CF-240DL EVIS COLONOVIDEOSCOPE Operation Manual Feb 2007

Contents

Contents Symbols...

1

Important Information - Please Read Before Use...

2

Intended use ...

2

Applicability of endoscopy and endoscopic treatment ...

2

Instruction manual...

3

User qualifications ...

3

Instrument compatibility ...

3

Reprocessing and storage ...

4

Spare equipment ...

4

Repair and modification ...

4

Signal words ...

4

Warnings and cautions ...

5

Chapter 1

Checking the Package Contents...

8

Chapter 2

Instrument Nomenclature and Specifications ...

10

2.1

Nomenclature...

10

2.2

Endoscope functions...

16

2.3

Specifications...

18

Preparation and Inspection ...

25

3.1

Preparation of the equipment...

26

3.2

Preparation and inspection of the endoscope...

27

3.3

Preparation and inspection of accessories ...

31

3.4

Attaching accessories to the endoscope ...

33

3.5

Preparation, inspection and connection of ancillary equipment...

35

3.6

Inspection of the endoscopic system ...

39

Operation ...

43

4.1

Insertion ...

46

4.2

Using endo-therapy accessories...

52

4.3

Withdrawal of the endoscope...

57

4.4

Transportation of the endoscope ...

58

Troubleshooting ...

59

5.1

Troubleshooting guide ...

60

5.2

Returning the endoscope for repair ...

63

Chapter 3

Chapter 4

Chapter 5

EVIS CF/PCF TYPE 240 Series OPERATION MANUAL

i

Contents

ii

Appendix...

65

System chart ...

65

EMC information...

75

EVIS CF/PCF TYPE 240 Series OPERATION MANUAL

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.

Endoscope

TYPE BF applied part

Manufacturer

Authorized representative in the European Community

EVIS CF/PCF TYPE 240 Series OPERATION MANUAL

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 video system center, light source, documentation equipment, video monitor, endo-therapy accessories such as a biopsy forceps and other ancillary equipment. Use the EVIS COLONOVIDEOSCOPE CF-240AL/I, CF-Q240AL/I, CF-Q240ZL/I, CF-240DL/I, PCF-P240AL/I for endoscopy and endoscopic surgery within the lower digestive tract (including the anus, rectum, sigmoid colon, colon and ileocecal valve). Do not use these instruments for any purpose other than their intended uses.

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 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.

2

EVIS CF/PCF TYPE 240 Series OPERATION MANUAL

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 which will be used during the procedure and use the equipment as instructed. Note that the complete instruction manual set for this endoscope consists of this manual and the “REPROCESSING MANUAL” whose cover lists the model of your endoscope. It also accompanied the endoscope at shipment. 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.

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.

EVIS CF/PCF TYPE 240 Series OPERATION MANUAL

3

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 given in the endoscope’s companion manual, the “REPROCESSING MANUAL” whose cover lists the model of your endoscope. After using this instrument, reprocess and store it according to the instructions given in the endoscope’s companion reprocessing manual. 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.

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 5, “Troubleshooting”. If the problem cannot be resolved using the information in Chapter 5, 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.

4

EVIS CF/PCF TYPE 240 Series OPERATION MANUAL

Important Information - Please Read Before Use

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.

•

Never insert or withdraw the endoscope’s insertion tube while the bending section is locked in position. Patient injury can result.

•

Do not strike, bend, hit, pull, twist, or drop the endoscope’s distal end, insertion tube, bending section, control section, universal cord, or endoscope connector of the endoscope with excessive force. The endoscope may be damaged and could cause patient injury, burns, bleeding and/or perforations. 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 flexibility adjustment, perform angulation control, feed air or perform suction, insert or withdraw the endoscope’s insertion tube without viewing the endoscopic image. Patient injury can result.

•

Never perform flexibility adjustment, operate the bending section, feed air or perform suction, insert or withdraw the endoscope’s insertion tube while the image is frozen. Patient injury can result.

•

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

•

Regardless of the flexibility of the endoscope’s insertion tube, never insert or withdraw the insertion tube with excessive force if an optimum field of view cannot be obtained. Otherwise, patient injury could result.

EVIS CF/PCF TYPE 240 Series OPERATION MANUAL

5

Important Information - Please Read Before Use

6

•

Do not pull on 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 pull on the UPD cable. The endoscope connector will be pull out from the output socket of the light source and the endoscopic image will not be visible or UPD cable will pull out from the UPD scope connector and the scope model will not be visible (for CF-240DL/I only).

•

Do not coil the insertion tube or universal cord into a diameter of less than 12 cm. Equipment damage can result.

•

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.

•

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.

