Olympus GF Type UCT180 User Manual
Uploaded by
Jimena Lopez CardenasOlympus GF Type UCT180 User Manual
Uploaded by
Jimena Lopez CardenasINSTRUCTIONS
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 i
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
ii 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 iii
Contents
iv 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
2 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 3
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.
4 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 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 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.
6 ULTRASOUND GASTROVIDEOSCOPE GF-UCT180
Important Information — Please Read Before Use
Warnings and cautions
Follow the warnings and cautions given below when handling this instrument.
This information is to be supplemented by the warnings and cautions given in
each chapter.
• After using this instrument, reprocess and store it according
to the instructions given in Chapter 7, “Cleaning, Disinfection,
and Sterilization Procedures”. Using improperly or
incompletely reprocessed or stored instruments may cause
patient cross-contamination and/or infection.
• Before endoscopy, remove any metallic objects (watch,
glasses, necklace, etc.) from the patient. Performing
high-frequency cauterization treatment while the patient is
wearing metallic objects may cause burns on the patient in
areas around the metallic objects.
• 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 7
Important Information — Please Read Before Use
• Never operate the bending section, feed air, perform suction,
insert or withdraw the endoscope’s insertion section, or use
EndoTherapy accessories without viewing the endoscopic
image. Patient injury, bleeding, and/or perforation may result.
• Never operate the bending section, feed air, perform suction,
insert or withdraw the endoscope’s insertion section, or use
EndoTherapy accessories while the image is frozen. Patient
injury, bleeding, and/or perforation may result.
• Never insert or withdraw the insertion section abruptly or with
excessive force. Patient injury, bleeding, and/or perforation
may result.
• Do not touch the light guide of the endoscope connector
immediately after removing it from the light source because it
is extremely hot. Operator or patient burns can result.
• That 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. 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.
8 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 9
Important Information — Please Read Before Use
• Do not twist or bend the bending section with your hands.
Equipment damage may result.
• Do not squeeze the bending section forcefully. The covering
of the bending section may stretch or break and cause water
leaks.
• Turn the video system center ON only when the videoscope
cable is connected to both the video system center and the
videoscope cable connector on the endoscope. In particular,
confirm that the video system center is OFF before
connecting or disconnecting the videoscope cable from the
electrical connector on the endoscope. Failure to do so can
result in equipment damage, including destruction of the
CCD.
• The endoscope’s remote switches cannot be removed from
the control section. Pressing, pulling, or twisting them with
excessive force can break the switches and/or cause water
leaks.
• If remote switch 1 does not return to the OFF position after
being pressed strongly from the side, gently pull the switch
upwards to return it to the OFF position.
• Do not hit or bend the electrical contacts on the endoscope
connector. The connection to the light source may be
impaired and faulty contact can result.
• Do not touch the electrical contacts in the 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.
• 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.
10 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 11
Important Information — Please Read Before Use
• For reasons described below, do not rely on the NBI1 observation mode
alone for primary detection of lesions or to make a decision regarding
any potential diagnostic or therapeutic intervention.
NBI has not been demonstrated to increase the yield or
sensitivity of finding any specific mucosal lesion including
colonic polyps or Barrett’s esophagus.
NBI has not been demonstrated to aid in differentiating
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”.
12 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 13
Chapter 1 Checking the Package Contents
Ultrasound endoscope
Mouthpiece
(MB-142, 2 pcs.)
Balloon 3 for the USA
(MAJ-249 sterile, 20 pcs.)
Balloon for countries other
than the USA (MAJ-213, Cleaning brush
nonsterile, 20 pcs.) (MAJ-1534)
Injection tube
Channel plug (MH-946)
(MAJ-621)
Single use channel cleaning Channel cleaning brush
brush for the USA (BW-7L, 2 pcs.1)
(BW-201T, 3 pcs.1) Single use single-ended
Channel cleaning brush for cleaning brush
Cleaning adapter for instrument
countries other than the USA (BW-400L, 3 pcs.1)
(BW-20T, 1 pcs.) channel port (MAJ-350)
Single use channel-opening cleaning
brush for the USA
(MAJ-1339, 3 pcs.1) Biopsy valve
Single use combination Channel-opening cleaning brush for (MAJ-853, nonsterile, 10 pcs.)
cleaning brush countries other than the USA
(BW-412T, 3 pcs.1) (MH-507, 1 pcs.)
Balloon applicator Water-resistant cap Suction cleaning adapter Air/water channel cleaning adapter
(MAJ-675) (MH-553, 2 pcs.) (MH-856) (MAJ-629)
Chain for water-resistant cap
Washing tube
(MAJ-1739) Instruction manual
(MH-974)
1 These products may not be available in some areas.
14 ULTRASOUND GASTROVIDEOSCOPE GF-UCT180
Chapter 1 Checking the Package Contents
1.2 Ultrasonic cable
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)
Endoscope-side
connector
Ultrasound
connector
Ultrasonic cable
(MAJ-1597)
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 15
Chapter 2 Instrument Nomenclature and Specifications
Chapter 2 Instrument Nomenclature
and Specifications
2.1 Nomenclature
Universal cord
1. Ultrasonic cable connector
2. Suction connector
3. S-cord connector mount
4. Endoscope connector
5. Air supply connector
5. Water supply connector
Water-resistant cap
(MH-553) Product number and serial number
6. Videoscope cable Electrical contact points
connector
Light guide
16 ULTRASOUND GASTROVIDEOSCOPE GF-UCT180
Chapter 2 Instrument Nomenclature and Specifications
9. UP/DOWN angulation lock
8. UP/DOWN angulation
control knob
Suction cylinder
7. Elevator control lever
10. Suction valve (MAJ-1443)
11. Air/water valve (MAJ-1444)
20. RIGHT/LEFT
angulation
control knob
19. RIGHT/LEFT Air/water cylinder
angulation lock
Control
section
Grip section
18. Color code
17. Elevator channel plug Biopsy valve (MAJ-853)
12. Instrument channel
Instrument channel port
Boot
Insertion section limit mark
Insertion section Ultrasound
transducer
Air/water
Balloon water nozzle
supply port is in
16. Remote this groove Objective
switches 1 to 4 lens
Balloon
attachment
groove Forceps
elevator
Light guide
Top view lens
Insertion tube Instrument
Balloon water channel
14. Bending section suction port is outlet
in this groove
Distal end
Detail of distal end
ULTRASOUND GASTROVIDEOSCOPE GF-UCT180 17
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.
