION CYCLES yD DISINFECTANT DATE amp TIME FILTERS PASSWORDS MACHINE INFORMATIONS gs EXPIRATION DATE O
27. 8 36 88 Email sales g flex com Website www g flex com US Commercial Office Only G Flex USA Inc 74 Southwood Pkwy Suite 600 Atlanta GA 30354 USA Creation Date 18 10 13 Page 52 of 87 Current Name IFU ScopeCleanerS20 doc Version 7 This document is only controlled in electronic format by the QM Fire Simple a R sa Ser Ar y Or OPEN N DESPRESSURIZATION VALVE HH MM SS gt When the Compressor is enabled the Depressurization valve will open automatically when the pressure is above the limited of the sensor gt Ifthe SCOPE CLEANER 20 were switched off when it is full or if there is a power outage while it is in use it will be necessary when the unit is switched on again to drain off the fluid in the tank manually by selecting the Output Control menu to coordinate manually the valves G Flex Europe S P R L 20 Rue de l industrie 1400 Nivelles Belgium Phone 32 0 67 88 36 65 Fax 32 0 67 88 36 88 Email sales g flex com Website www g flex com US Commercial Office Only G Flex USA Inc 74 Southwood Pkwy Suite 600 Atlanta GA 30354 USA Page 53 0f 87 Creation Date 18 10 13 Version 7 Current Name IFU ScopeCleanerS20 doc This document is only controlled in electronic format by the QM Changing the Disinfectant The SCOPE CLEANER 20 will alert of the need to change the disinfectant The alert is enabled when the maximum number of cycles or the expiration date o
28. 87 Current Name IF U ScopeCleanerS20 doc Version 7 This document is only controlled in electronic format by the QM ai Zi ia VY E T wz AT c g flex com performing 2 3 2 mt Appendix Il Accessories for SCOPE CLEANER S20 7600 NS0 Connection set with Nylon LL suitable for Olympus Fuji endoscopes comprising 7600 TOO suction tube with filter 7601 T00 biopsy channel tube 7610 T00 suction channel tube 7611 T00 air water channel tube 7600 NS1 Connection set with Nylon LL suitable for use with Pentax endoscopes comprising 7600 TOO suction tube with filter 7601 P00 biopsy channel tube 7610 T00 suction channel tube 7611 P00 air water channel tube 7615 100 15 L Tank for disinfection solution with filter and quick coupling in the cover plate G Flex Europe S P R L 20 Rue de l industrie 1400 Nivelles Belgium Phone 32 0 67 88 36 65 Fax 32 0 67 88 36 88 Email sales g flex com Website www g flex com US Commercial Office Only G Flex USA Inc 74 Southwood Pkwy Suite 600 Atlanta GA 30354 USA Creation Date 18 10 13 Page 78 of 87 Current Name IF U ScopeCleanerS20 doc Version 7 This document is only controlled in electronic format by the QM ELIE simple E Ge T wm T S e g flex com p rf rming Appendix III Spare part list for SCOPE CLEANER 20 11 0100 Pall strainer KA2 NFZP4 7006 350 Filling pipe for filter connection 7003 928 Micro fuse 3 15A G Fle
29. CLEANER S20 water intake e Press the filter intake against the quick coupler and press it into position e Slide the sheath up until it clicks into place e Pull the filter to ensure it is fitted correctly and firmly e Slide the silicone hose over the filter outlet G Flex Europe S P R L 20 Rue de l industrie 1400 Nivelles Belgium Phone 32 0 67 88 36 65 Fax 32 0 67 88 36 88 Email sales g flex com Website www g flex com US Commercial Office Only G Flex USA Inc 74 Southwood Pkwy Suite 600 Atlanta GA 30354 USA Creation Date 18 10 13 Page 61 of 87 Current Name IFU ScopeCleanerS20 doc Version 7 This document is only controlled in electronic format by the QM N 3 gt e D wwwg fexcom performing n Every 2 weeks Suction filter e Replace the suction tube filter in the disinfecting tank as well as the suction filter in the disinfectant reservoir every 14 days Ae gt Use only original G FLEX filters as these are calibrated specifically to the SCOPE CLEANER 20 flow volume MN gt The prescribed semi annual and annual services are essential to ensure that this unit works correctly We recommend you sign a service agreement with G Flex Europe SPRL or a service technician authorized by us This will ensure that all the semi annual and annual services listed in Appendix V are carried out at the required time If these regular services are not performed the warranty on the part
30. CREEN AE aly G 7 T s i simple JANI 754 performing r f CATALOG DOUBTS 15 02 2012 13 12 48 dd mm yy HH MM SS G Flex Europe S P R L 20 Rue de l industrie 1400 Nivelles Belgium Phone 32 0 67 88 36 65 Fax 32 0 67 88 36 88 Email sales g flex com Website www g flex com US Commercial Office Only G Flex USA Inc 74 Southwood Pkwy Suite 600 Atlanta GA 30354 USA Creation Date 18 10 13 Current Name IFU ScopeCleanerS20 doc Page 41 of 87 Version 7 This document is only controlled in electronic format by the QM rere be ci orming f e Tap one of the positions to add a new Use or Device e A virtual keyboard will be enabled e Type the name code of the Use or Device To finish tap the ENT INSERT USER INSERT USER INSERT USER b La a v is s N e 0 D w uw w _ t gt The process to insert devices and users are similar The difference between then is the quantity of positions available There are 15 positions for Users and 80 positions for Devices r gt The SCOPE CLEANER S20 has an internal counter to measure the quantity of cycle each device has been reprocessed It helps to manage the next maintenance G Flex Europe S P R L 20 Rue de l industrie 1400 Nivelles Belgium Phone 32 0 67 88 36 65 Fax 32 0 67 88 36 88 Email sales g flex com Website www g flex com US Commercial Office Only G Flex USA Inc 74 S
31. Cleaning Detach the connection tubes from the disinfection unit and the endoscope after the endoscope disinfection process Make up a cleaning solution in accordance with the instructions supplied by the manufacture of the cleaner in a suitable tank Submerge the connection tubes totally in the cleaning solution Clean the connection tubes using a brush to remove all visible soiling and residues Rinsing off the cleaning solution Thoroughly rinse the connection tubes in a tank of clean tap water and blast them out with compressed air to dry them Disinfection Make up a disinfection solution in accordance with the instructions supplied by the manufacturer of the disinfectant in a suitable tank Suitable disinfection solutions are aldehydic solutions amine derivatives and disinfection solutions based on oxidation e g peroxyacetic acid Please only use approved disinfection solutions Immerse the cleaned connection tubes totally in the disinfection solution and ensure that all the tubes are completely filled inside with disinfection solution and without any air bubbles Ensure the soak times given by the manufacturer of the disinfectant are adhered to After the disinfection process remove the connection tubes from the disinfection solution G Flex Europe S P R L 20 Rue de l industrie 1400 Nivelles Belgium Phone 32 0 67 88 36 65 Fax 32 0 67 88 36 88 Email sales g flex com Website www g flex com US Com
32. Email sales g flex com Website www g flex com US Commercial Office Only G Flex USA Inc 74 Southwood Pkwy Suite 600 Atlanta GA 30354 USA Creation Date 18 10 13 Page 37 of 87 Current Name IFU ScopeCleanerS20 doc Version 7 This document is only controlled in electronic format by the QM M ELE simple www g flexcom performing Configuring the unit before disinfection process For the first time that the SCOPE CLEANER 20 is turned on a buzzer and an alert message could be activated It is necessary to set Date and Time the parameter for the Self Disinfection as well as the parameters of Disinfectant and Filters If those configurations aren t set correctly the unit can not alert properly the warning alert messages The sterile water filter must be autoclaved before first use and thereafter once per week After it has been autoclaved 10 times or if it has been used for a maximum of 4 weeks without processing the sterile water filter Pall filter must be replaced Please refer to the operating instructions supplied with your endoscope for information on disinfectants which are approved for use with endoscopes If you want to use a disinfectant which is not expressly recommended for use by the endoscope manufacturer please obtain written evidence of compatibility from either the endoscope producer or the disinfectant manufacturer Instructions issued by the manufacturer of the endoscope on mate
33. F DISINFECTANT V dd mm yy 4 HH MM SS dd mm yy Piet tal G Flex Europe S P R L 20 Rue de l industrie 1400 Nivelles Belgium Phone 32 0 67 88 36 65 Fax 32 0 67 88 36 88 Email sales g flex com Website www g flex com US Commercial Office Only G Flex USA Inc 74 Southwood Pkwy Suite 600 Atlanta GA 30354 USA Creation Date 18 10 13 Page 39 of 87 Current Name IF U ScopeCleanerS20 doc Version 7 This document is only controlled in electronic format by the QM imple sHGrming Configure Filters s Parameters e At the Configuration Screen tap the Filters Button to set the parameters S www g flex com or dd mm yy HH MM SS e Enter the parameters of the next date to autoclave the sterile water filter A e Enter the parameters of the next date to replace sterile water filter B e Enter the parameters of the next date to replace pre filter C ELE simple M CLEE simple 4 e s at wwgfiexcom performing FILTERS PARAMETES FILTERS PARAMETES FILTERS PARAMETES Q Q ee AUTOCLAVE STERILE WATER FILTER E EB om AUTOCLAVE STERILE WATER FILTER g jae me AUTOCLAVE STERILE WATER FILTER E gt B Ea REPLACE STERILE WATER FILTER j Q REPLACE STERILE WATER FILTER g ee Ea REPLACE STERILE WATER FILTER eT E Cl E MARE dd mm yy P3 HH MM SS dd mm yy i HH MM SS dd mm yy Bs HH MM SS AB gt The sterile water filter must be autoclave
