Rhino-Laryngo Videoscope ENF-VQ Instructions

Contents

Chapter 6

Recommended Reprocessing Methods and Chemical Agents ...

39

6.1

Compatibility summary...

39

6.2

Detergent solution ...

42

6.3

Disinfectant solution ...

43

6.4

Rinsing water ...

44

6.5

Automatic cleaning/disinfection...

44

6.6

Ethylene oxide gas sterilization...

45

Cleaning, Disinfection, and Sterilization Procedures ...

47

7.1

Required reprocessing equipment ...

48

7.2

Cleaning, disinfection, and sterilization procedures ...

51

7.3

Precleaning ...

53

7.4

Transportation of the endoscope ...

55

7.5

Leakage testing...

56

7.6

Manual cleaning ...

61

7.7

Disinfection ...

64

7.8

Rinsing and drying after disinfection ...

66

7.9

Automatic cleaning/disinfection...

68

7.10 Sterilization ...

69

Chapter 7

Chapter 8

Storage and Disposal ...

70

8.1

Storage ...

70

8.2

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

71

8.3

Transporting outside the hospital ...

71

8.4

Disposal ...

71

Troubleshooting ...

72

9.1

Troubleshooting guide ...

72

9.2

Withdrawal of the endoscope with any irregularity...

74

9.3

Returning the endoscope for repair...

75

Appendix...

76

System chart ...

76

EMC information...

79

Chapter 9

ii

RHINO-LARYNGO VIDEOSCOPE OLYMPUS ENF TYPE VQ

Symbols

Symbols The meaning(s) of the symbol(s) shown on the component packaging, 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

RHINO-LARYNGO VIDEOSCOPE OLYMPUS ENF TYPE VQ

1

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, and other ancillary equipment for endoscopic diagnosis within the ear, nasal lumens and airway anatomy. Do not use this instrument for any purpose other than its intended use.

Applicability of endoscopy If there is an official standard on the applicability of endoscopy that is defined by the hospital’s administration or other official institutions such as academic societies on endoscopy, follow that standard. Before starting endoscopy thoroughly evaluate its properties, purposes, effects, and possible risks (their natures, 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.

2

RHINO-LARYNGO VIDEOSCOPE OLYMPUS ENF TYPE VQ

Important Information - Please Read Before Use

Instruction manual This instruction manual contains essential information on using this instrument safely and effectively. Before use, thoroughly review this manual and the manuals of all equipment that will be used during the procedure and use the 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 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 endoscopy safely 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 VQ

3

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 8, “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 interruption of the examination due to equipment failure or malfunction.

Maintenance management The probability of failure of the endoscope and ancillary equipment increases as the number of procedures performed and/or the total operating hours increase. In addition to the inspection before each procedure, the person in charge of medical equipment maintenance in each hospital should inspect the items specified in this manual periodically. An endoscope with that an irregularity is observed should not be used, but should be inspected by following Section 9.1, “Troubleshooting guide” on page 72. 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 user injury and/or equipment damage can result. Some problems that appear to be malfunctions may be correctable by referring to Chapter 9, “Troubleshooting”. If the problem cannot be resolved using the information in Chapter 9, contact Olympus. 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.

4

RHINO-LARYNGO VIDEOSCOPE OLYMPUS ENF TYPE VQ

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 8, “Storage and Disposal”. Using improperly or incompletely reprocessed or stored instruments may cause patient cross-contamination and/or infection.

•

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”.

RHINO-LARYNGO VIDEOSCOPE OLYMPUS ENF TYPE VQ

5

Important Information - Please Read Before Use

6

•

Never insert or withdraw the endoscope’s insertion tube while the angulation is locked. Patient injury and/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 without viewing the endoscopic image. Patient injury can result.

•

Never operate the bending section, insert or withdraw the endoscope’s insertion tube 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 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.

•

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.

RHINO-LARYNGO VIDEOSCOPE OLYMPUS ENF TYPE VQ

Important Information - Please Read Before Use

•

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 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 insertion immediately. Otherwise, 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 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 VQ

7

Important Information - Please Read Before Use

•

Although the illumination light emitted from the endoscope’s distal end is required for endoscopic observation it may also cause alteration of living tissues such as protein denaturation of living tissue and perforation of the tissue 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 for 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 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 VQ

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 result in a foggy video image. Any further use of the endoscope under this condition might lead to parts of the endoscope (e.g. 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 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.

•

Be sure to prepare a secondary endoscope to avoid that the examination be interrupted due to equipment failure or malfunction of the primary endoscope.

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 for 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.

RHINO-LARYNGO VIDEOSCOPE OLYMPUS ENF TYPE VQ

9

Important Information - Please Read Before Use

•

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 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 CV-180 or OTV-S7Pro1. 1 This product may not be available in some areas.

10

RHINO-LARYNGO VIDEOSCOPE OLYMPUS ENF TYPE VQ

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 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 into the video system center until it clicks. Otherwise, faulty contact can result.  Make sure that the video connector and its electrical contacts are completely dry before connecting the video connector to the video system center. Wet contacts could cause the equipment to malfunction.  Do not bend, hit, or twist the insertion tube, 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 ON or OFF only when the video connector is connected to it. In particular, confirm that the video system center is OFF before connecting or disconnecting the video connector to/from 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 VQ

11

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

12

RHINO-LARYNGO VIDEOSCOPE OLYMPUS ENF TYPE VQ

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

ETO cap (MB-156)

Instruction manual

RHINO-LARYNGO VIDEOSCOPE OLYMPUS ENF TYPE VQ

13

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

14

RHINO-LARYNGO VIDEOSCOPE OLYMPUS ENF TYPE VQ

Chapter 2 Instrument Nomenclature and Specifications

10. Identification mark for STERRAD® 200/NX material compatibility 7. UP/DOWN angulation lock

6. UP/DOWN angulation control lever

Control section

9. Remote switches

Boot Insertion tube/working length

Flexible tube

Distal end 9. Remote switches

RHINO-LARYNGO VIDEOSCOPE OLYMPUS ENF TYPE VQ

8. Bending section

15

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 become visible. The endoscope contains a memory chip that stores information about the endoscope and communicates this information to the video system center CV-180 or OTV-S7Pro1. For more details, refer to the instruction manual for the CV-180 or OTV-S7Pro1. 1 This product may not be available in some areas. 3. UP mark When the video connector 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. Bending section This bending section moves the distal end of the endoscope when the UP/DOWN angulation control lever is operated. 9. Remote switches “1” to “4” The functions of remote switches “1” to “4” can be selected on the video system center. When selecting functions, refer to the instruction manual for the video system center. 10. 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.

16

RHINO-LARYNGO VIDEOSCOPE OLYMPUS ENF TYPE VQ

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)

RHINO-LARYNGO VIDEOSCOPE OLYMPUS ENF TYPE VQ

17

Chapter 2 Instrument Nomenclature and Specifications

Specifications  Endoscope Model Optical system

ENF-VQ

Direction of view

Insertion tube

90

Field of view

0 (Forward viewing)

Depth of field

5 – 50 mm

Distal end outer diameter

ø 3.9 mm

Distal end enlarged

1. Objective lens 2. Examination light outlet UP

1.

2.

2. DOWN

Bending section

Flexible tube outer diameter

ø 3.6 mm

Working length

300 mm

Angulation range

UP 130, DOWN 130

Total length

528 mm

NBI1

Available

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

18

RHINO-LARYNGO VIDEOSCOPE OLYMPUS ENF TYPE VQ