ENF-V2 RHINO-LARYNGO VIDEOSCOPE Instructions July 2019

Contents

Chapter 6

Recommended Reprocessing Methods and Chemical Agents ...

35

6.1

Compatibility summary...

35

6.2

Detergent solution ...

38

6.3

Ultrasonic cleaning...

39

6.4

Disinfectant solution ...

40

6.5

Rinsing water ...

40

6.6

Automatic cleaning/disinfection...

41

6.7

Ethylene oxide gas sterilization...

42

6.8

Steam sterilization (autoclaving) of accessories ...

44

Chapter 7 7.1

Required reprocessing equipment ...

47

7.2

Cleaning, disinfection and sterilization procedures ...

51

7.3

Precleaning ...

52

7.4

Transportation of the endoscope ...

54

7.5

Leakage testing...

55

7.6

Manual cleaning ...

60

7.7

Disinfection ...

63

7.8

Rinsing and drying after disinfection ...

65

7.9

Automatic cleaning/disinfection...

66

7.10 Sterilization ...

67

Chapter 8

Maintenance Procedures of Equipments for Reprocessing ...

69

Storage, Transporting Outside the Hospital and Disposal ...

70

9.1

Storage ...

70

9.2

Transporting outside the hospital ...

71

9.3

Disposal ...

71

Chapter 10 Troubleshooting ...

72

10.1 Troubleshooting guide ...

73

10.2 Withdrawal of the endoscope with an abnormality...

74

10.3 Returning the endoscope for repair...

75

Appendix...

76

System chart ...

76

EMC information...

79

Chapter 9

ii

Cleaning, Disinfection and Sterilization Procedures for Endoscopic Instruments ... 47

VISERA RHINO-LARYNGO VIDEOSCOPE ENF-V2

Symbols

Symbols The meaning(s) of the symbol(s) shown on the package with the components, the back cover of this instruction manual and/or this instrument are as follows: Refer to instructions.

Caution

Type BF applied part

Endoscope

Manufacturer

Authorized representative in the European Community

Lot number

Serial number

VISERA RHINO-LARYNGO VIDEOSCOPE ENF-V2

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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 video system center, light source, documentation equipment, video monitor, and other ancillary equipment for endoscopic diagnosis within the ear, nasal lumens and airway anatomy (including nasopharyngeal and bronchus). Do not use this instrument for any purpose other than its intended use.

Applicability of endoscopy and endoscopic treatment If there is an official standard of the applicability of endoscopy and endoscopic treatment that is defined by the hospital’s administration or other official institutions such as academic societies of endoscopy, follow that standard. Before starting endoscopy and endoscopic treatment, thoroughly evaluate its properties, purposes, effects, and possible risk (their natures, 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 which will be used during the procedure and use the instruments as instructed. 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, please contact Olympus.

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VISERA RHINO-LARYNGO VIDEOSCOPE ENF-V2

Important Information - Please Read Before Use

User qualifications If there is an official standard of the qualification of endoscopy and endoscopic treatment that is defined by the medical administration or other official institutions such as the academic society of endoscopy, follow the standard. If there is no official qualification standard, 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 medical safety manager of the hospital or person in charge of the department should select a physician who is performing the planned endoscopy and endoscopic treatment safely by following the official guidelines set by the academic society of endoscopy, etc., and considering the difficulty of each type of endoscopy and endoscopic treatment.

Instrument compatibility Refer to the “System chart” in the Appendix to confirm that this instrument is compatible with the ancillary equipment being used. Using incompatible equipment can result in patient and 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 cleaned, disinfected or sterilized before shipment. Before using this instrument for the first time, reprocess it according to the instructions given in Chapter 5, “Reprocessing: General Policy” through Chapter 7, “Cleaning, Disinfection and Sterilization Procedures for Endoscopic Instruments”. After using this instrument, reprocess and store it according to the instructions given in Chapter 5, “Reprocessing: General Policy” through Chapter 9, “Storage, Transporting Outside the Hospital and Disposal”. Improper and/or incomplete reprocessing or storage can present an infection-control risk, cause equipment damage or reduce performance.

