Endoscope
EN-580T
Thank you for purchasing our product. Read this manual carefully before use to avoid unexpected accidents and to take full advantage of the product's capabilities.
English
OPERATION MANUAL
(Preparation and Operation)
Page 1: ...0T Thank you for purchasing our product Read this manual carefully before use to avoid unexpected accidents and to take full advantage of the product s capabilities English OPERATION MANUAL Preparatio...
Page 2: ...e are summarized in Chapter 1 Safety Safety precautions associated with individual operations or procedures are provided separately indicated WARNING or CAUTION 3 Warning Items that must be observed f...
Page 3: ...cal judgment 5 When Using the Endoscope for the First Time This product has not been sterilized When using it for the first time use the level of disinfection or sterilization suitable to the applicat...
Page 4: ...riate measures 10 Use of Personal Protective Equipment Patient s body fluids adhering to endoscopic accessories such as balloons used in combination with this product may splash resulting in infection...
Page 5: ...urce If an appropriate image does not appear even after resetting the processor and light source turn them off straighten the bending portion to unlock release the angle knobs and then withdraw the en...
Page 6: ...Switches for Images and Recording 4 5 4 4 Forceps Valve Forceps Inlet 4 6 Chapter 5 Preparation for Use of Endoscope 5 1 5 1 Preparing Equipment 5 2 5 2 Preparing Forceps Valve and Button 5 4 5 3 Conn...
Page 7: ...leaning Disinfection and Storage Chapter 7 Cleaning 7 1 Chapter 8 Chemical Disinfection 8 1 Chapter 9 Gas Sterilization 9 1 Chapter 10 Storage 10 1 Electrosurgical Instruments Chapter 11 Treatment wit...
Page 8: ...Indicates a potential danger that may cause harm to people WARNING Explains dangerous situations that may cause death or serious injury if not avoided CAUTION Explains situations that may cause injury...
Page 9: ...Chapter 1 Safety This chapter summarizes the information necessary for safe use of this product 1 1...
Page 10: ...the inspection result shows any abnormality do not use the same equipment 3 Combination of equipment The endoscope may be used in combination with peripherals To avoid an electric shock accident use o...
Page 11: ...ly but insert it slowly Do not insert or bend the endoscope without checking the image on the monitor 10 Handling of Endoscope When holding endoscope hold it by the control portion Holding it up by th...
Page 12: ...and Disinfection Sterilization Perform cleaning disinfection and sterilization of the endoscope according to respective guidelines Clean and disinfect the endoscope after understanding the latest gui...
Page 13: ...contains dibutyl phthalate DBP Its amount is so minuscule that it has little effect on patients health Note The URL of Eucomed is as follows http www eucomed be 6 WARNING and CAUTION Messages Appearin...
Page 14: ...ct wall with undue force It may damage mucous membrane Fix the hood securely to the endoscope before use Otherwise the hood may drop 5 9 Connecting Balloon Controller Connect the endoscope and the Ove...
Page 15: ...yes If parts fall into a body cavity due to the malfunction of the device immediately stop the examination and retrieve the parts by following appropriate measures There is a risk of damaging the insi...
Page 16: ...tructions and or non validated AER recommendations could result in unsuccessful cleaning and or disinfection which may increase risks to patient safety Chapter 8 Chemical Disinfection 8 3 Chemical Dis...
Page 17: ...other medical devices patient leakage current may increase 11 1 4 Setting the Conditions of Surgery Operate the instruments within specified output range Leakage current may cause burns 11 2 Polypecto...
Page 18: ...Chapter 1 Safety 1 10...
Page 19: ...Chapter 2 Composition of Set and System Configuration This chapter describes the composition of set and system configuration 2 1 Composition of Set 2 2 2 2 System Configuration 2 4 2 1...
Page 20: ...ope set is provided in a carrying case The set consists of the following items Note Figures in parentheses indicate quantities Carrying Case 1 Forceps Valve FOV DV7 10 Setting Tool ST 01B 1 Tube Kit T...
