FujiFilm EG-580UT Operation Manual
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FujiFilm EG-580UT Operation Manual

Ultrasonic endoscope
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English
フジノン和文
Ultrasonic Endoscope
EG-580UT
OPERATION MANUAL
This Operation Manual describes details on how to operate the ultrasonic endoscope and cautions
to be observed when operating it. Please read this manual thoroughly before actually operating the
ultrasonic endoscope.
After reading this manual, store it nearby the ultrasonic endoscope so that you can see it whenever
necessary.
202B1262575D

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Summary of Contents for FujiFilm EG-580UT

  • Page 1 English フジノン和文 Ultrasonic Endoscope EG-580UT OPERATION MANUAL This Operation Manual describes details on how to operate the ultrasonic endoscope and cautions to be observed when operating it. Please read this manual thoroughly before actually operating the ultrasonic endoscope. After reading this manual, store it nearby the ultrasonic endoscope so that you can see it whenever necessary.
  • Page 2 202B1262575D...

  • Page 3: Introduction

    Introduction Introduction Ultrasonic Endoscope EG-580UT is an upper gastrointestinal endoscope intended for the observation and diagnosis of the esophagus, stomach and duodenum, and for the observation, diagnosis and endoscopic treatment of submucosal and peripheral organs at medical facilities under the management of physicians.
  • Page 4 FUJIFILM Corporation. FUJIFILM Corporation shall not be liable for malfunctions and damages of FUJIFILM Corporation products due to products of other manufacturers not supplied by FUJIFILM Corporation.

  • Page 5: Endoscope Manuals

    This manual describes the cleaning, disinfection, sterilization and storage methods of the ultrasonic endoscope. [Note] In this manual, the Ultrasonic Endoscope EG-580UT Operation Manual is referred to as “this manual”, and the Ultrasonic Endoscope EG-580UT Reprocessing Manual as “Reprocessing Manual”.

  • Page 6: Contents At A Glance

    Contents at a Glance Contents at a Glance Chapter 1 Precautions This chapter describes the warnings and cautions for safe operation of the ultrasonic endoscope. Chapter 2 Product Overview This chapter describes the composition of the ultrasonic endoscope set of accessories and system configuration.

  • Page 7: Table Of Contents

    Contents Contents Introduction ........................3 Endoscope Manuals .....................5 How to Read This Manual ...................5 Contents at a Glance ....................6 Chapter 1 Precautions ....................10 1.1 For Safe Operation ...............10 1.2 Classification ................11 1.3 Safety ....................12 1.3.1 Infection ................12 1.3.2 Preventing Electrical Shock ..........15 1.3.3 Treatment with Electrosurgical Instruments ....16 1.3.4...
  • Page 8 Contents 2.6 Operating Bending Section ............40 2.6.1 Operating the Bending Section ........40 2.6.2 Angle Lock Function ............42 2.7 Control Valves ................44 2.8 Scope Switches ................45 2.9 Operating Forceps Stand Mechamism .........46 2.9.1 Forceps Stand Lever ............46 2.9.2 Stand Assist Mechanism ..........47 2.10 Ultrasonic Image ................48 Chapter 3 Preparation and Inspection Before Use ............49 3.1 Preparing Forceps Valve ..............49...
  • Page 9 Contents 4.3 How to Use Balloon ..............80 4.4 Biopsy ...................81 4.5 Puncture ..................83 4.6 Endoscope Withdrawal ..............88 4.7 Removing Balloon ................90 4.8 Pre-cleaning (Primary Cleaning) ..........91 Chapter 5 Troubleshooting ..................92 5.1 Troubleshooting................92 Main Specification ....................100 Service ........................108 Disposal of Electric and Electronic Equipment ............109 Index ........................110 Service Centers ......................111 202B1262575D...

  • Page 10: Chapter 1 Precautions

    Do not modify this product or its components, and do not disassemble, repair or in any other way reverse-engineer these products. Even if you find a defect, do not attempt to repair these products yourself. FUJIFILM Corporation shall not be liable for any defects or device failures caused by such modifications, disassembly, repairs or reverse-engineering.

  • Page 11: Classification

    Chapter 1 Precautions 1.2 Classification <Classification of Medical Electrical Equipment> 1. Type of protection against electric shock : Class I equipment (power supply: protected ground fault receptacle) 2. Degree of protection against electric shock : Type BF applied part 3. Degree of explosion protection : Use is prohibited in an oxygen-rich environment or in a flammable gas atmosphere.

