CYF-V2R VISERA CYSTO-NEPHRO VIDEOSCOPE Instructions July 2019

Contents

Chapter 5

Reprocessing: General Policy...

53

5.1

Importance of cleaning, disinfection, and sterilization...

53

5.2

Precautions ...

54

Compatible Reprocessing Methods and Chemical Agents...

57

6.1

Compatibility summary...

57

6.2

Detergent solution ...

62

6.3

Ultrasonic cleaning...

63

6.4

Disinfectant solution ...

64

6.5

Rinse water ...

65

6.6

Automatic cleaning/disinfection...

65

6.7

Ethylene oxide gas sterilization...

66

6.8

Ethylene oxide gas sterilization conditions...

68

6.9

Steam sterilization (autoclaving) of accessories ...

69

Cleaning, Disinfection, and Sterilization Procedures ...

72

7.1

Required reprocessing equipment ...

73

7.2

Cleaning, disinfection, and sterilization procedures ...

81

7.3

Precleaning ...

83

7.4

Transportation of the endoscope ...

88

7.5

Leakage testing...

90

7.6

Manual cleaning ...

95

7.7

Rinsing and drying after manual cleaning ...

105

7.8

Disinfection ...

107

7.9

Automatic cleaning/disinfection...

111

7.10 Rinsing and drying after disinfection ...

113

7.11 Sterilization ...

119

7.12 Cleaning, disinfection, and sterilization procedures for reusable parts ...

120

7.13 Maintenance procedures of equipment for reprocessing ...

121

Chapter 6

Chapter 7

Chapter 8

ii

Storage, Transporting the Endoscope Outside the Hospital and Disposal ... 127

8.1

Storage of the endoscope ...

128

8.2

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

129

8.3

Transporting the endoscope outside the hospital ...

129

8.4

Disposal ...

129

VISERA CYSTO-NEPHRO VIDEOSCOPE CYF-V2/VA2/V2R

Contents

Chapter 9

Troubleshooting ... 130

9.1

Troubleshooting guide ...

131

9.2

Withdrawal of the endoscope with any irregularity...

134

9.3

Returning the endoscope for repair ...

135

Appendix ... 136 System chart ...

136

EMC information ...

140

VISERA CYSTO-NEPHRO VIDEOSCOPE CYF-V2/VA2/V2R

iii

Contents

iv

VISERA CYSTO-NEPHRO VIDEOSCOPE CYF-V2/VA2/V2R

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:

Refer to instructions.

Caution

TYPE BF applied part

Endoscope

Lot number

Single use only

Manufacturer

Authorized representative in the European Community

Serial number

VISERA CYSTO-NEPHRO VIDEOSCOPE CYF-V2/VA2/V2R

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, EndoTherapy accessories, and other ancillary equipment for endoscopic diagnosis and treatment within the bladder, urethra and kidney. Do not use the 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.

2

VISERA CYSTO-NEPHRO VIDEOSCOPE CYF-V2/VA2/V2R

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.

 Terms used in this manual NBI (Narrow Band Imaging) observation This is a special observation mode using the narrow band observation light. Normal light observation (WLI (White Light Imaging) observation): This is an observation mode using the standard white light illumination.

User qualifications If there is an official standard for user qualifications to perform endoscopy and endoscopic treatment that is defined by the medical administration or other official institutions, such as academic societies on endoscopy, follow that 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 internal medicine, etc.). The physician should be capable of safely performing the planned endoscopy and endoscopic treatment following guidelines set by the academic societies on endoscopy, etc., and considering the difficulty of endoscopy and endoscopic treatment. This manual does not explain or discuss endoscopic procedures.

VISERA CYSTO-NEPHRO VIDEOSCOPE CYF-V2/VA2/V2R

3

Important Information - Please Read Before Use

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.

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, Transporting the Endoscope Outside the Hospital 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.

4

VISERA CYSTO-NEPHRO VIDEOSCOPE CYF-V2/VA2/V2R

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 inspect the items specified in this manual periodically. An endoscope with that an irregularity is suspected should not be used, but should be inspected by following Section 9.1, “Troubleshooting guide” on page 131. 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.

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.

VISERA CYSTO-NEPHRO VIDEOSCOPE CYF-V2/VA2/V2R

5

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.

6

•

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, Transporting the Endoscope Outside the Hospital and Disposal”. Using improperly or incompletely reprocessed or stored instruments may cause patient cross-contamination and/or infection.

•

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.

•

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

•

Never perform angulation control forcibly or abruptly. Never forcefully pull, twist or rotate the angulated bending section. Patient injury, bleeding, and/or perforation can result. It may also become impossible to straighten the bending section during an examination.

