CYF-5 OES CYSTONEPHROFIBERSCOPE Instructions July 2019

Contents

Contents Symbols...

1

Important Information - Please Read Before Use...

2

Intended use ...

2

Applicability of endoscopy and endoscopic treatment ...

2

Instruction manual ...

2

User qualifications...

3

Instrument compatibility ...

3

Reprocessing before the first use/reprocessing and storage after use ...

3

Spare equipment ...

3

Maintenance management...

4

Prohibition of improper repair and modification ...

4

Signal words ...

4

Warnings and cautions...

5

Examples of inappropriate handling ...

7

Chapter 1

Checking the Package Contents...

8

Checking the package contents...

8

Instrument Nomenclature and Specifications ...

9

2.1

Nomenclature...

9

2.2

Endoscope functions...

11

2.3

Specifications...

12

Preparation and Inspection ...

14

3.1

Preparation of the equipment...

15

3.2

Preparation and inspection of the endoscope...

16

3.3

Preparation and inspection of the accessories ...

18

3.4

Attaching accessories to the endoscope ...

19

3.5

Attaching the light source to the endoscope ...

21

3.6

Preparation, inspection and connection of ancillary equipment...

26

3.7

Inspection of the endoscopic system ...

27

Operation ...

29

4.1

Insertion ...

30

4.2

Using endo-therapy accessories...

35

4.3

Withdrawal of the endoscope...

39

Reprocessing: General Policy...

40

5.1

Notes for cleaning, disinfection and sterilization ...

40

5.2

Precautions ...

41

1.1

Chapter 2

Chapter 3

Chapter 4

Chapter 5

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Contents

Chapter 6

Recommended Reprocessing Methods and Chemical Agents...

44

6.1

Compatibility summary...

44

6.2

Detergent solution ...

49

6.3

Ultrasonic cleaning...

50

6.4

Disinfectant solution ...

51

6.5

Rinsing water ...

52

6.6

Automatic cleaning/disinfection...

52

6.7

Ethylene oxide gas sterilization...

53

6.8

Steam sterilization (autoclaving) of accessories ...

55

Chapter 7

Cleaning, Disinfection and Sterilization Procedures for Endoscopic Instruments ... 58

7.1

Required reprocessing equipment ...

59

7.2

Cleaning, disinfection and sterilization procedures ...

65

7.3

Precleaning ...

66

7.4

Transportation of the endoscope ...

71

7.5

Leakage testing...

72

7.6

Manual cleaning ...

77

7.7

Disinfection ...

88

7.8

Rinsing and drying after disinfection ...

91

7.9

Automatic cleaning/disinfection...

96

7.10 Sterilization ...

97

Chapter 8 Chapter 9

Maintenance Procedures of Equipments for Reprocessing ...

99

Storage, Transporting Outside the Hospital and Disposal... 100

9.1

Storage ...

100

9.2

Transporting outside the hospital ...

101

9.3

Disposal ...

101

Chapter 10 Troubleshooting ... 102 10.1 Troubleshooting guide ...

103

10.2 Withdrawal of the endoscope with an abnormality...

105

10.3 Returning the endoscope for repair...

106

Appendix... 107 System chart ...

ii

OES CYSTONEPHROFIBERSCOPE CYF-5/CYF-5A

107

Symbols

Symbols The meaning(s) of the symbol(s) shown on the package with the components, the back cover of this instruction manual and/or this instrument are as follows:

Refer to instructions.

Caution

Do not reuse.

Lot number

Type BF applied part

Endoscope

Manufacturer

Authorized representative in the European Community

Serial number

OES CYSTONEPHROFIBERSCOPE CYF-5/CYF-5A

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Important Information - Please Read Before Use

Important Information - Please Read Before Use Intended use These instruments have been designed to be used with an Olympus light source, documentation equipment, video monitor, endo-therapy accessories and other ancillary equipment for endoscopic diagnosis and treatment within the bladder, urethra and kidney. Do not use these instruments for any purpose other than their intended use.

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

Instruction manual This instruction manual contains essential information on using these instruments 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.

