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FSE-057-EN-3.0 Fuse 1G Gastroscope Reprocessing

1. cseeseeeeeeeeeeeeeeeeeeeaeaaaassseeeeeeeeeeeeeeees 27 Brush the Air Water and Suction Valves ccccccccccceeeeeeeeeeeeeeeeees 28 Brush the Suction Channel in the Umbilical Tube section 28 Brush the Suction Channel in the Insertion Tube section 28 Channel cleaning brush locations cccececcccceeeeeseeeeeeeeeeseeaeeeeeeeess 29 Flush the Air Water Channels with detergent solution 29 Flush the Suction Working Channels with Detergent Solution 30 Flush the Auxiliary Water Supply Channel with Detergent Solution 31 Flush the Air Water and Suction Valves with detergent solution 31 Wipe down the inserted section of the endoscope u022220000 31 Soak in detergent SOMITION anne een 31 Rinsing after Manual CICaning ccccccccseeeeeeesseeeeeeesseeeeeeeeeeeeeeeeeeas 32 Move the endoscope and accessories from detergent to clean water 33 Flush the Air Water Channels with water ccccccccsseeeeeeeeeeeeeeeeeees 33 Flush the Suction Working Channels with water cccccsssseeeseeseees 33 Flush the Auxiliary Water Channels with water 34 Flush the Air Water and Suction Valves with water 35 Remove the endoscope and accessories from the water 35 Discard the rinse water cccccccccesseseeeeeeceeeeesseeeeeeeeeaeaseeeeeeeseaaaasees 35 Flush the Air
2. before removing the endoscope from disinfectant disinfectant to sterile surfaces accessories with sterile water solution water Air Water Suction Working Air Water Suction Working Auxiliary water valves Auxiliary water valves Remove from Wipe down Flush all Channels and accessorie Flush all Channels and Wipe down external surfaces with air Air Water Suction Working accessories with alcohol external surfaces Auxiliary water valves Air Water Suction Working with alcohol Auxiliary water valves sterile water STEP 7 DRYING Wipe down all external Storage in a vertical surfaces with sterile position lint free cloth Fuse 1G Gastroscope Reprocessing Manual 57 Reprocessing Steps This page intentionally left blank 58 _ DENDCCHOICE FSE 057 EN 3 0 Storage and Disposal WARNING The endoscope and its parts must be reprocessed prior to storage Do not store the endoscope in direct sunlight at high temperature or in high humidity While in storage do not expose to X rays or ultraviolet rays While in storage do not coil into a small radius as this may result in contamination either to the user operator and or damage the device Improper storage and specifically not thoroughly drying external and internal surfaces lumens prior to storage will lead to an infection control risk Do not touch the reprocessed endoscope with contaminated gloves this will lead to an infection control risk Keep cabinet doors
3. ag 8 uulunludu El 1 Remove all the cleaning adaptors 2 Using a lint free cloth wipe away any bubbles clinging to the endoscope s external surfaces 3 Cover the basin with a tight fitting lid 4 Soak the endoscope and accessories in the basin of HLD solution for the amount of time and at the temperature recommended by the solution manufacturer Fuse 1G Gastroscope Reprocessing Manual 41 Reprocessing Steps AN Rinsing after High Level Disinfection is done to ensure that no disinfectant remains in the endoscope Meticulous care must be used to avoid contamination of the endoscope WARNING Adequate rinsing after high level disinfection is critical in order to remove disinfectant residuals as they can cause tissue damage to the subsequent patient Bacterial overgrowth within endoscope channels may result from contamination of tap water microorganism in moist channels This may lead to patient contamination therefore the final water rinse should be performed with sterile water Rinsing cycles are performed in order to remove residuals of disinfectant agents Empty basin after each subsequent use Failure to comply with this instruction may result in patient irritation and or injury Ensure all contact with the high level disinfected endoscope and accessories is via sterile equipment surfaces and materials Failure to do so may contaminate the device and pose an infection risk The auxiliary Water Channel must be
4. neutral pH or enzymatic detergent indicated for use with flexible endoscopes such as Pure by EndoChoice which is indicated for use with flexible endoscopes Follow the manufacturer s recommendations including personal protection to be used dilution temperature immersion duration storage date of expiration disposal etc o Sterile Water MUST be used for final rinsing step STEP 6 e Temperature 22 30 C 71 6 80 6 F e Minimum required volume 20 Liters e Clean potable tap water may be used for all other cleaning steps e Temperature 22 30 C 71 6 80 6 F e Minimum required volume 20 Liters Single use sterile 30 ml syringe at least 10 units Important Ensure the reprocessing room is adequately ventilated and lighted DO NOT REUSE DETERGENT SOLUTION Solution should be replaced after being used to reprocess one endoscope DO NOT REUSE RINSING WATER Water should be replaced after being used to reprocess one endoscope DO NOT REUSE RINSING WATER Water should be replaced after being used to reprocess one endoscope FSE 057 EN 3 0 v Equipment Disinfectant Solution 70 alcohol Basins Transportation Containers or Pads Pre cleaning containers Suction pump Reprocessing the Endoscope and Accessories Description Use an FDA cleared CE marked high level disinfectant like Cidex OPA by Advanced Sterilization Products Follow the manufacture
5. u 46 2 7 7 Remove the endoscope and accessories from sterile water 46 2 7 8 Wipe down external surfaces cccccsseeececceeeeeeesceeeeceessaaeeeeesaaeeeess 46 2 7 9 Flush the Air Water Channels with aif cceeeeeeeeeeeeeeeeeeeeeeeeeeeees 47 2 7 10 Flush the Suction Working Channels with air cccccccsseseeeeeeeeeeees 47 2 7 11 Flush the Auxiliary Water Channels with air cccccccssseeseeeeeeeeeees 48 2 7 12 Flush the Air Water and Suction Valves with air n 48 2 7 13 Flush the Air Water Channels with alcoho uee 49 2 7 14 Flush the Suction Working Channels with alcohol 49 2 7 15 Flush the Auxiliary Water Channels with alcohol 50 2 7 16 Flush the Air Water and Suction Valves with alcohol 50 2 7 17 Wipe down external surfaces with alcohol cccseeeceeeeseeeeeeeeaeeeees 51 aes Wie el sc DYNO Ween neon een een 52 2 8 1 Dry the endoscope accessories and cleaning equipment 52 282 Store the amp ndoscope a nenn 52 2 9 Processing Steps Summary Chart eneeeseneseeesnnnssnnnnneennnnnnnnnnnnnnnnnnnnnnnnnnnennnnn 55 CHAPTER 3 Storage and Disposal cscscsccscscecsccscsccccccscsceccccecscsccecccsces 59 3 1 Storage DEIWEEN USCS ua 59 3 2 Disposal of accessories and reprocessing SUPDIICS ccccseseeeeeeeeeeeeeeeeea
6. Brand Model Type Personal protective equipment Clean lint free cloth Basin 40x40x15 cm 38 MENDCCHOICE FSE 057 EN 3 0 Reprocessing Steps Use an FDA cleared high level disinfectant like Cidex OPA EndoChoice EndoChoice EndoChoice 1 Filla clean basin with disinfectant solution at the temperature and concentration recommended by the disinfectant manufacturer 2 Completely immerse the endoscope and accessories in disinfectant solution 3 Attach the Working Channel Cleaning Adaptor to the Working Channel by twisting it onto the Working Channel 4 Attach the cleaning adaptor to the Air Water and Suction openings For more information refer to Section 1 3 1 Connecting the Air Water Cleaning Adaptor 1 Fill a syringe with the disinfectant solution and connect the syringe to the Air Water opening in the cleaning adaptor 2 Block the Air Water inlets on the Main Connector side with a gloved finger and slowly flush a minimum of 90ml of disinfectant solution through the Air Water Channels 3 Unblock the Air Water inlet on the Main Connector side and slowly flush a minimum of 90ml of disinfectant solution through the Air Water Channels Fuse 1G Gastroscope Reprocessing Manual 39 Reprocessing Steps 1 Fill a syringe with disinfectant solution and connect the syringe to the Suction opening in the cleaning adaptor 2 Block the suction inlet on the Main Connector side with a gloved finger and block t
7. Contact EndoChoice for the most updated list of validated AERs for reprocessing the Fuse 1G system Do not reprocess the Fuse 1G system in any other AER Proper reprocessing has a minimal effect on the device degradation The end of the device s life is normally determined by wear and damage due to use Do not leave the device in solutions longer than necessary as this may accelerate the normal product aging and may result in patient injury Damage incurred by improper reprocessing will not be covered by the warranty Detergent solution refers to enzymatic or neutral pH detergent indicated for use with flexible endoscopes Fuse 1G Gastroscope Reprocessing Manual T Reprocessing the Endoscope and Accessories A i h gt Cn Oe A ia Br gar gt Ya aay ay ay a va ZINN wo ne Bee iy pe g En Ge Q a ZIEGE Ln Ge Ge amp Y A S Y u E pE ge S EE Su Oh gt a es www Ww M I I Reprocessing accessories functional features and inspection instructions are provided in this section The following table provides catalog and model numbers for the Fuse Reprocessing Adaptor Kit Catalog Number Description Endoscope Reprocessing Adaptor Kit e Air Water Suction Cleaning Adapter FSR 3300 KT e Working Channel Cleaning Adaptor e Auxiliary Water Supply Port Cleaning Adaptor e Soaking Cap also available separately see below FSR 2001 Soaking Cap Functionality Inspection The Soaki
