ED-580XT Duodenscope Operation Manual Sept 2020



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Contents at a Glance Introduction This chapter explains about this manual. Chapter 1

Precautions 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.

Chapter 2

Product Overview

Chapter 3

Contents at a Glance

This chapter describes details on the accessories supplied with this product, the nomenclature and functions of the endoscope, and related equipment connected to this product.

Workflow This chapter describes the workflow of endoscopy, which differs depending on the type of endoscope and accessories to be used.

Chapter 4

Preparation and Inspection This chapter describes the inspection and preparation methods to be performed before using the endoscope, its accessories and related equipment.

Chapter 5

How to Use This chapter describes the basic operation procedures of this product and precautions to observe.

Chapter 6

Troubleshooting This chapter describes actions which should be taken if problems or questions occur while inspecting or using the endoscope.

Chapter 7

Service This chapter explains the services regarding this product.

Appendix This chapter describes main specifications, related equipment used in combination with this product, electromagnetic compatibility (EMC), etc.

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Contents

Contents Contents at a Glance... iii

Introduction

1

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

1-1

1.1

Intended Use...1-1

1.2

Applicability of Endoscopy and Endoscopic Treatment...1-1

1.3

User Qualifications...1-2

1.4

Prohibition of Modification and Improper Repair...1-2

1.5

Reprocessing Before the First Use/Reprocessing and Storage After Use...1-3 1.5.1

Reprocessing Before the First Use/Reprocessing After Use...1-3

1.5.2

Storage After Use...1-4

1.5.3

Disposal...1-4

1.6

For Safe Operation...1-4

1.7

Maintenance...1-4

1.8

Symbols...1-5

1.9

Precautions for Transportation...1-6

1.10 Precautions Against Electric Shock...1-6 1.11 Electromagnetic Compatibility (EMC)...1-7 1.12 General Warnings and Cautions...1-9 1.12.1 Precautions for Inspection Before Use...1-9 1.12.2 Handling Precautions...1-10 1.12.3 Abnormalities during Use of This Product...1-15 1.12.4 Precautions for Distal Elevator/Recess...1-15 1.13 Precautions for Equipment Used in Combination...1-16 1.13.1 Precautions for High-Frequency Treatment...1-18 1.13.2 Precautions for Endotherapy Device and Syringe...1-19

Chapter 2 2.1

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Product Overview

2-1

Checking Package Contents...2-1 2.1.1

Endoscope...2-1

2.1.2

Accessories...2-2

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2.2

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

2.3

Nomenclature and Functions of Distal End of Endoscope...2-9

2.4

Location of Each Label...2-10 2.4.1

2.5

3.1

Chapter 4 4.1

System Configuration...2-11 2.5.1

System Configuration (Combination with VP-7000 and BL-7000)...2-12

2.5.2

System Configuration (Combination with EP-6000)...2-14

Workflow

Contents

Chapter 3

Location of Labels...2-10

3-1

When Using Standard Functions...3-2

Preparation and Inspection

4-1

Preparation of the Equipment...4-2 ♦ Endoscope...4-2 ♦ Accessories...4-2 ♦ Related Equipment (Essential)...4-3 ♦ Related Equipment (To be Prepared when Necessary)...4-3 ♦ Personal Protective Equipment...4-4 ♦ Others...4-4

4.2

Transporting Endoscope...4-5

4.3

Inspecting Endoscope...4-6 4.3.1

Inspecting Control Portion...4-6

4.3.2

Inspecting Insertion Portion...4-6

4.3.3

Inspecting Distal End...4-7

4.3.4

Inspecting Bending Section...4-8 ♦ Inspection for Smooth Operation...4-8 ♦ Inspecting Up/Down Angulation...4-9 ♦ Inspecting Left/Right Angulation...4-10

4.4

4.3.5

Inspecting Forceps Elevator Mechanism...4-11

4.3.6

Inspecting LG Connector...4-11

4.3.7

Inspecting Video Connector...4-12

Inspecting and Attaching Accessories...4-13 4.4.1

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Forceps Valve...4-13

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Contents

4.5

4.6

4.7

Chapter 5 5.1

5.2

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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