•

Never perform angulation control or insertion/withdrawal of the endoscope’s insertion tube without viewing the endoscopic image. Patient injury, bleeding, and/or perforation 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.

VISERA CYSTO-NEPHRO VIDEOSCOPE CYF-V2/VA2/V2R

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 alter living tissues by, for example, causing protein denaturation of living tissue, or perforation of the bladder or kidney. Observe the following warnings with regard to illumination.  Always set the minimum required brightness. The brightness of the image on a monitor may differ from the actual brightness at the distal end of the endoscope.  Pay 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 the function. The automatic brightness control function can better maintain the illumination level. Refer to the instruction manual for the light source and the video system center 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.

•

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

•

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

•

Never insert or withdraw the insertion tube abruptly or with excessive force. Patient injury, bleeding, and/or perforation can result.

•

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.

VISERA CYSTO-NEPHRO VIDEOSCOPE CYF-V2/VA2/V2R

7

Important Information - Please Read Before Use

•

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.

•

Generally, reprocessing agents1 are aggressive and might affect 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, 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 another endoscope to avoid that the examination be interrupted due to equipment failure or malfunction.

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

8

This product may not be available in some areas.

VISERA CYSTO-NEPHRO VIDEOSCOPE CYF-V2/VA2/V2R

Important Information - Please Read Before Use

•

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.

•

When reprocessing or transporting the endoscope, make sure not to damage the endoscope’s distal end, insertion tube and bending section by video connector and light guide connector.

•

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 it may cause water leaks.

•

Do not hit or bend the electrical contacts on the video connector. The connection to the video system center may be impaired and faulty contact can result.

•

Do not insert the video connector while the electrical contacts are wet and/or dirty. Doing so may result in electric shock, causing severe damage to the endoscope and compromising patient and/or operator safety.

•

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.

•

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.

VISERA CYSTO-NEPHRO VIDEOSCOPE CYF-V2/VA2/V2R

9

Important Information - Please Read Before Use

•

When the endoscope is dropped or the distal end of the endoscope receives hard impact, the endoscope may be damaged even if no visible damage of the lens on the distal end can be found. In this case, stop using the endoscope, and contact Olympus.

•

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.

•

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 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.

10

VISERA CYSTO-NEPHRO VIDEOSCOPE CYF-V2/VA2/V2R

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.  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 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 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.

VISERA CYSTO-NEPHRO VIDEOSCOPE CYF-V2/VA2/V2R

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 and endoscopic treatment can be ensured through appropriate handling by the physician and the medical facility. Examples of inappropriate handling are given below:

12

•

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.

•

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.

•

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

VISERA CYSTO-NEPHRO VIDEOSCOPE CYF-V2/VA2/V2R

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”.

VISERA CYSTO-NEPHRO VIDEOSCOPE CYF-V2/VA2/V2R

13

Chapter 1 Checking the Package Contents

CYF-V2, CYF-V2R

Endoscope

Forceps/irrigation plug (Isolated type) (MAJ-891)

1

14

Biopsy valve (MAJ-579, 10 pcs)

Biopsy forceps1 (FB-19SX-1)

Channel cleaning brush (BW-15B)

Grasping forceps1 (FG-53SX-1)

Instruction manual

Channel-opening cleaning brush (MH-507)

ETO cap (MB-156)

Instruction manual (Forceps/irrigation plug (Isolated type))

This accessory is not included in the package in some areas.

VISERA CYSTO-NEPHRO VIDEOSCOPE CYF-V2/VA2/V2R

Chapter 1 Checking the Package Contents

CYF-VA2

Endoscope

Forceps/irrigation plug (Isolated type) (MAJ-891)

1

Suction valve (MAJ-207, 10 pcs)

Biopsy forceps1 (FB-19SX-1)

Biopsy valve (MAJ-579, 10 pcs)

Channel-opening cleaning brush (MH-507)

Grasping forceps1 (FG-53SX-1)

ETO cap (MB-156)

Instruction manual

Suction cleaning adapter (MAJ-1077)

Channel cleaning brush (BW-15B)

Instruction manual (Forceps/irrigation plug (Isolated type))

This accessory is not included in the package in some areas.

VISERA CYSTO-NEPHRO VIDEOSCOPE CYF-V2/VA2/V2R

15

Chapter 2 Instrument Nomenclature and Specifications

Chapter 2 Instrument Nomenclature and Specifications 2.1

Nomenclature  CYF-V2, CYF-V2R

2. ETO Cap 3. Light guide connector

Universal cord 1. Venting connector

Video cable Light guide

Serial number

NTSC/PAL label

5. UP mark

Electrical contacts

16

4. Video connector

VISERA CYSTO-NEPHRO VIDEOSCOPE CYF-V2/VA2/V2R