EC-760 series Video Endoscope Operation Manual Rev G June 2016



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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 ♦ Video 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...1-3

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...1-8 1.12.1 Precautions for Inspection Before Use...1-8 1.12.2 Handling Precautions...1-9 1.12.3 Abnormalities during Use of This Product...1-13 1.12.4 Precautions for Flexibility Adjustment Mechanism...1-14 1.12.5 Precautions for Water Jet Function...1-15 1.12.6 Precautions for Optical Zoom Function...1-16 1.13 Precautions for Equipment Used in Combination...1-17 1.13.1 Precautions for High-Frequency Treatment...1-19 1.13.2 Precautions for Endotherapy Device and Syringe...1-20

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Chapter 2 2.1

Product Overview

2-1

Checking Package Contents...2-1 2.1.1

Endoscope...2-1

2.1.2

Accessories...2-2 ♦ Accessories Common to All Models...2-2 ♦ Accessories for Endoscopes with Specific Functions...2-2

2.2

Nomenclature and Functions of Endoscope...2-4 ♦ Scope Connector...2-6 ♦ LG Flexible Portion...2-6 ♦ Control Portion...2-7 ♦ Boot...2-8

2.3

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

2.4

Flexibility Adjustment Mechanism...2-11

2.5

Optical Zoom Function...2-12

2.6

2.5.1

Operating Optical Zoom Function...2-12

2.5.2

Focus Indicator...2-13

2.5.3

Multi Zoom Operating Mode...2-13

2.5.4

Resetting the Focal Point...2-15

Location of Each Label...2-16 2.6.1

2.7

Chapter 3

Location of Labels...2-16

System Configuration...2-17

Workflow

3-1

3.1

When Using Water Jet Function...3-2

3.2

When Using Flexibility Adjustment Mechanism and Water Jet Function...3-4

3.3

When Using Optical Zoom and Water Jet Functions...3-6

3.4

When Using Flexibility Adjustment Mechanism, Optical Zoom Function and Water Jet Function...3-8

Chapter 4 4.1

Contents

♦ Insertion Portion (Applied Part)...2-8

Preparation and Inspection

4-1

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

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Contents

4.2

Transporting Endoscope...4-4

4.3

Inspecting Endoscope...4-5 4.3.1

Inspecting Control Portion...4-5

4.3.2

Inspecting Flexibility Adjustment Mechanism...4-5

4.3.3

Inspecting Insertion Portion...4-6

4.3.4

Inspecting Distal End...4-7

4.3.5

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

4.3.6 4.4

4.5

4.6

4.7

Chapter 5 5.1

Inspecting and Attaching Accessories...4-12 4.4.1

Forceps Valve...4-12

4.4.2

Suction Valve...4-13

4.4.3

Air/Water Valve...4-14

4.4.4

J Tube...4-16

Preparing Related Equipment...4-18 4.5.1

Inspecting Related Equipment...4-18

4.5.2

Preparing System...4-18

Connecting Endoscope to Light Source and Related Equipment...4-20 4.6.1

Connecting to Light Source...4-20

4.6.2

Attaching Water Tank...4-21

4.6.3

Attaching Suction Unit...4-21

4.6.4

Attaching J Tube...4-22

4.6.5

Attaching Water Pump...4-23

Inspecting Functions Used in Combination with Related Equipment...4-24 4.7.1

Inspecting Endoscopic Images...4-24

4.7.2

Inspecting Scope Switch...4-25

4.7.3

Inspecting Air/Water Supply Function...4-26

4.7.4

Inspecting Suction Function...4-27

4.7.5

Inspecting Instrument Channel...4-27

4.7.6

Inspecting Water Jet Channel...4-27

How to Use

5-1

Preparation...5-2 5.1.1

Preparing Related Equipment...5-2

5.1.2

Pretreatment of Patient...5-2

5.1.3

Preparing Mouthpiece...5-2

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Inspecting Scope Connector...4-11

