BF-UC190F BRONCHOVIDEOSCOPE Operation Manual June 2018.pdf
Page 1
OPERATION MANUAL
INSTRUCTIONS
EVIS EUS ULTRASOUND
BRONCHOFIBERVIDEOSCOPE
Symbols
1
Important Information — Please Read Before
Use
3
Chapter 1
Checking the Package Contents
15
Chapter 2
Instrument Nomenclature and
Specifications
19
Chapter 3
Preparation and Inspection
29
Chapter 4
Operation
67
Chapter 5
Troubleshooting
89
OLYMPUS BF-UC190F
Appendix
CAUTION: Balloons used with this product contain natural rubber latex, which may cause allergic reactions.
Refer to the endoscope’s companion manual, the “REPROCESSING MANUAL” with your
endoscope model listed on the cover, for reprocessing information.
97
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Contents
Contents
Symbols .............................................................................................................................. 1
Important Information — Please Read Before Use ......................................................... 3
Intended use .......................................................................................................................... 3
Contraindications ................................................................................................................... 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
Precaution for disappeared or frozen endoscopic image .................................................... 13
Examples of inappropriate handling .................................................................................... 14
Natural rubber latex medical alert ........................................................................................ 14
Chapter 1 Checking the Package Contents ....................................... 15
1.1
Checking the package contents ........................................................................... 15
Packaged items ................................................................................................................... 16
1.2
Ultrasound cable .................................................................................................... 17
Chapter 2 Instrument Nomenclature and Specifications .................. 19
2.1
Nomenclature and functions ................................................................................. 19
Control section, insertion section ......................................................................................... 20
Endoscope connector .......................................................................................................... 24
2.2
Specifications ......................................................................................................... 25
Environment ........................................................................................................................ 25
Specifications ...................................................................................................................... 26
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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 mechanism ................................................................................. 36
3.4
Inspection of accessories ...................................................................................... 38
Inspection of the single use suction valve (MAJ-209) or suction valve
(MAJ-207, optional) .............................................................................................................
Inspection of the single-use adapter biopsy valve (MAJ-1414) ...........................................
Inspection of the single use biopsy valve (MAJ-210, optional) ............................................
Inspection of the mouthpiece (MA-651, optional) ................................................................
3.5
38
39
40
41
Inspection of the ultrasound cable (MAJ-2056, optional) ................................... 42
Inspection of the ultrasound cable (MAJ-2056, optional) .................................................... 42
3.6
Attaching accessories to the endoscope ............................................................. 43
Attaching the single use suction valve (MAJ-209) or suction valve (MAJ-207, optional) .... 43
Attaching the single-use adapter biopsy valve (MAJ-1414) ................................................ 45
Attaching the single use biopsy valve (MAJ-210) ................................................................ 46
3.7
Inspection of ancillary equipment ........................................................................ 46
3.8
Connection of the endoscope and ancillary equipment ..................................... 47
Connection to the light source .............................................................................................
Connection of the suction tube ............................................................................................
Connection of the endoscope and the ultrasound cable (MAJ-2056) ..................................
Connection of the ultrasound cable (MAJ-2056) and the endoscopic ultrasound center ....
Connection of the diagnostic ultrasound system (Hitachi, Ltd.) ProSound F75 ..................
3.9
47
48
48
49
50
Inspection of the endoscopic system .................................................................. 51
Inspection summary ............................................................................................................
Inspection of the ancillary equipment ..................................................................................
Inspection of the endoscopic image ....................................................................................
Inspection of the remote switches .......................................................................................
Inspection of the water feeding function ..............................................................................
Inspection of the suction function ........................................................................................
Inspection of the instrument channel ...................................................................................
Inspection of the water feeding function into the balloon .....................................................
Inspection of the ultrasound image with the Olympus universal endoscopic ultrasound
center EU-ME1 ....................................................................................................................
Inspection of the ultrasound image with the EVIS EUS endoscopic ultrasound center
EU-ME2 PREMIER PLUS, EU-ME2 PREMIER, EU-ME2 ...................................................
Inspection of the ultrasound image with the diagnostic ultrasound system (Hitachi, Ltd.)
ProSound F75 .....................................................................................................................