34. ME PATIENT CODE 1 2 3 4 5 6 7 8 9 P e Check if all the procedures that were set before will be executed The procedure that were not selected will have the expected time equal zero ELE simple www g flex com performing PROCESS STATUS EXPECTED min s TOTAL TIME 17 30 CLEANING 9 8 PRE RISING so 36 DISINFECTION 6 2 28 NEUTRALISATION 7 Q LEAKAGE TEST PRESSURE 0 0000 05 21 2013 16 57 28 gt The Process Status screen will show the expected time for each procedure and the total time of the disinfection process gt The current time will show the elapsed time of each procedure gt Ifthe alarm Malfunction in suction channel or Malfunction in air water channel shows at the Process Status screen this means that the channel monitoring device has detected that the pressure in the biopsy or suction channel or in the air water channel is too high gt For information on repairing the fault please refer to the Error and warning messages section G Flex Europe S P R L 20 Rue de l industrie 1400 Nivelles Belgium Phone 32 0 67 88 36 65 Fax 32 0 67 88 36 88 Email sales g flex com Website www g flex com US Commercial Office Only G Flex USA Inc 74 Southwood Pkwy Suite 600 Atlanta GA 30354 USA Creation Date 18 10 13 Page 48 of 87 Current Name IFU ScopeCleanerS20 doc Version 7 This document is only controlled in electronic
35. MUM NUMBER OF DISINFECTION CYCLES Py ee vere EXPIRATION DATE OF DISINFECTANT dd mm yy HH MM SS Phone 32 0 67 88 36 65 Fax 32 0 67 88 36 88 Email sales g flex com Website www g flex com oll G Flex Europe S P R L 20 Rue de l industrie 1400 Nivelles Belgium US Commercial Office Only G Flex USA Inc 74 Southwood Pkwy Suite 600 Atlanta GA 30354 USA Creation Date 18 10 13 Current Name IFU ScopeCleanerS20 doc Page 34 of 87 Version 7 This document is only controlled in electronic format by the QM gt Filters Parameters Autoclave Sterile Water Filter 2 Replace Sterile Water Fiter 3 Replace Pre Fiter a PreviousScreen gt Self Disinfection Parameter 1 Gap tor sef dsinfection hour 2 Sei disinfection time min a Previous Soren dd mm yy a M ELE simple e S EAPN wwgfiexcom performing FILTERS PARAMETES 1 ee AUTOCLAVE STERILE WATER FILTER 2 B oem REPLACE STERILE WATER FILTER 3 e REPLACE PRE FILTER dd mm yy HH MM SS SELF DISINFECTION SELF DISINFECTION TO EVERY kd HOURS 2 ya SELF DISINFECTION TIME MIN 3 HH MM SS oll G Flex Europe S P R L 20 Rue de l industrie 1400 Nivelles Belgium Phone 32 0 67 88 36 65 Fax 32 0 67 88 36 88 Email sales g flex com Website www g flex com US Commercial Office Only G Flex USA Inc 74 Southwood Pkwy Suite 600 Atlanta GA 30354 USA Creation Date 18 10 13 C
36. OTAL TIME a7 2 36 30 CLEANING Oo O 0 PRE RISING mA 30 DISINFECTION 11 NEUTRALISATION ra z LEAKAGE TEST PRESSURE 0 0000 05 21 2013 LG S725 e Increase pressure in the suction channel Malfunction in Water Air Channel ELE si E m a i SIME 2h a g www g f lex com Pe PROCESS STATUS EXPECTED CURRENT min S min S _TOTAL TIME 17 30 oe E A MALFUNCTION IN WATER AIR CHANNEL CLEANING TET we PRE RISING A 2 3h 39 DISINFECTION eu eG 41 NEUTRALISATION zeA T i 4p LEAKAGE TEST PRESSURE 0 0000 Bar 05 21 2013 16 57 28 e Increase pressure in the water air channel G Flex Europe S P R L 20 Rue de l industrie 1400 Nivelles Belgium Phone 32 0 67 88 36 65 Fax 32 0 67 88 36 88 Email sales g flex com Website www g flex com US Commercial Office Only G Flex USA Inc 74 Southwood Pkwy Suite 600 Atlanta GA 30354 USA Creation Date 18 10 13 Page Current Name IF U ScopeCleanerS20 doc Version This document is only controlled in electronic format by the QM 70 of 87 7 PROCESS STATUS EXPECTED CURRENT min S min S TOTAL TIME 17 30 F 30 l PARTIR ES rm DOSAGE OF ENZIMATIC FAILURE PRE RISING DISINFECTION 6 NEUTRALISATION 7 LEAKAGE TEST PRESSURE 0 0000 05 21 2013 16 57 28 e Error during the dosage of enzymatic G Flex Europe S P R L 20 Rue de l industrie 1400 Nivelles
37. USA Creation Date 18 10 13 Page 15 of 87 Current Name IFU ScopeCleanerS20 doc Version 7 This document is only controlled in electronic format by the QM 4 3 gt e D wwwg fiexcom performing n Operating the unit on a bench Make sure that the ergonomic principles are respected Is advised that the bench needs to be 900 mm from the floor but it could be adjusted from place to place The width and depth of the bench were calculated to ensure that the SCOPE CLEANER S20 is firmly positioned on the bench while it is important to maintain a minimum distance of 70 mm from the walls The bench needs to have an opening 200 X 100 mm for the drain system The drain leading to the building s sewers must not be higher than 450 mm from the floor min 70 Connecting to the water supply and drain The SCOPE CLEANER S20 is connected to a 3 4 drinking water mains supply using the combined connection tube and dirt trap supplied with the unit A in gt The maximum water pressure in the mains water tube should not be more than 5 bar but should be more than 2 6 bar If the pressure is greater install a pressure reducer A gt Ifthe unit is connected to the mains water supply we recommend using an additional aquastop device to cut off the water supply to the unit if there is a burst pipe gt The drain hose must have a uniform slope to ensure liquid can drain completely with no sagging in the hose which w
38. Website www g flex com US Commercial Office Only G Flex USA Inc 74 Southwood Pkwy Suite 600 Atlanta GA 30354 USA Creation Date 18 10 13 Page 68 of 87 Current Name IFU ScopeCleanerS20 doc Version 7 This document is only controlled in electronic format by the QM Alert message during the process Leakage test Error mm dd yy HH MM SS e This message indicates that the endoscope did not pass at the Leakage Test e Please check the endoscope Excessive time to fill Ove Lh ee g wwwo flexcom P ming PROCESS STATUS EXPECTED CURRENT min S min S EXCESSIVE TIME TO FILL CLEANING m p PRE RISING A 3p DISINFECTION OS Ws NEUTRALISATION 7 8 iy LEAKAGE TEST PRESSURE 0 0000 05 21 2013 16 57 28 G Flex Europe S P R L 20 Rue de l industrie 1400 Nivelles Belgium Phone 32 0 67 88 36 65 Fax 32 0 67 88 36 88 Email sales g flex com Website www g flex com US Commercial Office Only G Flex USA Inc 74 Southwood Pkwy Suite 600 Atlanta GA 30354 USA Creation Date 18 10 13 Page 69 of 87 Current Name IFU ScopeCleanerS20 doc Version 7 This document is only controlled in electronic format by the QM x deie simple www g fley flexcom performing e The time to fill the tank is longer than expected Malfunction in Suction Channel ELE si www g flex com pel o ide PROCESS STATUS EXPECTED CURRENT MALFUNCTION IN SUCTION CHANNEL T
39. adequate preventive measures to avoid contact or contamination of the user operator with disinfection agent or bacteria AB gt The functionality and efficiency of the SCOPE CLEANER S20 is independent of the water temperature Therefore there is no need to mix hot and cold water Water at room temperature coming directly from the water supply is enough G Flex Europe S P R L 20 Rue de l industrie 1400 Nivelles Belgium Phone 32 0 67 88 36 65 Fax 32 0 67 88 36 88 Email sales g flex com Website www g flex com US Commercial Office Only G Flex USA Inc 74 Southwood Pkwy Suite 600 Atlanta GA 30354 USA Creation Date 18 10 13 Page 31 of 87 Current Name IF U ScopeCleanerS20 doc Version 7 This document is only controlled in electronic format by the QM Screen s Main Buttons Main Buttons a eo Emergency Stop Cancel Start Process Home Screen Previous Screen Previous G Flex Europe S P R L 20 Rue de l industrie 1400 Nivelles Belgium Phone 32 0 67 88 36 65 Fax 32 0 67 88 36 88 Email sales g flex com Website www g flex com US Commercial Office Only G Flex USA Inc 74 Southwood Pkwy Suite 600 Atlanta GA 30354 USA Creation Date 18 10 13 Page 32o0f87 Current Name IFU ScopeCleanerS20 doc Version 7 This document is only controlled in electronic format by the QM 4 1 Screens and Buttons Descriptions gt Initial Screen Home Scr
40. blocked completely Exchange the filter min all 14 days Filter is not snapped in correctly in Snap in the filter in the fast coupling the fast coupling Wastewater filter is not setup in Correct the direction of the wastewater correct direction filter shown by arrows on the filter Warning message EXCESSIVE Line pressure is below 2 6 bar must Contact the company technician to set TIME TO FILL at the Process be min 2 6 bar max 5 bar up the line pressure of the water Status Screen supply to the requested pressure between 2 6 bar and 5 bar Sterile water filter is not deaerated Deaerate the sterile water filter by first opening the lower screw on the filter until water rinse out the close the screw again Repeat this secondary with the upper screw Warning message DOSAGE OF No flow of enzymatic into the tube Check if the enzymatic tank is empty or ENZYMATIC FAILURE at the if the tube is not blocked Process Status Screen Warning message Increase pressure inthe channels Check in the tube is not curled If is MALFUNCTION IN THE SUCTION Suction or Water Air not the endoscope could be CHANNEL OR WATER AIR obstructed CHANNEL at the Process Status Screen The monitoring sensor is not working Call technician Applicable to all error messages If the error cannot be remedied using the steps listed above please contact G Flex Europe SPRL or a service technician authorised by us G Flex Europe S P R L 2
41. ch individual step in accordance with the instructions issued by the manufacturer of the endoscope AN eto gt After cleaning the endoscope with the brush rinse the channels with potable water and then blast with air to avoid interaction between the detergent and disinfectant solutions gt Any fluid remaining in the channels could dilute the disinfectant solution thereby reducing its efficacy MN gt Ifthe endoscope is not cleaned properly thorough disinfection cannot be guaranteed gt All cleaning stages particularly brushing the endoscope channels should be performed with the endoscope fully submerged in the detergent solution to avoid sprays of contaminated fluid gt Brushes used for cleaning endoscopes must be cleaned and disinfected in accordance with RKI guidelines on non critical medical equipment The brushes should be cleaned and disinfected in an ultrasonic bath after each use to avoid cross contamination At the end of the working day after cleaning and disinfection the brushes should be stored in a dry area which is protected from contamination G Flex Europe S P R L 20 Rue de l industrie 1400 Nivelles Belgium Phone 32 0 67 88 36 65 Fax 32 0 67 88 36 88 Email sales g flex com Website www g flex com US Commercial Office Only G Flex USA Inc 74 Southwood Pkwy Suite 600 Atlanta GA 30354 USA Creation Date 18 10 13 Page 28 of 87 Current Name IF U ScopeCleanerS20 doc Version 7
