TJF TYPE Q180V EVIS EXERA II DUODENOVIDEOSCOPE Operation Manual March 2015

Revision History Note: The Revision History shows the latest changes. Version RC2408 02

RC2408 01

Date

Description of Changes

January, 2016 Revision History

March, 2015

Added Revision History RC2409 01.

Important Information - Please Read Before Use

Updated Maintenance management.

Chapter 1

Updated Checking the Package Contents.

Section 3.2

Added Step 4 on page 24 and WARNING statement for Inspection of the endoscope.

Chapter 6

Added Chapter 6 Inspection Schedule related to Forceps Elevator.

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 ...

4

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

4

Spare equipment ...

4

Maintenance management...

5

Prohibition of improper repair and modification ...

5

Signal words ...

5

Warnings and cautions...

6

Examples of inappropriate handling ...

9

Chapter 1

Checking the Package Contents...

10

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 ...

32

3.5

Inspection and connection of ancillary equipment ...

34

3.6

Inspection of the endoscopic system ...

37

Operation ...

41

4.1

Insertion ...

44

4.2

Using EndoTherapy accessories ...

49

4.3

Withdrawal of the endoscope...

62

4.4

Transportation of the endoscope ...

63

Chapter 3

Chapter 4

EVIS EXERA II TJF TYPE Q180V OPERATION MANUAL

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Contents

Chapter 5

Troubleshooting ...

64

5.1

Troubleshooting guide ...

64

5.2

Withdrawal of the endoscope with an irregularity...

68

5.3

Returning the endoscope for repair...

70

Inspection Schedule Related to Forceps Elevator

71

6.1

Inspection after each patient procedure...

71

6.2

Inspection before each patient procedure...

72

6.3

Annual inspection...

72

Appendix...

73

System chart ...

73

EMC information...

84

Chapter 6

ii

EVIS EXERA II TJF TYPE Q180V OPERATION MANUAL

Symbols

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

Refer to instructions.

Caution

Endoscope

TYPE BF applied part

Single use only

Lot number

Manufacturer

Authorized representative in the European Community

Serial number

EVIS EXERA II TJF TYPE Q180V OPERATION MANUAL

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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, monitor, EndoTherapy accessories (such as a biopsy forceps), 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. 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 are official standards on the applicability of endoscopy and endoscopic treatment that are defined by the hospital’s administrations or other official institutions, such as academic societies on endoscopy, follow those standards. Before starting endoscopy and endoscopic treatment, thoroughly evaluate its properties, purposes, effects, and possible risks (their nature, 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 EXERA II TJF TYPE Q180V 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 for all equipment that 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” with your endoscope model listed on the cover. 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, contact Olympus.

 Terms used in this manual NBI (Narrow Band Imaging) observation mode: This is an observation mode using narrowband light. Normal light observation mode (or WLI (White Light Imaging) observation mode): This is an observation mode using standard white light illumination.

User qualifications If there are official standards for user qualifications to perform endoscopy and endoscopic treatment that are defined by the hospital’s medical administrators or other official institutions, such as academic societies on endoscopy, follow those standards. If there are no official qualification standards, the operator of this instrument must be a 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.

EVIS EXERA II TJF TYPE Q180V OPERATION MANUAL

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Important Information - Please Read Before Use

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 the EMC standard for medical electrical equipment, edition 2 (IEC 60601-1-2: 2001). However, when connected with 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.

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 “REPROCESSING MANUAL” with your endoscope model listed on the cover. 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 pose an infection control risk, cause equipment damage, or reduce performance.

Spare equipment Be sure to prepare another endoscope to avoid interruption of the examination due to equipment failure or malfunction.

4

EVIS EXERA II TJF TYPE Q180V OPERATION MANUAL

Important Information - Please Read Before Use

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 an observed irregularity should not be used, but should be inspected by following Section 5.1, “Troubleshooting guide” on page 64. If the irregularity is still observed after inspection, contact Olympus. Maintenance of the forceps elevator has to be performed according to Chapter 6, “Inspection Schedule Related to Forceps Elevator” in the manual.

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 may result. Equipment that has been disassembled, repaired, altered, changed, or modified by persons other than Olympus’ own authorized service personnel is excluded from Olympus’ limited warranty and is not warranted by Olympus in any manner.

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.

EVIS EXERA II TJF TYPE Q180V OPERATION MANUAL

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Important Information - Please Read Before Use

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.

6

•

After using this instrument, reprocess and store it according to the instructions given in the endoscope’s companion “REPROCESSING MANUAL” with your endoscope model listed on the cover. 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. Performing high-frequency cauterization treatment while the patient is wearing metallic objects may cause burns on the patient in areas around the metallic objects.

•

Do not strike, hit, or drop the endoscope’s distal end, insertion tube, bending section, control section, universal cord, or endoscope connector. Also, do not bend, pull, or twist the endoscope’s distal end, insertion tube, bending section, control section, universal cord, or endoscope connector 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 may result. It may also become impossible to straighten the bending section during an examination.

•

Never insert or withdraw the endoscope’s insertion section while the bending section is locked in position. Patient injury, bleeding, and/or perforation may result.

•

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

EVIS EXERA II TJF TYPE Q180V OPERATION MANUAL

Important Information - Please Read Before Use

•

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

•

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

•

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.

•

Never insert or withdraw the endoscope’s insertion section or use EndoTherapy accessories while the image is magnified. Patient injury, bleeding, and/or perforation can result (when using the image magnification function of the video system center).

