ENF-VT2 RHINO-LARYNGO VIDEOSCOPE Instructions July 2019

Contents

Chapter 5

Reprocessing: General Policy...

55

5.1

Notes for cleaning and sterilization ...

55

5.2

Precautions ...

56

Recommended Reprocessing Methods and Chemical Agents ...

59

6.1

Compatibility summary...

59

6.2

Detergent solution ...

64

6.3

Ultrasonic cleaning...

64

6.4

Disinfectant solution ...

65

6.5

Rinsing water ...

66

6.6

Automatic cleaning/disinfection...

66

6.7

Ethylene oxide gas sterilization...

67

6.8

Steam sterilization (autoclaving) of accessories ...

70

Cleaning, Disinfection and Sterilization Procedures ...

73

7.1

Required reprocessing equipment ...

74

7.2

Cleaning, disinfection and sterilization procedures ...

79

7.3

Precleaning ...

81

7.4

Transporting to the reprocessing area ...

85

7.5

Leakage testing...

86

7.6

Manual cleaning ...

91

7.7

Disinfection ...

100

7.8

Rinsing and drying after disinfection ...

103

7.9

Automatic cleaning/disinfection...

106

7.10 Placing the endoscope in the tub (OER, OER-A, EW-30) ...

107

7.11 Sterilization ...

109

Chapter 6

Chapter 7

Chapter 8

Maintenance Procedures and Equipment for Reprocessing ... 111

Chapter 9

Storage and Disposal ... 112

9.1

Storage ...

112

9.2

Storage of reprocessing equipment and the leakage tester (WA23070A) ...

113

Disposal ...

113

9.3

Chapter 10 Troubleshooting ... 114

ii

10.1 Troubleshooting guide ...

114

10.2 Withdrawal of the endoscope with any abnormality ...

117

10.3 Returning the endoscope for repair...

118

RHINO-LARYNGO VIDEOSCOPE OLYMPUS ENF TYPE VT2

Contents

Appendix ... 119 System chart ...

119

EMC information ...

124

RHINO-LARYNGO VIDEOSCOPE OLYMPUS ENF TYPE VT2

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Contents

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RHINO-LARYNGO VIDEOSCOPE OLYMPUS ENF TYPE VT2

Symbols

Symbols The meaning(s) of the symbol(s) shown on the package of 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

Single use only

Manufacturer

Authorized representative in the European Community

Lot number

Serial number

RHINO-LARYNGO VIDEOSCOPE OLYMPUS ENF TYPE VT2

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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, monitor, EndoTherapy accessories, and other ancillary equipment for endoscopic diagnosis and treatment within the nasal lumens and airway anatomy. 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 on the applicability of endoscopy and endoscopic treatment that is defined by the hospital’s administration or other official institutions such as academic societies on endoscopy, follow that standard. Before starting endoscopy and endoscopic treatment, thoroughly evaluate its properties, purposes, effects, and possible risks (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.

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RHINO-LARYNGO VIDEOSCOPE OLYMPUS ENF TYPE VT2

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 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. NBI (Narrow Band Imaging) observation This is a special observation using the narrow band observation light.

User qualifications If there is an official standard on the qualification of endoscopy and endoscopic treatment that is defined by the medical administration or other official institutions such as the academic society on 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 endoscopic treatment safety by following the official guidelines set by the academic society of endoscopy, etc.

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 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.

RHINO-LARYNGO VIDEOSCOPE OLYMPUS ENF TYPE VT2

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Important Information - Please Read Before Use

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”. After using this instrument, reprocess and store it according to the instructions given in Chapter 5, “Reprocessing: General Policy” through Chapter 9, “Storage and Disposal”. Improper and/or incomplete reprocessing or storage can present an infection-control risk, cause equipment damage or reduce performance.

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 114. 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 user injury and/or equipment damage can result. Some problems that appear to be malfunctions may be correctable by referring to Chapter 10, “Troubleshooting”. If the problem cannot be resolved using the information in Chapter 10, contact Olympus. 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.

