JF-1T40 OES DUODENOFIBERSCOPE Operation Manual March 2008

Contents

Contents Symbols...

1

Important Information - Please Read Before Use...

2

Intended Use ...

2

Applicability of Endoscopy and Endoscopic Treatment ...

2

Instruction Manual...

3

User Qualifications ...

3

Instrument Compatibility ...

3

Reprocessing and Storage...

4

Spare Equipment ...

4

Repair and Modification ...

4

Signal Words ...

4

Warnings and Cautions ...

5

Chapter 1

Checking the Package Contents...

8

Checking the Package Contents...

8

Instrument Nomenclature and Specifications ...

10

2.1

Nomenclature...

10

2.2

Endoscope Functions ...

12

2.3

Specifications...

14

Preparation and Inspection ...

17

3.1

Preparation of the Equipment ...

17

3.2

Preparation and Inspection of the Endoscope ...

18

3.3

Preparation and Inspection of Accessories...

22

3.4

Attaching Accessories to the Endoscope...

26

3.5

Preparation, Inspection and Connection of the Ancillary Equipment ...

34

Inspection of the Endoscopic System ...

35

Operation ...

39

4.1

Insertion ...

41

4.2

Using Endo-Therapy Accessories...

46

4.3

Withdrawal of the Endoscope ...

50

4.4

Transportation of the Endoscope...

51

1.1

Chapter 2

Chapter 3

3.6

Chapter 4

OES DUODENOFIBERSCOPE JF-1T40 OPERATION MANUAL

i

Contents

Chapter 5

ii

Troubleshooting ...

52

5.1

Troubleshooting Guide...

53

5.2

Returning the Endoscope for Repair...

56

Appendix...

57

System Chart ...

57

EMC information...

64

OES DUODENOFIBERSCOPE JF-1T40 OPERATION MANUAL

Symbols

Symbols The meaning(s) of the symbol(s) shown on the package with the components, the back cover of this instruction manual and/or this instrument are as follows:

Refer to instructions.

Caution

Type BF applied part

Endoscope

Lot number

Serial number

OES DUODENOFIBERSCOPE JF-1T40 OPERATION MANUAL

1

Important Information - Please Read Before Use

Important Information - Please Read Before Use Intended Use This instrument has been designed to be used with an Light Source, Documentation Equipment, Endo-Therapy Accessories, such as Forceps, Electrosurgical Unit, and other Ancillary Equipment for endoscopy and endoscopic surgery within the Duodenum. Do not use this instrument for any purpose other than its intended use.

Applicability of Endoscopy and Endoscopic Treatment If there is an official standard on the applicability of endoscopy and endoscopic treatment that is defined by the hospital’s administration or other official institutions such as academic societies on endoscopy, follow that standard. Before starting endoscopy and endoscopic treatment, thoroughly evaluate its properties, purposes, effects, and possible risk (their natures, extent and probability). Perform endoscopy and endoscopic treatment only when its potential benefits are greater than its risks. Fully explain to the patient the potential benefits and risks of the endoscopy and endoscopic treatment as well as any examination/treatment methods that can be performed in its place, and perform the endoscopy and endoscopic treatment only after obtaining the consent of the patient. Even after starting the endoscopy and endoscopic treatment, continue to evaluate the potential benefits and risks, and immediately stop the endoscopy/treatment and take proper measures if the risks to the patient become greater than the potential benefits.

2

OES DUODENOFIBERSCOPE JF-1T40 OPERATION MANUAL

Important Information - Please Read Before Use

Instruction Manual This instruction manual contains essential information on using this instrument safely and effectively. Before use, thoroughly review this manual and the manuals of all equipment, such as the Distal Cover MAJ-411, which will be used during the procedure and use the equipment as instructed. Note that the complete instruction manual set for this endoscope consists of this manual and the “REPROCESSING MANUAL” whose cover lists the model of your endoscope. It also accompanied the endoscope at shipment. Keep this and all related instruction manuals in a safe, accessible location. If you have any questions or comments about any information in this manual, please contact Olympus.

