GF-UE190 ULTRASOUND GASTROINTESTINAL VIDEOSCOPE Operation Manual Jan 2020

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 ... 5 Instrument compatibility ... 5 Reprocessing before the first use/reprocessing and storage after use ... 5 Spare equipment ... 5 Maintenance management ... 6 Prohibition of improper repair and modification ... 6 Signal words ... 6 Precautions ... 7 Precautions for disappeared or frozen endoscopic image ... 11 Examples of inappropriate handling ... 12 Natural rubber latex medical alert ... 12

Chapter 1 Checking the Package Contents ... 13 1.1

Checking the package contents list ... 13 Packaged items for Europe, Australasia, Middle East, and Africa ... 15 Package items for countries other than Europe, Australasia, Middle East, and Africa ... 16

Chapter 2 Instrument Nomenclature and Specifications ... 17 2.1

Nomenclature and functions ... 17 Control section, insertion section ... 18 Endoscope connector ... 22

2.2

Specifications ... 24 Environment ... 24 Function list ... 24 Specifications ... 25

GF-UE190 OPERATION MANUAL

i

Contents

Chapter 3 Preparation and Inspection ... 29 3.1

The workflow of preparation and inspection ... 29

3.2

Preparation of the equipment ... 31

3.3

Inspection of the endoscope ... 33 Inspection of the endoscope ... 33 Inspection of the bending mechanisms ... 36

3.4

Inspection of accessories ... 40 Inspection of the air/water and suction valves ... 40 Inspection of the biopsy valve (MB-358) ... 41 Inspection of the single use biopsy valve (MAJ-1555) ... 42 Inspection of the mouthpiece (MB-142) ... 42

3.5

Attaching accessories to the endoscope ... 43 Attaching the suction valve ... 43 Attaching the air/water valve ... 44 Attaching the biopsy valve ... 45

3.6

Inspection of the ultrasound cable ... 46 Inspection of the ultrasound cable (MAJ-2056, sold separately) ... 46

3.7

Inspection of ancillary equipment ... 46

3.8

Connection of the endoscope and ancillary equipment ... 47 Connection to the light source ... 47 Connection of the water container ... 48 Connection of the suction tube ... 49 Connection of the endoscope and the ultrasound cable ... 50 Connection of the ultrasound cable and the endoscopic ultrasound center (EU-ME1, EU-ME2 PREMIER PLUS, EU-ME2 PREMIER, EU-ME2) ... 51 Connection of the diagnostic ultrasound system (Hitachi, Ltd.) ProSound F75 ... 52

3.9

Inspection of the endoscopic system ... 53 Inspection summary ... 53 Inspection of the endoscopic image ... 54 Inspection of the remote switches ... 56 Inspection of the air-feeding function ... 57 Inspection of the objective lens cleaning function ... 58 Inspection of the water feeding function into the balloon ... 60 Inspection of the suction function and aspiration from the balloon ... 61 Inspection of the instrument channel ... 64 Inspection of the ultrasound image with the Olympus universal endoscopic ultrasound center EU-ME1 ... 65 Inspection of the ultrasound image with the EVIS EUS endoscopic ultrasound center (EU-ME2 PREMIER PLUS, EU-ME2 PREMIER, EU-ME2) ... 66 Inspection of the ultrasound image with the diagnostic ultrasound system (Hitachi, Ltd.) ProSound F75 ... 67

3.10 Preparation and inspection of the balloon ... 68 Attaching the balloon ... 69 Inspection of the balloon and expelling air ... 72

ii

GF-UE190 OPERATION MANUAL

Contents

Chapter 4 Operation ... 75 4.1

Precautions ... 75

4.2

Insertion ... 77 Holding and manipulating the endoscope ... 77 Insertion of the endoscope ... 78 Observation of the endoscopic image ... 80 Angulation of the distal end ... 81 Air/water feeding and suction ... 82

4.3

Observation of the ultrasound image ... 86 The balloon method ... 86 The sterile de-aerated water immersion method ... 87

4.4

Using EndoTherapy accessories ... 88 Insertion of EndoTherapy accessories into the endoscope ... 90 Operation of EndoTherapy accessories ... 91 Withdrawal of EndoTherapy accessories ... 92