8. JaN er D u A F at ATATA l ul GE ENG ww WY LAY B7 ww I N CA L l lt i ki l Lo a I l l eH ZA CA wy ut u Below is the step by step explanation of how to connect the Working Channel Cleaning Adaptor The correct Working Channel Cleaning Adaptors are to be used in order to properly flush the working channels Failure to attach the Working Channel Cleaning Adaptor may result in improper reprocessing The term Working Channel Cleaning Adaptor in the reprocessing instructions refers to the Biopsy Cap attached to the silicone tube Use a new syringe for each reprocessing step 1 Connect the Working Channel Cleaning Adaptor silicone tube to the Working Channel Cleaning Adaptor o 2 2 iis E uslulunluu Wl la 2 Connect a syringe to the silicone tube by twisting it in the Luer lock thread verify the connection is sealed 30m ae a T g T bulku ln Wa 14 QQENDCCHOICE FSE 057 EN 3 0 Reprocessing the Endoscope and Accessories 3 When required connect the Working Channel Cleaning Adaptor to the Working Channel on the Control Handle verify proper connection by twisting the adaptor on the Working Channel GB zu E y E LL WAR PN Zn i E m E E A a I 4 m Ji a 1 mm E a L J 4 vi T z i n 5 E j me 4 a W Vay al DIGIO p p a 5 wi 4 H mA ne B E D NIE BEE iW WEEE EW SEE AAMA ALIG ww SALE nP WARS he EY u vn AASTETEL ZN A CAR
9. Ut i 1 Connect the Auxiliary Water Supply Port Cleaning Adaptor to the Auxiliary Water Supply Port by twisting clockwise until tight 2 Connect a syringe to the silicone tube by twisting it in the Luer lock thread verify the connection is sealed SS Q a a a S g Fuse 1G Gastroscope Reprocessing Manual 15 Reprocessing the Endoscope and Accessories The following equipment and materials are required for reprocessing The items listed below including cleaning agents responsible for removal of soil disinfecting agents responsible for reduction of microbes and rinsing water responsible for removal of agent residuals were validated and demonstrated to be compatible with the device and to meet the predefined reprocessing performance criteria Replace any of the reusable equipment listed below that shows signs of wear prior to reprocessing ov Equipment Personal Protective Equipment Clean Lint Free Cloths Sterile Lint Free Cloths Detergent Solution Rinsing Water Sterile Rinsing Water Potable Tap Syringe Luer Lock ENDCCHOICE Description Eyewear facemask moisture resistant clothing and long chemical resistant gloves Clean lint free cloth may be used for all reprocessing steps except the final drying step A new sterile lint free cloth MUST be used during final drying step and it may be used for all reprocessing steps Use a medical grade low foaming
10. between the instruments and other equipment Fuse 1G Gastroscope Reprocessing Manual 59 Storage and Disposal 3 2 Disposal of accessories and reprocessing supplies e Follow all applicable national and local laws and guidelines and manufacturer s instructions and product labels regarding the disposal of any reprocessing materials and single use components e Use caution when handling contaminated items in order to prevent the spread of contamination 60 DENDCCHOICE FSE 057 EN 3 0 CE on m EC REP EndoChoice Innovation Center Ltd 2 Hatochen Street Caesarea 38900 Israel Tel 972 4 632 7731 Fax 972 4 632 7734 Email info EndoChoice com European Authorized Representative MedNet GmbH Borkstra e 10 48163 Munster Germany Tel 49 251 32266 0 Email info medneteurope com 61
11. damage arising from the use of the device if such use is not in strict compliance with instructions and safety precautions contained in the relevant operating manuals and in all supplements thereto in all product labels and according to all terms of warranty and sale of this device or in any change not authorized by EndoChoice Inc WARNING e User provided ancillary equipment and or accessories are NOT validated or warranted by EndoChoice Inc The use of such user provided items is the sole responsibility of the party using such items CEu EC J REP EndoChoice Innovation Center Ltd European Authorized Representative 2 Hatochen Street MedNet GmbH Caesarea 38900 Israel BorkstraBe 10 Tel 972 4 632 7731 48163 Munster Germany Fax 972 4 632 7734 Tel 49 251 32266 0 Email info EndoChoice com Email info medneteurope com ENDCCHOICE FSE 057 EN 3 0 Contents CONTEN ee erneuern iii Safety Information Please Read Prior to Use ssesessesessssesssoessssessssesessecssseo 1 Weigle Bias aA e ee ee 1 SUO e a E E E GENRE INEERHRREUENENER AR 1 Summary of instrument symbols 22uu0sss2200020000nnennnnnnnnnnnennnnnnnnnnnnnnnnnnnnnnnnnen nennen 2 Bg 1672 1 6 gaan E E A EE E E eee oe E 2 Reprocessing IMportance uuossusnennennnnnnnnnnnnnnnnnnnnnnennnnnnnnnnnnnnnnnnnn nenne nnnnnnennnnnne nennen 5 Reprocessing before after first use and storage uu0444440Bnennnennennn nennen
12. reprocessed even when the channel was not used during the procedure Failure to perform this step may result in infection control risk The table below lists the components to be reprocessed and corresponding equipment materials to be used during final rinsing Reprocessing Step 6 Final Rinsing Location Reprocessing Room Fuse 1G Components for Fuse 1G Reprocessing Step 6 Air Water Valve disassembled Suction Valve disassembled Soaking Cap Air Water Cleaning Adaptor e Working Channel Cleaning Adaptor Equipment needed for this step Recommended Brand Model Type Personal protective equipment Sterile gloves 30ml syringe x3 Sterile clean lint free cloth Sterile single use Basin 40x40x15 cm Water Sterile water at least 20 Liters Air Water Cleaning Adaptor EndoChoice 42 JENDCCHOICE FSE 057 EN 3 0 Reprocessing Steps Working Channel Cleaning Adaptor EndoChoice Soaking Cap EndoChoice Alcohol 70 Ethanol 1 Uncover the high level disinfection basin after the time recommended by the HLD solution manufacturer has elapsed Before removing the endoscope from HLD solution perform the following 2 Attach the Air Water Cleaning Adaptor to the Air Water and Suction openings For more information refer to Section 1 3 1 Connecting the Air Water Cleaning Adaptor 3 Attach the Working Channel Cleaning Adaptor to the Working Channel by twisting it onto the Working Channel 1 Fill a syringe with air and connect t
13. suction inlet on the Main Connector using the screw cap provided with the Air Water Cleaning Adaptor 7 Using a syringe slowly flush a minimum of 90ml of detergent solution through the Working Channel 1 amp 2 3 amp 4 5 6 amp 7 30 MENDCCHOICE FSE 057 EN 3 0 Reprocessing Steps 2 4 10 Flush the Auxiliary Water Supply Channel with Detergent Solution 1 Connect the Auxiliary Water Supply Port Cleaning Adaptor to the Auxiliary Water Supply Port 2 Connect a syringe filled with a detergent solution to the Auxiliary Water Supply Port Cleaning Adaptor and slowly flush 90ml of the detergent solution through the Auxiliary Water Channel mu gt iii at a a s en a u Fa J 2 4 11 Flush the Air Water and Suction Valves with detergent solution 1 Using a syringe slowly flush a minimum of 90ml of detergent solution through the Suction Valve a luff Slee 2 Using a syringe slowly flush a minimum of 90ml of detergent solution through the Air Water Valve 2 4 12 Wipe down the inserted section of the endoscope e Using a clean lint free cloth thoroughly wipe down all external surfaces of the endoscope 2 4 13 Soak in detergent solution 1 Disconnect ALL cleaning attachments from the endoscope s interfaces 2 Allow the endoscope to soak in the detergent solution for the manufacturer s recommended time and temperature Fuse 1G Gastroscope Reprocessing Manual 31 Reprocessing Steps Rinsing after ma
14. that the silicone tube is firmly attached to the Leak Tester on both sides e Visually confirm that all plastic parts are intact 10 JENDCCHOICE FSE 057 EN 3 0 Functionality The Single use Channel Cleaning Brush is used to brush the inside of the instrument channel and Suction Channel of the endoscope Use a non metal single use channel cleaning brush suited for 2 8 mm channels such as EndoChoice s HedgeHog Single End Channel Brush SBS 227 50 or the HedgeHog Double End Channel Brush SBD 228 50 Functionality The single use channel opening cleaning brush is used to brush the suction cylinder and the instrument channel port of the endoscope Use a non metal single use channel opening cleaning brush such as the HedgeHog Valve Brush SBB 119 50 by EndoChoice Reprocessing the Endoscope and Accessories Inspection e Refer to the manufacturer s instructions Inspection Refer to the manufacturer s instructions Fuse 1G Gastroscope Reprocessing Manual 11 Reprocessing the Endoscope and Accessories g gr a TN Sa a l en Aas u u Ba oe m I oe Soe En A ZU ai L AAAI A EG kd III I i aw ara es N PN pL H j i N d neci N qine AIr Water gt aA alia Ae LG ee ed EAA ATE ENY iw Mi WWQAtyt IE A iw PAG ty Below is the step by step explanation of how to connect and operate the Air Water Cleaning Adaptor The correct adaptors are to be used in order to ensure prop
15. Reprocessing Manual Fuse 1G Gastroscope Part Number FSE 057 EN 3 0 Released November 2013 This manual includes complete reprocessing instructions for the Fuse 1G Gastroscope system Please refer to the companion Fuse 1G Gastroscope with FuseBox Processor User Manual for complete operating instructions Onl X y Caution Federal U S law restricts this device to sale by or on the order of a physician EndoChoice Inc 11810 Wills Road Alpharetta GA 30009 Tel 888 682 3636 Fax 866 567 8218 customercare endochoice com www endochoice com IMPORTANT Read the User and Reprocessing Manuals in their entirety prior to li using the Fuse 1G Gastroscope system 2013 EndoChoice Inc ALL RIGHTS RESERVED EndoChoice Inc reserves the right to alter the equipment specifications and descriptions in this publication without prior notice No part of this publication shall be deemed to be part of any contract or warranty unless specifically incorporated by reference into such contract or warranty The information contained herein is merely descriptive in nature and does not constitute a binding offer for the sale of the product described herein Neither EndoChoice Inc nor its agent make any representations for fitness for any purpose other than specifically mentioned in this manual DISCLAIMER EndoChoice Inc shall not be obligated in any manner in respect to bodily injury and or property
