ENF-V4 and VH2 RHINO-LARYNGO VIDEOSCOPE Operation Manual July 2019

Contents

Contents Symbols ... 1 Important Information - Please Read Before Use ... 2 Intended use ... 2 Contraindications ... 2 Applicability of endoscopy and endoscopic treatment (for ENF-VH2) ... 3 Instruction manual ... 3 User qualifications ... 4 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 Precautions ... 6 Precaution 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 ... 13

Chapter 2 Instrument Nomenclature and Specifications ... 15 2.1

Nomenclature and functions ... 15 Control section, insertion section ... 16 Light guide connector, video connector ... 17

2.2

Specifications ... 18 Environment ... 18 Specifications ... 19

Chapter 3 Preparation and Inspection ... 21 3.1

The workflow of preparation and inspection ... 21

3.2

Preparation of the equipment ... 23

3.3

Inspection of the endoscope ... 24 Inspection of the endoscope ... 24 Inspection of the bending mechanism ... 27

3.4

Inspection of ancillary equipment ... 28

3.5

Connection of the endoscope and ancillary equipment ... 29 Preparation ... 29 Connection to the light source and video system center ... 29

3.6

Inspection of the endoscopic system ... 31 Inspection of the ancillary equipment ... 31 Inspection of the endoscopic image ... 31 Inspection of the remote switches ... 32 ENF-V4, ENF-VH2 OPERATION MANUAL

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Contents

Chapter 4 Operation ... 33 4.1

Precautions ... 33

4.2

Insertion ... 36 Holding and manipulating the endoscope ... 36 Insertion of the endoscope ... 37 Angulation of the distal end ... 38 Observation of the endoscopic image ... 39

4.3

Using EndoTherapy accessories (for ENF-VH2) ... 40 Laser cauterization ... 40

4.4

Withdrawal of the endoscope ... 41

4.5

Transportation of the endoscope ... 42 Transporting within the hospital ... 42 Transporting outside the hospital ... 42

Chapter 5 Troubleshooting ... 43 5.1

Troubleshooting ... 43

5.2

Troubleshooting guide ... 44 Image quality or brightness ... 44 Other ... 44

5.3

Withdrawal of the endoscope with an irregularity ... 45 Withdrawal when the WLI and NBI endoscopic images appear on the monitor ... 45 Withdrawal when either the WLI or the NBI endoscopic image does not appear on the monitor ... 46 Withdrawal when no endoscopic image appears on the monitor or a frozen image cannot be restored ... 46

5.4

Returning the endoscope for repair ... 47

Appendix ... 49 Combination equipment ... 49 System chart ... 49 Reprocessing equipment ... 51

EMC information ... 52

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ENF-V4, ENF-VH2 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

Blue

Description Refer to instructions.

Refer to instructions.

Caution

Endoscope

TYPE BF applied part

Manufacturer

Date of Manufacture

Authorized representative in the European Community

Serial number

Ingress protection rating is 7.

ENF-V4, ENF-VH2 OPERATION MANUAL

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Important Information - Please Read Before Use

Important Information - Please Read Before Use

 Intended use  ENF-V4 This instrument is intended to be used with an Olympus video system center, light source, documentation equipment, display monitor, and other ancillary equipment for endoscopic diagnosis. This instrument is indicated for use within the ear, nasal lumens, oral cavity, and airway anatomy (including nasopharynx and trachea).

 ENF-VH2 This instrument is intended to be used with an Olympus video system center, light source, documentation equipment, display monitor, EndoTherapy accessories, and other ancillary equipment for endoscopic diagnosis and treatment. This instrument is indicated for use within the ear, nasal lumens, oral cavity, and airway anatomy (including nasopharynx and trachea).

 Contraindications None known.

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ENF-V4, ENF-VH2 OPERATION MANUAL

Important Information - Please Read Before Use

 Applicability of endoscopy and endoscopic treatment (for ENF-VH2) 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.

 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.

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.