18 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
Chapter 2 Instrument Nomenclature and Specifications
2.3 Specifications
Environment
Operating Ambient temperature 10 – 40C (50 – 104F)
environment Relative humidity 30 – 85%
Atmospheric 700 – 1060 hPa
pressure (0.7 – 1.1 kgf/cm2)
(10.2 – 15.4 psia)
Transportation Ambient temperature –47 to 70C (–52.6 to 158F)
and storage Relative humidity 10 – 95%
environment
Atmospheric 700 – 1060 hPa
pressure (0.7 – 1.1 kgf/cm2)
(10.2 – 15.4 psia)
ULTRASOUND GASTROVIDEOSCOPE GF-UCT180 21
Chapter 2 Instrument Nomenclature and Specifications
Specifications
Endoscope functions
Model GF-UCT180
Optical system Field of view 100
Direction of view 55 forward oblique
Depth of field 3 – 100 mm
Insertion tube Distal end outer
ø 14.6 mm
diameter
Distal end enlarged 1. Air/water nozzle
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
6. 1.
7. 8.
9. 2.
3.
5. 4.
Insertion tube outer
ø 12.6 mm
diameter
Working length 1250 mm
Instrument Channel inner
ø 3.7 mm
channel diameter
Minimum visible
6 mm from the objective lens
distance
Direction from which
EndoTherapy
accessories enter
and exit the
endoscopic image
Airflow rate 20 cm3/s
Note: Standard when CLV-180 (high air
pressure) is used.
22 ULTRASOUND GASTROVIDEOSCOPE GF-UCT180
Chapter 2 Instrument Nomenclature and Specifications
Bending Angulation range UP 130, DOWN 90,
section RIGHT 90, LEFT 90
Total length 1555 mm
NBI observation mode1 Available
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 F751
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 5, 6, 7.5, 10 MHz (SSD-10/ProSound F751)
4, 6.67, 10, 13.3 MHz (ProSound 7)1
Scanning range 180
Contacting method Balloon method, Direct contact method
Transducer surface
43C >
max. temperature
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
43C >
max. temperature
ULTRASOUND GASTROVIDEOSCOPE GF-UCT180 23
Chapter 2 Instrument Nomenclature and Specifications
General safety IEC 60601-1: 2005 Whole of this instrument is possible
standard for medical to contact live bodies of operators or
electrical equipment patients.
Medical Devices This device complies with the
Directive requirements of Directive 93/42/EEC
concerning medical devices.
Classification: Class II a
EMC Applied standards; This instrument complies with the
IEC 60601-1-2: 2007 standards listed in the left column.
IEC 60601-2-37: 2007
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.
Year of manufacture 1912345
The last digit of the year of
manufacture is given in the second
digit of the serial number.
Degree of protection
against electric TYPE BF applied part
shock
Ingress protection IPX7 This instrument complies with the
rating standards for medical electrical
equipment: IEC 60601-1: 2005
IEC 60601-2-37: 2007.
24 ULTRASOUND GASTROVIDEOSCOPE GF-UCT180
Chapter 2 Instrument Nomenclature and Specifications
2.4 Attaching the chain for water-resistant cap
(MAJ-1739)
• Do not lift the endoscope by the chain for water-resistant cap.
Doing so may result in the fitting part of the chain detaching
from the S-cord connector mount, causing the endoscope to
fall. This could cause operator or patient injury and/or
equipment damage.
• Connect the fitting part only to the S-cord connector mount.
Connecting the fitting part to the suction connector may
impair the connection of the suction tube to the suction
connector. It may also cause the suction tube to become
disconnected from the endoscope and allow patient debris to
spray.
• The chain for water-resistant cap and water-resistant cap
itself cannot be ultrasonically cleaned; doing so could
damage them. The water-resistant cap with the chain can
only be ultrasonically cleaned if connected to endoscopes
that are being cleaned in an endoscope reprocessor (such as
OER1, OER-A1) with an ultrasonic cleaning phase.
1 These products may not be available in some areas.
• Connecting the fitting part to the suction connector may
impair the connection of the suction tube to the suction
connector. It may also cause the suction tube to become
disconnected from the endoscope and allow patient debris to
spray.
• When attaching the water-resistant cap to the connector of
the endoscope, do not pinch the chain for water-resistant cap
between the connector of the endoscope and the
water-resistant cap. Otherwise, equipment damage may
result.
• The chain for water-resistant cap and water-resistant cap
cannot be steam sterilized (autoclaved); doing so can
damage them severely.
ULTRASOUND GASTROVIDEOSCOPE GF-UCT180 25
Chapter 2 Instrument Nomenclature and Specifications
Notch
Fitting part
Chain part
Connecting plate
Hole
Figure 2.1
To ensure that you do not forget to attach the water-resistant
cap, it is recommended that you connect the chain for
water-resistant cap to the endoscope’s S-cord connector
mount.
1. Confirm that the chain for water-resistant cap is free from cracks, flaws,
wear, deformation, or other damages (see Figure 2.1).
2. Align the notch on the connecting plate with the pin on the venting connector
of the water-resistant cap (MH-553, see Figure 2.2).
3. Place the connecting plate over the venting connector (see Figure 2.2).
4. Confirm that the connecting plate is securely attached to the foot of the
venting connector and can be smoothly rotated.
5. Place the hole on the fitting part over the endoscope’s S-cord connector
mount.
Connecting plate Notch
Pin
Venting connector
Water-resistant cap
Figure 2.2
26 ULTRASOUND GASTROVIDEOSCOPE GF-UCT180
Chapter 2 Instrument Nomenclature and Specifications
The instructions on the remaining pages of this manual are
given under the assumption that the chain for water-resistant
cap is detached from the endoscope.