4.5

Withdrawal of the endoscope ... 93

4.6

Removal of the balloon ... 95

4.7

Transportation of the endoscope ... 96 Transporting within the hospital ... 96 Transporting outside the hospital ... 97

Chapter 5 Troubleshooting ... 99 5.1

Troubleshooting ... 99

5.2

Troubleshooting guide ... 100 Angulation ... 100 Air/water feeding and water feeding function into the balloon ... 101 Suction and suction function into the balloon ... 102 Image quality or brightness ... 102 EndoTherapy accessories ... 103 The ultrasound image ... 104 Other ... 105

5.3

Withdrawal of the endoscope with an irregularity ... 105 Withdrawal when the WLI and NBI endoscopic images appear on the monitor ... 106 Withdrawal when either the WLI or the NBI endoscopic image does not appear on the monitor ... 107 Withdrawal when no endoscopic image appears on the monitor or a frozen image cannot be restored ... 107

5.4

Returning the endoscope for repair ... 108

GF-UE190 OPERATION MANUAL

iii

Contents

Appendix ... 109 Combination equipment ... 109 System chart ... 109 Reprocessing equipment ... 111 Compatible video system center ... 112 Compatible light source ... 112 Compatible accessories ... 112 Compatible EndoTherapy accessories ... 113 Image parameter setup ... 113

Labeling information for irrigation system ... 115 Backflow-prevention valve ... 115 Distal irrigation system and proximal irrigation system ... 115 Consumable device ... 117 Reusable device ... 117

EMC information ... 118 Acoustic output information in accordance with IEC 60601-2-37 ... 124 Acoustic output table with the Olympus universal endoscopic ultrasound center EU-ME1 ... 125 Acoustic output table with EVIS EUS endoscopic ultrasound center EU-ME2 PREMIER PLUS, EU-ME2 PREMIER, EU-ME2 ... 125

iv

GF-UE190 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: Symbol

Description Refer to instructions.

Caution

TYPE BF applied part

Serial number

Ingress protection rating (except for connectors)

Lock the ultrasound connector

Release the ultrasound connector

Ultrasound endoscope

Single use only

Do not resterilize

Use by (expiration date)

Sterilized using ethylene oxide

Sterilization lot number

Lot number

GF-UE190 OPERATION MANUAL

1

Symbols

Symbol

Description Non-sterile

Keep away from sunlight

Keep dry

Do not use if package is damaged

Contains or Presence of Natural Rubber Latex

Date of manufacture

Manufacturer

Authorized representative in the European Community

UDI Indication

2

GF-UE190 OPERATION MANUAL

Important Information - Please Read Before Use

Important Information - Please Read Before Use

 Intended use This instrument has been designed to be used with diagnostic ultrasound system, video system center, light source, documentation equipment, monitor, EndoTherapy accessories and other ancillary equipment. This instrument is designed for endoscopic real-time ultrasound imaging, and other endoscopic procedures within the upper gastrointestinal tract and surrounding organs.

 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.

GF-UE190 OPERATION MANUAL

3

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 for 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, contact Olympus.

 Terms used in this manual NBI (Narrow Band Imaging) observation This is optical-digital observation using narrowband light.

WLI (White Light Imaging) observation This is observation using white light.

Image sensor The image sensor is a device that converts light into electrical signals.

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 that elastography is available.

4

GF-UE190 OPERATION MANUAL

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 “Combination equipment” on page 109 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 reprocessed 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. The balloons are disposable, and are intended for a single use only; a new one must be used for each patient. Do not attempt to reuse or resterilize a balloon.

 Spare equipment Be sure to prepare another endoscope to avoid interruption of the examination due to equipment failure or malfunction.

GF-UE190 OPERATION MANUAL

5

Important Information - Please Read Before Use

 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 periodically inspect the items specified in this manual following applicable regulations, guidelines, etc. required of you. An endoscope with an observed irregularity should not be used, but should be inspected by following Section 5.2, “Troubleshooting guide”. If the irregularity is still observed 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 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:

WARNING

Indicates a potentially hazardous situation which, if not avoided, could result in death or serious injury.

CAUTION

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.

NOTE

6

Indicates additional helpful information.

GF-UE190 OPERATION MANUAL

Important Information - Please Read Before Use

 Precautions Follow the warnings and cautions given below when handling this endoscope. This information is to be supplemented by the warnings and cautions given in each chapter.

