Olympus UCT180 User manual
INSTRUCTIONS
EVIS EXERA II ULTRASOUND GASTROVIDEOSCOPE
OLYMPUS GF TYPE UCT180
CAUTION : Balloons Used with This Product Contain Natural Rubber Latex, Which May Cause
Allergic Reactions.
USA: CAUTION: Federal law restricts this device to sale by or on the order of a
physician.
Contents
Contents
Symbols......................................................................................... 1
Important Information — Please Read Before Use.................... 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........................................................................ 6
Prohibition of improper repair and modification ........................................ 6
Signal words ............................................................................................. 6
Warnings and cautions.............................................................................. 7
Examples of inappropriate handling ......................................................... 11
Chapter 1 Checking the Package Contents............................ 13
1.1 Standard components..................................................................... 13
1.2 Ultrasonic cable .............................................................................. 15
1.3 Optional components ...................................................................... 15
Chapter 2 Instrument Nomenclature and Specifications ...... 16
2.1 Nomenclature.................................................................................. 16
2.2 Endoscope functions....................................................................... 18
2.3 Specifications.................................................................................. 21
2.4 Attaching the chain for water-resistant cap (MAJ-1739) ................. 25
Chapter 3 Preparation and Inspection .................................... 28
3.1 Preparation of the equipment.......................................................... 29
3.2 Inspection of the endoscope ........................................................... 30
3.3 Preparation and inspection of accessories ..................................... 34
3.4 Attaching accessories to the endoscope ........................................ 38
3.5 Inspection and connection of ancillary equipment .......................... 40
3.6 Inspection of the endoscopic system .............................................. 46
3.7 Preparation and inspection of the balloon....................................... 52
ULTRASOUND GASTROVIDEOSCOPE GF-UCT180
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Contents
Chapter 4 Operation.................................................................. 57
4.1 Insertion .......................................................................................... 59
4.2 Observation of the ultrasound image .............................................. 64
4.3 Using EndoTherapy accessories .................................................... 66
4.4 Withdrawal of the endoscope.......................................................... 73
4.5 Removal of the balloon ................................................................... 74
4.6 Transportation of the endoscope .................................................... 75
Chapter 5 Reprocessing: General Policy................................ 76
5.1 Instructions...................................................................................... 76
5.2 Importance of cleaning, disinfection, and sterilization..................... 76
5.3 Precautions ..................................................................................... 77
5.4 Reprocessing before the first use/reprocessing
and storage after use ...................................................................... 80
Chapter 6 Compatible Reprocessing Methods and
Chemical Agents ..................................................... 81
6.1 Compatibility summary.................................................................... 81
6.2 Detergent solution........................................................................... 83
6.3 Disinfectant solution ........................................................................ 84
6.4 Rinse water ..................................................................................... 84
6.5 Ethylene oxide gas sterilization....................................................... 85
6.6 Steam sterilization (autoclaving) of accessories ............................. 87
Chapter 7 Cleaning, Disinfection, and Sterilization
Procedures .............................................................. 88
7.1 Required reprocessing equipment .................................................. 88
7.2 Cleaning, disinfection, and sterilization
procedures for the endoscope ........................................................ 102
7.3 Precleaning ..................................................................................... 103
7.4 Leakage testing............................................................................... 108
7.5 Manual cleaning .............................................................................. 113
7.6 High-level disinfection ..................................................................... 132
7.7 Rinsing after high-level disinfection................................................. 135
7.8 Sterilization ..................................................................................... 138
7.9 Cleaning, disinfection, and sterilization procedures for reusable
parts and reprocessing equipment.................................................. 139
7.10 Care of the ultrasonic cable (MAJ-1597)......................................... 147
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ULTRASOUND GASTROVIDEOSCOPE GF-UCT180
Contents
Chapter 8 Cleaning and Disinfection Equipment................... 148
Chapter 9 Storage and Disposal.............................................. 151
9.1 Storage of the endoscope............................................................... 152
9.2 Storage of the balloon..................................................................... 152
