Page 1 Precautions OPERATION MANUAL Product Overview Workflow Preparation and Inspection How to Use Duodenoscope ED-580XT Troubleshooting Service Appendix This Operation Manual provides details on how to prepare and operate the endoscope and describes cautions to be observed. Please read this manual thoroughly before operating the endoscope.
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Page 3: Contents At A Glance
Contents at a Glance Introduction This chapter explains about this manual. Precautions Chapter Before using this product, read this chapter carefully so that you can operate it correctly. This chapter describes the warnings and cautions for safe operation of the endoscope. Product Overview Chapter This chapter describes details on the accessories supplied with this product,...
Page 4: Table Of Contents
Contents Contents Contents at a Glance ......................iii Introduction About This Manual ......................1 ♦ Endoscope Operation Manuals ...............2 How to Read This Manual ....................3 ♦ Terms ......................3 ♦ Conventions Used in This Manual ............3 Chapter 1 Precautions Intended Use ......................1-1 Applicability of Endoscopy and Endoscopic Treatment .........1-1 1.3 User Qualifications ....................1-2 1.4 Prohibition of Modification and Improper Repair ............1-2...
Page 5 Nomenclature and Functions of Endoscope ............2-4 ♦ LG Connector ..................2-6 ♦ Video Connector ...................2-6 ♦ LG Flexible Portion ................2-6 ♦ Interconnect Cable ................2-6 ♦ Control Portion ..................2-7 ♦ Boot ......................2-8 ♦ Insertion Portion (Applied Part) ............2-8 Nomenclature and Functions of Distal End of Endoscope ........2-9 Location of Each Label ..................2-10 2.4.1 Location of Labels ..................2-10...
Page 6 Contents 4.4.2 Suction Valve ..................4-14 4.4.3 Air/Water Valve ..................4-16 4.4.4 Distal End Cap ..................4-18 Preparing Related Equipment ................4-20 4.5.1 Inspecting Related Equipment ..............4-20 4.5.2 Preparing System ...................4-20 Connecting Endoscope to Light Source, Processor and Related Equipment ..4-22 4.6.1 Connecting to Light Source ..............4-22 4.6.2 Connecting to Processor ................4-23 4.6.3...
Page 7 Chapter 6 Troubleshooting Troubleshooting .....................6-2 6.1.1 Problem with Displayed Images ...............6-2 6.1.2 Problem with Scope Switch ..............6-3 6.1.3 Problem with Bending Section ..............6-3 6.1.4 Problem with Air/Water Supply ..............6-4 6.1.5 Problem with Suction ................6-4 6.1.6 Problem with Related Equipment .............6-5 ♦...
Page 8 Contents ♦ Endoscopic CO Regulator and Accessories ......Appendix-5 ♦ Electrosurgical Unit ..............Appendix-6 ♦ Air Leak Tester ................Appendix-6 ♦ Mouthpiece ................Appendix-6 ♦ Compatible Endotherapy Devices ...........Appendix-6 ♦ Medical Device Directive ............Appendix-6 Electromagnetic Compatibility (EMC) Information ..........Appendix-7 Disposal of Electric and Electronic Equipment ..........Appendix-16 Index ........................Appendix-17 viii 897N200877B...
Page 9: Introduction
The company names and product names described in this manual are trademarks or registered trademarks of FUJIFILM Corporation or its subsidiaries. Other holders’ trademarks All other company names and product names described in this manual are trademarks or registered trademarks of their respective owners. Copyright © 2018 FUJIFILM Corporation. All rights reserved. 897N200877B...
Page 10: Endoscope Operation Manuals
♦ Endoscope Operation Manuals Manage and store “Operation Manual” and “Reprocessing Manual” together as a set. Endoscope Operation Manual Model: ED-580XT This manual provides necessary information for using the endoscope such as the equipment overview, operation procedures and precautions to observe.
Page 11: Terms
How to Read This Manual ♦ Terms Term Description It refers to disinfection or sterilization performed after the manual Reprocessing cleaning of the endoscope and its accessories according to the Reprocessing Manual supplied with this product. This product It refers to the endoscope with or without attached accessories. It refers to the parts and devices included in the package or Standard accessory supplied with this product.
Page 12 Introduction 897N200877B...
Page 13: Chapter 1 Precautions
Intended Use FUJIFILM Endoscope Model ED-580XT is intended for the observation, diagnosis and endoscopic treatment of the esophagus, stomach and duodenum at medical facilities under the management of physicians.
Page 14: User Qualifications
Even if you find a defect, do not attempt to repair these products yourself. FUJIFILM Corporation shall not be liable for any defects, adverse events or device failures caused by such modifications, disassembly, repairs or reverse-engineering.
Page 15: Reprocessing Before The First Use/Reprocessing And Storage After Use
Reprocessing Before the First Use/Reprocessing and Storage After Use 1.5.1 Reprocessing Before the First Use/Reprocessing After Use This product has not been reprocessed. The endoscope and its accessories must be reprocessed prior to first use as per instructions provided in the Reprocessing Manual. After using the endoscope and its accessories, reprocess and store them according to the instructions provided in the Reprocessing Manual.
Page 16: Storage After Use
The more the product is used, the greater the probability of failure of the endoscope and its accessories. Do not use the endoscope that shows any sign of abnormality or irregularity. Take appropriate measures by following “Chapter 6 Troubleshooting.” If the irregularity is still observed after inspection, contact your local FUJIFILM dealer. 897N200877B...