WARNING • Do not use this endoscope for any purpose other than its intended use. Patient or operator injury and/or equipment damage may result. • Never use high-frequency EndoTherapy accessories, because the distal end of this instrument is not isolated. Using high-frequency accessories places the patient at risk of an electric shock. • This endoscope is incompatible with laser cauterization. Performing laser cauterization may cause patient injury and/or equipment damage. • This endoscope has a “forward oblique” view. There is a difference between the direction of view and the insertion direction of the endoscope. The insertion direction appears in the lower portion of the endoscopic view, and the visible area in that direction is limited. Always view the endoscopic image carefully, and insert the endoscope prudently. Otherwise, patient injury may occur. • After using this endoscope, 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. • Do not strike, hit, or drop the distal end, insertion tube, bending section, control section, universal cord, or endoscope connector of the endoscope. Also, do not bend, pull, or twist the 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 may result due to unintended retroflexion of the bending section. It may also become impossible to straighten the bending section during an examination. • Never use EndoTherapy accessories, perform angulation control, air-feeding or suction, insert or withdraw the endoscope’s insertion section while the endoscopic image is frozen on the monitor or without viewing the endoscopic image. Patient injury, bleeding and/or perforation can result. • 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.

GF-UE190 OPERATION MANUAL

7

Important Information - Please Read Before Use

WARNING • 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. • When using the electronic zoom function of the video system center, 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. • 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. • If the endoscopic image becomes dimmer during the procedure, it may indicate that blood or mucus is adhering to the light guide lens on the distal end of the endoscope. Immediately withdraw the endoscope from the patient, remove blood or mucus, and confirm that the light guide lens has no irregularities to use it again. If you continue to use the endoscope with its obstructed light guide lens, the temperature at the distal end of the endoscope may rise, which may cause patient injury or operator and/or patient burns. • When the endoscopic image does not appear on the monitor, the image sensor may have been damaged. Turn the video system center OFF immediately. Continued power supply in such a case will cause the distal end of the endoscope to become hot and could cause operator and/or patient burns. • 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 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 cannot be performed as intended, and patient injury, bleeding, and/or perforation can result. • Never tie the elastic opening of both sides of the balloon with a thread. This may cause the balloon to rupture or come off the distal end of the endoscope when inflating it excessively. This can result in patient injury. • Never withdraw the endoscope while the balloon is still inflated. The balloon may burst or come off the distal end of the endoscope. If the balloon cannot be deflated, insert the channel cleaning brush into the irrigation port. Using slow, short strokes, carefully feed the brush to remove debris. After that, the balloon can be deflated. • When withdrawing the endoscope, make sure that the balloon is completely deflated, using the ultrasound image and endoscopic field of view. Withdrawing the endoscope while the balloon is inflated could result in patient injury.

8

GF-UE190 OPERATION MANUAL

Important Information - Please Read Before Use

WARNING • During the examination, select the appropriate ultrasound-image-direction.  NORMAL: The view from the distal end of the ultrasound endoscope or ultrasound probe.  INVERSE: The view from the insertion direction.

CAUTION • 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 disappear. • Do not coil the insertion tube or universal cord with a diameter of less than 12 cm. Equipment damage may result. • Do not attempt to bend or twist the endoscope’s insertion section with excessive force regardless of its flexibility. The insertion section may be damaged. • Do not apply shock to the distal end of the endoscope, in particular the objective lens surface at the distal end of the endoscope. An abnormal endoscopic image 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 leakage. • Turn the video system center ON only when the endoscope connector is connected to the light source. In particular, confirm that the video system center is OFF before connecting or disconnecting the endoscope connector. Failure to do so can result in equipment damage, including destruction of the image sensor. • 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 leakage. • 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 a faulty contact can result. • If endoscope’s suction is insufficient, select another suction system without using the endoscope and use it according to the directions given in its instruction manual. Otherwise, a proper endoscopic image may not appear on the monitor.

GF-UE190 OPERATION MANUAL

9

Important Information - Please Read Before Use

CAUTION • This endoscope supports radio communication function (receive frequency: 13.56 MHz) that identifies endoscopes. Electromagnetic interference may occur on this endoscope 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 moving the RF communications equipment away, reorienting or relocating this endoscope, or shielding the location.

