EG-580UR Ultrasonic Endoscope Operation Manual



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Introduction

Introduction Ultrasonic Endoscope EG-580UR is an upper gastrointestinal endoscope intended for the observation and diagnosis of the esophagus, stomach and duodenum, and for the observation, diagnosis and endoscopic treatment of submucosal and peripheral organs at medical facilities under the management of physicians. This product is not intended for use on children and infants. This manual provides necessary information for using the ultrasonic endoscope, such as the equipment overview, operation procedures and precautions to observe. The Reprocessing Manual describes precautions and the cleaning, disinfection and storage methods for the ultrasonic endoscope. If you are a first-time user of this product, be sure to read this manual before actual operation. Also, after reading this manual, store it close to this product for future reference to keep the ultrasonic endoscope in optimum working condition.

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

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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. FUJIFILM Corporation shall not be liable for malfunctions and damages caused by installation, relocation, remodeling, maintenance, and repair performed by dealers other than those specified by FUJIFILM Corporation. FUJIFILM Corporation shall not be liable for malfunctions and damages of FUJIFILM Corporation products due to products of other manufacturers not supplied by FUJIFILM Corporation. FUJIFILM Corporation shall not be liable for malfunctions and 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 and damages resulting from negligence of the precautions and operating methods contained in this manual. FUJIFILM Corporation shall not be liable for malfunctions and damages resulting from use under environment conditions outside the range specified for this product, such as the power supply, installation environment, etc., as described in this manual. FUJIFILM Corporation shall not be liable for malfunctions and damages resulting from natural disasters, such as fires, earthquakes, floods, lightning, etc.

This product has heavy metal parts. When disposing of this product, comply with local laws and regulations in your area. Determine whether or not the product is to be treated as a biohazard, then handle and dispose of accordingly. Before disposing of this product or an endoscopic accessory, perform cleaning and disinfection (or sterilization) according to the procedure described in the Reprocessing Manual. There is a risk of being a source of infection.

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Endoscope Manuals

Endoscope Manuals Manage and store the Operation Manual and Reprocessing Manual of this product as a set.

Ultrasonic Endoscope EG-580UR Operation Manual This manual provides necessary information for using the ultrasonic endoscope such as the equipment overview, operation procedures and precautions to observe.

Ultrasonic Endoscopes EG-580UT and EG-580UR Reprocessing Manual This manual describes the cleaning, disinfection, sterilization and storage methods of the ultrasonic endoscope.

[Note] In this manual, the Ultrasonic Endoscope EG-580UR Operation Manual is referred to as “this manual”, and the Ultrasonic Endoscopes EG-580UT and EG-580UR Reprocessing Manual as “Reprocessing Manual”.

How to Read This Manual Conventions Used in This Manual This manual uses the following conventions for easier understanding. General Conventions Convention

Description Indicates a potential danger that may cause harm to people.

WARNING

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

CAUTION

Explains situations that may cause injury if not avoided.

CAUTION

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

(1), (2), (3), ... [Note]

Indicates consecutive numbers in operating procedures for the order in which successive steps in the procedure should be taken. Indicates a comment or supplementary information. Indicates a reference.

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Contents at a Glance

Contents at a Glance

Chapter 1 Precautions This chapter describes the warnings and cautions for safe operation of the ultrasonic endoscope.

Chapter 2 Product Overview This chapter describes the composition of the ultrasonic endoscope set of accessories and system configuration.

Chapter 3 Preparation and Inspection Before Use This chapter describes the inspection and preparation methods to be performed for using the ultrasonic endoscope.

Chapter 4 Method of Use This chapter describes a series of operations of the ultrasonic endoscope.

Chapter 5 Troubleshooting This chapter describes actions should be taken if problems occur in the ultrasonic endoscope.

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Contents

Contents Introduction...3 Endoscope Manuals...5 How to Read This Manual...5 Contents at a Glance...6 Chapter 1 Precautions...10 1.1 For Safe Operation...10 1.2 Classification...11 1.3 Safety...12 1.3.1 Infection...12 1.3.2 Preventing Electrical Shock...15 1.3.3 Treatment with Electrosurgical Instruments...16 1.3.4 Direct Harm to Human Body...18 1.4 Electromagnetic Compatibility (EMC)...21 1.4.1 Electromagnetic Compatibility (EMC) Related Standard...21 1.5 Location of Each Label...22 1.5.1 Location of Labels...22 1.5.2 Symbols...24 1.6 Possible Combinations for Use...26 1.6.1 Accessories...26 1.6.2 Compatible Processor, Light Source and Ultrasonic Processor...26 1.6.3 Peripheral Devices...26 1.7 Cautions/Warnings...27 1.7.1 Abnormalities during Use of This Product...27 1.7.2 Transportation and Storage...28 1.7.3 Storage and Management...28 1.7.4 General Warnings...29 Chapter 2 Product Overview...30 2.1 Composition of Standard Set...30 2.2 System Configuration ...32 2.3 Nomenclature and Functions of Ultrasonic Endoscope...34 2.4 Nomenclature and Functions of Ultrasonic Endoscope Distal End...36 2.5 Nomenclature and Functions of Accessories...37 2.5.1 Forceps Valve...37 2.5.2 Balloon...38 2.5.3 Cleaning Adapter...38