ULTRASOUND GASTROVIDEOSCOPE GF-UCT180 27
Chapter 3 Preparation and Inspection
Chapter 3 Preparation and Inspection
Before each procedure, prepare and inspect this instrument as instructed below.
Inspect other equipment to be used with this instrument as described in their
respective instruction manuals. If this instrument malfunctions, do not use it.
Return it to Olympus for repair as described in Section 10.3, “Returning the
endoscope for repair” on page 161. If any irregularities are suspected after
inspection, follow the instructions given in Chapter 10, “Troubleshooting”.
• 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”.
• Using an instrument that is not functioning properly may
compromise patient or operator safety and may result in
more severe equipment damage.
Do not pull the universal cord or the ultrasonic cable with
excessive force when the endoscope is connected to the
other equipment. Doing so could cause equipment damage.
28 ULTRASOUND GASTROVIDEOSCOPE GF-UCT180
Chapter 3 Preparation and Inspection
3.1 Preparation of the equipment
Prepare the equipment shown in Figure 3.1 (for compatibility, see the “System
chart” in the Appendix) and personal protective equipment, such as eyewear,
face mask, moisture-resistant clothing, and chemical-resistant gloves that fit
properly and are long enough so that your skin is not exposed. Refer to the
respective instruction manuals for each piece of equipment.
Monitor
Olympus universal endoscopic
ultrasound center EU-ME1 or
Video system center ALOKA diagnostic ultrasound
system
Ultrasonic cable
Light source
Water container
Suction pump
Ultrasound endoscope
mouthpiece EndoTherapy accessories
• Paper towels • Trays • Lint-free cloths • Personal protective equipment
• 3-way stopcock • Syringe • Extension tube • Sterile deaerated water
• Medical-grade, water-soluble lubricant
Figure 3.1
ULTRASOUND GASTROVIDEOSCOPE GF-UCT180 29
Chapter 3 Preparation and Inspection
3.2 Inspection of the endoscope
Clean and disinfect or sterilize the endoscope as described in Chapter 7,
“Cleaning, Disinfection, and Sterilization Procedures” and Chapter 8, “Cleaning
and Disinfection Equipment” of this manual. Then remove the water-resistant
cap from the endoscope connector.
Inspection of the endoscope
1. Inspect the control section and the endoscope connector for excessive
scratching, deformation, loose parts, or other irregularities.
2. Inspect the boot and the insertion section near the boot for bends, twists, or
other irregularities.
3. Inspect the external surface of the entire insertion section including the
bending section and the distal end for dents, bulges, swelling, scratches,
holes, sagging, transformation, bends, adhesion of foreign bodies, missing
parts, protruding objects, or other irregularities.
4. Gently holding the insertion section with one hand, carefully run your other
hand back and forth over the entire length of the insertion section (see
Figure 3.2). Confirm that no objects or metallic wire protrude from the
insertion section. Also, confirm that the insertion tube is not abnormally rigid.
Figure 3.2
30 ULTRASOUND GASTROVIDEOSCOPE GF-UCT180
Chapter 3 Preparation and Inspection
5. Using both hands, bend the insertion tube of the endoscope into a
semicircle. Then, moving your hands as shown by the arrows in Figure 3.3,
confirm that the entire insertion tube can be smoothly bent to form a
semicircle and that the insertion tube is pliable.
Figure 3.3
6. Gently hold the midpoint of the bending section and a point 20 cm from the
distal end. Push and pull gently to confirm that the junction between the
bending section and the insertion tube is not loose.
7. Inspect the objective lens and light guide lens at the distal end of the
endoscope’s insertion section for scratches, cracks, stains, or other
irregularities.
8. Inspect the air/water nozzle at the distal end of the endoscope’s insertion
section for abnormal swelling, bulges, dents, or other irregularities.
9. Inspect the ultrasound transducer surface at the distal end of the
endoscope’s insertion tube for scratching, cracks, bulges, dents or other
irregularities.
Inspection of the bending mechanisms
Perform the following inspections while the bending section is straight.
If the movement of the UP/DOWN angulation lock,
RIGHT/LEFT angulation lock, and the angulation control
knobs are loose and/or not smooth, or the bending section
does not angulate smoothly, the bending mechanism may be
abnormal. In this case, do not use the endoscope because it
may be impossible to straighten the bending section during
an examination.
ULTRASOUND GASTROVIDEOSCOPE GF-UCT180 31
Chapter 3 Preparation and Inspection
Inspection for smooth operation
1. Confirm that both the UP/DOWN and RIGHT/LEFT angulation locks move
all the way in the “F ” direction.
2. Turn the UP/DOWN and RIGHT/LEFT angulation control knobs slowly in
each direction until they stop, and return them to their respective neutral
positions. Confirm that the bending section angulates smoothly and
correctly, that maximum angulation can be achieved, and that the bending
section returns to its neutral position.
3. When the UP/DOWN and RIGHT/LEFT angulation control knobs are turned
to their respective neutral positions as shown in Figure 3.4, confirm that the
bending section returns smoothly to an approximately straight condition.
Figure 3.4
Inspection of the UP/DOWN angulation mechanism
1. Move the UP/DOWN angulation lock all the way in the opposite direction of
the “F ” mark. Then turn the UP/DOWN angulation control knob in the
“ U” or the “D ” direction until it stops.
2. Confirm that the angle of the bending section is roughly stabilized when the
UP/DOWN angulation control knob is released.
3. Confirm that the bending section straightens out when the UP/DOWN
angulation lock is moved all the way in the “F ” direction and the
UP/DOWN angulation control knob is released.
32 ULTRASOUND GASTROVIDEOSCOPE GF-UCT180
Chapter 3 Preparation and Inspection
Inspection of the RIGHT/LEFT angulation mechanism
1. Turn the RIGHT/LEFT angulation lock all the way in the opposite direction of
the “F ” mark. Then turn the RIGHT/LEFT angulation control knob in the
“R ” or the “ L” direction until it stops.
