TJF TYPE 260VR EVIS LUCERA DUODENOVIDEOSCOPE Operation Manual Dec 2006

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

4

Spare equipment ...

4

Repair and modification ...

4

Signal words ...

4

Warnings and cautions...

5

Examples of inappropriate handling ...

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...

14

Preparation and Inspection ...

17

3.1

Preparation of the equipment...

18

3.2

Inspection of the endoscope ...

19

3.3

Preparation and inspection of accessories ...

23

3.4

Attaching accessories to the endoscope ...

28

3.5

Inspection and connection of ancillary equipment ...

37

3.6

Inspection of the endoscopic system ...

39

Operation ...

44

4.1

Insertion ...

46

4.2

Using endo-therapy accessories...

52

4.3

Withdrawal of the endoscope...

61

4.4

Transportation of the endoscope ...

62

Chapter 3

Chapter 4

EVIS EXERA TJF TYPE 160VR OPERATION MANUAL

i

Contents

Chapter 5

ii

Troubleshooting ...

63

5.1

Troubleshooting guide ...

63

5.2

Withdrawal of the endoscope with an abnormality...

67

5.3

Returning the endoscope for repair...

69

Appendix...

71

System chart ...

71

EMC information...

80

EVIS EXERA TJF TYPE 160VR 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 EXERA TJF TYPE 160VR OPERATION MANUAL

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, video monitor, endo-therapy accessories (such as a biopsy forceps) and other ancillary equipment for endoscopy and endoscopic surgery within the duodenum. Do not use this instrument for any purpose other than its intended use.

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 EXERA TJF TYPE 160VR 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. For details on clinical endoscopic procedures, the physician and operator are requested to form judgments from their viewpoints as specialists.

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 or operator 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 EXERA TJF TYPE 160VR OPERATION MANUAL

3

Important Information - Please Read Before Use

Reprocessing before the first use/reprocessing and storage after use This instrument was not cleaned, 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 operator injury and/or equipment damage can result. This instrument is to be repaired by Olympus technicians only.

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.

4

EVIS EXERA TJF TYPE 160VR OPERATION MANUAL

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.

•

After using this instrument, reprocess and store it according to the instructions given in the endoscope’s companion reprocessing manual. Using improperly or incompletely reprocessed or stored instruments may cause patient cross-contamination and/or infection.

•

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 insert or withdraw the endoscope’s insertion tube while the bending section is locked in position. 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 burns can result.

•

Do not twist the insertion tube within a narrow tube. This could cause the distal cover to come off.

•

Never operate the bending section, feed air or perform suction, insert or withdraw the endoscope’s insertion tube, without viewing the endoscopic image. Never use endo-therapy accessories without viewing the endoscopic image. Patient injury can result.

•

Never operate the bending section, feed air or perform suction, insert or withdraw the endoscope’s insertion tube while the image is frozen. Never use endo-therapy accessories while the image is frozen. Patient injury, can result.

EVIS EXERA TJF TYPE 160VR OPERATION MANUAL

5

Important Information - Please Read Before Use

6

•

Never insert or withdraw the endoscope’s insertion tube with excessive force. Otherwise, patient injury could result.

•

Do not pull the universal cord during an examination. 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 12 cm. Equipment damage can result.

•

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

•

The endoscope’s remote switches cannot be removed from the control section. Pressing, pulling or twisting them with excessive force can break the switches and/or may cause water leaks.

•

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

•

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 attempt to bend the endoscope’s insertion tube with excessive force. Otherwise, the insertion tube may be damaged.

EVIS EXERA TJF TYPE 160VR OPERATION MANUAL

Important Information - Please Read Before Use

•

The endoscope contains a memory chip that stores information about the endoscope and communicates this information to the CV-160. Although the memory chip is durable, damage will prevent data from being backed up on it. When data are lost or damaged, contact Olympus.

•

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.

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. •

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

•

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

•

Retroflexing the endoscope within the esophagus or duodenal bulb may cause mucosal trauma or impaction of the endoscope.

•

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

•

Inserting or withdrawing the endoscope, feeding air, applying suction or operating the bending section without a clear endoscopic image may cause patient injury.

EVIS EXERA TJF TYPE 160VR 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.

8

EVIS EXERA TJF TYPE 160VR OPERATION MANUAL

Chapter 1 Checking the Package Contents

Endoscope

Channel cleaning brush (BW-20T)

Water-resistant cap (MH-553)

Injection tube (MH-946)

Channel-opening cleaning brush (MH-507)

Suction valve (MH-443, 2 pcs)

AW channel cleaning adapter (MH-948)

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

Biopsy valve (MB-358, 10 pcs) Channel plug (MH-944)

Mouthpiece (MB-142, 2 pcs)

Washing tube (MH-974)

Distal cover (MAJ-311, 2 pcs)

Suction cleaning adapter (MH-856)

Operation manual

Reprocessing manual

Instruction manual (Distal cover)

Instructions (Caution for attaching the distal cover)

EVIS EXERA TJF TYPE 160VR OPERATION MANUAL

Instructions (Leaflet type, fixing the guidewire)