User Qualifications The operator of this instrument must be a physician or medical personnel under the supervision of a physician and must have received sufficient training in clinical endoscopic technique. This manual, therefore, does not explain or discuss clinical endoscopic procedures.

Instrument Compatibility Refer to the “System Chart” in the Appendix to confirm that this instrument is compatible with the ancillary equipment being used. Using incompatible equipment can result in patient injury or equipment damage. This instrument complies with EMC standard for medical electrical equipment; edition 2 (IEC 60601-1-2: 2001). However, when connected with an instrument that complies with EMC standard for medical electrical equipment; edition 1 (IEC 60601-1-2: 1993), the whole system complies with edition 1.

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3

Important Information - Please Read Before Use

Reprocessing and Storage This instrument was not disinfected or sterilized before shipment. Before using this instrument for the first time, reprocess it according to the instruction in the endoscope’s companion manual, the “REPROCESSING MANUAL” whose cover lists the model of your endoscope. After using this instrument, reprocess and store it according to the instructions in the endoscope’s companion manual, the “REPROCESSING MANUAL” whose cover lists the model of your endoscope. Improper and/or incomplete reprocessing or storage can present an infection control risk, cause equipment damage or reduce performance.

Spare Equipment Be sure to prepare another endoscope to avoid that the examination will be interrupted due to equipment failure or malfunction.

Repair and Modification This instrument does not contain any user-serviceable parts. Do not disassemble, modify or attempt to repair it; patient or user injury and/or equipment damage can result. Problems that appear not to be malfunctions may be correctable by referring to Chapter 5, “Troubleshooting”. If the problem cannot be resolved using the information in Chapter 5, contact Olympus.

Signal Words The following signal words are used throughout this manual:

Indicates a potentially hazardous situation which, if not avoided, could result in death or serious injury.

Indicates a potentially hazardous situation which, if not avoided, may result in minor or moderate injury. It may also be used to alert against unsafe practices or potential equipment damage.

4

OES DUODENOFIBERSCOPE JF-1T40 OPERATION MANUAL

Important Information - Please Read Before Use

Indicates additional helpful information.

Warnings and Cautions Follow the warnings and cautions described below when handling this instrument. This information is supplemented by the warnings and cautions described in each chapter.

•

Never insert or withdraw the endoscope’s Insertion Tube while the Angulation Locks are fixed. Patient injury can result.

•

Do not strike, bend, hit, pull, twist, or drop the endoscope’s Distal End, Insertion Tube, Bending Section, Control Section, Universal Cord, or Endoscope Connector of the endoscope with excessive force. The endoscope may be damaged and could cause patient injury, burns, bleeding and/or perforations. It could also cause parts of the endoscope to fall off inside the patient.

•

Never perform Angulation Control forcibly or abruptly. Never forcefully pull, twist or rotate the angulated Bending Section. Patient injury, bleeding and/or perforation can result. It may also become impossible to straighten the Bending Section during an examination.

•

Never perform angulation control, air feed control, suction control or insertion/withdrawal of the endoscope’s Insertion Tube without viewing the endoscopic image. Patient injury can result.

•

Never use the endoscope unless the Distal Cover is properly attached to the Distal End. If the Distal Cover is not attached correctly, it may fall off the Distal End during the examination. Continuing the examination after the Distal Cover has fallen off may cause patient injury by the exposed Distal End of the endoscope. It could also result in thermal injury when used in combination with high-frequency Endo-Therapy Accessories.

•

Do not touch the Light Guide immediately after removing it from the Light Source because it is extremely hot.

•

Do not twist the Insertion Tube within a narrow tube. This could cause the Distal Cover to come off.

