EN-450x5x Series Operation Manual May 2009

Important Safety Information

Important Safety Information 1. Intended Use This product is a medical Endoscope for the small intestine. It is intended for observation, diagnosis, and endoscopic treatment of the small 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.”

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. When performing observation, diagnosis, and endoscopic treatment of the small intestine, refer to the medical conditions that are generally regarded as contraindications in upper gastrointestinal endoscopy or colonoscopy. Also, in the case of a patient with an extremely poor general condition or a condition where performing endoscopy is regarded as dangerous including ileus, intestinal perforation, respiratory disease, cardiovascular disease, Crohn’s disease, acquired hemophilia, stenosis, large ulcer, and tumor, perform endoscopy only when the usefulness of performing endoscopy is judged to outweigh the risks. This manual does not provide information about clinical procedures. Regarding clinical procedures, use proper clinical judgment.

5. When Using the Endoscope for the First Time This product has not been sterilized. When using it for the first time, use the level of disinfection or sterilization suitable to the application, in accordance with Chapter 8 “Washing,” Chapter 9 “Chemical Disinfection,” and Chapter 10 “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. About the Use of the Balloon When the balloon is swollen too much, the enteric canal might be hurt. When using the balloon, the operator should conduct sufficient basic experiments outside the body and learn the degree of inflation of the balloon before using it.

8. About Latex Allergy This product is used with a product that contains natural rubber as a material. Natural rubber may rarely cause allergy symptoms, such as itching, reddening, hives, swelling, fever, dyspnea, asthma-like symptoms, drop of blood pressure and shock. If such symptoms are observed, stop use immediately and take appropriate measures.

9. If Any Abnormality Occurs During the Clinical Procedure If any abnormality occurs with the equipment, refer to “Troubleshooting.”

3

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 400 System Endoscope Set and System Configuration ................................................................... 2-1 2.1 Composition of 400 System Endoscope Set ................................ 2-2 2.2 System Configuration .................................................................. 2-4

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 Balloon Air feed 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 ............................................................ 5-5 5.4 Inspection of Forceps ............................................................... 5-10

Chapter 6

Method of Use .................................................................................... 6-1 6.1 Preparation .................................................................................. 6-2 6.2 Insertion and Observation ......................................................... 6-10 6.3 Biopsy ....................................................................................... 6-15 6.4 Pulling Out the Endoscope ........................................................ 6-17

Chapter 7

Image Recording ................................................................................. 7-1 7.1 Taking Photographs .................................................................... 7-2 7.2 Printing Using the Video Printer .................................................. 7-3 7.3 Recording Using a Video Cassette Recorder ............................... 7-6

Appendix ................................................................................................... Appendix-1 Main Specifications ............................................................... Appendix-2 Troubleshooting ................................................................... Appendix-5 Warranty and After-Sales Service ......................................... Appendix-7 Disposal of Electric and Electronic Equipment ...................... Appendix-8 Index ..................................................................................... Appendix-9

4

Important Safety Information Contents

(Cleaning, Disinfection and Storage) Chapter 8

Washing .............................................................................................. 8-1

Chapter 9

Chemical Disinfection .......................................................................... 9-1

Chapter 10 Gas Sterilization ................................................................................. 10-1 Chapter 11 Storage .............................................................................................. 11-1

(Electrosurgical Instruments) Chapter 12 Treatment with Electrosurgical Instruments ...................................... 12-1

[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 Endoscopes EN-450P5/20, EN-450T5, EN-450T5/W. Regarding their use, this manual describes endoscopic observation of the small intestine and tissue sampling with biopsy forceps. It also explains printing and VCR image recording, etc. during endoscopic observation. The EN-450P5/20, EN-450T5, EN-450T5/W are used in combination with the processor “VP-402,” the light source “XL-402,” cart and video printer, etc. For information on how to use the processor, light source and video printer, etc., refer to the respective operation manuals.

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) 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 50 cases. Also have it checked if there is anything wrong with the equipment. Do not disassemble or modify the equipment. 4) 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. 5) 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. 6) 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.

1-2

Chapter 1 Safety

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 rubber gloves 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.

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. If the inspection result shows any abnormality, do not use the same 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). 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 It may cause anaphylactic reaction. Do not use it for patients with a latex allergy. 6.2 Insertion and Observation There is a risk of damaging the walls of the digestive tract. Insert and draw out the over-tube slowly. There is a risk of damaging the walls of the digestive tract. Do not press the over-tube strongly onto the walls of the digestive tract. Do not insert or pull out the over-tube with the balloon inflated.