16. Water Channels with air cceceeeeeeeeeeeeeeeeeeeeeeeeeeees 35 Flush the Suction Working Channels with ai c ccccceessseeeeeeeaeees 36 Flush the Auxiliary Water Channels with i cccccssssecseeseeeeeeeeeeees 37 Flush the Air Water and Suction Valves with air 37 Following the rinse cccccceeeecceeeeecceeeeeceeseeceaeecseseecsauseecsseessaaees 37 High Level Disinfection ccccccseeceeceeeeeceeeeeeseeeeeeseeeeeenseeessaeeessnees 38 Move the endoscope and accessories to the HLD solution 39 Flush the Air Water Channels with HLD Solution 39 Flush the Suction Working Channels with HLD solution 40 Flush the Auxiliary Water Supply Channel with HLD solution 40 Flush the Air Water and Suction Valves with HLD solution 41 Soak In HLD solutiOr sissien eee en ee re 41 Final Mra Ns VG ea sect see ee ee 42 Prepare endoscope and accessories for removal from HLD solution 43 FSE 057 EN 3 0 Contents 2 7 2 Remove the endoscope and accessories from HLD solution 44 2 7 3 Flush the Air Water Channels with water 44444444 nenn 44 2 7 4 Flush the Suction Working Channels with sterile water 45 2 7 5 Flush the Auxiliary Water Channels with water 46 2 7 6 Flush the Air Water and Suction Valves with water
17. ailure to do so may result in injury or exposure to infection of reprocessing personnel Refer to the HLD manufacturer s recommendations when selecting personal protection equipment Completely remove air bubbles from all channels High level disinfection cannot be completed if air bubbles are present in the endoscope channels Incomplete high level disinfection may pose an infection control risk All high level disinfection steps should be performed with the endoscope and accessories completely immersed in the HLD solution If they are not immersed completely the HLD solution may not adequately contact all surfaces of the equipment which may result in incomplete high level disinfection Incomplete high level disinfection may pose an infection control risk CAUTION Immerse the endoscope only for the time and at the concentration and temperature recommended by the manufacturer Use of greater temperature concentration of length of time can increase the wear of the endoscope The table below lists the components to be reprocessed and corresponding equipment and materials to be used during high level disinfection Reprocessing Step 5 High Level Disinfection Location Reprocessing Room Fuse 1G Air Water Valve disassembled Fuse 1G Components for Reprocessing Step 5 Suction Valve disassembled Soaking Cap Air Water Cleaning Adaptor e Working Channel Cleaning Adaptor Equipment needed for this step Recommended
18. aking Cap Air Water Cleaning Adaptor e Working Channel Cleaning Adaptor Equipment needed for this step Personal protective equipment Se Clean lint free cloth new Air Water Cleaning Adaptor Working Channel Cleaning Adaptor 32 MENDCCHOICE FSE 057 EN 3 0 Reprocessing Steps Soaking Cap EndoChoice 1 Remove the endoscope and accessories from the detergent basin 2 Prepare aclean basin of clean potable tap water 3 Completely immerse the endoscope and accessories in a basin filled with clean water for rinsing 4 Attach the Working Channel Cleaning Adaptor to the Working Channel by twisting it onto the Working Channel For more information refer to Section 1 3 2 Connecting the Working Channel Cleaning Adaptor 5 Attach the cleaning adaptor to the Air Water and Suction openings For more information refer to Section 1 3 1 Connecting the Air Water Cleaning Adaptor 1 Fill a syringe with clean water and connect the syringe to the Air Water opening in the Cleaning Adaptor 2 Block the Air Water inlets on the Main Connector side with a gloved finger and slowly flush a minimum of 90ml of clean water through the Air Water Channels 3 Unblock the Air Water inlets on the Main Connector side and slowly flush a minimum of 90ml of clean water through the Air Water Channels 1 Fill a syringe with water and connect the syringe to the Suction opening in the Cleaning Adaptor Fuse 1G Gastroscope Reprocessing Manu
19. al 33 Reprocessing Steps Block the suction inlet on the Main Connector side with a gloved finger and block the Working Channel Using a syringe slowly flush a minimum of 90ml of water through the Suction Channel Unblock the suction inlet on the Main Connector and block the Working Channel outlet on the Distal Tip Using a syringe slowly flush a minimum of 90ml of water through the Suction Channel Attach the Working Channel Cleaning Adaptor to the Working Channel by twisting it onto the Working Channel For more information refer to Section 1 3 2 Connecting the Working Channel Cleaning Adaptor Block the suction inlet on the Main Connector and the Suction opening in the cleaning adaptor using the screw cap provided with the Air Water Cleaning Adaptor Using a syringe slowly flush a minimum of 90ml of water through the Working Channel 1 2 1 amp 2 3 amp 4 5 6 amp 7 Connect the Auxiliary Water Supply Port Cleaning Adaptor to the Auxiliary Water Supply Port Connect a syringe filled with water to the Auxiliary Water Supply Port Cleaning Adaptor and slowly flush 90ml of clean fresh water through the Auxiliary Water Channel tt Ato ALGAS LLA ALLAJ 8 ac gt 34 JENDCCHOICE FSE 057 EN 3 0 Reprocessing Steps 2 5 5 Flush the Air Water and Suction Valves with water 1 Using a syringe slowly flush a minimum of 90ml of water through the Suction Valve a MN a 2 Using a syringe slowly flush a min
20. alve disassembled Soaking Cap Air Water Cleaning Adaptor e Working Channel Cleaning Adaptor Equipment needed for this step Personal protective equipment Sterile gloves Sterile clean lint free cloth Sterile single use e Using a sterile lint free cloth wipe and dry all external surfaces of the endoscope accessories and cleaning equipment e The endoscope should be stored in a vertical position in a dry clean well ventilated cabinet The distal end of the endoscope should be hanging freely while the Insertion Tube is positioned in a vertically straight manner For more details refer to CHAPTER 3 Storage and Disposal 52 MENDCCHOICE FSE 057 EN 3 0 Reprocessing Steps This page intentionally left blank Fuse 1G Gastroscope Reprocessing Manual 53 Reprocessing Steps 2 9 Processing Steps Summary Chart The following chart summarizes the reprocessing steps this table should be used for reference only Wipe down the inserted Aspirate detergent Flush the air and water Flush the Auxiliary Disconnect system and section of the water and air channels Water Supply Channel transfer endoscope endoscope Connect the Leak Dry leak test Wet leak test Tester Fuse 1G Gastroscope Reprocessing Manual 55 Reprocessing Steps STEP 3 MANUAL CLEANING Aspirate Move the endoscope Clean the Brush the Brush the Suction Brush the Suction detergent and air and accessories to external surfaces Air Water and Channel in the C
21. ately after use according to local regulations and manufacturer s instructions The adequate time and temperature parameters for cleaning are critical therefore temperature should be monitored and contact time should be measured per manufacturer recommendations The use of a time and thermometer should be considered Cleaning of ancillary equipment such as the Air Water Valve and Suction Valve should also include active brushing failure to actively brush ancillary equipment could lead to cross contamination or cause an infection control risk Clean only one endoscope at a time as cleaning multiple endoscopes can reduce the detergent effectiveness and cause an infection control risk CAUTION Insert the cleaning brush only from the Control Handle toward the Distal Tip do not attempt to insert the brush in the Distal End This can damage the brush and potentially cause the brush to break inside the endoscope When inserting the Channel Opening Cleaning Brush into the Suction Port do not forcibly insert the brush When brushing make sure not to scratch the seals on the Air Water and Suction Valves Ancillary equipment and endoscope accessories refer to the following the Air Water Valve and Suction Valve Fuse 1G Gastroscope Reprocessing Manual 25 Reprocessing Steps The table below lists the components to be reprocessed and corresponding equipment and materials to be used during manual cleaning Reproces
22. block the Air Water inlets on the Main Connector side and slowly flush a minimum of 90ml of sterile water through the Air Water Channels Fill a syringe with sterile water and connect the syringe to the Suction opening in the Air Water Cleaning Adaptor Block the suction inlet on the Main Connector side with a gloved finger and block the Working Channel using a syringe slowly flush a minimum of 90ml of sterile water through the Suction Channel Unblock the suction inlet on the Main Connector and block the Working Channel outlet on the Distal Tip Using a syringe slowly flush a minimum of 90ml of sterile water through the Suction Channel Attach the Working Channel Cleaning Adaptor to the Working Channel by twisting it onto the Working Channel For more information refer to Section 1 3 2 Connecting the Working Channel Cleaning Adaptor Block the suction inlet on the Main Connector and the Suction opening in the cleaning adaptor using the screw cap provided with the Air Water Cleaning Adaptor Using a syringe slowly flush a minimum of 90ml of sterile water through the Working Channel 1 amp 2 3 amp 4 5 6 amp 7 Fuse 1G Gastroscope Reprocessing Manual 45 Reprocessing Steps 2 7 5 Flush the Auxiliary Water Channels with water 1 Connect the Auxiliary Water Supply Port Cleaning Adaptor to the Auxiliary Water Supply Port 2 Connect a syringe filled with sterile water to the Auxiliary Water Supply Port Cleaning Adaptor a