  • Page 12: Safety

    Chapter 1 Precautions 1.3 Safety Read the following precautions before using this product to ensure proper handling. 1.3.1 Infection WARNING This product has not been cleaned or disinfected (or sterilized). It must be cleaned and disinfected (or sterilized) for the first time prior to use and after any subsequent use as per instructions provided in the Reprocessing Manual.
  • Page 13 FUJIFILM recommendations. Once the balloon evacuation channel is clogged, it cannot be cleaned, disinfected or sterilized properly and can be a source of infection.
  • Page 14 Chapter 1 Precautions WARNING Slowly insert an endotherapy device (e.g. forceps), puncture needle or syringe straight into the ultrasonic endoscope. Also, when withdrawing it, slowly pull straight out. If it is inserted or withdrawn quickly, body fluid may be splattered around due to breakage or accidental detachment of the instrument, leading to infection.

  • Page 15: Preventing Electrical Shock

    Chapter 1 Precautions 1.3.2 Preventing Electrical Shock WARNING Insert the AC plug into a hospital grade receptacle. Not doing so may cause an electric shock accident. Use an electrosurgical instrument conforming to EN 60601-2-2. Refer to the manual of the electrosurgical instrument for how to operate the electrosurgical instrument.

  • Page 16: Treatment With Electrosurgical Instruments

    Chapter 1 Precautions 1.3.3 Treatment with Electrosurgical Instruments WARNING This product is not intended to stop bleeding with diathermic treatment equipment. Prepare an endoscope and diathermic treatment equipment that can be used with it, so as to take necessary actions in emergencies such as bleeding.
  • Page 17 Chapter 1 Precautions CAUTION We recommend use of only those peripheral products specified in this manual to avoid adverse outcomes such as electric shock when this product is used in combination with other devices. Prevent patient’s body from touching electric conductor such as metal part of bed while using an electrosurgical instrument and an accessory instrument.

  • Page 18: Direct Harm To Human Body

    Chapter 1 Precautions 1.3.4 Direct Harm to Human Body WARNING 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 in blood pressure and shock.
  • Page 19 Chapter 1 Precautions WARNING Never release your finger from the forceps stand lever during puncture. Doing so may cause bleeding due to an unintended puncture. To avoid the potential for patient injury including perforation, do not apply excessive force of the ultrasonic endoscope or endotherapy device against mucosal surfaces.
  • Page 20 Chapter 1 Precautions CAUTION When the ultrasonic endoscope projects light at high brightness and transmission of ultrasonic waves for a long time, the temperature may exceed 41°C at the distal end. Turn off the lamp and stop transmission of ultrasonic waves (Freeze the ultrasonic processor) when you hang the ultrasonic endoscope on the cart hanger.

  • Page 21: Electromagnetic Compatibility (Emc)

    • Consult the manufacturer or dealer of other devices. If the problem cannot be solved with the above measures, stop using this product and consult the manufacturer or your local FUJIFILM dealer for help. WARNING Do not place any objects that emit strong electromagnetic waves near this product.

  • Page 22: Location Of Each Label

    Chapter 1 Precautions 1.5 Location of Each Label The positions where the labels are affixed on this product are shown below. The relevant safety signs are also described. 1.5.1 Location of Labels <Control Portion> Model Label Instrument Channel Diameter Label <LG Connector>...
  • Page 23 Chapter 1 Precautions <US Connector> Caution Label 202B1262575D...

  • Page 24: Symbols

    Chapter 1 Precautions 1.5.2 Symbols Symbol Description Do not re-use / Single patient use only Use by date / Expiration date of use Lot number Serial number Date of manufacture Manufacturer Authorised representative in the European Community Consult instructions for use Temperature limitation Keep dry Non-sterile...
  • Page 25 Chapter 1 Precautions Symbol Description Atmospheric pressure limitation Super CCD model Minimum diameter of the instrument channel: 3.8 mm Applicable for autoclave [Note 1] This product shall not be treated as household waste. [Note 2] This symbol indicates that this specific type of medical device contains dibutyl phthalate (DBP).

  • Page 26: Possible Combinations For Use

    Chapter 1 Precautions 1.6 Possible Combinations for Use 1.6.1 Accessories Use this product in combination with the accessories described in “Main Specification”. WARNING Do not use the ultrasonic endoscope in combination with accessories other than those described in this manual. Otherwise, it is unable to ensure its functionality, and creates a risk of patient injury or equipment damage.

  • Page 27: Cautions/Warnings

    If any abnormality is noticed during use, carry out safety checks and discontinue use immediately. If any abnormality occurs with this product, refer to “Chapter 5 Troubleshooting”. Should any questions arise regarding information contained in the operation manuals or any safety concerns, contact your local FUJIFILM dealer. 202B1262575D...