9

Chapter 2 Instrument Nomenclature and Specifications

Chapter 2 Instrument Nomenclature and Specifications 2.1

Nomenclature

Universal cord

1. Suction connector 5. Electrical connector

2. S-cord connector mount

Air pipe

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

4. Endoscope connector

10

EVIS EXERA TJF TYPE 160VR 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

19. Elevator control lever

18. RIGHT/LEFT angulation control knob Suction cylinder

17. RIGHT/LEFT angulation lock

Control section

Air/water cylinder

Grip section Guidewire fixing function color (blue) 16. Color code

Biopsy valve (MB-358)

15. Elevator channel plug

10. Instrument channel port Boot 11. Insertion tube limit mark

Working length 12. Forceps elevator Insertion tube 14. Remote switches Guidewire fixing function mark

Distal cover (MAJ-311) Distal end 13. Bending section

Top view

EVIS EXERA TJF TYPE 160VR OPERATION MANUAL

11

Chapter 2 Instrument Nomenclature and Specifications

2.2

Endoscope functions 1. Suction connector This connector connects the endoscope to the suction tube of the suction pump. 2. S-cord connector mount This 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 These connectors connect the endoscope to the water container via the water container tube, to supply water to the distal end of the endoscope. 4. Endoscope connector This 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 This connector connects the endoscope to the video system center via the videoscope cable. The endoscope contains a memory chip that stores information about the endoscope and communicates this information to the video system center CV-160. For more details, refer to the instruction manual of the CV-160. 6. UP/DOWN angulation control knob When this 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 this 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 (MH-443) This valve is depressed to activate suction. The valve is used to remove any fluid, debris, flatus or air from the patient. 9. Air/water valve (MH-438) The hole in this 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)

12

EVIS EXERA TJF TYPE 160VR OPERATION MANUAL

Chapter 2 Instrument Nomenclature and Specifications

11. Insertion tube limit mark This mark shows the maximum point to which the endoscope may be inserted into the patient’s body. 12. Forceps elevator The elevator moves endo-therapy accessories when the elevator control lever is operated. In addition, the forceps elevator is used for assistance of the fixation function of the guidewire while inserting/withdrawing the wire guided type endo-therapy accessory. 13. Bending section This section moves the distal end of the endoscope when the UP/DOWN and RIGHT/LEFT angulation control knobs are operated. 14. Remote switches 1 to 4 The functions of remote switches 1 to 4 can be selected on the video system center. When selecting the functions, also refer to the instruction manual for the video system center. 15. Elevator channel plug This plug is used for connection of the washing tube to clean and disinfect the elevator channel. 16. Color code (orange) This 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. 17. RIGHT/LEFT angulation lock Turning this lock in the “F ” direction frees angulation. Turning the lock in the opposite direction locks the bending section at any desired position. 18. RIGHT/LEFT angulation control knob When this 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. 19. Elevator control lever When this lever is moved in the “ U” direction, the forceps elevator is raised. When the lever is turned in the opposite direction, the forceps elevator is lowered.

EVIS EXERA TJF TYPE 160VR OPERATION MANUAL

13

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)

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)

14

EVIS EXERA TJF TYPE 160VR OPERATION MANUAL

Chapter 2 Instrument Nomenclature and Specifications

Specifications  Endoscope functions Model Optical system

TJF-160VR Field of view

100°

Direction of view

Backward Sideviewing 5°

Insertion tube

Depth of field

5 – 60 mm

Distal end outer diameter

ø 13.5 mm

Distal end enlarged

1. Air/water nozzle 2. Objective lens 3. Light guide lens 4. Instrument channel outlet 5. Forceps elevator 6. Guidewire-locking groove 7. Elevator wire 8. Hook 9. White ring UP LEFT

3.

8.

RIGHT DOWN 6. 5. 7.

2.

4.

1. Insertion tube outer diameter Working length Instrument channel

Channel inner diameter Minimum visible distance

9. ø 11.3 mm 1240 mm ø 4.2 mm 10 mm

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

EVIS EXERA TJF TYPE 160VR OPERATION MANUAL

15

Chapter 2 Instrument Nomenclature and Specifications

Air flow rate

25 cm3/s Note: Standard when CLV-160 (high air pressure) is used.

Bending section

Angulation range

UP 120°, DOWN 90° RIGHT 110°, LEFT 90°

Total length

1550 mm

Medical Device Directive

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

EMC

Applied standard; IEC 60601-1-2: 2001

This instrument complies with the standards listed in the left column. CISPR 11 of emission: Group 1, Class B This instrument complies with the EMC standard for medical electrical equipment; edition 2 (IEC 60601-1-2: 2001). However, when connecting to an instrument that complies with the EMC standard for medical electrical equipment; edition 1 (IEC 60601-1-2: 1993), the whole system complies with edition 1.

Year of manufacture

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

Degree of protection against electric

TYPE BF applied part

shock

16

EVIS EXERA TJF TYPE 160VR OPERATION MANUAL

Chapter 3 Preparation and Inspection

Chapter 3 Preparation and Inspection 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. If the irregularities are suspected after inspection, follow the instructions given in Chapter 5, “Troubleshooting”. If this instrument malfunctions, do not use it. Return it to Olympus for repair as described in Section 5.3, “Returning the endoscope for repair”.

•

Using an endoscope that is not functioning properly may compromise patient or operator safety and may result in more severe equipment damage.

•

This instrument was not cleaned, 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.

EVIS EXERA TJF TYPE 160VR OPERATION MANUAL

17