23. carefully pull the brush back through the channel 2 Brush the Suction opening using the channel opening cleaning brush and detergent solution 3 Insert the 2 8mm cleaning brush into the Suction Channel opening and feed the brush through the Working Channel until it reaches the Distal Tip carefully pull the brush back through the channel Continue until no debris is visible on the brush 4 Brush the Suction opening using the channel opening cleaning brush and detergent solution 5 Repeat steps 1 through 4 a minimum of five times 1 Insert the 3 8mm cleaning brush into the Working Channel and feed the brush through the Suction Channel until it emerges from the Distal Tip of the endoscope carefully pull the brush back through the channel Continue until no debris is visible on the brush 2 Brush the Working Channel using the channel opening cleaning brush and detergent solution 3 Repeat steps 1 and 2 a minimum of five times 28 DENDCCHOICE FSE 057 EN 3 0 Reprocessing Steps a A Fr LL ee a E a a U Sn 0 ae raw TEE E AAF gt pa fr i rearAi a Ya vu Ten A A mT irhnrhH L ah f wi ia l iw I ed I i B l E f l LOLOT U p zu DM m B w E ri aww 4 I Ey SA u RS d GA a i II WUE ww ed IDIOHDANIG En amp pt a u mh ri _ ww 5 Ze 8 hof r i g f D Q un ia dh In PN Man f da m va fia AR A em VAT dh a Wr i am u A met AAlILIFIA m 2 4 0 FIUSN ine AIr Walter L
24. ccccccssseeceeeeeeeeeeeeeeeeeeeeeeeeeeeseeeeeeeesaeees 19 22 SIEPT el 52101 86 ee 20 2 2 1 Wipe down the inserted section of the ENdOSCOPE seeeeeeeeeeees 21 2 2 2 Aspirate detergent water and air uussssssssnennssennnnnnnnnnnnnnnnnnne nn 21 2 2 3 Flush the air and water channels 4444444444nnn nennen nnnnnnnnnnnnn 21 2 2 4 Flush the Auxiliary Water Supply Channel 44444nn Rennen 22 2 2 5 Disconnect system and transfer endoscope 0cccceeeseeeeeeeeaeeeeees 22 2 3 OTEP 2 Leak FOSUNG esse ae 23 2 3 1 Connecting the Leak Tester cccccccccscssseeeeeceeecseeeeeeeeeeessaaaeeeeeeess 24 232 Diy Leak TOT ene ee eee ee eee eee eee ee eee ee eee eee eee eee 24 Fuse 1G Gastroscope Reprocessing Manual iii Contents IV 2 4 2 5 2 6 2 ENDCCHOICE 2 3 3 STEP 3 2 4 1 2 4 2 2 4 3 2 4 4 2 4 5 2 4 6 2 4 2 4 8 2 4 9 2 4 10 2 4 11 2 4 12 2 4 13 STEP 4 2 5 1 2 5 2 2 5 3 2 5 4 2 5 9 2 5 6 2 5 2 5 8 2 5 9 2 9 10 2 5 11 2 9 12 STEP 5 2 6 1 2 6 2 2 6 3 2 6 4 2 6 5 2 6 6 STEP 6 2 1 1 Wet TES I SU ee ne seien se ee een een 24 Manual Cleaning cccccsssccccccesseececceeseeececeeeeeeeessaaeeeeesseaeeeesseeaeeeeseaas 25 Aspirate detergent and air through the Working Channel 26 Place the endoscope and accessories in detergent solution 27 Clean the external surfaces
25. closed in order to protect the equipment from environmental contaminants and accidental contact Limit access to stored equipment to authorized personnel only Do not store the endoscope in a carrying case as it does not provide proper storage conditions and can lead to an infection control risk Do not store a contaminated endoscope in its carrying case as this can lead to an infection control risk Prior to storage uncap the auxiliary water port to facilitate drying Some national and professional guidelines recommend reprocessing endoscopes prior to their first use every day Confirm that the endoscope and accessories have undergone proper reprocessing following their last use and that they have been properly stored Between uses after reprocessing the endoscope and its reusable accessories the reprocessed equipment should be kept separate from any contaminated equipment in order to avoid contamination either to the user and or operators The endoscope should be stored in a vertical position in a dry clean well ventilated cabinet e Detach all valves and caps from the endoscope e Confirm that the surfaces of the endoscope especially around and inside the channel inlets and the Distal Tip and Bending Section are completely dry e Hang the endoscope in the storage cabinet with the distal end hanging freely ensuring the Insertion Tube hangs vertically and as straight as possible in order to prevent damage minimize contact
26. ding of the following items e Routine practices and additional safety guidelines of the facility e Appropriate use of personal protective equipment e Occupational health and safety regulations related to reprocessing e Reprocessing procedures and internal structure of flexible endoscopes and its accessories e Safe handling and proper disposal of chemicals used in reprocessing Appropriate selection of cleaning and disinfecting methods must be taken into consideration with the applicable policies at your facility applicable national laws and standards and professional society guidelines This Fuse 1G Gastroscope was not reprocessed before shipment Before first time use reprocess the device according to the reprocessing manual After use reprocess and store it according to the storage instructions provided in this manual Improper and or incomplete reprocessing or storage can result in contamination equipment damage or a reduction in performance Fuse 1G Gastroscope Reprocessing Manual 5 Safety Information Please Read Prior to Use This page intentionally left blank 6 ENDCCHOICE FSE 057 EN 3 0 Reprocessing the Endoscope and Accessories These instructions were validated for reprocessing the endoscope and the endoscope accessories These reprocessing instructions have been validated by EndoChoice as being able to prepare the device for safe and effective re use Reprocessing in any AER requires validation
27. e parts attached to the endoscope s interfaces Suction Valve Air Water Valve and Biopsy Valve Soak the Air Water and Suction Valves in detergent solution Discard or reuse the Biopsy Valve per its manufacturer instruction for use Ensure that the Soaking Cap is dry attach the Soaking Cap onto the Video Socket Video Input Socket by placing the notches on the Video Socket Video Input Socket in the holes on the Soaking Cap and twisting the Soaking Cap to align the red dots Immediately transport the endoscope and valves in a covered container to the reprocessing area 22 QENDCCHOICE FSE 057 EN 3 0 A Reprocessing Steps The leak test detects physical breaks in the exterior or interior of the endoscope Physical breaks compromise the integrity of the endoscope and expose the internal structures i e electronics manipulation cables etc of the endoscope to damage during reprocessing as these internal components are not meant to be in contact with fluids WARNING If a leak is detected in the Fuse 1G do not use the device Remove the endoscope from service and contact EndoChoice immediately CAUTION Do not disconnect the Soaking Cap while the device is submerged in water as this may result in endoscope damage Do not place the gauge hand pump of the Leak Tester in liquid Be sure to fully rotate the Leak Tester connector onto the Leak Tester port If the connector is not fully attached a leak test cannot be
28. e the suction by pressing the Suction Valve down for a minimum of 30 seconds 2 2 3 Flush the air and water channels 1 Immerse the Distal Tip in clean water 2 Turn the pump to its highest setting 3 Activate the air flow by covering the hole on the Air Water Valve for 30 seconds Visually verify air emits from both Air and Water nozzles if any of the nozzles appear blocked contact EndoChoice 4 Activate the water flow by depressing the Air Water Valve for 30 seconds Fuse 1G Gastroscope Reprocessing Manual 21 Reprocessing Steps 2 2 4 Flush the Auxiliary Water Supply Channel 1 2 Open the Auxiliary Water Port Cap Connect the Auxiliary Water Supply Port Cleaning Adaptor to the Auxiliary Water Supply Port Connect a syringe filled with a detergent solution to the Auxiliary Water Supply Port Cleaning Adaptor and slowly flush 30ml of the detergent solution through the Auxiliary Water Channel Connect a syringe filled with water to the Auxiliary Water Supply Port Cleaning Adaptor and slowly flush the water through the Auxiliary Water Channel Repeat this process a minimum of 3 times Connect a syringe filled with air to the Auxiliary Water Supply Port Cleaning Adaptor and slowly flush air through the Auxiliary Water Channel Repeat this step until a steady stream of air with no water exits the channel 2 2 5 Disconnect system and transfer endoscope 6 Turn the FuseBox Processor off Remove all detachabl
29. ees 60 Fuse 1G Gastroscope Reprocessing Manual V Contents This page intentionally left blank vi QUENDCCHOICE FSE 057 EN 3 0 Safety Information Please Read Prior to Use This reprocessing manual provides information required to enable you to reprocess the Fuse 1G Gastroscope Read this manual thoroughly before using the device and ensure you understand the proper use and care of the device If you have any questions or comments regarding the use of the device please contact EndoChoice Inc Note that the complete instruction manual set for this endoscope also includes the companion Fuse 1G Gastroscope with FuseBox Processor User Manual For illustration purposes the Fuse 1C Colonoscope is pictured throughout this manual Keep this reprocessing manual in a safe and accessible location The following conventions are used in this manual Symbol Description A warning is a statement that alerts indicates a potentially hazardous situation associated with A WARN NG the use or misuse of the device which if not avoided could result in serious injury or death A caution is a statement that alerts indicates a potentially hazardous situation associated with CAUTION its use or misuse which may if not avoided result in minor or moderate injury It may also be used to alert against unsafe practices or potential equipment damage An informational note provides additional information of intere
