CF TYPE x180 Series EVIS EXERA II COLONOVIDEOSCOPE Operation Manual Dec 2009

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...

5

Spare equipment ...

5

Maintenance management ...

5

Prohibition of improper repair and modification...

6

Signal words ...

6

Warnings and cautions...

7

Examples of inappropriate handling...

13

Chapter 1

Checking the Package Contents...

14

Chapter 2

Instrument Nomenclature and Specifications ...

18

2.1

Nomenclature...

18

2.2

Endoscope functions...

28

2.3

Specifications...

31

2.4

Attaching the chain for water-resistant cap (MAJ-1119) ...

43

Preparation and Inspection ...

46

3.1

Preparation of the equipment...

46

3.2

Inspection of the endoscope ...

48

3.3

Preparation and inspection of accessories ...

53

3.4

Attaching accessories to the endoscope ...

58

3.5

Inspection and connection of ancillary equipment ...

60

3.6

Inspection of the endoscopic system ...

64

Operation ...

70

4.1

Insertion ...

75

4.2

Using EndoTherapy accessories ...

83

4.3

Withdrawal of the endoscope...

89

4.4

Transportation of the endoscope ...

90

Chapter 3

Chapter 4

EVIS EXERA II GIF/CF/PCF TYPE 180 Series OPERATION MANUAL

i

Contents

Chapter 5

Troubleshooting ...

92

5.1

Troubleshooting guide ...

92

5.2

Withdrawal of the endoscope with an irregularity...

97

5.3

Returning the endoscope for repair...

99

Appendix... 101

ii

System chart ...

101

EMC information...

128

EVIS EXERA II GIF/CF/PCF TYPE 180 Series OPERATION MANUAL

Symbols

Symbols The meaning(s) of the symbol(s) shown on the component packaging, the back cover of the instruction manual, and/or the instrument are as follows:

Refer to instructions.

Caution

Endoscope

TYPE BF applied part

Single use only

Lot number

Manufacturer

Authorized representative in the European Community

Serial number

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, endoscope position detecting unit (for CF-H180DL/I only), light source, documentation equipment, monitor, EndoTherapy accessories (such as a biopsy forceps), and other ancillary equipment. Use the EVIS EXERA II GASTROINTESTINAL VIDEOSCOPE GIF-N180, GIF-XP180N 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, GIF-H180J 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, CF-H180DL/I, PCF-Q180AL/I, PCF-H180AL/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 use. 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 are official standards on the applicability of endoscopy and endoscopic treatment that are defined by the hospital’s administrators or other official institutions, such as academic societies on endoscopy, follow those standards. Before starting endoscopy and endoscopic treatment, thoroughly evaluate its properties, purposes, effects, and possible risks (their nature, 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 that 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” with your endoscope model listed on the cover. 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.

 Terms used in this manual NBI (Narrow Band Imaging) observation mode: This is an observation mode using narrowband light. Normal light observation mode (or WLI (White Light Imaging) observation mode): This is an observation mode using standard white light illumination.

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 are official standards for user qualifications to perform endoscopy and endoscopic treatment that are defined by the hospital’s medical administrators or other official institutions, such as academic societies on endoscopy, follow those standards. If there are no official qualification standards, 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 the EMC standard for medical electrical equipment, edition 2 (IEC 60601-1-2: 2001). However, when connected with 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.

4

EVIS EXERA II GIF/CF/PCF TYPE 180 Series OPERATION MANUAL

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 “REPROCESSING MANUAL” with your endoscope model listed on the cover. 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 pose an infection control risk, cause equipment damage, or reduce performance.

Spare equipment Be sure to prepare another endoscope to avoid interruption of the examination 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 an observed irregularity should not be used, but should be inspected by following Section 5.1, “Troubleshooting guide” on page 92. If the irregularity is still observed after inspection, contact Olympus.

EVIS EXERA II GIF/CF/PCF TYPE 180 Series OPERATION MANUAL

5

Important Information - Please Read Before Use

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 may result. Equipment that 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.

Indicates additional helpful information.

