TGF-UC180J EVIS EXERA II ULTRASOUND GASTROVIDEOSCOPE Operation Manual Jan 2019

Contents

Contents Symbols...

1

Important Information - Please Read Before Use...

3

Intended use ...

3

Applicability of endoscopy and endoscopic treatment ...

3

Instruction manual...

4

User qualifications ...

4

Instrument compatibility ...

5

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 ...

6

Examples of inappropriate handling...

12

Chapter 1

Checking the Package Contents...

15

1.1

Standard components...

15

1.2

Ultrasound cable ...

18

Instrument Nomenclature and Specifications ...

19

2.1

Nomenclature...

19

2.2

Endoscope functions...

21

2.3

Specifications...

23

2.4

Attaching the chain for water-resistant cap (MAJ-1739) ...

27

Preparation and Inspection ...

30

3.1

Preparation of the equipment...

31

3.2

Inspection of the endoscope ...

32

3.3

Preparation and inspection of accessories ...

39

3.4

Attaching accessories to the endoscope ...

45

3.5

Inspection and connection of ancillary equipment ...

47

3.6

Inspection of the endoscopic system ...

54

Chapter 2

Chapter 3

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Contents

Chapter 4

Operation...

62

4.1

Insertion ...

64

4.2

Observation of the ultrasound image ...

70

4.3

Using EndoTherapy accessories ...

71

4.4

Withdrawal of the endoscope...

78

4.5

Transportation of the endoscope ...

79

Troubleshooting ...

81

5.1

Troubleshooting guide ...

81

5.2

Withdrawal of the endoscope with an irregularity...

85

5.3

Returning the endoscope for repair...

87

Appendix A: System Chart...

88

Appendix B: Inspection of the endoscope after cleaning, disinfection, or sterilization in accordance with IEC 60601-2-37 ...

96

Appendix C: EMC Information ...

98

Chapter 5

Appendix D: Acoustic Output Information in Accordance with the FDA Guidance: “Information for Manufacturers Seeking Marketing Clearance of Diagnostic Ultrasound Systems and Transducers” ... 104 Symbol key ...

104

Acoustic output table with the diagnostic ultrasound system (Hitachi, Ltd.) ...

106

Acoustic output table when combined with Olympus universal endoscopic ultrasound center EU-ME1 ... 109 Clinical measurement accuracy with the diagnostic ultrasound system (Hitachi, Ltd.) ...

110

Clinical measurement accuracy when combined with Olympus universal endoscopic ultrasound center EU-ME1 ...

110

Appendix E: Acoustic Output Information in Accordance with IEC 60601-2-37 ... 111

ii

Acoustic output table with the diagnostic ultrasound system (Hitachi, Ltd.) ...

111

Acoustic output table with Olympus universal endoscopic ultrasound center EU-ME1...

122

ULTRASOUND GASTROVIDEOSCOPE TGF-UC180J

Symbols

Symbols The meaning(s) of the symbol(s) shown on the package, the back cover of this instruction manual, and/or this instrument are as follows: Refer to instructions.

Caution

TYPE BF applied part

Serial number IPX7

Ingress protection rating (except for connectors) Lock the ultrasound connector

Release the ultrasound connector

Ultrasound endoscope

Single use only

Lot number

Keep away from sunlight

Keep dry

CV-100 is not applicable.

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Symbols

Manufacturer

Authorized representative in the European Community

This Product Contains No Natural Rubber Latex.

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Important Information - Please Read Before Use

Important Information - Please Read Before Use Intended use This instrument is indicated for use with an Olympus universal endoscopic ultrasound center or a diagnostic ultrasound system (Hitachi, Ltd.), video system center, light source, documentation equipment, monitor, EndoTherapy accessories and other ancillary equipment. This instrument is designed for endoscopic real-time ultrasound imaging, ultrasound guided needle aspiration and other endoscopic procedures within the upper gastrointestinal tract and surrounding organs. 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 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.

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Important Information - Please Read Before Use

Instruction manual This instruction manual contains essential information for 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”. It also accompanied the endoscope at shipment. Keep this and all related instruction manuals in a safe and 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: This is optical-digital observation using narrowband light. Normal light observation (or WLI (White Light Imaging) observation): This is observation using standard white light. Elastography: Mode for displaying the relative elasticity information of a tissue using color images. For more details, refer to the instruction manual for the ultrasound instrument for which elastography is available.

User qualifications If there are official standards for user qualifications for performing 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.

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Important Information - Please Read Before Use

Instrument compatibility Refer to “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 4 (IEC 60601-1-2: 2014). When connecting to an instrument that complies with a previous edition of the EMC standard for medical electrical equipment edition, the EMC characteristics could be vulnerable.

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”. 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 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 81. If the irregularity is still observed after inspection, contact Olympus.

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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 can 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.

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.

•

6

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.

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Important Information - Please Read Before Use

•

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.

