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.

3

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.

6

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.

1-3

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.

1-6

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

Chapter 3

Names and Functions of Parts

This chapter describes the names and functions of Endoscope parts as well as the composition of the main body.

3-1

Chapter 3 Names and Functions of Parts

Chapter 3 Names and Functions of Parts The main body of the Endoscope consists of the following parts.

Control portion Provides a grip for holding the Endoscope. Also contains parts for operating the Endoscope.

LG flexible portion Contains light guide, air/water supply tube, suction tube and cables.

3-2

Feed water connector

Ventilation connector

Connects to the water tank.

Connects to the air leak tester or ventilation adapter.

Chapter 3 Names and Functions of Parts

Insertion portion (applied part)

Enlarged view of distal end

This portion is inserted into body cavities and contains the distal end, bending portion and flexible portion.

Objective Lens Light Guide Imaging section (inside)

Flexible portion Connects bending portion and control portion. The Endoscope can be inserted into the body cavity up to this portion.

Air/Water Nozzle Forceps Channel Water Jet Nozzle EC-530FI, EC-530FL

Distal end Contains objective lens, air/water nozzles, forceps channel, etc. Air/water supply and suction are controlled by buttons on the control portion.

Bending portion

Waterproof cap

Bend this portion with the knobs on the control portion.

Prevent water from remaining on electric contact. LG connector This connector connects to the scope socket on the light source.

Suction connector Accepts tube from suction unit. S connector EVE connector

Accepts S-cord when using electrosurgical instrument (electric cautery).

This connector connects to the EVE connector socket on the processor.

3-3

Chapter 3 Names and Functions of Parts

<Indication Marks> Symbol

Description Serial number Date of manufacture Manufacturer Authorised representative in the European Community Temperature limitation Keep dry CE marking Degree of waterproof Type BF applied part

WEEE marking [Note 1] Phthalates marking [Note 2] Humidity limitation Atmospheric pressure limitation Super CCD model [Note 1] This product shall not be treated as household waste. [Note 2] This symbol indicates that this specific type of medical device contains dibutyl phthalate (DBP). But the device has little impact on patients' health because of its trace constituent.

3-4

Chapter 4

Control Portion

The control portion contains the angle knobs for operating the bending mechanism and valves for air/water supply and suction, etc. This chapter describes the operations and functions of these parts.

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

4-1

Chapter 4 Control Portion

Chapter 4 Control Portion 4.1 How to Operate the Bending Mechanism 1 Up-down angle knob

To bend the bending portion upward and downward.

2

<When up-down locking lever is slanted toward F

>

Turn the up-down angle knob in the direction of U

to bend the bending portion upward. Turn it in the direction of D to bend the bending portion downward. Release the up-down angle knob to unlock the bending portion. It will unbend a little.

1

<When up-down locking lever is slanted in the direction opposite to F > Release the up-down angle knob to lock the bending portion. It will remain bent.

2 Up-down locking lever

Used to retain the bent state of the bending portion. It switches between Lock and Unlock. Slant this lever in the direction opposite to F to lock the bending portion. Slant it in the direction of F to unlock the bending portion. Operate this lever either before or after operating the up-down angle knob. [Note] Lock : retains bent state of bending portion. Unlock : allows external force to bend bending portion freely.

D U

4-2

Chapter 4 Control Portion

3 Left-right angle knob

To bend the bending portion right or left. <When left-right locking knob is turned forward F

Turn the left-right angle knob in the direction of L

3

4

>

to bend the bending portion to the left. Turn it in the direction of R to bend the bending portion to the right. Release the left-right angle knob to unlock the bending portion. It will unbend a little. <When the left-right locking knob is turned in the direction opposite to F > Release the left-right angle knob to lock the bending portion. It will remain bent.

4 Left-right locking knob

To retain the bent state of the bending portion. It switches between Lock and Unlock. Turn this knob in the direction opposite to F locks the bending portion. Turning it in the direction of F unlocks the bending portion. Operate this knob either before or after operating the left-right angle knob.

L

R 4-3

Chapter 4 Control Portion

4.2 Valve Control Buttons, Forceps Inlet and Water Jet Inlet 5 Water Jet Inlet

The affected part can be cleaned by directly jetting water against it with a syringe.

5

6 Suction Button

Allows suction through forceps channel (port) in distal end. Suction is activated while this button is depressed. 7 Air/Water Button

Used to blow air or water onto the surface of objective lens from the nozzle in distal end. To supply air, stop the hole in the center of this button with a finger. To supply water, just depress this button. 8 Forceps Inlet

Opening for passing through endoscopic accessory. Normally, the forceps valve is attached.