VISERA RHINO-LARYNGO VIDEOSCOPE ENF-V2

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Important Information - Please Read Before Use

Spare equipment Be sure to prepare another endoscope to avoid that the examination will be interrupted 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 which an irregularity is suspected should not be used, but should be inspected by following Section 10.1, “Troubleshooting guide” on page 73. If the irregularity is still suspected 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 can result. Equipment which 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:

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

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.

Indicates additional helpful information.

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VISERA RHINO-LARYNGO VIDEOSCOPE ENF-V2

Important Information - Please Read Before Use

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

•

Push the video connector until it clicks into the video system center, then confirm that the video connector is securely attached by pulling it gently. Improper connection will damage the CCD. A damaged CCD will display no image and make the distal end hot, which could cause operator and/or patient burns.

•

Never perform angulation control forcibly. Never forcefully pull, twist or rotate the angulated bending section. Patient injury can result.

•

Never insert or withdraw the endoscope’s insertion tube while the UP/DOWN angulation is locked. Patient injury and/or equipment damage can result.

•

Never operate the bending section, perform suction, insert or withdraw the endoscope’s insertion tube without viewing the endoscopic image. Patient injury can result.

•

Never operate the bending section, perform suction, or insert or withdraw the endoscope’s insertion tube while the image is frozen. Patient injury can result.

•

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 with all patients. Before proceeding, always be sure to confirm that transnasal insertion is possible with the patient. Otherwise, operator and/or patient injury can result or the endoscope could become lodged and be 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 such as bleeding or perforation may result.

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Important Information - Please Read Before Use

•

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, operator and/or patient injury can result or the endoscope could become lodged and be difficult to withdraw. 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 insertion immediately. Otherwise, operator and/or patient injury can result or the endoscope could become lodged and be difficult to withdraw.

•

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.

•

Do not touch the metal parts of the light guide and the light guide connector immediately after removing the light guide from the endoscope and light source because they are extremely hot.

•

Although the illumination light emitted from the endoscope’s distal end is required for endoscopic observation and treatment, it may also cause alteration of living tissues such as protein denaturation of living tissue and perforation of the tissue by inappropriate using. Observe the following warnings on the illumination.  Always set the minimum required brightness. Please note that the brightness of the image on a video monitor may differ from the actual brightness at the distal end of the endoscope.

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VISERA RHINO-LARYNGO VIDEOSCOPE ENF-V2

Important Information - Please Read Before Use

 Pay special attention to the brightness level setting of the light source, particularly when operating the electrical shutter function of a video system. When using a light source and video system that are compatible with the light source’s automatic brightness control function, make sure to use this function. The automatic brightness control function can keep the illumination light level better. Refer to the instruction manuals of the light source and the video system for further details.  Do not continue observation in close proximity to tissue or keep the distal end of the endoscope in contact with living tissue for a long time.  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. •

If the endoscopic image becomes dimmer during the procedure, it may indicate that blood or mucus is adhering to the light guide on the distal end of the endoscope. Carefully withdraw the endoscope from the patient and remove blood or mucus in order to restore optimum illumination and to ensure the safety of examination. If you continue to use the endoscope with its obstructed distal end, the temperature at the distal end may rise and cause mucosal burns to the patient.

•

Never operate the bending section, perform suction, insert or withdraw the endoscope’s insertion tube without viewing the endoscopic image. Patient injury can result.

•

Be sure to prepare another endoscope to avoid that the examination must be interrupted due to equipment failure or malfunction.

•

For reasons described below, do not rely on the NBI1 imaging modality alone for primary detection of lesions or to make a decision regarding any potential diagnostic or therapeutic intervention.  It has not been demonstrated to increase the yield or sensitivity of finding any specific mucosal lesion.

VISERA RHINO-LARYNGO VIDEOSCOPE ENF-V2

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Important Information - Please Read Before Use

 It has not been demonstrated to aid in differentiation or establishing the presence or absence of dysplasia or neoplastic changes within mucosa or mucosal lesions. 1

NBI stands for Narrow Band Imaging. For more details, refer to the instruction manual of the video system center CV-180 or OTV-S7Pro2.

