PCF-H190L-I EVIS EXERA III COLONOVIDEOSCOPE Operation Manual July 2019

Contents

Contents Symbols ... 1 Important Information - Please Read Before Use ... 2 Intended use ... 2 Indications for use ... 2 Contraindications ... 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 ... 4 Prohibition of improper repair and modification ... 5 Signal words ... 5 Precautions ... 5 Precautions for disappeared or frozen endoscopic image ... 9 Examples of inappropriate handling ... 10

Chapter 1 Checking the Package Contents ... 11 1.1

Checking the package contents list ... 11 Packaged items for the Americas, Europe, Australasia, Middle East, and Africa ... 12 Packaged items for countries other than the Americas, Europe, Australasia, Middle East, and Africa ... 13

Chapter 2 Instrument Nomenclature and Specifications ... 15 2.1

Nomenclature and functions ... 15 Control section, insertion section ... 16 Endoscope connector ... 20

2.2

Specifications ... 22 Environment ... 22 Function list ... 23 Specifications ... 24

PCF-H190TL/I OPERATION MANUAL

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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 ... 31 Inspection of the endoscope ... 31 Inspection of the flexibility adjustment mechanism ... 34 Inspection of the bending mechanisms ... 35

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 auxiliary water inlet cap (MAJ-215) ... 41 Inspection of the auxiliary water tube (MAJ-855) ... 42

3.5

Attaching accessories to the endoscope ... 42 Attaching the suction valve ... 42 Attaching the air/water valve ... 44 Attaching the biopsy valve ... 45 Attaching the auxiliary water inlet cap ... 46

3.6

Inspection of ancillary equipment ... 46

3.7

Connection of the endoscope and ancillary equipment ... 47 Connection to the light source ... 47 Connection of the water container ... 48 Connection of the suction tube ... 49 Connection of the auxiliary water tube ... 50

3.8

Inspection of the endoscopic system ... 51 Inspection summary ... 51 Inspection of the endoscopic image ... 52 Inspection of the remote switches ... 53 Inspection of the air-feeding function ... 54 Inspection of the objective lens cleaning function ... 55 Inspection of the suction function ... 57 Inspection of the instrument channel ... 59 Inspection of the auxiliary water feeding function ... 59

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PCF-H190TL/I OPERATION MANUAL

Contents

Chapter 4 Operation ... 61 4.1

Precautions ... 61

4.2

Insertion ... 64 Holding and manipulating the endoscope ... 64 Insertion of the endoscope ... 65 Observation of the endoscopic image ... 66 Angulation of the distal end ... 67 Flexibility adjustment ... 68 Air/water feeding and suction ... 69

4.3

Using EndoTherapy accessories ... 74 Insertion of EndoTherapy accessories into the endoscope ... 76 Operation of EndoTherapy accessories ... 77 Withdrawal of EndoTherapy accessories ... 78 Use of nonflammable gases ... 78 High-frequency cauterization treatment ... 79

4.4

Withdrawal of the endoscope ... 80

4.5

Transportation of the endoscope ... 81 Transporting within the hospital ... 81 Transporting outside the hospital ... 82

Chapter 5 Troubleshooting ... 83 5.1

Troubleshooting ... 83

5.2

Troubleshooting guide ... 84 Angulation ... 84 Air/water feeding ... 84 Suction ... 85 Image quality or brightness ... 86 Flexibility adjustment ... 87 Auxiliary water feeding ... 87 EndoTherapy accessories ... 87 Other ... 87

5.3

Withdrawal of the endoscope with an irregularity ... 88 Withdrawal when the WLI and NBI endoscopic images appear on the monitor ... 88 Withdrawal when either the WLI or the NBI endoscopic image does not appear on the monitor ... 90 Withdrawal when no endoscopic image appears on the monitor or a frozen image cannot be restored ... 90

5.4

Returning the endoscope for repair ... 92

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Contents

Appendix ... 93 Combination equipment ... 93 System chart ... 93 Reprocessing equipment ... 96 Compatible video system center ... 97 Compatible light source ... 97 Compatible accessories ... 97 Compatible EndoTherapy accessories ... 98 Compatible electrosurgical accessories ... 101

Labeling information for irrigation system ... 103 Backflow-prevention valve ... 103 Distal irrigation system and proximal irrigation system ... 103 Consumable device ... 105 Reusable device ... 105

EMC information ... 106

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PCF-H190TL/I 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 Refer to instructions.