42. d before first use and there after once per week gt After it has been autoclaved 10 times or if it has been used for a maximum of 4 weeks without processing the sterile water filter Pall filter must be replaced gt The SCOPE CLEANER S20 will alert the user that the date to autoclave or replace the sterile water filter or to replace pre filter have expired showing an alert messenger in the main screen see Appendix IV Error and warning messages G Flex Europe S P R L 20 Rue de l industrie 1400 Nivelles Belgium Phone 32 0 67 88 36 65 Fax 32 0 67 88 36 88 Email sales g flex com Website www g flex com US Commercial Office Only G Flex USA Inc 74 Southwood Pkwy Suite 600 Atlanta GA 30354 USA Creation Date 18 10 13 Page 40 of 87 Current Name IFU ScopeCleanerS20 doc Version 7 This document is only controlled in electronic format by the QM M CLEE le tS Simple i Configure Self Disinfection s Parameter A gt At the Configuration Screen tap the Self Disinfection Button to set the parameters Enter the parameters of the Self Disinfection a Ee simple wwwofiexcom pe forming SELF DISINFECTION SELF DISINFECTION TO EVERY a HOURS r SELF DISINFECTION TIME MIN dd mm yy HH MM SS dd mm yy p d HH MM SS Insert Users and Devices Tap the Options Button at the main screen Select Insert Users or Devices f ELE simple www g flex com performing HOME S
43. displayed on the unit or set out in this manual The use of incorrect fuses can cause the unit to function incorrectly and may result in injury to users and others Phone 32 0 67 88 36 65 Fax 32 0 67 88 36 88 Email sales g flex com Website www g flex com asl G Flex Europe S P R L 20 Rue de l industrie 1400 Nivelles Belgium US Commercial Office Only G Flex USA Inc 74 Southwood Pkwy Suite 600 Atlanta GA 30354 USA Creation Date 18 10 13 Page 60f 87 Current Name IF U ScopeCleanerS20 doc Version 7 This document is only controlled in electronic format by the QM ELISE simple n www g flexcom performing gt Faulty unit It is generally dangerous to operate a faulty unit Do not operate the unit if you suspect it to be faulty or if it is Known to be faulty Make sure the unit cannot be operated until checked by an authorized technician gt Not trained Personnel Not trained personnel could endanger themself or someone The owner is responsible to regularly train the user operators of this unit Especially personnel that are in use of toxic chemicals gas or exposure of fumes must be regularly trained comprehensively in the procedure instructions Those procedure instructions must contain relevant information about possible dangers of health national guidelines for safe usage and special procedures in case of leaking active agent According to EN 61010 2 24 this trainings must be documented w
44. eCleanerS20 doc Version 7 This document is only controlled in electronic format by the QM ELIE simple www g flexcom performing Mm A Cleaning and disinfection must be accurately documented in a traceable manner Supplied with the unit is an optional Zebra TLP2844 Printer system to enable you to document this phase which should be attached to the SCOPE CLEANER 20 The printout must then be stored in a suitable place preferably inside the service manual or in the file for the patient on whom the endoscope was used Listed in the label printing e The quantity and the time of each cycle e The hour and date for the procedure e The code of the device e The name code of the responsible user e The name code of the patience e The disinfection life time e The total cycle realized by the unit e The unit ID An The unit has the option of storing information of the disinfection process using a USB storage device USB Flash Drive Recommended standard procedure The recommended standard procedure consists of leakage test prewashing disinfection and neutralizing 1 Leakage test 2 min 2 Prewash 4 5 min including 1min blow out 3 Disinfection cycle freely selectable 4 min filling and emptying including 1min blow out 4 Neutralization 7 min including 2 min blow out Total time 18 min disinfection time A Perform the self disinfection cycle without an endoscope once per working day a
45. een Configuration Catalog performing yor 5 Start Process mm dd yy HH MM SS gt Configuration Screen a Configurations www g flex com pe Disinfectant Parameter Filters Parameters Self Disinfection Parameter 7 Machine s Information fe 3 a 5 Date amp Time Adust g 7 e Rewn Home 15 02 2012 13 12 48 G Flex Europe S P R L 20 Rue de l industrie 1400 Nivelles Belgium Phone 32 0 67 88 36 65 Fax 32 0 67 88 36 88 Email sales g flex com Website www g flex com US Commercial Office Only G Flex USA Inc 74 Southwood Pkwy Suite 600 Atlanta GA 30354 USA Creation Date 18 10 13 Page 33 of 87 Current Name IFU ScopeCleanerS20 doc Version 7 This document is only controlled in electronic format by the QM gt Process Parameters aJ Quanity ofGieaning 2 Quanity of Enzymatic per iter m 3 Quantity of Preyising a Disinfection Time mim 5 Quantity of Neutralization e Final Blow Out seg e Previous Screen gt Disinfection Parameter A Maximum number of cydes 2 Expiration Date a Previous Screen PROCESS PARAMETERS 15 QUANTITY OF CLEANING D DISINFECTION TIME MIN 5 ML QUANTITY OF NEUTRALIZATION ML OF ENZYMATIC PER LITER OF WATER 3 a QUANTITY OF PRE RISING 6 3 FINAL BLOW OUT SEG JD uenaceresteorr p po dd mm yy HH MM SS s ELIE simple www gfiex com performing DISINFECTANT PARAMETER i e MAXI
46. erilised instruments AB gt Depending on the kind of sterile packaging it is possible to store the water filter filling pipe and silicone hose for up to six months in a protected dust free environment refer to DIN 58946 DIN 58953 7 8 DIN EN 868 5 gt The storage times should not exceed manufacturer s recommendations gt G Flex Europe S P R L 20 Rue de l industrie 1400 Nivelles Belgium Phone 32 0 67 88 36 65 Fax 32 0 67 88 36 88 Email sales g flex com Website www g flex com US Commercial Office Only G Flex USA Inc 74 Southwood Pkwy Suite 600 Atlanta GA 30354 USA Creation Date 18 10 13 Page 600f 87 Current Name IF U ScopeCleanerS20 doc Version 7 This document is only controlled in electronic format by the QM M CLIE simple T i E Ge Yy www g fle flex com perfo ming Assembling the sterile water filter A eatin gt Toensure the sterile water filter remains free from bacteria while in storage there should be no contact with the filter intake and discharge Assembly must be carried out under aseptic conditions In this connection we would remind users to ensure they disinfect their hands thoroughly e Attach the sterile water filter to the SCOPE CLEANER 20 water intake making sure that the arrows on the outside of the filter are pointing in the direction of the water flow e Pull back the knurled sheath to open the quick release coupler on the SCOPE
47. ersion 7 This document is only controlled in electronic format by the QM ELISE simple mt www g flexcom performing Connecting the suction tube with filter gt Connect the Suction pipe and strainer color coded yellow to the connection on the tank A r Normally the suction pipe remains in the tank and is connected up when the unit is commissioned next or the strainer is changed For information on repairing the fault please refer to the Troubleshooting section A eaten gt The suction tube and strainer guarantee that the liquid water disinfection solution flows through the endoscope channels unhindered Please ensure the suction tube is connected properly and that the filter is in the correct position on the floor of the disinfectant tank gt The filter in the suction tube must be replaced at the latest every 14 days A keaton gt Apart from channel openings on the distal end of the endoscope no air bubbles should emanate from any part of the endoscope Air bubbles forming on any other part e g on the control head are an indication that the endoscope is leaking gt If you notice air bubbles tap the Stop button from the control panel display and confirm to stop the process Wait till the reservoir is empty and then inspect the endoscope For information on repairing the fault please refer to the Troubleshooting section A Site gt Please follow the manufact
48. ex USA Inc 74 Southwood Pkwy Suite 600 Atlanta GA 30354 USA Creation Date 18 10 13 Page 650f 87 Current Name IFU ScopeCleanerS20 doc Version 7 This document is only controlled in electronic format by the QM ff cireg le SS Simple The massage indicate that the date to autoclave sterile water filter arrived Tapping the alert message it will open the Filter Parameter s screen The user can update the dates gt Replace Pre filter mm dd yy HH MM SS The message indicate that the date to replace Pre filter arrived Tapping the alert message it will open the Filter Parameter s screen The user can update the dates gt Replace Sterile water filter performing A OPTIONS CATALOG DOUBTS mm dd yy HH MM SS G Flex Europe S P R L 20 Rue de l industrie 1400 Nivelles Belgium Phone 32 0 67 88 36 65 Fax 32 0 67 88 36 88 Email sales g flex com Website www g flex com US Commercial Office Only G Flex USA Inc 74 Southwood Pkwy Suite 600 Atlanta GA 30354 USA Creation Date 18 10 13 Page 66 of 87 Current Name IFU ScopeCleanerS20 doc Version 7 This document is only controlled in electronic format by the QM amp FORE af le wwwa fiexcom Simple a The message indicate that the date to replace sterile water filter arrived Tapping the alert message it will open the Filter Parameter s screen The user can update the dates