4-4

6

7

8

Chapter 4 Control Portion

4.3 Remote Operating Switches for Images and Recording 9 RC switch

This is the remote switch for capturing image for a video printer.

9

10

10 MM Switch

11

This is the remote switch for electronic magnification. The image is enlarged to 1.5x when this switch is pushed. The field of view then narrows by the amount of enlargement. The image returns to the normal size when the switch is pushed again. 11 FR Switch

This is the remote switch for still image and the capture. The screen image is frozen while this button is being pushed. Image freezing is canceled a few seconds after it is released. If the switch is pushed again while the image is still frozen, a trigger signal is output to the device connected to the hard copy terminal.

Objective Lens Light Guide

Forceps Channel

Air/Water Nozzle Water Jet Nozzle

EC-530FI, EC-530FL

4-5

Chapter 4 Control Portion

4.4 Forceps Valve The forceps valve consists of a valve body and a lid. It performs the function of preventing the leak or flowback of air. By opening and closing this valve, you can change the frictional resistance of an endoscopic accessory by two levels as it is being inserted. 12 Valve Body

The valve body is a part that reduces the leakage or backflow of air when an accessory is used. It is mounted on the opening of the forceps inlet where a forceps is manipulated. Opening the lid of this valve body lowers the frictional resistance of an endoscopic accessory when it is inserted and weakens the backflow preventive effect. 13 Lid

The lid functions as a valve for preventing the leak or backflow of air. It should normally be kept closed. Closing this lid increases the backflow preventive effect, although it makes the frictional resistance of an endoscopic accessory larger when the accessory is inserted. If a cannulation tube or other soft endoscopic accessory is used, opening the lid makes it easier to insert and remove such soft endoscopic accessories. It is also effective in preventing them from breaking. [Note] If an endoscopic accessory is not inserted, this lid must be kept closed.

4-6

13

12

Chapter 5

Preparation for Use of the Endoscope

This chapter describes the system necessary for endoscopy.

5.1 Preparing Equipment.....................................................5-2 5.2 Preparing Forceps Valve...............................................5-4 5.2.1 Method of Cleaning, Disinfecting and Sterilizing Forceps Valve....................................................5-4 5.3 Connecting the Endoscope............................................5-6 5.4 Inspection of Endoscope...............................................5-9 5.4.1 Inspecting the Insertion Portion.........................5-9 5.4.2 Inspecting the Bending Mechanism.................5-10 5.4.3 Inspecting the Objective Lens..........................5-11 5.4.4 Inspecting the Air/Water Supply, Suction, Forceps Channel and Water Jet Channel.......................5-13 5.5 Inspection of Forceps..................................................5-15

5-1

Chapter 5 Preparation for Use of the Endoscope

Chapter 5 Preparation for Use of the Endoscope

CAUTION The use of abnormal equipment will cause wrong diagnosis or injury. Do not use the abnormal equipment.

5.1 Preparing Equipment (1) Move the cart with the processor to the place where the Endoscope is to be used.

(2) After turning the main switch on the cart to the OFF position, plug the power cord from the cart into a protective earth receptacle.

(3) Mount the suction bottle on the suction unit.

5-2

Chapter 5 Preparation for Use of the Endoscope

(4) Mount the water tank, 80% filled with water, on the hook. [Note] The water in the water tank should be changed every day using sterilized water.

In the case of EPX-4400 System

In the case of EPX-2500 System

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Chapter 5 Preparation for Use of the Endoscope

5.2 Preparing Forceps Valve For operational methods of the ultrasonic cleaning unit/autoclaving unit, please follow the instructions described in each operation manual for the respective units. 5.2.1 Method of Cleaning, Disinfecting and Sterilizing Forceps Valve (1) Open the lid of the forceps valve. (2) Wipe the surface of the parts with gauze soaked in cleaning fluid. (3) Brush the entire forceps valve in the cleaning fluid using a soft toothbrush.

(4) Clean the forceps valve using the ultrasonic cleaning unit. (5) Pull out the forceps valve from the cleaning fluid and rinse with running water (clean water). (6) Wipe off the remaining water on the parts with dry sterilized gauze.

<Autoclave sterilization> (1) Seal the forceps valve in a sterilized pack. (2) Carry out an autoclaving operation in accordance with the operation manual of the autoclaving unit.