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RHINO-LARYNGO VIDEOSCOPE OLYMPUS ENF TYPE VT2

Important Information - Please Read Before Use

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.

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.

•

After using this instrument, reprocess and store it according to the instructions given in Chapter 5, “Reprocessing: General Policy” through Chapter 9, “Storage and Disposal”. Using improperly or incompletely reprocessed or stored instruments may cause patient cross-contamination and/or infection.

•

Never use EndoTherapy accessories while the image is frozen. Patient injury can result.

RHINO-LARYNGO VIDEOSCOPE OLYMPUS ENF TYPE VT2

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Important Information - Please Read Before Use

6

•

Failure to properly clean and sterilize endoscopic equipment after each procedure can compromise patient safety. To minimize the risk of transmitting diseases from one patient to another, after each procedure the endoscope and the equipment must undergo thorough manual cleaning followed by sterilization, following the description in Chapter 7, “Cleaning, Disinfection and Sterilization Procedures”.

•

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

•

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 forcibly and press it forcefully against the walls of internal organs, as trauma may occur and/or equipment damage may result.

•

Never perform angulation control, insertion/withdrawal of the endoscope or manipulation of EndoTherapy accessories without viewing the endoscopic image. Patient injury can result.

•

Never operate the bending section, insert or withdraw the endoscope’s insertion tube, use EndoTherapy accessories while the image is frozen. Patient injury, bleeding and/or perforation 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 into all patients. Before proceeding, always be sure to confirm that transnasal insertion is possible with the patient. Otherwise, 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.

RHINO-LARYNGO VIDEOSCOPE OLYMPUS ENF TYPE VT2

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, 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 strike, bend, hit, pull, twist, or drop the endoscope’s distal end, insertion tube, bending section, and control section with excessive force. The endoscope may be damaged and could cause patient injury, such as burns, bleeding, and/or perforation. It could also cause parts of the endoscope to fall off inside the patient.

•

When the endoscopic image does not appear on the monitor, the CCD 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 touch the metal plug of the light guide connector immediately after removing it from the light source because it is extremely hot. Operator or patient injury can result.

RHINO-LARYNGO VIDEOSCOPE OLYMPUS ENF TYPE VT2

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Important Information - Please Read Before Use

•

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 use. Observe the following warnings on the illumination.  Always set the minimum required brightness. Please note that 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 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 this function. The automatic brightness control function can keep the illumination light properly. Refer to the instruction manuals of the light source and the video system center for further details.  Do not continue observation in the 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.

•

8

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. Carefully withdraw the endoscope from the patient and remove blood or mucus in order to restore optimum illumination and to ensure the safety of the 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. It may also cause patient and/or operator injury.

RHINO-LARYNGO VIDEOSCOPE OLYMPUS ENF TYPE VT2

Important Information - Please Read Before Use

•

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 results in a foggy video image. Any further use of the endoscope under this condition might lead the lens to come off. Before inserting the endoscope into a patient, make sure that no foggy video image appears, and wipe the outer surface of the lens at the distal end of the endoscope with a soft cloth. In case a foggy image appears, please stop using the endoscope immediately.

•

For reasons described below, do not rely on the NBI2 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.  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

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

2

NBI stands for Narrow Band Imaging. For more details, refer to the instruction manual of the video system center CV-180 or OTV-S7Pro3

3

This product may not be available in some areas.

•

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.

RHINO-LARYNGO VIDEOSCOPE OLYMPUS ENF TYPE VT2

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Important Information - Please Read Before Use

•

Do not squeeze the bending section forcefully. The covering of the bending section may stretch or break, and it may cause water leaks.

•

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

•

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.

•

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.

•

Electromagnetic interference may occur on this instrument 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 instrument, or shielding the location.

•

This endoscope contains a memory chip that stores information about the endoscope and communicates this information to the video system center OTV-S7Pro1 or CV-180. 1 This product may not be available in some areas.