OES DUODENOFIBERSCOPE JF-1T40 OPERATION MANUAL

5

Important Information - Please Read Before Use

•

Do not pull the Universal Cord. The endoscope’s Light Guide Connector Section will be pulled out from the output socket of the Light Source and the endoscopic image will not be visible.

•

Do not coil the Insertion Tube and Universal Cord with a diameter of less than 12 cm. Equipment damage can result.

•

Do not apply shock to the Distal End of the Insertion Tube, particularly the Objective Lens surface of the Distal End. Vision abnormalities may result.

•

Do not twist or bend the Bending Section by hands. Equipment damage may result.

•

Do not squeeze the Bending Section forcefully. The covering of the Bending Section may stretch or break and cause water leaks.

•

Do not hit or bend the Electrical Contacts on the endoscope’s Light Guide Connector Section. The connection to the Light Source may be impaired and faulty contact can result.

•

Electromagnetic interference may occur on this instrument near equipment marked with the following symbol or other portable and mobile RF (Radio Frequency) communications equipment such as cellular phones. If electromagnetic interference occurs, mitigation measures may be necessary, such as reorienting or relocating this instrument, or shielding the location.

Details on clinical endoscopic technique are the responsibility of trained specialists. Patient safety in endoscopic examinations and endoscopic treatment can be ensured through appropriate handling by the physician and the medical facility. Examples of inappropriate handling are given below.

6

•

Over-insufflating the lumen may cause patient pain and/or perforation.

•

Using improperly reprocessed or stored instruments may cause patient cross-contamination and infection.

•

Applying prolonged suction with the distal tip in contact with the mucous surface may cause bleeding or suction lesions.

•

Retroflexing the endoscope within the esophagus or duodenal bulb may cause mucous trauma or impaction the endoscope.

•

Inserting and using Endo-Therapy Accessories without a clear endoscopic image may cause burns perforation.

OES DUODENOFIBERSCOPE JF-1T40 OPERATION MANUAL

Important Information - Please Read Before Use

•

Patient injury may be caused by: Inserting or withdrawing the endoscope, feeding air or applying suction without a clear endoscopic view; withdrawing the endoscope with the angulation controls locked; forcefully pulling, twisting or rotating the angulated Bending Section.

OES DUODENOFIBERSCOPE JF-1T40 OPERATION MANUAL

7

Chapter 1 Checking the Package Contents

Chapter 1 Checking the Package Contents 1.1

Checking the Package Contents Match all items in the package with the components shown below. Inspect each item for damage. If the instrument is damaged, a component is missing or you have any questions, do not use the instrument; immediately contact Olympus. This instrument was not disinfected or sterilized before shipment. Before using this instrument for the first time, reprocess it according to the instructions in the endoscope’s companion manual, the “REPROCESSING MANUAL” whose cover lists the model of your endoscope.

8

OES DUODENOFIBERSCOPE JF-1T40 OPERATION MANUAL

Chapter 1 Checking the Package Contents

Washing Tube (MH-974)

Biopsy Valve (MB-358, 10 pieces, Non sterile)

Distal Cover (MAJ-411) Endoscope

Mouthpiece (MB-142) Channel Plug (MH-944)

Injection Tube (MH-946)

Suction Cleaning Adapter (MH-856)

Channel Cleaning Brush (BW-20T)

ETO Cap (MB-156)

Channel-opening Cleaning Brush (MH-507) AW Channel Cleaning Adapter (MH-948)

Instruction Manual (Reprocessing)

Instruction Manual (Distal Cover)

Instruction Manual (Operation)

Instructions (Caution for attaching the Distal Cover)

OES DUODENOFIBERSCOPE JF-1T40 OPERATION MANUAL

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Chapter 2 Instrument Nomenclature and Specifications

Chapter 2 Instrument Nomenclature and Specifications 2.1

Nomenclature The endoscope’s Main Body is illustrated with its valves and Distal Cover detached.

