CYF-4 OES CYSTOFIBERSCOPE Instructions April 2005

Contents

Contents Symbols...

1

Important Information - Please Read Before Use...

2

Intended Use ...

2

Instruction Manual ...

2

User Qualifications ...

2

Instrument Compatibility ...

2

Reprocessing and Storage...

3

Repair and Modification ...

3

Signal Words ...

3

Warnings and Cautions...

4

Chapter 1

Checking the Package Contents...

7

Checking the Package Contents...

7

Instrument Nomenclature and Specifications ...

8

2.1

Nomenclature...

8

2.2

Endoscope Functions ...

12

2.3

Specifications...

13

Preparation and Inspection ...

15

3.1

Preparation of the Equipment ...

15

3.2

Preparation and Inspection of the Endoscope ...

16

3.3

Preparation and Inspection of the Accessories...

19

3.4

Attaching Accessories to the Endoscope...

20

3.5

Preparation, Inspection and Connection of the Ancillary Equipment

22

3.6

Inspection of the Endoscopic System ...

23

Operation ...

25

4.1

Insertion ...

26

4.2

Using Endo-Therapy Accessories...

30

4.3

Withdrawal of the Endoscope ...

33

4.4

Transportation of the Endoscope...

34

Reprocessing: General Policy...

35

5.1

Instructions...

35

5.2

Precautions ...

35

1.1

Chapter 2

Chapter 3

Chapter 4

Chapter 5

OES CYSTOFIBERSCOPE CYF-4/CYF-4A

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Contents

Chapter 6

Compatible Reprocessing Methods and Chemical Agents ...

39

6.1

Compatibility Summary ...

39

6.2

Detergent Solution ...

41

6.3

Disinfectant Solution ...

41

6.4

Rinsing Water ...

42

6.5

ETO Gas Sterilization...

42

6.6

Steam Sterilization (Autoclaving) of Accessories...

43

Cleaning, Disinfection and Sterilization Procedures ...

45

7.1

Required Reprocessing Equipment ...

45

7.2

Cleaning, Disinfection and Sterilization Procedures ...

50

7.3

Precleaning ...

51

7.4

Leakage Testing ...

53

7.5

Manual Cleaning ...

56

7.6

High Level Disinfection...

63

7.7

Rinsing After High Level Disinfection ...

65

7.8

Sterilization ...

68

7.9

Cleaning, Disinfection and Sterilization Procedures for Reusable Parts and Cleaning Equipment ...

68

Storage ...

73

Storage ...

73

Troubleshooting ...

74

9.1

Troubleshooting Guide...

74

9.2

Returning the Endoscope for Repair...

76

Appendix...

77

System Chart ...

77

Chapter 7

Chapter 8 8.1

Chapter 9

ii

OES CYSTOFIBERSCOPE CYF-4/CYF-4A

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.

Do not reuse.

Lot number.

Type BF applied part

Endoscope

Manufacturer

Authorized representative in the European Community

OES CYSTOFIBERSCOPE CYF-4/CYF-4A

1

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, display monitor, Endo-Therapy Accessories and other ancillary equipment for endoscopic diagnosis and treatment within the bladder and urethra. Do not use these instruments for any purpose other than their intended use.

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 these 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 these instruments 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.

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 or equipment damage.

2

OES CYSTOFIBERSCOPE CYF-4/CYF-4A

Important Information - Please Read Before Use

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 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 in Chapters 5 through Chapter 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.

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.

OES CYSTOFIBERSCOPE CYF-4/CYF-4A

3

Important Information - Please Read Before Use

Warnings and Cautions Follow the warnings and cautions described below when handling this instrument. This information is supplemented by the warnings and cautions described 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 can result.

•

Never insert or withdraw the endoscope’s Insertion Tube while the UP/DOWN angulation is locked. Patient injury or equipment damage can result.

•

Do not touch the metal plug of the Light Guide Connector immediately after removing it from the Light Source because it is extremely hot.

•

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.

4

OES CYSTOFIBERSCOPE CYF-4/CYF-4A

Important Information - Please Read Before Use

− 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. •

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.

