JF TYPE 260V and TJF TYPE 260V EVIS LUCERA DUODENOVIDEOSCOPE Operation Manual Dec 2006

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 before the first use/reprocessing and storage after use...

4

Spare equipment ...

4

Maintenance management ...

4

Prohibition of improper repair and modification ...

4

Signal words...

5

Warnings and cautions ...

5

Examples of inappropriate handling ...

8

Chapter 1

Checking the Package Contents...

9

Chapter 2

Instrument Nomenclature and Specifications ...

12

2.1

Nomenclature...

12

2.2

Endoscope functions...

14

2.3

Specifications...

16

2.4

Attaching the chain for water-resistant cap (MAJ-1119) ...

19

Preparation and Inspection ...

22

3.1

Preparation of the equipment...

23

3.2

Inspection of the endoscope ...

24

3.3

Preparation and inspection of accessories ...

28

3.4

Attaching accessories to the endoscope ...

33

3.5

Inspection and connection of ancillary equipment ...

42

3.6

Inspection of the endoscopic system ...

44

Operation ...

49

4.1

Insertion ...

51

4.2

Using endo-therapy accessories...

56

4.3

Withdrawal of the endoscope...

65

4.4

Transportation of the endoscope ...

66

Chapter 3

Chapter 4

EVIS LUCERA JF/TJF TYPE 260V OPERATION MANUAL

i

Contents

Chapter 5

ii

Troubleshooting ...

67

5.1

Troubleshooting guide ...

67

5.2

Withdrawal of the endoscope with an abnormality...

71

5.3

Returning the endoscope for repair...

72

Appendix...

73

System chart ...

73

EMC information...

85

EVIS LUCERA JF/TJF TYPE 260V 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.

Endoscope

TYPE BF applied part

Manufacturer

Authorized representative in the European Community

EVIS LUCERA JF/TJF TYPE 260V 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 Olympus video system center, light source, documentation equipment, video monitor, endo-therapy accessories such as a biopsy forceps and other ancillary equipment. Use the EVIS LUCERA DUODENOVIDEOSCOPE JF-260V, TJF-260V for endoscopy and endoscopic surgery within the duodenum. Do not use these instrument for any purpose other than their intended use. Select the endoscope to be used according to the objective of the intended procedure based on the full understanding of the endoscope’s specifications and functionality as described in this instruction manual.

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, purpose, effects, and possible risk (that 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

EVIS LUCERA JF/TJF TYPE 260V 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 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 If there is an official standard on user qualifications to perform endoscopy and endoscopic treatment that is defined by the medical administration or other official institutions, such as academic societies on endoscopy, follow that standard. If there is no official qualification standard, the operator of this instrument must be physician approved by the medical safety manager of the hospital or person in charge of the department (department of internal medicine, etc.). The physician should be capable of safely performing the planned endoscopy and endoscopic treatment following guidelines set by the academic societies on endoscopy, etc., and considering the difficulty of endoscopy and endoscopic treatment. This manual does not explain or discuss 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 or operator injury and/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.

EVIS LUCERA JF/TJF TYPE 260V OPERATION MANUAL

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Important Information - Please Read Before Use

Reprocessing before the first use/reprocessing and storage after use This instrument was not cleaned, disinfected or sterilized before shipment. Before using this instrument for the first time, reprocess it according to the instructions given 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 given in the endoscope’s companion reprocessing manual. 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.

Maintenance management The probability of failure of the endoscope and ancillary equipment increases as the number of procedures performed and/or the total operating hours increase. In addition to the inspection before each procedure, the person in charge of medical equipment maintenance in each hospital should inspect the items specified in this manual periodically. An endoscope with which an irregularity is suspected should not be used, but should be inspected by following Section 5.1, “Troubleshooting guide”. If the irregularity is still suspected after inspection, contact Olympus before use.

Prohibition of improper repair and modification This instrument does not contain any user-serviceable parts. Do not disassemble, modify or attempt to repair it; patient or operator injury and/or equipment damage can result. Equipment which has been disassembled, repaired, altered, changed or modified by persons other Olympus’ own authorized service personnel is excluded from Olympus’ limited warranty and is not warranted by Olympus in any manner.