Page 17: Symbols
Symbols This section explains the safety signs used in this product. Symbol Description Do not re-use / Single patient use only Lot number Serial number Year of manufacture Manufacturer Authorised representative in the European Community Refer to instructions for use (Blue) Temperature limitation Keep dry...
Page 18: Precautions For Transportation
• Contact your local FUJIFILM dealer when this product is returned for repair. Be sure to reprocess this product before returning for repair. If a product which is not reprocessed is returned, it can create a risk of infection to users, service personnel or other persons in contact with it.
Page 19: Electromagnetic Compatibility (Emc)
• Take mitigation measures such as shielding the installation location of any affected device. 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. 897N200877B...
Page 20 Chapter 1 Precautions Do not use this product near devices, such as MRI systems, that generate strong electromagnetic waves. Doing so may cause malfunction of this product. (If this product is used in combination with an electrosurgical unit, follow the instructions provided in the operation manuals of the electrosurgical unit and high-frequency endotherapy device.) 897N200877B...
Page 21: General Warnings And Cautions
1.12 General Warnings and Cautions Observe the following cautions when handling this product. Also, there are same cautions in each chapter. 1.12.1 Precautions for Inspection Before Use WARNING • Make sure to inspect the endoscope and accessories before use according to the procedures provided in this manual.
Page 22: Handling Precautions
• If abnormalities and/or material changes including but not limited to cracking, flaking, pitting, corrosion, etc. which can create sharp edges, compromise sealed surfaces and/or negatively affect device functionality are found, contact your local FUJIFILM dealer. 1.12.2 Handling Precautions WARNING •...
Page 23 WARNING • During an inspection or procedure, use sterile water. If sterile water is not used, it can create a risk of infection. • Do not quickly release one’s finger from the suction valve during aspiration. Doing so may cause a splattering of body fluids from the suction valve and increase a risk of infection. •...
Page 24 • If the bending section does not return to its neutral position during a procedure, do not withdraw the endoscope forcibly. Consult your local FUJIFILM dealer. If the endoscope is withdrawn forcibly, injury to tissues in the body cavity, bleeding and/or perforation may result.
Page 25 CAUTION • Do not use this product outside the operating environment specified in “Main Specification.” Otherwise, it can cause product malfunction or failure. • Do not apply unnatural force or impact on the insertion portion, bending section, control portion, LG flexible portion, LG connector or video connector. Doing so may cause malfunction of the endoscope.
Page 26 Chapter 1 Precautions CAUTION • If the distal end cap becomes misaligned or falls off during a procedure, stop the procedure immediately and slowly withdraw the endoscope. Otherwise, it may cause injury to tissues in the body cavity. • Insert the endotherapy device slowly. The endotherapy device may bend if it is inserted quickly.
Page 27: Abnormalities During Use Of This Product
Note If any abnormality occurs with this product, refer to “Chapter 6 Troubleshooting.” Should any safety concerns arise with this product, contact your local FUJIFILM dealer. 1.12.4 Precautions for Distal Elevator/Recess CAUTION •...
Page 28: Precautions For Equipment Used In Combination
Chapter 1 Precautions 1.13 Precautions for Equipment Used in Combination Use this product in combination with related equipment described in this manual. “Appendix - Related Equipment Used in Combination” Using related equipment not described in this manual can result in not only abnormal operations but also equipment damage and/or patient or end-user injury.
Page 29 CAUTION • Use this product only in combination with related equipment described in this manual. Otherwise, it creates a risk of equipment malfunction. • Use the endoscopic CO regulator described in this manual. If another insufflation device is connected, the air/water supply function lessens and may result in improper cleaning of the lens.
Page 30: Precautions For High-Frequency Treatment
Chapter 1 Precautions 1.13.1 Precautions for High-Frequency Treatment WARNING • Set the minimum required output power of the electrosurgical unit and high-frequency endotherapy device within the specified output range as per instructions provided in the operation manual of the electrosurgical unit and high-frequency endotherapy device. If the output power is inappropriate, it may cause injury to tissues in the body cavity, thermal injury, bleeding or perforation.
Page 31: Precautions For Endotherapy Device And Syringe
CAUTION • Prevent patient’s body from touching electric conductor such as metal part of bed while performing high-frequency treatment. It could cause thermal injury to a patient due to energization via the conductive part. • When performing high-frequency treatment, take care that patient’s vomitus or body fluids do not make contact with the conductive parts such as a metal part of the bed.
Page 32 Chapter 1 Precautions 1-20 897N200877B...
Page 33: Chapter 2 Product Overview
Check the endoscope and other components in the package against the items shown in the figures below. Inspect the endoscope and each component for damage. If the endoscope or a component is damaged, or if a component is missing, contact your local FUJIFILM dealer. 2.1.1...
Page 34: Accessories
Chapter 2 Product Overview 2.1.2 Accessories Note Figures in parentheses indicate the number of articles. Air/Water Channel Forceps Valve * Suction Valve * Air/Water Valve * Cleaning Adapter FOV-DV7 (11) SB-605 (1) AW-603 (1) CA-611 (1) Injection Tube Cylinder Adapter Syringe WA-007 WA-010...