51
51
52
53
54
55
56
57
58
59
60
3.10 Preparation and inspection of the balloon ........................................................... 61
Attaching the balloon ........................................................................................................... 62
Inspection of the balloon and expelling air .......................................................................... 65
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Contents
Chapter 4 Operation ............................................................................. 67
4.1
Precautions ............................................................................................................. 67
4.2
Insertion .................................................................................................................. 70
Holding and manipulating the endoscope ...........................................................................
Insertion of the endoscope ..................................................................................................
Angulation of the distal end .................................................................................................
Feeding fluids ......................................................................................................................
Suction .................................................................................................................................
Observation of the endoscopic image .................................................................................
Observation of the ultrasound image ...................................................................................
4.3
70
71
73
73
74
75
76
Using EndoTherapy accessories .......................................................................... 77
Insertion of EndoTherapy accessories into the endoscope .................................................
Operation of EndoTherapy accessories ..............................................................................
Withdrawal of EndoTherapy accessories ............................................................................
High-frequency cauterization treatment ...............................................................................
Laser cauterization ..............................................................................................................
Bronchoalveolar lavage .......................................................................................................
79
81
82
82
82
83
4.4
Withdrawal of the endoscope ................................................................................ 84
4.5
Removal of the balloon .......................................................................................... 85
4.6
Transportation of the endoscope ......................................................................... 87
Transporting within the hospital ........................................................................................... 87
Transporting outside the hospital ......................................................................................... 87
Chapter 5 Troubleshooting .................................................................. 89
5.1
Troubleshooting ..................................................................................................... 89
5.2
Troubleshooting guide ........................................................................................... 89
Image quality or brightness .................................................................................................
Water feeding ......................................................................................................................
Suction .................................................................................................................................
EndoTherapy accessories ...................................................................................................
Ultrasound (display monitor image) .....................................................................................
Balloon water feeding and aspiration ..................................................................................
Others ..................................................................................................................................
5.3
90
91
91
91
92
92
93
Withdrawal of the endoscope with an irregularity .............................................. 94
Withdrawal when the WLI endoscopic images appear on the monitor ................................ 94
Withdrawal when no endoscopic image appears on the monitor or a frozen image
cannot be restored ............................................................................................................... 95
5.4
Returning the endoscope for repair ..................................................................... 96
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Contents
Appendix ................................................................................................. 97
Combination equipment .................................................................................................. 97
System chart ........................................................................................................................ 97
Reprocessing equipment ..................................................................................................... 99
Compatible EndoTherapy accessories .............................................................................. 100
Inspection of the endoscope after cleaning, disinfection, or sterilization in
accordance with IEC 60601-2-37 .................................................................................. 101
Inspection of the endoscope after cleaning, disinfection, or sterilization ........................... 101
EMC information ............................................................................................................ 103
Acoustic output information in accordance with IEC 60601-2-37 ............................. 108
Acoustic output table with EVIS EUS endoscopic ultrasound center
EU-ME2 PREMIER PLUS, EU-ME2 PREMIER, EU-ME2 ................................................. 108
Acoustic output table with the Olympus universal endoscopic ultrasound center
EU-ME1 .............................................................................................................................. 112
Acoustic output table with EVIS EUS endoscopic ultrasound center
EU-ME2 PREMIER PLUS, EU-ME2 PREMIER, EU-ME2 .................................................. 113
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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
Single use only
Do not resterilize
Lot number
Use by (expiration date)
Sterilization lot number
Sterilized using irradiation
Manufacturer
Authorized representative in the European Community
Serial number
Ingress protection rating is 7. (except for connectors)
Ultrasound endoscope
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Symbols
Symbol
Description
Keep away from sunlight
Keep dry
Do not use if package is damaged
Contains or Presence of Natural Rubber Latex
Lock the ultrasound cable connector
Release the ultrasound cable connector
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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, display monitor, EndoTherapy accessories such as an
aspiration biopsy needle.
This instrument is designed for endoscopic real-time ultrasound imaging, for performing endoscopic
ultrasound guided needle aspiration within the airways, trancheobronchial tree, esophagus and
surrounding organs.
Contraindications
None known.
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 administrations 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.