  • Page 28: Transportation And Storage

    Chapter 1 Precautions 1.7.2 Transportation and Storage WARNING Contact your local FUJIFILM dealer when this product is returned for repair. Be sure to clean and disinfect (or sterilize) this product before returning for repair. A returned product which is not cleaned and disinfected (or sterilized) may increase infection control risks to users, service personnel or other persons in contact with it.

  • Page 29: General Warnings

    Chapter 1 Precautions 1.7.4 General Warnings WARNING Make sure to inspect the equipment before use according to the procedures provided in this manual to avoid unexpected accidents and to take full advantage of the equipment’s capabilities. If the inspection result shows any abnormality, do not use the same equipment. This product is an ultrasonic endoscope for the upper digestive tract.

  • Page 30: Chapter 2 Product Overview

    Chapter 2 Product Overview Chapter 2 Product Overview 2.1 Composition of Standard Set The standard ultrasonic endoscope set is provided in a carrying case and consists of the following items. [Note] Figures in parentheses indicate the number of articles. Suction Valve SB-604 (1) Air/Water Valve AW-602 (1)
  • Page 31 Chapter 2 Product Overview Air/Water Channel Cleaning Adapter CA-609 (1) Injection Tube Channel Plug WA-007 WA-008 Cleaning Adapter CA-608 (1) Cleaning Brush Cleaning Brush Cleaning Brush Cleaning Brush WB2221FW2 (1) WB11003FW (1) WB1318EW (1) WB7024FW (1) US Waterproof Cap Ventilation Adapter WA-7000 (1) AD-7 (1) 202B1262575D...

  • Page 32: System Configuration

    Optional peripheral devices including but not limited to the following various functions can be used with this product. • Puncture • Recording video images • Printing still images Water Tank WT-4 Ultrasonic Processor WT-2 SU-1 Ultrasonic Endoscope EG-580UT Light Source XL-4450 Processor Balloon VP-4450HD B20UT Foot Switch Data Keyboard DK-4450E Forceps/Endotherapy Device/...
  • Page 33 Chapter 2 Product Overview [Note] The devices described here may have already been discontinued. For details on the devices used in combination with this product, contact your local FUJIFILM dealer. [Note 1] Electrosurgical Unit ICC 200 (ERBE) [Note 1] For details, refer...

  • Page 34: Nomenclature And Functions Of Ultrasonic Endoscope

    Chapter 2 Product Overview 2.3 Nomenclature and Functions of Ultrasonic Endoscope This product consists of the following parts. [Note 1] Use the processor to assign functions on each scope switch. For details, see the operation manual of the processor. Lock Handle Index Mark Fixes the US connector to LG Flexible Portion...
  • Page 35 Chapter 2 Product Overview Scope Switch 3 [Note 1] [Note 1] Scope Switch 2 [Note 1] Scope Switch 1 Up-down Angulation Lock Suction Valve Locks the up/down angulation of the bending A l l o w s s u c t i o n t h r o u g h t h e section.

  • Page 36: Ultrasonic Endoscope Distal End

    Chapter 2 Product Overview 2.4 Nomenclature and Functions of Ultrasonic Endoscope Distal End The distal end of the EG-580UT consists of the following parts. [Note] The transducer of this product is installed downward to the control portion. Forceps Stand Adjusts the protrusion angle of the forceps, puncture needle, and other treatment equipment.

  • Page 37: Nomenclature And Functions Of Accessories

    Chapter 2 Product Overview 2.5 Nomenclature and Functions of Accessories 2.5.1 Forceps Valve The forceps valve is provided without sterilization and must be cleaned and disinfected (or sterilized) prior to use following the instructions of the Reprocessing Manual. Reprocessing Manual “7.1 Cleaning and Disinfecting (or Sterilizing) Forceps Valve” Ring This portion is hooked onto the instrument channel inlet on the ultrasonic endoscope.

  • Page 38: Balloon

    Chapter 2 Product Overview 2.5.2 Balloon Balloon Ring Balloon B20UT 2.5.3 Cleaning Adapter The cleaning adapter (CA-608) is comprised of the injection tube (WA-007) and channel plug (WA-008). <Injection Tube (WA-007)> Tube for Instrument/Suction Channel Connects to the suction channel. Air Supply Tube Port Connects to the air Air/Water Channel Connector...
  • Page 39 Chapter 2 Product Overview <Channel Plug (WA-008)> Balloon Channel Port Suction Plug The syringe is attached to this port to feed air or fluid to the balloon This plug is inserted into the channel of the ultrasonic endoscope. suction valve cylinder of the ultrasonic endoscope.

