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FujiFilm EN-580T Operation Manual
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FujiFilm EN-580T Operation Manual

FujiFilm EN-580T Operation Manual

Endoscope
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English
Endoscope
EN-580T
OPERATION MANUAL
(Preparation and Operation)
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.

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Summary of Contents for FujiFilm EN-580T

  • Page 1 English Endoscope EN-580T OPERATION MANUAL (Preparation and Operation) 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.

  • Page 2: Important Safety Information

    Important Safety Information Important Safety Information 1. Intended Use This product is a medical endoscope intended for observation, diagnosis and endoscopic treatment of the esophagus, stomach, duodenum, small intestine and large intestine in medical facilities under management of physicians. Do not use this product for any other purpose.
  • Page 3 Important Safety Information 4. Clinical Procedures This manual assumes that the product will be used by medical specialists who have received proper training in endoscopic procedures. When performing observation, diagnosis and endoscopic treatment of small intestine, refer to general contraindications to upper gastrointestinal tract endoscopy and colonoscopy. In addition, if the general condition of the patient is extremely critical, or if there are any risks involved in performing the endoscopic examination of ileus, gastrointestinal perforation, respiratory disease, cardiovascular disease, Crohn's disease, acquired...
  • Page 4 Important Safety Information 9. Latex Allergy WARNING Do not use Over-tubes and balloons on patients allergic to latex. There is a risk of an anaphylactic reaction/shock. This product is used with a product that contains natural rubber as a material. Natural rubber may rarely cause allergy symptoms, such as itching, reddening, hives, swelling, fever, dyspnea, asthma-like symptoms, drop of blood pressure and shock.
  • Page 5 Important Safety Information 12. Loss of Function During an examination, if the endoscopic image disappears, a live image is not displayed after freeze mode has been cancelled, or the endoscopic image is discolored, reset the processor and light source. During treatment, if the endoscopic image disappears, a live image is not displayed after freeze mode has been cancelled, or the endoscopic image is discolored, stop treatment immediately, remove the endotherapy device from the endoscope, and then reset the processor and light source.

  • Page 6: Table Of Contents

    Contents Contents (Preparation and Operation) Important Safety Information ..................2 Preface .........................8 Conventions Used in This Manual ................8 Chapter 1 Safety ....................1-1 Chapter 2 Composition of Set and System Configuration ........2-1 2.1 Composition of Set ..............2-2 2.2 System Configuration ..............2-4 Chapter 3 Names and Functions of Parts .............
  • Page 7 Contents Appendix .....................Appendix-1 Main Specifications ..............Appendix-2 Troubleshooting ..............Appendix-8 After-Sales Service ...............Appendix-12 Disposal of Electric and Electronic Equipment....Appendix-13 Index ..................Appendix-14 (Cleaning, Disinfection and Storage) Chapter 7 Cleaning ....................7-1 Chapter 8 Chemical Disinfection ................. 8-1 Chapter 9 Gas Sterilization .................. 9-1 Chapter 10 Storage ....................

  • Page 8: Preface

    Preface Preface This manual describes how to use endoscope EN-580T. For how to use the peripherals used in combination with this product, refer to the respective operation manuals. Conventions Used in This Manual This manual uses the following conventions for easier understanding.

