Operation Manual
84 Pages
Preview
Page 1
INSTRUCTIONS
EVIS EXERA DUODENOVIDEOSCOPE
OLYMPUS TJF TYPE 160R
Refer to the endoscope’s companion manual, the “OLYMPUS TJF TYPE 160R ENDOSCOPE REPROCESSING MANUAL” for reprocessing information.
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...
5
Warnings and cautions ...
5
Chapter 1
Checking the Package Contents...
9
Chapter 2
Instrument Nomenclature and Specifications ...
12
2.1
Nomenclature...
12
2.2
Endoscope functions...
14
2.3
Specifications...
16
Preparation and Inspection ...
20
3.1
Preparation of the equipment...
21
3.2
Preparation and inspection of the endoscope...
22
3.3
Preparation and inspection of accessories ...
26
3.4
Attaching accessories to the endoscope ...
30
3.5
Preparation, inspection and connection of ancillary equipment...
39
3.6
Inspection of the endoscopic system ...
42
Operation ...
46
4.1
Insertion ...
48
4.2
Using endo-therapy accessories...
53
4.3
Withdrawal of the endoscope...
58
4.4
Transportation of the endoscope ...
59
Troubleshooting ...
60
5.1
Troubleshooting guide ...
60
5.2
Returning the endoscope for repair ...
64
Chapter 3
Chapter 4
Chapter 5
EVIS EXERA TJF TYPE 160R OPERATION MANUAL
i
Contents
ii
Appendix...
65
System chart ...
65
EMC information ...
72
EVIS EXERA TJF TYPE 160R 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.
Caution
Endoscope
TYPE BF applied part
Manufacturer
Authorized representative in the European Community
Lot number
Serial number
EVIS EXERA TJF TYPE 160R 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 160R 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 “OLYMPUS TJF TYPE 160R ENDOSCOPE REPROCESSING MANUAL” which 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 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 160R 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 “OLYMPUS TJF TYPE 160R ENDOSCOPE REPROCESSING MANUAL”. After using this instrument, reprocess and store it according to the instructions given in the endoscope’s 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.
4
EVIS EXERA TJF TYPE 160R OPERATION MANUAL
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.
•
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 angulation control, feed air, perform suction or insert/withdraw the endoscope’s insertion tube without viewing the endoscopic image. Patient injury can result.
EVIS EXERA TJF TYPE 160R OPERATION MANUAL
5
Important Information - Please Read Before Use
6
•
Do not 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.
•
Never use the endoscope unless the distal cover is properly attached to the distal end. If the distal cover is not attached correctly, it may fall off the distal end during the examination. Continuing the examination after the distal cover has fallen off may cause patient injury by the exposed distal end of the endoscope. It could also result in thermal injury when used in combination with high-frequency endo-therapy accessories.
•
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.
•
Do not twist the insertion tube within a narrow tube. This could cause the distal cover to come off.
•
Never insert/withdraw the insertion tube with excessive force or while an optimum field of view cannot be obtained. Otherwise, patient injury could result.
•
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 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 EVIS video system center OFF before connecting or disconnecting the videoscope cable from the electrical connector on the endoscope. Turn the it 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.
EVIS EXERA TJF TYPE 160R OPERATION MANUAL
Important Information - Please Read Before Use
•
The endoscope’s remote switches cannot be removed from the control section. Pressing or pulling them with excessive force can break the switches.
•
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.
•
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 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.
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.
•
Retroflexing the endoscope within the esophagus or duodenal bulb may cause mucosal trauma or impaction of the endoscope.
EVIS EXERA TJF TYPE 160R OPERATION MANUAL
7
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, feeding air or applying suction without a clear endoscopic view withdrawing the endoscope with the angulation controls locked forcefully pulling, twisting or rotating the angulated bending section
8
EVIS EXERA TJF TYPE 160R OPERATION MANUAL
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 “OLYMPUS TJF TYPE 160R ENDOSCOPE REPROCESSING MANUAL”.
