EVIS Cystovideoscope CYF-240/A Instructions

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...

6

Examples of inappropriate handing...

7

Chapter 1

Checking the Package Contents...

8

Chapter 2

Instrument Nomenclature and Specifications ...

10

2.1

Nomenclature...

10

2.2

Endoscope functions...

12

2.3

Specifications...

13

Preparation and Inspection ...

16

3.1

Preparation of the equipment...

17

3.2

Preparation and inspection of the endoscope...

18

3.3

Preparation and inspection of accessories ...

20

3.4

Attaching accessories to the endoscope ...

21

3.5

Preparation, inspection and connection of ancillary equipment...

23

3.6

Inspection of the endoscopic system ...

25

Operation ...

28

4.1

Insertion ...

29

4.2

Using endo-therapy accessories...

32

4.3

Withdrawal of the endoscope...

37

4.4

Transportation of the endoscope ...

37

Reprocessing: General Policy...

38

5.1

Instructions...

38

5.2

Precautions ...

39

Chapter 3

Chapter 4

Chapter 5

EVIS CYSTOVIDEOSCOPE CYF-240/CYF-240A

i

Contents

Chapter 6 6.1

Compatibility summary...

42

6.2

Detergent solution ...

44

6.3

Disinfectant solution ...

44

6.4

Rinsing water ...

45

6.5

ETO gas sterilization ...

45

6.6

Steam sterilization (autoclaving) of accessories ...

46

Chapter 7

Cleaning, Disinfection and Sterilization Procedures ... 48

7.1

Required reprocessing equipment ...

48

7.2

Cleaning, disinfection and sterilization procedures ...

53

7.3

Precleaning ...

55

7.4

Leakage testing...

58

7.5

Manual cleaning ...

61

7.6

High-level disinfection ...

69

7.7

Rinsing after high-level disinfection...

72

7.8

Sterilization ...

75

7.9

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

79

Storage and Disposal ...

86

8.1

Storage ...

86

8.2

Disposal ...

86

Troubleshooting ...

87

9.1

Troubleshooting guide ...

87

9.2

Withdrawal of the endoscope with an abnormality...

90

9.3

Returning the endoscope for repair...

91

Appendix...

92

System chart ...

92

EMC information...

96

Chapter 8

Chapter 9

ii

Compatible Reprocessing Methods and Chemical Agents... 42

EVIS CYSTOVIDEOSCOPE CYF-240/CYF-240A

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

EVIS CYSTOVIDEOSCOPE CYF-240/CYF-240A

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

EVIS CYSTOVIDEOSCOPE CYF-240/CYF-240A

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 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 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.

EVIS CYSTOVIDEOSCOPE CYF-240/CYF-240A

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

•

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

•

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

•

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

•

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.

•

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

EVIS CYSTOVIDEOSCOPE CYF-240/CYF-240A

Important Information - Please Read Before Use

•

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 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 cause water leaks.

•

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

•

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.

•

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.

EVIS CYSTOVIDEOSCOPE CYF-240/CYF-240A

5

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, 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 endoscope connector, videoscope cable and video system center completely. Otherwise, faulty contact can result.  Do not bend, hit or twist the insertion section, control section, universal cord and endoscope connector. The endoscope may be damaged and water leaks and/or breakage of internal parts like CCD cable can result.  Before immersing the endoscope, always attach the water-resistant cap. Otherwise, water will enter the endoscope and may cause short of the internal circuit. This may result in breakage of the switch and CCD.  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.

6

•

Turn the video system center OFF before connecting or disconnecting the videoscope cable from the electrical connector on the endoscope. Turn the switch ON or OFF only when the videoscope cable is connected to both the video system center and electrical connector on the endoscope. Failure to do so can result in equipment damage, including destruction of the CCD.

•

Do not touch the electrical contacts inside the electrical connector. CCD damage may result.

•

Do not hit or bend the electrical contacts on the endoscope connector. The connection to the light source may be impaired and faulty contact can result.

EVIS CYSTOVIDEOSCOPE CYF-240/CYF-240A

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. •

Using improperly or incompletely 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 or applying suction without a clear endoscopic image  forcefully pulling, twisting or rotating the angulated bending section

EVIS CYSTOVIDEOSCOPE CYF-240/CYF-240A

7

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 Chapter 5, “Reprocessing: General Policy” through 7, “Cleaning, Disinfection and Sterilization Procedures”.