•

Turn the EVIS video system center OFF before connecting or disconnecting the videoscope cable from the electrical connector on the endoscope. Turn the EVIS video system center 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.

•

Turn the endoscope position detecting unit (UPD) OFF before connecting or disconnecting the UPD cable from the UPD scope connector on the endoscope. Turn the UPD ON or OFF only when the UPD cable is connected to the UPD scope connector on the endoscope. Failure to do so can result in the UPD damage (for CF-240DL/I only).

•

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

EVIS CF/PCF TYPE 240 Series OPERATION MANUAL

Important Information - Please Read Before Use

•

If remote switch 1 does not return to the OFF position after being pressed strongly from the side, gently pull the switch upward to return it to the OFF position.

•

Do not attempt to bend the endoscope’s insertion tube with excessive force. Otherwise, the insertion tube may be damaged.

•

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.

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. •

Over-insufflating the lumen may cause patient pain and/or perforation.

•

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 image may cause patient injury.

•

Patient injury may be caused by:  inserting or withdrawing the endoscope, feeding air or applying suction without a clear endoscopic image  withdrawing the endoscope with the angulation controls locked  forcefully pulling, twisting or rotating the angulated bending section

EVIS CF/PCF TYPE 240 Series OPERATION MANUAL

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 the endoscope’s companion manual, the “REPROCESSING MANUAL” whose cover lists the model of your endoscope.

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EVIS CF/PCF TYPE 240 Series OPERATION MANUAL

Chapter 1 Checking the Package Contents

Endoscope

Air/water valve (MH-438, 2 pcs)

Biopsy valve (MB-358, 10 pcs)

Suction valve (MH-443, 2 pcs)

Channel-opening cleaning brush (MH-507)

Water-resistant cap (MH-553)

AW channel cleaning adapter (MH-948)

Suction cleaning adapter (MH-856) Channel cleaning brush (BW-20T) Injection tube (MH-946)

Instruction manual (Reprocessing)

Instructions (Leaflet type, for endoscopes with flexibility adjustment only)

EVIS CF/PCF TYPE 240 Series OPERATION MANUAL

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Channel plug (MH-944)

Instruction manual (Operation)

Chapter 2 Instrument Nomenclature and Specifications

Chapter 2 Instrument Nomenclature and Specifications 2.1

Nomenclature  CF-240AL/I, Q240AL/I, PCF-P240AL/I only

Universal cord

5. Electrical connector

1. Suction connector

2. S-cord connector mount

Air pipe

3. Air supply connector 3. Water supply connector Light guide Product number and serial number Electrical contacts 4. Endoscope connector

10

EVIS CF/PCF TYPE 240 Series OPERATION MANUAL

Chapter 2 Instrument Nomenclature and Specifications

8. Suction valve (MH-443)

9. Air/water valve (MH-438)

7. UP/DOWN angulation lock

6. UP/DOWN angulation control knob

16. RIGHT/LEFT angulation control knob Suction cylinder

Control section

15. RIGHT/LEFT angulation lock Air/water cylinder Grip section 14. Color code

Mark

Biopsy valve (MB-358)

17. Flexibility adjustment ring 10. Instrument channel port Mark Boot 11. Insertion tube limit mark Working length Insertion tube

13. Remote switches

Distal end

12. Bending section Top view

EVIS CF/PCF TYPE 240 Series OPERATION MANUAL

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Chapter 2 Instrument Nomenclature and Specifications

 CF-Q240Z/L only

Mark 23. Seal ring

Front view of the zoom connector

Universal cord 1. Suction connector 5. Electrical connector

2. S-cord connector mount 19. Zoom connector

Air pipe 20. Water-resistant cap (MAJ-583)

3. Air supply connector Light guide

3. Water supply connector

Electrical contacts Product name and serial number 4. Endoscope connector

12

EVIS CF/PCF TYPE 240 Series OPERATION MANUAL

Chapter 2 Instrument Nomenclature and Specifications

8. Suction valve (MH-443)

9. Air/water valve (MH-438)

7. UP/DOWN angulation lock 6. UP/DOWN angulation control knob 18. Zoom lever

16. RIGHT/LEFT angulation control knob 15. RIGHT/LEFT angulation lock

Control section

Suction cylinder

Grip section

Air/water cylinder

14. Color code Biopsy valve (MB-358) 10. Instrument channel port

Boot 11. Insertion tube limit mark Working length

Insertion tube

Distal end Top view

13. Remote switches

EVIS CF/PCF TYPE 240 Series OPERATION MANUAL

12. Bending section

13

Chapter 2 Instrument Nomenclature and Specifications

 CF-240DL/I only

Mark 24. Seal ring

Front view of the UPD scope connector

Universal cord 1. Suction connector 5. Electrical connector

2. S-cord connector mount 21. UPD scope connector

Air pipe 22. Water-resistant cap (MAJ-942)

