EC-530 Fx Operation Manual Aug 2017

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 Endoscope for the lower digestive tract. It is intended for observation, diagnosis, and endoscopic treatment of the rectum and large intestine at medical facilities under management of physicians. Never use this product for any other purposes.

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 Improper use or operation of the equipment may injure patients, physicians, or people in the vicinity. Read and understand this manual carefully before operating the equipment. 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 endoscopic procedures. It does not provide information about clinical procedures. Regarding clinical procedures, use proper clinical judgment.

5. Applicability of Endoscopy and Endoscopic Treatment Proper clinical judgment should be exercised for the applicability of endoscopy and endoscopic treatment. If there are official standards on the applicability of endoscopy and endoscopic treatment that are defined by the hospital’s administrators or other official institutions, such as academic societies on endoscopy, follow those standards. Perform endoscopy and endoscopic treatment only when the benefits outweigh the risks. 2

Important Safety Information

6. 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.”

7. Single Use Only Forceps valve are intended for single use. To prevent infection, do not reuse them.

8. 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 therapeutic accessories.

9. If Any Abnormality Occurs During the 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 Endoscope.

10. Loss of Function During an examination and treatment, if the endoscopic image disappears, a live image is not displayed after freeze mode has been cancelled, or the endoscopic image is discolored, turn the processor and the light source off immediately, straighten the bending portion to its neutral position, release the angle knobs, and then slowly withdraw the Endoscope from the patient. Send the Endoscope for repair. Should the endoscopic image disappear during an examination or treatment, and if the processor and the 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.

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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 (Combination with the EPX-4400 system)... 2-4 2.3 System Configuration (Combination with the EPX-2500 system)... 2-6

Chapter 3

Names and Functions of Parts... 3-1

Chapter 4

Control Portion... 4-1 4.1 How to Operate the Bending Mechanism... 4-2 4.2 Valve Control Buttons, Forceps Inlet and Water Jet Inlet... 4-4 4.3 Remote Operating Switches for Images and Recording... 4-5 4.4 Forceps Valve... 4-6

Chapter 5

Preparation for Use of the Endoscope... 5-1 5.1 Preparing Equipment... 5-2 5.2 Preparing Forceps Valve... 5-4 5.3 Connecting the Endoscope... 5-6 5.4 Inspection of Endoscope... 5-9 5.5 Inspection of Forceps... 5-15

Chapter 6

Method of Use... 6-1 6.1 Preparation... 6-2 6.2 Insertion and Observation... 6-3 6.3 Biopsy... 6-7 6.4 Cleaning of Affected Part... 6-9 6.5 Pulling Out the Endoscope... 6-10 6.6 Pre Cleaning (performed at bedside immediately after use of Endoscope)... 6-12

4

Contents

Appendix...Appendix-1 Main Specification...Appendix-2 Troubleshooting (Combination with the EPX-4400 system)...Appendix-7 Troubleshooting (Combination with the EPX-2500 system)...Appendix-10 Warranty and After-Sales Service...Appendix-13 Disposal of Electric and Electronic Equipment...Appendix-14 Index...Appendix-15 Service Centers...Appendix-16

(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 Using Electrosurgical Instruments ... 11-1 [Note] As for the table of contents details “Cleaning, Disinfection and Storage” “Electrosurgical Instruments”, please look at each operation manual.

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Preface

Preface This manual describes how to use EC-530FI and EC-530FL. Thoroughly read the operation manuals of the processor, light source and peripherals used in combination with this product. In this manual, illustrations and nomenclature of the processor VP-4400 and the light source XL-4400 are used for explanation unless otherwise noted.

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 harm to people.

WARNING

Explains the dangerous conditions that may cause to death or serious accident unless it is avoided.

CAUTION

Explains the conditions that may cause to light or medium injury unless it is avoided.

CAUTION

Explains the conditions that may damage to equipment unless it is avoided.

(1), (2), (3), ...

Consecutive numbers in operating procedures indicate the sequence of successive operations.

[Note]

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 Endoscope.

1-1

Chapter 1 Safety

Chapter 1 Safety 1. Precautions in Using Endoscope 1) 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. 2) Combination of equipment 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 operation manual. Thoroughly read the operation manuals of the peripherals used in combination with this product. 3) Abnormality in use If any abnormality is noticed during use, carry out safety checks and discontinue use immediately. 4) 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 100 cases. Also have it checked if there is anything wrong with the equipment. Do not disassemble or modify the equipment. This product should not be subjected to any type of repair or maintenance procedure while it is being clinically used on a patient (or while it is being reprocessed). 5) Operation of Endoscope 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 encounter any resistance, insert it slowly. Do not force it in. Do not insert or bend the Endoscope without securing the view on the monitor. 6) Handling of Endoscope When holding 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. Pull on rubber gloves when handling an Endoscope to prevent infection and static charges.