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Page 36: Nomenclature And Functions Of Endoscope
Chapter 2 Product Overview Nomenclature and Functions of Endoscope This product consists of the following parts. ♦ LG Flexible Portion ♦ Interconnect Cable ♦ LG Connector ♦ Video Connector 8. Lock Handle 6. Ventilation Connector 9. Waterproof Cap 5. Water Supply Connector 4. Light Guide Cover Glass 3.
Page 37 10. Up/Down Angulation Lock 21. Scope Switches “1” to “3” 11. Up/Down Angulation Knob 20. Suction Valve Cylinder 19. Suction Valve ♦ Control Portion 18. Air/Water Valve 12. Left/Right Angulation Lock 17. Air/Water Valve Cylinder 13. Left/Right Angulation Knob 22. Scope Switches “4” 16.
Page 38: Lg Connector
Chapter 2 Product Overview ♦ LG Connector The LG connector is connected to the light source. Name Function Suction Connector Accepts the tube from the suction unit. Supplies air from the pump of the light source to the Air Guide Port endoscope.
Page 39: Control Portion
♦ Control Portion The control portion is used for operating each function of the endoscope. Hold this portion during a procedure. Name Function Maintains the up/down angle of the bending section. Moving this lock in the direction of F (Free) unlocks the up/ down movement of the bending section, allowing external Up/Down Angulation force to angulate the bending section freely.
Page 40: Boot
Chapter 2 Product Overview Name Function One of the accessories for the endoscope. Pressing this valve supplies water and covering the hole in this valve with Air/Water Valve one's finger supplies air to the air/water nozzle in the distal end of the endoscope. One of the accessories for the endoscope.
Page 41: Nomenclature And Functions Of Distal End Of Endoscope
Nomenclature and Functions of Distal End of Endoscope 3. Instrument Channel <Direction of Forceps> 1. Imaging Section Outlet 2. Air/Water Nozzle 4. Objective Lens 5. Light Guides 6. Forceps Elevator Name Function This section receives an image focused on its surface by the Imaging Section distal objective lens.
Page 42: Location Of Each Label
Chapter 2 Product Overview Location of Each Label The positions where the labels are affixed on this product are shown below. 2.4.1 Location of Labels <Control Portion> Instrument Channel Diameter Label Model Label <LG Connector> Label for the Serial Number Label for the Year of Manufacture LG Connector Label...
Page 43: System Configuration
System Configuration This product is used in combination with related equipment. The recommended combination of related equipment that can be used with this product is listed below. Related equipment is optional. WARNING • Use this product only in combination with related equipment described in this manual. Otherwise, it is unable to ensure its functionality, and may cause severe harm to patient or end-users.
Page 44 Chapter 2 Product Overview 2.5.1 System Configuration (Combination with VP-7000 and BL-7000) Cart Data Keyboard Suction Unit * Foot Switch Processor * VP-7000 VP-4450HD VP-3500HD Water Tank Water Tank WT-2 WT-04G WT-4 Light Source * BL-7000 XL-4450 Endoscopic CO Regulator Monitor GW-100 Printer...
Page 45 In addition, the related equipment described here may have already been discontinued or not marketed depending on the country or region. For details on the devices used in combination with this product, contact your local FUJIFILM dealer. Gas/Water Valve * AW-604G...
Page 46: System Configuration (Combination With Ep-6000)
Chapter 2 Product Overview 2.5.2 System Configuration (Combination with EP-6000) Suction Unit * Cart Data Keyboard Foot Switch Water Tank Water Tank WT-2 WT-04G WT-4 Processor EP-6000 Monitor Endoscopic CO Regulator Printer GW-100 Video Recorder *1 Use a suction unit which complies with EN 60601-1 (IEC 60601-1) and can set suction pressure to 40 to 53 kPa. 2-14 897N200877B...
Page 47 In addition, the related equipment described here may have already been discontinued or not marketed depending on the country or region. For details on the devices used in combination with this product, contact your local FUJIFILM dealer. Gas/Water Valve * AW-604G...
Page 48 Chapter 2 Product Overview 2-16 897N200877B...
Page 49: Chapter 3 Workflow
Chapter Workflow This chapter describes the workflow of endoscopy, which differs depending on the type of endoscope and accessories to be used. Have an understanding about the workflow and read the relevant sections thoroughly before use. 897N200877B...
Page 50: When Using Standard Functions
Chapter 3 Workflow When Using Standard Functions Inspecting Endoscope Inspecting and Connecting Related Inspecting Each Attaching Equipment Function Accessories 4.3.1 4.4.1 4.7.1 Inspecting Control Forceps Valve Preparing Related Inspecting Endoscopic Portion Equipment Images 4.3.2 4.4.2 4.6.1 4.7.2 Inspecting Insertion Suction Valve Connecting to Light Inspecting Scope Switch Portion...
Page 51 Preparation Insertion and Treatment Withdrawal Before Use Observation 5.2.1 Treatment Endoscope Withdrawal Preparation Insertion 5.2.2 Observing Endoscopic Detaching Distal End Image 5.2.3 Operating Scope Switch 5.2.4 Bending Operation 5.2.5 Operating Air/Water Valve 5.2.6 Operating Suction Valve Injecting Fluids from Instrument Channel Inlet ERCP 897N200877B...
Page 52 Chapter 3 Workflow 897N200877B...