Page 21: ...Cleaning Adapter CA 503 A 1 Cleaning Brush WB4324FW2 1 Valve Cleaning Brush WB11002FW2 1 Suction Button SB 500 1 Air Water Button AW 500 1 O P E R A T I O N M A N U A L Valve Adapter CA 503S A 1 Tube...
Page 22: ...possible Endoscopic treatment Ultrasonography through forceps channel Printer output Endoscope EN 580T Balloon Controller PB 20 Sonoprobe System Water Tank WT 2 WT 4 Endoscopic CO2 Regulator GW 1 Dat...
Page 23: ...are connected via an S video signal the image may be distorted on the LCD monitor Processor VP 4450HD Foot Switch FS1 Cart Light Source XL 4450 LCD Monitor CDL1576A CDL1909A RADIANCE24 NDS Electrosur...
Page 24: ...2 6 Chapter 2 Composition of Set and System Configuration...
Page 25: ...Chapter 3 Names and Functions of Parts This chapter describes the names and functions of endoscope parts and the composition of the main unit 3 1 Endoscope 3 2 3 2 Symbols 3 4 3 1...
Page 26: ...for operating the endoscope LG flexible portion Consists of the light guide air water supply tube suction tube and cables Balloon air feed inlet Connects a syringe or tube kit to supply air to the bal...
Page 27: ...ideo connector socket of the processor Suction connector Accepts tube from suction unit LG connector This connector connects to the scope socket on the light source Waterproof cap Prevents water from...
Page 28: ...uthorised representative in the European Community LG connector CE marking LG connector Degree of waterproof LG connector Type BF applied part LG connector WEEE marking Note LG connector Phthalates ma...
Page 29: ...the bending mechanism and valves for air water supply and suction etc This chapter describes the operations and functions of these parts 4 1 Operating Bending Mechanism 4 2 4 2 Valve Control Buttons 4...
Page 30: ...e up down locking lever is slanted in the direction opposite to F The bending portion retains the position even when the finger is released from the up down angle knob The bending portion is locked 2...
Page 31: ...g portion is unlocked When the left right locking knob is turned in the direction opposite to F The bending portion retains the position even when the finger is released from the left right angle knob...
Page 32: ...Suction is activated while this button is depressed 6 Air Water button Used to blow air or water onto the surface of objective lens from the nozzle in distal end To supply air stop the hole in the cen...
Page 33: ...he field of view then narrows by the amount of enlargement The image returns to the normal size when the switch is pushed again 9 FR switch This is the remote switch for still image and the capture Th...
Page 34: ...of air It should normally be kept closed Closing this lid increases the backflow preventive effect although it makes the frictional resistance of an endotherapy device larger when it is inserted When...
Page 35: ...sertion Portion 5 10 5 4 2 Inspecting Bending Mechanism 5 11 5 4 3 Inspecting Air Water Supply Channel Suction Channel Forceps Channel and Balloon Air feed Inlet 5 12 5 4 4 Inspecting Distal End 5 14...
Page 36: ...not use the same product Store the endoscope under the storage conditions described in Appendix Use the endoscope under the operating conditions described in Appendix The use of abnormal equipment wil...
Page 37: ...te The water in the water tank should be changed every day using sterile water Note For details on how to use and clean the water tank refer to the operation manual of the water tank Prepare diathermi...
Page 38: ...re a new forceps valve before use The forceps valve has not been sterilized Perform cleaning and disinfection or sterilization before use according to the following procedure Wipe the surface of the p...
Page 39: ...Cleaning Disinfection and Storage Pull out the forceps valve from the disinfectant and rinse it with running water sterile water Wipe off the remaining water on the forceps valve with sterile gauze R...
Page 40: ...valve before attachment If any abnormality is found during inspection do not use the product It could be a source of infection Visually check that the slits a on the lid and circular hole b of the fo...