6

EVIS EXERA II GIF/CF/PCF TYPE 180 Series 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” with your endoscope model listed on the cover. 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. Performing high-frequency cauterization treatment while the patient is wearing metallic objects may cause burns on the patient in areas around the metallic objects.

•

Do not strike, hit, or drop the endoscope’s distal end, insertion tube, bending section, control section, universal cord, or endoscope connector. Also, do not bend, pull, or twist the endoscope’s distal end, insertion tube, bending section, control section, universal cord, or endoscope connector 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 with the GIF-N180, GIF-XP180N, 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 the GIF-N180, GIF-XP180N, can always be inserted transnasally into all patients. Before proceeding, always be sure to confirm that transnasal insertion is possible with the patient by considering both the size of the patient’s nasal cavity as well as the size of the endoscope’s insertion section. Otherwise, patient injury can result or the endoscope could become lodged and difficult to withdraw.

EVIS EXERA II GIF/CF/PCF TYPE 180 Series OPERATION MANUAL

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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, bleeding, and/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, patient injury can result or the endoscope could become lodged and 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’s 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 the insertion immediately. Otherwise, patient injury can result or the endoscope could become lodged and 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. •

8

Never perform angulation control forcibly or abruptly. Never forcefully pull, twist, or rotate the angulated bending section. Patient injury, bleeding, and/or perforation may 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

Important Information - Please Read Before Use

•

Never insert or withdraw the endoscope’s insertion section while the bending section is locked in position. Patient injury, bleeding, and/or perforation may result.

•

The bending section will never bend to the RIGHT or LEFT direction but to the UP or DOWN direction. To insert or withdraw, operate the endoscope by considering the direction in which the bending section is angulated. Never apply excessive force to the RIGHT or LEFT direction when inserting or withdrawing the endoscope. Patient injury, bleeding, and/or perforation can result (for GIF-N180 only).

•

Never perform flexibility adjustment, operate the bending section, feed air or perform suction, insert or withdraw the endoscope’s insertion section, or use EndoTherapy accessories without viewing the endoscopic image. Patient injury, bleeding, and/or perforation may result.

•

Never perform flexibility adjustment, operate the bending section, feed air or perform suction, insert or withdraw the endoscope’s insertion section, or use EndoTherapy accessories while the image is frozen. Patient injury, bleeding, and/or perforation may result.

•

Regardless of the flexibility of the endoscope’s insertion section, never insert or withdraw the insertion section abruptly or with excessive force. Patient injury, bleeding, and/or perforation may result.

•

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.

•

Never insert or withdraw the endoscope’s insertion section or use EndoTherapy accessories while the image is magnified. Patient injury, bleeding, and/or perforation can result (when using the image magnification function of the video system center).

•

The endoscope position detecting unit is designed only to assist the insertion of an endoscope. Never insert the endoscope into the patient’s body by observing only the endoscope position display of the endoscope position detecting unit. Be sure to observe the endoscopic image and insert the endoscope while confirming the safety. If the endoscope is inserted without observing the endoscopic image, patient injury, bleeding, and/or perforation can result (for CF-H180DL/I only).

EVIS EXERA II GIF/CF/PCF TYPE 180 Series OPERATION MANUAL

9

Important Information - Please Read Before Use

10

•

Do not touch the light guide on 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.

•

When combining the endoscope with a splinting tube, there is a risk of perforation or bleeding due to entanglement of the mucous membrane, or of the tube to become 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 (for CF/PCF models only).

•

Do not rely on the NBI observation mode alone for primary detection of lesions or to make a decision regarding any potential diagnostic or therapeutic intervention.

•

During the endoscopic treatment, keep the insertion section and the bending section as straight as possible. If there is a loop or a bend on the insertion section or the bending section, the operation can not be performed as intended, and patient injury, bleeding, and/or perforation can 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 with a diameter of less than 12 cm. Equipment damage can result.

•

Do not attempt to bend the endoscope’s insertion section with excessive force regardless of its flexibility. Otherwise, the insertion section may be damaged.

•

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 section, particularly the objective lens surface at the distal end. Visual irregularities may result.