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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 the 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
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.
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.
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Important Information — Please Read Before Use
Instrument compatibility
Refer to “Combination equipment” on page 97 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) and edition 3 (IEC 60601-1-2: 2007). 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.
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.
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 following 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.
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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 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
Indicates additional helpful information.
Warnings and cautions
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 indications for use.
Patient or operator injury and/or equipment damage may result.
• 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.
• 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.
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Important Information — Please Read Before Use
WARNING
• This endoscope is incompatible with laser cauterization. Performing laser
cauterization may cause patient injury and/or equipment damage.
• 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.
• 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 perform high-suction continuously. Patient injury 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.
• Never operate the bending section, perform suction, insert or withdraw the
endoscope’s insertion section or use EndoTherapy accessories while no
endoscopic image is observed or the endoscopic image is frozen. Patient injury,
bleeding, and/or perforation may result.
• Never insert or withdraw the endoscope’s insertion section with excessive force or
while an optimum field of view cannot be obtained. 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 insertion section abruptly or with excessive force.
Patient injury, bleeding, and/or perforation may 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.
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Important Information — Please Read Before Use
WARNING
• Although the illumination light emitted from the endoscope’s distal end is required
for endoscopic observation, it may also cause alteration of living tissues such as
protein denaturation of living tissue and perforation of the tissue through improper
usage. Observe the following warnings for illumination.
Always set the minimum required brightness. The brightness of the image on a
monitor may differ from the actual brightness at the distal end of the endoscope.
Pay attention to the brightness level setting of the light source, particularly when
operating the electrical shutter function of a video system center. When using a
light source and video system center that are compatible with the light source’s
automatic brightness control function, make sure to use the automatic
brightness control function. This function can better maintain the illumination
level. Refer to the instruction manual for the light source and the video system
center for further details.
Always maintain a suitable distance necessary for adequate viewing while using
the minimum level of illumination for the minimum amount of time. Do not use
close stationary viewing or leave the distal end of the endoscope close to the
mucous membrane for a long time without necessity.
When the endoscope will not be used for a long period, be sure to turn OFF the
light source or activate the light shield function (standby mode, etc.) so that the
endoscope is not illuminated unnecessarily.
• Do not connect the endoscope connector while the electrical contacts are wet
and/or dirty, which may result in an electric shock, causing severe damage to the
endoscope and compromising patient and/or operator safety.
• 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 the obstructed light guide lens, the
temperature at the distal end 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 to become hot and
could cause operator and/or patient burns.
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Important Information — Please Read Before Use
WARNING
• When performing transnasal insertion with the endoscope, follow the warnings
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 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. Patient injury can result or the endoscope could become
lodged and difficult to withdraw.
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. Patient injury can result or the endoscope could become lodged
and difficult to withdraw.
If it becomes impossible to withdraw the transnasally inserted endoscope,
detach the ultrasound cable from the ultrasound cable connector, 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.
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Important Information — Please Read Before Use
WARNING
• 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 electronically zoomed. Patient injury, bleeding, and/or perforation can
result.
• The bending section will only bend 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.
• 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 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 inflate the balloon to a diameter of more than 20 mm when using the
endoscope in the trachea. This could result in suffocation of the patient.
• Never withdraw the endoscope while the balloon is still inflated. Otherwise, the
balloon may burst or come off the distal end of the endoscope. If the balloon cannot
be deflated, insert the channel cleaning brush (BW-400B) 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.
• If any irregularity in the ultrasound image is observed, turn the endoscopic
ultrasound center OFF immediately. Continued ultrasound radiation will cause the
distal end to become hot and could cause operator and/or patient burns.
• Elastography*1 uses the pulsation of a living body. The intentional pressurization is
not necessary. Compression onto the tissue by operating the bending section and
inserting or withdrawing the endoscope may cause tissue damage, bleeding, or
perforation.
*1 Elastography is not available with the diagnostic ultrasound system (Hitachi, Ltd.)
ProSound F75 in Canada.
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Important Information — Please Read Before Use
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. The insertion section may be damaged.
• Do not apply shock to the distal end of the insertion section, in particular the
objective lens surface at the distal end. Visual irregularities may result.