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OES CYSTONEPHROFIBERSCOPE CYF-5/CYF-5A

Important Information - Please Read Before Use

User qualifications If there is an official standard of the qualification of endoscopy and endoscopic treatment that is defined by medical administration or other official institutions such as the academic society of 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 internal medicine, 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 safely by following the official guidelines set by the academic society of endoscopy, etc., and considering the difficulty of each type of endoscopy and endoscopic treatment.

Instrument compatibility Refer to the “System chart” in the Appendix to confirm that these instruments are compatible with the ancillary equipment being used. Using incompatible equipment can result in patient injury and/or equipment damage.

Reprocessing before the first use/reprocessing and storage after use These instruments were not cleaned, disinfected or sterilized before shipment. Before using these instruments for the first time, reprocess them according to the instructions in Chapter 5, “Reprocessing: General Policy” through Chapter 8, “Maintenance Procedures of Equipments for Reprocessing”. After using the instrument, reprocess and store it according to the instructions in Chapter 5, through Chapter 9. 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.

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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 which an irregularity is suspected should not be used, but should be inspected by following Section 10.1, “Troubleshooting guide” on page 103. If the irregularity is still suspected after inspection, contact Olympus.

Prohibition of improper repair and modification Never repair by persons other than Olympus-qualified technicians or modify the instrument, as this may result injury of the patient or operator as well as damage to the equipment. These instruments do not contain any user-serviceable parts. Do not disassemble, modify or attempt to repair; 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.

Signal words The following signal words are used throughout this manual:

Indicates an imminently hazardous situation which, if not avoided, will 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.

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OES CYSTONEPHROFIBERSCOPE CYF-5/CYF-5A

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.

•

Never perform angulation control, suction 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.

•

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. Keep in mind that the brightness of the image on a video monitor may differ from the actual brightness at the distal end of the endoscope. Pay close attention to the brightness level setting of the light source, particularly when operating the electrical shutter function of a video system. When using a light source and video system 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 light level. Refer to the instruction manual of the light source and the video system 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.

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Important Information - Please Read Before Use

•

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

•

If the endoscopic image becomes dimmer during the procedure, may indicate that blood or mucus is adhering to the light guide on the distal end of endoscope. Carefully withdraw the endoscope from the patient and remove the blood or mucus in order to restore optimum illumination and to ensure the safety of examination. If you continue to use the endoscope with its light guide obstructed, the temperature at the distal end may rise and cause mucosal burns in the patient. It may also cause operator injury.

•

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

•

Always clean, disinfect or sterilize the endoscope after removing it from the carrying case. If the endoscope is not cleaned, disinfected or sterilized, the patient might be infected.

•

Do not strike the distal end of the insertion tube or allow it to strike other objects. The objective lens surface at the distal end is particularly fragile, and 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 cause water leaks.

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.

6

•

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

•

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

OES CYSTONEPHROFIBERSCOPE CYF-5/CYF-5A

Important Information - Please Read Before Use

•

Inserting and using endo-therapy accessories without a clear endoscopic view may cause burns or perforation.

•

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

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. •

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 endo-therapy accessories without a clear endoscopic image may cause patient injury, bleeding, burns and/or perforation.

•

Inserting or withdrawing the endoscope, applying suction 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.

OES CYSTONEPHROFIBERSCOPE CYF-5/CYF-5A

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Chapter 1 Checking the Package Contents

Chapter 1 Checking the Package Contents 1.1

Checking the package contents Match all items in the package with the components shown below. Inspect each item for damages. 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 in Chapter 5, “Reprocessing: General Policy” through Chapter 7, “Cleaning, Disinfection and Sterilization Procedures for Endoscopic Instruments”.

Endoscope

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

Biopsy valve (MAJ-579) (10 pcs)

Biopsy forceps1 (FB-19SX-1) 1

8

Suction valve (MAJ-207) (10 pcs, CYF-5A only)

Light guide adapter (MAJ-1413)

Grasping forceps1 (FG-53SX-1)

Suction cleaning adapter (MAJ-1077) (CYF-5A only)

ETO cap (MB-156)

Channel cleaning brush (BW-15B)

Channel-opening cleaning brush (MH-507)

Instruction manual

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

OES CYSTONEPHROFIBERSCOPE CYF-5/CYF-5A

Instruction manual (forceps/irrigation plug (isolated type))

