BF-xx190 Series EVIS EXERA III BRONCHOVIDEOSCOPE Operation Manual April 2013

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 ... 4 Prohibition of improper repair and modification ... 5 Signal words ... 5 Warnings and cautions ... 6 Warnings and cautions: disappeared or frozen endoscopic image ... 11 Examples of inappropriate handling ... 12

Chapter 1 Checking the Package Contents ... 13 1.1

Checking the package contents ... 13 Packaged items for North America, Europe, Australasia, Middle East, and Africa ... 14 Packaged items for countries other than North America, Europe, 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 ... 21

2.2

Specifications ... 22 Environment ... 22 Specifications ... 23

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 mechanism ... 33 Inspection of the insertion tube rotation mechanism ... 35

3.4

Inspection of accessories ... 36 Inspection of the suction valve (MAJ-207) or single use suction valve (MAJ-209) ... 36 Inspection of the biopsy valve (MD-495) ... 37 Inspection of the single use biopsy valve (MAJ-210) ... 38 Inspection of the mouthpiece (MA-651) ... 39

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3.5

Attaching accessories to the endoscope ... 40 Attaching the suction valve (MAJ-207) or the single use suction valve (MAJ-209) ... 40 Attaching the biopsy valve (MD-495) or single use biopsy valve (MAJ-210) ... 41

3.6

Inspection of ancillary equipment ... 42

3.7

Connection of the endoscope and ancillary equipment ... 42 Connection to the light source ... 42 Connection of the suction tube ... 43

3.8

Inspection of the endoscopic system ... 44 Inspection summary ... 44 Inspection of the ancillary equipment ... 44 Inspection of the endoscopic image ... 44 Inspection of the remote switches ... 46 Inspection of the water feeding function ... 47 Inspection of the suction function ... 48 Inspection of the instrument channel ... 49

Chapter 4 Operation ... 51 4.1

Warnings and cautions: operation ... 51

4.2

Insertion ... 53 Holding and manipulating the endoscope ... 53 Insertion of the endoscope ... 54 Observation of the endoscopic image ... 56 Angulation of the distal end ... 56 Operation of the insertion tube rotation ... 57 Feeding fluids ... 58 Suction ... 59

4.3

Using EndoTherapy accessories ... 60 Insertion of EndoTherapy accessories into the endoscope ... 61 Operation of EndoTherapy accessories ... 64 Withdrawal of EndoTherapy accessories ... 64 High-frequency cauterization treatment ... 65 Argon plasma coagulation (APC) ... 67 Laser cauterization ... 69 Ultrasonic observation ... 70 Bronchoalveolar lavage ... 71

4.4

Withdrawal of the endoscope ... 72

4.5

Transportation of the endoscope ... 73 Transporting within the hospital ... 73 Transporting outside the hospital ... 73

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BF-190 Series OPERATION MANUAL

Contents

Chapter 5 Troubleshooting ... 75 5.1

Troubleshooting ... 75

5.2

Troubleshooting guide ... 76 Image quality or brightness ... 76 Water feeding ... 77 Suction ... 77 EndoTherapy accessories ... 78 Others ... 78

5.3

Withdrawal of the endoscope with an irregularity ... 79 Withdrawal when the WLI and NBI endoscopic images appear on the monitor ... 79 Withdrawal when either the WLI or the NBI endoscopic image does not appear on the monitor ... 80 Withdrawal when no endoscopic image appears on the monitor or a frozen image cannot be restored ... 80

5.4

Returning the endoscope for repair ... 81

Appendix ... 83 Combination equipment ... 83 System chart ... 83 Reprocessing equipment ... 85 Compatible EndoTherapy accessories ... 86

EMC information ... 92

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BF-190 Series 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.

Caution

Endoscope

TYPE BF applied part

Single use only

Lot number

Use by (expiration date)

Sterilization lot number

Sterilized using irradiation

Manufacturer

Authorized representative in the European Community

Serial number

BF-190 Series 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. This instrument is indicated for use within the airways and tracheobronchial tree. 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.

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BF-190 Series 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 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.

Normal light observation (or 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 83 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) and edition 3 (IEC 60601-1-2: 2007). 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 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 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 5.2, “Troubleshooting guide”. If the irregularity is still observed after inspection, contact Olympus.

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BF-190 Series 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.

