EN-580T Endoscope Operation Manual

Important Safety Information

Important Safety Information 1. Intended Use This product is a medical endoscope intended for observation, diagnosis and endoscopic treatment of the esophagus, stomach, duodenum, small intestine and large intestine in medical facilities under management of physicians. Do not use this product for any other purpose.

2. Safety Read and understand this manual carefully before use. Use the endoscope by following the provided instructions. Items important for the safe use of the 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.”

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Important Safety Information

4. Clinical Procedures This manual assumes that the product will be used by medical specialists 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. Regarding clinical procedures, use proper clinical judgment.

5. When Using the Endoscope 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.”

6. Single Patient Use Only The Over-tube, balloon, setting tool ST-05B and forceps valve are intended for single patient use. To prevent infection, do not reuse them.

7. Treatment with Electrosurgical Instruments Before electrosurgery, basic in vitro experiments must be performed to learn how to tighten the snare properly and how repeated use affects the cutting quality of endotherapy devices.

8. Use of Over-tube and Balloon When the balloon is swollen too much, the enteric canal might be hurt. When using the Over-tube and balloon, the operator should conduct sufficient basic experiments outside the body and learn the degree of inflation of the balloon before using it.

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Important Safety Information

9. Latex Allergy

WARNING Do not use Over-tubes and balloons on patients allergic to latex. There is a risk of an anaphylactic reaction/shock. 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.

10. Use of Personal Protective Equipment Patient's body fluids adhering to endoscopic accessories such as balloons used in combination with this product may splash, resulting in infection to the operator or assistant. Wear appropriate personal protective equipment when attaching or removing endoscopic accessories.

11. If Any Abnormality Occurs During Clinical Procedure If any abnormality occurs with the equipment, refer to “Troubleshooting.” In particular, continuing to use this product even after it displays abnormal images may cause overheating of the distal end, resulting in burns or other injury.

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Important Safety Information

12. 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 endotherapy device from the 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 to unlock, release the angle knobs, and then withdraw the 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 endoscope, possibly resulting in mucosal burns or other injury. [Note] Reset: Turn off the processor and the light source, 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.

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Contents

Contents (Preparation and Operation) Important Safety Information...2 Preface...8 Conventions Used in This Manual...8

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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 Endoscope... 3-2 3.2 Symbols... 3-4

Chapter 4

Control Portion... 4-1 4.1 Operating Bending Mechanism... 4-2 4.2 Valve Control Buttons... 4-4 4.3 Switches for Images and Recording... 4-5 4.4 Forceps Valve/Forceps Inlet... 4-6

Chapter 5

Preparation for Use of Endoscope... 5-1 5.1 Preparing Equipment... 5-2 5.2 Preparing Forceps Valve and Button... 5-4 5.3 Connecting Endoscope... 5-8 5.4 Inspecting Endoscope... 5-10 5.5 Inspecting Forceps... 5-15 5.6 Inspecting Setting Tools ST-01B and ST-05B... 5-16 5.7 Attaching and Inspecting Over-tube and Balloon... 5-17 5.8 Inspecting Balloon... 5-24 5.9 Connecting Balloon Controller... 5-25

Chapter 6

Method of Use... 6-1 6.1 Preparation... 6-3 6.2 Insertion and Observation... 6-4 6.3 Biopsy... 6-15 6.4 Withdrawal... 6-18 6.5 Pre-cleaning (Primary Cleaning)... 6-21

Contents

Appendix...Appendix-1 Main Specifications...Appendix-2 Troubleshooting...Appendix-8 After-Sales Service...Appendix-12 Disposal of Electric and Electronic Equipment...Appendix-13 Index...Appendix-14

(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

(Electrosurgical Instruments) Chapter 11 Treatment with Electrosurgical Instruments ... 11-1 [Note] As for the table of contents details of “Cleaning, Disinfection and Storage” and “Electrosurgical Instruments”, refer to each operation manual.