  • Page 40: Operating Bending Section

    Chapter 2 Product Overview 2.6 Operating Bending Section 2.6.1 Operating the Bending Section CAUTION Do not forcibly twist or bend too sharply the insertion tube and the bending section by hand. It may cause a failure. The bending section is operated by using up-down/left-right angulation knobs. <Up-down Angulation Knob>...
  • Page 41 Chapter 2 Product Overview <Left-right Angulation Knob> Turn the left-right angulation knob in the direction of L to angulate the bending section to the left. Turn it in the direction of R to angulate the bending section to the right. 202B1262575D...

  • Page 42: Angle Lock Function

    Chapter 2 Product Overview 2.6.2 Angle Lock Function This angle lock function is used to maintain a bent condition of the bending section. With the up-down angulation lock operation, it switches between lock and free (unlock) of the up/down angulation. With the left-right angulation lock operation, it switches between lock and free (unlock) of the left/right angulation.
  • Page 43 Chapter 2 Product Overview <Left-right Angulation Lock> Rotate the knob in the direction of F to unlock the bending section. [Note] Free (unlock) : Allows external force to angulate the bending section freely. Rotate the knob in the direction opposite to F to lock the bending section.

  • Page 44: Control Valves

    Chapter 2 Product Overview 2.7 Control Valves <Suction Valve> Used for suction from the instrument channel outlet at the distal end. Also used to discharge water from the balloon. When the suction valve is pressed halfway, suction continues while the valve is pressed. When the suction valve is fully pressed, water is discharged from the balloon.

  • Page 45: Scope Switches

    Chapter 2 Product Overview 2.8 Scope Switches CAUTION Use the processor to assign functions on each scope switch. For details, see the operation manual of the processor. Scope Switch 4 Scope Switch 5 Scope Switch 3 Scope Switch 2 Scope Switch 1 For details, see the operation manual of the processor.

  • Page 46: Operating Forceps Stand Mechamism

    Chapter 2 Product Overview 2.9 Operating Forceps Stand Mechamism 2.9.1 Forceps Stand Lever The forceps stand lever is used to position the forceps stand upright. <When the forceps stand lever is slid toward the direction opposite from U > The forceps stand at the distal end is lowered. The endotherapy device in the field of view moves downward on the monitor.

  • Page 47: Stand Assist Mechanism

    Chapter 2 Product Overview 2.9.2 Stand Assist Mechanism The stand assist mechanism suppresses the returning of the forceps stand due to a reaction force of the endotherapy device. <When the forceps stand lever is slid further toward the direction U >...

  • Page 48: Ultrasonic Image

    Chapter 2 Product Overview 2.10 Ultrasonic Image This section describes the functions specific to this ultrasonic endoscope. The following image is an overview image of the ultrasonic image. Puncture guiding line Used as a reference for the insertion direction of puncture needle. [Note] The puncture guiding line is only a rough guide.

  • Page 49: Chapter 3 Preparation And Inspection Before Use

    Chapter 3 Preparation and Inspection Before Use Chapter 3 Preparation and Inspection Before Use CAUTION Do not use the ultrasonic endoscope if the inspection result shows any abnormality. Doing so can negatively affect the functionality of the instrument or increase risks to patient safety. 3.1 Preparing Forceps Valve WARNING Ensure that the forceps valve is properly attached to the instrument...

  • Page 50: Inspecting The Forceps Valve

    Chapter 3 Preparation and Inspection Before Use 3.1.2 Inspecting the Forceps Valve The forceps valve is intended for single use. If any abnormality is found, do not use the product, and use a new disinfected (or sterilized) forceps valve. (1) Visually check that the slit (a) of the forceps valve are free from abnormalities such as tears, cracks, discoloration, etc.

  • Page 51: Preparing Air/Water Valve And Suction Valve

    Chapter 3 Preparation and Inspection Before Use 3.2 Preparing Air/Water Valve and Suction Valve WARNING Use a cleaned and disinfected (or sterilized) air/water valve and suction valve. An inadequately cleaned and disinfected (or sterilized) valve may pose an infection risk. CAUTION Do not apply silicone oil to the air/water valve or suction valve.

  • Page 52: Attaching The Air/Water Valve And Suction Valve

    Chapter 3 Preparation and Inspection Before Use 3.2.2 Attaching the Air/Water Valve and Suction Valve Attach the air/water valve and suction valve to the control portion of the ultrasonic endoscope. (1) Attach the air/water valve to the ultrasonic endoscope's air/water valve cylinder and push in the valve firmly. [Note] The air/water valve and the air/water valve cylinder have a blue mark.