  • Page 9: Chapter 1 Safety

    Chapter 1 Safety This chapter summarizes the information necessary for safe use of this product.
  • Page 10 Chapter 1 Safety Chapter 1 Safety 1. Precautions in Using Endoscope 1) Applicable processor and light source This product is used in combination with processor VP-4450HD and light source XL-4450. 2) Preparation and inspection before use Prior to using this product, prepare a spare one to avoid unexpected accidents such as equipment failure.
  • Page 11 Chapter 1 Safety 7) Abnormality in use If any abnormality is found during its use, perform safety checks and immediately stop using this product. 8) Maintenance The equipment will wear out and degrade after repeated use for a long period. In particular, resin and rubber parts wear out over time or due to the chemicals used.
  • Page 12 Chapter 1 Safety 12) Electromagnetic interference This equipment has been tested and found to comply with the limits for medical devices defined in EN 60601-1-2:2007. These limits are designed to provide reasonable protection against harmful interference in a typical medical installation. However, it is possible that it may cause harmful interference to other devices in the vicinity, if it is installed and used in accordance with the instructions.
  • Page 13 There is a risk of being a source of infection. 4. Repair or Inspection Contact your local FUJIFILM dealer when this product is returned for repair or inspection. In addition, be sure to clean and disinfect (or sterilize) this product before returning for repair or inspection.
  • Page 14 Chapter 1 Safety 5.3 Connecting Endoscope Do not touch the LG connector tip until it cools down (approximately 5 minutes). Touching the LG connector with hands immediately after use of the endoscope may cause a burn injury. Set a suction pressure at 53 kPa or less. Endoscope may be adhered to mucous membrane, resulting in damage to the mucous membrane.
  • Page 15 Chapter 1 Safety 6.2 Insertion and Observation Do not bend the endoscope quickly. There is a risk of damaging the inside of the body cavity. Do not inflate the balloon in the pharynx or esophagus. There is a risk of suffocation. Insert and withdraw the endoscope or Over-tube slowly.
  • Page 16 Chapter 1 Safety 6.5.6 Detaching Forceps Valve Discard the forceps valve after use. It could be a source of infection. Chapter 7 Cleaning 7.4 Manual Cleaning (Cleaning in Sink) In case the cleaning brush is damaged during a cleaning process, remove any residue from inside the tube.
  • Page 17 Chapter 1 Safety Chapter 11 Treatment with Electrosurgical Instruments 11.1 Preparing and Inspecting Equipment and Materials Always keep pacemaker users away from electrosurgical instruments. The operation of the pacemaker will be malfunctioned by the electrosurgical instruments. Replace any flammable gas in body cavities with non-flammable gas before using the electrosurgical instruments.
  • Page 18 Chapter 1 Safety 1-10...

  • Page 19: Chapter 2 Composition Of Set And System Configuration

    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...

  • Page 20: Composition Of Set

    Chapter 2 Composition of Set and System Configuration Chapter 2 Composition of Set and System Configuration Composition of Set The endoscope set is provided in a carrying case. The set consists of the following items. [Note] Figures in parentheses indicate quantities. Tube Kit Carrying Case (1) TY-06S (1)
  • Page 21 WB4324FW2 (1) Suction Button SB-500 (1) Air / Water Button AW-500 (1) Valve Cleaning Brush WB11002FW2 (1) Endoscope EN-580T Ventilation Adapter Waterproof Cap (1) AD-7 (1) Syringe (1) Tank Receiving Cap (1) Tube for Air/ Water Supply Channel (1) Valve Set (1)

  • Page 22: System Configuration

    Extension makes the following possible. • Endoscopic treatment • Ultrasonography through forceps channel • Printer output Water Tank WT-2 WT-4 Sonoprobe System Endoscope EN-580T Endoscopic CO Regulator GW-1 Air Leak Tester LT-7 Forceps/Endotherapy Device Data Keyboard Balloon DK-4450E BS-1 BS-2...
  • Page 23 Chapter 2 Composition of Set and System Configuration [Note] For details on the connections of peripherals other than those listed here, contact your local FUJIFILM dealer. [Note] When using a high-frequency power supply, connect CDL1904A and VP-4450HD via a DVI signal. If they are connected via an S-video signal, the image may be distorted on the LCD monitor.
  • Page 24 Chapter 2 Composition of Set and System Configuration...

  • Page 25: Chapter 3 Names And Functions Of Parts

    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...