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Preface

Preface This manual describes how to use endoscope EN-580T. For how to use the peripherals used in combination with this product, refer to the respective operation manuals.

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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Chapter 1

Safety

This chapter summarizes the information necessary for safe use of this product.

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Chapter 1 Safety

Chapter 1 Safety 1. Precautions in Using Endoscope 1) Applicable processor and light source This product is used in combination with processor VP-4450HD and light source XL-4450. 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. Have this product inspected by medical specialists who have received proper training in endoscopic procedures 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 endoscope may be used in combination with peripherals. To avoid an electric shock accident, use only the peripherals that are described in this operation manual. Read also the attached document and operation manual of the peripherals used in combination with this product. 4) Prohibition of reuse The Over-tube, balloon, setting tool ST-05B and forceps valve are intended for single patient use. To prevent infection, do not reuse them. 5) Expiration date for use Do not use Over-tube, balloon, setting tool ST-05B or forceps valve after its expiration date has passed. 6) Preparation before use Use diathermic treatment equipment or an endoscope which can be used with diathermic treatment equipment to provide proper emergency treatment, in cases of bleeding.

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Chapter 1 Safety

7) Abnormality in use If any abnormality is found during its use, perform safety checks and immediately stop using this product. 8) Maintenance The equipment will wear out and degrade after repeated use for a long period. In particular, resin and rubber parts wear out over time or due to the chemicals used. Have it checked by specialists once every six months or once every 100 cases. Also have it checked if there is anything wrong with the equipment. Do not disassemble or modify the equipment. 9) Operation of Endoscope Endoscope is a precision instrument. Excessive force or impact on the insertion portion, flexible portion, or distal end may injure the patient's body cavity as well as damage the instrument. If any resistance is sensed during the operation, do not continue operating it forcedly, but insert it slowly. Do not insert or bend the endoscope without checking the image on the monitor. 10) Handling of Endoscope When holding endoscope, hold it by the control portion. Holding it up by the insertion portion or LG flexible portion is difficult to hold and may exert an excessive force, resulting in failure. Do not apply any impact to the distal end of endoscope, especially to the lenses. It may result in abnormal endoscopic images or insufficient airtightness of the endoscope. When carrying the endoscope, keep the endoscope clean. In addition, put the endoscope into a clean carrying case to avoid hitting against other objects. Wear personal protective equipment when handling an endoscope to prevent infection and electrostatic discharge. 11) Temperature at distal end When the endoscope projects light at high brightness for an extended time, the temperature may exceed 41°C at the distal end. Turn off the lamp when you hang the endoscope on the cart hanger.

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Chapter 1 Safety

12) 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.

2. Cleaning and Disinfection/Sterilization Perform cleaning, disinfection and sterilization of the endoscope according to respective guidelines. Clean and disinfect the endoscope after understanding the latest guidelines. This product has not been sterilized. When using it for the first time, perform cleaning, disinfection and 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 air feed channel especially. Wear personal protective equipment during chemical washing and disinfection to protect your 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 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 operation manual. There is a risk of being a source of infection.

4. Repair or Inspection Contact your local FUJIFILM dealer when this product is returned for repair or inspection. In addition, be sure to clean and disinfect (or sterilize) this product before returning for repair or inspection. A returned product which is not cleaned and disinfected (or sterilized) may increase infection control risks.

5. 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/

6. “

WARNING” and “

CAUTION” Messages Appearing in Individual Chapters

Chapter 5 Preparation for Use of Endoscope Insert the AC plug into a hospital grade receptacle. When carrying or connecting the endoscope, take care to keep it clean. Not doing so may cause an electric shock. If an inspection result shows any abnormality, do not use the same product. Store the endoscope under the storage conditions described in Appendix. Use the endoscope under the operating conditions described in Appendix. The use of abnormal equipment will cause wrong diagnosis or injury. 5.2.2 Attaching Forceps Valve Ensure that an appropriately reprocessed forceps valve is properly attached to the forceps inlet. If not attached, body fluid may flow back and it could be a source 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.

