OLYMPUS
OLYMPUS Scopes Gastrointestinal System
GIF TYPE xxx180 Series, TYPE CF and PCF x180xxx Series EVIS EXERA II GASTROINTESTINAL VIDEOSCOPE Operation Manual Dec 2006
Operation Manual
110 Pages
Preview
Page 1
INSTRUCTIONS
EVIS EXERA II GASTROINTESTINAL VIDEOSCOPE
OLYMPUS GIF TYPE N180 OLYMPUS GIF TYPE Q180 OLYMPUS GIF TYPE H180 EVIS EXERA II COLONOVIDEOSCOPE
OLYMPUS CF TYPE Q180AL/I OLYMPUS CF TYPE H180AL/I OLYMPUS PCF TYPE Q180AL/I
Refer to the endoscope’s companion manual, the “REPROCESSING MANUAL” whose cover lists the model of your endoscope, for reprocessing information. USA: CAUTION: Federal law restricts this device to sale by or on the order of a physician.
Contents
Contents Symbols...
1
Important Information - Please Read Before Use...
2
Intended use ...
2
Applicability of endoscopy and endoscopic treatment ...
3
Instruction manual ...
3
User qualifications...
4
Instrument compatibility ...
4
Reprocessing before the first use/reprocessing and storage after use ...
4
Spare equipment...
5
Maintenance management ...
5
Prohibition of improper repair and modification ...
5
Signal words ...
5
Warnings and cautions ...
6
Examples of inappropriate handling...
11
Chapter 1
Checking the Package Contents...
12
Chapter 2
Instrument Nomenclature and Specifications ...
16
2.1
Nomenclature...
16
2.2
Endoscope functions...
22
2.3
Specifications...
24
2.4
Attaching the chain for water-resistant cap (MAJ-1119) ...
32
Preparation and Inspection ...
35
3.1
Preparation of the equipment...
36
3.2
Inspection of the endoscope ...
37
3.3
Preparation and inspection of accessories ...
43
3.4
Attaching accessories to the endoscope ...
47
3.5
Inspection and connection of ancillary equipment ...
50
3.6
Inspection of the endoscopic system ...
53
Operation ...
58
4.1
Insertion ...
62
4.2
Using endo-therapy accessories...
70
4.3
Withdrawal of the endoscope...
76
4.4
Transportation of the endoscope ...
77
Chapter 3
Chapter 4
EVIS EXERA II GIF/CF/PCF TYPE 180 Series OPERATION MANUAL
i
Contents
Chapter 5
ii
Troubleshooting ...
79
5.1
Troubleshooting guide ...
79
5.2
Withdrawal of the endoscope with an abnormality...
83
5.3
Returning the endoscope for repair...
86
Appendix...
87
System chart ...
87
EMC information...
101
EVIS EXERA II GIF/CF/PCF TYPE 180 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
Single use only
Lot number
Manufacturer
Authorized representative in the European Community
EVIS EXERA II GIF/CF/PCF TYPE 180 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 EXERA II GASTROINTESTINAL VIDEOSCOPE GIF-N180 for transoral or transnasal endoscopy and endoscopic surgery within the upper digestive tract (including the esophagus, stomach and duodenum). Use the EVIS EXERA II GASTROINTESTINAL VIDEOSCOPE, GIF-Q180, GIF-H180 for endoscopy and endoscopic surgery within the upper digestive tract (including the esophagus, stomach and duodenum). Use the EVIS EXERA II COLONOVIDEOSCOPE CF-Q180AL/I, CF-H180AL/I, PCF-Q180AL/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. Select the endoscope to be used according to the objective of the intended procedure based on the full understanding of the endoscope’s specifications and functionality as described in this instruction manual.
2
EVIS EXERA II GIF/CF/PCF TYPE 180 Series OPERATION MANUAL
Important Information - Please Read Before 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.
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.