Page 53: Chapter 4 Preparation And Inspection
FUJIFILM dealer. Note The endoscope and accessories are not reprocessed before shipping from FUJIFILM. Reprocess them according to the instructions given in the Reprocessing Manual before using them in a procedure.
Page 54: Preparation Of The Equipment
Chapter 4 Preparation and Inspection Preparation of the Equipment Prepare the endoscope, accessories, related equipment and personal protective equipment. Related equipment not supplied with this product is optional. Also refer to the operation manual of related equipment and personal protective equipment. ♦ Endoscope Note Prepare the endoscope that has been reprocessed as per instructions provided in the...
Page 55: Related Equipment (Essential)
In addition, the devices described here may have already been discontinued or not marketed depending on the country or region. For details on the devices used in combination with this product, contact your local FUJIFILM dealer. Endoscopic CO Regulator...
Page 56: Personal Protective Equipment
Chapter 4 Preparation and Inspection ♦ Personal Protective Equipment Chemical-resistant and Protective Goggles Facemask Waterproof Gloves * Clothing * *1 It is also recommended to use shoes that can be disinfected and/or a single-use shoes cover. *2 Chemical-resistant and waterproof gloves are recommended to be long enough to prevent your skin from being exposed.
Page 57: Transporting Endoscope
Transporting Endoscope This section explains how to transport the reprocessed endoscope. When transporting the endoscope that has been pre-cleaned after use, refer to the Reprocessing Manual. “Reprocessing Manual” WARNING • Carry a reprocessed endoscope in a clean manner. If personal protective equipment such as gloves is contaminated, the contaminants adhere to the endoscope and it can be a source of infection.
Page 58: Inspecting Endoscope
Chapter 4 Preparation and Inspection Inspecting Endoscope Prior to inspection, make sure that dirt does not adhere to the endoscope. If dirt adheres to the endoscope, reprocess it according to the instructions given in the Reprocessing Manual. 4.3.1 Inspecting Control Portion Visually and manually inspect the control portion for excessive scratches, deformation, cracks, residue, loose parts, or other irregularities.
Page 59: Inspecting Distal End
4.3 Inspecting Endoscope Control Portion Insertion Portion Distal End Bending Section Forceps Elevator LG Connector Hold the insertion tube with both hands to make a semicircle with a diameter of approximately 200 mm. Then, move the apex of semicircle sliding insertion tube for full length. Check that the tube bends fully and there are no areas of excessive rigidness or stiffness.
Page 60: Inspecting Bending Section
Chapter 4 Preparation and Inspection 4.3.4 Inspecting Bending Section WARNING • Turn the up/down and left/right angulation knobs slowly in each direction until they stop. Repeat this operation several times to confirm that the bending section angulates smoothly and correctly. If the endoscope with an abnormal angulation knob is used, the bending section does not return to its neutral position, causing patient injury.
Page 61: Inspecting Up/Down Angulation
4.3 Inspecting Endoscope Control Portion Insertion Portion Distal End Bending Section Forceps Elevator LG Connector <When the up/down and left/right angulation knobs are in the neutral positions> When the up/down and left/right angulation knobs are turned to their respective neutral positions, visually check that the bending section returns smoothly to an approximately straight condition.
Page 62: Inspecting Left/Right Angulation
Chapter 4 Preparation and Inspection ♦ Inspecting Left/Right Angulation Move the left/right angulation lock all the way in the opposite direction of F (Free) to lock the left/right angulation knob. Note When the up/down or left/right angulation lock is moved in the opposite direction of F (Free), the rotation of the up/down or left/right angulation knob becomes harder, and even when fully locked the angulation knob and the distal bending section still can be moved.
Page 63: Inspecting Forceps Elevator Mechanism
4.3 Inspecting Endoscope Control Portion Insertion Portion Distal End Bending Section Forceps Elevator LG Connector 4.3.5 Inspecting Forceps Elevator Mechanism Lower the forceps elevator lever to raise the forceps elevator. Raise the forceps elevator lever to lower the forceps elevator. 4.3.6 Inspecting LG Connector S Connector...
Page 64: Inspecting Video Connector
Chapter 4 Preparation and Inspection 4.3.7 Inspecting Video Connector Visually and manually inspect the video connector for abnormalities such as dirt on the pin, broken or bent pin, excessive scratches, dents, deformation or loose parts. 4-12 897N200877B...
Page 65: Inspecting And Attaching Accessories
<Preparation> The forceps valve is not reprocessed before shipping from FUJIFILM. Reprocess it according to the instructions given in the Reprocessing Manual before using it in a procedure. Reprocessing Manual <Inspection>...
Page 66: Suction Valve
If the suction valve is attached forcibly, it may be damaged. <Preparation> The suction valve is not reprocessed before shipping from FUJIFILM. Reprocess it according to the instructions given in the Reprocessing Manual before using it in a procedure. Reprocessing Manual...
Page 67 4.4 Inspecting and Attaching Accessories Forceps Valve Suction Valve Air/Water Valve Distal End Cap <Inspection> Visually check that the suction valve is free from abnormalities such as tears, distortions, cracks, indentations, etc. Note The suction valve is a consumable item. If any abnormality is found, use a new reprocessed valve.