  • Page 26: Endoscope

    Chapter 3 Names and Functions of Parts Chapter 3 Names and Functions of Parts Endoscope The endoscope consists of the following parts. Control portion Provides a grip for holding the endoscope, and also contains parts for operating the endoscope. LG flexible portion Consists of the light guide, air/water supply tube, suction tube and cables.
  • Page 27 Chapter 3 Names and Functions of Parts Enlarged view of distal end Light guide Balloon air feed outlet * Insertion portion (applied part) This portion is inserted into body cavities Objective lens and consists of the distal end, bending Air/water nozzle portion and flexible portion.
  • Page 28 Chapter 3 Names and Functions of Parts Symbols Symbol Location Description LG connector Serial number LG connector Date of manufacture This manual Manufacturer Authorised representative in the This manual European Community LG connector CE marking LG connector Degree of waterproof LG connector Type BF applied part [Note]...
  • Page 29 Chapter 4 Control Portion The control portion contains the angle knobs for operating 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 ..........4-4 4.3 Switches for Images and Recording ......4-5 4.4 Forceps Valve/Forceps Inlet .........4-6...

  • Page 30: Operating Bending Mechanism

    Chapter 4 Control Portion Chapter 4 Control Portion Operating Bending Mechanism Up-down angle knob Used to bend the bending portion upward and downward. <When the up-down locking lever is slanted toward F > Turn the up-down angle knob in the direction of U bend the bending portion upward.
  • Page 31 Chapter 4 Control Portion Left-right angle knob Used to bend the bending portion right or left. <When the left-right locking knob is turned forward F > Turn the left-right angle knob in the direction of L to bend the bending portion to the left. Turn it in the direction of R to bend the bending portion to the right.

  • Page 32: Valve Control Buttons

    Chapter 4 Control Portion Valve Control Buttons Suction button Allows suction through forceps channel (port) in distal end. Suction is activated while this button is depressed. 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 center of this button with a finger.

  • Page 33: Switches For Images And Recording

    Chapter 4 Control Portion Switches for Images and Recording RC switch This is the switch that starts and stops VCR recording. Pushing it once starts the recording. Pushing it again stops the recording. MM switch This switch electronically enlarges the image. The image is enlarged to 1.5x when this switch is pushed.

  • Page 34: Forceps Valve/Forceps Inlet

    Chapter 4 Control Portion Forceps Valve/Forceps Inlet The forceps valve consists of a valve body and a lid. It performs the function of preventing the leak or flowback of air. By opening and closing this valve, you can change the frictional resistance of an endotherapy device by two levels as it is being inserted.

  • Page 35: Chapter 5 Preparation For Use Of Endoscope

    Chapter 5 Preparation for Use of Endoscope This chapter describes the system necessary for endoscopy. 5.1 Preparing Equipment ............5-2 5.2 Preparing Forceps Valve and Button......5-4 5.2.1 Method of Cleaning, Disinfecting and Sterilizing Forceps Valve ........5-4 5.2.2 Attaching Forceps Valve ........5-6 5.2.3 Attaching Air/Water Button and Suction Button...........5-7 5.3 Connecting Endoscope ..........5-8...

  • Page 36: Preparing Equipment

    Chapter 5 Preparation for Use of Endoscope Chapter 5 Preparation for Use of Endoscope WARNING Insert the AC plug into a hospital grade receptacle. When carrying or connecting the endoscope, take care to keep it clean. Not doing so may cause an electric shock. CAUTION If an inspection result shows any abnormality, do not use the same product.
  • Page 37 Chapter 5 Preparation for Use of Endoscope (3) Mount the collection bottle for liquid on the suction unit. (4) Mount the water tank, 80% filled with water, on the processor. [Note] The water in the water tank should be changed every day using sterile water.

