URF-V Instructions July 2007

Contents

Chapter 5

Reprocessing: General Policy...

48

5.1

Notes for cleaning, disinfection, and sterilization ...

48

5.2

Precautions ...

49

Compatible Reprocessing Methods and Chemical Agents ...

52

6.1

Compatibility summary...

52

6.2

Detergent solution ...

57

6.3

Ultrasonic cleaning...

58

6.4

Disinfectant solution ...

59

6.5

Rinsing water ...

60

6.6

Automatic cleaning/disinfection...

60

6.7

Ethylene oxide gas sterilization...

61

6.8

Steam sterilization (autoclaving) of accessories ...

64

Cleaning, Disinfection, and Sterilization Procedures ...

67

7.1

Required reprocessing equipment ...

68

7.2

Cleaning, disinfection, and sterilization procedures ...

76

7.3

Precleaning ...

77

7.4

Transportation of the endoscope ...

80

7.5

Leakage testing...

81

7.6

Manual cleaning ...

87

7.7

Disinfection ...

94

7.8

Rinsing and drying after disinfection ...

97

7.9

Automatic cleaning/disinfection...

99

7.10 Sterilization ...

100

Chapter 6

Chapter 7

Chapter 8

Maintenance Procedures of Equipment for Reprocessing ... 102

Chapter 9

Storage, transporting outside the hospital and Disposal ... 103

9.1

Storage ...

103

9.2

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

104

9.3

Transporting the endoscope outside the hospital ...

104

9.4

Disposal ...

104

Chapter 10 Troubleshooting ... 105

ii

10.1 Troubleshooting guide ...

105

10.2 Withdrawal of the endoscope with any irregularity...

108

10.3 Returning the endoscope for repair...

109

URETERO-RENO VIDEOSCOPE OLYMPUS URF TYPE V

Contents

Appendix ... 110 System chart ...

110

EMC information ...

114

URETERO-RENO VIDEOSCOPE OLYMPUS URF TYPE V

iii

Contents

iv

URETERO-RENO VIDEOSCOPE OLYMPUS URF TYPE V

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

Manufacturer

Authorized representative in the European Community

Lot number

Serial number

URETERO-RENO VIDEOSCOPE OLYMPUS URF TYPE V

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 ureter and kidney through a percutaneous route and transurethrally. 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

URETERO-RENO VIDEOSCOPE OLYMPUS URF TYPE V

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 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 urology, 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 2 (IEC 60601-1-2: 2001). However, when connecting with an instrument that complies with the EMC standard for medical electrical equipment; edition 1 (IEC 60601-1-2: 1993), the whole system complies with edition 1 (see “EMC information” on page 114 for EMC compliance level).

URETERO-RENO VIDEOSCOPE OLYMPUS URF TYPE V

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 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.

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 that an irregularity is observed should not be used, but should be inspected by following Section 10.1, “Troubleshooting guide” on page 105. If the irregularity is still observed after inspection, contact Olympus.

4

URETERO-RENO VIDEOSCOPE OLYMPUS URF TYPE V

Important Information - Please Read Before Use

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 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.

URETERO-RENO VIDEOSCOPE OLYMPUS URF TYPE V

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 into the video system center until it clicks, then confirm that the video connector is securely attached by pulling it gently. An 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, transporting 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 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 and rotate the 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.

•

If significant resistance is felt during insertion due to an anatomical reason, do not insert, withdraw or turn the insertion tube of the endoscope with excessive force. Otherwise, ureter injury, bleeding, and/or perforation may occur.

URETERO-RENO VIDEOSCOPE OLYMPUS URF TYPE V

Important Information - Please Read Before Use

•

Do not insert, withdraw, or turn the insertion tube unless you have a clear endoscopic field of view. Patient injury, bleeding, and/or perforation could result. Never insert, withdraw, or turn the insertion tube with excessive force.

•

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 intestines. 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 insert or withdraw the insertion tube abruptly or with excessive force. Patient injury, bleeding, and/or perforation can result.

•

Never use high-frequency EndoTherapy accessories because the endoscope’s distal end is not insulated. Using high-frequency accessories presents a risk of electric shock to the patient and/or may damage the endoscope.

•

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.

URETERO-RENO VIDEOSCOPE OLYMPUS URF TYPE V

7

Important Information - Please Read Before Use

•

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.

•

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 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 for the video system center CV-180 or OTV-S7Pro3

3 •

8

This product may not be available in some areas. Be sure to prepare a another endoscope to avoid that the examination will be interrupted due to equipment failure or malfunction.