1-2

Chapter 1 Safety

7) 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. 8) Electromagnetic interference 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. Electromagnetic interference may occur in the vicinity of equipment marked with the following symbol or other portable and mobile RF (radio frequency) communications equipment, such as cellular phones.

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 the monitor. 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. This equipment complies with the requirements of EN 60601-1-2:2001+A1:2006 when connected to VP-4400 and XL-4400. This equipment complies with the requirements of IEC 60601-1-2:2001 when connected to the processor and light source with power supply voltage of 120V.

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Chapter 1 Safety

2. Cleaning and Disinfection/Sterilization This product has not been sterilized. When using it for the first time, perform disinfection 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 water jet channel especially. Wear protective gear during chemical cleaning 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.

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. Before disposing of this product or an endoscopic accessory, perform cleaning and disinfection (or sterilization) according to the procedure described in the operation manual. Otherwise, this may pose an infection control risk.

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/

1-4

Chapter 1 Safety

6. “ Warning” and “ Caution” Messages Appearing in Individual Chapters Chapter 5 Preparation for Use of the Endoscope The use of abnormal equipment will cause wrong diagnosis or injury. Do not use the abnormal equipment. 5.3 Connecting the Endoscope Touching the LG connector with hands immediately after use of the Endoscope may cause to burn. Do not touch the LG connector tip until it will be cooled down (approximately 5 minutes). <Combination with the EPX-4400 system> Endoscope may be adhered to mucous membrane, resulting in damage to the mucous membrane. Set a suction pressure at 53kPa or less. <Combination with the EPX-2500 system> Endoscope may be adhered to mucous membrane, resulting in damage to the mucous membrane. Set a suction pressure at 53kPa or less. 5.3.4 Inspecting the Objective Lens Viewing the light of light guide directly may damage your eyes. Switch off the light before inspecting the lens. Chapter 6 Method of Use Do not supply an excessive amount of air or gas during the procedure. It could cause an embolism. 6.2 Insertion and Observation Energy of illumination may burn. Do not allow the distal end to touch the same part for 5 minutes or more. 6.3 Biopsy It may cause perforation or bleeding. Do not press them the digestive tract wall with undue force. 6.6.4 Removing Endoscope from the Processor Touching the LG connector with hands immediately after use of the Endoscope may cause to burn. Do not touch the LG connector tip until it will be cooled down (approximately 5 minutes). Chapter 7 Cleaning 7.4 Manual Cleaning The Endoscope could be a source of infection. In case the cleaning brush is damaged during a cleaning process, remove any residue from inside the tube. 7.4.9 Cleaning the Entire Endoscope Cleaning liquid might flow into a patient’s body. After cleaning, rinse off any remaining chemical with water.

1-5

Chapter 1 Safety

7.5 Cleaning and Sterilize Biopsy Forceps Sterility might not be maintained if the sterilized pack is ruptured. Close the cap before putting the forceps in a sterilized pack. Chapter 8 Chemical Disinfection 8.1 Methods of Chemical Disinfection Disinfecting liquid might flow into a patient’s body. After immersing in the chemical solution, rinse off remaining chemical solution with sterilized water. 8.4.1 Injecting Sterilized Water Disinfecting liquid might flow into a patient’s body. After immersing in the chemical solution, rinse off remaining chemical solution with sterilized water. Chapter 9 Gas Sterilization Applying gas sterilization to wet parts presents incomplete sterilization. Proceed gas sterilization after vaporizing water out of Endoscope. Gas remaining in Endoscope after gas sterilization is harmful to human body. Proceed aeration after gas sterilization. Chapter 10 Storage Storage of Endoscope in a carrying case may cause infection. Do not store Endoscope in a carrying case. Chapter 11 Using Electrosurgical Instruments 11.1 High-frequency cauterization Never use electrosurgical equipment while oxygen is being supplied. Never use the electrosurgical instruments in atmosphere of flammable gas. Wear electrically insulating gloves when using an electrosurgical unit or accessory. If not worn, there is a risk of thermal injury or electric shock. Be sure electrically conductive parts within the patient vicinity such as metal parts of a bed are not in direct contact with a patient's body. There is a risk of thermal injury. Always keep patients with a pacemaker away from electrosurgical instruments. The operation of the pacemaker may malfunction by the electrosurgical instruments. When performing electrosurgery, maintain enough distance between the distal end of Endoscope and the tip of the electrosurgical unit. Energize the electrosurgical unit after bringing the tip of the endotherapy device into the field of view. Do not energize the electrosurgical instruments when the electrically active portion of high-frequency surgical instrument and the metal part at the distal end of Endoscope are in contact with each other. Thermal injury or scope damage may occur. Connect the electrosurgical instruments and electrosurgical generators in accordance with each operating manual. Incorrect connection may cause electric shock and/or burns. Operate the instruments within specified output range as per the device’s operating instructions. Leakage current may cause thermal injury. Prior to performing endoscopic electrosurgery, one should have a thorough understanding of the manufacturers' instructions for all equipment involved and one should be familiar with the specific safety and usage aspects of each endotherapy device.