Attaching Water Tank...4-24

4.6.4

Attaching Suction Unit...4-25

Inspecting Functions Used in Combination with Related Equipment...4-26 4.7.1

Inspecting Endoscopic Images...4-26

4.7.2

Inspecting Scope Switch...4-27

4.7.3

Inspecting Air/Water Supply Function...4-28

4.7.4

Inspecting Suction Function...4-29

4.7.5

Inspecting Instrument Channel...4-29

How to Use

5-1

Preparation...5-3 5.1.1

Preparing Related Equipment...5-3

5.1.2

Pretreatment of Patient...5-3

5.1.3

Preparing Mouthpiece...5-3

Insertion and Observation...5-4 5.2.1

Insertion...5-4

5.2.2

Observing Endoscopic Image...5-6

5.2.3

Operating Scope Switch...5-7

5.2.4

Bending Operation...5-7

5.2.5

Operating Air/Water Valve...5-9

5.2.6

Operating Suction Valve...5-10

5.3

Injecting Fluids from Instrument Channel Inlet...5-11

5.4

ERCP...5-12

5.5

Treatment...5-14 5.5.1

Using Endotherapy Devices...5-14

5.5.2

Use of Non-Flammable Gases...5-16

5.5.3

High-Frequency Treatment...5-16

5.6

Endoscope Withdrawal...5-18

5.7

Detaching Distal End Cap...5-19

5.8

Reprocessing Endoscope...5-20

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Chapter 6 6.1

Troubleshooting

6-1

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 ♦ Problem with Endotherapy Devices...6-5 ♦ Problem with Image Recorder...6-6

6.2

6.2.1

When Endoscopic Images Appear on the Monitor...6-7

6.2.2

When Endoscopic Images Do Not Appear on the Monitor or a Frozen Image Cannot be Restored...6-8

Handling of Endoscope with Abnormality...6-9 6.3.1

6.4

Chapter 7

Contents

6.3

Withdrawal of Endoscope with Abnormality...6-7

When Suction Valve Does Not Return to Its Original Position ...6-9

Returning Endoscope for Repair...6-11

Service

7-1

7.1

Service...7-1

7.2

After-Sales Service...7-1 ♦ Repairs during the warranty period...7-1 ♦ Repairs after the warranty period...7-1

Appendix

Appendix-1

Main Specification...Appendix-1 ♦ Classification of Medical Electrical Equipment...Appendix-1 ♦ Electromagnetic Compatibility (EMC) Related Standard...Appendix-1 ♦ Applied Part...Appendix-1 ♦ Specifications...Appendix-2 Operating Environment, Transport Environment and Storage Environment...Appendix-3 ♦ Operating Environment...Appendix-3 ♦ Transport Environment...Appendix-3 ♦ Storage Environment...Appendix-3 ♦ Term of Validity/Period for Use (Durability)...Appendix-3 Accessories...Appendix-4 Related Equipment Used in Combination...Appendix-5 ♦ Compatible Processor and Light Source...Appendix-5 ♦ Water Tank...Appendix-5 ♦ Suction Unit...Appendix-5 vii

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Contents

♦ Endoscopic CO2 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

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Introduction This chapter explains about this manual.

About This Manual

Introduction

This manual provides necessary information for using this product, such as the equipment overview, operation procedures and precautions to observe. In addition, the Reprocessing Manual supplied with this product describes the reprocessing and storage methods for the endoscope. This manual does not provide information about procedures or any aspects of endoscopic techniques. Before using this product, thoroughly read and understand this manual, the Reprocessing Manual and the manual of related equipment and use this product as instructed. Also, after reading this manual, store it close to this product for future reference to keep this product in optimum working condition. If you have any questions or comments about any information in this manual, contact your local FUJIFILM dealer.

This manual may not be reproduced in whole or in part in any form without prior permission. The information contained in this manual may be subject to change without prior notice. Trademarks 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.

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Introduction

♦ 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.

Endoscope Reprocessing Manual Model: ED-580XT This manual describes the reprocessing and storage methods of the endoscope.

Note

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In this manual, the Endoscope Operation Manual is referred to as “this manual”, and the Endoscope Reprocessing Manual as “the Reprocessing Manual.”

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How to Read This Manual ♦ Terms Term

Description It refers to disinfection or sterilization performed after the manual 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.

Standard accessory

It refers to the parts and devices included in the package or supplied with this product.

Accessory

It refers to the parts and devices directly attached to or used with the endoscope.

Related equipment

It refers to the devices directly or indirectly connected to or used with this product during a procedure.