EVIS EXERA II GIF/CF/PCF TYPE 180 Series OPERATION MANUAL
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Important Information - Please Read Before Use
User qualifications If there is an official standard on user qualifications to perform endoscopy and endoscopic treatment that is defined by the medical administration or other official institutions, such as academic societies on endoscopy, follow that standard. If there is no official qualification standard, the operator of this instrument must be a physician approved by the medical safety manager of the hospital or person in charge of the department (department of internal medicine, etc.). The physician should be capable of safely performing the planned endoscopy and endoscopic treatment following guidelines set by the academic societies on endoscopy, etc., and considering the difficulty of endoscopy and endoscopic treatment. This manual does not explain or discuss 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 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.
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.
4
EVIS EXERA II GIF/CF/PCF TYPE 180 Series OPERATION MANUAL
Important Information - Please Read Before Use
Spare equipment Be sure to prepare another endoscope to avoid that the examination will be interrupted due to equipment failure or malfunction.
Maintenance management The probability of failure of the endoscope and ancillary equipment increases as the number of procedures performed and/or the total operating hours increase. In addition to the inspection before each procedure, the person in charge of medical equipment maintenance in each hospital should inspect the items specified in this manual periodically. An endoscope with which an irregularity is suspected should not be used, but should be inspected by following Section 5.1, “Troubleshooting guide” on page 79. If the irregularity is still suspected after inspection, contact Olympus.
Prohibition of improper 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. Equipment which has been disassembled, repaired, altered, changed or modified by persons other than Olympus’ own authorized service personnel is excluded from Olympus’ limited warranty and is not warranted by Olympus in any manner.
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.
EVIS EXERA II GIF/CF/PCF TYPE 180 Series OPERATION MANUAL
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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.
•
After using this instrument, reprocess and store it according to the instructions given in the endoscope’s companion reprocessing manual whose cover lists the model of your endoscope. Using improperly or incompletely reprocessed or stored instruments may cause patient cross-contamination and/or infection.
•
Before endoscopy, remove any metallic objects (watch, glasses, necklace, etc.) from the patient. If performing high-frequency cauterization becomes necessary while the patient wears a metallic object, it may cause burns on the patient in areas around the metallic object.
•
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.
•
When performing transnasal insertion of the GIF-N180, please follow the cautions below. − The shape and size of the nasal cavity and its suitability for transnasal insertion may vary from patient to patient. No endoscope, including this one, can always be inserted transnasally with all patients. Before proceeding, always be sure to confirm that transnasal insertion is possible with the patient. Otherwise, operator and/or patient injury can result, or the endoscope could become lodged and be difficult to withdraw.
6
EVIS EXERA II GIF/CF/PCF TYPE 180 Series OPERATION MANUAL
Important Information - Please Read Before Use
− Transnasal insertion is accompanied by the risk of inflammation of the nasal cavity. If this happens, the nasal passage will be constricted, making it more difficult to withdraw the endoscope. In this case, do not use force to withdraw the endoscope because patient injury such as bleeding or perforation may result. − Transnasal insertion is accompanied by the risk of bleeding in the nasal cavity. Be sure to be prepared to deal with any bleeding. When withdrawing the endoscope, observe the inside of the nasal cavity to ensure that there is no bleeding. Even when the endoscope has been withdrawn without bleeding, do not allow the patient to blow his or her nose strongly because this could cause it to start bleeding. − Before transnasal insertion, apply the appropriate pretreatment and lubrication to the patient to enlarge the nasal cavity. Otherwise, operator and/or patient injury can result or the endoscope could become lodged and be difficult to withdraw. When applying a pretreatment agent through a tube, insert the tube into the same path as the path planned for the endoscope insertion. Otherwise, the treatment will have no effect. The effects of the pretreatment agent and lubricant will decrease the longer the procedure lasts. Apply the pretreatment agent or lubricant as required during the procedure – for example, when withdrawal seems to be difficult. − Transnasal insertion of the endoscope should be performed carefully. If resistance to insertion is felt, or the patient reports pain, stop insertion immediately. Otherwise, operator and/or patient injury can result or the endoscope could become lodged and be difficult to withdraw. − If it becomes impossible to withdraw the transnasally inserted endoscope, pull its distal end out of the mouth, cut the flexible tube using wire cutters, and after ensuring that the cut section will not injure the body cavity or nasal cavity of the patient, withdraw the endoscope carefully. Therefore, always prepare wire cutters in advance. •
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.