9.3 Storage of reusable parts and reprocessing equipment ................. 152
9.4 Storage of the ultrasonic cable ....................................................... 153
9.5 Disposal .......................................................................................... 153
Chapter 10 Troubleshooting ...................................................... 154
10.1 Troubleshooting guide .................................................................... 154
10.2 Withdrawal of the endoscope with an irregularity ........................... 159
10.3 Returning the endoscope for repair ................................................ 161
Appendix A: System Chart .......................................................... 163
Appendix B: Inspection of the endoscope after cleaning,
disinfection or sterilization in accordance with
IEC 60601-2-37 ......................................................... 170
Appendix C: EMC Information..................................................... 172
Appendix D: Acoustic Output Information in Accordance
with the FDA Guidance:
“Information for Manufacturers Seeking
Marketing Clearance of Diagnostic Ultrasound
Systems and Transducers” .................................... 177
Symbol key ............................................................................................... 177
Acoustic output table with ALOKA diagnostic ultrasound system ............. 179
Acoustic output table when combined with Olympus universal
endoscopic ultrasound center EU-ME1 .................................................... 182
Clinical measurement accuracy with ALOKA diagnostic
ultrasound system ..................................................................................... 183
Clinical measurement accuracy when combined with Olympus
universal endoscopic ultrasound center EU-ME1 .................................... 183
Appendix E: Acoustic Output Information Accordance with
IEC 60601-2-37 ......................................................... 184
Acoustic output table with ALOKA diagnostic ultrasound system ............ 184
Acoustic output table with Olympus universal endoscopic ultrasound
center EU-ME1 ......................................................................................... 195
ULTRASOUND GASTROVIDEOSCOPE GF-UCT180
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Contents
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ULTRASOUND GASTROVIDEOSCOPE GF-UCT180
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
Ultrasonic endoscope
Single use only
Do not resterilize
Use by (expiration date)
Sterilized using ethylene oxide
Sterilization lot number
Lot number
ULTRASOUND GASTROVIDEOSCOPE GF-UCT180
1
Symbols
Nonsterile
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
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ULTRASOUND GASTROVIDEOSCOPE GF-UCT180
Important Information — Please Read Before Use
Important Information — Please Read
Before Use
Intended use
This instrument has been designed to be used with an Olympus universal
endoscopic ultrasound center or a diagnostic ultrasound system (ALOKA CO.,
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.
ULTRASOUND GASTROVIDEOSCOPE GF-UCT180
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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. Then use the
equipment as instructed.
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 mode:
This is an observation mode using narrow band observation light.
Normal light observation (or WLI (White Light Imaging) observation
mode):
This is an observation mode using the standard white light illumination.
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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ULTRASOUND GASTROVIDEOSCOPE GF-UCT180
Important Information — Please Read Before Use
Instrument compatibility
Refer to the “System chart” in the Appendix to confirm that this instrument is
compatible with the ancillary equipment being used. Using incompatible
equipment can result in patient or operator injury and/or equipment damage.
This instrument complies with EMC standard for medical electrical equipment,
edition 3 (IEC 60601-1-2: 2007). However, when connected with an instrument
that complies with EMC standard for medical electrical equipment, edition 1
(IEC 60601-1-2: 1993), the whole system complies with edition 1.
Reprocessing before the first use/reprocessing and storage after use
This instrument was not cleaned, disinfected, or sterilized before shipment.
Before using this instrument for the first time, reprocess it according to the
instructions given in Chapter 7, “Cleaning, Disinfection, and Sterilization
Procedures”.
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.
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.
ULTRASOUND GASTROVIDEOSCOPE GF-UCT180
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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 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 10.1,
“Troubleshooting guide” on page 154. 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 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.
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ULTRASOUND GASTROVIDEOSCOPE GF-UCT180
Warnings and cautions
Follow the warnings and cautions given below when handling this instrument.
This information is to be supplemented by the warnings and cautions given in
each chapter.
• After using this instrument, reprocess and store it according
• Before endoscopy, remove any metallic objects (watch,
Important Information — Please Read Before Use
to the instructions given in Chapter 7, “Cleaning, Disinfection,
and Sterilization Procedures”. Using improperly or
incompletely reprocessed or stored instruments may cause
patient cross-contamination and/or infection.
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.
• Move the elevator control lever slowly in the opposite
direction of the “ U” direction until it stops and visually
confirm that the portion of the elevator wire extending from
the distal end of the insertion section is not broken or bent. If
the elevator wire is broken or bent, patient injury, bleeding,
and/or perforation could result.