Endoscope

TYPE BF applied part

Single use only

Lot number

Manufacturer

Date of Manufacture

Authorized representative in the European Community

Serial number

Ingress protection rating is 7.

For US Customers only For a Symbols Glossary, visit us: http://www.olympus-global.com/en/common/pdf/symbolsglossary.pdf

PCF-H190TL/I OPERATION MANUAL

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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. The EVIS EXERA III COLONOVIDEOSCOPE PCF-H190TL/I is indicated for use within the lower digestive tract (including the anus, rectum, sigmoid colon, colon, and ileocecal valve).

 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.

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PCF-H190TL/I 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.

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Important Information - Please Read Before Use

 Instrument compatibility Refer to “Combination equipment” on page 93 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.

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PCF-H190TL/I 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 intended 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.

PCF-H190TL/I OPERATION MANUAL

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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. • Retroflexed observation in a lumen should be performed only when its usefulness is determined to be greater than the risk that is posed to the patient. Especially do not forcibly perform retroflexed observation when the distal end of the endoscope is contacted with the intestinal wall and occurs any of the following conditions. Patient injury, bleeding, and/or perforation may result.  When the distal end does not follow by pushing and pulling the insertion section.  When feeling excessive resistance on the hand holding the insertion section. Also, do not operate the endoscope forcibly in retroflexed observation. • 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 perform flexibility adjustment, 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. • Regardless of the flexibility of the endoscope’s insertion tube, 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.

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PCF-H190TL/I OPERATION MANUAL

Important Information - Please Read Before Use

WARNING • 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. • 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. • When combining the endoscope with a splinting tube, there is a risk of perforation or bleeding due to entanglement of the mucous membrane, or of the tube separating from the endoscope and remaining in the body. Before use, be sure to read the instruction manual for the splinting tube to fully understand its characteristics. • 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.

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 regardless of its flexibility. The insertion section may be damaged. • Do not apply shock to the distal end of the endoscope, in particular the objective lens surface at the distal end of the endoscope. An abnormal endoscopic image 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.

PCF-H190TL/I OPERATION MANUAL

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Important Information - Please Read Before Use

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. • 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. • 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 reorienting or relocating this endoscope, or shielding the location.

• 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.

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

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PCF-H190TL/I OPERATION MANUAL

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 flexibility adjustment, 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.

PCF-H190TL/I OPERATION MANUAL

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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. • 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

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

PCF-H190TL/I 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

PCF-H190TL/I

PCF-H190TL/I OPERATION MANUAL

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1.1 Checking the package contents list

 Packaged items for the Americas, Europe, 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)

Auxiliary water tube (MAJ-855)

ETO cap (MB-156)

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

Instruction manual for MAJ-1555

Operation manual

Reprocessing manual

Instructions (Caution for flexibility adjustment control operation)

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PCF-H190TL/I OPERATION MANUAL

1.1 Checking the package contents list

 Packaged items for countries other than the Americas, Europe, 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)

Auxiliary water tube (MAJ-855)

ETO cap (MB-156)

Biopsy valve (MB-358, 10 pcs)

Operation manual

Reprocessing manual

Instructions (Caution for flexibility adjustment control operation)

PCF-H190TL/I OPERATION MANUAL

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1.1 Checking the package contents list

Ch.1

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PCF-H190TL/I OPERATION MANUAL

2.1 Nomenclature and functions

Chapter 2

Instrument Nomenclature and Specifications

The instrument nomenclature, functions, and specifications are described in this chapter.

2.1

Nomenclature and functions

PCF-H190TL/I OPERATION MANUAL

Ch.2

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