Recommended steam sterilization (autoclaving) conditions Sterilization temperature (ºC)

Operation time

121

Max 20 minutes Min 15 minutes

126

Max 15 minutes Min 10 minutes

134

Max 8 minutes Min 5 minutes

For France and Switzerland only: Sterilization temperature 134ºC with minimum exposure time (while sterilization temperature) of 18 minutes. Steam Sterilizer Class B according EN 13060

5-4

Chapter 5 Preparation for Use of the Endoscope

<Chemical disinfection> (1) Immerse the forceps valve in disinfectant and disinfect. [Note] When you carry out disinfection using chemical solution, follow the conditions indicated in “Cleaning, Disinfection and Storage” Table App.1 and App.2.

(2) Pull out the forceps valve from the disinfectant and rinse with running water (sterilized water).

(3) Wipe off the remaining water on the forceps valve with sterilized gauze.

5-5

Chapter 5 Preparation for Use of the Endoscope

5.3 Connecting the Endoscope

CAUTION 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> (1) Insert the LG connector of the Endoscope into the Endoscope socket on the light source. (2) Insert the EVE connector of the Endoscope into the 500 system connector socket on the processor.

(3) Connect the dedicated connector cap to the connector socket not in use. (For VP-4450HD only)

(4) Insert the connector of the water tank into the feed water connector on the Endoscope.

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Chapter 5 Preparation for Use of the Endoscope

(5) Connect the suction unit and suction connector of the Endoscope to the suction tube.

CAUTION Endoscope may be adhered to mucous membrane, resulting in damage to the mucous membrane. Set a suction pressure at 53kPa or less.

(6) Set the suction pressure to 40 to 53 kPa. 40

60

80

20

0

100 kpa

<Combination with the EPX-2500 system> (1) Insert the LG connector of the Endoscope into the Endoscope socket on the processor. (2) Insert the EVE connector of the Endoscope into the 500 system connector socket on the processor.

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Chapter 5 Preparation for Use of the Endoscope

(3) Insert the connector of the water tank into the feed water connector on the Endoscope.

(4) Connect the suction unit and suction connector of the Endoscope to the suction tube.

CAUTION Endoscope may be adhered to mucous membrane, resulting in damage to the mucous membrane. Set a suction pressure at 53kPa or less.

(5) Set the suction pressure to 40 to 53 kPa. 40

60

80

20

0

100 kpa

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Chapter 5 Preparation for Use of the Endoscope

5.4 Inspection of Endoscope Prior to inspection, make sure that dirt does not adhere to the Endoscope. If dirt adheres to the Endoscope, clean and disinfect (or sterilize) it according to the instructions given in the Operation Manual (Cleaning, Disinfection and Storage). 5.4.1 Inspecting the Insertion Portion (1) Visually check the insertion portion (distal end, bending portion and flexible portion) for abnormalities such as flaws or dents and for sharp edges on protrusions that may injure the patient.

(2) Hold the flexible portion with both hands and allow it to go over its full length in such a way that the apex of the semicircle with a diameter of about 200 mm gradually begins to slide. Check that the portion bends fully and there is no local difficulty in bending it.

[Note] Do not forcibly twist or bend too sharply the flexible portion by hand. It may cause a failure.

[Note] Do not forcibly twist or bend too sharply the bending portion by hand. It may cause a failure.

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Chapter 5 Preparation for Use of the Endoscope

5.4.2 Inspecting the Bending Mechanism (1) Unlock the up-down locking lever and left-right locking knob by turning them in the direction of F .

(2) Turn the up-down angle knob and left-right angle knob in the U, D, L and R directions until they stop. Check that the bending portion turns smoothly. Check that releasing the knobs unbends the bending portion a little.

(3) Turn the up-down locking lever and left-right locking knob in the direction opposite to F , and then lock them.

(4) Turn the angle knobs in similar manner as in step (2), and check how the bending portion bends. Here, the angle knobs should feel a little heavier than in step (2). Check that bending portion retains its bent state after the angle knobs are released.

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Chapter 5 Preparation for Use of the Endoscope

5.4.3 Inspecting the Objective Lens

CAUTION Viewing the light of light guide directly may damage your eyes. Switch off the light before inspecting the lens.

(1) Turn on the cart, processor and light source, and observe the endoscopic image on monitor. Check that image is clear and nothing obstructs endoscopic view. Be sure that images are displayed normally. If any abnormality occurs with images, immediately stop using the Endoscope and send it for repair. [Note] If wiping does not remove cloudiness from objective lens, it is possible that Endoscope is not sufficiently watertight. Perform a leak test.

In the case of EPX-4400 System

“7.4.1 Air Tightness Test” (Operation Manual (Cleaning, Disinfection and Storage))

In the case of EPX-2500 System

(2) Turn off the lamp of the light source.