2. Confirm that the angle of the bending section is roughly stabilized when the
RIGHT/LEFT angulation control knob is released.
3. Confirm that the bending section straightens out when the RIGHT/LEFT
angulation lock is turned in the “F ” direction and the RIGHT/LEFT
angulation control knob is released.
Inspection of the forceps elevator mechanism
Perform the following inspections while the bending section is straight.
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.
Inspection for smooth operation
1. Move the elevator control lever slowly all the way in the opposite direction of
the “ U” direction. Visually confirm that the portion of the elevator wire
extending from the distal end of the insertion section is not broken or bent
(see Figure 3.5).
2. While observing the forceps elevator at the distal end of the insertion
section, slowly move the elevator control lever all the way in the “ U”
direction. Confirm that the lever can be operated smoothly and that the
forceps elevator is raised smoothly. Also confirm that the forceps elevator
remains stationary when pushed from behind while holding the elevator
control lever stationary (see Figure 3.5).
3. Move the elevator control lever slowly all the way in the opposite direction of
the “ U” direction. Confirm that the lever can be operated smoothly and
that the forceps elevator is lowered smoothly (see Figure 3.5).
ULTRASOUND GASTROVIDEOSCOPE GF-UCT180 33
Chapter 3 Preparation and Inspection
Elevator control lever
Forceps elevator
Figure 3.5
3.3 Preparation and inspection of accessories
Clean and disinfect or sterilize the air/water valve, suction valve, biopsy valve as
described in Chapter 7, “Cleaning, Disinfection, and Sterilization Procedures”.
Inspection of the air/water and suction valves
Confirm that the top hole of the air/water valve is not blocked
(see Figure 3.6). If the hole is blocked, air is fed continuously
and patient pain, bleeding, and/or perforation can result.
1. Confirm that the holes of the valves are not blocked (see Figures 3.6 and
3.7).
2. Confirm that the valves are not deformed or cracked (see Figures 3.6 and
3.7).
3. Check for excessive scratching or tears in the air/water valve’s seals (see
Figure 3.6).
34 ULTRASOUND GASTROVIDEOSCOPE GF-UCT180
Chapter 3 Preparation and Inspection
Hole
Cap
Spring Skirt
Top view
Packings
Seal
Air/water valve (MAJ-1444)
Figure 3.6
Cap
Spring
Skirt
Packing
Hole
Suction valve (MAJ-1443)
Figure 3.7
The air/water and suction valves are consumables. If the
inspection of the air/water or suction valve reveals any
irregularity, use new valves.
ULTRASOUND GASTROVIDEOSCOPE GF-UCT180 35
Chapter 3 Preparation and Inspection
Inspection of the biopsy valve
The biopsy valve is a consumable that should be inspected
as follows before each use. Replace it with a new one if any
irregularity is observed during the inspection. An irregular,
abnormal, or damaged valve can reduce the efficacy of the
endoscope’s suction system, and may leak or spray patient
debris or fluids, posing an infection control risk.
1. Confirm that the slit and hole on the biopsy valve have no splits, cracks,
deformations, discoloration, or other damage (see Figure 3.8).
Normal Abnormal
Slit Discoloration
Hole
Cap Main body Splits, cracks
Figure 3.8
2. Attach the cap to the main body (see Figure 3.9).
Slit
Cap Main body
Figure 3.9
36 ULTRASOUND GASTROVIDEOSCOPE GF-UCT180
Chapter 3 Preparation and Inspection
Inspection of the mouthpiece
Do not use a mouthpiece that is damaged, deformed, or
reveals other irregularities. Doing so may cause patient injury
and/or equipment damage.
Placing the mouthpiece in the patient’s mouth before the
procedure prevents the patient from biting and/or damaging
the endoscope’s insertion section.
1. Confirm that the mouthpiece is free from cracks, deformations, or
discoloration (see Figure 3.10).
2. Using your fingers, check all surfaces of the mouthpiece for scratches,
cracks, or other irregularities (see Figure 3.10).
Opening
Outer flange
Main body
Figure 3.10
ULTRASOUND GASTROVIDEOSCOPE GF-UCT180 37
Chapter 3 Preparation and Inspection
3.4 Attaching accessories to the endoscope
The air/water valve and the suction valve do not require
lubrication. Lubricants can cause swelling of the valves’
seals, which will impair valve function.
Attaching the suction valve
Attach the suction valve (MAJ-1443) to the suction cylinder of the endoscope
(see Figure 3.11). Confirm that valve is fitted properly without any bulging of the
skirt.
Suction valve
Skirt
Moving surface Suction cylinder
Figure 3.11
The suction valve will make a whistling noise when it is dry;
this does not indicate a malfunction.
38 ULTRASOUND GASTROVIDEOSCOPE GF-UCT180
Chapter 3 Preparation and Inspection
Attaching the air/water valve
Attach the air/water valve (MAJ-1444) to the air/water cylinder of the endoscope
(see Figure 3.12). Confirm that valve is fitted properly without any bulging of the
skirt.
Air/water valve
Skirt
Air/water cylinder
Figure 3.12
The air/water valve may stick at first, but it should operate
smoothly after it is depressed a few times.
Attaching the biopsy valve
If a biopsy valve is not properly connected to the instrument
channel port, it can reduce the efficacy of the endoscope’s
suction system, and leak or spray patient debris, posing an
infection control risk.
Attach the biopsy valve to the instrument channel port of the endoscope (see
Figure 3.13). Confirm that the biopsy valve fits properly.
Biopsy valve
Instrument
channel port
Figure 3.13
ULTRASOUND GASTROVIDEOSCOPE GF-UCT180 39
Chapter 3 Preparation and Inspection
3.5 Inspection and connection of ancillary
equipment
Inspection of ancillary equipment
• Attach the water container to the specified receptacle on the
trolley (cart) or the light source. If the water container is
attached anywhere else, water may drip from the water
container’s water supply tube, and equipment malfunction
can result.
• Take care not to spill water from the water container’s
connection adapter when detaching the connection adapter
from the endoscope. Spilled water could splash on the
equipment, and may cause equipment malfunction.