Page 68: Air/Water Valve
<Preparation> The air/water valve is not reprocessed before shipping from FUJIFILM. Reprocess it according to the instructions given in the Reprocessing Manual before using it in a procedure. Reprocessing Manual <Inspection>...
Page 69 4.4 Inspecting and Attaching Accessories Forceps Valve Suction Valve Air/Water Valve Distal End Cap <Attachment> CAUTION • Slowly insert the air/water valve straight into the air/water valve cylinder of the endoscope. If the air/water valve is attached forcibly, it may be damaged. Note The air/water valve and the air/water valve cylinder have a blue marking.
Page 70: Distal End Cap
• Do not hold the bending portion tightly when attaching or detaching the distal end cap. There is a risk of damaging the endoscope. <Preparation> The distal end cap is not reprocessed before shipping from FUJIFILM. Reprocess it according to the instructions given in the Reprocessing Manual before using it in a procedure. Reprocessing Manual <Inspection>...
Page 71 4.4 Inspecting and Attaching Accessories Forceps Valve Suction Valve Air/Water Valve Distal End Cap <Attachment> Installation groove Hold the bending section (hard portion). Cover the distal end cap until the installation groove of the distal end is hidden completely. Embed the distal end cap into the installation groove by pushing the edge of the cap with one's finger.
Page 72: Preparing Related Equipment
Inspect related equipment as per instructions provided in each operation manual. Note Some pieces of related equipment are not reprocessed before shipping from FUJIFILM or the manufacturer. Reprocess them for the first time prior to use as per instructions provided in respective operation manuals.
Page 73 • The water in the water tank should be changed at least daily using sterile water. • Use a reprocessed water tank. • FUJIFILM water tanks must be reprocessed at least daily. These water containers are 24-hour multiple patient use devices which should not be used longer than 24 hours without additional reprocessing.
Page 74: Connecting Endoscope To Light Source, Processor And Related Equipment
Chapter 4 Preparation and Inspection Connecting Endoscope to Light Source, Processor and Related Equipment This section explains how to connect the endoscope to the light source, processor and related equipment. 4.6.1 Connecting to Light Source WARNING • Firmly connect the LG connector of the endoscope and the light source as well as the video connector and the processor.
Page 75: Connecting To Processor
4.6 Connecting Endoscope to Light Source, Processor and Related Equipment Light Source Processor Water Tank Suction Unit 4.6.2 Connecting to Processor WARNING • Firmly connect the video connector of the endoscope and the processor. If the video connector is not connected properly, the endoscopic image may flicker or be lost, which may cause patient injury, bleeding and/or perforation.
Page 76: Attaching Water Tank
Chapter 4 Preparation and Inspection 4.6.3 Attaching Water Tank CAUTION • Attach the water tank to the specified position of the cart or light source. Otherwise, fluid may leak from the connector of the water tank and it may come into contact with related equipment, causing equipment failure.
Page 77: Attaching Suction Unit
4.6 Connecting Endoscope to Light Source, Processor and Related Equipment Light Source Processor Water Tank Suction Unit 4.6.4 Attaching Suction Unit WARNING • Firmly connect the suction tube from the suction unit to the suction connector on the LG connector. If the suction tube is not attached properly, body fluid may drip from the tube and can pose an infection control risk.
Page 78: Inspecting Functions Used In Combination With Related Equipment
Chapter 4 Preparation and Inspection Inspecting Functions Used in Combination with Related Equipment 4.7.1 Inspecting Endoscopic Images Confirm that endoscopic images are normally displayed on the monitor and that the images are clear, sharp, of appropriate color and accuracy of observed target sites. WARNING •...
Page 79: Inspecting Scope Switch
4.7 Inspecting Functions Used in Combination with Related Equipment Endoscopic Images Scope Switch Air/Water Supply Function Suction Function Up/Down Angulation Knob Left/Right Angulation Knob Angulate the bending section by operating the up/down or left/right angulation knob of the endoscope and confirm that the endoscopic image is free from momentary disappearing or other irregularities.
Page 80: Inspecting Air/Water Supply Function
Chapter 4 Preparation and Inspection 4.7.3 Inspecting Air/Water Supply Function WARNING • If water leaks from the air/water valve during the inspection of the air/water supply function, replace it with a new one already reprocessed. A leaking air/water valve may cause backflow of body fluid, posing an infection control risk.
Page 81: Inspecting Suction Function
4.7 Inspecting Functions Used in Combination with Related Equipment Endoscopic Images Scope Switch Air/Water Supply Function Suction Function 4.7.4 Inspecting Suction Function WARNING • If water leaks from the forceps valve or suction valve during the inspection of the suction function, replace it with a new one already reprocessed.
Page 82 Chapter 4 Preparation and Inspection 4-30 897N200877B...
Page 83: Chapter 5 How To Use
Chapter How to Use This chapter describes the basic operation procedures of this product and precautions to observe. This product is intended for use by medical professionals who have received proper training in endoscopic procedures at medical facilities under the management of physicians. This manual does not provide information about procedures or any aspects of endoscopic techniques.
Page 84 Chapter 5 How to Use CAUTION • Do not subject the video connector or the LG connector to strong impact. Install the processor and the light source away from obstacles to prevent the video connector connected to the processor and the LG connector connected to the light source from accidental impact damage.
