EI-580BT Video Endoscope Operation Manual



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Introduction

Introduction Video Endoscope EI-580BT is a medical endoscope intended for the observation, diagnosis and endoscopic treatment of the esophagus, stomach, duodenum, small intestine, ileocecal region, large intestine, sigmoid colon and rectum at medical facilities under the management of physicians. This manual provides necessary information for using the 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 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 endoscope in optimum working condition. In this manual, illustrations and nomenclature of the video processor VP-4450HD and the light source XL-4450 are used for explanation unless otherwise noted.

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 FUJIFILM Corporation. All rights reserved.

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Introduction

CAUTION 1 2 3

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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.

Video Endoscope EI-580BT Operation Manual This manual provides necessary information for using the video endoscope such as the equipment overview, operation procedures and precautions to observe.

Video Endoscope EI-580BT Reprocessing Manual This manual describes the cleaning, disinfection, sterilization and storage methods of the video endoscope.

[Note] In this manual, the Video Endoscope EI-580BT Operation Manual is referred to as “this manual”, and the Video Endoscope EI-580BT 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), ...

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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Contents at a Glance

Contents at a Glance

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

Chapter 2 Product Overview This chapter describes the composition of the 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 endoscope.

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

Chapter 5 Troubleshooting This chapter describes actions should be taken if problems occur in the 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...10 1.3 Safety...11 1.3.1 Infection...11 1.3.2 Preventing Electrical Shock...14 1.3.3 Treatment with Electrosurgical Instruments...14 1.3.4 Direct Harm to Human Body...16 1.3.5 Balloon Instructions...17 1.4 Electromagnetic Compatibility (EMC)...19 1.4.1 Electromagnetic Compatibility (EMC) Related Standard...19 1.5 Location of Each Label...20 1.5.1 Location of Labels...20 1.5.2 Symbols...21 1.6 Possible Combinations for Use...22 1.6.1 Accessories...22 1.6.2 Compatible Video Processor and Light Source...22 1.6.3 Peripheral Devices...23 1.7 Cautions/Warnings...24 1.7.1 Abnormalities during Use of This Product...24 1.7.2 Transportation and Storage...25 1.7.3 Storage and Management...25 1.7.4 General Warnings...26 Chapter 2 Product Overview...28 2.1 Composition of Standard Set...28 2.2 System Configuration ...30 2.2.1 Combination with VP-4450HD...30 2.2.2 Combination with VP-7000...32 2.3 Nomenclature and Functions of Endoscope...34 2.4 Nomenclature and Functions of Endoscope Distal End...36 2.5 Nomenclature and Functions of Accessories...37 2.5.1 Forceps Valve...37 2.5.2 Cleaning Adapter...38

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Contents

2.6

2.7

2.8

Operating Bending Section...40 2.6.1 Operating the Bending Section...40 2.6.2 Angle Lock Function...42 Control Valves...44 2.7.1 Suction Valve...44 2.7.2 Air/Water Valve...44 Scope Switches for Images and Recording...45

Chapter 3 Preparation and Inspection Before Use...46 3.1 Preparing Forceps Valve...46 3.1.1 Cleaning and Disinfecting (or Sterilizing) the Forceps Valve...47 3.1.2 Inspecting the Forceps Valve...47 3.1.3 Attaching the Forceps Valve...47 3.2 Preparing Air/Water Valve and Suction Valve...48 3.2.1 Inspecting the Air/Water Valve and Suction Valve...48 3.2.2 Attaching the Air/Water Valve and Suction Valve...49 3.3 Preparing and Inspecting Over-tube and Balloon...50 3.3.1 Preparing and Inspecting Necessary Equipment...50 3.3.2 Attaching the Over-tube...52 3.3.3 Mounting the Endoscope Balloon...52 3.3.4 Attaching the Fixing Rubber...54 3.3.5 Attaching the Hood (Only When Necessary)...57 3.3.6 Inspecting the Balloon...59 3.4 Connecting Balloon Controller...60 3.4.1 Connecting the Balloon Controller...60 3.4.2 Inspecting the Balloon (Balloon Controller)...61 3.5 Preparing System...63 3.5.1 Preparing Peripheral Devices...63 3.5.2 Preparing the System...63 3.6 Connecting Endoscope (Attachment)...65 3.6.1 Connecting the Endoscope (Video Processor and Light Source)...65 3.6.2 Connecting the Water Tank and Suction Unit...67 3.7 Inspecting Endoscope...68 3.7.1 Inspecting the Insertion Portion...68 3.7.2 Inspecting the Bending Mechanism...69 3.7.3 Inspecting the Air/Water Supply and Suction Channels...69 3.7.4 Inspecting the Balloon Air Feed Inlet...71 3.7.5 Inspecting the Instrument Channel...71 3.8 Inspecting Distal End of Endoscope...72

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Contents

Chapter 4 Method of Use...74 4.1 Preparation...76 4.1.1 Preparing Necessary Equipment...76 4.1.2 Pretreatment of the Patient...76 4.2 Insertion and Observation...77 4.2.1 Peroral Insertion...79 4.2.2 Transanal Insertion...83 4.2.3 To Suck Mucus...87 4.2.4 If Mucus Adheres to the Distal Objective Lens or If the Image is Obscured...87 4.3 Treatment...88 4.4 Endoscope Withdrawal...89 4.5 Removing Hood, Over-tube and Balloon...91 4.5.1 Removing the Hood (Only When Used)...91 4.5.2 Removing the Balloon...92 4.5.3 Removing the Over-tube...92 4.6 Pre-cleaning (Primary Cleaning)...93 Chapter 5 Troubleshooting...94 5.1 Troubleshooting...94 Main Specification...103 Service...109 Disposal of Electric and Electronic Equipment...110 Index...111 Service Centers...112

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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. 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.