1. Prepare and inspect the light source, video system center, ultrasound
diagnostic equipment, monitor, water container, suction pump, and
EndoTherapy accessories as described in their respective instruction
manuals.
2. Confirm that there are no scratches, cracks, excessive wear, or deformation
of the ultrasonic cable.
Connection of the ultrasonic cable (MAJ-1597) and Olympus
universal endoscopic ultrasound center
Insert the ultrasonic connector properly into the transducer port of the Olympus
universal endoscopic ultrasound center. Rotate the connector’s lock handle 1/4
turn clockwise (see Figure 3.14).
Figure 3.14
40 ULTRASOUND GASTROVIDEOSCOPE GF-UCT180
Chapter 3 Preparation and Inspection
Connection of the ultrasonic cable (MAJ-1597) and ALOKA
diagnostic ultrasound system
Insert the ultrasound connector properly into the transducer port of the
diagnostic ultrasound system. Rotate the connector’s lock handle 1/4 turn
clockwise (see Figure 3.15).
Connect the Ultrasound connector to one of the probe
connectors on the lower side (PROBE 3 or 4) of the
ProSound F75 (see Figure 3.15).
If the Ultrasound connector is connected to one of the probe
connectors on the upper side (PROBE 1 or 2) , the operation
panel of the ProSound F75 may hit the Ultrasound connector,
which may result in the equipment damage. When adjusting
the height, a horizontal and / or vertical position of the
operation panel of the ProSound F75 with the Ultrasound
connector connected to the PROBE 1 or 2, move slowly the
operation panel with visually confirming the position of the
bottom of the operation panel.
ULTRASOUND GASTROVIDEOSCOPE GF-UCT180 41
Chapter 3 Preparation and Inspection
SSD-10
Transducer port Ultrasound connector
Lock handle
ProSound 71
Ultrasonic connector
Lock handle
ProSound F751
PROBE 2 PROBE 1
PROBE 3
PROBE 4
Lock handle
Ultrasound connector
1 These products may not be available in some areas.
Figure 3.15
42 ULTRASOUND GASTROVIDEOSCOPE GF-UCT180
Chapter 3 Preparation and Inspection
Connection of the endoscope and ancillary equipment
Firmly connect the suction tube from the suction pump to the
suction connector on the endoscope connector. If the suction
tube is not attached properly, debris may drip from the tube
and can pose an infection control risk, cause equipment
damage, and/or reduce suction capability.
The electrical contacts inside the ultrasound connector may
be damaged by handling. Do not touch the electrical
contacts. If electrical contacts are dirty, wipe the contacts with
a soft and lint-free cloth.
1. If any ancillary equipment is ON, turn it OFF.
2. Insert the endoscope connector completely into the output socket of the light
source.
3. Make sure that the inside of the videoscope cable connector is dry and free
of debris.
4. Place the water container’s water supply channel onto the water supply
connector on the endoscope connector at an angle of 90 and push it in until
it stops (see Figure 3.16 (1)).
5. Turn the water container’s connection adapter 90 clockwise to align the air
supply channel with the air supply connector of the endoscope connector
(see Figure 3.16 (2)).
6. Push the water container’s connection adapter again until it stops (see
Figure 3.16 (3)).
7. Confirm that the water container’s connection adapter fits properly and that
it cannot be rotated (see Figure 3.16 (4)).
ULTRASOUND GASTROVIDEOSCOPE GF-UCT180 43
Chapter 3 Preparation and Inspection
(1) (2) (3) (4)
Air supply connector
Water supply connector
Water container’s connection adapter
Endoscope connector
Air supply channel
Metal tip
Water supply channel
Figure 3.16
8. Align the mark on the videoscope cable with mark 1 on the endoscope
connector and push it in until it stops (see Figure 3.17).
Mark (gray)
Mark 1 (gray) Mark 2 (gray)
Figure 3.17
9. Turn the connector of the videoscope cable towards mark 2 until it stops
(see Figure 3.17).
10. Confirm that the mark on the videoscope cable is aligned with mark 2 on the
endoscope connector.
44 ULTRASOUND GASTROVIDEOSCOPE GF-UCT180
Chapter 3 Preparation and Inspection
11. Connect the suction tube from the suction pump to the suction connector on
the endoscope connector (see Figure 3.18).
Suction pump
Suction connector
Suction tube
Figure 3.18
Connection of the endoscope and ultrasonic cable
The electrical contacts inside the ultrasound connector have
sharp tips and may be damaged by handling. Do not touch
the electrical contacts.
For more information on combining the endoscope with the
ultrasonic cable, refer to the “System chart” in the Appendix.
When connect the endoscope-side connector of the
ultrasonic cable to the ultrasonic cable connector, do not
entwine the universal cord with the ultrasonic cable.
Equipment damage can result.
1. Make sure that the inside of the ultrasonic cable connector is dry and free of
debris.
2. Align the mark on the ultrasonic cable with mark A on the ultrasound
connector and push it until it stops (see Figure 3.19).
3. Turn the endoscope-side connector of the ultrasonic cable clockwise until it
stops (see Figure 3.19).
4. Confirm that the mark on the ultrasonic cable is aligned with mark B on the
endoscope connector (see Figure 3.19).
ULTRASOUND GASTROVIDEOSCOPE GF-UCT180 45
Chapter 3 Preparation and Inspection
Mark B (red) Mark B (red)
Mark A (red)
Mark A (red)
Mark (red)
Mark (red)
Endoscope-side connector of the ultrasonic cable
Figure 3.19
3.6 Inspection of the endoscopic system
Inspection of the endoscopic image
Do not stare directly into the distal end of the endoscope
while the examination light is ON. Otherwise, eye injury may
result.
1. Turn the video system center, light source, and monitor ON and inspect the
WLI and NBI endoscopic image as described in their respective instruction
manuals.
2. Confirm that light is output from the endoscope’s distal end.
3. While observing the palm of your hand, confirm that the WLI and NBI
endoscopic image is free from noise, blur, fog, or other irregularities.