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Contents

2.6

2.7 2.8 2.9

Operating Bending Section...40 2.6.1 Operating the Bending Section...40 2.6.2 Angle Lock Function...42 Control Valves...44 Scope Switches...45 Ultrasonic Image...46

Chapter 3 Preparation and Inspection Before Use...47 3.1 Preparing Forceps Valve...47 3.1.1 Cleaning and Disinfecting (or Sterilizing) the Forceps Valve...47 3.1.2 Inspecting the Forceps Valve...48 3.1.3 Attaching the Forceps Valve...48 3.2 Preparing Air/Water Valve and Suction Valve...49 3.2.1 Inspecting the Air/Water Valve and Suction Valve...49 3.2.2 Attaching the Air/Water Valve and Suction Valve...50 3.3 Preparing Peripheral Devices...51 3.4 Preparing System...52 3.4.1 Preparing the System...52 3.5 Connecting Ultrasonic Endoscope (Attachment)...54 3.5.1 Connecting the Ultrasonic Endoscope (Processor, Light Source, Water Tank and Suction Unit)...54 3.6 Inspecting Ultrasonic Endoscope...56 3.6.1 Inspecting the Insertion Portion...56 3.6.2 Inspecting the Bending Mechanism...57 3.6.3 Inspecting the Air/Water and Instrument Channels...58 3.6.4 Inspecting the Instrument Channel...59 3.7 Inspecting Distal End of Ultrasonic Endoscope...60 3.8 Inspecting Ultrasonic Image...64 3.9 Attaching and Inspecting Balloon...65 Chapter 4 Method of Use...69 4.1 Preparation...70 4.1.1 Preparing Necessary Equipment...70 4.1.2 Pretreatment of Patient...70 4.2 Insertion and Observation...71 4.2.1 Preparing the Mouthpiece...73 4.2.2 Insertion...73 4.2.3 To Suck Mucus...76 4.2.4 If Mucus Adheres to the Distal Objective Lens or If the Image is Obscured...76 4.3 How to Use Balloon...77 4.4 Biopsy...79 4.5 Endoscope Withdrawal...81 4.6 Removing Balloon...83 4.7 Pre-cleaning (Primary Cleaning)...84 8

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Contents

Chapter 5 Troubleshooting...85 5.1 Troubleshooting...85 Main Specification...93 Service...100 Disposal of Electric and Electronic Equipment...101 Index...102 Service Centers...103

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Chapter 1 Precautions

Chapter 1 Precautions 1.1 For Safe Operation Before using this product, read this section carefully so that you can operate it correctly. Whenever you operate this product, be sure to observe those precautions. Failure to do so may cause you to subject to injuries or property damage to occur.

The institution is responsible for the use and maintenance of this product. In addition, this product should not be used by persons other than doctors or suitably trained staff.

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. This product is intended for use by medical professionals who have received proper training in endoscopic procedures. When performing observation, diagnosis and endoscopic treatment of small intestine, refer to general contraindications to upper gastrointestinal tract endoscopy and colonoscopy. In addition, if the general condition of the patient is extremely critical, or if there are any risks involved in performing the endoscopic examination of ileus, gastrointestinal perforation, respiratory disease, cardiovascular disease, Crohn's disease, acquired hemophilia, stenosis, large ulcer, tumor, etc., perform endoscopy only when the benefits outweigh the risks. This manual does not provide information about clinical procedures or any aspects of endoscopic techniques.

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.

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Chapter 1 Precautions

1.2 Classification <Classification of Medical Electrical Equipment> 1. Type of protection against electric shock

: Class I equipment (power supply: protected ground fault receptacle) 2. Degree of protection against electric shock : Type BF applied part 3. Degree of explosion protection : Use is prohibited in an oxygen-rich environment or in a flammable gas atmosphere. 4. Degree of waterproof : IEC 60529 IPX7 (with US waterproof cap attached) [Note] Use in combination with the VP-4450HD processor, XL-4450 light source and SU-1 ultrasonic processor.