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Chapter 1 Safety

5.3 Connecting 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. Set a suction pressure at 53 kPa or less. Endoscope may be adhered to mucous membrane, resulting in damage to the mucous membrane. 5.4.4 Inspecting Distal End Turn off the light before inspecting the lens. Viewing the light of light guide directly may damage your eyes. 5.7 Attaching and Inspecting Over-tube and Balloon Use a sterilized balloon installation tool. Do not use the balloon or Over-tube after its expiration date has elapsed. There is a risk of infection. Do not use Over-tubes and balloons on patients allergic to latex. There is a risk of an anaphylactic reaction/shock. 5.7.3 Attaching Hood (Only When Necessary) Do not press the hood against the digestive tract wall with undue force. It may damage mucous membrane. Fix the hood securely to the endoscope before use. Otherwise, the hood may drop. 5.9 Connecting Balloon Controller Connect the endoscope and the Over-tube to the balloon controller properly. Before insertion, make sure that the balloon operates as intended. Otherwise, it may cause an injury. Chapter 6 Method of Use Wear personal protective equipment when using the endoscope. There is a risk of infection. Be sure to attach a balloon and Over-tube when using the endoscope. If not attached, body fluid may flow back and it could be a source of infection. Wear personal protective equipment when removing Over-tubes, balloons or hoods. There is a risk of infection. Do not use Over-tubes and balloons on patients allergic to latex. There is a risk of an anaphylactic reaction/shock. Do not supply excessive amount of air or gas during the procedure. It may result in perforation or rupture of digestive tract wall. Do not supply an excessive amount of air or gas during electrosurgery. It could cause an embolism.

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Chapter 1 Safety

6.2 Insertion and Observation Do not bend the endoscope quickly. There is a risk of damaging the inside of the body cavity. Do not inflate the balloon in the pharynx or esophagus. There is a risk of suffocation. Insert and withdraw the endoscope or Over-tube slowly. Do not press the endoscope or Over-tube strongly onto the walls of the digestive tract. Do not insert or withdraw the endoscope or Over-tube with the balloon inflated. Make sure water never enters the air feed inlet (clear tube) of the Over-tube. It may damage to the walls of the digestive tract, causing perforation. Use of devices such as endoscopic/enteroscopy overtubes may be associated with potential complications including but not limited to mucosal trauma, pancreatitis and/or hyperamylasemia. Users are encouraged to closely monitor patients for such complications during and after procedures and to appropriately treat patients as required. Do not allow the distal end to touch the same part for 5 minutes or more. Heat from the light may cause a burn. Do not look at the light emitted from the light guide directly. There is a risk of damaging eyes. If parts fall into a body cavity due to the malfunction of the device, immediately stop the examination and retrieve the parts by following appropriate measures. There is a risk of damaging the inside of the body cavity. 6.3 Biopsy Do not insert an endotherapy device if you cannot see the forceps outlet on the endoscopic image. There is a risk of perforation and bleeding. Slowly insert an endotherapy device straight into the forceps inlet of the endoscope. Also, when withdrawing it, slowly pull straight out. In addition, slowly attach or remove a syringe, etc. straight to/from the forceps inlet. If inserted or pulled out obliquely to the forceps inlet, the frictional resistance will increase and body fluid may be splattered around due to breakage or accidental detachment of the forceps valve, leading to infection. Do not strongly press an endotherapy device against the digestive tract wall. There is a risk of perforation and bleeding. 6.4.1 Removing Hood (Only When Used) Wear personal protective equipment when removing the balloon or hood. There is a risk of infection. 6.5.5 Removing 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.