• 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.
ULTRASOUND GASTROVIDEOSCOPE GF-UCT180
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Important Information — Please Read Before Use
• Never operate the bending section, feed air, perform suction,
• Never operate the bending section, feed air, perform suction,
• Never insert or withdraw the insertion section abruptly or with
• Do not touch the light guide of the endoscope connector
• That before each use or after a change of viewing
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.
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.
excessive force. Patient injury, bleeding, and/or perforation
may result.
immediately after removing it from the light source because it
is extremely hot. Operator or patient burns can result.
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. Patient injury,
bleeding, and/or perforation could result.
• When the endoscopic image does not appear on the monitor,
the CCD may have been damaged. Turn the video system
center OFF immediately. Continued power supply in such a
case will cause the distal end to become hot and could cause
operator and/or patient burns.
• Turn ON the diagnostic ultrasound system only when the
ultrasonic cable is connected to both the diagnostic
ultrasound system and the ultrasonic cable connector on the
endoscope. In particular, confirm that the diagnostic
ultrasound system is OFF before connecting or
disconnecting the ultrasonic cable from the ultrasonic cable
connector on the endoscope. Operator injury may result
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.
• Never withdraw the endoscope while the balloon is still
inflated. Otherwise, the balloon may burst or detach from the
distal end of the endoscope. If the balloon cannot be
deflated, insert the channel cleaning brush (BW-7L) into the
balloon channel. Using slow, short strokes, carefully feed the
brush to remove debris.
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ULTRASOUND GASTROVIDEOSCOPE GF-UCT180
Important Information — Please Read Before Use
• 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 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.
• 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 Aloka Medical, Ltd.) in
Canada.
• After using the endoscope reprocess it according to the
instructions given in Chapter 7, “Cleaning, Disinfection, and
Sterilization Procedures”. Using improperly or incompletely
reprocessed, the endoscope’s distal end damage may result.
• Do not pull the universal cord during an examination. The
endoscope connector will be pulled out from the output
socket of the light source and the endoscopic image will not
be visible.
• Do not coil the insertion tube or universal cord with a
diameter of less than 12 cm. Equipment damage can result.
• Do not attempt to bend the endoscope’s insertion section
with excessive force. 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 hold the ultrasonic transducer when holding the
insertion tube. The ultrasonic transducer damage can result
and/or the ultrasonic image will be abnormal.
ULTRASOUND GASTROVIDEOSCOPE GF-UCT180
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Important Information — Please Read Before Use
• Do not twist or bend the bending section with your hands.
• Do not squeeze the bending section forcefully. The covering
• Turn the video system center ON only when the videoscope
• The endoscope’s remote switches cannot be removed from
Equipment damage may result.
of the bending section may stretch or break and cause water
leaks.
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 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 ultrasonic cable
connector. Equipment damage can result.
• Do not pull, twist or tightly coil the ultrasonic cable. Noise can
develop in the ultrasound image.
• 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.
10
• 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.
ULTRASOUND GASTROVIDEOSCOPE GF-UCT180
Important Information — Please Read Before Use
• 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 ultrasonic cable be
available to continue clinical procedures in case of a
malfunction.
• This endoscope contains a memory chip that stores
information about the endoscope and communicates this
information to the video system center CV-160 and CV-180.
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.
ULTRASOUND GASTROVIDEOSCOPE GF-UCT180
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Important Information — Please Read Before Use
• For reasons described below, do not rely on the NBI
alone for primary detection of lesions or to make a decision regarding
any potential diagnostic or therapeutic intervention.
NBI has not been demonstrated to increase the yield or
sensitivity of finding any specific mucosal lesion including
colonic polyps or Barrett’s esophagus.
NBI has not been demonstrated to aid in differentiating
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.
Natural rubber latex medical alert
Balloons used with this instrument contain natural rubber
latex that may cause allergic reactions.
Do not use the balloon on a latex-sensitive patient. Instead,
perform the procedure using “The sterile deaerated water
immersion method” described in Section 4.2, “Observation of
the ultrasound image” on page 64, in Chapter 4, “Operation”.