•

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

•

Do not pull the Universal Cord. The Endoscope Connector will be pulled out from the output socket of the Light Source and the endoscopic image will not be visible.

•

Do not coil the Insertion Tube or Universal Cord into a diameter of less than 10 cm. Equipment damage can result.

•

Do not hit to the Distal End of the Insertion Tube or allow it to strike other objects. The objective lens surface of 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.

OES CYSTOFIBERSCOPE CYF-4/CYF-4A

5

Important Information - Please Read Before Use

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 infection.

•

Applying prolonged suction with the Distal End in contact with the mucosal surface may cause bleeding or suction lesions.

•

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.

OES CYSTOFIBERSCOPE CYF-4/CYF-4A

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”.

Endoscope

Channel Cleaning Brush (BW-15B)

Channel-opening Cleaning Brush (MH-507)

Suction Valve (MAJ-207 for CYF-4A, 10 pieces)

ETO Cap (MB-156) Forceps/Irrigation Plug (Isolated Type) (MAJ-891, MAJ-668)

Biopsy Valve (MAJ-579, 10 pieces)

Instruction Manual (Forceps/Irrigation Plug)

OES CYSTOFIBERSCOPE CYF-4/CYF-4A

Instruction Manual (This Manual)

7

Chapter 2 Instrument Nomenclature and Specifications

Chapter 2 Instrument Nomenclature and Specifications 2.1

Nomenclature CYF-4

Universal Cord

8. Forceps/Irrigation Plug 1. Eyepiece Frame (Viewfinder)

4. UP/DOWN Angulation Lock 2. Diopter Adjustment Ring

7. Instrument Channel Port 6. Color Code

3. UP/DOWN Angulation Control Lever Boot Eyepiece Section

8

Control Section

OES CYSTOFIBERSCOPE CYF-4/CYF-4A

Chapter 2 Instrument Nomenclature and Specifications

10. Venting Connector 12. ETO Cap Serial Number

9. Light Guide Connector Distal End

Instrument Channel 11. Bending Section Objective Lens Insertion Tube (Working Length)

Metal Part

Light Guide Lens

Distal End (Enlarged)

OES CYSTOFIBERSCOPE CYF-4/CYF-4A

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Chapter 2 Instrument Nomenclature and Specifications

CYF-4A

5. Suction Valve (MAJ-207)

Universal Cord

8. Forceps/Irrigation Plug 1. Eyepiece Frame (Viewfinder) 2. Diopter Adjustment Ring

7. Instrument Channel Port

Suction Cylinder

6. Color Code

4. UP/DOWN Angulation Lock 3. UP/DOWN Angulation Control Lever Eyepiece Section Control Section

10

OES CYSTOFIBERSCOPE CYF-4/CYF-4A

Boot

Chapter 2 Instrument Nomenclature and Specifications

10. Venting Connector 12. ETO Cap Serial Number

9. Light Guide Connector Distal End

Instrument Channel 11. Bending Section Objective Lens Insertion Tube (Working Length)

Metal Part

Light Guide Lens

Distal End (Enlarged)

OES CYSTOFIBERSCOPE CYF-4/CYF-4A

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Chapter 2 Instrument Nomenclature and Specifications

2.2

Endoscope Functions 1. Eyepiece Frame (Viewfinder) The viewfinder mask is seen with an index mark indicating the UP direction of the Bending Section. 2. Diopter Adjustment Ring Turn the ring to adjust focus to the operator’s diopter. For photography, set the ring to the click stop position before mounting the camera. 3. 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. 4. UP/DOWN Angulation Lock Pushing this lever in the “F ” direction frees angulation. Pushing the lever in the opposite direction locks the Bending Section at any desired position. 5. Suction Valve (CYF-4A only) Depress the valve to activate suction. Used to remove fluid and debris that obstructs the visual field.

A Suction Valve (MAJ-207) should not be used in more than six (6) procedures. 6. Color Code 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.) 7. Instrument Channel Port Functions as: Channel for insertion of Endo-Therapy Accessories: Irrigation channel. 8. Forceps/Irrigation Plug Accessories are inserted through the Forceps Port. Fluid can be fed through the Irrigation Port. 9. Light Guide Connector Connects to the Light Source. Transfers light from the Light Source to the operative site. 10. Venting Connector Accepts ETO Cap or Leakage Tester.