  • Page 53: Preparing Peripheral Devices

    Chapter 3 Preparation and Inspection Before Use 3.3 Preparing Peripheral Devices For details on preparation and inspection of peripheral devices, refer to their manuals. 202B1262575D...

  • Page 54: Preparing System

    Chapter 3 Preparation and Inspection Before Use 3.4 Preparing System WARNING This product is not intended to stop bleeding with diathermic treatment equipment. Prepare an endoscope and diathermic treatment equipment that can be used with it, so as to take necessary actions in emergencies such as bleeding.
  • Page 55 Chapter 3 Preparation and Inspection Before Use (3) Prepare the suction unit. [Note] For details on the suction unit, refer to the manual of the suction unit. Collection canister Suction unit (4) Mount the water tank, 80% filled with sterile water, on the hook.

  • Page 56: Connecting Ultrasonic Endoscope (Attachment)

    Chapter 3 Preparation and Inspection Before Use 3.5 Connecting Ultrasonic Endoscope (Attachment) CAUTION Set the suction pressure between 40 and 53 kPa. If the suction pressure is too high, the ultrasonic endoscope may adhere to mucous membrane, resulting in damage to the mucous membrane. 3.5.1 Connecting the Ultrasonic Endoscope (Processor, Light Source, Water Tank and Suction Unit) (1) Before attaching the LG connector to the light source, Light incident distal face...
  • Page 57 Chapter 3 Preparation and Inspection Before Use (4) Make sure that the forceps valve is attached to the instrument channel inlet of the ultrasonic endoscope. (5) Insert the connector of the water tank to the water feed connector of the ultrasonic endoscope. Align the groove on the connector and the pin of the water feed connector on the ultrasonic endoscope, and attach it firmly by turning the connector clockwise until it stops.

  • Page 58: Inspecting Ultrasonic Endoscope

    If the adhesive surfaces are rough, pitted or flaking, return the instrument to your local FUJIFILM dealer. (2) Hold the insertion tube with both hands to make a semicircle with a diameter of approximately 200 mm, referring to the figure at right.

  • Page 59: Inspecting The Bending Mechanism

    Chapter 3 Preparation and Inspection Before Use 3.6.2 Inspecting the Bending Mechanism [Note] For information on how to operate the bending mechanism, refer to “2.6 Operating Bending Section” of this manual. “2.6 Operating Bending Section” (1) Unlock both up-down and left-right angulation locks by turning them in the “Free”...

  • Page 60: Inspecting The Forceps Stand Mechanism

    Chapter 3 Preparation and Inspection Before Use 3.6.3 Inspecting the Forceps Stand Mechanism (1) Move the forceps stand lever. (2) Check that the forceps stand at the distal end moves properly according to the movement of the lever. (3) Slide the forceps stand lever toward the direction U until it clicks to check that the stand assist function is activated normally.

  • Page 61: Inspecting The Air/Water And Instrument Channels

    Chapter 3 Preparation and Inspection Before Use 3.6.4 Inspecting the Air/Water and Instrument Channels (1) Turn on the suction unit, cart, processor and light source. Keep the lamp off. (2) Prepare a clean basin of sterile water. (3) Place the distal end of the ultrasonic endoscope without touching the floor, etc., depress the air/water valve halfway, and check that sterile water comes out of the nozzle.

  • Page 62: Inspecting The Instrument Channel

    Chapter 3 Preparation and Inspection Before Use (6) Attach the forceps valve to the instrument channel inlet. While immersing the distal end of the ultrasonic endoscope in water, check that the water is sucked in when the suction valve is pressed halfway and the suction stops when the finger is released from the valve.

  • Page 63: Inspecting Distal End Of Ultrasonic Endoscope

    Chapter 3 Preparation and Inspection Before Use 3.7 Inspecting Distal End of Ultrasonic Endoscope CAUTION Turn off the lamp and stop the transmission of ultrasonic waves (freeze the ultrasonic processor) except during a procedure, inspection, etc., when necessary. If the lamp is left on, the distal end may become hot, causing burn injury to the operator, assistant or patient.
  • Page 64 Chapter 3 Preparation and Inspection Before Use (3) Touch the transducer with a finger and check that it is not heated. (4) Visually check the transducer, the US connector and the cables for abnormalities such as cracks or dents etc. 202B1262575D...
  • Page 65 [Note] If the distal adhesives are missing, peeling, deteriorated or if any lens is damaged or missing, contact your local FUJIFILM dealer. (6) If the objective lens and the light guides are dirty or stained, thoroughly clean them. [Note]...
  • Page 66 Chapter 3 Preparation and Inspection Before Use (7) Press the Lamp button on the light source to turn on the lamp, and observe the endoscopic image on the monitor. Check that image is clear and nothing obstructs endoscopic view. [Note] If wiping does not remove cloudiness from objective lens, it is possible that ultrasonic endoscope is not sufficiently watertight.

