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.