Olympus EVIS LUCERA JF 260V, Reprocessing Manual

Page 1: ...he endoscope s companion manual the OPERATION MANUAL whose cover lists the model of your endoscope for operation information INSTRUCTIONS EVIS LUCERA DUODENOVIDEOSCOPE OLYMPUS JF TYPE 260V OLYMPUS TJF...

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Page 3: ...insing water 10 2 5 ETO gas sterilization 10 2 6 Steam sterilization autoclaving of accessories 11 Chapter 3 Cleaning Disinfection and Sterilization Procedures 13 3 1 Required reprocessing equipment 1...

Page 4: ...ontents ii EVIS LUCERA JF TJF TYPE 260V REPROCESSING MANUAL Chapter 5 Storage and Disposal 71 5 1 Storage of the endoscope 71 5 2 Storage of reusable parts and reprocessing equipment 72 5 3 Disposal 7...

Page 5: ...LUCERA JF TJF TYPE 260V REPROCESSING MANUAL Symbols The meaning s of the symbol s shown on the back cover of this instruction manual are as follows Manufacturer Authorized representative in the Europ...

Page 6: ...l related manuals in a safe accessible location If you have any questions or comments about any information in this manual or if a problem that cannot be solved occurs while reprocessing contact Olymp...

Page 7: ...nd high level disinfect or sterilize endoscopic equipment after each procedure can compromise patient safety To minimize the risk of transmitting diseases from one patient to another after each proced...

Page 8: ...scope reprocessor Otherwise insufficient cleaning and disinfection or sterilization of the endoscope may pose an infection control risk to the patient and or operators performing the next procedure wi...

Page 9: ...isease CJD cannot be destroyed or inactivated When using this instrument on a patient with CJD or variant Creutzfeldt Jakob disease vCJD be sure to use this product for such patient only and or immedi...

Page 10: ...r the endoscope and damage the equipment 1 5 Reprocessing before the first use and reprocessing and storage after use This instrument was not cleaned disinfected or sterilized before shipment Before u...

Page 11: ...bility summary Olympus endoscopic equipment is compatible with several methods of reprocessing Certain components and accessories however are not compatible with some methods which can cause equipment...

Page 12: ...water valve MH 438 Suction valve MH 443 Biopsy valve MB 358 Channel plug MH 944 Injection tube MH 946 AW channel cleaning adapter MH 948 Suction cleaning adapter MH 856 Mouthpiece MB 142 Washing tube...

Page 13: ...els 2 3 Disinfectant solution In the U S agents used to achieve high level disinfection are defined as liquid chemical germicides registered with the U S Food and Drug Administration as sterilant disi...

Page 14: ...ospital and the instruction manuals of the sterilization equipment Before sterilization the instrument must be thoroughly cleaned and dried Residual moisture inhibits sterilization The results of ster...

Page 15: ...packed or the positioning method of placing and loading of the instrument in the sterilization device Please verify the sterilization effects by using biological or chemical indicators Also follow the...

Page 16: ...LUCERA JF TJF TYPE 260V REPROCESSING MANUAL Exceeding the recommended parameters may cause equipment damage see Table 2 3 Table 2 3 Steam sterilization autoclaving exposure parameters Process Paramet...

Page 17: ...revious patient procedure Otherwise insufficient cleaning and disinfection or sterilization of the endoscope may pose an infection control risk to the patient and or operators performing the next proc...

Page 18: ...detergent and disinfectant solution Personal protective equipment Clean water Large basins for rinsing and leakage testing Clean lint free cloths Sterile water 30 cm3 30 ml syringe Sterile lint free...

Page 19: ...ter resistant cap is attached to the electrical connector on the endoscope to protect the connector from water penetration during reprocessing For leakage testing the venting connector on the water re...

Page 20: ...expel fluids see Figure 3 4 Figure 3 4 Channel cleaning brush BW 20T The channel cleaning brush is used to brush the inside of the instrument and suction channels and the interior and or openings of t...

Page 21: ...external surfaces of the distal end of the endoscope the suction cylinder and the instrument channel port see Figure 3 6 Figure 3 6 Washing tube MH 974 The washing tube is used to inject detergent so...

Page 22: ...of the endoscope through the instrument channel see Figure 3 8 Figure 3 8 AW channel cleaning adapter MH 948 During precleaning the AW channel cleaning adapter is connected to the air water cylinder W...

Page 23: ...m debris see Figure 3 2 on page 15 Wipe with a dry cloth if the inside of the water resistant cap is wet or there is debris 2 Confirm that the seal inside the water resistant cap is free from scratche...

Page 24: ...or loose or missing bristles see Figure 3 5 on page 16 2 Check for bends scratches and other damage to the shaft 3 Check for debris on the shaft and or in the bristles of the brush Inspection of the c...

Page 25: ...leaned and high level disinfected or sterilized during EVERY reprocessing cycle even if the channels were not used during the previous patient procedure Otherwise insufficient cleaning and disinfectio...