12

OES CYSTOFIBERSCOPE CYF-4/CYF-4A

Chapter 2 Instrument Nomenclature and Specifications

11. Bending Section Moves the Distal End of the endoscope by operating the UP/DOWN Angulation Control Lever. 12. ETO Cap The ETO Cap must be installed prior to ETO gas sterilization and aeration and removed prior to immersion or clinical examination. The cap must also be attached when the endoscope is transported outside the hospital (shipment, return for repairs, etc.).

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)

Transportation and storage environment

Ambient temperature

–47 to 70°C (–52.6 to 158°F)

Relative humidity

10 – 95%

Atmospheric pressure

700 – 1060 hPa (0.7 – 1.1 kgf/cm2) (10.2 – 15.4 psia)

OES CYSTOFIBERSCOPE CYF-4/CYF-4A

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Chapter 2 Instrument Nomenclature and Specifications

Specifications  Endoscope Optical System

Field of View

120°

Direction of View

0° (Forward Viewing)

Depth of Field

3 – 50 mm

Insertion

Distal End Outer Diameter

14.4 Fr (ø 4.8 mm)

Portion

Insertion Tube Outer Diameter

15.6 Fr (ø 5.2 mm)

Working Length

380 mm

Instrument

Inner Channel Diameter

Channel

7.2 Fr (ø 2.4 mm)

Compatible Olympus Endo-Therapy Accessories

Endo-Therapy Accessories for ø 2.2 mm (6.6 Fr) Channel

Minimum Visible Distance

1 mm

Direction from which Endo-Therapy Accessories enter and exit the endoscopic image

Bending Section

Angulation Range

Total Length

UP 210°, DOWN 120° 680 mm

Rated High-frequency Voltage for Electrosurgical Instruments

CUT: 880 Vp COAG: 1790 Vp

Medical Device

This device complies with the

Directive

requirements of Directive 93/42/EEC concerning medical devices. Classification: Class II a

Year of manufacture

2912345 The last digit of the year of manufacture is given in the second digit of the serial number.

Degree of protection against electric shock

14

OES CYSTOFIBERSCOPE CYF-4/CYF-4A

TYPE BF applied part

Chapter 3 Preparation and Inspection

Chapter 3 Preparation and Inspection

3.1

•

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 9, “Troubleshooting”. If the irregularity is still suspected after consulting Chapter 9, 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”.

Preparation of the Equipment According to the “System Chart” in the Appendix, prepare this instrument, ancillary equipment, 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 manual for each piece of equipment.

OES CYSTOFIBERSCOPE CYF-4/CYF-4A

15

Chapter 3 Preparation and Inspection

Endo-Therapy Accessories

Suction Valve (CYF-4A only)

Light Source

Endoscope

Suction Pump (CYF-4A only) Forceps/Irrigation Plug (Isolated Type)

Figure 3.1

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”.

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 surface of the Insertion Tube for dents, bulges, swelling, peeling or other irregularities.

4. Carefully run your fingertips over the entire length of the Insertion Tube. Inspect for any protruding objects or other irregularities (see Figure 3.2).

16

OES CYSTOFIBERSCOPE CYF-4/CYF-4A

Chapter 3 Preparation and Inspection

Figure 3.2

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

6. Loosely hold the midpoint of the Bending Section and a point 10 cm from the Distal End. Push and pull gently to confirm that there is no play.

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.

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 of defects, such as scratches or deformations.

When cleaning or wiping the eyepiece lens surface, the cover glass of the Light Guide Plug, and the Objective/the Light Guide Lens at the Distal End of the endoscope, do not use abrasive cleansers because they may scratch the lens surface.

9. Wipe the eyepiece lens surface, the cover glass of the Light Guide Plug, and the Objective/the Light Guide Lens at the Distal End of the endoscope using a clean, lint-free cloth moistened with 70% ethyl or isopropyl alcohol.

OES CYSTOFIBERSCOPE CYF-4/CYF-4A

17