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Important Information - Please Read Before Use

 Warnings and cautions 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 • 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. • 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, perform suction, insert or withdraw the endoscope’s insertion section, rotate the insertion section, or use EndoTherapy accessories while no endoscopic image is observed or the endoscopic image is frozen. Patient injury, bleeding, and/or perforation may result. • Never insert, withdraw, or rotate the endoscope’s insertion section with excessive force or while an optimum field of view cannot be obtained. 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 insertion section abruptly or with excessive force. Patient injury, bleeding, and/or perforation may result.

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BF-190 Series OPERATION MANUAL

Important Information - Please Read Before Use

WARNING • 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. • Although the illumination light emitted from the endoscope’s distal end is required for endoscopic observation, it may also cause alteration of living tissues such as protein denaturation of living tissue and perforation of the tissue through improper usage. Observe the following warnings for illumination.  Always set the minimum required brightness. The brightness of the image on a monitor may differ from the actual brightness at the distal end of the endoscope. Pay attention to the brightness level setting of the light source, particularly when operating the electrical shutter function of a video system center. When using a light source and video system center that are compatible with the light source’s automatic brightness control function, make sure to use the automatic brightness control function. This function can better maintain the illumination level. Refer to the instruction manual for the light source and the video system center for further details.  Always maintain a suitable distance necessary for adequate viewing while using the minimum level of illumination for the minimum amount of time. Do not use close stationary viewing or leave the distal end of the endoscope close to the mucous membrane for a long time without necessity.  When the endoscope will not be used for a long period, be sure to turn OFF the light source or activate the light shield function (standby mode, etc.) so that the endoscope is not illuminated unnecessarily. • Do not connect the endoscope connector while the electrical contacts are wet and/or dirty, which may result in an electric shock, causing severe damage to the endoscope and compromising patient and/or operator safety. • 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 or that the light guide lens has been discolored. 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 or discolored light guide lens, the temperature at the distal end may rise, which may cause patient injury or operator and/or patient burns.

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Important Information - Please Read Before Use

WARNING • 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 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 performing transnasal insertion with the endoscope, follow the warnings below.  The shape and size of the nasal cavity and its suitability for transnasal insertion may vary from patient to patient. No endoscope, including this one, can always be inserted transnasally into all patients. Before proceeding, always be sure to confirm that transnasal insertion is possible with the patient by considering both the size of the patient’s nasal cavity as well as the size of the endoscope’s insertion section. Patient injury can result or the endoscope could become lodged and difficult to withdraw.  Transnasal insertion is accompanied by the risk of inflammation of the nasal cavity. If this happens, the nasal passage will be constricted, making it more difficult to withdraw the endoscope. In this case, do not use force to withdraw the endoscope because patient injury, bleeding, and/or perforation may result.  Transnasal insertion is accompanied by the risk of bleeding in the nasal cavity. Be sure to be prepared to deal with any bleeding. When withdrawing the endoscope, observe the inside of the nasal cavity to ensure that there is no bleeding. Even when the endoscope has been withdrawn without bleeding, do not allow the patient to blow his or her nose strongly because this could cause it to start bleeding.  Before transnasal insertion, apply the appropriate pretreatment and lubrication to the patient to enlarge the nasal cavity. Otherwise, patient injury can result or the endoscope could become lodged and difficult to withdraw. When applying a pretreatment agent through a tube, insert the tube into the same path as the path planned for the endoscope’s insertion. Otherwise, the treatment will have no effect. The effects of the pretreatment agent and lubricant will decrease the longer the procedure lasts. Apply the pretreatment agent or lubricant as required during the procedure – for example, when withdrawal seems to be difficult.  Transnasal insertion of the endoscope should be performed carefully. If resistance to insertion is felt, or the patient reports pain, stop the insertion immediately. Patient injury can result or the endoscope could become lodged and difficult to withdraw.

