EG-530FP Operation Manual Ver. 1.1 Dec 2008

Important Safety Information

Important Safety Information 1. Intended Use This product is a medical Endoscope for the upper digestive tract. It is intended for observation, diagnosis, and endoscopic treatment of the esophagus, stomach, and duodenal bulb 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.”

2

Important Safety Information

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. 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 “Washing,” Chapter 8 “Chemical Disinfection,” and Chapter 9 “Gas Sterilization.”

6. 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.

7. 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.

8. Loss of Function If an image disappears during examination, reset Note the processor and the light source. If the image is still not displayed, turn the processor and the light source off, and then straiten the bending portion to unlock and release the angle knobs. Pull out the Endoscope slowly. If a live image is not displayed after image freezing is cancelled during examination, reset Note the processor and the light source. If the live image is still not displayed, turn the processor and the light source off, and then straiten the bending portion to unlock and release the angle knobs. Pull out the Endoscope slowly. If an image is suddenly discolored during examination, reset Note the processor and the light source. If the image is not recovered, turn the processor and the light source off, and then straiten the bending portion to unlock and release the angle knobs. Pull out the Endoscope slowly. [Note] Reset: turning a processor and a light source off, and turning on again after 5 seconds, and then lighting the lamp by pressing the lamp button.

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Important Safety Information 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 and Forceps 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 EVE Endoscope ......................................... 5-1 5.1 Preparing Equipment ................................................................... 5-2 5.2 Connecting the Endoscope ......................................................... 5-3 5.3 Inspection of Endoscope ............................................................ 5-7 5.4 Inspection of Forceps ............................................................... 5-12

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 Pulling Out the Endoscope .......................................................... 6-9

Appendix ................................................................................................... Appendix-1 Main Specifications ............................................................... Appendix-2 Troubleshooting (Combination with the EPX-4400 system) .............................. Appendix-5 Troubleshooting (Combination with the EPX-2500 system) .............................. Appendix-8 Warranty and After-Sales Service ........................................ Appendix-11 Disposal of Electric and Electronic Equipment ..................... Appendix-12 Index .................................................................................... Appendix-13

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Important Safety Information Contents

(Cleaning, Disinfection and Storage) Chapter 7

Washing .............................................................................................. 7-1

Chapter 8

Chemical Disinfection .......................................................................... 8-1

Chapter 9

Gas Sterilization ................................................................................... 9-1

Chapter 10 Storage .............................................................................................. 10-1

(Electrosurgical Instruments) Chapter 11 Treatment with Electrosurgical Instruments ...................................... 11-1

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

5

Important Safety Information Preface

Preface This manual describes how to use EG-530FP.

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

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) Inspection before use 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. 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. 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 equipment has been tested and found to comply with the limits for medical devices defined in EN 60601-1-2:2001. These limits are designed to provide reasonable protection against harmful interference in a typical medical installation. However, it is possible that it may cause harmful interference to other devices in the vicinity, if it is installed and used in accordance with the instructions. Also, there is no guarantee that interference will not occur in a particular installation. Therefore, if this equipment does cause harmful interference to other devices, which can be determined by turning the equipment off and on, the user is encouraged to try to correct the interference by one or more of the following measures: Change the orientation or position of any affected device. Increase the spacing between devices. Consult the manufacturer or dealer of the device. Noise may appear on the monitor of this equipment due to the effect of electromagnetic waves. In this case, turn off the device emitting the electromagnetic waves or move the device away from this equipment.

2. Washing and Disinfection This product has not been sterilized. When using it for the first time, perform disinfection or sterilization suitable for the application. When reusing it, wash and disinfect it according to the procedures in the manual (Cleaning, Disinfection and Storage). Inadequate washing may result in infection. Wash the insertion portion and channels especially carefully. Wear protective gear during chemical washing and disinfection to protect your skin and to prevent infection.

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.