Page 41: ...Attaching Air Water Button and Suction Button 555555 Attach the air water button and suction button to the control portion of the endoscope 5 7 Chapter 5 Preparation for Use of Endoscope...
Page 42: ...connector of the endoscope into the endoscope socket on the light source Insert the video connector of the endoscope into the video connector socket on the processor Note Place the waterproof cap on...
Page 43: ...ith the suction tube CAUTION Set a suction pressure at 53 kPa or less Endoscope may be adhered to mucous membrane resulting in damage to the mucous membrane Set the suction pressure to 40 to 53 kPa 40...
Page 44: ...both hands and allow it to go over its total length in such a way that the apex of the semicircle with a diameter of about 200 mm gradually begins to slide Check that the portion bends fully and there...
Page 45: ...oothly Check that releasing the knobs unbends the bending portion a little Turn the up down locking lever and left right locking knob in the direction opposite to F and then lock them Turn the angle k...
Page 46: ...the air press the air water button completely Check that water is discharged from the balloon water port Note Note that the direction that water comes out Immerse the distal end of the endoscope in w...
Page 47: ...its expiration date has elapsed Insert an endotherapy device from the forceps inlet and check that the tip of the endotherapy device projects smoothly from the forceps channel of the distal end Note...
Page 48: ...lging The light guides are free from cracks and are securely fixed The air water nozzle is free from cracks and is securely fixed If any dirt or foreign matter adheres to the lens clean it off Note To...
Page 49: ...he forceps Visually check the forceps for breakage or significant bends and for sharp edges on protrusions that may injure the patient Form the spring of the forceps into a double ring approximately 2...
Page 50: ...o not use the setting tools ST 01B and ST 05B for purposes other than mounting the balloon Check that the exterior of the setting tools ST 01B and ST 05B is free from defects such as damage and foldin...
Page 51: ...ers the air feed inlet clear tube of the Over tube If water enters the air feed inlet deflate the balloon using a syringe and then slowly pull out the Over tube along with the endoscope Attaching Over...
Page 52: ...1 or BS 2 applicable to this product Prepare the balloon setting tools ST 01B and ST 05B and fixing rubber ST 01B Fixing rubber setting tool ST 05B Balloon setting tool Note Do not use the balloon aft...
Page 53: ...to the outside of the setting tool ST 05B Put the balloon on the setting tool ST 05B Insert the distal end of the endoscope into the setting tool ST 05B and form the balloon so as not to be twisted 5...
Page 54: ...al form Note Make the ethanol inside the balloon evaporate by widening the end of the balloon Note Handle the setting tool ST 05B without applying an excessive force to it Extract the air in the ballo...
Page 55: ...a hood attach a hood by following the procedure described in 5 7 3 Attaching Hood 5 7 3 Attaching Hood When a hood is not used Slide the fixing rubber to the end of the balloon as in step 9 Note Care...
Page 56: ...grasp the bending portion forcefully when attaching or removing the hood It may damage the endoscope Attach the balloon by following steps 1 to 9 in 5 7 2 Mounting Endoscope Balloon Attach a hood DH 1...
Page 57: ...Make sure the hood is fixed correctly 5 23 Chapter 5 Preparation for Use of Endoscope...
Page 58: ...on attached to the distal end of Over tube inflates Remove air from the air feed inlet of the Over tube to make sure that the balloon deflates Immerse the distal end of the endoscope into water and by...
Page 59: ...0 Connecting Balloon Controller 555555 Install the balloon controller referring to the operation manual of the balloon controller Connect the tube kit as follows Balloon controller Applicable tube Tub...
Page 60: ...roller is connected to the air feed inlet of the Over tube Press the endoscope side switch on the balloon controller and then make sure that the balloon attached to the distal end of endoscope inflate...
Page 61: ...ansanal Insertion 6 10 6 3 Biopsy 6 15 6 4 Withdrawal 6 18 6 4 1 Removing Hood Only When Used 6 19 6 4 2 Removing Balloon 6 20 6 4 3 Removing Over tube 6 20 6 5 Pre cleaning Primary Cleaning 6 21 6 5...