3. Air supply connector Light guide 3. Water supply connector Electrical contacts Product name and serial number 4. Endoscope connector

14

EVIS CF/PCF TYPE 240 Series OPERATION MANUAL

Chapter 2 Instrument Nomenclature and Specifications

8. Suction valve (MH-443)

7. UP/DOWN angulation lock

9. Air/water valve (MH-438)

6. UP/DOWN angulation control knob

16. RIGHT/LEFT angulation control knob Suction cylinder

Control section

15. RIGHT/LEFT angulation lock Air/water cylinder Grip section 14. Color code

Mark

Biopsy valve (MB-358)

17. Flexibility adjustment ring 10. Instrument channel port Mark Boot 11. Insertion tube limit mark Working length Insertion tube

13. Remote switches

Distal end 12. Bending section Top view

EVIS CF/PCF TYPE 240 Series OPERATION MANUAL

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Chapter 2 Instrument Nomenclature and Specifications

2.2

Endoscope functions 1. Suction connector The suction connector connects the endoscope to the suction tube of the suction pump. 2. S-cord connector mount The S-cord connector mount connects the endoscope with the Olympus electrosurgical unit via the S-cord. The S-cord conducts leakage current from the endoscope to the electrosurgical unit. To connect the S-cord, refer to the instruction manual for the electrosurgical unit. 3. Water supply connector and air supply connector The water supply connector and the air supply connector connect the endoscope to the water container via the water container tube, to supply water and pressurized air to the distal end of the endoscope. 4. 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. 5. Electrical connector The electrical connector connects the endoscope to the EVIS video system center via the videoscope cable. 6. UP/DOWN angulation control knob When the knob is turned in the “ U” direction, the bending section moves UP; when the knob is turned in the “D ” direction, the bending section moves DOWN. 7. UP/DOWN angulation lock Moving the lock in the “F ” direction frees angulation. Moving the lock in the opposite direction locks the bending section at any desired position. 8. Suction valve The suction valve is depressed to activate suction. The valve is also used to remove any fluid or debris adhering to the objective lens. 9. Air/water valve The hole in the air/water valve is covered to insufflate air and the valve is depressed to feed water for lens washing. It also can be used to feed air to remove any fluid or debris adhering to the objective lens. 10. Instrument channel port The instrument channel port functions as:  channel for the insertion of endo-therapy accessories  suction channel  fluid feed channel (from a syringe via the biopsy valve)

16

EVIS CF/PCF TYPE 240 Series OPERATION MANUAL

Chapter 2 Instrument Nomenclature and Specifications

11. Insertion tube limit mark The insertion tube limit mark shows the maximum point to which the endoscope may be inserted into the patient’s body. 12. Bending section The bending section moves the distal end of the endoscope when the UP/DOWN and RIGHT/LEFT angulation control knobs are operated. 13. Remote switches 1 to 4 The functions of remote switches 1 to 4 can be selected on the EVIS video system center. When selecting the functions, refer to the instruction manual for the EVIS video system center. 14. 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. • Yellow:

CF-240AL/I, CF-240DL/I, CF-Q240ZL/I, PCF-P240AL/I

• Orange:

CF-Q240AL/I

15. RIGHT/LEFT angulation lock Turning the lock in the “F ” direction frees angulation. Turning the lock in the opposite direction locks the bending section at any desired position. 16. RIGHT/LEFT angulation control knob When the knob is turned in the “R ” direction, the bending section moves RIGHT; when the knob is turned in the “ L” direction, the bending section moves LEFT. 17. Flexibility adjustment ring (for CF-240AL/I, CF-Q240AL/I, CF-240DL/I and PCF-P240AL/I only) Turn the ring to adjust the flexibility of the insertion tube. When the “” mark on the ring is aligned with the “ ” mark at the bottom of the grip section, the insertion tube has softest condition. To decrease the flexibility, turn the ring so that the numbers are aligned with the “ ” mark (“3” corresponds to the hardest condition). Between “” and “3”, insertion tube flexibility can be changed gradually regardless of the positions of other index markings (“1” and “2”). 18. Zoom lever (for CF-Q240ZL/I only) Moving the lever toward “ T” magnifies the monitor image (close-up observation). Moving the lever toward “W ” reduces the monitor image (wide-angle observation). 19. Zoom connector (for CF-Q240ZL/I only) The zoom connector connects the endoscope to the magnification controller via the magnification control cable.

EVIS CF/PCF TYPE 240 Series OPERATION MANUAL

17