4. Angulate the endoscope and confirm that the WLI and NBI endoscopic
image does not momentarily disappear or display any other irregularities.
If the object cannot be seen clearly, wipe the objective lens
using a clean, lint-free cloth moistened with 70% ethyl or
isopropyl alcohol.
46 ULTRASOUND GASTROVIDEOSCOPE GF-UCT180
Chapter 3 Preparation and Inspection
Inspection of the remote switches
All remote switches should be checked prior to the
examination, even when they are not expected to be used.
The endoscopic image may freeze, or other irregularities
may occur during examination and may cause patient injury,
bleeding, and/or perforation.
Depress every remote switch and confirm that the specified functions work
normally.
Inspection of the air-feeding function
1. Set the airflow regulator on the light source to “High”, as described in the
light source’s instruction manual.
2. Immerse the distal end of the insertion section in sterile water to a depth of
10 cm and confirm that no air bubbles are emitted when the air/water valve
is not operated.
3. Cover the hole in the air/water valve with your finger and confirm that air
bubbles are continuously emitted from the air/water nozzle.
4. Uncover the hole in the air/water valve and confirm that no air bubbles are
emitted from the air/water nozzle.
If a stream of air bubbles is emitted from the air/water nozzle
even though the air/water valve is not being operated and the
distal end of the insertion section is 10 cm or more below the
surface of the sterile water, there may be an irregularity in the
air-feeding function. If the endoscope is used while air is
continuously fed, over-insufflation and patient injury may
result. If air bubbles are emitted from the air/water nozzle,
remove and reattach the air/water valve correctly, or replace
it with a new one. If this fails to stop air bubbles from being
emitted, do not use the endoscope because there may be a
malfunction. Contact Olympus.
When the distal end of the insertion section is immersed less
than 10 cm below the surface of the sterile water, a small
amount of air bubbles may be emitted from the air/water
nozzle even when the air/water valve is not operated. This
does not indicate a malfunction.
ULTRASOUND GASTROVIDEOSCOPE GF-UCT180 47
Chapter 3 Preparation and Inspection
Inspection of the objective lens cleaning function
Use sterile water only. Nonsterile water may cause patient
cross-contamination and/or infection.
• When the air/water valve is depressed for the first time, it
may take a few seconds before water is emitted.
• If the air/water valve returns to its original position slowly after
water feeding, remove the air/water valve and moisten the
seals with sterile water.
• During the inspection, place the distal end of the endoscope
in a beaker or other container so that the floor does not get
wet.
1. Keep the air/water valve’s hole covered with your finger and depress the
valve to the first stage. Observe the endoscopic image and confirm that
water flows on the entire objective lens.
2. Release the air/water valve. While observing the endoscopic image, confirm
that the emission of water stops and that the valve returns smoothly to its
original position.
3. While observing the endoscopic image, feed air after feeding water by
covering the hole in the air/water valve with your finger. Confirm that the
emitted air removes the remaining water from the objective lens and clears
the endoscopic image.
Inspection of the water feeding function into the balloon
Cover the air/water valve’s hole and completely depress the valve. Confirm that
water is emitted through the balloon water supply port. It may take a few seconds
until water is emitted when the air/water valve is depressed for the first time.
48 ULTRASOUND GASTROVIDEOSCOPE GF-UCT180
Chapter 3 Preparation and Inspection
Inspection of the suction function
• If the suction valve does not operate smoothly, detach it and
reattach it, or replace it with a new one. If the endoscope is
used while the suction valve is not working properly, it may
be impossible to stop suction, which could cause patient
injury. If the reattached or replaced suction valve fails to
operate smoothly, the endoscope may be malfunctioning;
stop using it and contact Olympus.
• If the biopsy valve leaks, replace it with a new one. A leaking
biopsy valve can reduce the efficacy of the endoscope’s
suction system and may leak or spray patient debris or fluids,
posing an infection control risk.
1. Place the container of sterile water and the endoscope at the same height.
For the inspection, adjust the suction pressure to the same level as it will be
during the procedure.
2. Immerse the distal end of the insertion section in sterile water with the
endoscope’s instrument channel port at the same height as the water level
in the water container. Press the suction valve and confirm that water is
continuously aspirated into the suction bottle of the suction pump.
3. Release the suction valve. Confirm that suction stops and the valve returns
to its original position.
4. Depress the suction valve to the first stage and aspirate water for one
second. Then, release the suction valve for one second. Repeat this several
times and confirm that no water leaks from the biopsy valve.
5. Remove the distal end of the endoscope from the water. Depress the
suction valve and aspirate air for a few seconds to remove any water from
the instrument and suction channels.
Inspection of aspiration from the balloon water suction port
1. Immerse the distal end of the insertion tube in sterile water and completely
depress the suction valve. Confirm that water is continuously aspirated.
2. Release the suction valve. Confirm that suction stops and the suction valve
returns to its original position.
3. Remove the distal end from the water.
ULTRASOUND GASTROVIDEOSCOPE GF-UCT180 49
Chapter 3 Preparation and Inspection
Inspection of the instrument channel and forceps elevator
Keep your eyes away from the distal end when inserting
EndoTherapy accessories. Extending the EndoTherapy
accessory from the distal end could cause eye injury.
1. Confirm that the forceps elevator is lowered, then insert the EndoTherapy
accessory through the biopsy valve. Confirm that the EndoTherapy
accessory extends smoothly from the distal end, and that a foreign object
does not come out.
2. Extend the EndoTherapy accessory approximately 3 cm from the distal end.
Move the elevator control lever in the “ U” direction and confirm that the
forceps elevator is raised smoothly.
3. Move the elevator control lever in the opposite direction of the “ U”
direction and confirm that the forceps elevator is lowered.
4. Confirm that the EndoTherapy accessory can be withdrawn smoothly from
the biopsy valve.
Inspection of the ultrasound image with the Olympus
universal endoscopic ultrasound center EU-ME1
1. Turn on Olympus universal endoscopic ultrasound center EU-ME1.
A progress bar is displayed after connecting the ultrasound
endoscope (see Figure 3.20). During displaying the progress
bar, the information on the connected ultrasonic endoscope
has been updated to the ultrasound center. Do not turn OFF
the ultrasound center while the progress bar is displayed.