  • Page 38: Preparing Forceps Valve And Button

    Chapter 5 Preparation for Use of Endoscope Preparing Forceps Valve and Button For operational methods of the ultrasonic cleaning unit/autoclaving unit, follow the instructions described in each operation manual for the respective units. [Note] Do not use the forceps valve after its expiration date has elapsed. 5.2.1 Method of Cleaning, Disinfecting and Sterilizing Forceps Valve The forceps valve is a single-use product.
  • Page 39 Chapter 5 Preparation for Use of Endoscope <Autoclave sterilization> (1) Seal the forceps valve in a sterile pack. Recommended steam sterilization (autoclaving) conditions Sterilization temperature (ºC) Operation time Carry out an autoclaving operation in accordance with the Max 20 minutes Min 15 minutes operation manual of the autoclaving unit.

  • Page 40: Attaching Forceps Valve

    Chapter 5 Preparation for Use of Endoscope 5.2.2 Attaching Forceps Valve WARNING Ensure that an appropriately reprocessed forceps valve is properly attached to the forceps inlet. If not attached, body fluid may flow back and it could be a source of infection.

  • Page 41: Attaching Air/Water Button And Suction Button

    Chapter 5 Preparation for Use of Endoscope 5.2.3 Attaching Air/Water Button and Suction Button (1) Attach the air/water button and suction button to the control portion of the endoscope.

  • Page 42: Connecting Endoscope

    Chapter 5 Preparation for Use of Endoscope Connecting Endoscope CAUTION Do not touch the LG connector tip until it cools down (approximately 5 minutes). Touching the LG connector with hands immediately after use of the endoscope may cause a burn injury. (1) Insert the LG connector of the endoscope into the endoscope socket on the light source.
  • Page 43 Chapter 5 Preparation for Use of Endoscope (5) Connect the suction unit and suction connector of the endoscope with 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.

  • Page 44: Inspecting Endoscope

    Chapter 5 Preparation for Use of Endoscope Inspecting Endoscope 5.4.1 Inspecting Insertion Portion (1) Visually check the insertion portion (distal end, bending portion and flexible portion) for abnormalities such as flaws or dents and for sharp edges or protrusions that may injure the patient.

  • Page 45: Inspecting Bending Mechanism

    Chapter 5 Preparation for Use of Endoscope 5.4.2 Inspecting Bending Mechanism (1) Unlock the up-down locking lever and left-right locking knob by turning them in the direction of F (2) Turn the up-down angle knob and left-right angle knob in the U, D, L and R directions until they stop.

  • Page 46: Inspecting Air/Water Supply Channel

    Chapter 5 Preparation for Use of Endoscope 5.4.3 Inspecting Air/Water Supply Channel, Suction Channel, Forceps Channel and Balloon Air feed Inlet (1) Turn on the power of the suction unit, cart and processor. Keep the lamp off. Prepare a cup of sterile water. (3) With the distal end of the endoscope held in the air, press the air/water button completely.
  • Page 47 Chapter 5 Preparation for Use of Endoscope (5) While immersing the distal end of the endoscope in water, check that the water is sucked in when the suction button is pressed and the suction stops when the finger is released from the button.

  • Page 48: Inspecting Distal End

    Chapter 5 Preparation for Use of Endoscope 5.4.4 Inspecting Distal End CAUTION Turn off the light before inspecting the lens. Viewing the light of light guide directly may damage your eyes. (1) Turn OFF the lamp. Look at the distal end of the endoscope at an angle and check that the objective lens and light guide are free of dirt or foreign matter.

  • Page 49: Inspecting Forceps

    Chapter 5 Preparation for Use of Endoscope Inspecting Forceps CAUTION Do not bend forceps with a curvature radius of 10 mm or less. Bending forceps with a small curvature may break it. (1) Inspect the operation of the forceps. Visually check the forceps for breakage or significant bends, and for sharp edges on protrusions that may injure the patient.

  • Page 50: Inspecting Setting Tools St-01B And St-05B

    Chapter 5 Preparation for Use of Endoscope Inspecting Setting Tools ST-01B and ST-05B Do 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 folding. 5-16...