ENF-V4, ENF-VH2 OPERATION MANUAL

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Important Information - Please Read Before Use

 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 otorhinolaryngology, etc.). The physician should be capable of safely performing the planned endoscopy and endoscopic treatment following guidelines set by the academic societies on endoscopy, etc., and considering the difficulty of endoscopy and endoscopic treatment. This manual does not explain or discuss endoscopic procedures.

 Instrument compatibility Refer to “Combination equipment” on page 49 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.

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ENF-V4, ENF-VH2 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 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.

 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

 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. • Do not strike, hit, or drop the distal end, insertion tube, bending section, control section, universal cord, video connector, or light guide connector of the endoscope. Also, do not bend, pull, or twist the distal end, insertion tube, bending section, control section, universal cord, video connector, or light guide 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. It may also become impossible to straighten the bending section during an examination. • Never operate the bending section, insert or withdraw the endoscope’s insertion section, or use the EndoTherapy accessories without viewing the endoscopic image. Patient injury, bleeding, and/or perforation may result. • Never use EndoTherapy accessories (for ENF-VH2), insert or withdraw the insertion section or perform angulation control while the image is frozen. 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. • Do not touch the light guide on the light guide connector immediately after removing it from the light source because it is extremely hot. Operator or patient burns can result.

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ENF-V4, ENF-VH2 OPERATION MANUAL

Important Information - Please Read Before Use

WARNING • Although the illumination light emitted from the distal end of the endoscope 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 special attention to the brightness level setting of the light source, particularly when operating the electronic shutter function of a video system center. When both a light source and a video system center have the automatic brightness control function, use the function on the light source. 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. • Light emitted from the device can be hazardous to the eye. Keep the light off when the device is not in use. Do not view directly into the light beam and do not point the light beam to any persons. This may cause harm to the retina and damage the person’s vision. • Push the video connector into the video system center until it clicks, then confirm that the video connector is securely attached by pulling it gently. Improper connection will damage the image sensor. The damaged image sensor will display no image and make the distal end of the endoscope hot, which could cause operator and/or patient burns. • Do not insert the video connector while the electrical contacts are wet and/or dirty. This 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 examination light outlet on the distal end of the endoscope or that the examination light outlet has been discolored. Immediately withdraw the endoscope from the patient, remove blood or mucus, and confirm that the examination light outlet has no irregularities to use it again. If you continue to use the endoscope with its obstructed or discolored examination light outlet, the temperature at the distal end of the endoscope may rise, which may cause patient injury or operator and/or patient burns.

ENF-V4, ENF-VH2 OPERATION MANUAL

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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 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. • 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. Otherwise, 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. • If it becomes impossible to withdraw the transnasally inserted endoscope, pull the distal end of the endoscope 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 performing the NBI observation of an oral cavity, cut off the extraneous light as much as possible, such as dimming the room light. Otherwise, the examination might not be done properly.

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ENF-V4, ENF-VH2 OPERATION MANUAL

Important Information - Please Read Before Use

WARNING • 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 use high-frequency electrosurgical equipment with this endoscope. The electrode of the electrosurgical equipment can get in contact with the endoscope, and it may cause patient injury, burns, bleeding, perforations, and/or equipment damage. • For ENF-V4 Do not use a laser unit with this endoscope. Endoscopic observation may not be performed normally.

CAUTION • Do not pull the universal cord and video cable during an examination. The light guide 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, universal cord, or video cable with a diameter of less than 10 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, in particular the objective lens surface at the distal end of the endoscope. An abnormal endoscopic image 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 of the endoscope 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 leaks. • Do not put or press the video connector and light guide connector on the insertion section when transporting or reprocessing. The insertion section may be damaged. • Turn the video system center ON only when the video connector is connected to the video system center. In particular, confirm that the video system center is OFF before connecting or disconnecting the video connector. Failure to do so can result in equipment damage, including destruction of the image sensor.