49. f Enzymatic per liter Quantity of Pre rinsing PROCESS PARAMETERS PROCESS PARAMETERS E TY OF CLEANING TME MN E OF CLEANING TIME MIN F at OF aera tan RER OP gt G OF NEUTRAUZATION g nT 2 a OF NEUTRALIZATION Z A aa T LITER OF WATER ML OF ENZYMATIC PER LITER OF WATER gA QUANTITY OF PRE OSING a l FINAL BLOW OUT SEG i l OUANTITY OF PRE RISING fie FINAL BLOW OUT SEG T pr 1 ee LEAK AKAGE TESTE OFF t dd mm yy HH MM SS dd mm yy x HH MM SS Concentration of solution Concentrated Enzymatic detergent ml 150 ml 300 ml Quantity of Enzymatic per liter ml Phone 32 0 67 88 36 65 Fax 32 0 67 88 36 88 Email sales g flex com Website www g flex com US Commercial Office Only G Flex USA Inc 74 Southwood Pkwy Suite 600 Atlanta GA 30354 USA oll G Flex Europe S P R L 20 Rue de l industrie 1400 Nivelles Belgium Creation Date 18 10 13 Page 45 of87 Current Name IFU ScopeCleanerS20 doc Version 7 This document is only controlled in electronic format by the QM A easton gt Please follow the manufacturer s instructions exactly when preparing the gt Ifthe exposure time is too short the disinfection process will be negatively Disinfection Time f2 ELE sim _wwwa fiexcom P Sing PROCESS PARAMETERS ae OF CLEANING Z e TIME MIN oe QUANTITY OF NEUTRALIZATION ML OF ENZYMATIC PER UTER OF WATER e QUANTITY OF PRE RISING Heil FINAL GLOW OUT
50. f the disinfectant are reached All the disinfectant parameters are configured by the user gt Please follow the manufacturer s instructions exactly when preparing the disinfectant solution and observe the specified concentration and exposure times If the exposure time is too short the disinfection process will be negatively affected while a long exposure time can damage the endoscope e At Options menu tap the Change Disinfectant button e The unit will ask if you really want to start the procedure e The user will manually turn on the disinfection pump and open the drain valve to discard the solution sHGrming our EF PUT CO TRO J HH MM SS HH MM SS a A Sippe o R RE a p E dd mm yy HH MM SS dd mm yy HH MM SS G Flex Europe S P R L 20 Rue de l industrie 1400 Nivelles Belgium Phone 32 0 67 88 36 65 Fax 32 0 67 88 36 88 Email sales g flex com Website www g flex com US Commercial Office Only G Flex USA Inc 74 Southwood Pkwy Suite 600 Atlanta GA 30354 USA Creation Date 18 10 13 Page 54of 87 Current Name IFU ScopeCleanerS20 doc Version 7 This document is only controlled in electronic format by the QM After finishing the coordinating process tap the CONFIRM button It will open the Disinfectant Parameter s screen e Set the new parameters to finish the procedure DISINFECTANT PARAMETER TURN ON DISINFECTION PUMP JPEN DRAIN VALVE MAXIMUM
51. format by the QM gt The maximum water pressure in the mains water tube should not be more than 5 bar but should be more than 2 6 bar If the pressure is greater install a pressure reducer G Flex Europe S P R L 20 Rue de l industrie 1400 Nivelles Belgium Phone 32 0 67 88 36 65 Fax 32 0 67 88 36 88 Email sales g flex com Website www g flex com US Commercial Office Only G Flex USA Inc 74 Southwood Pkwy Suite 600 Atlanta GA 30354 USA Creation Date 18 10 13 Page 49o0f 87 Current Name IFU ScopeCleanerS20 doc Version 7 This document is only controlled in electronic format by the QM Finishing process e After all the procedures were concluded A CONFIRM button will be enabled to finish the disinfection process e To print the result of the disinfection process tap the PRINT button or tap the HOME button cancel the print e Or to save in a USB storage device USB Flash drive tap the USB button s DLEE simple z pF z ol J as g fexcom performing PROCESS STATUS PRINT SAVE EXPECTED men s TOTAL TIME 30 CLEANING QO PRE RISING 30 DISINFECTION O NEUTRALISATION 0 LEAKAGE TEST PRESSURE 0 0000 Bar va 05 21 2012 16 57 28 e Y A www cfiorcom pP e The print label structure HOSPITAL ABCD 4BCDEFGHIIKLMNOP 4BCDEFGHIIKLMNOP ABCDEFGHIIKLMNOP PROCESS LE ANING PRE RISING DISINFECTION EUTRALISATION OTAL TIME DISINFECTION
52. format by the QM CLIE simple Ae Ge wae EP g flexcom performing n AB gt Please follow the manufacturer s instructions exactly when preparing the disinfectant solution and observe the specified concentration and exposure times If the exposure time is too short the disinfection process will be negatively affected while a long exposure time can damage the endoscope MN gt The suction pipe and strainer guarantee that the liquid disinfection solution flows through the endoscope channels unhindered Please ensure the suction tube is connected properly and that the filter is in the correct position on the floor of the disinfectant reservoir gt The filter on the suction tube must be replaced at the latest every 14 days The date when the filter was last changed has to be documented in the Maintenance book AS We recommend using a WG enzymatic detergent solution An enzymatic detergent concentration of 0 5 1 is sufficient for use with SCOPE CLEANER 820 If the endoscope is heavily soiled the concentration may be increased to 5 The following table provides guidelines for the preparation of enzymatic solutions of various concentrations for disinfectant reservoirs of various sizes Concentrated enzymatic detergent ml 150 ml 300 ml 450 ml 750 ml G Flex Europe S P R L 20 Rue de l industrie 1400 Nivelles Belgium Phone 32 0 67 88 36 65 Fax 32 0 67 88 36 88 Email
53. fter endoscope processing has completed and if the machine has not been used for 12 hours refer to the Chapter entitled Self disinfection cycle for the SCOPE CLEANER 20 G Flex Europe S P R L 20 Rue de l industrie 1400 Nivelles Belgium Phone 32 0 67 88 36 65 Fax 32 0 67 88 36 88 Email sales g flex com Website www g flex com US Commercial Office Only G Flex USA Inc 74 Southwood Pkwy Suite 600 Atlanta GA 30354 USA Creation Date 18 10 13 Page 8of 87 Current Name IF U ScopeCleanerS20 doc Version 7 This document is only controlled in electronic format by the QM ELE simple E Ge v T Bw www g flex com pe rfo mi ng n Contraindications Do not use the SCOPE CLEANER S20 for reprocessing endoscopes if no information regarding suitability for use with SCOPE CLEANER 20 is available Do not use the SCOPE CLEANER 820 for hygienic processing of endoscopes equipped with additional auxiliary channels i e more than the five channels indicated jet channel air water channel biopsy 1 and 2 channel suction channel If in doubt please contact the manufacturer of the endoscopes or G Flex Europe SPRL or a service engineer authorized by us 3 Using the unit for the first time Check the inventory gt Check the unit and accessories immediately upon delivery to ensure all components are included and look for any visible external damage The following components should be suppl
54. g the process An alert message will show up in the touch screen panel when the sensor is activated AS gt When operating the SCOPE CLEANER 20 and while processing flexible endoscopes observe the general requirements relating to handling endoscopes o Robert Koch Institute Hygiene requirements when processing medical equipment Hygiene requirements when processing flexible endoscopes and additional instruments used in endoscopy Hygiene requirements as applied to the design and construction of endoscopy instruments o Employees safety organizations Organic substances o Regulations relating to suppliers of medical products o Drinking water regulations Preparative tasks Preparing the sterile water filter Before using the device for the first time the sterile water filter and the feed pipe and silicone tube which connect to it must be sterilized in an autoclave The sterilization method is described in the Service and Maintenance section AS gt The sterile water filter must be autoclaved before first use and thereafter once per week gt After ithas been autoclaved 10 times or if it has been used for a maximum of 4 weeks without processing the sterile water filter Pall filter must be replaced G Flex Europe S P R L 20 Rue de l industrie 1400 Nivelles Belgium Phone 32 0 67 88 36 65 Fax 32 0 67 88 36 88 Email sales g flex com Website www g flex com US Commercial Office Onl
55. hannel 5 Biopsy Channel 2 in Connection with connection caps 7524 A00 6 _ freei not all models D _ _ s Pressure Leakage Test Connector Suction Connector Tank Add the electronic protection cap Olympus MH 553 before you insert the endoscope into the desinfection tank Pressure Leakage Test Connector The water protection cap Olympus MAJ 583 must be connected on the water bottle connector k G Flex Europe S P R L 20 Rue de l industrie 1400 Nivelles Belgium Phone 32 0 67 88 36 65 Fax 32 0 67 88 36 88 Email sales g flex com Website www g flex com US Commercial Office Only G Flex USA Inc 74 Southwood Pkwy Suite 600 Atlanta GA 30354 USA Creation Date 18 10 13 Page 75 of 87 Current Name IF U ScopeCleanerS20 doc Version 7 This document is only controlled in electronic format by the QM Connecting to Fujinon endoscopes A gt fan endoscope does not have a jet channel ensure the dummy jet channel tube is connected to the SCOPE CLEANER 20 FUJINON CA 503A Channel Description Jet Channel Biopsy Channel Suction Channel 4 Air Water Channel 5 _ Biopsy Channel 2 Double Channel DBE Balloon Channel 6 freei not all models dD Pressure Leakage Test Connector Suction Connector Tank Fujinon Adapter CA 503 S A Luer Lock Connectors ust be closed with caps see figure Fuji
56. he vent of the drain is blocked so Fluid in the disinfection tank fluid in rinsing into the drain decrease Fluid in the tank is disappears Return tube is buckled completely afte a cyclus Exchange the filter of the tank min all 14 days Lock snap into place the coupling of the suction tube Remove the zigzag of the suction tube to the tank Exchange the suction filter of the disinfection tank min all 14 days Call technician Replace the O ring on the coupling connector of the suction tube tank Fill the tank with disinfecion solution Replace the wrong filter inlay in the suction filter to tank by an original filter inlay Remove the foreign substance and clean the vent Chek the drain tube for blockades and rectify them Remove the foreign substance and clean the vent Remove the zigzag in the return tube G Flex Europe S P R L 20 Rue de l industrie 1400 Nivelles Belgium wl Phone 32 0 67 88 36 65 Fax 32 0 67 88 36 88 Email sales g flex com Website www g flex com US Commercial Office Only G Flex USA Inc 74 Southwood Pkwy Suite 600 Atlanta GA 30354 USA 18 10 13 IFU ScopeCleanerS20 doc Creation Date Current Name Page 72 of 87 Version 7 This document is only controlled in electronic format by the QM Water does not rinse throu the Water supply is turned off Turn on the water supply sterile water filter into the disinfection tank Filter is