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Chapter 1 Precautions

1.3 Safety Read the following precautions before using this product to ensure proper handling.

1.3.1 Infection

WARNING This product has not been cleaned or disinfected (or sterilized). It must be cleaned and disinfected (or sterilized) for the first time prior to use and after any subsequent use as per instructions provided in the Reprocessing Manual. Prior to reuse, this product must be precleaned, cleaned and disinfected (or sterilized) according to the procedures given in the Reprocessing Manual. Inadequate cleaning may compromise successful disinfection or sterilization, increasing the risk of infection. Meticulously clean the ultrasonic endoscope’s all surfaces including channels as per provided reprocessing instructions. Wear personal protective equipment during a procedure as well as during cleaning and disinfection (or sterilization) to protect your eye and skin and to prevent infection. 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. Ensure that the forceps valve is properly attached to the instrument channel inlet. If this product is used without the forceps valve attached, body fluid may flow back and it could be a source of infection. Attach a properly disinfected (or sterilized) forceps valve. If the forceps valve is not cleaned or disinfected (or sterilized) properly, it can create a risk of infection to patients and/or end-users.

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Chapter 1 Precautions

WARNING The forceps valve must be completely immersed in a disinfectant solution. Remove air bubbles completely. If any air bubbles remain, effective disinfection cannot be achieved and an inadequately cleaned and disinfected (or sterilized) forceps valve may increase a risk of infection. Be sure to inspect the forceps valve before attachment. If any abnormality is found during inspection, do not use the product. It could be a source of infection. The lid of the forceps valve must be closed when using the ultrasonic endoscope. Not doing so may cause backflow of body fluids and increase a risk of infection. Use a disinfected (or sterilized) balloon attachment tool. There is a risk of infection. During ultrasonic procedures in which a balloon is not used, do not fully depress the suction valve and do not attempt to aspirate patient material into/through the balloon evacuation channel. Doing so can result in partial or complete clog of the narrow balloon evacuation channel, especially if the ultrasonic endoscope is not cleaned immediately after each procedure and if not reprocessed as per FUJIFILM recommendations. Once the balloon evacuation channel is clogged, it cannot be cleaned, disinfected or sterilized properly and can be a source of infection. If the lid of the forceps valve needs to be open during a procedure, put sterile gauze around the forceps valve before opening the lid. If sterile gauze is not applied, body fluid may be splattered, leading to infection.

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Chapter 1 Precautions

WARNING Slowly insert an endotherapy device (e.g. forceps) or syringe straight into the ultrasonic endoscope. Also, when withdrawing it, slowly pull straight out. If it is inserted or withdrawn quickly, body fluid may be splattered around due to breakage or accidental detachment of the instrument, leading to infection. Do not perform procedures with an endotherapy device hung over the forceps valve. Doing so may cause backflow of body fluids and increase a risk of infection. The forceps valve and balloon are intended for single use. To prevent infection, do not reuse them. Discard the forceps valve and balloon after use. Used forceps valve and balloon could be a source of infection. Use a cleaned and disinfected (or sterilized) air/water valve and suction valve. An inadequately cleaned and disinfected (or sterilized) valve may pose an infection risk. Use a cleaned and disinfected (or sterilized) endotherapy device. An inadequately cleaned and disinfected (or sterilized) endotherapy device may pose an infection risk. When supplying water, use sterile water. If sterile water is not used, it can create a risk of infection. Carry a cleaned and disinfected (or sterilized) ultrasonic endoscope at a clean state. If personal protective equipment such as gloves is contaminated, the contaminants adhere to the ultrasonic endoscope and it can be a source of infection. When removing the balloon, wear personal protective equipment and slowly remove the balloon. There is a risk of infection.

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Chapter 1 Precautions

1.3.2 Preventing Electrical Shock

WARNING Insert the AC plug into a hospital grade receptacle. Not doing so may cause an electric shock accident. Use an electrosurgical instrument conforming to EN 60601-2-2. Refer to the manual of the electrosurgical instrument for how to operate the electrosurgical instrument. Connect the electrosurgical instruments and electrosurgical generators in accordance with each operation manual. Incorrect connection may cause electric shock and/or burns.

CAUTION The ultrasonic endoscope may be used in combination with peripherals. To avoid an electric shock accident, do not use any peripherals than the ones specified in this manual.

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Chapter 1 Precautions

1.3.3 Treatment with Electrosurgical Instruments

WARNING This product is not intended to stop bleeding with diathermic treatment equipment. Prepare an endoscope and diathermic treatment equipment that can be used with it, so as to take necessary actions in emergencies such as bleeding. Do not use an electrosurgical instrument when supplying flammable gas. There is a risk of ignition. If necessary, use non-flammable gas such as carbon dioxide. Do not use excessive non-flammable gas. Wear electrically insulating gloves when using an electrosurgical instrument or accessory. If not worn, there is a risk of thermal injury or electric shock. Always keep pacemaker users away from electrosurgical instruments. The operation of the pacemaker will be malfunctioned by the electrosurgical instruments. When using diathermic treatment equipment, suck mucus adhered to the tissues in the body cavity first and then energize the instrument. If the equipment is energized when in contact with mucus, it may cause thermal injury. Before electrosurgery, basic in vitro experiments must be performed to learn how repeated use affects the cutting quality of therapeutic accessories.