Chapter 2 Instrument Nomenclature and Specifications

Chapter 2 Instrument Nomenclature and Specifications 2.1

Nomenclature  CYF-5 3. Eyepiece frame (viewfinder) 4. Diopter adjustment ring

Eyepiece section

13. Identification mark for STERRAD® 200/NX material compatibility 2. UP/DOWN angulation control lever

Serial number 5. Light guide connector

1. UP/DOWN angulation lock Control section

7. Forceps/irrigation plug (MAJ-891) 8. Instrument channel port Boot

Objective lens Instrument channel

9. Color code

10. Venting connector

12. ETO cap (MB-156)

Light guide lenses Distal end (enlarged) Distal end 11. Bending section

OES CYSTONEPHROFIBERSCOPE CYF-5/CYF-5A

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Chapter 2 Instrument Nomenclature and Specifications

 CYF-5A

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

3. Eyepiece frame (viewfinder) Eyepiece section

4. Diopter adjustment ring

Serial number

2. UP/DOWN angulation control lever

5. Light guide connector

1. UP/DOWN angulation lock

Suction cylinder

Control section 6. Suction valve 7. Forceps/irrigation plug (MAJ-891) 8. Instrument channel port

Objective lens Instrument channel

Boot

9. Color code

10. Venting connector

Light guide lenses 12. ETO cap (MB-156)

Distal end (enlarged)

Distal end 11. Bending section

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OES CYSTONEPHROFIBERSCOPE CYF-5/CYF-5A

Chapter 2 Instrument Nomenclature and Specifications

2.2

Endoscope functions 1. UP/DOWN angulation lock Turning this lever in the “F

” direction frees angulation. Turning the lever in

the opposite direction locks the bending section at any desired position. 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. Eyepiece frame (viewfinder) The viewfinder mask has an index mark indicating the UP direction of the bending section. 4. Diopter adjustment ring Turn the ring to adjust the focus. For photography, set the ring to the ‘click stop’ position before mounting the camera. 5. Light guide connector Connects to the light guide cable or miniature light source. Transfers light from the light source to the distal end of the endoscope. 6. Suction valve (CYF-5A only) Depress the valve to activate suction. Used to remove fluid and debris that may obstruct the visual field. 7. Forceps/irrigation plug (MAJ-891) Accessories are inserted through the forceps port. Fluid can be fed through the irrigation port. 8. Instrument channel port Functions as: channel for insertion of endo-therapy accessories; irrigation channel. 9. Color code Indicates the compatibility of endo-therapy accessories. (The endoscope can be used with endo-therapy accessories that have the same color code.) 10. Venting connector Attach the ETO cap or leakage tester here. 11. Bending section Moves the distal end of the endoscope by operating the UP/DOWN angulation control lever. 12. ETO cap ETO cap is equalizing the outer and inner pressure. The ETO cap must be attached prior to gas sterilization (ethylene oxide gas, STERRAD® 50/100 etc.) 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.).

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Chapter 2 Instrument Nomenclature and Specifications

13. 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.

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)

Ambient temperature Transportation 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)

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OES CYSTONEPHROFIBERSCOPE CYF-5/CYF-5A

Chapter 2 Instrument Nomenclature and Specifications

Specifications  Endoscope Model Optical system

CYF-5 120

Field of view

0 (forward viewing)

Direction of view

Insertion portion

CYF-5A

Depth of field

3 mm – 50 mm

Distal end outer diameter

ø 4.6 mm (bullet shape)

Insertion tube outer diameter

ø 5.5 mm (16.5 Fr)

Working length Instrument

Inner channel

channel

diameter Compatible Olympus endo-therapy accessories

380 mm ø 2.4 mm (7.2 Fr) Endo-therapy accessories for ø 2 mm (6 Fr) channel

Minimum visible distance

5 mm

Direction from which endo-therapy accessories enter and exit the endoscopic image Bending section

Angulation range

UP 210, DOWN 120

Total length

700 mm

Degree of protection against electric shock Year of manufacture

TYPE BF applied part

2412345 The last digit of the year of manufacture is the second digit of the serial number.

Medical Devices Directive

This device complies with the requirements of Directive 93/42/EEC concerning medical devices. Classification: Class II a

OES CYSTONEPHROFIBERSCOPE CYF-5/CYF-5A

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Chapter 3 Preparation and Inspection

Chapter 3 Preparation and Inspection

14

•

Before each case, prepare and inspect this instrument as instructed below. Inspect other equipment to be used with this instrument as instructed in their respective instruction manuals. Should the slightest irregularity be suspected, do not use this instrument and see Chapter 10, “Troubleshooting”. If the irregularity is still suspected after consulting Chapter 10, contact Olympus. Damage or irregularity may compromise patient or user safety and may result in more-severe equipment damage.

