Ultrasonic Endoscope EB-530US Operation Manual

Important Safety Information

Important Safety Information For the USA Market - CAUTION: Federal law restricts this device to sale by or on the order of a physician.

1. Intended Use This product is a medical Ultrasonic Endoscope to be used under the control of doctors in medical facilities for the observation, diagnosis and medical treatment of tracheae and bronchi, as well as the inspection of tracheae, bronchi and adjacent organs, using ultrasonic imaging. Never use this product for any other purpose. This product is not intended for use on children and infants.

2. Safety Read and understand this manual carefully before use. Use the Ultrasonic Endoscope by following the provided instructions. Items important for the safe use of the Ultrasonic Endoscope are summarized in Chapter 1 “Safety.” Safety precautions associated with individual operations or procedures are provided separately, indicated “ WARNING” or “ CAUTION.”

3. Warning Items that must be observed for safety when performing endoscopy or electrosurgery are identified by “ WARNING” or “ CAUTION.” Perform procedures correctly by reading and understanding the warning information carefully.

WARNING Read and understand this manual carefully before operating the equipment. Improper use or operation of the equipment may injure patients, physicians, or people in the vicinity. Improper operations that will damage the equipment only are identified by “CAUTION.”

4. About Clinical Procedures This manual assumes that the product will be used by medical specialists who have received proper training in ultrasonic endoscopic procedures. It does not provide information about clinical procedures. Regarding clinical procedures, use proper clinical judgment.

5. When Using this Product for the First Time This product has not been sterilized. When using it for the first time, use the level of disinfection or sterilization suitable to the application, in accordance with Chapter 7 “Cleaning,” Chapter 8 “Chemical Disinfection,” and Chapter 9 “Gas Sterilization.” 2

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Important Safety Information

6. Treatment with Electrosurgical Instruments This product cannot be used with an electrosurgical instrument for treatment.

7. About Latex Allergy 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 of blood pressure and shock. If such symptoms are observed, stop use immediately and take appropriate measures.

8. If Any Abnormality Occurs During Clinical Procedure If any abnormality occurs with the equipment, refer to “Troubleshooting.” Especially, continued use of the equipment with abnormal images can cause burn and injury by heat generation from the distal of the Ultrasonic Endoscope.

9. Loss of Function During an examination, if the endoscopic image disappears, a live image is not displayed after freeze mode has been cancelled, or the endoscopic image is discolored, reset the processor and light source. During treatment, if the endoscopic image disappears, a live image is not displayed after freeze mode has been cancelled, or the endoscopic image is discolored, stop treatment immediately, remove the treatment tool from the ultrasonic endoscope, and then reset the processor and light source. If an appropriate image does not appear even after resetting the processor and light source, turn them off, straighten the bending portion, release the angle lever, and then withdraw the ultrasonic endoscope slowly from the patient. Should the endoscopic image disappear during an examination or treatment, and if the processor and light source are not turned off, it may cause overheating of the distal end of the ultrasonic endoscope, possibly resulting in mucosal burns or other injury. During an examination, if the ultrasonic image disappears, or a live image is not displayed after freeze mode has been cancelled, reset the ultrasonic processor. During treatment, if the ultrasonic image disappears, or a live image is not displayed after freeze mode has been cancelled stop treatment immediately, remove the treatment tool from the ultrasonic endoscope, and then reset the ultrasonic processor. If an appropriate ultrasonic image does not appear even after resetting the ultrasonic processor, turn it off, straighten the bending portion, release the angle knobs, and then withdraw the ultrasonic endoscope slowly from the patient. [Note] Reset: •• To reset the processor and the light source, turn them off, and wait for at least 5 seconds. Turn on the processor and the light source again, and then light the lamp by pressing the Lamp button. •• To reset the ultrasonic processor, turn it off, and wait for at least 5 seconds. Turn on the ultrasonic processor again.