URETERO-RENO VIDEOSCOPE OLYMPUS URF TYPE V

Important Information - Please Read Before Use

•

This endoscope does not correspond to the Nd:YAG laser cauterization. Patient injury or equipment damage can result.

•

Avoid aspirating solid matter or thick fluids; channel clogging can occur. If the suction cannot be stopped, disconnect the suction tube from the irrigation port of the forceps/irrigation plug.

•

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 it may cause water leaks.

•

Do not insert the video connector while the electrical contacts are wet and/or dirty. Doing so may result in an 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 OFF before connecting or disconnecting the video connector and the video system center. Turn the video system center 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 light source may be impaired and faulty contact can result.

URETERO-RENO VIDEOSCOPE OLYMPUS URF TYPE V

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.

•

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

URETERO-RENO VIDEOSCOPE OLYMPUS URF TYPE V

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. 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 switches 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.

URETERO-RENO VIDEOSCOPE OLYMPUS URF TYPE V

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

•

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, operating the bending section or rotating the insertion tube without a clear endoscopic image may cause patient injury, bleeding, and/or perforation.

URETERO-RENO VIDEOSCOPE OLYMPUS URF TYPE V

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”.

Never use high-frequency EndoTherapy accessories because the endoscope’s distal end is not insulated. Using high-frequency accessories presents a risk of electrical shock to the patient and/or damage of the endoscope may result. This could also happen when using the forceps/irrigation plug of the isolated type.

Endoscope

Channel-opening cleaning brush (MH-507) Biopsy valve (MAJ-579, 10 pcs)

ETO cap (MB-156) Suction connector cleaning brush (BW-15SH)

Single use single-ended cleaning brush (BW-400B)1

Channel cleaning brush (BW-7B)1 Instruction manual

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

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

1 These products may not be available in some areas. URETERO-RENO VIDEOSCOPE OLYMPUS URF TYPE V

13

Chapter 2 Instrument Nomenclature and Specifications

Chapter 2 Instrument Nomenclature and Specifications 2.1

Nomenclature

16. ETO cap 12. Light guide connector

Universal cord 15. Venting connector

Video cable Light guide

Serial number

14. UP mark

Electrical contacts

14

NTSC/PAL label

13. Video connector

URETERO-RENO VIDEOSCOPE OLYMPUS URF TYPE V

Chapter 2 Instrument Nomenclature and Specifications

17. Identification mark for STERRAD® 200/NX material compatibility 3. UP/DOWN angulation lock

&

2. UP/DOWN angulation control lever

7

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

Control section L

9. Instrument channel port

Control section UP mark

10. Color code

F

4. Insertion tube lock/free knob

7. Insertion tube UP mark

6. Boot 11. Remote switches

Light guide lens Objective lens 5. Insertion tube Instrument channel

Distal end 1. Bending section

11. Remote switches

URETERO-RENO VIDEOSCOPE OLYMPUS URF TYPE V

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 turned in the “D” direction, the bending section moves DOWN. 3. UP/DOWN angulation lock Pushing this lever in the “F ” direction frees the angulation. Pushing the lever in the opposite direction locks the bending section at any desired position. 4. Insertion tube lock/free knob When the knob indicator “” is set to the “F” position, the insertion tube is free to rotate; when it is set to the “L” position, the insertion tube can be locked at the desired position. 5. Insertion tube This insertion tube is inserted into the patient. The insertion tube can be turned to the both directions from the neutral position and can be locked in any position within the range of both 90 degrees from the neutral position with operating the insertion tube lock/free knob. 6. Boot Turn the insertion tube with holding the boot when turning the insertion tube against the control section. 7. Insertion tube UP mark This projection on the boot is the UP mark that indicates the UP direction of the insertion tube. The direction of this mark is the same as the UP direction of the bending section. Turn the insertion tube with holding the boot until this mark aligns with the “ ” mark on the control section when returning the insertion tube to the neutral position. 8. Forceps/irrigation plug (Isolated type) (MAJ-891) Accessories are inserted through the forceps port. Fluid can be fed through the irrigation port. 9. Instrument channel port This channel is used for the insertion of EndoTherapy accessories and for feeding fluid. 10. Color code The color code is used to quickly determine the compatibility of EndoTherapy accessories. The endoscope can be used with EndoTherapy accessories that have the same color code. • White:

16

URF-V

URETERO-RENO VIDEOSCOPE OLYMPUS URF TYPE V