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5.2

Insertion and Observation...5-3 5.2.1

Using Flexibility Adjustment Mechanism...5-3

5.2.2

Insertion...5-4

5.2.3

Observing Endoscopic Image...5-6

5.2.4

Operating Scope Switch...5-7

5.2.5

Bending Operation...5-7

5.2.6

Operating Air/Water Valve...5-9

5.2.7

Operating Suction Valve...5-9

5.3

Using Water Jet Function...5-11

5.4

Using Optical Zoom Function...5-13

5.5

Injecting Fluids from Instrument Channel Inlet...5-14

5.6

Treatment...5-15 Using Endotherapy Devices...5-15

5.6.2

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

5.6.3

High-Frequency Treatment...5-17

5.7

Endoscope Withdrawal...5-19

5.8

Reprocessing Endoscope...5-20

Chapter 6 6.1

Troubleshooting

Contents

5.6.1

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...6-3

6.1.5

Problem with Suction...6-4

6.1.6

Problem with Model-Specific Functions...6-5 ♦ Problem with Water Jet Function...6-5 ♦ Problem with Flexibility Adjustment Mechanism...6-5 ♦ Problem with Optical Zoom Function...6-5

6.1.7

Problem with Related Equipment...6-6 ♦ Problem with Endotherapy Devices...6-6 ♦ Problem with Image Recorder...6-6

6.2

6.3

Withdrawal of Endoscope with Abnormality...6-7 6.2.1

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

6.2.2

When Either Normal Observation Mode or Special Light Observation Mode is Not Available...6-8

6.2.3

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

Returning Endoscope for Repair...6-10

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Contents

Chapter 7

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-4 ♦ Operating Environment...Appendix-4 ♦ Transport Environment...Appendix-4 ♦ Storage Environment...Appendix-4 ♦ Term of Validity/Period for Use (Durability)...Appendix-4 Accessories...Appendix-5 ♦ Accessories Common to All Models...Appendix-5 ♦ Accessories for Endoscopes with Specific Functions...Appendix-5 Related Equipment Used in Combination...Appendix-6 ♦ Compatible Processor and Light Source...Appendix-6 ♦ Water tank...Appendix-6 ♦ Suction unit...Appendix-6 ♦ Endoscopic CO2 Regulator...Appendix-6 ♦ Water Pump...Appendix-7 ♦ Electrosurgical Unit...Appendix-7 ♦ Sonoprobe System...Appendix-7 ♦ Air Leak Tester...Appendix-7 ♦ Compatible Endotherapy Devices...Appendix-8 ♦ Medical Device Directive...Appendix-9 Electromagnetic Compatibility (EMC) Information...Appendix-10 Disposal of Electric and Electronic Equipment...Appendix-14 Index...Appendix-15

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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.

No part or all of this manual may be reproduced 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 © 2015-2016 FUJIFILM Corporation. All rights reserved.

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Introduction

♦ Video Endoscope Operation Manuals Manage and store “Operation Manual” and “Reprocessing Manual” together as a set.

Video Endoscope Operation Manual Model: EG-760R, EG-760Z, EC-760R-V/M, EC-760R-V/I, EC-760R-V/L, EC-760ZP-V/M, EC-760ZP-V/L This manual provides necessary information for using the video endoscope such as the equipment overview, operation procedures and precautions to observe.

Video Endoscope Reprocessing Manual Model: EG-760R, EG-760Z, EC-760R-V/M, EC-760R-V/I, EC-760R-V/L, EC-760ZP-V/M, EC-760ZP-V/L This manual describes the reprocessing and storage methods of the video endoscope.

Note

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

Chapter 1 Precautions

Video Endoscope EG-760R, EG-760Z is an upper gastrointestinal endoscope intended for the observation, diagnosis and endoscopic treatment of the pharynx, larynx, esophagus, stomach and duodenum, and for the observation of the oral cavity at medical facilities under the management of physicians. Video Endoscope EC-760R-V/M, EC-760R-V/I, EC-760R-V/L, EC-760ZP-V/M, EC-760ZP-V/L is a lower gastrointestinal endoscope intended for the observation, diagnosis and endoscopic treatment of the rectum, sigmoid colon, large intestine and ileocecal region at medical facilities under the management of physicians. Never use this product for any other purposes.

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 its potential benefits outweigh its risks.