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Contents

Contents (Preparation and Operation) Important Safety Information...2 Preface...6 Conventions Used in This Manual...6 Chapter 1

Safety... 1-1

Chapter 2

Composition of Set and System Configuration... 2-1 2.1 Composition of Set... 2-2 2.2 System Configuration... 2-4

Chapter 3

Names and Functions of Parts... 3-1 3.1 Ultrasonic Endoscope... 3-2 3.2 Distal End of Ultrasonic Endoscope... 3-5 3.3 Ultrasonic Image... 3-6 3.4 Balloon Installation Tool... 3-6

Chapter 4

Control Portion... 4-1 4.1 How to Operate Bending Mechanism... 4-2 4.2 Suction Valve, Forceps Inlet and Water Feed Inlet... 4-3 4.3 Remote Operating Switches... 4-4 4.4 Forceps Valve... 4-5 4.5 Suction Button... 4-6

Chapter 5

Preparation for Use of Ultrasonic Endoscope... 5-1 5.1 Preparing Equipment... 5-2 5.2 Preparing Suction Button... 5-4 5.3 Preparing Forceps Valve... 5-5 5.4 Connecting Ultrasonic Endoscope (Installation)... 5-7 5.5 Inspection of Ultrasonic Endoscope... 5-11 5.6 Removing Ultrasonic Endoscope... 5-18 5.7 Attachment and Inspection of Balloon... 5-21 5.8 Inspection of Puncture Needle... 5-25 5.9 Inspection of Forceps... 5-26

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Contents

Chapter 6

Method of Use... 6-1 6.1 Preparation... 6-2 6.2 Insertion and Observation... 6-3 6.3 How to Use Balloon... 6-8 6.4 Biopsy... 6-9 6.5 Puncture... 6-12 6.6 Pulling Out Ultrasonic Endoscope... 6-16 6.7 Pre-Cleaning (performed at bedside immediately after use of Ultrasonic Endoscope)... 6-17

Appendix...Appendix-1 Main Specification...Appendix-2 Troubleshooting (Combination with EPX-4400 system)...Appendix-8 Troubleshooting (Combination with EPX-2500 system)...Appendix-12 After-Sales Service...Appendix-16 Disposal of Electric and Electronic Equipment...Appendix-17 Index...Appendix-18 Service Centers...Appendix-19

(Cleaning, Disinfection and Storage) Chapter 7

Cleaning... 7-1

Chapter 8

Chemical Disinfection... 8-1

Chapter 9

Gas Sterilization... 9-1

Chapter 10 Storage... 10-1

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Preface

Preface This manual describes how to use EB-530US.

Conventions Used in This Manual This manual uses the following conventions to make it easy to understand operations.

General Conventions Convention

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

WARNING

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

CAUTION

Explains situations that may cause slight or moderate levels of injury if not avoided.

CAUTION

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

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

Consecutive numbers in operating procedures indicate 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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Chapter 1

Safety

This chapter summarizes the information necessary for safe use of Ultrasonic Endoscope.

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Chapter 1 Safety

Chapter 1 Safety 1. Precautions in Using Ultrasonic Endoscope 1) Applicable processor and light source This product may be used in the following combinations: • Processor VP-4450HD, light source XL-4450 and ultrasonic processor SU-8000 • Processor VP-4400, light source XL-4400 and ultrasonic processor SU-8000 • Processor VP-4400, light source XL-4400 and ultrasonic processor SU-7000 • Processor EPX-2500 and ultrasonic processor SU-8000 • Processor EPX-2500 and ultrasonic processor SU-7000 This product complies with the requirements of EN 60601-1:2006 when used in combination with VP-4450HD, XL-4450 and SU-8000 and those of EN 60601-1:1990+A1:1993+A2:1995 when connected to other equipment. 2) Preparation and inspection before use Prior to using this product, prepare a spare one to avoid unexpected accidents such as equipment failure. If a replacement is not available, you may not be able to continue endoscopic procedures. Make sure to inspect the equipment before use according to the procedures provided in this manual, to avoid unexpected accidents, and take full advantage of the equipment’s capabilities. If the inspection result shows any abnormality, do not use the same equipment. 3) Combination of equipment 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 operation manual. Be sure to fully understand the contents of related operation manuals when using any peripherals. 4) Single use only Balloon, suction button and forceps valve are intended for single use. To prevent infection, do not reuse them. 5) Expiration date for use Do not use any balloon after its expiration date has passed.