Page 26: ...F 2 Prepare a 500 cm3 500 ml container of detergent solution at the temperature and concentration recommended by the detergent manufacturer 3 Prepare clean water in a 500 cm3 500 ml container Wipe dow...

Page 27: ...of the insertion tube in detergent solution Depress the suction valve and aspirate detergent solution into the instrument channel for 30 seconds see Figure 3 10 4 Remove the distal end of the inserti...

Page 28: ...er Lubricants may cause malfunction of the AW channel cleaning adapter 1 Turn the light source ON 2 Switch OFF the airflow regulator on the light source 3 Remove the air water valve from the endoscope...

Page 29: ...leaning adapter to feed water through the channels for 30 seconds Release the adapter to feed air through the channels for 10 seconds or more see Figure 3 12 Figure 3 12 8 Turn the light source OFF Fl...

Page 30: ...endoscope reusable parts and cleaning equipment Do not touch the light guide of the endoscope connector immediately after removing it from the light source because it is extremely hot Operator or pati...

Page 31: ...bending mechanism of the bending section or deform its covering After the distal cover has been removed make sure not to subject the forceps elevator to impact or bend the elevator wire during cleani...

Page 32: ...s possible toward the endoscope see Figure 3 16 4 Turn it counterclockwise until it stops see Figure 3 16 5 Pull the distal cover off the endoscope slowly and straightly see Figure 3 16 Figure 3 16 6...

Page 33: ...l connector is scratched send it immediately to Olympus for repairs Always use a dry water resistant cap Any water remaining on the water resistant cap may cause damage to the endoscope maintenance un...

Page 34: ...endoscope If you locate a leak remove the endoscope from the water and contact Olympus Never connect or disconnect the water resistant cap or the leakage tester s connector cap while immersed Doing s...

Page 35: ...with clean water Use a basin which is at least 40 cm by 40 cm 16 by 16 in size and deep enough to allow the endoscope to be completely immersed 2 Insert the leakage tester connector into the output s...

Page 36: ...er attached 7 Turn the maintenance unit or the light source OFF 8 Disconnect the leakage tester from the maintenance unit or the light source Always disconnect the leakage tester connector from the li...

Page 37: ...ch procedure on page 47 then follow the procedure described below Reusable parts which are normally reprocessed with the endoscope Equipment needed Prepare the following equipment and wear appropriate...

Page 38: ...e endoscope to be completely immersed 2 Fill a basin with clean water Use a basin which is at least 40 cm by 40 cm 16 by 16 in size and deep enough to allow the endoscope to be completely immersed Cle...

Page 39: ...o the instrument channel opening at the distal end of the endoscope then pull it out see Figure 3 20 3 Repeat until all debris is removed 4 Brush along the forceps wire and the groove of the instrumen...

Page 40: ...pter 3 Cleaning Disinfection and Sterilization Procedures EVIS LUCERA JF TJF TYPE 260V REPROCESSING MANUAL Figure 3 21 Figure 3 22 Figure 3 23 Groove Channel opening cleaning brush Guidewire locking g...

Page 41: ...h use Should a part of the brush come off inside the endoscope immediately retrieve it and carefully confirm that no parts remain inside the channel of the endoscope by passing a new cleaning brush or...

Page 42: ...plattering 2 Straighten the endoscope s bending section Grip the channel cleaning brush at a point 3 cm from the bristles 3 Insert the channel cleaning brush at a 45 angle into the opening located in...

Page 43: ...suction cylinder location C When inserting the channel opening cleaning brush into the suction cylinder do not forcibly insert the brush beyond the middle of the brush section Otherwise the brush may...

Page 44: ...nnect the suction tube from the suction pump to the suction connector on the endoscope connector Turn the suction pump ON 3 Immerse both the endoscope s distal end and the weighted end of the suction...

Page 45: ...ise and lower the forceps elevator 3 times 2 With the forceps elevator raised flush the interior of the forceps elevator with detergent solution using the 30 cm3 30 ml syringe see Figure 3 27 Figure 3...

Page 46: ...ly connectors on the endoscope connector see Figures 3 29 and 3 30 5 Attach the injection tube s air pipe port to the air pipe on the endoscope connector see Figures 3 29 and 3 30 6 Attach the injecti...

Page 47: ...Suction channel tube Air pipe port Suction port Basin Detergent solution Connector plug Biopsy valve cap Channel plug Air channel Water channel Air water cylinder Air water nozzle Connector plug Sucti...

Page 48: ...r channel plug see Figure 3 31 Figure 3 31 2 Using the 5 cm3 5 ml syringe inject 15 cm3 15 ml of detergent solution into the elevator wire channel via the washing tube see Figure 3 32 Figure 3 32 3 Di...

Page 49: ...g equipment in clean water and gently agitate them to thoroughly rinse Removing detergent solution from all channels 1 Attach the channel plug and the injection tube to the endoscope Place the suction...

Page 50: ...ee cloth from the distal end and the control section of the endoscope 11 Detach the channel plug and injection tube from the endoscope 12 Disconnect the washing tube from the endoscope Figure 3 33 Dry...