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EVIS LUCERA JF/TJF TYPE 260V OPERATION MANUAL

Important Information - Please Read Before Use

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.

Indicates additional helpful information.

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

•

After using this instrument, reprocess and store it according to the instructions given in the endoscope’s companion reprocessing manual whose cover lists the model of your endoscope. Using improperly or incompletely reprocessed or stored instruments may cause patient cross-contamination and/or infection.

•

Before endoscopy, remove any metallic objects (watch, glasses, necklace, etc.) from the patient. If performing high-frequency cauterization becomes necessary, while the patient wears a metallic object, it may cause burns on the patient in areas around the metallic object.

•

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.

EVIS LUCERA JF/TJF TYPE 260V OPERATION MANUAL

5

Important Information - Please Read Before Use

6

•

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 insert or withdraw the endoscope’s insertion tube while the bending section is locked in position. Patient injury, bleeding and/or perforation can result.

•

Never operate the bending section, feed air or perform suction, insert or withdraw the endoscope’s insertion tube, or use endo-therapy accessories without viewing the endoscopic image. Patient injury, bleeding and/or perforation can result.

•

Never operate the bending section, feed air or perform suction, insert or withdraw the endoscope’s insertion tube or use endo-therapy accessories while the image is frozen. Patient injury, bleeding and/or perforation 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.

•

Never insert or withdraw the insertion tube abruptly or with excessive force. Patient injury, bleeding and/or perforation can result.

•

Do not touch the light guide of the endoscope connector immediately after removing it from the light source because it is extremely hot. Operator or patient burns can result.

•

Do not twist the insertion tube within a narrow tube. This could cause the distal cover to come off.

•

When the endoscopic image does not appear on the monitor, the CCD may have been damaged. Turn the video system center OFF immediately. Continued power supply in such a case will cause the distal end to become hot and could cause operator and/or patient burns.

•

If it is difficult to insert the endoscope, do not forcibly insert the endoscope; stop the endoscopy. Forcible insertion can result in patient injury, bleeding and/or perforation.

EVIS LUCERA JF/TJF TYPE 260V OPERATION MANUAL

Important Information - Please Read Before Use

•

Do not pull the universal cord during an examination. The endoscope connector 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 or universal cord with a diameter of less than 12 cm. Equipment damage can result.

•

Do not touch the electrical contacts inside the electrical connector. CCD damage may result.

•

Do not apply shock to the distal end of the insertion tube, particularly the objective lens surface at the distal end. Visual abnormalities may result.

•

Do not twist or bend the bending section with your 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.

•

Turn the video system center OFF before connecting or disconnecting the videoscope cable from the electrical connector on the endoscope. Turn the video system center ON or OFF only when the videoscope cable is connected to both the video system center and the electrical connector on the endoscope. Failure to do so can result in equipment damage, including destruction of the CCD.

•

The endoscope’s remote switches cannot be removed from the control section. Pressing, pulling or twisting them with excessive force can break the switches and/or may cause water leaks.

•

If remote switch 1 does not return to the OFF position after being pressed strongly from the side, gently pull the switch upwards to return it to the OFF position.

•

Do not hit or bend the electrical contacts on the endoscope connector. The connection to the light source may be impaired and faulty contact can result.

•

Do not attempt to bend the endoscope’s insertion tube with excessive force. Otherwise, the insertion tube may be damaged.

•

To avoid the electromagnetic influence from other equipment (any equipment other than this instrument or the components that constitute this system), the system should be observed to verify its normal operation in the configuration in which it will be used.

EVIS LUCERA JF/TJF TYPE 260V OPERATION MANUAL

7

Important Information - Please Read Before Use

•

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.

This endoscope contains a memory chip that stores information about the endoscope and communicates this information to the CV-260.

Examples of inappropriate handling 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.

8

•

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

•

Applying suction with the distal end in prolonged contact with the mucosal surface, with higher suction pressure than required or with prolonged suction time may cause bleeding and/or lesions.