EVIS EXERA TJF TYPE 160R OPERATION MANUAL
9
Chapter 1 Checking the Package Contents
Endoscope
Mouthpiece (MB-142, 2 pcs)
Channel plug (MH-944)
Biopsy valve (MB-358, 10 pcs)
Injection tube (MH-946)
Channel cleaning brush (BW-20T) Distal cover (MAJ-311, 2 pcs) Suction valve (MH-443, 2 pcs)
Air/water valve (MH-438, 2 pcs) Water-resistant cap (MH-553)
Channel-opening cleaning brush (MH-507)
Washing tube (MH-974) Suction cleaning adapter (MH-856) AW channel cleaning adapter (MH-948)
Operation manual
10
Reprocessing manual
Instruction manual (Distal cover)
EVIS EXERA TJF TYPE 160R OPERATION MANUAL
Instructions (Caution for attaching the distal cover)
Chapter 1 Checking the Package Contents
EVIS EXERA TJF TYPE 160R OPERATION MANUAL
11
Chapter 2 Instrument Nomenclature and Specifications
Chapter 2 Instrument Nomenclature and Specifications 2.1
Nomenclature The endoscope’s main body is illustrated with its valves and distal cover detached.
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
12
EVIS EXERA TJF TYPE 160R OPERATION MANUAL
Chapter 2 Instrument Nomenclature and Specifications
8. Suction valve (MH-443) 9. Air/water valve (MH-438) 7. UP/DOWN angulation lock 12. Remote switches 6. UP/DOWN angulation control knob
18. Elevator control lever
17. RIGHT/LEFT angulation control knob Control section
Suction cylinder
16. RIGHT/LEFT angulation lock
Air/water cylinder
Grip section
15. Color code
14. Elevator channel plug
Biopsy valve (MB-358)
10. Instrument channel port Boot
Working length
Distal cover (MAJ-311)
Insertion tube 13. Insertion tube limit mark
12. Remote switches Distal end 11. Bending section Top view
EVIS EXERA TJF TYPE 160R OPERATION MANUAL
13
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. 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. This endoscope contains a memory chip that stores information about the endoscope and communicates this information to the CV-160. For more details, refer to the instruction manual of the CV-160. 6. UP/DOWN angulation control knob When turned in the “ U” direction, the bending section moves UP; when turned in the “D ” direction, the bending section moves DOWN. 7. UP/DOWN angulation lock Pushing the lever in the “F ” direction frees angulation. Pushing the lever 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 remaining 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 remaining 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)
14
EVIS EXERA TJF TYPE 160R OPERATION MANUAL
Chapter 2 Instrument Nomenclature and Specifications
11. Bending section The bending section moves the distal end of the endoscope when the UP/DOWN and RIGHT/LEFT angulation control knobs are operated. 12. Remote switches 1 to 4 The functions of the 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. 13. 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. 14. Elevator channel plug The elevator channel plug is used for connection of the washing tube to clean and disinfect the elevator channel. 15. 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. Orange : TJF-160R 16. 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. 17. RIGHT/LEFT angulation control knob When turned in the “R ” direction, the bending section moves RIGHT; when turned in the “ L” direction, the bending section moves LEFT. 18. Elevator control lever When this lever is moved in the “ U” direction, the forceps elevator is raised. When turned in the opposite direction, the forceps elevator is lowered.
EVIS EXERA TJF TYPE 160R OPERATION MANUAL
15
Chapter 2 Instrument Nomenclature and Specifications
2.3
Specifications Environment Operating environment
Ambient temperature
10 – 40C (50 – 104F)
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 – 40C (41 – 104F) 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 70C (–52.6 to 158F) 10 – 95% 700 – 1060 hPa (0.7 – 1.1 kgf/cm2) (10.2 – 15.4 psia)
16
EVIS EXERA TJF TYPE 160R OPERATION MANUAL
Chapter 2 Instrument Nomenclature and Specifications
Specifications Endoscope functions Model Optical system
TJF-160R Field of view
100
Direction of view
Insertion tube
Backward Sideviewing 5
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. Forceps elevator 5. Instrument channel outlet 3.
4.
2. 5.
1.
Instrument channel
Insertion tube outer diameter
ø 11.3 mm
Working length
1240 mm
Channel inner diameter
ø 4.2 mm
Minimum visible distance
10 mm
Direction from which endo-therapy accessories enter and exit the endoscopic image Air flow rate
25 cm3/s Note: Standard when CLV-160 (high air pressure) is used.
Bending section
Angulation range
Total length
EVIS EXERA TJF TYPE 160R OPERATION MANUAL
UP 120 DOWN 90 RIGHT 110 LEFT 90 1550 mm
17