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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 or device failures caused by such modifications, disassembly, repairs or reverse-engineering. FUJIFILM Corporation shall not be liable for malfunctions or damages caused by remodeling, maintenance, and repair using repair parts other than those specified by FUJIFILM Corporation. FUJIFILM Corporation shall not be liable for malfunctions or damages caused by installation, relocation, remodeling, maintenance, and repair performed by dealers other than those specified 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 for the first time prior to 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.

WARNING

Chapter 1 Precautions

• The entire surface and each channel of the endoscope and the accessories must be reprocessed for the first time prior to use, after any servicing and after any subsequent use as per instructions provided in the Reprocessing Manual, even if they 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 efficacy, causing infection.

CAUTION • The entire surface and each channel of the endoscope and the accessories must be reprocessed for the first time prior to use, after any servicing and after any subsequent use as per instructions provided in the Reprocessing Manual, even if they 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 equipment damage, or reduce performance. • Do not forcibly twist or bend too sharply the insertion tube of the endoscope. It could damage the endoscope and/or negatively affect instrument functionality.

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.

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Chapter 1 Precautions

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 against unexpected accidents 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.

1.7

Maintenance

WARNING • Component deterioration or functional degradation of the endoscope 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 abnormal equipment may cause severe harm to patient or end-users. 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 Authorised representative in the European Community Chapter 1 Precautions

Temperature limitation Keep dry Non-sterile CE marking Type BF applied part WEEE marking [Note] Humidity limitation Atmospheric pressure limitation

2.8 3.2 3.8

Minimum diameter of the instrument channel: 2.8 mm Minimum diameter of the instrument channel: 3.2 mm Minimum diameter of the instrument channel: 3.8 mm

[Note] 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 at a clean state. 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 scope 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. • When transporting the endoscope with the flexibility adjustment mechanism to the outside of the hospital, make sure that the insertion portion is set to the most flexible condition before storing the endoscope in a FUJIFILM-specified carrying case. Putting the endoscope in the carrying case while the insertion portion is not set to its most flexible condition could damage the endoscope.

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 • We recommend use of only related equipment specified in this manual to avoid adverse outcomes such as electric shock due to an increase in patient leakage current when this product is used in combination with other devices.

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1.11 Electromagnetic Compatibility (EMC) This product generates, uses and can radiate radio frequency 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.

WARNING • Do not place any objects that emit strong electromagnetic waves near this product. Otherwise, malfunction of this product may occur.

CAUTION • 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 this product. Chapter 1 Precautions

This product may receive electromagnetic interference even if related equipment confirming to EN 55011 is used. 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, that can be determined by turning the processor off and on, 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. Electromagnetic interference may occur in the vicinity of equipment marked with the following symbol or other portable and mobile RF (radio frequency) communications equipment, such as cellular phones.

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Chapter 1 Precautions

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 check the endoscope and accessories before use according to the procedures provided in this manual. Do not use the equipment that shows any signs of abnormality or irregularity. Use of abnormal equipment may lead to misdiagnosis or increase risks to patient safety. • Make sure to check the forceps valve before use. If the inspection result shows any sign of abnormality or irregularity, replace the forceps valve with a new one already reprocessed. Use of abnormal forceps valve may cause the leakage of body fluid, posing an infection risk. • 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 damage to the patient. • If water leaks form the forceps valve during the inspection of suction function, replace it with a new one already reprocessed. A leaking forceps valve may cause backflow of body fluid, posing an infection control risk. • Turn off the light of the light source before inspecting the objective lens. Viewing the light from the light guide directly may damage your eyes.

CAUTION • Make sure to check the endoscope and accessories before use according to the procedures provided in this manual. Do not use the equipment that shows any signs of abnormality or irregularity. Use of abnormal equipment may cause equipment malfunction. • Do not forcibly turn the angulation knob further after turning the knob until it stops. If the angulation knob is forcibly turned, it may cause malfunction of the endoscope. • Make sure that no moisture or foreign matter adheres to the scope connector before connecting it to the light source. If the scope connector with moisture or foreign matter is connected, it may cause malfunction or failure of the devices. • Do not attach anything to the power-receiving section. In addition, make sure that no foreign matter such as a metallic fragment adheres to the power-receiving section. Adhesion of foreign matter may cause thermal injury, or malfunction or failure of the devices. • 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.

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