ENF-GP2 RHINO-LARYNGO FIBERSCOPE Operation Manual July 2019

Contents

Contents Symbols ... 1 Important Information - Please Read Before Use ... 2 Intended use ... 2 Contraindications ... 2 Applicability of endoscopy ... 2 Instruction manual ... 2 User qualifications ... 3 Instrument compatibility ... 3 Reprocessing before the first use/reprocessing and storage after use ... 3 Spare equipment ... 3 Maintenance management ... 4 Prohibition of improper repair and modification ... 4 Signal words ... 4 Precautions ... 4 Examples of inappropriate handling ... 8

Chapter 1 Checking the Package Contents ... 9 1.1

Checking the package contents ... 9

Chapter 2 Instrument Nomenclature and Specifications ... 11 2.1

Nomenclature and functions ... 11 Control section, insertion section ... 12

2.2

Specifications ... 14 Environment ... 14 Specifications ... 15

Chapter 3 Preparation and Inspection ... 17 3.1

The workflow of preparation and inspection ... 17

3.2

Preparation of the equipment ... 19

3.3

Inspection of the endoscope ... 20 Inspection of the endoscope ... 20 Inspection of the bending mechanisms ... 23

3.4

Inspection of accessories ... 25 Inspection of the light guide adapter (MAJ-900) ... 25

3.5

Attaching accessories to the endoscope ... 26 Attaching the light guide adapter (MAJ-900) ... 26

3.6

Inspection of ancillary equipment ... 26

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Contents

3.7

Connection of the endoscope and ancillary equipment ... 27 Connection of the light guide cable ... 27 Connection to the light source ... 28 Connection of the miniature light source (MAJ-922, sold separately) or ENDOLED (WA91502A, sold separately) ... 28

3.8

Inspection of the endoscopic system ... 29 Inspection summary ... 29 Inspection of the ancillary equipment ... 30 Inspection of the endoscopic image ... 31

Chapter 4 Operation ... 33 4.1

Precautions ... 33

4.2

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

4.3

Withdrawal of the endoscope ... 39

4.4

Transportation of the endoscope ... 40 Transporting within the hospital ... 40 Transporting outside the hospital ... 40

Chapter 5 Troubleshooting ... 41 5.1

Troubleshooting ... 41

5.2

Troubleshooting guide ... 42 Image quality or brightness ... 42

5.3

Withdrawal of the endoscope with an irregularity ... 43

5.4

Returning the endoscope for repair ... 44

Appendix ... 45 Combination equipment ... 45 System chart ... 45 Reprocessing equipment ... 48

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ENF-GP2 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.

Blue

Refer to instructions.

Caution

Endoscope

TYPE BF applied part

Lot number

Manufacturer

Authorized representative in the European Community

Serial number

ENF-GP2 OPERATION MANUAL

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Important Information - Please Read Before Use

Important Information - Please Read Before Use

 Intended use This instrument has been designed to be used with an Olympus light source, documentation equipment, display monitor, and other ancillary equipment for endoscopic diagnosis within the ear, nasal, and nasopharyngeal lumen.

 Contraindications None known.

 Applicability of endoscopy If there are official standards on the applicability of endoscopy that are defined by the hospital’s administrations or other official institutions, such as academic societies on endoscopy, follow those standards. Before starting endoscopy, thoroughly evaluate its properties, purposes, effects, and possible risks (their nature, extent, and probability). Perform endoscopy only when its potential benefits are greater than its risks. Fully explain to the patient the potential benefits and risks of the endoscopy as well as any examination methods that can be performed in its place, and perform the endoscopy only after obtaining the consent of the patient. Even after starting the endoscopy, continue to evaluate the potential benefits and risks, and immediately stop the endoscopy 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 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.

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ENF-GP2 OPERATION MANUAL

Important Information - Please Read Before Use

 User qualifications If there are official standards for user qualifications to perform endoscopy 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 following guidelines set by the academic societies on endoscopy, etc., and considering the difficulty of endoscopy. This manual does not explain or discuss endoscopic procedures.

 Instrument compatibility Refer to “Combination equipment” on page 45 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.

 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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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.

 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.

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ENF-GP2 OPERATION MANUAL

Important Information - Please Read Before Use

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, or light guide connector of the endoscope. Also, do not bend, pull, or twist the distal end, insertion tube, bending section, control section, 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 or insert or withdraw the endoscope’s insertion section without viewing the endoscopic image. 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 connector of the endoscope while using the endoscope because it is extremely hot. Operator or patient burns can result. • Do not touch the metal part of the light guide cable immediately after removing it from the light source because it is extremely hot. Operator or patient burns can result. • Do not touch the light guide connector of the endoscope immediately after using the endoscope because it is extremely hot. Disconnect the light guide cable from the endoscope after the temperature decreases. Otherwise, operator or patient burns can result.

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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. Refer to the instruction manual for the light source 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. • 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. • 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.

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ENF-GP2 OPERATION MANUAL

Important Information - Please Read Before Use

WARNING • 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. • Only use Olympus light guide cables (WA03300A, WA03200A, A3093, A3293) with this endoscope. Other light guide cables could cause the control section of the endoscope to overheat, which could cause operator burns.