• Be sure that this endoscope is not used adjacent to or stacked with other equipment (other than the components of this endoscope or system) to avoid electromagnetic interference. • Do not touch the electrical contacts in the ultrasound cable connector. Equipment damage can result. • To prevent unnecessary patient exposure to ultrasound radiation, follow the “as-low-as-reasonably achievable” (ALARA) principle when using Olympus 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.

NOTE All endoscopes listed on the front cover contain a memory chip that stores information about the endoscope and communicates this information to the video system center CV-190, CV-190 PLUS.

10

GF-UE190 OPERATION MANUAL

Important Information - Please Read Before Use

 Precautions for disappeared or frozen endoscopic image WARNING • If the endoscopic image disappears unexpectedly or the frozen image cannot be restored during an examination, immediately stop using the endoscope and withdraw it from the patient as described in Section 5.3, “Withdrawal of the endoscope with an irregularity”. Inserting or withdrawing the endoscope, using EndoTherapy accessories, performing flexibility adjustment, performing suction, feeding air, or performing angulation control under these conditions could result in patient injury, bleeding, and/or perforation. • Follow the precautions given below. Otherwise, the endoscopic image may disappear unexpectedly or the frozen image may not be restored during the examination.  Connect the endoscope connector to the light source completely by pushing the video connector until it clicks. Otherwise, a faulty contact can result.  Do not bend, hit, pull, or twist the insertion section, bending section, control section, universal cord, and endoscope connector. The endoscope may be damaged, and water leakage and/or breakage of internal parts like the cable can result.  Before connecting the endoscope connector to the light source, confirm that the endoscope connector, including the electrical contacts, is completely dry and clean. If the endoscope is used with the electrical contacts wet and/or dirty, the endoscope and light source may malfunction.  If air bubbles emerge from the endoscope continuously during the leakage test, do not use the endoscope. Water may enter the endoscope and cause a short circuit. This may result in image sensor damage.

CAUTION • Turn the video system center ON only when the endoscope connector is connected to the light source. In particular, confirm that the video system center is OFF before connecting or disconnecting the endoscope connector. Failure to do so can result in equipment damage, including destruction of the image sensor. • Do not hit or bend the electrical contacts on the endoscope connector. The connection to the light source may be impaired and a faulty contact can result.

GF-UE190 OPERATION MANUAL

11

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.

WARNING • Over-insufflating the lumen may cause patient pain, injury, bleeding, and/or perforation. • Applying suction with the distal end of the endoscope 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 its usefulness is determined to be greater than the risk that is posed to the patient. Also, do not operate the endoscope forcibly in retroflexed observation. • 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. *1

Narrow Band Imaging. For more details, refer to the instruction manual for the video system center CV-190, CV-190 PLUS.

 Natural rubber latex medical alert Balloons used with this instrument contain natural rubber latex that may cause allergic reactions in some patients. Do not use this instrument on a latex sensitive patient.

12

GF-UE190 OPERATION MANUAL

1.1 Checking the package contents list

Chapter 1

1.1

Checking the Package Contents Ch.1

Checking the package contents list

Match all items in the package with the components shown below. Inspect each item for damage. If the endoscope is damaged, a component is missing, or you have any questions, do not use the items; immediately contact Olympus.

GF-UE190 OPERATION MANUAL

13

1.1 Checking the package contents list

 Endoscope

Ch.1

GF-UE190

14

GF-UE190 OPERATION MANUAL

1.1 Checking the package contents list

 Packaged items for Europe, Australasia, Middle East, and Africa  Accessories Ch.1

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

Single use single-ended cleaning brush (BW-400L, 3 pcs)

Cleaning brush (MAJ-1534)

Injection tube (MH-946)

Channel plug (MAJ-621)

Air/water channel cleaning adapter (MAJ-629)

Suction cleaning adapter (MH-856)

Mouthpiece (MB-142, 2 pcs)

Balloon 2 (MH-303, non-sterile, 20 pcs.)

Balloon applicator (MAJ-864)

US connector cap (MAJ-2295)

Operation manual

Reprocessing manual

Instructions (Suction valve (MAJ-1443), Air/Water valve (MAJ-1444))

GF-UE190 OPERATION MANUAL

15