•

The endoscope has not been designed for use in retroflexed observation in parts of the body other than the stomach. Performing retroflexed observation in a narrow lumen may make it impossible to straighten and/or withdraw the endoscope. Retroflexed observation in parts of the body other than the stomach should be performed only when the usefulness of doing so is determined to be greater than the risk that is posed to the patient.

•

Inserting, withdrawing and using endo-therapy accessories without a clear endoscopic image may cause patient injury, burns, bleeding and/ or perforation.

•

Inserting or withdrawing the endoscope, feeding air, applying suction or operating the bending section without a clear endoscopic image may cause patient injury, bleeding and/or perforation.

EVIS LUCERA JF/TJF TYPE 260V OPERATION MANUAL

Chapter 1 Checking the Package Contents

Chapter 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 given in the endoscope’s companion manual, the “REPROCESSING MANUAL” whose cover lists the model of your endoscope.

EVIS LUCERA JF/TJF TYPE 260V OPERATION MANUAL

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Chapter 1 Checking the Package Contents

Endoscope

Channel cleaning brush (BW-20T)

Water-resistant cap (MH-553) Injection tube (MH-946)

AW channel cleaning adapter (MH-948)

Channel-opening cleaning brush (MH-507)

Biopsy valve (MB-358, 10 pcs) Suction valve (MH-443, 2 pcs)

Air/water valve (MH-438, 2 pcs) Channel plug (MH-944) Mouthpiece (MB-142, 2 pcs)

Chain for water-resistant cap (MAJ-1119)

Washing tube (MH-974)

Operation manual

10

Reprocessing manual

Distal cover (MAJ-411 for JF-260V only, 2 pcs) (MAJ-311 for TJF260V only, 2 pcs)

Instructions (Caution for fixing the guidewire)

Suction cleaning adapter (MH-856)

Instruction manual (Distal cover)

Instructions (Caution for attaching the distal cover)

EVIS LUCERA JF/TJF TYPE 260V OPERATION MANUAL

Chapter 1 Checking the Package Contents

EVIS LUCERA JF/TJF TYPE 260V OPERATION MANUAL

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Chapter 2 Instrument Nomenclature and Specifications

Chapter 2 Instrument Nomenclature and Specifications 2.1

Nomenclature

Universal cord

1. Suction connector 5. Electrical connector

Air pipe

2. S-cord connector mount 3. Air supply connector 3. Water supply connector Light guide Product name and serial number Electrical contacts

4. Endoscope connector

12

EVIS LUCERA JF/TJF TYPE 260V OPERATION MANUAL

Chapter 2 Instrument Nomenclature and Specifications

9. Air/water valve (MH-438) 8. Suction valve (MH-443) 7. UP/DOWN angulation lock 6. UP/DOWN angulation control knob 19. Elevator control lever

18. RIGHT/LEFT angulation control knob 17. RIGHT/LEFT angulation lock

Control section

Suction cylinder Air/water cylinder

Grip section

Guidewire fixing function color (blue) 16. Color code (orange)

Biopsy valve (MB-358)

15. Elevator channel plug

10. Instrument channel Boot

Instrument channel port

11. Insertion tube limit mark Distal cover (MAJ-411) (for JF-260V only) Distal cover (MAJ-311) (for TJF-260V only) Working length 12. Forceps elevator 14. Remote switches Guidewire fixing function mark

Distal end 13. Bending section Top view

Insertion tube

EVIS LUCERA JF/TJF TYPE 260V OPERATION MANUAL

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Chapter 2 Instrument Nomenclature and Specifications

2.2

Endoscope functions 1. Suction connector Connects the endoscope to the suction tube of the suction pump. 2. S-cord connector mount Connects the endoscope with the Olympus electrosurgical unit via the S-cord. The S-cord conducts leakage current from the endoscope to the electrosurgical unit. To connect the S-cord, refer to the instruction manual for the electrosurgical unit. Connect the fitting of the chain for water-resistant cap to this mount as required (see Section 2.4). 3. Water supply connector and air supply connector Connects the endoscope to the water container via the water container tube, to supply water to the distal end of the endoscope. 4. Endoscope connector Connects the endoscope to the output socket of the light source and transmits light from the light source to the endoscope. 5. Electrical connector Connects the endoscope to the video system center via the videoscope cable. The endoscope contains a memory chip that stores information about the endoscope and communicates this information to the video system center CV-260. For more details, refer to the instruction manual of the CV-260. 6. UP/DOWN angulation control knob When this knob is turned in the “