  • Page 51: Attaching And Inspecting Over-Tube And Balloon

    Chapter 5 Preparation for Use of Endoscope Attaching and Inspecting Over-tube and Balloon WARNING Use a sterilized balloon installation tool. Do not use the balloon or Over-tube after its expiration date has elapsed. There is a risk of infection. Do not use Over-tubes and balloons on patients allergic to latex. There is a risk of an anaphylactic reaction/shock.
  • Page 52 Chapter 5 Preparation for Use of Endoscope (3) Feed air from the balloon air feed inlet several times and let air come out from the balloon air feed outlet. [Note] Discharge water completely to remove moisture from inside the channel. 5.7.2 Mounting Endoscope Balloon [Note]...
  • Page 53 Chapter 5 Preparation for Use of Endoscope (3) Apply a small amount of 70% ethanol solution to the outside of the setting tool (ST-05B). (4) Put the balloon on the setting tool (ST-05B). (5) Insert the distal end of the endoscope into the setting tool (ST-05B) and form the balloon so as not to be twisted.
  • Page 54 Chapter 5 Preparation for Use of Endoscope (6) Roll up the edge of the balloon, and slide the setting tool (ST-05B) toward the control portion of the endoscope to mount the balloon on the endoscope. Return the edge of the balloon to the original form. [Note] Make the ethanol inside the balloon evaporate by widening the end of the balloon.
  • Page 55 Chapter 5 Preparation for Use of Endoscope (9) Slide the fixing rubber down from the mounting fixture (ST-01B) to the end of the balloon on the curved section side. When using a hood, attach a hood by following the procedure described in “5.7.3 Attaching Hood.” “5.7.3 Attaching Hood”...

  • Page 56: Mounting Endoscope Balloon

    Chapter 5 Preparation for Use of Endoscope 5.7.3 Attaching Hood (Only When Necessary) Attach a hood to hold the endoscope in an appropriate position for close-up observation during an examination. CAUTION Do not press the hood against the digestive tract wall with undue force. It may damage mucous membrane.
  • Page 57 Chapter 5 Preparation for Use of Endoscope (4) Make sure the hood is fixed correctly. 5-23...

  • Page 58: Inspecting Balloon

    Chapter 5 Preparation for Use of Endoscope Inspecting Balloon (1) Supply air into the balloon air feed inlet to make sure that the balloon attached to the endoscope inflates. Remove air from the balloon air feed inlet to make sure that the balloon deflates.

  • Page 59: Connecting Balloon Controller

    Chapter 5 Preparation for Use of Endoscope Connecting Balloon Controller CAUTION Connect the endoscope and the Over-tube to the balloon controller properly. Before insertion, make sure that the balloon operates as intended. Otherwise, it may cause an injury. [Note] This endoscope cannot be connected to the balloon controller PB-10. 5.9.1 Connecting Balloon Controller (1) Install the balloon controller referring to the operation...
  • Page 60 Chapter 5 Preparation for Use of Endoscope (3) Connect the tube 1 (white tube) of the balloon controller to the air feed inlet (clear tube) of the Over-tube. 5.9.2 Inspecting Balloon (Balloon Controller) Make sure that the "SCOPE" side connector of the balloon controller is connected to the balloon air feed inlet of the endoscope, and the "OVERTUBE"...

  • Page 61: Chapter 6 Method Of Use

    Chapter 6 Method of Use This chapter outlines how to operate of the equipment, according to the general procedures. Regarding clinical procedures, use proper clinical judgment. 6.1 Preparation..............6-3 6.1.1 Preparing Necessary Equipment .......6-3 6.1.2 Pre-treatment of Patient ........6-3 6.2 Insertion and Observation ..........6-4 6.2.1 Peroral Insertion ..........6-5 6.2.2 Transanal Insertion ..........6-10 6.3 Biopsy .................6-15...
  • Page 62 The balloon may burst. When removing a balloon, take care not to apply excessive force to the endoscope. It may damage the endoscope. [Note] Check the status of the balloon by fluoroscopy. [Note] Use the FUJIFILM-specified balloon controller to operate balloons.