•

Do not twist or bend the bending section with your hands. Equipment damage may result.

EVIS EXERA II GIF/CF/PCF TYPE 180 Series OPERATION MANUAL

Important Information - Please Read Before Use

•

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 ON only when the videoscope cable is connected to both the video system center and the electrical connector on the endoscope. In particular, confirm that the video system center is OFF before connecting or disconnecting the videoscope cable from 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 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 pull the UPD cable 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. The UPD cable will be pulled out from the UPD scope connector and the scope model will not be visible (for CF-H180DL/I only).

•

Turn the endoscope position detecting unit (UPD) OFF before connecting or disconnecting the UPD cable from the UPD scope connector. Turn the UPD ON or OFF only when the UPD cable is connected to the UPD scope connector. Failure to do so can damage the UPD (for CF-H180DL/I only).

•

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.

EVIS EXERA II GIF/CF/PCF TYPE 180 Series OPERATION MANUAL

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Important Information - Please Read Before Use

•

To check the electromagnetic interference 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.

This endoscope contains a memory chip that stores information about the endoscope and communicates this information to the video system center CV-160, CV-180.

12

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 the angle of the bending section and/or withdraw the endoscope from the patient. 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 EndoTherapy 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.

•

For reasons described below, do not rely on the NBI∗1 observation mode alone for primary detection of lesions or to make a decision regarding any potential diagnostic or therapeutic intervention. − NBI has not been demonstrated to increase the yield or sensitivity of finding any specific mucosal lesion, including colonic polyps or Barrett’s esophagus. − NBI has not been demonstrated to aid in differentiating or establishing the presence or absence of dysplasia or neoplastic changes within mucosa or mucosal lesions. ∗1 Narrow Band Imaging. For more details, refer to the instruction manual for the video system center CV-180.

EVIS EXERA II GIF/CF/PCF TYPE 180 Series OPERATION MANUAL

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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 “REPROCESSING MANUAL” with your endoscope model listed on the cover.

GIF-N180

Endoscope GIF-XP180N, GIF-Q180, GIF-H180

Endoscope

14

EVIS EXERA II GIF/CF/PCF TYPE 180 Series OPERATION MANUAL

Chapter 1 Checking the Package Contents

GIF-H180J

Endoscope CF-Q180AL/I, CF-H180AL/I, PCF-Q180AL/I, PCF-H180AL/I

Endoscope CF-H180DL/I

Endoscope

EVIS EXERA II GIF/CF/PCF TYPE 180 Series OPERATION MANUAL

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Chapter 1 Checking the Package Contents

Packaged for the USA, Canada, Australia, and New Zealand

Single use channel cleaning brush (BW-201T, 3 pcs)

Water-resistant cap (MH-553)

Injection tube (MH-946) Single use channel-opening cleaning brush (MAJ-1339, 3 pcs)

Suction valve (MH-443, 2 pcs)

AW channel cleaning adapter (MH-948)

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

Channel plug (MH-944)

Biopsy valve (MB-358, 10 pcs) Chain for water-resistant cap (MAJ-1119)

Auxiliary water tube (MAJ-855, for endoscopes with auxiliary water feeding only)

Suction cleaning adapter (MH-856)

Operation manual

16

Mouthpiece (MA-474, MB-142, 1 pc each) (for GIF-N180, GIF-XP180N)

Reprocessing manual

Mouthpiece (MB-142, 2 pcs) (for GIF-Q180, GIF-H180, GIF-H180J)

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, Canada, Australia, and New Zealand

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)

Auxiliary water tube (MAJ-855, for endoscopes with auxiliary water feeding only)

Mouthpiece (MA-474, MB-142, 1 pc each) (for GIF-N180, GIF-XP180N) Suction cleaning adapter (MH-856)

Operation manual

Reprocessing manual

Mouthpiece (MB-142, 2 pcs) (for GIF-Q180, GIF-H180, GIF-H180J)

Instructions (leaflet type for endoscopes with flexibility adjustment only)

EVIS EXERA II GIF/CF/PCF TYPE 180 Series OPERATION MANUAL

17