• If the endoscope is dropped or the distal end of the endoscope receives a hard
impact, the endoscope may be damaged even if no visible damage of the lens on
the distal end can be found. In this case, stop using the endoscope, and contact
Olympus.
• 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.
• Do not put or press the endoscope connector on the insertion section when
transporting or reprocessing. The insertion section may be damaged.
• 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.
• 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.
• 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 reorienting or relocating this endoscope, or shielding the location.
• When using an endotracheal tube with the endoscope, select the tube that gives a
sufficient gap between the insertion section of the endoscope and itself. A narrow
gap may make it difficult for a patient to breathe and/or damage the endoscope.
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Important Information — Please Read Before Use
CAUTION
• Before inserting the endoscope with an endotracheal tube into the patient, confirm
that the insertion section of the endoscope can be inserted to the endotracheal
tube smoothly by running it back and forth over the entire length of the insertion
section and that the tube does not damage the endoscope. Any protrusions may
damage the bending section cover or strip the external surface of the insertion
section. When using lubrication, make above confirmation before applying
lubrication.
• 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.
• Do not pull, twist, or tightly coil the ultrasound cable. Noise can develop in the
ultrasound image.
• 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
• This endoscope contains a memory chip that stores information about the
endoscope and communicates this information to the video system center CV-190.
• When the endoscope gets strong static electricity, noise may be observed in the
endoscopic image. This does not indicate a malfunction.
• It is highly desirable that a backup ultrasound cable be available to continue clinical
procedures in case of a malfunction.
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Important Information — Please Read Before Use
Precaution 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”. Continued use of the endoscope under this
condition 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
endoscope connector until it clicks. Otherwise, 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 leaks and/or breakage of internal parts like the image
sensor 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.
When inserting the endoscope through the mouth, place the mouthpiece in the
patient’s mouth as necessary before inserting the endoscope to prevent the
patient from accidentally biting the insertion section. Biting the insertion section
may result in breakage of the cable or malfunction of the light guide.
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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.
• Applying suction with the distal end in 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. 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. In case the patient
moves due to coughing and other reasons while the endoscope is angulated in the narrow
lumen, the bending section of the endoscope may be pushed into the lumen and be
retroflexed.
Pretreatment to control patient's coughing reflex and other possible unexpected moves is the
responsibility of trained specialists.
Retroflexed observation 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, rotating the insertion section, applying suction, or
operating the bending section without a clear endoscopic image may cause patient injury,
bleeding, and/or perforation.
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.
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1.1 Checking the package contents
Chapter 1
1.1
Checking the Package
Contents
Ch.1
Checking the package contents
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.
Endoscope
BF-UC190F
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1.1 Checking the package contents
Packaged items
Accessories
Ch.1
Suction cleaning adapter
(MAJ-222)
Single use suction valve
(MAJ-209, 20 pcs (1 box))
Single use combination cleaning
brush (BW-411B, 3 pcs)
Single use single-ended cleaning
brush (BW-400B, 3 pcs)
Single-use adapter biopsy valve
(MAJ-1414, 10 pcs, sterile)
Balloon (MAJ-1351, 20 pieces,
sterile)
Balloon applicator (MAJ-1352)
US connector cap (MAJ-2295)
Operation manual
Reprocessing manual
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1.2 Ultrasound cable
1.2
Ultrasound cable
The ultrasound cable (MAJ-2056, optional) is necessary to use this endoscope (BF-UC190F) and may
be purchased from Olympus.
Ch.1
For the Olympus ultrasound center and the diagnostic
ultrasound system (Hitachi, Ltd.) ProSound F75
Endoscope-side
connector
Ultrasound
connector
Ultrasound cable
(MAJ-2056)
Figure 1.1
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1.2 Ultrasound cable
Ch.1
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2.1 Nomenclature and functions
Chapter 2
Instrument Nomenclature
and Specifications
The instrument nomenclature, functions, and specifications are described in this chapter.
2.1
Nomenclature and functions
BF-UC190F OPERATION MANUAL
Ch.2
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2.1 Nomenclature and functions
Control section, insertion section
2
1
Ch.2
3
4
5
6
Distal end
7
8
9
10
11
Top view
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