  • Page 63: Preparation

    Chapter 6 Method of Use Preparation 6.1.1 Preparing Necessary Equipment Prepare the accessories, endotherapy devices, etc. to be used. 6.1.2 Pre-treatment of Patient Use pretreatment that suits the purpose of examination.

  • Page 64: Insertion And Observation

    Chapter 6 Method of Use Insertion and Observation WARNING Do not bend the endoscope quickly. There is a risk of damaging the inside of the body cavity. Do not inflate the balloon in the pharynx or esophagus. There is a risk of suffocation. Insert and withdraw the endoscope or Over-tube slowly.

  • Page 65: Peroral Insertion

    Chapter 6 Method of Use CAUTION Do not directly apply Xylocaine spray to the insertion portion. It may cause deterioration of the outer surface. Do not use olive oil as a lubricant for insertion. It may cause swelling on the outer surface. The method described in this operation manual is only an example.
  • Page 66 Chapter 6 Method of Use (3) Unlock the bending portion by turning the up-down locking lever and the left-right locking knob in the direction of F until they stop. [Note] Another procedure is also available: you can insert the endoscope by locking the bending portion only in the left-right direction and unlocking it in the up-down direction.
  • Page 67 Chapter 6 Method of Use (7) Feed air to inflate the balloon on the distal end of the endoscope, 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.
  • Page 68 Chapter 6 Method of Use (10) Remove air to deflate the balloon on the distal end of the endoscope. (11) Insert the endoscope. (12) Feed air to inflate the balloon on the distal end of the endoscope, and stabilize it within the body cavity. (13) Remove air to deflate the balloon on the Over-tube.
  • Page 69 Chapter 6 Method of Use (17) Stop the center hole in the air/water button with a finger to supply air to the digestive tract. The mucous membrane of the digestive tract will become clearly visible. (18) Steer the distal end of the endoscope to the region of interest by turning the up-down and left-right angle knobs.

  • Page 70: Transanal Insertion

    Chapter 6 Method of Use 6.2.2 Transanal Insertion (1) Instruct the patient to take an appropriate position for the insertion procedure. (2) Unlock the bending portion by turning the up-down locking lever and the left-right locking knob in the direction of F until they stop.
  • Page 71 Chapter 6 Method of Use (5) Insert the distal end of the endoscope from the anus to the rectum while observing them. Adjust the brightness with the level button on the light source. (6) Feed air to inflate the balloon on the distal end of the endoscope, and stabilize it within the enteric canal.
  • Page 72 Chapter 6 Method of Use (8) Feed air to inflate the balloon on the Over-tube, and stabilize it within the body cavity (small intestine). (9) Remove air to deflate the balloon on the distal end of the endoscope. (10) Insert the endoscope. (11) Feed air to inflate the balloon on the distal end of the endoscope, and stabilize it within the body cavity.
  • Page 73 Chapter 6 Method of Use (14) Feed air to inflate the balloon on the Over-tube, and stabilize it within the body cavity. (15) Repeat steps (9) through (14) to advance the endoscope. (16) Stop the center hole in the air/water button with a finger to supply air to the digestive tract.
  • Page 74 Chapter 6 Method of Use <When sucking mucus> To suck mucus, insert the distal end of the endoscope in the mucous lake and 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.

  • Page 75: Biopsy

    Chapter 6 Method of Use Biopsy WARNING Do not insert an endotherapy device if you cannot see the forceps outlet on the endoscopic image. There is a risk of perforation and bleeding. Slowly insert an endotherapy device straight into the forceps inlet of the endoscope.
  • Page 76 Chapter 6 Method of Use (2) Check the opening and closing of the forceps. Slowly insert the forceps straight into the forceps inlet while observing the image. (3) Stop the insertion of the forceps when its tip appears on the field of view. (4) Slowly move the forceps to the site.
  • Page 77 Chapter 6 Method of Use (6) Slowly pull the forceps straight out of the forceps valve and take out the biopsy specimen. 6-17...