Page 85: Preparation
Preparation 5.1.1 Preparing Related Equipment Prepare related equipment to be used, including back-up or spare endoscope, scope components (valves, distal caps, etc.) and accessories (ex. water tank, endotherapy devices, etc.) 5.1.2 Pretreatment of Patient Prepare the patient in the normal endoscopy regimen. 5.1.3 Preparing Mouthpiece Prepare a mouthpiece per manufacturer’s instructions.
Page 86: Insertion And Observation
Chapter 5 How to Use Insertion and Observation 5.2.1 Insertion WARNING • Do not forcibly advance or withdraw the endoscope into/from the patient, angulate the bending section forcibly or operate it quickly. It may cause patient injury, bleeding or perforation. •...
Page 87 Unlock the bending section by turning the up/down and left/right angulation locks in the direction of F (Free) until they stop. Note The procedure described above is recommended. However, other techniques are also available: you can insert endoscope by locking the bending section only in the left-right direction and unlocking it in the up-down direction.
Page 88: Observing Endoscopic Image
Chapter 5 How to Use 5.2.2 Observing Endoscopic Image Refer to the operation manual of the light source and processor for instructions on how to adjust the brightness, color, etc. CAUTION • During an observation, do not perform close observation for an extended period of time. Use the endoscope with a minimum necessary amount of brightness and time while maintaining an appropriate distance.
Page 89: Operating Scope Switch
• If the bending section does not return to its neutral position during a procedure, do not withdraw the endoscope forcibly. Consult your local FUJIFILM dealer. If the endoscope is withdrawn forcibly, injury to tissues in the body cavity, bleeding and/or perforation may result.
Page 90 Chapter 5 How to Use Operation of Up/Down Angulation Knob Operation of Left/Right Angulation Knob Steer the distal end of the endoscope to the region of interest by turning the up/down and left/ right angulation knobs. Note To retain the bending angle securely, hold the up/down and left/right angulation knobs by hand.
Page 91: Operating Air/Water Valve
5.2.5 Operating Air/Water Valve Operate the air/water valve to supply air or water from the air/water nozzle in the distal end during a procedure. Note Do not operate the air/water valve under the following conditions while the endoscope is inserted in the body cavity. Doing so may cause the backflow of body fluid and contaminate the sterile water in the water tank.
Page 92: Operating Suction Valve
Chapter 5 How to Use 5.2.6 Operating Suction Valve WARNING • Set the suction pressure between 40 and 53 kPa. If the suction pressure is too high, patient debris or fluids may leak or splash from the forceps valve, posing infection control risks to patient or operator.
Page 93: Injecting Fluids From Instrument Channel Inlet
Injecting Fluids from Instrument Channel Inlet WARNING • When injecting fluids by attaching a syringe to the forceps valve, open the lid of the forceps valve and insert the syringe straight into the forceps valve. Otherwise, the forceps valve may be damaged or the syringe may be accidentally detached during fluid injection and body fluids may leak or splash from the forceps valve, posing an infection control risk to the patient or end-user.
Page 94: Ercp
Chapter 5 How to Use ERCP WARNING • Do not strongly press the cannulation tube against tissues in the body cavity. Otherwise, injury to tissues in the body cavity, bleeding and/or perforation may result. CAUTION • Insert the cannulation tube slowly. The cannulation tube may bend if it is inserted quickly. Angulate the bending section so that the duodenal papilla aperture comes to the center of the field of view.
Page 95 When the cannulation tube is advanced and contacts the forceps elevator and is unable to advance any further, slowly raise the forceps elevator lever and insert the cannulation tube by approximately 30mm. Note When the forceps elevator lever is slowly raised, the tip of the cannulation tube comes into the field of view from the right lower portion of the screen.
Page 96: Treatment
Chapter 5 How to Use Treatment Prior to performing endoscopic electrosurgery, one should have a thorough understanding of the manufacturers' instructions for all equipment involved and one should be familiar with the specific safety and usage aspects of each endotherapy device. 5.5.1 Using Endotherapy Devices WARNING...
Page 97 CAUTION • If resistance is encountered while advancing an endotherapy device within the instrument channel, do not forcibly advance the endotherapy device. Otherwise, it may cause malfunction of the endoscope. • When inserting an endotherapy device, close the lid of the forceps valve. If the lid is open, it can reduce the efficacy of the endoscope’s suction system, making it impossible to perform aspiration.
Page 98: Use Of Non-Flammable Gases
Chapter 5 How to Use 5.5.2 Use of Non-Flammable Gases If the intestines contain a flammable gas, replace it with air or a non-flammable gas such as air or CO before performing high-frequency treatment. WARNING • If the intestines contain a flammable gas, replace it with air or a non-flammable gas such as air or CO before performing high-frequency treatment.
Page 99 WARNING • Use an electrosurgical unit conforming to EN 60601-2-2 (IEC 60601-2-2). If any other electrosurgical unit is used, it may cause severe harm to patient and/or end-users. • Use the electrosurgical unit and related endotherapy devices per instructions provided in the operation manual for each respective device.
Page 100: Endoscope Withdrawal
Chapter 5 How to Use Endoscope Withdrawal (4) (5) WARNING • Unless the endoscope's bending section is in a neutral position (essentially "straight"), do not withdraw the endoscope whenever the endoscopic image is compromised, unclear, blurry, etc. due to any reason or condition including loss of image, power interruption, water droplets or dirt/debris adhering to the objective lens, etc.
