CYF-V VISERA CYSTOVIDEOSCOPE Instructions April 2006

Contents

Contents Symbols...

1

Important Information - Please Read Before Use...

2

Intended use...

2

Instruction manual...

2

User qualifications...

2

Instrument compatibility...

3

Reprocessing and storage...

3

Repair and modification...

3

Signal words...

4

Warnings and cautions...

4

Precaution for disappeared or frozen endoscopic image...

7

Examples of inappropriate handing...

8

Chapter 1

Checking the Package Contents...

9

Chapter 2

Instrument Nomenclature and Specifications...

11

2.1

Nomenclature...

11

2.2

Endoscope functions...

16

2.3

Specifications...

18

Preparation and Inspection...

20

3.1

Preparation of the equipment...

21

3.2

Preparation and inspection of the endoscope...

22

3.3

Preparation and inspection of accessories...

24

3.4

Attaching accessories to the endoscope...

25

3.5

Preparation, inspection and connection of ancillary equipment...

26

3.6

Inspection of the endoscopic system...

28

Operation...

30

4.1

Insertion...

31

4.2

Using endo-therapy accessories...

35

4.3

Withdrawal of the endoscope...

39

4.4

Transportation of the endoscope...

40

Reprocessing: General Policy...

41

5.1

Instructions...

41

5.2

Precautions...

42

Chapter 3

Chapter 4

Chapter 5

VISERA CYSTOVIDEOSCOPE CYF-V/CYF-VA

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Contents

Chapter 6

Agents...

45

6.1

Compatibility summary...

45

6.2

Detergent solution...

47

6.3

Disinfectant solution...

47

6.4

Rinsing water...

48

6.5

ETO gas sterilization...

48

6.6

Steam sterilization (autoclaving) of accessories...

50

Chapter 7

Cleaning, Disinfection and Sterilization Procedures ...

52

7.1

Required reprocessing equipment...

52

7.2

Cleaning, disinfection and sterilization procedures...

57

7.3

Precleaning...

59

7.4

Leakage testing...

63

7.5

Manual cleaning...

65

7.6

High-level disinfection...

74

7.7

Rinsing after high-level disinfection...

77

7.8

Sterilization...

81

7.9

Cleaning, disinfection and sterilization procedures for reusable parts and cleaning equipment...

82

Storage and Disposal...

89

8.1

Storage...

89

8.2

Disposal...

89

Troubleshooting...

90

9.1

Troubleshooting guide...

90

9.2

Withdrawal of the endoscope with an abnormality...

93

9.3

Returning the endoscope for repair...

95

Appendix...

96

System chart...

96

EMC information...

99

Chapter 8

Chapter 9

ii

Compatible Reprocessing Methods and Chemical

VISERA CYSTOVIDEOSCOPE CYF-V/CYF-VA

Symbols

Symbols The meaning(s) of the symbol(s) shown on the package and/or this instrument are as follows:

Refer to instructions. Do not reuse. LOT

Lot number TYPE BF applied part Endoscope

VISERA CYSTOVIDEOSCOPE CYF-V/CYF-VA

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, display monitor, endo-therapy accessories, and other ancillary equipment for endoscopic diagnosis and treatment within the bladder and urethra. Do not use the instrument for any purpose other than its intended 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.

User qualifications The operator of this instrument must be a physician or medical personnel under the supervision of a physician and must have received sufficient training in clinical endoscopic technique. This manual, therefore, does not explain or discuss clinical endoscopic procedures.

2

VISERA CYSTOVIDEOSCOPE CYF-V/CYF-VA

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 EMC standard for medical electrical equipment; edition 2 (IEC 60601-1-2: 2001). However, when connected with an instrument that complies with EMC standard for medical electrical equipment; edition 1 (IEC 60601-1-2: 1993), the whole system complies with edition 1.

Reprocessing and storage This instrument was not 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 Chapters 5 through 8. Improper and/or incomplete reprocessing or storage can present an infection control risk, cause equipment damage or reduce performance.

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.