1-3

Chapter 1 Safety

4. “

Warning” and “

Caution” Messages Appearing in Individual Chapters

Chapter 5 Preparation for Use of the EVE Endoscope The use of abnormal equipment will cause wrong diagnosis or injury. Do not use the abnormal equipment. 5.2 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 (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 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. Chapter 7 Washing 7.5 Second Washing The Endoscope could be a source of infection. In case the cleaning brush is damaged during a washing process, remove any residue from inside the tube. 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 (5 minutes). 7.5.13 Washing the Entire Endoscope Cleaning liquid might flow into a patient’s body. Alter cleaning, wash away any remaining chemical with water. 7.6 Washing 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.

1-4

Chapter 1 Safety

Chapter 8 Chemical Disinfection 8.4.1 Injecting Sterilized Water Disinfecting liquid might flow into a patient’s body. After immersing in the chemical solution, wash 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 Treatment with Electrosurgical Instruments 11.1 Preparing and Inspecting Equipment and Materials The operation of the pacemaker will be malfunctioned by the electrosurgical instruments. Always keep pacemaker users away from electrosurgical instruments. Ignition and explosion may be occurred. Replace any flammable gas in body cavities with nonflammable gas before using the electrosurgical instruments. Never use the electrosurgical instruments in atmosphere of flammable gas. 11.1.3 Connecting Electrosurgical Instruments Wrong connection will cause electric shock accident and burns. Connect surgical instruments correctly in accordance with the operation manual. 11.1.4 Setting the Conditions of Surgery Leakage current may cause burns. Operate the instruments within specified output range. 11.2 Polypectomy Ignition and explosion may be occurred. Replace any flammable gas in body cavities with nonflammable gas before using the electrosurgical instruments. Leakage current may cause burns. Prevent patient’s body from touching electric conductor such as metal part of bed. Physicians and assistants should wear rubber gloves. 11.3 Papillotomy Ignition and explosion may be occurred. Replace any flammable gas in body cavities with nonflammable gas before using the electrosurgical instruments. Leakage current may cause burns. Prevent patient’s body from touching electric conductor such as metal part of bed. Physicians and assistants should wear rubber gloves.

1-5

Chapter 1 Safety

1-6

Chapter 2 Composition of Set and System Configuration

Chapter 2

Composition of Set and System Configuration

This chapter describes the composition of Endoscope 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 Endoscope set is provided in a carrying case. The set consists of the following items. [Note] Figures in parentheses indicate quantities.

Mouthpiece MPC-ST (2)

Carrying Case (1)

Protective Cap Suction (1)

Silicon Oil SLC-2000 (1)

Protective Cap A/W Ventilation Connector (1)

S Connector Cap CAP-E (1) Forceps Valve FOV-DV7 (10)

2-2

Chapter 2 Composition of Set and System Configuration

Forceps (2)

Operation Manual Preparation and Operation (1) Cleaning, Disinfection and Storage (2) Electrosurgical Instruments (1)

Cleaning Brush (1)

Endoscope (1)

Cleaning Brush (1) (for Valve)

Ventilation Adapter AD-7 (1) Syringe (1)

Tank Receiving Cap (1)

Tube for Air/Water Supply Channel (1)

Valve Set (1)

Valve Adapter CA-503S/A (1) Forceps Inlet Cleaning Adapter (with a Cap) CA-503B/C (1) Tube for Suction Channel (1) Cleaning Adapter CA-503/A (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 EG-530FP 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

Sonoprobe System

Water Tank WT-2

Light Source XL-4400

Processor VP-4400

Endoscope EG-530FP

Data Keyboard DK-4400E

Foot Switch FS1 Cart

2-4

Chapter 2 Composition of Set and System Configuration

LCD Monitor CDL1566A CDL1576A CDL1904A CDL1909A

Video Printer UP-51MD-120V, 230V-(SONY) UP-51MDU-120V-(SONY) UP-21MD (SONY) UP-55MD (SONY) CP900E-230V-(MITSUBISHI) CP900UM-120V-(MITSUBISHI)