CAUTION • Do not pull the light guide cable. The light guide will be pulled out from the output socket of the light source and the endoscopic image will disappear. • Do not coil the insertion tube 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 leakage. • The eyepiece section cannot be removed. Do not attempt to rotate it by force. ENF-GP2 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 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. • Inserting or withdrawing the endoscope or operating the bending section without a clear endoscopic image may cause patient injury, bleeding, and/or perforation.

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ENF-GP2 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-GP2

 Accessories

Light guide adapter (MAJ-900)

ETO cap (MB-156)

Operation manual

Reprocessing manual

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1.1 Checking the package contents

Ch.1

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ENF-GP2 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-GP2 OPERATION MANUAL

Ch.2

11

2.1 Nomenclature and functions

 Control section, insertion section 1 2

17

3

Ch.2

16

15 14

4

13

5

6 7 8

9

10 12

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2.1 Nomenclature and functions

No.

Nomenclature

Description

1

Eyepiece section

Observe endoscopic images from here.

2

Eyepiece lens

The viewfinder mask has an index mark indicating the UP direction of the bending section.

3

Diopter adjustment ring

Rotate the ring to adjust the focus. This does not affect focusing for photography.

4

Control section

Operates the endoscope, such as controlling angulation.

5

ETO cap (MB-156)

The sterilization 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.).

6

Venting connector

Attach the ETO cap or leakage tester here.

7

Serial number

The serial number is marked here.

8

Boot

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

9

Insertion section

This section is inserted into the patient body cavity.

10

Distal end

The objective lens and light guide lens are on this distal end.

11

Bending section

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

12

Insertion tube

Connects the control section and bending section.

13

UP/DOWN angulation control lever

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

14

Light guide connector

Connects the endoscope to the light source using the light guide cable. Transfers light from the light source to the distal end of the endoscope.

15

Light guide adapter Connects the light guide cable to the endoscope. The adapter is constructed of the light (MAJ-900) guide adapter (main body) and LG adapter (A0460).

16

Light guide adapter When connecting the light guide cable (WA03300A, WA03200A), detach the LG adapter (main body) (A0460) and connect the light guide cable directly to the light guide adapter (main body).

17

LG adapter

When connecting the light guide cable (A3093, A3293), connect it using the LG adapter (A0460).

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Ch.2

2.2 Specifications

2.2

Specifications

 Environment Operating environment

Ch.2

Ambient temperature

10 – 40C (50 – 104F)

Relative humidity

30 – 85%

Atmospheric pressure

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

Standard storage environment (e.g. within the hospital)

Ambient temperature

5 – 40C (41 – 104F)

Relative humidity

10 – 95%

Atmospheric pressure

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

Transportation environment (conditions during transportation and short-term storage)

Ambient temperature

–47 to +70C (–52.6 to +158F)

Relative humidity

10 – 95%

Atmospheric pressure

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

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ENF-GP2 OPERATION MANUAL

2.2 Specifications

 Specifications Model

ENF-GP2

Optical system

Field of view

85

Direction of view Insertion section

0(Forward viewing)

Depth of field

5 – 50 mm

Distal end outer diameter

ø 3.1 mm

Distal end enlarged

1

1 Objective lens 2 Light guide lens

UP

Ch.2

2

DOWN

Bending section

Insertion tube outer diameter

ø 3.5 mm

Insertion section working length

300 mm

Angulation range

UP 130 DOWN 130

Total length

550 mm

Medical Devices Directive

This device complies with the requirements of Directive 93/42/EEC concerning medical devices. Classification: Class II a RoHS Directive

This device complies with the requirements of Directive 2011/65/EU concerning electrical and electronic equipment. Year of manufacture

The last digit of the year of manufacture is the second digit of the serial number. In this example, the year is 2017.

Ex. 2701234 (serial number) Degree of protection against electric shock

TYPE BF applied part

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2.2 Specifications

Ch.2

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ENF-GP2 OPERATION MANUAL

3.1 The workflow of preparation and inspection

Chapter 3

Preparation and Inspection

The equipment prepared before using this endoscope and procedures for the inspection of the endoscope and equipment are described in this chapter.

3.1

The workflow of preparation and inspection

The workflow of preparation and inspection is shown below. Before each case, prepare and inspect this endoscope as instructed below. Inspect other equipment to be used with this endoscope as instructed in their respective instruction manuals. Should any irregularity be observed after inspection, follow the instructions as described in Chapter 5, “Troubleshooting”. If this endoscope malfunctions, do not use it. Return it to Olympus for repair as described in Section 5.4, “Returning the endoscope for repair”.

WARNING • Never use the endoscope on a patient if any irregularity is observed. The irregular endoscope may compromise patient or user safety and may result in more severe equipment damage. In addition, it may pose an infection control risk. • This endoscope was not reprocessed before shipment. Before using this endoscope for the first time, reprocess it according to the instructions as described in the endoscope’s companion “REPROCESSING MANUAL” with your endoscope model listed on the cover.

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Ch.3