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6) Preparation for operation Use a high-frequency surgical instrument and an Endoscope which can be used with a high-frequency surgical instrument to provide proper emergency treatment, in cases of bleeding. 7) Abnormality in use If any abnormality is noticed during use, carry out safety checks and discontinue use immediately. 8) Maintenance The equipment will wear out and degrade after repeated use for a long period. Especially, the portions such as rubber and resin deteriorate also by chemicals to be used a change with the passage of time. Have it checked by specialists once every six months or once every 50 cases. Also have it checked if there is anything wrong with the equipment. Do not disassemble or modify the equipment. 9) Operation of Ultrasonic Endoscope Ultrasonic Endoscope is a precision instrument. Unnatural force or impact on the insertion portion, flexible portion, or distal end may injure the inside of the patient as well as damage the instrument. If you feel any abnormal resistance, do not force the Ultrasonic Endoscope to insert and pull out. Please operate the Ultrasonic Endoscope slowly. Do not perform the insertion, withdrawal, or bending without keeping a field of view. A forward-oblique viewing direction is employed with this product and there is a difference between the inserting direction and viewing direction. Be sure to understand the characteristics of the equipment upon use. 10) Handling of Ultrasonic Endoscope When holding Ultrasonic Endoscope, hold it by the control portion. Handling it up by the insertion portion or LG flexible portion is difficult to hold and may exert an unnatural force, resulting in instrument failure. Wear protective gear when handling an Ultrasonic Endoscope to prevent infection and static charges. 11) Handling of balloon If the balloon is inflated while it is in patient’s air passage, the air flow may become blocked. Before using the balloon, thoroughly check the balloon position in the air passage and the water flow rate to the balloon.

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12) Temperature at distal end 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. 13) Electromagnetic interference This equipment has been tested and found to comply with the limits for medical devices defined in EN 60601-1-2:2007. These limits are designed to provide reasonable protection against harmful interference in a typical medical installation. However, it is possible that it may cause harmful interference to other devices in the vicinity, if it is installed and used in accordance with the instructions. Also, there is no guarantee that interference will not occur in a particular installation. Therefore, if this equipment does cause harmful interference to other devices, which can be determined by turning the equipment off and on, the user is encouraged to 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. •• Consult the manufacturer or dealer of the device. Noise may appear on the monitor of this equipment due to the effect of electromagnetic waves. In this case, turn off the device emitting the electromagnetic waves or move the device away from this equipment. This equipment complies with the requirements of EN 60601-1-2:2001+A1:2006 when connected to VP-4400, XL-4400, EPX-2500 and SU-7000.

2. Cleaning and Disinfection/Sterilization This product has not been sterilized. When using it for the first time, perform cleaning, disinfection and or sterilization suitable for the application. After using it, clean and disinfect/sterilize it according to the procedures in the manual (Cleaning, Disinfection and Storage). Inadequate cleaning may result in infection. Carefully clean the insertion portion and all the channels including the balloon water feed channel especially. Wear protective gear during chemical cleaning and disinfection 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 manual (Cleaning, Disinfection and Storage) 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 the guidelines for it available.

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Chapter 1 Safety

3. Disposal 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 infective waste, depending on the usage state.

4. Indication symbol This symbol, developed by Eucomed [Note], indicates that this specific type of medical device contains dibutyl phthalate (DBP). Its amount is so minuscule that it has little effect on patients’ health. [Note] The URL of Eucomed is as follows; http://www.eucomed.be/

5. “ Warning” and “ Caution” Messages Appearing in Individual Chapters Chapter 5 Preparation for Use of Ultrasonic Endoscope Do not use the abnormal equipment. The use of abnormal equipment will cause wrong diagnosis or injury. 5.4 Connecting Ultrasonic Endoscope Do not touch the LG connector tip until it cools down (approximately 5 minutes). Touching the LG connector with hands immediately after use of the Endoscope may cause a burn injury. <Combination with the VP-4400 and XL-4400 or VP-4450HD and XL-4450> Set a suction pressure at 53kPa or less. Ultrasonic Endoscope may adhere to mucous membrane, resulting in damage to the mucous membrane. <Combination with the EPX-2500 system> Set a suction pressure at 53kPa or less. Ultrasonic Endoscope may adhere to mucous membrane, resulting in damage to the mucous membrane. 5.5.3 Inspecting Suction, Water Feed and Forceps Channel Firmly attach the forceps valve to the forceps inlet of the Ultrasonic Endoscope. There is a risk of infection. 5.5.5 Inspecting Objective Lens Turn off the light before inspecting the lens. Viewing the light of light guide directly may damage your eyes. 5.7 Installation and Inspection of Balloon Use a disinfected and sterilized balloon installation tool. There is a risk of infection. Do not use a balloon on patients allergic to latex. It may cause an anaphylactic reaction.