1-3

Chapter 1 Safety

Energy of illumination may burn. Do not allow the distal end to touch the same part for 5 minutes or more. 6.3 Biopsy Pressing forceps strongly against the digestive tract wall may cause holing or bleeding. Do not press them the digestive tract wall with undue force. Chapter 8 Washing 8.5 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). 8.5.13 Washing the Entire Endoscope Cleaning liquid might flow into a patient’s body. Alter cleaning, wash away any remaining chemical with water. 8.6 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. Chapter 9 Chemical Disinfection 9.4.1 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 10 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 11 Storage Storage of Endoscope in a carrying case may cause infection. Do not store Endoscope in a carrying case. Chapter 12 Treatment with Electrosurgical Instruments 12.1 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.

1-4

Chapter 1 Safety

12.1.3 Connecting Electrosurgical Instruments Wrong connection will cause electric shock accident and burns. Connect surgical instruments correctly in accordance with the operation manual. 12.1.4 Setting the Conditions of Surgery Leakage current may cause burns. Operate the instruments within specified output range. 12.2 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.

12.3 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 400 System Endoscope Set and System Configuration

Chapter 2

Composition of 400 System Endoscope Set and System Configuration

This chapter describes the composition of 400 System Endoscope set and system configuration.

2.1 Composition of 400 System Endoscope Set ................. 2-2 2.2 System Configuration .................................................. 2-4

2-1

Chapter 2 Composition of 400 System Endoscope Set and System Configuration

Chapter 2 Composition of 400 System Endoscope Set and System Configuration 2.1 Composition of 400 System Endoscope Set The 400 System Endoscope set is provided in a carrying case. The set consists of the following items. [Note] Figures in parentheses indicate quantities.

Protective Cap Suction (1)

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

S Connector Cap CAP-E (1)

Silicon Oil SLC-2000 (1)

Mouthpiece MPC-ST (2)

Forceps Valve FOV-DV7 (10)

2-2

Hood DH-17EN (10) (EN-450T5 only)

Setting Tool ST-01B (1)

Setting Tool ST-02B (2)

Chapter 2 Composition of 400 System Endoscope Set and System Configuration

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

Forceps (2)

Cleaning Brush (1)

Endoscope (1)

Cleaning Brush (1) (for Valve)

Waterproof Cap (1)

Tank Receiving Cap (1) Ventilation Adapter AD-7 (1)

Syringe (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 400 System Endoscope Set and System Configuration

2.2 System Configuration You may use the 400 System Endoscope 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

Light Source XL-402

400 System Endoscope Processor VP-402

Balloon BS-1

Over-Tube TS-12140 TS-13140

2-4

Foot Switch FS-1 Data Keyboard DK-402E

Cart PC-20

Chapter 2 Composition of 400 System Endoscope Set and System Configuration

Monitor PVM-1453MD-230V-(SONY) PVM-1353MD-120V-(SONY) PVM-2053MD-230V-(SONY) PVM-1953MD-120V-(SONY)

Video Printer UP-5600MDP-230V-(SONY) UP-5600MD(UC2)-120V-(SONY) UP-2900MD-120V-(SONY) UP-2800P-230V-(SONY)

VCR SVO-9500MDP-230V-(SONY) SVO-9500MD-120V-(SONY)

Electrosurgical Instrument ICC-200 (ERBE)

2-5

Chapter 2 Composition of 400 System Endoscope Set and System Configuration

2-6

Chapter 3 Names and Functions of Parts

Chapter 3

Names and Functions of Parts

This chapter describes the names and functions of 400 System 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 400 System 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

Ventilation connector

Feed water connector

Connects to the airtight tester or ventilation adapter.

Connects to the water tank.

Chapter 3 Names and Functions of Parts

Enlarged view of distal end

Insertion portion This portion is inserted into body cavities and contains the distal end, bending portion and flexible portion. EN-450P5/20

EN-450T5, EN-450T5/W

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

Flexible portion

Bending portion

Connects bending portion and control

Bend this portion with the knobs

portion.

on the control portion.

The Endoscope can be inserted into the body cavity up to this portion.

LG connector This connector connects to the scope socket on the light source.

Suction connector Accepts tube from suction unit. S terminal Accepts S-cord when using electrosurgical instrument (electric cautery).