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RHINO-LARYNGO VIDEOSCOPE OLYMPUS ENF TYPE VT2

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 to the video system center completely by pushing the video connector until it clicks. Otherwise, faulty contact can result.  Make sure that the video connector and its electrical contacts are completely dry before connecting the plug to the video system center. Wet contacts could cause the equipment to malfunction.  Do not bend, hit or twist the insertion section, control section, universal cord and video 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.

•

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.

•

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.

RHINO-LARYNGO VIDEOSCOPE OLYMPUS ENF TYPE VT2

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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 given below:

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•

Inserting, withdrawing and using EndoTherapy accessories without a clear endoscopic image may cause patient injury, bleeding, burns 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.

•

Applying prolonged 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.

RHINO-LARYNGO VIDEOSCOPE OLYMPUS ENF TYPE VT2

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 Chapters 5, “Reprocessing: General Policy” through 7, “Cleaning, Disinfection and Sterilization Procedures”.

Endoscope

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

Biopsy valve3 (MD-495,10 pcs)

ETO cap (MB-156)

Suction cleaning adapter (MAJ-222) Suction valve2 (MAJ-207, 10 pcs) Single use suction valve2 (MAJ-209, 20 pcs)

Channel cleaning brush (BW-15B)

1

for Europe and other countries (except for Asia)

2

This product is not available in some areas.

3

for Asia only

Channel-opening cleaning brush (MH-507)

Instruction manual

RHINO-LARYNGO VIDEOSCOPE OLYMPUS ENF TYPE VT2

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Chapter 2 Instrument Nomenclature and Specifications

Chapter 2 Instrument Nomenclature and Specifications 2.1

Nomenclature 5. ETO cap 1. Light guide connector

Universal cord

4. Venting connector

Serial number

Light guide

Video cable

3. UP mark

Electrical contacts 2. Video connector

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RHINO-LARYNGO VIDEOSCOPE OLYMPUS ENF TYPE VT2

Chapter 2 Instrument Nomenclature and Specifications

7. UP/DOWN angulation lock 8. Single use suction valve (MAJ-209) or suction valve (MAJ-207)

6. UP/DOWN angulation control lever Suction cylinder Slit

Control section 9. Single use biopsy valve (MAJ-210) or biopsy valve (MD-495)

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

10. Instrument channel port

11. Color code 13. Remote switches Boot Insertion tube/working length

Distal end Suction cylinder 12. Bending section 13. Remote switches

RHINO-LARYNGO VIDEOSCOPE OLYMPUS ENF TYPE VT2

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Chapter 2 Instrument Nomenclature and Specifications

2.2

Endoscope functions 1. Light guide connector This connector connects the endoscope to the output socket of the light source and transmits light from the light source to the endoscope. 2. Video connector This connector connects the endoscope to the output 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-S7Pro1 or CV-180. For more details, refer to the instruction manual of the OTV-S7Pro1 or CV-180. 1 This product may not be available in some areas. 3. UP mark When the video plug is connected to the video system center, this mark is facing upward. 4. Venting connector Attach the ETO cap or leakage tester here. 5. ETO cap The ETO cap must be installed 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.). 6. UP/DOWN angulation control lever When turned in the “U” direction, the bending section moves UP; when turned in the “D” direction, the bending section moves DOWN. 7. UP/DOWN angulation lock Pushing this lever in the “F ” direction frees angulation. Pushing the lever in the opposite direction locks the bending section at any desired position. 8. Single use suction valve (MAJ-209) or suction valve (MAJ-207) The suction valve is depressed to activate suction. The valve is also used to remove any fluid or debris adhering to the objective lens. 9. Single use biopsy valve (MAJ-210) or biopsy valve (MD-495) Accessories may be inserted through the slit in this valve. A syringe may be inserted for the injection of fluids. 10. Instrument channel port This channel port functions as:  channel for the insertion of EndoTherapy accessories  suction channel  fluid feed channel (from a syringe via the biopsy valve)

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RHINO-LARYNGO VIDEOSCOPE OLYMPUS ENF TYPE VT2