Page 51: ...0 cm 16 by 16 in size and deep enough to allow the endoscope to be completely immersed 2 Carefully coil the endoscope s insertion tube and universal cord and completely immerse the endoscope in the de...

Page 52: ...repare the following equipment and wear appropriate personal protective equipment Preparation 1 Fill a basin with disinfectant solution at the temperature and concentration recommended by the disinfec...

Page 53: ...t solution through the elevator wire channel via the washing tube Confirm that no air bubbles exit the distal end of the endoscope see Figure 3 31 and 3 32 5 While immersed in disinfectant solution ra...

Page 54: ...n tube to the endoscope Attach the channel plug s biopsy valve cap to the instrument channel port 2 Before removing the endoscope from the disinfectant solution connect the washing tube to the elevato...

Page 55: ...idue If sterile water is not available fresh potable tap water or water which has been processed e g filtered to improve its microbiological quality may be used with 70 ethyl or isopropyl alcohol rins...

Page 56: ...ly via the injection tube 6 Connect the washing tube to the elevator channel plug 7 Using the 5 cm3 5 ml syringe flush the elevator wire channel with 15 cm3 15 ml of sterile water via the washing tube...

Page 57: ...ls respectively via the injection tube 6 Remove the suction port of the injection tube from the alcohol Using the 30 cm3 30 ml syringe flush 90 cm3 90 ml of air through the air water and the suction c...

Page 58: ...nt cap is attached the covering of the bending section can be damaged The chain for water resistant cap MAJ 1119 and the water resistant cap itself MH 553 cannot be sterilized by ETO gas and may be da...

Page 59: ...g to the recommended ETO gas exposure parameters described in Section 2 5 ETO gas sterilization and the sterilizer manufacturer s instructions 5 Aerate the components following the minimum aeration pa...

Page 60: ...nt and wear appropriate personal protective equipment Air water valve MH 438 Suction valve MH 443 AW channel cleaning adapter MH 948 Mouthpiece MB 142 Biopsy valve MB 358 Channel opening cleaning brus...

Page 61: ...to be completely immersed 3 Detach the biopsy valve s cap from the main body before immersing in the detergent solution see Figure 3 35 Figure 3 35 4 Immerse all other equipment in the detergent solu...

Page 62: ...centration recommended by the detergent manufacturer 15 Remove all equipment from the detergent solution and inspect it If debris remains on any of the equipment ultrasonically clean it at 33 48 kHz f...

Page 63: ...ecessed parts of them while they are immersed Ensure that all air bubbles are expelled 5 While immersed depress and release the pistons of the valves and AW channel cleaning adapter Ensure that all ai...

Page 64: ...letely immersed 2 Immerse all equipment in the sterile water 3 Gently agitate the equipment to thoroughly rinse them 4 Using the 30 cm3 30 ml syringe flush the interior and recessed parts of all equip...

Page 65: ...recessed parts of all equipment with alcohol to remove all air bubbles 7 While immersed depress and release the pistons of the air water valve suction valve and AW channel cleaning adapter Ensure tha...

Page 66: ...d in Section 3 8 Sterilization Steam sterilization autoclaving After cleaning as described in Manual cleaning on page 57 steam sterilize autoclave the equipment according to the procedures given below...

Page 67: ...zer manufacturer s instructions 3 Following steam sterilization autoclaving let all components gradually cool down to room temperature 4 Store the components following the instructions given in chapte...

Page 68: ...tergent solution 4 Using the 30 cm3 30 ml syringe flush the interior and recessed parts of the distal cover with detergent solution while the distal cover is immersed 5 Using a clean soft brush or lin...

Page 69: ...ng lid to minimize the diffusion of disinfectant vapors Soak the distal cover for the amount of time at the temperature and concentration recommended by the disinfectant manufacturer 6 Remove the dist...

Page 70: ...ge and Disposal Sterilization Steam sterilization autoclaving After cleaning as described in Manual cleaning on page 64 steam sterilize autoclave according to the procedures given below Before taking...

Page 71: ...ing do not place it together with other cleaning equipment accessories etc The distal cover could be deformed and may become difficult to attach or the risk of the distal cover falling off during the...

Page 72: ...ay impair the cleaning and disinfection capabilities of the reprocessor and the endoscope can pose an infection control risk to the patient and or operators who perform the next procedure with it Note...

Page 73: ...formation on connectors When cleaning and disinfecting an endoscope in an endoscope reprocessor use connectors that are compatible with the endoscope model Otherwise insufficient cleaning and disinfec...

Page 74: ...infected by a reprocessor clean and disinfect the elevator wire channel according to procedures described in Chapter 3 Cleaning Disinfection and Sterilization Procedures If using the endoscope reproce...

Page 75: ...e the endoscope or present an infection control risk Do not store the endoscope in the carrying case Use the carrying case only for shipping the endoscope Routinely storing the endoscope in a humid no...

Page 76: ...cessing equipment are dry 2 Store all reusable parts in the storage cabinet Make sure that the parts do not touch each other during storage 3 Store all reprocessing equipment in a container then place...

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