TJF-Q190V EVIS EXERA III DUODENOVIDEOSCOPE Operation Manual

Contents

Contents Symbols ... 1 Important Information - Please Read Before Use ... 3 Intended use ... 3 Indications for use ... 3 Contraindications ... 3 Applicability of endoscopy and endoscopic treatment ... 3 Instruction manual ... 4 User qualifications ... 4 Instrument compatibility ... 5 Reprocessing before the first use/reprocessing and storage after use ... 5 Spare equipment ... 5 Maintenance management ... 5 Prohibition of improper repair and modification ... 6 Signal words ... 6 Precautions ... 6 Precautions for disappeared or frozen endoscopic image ... 11 Examples of inappropriate handling ... 12

Chapter 1 Checking the Package Contents ... 13 1.1

Checking the package contents list ... 13 Packaged items for Australasia, Middle East, and Africa ... 14 Packaged items for countries other than Australasia, Middle East, and Africa ... 15

Chapter 2 Instrument Nomenclature and Specifications ... 17 2.1

Nomenclature and functions ... 17 Control section, insertion section ... 18 Endoscope connector ... 22

2.2

Specifications ... 24 Environment ... 24 Function list ... 24 Specifications ... 25

TJF-Q190V OPERATION MANUAL

i

Contents

Chapter 3 Preparation and Inspection ... 27 3.1

The workflow of preparation and inspection ... 27

3.2

Preparation of the equipment ... 29

3.3

Inspection of the endoscope ... 30 Inspection of the endoscope ... 30 Inspection of the bending mechanisms ... 34 Inspection of the forceps elevator mechanism ... 38

3.4

Inspection of accessories ... 39 Inspection of the air/water and suction valves ... 39 Inspection of the biopsy valve (MB-358) ... 40 Inspection of the single use biopsy valve (MAJ-1555) ... 41 Inspection of the mouthpiece (MA-392) ... 41 Inspection of the single use distal cover (MAJ-2315) ... 42

3.5

Attaching accessories to the endoscope ... 43 Attaching the suction valve ... 43 Attaching the air/water valve ... 45 Attaching the biopsy valve ... 46 Attaching the single use distal cover ... 47 Detaching the single use distal cover ... 52

3.6

Inspection of ancillary equipment ... 54

3.7

Connection of the endoscope and ancillary equipment ... 55 Connection to the light source ... 55 Connection of the water container ... 56 Connection of the suction tube ... 57

3.8

Inspection of the endoscopic system ... 58 Inspection summary ... 58 Inspection of the endoscopic image ... 59 Inspection of the remote switches ... 60 Inspection of the suction function ... 61 Inspection of the air-feeding function ... 63 Inspection of the objective lens cleaning function ... 64 Inspection of the instrument channel and forceps elevator ... 66

ii

TJF-Q190V OPERATION MANUAL

Contents

Chapter 4 Operation ... 69 4.1

Precautions ... 69

4.2

Insertion ... 71 Holding and manipulating the endoscope ... 71 Insertion of the endoscope ... 72 Observation of the endoscopic image ... 73 Angulation of the distal end ... 74 Air/water feeding and suction ... 75

4.3

Using EndoTherapy accessories ... 79 Insertion of EndoTherapy accessories into the endoscope ... 81 Operation of EndoTherapy accessories ... 83 Withdrawal of EndoTherapy accessories ... 84 Locking the guidewire ... 84 Use of nonflammable gases ... 91 High-frequency cauterization treatment ... 92

4.4

Withdrawal of the endoscope ... 93

4.5

Transportation of the endoscope ... 96 Transporting within the hospital ... 96 Transporting outside the hospital ... 97

Chapter 5 Troubleshooting ... 99 5.1

Troubleshooting ... 99

5.2

Troubleshooting guide ... 100 Angulation ... 100 Air/water feeding ... 100 Suction ... 101 Image quality or brightness ... 102 EndoTherapy accessories ... 103 Single use distal cover ... 103 Other ... 103