30. efore reprocessing Do not reprocess if any abnormality or defect is found Prior to each procedure confirm that the endoscope has undergone proper cleaning and disinfection and if in doubt reprocess again according to the instructions provided in this manual Every channel of the endoscope must go through every reprocessing step and must be reprocessed each time the endoscope is used even if the channel was not utilized during the procedure Failure to do so may result in patient cross contamination and or infection To receive the latest list of Automated Endoscope Reprocessors AERs in which the Fuse 1G system has been validated for disinfection please contact your local EndoChoice representative The Fuse 1G system has not been validated to be used with ultrasonic cleaners Do not reprocess the device in any ultrasonic cleaner as this may result in cross contamination or damage to the device Do not steam sterilize the endoscope steam sterilization will severely damage the endoscope The product and ancillary equipment must be inspected before each use for deformed parts or tips Do not use the endoscope or ancillary equipment if any irregularity is suspected If a problem is observed or suspected contact your EndoChoice representative Patient debris and reprocessing chemicals are hazardous Wear personal protective equipment to guard against dangerous chemicals and potentially infectious materials During cleaning and d
31. er flushing of all channels Failure to attach the adaptor may result in improper reprocessing The Air Water Cleaning Adaptor is used to allow access to the Air Water and suction ports on the Control Handle 1 Disassemble the Air Water and Suction Valves from the Control Handle 2 Open the Air Water Cleaning Adaptor lever 3 12 QQENDCCHOICE FSE 057 EN 3 0 Reprocessing the Endoscope and Accessories 4 Secure the Air Water Cleaning Adaptor on the Control Handle by closing the lever The Air Water Cleaning Adaptor has a Luer interface to allow connection to Luer Lock syringes during reprocessing steps To use the Luer port perform the following 5 Unscrew the two cap screws located on the Air Water Cleaning Adaptor AN ON 6 Connect the syringe to the Luer connector Fa 301 N Fuse 1G Gastroscope Reprocessing Manual 13 Reprocessing the Endoscope and Accessories 7 Replace the cap screws on the Air Water Cleaning Adaptor after use of the syringe j N 8 To remove the Air Water Cleaning Adaptor from the Control Body open the lever on the Air Water Cleaning Adaptor g nu LAT I a i E s A i H m uh ear an Aw Tee AZ miyu na aa A aia m au Bu Aa f WE nm m au a A A Alm nen a 4 J 4 d qi ya Ya a y gel Aa Wath q D A Fd ala i al A a ry a y Cd lt A r a i y Ava A K l g np D P a su S iis E _ I wien ww bre i a y f U y aad E
32. ew cap provided with the Air Water Cleaning Adaptor Using a syringe slowly flush a minimum of 90ml of air through the Working Channel 1 amp 2 3 amp 4 5 6 amp 7 36 NDENDCCHOICE FSE 057 EN 3 0 Reprocessing Steps 1 Connect the Auxiliary Water Supply Port Cleaning Adaptor to the Auxiliary Water Supply Port 2 Connect a syringe filled with air to the Auxiliary Water Supply Port Cleaning Adaptor and slowly flush 90ml of air through the Auxiliary Water Channel a mu m gt ST AA g aaa i a 1 Using a syringe slowly flush a minimum of 90ml of air through the Suction Valve E 8 a uululunluu lila 2 Using a syringe slowly flush a minimum of 90ml of air through the Air Water Valve _ SE a 5 Rath 1 Remove all cleaning adaptors 2 Using aclean lint free cloth thoroughly wipe down all external surfaces of the endoscope and accessories 3 Visually inspect the endoscope for any residual debris Pay particular attention to the Insertion Tube Bending Section and Distal Tip If there is any debris remaining on the endoscope repeat all instructions in Section 2 4 STEP 3 Manual Cleaning Fuse 1G Gastroscope Reprocessing Manual 3 Reprocessing Steps As cleaning alone is not adequate the Fuse 1G Gastroscope must also be high level disinfected before each procedure WARNING Ensure appropriate personal protection equipment is worn while working with high level disinfectant HLD solutions F
33. hannel in the in Working detergent solution Suction Valves Umbilical Tube section Insertion Tube Section Channel Flush the Air Water Flush the Flush the Auxiliary Flush the Air Water Wipe down the Soak in Channels with Suction Working Water Channel with and Suction Valves external surfaces of Detergent Detergent Solution Channels with Detergent Solution with Detergent the endoscope Solution Detergent Solution Solution STEP 4 RINSING AFTER MANUAL CLEANING Move the endoscope Flush the Air Water Flush the Flush the Auxiliary Flush the Air Water and accessories from Channels with water Suction Working Water Channels and Suction Valves detergent to clean Channels with water with water with water water Remove from water Flush the Air Water Flush the Flush the Auxiliary Flush the Wipe down the Channels with air Suction Working Water Channels with Air Water and external surfaces Channels with air air Suction Valves with air 56 MQENDOCCHOICE FSE 057 EN 3 0 Reprocessing Steps Move the endoscope Flush the Air Water Flush the Flush the Auxiliary Flush the Soak in and accessories to Channels with Suction Working Water Supply Channel Air Water and disinfectant disinfectant solution Channels with with disinfectant Suction Valves solution disinfectant solution solution with disinfectant solution disinfectant solution STEP 6 FINAL RINSING Flush all Channels and accessories with air Remove form Wipe down external Flush all Channels and
34. he Working Channel Using a syringe slowly flush a minimum of 90ml of disinfectant solution through the Suction Channel 3 Unblock the suction inlet on the Main Connector and block the Working Channel outlet on the Distal Tip 4 Using a syringe slowly flush a minimum of 90ml of disinfectant solution through the Suction Channel 5 Attach the Working Channel Cleaning Adaptor to the Working Channel by twisting it onto the Working Channel For more information refer to Section 1 3 1 Connecting the Air Water Cleaning Adaptor 6 Block the suction inlet on the Main Connector and the Suction opening in the cleaning adaptor using the screw cap provided with the Air Water Cleaning Adaptor 7 Using a syringe slowly flush a minimum of 90ml of disinfectant solution through the Working Channel 1 amp 2 3 amp 4 5 6 amp 7 1 Connect the Auxiliary Water Supply Port Cleaning Adaptor to the Auxiliary Water Supply Port 40 ENDCCHOICE FSE 057 EN 3 0 Reprocessing Steps 2 Connect a syringe filled with a HLD solution to the Auxiliary Water Supply Port Cleaning Adaptor and slowly flush 90ml of the HLD solution through the Auxiliary Water Channel a a mu mn mul di LA g ad a pa a 1 Using a syringe slowly flush a minimum of 90ml of disinfectant solution through the Suction Valve o n 2 fF m 5 uuluuluuluu ls 2 Using a syringe slowly flush a minimum of 90ml of disinfectant solution through the Air Water Valve
35. he syringe to the Air Water opening in the Air Water Cleaning Adaptor 2 Block the Air Water inlets on the Main Connector side with a gloved finger and slowly flush a minimum of 90ml of air through the Air Water Channels 3 Unblock the Air Water inlets on the Main Connector side and slowly flush a minimum of 90ml of air through the Air Water Channels 1 Fill a syringe with air and connect the syringe to the Suction opening in the Air Water Cleaning Adaptor 2 Block the suction inlet on the Main Connector side with a gloved finger and block the Working Channel using a syringe slowly flush a minimum of 90ml of air through the Suction Channel 3 Unblock the suction inlet on the Main Connector and block the Working Channel outlet on the Distal Tip 4 Using a syringe slowly flush a minimum of 90ml of air through the Suction Channel 5 Attach the Working Channel Cleaning Adaptor to the Working Channel by twisting it onto the Working Channel For more information refer to Section 1 3 2 Connecting the Working Channel Cleaning Adaptor 6 Block the suction inlet on the Main Connector and the Suction opening in the cleaning adaptor using the screw cap provided with the Air Water Cleaning Adaptor 7 Using a syringe slowly flush a minimum of 90ml of air through the Working Channel e Using a syringe slowly flush a minimum of 90ml of air through the Auxiliary Water Channel Fuse 1G Gastroscope Reprocessing Manual 43 Reprocessing Step
36. ight container Alcohol stored in an open container is a fire hazard and will result in a loss of efficacy due to evaporation e Disposable accessories Do not attempt to reprocess and reuse disposable accessories After use discard according to the manufacturer instructions and per all applicable national and local laws and guidelines CAUTION m Before each procedure inspect the endoscope and accessories for damage according to instructions described in the Fuse 1G Gastroscope with FuseBox Processor User Manual 4 ENDCCHOICE FSE 057 EN 3 0 Safety Information Please Read Prior to Use The endoscope is made of plastic materials Take special care not to scratch puncture the endoscope with any sharp edge components such as endoscopy tools as this can result in equipment damage and leaks Pay particular attention to avoid damaging the Bending Section Do not immerse the endoscope with any objects that are not used for reprocessing the endoscope as this can damage the endoscope Do not apply lubricants to the Air Water Channel cleaning adapter as this may result in a malfunction Flush the Air Water Channels during the Pre Cleaning stage to reduce the possibility of Air Water nozzles blockage Improper reprocessing may result in contamination It is strongly recommended that all individuals involved in the reprocessing of the device comply with all instructions given in this manual and have a comprehensive understan