2 •

This product may not be available in some areas. Generally reprocessing agents1 are aggressive and might effect the distal end of the endoscope. When the effect progresses, fogging of the inner lenses might appear, which result in a foggy video image. Any further use of the endoscope under this condition might lead to lens to come off. Before inserting the endoscope to a patient, make sure that there is no fogging by checking the video image, and by wiping the outer surface of the lens at the distal end of the endoscope with a soft cloth. In case fogging is found to be apparent, please stop using the scope immediately.

8

1

Contact Olympus for the names of specific brands that have been tested for compatibility with the endoscope.

•

Do not pull the universal cord during an examination. The light guide connector will be pulled out from the output socket of the light source and the endoscopic image will not be visible.

•

Do not pull the video cable during an examination. The endoscopic image may not be visible anymore.

•

Do not coil the insertion tube, universal cord or video cable into a diameter of less than 10 cm. Equipment damage can result.

•

Do not apply shock to the distal end of the insertion tube, particularly the objective lens surface at the distal end. Visual abnormalities 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 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.

VISERA RHINO-LARYNGO VIDEOSCOPE ENF-V2

Important Information - Please Read Before Use

•

Do not insert the video connector while the electrical contacts are wet and/or dirty. The endoscopic image may not be visible.

•

Turn the video system center OFF before connecting or disconnecting the video connector to/from the video system center. Turn it ON or OFF only when the video connector is connected to the video system center. Failure to do so can result in equipment damage, including destruction of the CCD chip.

•

The endoscope’s remote switches cannot be removed from the control section. Pressing or pulling them with excessive force can break the switches and/or may cause water leaks.

•

Do not attempt to bend the endoscope’s insertion tube with excessive force. Otherwise, the insertion tube may be damaged.

•

To check the electromagnetic influence from other equipment (any equipment other than this instrument 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.

•

Electromagnetic interference may occur in the vicinity of equipment marked with the following symbol, or portable and mobile RF communications equipment.

•

Be sure that this instrument is not used adjacent to or stacked with other equipment (other than the components of this instrument or system) to avoid electromagnetic interference.

It is highly desirable that a backup endoscope be available to continue clinical procedures in case of a malfunction.

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Important Information - Please Read Before Use

Precaution for disappeared or frozen endoscopic image •

If the endoscopic image unexpectedly disappears or the frozen image cannot be restored during an examination, immediately stop using the instrument and withdraw the endoscope from the patient. Continued use of the endoscope in such condition may cause patient injury, such as 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 and video system center properly by pushing the video connector until it clicks. Otherwise, faulty contact can result.  Do not bend, hit or twist the insertion section, control section, universal cord, video connector and light guide connector. The endoscope may be damaged and water leaks and/or breakage of internal parts like the CCD cable can result.  If air bubbles emerge from the endoscope continuously during the leakage test, do not use the endoscope. Water may enter the instrument and cause a short circuit. This may result in breakage of the switch and CCD.

10

•

Turn the video system center OFF before connecting or disconnecting the video connector to/from the video system center. Turn the switch ON or OFF only when the video connector is connected to the video system center. Failure to do so can result in equipment damage, including breakage of the CCD.

•

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.

VISERA RHINO-LARYNGO VIDEOSCOPE ENF-V2

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 given below. •

Inserting or withdrawing the endoscope, applying suction or operating the bending section without a clear endoscopic image may cause patient injury, bleeding and/or perforation.

•

Using improperly or incompletely reprocessed or stored instruments may cause patient cross-contamination and infection.

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Important Information - Please Read Before Use

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VISERA RHINO-LARYNGO VIDEOSCOPE ENF-V2

Chapter 1 Checking the Package Contents

Chapter 1 Checking the Package Contents Match all items in the package with the components shown below. Inspect each item for damage. If the instrument is damaged, a component is missing or you have any questions, do not use the instrument; immediately contact Olympus. This instrument was not cleaned, disinfected or sterilized before shipment. Before using this instrument for the first time, reprocess it according to the instructions given in Chapter 5, “Reprocessing: General Policy” through Chapter 7, “Cleaning, Disinfection and Sterilization Procedures for Endoscopic Instruments”.