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Chapter 1 Safety

5.8 Inspection of Puncture Needle Do not use the puncture needle with an abnormally bent or deformed needle. There is a risk of bleeding or wrong puncturing. Chapter 6 Method of Use Do not use force during insertion or withdrawal of the Ultrasonic Endoscope. Slowly advance the instrument under direct visualization. Since this product is a precision instrument, excessive force or impact on the insertion portion, flexible portion, or distal end may cause patient injury as well as damage to the instrument. Do not advance or angulate the Ultrasonic Endoscope without obtaining a clear endoscopic view on the monitor. 6.2 Insertion and Observation When a balloon is not used, fit the cap on the balloon water feed inlet. There is a risk of infection. Do not sharply twist or bend during operation. It may cause damage inside body cavities. Before attempting to clinically use this Ultrasonic Endoscope with an endotracheal tube, select an appropriate size tube whose inner diameter has sufficient clearance between the endotracheal tube and the Ultrasonic Endoscope to avoid restriction of oxygen flow which may impair patient breathing. The endotracheal tube should pass easily over the Ultrasonic Endoscope’s insertion tube never force an endotracheal tube onto the Ultrasonic Endoscope and never apply excessive pressure or force when attempting to pass or withdraw the Ultrasonic Endoscope. Do not insert the Ultrasonic Endoscope through the nose. There is a risk of bleeding. Do not allow the distal end to touch the same part for 5 minutes or more. Energy of illumination may burn. Do not look directly at the illuminated light guide. It may damage your eyes. In order to inject solution by using a syringe, firmly and deeply insert the syringe straight into the forceps valve. Chemical solutions might splatter. If the balloon or parts fall into a body cavity due to equipment failure or for other reasons, immediately stop the inspection and properly retrieve the parts in question. It may cause damage inside body cavities. Whenever using the Ultrasonic Endoscope with other peripheral devices including endotracheal tubes, etc. strictly adhere to all manufacturers' instructions, cautions and warnings. Failure to follow the recommendations above can lead to Ultrasonic Endoscope damage and/or patient injury. 6.3 How to Use Balloon Do not use a balloon on patients allergic to latex. It may cause an anaphylactic reaction. Do not feed more than 1 mL of water into the balloon. There is a risk of suffocation. Do not feed more than 1 mL of water into the balloon. There is a risk of aspiration.

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Chapter 1 Safety

6.4 Biopsy Do not press forceps against the trachea or broncho wall with undue force. It may cause perforation or bleeding. Do not insert the forceps if you cannot obtain a endoscopic image. Do not insert the forceps into the Ultrasonic Endoscope if you cannot see the forceps outlet on the endoscopic image. It may cause perforation or bleeding. 6.5 Puncture Wear protective gear. There is a risk of infection. Do not insert the puncture needle into the Ultrasonic Endoscope if you cannot see the forceps outlet on the endoscopic image. Do not perform puncture if you cannot see the puncture needle on the endoscopic image. Operate the puncture needle while checking the endoscopic and ultrasonic images. Do not insert the puncture needle into the forceps inlet while the bending portion of the Ultrasonic Endoscope is bent. Do not insert a bent puncture needle into the forceps inlet. Stop puncturing immediately if you cannot obtain an endoscopic or ultrasonic image. It may cause perforation or bleeding. 6.7.3 Removing Ultrasonic Endoscope from Processor Do not touch the LG connector tip until it cools down (approximately 5 minutes). Touching the LG connector with hands immediately after use of the Endoscope may cause a burn injury. Chapter 7 Cleaning 7.1 Methods of Cleaning Be sure to clean and disinfect or otherwise sterilize all the channels after every case, regardless of whether used or not. There is a risk of infection. 7.4 Manual Cleaning (cleaning in sink) In case the cleaning brush is damaged during a cleaning process, remove any residue from inside the tube. A damaged cleaning brush could be a source of infection. 7.4.2 Remove Suction Button and Forceps Valve Do not reutilize an already used suction button and forceps valve. There is a risk of being a source of infection. 7.4.9 Cleaning Entire Ultrasonic Endoscope Remove the balloon before cleaning, disinfecting or sterilizing the Ultrasonic Endoscope. There is a risk of infection. After cleaning, rinse off any remaining chemical with water. Cleaning liquid might flow into a patient’s body. 7.5 Cleaning and Sterilizing Biopsy Forceps Close the cap before putting the forceps in a sterile pack. Sterility might not be maintained if the sterile pack is ruptured.