DVD Recorder DSR-20MD (SONY) LQ-MD800 (Panasonic)

Electrosurgical Instrument ICC 200 (ERBE)

2-5

Chapter 2 Composition of Set and System Configuration

2.3 System Configuration (Combination with the EPX-2500 system) You may use the EG-530FP 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

Water Tank WT-2

Processor EPX-2500

Endoscope EG-530FP

Data Keyboard DK-2500 Cart

2-6

Chapter 2 Composition of Set and System Configuration

LCD Monitor CDL1566A CDL1576A CDL1904A CDL1909A

Video Printer UP-21MD (SONY) UP-55MD (SONY) CP900E -230V-(MITSUBISHI) CP900UM -120V-(MITSUBISHI)

DVD Recorder DVO-1000MD (SONY) LQ-MD800 (Panasonic)

Electrosurgical Instrument ICC 200 (ERBE)

2-7

Chapter 2 Composition of Set and System Configuration

2-8

Chapter 3 Names and Functions of Parts

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 airtight tester or ventilation adapter.

Chapter 3 Names and Functions of Parts

Insertion portion

Enlarged view of distal end

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

Flexible portion Connects bending portion and control portion. EG-530FP

The Endoscope can be inserted into the body cavity up to this portion. 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 Bend this portion with the knobs Waterproof cap

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.

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

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

3-3

Chapter 3 Names and Functions of Parts

<Indication Marks>

Symbols

3-4

Location

Meanings (Standard)

LG connector

Type BF applied part (IEC 60601-1)

LG connector

Date of manufacture (EN 980)

LG connector

Serial number (EN 980)

LG connector

CE marking (93/42/EEC)

LG connector

WEEE marking (EN 50419)

Chapter 4 Control Portion

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 and Forceps 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 Up-down angle knob To bend the bending portion upward and

2

downward. <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

1

to bend the

bending portion downward. Release the up-down angle knob to unlock the bending portion. It will unbend a little. <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.

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 por-

tion. 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.

4-2

D U

Chapter 4 Control Portion

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

3

>

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

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

4

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.

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 and Forceps Inlet Suction Button Allows aspiration through forceps channel (port) in distal end. Suction is activated while this button is depressed.

5 Air/Water Button Used to blow air or water onto the surface of objective lens from the nozzle in distal end.

6

To supply air, stop the hole in the center of this button with a finger. To supply water, just depress this button. Forceps Inlet

7

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

Objective Lens Light Guide

Air/Water Nozzle

EG-530FP

4-4

Forceps Channel

Chapter 4 Control Portion

4.3 Remote Operating Switches for Images and Recording RC Switch This is the remote switch for capturing image for a video printer.

8

9

MM Switch This is the remote switch for electronic magnification. The image is enlarged to 1.5x when this switch is pushed.

10

The field of view then narrows by the amount of enlargement. The image returns to the normal size when the switch is pushed again. 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.

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.

Valve Body The valve body is a part that reduces the leakage or backflow

12

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. 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

11

Chapter 5 Preparation for Use of the EVE Endoscope

Chapter 5

Preparation for Use of the EVE Endoscope

This chapter describes the system necessary for endoscopy.

5.1 Preparing Equipment ................................................... 5-2 5.2 Connecting the Endoscope ......................................... 5-3 5.3 Inspection of Endoscope ............................................. 5-7 5.3.1 Inspecting the Insertion Portion ........................ 5-7 5.3.2 Inspecting the Bending Mechanism .................. 5-8 5.3.3 Inspecting the Air/Water Supply, Suction and Forceps Channel ......................................... 5-9 5.3.4 Inspecting the Objective Lens ......................... 5-11 5.4 Inspection of Forceps ................................................ 5-12

5-1

Chapter 5 Preparation for Use of the EVE Endoscope

Chapter 5 Preparation for Use of the EVE 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 EVE 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

5.2 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 (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.