37. imum of 90ml of water through the Air Water Valve ee S Sans u a 2 5 6 Remove the endoscope and accessories from the water 2 5 7 Discard the rinse water 2 5 8 Flush the Air Water Channels with air 1 Fill a syringe with air and connect the syringe to the Air Water opening in the Cleaning Adaptor 2 Block the Air Water inlets on the Main Connector side with a gloved finger and slowly flush a minimum of 90ml of air through the Air Water Channels 3 Unblock the Air Water inlets on the Main Connector side and slowly flush a minimum of 90ml of air through the Air Water Channels Fuse 1G Gastroscope Reprocessing Manual 35 Reprocessing Steps 1 Fill a syringe with air and connect the syringe to the Suction opening in the Cleaning Adaptor Block the suction inlet on the Main Connector side with a gloved finger and block the Working Channel using a syringe slowly flush a minimum of 90ml of air through the Suction Channel Unblock the suction inlet on the Main Connector and block the Working Channel outlet on the Distal Tip Using a syringe slowly flush a minimum of 90ml of air through the Suction Channel Attach the Working Channel Cleaning Adaptor to the Working Channel by twisting it onto the Working Channel For more information refer to Section 1 3 2 Connecting the Working Channel Cleaning Adaptor Block the suction inlet on the Main Connector and the Suction opening in the cleaning adaptor using the scr
38. inimum of 90ml of air through the Suction Channel Unblock the suction inlet on the Main Connector and block the Working Channel outlet on the Distal Tip Using a syringe slowly flush a minimum of 90ml of air through the Suction Channel Attach the Working Channel Cleaning Adaptor to the Working Channel by twisting it onto the Working Channel For more information refer to Section 1 3 2 Connecting the Working Channel Cleaning Adaptor Block the suction inlet on the Main Connector and the Suction opening in the cleaning adaptor using the screw cap provided with the Air Water Cleaning Adaptor Fuse 1G Gastroscope Reprocessing Manual 47 Reprocessing Steps 7 Using a syringe slowly flush a minimum of 90ml of air through the Working Channel 1 amp 2 3 amp 4 5 6 amp 7 2 7 11 Flush the Auxiliary Water Channels with air 1 Connect the Auxiliary Water Supply Port Cleaning Adaptor to the Auxiliary Water Supply Port 2 Connect a syringe filled with air to the Auxiliary Water Supply Port Cleaning Adaptor and slowly flush 90ml of air through the Auxiliary Water Channel m a HERE BEE gt a a 2 7 12 Flush the Air Water and Suction Valves with air 1 Using a syringe slowly flush a minimum of 90ml of air through the Suction Valve a Mm 1 2 Using a syringe slowly flush a minimum of 90ml of air through the Air Water Valve er tg M 48 ENDCCHOICE FSE 057 EN 3 0 Reprocessing Steps Fill a syringe with a
39. isinfection wear appropriate personal protective equipment such as eyewear facemask moisture resistant clothing and long sleeve chemical resistant gloves Always remove contaminated personal protective equipment before leaving the reprocessing area and ensure the reprocessing room is adequately ventilated and lighted Thoroughly rinse off the disinfectant solution Rinse the external surface of the endoscope all channels and the cleaning equipment thoroughly with water to remove any disinfectant solution residuals Avoid the use of metallic brushes scrub pads or other articles that may damage the instrument Chemicals such as organic or ammoniated acids or solvents that are likely to damage the instrument must not be used Fuse 1G Gastroscope Reprocessing Manual 3 Safety Information Please Read Prior to Use e When reprocessing the endoscope confirm that the water resistance cap is securely attached to the endoscope before immersion in fluids Failure to follow this instruction may result in damage to the equipment e Be sure to perform a leak test on the endoscope prior to reprocessing and do not use the endoscope if a leak has been detected Use of an endoscope with a leak may result in product malfunction e Establish an internal method of identifying and separating contaminated versus reprocessed endoscopes and accessories Pay particular attention to avoid exposing reprocessed endoscopes and or accessories with contami
40. lcohol and connect the syringe to the Air Water opening in the cleaning adaptor Block the Air Water inlets on the Main Connector side with a gloved finger and slowly flush a minimum of 90ml of alcohol through the Air Water Channels Visually ensure that the fluids are flushing out from both nozzles located in the distal head Unblock the Air Water inlets on the Main Connector side and slowly flush a minimum of 90ml of alcohol through the Air Water Channels Fill a syringe with alcohol and connect the syringe to the Suction opening in the cleaning adaptor Block the suction inlet on the Main Connector side with a gloved finger and block the Working Channel using a syringe slowly flush a minimum of 90ml of alcohol through the Suction Channel Unblock the suction inlet on the Main Connector and block the Working Channel outlet on the Distal Tip Using a syringe slowly flush a minimum of 90ml of alcohol through the Suction Channel Attach the Working Channel Cleaning Adaptor to the Working Channel by twisting it onto the Working Channel For more information refer to Section 1 3 2 Connecting the Working Channel Cleaning Adaptor Block the suction inlet on the Main Connector and the Suction opening in the cleaning adaptor using the screw cap provided with the Air Water Cleaning Adaptor Fuse 1G Gastroscope Reprocessing Manual 49 Reprocessing Steps 7 Using a syringe slowly flush a minimum of 90ml of alcohol through the Wo
41. le the endoscope is still pressurized Observe the Leak Tester dial closely for a minimum of 30 seconds while angulating the Bending Section Verify that the pressure does not drop Check the Insertion Tube the Distal Bending Section and the Umbilical Tube to confirm there is no continuous stream of air bubbles emerging which would indicate a leak in the endoscope Remove the endoscope from the basin 24 JENDCCHOICE FSE 057 EN 3 0 Reprocessing Steps Manual cleaning refers to the physical removal of organic material and soil WARNING Read all warnings thoroughly Failure to observe the following warnings may cause device damage and or result in patient or user cross contamination infection or injury The scope must remain immersed during the cleaning process to prevent splashing of contaminated fluid especially when brushes are being pulled out Brush channels thoroughly Inadequate brushing of the channels may pose an infection control risk to a subsequent patient and or operator Use of excessive force may damage or deform the single use brushes during cleaning During and after use ensure that the brush integrity has not been compromised Should part of the brush come off inside the scope immediately retrieve it and confirm removal If in doubt immediately call EndoChoice for service and do not use the device as the brush part my cause patient infection or injury Do not attempt to reuse single use brushes Discard immedi
42. nannels wiin aetergent solution 1 Attach the cleaning adaptor to the Air Water and Suction openings For more information refer to Section 1 3 1 Connecting the Air Water Cleaning Adaptor 2 Fill a syringe with the detergent solution and connect the syringe to the Air Water opening in the cleaning adaptor 3 Block the Air Water inlets on the Main Connector side with a gloved finger and slowly flush a minimum of 90ml of detergent solution through the Air Water Channels 4 Unblock the Air Water inlets on the Main Connector side and slowly flush a minimum of 90ml of detergent solution through the Air Water Channels Fuse 1G Gastroscope Reprocessing Manual 29 Reprocessing Steps 1 Fill a syringe with the detergent solution and connect the syringe to the Suction opening in the Air Water Cleaning Adaptor 2 Block the suction inlet on the Main Connector side with a gloved finger and block the Working Channel Using a syringe slowly flush a minimum of 90ml of detergent solution through the Suction Channel 3 Unblock the suction inlet on the Main Connector and block the Working Channel outlet on the Distal Tip 4 Using a syringe slowly flush a minimum of 90ml of detergent solution through the Suction Channel 5 Attach the Working Channel Cleaning Adaptor to the Working Channel by twisting it onto the Working Channel For more information refer to Section 1 3 2 Connecting the Working Channel Cleaning Adaptor 6 Block the
43. nated gloves or surfaces Failure to effectively separate reprocessed from contaminated materials may result in patient cross contamination or infection e When using the product on a patient with CJD Creutzfeldt Jakob disease or vCJD variant Creutzfeldt Jakob disease be sure to use this product only once for such patient and immediately dispose of the product after use in an appropriate manner For methods to handle CJD please follow the respective guidelines in your country e This instrument does not have sufficient durability against the methods stated in the guidelines of each country for destroying or inactivating prions For information on the durability against each method please contact EndoChoice e The endoscope s auxiliary buttons cannot be removed from the control section Pressing pulling or twisting them with excessive force can break the buttons and or cause water leaks e Ifthe endoscope is not cleaned meticulously effective high level disinfection may not be possible Clean the endoscope and accessories thoroughly before high level disinfection to remove microorganisms or organic material that could reduce the efficacy of disinfection e EndoChoice only confirms validation of the endoscope reprocessing procedure described in this manual Use of other reprocessing procedures or AERs has not been validated and their use may fail to result in effective cleaning and high level disinfection e Store alcohol in an air t