•

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

•

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.

•

Do not rely on the NBI observation mode alone for primary detection of lesions or to make a decision regarding any potential diagnostic or therapeutic intervention.

•

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 attempt to bend the endoscope’s insertion section with excessive force. Otherwise, the insertion section may be damaged.

•

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

EVIS EXERA II TJF TYPE Q180V OPERATION MANUAL

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Important Information - Please Read Before Use

8

•

Do not apply shock to the distal end of the insertion section, particularly the objective lens surface at the distal end. Visual irregularities 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 ON only when the videoscope cable is connected to both the video system center and the electrical connector on the endoscope. In particular, confirm that the video system center is OFF before connecting or disconnecting the videoscope cable from 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 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.

•

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.

•

To check the electromagnetic interference 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 EXERA II TJF TYPE Q180V OPERATION MANUAL

Important Information - Please Read Before Use

This endoscope contains a memory chip that stores information about the endoscope and communicates this information to the video system center CV-180, CV-160.

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 described below. •

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 the angle of the bending section and/or withdraw the endoscope from the patient. 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 EndoTherapy 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.

•

For reasons described below, do not rely on the NBI1 observation mode alone for primary detection of lesions or to make a decision regarding any potential diagnostic or therapeutic intervention.  NBI has not been demonstrated to increase the yield or sensitivity of finding any specific mucosal lesion, including colonic polyps or Barrett’s esophagus.  NBI has not been demonstrated to aid in differentiating or establishing the presence or absence of dysplasia or neoplastic changes within mucosa or mucosal lesions. 1 Narrow Band Imaging. For more details, refer to the instruction manual for the video system center CV-180.

EVIS EXERA II TJF TYPE Q180V OPERATION MANUAL

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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 described in the endoscope’s companion “REPROCESSING MANUAL” with your endoscope model listed on the cover.

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EVIS EXERA II TJF TYPE Q180V OPERATION MANUAL

Chapter 1 Checking the Package Contents

Endoscope

Single use channel cleaning brush (BW-201T, 3 pcs)1

Single use combination cleaning brush (BW-412T, 3 pcs)1

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

Single use channel-opening cleaning brush (MAJ-1339, 3 pcs)1

Suction valve (MH-443, 2 pcs)

Suction cleaning adapter (MH-856)

Air/water valve (MH-438, 2 pcs)

Chain for water-resistant cap (MAJ-1119)

Operation manual

1

Mouthpiece (MB-142, 2 pcs)

AW channel cleaning adapter (MH-948)

Single use biopsy valve (MAJ-1555, 10 pcs)

Reprocessing manual

Instruction manual for MAJ-1555

Channel plug (MH-944)

Single use soft brush (MAJ-1888, 5 pcs)

Instructions (caution for locking the guidewire)

These products may not be available in some areas.

EVIS EXERA II TJF TYPE Q180V 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

2. S-cord connector mount

Air pipe

3. Air supply connector 3. Water supply connector Product name (model) and serial number Light guide Contact pins 4. Endoscope connector

12

EVIS EXERA II TJF TYPE Q180V OPERATION MANUAL

Chapter 2 Instrument Nomenclature and Specifications

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

Suction cylinder

18. Elevator control lever

17. RIGHT/LEFT angulation control knob 16. RIGHT/LEFT angulation lock

Control section

Air/water cylinder Biopsy valve (MB-358) or Single use biopsy valve (MAJ-1555)

Grip section Guidewire locking function color (blue) 15. Color code (orange)

10. Instrument channel Instrument channel port Boot 11. Insertion section limit mark

Insertion section 12. Forceps elevator

14. Remote switches 1 to 4 Guidewire locking function mark

Distal end 13. Bending section

Top view

Insertion tube

EVIS EXERA II TJF TYPE Q180V 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. When the endoscope is used with the electrosurgical unit ESG-100, it is not necessary to use the S-cord. Connect the fitting part of the chain for water-resistant cap to this mount, as required (refer to Section 2.4 on page 19). 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-180, CV-160. For more details, refer to the instruction manual for the CV-180, CV-160. 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 fluids, 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 for removing any fluids or debris adhering to the objective lens.

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EVIS EXERA II TJF TYPE Q180V OPERATION MANUAL

Chapter 2 Instrument Nomenclature and Specifications

10. Instrument channel The instrument channel functions as:  Channel for the insertion of EndoTherapy accessories  Suction channel  Fluid feed channel (from a syringe via the biopsy valve) 11. Insertion section 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 EndoTherapy accessories when the elevator control lever is operated. In addition, the elevator is used to assist the locking function of the guidewire while inserting/withdrawing the wire-guided type EndoTherapy 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 remote switches 1 to 4 can be selected on the video system center. Refer to the instruction manual for the video system center when setting these functions. 15. Color code (orange) The endoscope can be used with EndoTherapy accessories that have the same color code. For more information on combining the endoscope with particular EndoTherapy accessories, refer to the “System chart” in the Appendix and the instruction manuals for the compatible accessories. 16. 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. 17. 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. 18. 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 EXERA II TJF TYPE Q180V OPERATION MANUAL

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Chapter 2 Instrument Nomenclature and Specifications

2.3

Specifications Environment Operating environment

Hospital storage environment

Transportation and storage environment

16

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)

Ambient temperature

5 – 40C (41 – 104F)

Relative humidity

10 – 95%

Atmospheric pressure

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

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)

EVIS EXERA II TJF TYPE Q180V OPERATION MANUAL