Page 62: ...gestive tract wall Do not supply an excessive amount of air or gas during electrosurgery It could cause an embolism Note Always observe the patient closely If the patient has symptoms suggestive of an...
Page 63: ...66 Preparing Necessary Equipment 666666 Prepare the accessories endotherapy devices etc to be used Pre treatment of Patient 666666 Use pretreatment that suits the purpose of examination 6 3 Chapter 6...
Page 64: ...te If any resistance is felt stop use immediately When using this product check the status of the balloon Over tube and endoscope by fluoroscopy Note If water enters the air feed inlet of the Over tub...
Page 65: ...nual is only an example Regarding clinical procedures use proper clinical judgment Peroral Insertion 666666 Instruct the patient to take an appropriate position for the insertion procedure Have the pa...
Page 66: ...witch on the power to the processor and turn on the lamp Deflate the balloon on the distal end of endoscope and the balloon on the Over tube Apply clean lubricant Xylocaine jelly or the like to the in...
Page 67: ...balloon on the distal end of the endoscope Note There is a thick line indicator on the insertion portion of the endoscope When the Over tube is inserted into the body or the endoscope is pulled out f...
Page 68: ...tabilize it within the body cavity Remove air to deflate the balloon on the Over tube Advance the Over tube over the endoscope to a point close to the balloon on the distal end of the endoscope Feed a...
Page 69: ...ck mucus insert the distal end of the endoscope in the mucous lake and press the suction button Note Do not suck in solid or viscous materials with the endoscope Such material may clog the suction pip...
Page 70: ...an insert the endoscope by locking the bending portion only in the left right direction and unlocking it in the up down direction Switch on the power to the processor and turn on the lamp Remove air f...
Page 71: ...and stabilize it within the enteric canal Insert the Over tube into the body cavity along the endoscope to a point close to the balloon on the distal end of the endoscope Note There is a thick line i...
Page 72: ...e distal end of the endoscope Insert the endoscope Feed air to inflate the balloon on the distal end of the endoscope and stabilize it within the body cavity Remove air to deflate the balloon on the O...
Page 73: ...pply air to the digestive tract The mucous membrane of the digestive tract will become clearly visible Steer the distal end of the endoscope to the region of interest by turning the up down and left r...
Page 74: ...press the suction button If the surface of the lens is fogged with mucus or if the image is obscured Clean the lens surface by pressing the air water button After completing the cleaning remove water...
Page 75: ...splattered around due to breakage or accidental detachment of the forceps valve leading to infection Do not strongly press an endotherapy device against the digestive tract wall There is a risk of pe...
Page 76: ...ceps straight into the forceps inlet while observing the image Stop the insertion of the forceps when its tip appears on the field of view Slowly move the forceps to the site Perform a biopsy by contr...
Page 77: ...Slowly pull the forceps straight out of the forceps valve and take out the biopsy specimen 6 17 Chapter 6 Method of Use...
Page 78: ...the up down and left right knobs Unbend the bending portion until it is almost straight by operating the angle knobs Deflate the balloon and then slowly withdraw the Over tube along with the endoscop...
Page 79: ...e care not to apply excessive force to the endoscope It may damage the endoscope Remove the hood from the endoscope after withdrawal Remove the fixing rubber securing the hood Slowly remove the hood f...
Page 80: ...lippery to be held cover the balloon with gauze for easier removal Note Dispose of the removed balloon Note Make sure to remove the balloon before cleaning the endoscope Removing Over tube 666666 Remo...
Page 81: ...uze or a paper towel Purging Air Water Supply Channel 666666 Remove mucosal fluids blood etc from the air water supply channel of the endoscope in accordance with the following procedure Note When CA...