Consumable item

It refers to parts and products whose life expectancy is limited and which require replacement once they show signs of wear or irregularity. Such parts and products cannot be repaired or refurbished and should be replaced after any irregularity (described in “Section 4.4 Inspecting and Attaching Accessories”) is observed.

Introduction

Reprocessing

♦ Conventions Used in This Manual This manual uses the following conventions for easier understanding. Convention

Description

WARNING

Explains dangerous situations that may cause death or serious injury if not avoided.

CAUTION

Explains situations that may cause injury if not avoided. Explains situations that may cause damage to equipment if not avoided.

(1), (2), (3), ...

Indicates consecutive numbers in operating procedures for the order in which successive steps in the procedure should be taken.

Note

Indicates a comment or supplementary information. Indicates a reference.

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Introduction

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Chapter

1 Precautions 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.

1.1

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. Never use this product for any other purposes. Chapter 1 Precautions

WARNING • Never use this product for any other purposes. It may cause severe harm to patient and/or end-users.

1.2

Applicability of Endoscopy and Endoscopic Treatment Proper clinical judgment should be exercised for the applicability of endoscopy and endoscopic treatment. If there are official standards on the applicability of endoscopy and endoscopic treatment that are defined by the hospital’s administrators or other official institutions, such as academic societies on endoscopy, follow those standards. Perform endoscopy and endoscopic treatment only when the benefits outweigh the risks.

1-1

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Chapter 1 Precautions

1.3

User Qualifications

WARNING • The healthcare facilities owning this product are responsible for the use and maintenance of this product. If this product is not used or maintained properly, it may cause severe harm to patient or end-users. • This product is intended for use by medical professionals who have received proper training in endoscopic procedures. This manual does not provide information about procedures or any aspects of endoscopic techniques. Not following the recommendations may cause severe harm to patient or end-users. If there are official standards for user qualifications for performing endoscopy and endoscopic treatment that are defined by the hospital’s medical administrators or other official institutions such as academic societies on endoscopy, follow those standards. The physician should be capable of safely performing the planned endoscopy and endoscopic treatment following guidelines set by the academic societies on endoscopy, etc., and considering the difficulty of endoscopy and endoscopic treatment.

1.4

Prohibition of Modification and Improper Repair 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, adverse events or device failures caused by such modifications, disassembly, repairs or reverse-engineering. FUJIFILM Corporation shall not be liable for malfunctions, adverse events or damages caused by remodeling, maintenance, and repair using repair parts other than those authorized by FUJIFILM Corporation. FUJIFILM Corporation shall not be liable for malfunctions, adverse events or damages caused by installation, relocation, remodeling, maintenance, and repair not performed by FUJIFILM Corporation or by dealers authorized by FUJIFILM Corporation.

WARNING • Do not disassemble or modify this product. Do not perform unauthorized repairs. If any disassembly, modification or improper repair is performed, it may cause severe harm to patient or end-users.

CAUTION • Do not disassemble or modify this product. Do not perform unauthorized repairs. If any disassembly, modification or improper repair is performed, it may cause equipment failure.

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1.5

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. Note

Delayed reprocessing of endoscopes, particularly duodenoscopes, is not recommended.

WARNING

Chapter 1 Precautions

• The entire surface and each channel of the endoscope and the accessories must be reprocessed prior to first use, after any servicing, after any subsequent use, and after storage as per instructions provided in the Reprocessing Manual, even if the accessories were not used during a procedure. In addition, store this product as per instructions provided in the Reprocessing Manual. Inadequate reprocessing or storage may cause infection. • When using this product for a patient with Creutzfeldt-Jakob disease (especially variant Creutzfeldt-Jakob disease), use it exclusively for a patient with the same disease, or properly discard this product after use. Since the cleaning, disinfection and sterilization methods described in the Reprocessing Manual of this product cannot eliminate the causal agents of Creutzfeldt-Jakob disease, the product could be a source of infection. For the treatment of Creutzfeldt-Jakob disease, refer to local guidelines. • Immediately upon completion of the procedure, it is imperative that pre-cleaning is performed as per instructions provided in the Reprocessing Manual. Otherwise, residual organic debris may begin to dry and solidify and hinder effective removal and reprocessing, causing infection.

CAUTION • The entire surface and each channel of the endoscope and the accessories must be reprocessed prior to first use, after any servicing, after any subsequent use, and after storage as per instructions provided in the Reprocessing Manual. In addition, store this product as per instructions provided in the Reprocessing Manual. Inadequate reprocessing or storage may cause equipment damage, or reduce performance. • Do not forcibly twist or bend the insertion tube of the endoscope. It could damage the endoscope.