U” direction, the bending section moves

UP; when the knob is turned in the “D

” direction, the bending section

moves DOWN. 7. UP/DOWN angulation lock Moving this lock in the “F

” direction frees angulation. Moving the lock in

the opposite direction locks the bending section at any desired position. 8. Suction valve (MH-443) This valve is depressed to activate suction. The valve is used to remove any fluid, debris, flatus or air from the patient. 9. Air/water valve (MH-438) The hole in this valve is covered to insufflate air and the valve is depressed to feed water for lens washing. It also can be used to feed air to remove any fluid or debris adhering to the objective lens. 10. Instrument channel The instrument channel functions as: − channel for the insertion of endo-therapy accessories − suction channel − fluid feed channel (from a syringe via the biopsy valve)

14

EVIS LUCERA JF/TJF TYPE 260V OPERATION MANUAL

Chapter 2 Instrument Nomenclature and Specifications

11. Insertion tube limit mark This mark shows the maximum point to which the endoscope may be inserted into the patient’s body. 12. Forceps elevator The elevator moves endo-therapy accessories when the elevator control lever is operated. In addition, the elevator is used for assistance of the fixation function of the guidewire while inserting/withdrawing the wire guided type endo-therapy accessory. 13. Bending section This section moves the distal end of the endoscope when the UP/DOWN and RIGHT/LEFT angulation control knobs are operated. 14. Remote switches 1 to 4 The functions of the remote switches 1 to 4 can be selected on the video system center. When selecting the functions, also refer to the instruction manual for the video system center. 15. Elevator channel plug This plug is used for connection of the washing tube to clean and disinfect the elevator channel. 16. Color code (orange) This code is 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. However, please note that endo-therapy accessories for ø 4.2 mm channel are not compatible with JF-260V because the channel diameter of JF-260V is ø 3.7 mm. 17. RIGHT/LEFT angulation lock Turning this lock in the “F

” direction frees angulation. Turning the lock in

the opposite direction locks the bending section at any desired position. 18. RIGHT/LEFT angulation control knob When this knob is turned in the “R

” direction, the bending section moves

RIGHT; when the knob is turned in the “

L” direction, the bending section

moves LEFT. 19. Elevator control lever When this lever is moved in the “

U” direction, the forceps elevator is

raised. When the lever is turned in the opposite direction, the forceps elevator is lowered.

EVIS LUCERA JF/TJF TYPE 260V OPERATION MANUAL

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Chapter 2 Instrument Nomenclature and Specifications

2.3

Specifications Environment Operating environment

Ambient temperature

10 – 40°C (50 – 104°F)

Relative humidity

30 – 85%

Atmospheric pressure

700 – 1060 hPa (0.7 – 1.1 kgf/cm2) (10.2 – 15.4 psia)

Transportation and storage environment

Ambient temperature

–47 to 70°C (–52.6 to 158°F)

Relative humidity

10 – 95%

Atmospheric pressure

700 – 1060 hPa (0.7 – 1.1 kgf/cm2) (10.2 – 15.4 psia)

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EVIS LUCERA JF/TJF TYPE 260V OPERATION MANUAL

Chapter 2 Instrument Nomenclature and Specifications

Specifications  Endoscope functions Model Optical system

JF-260V Field of view

100°

Direction of view

Backward Sideviewing 15°

Depth of field Insertion tube

TJF-260V

Distal end outer diameter Distal end enlarged

5 – 60 mm ø 12.6 mm

ø 13.5 mm

1. Air/water nozzle 2. Objective lens 3. Light guide lens 4. Instrument channel outlet 5. Forceps elevator 6. Guidewire-locking groove 7. Elevator wire 8. Hook 9. White ring UP RIGHT

LEFT DOWN

6.

8.

5.

3.

7.

2.

4.

1.

9.

Insertion tube outer diameter

ø 11.3 mm

Working length

1240 mm

EVIS LUCERA JF/TJF TYPE 260V OPERATION MANUAL

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