VISERA CYSTOVIDEOSCOPE CYF-V/CYF-VA

3

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.

4

S

Never perform angulation control, suction or insertion/withdrawal of the endoscope’s insertion tube without viewing the endoscopic image. Patient injury can result.

S

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

S

Never use endo-therapy accessories while the image is frozen. Patient injury can result.

S

Do not touch the light guide of the endoscope immediately after removing it from the light source because it is extremely hot. Operator or patient injury can result.

S

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

VISERA CYSTOVIDEOSCOPE CYF-V/CYF-VA

Important Information – Please Read Before Use

S

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 liver tissue and perforation of the intestines by inappropriate using. Observe the following warnings on the illumination. – Always set the minimum required brightness. The brightness of the image on a video monitor may differ from actual brightness at the distal end of endoscope. Especially, operating the electrical shutter function of a video system, pay attention to the brightness level setting of the light source. When a light source and a video system are compatible with the automatic brightness control function, be sure to use the function of the light source. The automatic brightness control function can keep the illumination light properly. Refer to the instruction manual of the light source and the video system for details. – Do not continue observation in proximity to tissue or keep the distal end of the endoscope in contact with a living tissue for a long time. – When discontinuing the use of the endoscope, be sure to turn the light source OFF or activate the light shield function (standby mode etc.) so that the endoscope does not irradiate unnecessary light.

S

If the endoscopic image dims during use, this may be a sign that blood or mucus is adhered to the light guide on the distal end of endoscope. Carefully withdraw the endoscope from patient and remove the blood or mucus in order to obtain optimum illumination and to ensure the safety of examination. If you continue to use the endoscope in such a condition, the distal end temperature may rise and cause mucosa burns. It may also cause patient and/or operator injury.

VISERA CYSTOVIDEOSCOPE CYF-V/CYF-VA

5

Important Information – Please Read Before Use

6

S

Do not pull the universal cord. The light guide connector will be pulled out from the output socket of the light source.

S

Do not pull the video cable. The endoscopic image may not be visible.

S

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

S

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.

S

Do not twist or bend the bending section with your hands. Equipment damage may result.

S

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

S

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

S

The endoscope’s remote switches cannot be removed from the control section. Pressing or pulling them with excessive force can break the switches.

S

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.

VISERA CYSTOVIDEOSCOPE CYF-V/CYF-VA

Important Information – Please Read Before Use

Precaution for disappeared or frozen endoscopic image S

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, bleeding and/or perforation.

S

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 completely. Otherwise, faulty contact can result. – 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 CCD cable can result. – If bubbles emerge from the endoscope continuously during leakage test, do not use the endoscope. Water may enter from the hole and short the internal circuit. This may result in breakage of the switch and CCD.

S

Turn the VISERA 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.

S

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 CYSTOVIDEOSCOPE CYF-V/CYF-VA

7

Important Information – Please Read Before Use

Examples of inappropriate handing 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: S

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

S

Applying prolonged suction with the distal end in contact with the mucosal surface may cause bleeding or suction lesions.

S

Inserting and using endo-therapy accessories without a clear endoscopic view may cause patient injury.

S

Patient injury may be caused by: – inserting or withdrawing the endoscope or applying suction without a clear endoscopic image – forcefully pulling, twisting or rotating the angulated bending section

8

VISERA CYSTOVIDEOSCOPE CYF-V/CYF-VA

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 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

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

Biopsy valve (MAJ-579, 10 pcs)

Instruction manual

Suction valve (for countries other than the USA) (MAJ-207, 10 pcs, CYF-VA only) Single-use suction valve (for USA) (MAJ-209, 20 pcs, CYF-VA only)

Channel-opening cleaning brush (MH-507)

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

VISERA CYSTOVIDEOSCOPE CYF-V/CYF-VA

Suction cleaning adapter (MAJ-1077, CYF-VA only)

Channel cleaning brush (BW-15B)

ETO cap (MB-156)