  • Page 67: Inspecting Ultrasonic Image

    Chapter 3 Preparation and Inspection Before Use 3.8 Inspecting Ultrasonic Image (1) Prepare a cup of water and immerse the distal end of the ultrasonic endoscope into water. (2) Press the [FREEZE] key on the keyboard of the ultrasonic processor to cancel the freeze mode. (3) Check that an ultrasonic image appears.

  • Page 68: Attaching And Inspecting Balloon

    Chapter 3 Preparation and Inspection Before Use 3.9 Attaching and Inspecting Balloon WARNING Use a disinfected (or sterilized) balloon attachment tool. There is a risk of infection. Do not use a balloon on patients allergic to latex. There is a risk of an anaphylactic reaction.
  • Page 69 Chapter 3 Preparation and Inspection Before Use (3) Immerse the balloon into sterile water. (4) Hold the balloon ring with your fingers and put it around the balloon attachment tool. (5) Attach a syringe to the balloon attachment tool and then suck air out of the balloon.
  • Page 70 Chapter 3 Preparation and Inspection Before Use (7) Point the distal end of the ultrasonic endoscope downward. Press down the air/water valve fully to feed sterile water of 5 ml or less. [Note] It takes approximately 3 seconds to feed in 5 ml of water. Check the amount of water to be fed before use.

  • Page 71: Inspecting Puncture Needle

    Chapter 3 Preparation and Inspection Before Use 3.10 Inspecting Puncture Needle (1) Check the expiration date of the puncture needle. [Note] Do not use the puncture needle if the expiration date has expired. (2) Inspect the puncture needle according to its operation manual.

  • Page 72: Chapter 4 Method Of Use

    Chapter 4 Method of Use Chapter 4 Method of Use WARNING Wear personal protective equipment during a procedure as well as during cleaning and disinfection (or sterilization) to protect your eye and skin and to prevent infection. Use a properly cleaned and disinfected (or sterilized) puncture needle. An inadequately cleaned and disinfected (or sterilized) puncture needle can be a source of infection.

  • Page 73: Preparation

    Chapter 4 Method of Use 4.1 Preparation 4.1.1 Preparing Necessary Equipment Prepare the accessories and endotherapy devices, etc. to be used, and a spare forceps valve as well. [Note] Use a cleaned and disinfected (or sterilized) mouthpiece only. 4.1.2 Pretreatment of Patient Prepare the patient in the normal endoscopy regimen.

  • Page 74: Insertion And Observation

    FUJIFILM recommendations. Once the balloon evacuation channel is clogged, it cannot be cleaned, disinfected or sterilized properly and can be a source of infection.
  • Page 75 Chapter 4 Method of Use If the balloon or other parts fall into a body cavity due to a malfunction of the device, immediately stop the procedure and retrieve the parts by following appropriate measures. There is a risk of damaging the inside of the body cavity.

  • Page 76: Preparing The Mouthpiece

    Chapter 4 Method of Use 4.2.1 Preparing the Mouthpiece (1) Have the patient hold the mouthpiece in his/her mouth. [Note] If you choose to have the patient hold the mouthpiece after insertion, attach the mouthpiece to the insertion portion in advance.
  • Page 77 Chapter 4 Method of Use (3) When necessary, apply lens cleaner to the objective lens and light guides. [Note] Use lint-free sterile gauze to prevent fibers from entering the air/water nozzle. (4) Apply lubricant (Xylocaine jelly or the like) to the insertion portion.
  • Page 78 Chapter 4 Method of Use (7) Stop the center hole in the air/water valve with a finger to supply air to the digestive tract. The mucous membrane of the digestive tract is displayed clearly. (8) Steer the distal end of the ultrasonic endoscope to the region of interest by turning the up-down and left-right angulation knobs.

  • Page 79: To Suck Mucus

    FUJIFILM recommendations. 4.2.4 If Mucus Adheres to the Distal Objective Lens or If the Image is Obscured If mucus adheres to the distal objective lens or if the image is obscured, clean the surface of the lens by pressing the air/water valve halfway.

  • Page 80: How To Use Balloon

    Chapter 4 Method of Use 4.3 How to Use Balloon WARNING Do not use a balloon on patients allergic to latex. There is a risk of an anaphylactic reaction. CAUTION Do not feed more than 5 ml of water into the balloon. There is a risk of rupturing the balloon.