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Chapter 5 Preparation for Use of the Endoscope

(3) Visually and manually check the following points. • The objective lens is free from scratches, cracks or disengagement. • The areas around the objective lens are free from cracks or gaps. • The light guides are free from scratches, cracks or disengagement. • The areas around the light guides are free from abnormalities such as gaps. • The distal cap is free from abnormalities such as disengagement. • The air/water nozzle is free from abnormalities such as cracks, abnormal protrusion, disengagement, crushes, dents or deformation. • The side surface of the distal end is free from abnormalities such as scratches, peeling or abnormal bulging. • The distal adhesives are free from abnormalities such as loss, peeling or deterioration.

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Chapter 5 Preparation for Use of the Endoscope

5.4.4 Inspecting the Air/Water Supply, Suction, Forceps Channel and Water Jet Channel (1) Switch on the power to the suction unit.

(2) Have a glass of water ready.

(3) Place the distal end of the Endoscope in air, depress the air/water button, and check that water comes out of the nozzle.

(4) Dip the distal end of the Endoscope in water, stop the center hole in air/water button with your finger, and check that air comes out of the nozzle. Then take your finger off the hole and check that air does not come out of nozzle.

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Chapter 5 Preparation for Use of the Endoscope

(5) Put a forceps valve in forceps inlet. Dip the distal end of the Endoscope in water, and check that depressing the suction button sucks in water and that releasing it stops suction.

(6) Insert the forceps from the forceps inlet and check that their tips come smoothly out of the outlet in the distal end of the Endoscope.

(7) Attach the J check valve for the water jet inlet.

(8) By supplying the water through a water jet inlet, make sure that the water comes out from the water jet nozzle at the distal end. [Note] Use sterilized water for water jetting. Replace the syringe and conduits of the water pump with disinfected and sterilized ones after each examination.

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Chapter 5 Preparation for Use of the Endoscope

5.5 Inspection of Forceps

CAUTION Bending forceps with a small curvature may break it. Do not bend forceps with a curvature radius of 10 mm or less.

(1) Inspect the operation of the forceps. Visually check the forceps for breakage or significant bends, and for sharp edges on protrusions that may injure the patient.

(2) Form the spring of the forceps into a double ring approximately 200 mm in diameter, as shown in the figure.

m

0m

20

(3) Operate the handle of the forceps and check that their tips open and close.

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Chapter 5 Preparation for Use of the Endoscope

5-16

Chapter 6

Method of Use

This chapter outlines how to operate of the equipment, according to the general procedures. Regarding clinical procedures, use proper clinical judgment.

6.1 Preparation....................................................................6-2 6.1.1 Preparing the Necessary Equipment..................6-2 6.1.2 Pretreatment of Patient.......................................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 6.6.1 6.6.2 6.6.3 6.6.4 6.6.5 6.6.6

Wiping..............................................................6-12 Washing Air/Water Supply Channel...............6-12 Washing Suction Channel................................6-13 Removing Endoscope from the Processor.......6-14 Water Proofing the EVE Connector.................6-15 Remove the Air/Water Button, Suction Button and Forceps Valve............................................6-15

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Chapter 6 Method of Use

Chapter 6 Method of Use

WARNING Do not supply an excessive amount of air or gas during the procedure. It could cause an embolism. [Note] Always observe the patient closely. If the patient has symptoms suggestive of an embolism, discontinue the endoscopic procedure immediately and give proper treatment to him/her.

6.1 Preparation 6.1.1 Preparing the Necessary Equipment Prepare the accessories and forceps, etc. to be used.

6.1.2 Pretreatment of Patient Use pretreatment that suits the purpose of examination.

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Chapter 6 Method of Use

6.2 Insertion and Observation

CAUTION Energy of illumination may burn. Do not allow the distal end to touch the same part for 5 minutes or more.

CAUTION It may cause deterioration of the outer surface. Do not directly apply Xylocaine spray to the insertion portion. Do not use olive oil as a lubricant for insertion.

(1) Instruct the patient to take a posture to meet the applied inserting way.

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Chapter 6 Method of Use

(2) Unlock the bending portion by turning the up-down locking lever and the left-right locking knob in the direction of F until they stop. [Note] Another procedure is also available: you can insert the Endoscope by locking the bending portion only in the left-right direction and unlocking it in the up-down direction.

(3) Switch on the power to the processor and turn on the lamp.

In the case of EPX-4400 System

In the case of EPX-2500 System

(4) Apply clean lubricant (Xylocaine jelly or the like) to the insertion portion as required. [Note] Do not apply Xylocaine spray, olive oil or the like directly to the insertion portion.

6-4