Endoscope

Channel cleaning brush (BW-15B) Suction valve (MAJ-207, 10 pieces, CYF-240A only) Channel-opening cleaning brush (MH-507)

Water-resistant cap (MH-553)

Forceps/irrigation plug (Isolated type) (MAJ-891/MAJ-668) Instruction manual (Forceps/irrigation plug (Isolated type)) Biopsy valve (MAJ-579, 10 pieces)

8

EVIS CYSTOVIDEOSCOPE CYF-240/CYF-240A

Instruction manual (This manual)

Chapter 1 Checking the Package Contents

EVIS CYSTOVIDEOSCOPE CYF-240/CYF-240A

9

Chapter 2 Instrument Nomenclature and Specifications

Chapter 2 Instrument Nomenclature and Specifications 2.1

Nomenclature

Universal cord

Water-resistant cap (MH-553)

Venting connector

Electrical connector

Serial number Electrical contacts Light guide

10

EVIS CYSTOVIDEOSCOPE CYF-240/CYF-240A

8. Endoscope connector

Chapter 2 Instrument Nomenclature and Specifications

3. UP/DOWN angulation lock

4. Suction valve (MAJ-207) (CYF-240A only)

2. UP/DOWN angulation control lever

Suction cylinder (CYF-240A only)

Control section 5. Forceps/irrigation plug (Isolated type) (MAJ-891/MAJ-668)

6. Instrument channel port

7. Color code Boot Insertion tube/working length

9. Remote switches

Suction cylinder (CYF-240A only)

Distal end

9. Remote switches

1. Bending section

EVIS CYSTOVIDEOSCOPE CYF-240/CYF-240A

11

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 angulation. Pushing the lever in the opposite direction locks the bending section at any desired position. 4. Suction valve (CYF-240A only) The suction valve is depressed to activate suction. The valve is also used to remove any fluid or debris adhering to the objective lens.

Use of the suction valve (MAJ-207) is not recommended for more than 6 procedures. 5. Forceps/irrigation plug (Isolated type) (MAJ-891/MAJ-668) Accessories are inserted through the forceps port. Fluid can be fed through the irrigation port. 6. Instrument channel port This channel is used for insertion of endo-therapy accessories and feeding fluid. 7. 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.) • Blue:

CYF-240, CYF-240A

8. Endoscope connector The endoscope connector connects the endoscope to the output socket of the light source and transmits light from the light source to the endoscope. 9. 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 EVIS video system center.

12

EVIS CYSTOVIDEOSCOPE CYF-240/CYF-240A

Chapter 2 Instrument Nomenclature and Specifications

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)

Transportation Ambient temperature 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)

EVIS CYSTOVIDEOSCOPE CYF-240/CYF-240A

13

Chapter 2 Instrument Nomenclature and Specifications

Specifications  CYF-240/240A Optical system

Insertion tube

120

Field of view

0 (Forward viewing)

Direction of view Depth of field

3 – 50 mm

Distal end size

15.4 Fr

Distal end enlarged

1. Objective lens 2. Light guide lens 3. Instrument channel outlet 3.

2.

Flexible tube outer diameter

Instrument channel

UP

2.

1. DOWN

15.9 Fr (ø 5.3 mm)

Working length

380 mm

Channel inner diameter

6 Fr (ø 2.0 mm)

Minimum visible distance

1 mm

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

Angulation range

Total length Rated high-frequency voltage for electrosurgical instruments

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EVIS CYSTOVIDEOSCOPE CYF-240/CYF-240A

UP 210, DOWN 120 650 mm CUT: 880 Vp COAG: 1790 Vp

Chapter 2 Instrument Nomenclature and Specifications

Medical Devices Directive

EMC

This device complies with the requirements of Directive 93/42/EEC concerning medical devices. Classification: Class II a Applied standard; IEC 60601-1-2: 2001 IEC 60601-1-2: 2007

This instrument complies with the standards listed in the left column.

IEC 60601-1-2: 20141 IEC 60601-2-18: 1996 IEC 60601-2-18: 2009

CISPR 11 of emission: Group 1, Class B 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.

Year of manufacture

2012345 The last digit of the year of manufacture is given in the second digit of the serial number.

Degree of protection against electric shock

TYPE BF applied part

1 For except CYF-240

EVIS CYSTOVIDEOSCOPE CYF-240/CYF-240A

15

Chapter 3 Preparation and Inspection

Chapter 3 Preparation and Inspection

16

•

Before each case, prepare and inspect this instrument as instructed below. Inspect other equipment 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 given in Chapter 5, “Reprocessing: General Policy” through Chapter 7, “Cleaning, Disinfection and Sterilization Procedures”.

EVIS CYSTOVIDEOSCOPE CYF-240/CYF-240A

Chapter 3 Preparation and Inspection

3.1

Preparation of the equipment Prepare the equipment shown in Figure 3.1 (for compatibility, see “System chart” in the Appendix) and personal protective equipment, such as eye wear, face mask, moisture-resistant clothing and chemical-resistant gloves, before each use. Refer to their respective instruction manuals for each piece of equipment.

Forceps/irrigation plug (Isolated type)

Suction valve (CYF-240A only)

Endo-therapy accessories

Endoscope

Videoscope cable

Suction pump

• Paper towels

Light source

• Trays

Display monitor

• Lint-free cloths

Video system center

• Personal protective equipment

Figure 3.1

EVIS CYSTOVIDEOSCOPE CYF-240/CYF-240A

17