44. nd slowly flush 90ml of sterile water through the Auxiliary Water Channel Toe uU u U u a 8 a goa i 2 7 6 Flush the Air Water and Suction Valves with water 1 Using a syringe slowly flush a minimum of 90ml of sterile water through the Biopsy Valve a while 2 Using a syringe slowly flush a minimum of 90ml of sterile water through the Air Water Valve roy MAN ne 2 7 7 Remove the endoscope and accessories from sterile water 1 Remove all cleaning adaptors 2 Remove the endoscope and accessories from the sterile water basin 2 8 Wipe down external surfaces 1 Using a sterile clean lint free cloth thoroughly wipe all external surfaces of the endoscope 2 Connect the Air Water Suction and Working Channel Cleaning Adaptors 46 JENDCCHOICE FSE 057 EN 3 0 Reprocessing Steps Fill a syringe with air and connect the syringe to the Air Water opening in the Air Water Cleaning Adaptor Block the Air Water inlets on the Main Connector side with a gloved finger and slowly flush a minimum of 90ml of air through the Air Water Channels Unblock the Air Water inlets on the Main Connector side and slowly flush a minimum of 90ml of air through the Air Water Channels Fill a syringe with air and connect the syringe to the Suction opening in the cleaning adaptor Block the suction inlet on the Main Connector side with a gloved finger and block the Working Channel Using a syringe slowly flush a m
45. ndations Do not use solutions beyond their expiration date Test disinfectant MEC Minimal Effective Concentration routinely Alcohol is not a sterilant or high level disinfectant DO NOT REUSE ALCOHOL Fuse 1G Gastroscope Reprocessing Manual 17 Reprocessing the Endoscope and Accessories This page intentionally left blank 18 JENDCCHOICE FSE 057 EN 3 0 Reprocessing Steps CHAPTER 2 Reprocessing Steps 2 1 Reprocessing Steps Flow Chart Withdraw of colonoscope Fuse 1G Gastroscope Reprocessing Manual 19 Reprocessing Steps The initial steps in the cleaning process begin immediately after the patient procedure at the point of use as this step must be done while the scope is connected to FuseBox Processor and the system is still connected to the water bottle and suction source N WARNING e After use immediately discard the Biopsy Valve according to local regulations as it is a single use accessory For a reusable Biopsy Valve discard or reuse the valve according to local regulations and according to the manufacturer s instructions for use Not following this instruction could result in cross contamination between patients Immediate flushing of the channels prevents drying of organic and inorganic debris on lumen surfaces and may remove large numbers of microorganisms The table below lists the Fuse 1G components and required equipment materials for Pre Cleaning Reprocessing Step 1 P
46. nennen nenn 5 CHAPTER 1 Reprocessing the Endoscope and ACCESSOTIECS ececescscscecsecsces 7 1 1 Limitations ON Reprocessing u 2 uuus04ennenennnnnennne nennen nennen nennen nnnnnnnnennnn nennen 7 1 2 Reprocessing Accessorfies uuunsessennnennennnnnnnnnnnnnnnnnnnennnnnnnnnnnnnnnnnnnnnnnnennnennennnn 8 1 2 1 BAKIN EI nee ae ee ee eee eee ee eee 8 1 2 2 Air Water Cleaning Adaptor ccccseeeececceseeeeeeeeeeeeeeeeeeeeeeeseeeeeeeeeas 9 1 2 3 Working Channel Cleaning Adaptor cccccccsseeeceeeeeseseeeeeeeeeeaeeeees 9 1 2 4 Auxiliary Water Supply Port Cleaning Adaptor cc ccceceeeeeeeees 10 1 29 AIG OS LOU ee Se ee ee ee 10 1 2 6 _ Single use Channel Cleaning Brush cccccceccsseeceeeeeseeeeesaeeeeees 11 1 2 7 Single use Channel Opening Cleaning Brush en 11 1 3 Connecting Reprocessing Adaptors cccccccccccccssseseeeeeeseseeeeeeeeeeeessaaaeeeeeeess 12 150 1 Connecting the Air Water Cleaning Adaptor ccccccceeesesseeeeeeees 12 1 3 2 Connecting the Working Channel Cleaning Adaptor 14 1 3 3 Connecting the Auxiliary Water Supply Port Cleaning Adaptor 15 1 4 Required Equipment and MaterialS cccccccssssecceeceeseeeeeeeeeeeeeeseeeseeeesaaeseees 16 CHAPTER 2 Reprocessing Steps cccscscscscscscsccccccccccscscscscccecsceccscscscsceses 19 2 1 Reprocessing Steps Flow Chart cc
47. ng Cap is used to seal the Video Socket Video Input Socket on e Visually confirm that the Soaking Cap is dry the endoscope during leak testing and and free of debris reprocessing steps The Soaking Cap is e Visually confirm that the O Ring seals are attached to the Main Connector video intact interface CAUTION m fthe Main Connector external surface is damaged it may no longer be waterproof and leak can occur damaging the electronics in subsequent use if the connector is damaged do not use the endoscope and immediately contact EndoChoice see Support on page 1 8 QENDCCHOICE FSE 057 EN 3 0 n i _ _ _ fed gt _ 1 _ Fx Fax PRE N A A erate i eal ji Te AqanTot ae a ra LF as A Bl v A A CA ny LY u a ro ga a er Cl Functionality The Air Water Cleaning Adaptor is used to allow direct flushing of the Air Water Channels of the endoscope For more details refer to Section 1 3 1Connecting the Air Water Cleaning Adaptor rT Functionality The Working Channel Cleaning Adaptor is used for adaptation of the syringe to the Working Channel also known as the Biopsy Port of the endoscope allowing direct flushing of the Working Channel For more details refer to Section 1 3 2 Connecting the Working Channel Cleaning Adaptor Reprocessing the Endoscope and Accessories Inspection e Visually confirm that the Air Water Cleaning Adaptor is dry and free
48. nual cleaning is performed to ensure no detergent residuals remain in the endoscope following the manual cleaning step WARNING e Residual detergent from Step 3 Manual Cleaning must be thoroughly removed by rinsing The enzymatic detergent used for manual cleaning is a protein solution and therefore if rinsing is not adequate residual protein will remain on the endoscope and accessories Failure to thoroughly rinse the residual detergent may lead to the detergent protein being fixed on the device surface during high level disinfection The fixed protein may protect underlying bacteria from exposure to the disinfectant leading to a cross contamination or infection risk e Replace rinsing water after each individual rinse as rinsing may not be effective if residual detergents are present Adequate removal of detergent is achieved only when a sufficient amount of rinsing with fresh clean water is performed e The Auxiliary Water Channel must be reprocessed even when the channel was not used during the procedure Failure to perform this step may result in infection control risk The table below lists the components to be reprocessed and corresponding equipment and materials to be used during rinsing steps after manual cleaning Reprocessing Step 4 Rinsing after Manual Cleaning Location Reprocessing Room Fuse 1G Components for e Fuse 1G Reprocessing Step 4 Air Water Valve dissembled Suction Valve dissembled So
49. of debris e Visually confirm that the two O Ring seals are intact e _ Confirm that both Luer caps are in place Inspection e Visually confirm that the Working Channel Cleaning Adaptor is dry and free of debris e Visually inspect that the adaptor is not scratched or deformed Fuse 1G Gastroscope Reprocessing Manual 9 Reprocessing the Endoscope and Accessories amp F a uA p a a ay F E a IR ni A _ u IAS a Lan A aa in Re ek Arl a wes wea A al a be P j aX GB ay Lay F aTrK w 1 EN V LJ ArT iA A TTA IA N NRANaAaAATR KF f ran LA E w Yi ww i DERE DED LY ei wp Wien BE Orol as 1 T AN a GAG w Gh Y a va dl tw GA EU LA CAR EI s y ed 7 a us fi Functionality Inspection The Auxiliary Water Supply Port Cleaning Adaptor is used for adaptation of the syringe to the Auxiliary Water e Visually confirm that the Auxiliary Supply Port of the endoscope allowing Water Supply Port Cleaning Adaptor direct flushing of the Auxiliary Water is dry and free of debris Channels e Visually inspect that the adaptor is not For more details refer to Section 1 3 3 scratched or deformed Connecting the Working Channel Cleaning Adaptor Functionality Inspection The Leak Tester is used to test the endoscope for sealing integrity The Leak Tester is connected to the endoscope Main Connector For more details refer to step 2 Leak Test e Visually confirm
50. performed A slight one time drop in pressure may be observed during leak testing and does not indicate there is a leak A leak will be observed as pressure drops over time The table below lists the Fuse 1G components and required equipment and materials for leak testing Reprocessing Step 2 Leak Testing Location Reprocessing Room Fuse 1G Components for e Fuse 1G Reprocessing Step 2 e Soaking Cap Equipment needed for this step Specified Brand Model Type Leak Tester EndoChoice Basin 40x40x15 cm 16 x 16 x 6 Clean water Clean potable water 22 30 C Fuse 1G Gastroscope Reprocessing Manual 23 Reprocessing Steps 1 2 ri kore te An Ensure the Soaking Cap is firmly attached to the Video Socket Video Input Socket Visually confirm that both the Leak Tester and the Leak Tester ports are dry Connect the Leak Tester to the endoscope by sliding the notch on the Auxiliary Water Supply Port into the opening on the Leak Tester port Twist the connector clockwise to securely close the connection amp ENDCCHOIcCE 260 ie 0 00 y 17 aniio aahi Observe the Leak Tester dial closely for a minimum of 30 seconds while angulating the Bending Section Verify that the pressure does not drop This indicates that there are no leaks and that a wet water leak test can be performed next Prepare a basin with clean water Completely submerge the endoscope in water whi