•

This instrument was not disinfected or sterilized before shipment. Before using this instrument for the first time, reprocess it according to the instructions in Chapter 5, “Reprocessing: General Policy” through Chapter 7, “Cleaning, Disinfection and Sterilization Procedures for Endoscopic Instruments”.

OES CYSTONEPHROFIBERSCOPE CYF-5/CYF-5A

Chapter 3 Preparation and Inspection

3.1

Preparation of the equipment Prepare the instrument, compatible ancillary equipment, (shown in the “System chart” in the Appendix), paper towels, basin, lint-free cloths and personal protective equipment, such as eye wear, a face mask, moisture-resistant clothing and chemical-resistant gloves, for the particular case. Refer to the respective instruction manuals for each piece of equipment.

Endo-therapy accessories

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

Suction valve (MAJ-207) (for CYF-5A only)

Endoscope

Light source

Light guide cable

Light guide adapter

Suction pump (CYF-5A only)

Figure 3.1

OES CYSTONEPHROFIBERSCOPE CYF-5/CYF-5A

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Chapter 3 Preparation and Inspection

3.2

Preparation and inspection of the endoscope Clean and disinfect or sterilize the endoscope as described in Chapter 5, “Reprocessing: General Policy” through Chapter 7, “Cleaning, Disinfection and Sterilization Procedures for Endoscopic Instruments”.

Inspection of the Endoscope 1. Visually inspect the control section and the light guide connector for excessive scratching.

2. Visually inspect the boot and the insertion tube near the boot for bends, twists or other irregularities.

3. Visually inspect the external surface of the entire insertion tube for dents, bulges, swelling, peeling or other irregularities.

4. Holding the insertion tube gently with a hand carefully run your fingertips over the entire length of the insertion tube in both directions (see Figure 3.2). Confirm that there is no object stopping the hand or protruding objects or other irregularities.

Figure 3.2

5. Visually inspect the covering of the bending section for sagging, swelling, cuts, holes or other irregularities.

6. Gently hold the midpoint of the bending section and a point 10 cm from the distal end of the endoscope’s insertion tube for scratching, cracks, stains or other irregularities.

7. Inspect the objective lens at the distal end of the endoscope’s insertion tube for scratching, cracks, stains, gaps around the lens or other irregularities.

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OES CYSTONEPHROFIBERSCOPE CYF-5/CYF-5A

Chapter 3 Preparation and Inspection

8. Confirm that the diopter adjustment ring turns smoothly and that the eyepiece section is attached securely to the control section. Confirm that the eyepiece is free from defects, such as scratches or deformations.

When cleaning or wiping the eyepiece lens surface, the cover glass of the light guide, and the objective/light guide lens at the distal end of the endoscope, do not use abrasive cleansers because they may scratch the glass surfaces.

9. Wipe the eyepiece lens surface, the cover glass of the light guide, and the objective/light guide lens at the distal end of the endoscope using a clean, lint-free cloth moistened with 70% ethyl alcohol.

Inspection of the bending mechanism Perform the following inspection while the bending section is straight.

If the movement of UP/DOWN angulation lock and angulation control lever are not smooth, the bending mechanism may be abnormal. In this case, do not use the endoscope because it may be impossible to straighten the bending section in the middle of examination.

 Inspection for smooth operation

1. Confirm that the UP/DOWN angulation lock is placed in the free “F

”

position.

2. Turn the UP/DOWN angulation control lever slowly in each direction until it stops. Confirm that the bending section angulates smoothly and correctly and that maximum deflection can be achieved.

3. Turn the UP/DOWN angulation control lever slowly to its straight (neutral) position. Confirm that the bending section returns smoothly to an approximately straight condition.

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