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Chapter 1 Precautions

1.5.2

Storage After Use Store this product after reprocessing. For details on the reprocessing and storage of the endoscope, refer to the Reprocessing Manual.

1.5.3

Disposal For details on the disposal of the endoscope and accessories, refer to the Reprocessing Manual.

1.6

For Safe Operation Be sure to prepare a spare endoscope for unexpected events such as the failure of this product. Otherwise, you may not be able to continue the endoscopic procedure. If the spare endoscope is not available, prepare other alternative means such as abdominal surgery. Note

• It is highly recommended that spare or back-up equipment be available to complete procedures due to unforeseen circumstances including but not limited to interruption or loss of a clear endoscopic image, equipment failure, etc. • If an endoscopic image is lost or compromised during a therapeutic procedure, immediately stop treatment and withdraw the endotherapy device together with the endoscope. Use back-up equipment to complete the procedure as necessary.

1.7

Maintenance

WARNING • Deterioration or degradation of the endoscope components or its accessories may occur due to factors such as long-term use, procedures, routine handling and repeated reprocessing. Have this product checked by service personnel once every six months or once every 100 cases, whichever comes first. Use of nonfunctional equipment may cause severe harm to patient or end-users. This product should not be subjected to any type of repair or maintenance procedure while it is being clinically used on a patient (or while it is being reprocessed). 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.

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1.8

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

(Blue)

Chapter 1 Precautions

Authorised representative in the European Community Refer to instructions for use Temperature limitation Keep dry Non-sterile CE marking Type BF applied part WEEE marking * Humidity limitation Atmospheric pressure limitation

4.2

Minimum diameter of the instrument channel: 4.2 mm

* This product shall not be treated as household waste.

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Chapter 1 Precautions

1.9

Precautions for Transportation

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. • 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.

CAUTION • When transporting a reprocessed endoscope, firmly grasp the control portion and LG connector. If only the LG flexible portion or the boot is grasped, it may damage the endoscope. • When transporting a reprocessed endoscope, do not coil the insertion tube or the LG flexible portion of the endoscope with a small diameter. Doing so may cause endoscope failure. • When transporting the endoscope to the outside of the hospital, store the endoscope in a FUJIFILM-specified carrying case. Not doing so may cause product failure.

1.10 Precautions Against Electric Shock WARNING • Connect the power plug of related equipment to be used to the protective earth receptacle. Not doing so may cause an electric shock.

CAUTION • Do not use related equipment which is not described in this manual. If the endoscope is used in combination with endoscopic accessories connected to other medical devices, it may cause an electric shock due to an increase in patient leakage current.

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1.11 Electromagnetic Compatibility (EMC) This product generates, uses and can radiate electromagnetic energy. To prevent electromagnetic interference within the vicinity of this product, read the following precautions and properly handle this product and other devices in the vicinity. Install and use this product according to "Electromagnetic Compatibility (EMC) Information" in Appendix.

WARNING • Do not place any objects that emit strong electromagnetic waves near this product. Otherwise, malfunction of this product may occur. • Do not use this product adjacent to other equipment. If such use is necessary, this product and the other equipment should be observed to verify that they are operating normally. Failure to do so could result in improper operation. Chapter 1 Precautions

• Do not use portable and mobile RF communications equipment closer than 30 cm to any part of this product. Otherwise, degradation of the performance of this product could result.

CAUTION • Use this product in the specified environment and with specified methods. Failure to do so may result in an abnormality of an endoscopic image (rotation or inversion of the viewing image). • Noise may appear on the monitor of this product due to the effect of electromagnetic interference. In this case, turn off the device emitting the electromagnetic waves or move the device away from the monitor. This product may receive electromagnetic interference even if related equipment conforming to EN 55011 is used. Use of this product may cause electromagnetic interference. Depending upon the strength of electromagnetic interference within the vicinity of this product, malfunction of this product or peripherals may occur. If this product does cause harmful electromagnetic interference to other devices, or if this product receives electromagnetic interference from other devices, we recommend that you may try to correct the interference by one or more of the following measures: • Change the orientation or position of any affected device. • Increase the spacing between devices. • ‌Connect the product into an outlet on a circuit different from that to which the other device(s) are connected. • 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.

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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.)

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