Figure 3.20
50 ULTRASOUND GASTROVIDEOSCOPE GF-UCT180
Chapter 3 Preparation and Inspection
2. Inspect the endoscopic ultrasound center as described in its instruction
manual.
3. When setting the frequency, choose the setting value CLA2, and then the
frequencies available with the keyboard (see Figure 3.21). Refer to
EU-ME1’s instruction manual for instructions on how to set the frequency.
Figure 3.21
4. Press the “FREEZE” switch on the diagnostic ultrasound system to change
the ultrasound image to the REAL-TIME mode.
5. Confirm that the ultrasound image is visible on the endoscopic ultrasound
center (see Figure 3.22).
Ultrasound image (B-mode)
Figure 3.22
6. Press the “FREEZE” switch to change the ultrasound image to the FREEZE
mode.
ULTRASOUND GASTROVIDEOSCOPE GF-UCT180 51
Chapter 3 Preparation and Inspection
Inspection of the ultrasound image with the ALOKA
diagnostic ultrasound system
1. Inspect the diagnostic ultrasound system as described in its instruction
manual.
2. Turn the diagnostic ultrasound system ON.
3. Confirm that the ultrasound image is visible on the diagnostic ultrasound
system (see Figure 3.23).
Ultrasound image (B-mode)
Figure 3.23
4. Press the “FREEZE” switch to change the ultrasound image to the FREEZE
mode.
3.7 Preparation and inspection of the balloon
• Balloons used with this instrument contain natural rubber
latex that may cause allergic reactions in some individuals.
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.
• When using the sterile balloon (MAJ-249), do not use an
instrument after the expiration date displayed on the sterile
package. Doing so may pose an infection control risk.
• 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 the balloon. This could pose an
infection-control risk or cause equipment damage.
52 ULTRASOUND GASTROVIDEOSCOPE GF-UCT180
Chapter 3 Preparation and Inspection
• Confirm that the balloon applicator (MAJ-675) and cotton
thread that is used to tie the balloon have been properly
reprocessed as described in Chapters 5, “Reprocessing:
General Policy” through 7, “Cleaning, Disinfection, and
Sterilization Procedures”.
• If you find that a sterile balloon’s peel pack is open,
damaged, or soiled, do not use that balloon.
• When using the sterile balloon (MAJ-249), inspect the sterile
package for tears, inadequate sealing, or water damage. If
the sterile package shows any irregularity, the sterile
condition of the instrument may have been compromised.
• The balloons and the balloon applicator to be used with this
endoscope are listed below. Balloon1 is provided clean and
should be ETO gas sterilized before use. Balloon 3 is
shipped sterile.
Balloon (nonsterile) MAJ-213
Balloon 3 (sterile) MAJ-249
Balloon applicator MAJ-675
1 This item is not available in the USA.
• The balloon can easily tear, so beware of sharp objects.
• Store the balloon in a cool environment with low humidity.
• The resealable package containing the balloons also
contains a deoxidizer to maintain a deoxygenated condition
until the sterile peel pack is opened. After the resealable
package is opened, the balloons will gradually deteriorate. To
minimize deterioration, always keep the package sealed.
• The balloon applicator is reusable and supplied nonsterile.
Prepare the balloon and the balloon applicator.
ULTRASOUND GASTROVIDEOSCOPE GF-UCT180 53
Chapter 3 Preparation and Inspection
Attaching the balloon
1. Inspect the balloon and confirm that there are no holes, swelling, color
changes or any other irregularities. If an irregularity is detected, do not use
the balloon; use a spare instead, inspecting it thoroughly before use.
2. Insert the front end of the balloon into the installation side of the balloon
applicator. Slide the rear band of the balloon into the groove of the balloon
applicator (see Figure 3.24).
Front end Balloon
Balloon applicator
Rear band
Rear end
Groove Installation side
Figure 3.24
3. Insert the distal end of the endoscope into the balloon applicator until it
contacts the front end of the balloon.
4. Remove the rear band from the balloon applicator and attach it to the
endoscope’s balloon attachment groove (see Figure 3.25).
Balloon attachment
groove
Distal end of
the endoscope
Figure 3.25
Do not apply excessive force to the distal end of the
endoscope or bend it. Instrument damage may occur.
5. Remove the balloon applicator from the endoscope.
54 ULTRASOUND GASTROVIDEOSCOPE GF-UCT180
Chapter 3 Preparation and Inspection
Inspection of the balloon and expelling air
• Do not feed water into the balloon when the water level in the
water container is too low. The balloon may not be inflated
properly. If this occurs, refer to Section 10.1,
“Troubleshooting guide” on page 154.
• Disconnecting the water container from the endoscope just
after removing the air bubbles from the balloon may cause
them to reenter the balloon when inflating the balloon again.
Therefore, confirm that there are no air bubbles in the balloon
according to the following procedure.
1. Check the water level in the water container. If the water level is low, fill the
water container with sterile deaerated water. After adding water to the water
container or removing the water container from the endoscope, cover the
hole in the air/water valve and depress it to the first stage for about
15 seconds. Turn the light source and suction pump ON.
2. Cover the hole in the air/water valve and completely depress the valve to fill
the balloon with deaerated water.
3. Fill the balloon with deaerated water to a diameter of approximately 3 cm.
Remove your finger from the air/water valve. If the balloon is eccentrically
shaped after inflation, gently hold the balloon and turn it around. Confirm
that there are no holes or other irregularities in the balloon.
4. Confirm that there are no air bubbles in the balloon.
5. If the balloon has no air bubbles in it, completely depress the suction valve
until all the water has been aspirated from the balloon.
6. If air bubbles are observed in the balloon, lower the distal end of the
endoscope and repeat Steps 2 through 5 until they are completely removed
from the balloon. After confirming that all air bubbles have been removed,
repeat Steps 2 through 5 two times to make sure they are completely
removed.
7. Completely depress the suction valve until all the water has been aspirated
from the balloon.