1
observation mode
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ULTRASOUND GASTROVIDEOSCOPE GF-UCT180
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 Chapter 7, “Cleaning, Disinfection, and Sterilization Procedures”.
ULTRASOUND GASTROVIDEOSCOPE GF-UCT180
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Chapter 1 Checking the Package Contents
Ultrasound endoscope
Balloon 3 for the USA
(MAJ-249 sterile, 20 pcs.)
Balloon for countries other
than the USA (MAJ-213,
nonsterile, 20 pcs.)
Mouthpiece
(MB-142, 2 pcs.)
Single use channel cleaning
brush for the USA
(BW-201T, 3 pcs.
1
)
Channel cleaning brush for
countries other than the USA
(BW-20T, 1 pcs.)
Channel cleaning brush
(BW-7L, 2 pcs.
1
)
Single use single-ended
cleaning brush
(BW-400L, 3 pcs.
1
)
Water-resistant cap
(MH-553, 2 pcs.)
Washing tube
(MH-974)
Chain for water-resistant cap
(MAJ-1739)
Air/water channel cleaning adapter
(MAJ-629)
Instruction manual
Suction cleaning adapter
(MH-856)
Single use channel-opening cleaning
brush for the USA
(MAJ-1339, 3 pcs.
1
)
Channel-opening cleaning brush for
countries other than the USA
(MH-507, 1 pcs.)
Balloon applicator
(MAJ-675)
Biopsy valve
(MAJ-853, nonsterile, 10 pcs.)
Cleaning adapter for instrument
channel port (MAJ-350)
Injection tube
(MH-946)
Channel plug
(MAJ-621)
Cleaning brush
(MAJ-1534)
1 These products may not be available in some areas.
Single use combination
cleaning brush
(BW-412T, 3 pcs.
1
)
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ULTRASOUND GASTROVIDEOSCOPE GF-UCT180
1.2 Ultrasonic cable
Ultrasonic cable
(MAJ-1597)
Endoscope-side
connector
Ultrasound
connector
The ultrasonic cable (MAJ-1597) is necessary to use this endoscope
(GF-UCT180), but it must be purchased separately (optional) from Olympus.
For Olympus universal endoscopic ultrasound center
EU-ME1 and the diagnostic ultrasound system (ALOKA
CO., LTD)
Chapter 1 Checking the Package Contents
1.3 Optional components
The item listed below is optional for countries other than the USA, and may be
purchased from Olympus.
Balloon 3
Balloon 3 is shipped sterile in sets of 20 pieces, enclosed in a resealable
package. The correct model to be used with this endoscope is listed in Table 1.1
below.
Endoscope Balloon 3
GF-UCT180 MAJ-249
Table 1.1
ULTRASOUND GASTROVIDEOSCOPE GF-UCT180
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Chapter 2 Instrument Nomenclature and Specifications
Universal cord
Product number and serial number
Electrical contact points
4. Endoscope connector
Light guide
1. Ultrasonic cable connector
6. Videoscope cable
connector
Water-resistant cap
(MH-553)
2. Suction connector
3. S-cord connector mount
5. Air supply connector
5. Water supply connector
Chapter 2 Instrument Nomenclature
and Specifications
2.1 Nomenclature
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ULTRASOUND GASTROVIDEOSCOPE GF-UCT180
Control
section
Top view
Suction cylinder
11. Air/water valve (MAJ-1444)
9. UP/DOWN angulation lock
7. Elevator control lever
8. UP/DOWN angulation
control knob
18. Color code
17. Elevator channel plug
20. RIGHT/LEFT
angulation
control knob
19. RIGHT/LEFT
angulation lock
Grip section
Boot
Insertion section
Insertion tube
Distal end
14. Bending section
Instrument channel port
12. Instrument channel
Air/water cylinder
Biopsy valve (MAJ-853)
Insertion section limit mark
16. Remote
switches 1 to 4
10. Suction valve (MAJ-1443)
Air/water
nozzle
Detail of distal end
Objective
lens
Forceps
elevator
Instrument
channel
outlet
Light guide
lens
Balloon
attachment
groove
Balloon water
supply port is in
this groove
Ultrasound
transducer
Balloon water
suction port is
in this groove
Chapter 2 Instrument Nomenclature and Specifications
ULTRASOUND GASTROVIDEOSCOPE GF-UCT180
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Chapter 2 Instrument Nomenclature and Specifications
2.2 Endoscope functions
1. Ultrasonic cable connector
Connects the ultrasonic cable of the ultrasound diagnostic equipment to the
endoscope.