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BF-190 Series OPERATION MANUAL

Important Information - Please Read Before Use

WARNING  If it becomes impossible to withdraw the transnasally inserted endoscope, pull its distal end out of the mouth, cut the flexible tube using wire cutters, and after ensuring that the cut section will not injure the body cavity or nasal cavity of the patient, withdraw the endoscope carefully. Therefore, always prepare wire cutters in advance. • 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 electronically zoomed. Patient injury, bleeding, and/or perforation can result. • The bending section will only bend to the UP or DOWN direction. To insert or withdraw, operate the endoscope by considering the direction in which the bending section is angulated. Never apply excessive force to the RIGHT or LEFT direction when inserting or withdrawing the endoscope. 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. The insertion section may be damaged. • Do not apply shock to the distal end of the insertion section, in particular the objective lens surface at the distal end. Visual abnormalities may result. • If the endoscope is dropped or the distal end of the endoscope receives a hard impact, the endoscope may be damaged even if no visible damage of the lens on the distal end can be found. In this case, stop using the endoscope, and contact Olympus. • 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. • Do not put or press the endoscope connector on the insertion section when transporting or reprocessing. The insertion section may be damaged.

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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. • 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. • 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.

• When using an endotracheal tube with the endoscope, select the tube that gives a sufficient gap between the insertion section of the endoscope and itself. A narrow gap may make it difficult for a patient to breathe and/or damage the endoscope. • Before inserting the endoscope with an endotracheal tube into the patient, confirm that the insertion section of the endoscope can be inserted into the endotracheal tube smoothly by running it back and forth over the entire length of the insertion section and that the tube does not damage the endoscope. Any protrusions may damage the bending section cover or strip the external surface of the insertion section. When using lubrication, make above confirmation before applying lubrication. • To check the electromagnetic interference from other equipment (any equipment other than this endoscope 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.

NOTE • This endoscope contains a memory chip that stores information about the endoscope and communicates this information to the video system center CV-190. • When the endoscope gets strong static electricity, noise may be observed in the endoscopic image. This does not indicate a malfunction.

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BF-190 Series OPERATION MANUAL

Important Information - Please Read Before Use

 Warnings and cautions: 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”. Continued use of the endoscope under this condition could result in patient injury, bleeding, and/or perforation. • Follow the warnings 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 image sensor 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.  When inserting the endoscope through the mouth, place the mouthpiece (MA-651) in the patient’s mouth as necessary before inserting the endoscope to prevent the patient from accidentally biting the insertion section. Biting the insertion section may result in a break in the cable or malfunction of the light guide.

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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. • Applying suction with the distal end in 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. 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. In case the patient moves due to coughing and other reasons while the endoscope is angulated in the narrow lumen, the bending section of the endoscope may be pushed into the lumen and be retroflexed. Pretreatment to control patient’s coughing reflex and other possible unexpected moves is the responsibility of trained specialists. Retroflexed observation 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, rotating the insertion section, 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.  NBI has not been demonstrated to aid in differentiating and establishing the presence or absence of dysplasia or neoplastic changes within mucosa or mucosal lesions. *1

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

BF-190 Series OPERATION MANUAL

1.1 Checking the package contents

Chapter 1

1.1

Checking the Package Contents Ch.1

Checking the package contents

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

BF-XP190, BF-P190, BF-Q190, BF-H190, BF-1TH190

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1.1 Checking the package contents

 Packaged items for North America, Europe, Australasia, Middle East, and Africa  Accessories BF-XP190

Ch.1

Single use single-ended cleaning brush (BW-400B, 3 pcs)

Single use combination cleaning brush (BW-411B, 3 pcs)

Mouthpiece (MA-651, 2 pcs)

Sterilization cap (MAJ-1538)

Suction cleaning adapter (MAJ-222)

Single use biopsy valve (MAJ-210, 20 pcs (1 box))

Single use suction valve (MAJ-209, 20 pcs (1 box))

Operation manual

Reprocessing manual

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BF-190 Series OPERATION MANUAL

1.1 Checking the package contents

 Packaged items for countries other than North America, Europe, Australasia, Middle East, and Africa  Accessories BF-XP190

BF-XP190

Except BF-XP190

Single use single-ended cleaning brush (BW-400B, 3 pcs)

Suction connector cleaning brush (BW-15SH)

Channel cleaning brush (BW-15B)

Channel-opening cleaning brush (MH-507)

Mouthpiece (MA-651, 2 pcs)

Sterilization cap (MAJ-1538)

Suction cleaning adapter (MAJ-222)

Biopsy valve (MD-495, 10 pcs (1 set))

Suction valve (MAJ-207, 10 pcs (1 set))

Operation manual

Reprocessing manual

BF-190 Series OPERATION MANUAL

Ch.1

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