  • Page 81: Biopsy

    Chapter 4 Method of Use 4.4 Biopsy WARNING Do not strongly press the forceps onto the digestive tract wall. There is a risk of perforation and bleeding. Do not insert the forceps if you cannot see the instrument channel outlet on the endoscopic image. There is a risk of perforation and bleeding.
  • Page 82 Chapter 4 Method of Use (3) Stop the insertion of the forceps when its tip appears on the field of view. (4) Slowly move the forceps to the biopsy site. (5) Perform a biopsy by controlling the forceps and the angulation knobs.

  • Page 83: Puncture

    Chapter 4 Method of Use 4.5 Puncture WARNING Wear personal protective equipment during puncture to protect your eye and skin and to prevent infection. Do not perform puncture if the patient is prone to bleeding, lesions are not clearly observed with this product, puncturing seriously increases the risk of accidental symptoms, blood vessels appear on the puncture guiding lines, puncturing poses a risk of damaging the internal organs due to respiratory displacement, or tumors are highly likely to...
  • Page 84 Chapter 4 Method of Use CAUTION Do not insert/pull out the puncture needle forcibly. Do not insert the inner needle without the outer cylinder protruding from the instrument channel outlet at the distal end. Do not insert the ultrasonic endoscope with the inner puncture needle protruding from the outer cylinder.
  • Page 85 Chapter 4 Method of Use (3) If a balloon is attached, deflate it so that the puncture needle does not come into contact with it while checking the endoscopic image and ultrasonic image. [Note] If the balloon does not deflate while depressing the suction valve fully, remove clogs in the balloon channel using the cleaning brush (WB2221FW2).
  • Page 86 Chapter 4 Method of Use (6) Insert the puncture needle into the ultrasonic endoscope. (7) Stop inserting the puncture needle when its tip appears in the endoscopic image. (8) Bring the puncture needle close to the target area slowly. [Note] The puncture needle may remain bent if the ultrasonic endoscope is angulated with the puncture needle inserted.
  • Page 87 Chapter 4 Method of Use (10) After performing puncture, store the inner needle in the outer syringe and then pull out the puncture needle slowly. (11) Push out the collected tissue using the syringe or wire. 202B1262575D...

  • Page 88: Endoscope Withdrawal

    Chapter 4 Method of Use 4.6 Endoscope Withdrawal (1) When a procedure is over, discharge any excessive air from the body cavity. (2) Unlock the up-down and left-right knobs. (3) Operate the forceps stand lever to lower the forceps stand. (4) If the balloon is attached, deflate it completely.
  • Page 89 Chapter 4 Method of Use (6) Slowly pull out the ultrasonic endoscope. (7) Press the Lamp button on the light source to turn off the lamp. 202B1262575D...

  • Page 90: Removing Balloon

    Chapter 4 Method of Use 4.7 Removing Balloon WARNING When removing the balloon, wear personal protective equipment and slowly remove the balloon. There is a risk of infection. (1) Remove the balloon ring from the balloon attachment groove. (2) Roll the balloon slowly toward the distal end of the ultra- sonic endoscope to remove.

  • Page 91: Pre-Cleaning (Primary Cleaning)

    Chapter 4 Method of Use 4.8 Pre-cleaning (Primary Cleaning) Pre-cleaning (primary cleaning) means cleaning performed at bedside immediately after use of the ultrasonic endoscope. The ultrasonic endoscope is removed after pre-cleaning. [Note] For details on pre-cleaning and removal of the ultrasonic endoscope, refer to the Reprocessing Manual.