5.3

Withdrawal of the endoscope with an irregularity ... 104 Withdrawal when the WLI and NBI endoscopic images appear on the monitor ... 105 Withdrawal when either the WLI or the NBI endoscopic image does not appear on the monitor ... 106 Withdrawal when no endoscopic image appears on the monitor or a frozen image cannot be restored ... 106

5.4

Returning the endoscope for repair ... 108

Chapter 6 Inspection Schedule Related to Forceps Elevator ... 109 6.1

Inspection after each patient procedure ... 109

6.2

Inspection before each patient procedure ... 110

6.3

Annual inspection ... 110

TJF-Q190V OPERATION MANUAL

iii

Contents

Appendix ... 111 Combination equipment ... 111 System chart ... 111 Reprocessing equipment ... 114 Compatible video system center ... 115 Compatible light source ... 115 Compatible accessories ... 115 Compatible distal cover ... 115 Compatible EndoTherapy accessories ... 116 Compatible electrosurgical accessories ... 122

Labeling information for irrigation system ... 124 Backflow-prevention valve ... 124 Distal irrigation system and proximal irrigation system ... 125 Consumable device ... 126 Reusable device ... 126

EMC information ... 127

iv

TJF-Q190V 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: Symbol

Description

Symbol

Description

Consult instructions for use or consult electronic instructions for use

Endoscope

TYPE BF applied part

Caution

Single use only

Lot number

Keep away from sunlight

Keep dry

Non-sterile

Not Made with Natural Rubber Latex

Manufacturer

Date of Manufacture

Authorized representative in the European Community

Serial number

Ingress protection rating is 7.

Importer (into European Union)

TJF-Q190V OPERATION MANUAL

1

Important Information - Please Read Before Use

Important Information - Please Read Before Use

 Intended use This instrument is intended 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.

 Indications for 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.

 Contraindications None known.

 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 administrators 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

TJF-Q190V 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: This is optical-digital observation using narrowband light.

WLI (White Light Imaging) observation: This is observation using white light.

Image sensor: The image sensor is a device that converts light into electrical signals.

 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.

TJF-Q190V OPERATION MANUAL

3

Important Information - Please Read Before Use

 Instrument compatibility Refer to “Combination equipment” on page 111 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 4 (IEC 60601-1-2: 2014). When connecting to an instrument that complies with a previous edition of the EMC standard for medical electrical equipment edition, the EMC characteristics could be vulnerable.

 Reprocessing before the first use/reprocessing and storage after use This instrument was not reprocessed 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.

 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 periodically inspect the items specified in this manual following applicable regulations, guidelines, etc. required of you. An endoscope with an observed irregularity should not be used, but should be inspected by following Section 5.2, “Troubleshooting guide”. 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.

4

TJF-Q190V OPERATION MANUAL

Important Information - Please Read 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 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:

WARNING

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

CAUTION

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.

NOTE

Indicates additional helpful information.

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

WARNING • Do not use this endoscope for any purpose other than its indications for use. Patient or operator injury and/or equipment damage may result. • After using this endoscope, 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.

TJF-Q190V OPERATION MANUAL

5

Important Information - Please Read Before Use

WARNING • Do not strike, hit, or drop the distal end, insertion tube, bending section, control section, universal cord, or endoscope connector of the endoscope. Also, do not bend, pull, or twist the 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 may result due to unintended retroflexion of the bending section. 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 or while the endoscopic 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. • When using the electronic zoom function of the video system center, 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. • 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. • If the endoscopic image becomes dimmer during the procedure, it may indicate that blood or mucus is adhering to the light guide lens on the distal end of the endoscope. Immediately withdraw the endoscope from the patient, remove blood or mucus, and confirm that the light guide lens has no irregularities to use it again. If you continue to use the endoscope with its obstructed light guide lens, the temperature at the distal end of the endoscope may rise, which may cause patient injury or operator and/or patient burns. • When the endoscopic image does not appear on the monitor, the image sensor may have been damaged. Turn the video system center OFF immediately. Continued power supply in such a case will cause the distal end of the endoscope to become hot and could cause operator and/or patient burns.