EVE connector

Water proof cap

This connector connects to the EVE connector

Prevent water from remaining on electric contact.

socket on the processor.

3-3

Chapter 3 Names and Functions of Parts

<Over-Tube>

2

3

1

4

5

Scope insertion inlet Insert the endoscope from here. Insertion portion This portion can be inserted into the body cavity. Balloon

Air feed inlet Air is fed and taken out from here. Water feed inlet Water can be injected into the inside of the over-tube from here.

3-4

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, Forceps Inlet and Balloon Air feed 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. to bend the

Turn it in the direction of R bending portion to the right.

4

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.

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 Balloon Air feed Inlet Balloon Air feed Inlet This is the portion to feed air into the balloon on the distal

5

end of the Endoscope. Air fed by a syringe, etc., is supplied through the hole on the side of the distal end to the balloon. Suction Button

6

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

7

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

4-4

8

Chapter 4 Control Portion

4.3 Remote Operating Switches for Images and Recording RC switch This is the switch that starts and stops VCR recording.

9

10

Pushing it once starts the recording. Pushing it again stops the recording.

11

MM Switch This switch electronically enlarges the image. 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. FR switch This is the remote switch for still image and the hard copy unit. 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 photo signal is output to the device connected to the hard copy terminal.

Objective Lens

Air/Water Nozzle

Light Guide

Forceps Channel

EN-450P5/20

Objective Lens

Air/Water Nozzle

Light Guide

Forceps Channel

EN-450T5, EN-450T5/W

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

13

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. [Note] Re-using the forceps valve is prohibited. To prevent infection, replace the valve by a new one for each patient.

4-6

12

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 ............................................. 5-5 5.3.1 Inspecting the Insertion Portion ........................ 5-5 5.3.2 Inspecting the Bending Mechanism .................. 5-6 5.3.3 Inspecting the Air/Water Supply, Suction, Forceps Channel and Balloon Air feed Inlet ...... 5-7 5.3.4 Inspecting the Objective Lens ........................... 5-9 5.4 Inspection of Forceps ................................................ 5-10

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. If the inspection result shows any abnormality, do not use the same 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 processor. [Note] The water in the water tank should be changed every day using sterilized water.

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).

(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 EVE connector socket on the processor.

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

5-3

Chapter 5 Preparation for Use of the EVE Endoscope

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

[Note] When attaching the Endoscope and turning ON the power to the processor, press the scope switch on the processor

IRIS MODE

SHUTTER SPEED

DATA ON/OFF

COLOR

SCOPE

when a “PLEASE PUSH SCOPE SW” message appears.

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

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.

5-5

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.

5-6

Chapter 5 Preparation for Use of the EVE Endoscope

5.3.3 Inspecting the Air/Water Supply, Suction, Forceps Channel and Balloon Air feed Inlet (1) Switch on the power to the suction unit, cart and light source. Keep the lamp off. (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.

5-7

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.

(7) Feed air from the balloon air inlet and make sure that air comes out from the hole on the side of the tip.

5-8

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. [Note] It checks that there are no scratches on the lens and its circumference of the lens.

(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 air tightness test with an air tightness tester LT-7. “8.5.3 Air Tightness Test” (p.8-10)

5-9

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.

5-10

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 6.1.3 Combining Devices ........................................... 6-3 6.1.4 How to mount the Endoscope Balloon (BS-1) ... 6-3 6.2 Insertion and Observation ......................................... 6-10 6.3 Biopsy ....................................................................... 6-15 6.4 Pulling Out the Endoscope ........................................ 6-17

6-1

Chapter 6 Method of Use

Chapter 6 Method of Use WARNING It may cause anaphylactic reaction. Do not use it for patients with a latex allergy.

CAUTION The balloon may burst. When inserting it into or drawing it out of the body, deflate the balloon in advance. [Note] Check the status of the balloon by X-ray fluoroscopy.

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

6.1.3 Combining Devices (1) After moistening the over-tube with water, mount the overtube on the Endoscope. [Note] If the Endoscope and over-tube do not slide smoothly, inject water from the blue tube (water inlet) using the syringe.

(2) Send air from the balloon air inlet and let air come out from the hole on the side of the tip. Make sure that water is removed and air comes out.

6.1.4 How to mount the Endoscope Balloon (BS-1) ST-02B

<When the hood is not mounted> (1) Prepare the setting tools (ST-01B, ST-02B) and the fixing

FX-01G

rubber (FX-01G). ST-01B : Fixing rubber setting tool

ST-01B

ST-02B : Balloon setting tool

(2) Apply a small amount of 70% ethanol solution to the tip of the Endoscope.