Universal Cord

ETO Cap (MB-156)

14. Suction Connector 17. S-Cord Connector Mount

18. Venting Connector

15. Air Supply Connector 15. Water Supply Connector Product Name & Serial No. Electrical Contacts Air Pipe Light Guide

10

16. Light Guide Connector Section

OES DUODENOFIBERSCOPE JF-1T40 OPERATION MANUAL

Chapter 2 Instrument Nomenclature and Specifications

10. Diopter Adjustment Ring

6. Air/Water Valve (MH-438)

7. Suction Valve (MH-443) Suction Cylinder

3. UP/DOWN Angulation Lock 1. UP/DOWN Angulation Control Knob

5. Elevator Control Lever 2. RIGHT/LEFT Angulation Control Knob

Control Section

4. RIGHT/LEFT Angulation Lock

Air/Water Cylinder

Grip Section Biopsy Valve (MB-358) <Non-Sterile>

8. Color Code (Yellow)

12. Elevator Channel Plug

11. Instrument Channel Port Boot Insertion Tube Limit Mark Working Length

Insertion Tube

Distal Cover (MAJ-411) <Non-Sterile> Distal End 13. Bending Section

9. Eyepiece Section Electrical Contacts

OES DUODENOFIBERSCOPE JF-1T40 OPERATION MANUAL

11

Chapter 2 Instrument Nomenclature and Specifications

2.2

Endoscope Functions 1. UP/DOWN Angulation Control Knob When turned in the “ U” direction, the Bending Section moves UP; when turned in the “ D” direction, the Bending Section moves DOWN. 2. RIGHT/LEFT Angulation Control Knob When turned in the “R ” direction, the Bending Section moves RIGHT; when turned in the “ L” direction, the Bending Section moves LEFT. 3. UP/DOWN Angulation Lock Pushing the lever in the “F ” direction frees angulation. Pushing the lever in the opposite direction locks the Bending Section at any desired position. 4. RIGHT/LEFT Angulation Lock Pushing this lever in the “F ” direction frees angulation. Pushing the lever in the opposite direction locks the Bending Section at any desired position. 5. Elevator Control Lever Turning the lever to “ U” direction raises the Forceps Elevator. Turning the opposite direction lowers the Forceps Elevator. 6. Air/Water Valve Cover the top hole of valve with a finger to insufflate air. Depress the valve to feed water for lens washing. If necessary, this valve can be used to feed air to remove any remaining water droplets or debris adhering to the Objective Lens. 7. Suction Valve Depress to activate suction. If necessary, suction can be used to remove any fluids and/or debris that obstruct that visual field. 8. Color Code (Yellow) Used to quickly determine the compatibility of Endo-Therapy Accessories. (The endoscope can be used with Endo-Therapy Accessories that have the same Color Code.) 9. Eyepiece Section Looking through the Eyepiece Section’s lens, an indication is provided in the visual field in the UP direction in which the bending section moves UP. 10. Diopter Adjustment Ring Adjusts the operator’s focus, This does not affect focussing for photography. 11. Instrument Channel Port Functions as: Channel for the insertion of Endo-Therapy Accessories; Suction Channel; fluid feed channel (from a syringe via the Biopsy Valve). 12. Elevator Channel Plug To connect the Washing Tube for cleaning and disinfection of Elevator Channel.

12

OES DUODENOFIBERSCOPE JF-1T40 OPERATION MANUAL

Chapter 2 Instrument Nomenclature and Specifications

13. Bending Section Moves the Distal End of the endoscope by operating the UP/DOWN and RIGHT/LEFT Angulation Control Knobs. 14. Suction Connector Connects to the Suction Tube. 15. Water Supply Connector and Air Supply Connector Connects the Water Container (accepts the Water Container tube) to a sterile water supply. 16. Light Guide Connector Section Connects to the output socket of EVIS Universal Light Source. 17. S-Cord Connector Mount Connects to the S-cord to conduct leakage current from the endoscope to the Olympus Electrosurgical Unit. To connect the S-Cord, refer to the instruction manual for the Olympus Electrosurgical Unit. 18. Venting Connector Install the ETO Cap before performing ETO gas sterilization.