6

TJF-Q190V OPERATION MANUAL

Important Information - Please Read Before Use

WARNING • 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. • During endoscopic treatment, keep the insertion section and the bending section as straight as possible. If there is a loop or a bend on the insertion section or the bending section, the operation cannot be performed as intended, and patient injury, bleeding, and/or perforation can result. • Never use the endoscope unless the single use distal cover is properly attached to the distal end. If the single use distal cover is not attached properly, it may slip off or fall off the distal end during the examination. This could result in thermal injury when the endoscope is used with high-frequency EndoTherapy accessories. Also, continuing the examination with the single use distal cover off may cause patient injury by the uncovered distal end of the endoscope. In addition, if the single use distal cover falls off in the oral cavity, it may cause aspiration or respiratory distress if not promptly identified and removed. • If the single use distal cover should fall off the distal end during the examination, the single use distal cover is seen partly on the endoscopic image. When the single use distal cover should fall off the distal end or seems to fall off, immediately stop the examination, and slowly withdraw the endoscope from the patient. Continuing the examination after the single use distal cover has fallen off may cause patient injury by the uncovered distal end of the endoscope and this could result in thermal injury when the endoscope is used with high-frequency EndoTherapy accessories. In addition, if the single use distal cover falls off in the oral cavity, it may cause aspiration or respiratory distress if not promptly identified and removed. If a single use distal cover falls off inside the patient’s body, stop using the endoscope immediately and retrieve the single use distal cover in an appropriate way. • Take caution applying suction when the distal end is in contact with the mucosal surface. The suction can cause the distal end to aspirate the mucosal membrane. Moving or withdrawing the endoscope under this condition may cause patient injury and/or bleeding. This can be more common while degassing in the stomach, suctioning debris, and operating in a narrow lumen (e.g., esophagus, duodenum). To prevent patient injury and bleeding, make sure to:  Only apply suction when the endoscope is stationary.  After releasing the suction valve, check the endoscopic image to confirm that the mucosal membrane is not aspirated before moving the endoscope. Releasing the suction valve might not immediately release the mucosal membrane if it becomes aspirated.

TJF-Q190V OPERATION MANUAL

7

Important Information - Please Read Before Use

WARNING • Never use a single use distal cover with cracks or pinholes. Replace it with a new one. If a single use distal cover with cracks or pinholes is used, it could fall off during the examination and/or, it may cause thermal injury due to electric current leaks from cracks or pinholes when high-frequency cauterization treatment is performed. Also, using the single use distal cover with cracks may cause patient injury due to sharp edges.

CAUTION • 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 disappear. • Do not coil the insertion tube or universal cord with a diameter of less than 12 cm. Equipment damage may result. • Do not attempt to bend or twist the endoscope’s insertion section with excessive force. The insertion section may be damaged. • Do not apply shock to the distal end of the endoscope including the objective lens surface. An abnormal endoscopic image and/or water leakage 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 leakage. • Turn the video system center ON only when the endoscope connector is connected to the light source. In particular, confirm that the video system center is OFF before connecting or disconnecting the endoscope connector. Failure to do so can result in equipment damage, including destruction of the image sensor. • 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 leakage. • 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 a faulty contact can result. • If endoscope’s suction is insufficient, select another suction system without using the endoscope and use it according to the directions given in its instruction manual. Otherwise, a proper endoscopic image may not appear on the monitor. • Be sure that this endoscope is not used adjacent to or stacked with other equipment (other than the components of this endoscope or system) to avoid electromagnetic interference.

8

TJF-Q190V OPERATION MANUAL

Important Information - Please Read Before Use

CAUTION • This endoscope supports radio communication function (receive frequency: 13.56 MHz) that identifies endoscopes. Electromagnetic interference may occur on this endoscope 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 moving the RF communications equipment away, reorienting or relocating this endoscope, or shielding the location.

NOTE This endoscope contains a memory chip that stores information about the endoscope and communicates this information to the video system center CV-190.