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. [Note] Use in combination with the VP-4450HD video processor and XL-4450 light source or with the VP-7000 video processor and BL-7000 light source.

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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 endoscope’s all surfaces including channels as per provided reprocessing instructions. Wear personal protective equipment during clinical procedures as well as during cleaning and disinfection (or sterilization) to protect your eye and skin and to prevent infection. Wear personal protective equipment when using the endoscope. Otherwise, it 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. 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 endoscope. Not doing so may cause backflow of body fluids and increase a risk of infection. If the lid of the forceps valve needs to be open during an examination or treatment, 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. 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. Do not use the balloon or Over-tube after its expiration date has elapsed. Doing so may pose an infection risk. The filter and tube of the tube kit are consumables. Replace them once a month or once every 10 cases, whichever comes first. If body fluid flows back into the tube, replace the tube kit. Not doing so may pose an infection risk. When removing the hood, Over-tube and balloon, wear personal protective equipment and slowly remove them. Not doing so may pose an infection risk. Do not release your finger suddenly from the suction valve during suction. Doing so may cause body fluid to splatter and pose an infection risk.

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Chapter 1 Precautions

WARNING Slowly insert an endotherapy device (e.g. forceps) or syringe straight into the 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 examinations 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, setting tool ST-05B, balloon and Over-tube are intended for single use. To prevent infection, do not reuse them. Discard the forceps valve, balloon and Over-tube after use. Used forceps valve, balloon and Over-tube 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) accessory 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) 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.

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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 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.

1.3.3 Treatment with Electrosurgical Instruments

WARNING When using diathermic treatment equipment, maintain enough distance between the distal end of 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. 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.

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Chapter 1 Precautions

WARNING 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 to tighten the snare properly and how repeated use affects the cutting quality of therapeutic accessories.

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. It could cause thermal injury to a patient. Make sure that the patient's vomit or body fluid does not contact the electric conductor such as metal parts of the bed while using an electrosurgical instrument. Not doing so could cause electricity to pass through the vomit or body fluid, resulting in thermal injury. Be careful not to touch the patient while using an electrosurgical instrument. 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.

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Chapter 1 Precautions

1.3.4 Direct Harm to Human Body

WARNING Use the air/water channel cleaning adapter CA-611 only for cleaning the air/water channel. If it is used during an examination or treatment, continuous air supply may occur and cause patient injury. 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 endoscope or endotherapy device against mucosal surfaces. Only advance the endotherapy device under direct visualization. Do not angulate the bending section or insert the endoscope while an endotherapy device is out of the distal end. Doing so may cause the endotherapy device to be pressed against the mucosal surfaces, resulting in bleeding or perforation.

CAUTION During an observation, do not perform close observation for an extended period of time. Use the 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 video 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. 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.

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Chapter 1 Precautions

CAUTION Set the suction pressure between 40 and 53 kPa. If the suction pressure is too high, the 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 endoscope. Turn off the lamp before inspecting the objective lens. Viewing the light from the light guide directly may damage your eyes.

1.3.5 Balloon Instructions

WARNING 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. If the balloon is swollen too much, the intestinal tract might be damaged. 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. Do not use the TS-13101 Over-tubes and BS-2 balloons on patients allergic to latex. Doing so can create a risk of an anaphylactic reaction/ shock. 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. Do not supply excessive amount of air or gas during the procedure. Doing so may result in perforation or rupture of the digestive tract wall. Do not inflate the balloon in the pharynx or esophagus. Doing so can create a risk of suffocation.

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Chapter 1 Precautions

WARNING Insert and withdraw the endoscope or Over-tube slowly. Slowly insert the Over-tube so as not to have the intestinal tract caught in a gap between the endoscope and Over-tube. When holding the Overtube, take care not to fold or crush the air feed inlet (clear tube). 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. It may damage to the walls of the digestive tract, causing perforation. Make sure that water never enters the balloon air feed inlet (clear tube) of the Over-tube or the balloon air feed inlet of the endoscope. Inflation or deflation of the balloon with the balloon controller may become impossible, damaging the walls of the digestive tract. 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.

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Chapter 1 Precautions

1.4 Electromagnetic Compatibility (EMC) To avoid electromagnetic interference in the operational environment, read the following precautions and properly handle this product and other devices in the vicinity.

1.4.1 Electromagnetic Compatibility (EMC) R ‌ elated Standard This product has been tested and confirmed 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 electromagnetic interference in a typical installation at medical facilities. However, there is a possibility that this product may cause harmful electromagnetic interference to other devices in the vicinity, even if it is used according to the video processor instructions. Also, there is no guarantee that interference will not occur in a particular installation. 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. • Consult the manufacturer or dealer of other devices. 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.

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 waves. In this case, turn off the device emitting the electromagnetic waves or move the device away from this product. Use the cable specified in the Installation Manual of the processor for this product. Use of other cables may cause an increase in electromagnetic emission or decrease in electromagnetic immunity of this product.

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Chapter 1 Precautions

1.5 Location of Each Label The positions where the labels are affixed on this product are shown below. The relevant safety signs are also described.

1.5.1 Location of Labels <Control Portion> Model Label

Instrument Channel Diameter Label

<LG Connector>

Label for the Serial Number

LG Connector Label

Label for the Year of Manufacture

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