51. re Cleaning Location Procedure Room Fuse 1G Components for Fuse 1G Reprocessing Step 1 Air Water Valve assembled Suction Valve assembled Equipment needed for this step Specified Brand Model Type Personal protective equipment 30ml syringe x3 Clean Lint free cloth Use acloth or sponge like Koala by EndoChoice 500 ml container x2 Transportation container or Container 40 cm X 40 cm x 15 cm 16 x 16 x 6 Pad CinchPad by EndoChoice transportation pad 500ml Clean water Clean potable water 22 30 C 500m Detergent solution Use an enzymatic detergent like Pure by EndoChoice which is indicated for use with flexible endoscopes Video processor FuseBox Soaking Cap EndoChoice Perform the following steps immediately after the procedure at the point of use 20 QENDCCHOICE FSE 057 EN 3 0 Reprocessing Steps 2 2 1 Wipe down the inserted section of the endoscope 1 Thoroughly wipe the Insertion Tube Bending Section and Distal Tip with a clean soft lint free cloth soaked in detergent 2 2 2 Aspirate detergent water and air 2 Immerse the Distal Tip in a container with detergent solution and activate the suction by pressing the Suction Valve down for a minimum of 30 seconds 3 Immerse the Distal Tip in a container with clean water and activate the suction by pressing the Suction Valve down for a minimum of 30 seconds 4 Remove the Distal Tip from the water 5 Activat
52. rking Channel 1 amp 2 3 amp 4 5 6 amp 7 2 7 15 Flush the Auxiliary Water Channels with alcohol 1 Connect the Auxiliary Water Supply Port Cleaning Adaptor to the Auxiliary Water Supply Port 2 Connect a syringe filled with alcohol to the Auxiliary Water Supply Port Cleaning Adaptor and slowly flush 90ml of the alcohol through the Auxiliary Water Channel a EEE BEE EEE ei u a t 2 7 16 Flush the Air Water and Suction Valves with alcohol 1 Using a syringe slowly flush a minimum of 90ml of alcohol through the Suction Valve a islstl 2 Using a syringe slowly flush a minimum of 90ml of alcohol through the Air Water Valve 2 8 o M E Wa 50 DENDCCHOICE FSE 057 EN 3 0 Reprocessing Steps 2 7 17 Wipe down external surfaces with alcohol e Using a clean sterile lint free cloth soaked in alcohol thoroughly wipe all external surfaces of the endoscope Fuse 1G Gastroscope Reprocessing Manual 51 Reprocessing Steps N WARNING e This stage of drying the device demands the use of a STERILE lint free cloth to ensure minimum contamination Failure to follow this instruction may result in user contamination The table below lists the components to be reprocessed and corresponding equipment and materials to be used during drying Reprocessing Step 7 Drying Location Reprocessing Room Fuse 1G Air Water Valve disassembled Fuse 1G Components for Reprocessing Step 7 Suction V
53. rs recommendations including personal protection to be used dilution temperature immersion duration storage date of expiration disposal etc Ethanol should be stored in closed container to avoid evaporation Containers sinks and basins should be large enough so the endoscope is not damaged by being coiled too tightly Minimum recommended basin dimension is 40 cm X 40 cm x 15 cm 16 x 16 x 6 The basin should have a tight fitting lid if it is also used for high level disinfection Number of basins required is five 5 Used during Leak Test Water Used during Manual Cleaning Detergent Used during Manual Cleaning Water Used during High level Disinfection Disinfectant 1 Used during Rinsing Sterile Water 1 1 1 1 It is recommended that the endoscope is transported in a closed container or closed transport pad such as the EndoChoice CinchPad to prevent contamination or equipment damage during transport A 40 cm X 40 cm x 15 cm 16 x 16 x 6 container may be used Two 2 500ml containers are needed for aspirating detergent and water in the Pre Cleaning stage Suction pumps such as a Basic 30 Suction Pump by Medela or equivalent is necessary for detergent aspiration during the manual cleaning step Use appropriate tube set Important If the disinfectant solutions are reused routinely check their efficiency with test strips according to the manufacturer recomme
54. s 1 Using a syringe slowly flush a minimum of 90ml of air through the Suction Valve 2 Using a syringe slowly flush a minimum of 90ml of air through the Air Water Valve 1 Fill a clean basin with fresh sterile water CAUTION m A clean basin is required for final rinsing to ensure the endoscope does not get contaminated It is recommended that a dedicated basin is used for this rinsing if possible 1 Remove all the cleaning adaptors 2 Remove the endoscope and accessories from the HLD solution 3 Immerse the endoscope and accessories in the sterile water 4 Attach the Working Channel Cleaning Adaptor to the Working Channel by twisting it onto the Working Channel For more information refer to Section 1 3 2 Connecting the Working Channel Cleaning Adaptor 5 Attach the cleaning adaptor to the Air Water and Suction openings For more information refer to Section 1 3 2 Connecting the Working Channel Cleaning Adaptor Wipe down external surfaces e Using a clean sterile lint free cloth thoroughly wipe all external surfaces of the endoscope while in the basin of water 1 Fill a syringe with sterile water and connect the syringe to the Air Water opening in the Air Water Cleaning Adaptor pon uhud 2 Block the Air Water inlets on the Main Connector side with a gloved finger and slowly flush a minimum of 90ml of sterile water through the Air Water Channels 44 JENDCCHOICE FSE 057 EN 3 0 Reprocessing Steps Un
55. sing Step 3 Manual Cleaning Location Reprocessing Room Fuse 1G Components for e Fuse 1G Reprocessing Step 3 Air Water Valve disassembled Suction Valve disassembled Soaking Cap Air Water Cleaning Adaptor e Working Channel Cleaning Adaptor Equipment needed for this step Clean lint free cloth new Use acloth or sponge like Koala by EndoChoice Detergent solution Use an enzymatic detergent like Pure by EndoChoice which is indicated for use with flexible endoscopes Brush Non metal single use 3 8 mm channel HedgeHog Single End Channel Brush SBS 227 cleaning brush 50 by EndoChoice or HedgeHog Double End Channel Brush SBD 228 50 by EndoChoice Brush Non metal single use channel opening HedgeHog Valve Brush SBB 119 50 by cleaning brush EndoChoice Suction pump Use a suction pump with a tube set that suctions at rates up to 30L min Basin x2 40x40x15 cm Air Water Cleaning Adaptor EndoChoice Working Channel Cleaning Adaptor EndoChoice Soaking Cap EndoChoice Immediately after successfully carrying out the Leak test perform the following steps Prepare the suction pump for operation Fill a basin with detergent solution at the temperature and concentration recommended by the detergent manufacturer Connect the Air Water Cleaning Adaptor Verify that the Luer caps are screwed on Connect the suction pump to the Suction Port on the Main Connector Operate the suction pump Insert the Dis
56. st to the user Outside the United States United States EndoChoice GmbH EndoChoice Inc Otto Hahn Str 11 11810 Wills Rd 25337 Elmshorn Alpharetta GA 30009 Germany USA 49 0 4121 649390 Phone 888 682 ENDO 3636 Phone 49 0 4121 649383 Fax 866 567 8218 Fax Fuse 1G Gastroscope Reprocessing Manual 1 Safety Information Please Read Prior to Use Symbol Description Serial number li O Consult instructions for use Attention see instructions Manufactured by REP European Representative Federal US law restricts this device for sale by or y on the order of a physician SE Non Sterile Catalog Number E gt OTY Number of units N WARNING Read all warnings thoroughly Failure to observe the following warnings may cause device damage and or result in patient or user cross contamination infection or injury e The following manual cleaning and high level disinfection instructions have been validated Failure to follow all steps may result in an infection control risk to patients and or operators e Improper reprocessing may result in patient cross contamination and or infection 2 ENDCCHOICE FSE 057 EN 3 0 Safety Information Please Read Prior to Use The endoscope was not cleaned and high level disinfected before shipping It must be cleaned and high level disinfected prior to first use Always examine the device and confirm that there are no observable abnormalities or defect b
57. tal Tip to the detergent oF Ol a 26 QENDCCHOICE FSE 057 EN 3 0 Reprocessing Steps Using your finger cover the Working Channel for at least 30 seconds to allow aspiration Remove the Distal Tip from detergent Using your finger cover the Working Channel for at least 30 seconds to allow aspiration Completely immerse the endoscope in detergent solution Remove all cleaning adaptors from the endoscope Using a clean lint free cloth thoroughly wipe down all external surfaces of the endoscope Wipe the scope in a circular motion and remove all debris from the exterior Pay particular attention to the Air Water nozzle openings and the objective lenses and ensure that all the surfaces of the distal end are thoroughly cleaned being careful not to scratch them Fuse 1G Gastroscope Reprocessing Manual 2 Reprocessing Steps 1 Immerse the Air Water and Suction Valves in detergent solution 2 Using the single use channel opening cleaning brush clean the valves thoroughly inside and out 3 Brush the Air Water Valve opening using the channel opening cleaning brush and detergent solution 4 Repeat Step 3 a minimum of five times 5 Allow the valves to soak in the detergent solution for as long as recommended by the detergent solution manufacturer 1 Insert the 2 8mm cleaning brush straight into the Suction opening and feed the brush through the Umbilical Tube until it emerges from the Main Connector of the endoscope

FSE-057-EN-3.0 Fuse 1G Gastroscope Reprocessing

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