TJF-Q190V OPERATION MANUAL

9

Important Information - Please Read Before Use

 Precautions for disappeared or frozen endoscopic image WARNING • If the endoscopic image disappears unexpectedly or the frozen image cannot be restored during an examination, immediately stop using the endoscope and withdraw it from the patient as described in Section 5.3, “Withdrawal of the endoscope with an irregularity”. Inserting or withdrawing the endoscope, using EndoTherapy accessories, performing suction, feeding air, or performing angulation control under these conditions could result in patient injury, bleeding, and/or perforation. • Follow the precautions given below. Otherwise, the endoscopic image may disappear unexpectedly or the frozen image may not be restored during the examination.  Connect the endoscope connector to the light source completely by pushing the endoscope connector until it clicks. Otherwise, a faulty contact can result.  Do not bend, hit, pull, or twist the insertion section, bending section, control section, universal cord, and endoscope connector. The endoscope may be damaged, and water leakage and/or breakage of internal parts like the cable can result.  Before connecting the endoscope connector to the light source, confirm that the endoscope connector, including the electrical contacts, is completely dry and clean. If the endoscope is used with the electrical contacts wet and/or dirty, the endoscope and light source may malfunction.  If air bubbles emerge from the endoscope continuously during the leakage test, do not use the endoscope. Water may enter the endoscope and cause a short circuit. This may result in image sensor damage.

CAUTION • Turn the video system center ON only when the endoscope connector is connected to the light source. In particular, confirm that the video system center is OFF before connecting or disconnecting the endoscope connector. Failure to do so can result in equipment damage, including destruction of the image sensor. • Do not hit or bend the electrical contacts on the endoscope connector. The connection to the light source may be impaired and a faulty contact can result.

10

TJF-Q190V OPERATION MANUAL

Important Information - Please Read Before Use

 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.

WARNING • Over-insufflating the lumen may cause patient pain, injury, bleeding, and/or perforation. • Applying suction with the distal end of the endoscope 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 its usefulness is determined to be greater than the risk that is posed to the patient. Also, do not operate the endoscope forcibly in retroflexed observation. • 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. *1

Narrow Band Imaging. For more details, refer to the instruction manual for the video system center CV-190.

TJF-Q190V OPERATION MANUAL

11

Important Information - Please Read Before Use

12

TJF-Q190V OPERATION MANUAL

1.1 Checking the package contents list

Chapter 1

1.1

Checking the Package Contents Ch.1

Checking the package contents list

Match all items in the package with the components shown below. Inspect each item for damage. If the endoscope is damaged, a component is missing, or you have any questions, do not use the items; immediately contact Olympus.

 Endoscope

TJF-Q190V

TJF-Q190V OPERATION MANUAL

13

1.1 Checking the package contents list

 Packaged items for Australasia, Middle East, and Africa  Items Ch.1 Single use combination cleaning brush (BW-412T, 3 pcs)

Injection tube (MH-946)

Channel plug (MH-944)

AW channel cleaning adapter (MH-948)

Suction cleaning adapter (MH-856)

ETO cap (MB-156)

Mouthpiece (MA-392, 2 pcs)

Distal-end flushing adapter (MAJ-2319)

Operation manual

Reprocessing manual

Instructions (warning for locking the guidewire)

NOTE Single use distal cover (MAJ-2315) and single use biopsy valve (MAJ-1555) are sold separately.

14

TJF-Q190V OPERATION MANUAL

1.1 Checking the package contents list

 Packaged items for countries other than Australasia, Middle East, and Africa  Items Ch.1

Channel cleaning brush (BW-20T)

Injection tube (MH-946)

Channel plug (MH-944)

Channel-opening cleaning brush (MH-507)

AW channel cleaning adapter (MH-948)

Suction cleaning adapter (MH-856)

ETO cap (MB-156)

Biopsy valve (MB-358, 10 pcs)

Mouthpiece (MA-392, 2 pcs)

Distal-end flushing adapter (MAJ-2319)

Operation manual

Reprocessing manual

Instructions (warning for locking the guidewire)

NOTE Single use distal cover (MAJ-2315) is sold separately.

TJF-Q190V OPERATION MANUAL

15