OES DUODENOFIBERSCOPE JF-1T40 OPERATION MANUAL

13

Chapter 2 Instrument Nomenclature and Specifications

2.3

Specifications Environment Operating environment

Transportation and storage environment

14

Ambient temperature

10 – 40C

Relative humidity

30 – 85%

Atmospheric pressure

700 – 1060 hPa

Ambient temperature

–47 to 70C

Relative humidity

10 – 95%

Atmospheric pressure

700 – 1060 hPa

OES DUODENOFIBERSCOPE JF-1T40 OPERATION MANUAL

Chapter 2 Instrument Nomenclature and Specifications

Specifications  Endoscope Functions Model Optical System

JF-1T40 Field of View Direction of View

Insertion Tube

80 Backward Sideviewing 15

Depth of Field

5 – 60 mm

Distal End Outer Diameter

ø 12.6 mm

Distal End Enlarged

1. Air/Water Nozzle 2. Light Guide Lens 3. Objective Lens 4. Instrument Channel 5. Forceps Elevator 2.

5.

3. 4.

1.

Instrument Channel

Insertion Tube Outer Diameter

ø 11.0 mm

Working Length

1235 mm

Channel Inner Diameter

ø 3.2 mm

Minimum Visible Distance

10 mm

Direction from which Endo-Therapy Accessories enter and exit the endoscopic image Air Flow Rate

Bending Section

25 cm3/s Note: Standard when CLV-U40 (high air pressure) is used. Angulation Range

Total Length

OES DUODENOFIBERSCOPE JF-1T40 OPERATION MANUAL

UP 120 DOWN 90 RIGHT 110 LEFT 90 1555 mm

15

Chapter 2 Instrument Nomenclature and Specifications

Medical Devices Directive

EMC

This device complies with the requirements of Directive 93/42/EEC concerning medical devices. Classification: Class II a Applied standard; IEC 60601-1-2: 2001

This instrument complies with the standards listed in the left column. CISPR 11 of emission: Group 1, Class B This instrument complies with the EMC standard for medical electrical equipment; edition 2 (IEC 60601-1-2: 2001). However, when connecting to an instrument that complies with the EMC standard for medical electrical equipment; edition 1 (IEC 60601-1-2: 1993), the whole system complies with edition 1.

Year of manufacture

Degree of protection against electric shock

16

2712345 The last digit of the year of manufacture is given in the second digit of the serial number. TYPE BF applied part

OES DUODENOFIBERSCOPE JF-1T40 OPERATION MANUAL

Chapter 3 Preparation and Inspection

Chapter 3 Preparation and Inspection

3.1

•

Before each case, prepare and inspect this instrument as instructed below. Inspect other equipment that are used with this instrument as instructed in their respective instruction manuals. Should the slightest irregularity be suspected, do not use this instrument and see Chapter 5, “Troubleshooting”. If the irregularity is still suspected after consulting Chapter 5, contact Olympus. Damage or irregularity may compromise patient or user safety and may result in more-severe equipment damage.

•

This instrument was not disinfected or sterilized before shipment. Before using this instrument for the first time, reprocess it according to the instructions in the endoscope’s companion manual, the “REPROCESSING MANUAL” whose cover lists the model of your endoscope.

Preparation of the Equipment According to the “System Chart” in the Appendix, prepare this instrument, other equipment that are used with this instrument, paper towels, tray, lint-free cloth and protective equipment, such as eye wear, face mask, moisture-resistant clothing and chemical-resistant gloves, for the particular case. Refer to the respective instruction manual for each piece of equipment.

OES DUODENOFIBERSCOPE JF-1T40 OPERATION MANUAL

17