  • Page 92: Chapter 5 Troubleshooting

    7) The light guide cable is broken. 7) Contact your local FUJIFILM dealer. [Note] To reset the processor and the light source, turn them off, 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 93 Chapter 5 Troubleshooting Problem Cause Remedy [Note] Halation 1) The imaging section is damaged. 1) Reset the processor and the light source. If an appropriate image does not appear even after resetting, turn them off, straighten the bending section to unlock, release the angulation knobs, and then withdraw the ultrasonic endoscope slowly 2) The brightness level is set around “MAX.”...
  • Page 94 Chapter 5 Troubleshooting Problem Cause Remedy Live image is not The system is malfunctioning possibly due to If the problem occurred during puncture, stop puncture and remove the puncture needle from displayed after image static charge. [Note] the ultrasonic endoscope. Then, reset freezing is canceled processor and the light source.
  • Page 95 2) The air/water channels are damaged. 2) Contact your local FUJIFILM dealer. [Note] To reset the processor and the light source, turn them off, 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 4) The forceps valve is not attached properly. 4) Reattach the forceps valve. Suction valve cannot The suction valve or the control portion of the Contact your local FUJIFILM dealer. be removed. ultrasonic endoscope has been damaged. The volume of 1) The suction pump is turned “OFF”.
  • Page 97 Chapter 5 Troubleshooting Problem Cause Remedy Endotherapy device 1) The endotherapy device (such as biopsy 1) Close the endotherapy device and pull it out cannot be withdrawn. forceps) is left open. from the ultrasonic endoscope. 2) The handle of the endotherapy device (such 2) Loosen the grip and pull out the as biopsy forceps) is held firmly.
  • Page 98 Do not forcibly withdraw the ultrasonic endoscope from the patient, or it may cause damage to tissues in the body cavity. Contact your local FUJIFILM dealer. The bending section The angle wire is damaged. Immediately stop using the ultrasonic cannot bend by endoscope.
  • Page 99 Chapter 5 Troubleshooting Problem Cause Remedy The ultrasonic image 1) The gain level is close to the minimum 1) Rotate the gain knob clockwise to adjust the is dark. value. brightness of the ultrasonic image. 2) The STC level is close to the minimum 2) Press the STC key to set the STC level value.

  • Page 100: Main Specification

    [Note] Use in combination with the VP-4450HD processor, XL-4450 light source and SU-1 ultrasonic processor. <Applied Part> Insertion portion <Data about Main Unit> Model EG-580UT Viewing direction 40° Observation range 3 to 100 mm Field of view 140° Distal end diameter 13.9 mm...
  • Page 101 Main Specification Model EG-580UT Color Doppler , Power Doppler, Pulse wave, Scanning mode B mode, M mode Scanning method Electronic convex scanning method Same as the insertion direction of the ultrasonic Scanning direction endoscope Scanning angle 150° (Combination with SU-1)
  • Page 102 Main Specification <Term of Validity, Period for Use (Durability)> The term of validity (durability) is six years after beginning of use, if proper maintenance and inspection are performed. “Based on our company’s criteria” [Note] Except consumable supplies <Compatible Processor, etc.> Ultrasonic processor SU-1 Processor...
  • Page 103 Slotted hole BF2418LN Alligator BF2218A Grasping forceps: Three prong GF2318T V-shape GF2418V Basket GF2318B High-frequency snare: Half-moon DS2323M Square DS2323H Coagulation: Round DC1818R Cleaning DC2318S [Note] For combination with accessories other than those above, contact your local FUJIFILM dealer. 202B1262575D...
  • Page 104 Main Specification <Image Size> <Direction of Forceps> <Medical Device Directive> This product complies with the requirements of European Directive 93/42/EEC. Classification : Class II a 202B1262575D...
  • Page 105 Main Specification <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 106 Main Specification 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 EN 61000-4-2 ±...
  • Page 107 Main Specification 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 transmitter.

  • Page 108: Service

    1) If this product does not work properly, check it first by reading this manual again and follow all instructions and troubleshooting tips. 2) If this product is still not working well, contact your local FUJIFILM dealer. Contact your local Fujinon/Fujifilm dealer when this product is returned for repair.

  • Page 109: Disposal Of Electric And Electronic Equipment

    The recycling of materials will help to conserve natural resources. For more detailed information about recycling of this product, contact your local FUJIFILM dealer. In Countries outside the EU: If you wish to discard this product, contact your local authorities and ask for the correct way of disposal.

  • Page 110: Index

    Index Index <A> <S> Accessories ............102 S connector ............34 Air/water valve ............35 Storage environment ...........101 Angulation knob ........35, 40, 41 SU-1 ..............32 Suction connector ..........34 <B> Suction valve ..........30, 35, 44 Bending section .........35, 40, 41 <T> <C> Transducer ............36, 63 Cart ................32 Transport environment ........101 CAUTION ...............5...

  • Page 111: Service Centers

    Contact our regional representative below or the distributor from which you purchased the product. <Europe> FUJIFILM Europe GmbH http://www.fujifilm.eu/eu/ See our website to locate our representative in your country. <USA> Fujifilm Medical Systems U.S.A., Inc http://www.fujifilmendoscopy.com/ (800) 385-4666 <Australia> FUJIFILM Australia Pty Ltd. http://www.fujifilm.com.au/ 1800 060 209 <Asia>...
  • Page 112 FUJIFILM Corporation 26-30, Nishiazabu 2-chome, Minato-ku, Tokyo 106-8620, Japan FUJIFILM Europe GmbH Heesenstrasse 31, 40549 Duesseldorf, Germany 202B1262575D 160705 - 5.0 - DT - E2 FU47A Printed in Japan...

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