2. Suction connector
Connects the endoscope to the suction tube of the suction pump.
3. S-cord connector mount
Connects the endoscope with the Olympus electrosurgical unit via the
S-cord. The S-cord conducts leakage current from the endoscope to the
electrosurgical unit. To connect the S-cord, refer to the instruction manual
for the electrosurgical unit. Connect the fitting part of the chain for
water-resistant cap to this mount, as required (see Section 2.4, “Attaching
the chain for water-resistant cap (MAJ-1739)” on page 25).
4. Endoscope connector
Connects the endoscope to the output socket of the light source and
transmits light from the light source to the endoscope.
5. Water supply connector and air supply connector
Connects the endoscope to the water container via the water container tube
to supply water to the distal end of the endoscope.
6. Videoscope cable connector
Connects the endoscope to the video system center via the videoscope
cable. The endoscope contains a memory chip that stores information about
the endoscope and communicates this information to the video system
center CV-160, CV-180. For more details, refer to the instruction manual for
the CV-160, CV-180.
7. Elevator control lever
When this lever is moved in the “ U” direction, the forceps elevator is
raised; when the lever is moved in the opposite direction, the forceps
elevator is lowered.
8. UP/DOWN angulation control knob
When this knob is turned in the “ U” direction, the bending section moves
UP; when the knob is turned in the “D ” direction, the bending section
moves DOWN.
9. UP/DOWN angulation lock
Moving this lock in the “F ” direction frees angulation. Moving the lock in
the opposite direction locks the bending section at any desired position.
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ULTRASOUND GASTROVIDEOSCOPE GF-UCT180
Chapter 2 Instrument Nomenclature and Specifications
10. Suction valve (MAJ-1443)
The suction valve is depressed to the first stage to activate suction. The
valve is also used to remove any fluid or debris adhering to the objective
lens.
The suction valve is depressed completely to activate suction of sterile
water from the balloon through the balloon channel.
11. Air/water valve (MAJ-1444)
The hole in the air/water valve is covered to insufflate air and the valve is
depressed to the first stage to feed water for lens washing. It also can be
used to feed air to remove any fluid or debris adhering to the objective lens.
The valve is depressed completely to fill the balloon with sterile water
through the balloon channel.
12. Instrument channel
The instrument channel functions as:
channel for the insertion of EndoTherapy accessories
suction channel
Fluid feed channel (from a syringe via the biopsy valve)
13. Insertion section limit mark
This mark shows the maximum point to which the endoscope may be
inserted into the patient’s body.
14. Bending section
This section moves the distal end of the endoscope when the UP/DOWN
and RIGHT/LEFT angulation control knobs are operated.
15. Forceps elevator
The elevator moves EndoTherapy accessories when the elevator control
lever is operated.
16. Remote switches 1 to 4
The functions of remote switches 1 to 4 can be selected on the video system
center. Refer to the instruction manual for the video system center when
setting these functions.
17. Elevator channel plug
This plug is used for connection of the washing tube to clean and disinfect
the elevator channel.
18. Color code (orange)
This code is used to quickly determine the compatibility of EndoTherapy
accessories. The endoscope can be used with EndoTherapy accessories
that have the same color code. For more information on combining the
endoscope with particular EndoTherapy accessories, refer to the “System
chart” in the Appendix and the instruction manuals for the compatible
accessories.
ULTRASOUND GASTROVIDEOSCOPE GF-UCT180
19
Chapter 2 Instrument Nomenclature and Specifications
19. RIGHT/LEFT angulation lock
Turning this lock in the “F ” direction frees angulation. Turning the lock in
the opposite direction locks the bending section at any desired position.
20. RIGHT/LEFT angulation control knob
When this knob is turned in the “R ” direction, the bending section moves
RIGHT; when the knob is turned in the “ L” direction, the bending section
moves LEFT.