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Chapter 1 Safety

6.5.6 Detaching Forceps Valve Discard the forceps valve after use. It could be a source of infection. Chapter 7 Cleaning 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. 7.4.11 Cleaning Entire Endoscope After cleaning, rinse off any remaining chemical with water. Cleaning fluid might flow into a patient’s body. After cleaning, rinse off any remaining cleaning fluid with water. If cleaning fluid remains, the chemical disinfection to be performed at the next step will lose its effectiveness. 7.9 Cleaning and/or Disinfection Using an Automated Endoscope Reprocessor (AER) Some legally marketed automated endoscope reprocessors (AERs) may be able to clean and/or disinfect the endoscope. However, endusers should check with each AER manufacturer to confirm they have validation data to support their reprocessing claims for the endoscope and removable endoscope components, such as valve mechanisms. Inadequate device-specific instructions and/or non-validated AER recommendations could result in unsuccessful cleaning and/or disinfection which may increase risks to patient safety. Chapter 8 Chemical Disinfection 8.3 Chemical Disinfection of Endoscope When immersing the endoscope and the cleaning adapter in disinfectant solution, remove bubbles completely from the endoscope and the cleaning adapter. If any bubbles remain, effective disinfection cannot be achieved. Immerse the entire endoscope and cleaning adapter in disinfectant solution. If any portion of the endoscope or cleaning adapter protrudes from disinfectant solution, insufficient chemical disinfection will result. 8.4.1 Injecting Sterile Water After immersing in the disinfectant solution, rinse off remaining disinfectant solution with sterile water. Disinfecting liquid might flow into a patient’s body. Chapter 9 Gas Sterilization Proceed gas sterilization after vaporizing water out of endoscope. Applying gas sterilization to wet parts presents incomplete sterilization. Proceed aeration after gas sterilization. Gas remaining in endoscope after gas sterilization is harmful to human body. Chapter 10 Storage Do not store endoscope in a carrying case. Storage of endoscope in a carrying case may cause infection. 1-8

Chapter 1 Safety

Chapter 11 Treatment with Electrosurgical Instruments 11.1 Preparing and Inspecting Equipment and Materials Always keep pacemaker users away from electrosurgical instruments. The operation of the pacemaker will be malfunctioned by the electrosurgical instruments. Replace any flammable gas in body cavities with non-flammable gas before using the electrosurgical instruments. Never use the electrosurgical instruments in atmosphere of flammable gas. Ignition and explosion may occur. Do not apply the current when the electrode of diathermic treatment equipment and the metal part at the distal end of the endoscope are in contact with each other. Burns may occur. 11.1.3 Connecting Electrosurgical Instruments Connect surgical instruments correctly in accordance with the operation manual. Wrong connection will cause electric shock accident and burns. Do not use peripherals other than those described in the operation manual. If the endoscope is used in combination with the endoscopic accessories that have been connected to other medical devices, patient leakage current may increase. 11.1.4 Setting the Conditions of Surgery Operate the instruments within specified output range. Leakage current may cause burns. 11.2 Polypectomy Replace any flammable gas in body cavities with non-flammable gas before using the electrosurgical instruments. Ignition and explosion may occur. Prevent patient’s body from touching electric conductor such as metal part of bed. Physicians and assistants should wear rubber gloves. Leakage current may cause burns. Do not apply the current when the electrode of diathermic treatment equipment and the metal part at the distal end of the endoscope are in contact with each other. Burns may occur. 11.3 Papillotomy Replace any flammable gas in body cavities with non-flammable gas before using the electrosurgical instruments. Ignition and explosion may occur. Prevent patient’s body from touching electric conductor such as metal part of bed. Physicians and assistants should wear rubber gloves. Leakage current may cause burns. Do not apply the current when the electrode of diathermic treatment equipment and the metal part at the distal end of the endoscope are in contact with each other. Burns may occur.

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Chapter 1 Safety

1-10

Chapter 2

Composition of Set and System Configuration

This chapter describes the composition of set and system configuration.

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

2-1

Chapter 2 Composition of Set and System Configuration

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

Carrying Case (1)

Forceps Valve FOV-DV7 (10)

Tube Kit TY-06S (1)

Setting Tool ST-01B (1)

Setting Tool ST-05B (20)

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