ENF-V4, ENF-VH2 OPERATION MANUAL

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Important Information - Please Read Before Use

CAUTION • 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. • Do not hit or bend the electrical contacts on the video connector. The connection to the video system center may be impaired and faulty contact can result. • Do not pull the video cable during an examination. The endoscopic image may not be visible. • 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 OTV-S190/S200/S300 or CV-170. • 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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ENF-V4, ENF-VH2 OPERATION MANUAL

Important Information - Please Read Before Use

 Precaution 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”. Continued use of the endoscope under this condition 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 video connector to the video system center completely by pushing the video connector until it clicks. Otherwise, faulty contact can result.  Do not bend, hit, pull, or twist the insertion section, bending section, control section, universal cord, video cable, video connector, and light guide connector. The endoscope may be damaged, and water leakage and/or breakage of internal parts like the image sensor cable can result.  Make sure that the video connector and its electrical contacts are completely dry and clean before connecting the video connector to the video system center. If the endoscope is used with the electrical contacts wet and/or dirty, the endoscope and video system center 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 video connector is connected to the video system center. In particular, confirm that the video system center is OFF before connecting or disconnecting the video 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 video connector. The connection to the video system center may be impaired and faulty contact can result.

ENF-V4, ENF-VH2 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 • 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. 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. • For ENF-VH2 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 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 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 OTV-S190/S200/S300 or CV-170.

ENF-V4, ENF-VH2 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

ENF-V4/VH2

 Accessories

ETO cap (MB-156)

Operation manual

ENF-V4, ENF-VH2 OPERATION MANUAL

Reprocessing manual

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1.1 Checking the package contents

Ch.1

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ENF-V4, ENF-VH2 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

ENF-V4, ENF-VH2 OPERATION MANUAL

Ch.2

15

2.1 Nomenclature and functions

 Control section, insertion section 3 7

1

Ch.2 2 4 6 5

8

No.

Nomenclature

Description

1

UP/DOWN angulation control lever

When this lever is turned in the “U” direction, the bending section moves UP; when the lever is turned in the “D” direction, the bending section moves DOWN.

2

Boot

Prevents the junction between the insertion tube and control section from bending.

3

Control section

Operates the endoscope, such as controlling angulation.

4

Insertion section

This section is inserted into the patient body cavity.

5

Distal end

The objective lens and examination light outlet are on this distal end.

6

Bending section

The bending section moves the distal end of the endoscope when the UP/DOWN angulation control lever is operated.

7

Insertion tube

Connects the control section and bending section.

8

Remote switches 1 to 4

The functions of the 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.

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ENF-V4, ENF-VH2 OPERATION MANUAL

2.1 Nomenclature and functions

 Light guide connector, video connector 11

12

10 9 13

Ch.2 14 18 17

16

15

No.

Nomenclature

Description

9

Light guide

Connects the endoscope to the light source and transmits light to the distal end of the endoscope.

10

Venting connector

Attach the ETO cap or leakage tester here.

11

ETO cap (MB-156)

The ETO cap equalizes the outer and inner pressure of the endoscope. The cap must be attached prior to gas sterilization (ethylene oxide gas, STERRAD®, etc.) and aeration and removed prior to immersion or clinical examination. The cap must also be attached when the endoscope is transported outside the hospital (shipment, return for repairs, etc.).

12

Light guide connector

The light guide connector connects the endoscope to the output socket of the light source and transmits light from the light source to the distal end of the endoscope.

13

Universal cord

Connects the light guide connector and the control section.

14

Video cable

Connects the light guide connector and the video connector.

15

Video connector

The video connector connects the endoscope to the video connector socket of the video system center so that the endoscopic image becomes visible. The endoscope contains a memory chip that stores information about the endoscope and communicates this information to the video system center OTV-S190/S200/S300 or CV-170. For more details, refer to the instruction manual for the OTV-S190/S200/S300 or CV-170.

16

Electrical contacts

Connects the video system center and the endoscope electrically.

17

UP mark

When the video connector is connected to the video system center, this mark is facing upward.

18

Serial number

The serial number is marked here.

ENF-V4, ENF-VH2 OPERATION MANUAL

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