57. heck the equipment to ensure all components are in place and that the unit is working properly Before using the unit for the first time and after repairs have been carried out always check that the equipment has been installed properly Function checks are listed in Chapter 3 under Functional r D A V Unauthorized opening of the unit Live components become exposed when the unit is open and can cause electric shocks if touched Never open the unit yourself The unit may only be opened by an authorized G Flex Europe SPRL service technician gt Penetration of liquids Liquid entering the unit may prevent the unit from working properly and or present the risk of electric shock Fluids should therefore never be permitted to enter the unit Always avoid placing fluids in the vicinity of the electrical components Do not operate if liquid has penetrated the unit gt Operation in explosion proof areas The unit is not explosion proof Operation in areas with explosive gases can led to severe damage and cause injury gt Use of inappropriate accessories The use of inappropriate accessories can cause the unit to operate incorrectly which may result in injury to patients users and service technicians Use only accessories specified as being compatible with the SCOPE CLEANER S20 see Chapter 8 Technical specifications gt Faulty fuses When replacing a faulty fuse please ensure the new fuse corresponds with the specifications
58. ied with the unit customized orders may differ somewhat SCOPE CLEANER S20 incl Floor mounted 15 I tank for disinfectant with filter and quick release couplers in the lid Spare part number 7615 A00 G Flex Europe S P R L 20 Rue de l industrie 1400 Nivelles Belgium Phone 32 0 67 88 36 65 Fax 32 0 67 88 36 88 Email sales g flex com Website www g flex com US Commercial Office Only G Flex USA Inc 74 Southwood Pkwy Suite 600 Atlanta GA 30354 USA Creation Date 18 10 13 Page 9of 87 Current Name IFU ScopeCleanerS20 doc Version 7 This document is only controlled in electronic format by the QM mple m meine ming Enzymatic tank with quick release couplers in the lid Spare part number 7885 075 Connection tube to drinking water mains with dirt trap Spare part number 7002 511 Sterile water filter Spare part number 11 0100 The sterile water filter must be autoclaved before first use and thereafter once per week After it has been autoclaved 10 times or if it has been used for a maximum of 4 weeks without processing the sterile water filter Pall filter must be replaced G Flex Europe S P R L 20 Rue de l industrie 1400 Nivelles Belgium Phone 32 0 67 88 36 65 Fax 32 0 67 88 36 88 Email sales g flex com Website www g flex com US Commercial Office Only G Flex USA Inc 74 Southwood Pkwy Suite 600 Atlanta GA 30354 USA
59. ith lists of attendants and verification protocols for expert knowledge Additional safety instructions specific to this unit are described in other sections of this manual 2 Intended use and purpose The SCOPE CLEANER 820 is used for semi machine based hygienic processing of waterproof flexible endoscopes made by OLYMPUS FUJINON PENTAX and STORZ which have a maximum of five additional channels jet channel air channel water channel biopsy channel suction channel The units are equipped with a channel monitoring system which detects blockages in the endoscope channels to be cleaned or disinfected monitoring only applies to air water and suction channels As additional options there is a permanent Leakage Test implemented To activate the test press the button in the Process Parameters menu using the touch panel see Chapter 4 Operating the SCOPE CLEANER 20 The SCOPE CLEANER 820 is equipped with a sterile water filter which enables the water required for processing the endoscopes to be drawn from the normal mains drinking water supply The unit is supplied on a floor mounted cabinet G Flex Europe S P R L 20 Rue de l industrie 1400 Nivelles Belgium Phone 32 0 67 88 36 65 Fax 32 0 67 88 36 88 Email sales g flex com Website www g flex com US Commercial Office Only G Flex USA Inc 74 Southwood Pkwy Suite 600 Atlanta GA 30354 USA Creation Date 18 10 13 Page 7of 87 Current Name IF U Scop
60. l of particles in suspension or rust particles it will be necessary to monitor the filtering effectiveness of the sterile filter to be sure To have the actual level of contamination tested please contact a professional plumber or G Flex Europe SPRL or a service technician authorised by us gt The degree of efficiency of the sterilisation effect of the sterile water filter filling pipe and silicone hose depends on the function and parameters of the steam sterilising unit According to EN 13060 the function and program cycle of the autoclave will be a checked and logged G Flex Europe S P R L 20 Rue de l industrie 1400 Nivelles Belgium Phone 32 0 67 88 36 65 Fax 32 0 67 88 36 88 Email sales g flex com Website www g flex com US Commercial Office Only G Flex USA Inc 74 Southwood Pkwy Suite 600 Atlanta GA 30354 USA Creation Date 18 10 13 Page 58 of 87 Current Name IF U ScopeCleanerS20 doc Version 7 This document is only controlled in electronic format by the QM ELEM le S aaicon Sipple a Dismantling the sterile water filter and preparation for sterilisation e To remove the sterile water filter from the SCOPE CLEANER S20 pull back the knurled sheath on the quick release coupler located on the lower connection port filter intake and pull the filter up and out e Unscrew the air discharge valves on the side of the filter by one turn each Caution liquid will exit the unit due to
61. led in electronic format by the QM Connections in disinfection tank 1 LL W small white jet channel 2 LL W small green biopsy channel 3 LL W small red suction channel 4 LL W small blue air water channel 5 LL W small blue biopsy channel 2 6 LL W big suction pipe 7 Level sensor black 8 Leakagetest connector 9 Additional connection for dosing enzymatic cleaner wall G Flex Europe S P R L 20 Rue de l industrie 1400 Nivelles Belgium Phone 32 0 67 88 36 65 Fax 32 0 67 88 36 88 Email sales g flex com Website www g flex com US Commercial Office Only G Flex USA Inc 74 Southwood Pkwy Suite 600 Atlanta GA 30354 USA Creation Date Current Name 18 10 13 Page 21 of 87 IFU ScopeCleanerS20 doc Version 7 This document is only controlled in electronic format by the QM I paaa E Ge v T Bw Wwww g flex cor gt simple a oo 3 O n Functional Test gt To perform the functional test proceed as follows e Check all connections to the drinking water electrical supplies and the drains Ensure they are firm e Check ifthe sterile water filter has been autoclaved and correctly connected e Open the drinking water stopcock e Switch on the unit with the main switch Switch position I The main switch will show green and the display will show the main menu gt To check the pumps and valves proceed as follows e Tap the Options
62. lled in electronic format by the QM en a 4 eG Sing www g flex com p e To see the SCOPE CLEANER 820 information tap the MACHINE INFORMATION Button from the Configuration Menu pei ci orming MACHINE INFOMATION SCOPECLEANER 20 LOT 1488 VERSION 1 0 MANUFACTURE DATE 01 2013 dd mm yy l HH MM SS 05 22 2012 14 51 29 Device Status on SCOPE CLEANER S20 Ap The devices registered in the SCOPE CLEANER S20 are stored in the internal database of the unit Each position has a cycle counter that reports the number of times each device were reprocessed by the unit v yvy o To check the device s status tap the Device Status button at the Options menu ABCDE1111 ABCDE2222 ABCDE3333 ABCDE4444 ir 0 0 0 0 0 0 0 0 0 GE Fan o eG a dd mm yy HH MM SS G Flex Europe S P R L 20 Rue de l industrie 1400 Nivelles Belgium Phone 32 0 67 88 36 65 Fax 32 0 67 88 36 88 Email sales g flex com Website www g flex com US Commercial Office Only G Flex USA Inc 74 Southwood Pkwy Suite 600 Atlanta GA 30354 USA Creation Date 18 10 13 Page 56 of 87 Current Name IFU ScopeCleanerS20 doc Version 7 This document is only controlled in electronic format by the QM ELISE simple n www g flexcom performing Ae gt The Device Status screen shows the device code and the quantity of reprocessing cycles gt Itis po
63. mercial Office Only G Flex USA Inc 74 Southwood Pkwy Suite 600 Atlanta GA 30354 USA Creation Date 18 10 13 Page 63 0f87 Current Name IF U ScopeCleanerS20 doc Version 7 This document is only controlled in electronic format by the QM M CLEE simple www g fie flexcom performing Blowing out the disinfection solution Blow out the inside of the tubes with sterile compressed air A leauton Wear protective gloves and goggles Final rinse Place the disinfected connection tubes in a tank of water which is sterile and microbiologically stable Rinse the connection tubes thoroughly inside and out with microbiologically stable sterile water DRYING Blast the insides of the connection tubes with sterile compressed air until fully dry recommendation 0 5 bar Wipe off the outsides of the tubes with a new disposable wipe Sterilisation Seal the dried tubes in a suitable sterile packaging The connection tubes can be autoclaved at 134 C 3 bar for a period of 5 minutes A After processing of the connection tubes has been completed and before they are used again they must be checked to see they are functioning correctly The processing of the connection tubes is subject to the following criteria After processing connection tubes must be transparent and flexible Take careful note of the surface of the tubing Minor discoloration is acceptable If major changes are visible in the