EVIS EXERA II GIF/CF/PCF TYPE 180 Series OPERATION MANUAL
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Important Information - Please Read Before Use
8
•
Never insert or withdraw the endoscope’s insertion tube while the bending section is locked in position. Patient injury, bleeding and/or perforation can result.
•
Never perform flexibility adjustment, operate the bending section, feed air or perform suction, insert or withdraw the endoscope’s insertion tube, or use endo-therapy accessories without viewing the endoscopic image. Patient injury, bleeding and/or perforation can result.
•
Never perform flexibility adjustment, operate the bending section, feed air or perform suction, insert or withdraw the endoscope’s insertion tube, or use endo-therapy accessories while the image is frozen. Patient injury, bleeding and/or perforation can result.
•
Regardless of the flexibility of the endoscope’s insertion tube, never insert or withdraw the insertion tube abruptly or with excessive force. Patient injury, bleeding and/or perforation can result.
•
Never insert or withdraw the endoscope’s insertion tube, use endo-therapy accessories while the image is magnified. Patient injury, bleeding and/or perforation can result (only when using the image magnification of the video system center CV-180).
•
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.
•
When the endoscopic image does not appear on the monitor, the CCD may have been damaged. Turn the video system center OFF immediately. Continued power supply in such a case will cause the distal end to become hot and could cause operator and/or patient burns.
•
If it is difficult to insert the endoscope, do not forcibly insert the endoscope; stop the endoscopy. Forcible insertion can result in patient injury, bleeding and/or perforation.
•
When combining the endoscope with a splinting tube, there is the risk of perforation or bleeding due to entanglement of the mucous membrane, or of the tube to becoming separated from the endoscope and remaining in the body. Before use, be sure to read the instruction manual for the splinting tube to fully understand its characteristics.
EVIS EXERA II GIF/CF/PCF TYPE 180 Series OPERATION MANUAL
Important Information - Please Read Before Use
•
For reasons described below, do not rely on the NBI∗1 imaging modality alone for primary detection of lesions or to make a decision regarding any potential diagnostic or therapeutic intervention. − It has not been demonstrated to increase the yield or sensitivity of finding any specific mucosal lesion including colonic polyps or Barrett’s esophagus. − It has not been demonstrated to aid in differentiating establishing the presence or absence of dysplasia or neoplastic changes within mucosa or mucosal lesions.
∗1 NBI stands for Narrow Band Imaging. For more details, refer to the instruction manual of the CV-180.
•
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 with 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 video system center ON or OFF only when the videoscope cable is connected to both the video system center and the 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.
EVIS EXERA II GIF/CF/PCF TYPE 180 Series OPERATION MANUAL
9
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 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.
•
Do not attempt to bend the endoscope’s insertion tube with excessive force unless its flexibility is set to the most-rigid position. Otherwise, the insertion tube may be damaged (for endoscopes with flexibility adjustment only).
•
To check the electromagnetic influence from other equipment (any equipment other than this instrument or the components that constitute this system), the system should be observed to verify its normal operation in the configuration in which it will be used.
•
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.
This endoscope contains a memory chip that stores information about the endoscope and communicates this information to the video system center CV-160 and CV-180.
10
EVIS EXERA II GIF/CF/PCF TYPE 180 Series OPERATION MANUAL
Important Information - Please Read Before Use
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 described below; •
Over-insufflating the lumen may cause patient pain, injury, bleeding and/or perforation.
•
Applying suction with the distal end in prolonged contact with the mucosal surface, with higher suction pressure than required or with prolonged suction time may cause bleeding and/or lesions.
•
The endoscope has not been designed for use in retroflexed observation in parts of the body other than the stomach. Performing retroflexed observation in a narrow lumen may make it impossible to straighten and/or withdraw the endoscope. Retroflexed observation in parts of the body other than the stomach should be performed only when the usefulness of doing so is determined to be greater than the risk that is posed to the patient.