9

Chapter 1 Checking the Package Contents

10

VISERA CYSTOVIDEOSCOPE CYF-V/CYF-VA

Chapter 2 Instrument Nomenclature and Specifications

Chapter 2 Instrument Nomenclature and Specifications 2.1

Nomenclature

VISERA CYSTOVIDEOSCOPE CYF-V/CYF-VA

11

Chapter 2 Instrument Nomenclature and Specifications

` CYF-VA

ETO cap 9. Light guide connector

Universal cord Venting connector

Light guide

Serial number, NTSC/PAL label

Video cable

12. UP mark

Electrical contacts

12

VISERA CYSTOVIDEOSCOPE CYF-V/CYF-VA

11. Video connector

Chapter 2 Instrument Nomenclature and Specifications

4. Suction valve (MAJ-207)

3. UP/DOWN angulation lock

5. Single-use suction valve (MAJ-209)

MAJ-209

2. UP/DOWN angulation control lever Suction cylinder

Control section 6. Forceps/irrigation plug (Isolated type) (MAJ-891)

7. Instrument channel port

8. Color code 10. Remote switches Boot 4

1

Insertion tube/working length OLYMPUS

2

3

Distal end Suction cylinder 1. Bending section 10. Remote switches

VISERA CYSTOVIDEOSCOPE CYF-V/CYF-VA

13

Chapter 2 Instrument Nomenclature and Specifications

` CYF-V

ETO cap 9. Light guide connector

Universal cord Venting connector

Light guide

Serial number, NTSC/PAL label

Video cable

12. UP mark

Electrical contacts

14

VISERA CYSTOVIDEOSCOPE CYF-V/CYF-VA

11. Video connector

Chapter 2 Instrument Nomenclature and Specifications

3. UP/DOWN angulation lock

2. UP/DOWN angulation control lever

Control section 6. Forceps/irrigation plug (Isolated type) (MAJ-891)

7. Instrument channel port

8. Color code 10. Remote switches Boot Insertion tube/working length

Distal end 10. Remote switches

VISERA CYSTOVIDEOSCOPE CYF-V/CYF-VA

1. Bending section

15

Chapter 2 Instrument Nomenclature and Specifications

2.2

Endoscope functions 1. Bending section The bending section moves the distal end of the endoscope when the UP/DOWN angulation control lever is operated. 2. UP/DOWN angulation control lever When turned in the “U” direction, the bending section moves UP; when turned in the “D” direction, the bending section moves DOWN. 3. UP/DOWN angulation lock Pushing this lever in the “FB” direction frees angulation. Pushing the lever in the opposite direction locks the bending section at any desired position. 4. Suction valve (CYF-VA only) (MAJ-207, for countries other than the USA) The suction valve is depressed to activate suction. The valve is also used to remove any fluid or debris adhering to the objective lens. 5. Single-use suction valve (CYF-VA only) (MAJ-209, for the USA) The suction valve is depressed to activate suction. The valve is also used to remove any fluid or debris adhering to the objective lens. 6. Forceps/irrigation plug (Isolated type) (MAJ-891) Accessories are inserted through the forceps port. Fluid can be fed through the irrigation port. 7. Instrument channel port This channel is used for the insertion of endo-therapy accessories and feeding fluid. 8. Color code The color code is used to quickly determine the compatibility of endo-therapy accessories. The endoscope can be used with endo-therapy accessories that have the same color code. S Blue:

CYF-V, CYF-VA

9. Light guide connector The light guide connector connects the endoscope to the output socket of the light source and transmits light from the light source to the endoscope. 10. Remote switches “1” to “4” The functions of switches “1” to “4” should be selected on the video system center. When selecting functions, refer to the instruction manual for the VISERA video system center.

16

VISERA CYSTOVIDEOSCOPE CYF-V/CYF-VA

Chapter 2 Instrument Nomenclature and Specifications

11. Video connector The video connector connects the endoscope to the socket of the VISERA video system center and makes the endoscopic image visible. 12. UP mark When the video plug is connected to the OTV-S7V, this mark is facing upward.

VISERA CYSTOVIDEOSCOPE CYF-V/CYF-VA

17