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Chapter 1 Precautions

CAUTION We recommend use of only those peripheral products specified in this manual to avoid adverse outcomes such as electric shock when this product is used in combination with other devices. Prevent patient’s body from touching electric conductor such as metal part of bed while using an electrosurgical instrument and an accessory instrument. Not doing so could cause thermal injury to a patient. Do not energize the electrosurgical instruments when the electrically active portion of diathermic treatment equipment and the metal part at the distal end of the ultrasonic endoscope are in contact with each other. Thermal injury or scope damage may occur. Do not apply the current under the circumstance that patient’s clothing is wet when using electrosurgical instruments. Doing so may cause thermal injury. Operate the instruments within specified output range as per the device’s operating instructions. Leakage current may cause thermal injury. Perform electrosurgical procedures as per instructions provided in the operation manual for an electrosurgical instrument. When using diathermic treatment equipment, maintain enough distance between the distal end of the ultrasonic endoscope and the tip of the treatment equipment. Energize the high-frequency power supply after bringing the tip of the treatment equipment into the field of view. Set the output power of the high-frequency power supply and treatment equipment below the rated output. Also, set the output power to the minimum within the required range. If the output power is inappropriate, it may cause damage to tissues in the body cavity, thermal injury, bleeding or perforation.

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Chapter 1 Precautions

1.3.4 Direct Harm to Human Body

WARNING This product is used with a product that contains natural rubber as a material. Natural rubber may rarely cause allergy symptoms, such as itching, reddening, hives, swelling, fever, dyspnea, asthma-like symptoms, drop in blood pressure and shock. If such symptoms are observed, stop the use of this product immediately and take appropriate measures. Do not use this product with an endoscopic CO2 regulator. If used, air bubbles may be generated in the sterile water inside the water tank and enter the balloon channel. This could prevent water discharge from the balloon and disable deflation of the balloon. Do not use a balloon on patients allergic to latex. There is a risk of an anaphylactic reaction. Do not supply an excessive amount of air or gas during the procedure as doing so could cause an embolism. Do not overinsufflate during any clinical procedure to minimize the potential for pneumatic perforation. To avoid the potential for patient injury including perforation, do not apply excessive force of the ultrasonic endoscope or endotherapy device against mucosal surfaces. Only advance the endotherapy device while viewing the endoscopic image. Use the air/water channel cleaning adapter CA-609 only for cleaning the air/water channel. If it is used during a procedure, continuous air supply may occur and cause patient injury.

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Chapter 1 Precautions

CAUTION Take extreme care when inserting the ultrasonic endoscope into the oral cavity. Otherwise, it may cause pain to the patient. Do not forcibly advance or withdraw the ultrasonic endoscope into/ from the patient. It may cause damage to the body lumen, bleeding or perforation. Do not angulate the bending section forcibly or operate it quickly. It may cause damage to the body lumen, bleeding or perforation. During an observation, do not perform close observation for an extended period of time. Use the ultrasonic endoscope with a minimum necessary amount of brightness and time while maintaining an appropriate distance. When the shutter speed is set to “HIGH”, take care not to set the brightness level too high. Thermal energy created by illumination may cause burn injury. For details on the settings, refer to the operation manual of the light source and processor in use. If the brightness level is high, the temperature at the distal end may exceed 41°C. Do not allow the distal end to remain in contact with the same site for an extended period of time. It may cause burn injury.

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Chapter 1 Precautions

CAUTION When the ultrasonic endoscope projects light at high brightness and transmission of ultrasonic waves for a long time, the temperature may exceed 41°C at the distal end. Turn off the lamp and stop transmission of ultrasonic waves (Freeze the ultrasonic processor) when you hang the ultrasonic endoscope on the cart hanger. Immediately after removing the LG connector from the light source, do not touch the light guide rod with hands since it is extremely hot. There is a risk of burn injury. Set the suction pressure between 40 and 53 kPa. If the suction pressure is too high, the ultrasonic endoscope may adhere to mucous membrane, resulting in damage to the mucous membrane. Do not look directly into the light coming from the light guide at the distal end of the ultrasonic endoscope. Turn off the lamp before inspecting the objective lens. Viewing the light from the light guide directly may damage your eyes. If the balloon or other parts fall into a body cavity due to a malfunction of the device, immediately stop the procedure and retrieve the parts by following appropriate measures. There is a risk of damaging the inside of the body cavity.

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