•

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.

•

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.

•

Never operate the bending section, feed air, 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 operate the bending section, feed air, 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.

•

Never insert or withdraw the insertion section abruptly or with excessive force. Patient injury, bleeding, and/or perforation may 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.

•

Before each use or after a change of viewing modes/settings, check to ensure the view observed through the endoscope provides a live image (rather than a stored one) and has the correct image orientation. Otherwise, patient injury, bleeding, and/or perforation could result.

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Important Information - Please Read Before Use

•

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.

•

Turn ON the diagnostic ultrasound system only when the ultrasound cable is connected to both the diagnostic ultrasound system and the ultrasound cable connector on the endoscope. In particular, confirm that the diagnostic ultrasound system is OFF before connecting or disconnecting the ultrasound cable from the ultrasound cable connector on the endoscope. Otherwise, operator injury and/or equipment damage may result.

•

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.

•

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.

•

If any irregularity in the ultrasound image is observed, turn the ultrasound center OFF immediately. Continued ultrasound radiation will cause the distal end to become hot and could cause operator and/or patient burns.

•

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.

•

Elastography*1 uses the pulsation of a living body. Intentional pressurization is not necessary. Compression onto the tissue by operating the bending section, inserting or withdrawing the endoscope may cause tissue damage, bleeding or perforation. 1 Elastography is not available with the diagnostic ultrasound system (Hitachi, Ltd.) in Canada.

•

8

Be sure that this instrument is not used adjacent to or stacked with other equipment (other than the components of this instrument or system) to avoid electromagnetic interference.

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Important Information - Please Read Before Use

•

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.

•

After using the endoscope, reprocess it according to the instructions given in the endoscope’s companion “REPROCESSING MANUAL”. Using an improperly or incompletely reprocessed endoscope may damage the endoscope's distal end.

•

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. Otherwise, the insertion section may be damaged.

•

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

•

Do not apply shock to the distal end of the insertion section, particularly the ultrasound transducer and the objective lens surface at the distal end. Visual abnormalities may result.

•

Do not pull or twist the ultrasound transducer at the distal end. Visual abnormalities may result.

•

Do not hold the ultrasound transducer when holding the insertion tube. Ultrasound transducer damage can result and/or the ultrasound image will be abnormal.

•

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.

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Important Information - Please Read Before Use

10

•

Turn the video system center ON only when the videoscope cable is connected to both the video system center and the videoscope cable 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 touch the electrical contacts in the ultrasound cable connector. Equipment damage can result.

•

Do not pull, twist or tightly coil the ultrasound cable. Noise can develop in the ultrasound image.

•

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.

•

To prevent unnecessary patient exposure to ultrasound radiation, follow the ‘as-low-as-reasonably achievable’ (ALARA) principle when using ultrasound equipment. Freeze the image whenever you are not actively viewing the “live” ultrasound image. When the equipment is in the FREEZE mode, no ultrasound energy is emitted.

•

It is highly recommended that a backup ultrasound cable is available to continue clinical procedures in case of a malfunction.

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Important Information - Please Read Before Use

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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, and CV-190.

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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.

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Important Information - Please Read Before Use

 NBI 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 for the video system center CV-180 or CV-190.

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Important Information - Please Read Before Use

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Chapter 1 Checking the Package Contents

Chapter 1 Checking the Package Contents 1.1

Standard components 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 “REPROCESSING MANUAL”.

Ultrasound endoscope

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Chapter 1 Checking the Package Contents

Packaged for the North America, Latin America, and Australasia

Water-resistant cap (MH-553, 2 pcs)

Single use combination cleaning brush (BW-412T, 3pcs)

Injection tube (MH-946) AW channel cleaning adapter (MH-948)

Auxiliary water tube (MAJ-2021)

Biopsy valve (MAJ-853, nonsterile, 10 pcs)

Channel plug (MH-944) Mouthpiece (MA-392, 2 pcs) Chain for water-resistant cap (MAJ-1739)

Suction cleaning adapter (MH-856)

Operation manual

16

Reprocessing manual

Cleaning adapter for instrument channel port (MAJ-350)

ULTRASOUND GASTROVIDEOSCOPE TGF-UC180J

Chapter 1 Checking the Package Contents

Packaged for countries other than the North America, Latin America, and Australasia

Channel cleaning brush (BW-20T)

Water-resistant cap (MH-553, 2 pcs)

Injection tube (MH-946) Channel-opening cleaning brush (MH-507)

Auxiliary water tube (MAJ-2021)

AW channel cleaning adapter (MH-948)

Biopsy valve (MAJ-853, nonsterile, 10 pcs)

Channel plug (MH-944) Mouthpiece (MA-392, 2 pcs) Suction cleaning adapter (MH-856)

Operation manual

Chain for water-resistant cap (MAJ-1739)

Reprocessing manual

Cleaning adapter for instrument channel port (MAJ-350)

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