20
ULTRASOUND GASTROVIDEOSCOPE GF-UCT180
2.3 Specifications
Environment
Chapter 2 Instrument Nomenclature and Specifications
Operating
environment
Transportation
and storage
environment
Ambient temperature 10 – 40C (50 – 104F)
Relative humidity 30 – 85%
Atmospheric
pressure
Ambient temperature –47 to 70C (–52.6 to 158F)
Relative humidity 10 – 95%
Atmospheric
pressure
700 – 1060 hPa
(0.7 – 1.1 kgf/cm
(10.2 – 15.4 psia)
700 – 1060 hPa
(0.7 – 1.1 kgf/cm
(10.2 – 15.4 psia)
2
)
2
)
ULTRASOUND GASTROVIDEOSCOPE GF-UCT180
21
Chapter 2 Instrument Nomenclature and Specifications
6.
7.
9.
3.
2.
4.
5.
1.
8.
Specifications
Endoscope functions
Model GF-UCT180
Optical system Field of view
100
Direction of view
Depth of field 3 – 100 mm
Insertion tube Distal end outer
diameter
Distal end enlarged 1. Air/water nozzle
55
forward oblique
ø 14.6 mm
2. Objective lens
3. Light guide lens
4. Forceps elevator
5. Instrument channel outlet
6. Ultrasonic transducer
7. Balloon water supply port
8. Balloon suction port
9. Balloon attachment groove
Insertion tube outer
diameter
Working length 1250 mm
Instrument
channel
Airflow rate
22
ULTRASOUND GASTROVIDEOSCOPE GF-UCT180
Channel inner
diameter
Minimum visible
distance
Direction from which
EndoTherapy
accessories enter
and exit the
endoscopic image
6 mm from the objective lens
Note: Standard when CLV-180 (high air
pressure) is used.
ø 12.6 mm
ø3.7mm
3
20 cm
/s
Chapter 2 Instrument Nomenclature and Specifications
Bending
section
Total l e ngth 1555 mm
NBI observation mode
Angulation range
1
UP 130
, DOWN 90,
RIGHT 90
Available
, LEFT 90
1 For more details, refer to the instruction manual for the CV-180.
Ultrasound function with ALOKA diagnostic ultrasound
system SSD-10/ProSound 71/ProSound F75
Operation mode B-mode, M-mode, D-mode, Bflow mode, Powerflow mode
Scanning method Electronic curved linear array
Scanning direction Parallel to the insertion direction
Receiving frequency
Scanning range 180
Contacting method Balloon method, Direct contact method
Transducer surface
max. temperature
5, 6, 7.5, 10 MHz (SSD-10/ProSound F75
4, 6.67, 10, 13.3 MHz (ProSound 7)
43C >
1
1
)
1
1 These products may not be available in some areas.
Ultrasound function with Olympus universal endoscopic
ultrasound center EU-ME1
Operation mode B mode, color flow mode, power flow mode
Scanning method Electronic curved linear array
Scanning direction Parallel to the insertion direction
Receiving frequency 5, 6, 7.5, 10, 12 MHz
Scanning range 180
Contacting method Balloon method, Direct contact method
Transducer surface
max. temperature
43C >
ULTRASOUND GASTROVIDEOSCOPE GF-UCT180
23
Chapter 2 Instrument Nomenclature and Specifications
1912345
General safety
standard for medical
electrical equipment
Medical Devices
Directive
EMC Applied standards;
Year of manufacture
IEC 60601-1: 2005 Whole of this instrument is possible
IEC 60601-1-2: 2007
IEC 60601-2-37: 2007
to contact live bodies of operators or
patients.
This device complies with the
requirements of Directive 93/42/EEC
concerning medical devices.
Classification: Class II a
This instrument complies with the
standards listed in the left column.
CISPR 11 of emission:
Group 1, Class B
This instrument complies with the
EMC standard for medical electrical
equipment, edition 3 (IEC 60601-1-2:
2007). However, when connecting to
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.
The last digit of the year of
manufacture is given in the second
digit of the serial number.
24
Degree of protection
against electric
shock
Ingress protection
rating
IPX7 This instrument complies with the
TYPE BF applied part
standards for medical electrical
equipment: IEC 60601-1: 2005
IEC 60601-2-37: 2007.
ULTRASOUND GASTROVIDEOSCOPE GF-UCT180
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