  • Page 78: Withdrawal

    Chapter 6 Method of Use Withdrawal (1) When the examination is over, remove any excessive air from the body cavity. (2) Unlock the up-down and left-right knobs. (3) Unbend the bending portion until it is almost straight by operating the angle knobs. (4) Deflate the balloon, and then slowly withdraw the Over-tube along with the endoscope.

  • Page 79: Removing Hood (Only When Used)

    Chapter 6 Method of Use 6.4.1 Removing Hood (Only When Used) WARNING Wear personal protective equipment when removing the balloon or hood. There is a risk of infection. CAUTION When removing the balloon or hood, take care not to apply excessive force to the endoscope.

  • Page 80: Removing Balloon

    Chapter 6 Method of Use 6.4.2 Removing Balloon (1) Remove the fixing rubber securing the balloon. Roll the balloon slowly toward the distal end of the endoscope to remove. [Note] If the balloon is too slippery to be held, cover the balloon with gauze for easier removal.

  • Page 81: Pre-Cleaning (Primary Cleaning)

    Chapter 6 Method of Use Pre-cleaning (Primary Cleaning) Pre-cleaning (primary cleaning) means cleaning performed at bedside immediately after use of endoscope. 6.5.1 Wiping off Endoscope Wipe off any matter adhering to the outer surface of the insertion portion by using gauze or a paper towel. 6.5.2 Purging Air/Water Supply Channel Remove mucosal fluids, blood, etc.

  • Page 82: Pre-Cleaning Suction Channel

    Chapter 6 Method of Use (3) Turn the connector of water tank attached to the endoscope to remove it. Then cover the feed water connector of the endoscope with a finger. Continue depressing the air/water button until the water remaining in the channel is discharged completely. 6.5.3 Pre-cleaning Suction Channel Remove body fluids from the suction channel of endoscope in accordance with the...

  • Page 83: Cleaning Air/Water Supply Channel Using

    Chapter 6 Method of Use 6.5.4 Cleaning Air/Water Supply Channel Using CA-511N This section explains how to clean the air/water supply channel using the CA-511N (optional item). For details on how to use the CA-511N, refer to the operation manual of the CA-511N. Perform pre-cleaning of items other than the air/water supply channel referring to 6.5.1 “Wiping off Endoscope”...

  • Page 84: Removing Endoscope From Processor

    Chapter 6 Method of Use (9) Disconnect the connector of the water tank and cover the feed water connector of the endoscope with your finger. (10) Press the button on the cleaning adapter CA-511N to supply air until water in the air/water supply channel is completely discharged.

  • Page 85: Detaching Forceps Valve

    Chapter 6 Method of Use (3) Remove the video connector from the processor. Remove the LG connector from the light source. 6.5.6 Detaching Forceps Valve WARNING Discard the forceps valve after use. It could be a source of infection. Detach the forceps valve from the endoscope. Discard the detached forceps valve.

  • Page 86: Transporting Endoscope

    Chapter 6 Method of Use 6.5.8 Transporting Endoscope Transport the 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 the endoscope.