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(3) Apply a small amount of 70% ethanol solution to the outside of the setting tool (ST-02B).

(4) Put the balloon (BS-1) on the setting tool (ST-02B).

(5) Insert the distal end of the Endoscope into the setting tool (ST-02B) and form the balloon so as not to be twisted.

(6) Slide the setting tool (ST-02B) toward the control portion of the Endoscope to mount the balloon on the Endoscope. [Note] Make the ethanol inside the balloon evaporate by widening the end of the balloon.

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(7) Extract the air in the balloon and remove the setting tool (ST-02B).

(8) Press the fixing rubber (FX-01G) into the mounting fixture (ST-01B).

(9) Slide the fixing rubber down from the mounting fixture (ST-01B) to the end of the balloon on the curved section side.

(10) Mount it on the tip in the same manner. [Note] If it cannot be fixed sufficiently with only the fixing rubber, fix the end of the balloon with a thread. A groove is provided on the end.

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(11) Put the tip of the Endoscope into water and, by feeding air from the balloon air inlet, make sure that there is no air leakage.

<When the hood is mounted> (1) Prepare the setting tools (ST-01B, ST-02B), fixing rubber (FX-01G), hood and medical tape. DH-14EN : EN-450P5/20 DH-17EN : EN-450T5, EN-450T5/W [Note] Use a medical tape made of elastic plastic. (2) Apply a small amount of 70% ethanol solution to the tip of the Endoscope.

(3) Apply a small amount of 70% ethanol solution to the outside of the setting tool (ST-02B).

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(4) Put the balloon (BS-1) on the setting tool (ST-02B).

(5) Insert the distal end of the Endoscope into the setting tool (ST-02B) and form the balloon so as not to be twisted.

(6) Slide the setting tool (ST-02B) toward the control portion of the Endoscope to mount the balloon on the Endoscope. [Note] Make the ethanol inside the balloon evaporate by widening the end of the balloon.

(7) Extract the air in the balloon and remove the setting tool (ST-02B).

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(8) Press the fixing rubber (FX-01G) into the mounting fixture (ST-01B).

(9) Slide the fixing rubber down from the mounting fixture (ST-01B) to the end of the balloon on the curved section side.

(10) Mount the hood on the end. [Note] Fix the hood reliably with medical tape so that it does not drop. DH-14EN : EN-450P5/20 DH-17EN : EN-450T5, EN-450T5/W

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(11) Mount the fixing rubber on the medical tape.

(12) Put the tip of the Endoscope into water and, by feeding air from the balloon air inlet, make sure that there is no air leakage.

[Note] There is a thick line (indicator) on the insertion portion of the Endoscope. When the Over-tube is inserted into the body or the Endoscope is pulled out from this position, the tip of the Over-tube touches the balloon.

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6.2 Insertion and Observation

WARNING There is a risk of damaging the walls of the digestive tract. Insert and draw out the over-tube slowly. There is a risk of damaging the walls of the digestive tract. Do not press the over-tube strongly onto the walls of the digestive tract. Do not insert or pull out the over-tube with the balloon inflated. [Note] If any resistance is felt, stop use immediately. When using this product, check the status of the balloon, over-tube and Endoscope by X-ray fluoroscopy.

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

CAUTION Direct application of Xylocaine spray will 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. The method described in this operation manual is just an example. Regarding clinical procedures, use proper clinical judgment. (1) Have the patient hold the mouthpiece in his/her mouth.

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(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 turn on the lamp.

(4) Remove air from the balloon on the distal end of the Endoscope and the balloon on the overtube. 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.

(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.

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(6) Feed air to inflate the balloon on the distal end of the Endoscope, and fix it to the enteric canal

[Note] When used for the average gastrointestinal tract, the amount of air injected into the balloon by the syringe is 40 ml. The amount of air injected should range from 35 to 50 ml, depending on the site of use or circumstances. Use at the affected site or adhesion site should be judged from the professional viewpoint.

(7) Insert the over-tube along the Endoscope to the point close to the balloon on the distal end of the Endoscope. (8) Feed air to inflate the balloon on the over-tube, and stabilize it in the body cavity (small intestine).

(9) Discharge air to deflate the balloon on the distal end of the Endoscope. (10) Insert the Endoscope.

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