64. n disinfection time including 2 min blow out Endoscope disinfection with SCOPE CLEANER 20 A e The SCOPE CLEANER 820 is able to run just the Disinfection step followed by the Neutralization of the endoscope Leakage test 2 min Disinfection cycle freely selectable 4 min filling and emptying including 1min blow out Neutralization 7 min including 2 min blow out Total time 13 min disinfection time including 2 min blow out The following points apply According to current guidelines endoscopes must always be subjected to manual precleaning wipe the endoscope brush out all accessible channels and valve openings etc G Flex Europe S P R L 20 Rue de l industrie 1400 Nivelles Belgium Phone 32 0 67 88 36 65 Fax 32 0 67 88 36 88 Email sales g flex com Website www g flex com US Commercial Office Only G Flex USA Inc 74 Southwood Pkwy Suite 600 Atlanta GA 30354 USA Creation Date 18 10 13 Page 44 of 87 Current Name IFU ScopeCleanerS20 doc Version 7 This document is only controlled in electronic format by the QM le Wwww g PTE Simple o Setting Procedures e To configure the parameters of each procedure tap the button sae portorning from the main screen and select Process ple www gflex com performing OPTIONS mm dd yy HH MM SS dd mm yy HH MM SS e Set the parameters that will be executed Quantity of Cleaning E Quantity o
65. n visibly soiled once per working day at the latest Sterilisation sterile water before first use at an appropriate location filter then every 7 days on the unit or nearby visible for all users and in the User Information Pack Filter in the dirt trap annually at an appropriate location on the unit or nearby visible for all users and in the User Information Pack Pre filter Latest after 6 month at an appropriate location depending on water on the unit or nearby quality and visible for all users and in contamination of the the User Information Pack filter G Flex Europe S P R L 20 Rue de l industrie 1400 Nivelles Belgium Phone 32 0 67 88 36 65 Fax 32 0 67 88 36 88 Email sales g flex com Website www g flex com US Commercial Office Only G Flex USA Inc 74 Southwood Pkwy Suite 600 Atlanta GA 30354 USA Creation Date 18 10 13 Page 800f 87 Current Name IF U ScopeCleanerS20 doc Version 7 This document is only controlled in electronic format by the QM UO PSHUBYD UOINIOS UOlIBjUISIg UO Psde Ceal 137 1 UONONS UO Pex Jazip JSJEM sjLa s TWANVW SONVNSALNIVIN Phone 32 0 67 88 36 65 Fax 32 0 67 88 36 88 Email sales g flex com Website www g flex com G Flex Europe S P R L 20 Rue de l industrie 1400 Nivelles Belgium wl Creation Date US Commercial Office Only G Flex USA Inc 74 Southwood Pkwy Suite 600 Atlanta GA 30354 USA 18 10 13 81 of 87 7
66. non Waterbottles must be closed k G Flex Europe S P R L 20 Rue de l industrie 1400 Nivelles Belgium Phone 32 0 67 88 36 65 Fax 32 0 67 88 36 88 Email sales g flex com Website www g flex com US Commercial Office Only G Flex USA Inc 74 Southwood Pkwy Suite 600 Atlanta GA 30354 USA Creation Date 18 10 13 Page 76 of87 Current Name IFU ScopeCleanerS20 doc Version 7 This document is only controlled in electronic format by the QM ELIE simple s www g flexcom performing Connecting to Pentax endoscopes MN gt f an endoscope does not have a jet channel ensure the dummy jet channel tube is connected to the SCOPE CLEANER 20 Number Channel Description Z Z O Z S O 1 JetChannel o 2 _____ Biopsy Channel o 3 _ Suction Channel S O 4 Air Water Channel 5 Biopsy Channel2 Double Channel Z S 6 _ Pentax Endoscope Series with separate Air Water Channel __ D __ Pressure Leakage Test Connector gt Z o Z S 7521 100 Adapter for models with single connectors for Air and Water Channel a 7521 000 Adapter for models with Air Water Channel System G Flex Europe S P R L 20 Rue de l industrie 1400 Nivelles Belgium Phone 32 0 67 88 36 65 Fax 32 0 67 88 36 88 Email sales g flex com Website www g flex com US Commercial Office Only G Flex USA Inc 74 Southwood Pkwy Suite 600 Atlanta GA 30354 USA Creation Date 18 10 13 Page 77o0f
67. ntrolled in electronic format by the QM ELISE simple n www g flexcom performing Safety Instructions Liability Disclaimer G Flex Europe SPRL is not liable for any damage direct or consequential which occurs under the following conditions the unit or accessories are operated treated or maintained inappropriately the instructions and specifications set out in this manual are not observed repairs adjustments or modifications to the unit or accessories have been carried out by unauthorized persons the unit has been opened by unauthorized persons the prescribed inspection and maintenance intervals are not observed Authorized Service Technicians AS Only service technicians certified by G Flex Europe SPRL are authorized to carry out repairs adjustments or modifications to the unit and accessories Authorized service technicians are trained and certified exclusively by G Flex Proper use of the equipment A Keaton The SCOPE CLEANER 20 unit should only be operated in accordance with its intended purpose in the manner described in this manual Space requirements Aw Before installing the SCOPE CLEANER S20 ensure that there is sufficient space on the contaminated side of the reprocessing room for the installation of the unit and that all the required mains and other supplies including a drain pipe are available see Chapter 3 Using the equipment for the first time
68. nts and disconnect loose components The disconnected and capped endoscope ha to be stored and transported to the reprocessing room in a closed container e g a pan with a lid Then place the endoscope in a sink filled with a detergent solution Transporting the endoscope in a closed container avoids contaminating the immediate environment G Flex Europe S P R L 20 Rue de l industrie 1400 Nivelles Belgium Phone 32 0 67 88 36 65 Fax 32 0 67 88 36 88 Email sales g flex com Website www g flex com US Commercial Office Only G Flex USA Inc 74 Southwood Pkwy Suite 600 Atlanta GA 30354 USA Creation Date 18 10 13 Page 27 of 87 Current Name IF U ScopeCleanerS20 doc Version 7 This document is only controlled in electronic format by the QM a 3 ef www g flex com performing n Manual cleaning in the processing room A gt Before performing manual cleaning it is essential to carry out a leakage test on the endoscope concerning the instructions of the endoscope manufacturer gt Alternatively you could perform a leakage test by using the LEAKAGE MASTER The next cleaning stage is carried out on the dirty side of the reprocessing room since spray from the cleaning fluid can contaminate surfaces To prevent internal residues from hardening clean the outside and on the vents entries of the endoscope carefully with a brush according to the manufacturer s instructions Carry out ea
69. ould cause liquid to remain in the hose G Flex Europe S P R L 20 Rue de l industrie 1400 Nivelles Belgium Phone 32 0 67 88 36 65 Fax 32 0 67 88 36 88 Email sales g flex com Website www g flex com US Commercial Office Only G Flex USA Inc 74 Southwood Pkwy Suite 600 Atlanta GA 30354 USA Creation Date 18 10 13 Page 16 of 87 Current Name IF U ScopeCleanerS20 doc Version 7 This document is only controlled in electronic format by the QM CLIE simple mt www g flexcom performing MN gt The SCOPE CLEANER 820 has a built in device which prevents any contaminated fluid in the device from being returned into the drinking water supply When performing daily surface disinfection work on the SCOPE CLEANER S20 ensure under all circumstances that there is no transfer of infection into the filling tube from contaminated utensils e g swabs cloths which would contaminate the drinking water The professionals installing the equipment will be able to advise you on the EN 1717 and DIN 1988 4 standards which must be adhered to We recommend that you also fit an aqua stop system which blocks off the inflow of water if one of the tubes springs a leak or bursts gt Depending on the water quality of the water supply domestic water we recommend a PALL prefilter optional to prefilter coarse particles A gt The SCOPE CLEANER 820 drain tube silicone tube tapered to be wider at the end is
70. outhwood Pkwy Suite 600 Atlanta GA 30354 USA Creation Date 18 10 13 Page 42 of 87 Current Name IFU ScopeCleanerS20 doc Version 7 This document is only controlled in electronic format by the QM M CLEE simple www g flexcom performing Processing endoscopes with the SCOPE CLEANER 20 The SCOPE CLEANER S20 is able to perform procedures that were previously selected in the Process Parameter Configuration A lemon gt All the Parameter s Configuration might be exactly set according to manufacturer s instructions gt Different sets including the exposure time and or inadequate dosage of disinfection solution could negatively affect the process or damage the endoscope Recommended standard procedure Leakage Test Cleaning Prerinsing Disinfection Neutralization A gt f you performed enzymatic precleaning outside the SCOPE CLEANER 820 first the unit allows you to run the automatic prewash before the disinfection operation to ensure that all the residues of cleansing agents are removed from the endoscope completely before the disinfection procedure begins If the automatic prewash function in the SCOPE CLEANER S20 is used it is not necessary to perform the rinse stage in the precleaning sink Check all connections to the drinking supplies and the drains Ensure they are firm Check if the strainer has been autoclaved and correctly connected Open the drinking water stopcock Switch the unit via