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Chapter 1 Safety

Chapter 8 Chemical Disinfection 8.1 Methods of Chemical Disinfection Be sure to clean and disinfect or otherwise sterilize all the channels after every case, regardless of whether used or not. Remove the balloon before cleaning, disinfecting or sterilizing the Ultrasonic Endoscope. There is a risk of infection. 8.4.1 Injecting Sterile Water After immersing in the chemical solution, rinse off remaining chemical solution with sterile water. Disinfectant might flow into a patient’s body. 8.5 Cleaning and Disinfection Using Cleaning and Disinfection Devices Use cleaning and disinfection devices appropriate for this Ultrasonic Endoscope. There is a risk of infection. Chapter 9 Gas Sterilization Clean, disinfect and sterilize all the channels after every case, regardless of whether used or not. Remove the balloon before cleaning, disinfecting or sterilizing the Ultrasonic Endoscope. Applying gas sterilization to wet parts presents incomplete sterilization. Proceed gas sterilization after vaporizing water out of Ultrasonic Endoscope. There is a risk of infection. Proceed aeration after gas sterilization. Gas remaining in Ultrasonic Endoscope after gas sterilization is harmful to human body. Chapter 10 Storage Do not store Ultrasonic Endoscope in a carrying case. Storage of Ultrasonic Endoscope in a carrying case may cause infection.

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Chapter 2

Composition of Set and System Configuration

This chapter describes the composition of Ultrasonic Endoscope set and system configuration.

2.1 Composition of Set...2-2 2.2 System Configuration...2-4 2.2.1 Combination with VP-4450HD or VP-4400 and SU-8000...2-4 2.2.2 Combination with VP-4400 and SU-7000...2-6 2.2.3 Combination with EPX-2500 system and SU-8000...2-8 2.2.4 Combination with EPX-2500 system and SU-7000...2-10

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Chapter 2 Composition of Set and System Configuration

Chapter 2 Composition of Set and System Configuration 2222 Composition of Set The Ultrasonic Endoscope set is provided in a carrying case. The set consists of the following items. [Note] Figures in parentheses indicate quantities.

Ventilation Adapter AD-7 (1)

Carrying Case (1)

Cleaning Brush WB3503FW (1)

Forceps Valve FOV-BU1 (10)

Cleaning Brush WB3212FW2 (1)

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Chapter 2 Composition of Set and System Configuration

Cleaning Brush (for Valve) WB11002FW2 (1)

Operation Manual Preparation and Operation (1) Cleaning, Disinfection and Storage (1)

Ultrasonic Endoscope (1) Suction Button SB-500B/D (20)

US Waterproof Cap WA-7000 (1)

Forceps Inlet Cleaning Adapter (with a Cap) WA-003 (1)

Tube for Suction Channel WA-002 (1)

Balloon Installation Tool BA-BU1 (1)

Dry Adapter WA-004 (1) Syringe (1)

Valve Adapter WA-001 (1)

Cleaning Adapter CA-500BU (1)

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Chapter 2 Composition of Set and System Configuration

2222 System Configuration You may use the EB-530US with various peripherals attached to it. These peripherals are available separately. Extension makes the following possible. •• Recording of video images •• Printer output 222222 Combination with VP-4450HD or VP-4400 and SU-8000

Ultrasonic Processor SU-8000 Ultrasonic Endoscope EB-530US

Light Source XL-4450 XL-4400

Processor VP-4450HD VP-4400 Balloon

Foot Switch FS1 Endoscopic Accessory Data Keyboard DK-4450E DK-4400E

Airtightness Tester LT-7

Cart

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Chapter 2 Composition of Set and System Configuration

[Note] For details on the connections of peripherals other than those listed here, please contact your local dealer.

Monitor CDL1576A CDL1909A RADIANCE24 (NDS)

Keyboard CP-8000

Foot Switch FS1

Monitor CDL1576A CDL1909A RADIANCE24 (NDS) [Note] [Note] Only when using the VP-4450HD

Printer UP-51MD (SONY) UP-55MD (SONY) UP-21MD (SONY) CP900UM(120W) (MITSUBISHI) CP900DW (MITSUBISHI)

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Chapter 2 Composition of Set and System Configuration

222222 Combination with VP-4400 and SU-7000

Ultrasonic Processor SU-7000 Ultrasonic Endoscope EB-530US

Light Source XL-4400

Processor VP-4400 Balloon

Foot Switch FS1 Endoscopic Accessory Data Keyboard DK-4400E

Airtightness Tester LT-7

Cart

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