Endoscope

ETO cap (MB-156)

Instruction manual

VISERA RHINO-LARYNGO VIDEOSCOPE ENF-V2

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Chapter 2 Instrument Nomenclature and Specifications

Chapter 2 Instrument Nomenclature and Specifications 2.1

Nomenclature

8. ETO cap

4. Light guide connector

7. Venting connector

Universal cord

Video cable Serial number

Light guide

6. UP mark

Electrical contacts

14

5. Video connector

VISERA RHINO-LARYNGO VIDEOSCOPE ENF-V2

Chapter 2 Instrument Nomenclature and Specifications

9. Identification mark for STERRAD® 200/NX material compatibility

2. UP/DOWN angulation control lever Control section

Boot 3. Remote switches

Insertion tube/working length

Distal end 3. Remote switches

VISERA RHINO-LARYNGO VIDEOSCOPE ENF-V2

1. Bending section

15

Chapter 2 Instrument Nomenclature and Specifications

2.2

Endoscope functions 1. Bending section The bending section moves the distal end of the endoscope when the UP/DOWN angulation control lever is operated. 2. UP/DOWN angulation control lever When turned in the “U” direction, the bending section moves UP; when moved in the “D” direction, the bending section moves DOWN. 3. Remote switches 1 to 4 The functions of the remote switches 1 to 4 can be selected on the video system center. When selecting the functions, refer to the instruction manual for the video system center. 4. 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 endoscope. 5. Video connector The video connector connects the endoscope to the output socket of the video system center and makes the endoscopic image visible. 6. UP mark When the video plug is connected to the video system center, this mark is facing upward. 7. Venting connector Attach the ETO cap or leakage tester here. 8. ETO cap The ETO cap must be attached prior to ethylene oxide gas sterilization 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.). 9. Identification mark for STERRAD® 200/NX material compatibility This mark indicates that this endoscope has material compatibility with the STERRAD® 200/NX Sterilization System. The endoscope without this mark is not applicable to STERRAD® 200/NX.

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VISERA RHINO-LARYNGO VIDEOSCOPE ENF-V2

Chapter 2 Instrument Nomenclature and Specifications

2.3

Specifications Environment Operating environment

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 Ambient temperature environment (e.g. Relative humidity within the hospital) Atmospheric pressure

5 – 40C (41 – 104F) 10 – 95% 700 – 1060 hPa (0.7 – 1.1 kgf/cm2) (10.2 – 15.4 psia)

Transportation Ambient temperature environment Relative humidity (conditions during Atmospheric pressure transportation and short-term storage)

–47 to 70C (–52.6 to 158F) 10 – 95% 700 – 1060 hPa (0.7 – 1.1 kgf/cm2) (10.2 – 15.4 psia)

Specifications Model Optical system

Insertion tube

Bending section

ENF-V2 Field of view

90

Directions of view

0 (forward viewing)

Depth of field

5 – 50 mm

Distal end outer diameter

ø 3.2 mm

Flexible tube outer diameter

ø 3.4 mm

Working length

300 mm

Angulation range

UP 130, DOWN 130

Total length

528 mm

NBI1

Available

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Chapter 2 Instrument Nomenclature and Specifications

Medical Devices Directive (for PAL type only) EMC

Applied standards; IEC 60601-1-2: 2001 IEC 60601-1-2: 2007 IEC 60601-1-2: 2014 IEC 60601-2-18: 1996 IEC 60601-2-18: 2009

This device complies with the requirements of Directive 93/42/EEC concerning medical devices. Classification: Class II a This instrument complies with the standards listed in the left column. CISPR 11 of emission: Group 1, Class B

(for PAL type only) 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. Year of

2512345

manufacture

The year of manufacture is the second digit of the serial number.

Degree of protection against electric shock

TYPE BF applied part

1 NBI stands for Narrow Band Imaging. For more details, refer to the instruction manual of the video system center CV-180 or OTV-S7Pro2. 2 This product may not be available in some areas.

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VISERA RHINO-LARYNGO VIDEOSCOPE ENF-V2