71. rial compatibility must be followed exactly Use only disinfectants whose germicidal fungicidal mycogermicidal and virucidal effectiveness have been verified All disinfectants approved in accordance with DIN EN standards on disinfecting surgical instruments and or in accordance with the standard methods of the VAH are considered suitable Efficacy in destroying viruses must be separately demonstrated Observe the recommendations issued by RKI on the testing and declaring the effectiveness of disinfectants in combating viruses A in gt After the disinfectant reservoir has been filled make a note of the date when the disinfection solution was mixed in a clearly visible suitable place and in the service manual service manual table refer to the Appendix The disinfectant should be changed according to the manufacturer s instructions or sooner if there is visible contamination We recommend replacing the disinfectant after one week at the latest Where colonoscopes are to be processed the disinfectant solution must be changed daily or at the latest every second day All the Parameter s Configuration might be exactly set according to manufacturer s instructions G Flex Europe S P R L 20 Rue de l industrie 1400 Nivelles Belgium Phone 32 0 67 88 36 65 Fax 32 0 67 88 36 88 Email sales g flex com Website www g flex com US Commercial Office Only G Flex USA Inc 74 Southwood Pkwy Suite 600 Atlanta GA 3035
72. s to be serviced will lapse Dirt trap e Check the water intake dirt trap at least once a year for soiling and remove any blockages that may be forming Pipes amp tubes e Both the tubes inside the unit and the connection tubes in the tank must be replaced once a year Up to 6 months corresponding to DIN 1988 depending on water quality PALL prefilter change the filter cartridge if one is used e Open the housing and remove the filter cartridge e f necessary clean the housing e Remove the new filter cartridge from its packaging and insert it into the housing G Flex Europe S P R L 20 Rue de l industrie 1400 Nivelles Belgium Phone 32 0 67 88 36 65 Fax 32 0 67 88 36 88 Email sales g flex com Website www g flex com US Commercial Office Only G Flex USA Inc 74 Southwood Pkwy Suite 600 Atlanta GA 30354 USA Creation Date 18 10 13 Page 62o0f87 Current Name IF U ScopeCleanerS20 doc Version 7 This document is only controlled in electronic format by the QM ELIE simple n www g flexcom performing AS gt The maximum operating temperature of the liquid to be filtered must not exceed 40 C Higher temperatures may diminish the ability of the strainer or even cause damage to the strainer and housing Processing the connection tubes A The connection tubes may only be used after they have been processed cleaning disinfection sterilisation
73. serting the tag directly in the opening of the gallon lid See picture below Switch on the unit The switch is on the right side VV Y Y Reprocessing endoscopes using the SCOPE CLEANER 20 B gt Employee health and safety regulations must be observed during all procedures which require contact with disinfectants or in relation to the cleaning and disinfection of endoscopes gt Throughout all the steps outlined below it is essential to wear protective clothing i e disposable gloves mouth and nose masks goggles and a waterproof protective coat or apron gt Because the air in the reprocessing room may contain a high level of disinfectant fumes there must be adequate ventilation or air extraction gt Since itis common for contaminated liquids to splash it is essential to perform a thorough surface disinfection procedure afterwards Phone 32 0 67 88 36 65 Fax 32 0 67 88 36 88 Email sales g flex com Website www g flex com tal G Flex Europe S P R L 20 Rue de l industrie 1400 Nivelles Belgium US Commercial Office Only G Flex USA Inc 74 Southwood Pkwy Suite 600 Atlanta GA 30354 USA Creation Date 18 10 13 Page 23 0f87 Current Name IF U ScopeCleanerS20 doc Version 7 This document is only controlled in electronic format by the QM ELISE simple n www g flexcom performing gt The SCOPE CLEANER 820 has a security sensor that check if the door is open durin
74. ssible to save the data in an USB storage device USB Flash Drive Ae gt The device counter helps to manage the device s maintenance Every time that the device is replaced or returned of the maintenance job we suggest to clear the cycle counter gt Toclear the counter select the Insert Device button at the Options menu and tap the Clear Counter button of the device 5 Service and maintenance Daily cleaning e Clean and disinfect the disinfection tank and lid thoroughly at least once per working day after use and after every period of 12 hours if not used and then dry the tank and lid properly A emo gt Ifthe disinfection tank and lid are visibly soiled the unit should be cleaned more often gt Ifthe lid is not sufficiently cleaned this can result in the disinfection tank becoming recontaminated gt Do not use aggressive detergents or solutions containing alcohol to clean the SCOPE CLEANER S20 housing To clean the outer housing use only a damp cloth together with a paint friendly cleaning and disinfectant observe the instructions issued by the manufacturer of the cleaner and or disinfectant The tank and lid must be disinfected with a surface disinfectant Weekly Disinfectant solution AE gt We recommend that the disinfection solution in the disinfectant reservoir be changed at least once a week but if colonoscopes are reprocessed this should be reduced to every day or every second da
75. st the SCOPE CLEANER S20 with the voltage selector switch 230V 115V Supply a voltage different from that defined by the voltage selector switch 230V 115V might cause the unit to malfunction or even damage it If any doubt persist contact the G Flex Europe SPRL or a professional authorized by us gt 1 USB connection for printer or USB storage device USB Flash drive G Flex Europe S P R L 20 Rue de l industrie 1400 Nivelles Belgium Phone 32 0 67 88 36 65 Fax 32 0 67 88 36 88 Email sales g flex com Website www g flex com US Commercial Office Only G Flex USA Inc 74 Southwood Pkwy Suite 600 Atlanta GA 30354 USA Creation Date 18 10 13 Page 19 of 87 Current Name IFU ScopeCleanerS20 doc Version 7 This document is only controlled in electronic format by the QM ELE simple wwwgfie com performing Openings for adjusting on front side Ey a n gt 1 Opening for adjusting channel monitoring Left side Suction channel ya a Right side Air water channel SGOR ci a a n 4 G Flex Europe S P R L 20 Rue de l industrie 1400 Nivelles Belgium Phone 32 0 67 88 36 65 Fax 32 0 67 88 36 88 Email sales g flex com Website www g flex com US Commercial Office Only G Flex USA Inc 74 Southwood Pkwy Suite 600 Atlanta GA 30354 USA Page 20 of 87 Creation Date 18 10 13 Version 7 Current Name IFU ScopeCleanerS20 doc This document is only control
76. surface structure or roughness compared with a new connection tube the tube must be replaced with a new one Leaky and porous tubes must be replaced immediately The number of reprocessing activities must be recorded G Flex Europe S P R L 20 Rue de l industrie 1400 Nivelles Belgium Phone 32 0 67 88 36 65 Fax 32 0 67 88 36 88 Email sales g flex com Website www g flex com US Commercial Office Only G Flex USA Inc 74 Southwood Pkwy Suite 600 Atlanta GA 30354 USA Creation Date 18 10 13 Page 640f87 Current Name IF U ScopeCleanerS20 doc Version 7 This document is only controlled in electronic format by the QM 6 Error and warning messages gt Tank Full oreenmina tk TANK FULL ST OPTIONS CATALOG DOUBTS mm dd yy HH MM SS e The message indicates that the level sensor is activated when the unit is not performing any process Tapping the alert message it will open the Output Control s screen The user can coordinate the valves to discard or to return the solution to the tank Autoclave Sterile Water Filter FLE AY ie AUT OCLAVE STERILE WATER FITER SOUT IS x 4 IT performing NAA My Pe Ln OPTIONS CATALOG DOUBTS mm dd yy HH MM SS G Flex Europe S P R L 20 Rue de l industrie 1400 Nivelles Belgium Phone 32 0 67 88 36 65 Fax 32 0 67 88 36 88 Email sales g flex com Website www g flex com US Commercial Office Only G Fl
77. the existing water pressure e Pour out the residual water from both the intake and outlet It is not necessary to blow out the residual moisture in the filter using compressed air On the contrary doing so might damage the filter membrane G Flex Europe S P R L 20 Rue de l industrie 1400 Nivelles Belgium Phone 32 0 67 88 36 65 Fax 32 0 67 88 36 88 Email sales g flex com Website www g flex com US Commercial Office Only G Flex USA Inc 74 Southwood Pkwy Suite 600 Atlanta GA 30354 USA Creation Date 18 10 13 Page 59 o0f 87 Current Name IFU ScopeCleanerS20 doc Version 7 This document is only controlled in electronic format by the QM A kml Simple ena r s a ra EUr NSA www g flexcom performing Sterilising the sterile water filter e Place the filter feed pipe and silicone tube in suitable sterile packaging paper sheet pouch or sterilisation container e Place the packaged filter feed pipe and silicone tube in the autoclave e Select the appropriate sterilisation cycle based on the information set out below 121 On 5 min e If sterilisation is performed outside the institute we recommend using double film outers to prevent the normal outer package from being contaminated iN gt Sterilisation of the sterile water filter filling and silicone tubes should be validated according to the recommendations of the Robert Koch Institute gt Storing the st
78. uction channels door open insufficient water low level of disinfectant low level of enzymatic leakage test fail process concluded Process Alerts audible and visual Sterile water filter 0 2 u ul G Flex Europe S P R L 20 Rue de l industrie 1400 Nivelles Belgium Phone 32 0 67 88 36 65 Fax 32 0 67 88 36 88 Email sales g flex com Website www g flex com US Commercial Office Only G Flex USA Inc 74 Southwood Pkwy Suite 600 Atlanta GA 30354 USA Creation Date Current Name 18 10 13 IFU ScopeCleanerS20 doc This document is only controlled in electronic format by the QM Page Version 74 of 87 7 m Zi ia VY E a AT S g flexcom performing 2 3 J n Appendix I Connecting to Olympus endoscopes A gt fan endoscope does not have a jet channel ensure the dummy jet channel tube is connected to the SCOPE CLEANER 20 Biopsy Channel Connector Caps Endo Technik 7524 A00 LON Air Water Channel Closing Cap Endo Technik 7523 000 mm bal i ANIN AA at TL SS gt eel 2 a l 7 d f 7 lal El ic Protection C E ectronic Protection Cap r Olympus MH 553 f i la A a S j p TN h TE a p P TN thet i s g Water Protection Cap y Olympus MAJ 583 OEELA EE AAO Channel Description Jet Channel Biopsy Channel Suction Channel Air Water C