Page 101: Detaching Distal End Cap
Detaching Distal End Cap WARNING • Unless the endoscope’s bending section is in a neutral position (essentially “straight”), do not withdraw the endoscope whenever the endoscopic image is compromised, unclear, blurry, etc. due to any reason or condition including loss of image, power interruption, water droplets or dirt/debris adhering to the objective lens, etc.
Page 102: Reprocessing Endoscope
Chapter 5 How to Use Reprocessing Endoscope After withdrawing the endoscope and discarding single-use components/accessories consistent with manufacturers' recommendations, reprocess the endoscope and its accessories as per instructions provided in the Reprocessing Manual. Reprocessing Manual WARNING • Immediately upon completion of the procedure, it is imperative that pre-cleaning is performed as per instructions provided in the Reprocessing Manual.
Page 103: Chapter 6 Troubleshooting
“6.1 Troubleshooting.” If the problem persists even after following troubleshooting chart in “6.1 Troubleshooting”, consult your local FUJIFILM dealer and return the product for evaluation and/or repair according to “6.4 Returning Endoscope for Repair.” If any abnormality occurs during a procedure, immediately stop using the product and withdraw the endoscope from the patient according to “6.2 Withdrawal of Endoscope with Abnormality.”...
Page 104: Problem With Displayed Images
Chapter 6 Troubleshooting Troubleshooting 6.1.1 Problem with Displayed Images Problem Cause Remedy No images The cart, monitor, processor or light Plug the cart, monitor, processor or light source is unplugged from the outlet. source into the main outlet. The cart, monitor, processor or light Power ON the cart, monitor, processor or source is OFF.
Page 105: Problem With Scope Switch
Problem Cause Remedy Distorted image High-frequency interference. Stop power supply to the high-frequency endotherapy device to restore image output. The endoscope is working properly. The endoscope is not connected Connect the endoscope properly to the light correctly to the light source. source.
Page 106: Problem With Air/Water Supply
Chapter 6 Troubleshooting 6.1.4 Problem with Air/Water Supply Problem Cause Remedy No air/water The operation of the air pump in the Select the operation of the air pump from supply light source is set to off. among “HI”, “MID” and “LOW” by following the instructions described in the operation manual of the light source.
Page 107: Problem With Related Equipment
Suction valve is damaged. Replace with a new suction valve. Suction valve The suction valve or the control Contact your local FUJIFILM dealer. cannot be portion of the endoscope has been detached. damaged. Fluid leaks from...
Page 108: Problem With Image Recorder
Chapter 6 Troubleshooting Problem Cause Remedy Endotherapy The endotherapy device (such as Close the endotherapy device and pull it out device cannot biopsy forceps) is left open. from the endoscope. be withdrawn. The handle of the endotherapy Loosen the grip and pull out the endotherapy device (such as biopsy forceps) is device from the endoscope.
Page 109: Withdrawal Of Endoscope With Abnormality
Cannot be Restored.” If abnormalities of the withdrawn endoscope are not described in “6.3 Handling of Endoscope with Abnormality”, contact your local FUJIFILM dealer and return the endoscope for repair as described in “6.4 Returning Endoscope for Repair.” In addition, if the endoscope cannot be withdrawn smoothly, do not withdraw the endoscope forcibly and consult your local FUJIFILM dealer.
Page 110: When Endoscopic Images Do Not Appear On The Monitor Or A Frozen Image Cannot Be Restored
Chapter 6 Troubleshooting 6.2.2 When Endoscopic Images Do Not Appear on the Monitor or a Frozen Image Cannot be Restored Turn off the processor, light source, monitor, suction pump and other related equipment. When using an endotherapy device, slowly withdraw the endotherapy device from the endoscope.
Page 111: Handling Of Endoscope With Abnormality
Handling of Endoscope with Abnormality If the problem persists even after following “6.3.1 When Suction Valve Does Not Return to Its Original Position”, contact your local FUJIFILM dealer. 6.3.1 When Suction Valve Does Not Return to Its Original Position WARNING •...
Page 112 Chapter 6 Troubleshooting (14) Attach a sterile syringe to the suction channel side of the injection tube and aspirate sterile water with the syringe. While pressing the suction valve, flush sterile water into the instrument/ suction channel until the solid materials clogging the channel are removed. (15) Remove the weight of the injection tube from the clean basin filled with sterile water.
Page 113: Returning Endoscope For Repair
“Chapter 7 Service” WARNING • Contact your local FUJIFILM dealer when this product is returned for repair. Be sure to reprocess this product before returning for repair. If a product which is not reprocessed is returned, it can create a risk of infection to users, service personnel or other persons in contact with it.
Page 114 Chapter 6 Troubleshooting 6-12 897N200877B...
Page 115: Chapter 7 Service
• Problem caused by careless handling or misuse including use of non-compatible reprocessing systems or agents. • Malfunctions or damages due to products of other manufacturers not supplied by FUJIFILM. • Remodeling, maintenance, and repair using repair parts other than those specified by FUJIFILM.
Page 116 Chapter 7 Service 897N200877B...
Page 117: Appendix
Appendix This chapter describes main specifications, related equipment used in combination with this product, electromagnetic compatibility (EMC), etc. Main Specification ♦ Classification of Medical Electrical Equipment 1. Type of protection against electric shock: Class I equipment (power supply: protected ground fault receptacle) 2.