•
Inserting, withdrawing and using endo-therapy accessories without a clear endoscopic image may cause patient injury, burns, bleeding and/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, bleeding and/or perforation.
EVIS EXERA II GIF/CF/PCF TYPE 180 Series OPERATION MANUAL
11
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 described in the endoscope’s companion manual, the “REPROCESSING MANUAL” whose cover lists the model of your endoscope.
12
EVIS EXERA II GIF/CF/PCF TYPE 180 Series OPERATION MANUAL
Chapter 1 Checking the Package Contents
GIF-N180
Endoscope
GIF-Q180, GIF-H180
Endoscope
CF-Q180AL/I, CF-H180AL/I, PCF-Q180AL/I
Endoscope
EVIS EXERA II GIF/CF/PCF TYPE 180 Series OPERATION MANUAL
13
Chapter 1 Checking the Package Contents
Packaged for the USA and CAN
Single use channel cleaning brush (BW-201T) (3 pcs) Injection tube (MH-946)
Water-resistant cap (MH-553)
AW channel cleaning adapter (MH-948)
Chain for water-resistant cap (MAJ-1119) Channel plug (MH-944) Biopsy valve (MB-358) (10 pcs)
Single use channel-opening cleaning brush (MAJ-1339) (3 pcs)
Suction cleaning adapter (MH-856)
Suction valve (MH-443) (2 pcs)
Auxiliary water tube (MAJ-855 for endoscopes with auxiliary water feeding only)
Operation manual
14
Air/water valve (MH-438) (2 pcs)
Mouthpiece (MB-142 for GIF-Q180, GIF-H180) (2 pcs)
Reprocessing manual
Mouthpiece (MA-474, MB-142 for GIF-N180) (1 pc each)
Instructions (leaflet type, for endoscopes with flexibility adjustment only)
EVIS EXERA II GIF/CF/PCF TYPE 180 Series OPERATION MANUAL
Chapter 1 Checking the Package Contents
Packaged for countries other than the USA and CAN
Channel cleaning brush (BW-20T)
Injection tube (MH-946)
Water-resistant cap (MH-553)
Channel-opening cleaning brush (MH-507)
AW channel cleaning adapter (MH-948)
Biopsy valve (MB-358) (10 pcs)
Channel plug (MH-944)
Suction cleaning adapter (MH-856) Suction valve (MH-443) (2 pcs)
Auxiliary water tube (MAJ-855 for endoscopes with auxiliary water feeding only)
Operation manual
Mouthpiece (MB-142 for GIF-Q180, GIF-H180) (2 pcs)
Reprocessing manual
Air/water valve (MH-438) (2 pcs)
Mouthpiece (MA-474, MB-142 for GIF-N180) (1 pc each)
Instructions (leaflet type, for endoscopes with flexibility adjustment only)
EVIS EXERA II GIF/CF/PCF TYPE 180 Series OPERATION MANUAL
15
Chapter 2 Instrument Nomenclature and Specifications
Chapter 2 Instrument Nomenclature and Specifications 2.1
Nomenclature GIF-N180
Universal cord
1. Suction connector 5. Electrical connector
15. Chain connector
Air pipe
3. Air supply connector 3. Water supply connector Light guide
Product name and serial number Contact pins
4. Endoscope connector
16
EVIS EXERA II GIF/CF/PCF TYPE 180 Series OPERATION MANUAL
Chapter 2 Instrument Nomenclature and Specifications
9. Air/water valve (MH-438)
8. Suction valve (MH-443) 7. UP/DOWN angulation lock
6. UP/DOWN angulation control knob
Control section
Suction cylinder Grip section
Air/water cylinder
14. Color code
Biopsy valve (MB-358) Boot 10. Instrument channel Instrument channel port 11. Insertion tube limit mark Working length
Distal end
13. Remote switches 1 to 4
12. Bending section Insertion tube
EVIS EXERA II GIF/CF/PCF TYPE 180 Series OPERATION MANUAL
17