79. urer s instructions exactly when preparing the disinfectant solution and observe the specified concentration and exposure times If the exposure time is too short the disinfection process will be negatively affected while a long exposure time can damage the endoscope G Flex Europe S P R L 20 Rue de l industrie 1400 Nivelles Belgium Phone 32 0 67 88 36 65 Fax 32 0 67 88 36 88 Email sales g flex com Website www g flex com US Commercial Office Only G Flex USA Inc 74 Southwood Pkwy Suite 600 Atlanta GA 30354 USA Creation Date 18 10 13 Page 300f87 Current Name IF U ScopeCleanerS20 doc Version 7 This document is only controlled in electronic format by the QM Fired simple www g flexcom performing ip A gt Ifthe SCOPE CLEANER 20 were switched off when it is full or if there is a power outage while it is in use it will be necessary when the unit is switched on again to drain off the fluid in the tank manually by selecting the Output Control from the Options Menu MN gt The accordingly operation of the SCOPE CLEANER 820 is only allowed with closed disinfection tank cover gt Please look out when opening or closing the disinfection tank cover on your hands possible clamped parts of the endoscope or parts that are laying on the top of the disinfection tank cover gt In Singe fault i e loss of power or unit error it is not allowed to open the disinfection tank cover without
80. urrent Name IFU ScopeCleanerS20 doc Page 350f 87 Version 7 This document is only controlled in electronic format by the QM i a le www g flex com Simple e gt Adjust Date amp Time Password A pea aan aa eS pe ising ADJUST DATE amp TIME mm dd yy HH MM SS mm dd yy HH MM SS Adjust Date amp Time Password Pi Set Password 2 Previous Screen Ka Adjust Date amp Time 2 Previous Sereen gt Options 3 si ie CJ chance pisinrectant s gt s SCREEN CALIBRATION 15 02 2012 bi A 13 12 48 G Flex Europe S P R L 20 Rue de l industrie 1400 Nivelles Belgium Phone 32 0 67 88 36 65 Fax 32 0 67 88 36 88 Email sales g flex com Website www g flex com US Commercial Office Only G Flex USA Inc 74 Southwood Pkwy Suite 600 Atlanta GA 30354 USA Creation Date 18 10 13 Page 36 of 87 Current Name IFU ScopeCleanerS20 doc Version 7 This document is only controlled in electronic format by the QM gt Output Control Output Control Turn On Enzymatic Pump Turn On Disinfection Pump Open Tank Valve Turn On Compressor Turn On Circulation Pump Open Water Valve Open Drain Valve LEAKAGE TESTPRESSURE 1 2345 Open Depressurization Valve 15 02 2012 13 12 48 Previous Screen G Flex Europe S P R L 20 Rue de l industrie 1400 Nivelles Belgium Phone 32 0 67 88 36 65 Fax 32 0 67 88 36 88
81. x Europe S P R L 20 Rue de l industrie 1400 Nivelles Belgium Phone 32 0 67 88 36 65 Fax 32 0 67 88 36 88 Email sales g flex com Website www g flex com US Commercial Office Only G Flex USA Inc 74 Southwood Pkwy Suite 600 Atlanta GA 30354 USA Creation Date 18 10 13 Page 79o0f 87 Current Name IFU ScopeCleanerS20 doc Version 7 This document is only controlled in electronic format by the QM ELISE simple n www g flexcom performing Appendix IV Regular maintenance and cleaning requirements When Documentation Cleaning and disinfection once per working day in definition by the user of the tank and lid at the latest after 12 hours of non USE Self disinfection cycle once per working day in definition by the user without an endoscope at the latest after 12 hours of inactivity or the period set during setup Replace suction filter every 14 days at an appropriate location disinfection filter tank on the unit or nearby visible for all users and in the User Information Pack Change the disinfection when visibly soiled at an appropriate location solution at the end of a working on the unit or nearby week at the latest visible for all users and in the User Information Pack Replace detergent if contaminated with no documentation solution for cleaning organic waste endoscopes before substances do this reprocessing in the immediately after the SCOPE CLEANER S20 cleaning process whe
82. x com 18 10 13 G Flex Europe S P R L 20 Rue de l industrie 1400 Nivelles Belgium ul Creation Date 86 of 87 7 Page Version IFU ScopeCleanerS20 doc Current Name This document is only controlled in electronic format by the QM ELIE simple g www g flexcom performing Appendix V Reprocessing plan SEMI MACHINE BASED REPROCESSING OF ENDOSCOPES CLEANING IN ACCORDANCE WITH MANUFACTURER S INSTRUCTIONS PRECLEANING CONNECTED TO THE LIGHT SOURCE The outer mantle is wiped off from top to bottom using a saturated lint free cloth while the endoscope is still connected to the light source Draw in copious amounts of enzymatic cleanser alternately via the distal tip and the cleaning adapter Operate the air water infeed for several seconds for each operation Insert the cleaning adapter Separate the flexible endoscope from the light source CLEANING IN THE REPROCESSING ROOM Carry out a leakage test Immerse the flexible endoscope Clean all the channels with special cleaning brushes Clean the entire air water system thoroughly Flush the channels REPROCESSING IN THE DISINFECTING UNIT The machine must meet all requirements in terms of its ability to ensure cleanliness disinfection flushing and drying s Note Before immersing the endoscopes thoroughly clean and brush all existing channels instrument channels water channels Albarran channels
83. y G Flex Europe S P R L 20 Rue de l industrie 1400 Nivelles Belgium Phone 32 0 67 88 36 65 Fax 32 0 67 88 36 88 Email sales g flex com Website www g flex com US Commercial Office Only G Flex USA Inc 74 Southwood Pkwy Suite 600 Atlanta GA 30354 USA Creation Date 18 10 13 Page 57 of 87 Current Name IF U ScopeCleanerS20 doc Version 7 This document is only controlled in electronic format by the QM CLIE simple n www g flexcom performing AN eto gt lf the disinfectant is visibly soiled or if the disinfectant manufacturer specifies otherwise the solution should be replaced more frequently Sterile water filter AE gt The sterile water filter and the filling tube and silicone hose must be resterilised every 7 days in a suitable autoclave which meets the requirements of EN 13060 Process Cycle B i e one which allows a fractionated vacuum process gt The sterile water filter may only be resterilised 10 times The number of times it is resterilised is entered in the Service Manual see Appendix A Site gt The maximum of 10 resterilisation processes and reuse of the filter are based on historical values where the drinking water used is of normal quality DIN 38409 carbonate hardness 7 21 dH water hardness rating of 2 or 3 substances in suspension lt 10 mg l TrinkwV 2001 opacity lt 1 0 NTU Where the mains drinking water is known to have a relatively high leve
84. y G Flex USA Inc 74 Southwood Pkwy Suite 600 Atlanta GA 30354 USA Creation Date 18 10 13 Page 240f87 Current Name IF U ScopeCleanerS20 doc Version 7 This document is only controlled in electronic format by the QM CLIE simple mt www g flexcom performing Preparing disinfection solution A gt Please refer to the operating instructions supplied with your endoscope for information on disinfectants which are approved for use with endoscopes If you want to use a disinfectant which is not expressly recommended for use by the endoscope manufacturer please obtain written evidence of compatibility from either the endoscope producer or the disinfectant manufacturer Instructions issued by the manufacturer of the endoscope on material compatibility must be followed exactly gt Use only disinfectants whose germicidal fungicidal mycogermicidal and virucidal effectiveness have been verified All disinfectants approved in accordance with DIN EN standards on disinfecting surgical instruments and or in accordance with the standard methods of the VAH are considered suitable Efficacy in destroying viruses must be separately demonstrated Observe the recommendations issued by RKI on the testing and declaring the effectiveness of disinfectants in combating viruses gt The following table provides guidelines for formulating disinfectants of various concentrations with a total volume of 17 liters Water ml 16660 15
85. y Suite 600 Atlanta GA 30354 USA Creation Date 18 10 13 Page 17 of 87 Current Name IF U ScopeCleanerS20 doc Version 7 This document is only controlled in electronic format by the QM Controls e Main switch Switch position I The main switch will show green The display will show the main menu e Touch panel n of simple www g fiexcom perrorming All machine controls are made through the Touch Screen panel simple Ne performing N EA OPTIONS CATALOG mm dd yy HH MM SS G Flex Europe S P R L 20 Rue de l industrie 1400 Nivelles Belgium Phone 32 0 67 88 36 65 Fax 32 0 67 88 36 88 Email sales g flex com Website www g flex com US Commercial Office Only G Flex USA Inc 74 Southwood Pkwy Suite 600 Atlanta GA 30354 USA Creation Date 18 10 13 Page 18 of 87 Current Name IFU ScopeCleanerS20 doc Version 7 This document is only controlled in electronic format by the QM Connection on back and right side e Shrouded 3 pin plug with mains fuses To change the mains fuses disconnect the unit from the mains and use a small screwdriver to extract the fuse holder and the fuses Replace with new ones e The voltage selector 230V 115V gt The SCOPE CLEANER 820 has the voltage supply 230V and an optional version with voltage selector switch 230V 115V A gt Make sure to know the voltage supply If the local voltage is 115V reque

Scope Cleaner S20 - G-Flex

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