Page 118: Specifications
Appendix ♦ Specifications ED-580XT Optical system: Viewing direction 95° (retro-viewing 5°) Field of view 100° Observation range (mm) 4 to 60 Method of illumination Light guide method Image size Semi-super image Distal end diameter (mm) 13.1 Insertion tube diameter (mm) 11.3...
Page 119: Operating Environment, Transport Environment And Storage Environment
Operating Environment, Transport Environment and Storage Environment ♦ 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 Environment Temperature -20 to +60°C Humidity 10 to 85%RH (no dew condensation) Pressure 70 to 106 kPa (within range of atmospheric pressure) ♦ Storage Environment...
Page 120: Accessories
Appendix Accessories Accessories in the following tables are items whose life expectancy is limited and will require replacement once they show signs of wear or irregularity. Such accessories cannot be repaired or refurbished and should be replaced after any irregularity is observed. Name Model Forceps valve...
Page 121: Related Equipment Used In Combination
Note that 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. ♦ Compatible Processor and Light Source...
Page 122: Electrosurgical Unit
Endotherapy devices cannot be repaired or refurbished. Thus, if any abnormality is found, replace with a new one. Note For details on endotherapy devices used in combination with this product, consult your local FUJIFILM dealer. ♦ Medical Device Directive This product complies with the requirements of European Directive 93/42/EEC.
Page 123: Electromagnetic Compatibility (Emc) Information
Electromagnetic Compatibility (EMC) Information Medical electronic equipment requires special care with regards to EMC. This product must be installed and used according to the EMC information provided in Table 1 through Table 4 if both this product and the processor and light source , which are used in combination, comply with the requirements of EN 60601-1-2:2015 or that provided in Table 5 through Table 8 if either this product...
Page 124 Appendix <Electromagnetic Immunity Compliance Information and Guidance> Table 2 Guidance and Manufacturer Declaration - Electromagnetic Immunity - This device is intended for use in the following prescribed electromagnetic environments. Customers and users of this product are advised to check that it is being used in such environments. IEC 60601 Immunity test Compliance level...
Page 125 <Portable and Mobile RF Communications Equipment Compliance Information and Guidance> Table 3 Guidance and Manufacturer Declaration - Electromagnetic Immunity - This device is intended for use in the following prescribed electromagnetic environments. Customers and users of this product are advised to check that it is being used in such environments. IEC 60601 Immunity test Compliance level...
Page 126 Appendix a. Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless) telephones and land mobile radios, amateur radio, AM and FM radio broadcast and TV broadcast cannot be predicted theoretically with accuracy. To assess the electromagnetic environment due to fixed RF transmitters, an electromagnetic site survey should be considered.
Page 127 <Recommended Separation Distance Between Portable and Mobile RF Communications Equipment and this Product> Table 4 Recommended separation distance between portable and mobile RF communications equipment and this product. This product is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled.
Page 128 Appendix <Electromagnetic emission compliance information and guidance> Table 5 Guidance and Manufacturer Declaration - Electromagnetic Emission - This device is intended for use in the following prescribed electromagnetic environments. Customers and users of this product are advised to check that it is being used in such environments. Emission standard Compliance Guidance...
Page 129 <Electromagnetic Immunity Compliance Information and Guidance> Table 6 Guidance and Manufacturer Declaration - Electromagnetic Immunity - This device is intended for use in the following prescribed electromagnetic environments. Customers and users of this product are advised to check that it is being used in such environments. IEC 60601 Immunity test Compliance level...
Page 130 Appendix <Portable and Mobile RF Communications Equipment Compliance Information and Guidance> Table 7 Guidance and Manufacturer Declaration - Electromagnetic Immunity - This device is intended for use in the following prescribed electromagnetic environments. Customers and users of this product are advised to check that it is being used in such environments. IEC 60601 Immunity test Compliance level...
Page 131 <Recommended Separation Distance Between Portable and Mobile RF Communications Equipment and this Product> Table 8 Recommended separation distance between portable and mobile RF communications equipment and this product. This product is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled.
Page 132: 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 133: Index
Index Air guide port ........... 2-4 S Connector ............ 2-4 Air/water nozzle ..........2-9 Suction Connector ........... 2-4 Air/water valve ..........2-5 Suction Valve ..........2-5 Air/water valve cylinder ........2-5 Suction Valve Cylinder ........2-5 Bending Section ..........2-5 Up/Down Angulation Knob ......
Page 134 Appendix Appendix-18 897N200877B...
Page 135 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 136 Heesenstrasse 31, 40549 Duesseldorf, Germany EU Importer: FUJIFILM Europe B.V. Oudenstaart 1, 5047 TK Tilburg, The Netherlands Imported to Australia by: FUJIFILM Australia Pty Ltd 114 Old Pittwater Road, Brookvale, NSW. 2100, Australia 897N200877B 180920 - 3.0 - DT - E2 Printed in Japan...

FujiFilm ED-580XT Operation Manual

Chapter 1 Precautions

Chapter 2 Product Overview

Chapter 3 Workflow

Chapter 4 Preparation and Inspection

Chapter 5 How to Use

Chapter 6 Troubleshooting

Chapter 7 Service

Appendix

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Summary of Contents for FujiFilm ED-580XT

Table of Contents