  • Page 87: Appendix

    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: Main Specifications

    Use is prohibited in an oxygen-rich environment or in a flammable gas atmosphere. [Note] Use in combination with VP-4450HD and XL-4450. <Applied Part> Insertion portion <Specifications> Model EN-580T Optical system: Viewing direction 0° (Forward) Field of view 140° Observation range (mm) 2 to 100...
  • Page 89 Appendix <Operating Environment> Temperature +10 to +40°C Humidity 30 to 85%RH (no dew condensation) Pressure 70 to 106 kPa (within range of atmospheric pressure) <Transport and Storage Environment> Temperature +10 to +40°C Humidity 30 to 85%RH (no dew condensation) Pressure 70 to 106 kPa (within range of atmospheric pressure) <Term of Validity/Period for Use (Durability)>...
  • Page 90 FUJIFILM VTR M99 F10 2004/03/25 *1.5 AVE 12:10:22 1/200 000:00 A1SHB 40 M 1963-11-23 Dr. Sato 123456789 FUJIFILM HP Yamada Taro <Medical Device Directive> This product complies with the requirements of European Directive 93/42/EEC. Classification : Class II a Appendix-4...
  • Page 91 Appendix <Electromagnetic Compatibility (EMC) Information> This product is intended for use in the electromagnetic environments specified below. The customer or the user of this product should assure that it is used in such an environment. Electromagnetic emission compliance information and guidance Emission standard Compliance Guidance...
  • Page 92 Appendix Electromagnetic immunity compliance information and guidance Compliance EN 60601-1-2 Immunity test Guidance Test level level Floors should be wood, concrete, or Electrostatic discharge (ESD) ± 6kV: contact ceramic tile. If floors are covered with Same as left ± 8kV: air synthetic material, the relative humidity EN 61000-4-2 should be at least 30%.
  • Page 93 Appendix Electromagnetic immunity compliance information and guidance Compliance EN 60601-1-2 Immunity test Guidance Test level level Portable and mobile RF communications equipment should be used no closer to any part of this product, including cables, than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter.

  • Page 94: Troubleshooting

    Appendix Troubleshooting If the endoscope should fail during use, follow these instructions to troubleshoot it. Problem Cause Remedy No images come out. 1) The cart, monitor or processor is unplugged 1) Plug the cart, monitor or processor into the from the main outlet. main outlet.
  • Page 95 2) The air/water supply channel is damaged. 2) Consult your local FUJIFILM dealer. [Note] Reset: Turn off the processor and the light source, and wait for at least 5 seconds. Turn on the processor and the light source again, and then light the lamp by pressing the Lamp button.
  • Page 96 Appendix Problem Cause Remedy Air/Water button The air/water button has deteriorated. Replace the air/water button with a new one. won’t reset. Suction is disabled. 1) The pump is switched off. 1) Switch on the pump. 2) The pump is not connected. 2) Connect the pump.
  • Page 97 2) The bending control mechanism is 2) Discontinue use immediately, and contact neutral position. malfunctioning. your local FUJIFILM dealer or the nearest service center without forcing the bending portion out of position. Forcing the bending portion out of position could result in body cavity damage.

  • Page 98: After-Sales Service

    If the equipment does not work properly, check it first by reading this manual again and follow all instructions. If the equipment is still not working well, contact your local FUJIFILM dealer. Repairs during the warranty period We will repair the endoscope free of charge according to the provisions of the warranty.

  • Page 99: Disposal Of Electric And Electronic Equipment

    Appendix Disposal of Electric and Electronic Equipment Disposal of Used Electrical and Electronic Equipment (Applicable in the European Union and other European countries with separate collection systems) This symbol on the product, or in the manual and/or on this packaging, indicates that this product shall not be treated as household waste.

  • Page 100: Index

    Appendix Index <A> <M> Aeration ............... 9-8 Maintenance ............1-3 Air/water button ..........4-4 MM switch ............4-5 Monitor ..............2-5 <B> Mouthpiece ............6-5 Bending mechanism ..........4-2 Bending portion ........... 3-3 <O> Operating environment ......Appendix-3 <C> Cart ..............2-5 <P>...
  • Page 102 Manufacturer: FUJIFILM Corporation 26-30, Nishiazabu 2-chome, Minato-ku, Tokyo 106-8620, Japan European Authorized Representative: FUJIFILM Europe GmbH Heesenstrasse 31, 40549 Duesseldorf, Germany 202B1262414 130305 - 1.0 - DT - E2 FC675A Printed in Japan...