Page 82: ...f endoscope in accordance with the following procedure Immerse the distal end of endoscope in cleaning fluid and depress suction button to suck cleaning fluid for 10 seconds Keeping suction button dep...
Page 83: ...pe in clean water Turn OFF the air supply pump of the light source Remove the air water button AW 500 from the endoscope and then immerse it in cleaning fluid Attach the cleaning adapter CA 511N to th...
Page 84: ...ompletely discharged Removing Endoscope from Processor 666666 CAUTION Do not touch the LG connector tip until it cools down approximately 5 minutes Touching the LG connector with hands immediately aft...
Page 85: ...could be a source of infection Detach the forceps valve from the endoscope Discard the detached forceps valve Protecting Video Connector from Water 666666 If the video connector is used with water rem...
Page 86: ...endoscope to the room where the secondary cleaning manual cleaning is performed Place the endoscope in a transport container so as not to hit it against other objects or to splatter residual fluids in...
Page 87: ...Appendix Main Specifications Appendix 2 Troubleshooting Appendix 8 After Sales Service Appendix 12 Disposal of Electric and Electronic Equipment Appendix 13 Index Appendix 14 Appendix 1...
Page 88: ...pecifications Model EN 580T Optical system Viewing direction Field of view Observation range mm Method of illumination Image size Distal end diameter mm Flexible portion diameter mm Forceps channel di...
Page 89: ...te after beginning of use if proper maintenance and inspection are performed Based on our company s criteria Note Except for consumable supplies Applicable Processor and Light Source Processor VP 4450...
Page 90: ...n consumable supplies during inspection before use replace them with new ones Applicable Optional Supplies Name Model Air Water supply channel cleaning adapter Air leak tester CA 511N LT 7 LT 7F Image...
Page 91: ...internal function Therefore its RF emissions are very low and are not likely to cause any interference in nearby electric equipment Radiated emissions CISPR 11 Class A This product is intended for use...
Page 92: ...Same as left Main power quality should be that of a typical commercial or hospital Voltage dips short interruptions and voltage variations on power supply input lines EN 61000 4 11 11 5V 218 5V dip F...
Page 93: ...m This product complies with the requirements of EN 60601 1 2 2007 However electromagnetic interference may occur on this product under electromagnetic environment that exceeds its noise level Electro...
Page 94: ...n of light source 7 Release the timer by pressing the FR switch of endoscope Note If the image still appears dark even after performing 4 to 7 slowly pull out the endoscope and clean the distal end Hi...
Page 95: ...to restore image output The endoscope is working all right 2 Connect properly 3 4 Reset the processor and the light source If the image is not recovered turn the processor and the light source off an...
Page 96: ...being inserted due to bending 4 Non applicable endotherapy device is used 1 Close the endotherapy device for insertion 2 Loosen the grip to insert the endotherapy device 3 Return the bending portion s...
Page 97: ...ed inlet 5 The balloon or fixing rubber is attached improperly and air is leaking from the balloon 6 The balloon has been perforated 1 Replace the endoscope with a spare one 2 Replace the tube kit wit...
Page 98: ...iod of the Over tube and balloon is from the date of purchase to the expiration date of the product For the warranty period of the balloon controller refer to the operation manual of the balloon contr...
Page 99: ...or the recycling of electrical and electronic equipment By ensuring this product is disposed of correctly you will help prevent potential negative consequences to the environment and human health whic...
Page 100: ...ptacle 5 2 I Insertion portion 3 3 L Left right angle knob 4 3 Left right locking knob 4 3 LG connector 3 3 LG flexible portion 3 2 Lid 4 6 Lock 4 2 4 3 M Maintenance 1 3 MM switch 4 5 Monitor 2 5 Mou...
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Page 102: ...0305 1 0 DT E2 Printed in Japan European Authorized Representative FUJIFILM Europe GmbH Heesenstrasse 31 40549 Duesseldorf Germany FUJIFILM Corporation 26 30 Nishiazabu 2 chome Minato ku Tokyo 106 862...