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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 (Combination with the EPX-4400 system)...2-4 2.3 System Configuration (Combination with the EPX-2500 system)...2-6

2-1

Chapter 2 Composition of Set and System Configuration

Chapter 2 Composition of Set and System Configuration 2.1 Composition of Set The set is provided in a carrying case. The set consists of the following items. [Note] Figures in parentheses indicate quantities.

Protective Cap Suction (1)

Carrying Case (1) Protective Cap A/W Ventilation Connector (1)

S Connector Cap CAP-E (1)

J Cleaning Adapter CJ-500 (1)

Forceps Valve FOV-DV7 (10)

J Check Valve AJ-500 (2) Flexible Adapter FAX-3 (1)

2-2

J Adapter set JA-500 (1)

J Protective Cap CAP-J (1)

Chapter 2 Composition of Set and System Configuration

AN NM TIO RA

E OP L

UA Operation Manual Preparation and Operation (1) Cleaning, Disinfection and Storage (1) Electrosurgical Instruments (1) Cleaning Brush WB4321FW2 (1)

Suction Button SB-500 (1) Air / Water Button AW-500 (1)

Cleaning Brush (for Valve) WB11001FW2 (1) Endoscope (1)

Ventilation Adapter AD-7 (1)

Syringe (1)

Tube for Air/Water Supply Channel (1) Tank Receiving Cap (1)

Valve Adapter CA-503S/A (1) Valve Set (1)

Forceps Inlet Cleaning Adapter (with a Cap) CA-503B/C (1) Cleaning Adapter CA-503/A (1)

Tube for Suction Channel (1)

2-3

Chapter 2 Composition of Set and System Configuration

2.2 System Configuration (Combination with the EPX-4400 system) You may use the EC-530FI and EC-530FL with various peripherals attached to it. These peripherals are available separately. Extension makes the following possible. • Endoscopic treatment • Ultrasonography through forceps channel • Recording of Video images • Printer output Suction Unit [Note] Use a suction unit which complies with EN 60601-1 (IEC 60601-1) and can set suction pressure to 40 to 53 kPa. Water Tank WT-2 WT-4 [Note 1]

Sonoprobe System

Light Source XL-4400 XL-4450 [Note 1]

Endoscope EC-530FI EC-530FL Processor VP-4400 VP-4450HD [Note 1]

Forceps/ Endotherapy Device

Electrosurgical Unit [Note] For details, refer to the manual of the electrosurgical instrument.

Cart Data Keyboard Foot Switch

[Note 1] Not available in USA.

2-4

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 Printer Video Recorder

2-5

Chapter 2 Composition of Set and System Configuration

2.3 System Configuration (Combination with the EPX-2500 system) You may use the EC-530FI and EC-530FL with various peripherals attached to it. These peripherals are available separately. Extension makes the following possible. • Endoscopic treatment • Recording of video images • Printout of still images

Suction Unit [Note] Use a suction unit which complies with EN 60601-1 (IEC 60601-1) and can set suction pressure to 40 to 53 kPa.

Water Tank WT-2 WT-4 [Note 1]

Processor EPX-2500

Endoscope EC-530FI EC-530FL

Cart Data Keyboard

Forceps/ Endotherapy Device

Electrosurgical Unit [Note] For details, refer to the manual of the electrosurgical instrument.

[Note 1] Not available in USA.

2-6

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 Printer Video Recorder

2-7

Chapter 2 Composition of Set and System Configuration

2-8