5-3

Chapter 5 Preparation for Use of the EVE 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

5-4

Chapter 5 Preparation for Use of the EVE Endoscope

<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.

(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.

5-5

Chapter 5 Preparation for Use of the EVE Endoscope

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

5-6

Chapter 5 Preparation for Use of the EVE Endoscope

5.3 Inspection of Endoscope 5.3.1 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.

5-7

Chapter 5 Preparation for Use of the EVE Endoscope

5.3.2 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.

5-8

Chapter 5 Preparation for Use of the EVE Endoscope

5.3.3 Inspecting the Air/Water Supply, Suction and Forceps Channel (1) Switch on the power to the suction unit, cart, processor and light source. Keep the lamp off. (2) Have a glass of water ready.

In the case of EPX-4400 System

In the case of EPX-2500 System

(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.

5-9

Chapter 5 Preparation for Use of the EVE 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.

5-10

Chapter 5 Preparation for Use of the EVE Endoscope

5.3.4 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 OFF the lamp. Look at the distal end of the Endoscope at an angle and check that the objective lens is free of dirt or foreign matter.

(2) If the lens is dirty, clean it. [Note] To clean the lens, wipe it with gauze (or something similarly soft) dampened with lens cleaner or ethanol.

(3) Switch on the lamp and observe the endoscopic image on the monitor. Check that the image is free of cloudiness or blurs. [Note] If wiping does not remove cloudiness from the objective lens, it is likely that the Endoscope is not sufficiently airtight. Run an airtightness test with an airtightness tester LT-7. “7.5.3 Airtightness Test” (p.7-10)

5-11

Chapter 5 Preparation for Use of the EVE Endoscope

5.4 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.

mm 200

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

5-12

Chapter 6 Method of Use

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 Pulling Out the Endoscope .......................................... 6-9

6-1

Chapter 6 Method of Use

Chapter 6 Method of Use 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.

6-2

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) Have the patient hold the mouthpiece in his/her mouth.

[Note] If you choose to have the patient hold the mouthpiece after insertion, attach the mouthpiece to the insertion portion in advance. Have the patient hold it promptly after insertion.

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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 leftright direction and unlocking it in the up-down direction.

(3) Switch on the power to the processor and the light source 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.

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Chapter 6 Method of Use

[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.

(5) Insert the distal end of the Endoscope from the oral cavity to the pharynx, while observing the process. Control the brightness by the level button on the light source.

(6) Stop the center hole in the air/water button with a finger to supply air to the digestive tract. The mucous membrane of the digestive tract will become clearly visible.

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Chapter 6 Method of Use

(7) Direct the distal end of the Endoscope to the region of interest by turning the up-down and left-right angle knobs.

<To suction mucus> To suction mucus, put the distal end of the Endoscope in the mucous lake and press the suction button.

<If the surface of the lens is clouded with mucus or if the image is obscured> Wash the surface of the lens by pressing the water supply button. When washing is complete, remove the water from the surface of the lens by air blow and suction.

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Chapter 6 Method of Use

6.3 Biopsy

WARNING It may cause perforation or bleeding. Do not press them the digestive tract wall with undue force.

CAUTION It may damage Endoscope. Do not push the forceps forcefully, when having in difficulty in insertion. [Note] Sometimes the forceps become stuck in the bending portion and will not pass smoothly. In such case, unbend the bending portion a little and try to insert again.

(1) Direct the distal end of the Endoscope to the biopsy site.

(2) Check the opening and closing of the forceps. Insert the forceps from the forceps inlet by observing the image.

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Chapter 6 Method of Use

(3) When the distal end of the forceps come into the field of view, stop insertion temporarily.

(4) Bring the forceps closer to the biopsy site slowly.

(5) Take a biopsy specimen by manipulating the angle knobs and letting the forceps in and out.

(6) Pull out the forceps slowly and take out the biopsy specimen.

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