8. Tie the rear end of the balloon tightly with a sterile cotton thread.
ULTRASOUND GASTROVIDEOSCOPE GF-UCT180 55
Chapter 3 Preparation and Inspection
Do not obstruct the balloon water supply port with the cotton
thread. If the balloon water supply port is obstructed, the
balloon cannot be inflated or deflated (see Figure 3.26).
Balloon water supply port
Balloon attachment groove
Figure 3.26
56 ULTRASOUND GASTROVIDEOSCOPE GF-UCT180
Chapter 4 Operation
Chapter 4 Operation
This manual does not explain or discuss clinical endoscopic procedures. It only
describes basic operation and precautions related to the operation of this
instrument. Therefore, the operator of this instrument must be a physician or
medical personnel under the supervision of a physician and must have received
sufficient training in clinical endoscopic technique.
• To guard against dangerous chemicals and potentially
infectious material during the procedure, wear personal
protective equipment, such as eyewear, face mask,
moisture-resistant clothing, and chemical-resistant gloves
that fit properly and are long enough so that your skin is not
exposed.
• The temperature of the distal end of the endoscope may
exceed 41C (106F) and reach 50C (122F) due to intense
endoscopic illumination. Surface temperatures over 41C
(106F) may cause mucosal burns. 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.
• Whenever possible, do not leave the endoscope illuminated
before and/or after an examination. Continued illumination
will cause the distal end of the endoscope to become hot and
could cause operator and/or patient burns.
• Turn the video system center ON to operate the light source’s
automatic brightness function. When the video system center
is OFF, it cannot operate the light source’s automatic
brightness function, and the light intensity is set to the
maximum level. In this case, the distal end of the endoscope
can become hot and could cause operator and/or patient
burns, when using the light source CLV-160, CLV-U40.
ULTRASOUND GASTROVIDEOSCOPE GF-UCT180 57
Chapter 4 Operation
• Never insert or withdraw the endoscope under any of the
following conditions. Otherwise, patient injury, bleeding,
and/or perforation can result.
While the EndoTherapy accessory extends from the distal
end of the endoscope.
While the bending section is locked in position.
Insertion or withdrawal with excessive force.
Insertion or withdrawal while the forceps elevator is
raised.
• If any of the following phenomena occur during an
examination, immediately stop the examination and withdraw
the endoscope from the patient as described in Section 10.2,
“Withdrawal of the endoscope with an irregularity” on
page 159.
Should any irregularity be observed with the functionality
of the endoscope.
If the endoscopic image on the monitor disappears or
freezes unexpectedly.
If the angulation control knob is locked.
If the angulation control mechanism is not functioning
properly.
Continued use of the endoscope under these conditions
could result in patient injury, bleeding, and/or perforation.
• If an abnormal endoscopic image or function occurs, but
quickly corrects itself, the endoscope may have
malfunctioned. In this case, stop using the endoscope
because the irregularity can occur again and the endoscope
may not return to its normal condition. Therefore, stop the
examination immediately and slowly withdraw the endoscope
while viewing the endoscopic image. Otherwise, patient
injury, bleeding, and/or perforation can result.
• The endoscopic image may be disturbed while switching
between WLI observation mode and NBI observation mode.
Therefore, do not perform an endoscopic operation or
treatment while switching between WLI observation mode
and NBI observation mode. Otherwise, injury in the body
cavity may result.
58 ULTRASOUND GASTROVIDEOSCOPE GF-UCT180
Chapter 4 Operation
• Set the brightness of the light source to the minimum level
necessary to perform the procedure safely. If the endoscope
is used for a prolonged period at or near maximum light
intensity, vapor may be observed in the endoscopic image.
This is caused by the evaporation of organic material (blood,
moisture in stool, etc.) due to heat generated by the light
guide near the light guide lens. If this vapor continues to
interfere with the examination, remove the endoscope, wipe
the distal end with a lint-free cloth moistened with 70% ethyl
or isopropyl alcohol, reinsert the endoscope, and continue
the examination.
• The color tone and brightness of NBI observation mode is
different from WLI observation mode. Use NBI observation
mode only when fully understanding its features.
4.1 Insertion
Holding and manipulating the endoscope
The control section of the endoscope is designed to be held in the left hand. The
air/water and suction valves can be operated using the left index finger. The
UP/DOWN angulation control knob and the elevator control lever can be
operated using the left thumb. The right hand is free to manipulate the insertion
section and the RIGHT/LEFT angulation control knob (see Figure 4.1).
Figure 4.1
ULTRASOUND GASTROVIDEOSCOPE GF-UCT180 59
Chapter 4 Operation
Insertion of the endoscope
Keep the elevator control lever moved all the way in the
opposite direction of the “ U” direction while inserting or
withdrawing the endoscope into or from the patient. If the
elevator control lever is moved all the way in the “ U”
direction and the forceps elevator is raised while inserting or
withdrawing the endoscope into or from the patient, this may
cause patient injury.
• To prevent the patient from accidentally biting the insertion
section during an examination, it is strongly recommended
that a mouthpiece be placed in the patient’s mouth before
inserting the endoscope.
• To prevent the patient from accidentally loosing dental
prosthesis, make sure that the patient removes it before the
examination.
• Do not apply olive oil or products containing petroleum-based
lubricants (e.g., Vaseline®) to the endoscope. These
products may cause stretching and deterioration of the
bending section’s covering.
• Do not allow the insertion section to be bent within a distance
of 10 cm or less from the junction of the boot. Insertion
section damage can occur (see Figure 4.2).
> 10 cm
Figure 4.2
60 ULTRASOUND GASTROVIDEOSCOPE GF-UCT180
Chapter 4 Operation
1. Move the elevator control lever in the opposite direction of the “ U” until it
stops.
2. If necessary, apply a medical-grade, water-soluble lubricant to the insertion
section.
3. Place the mouthpiece between the patient’s teeth or gums, with the outer
flange on the outside of the patient’s mouth.
Angulation of the distal end
Avoid forcible or excessive angulation as this imposes load
on the wire controlling the bending section. This may cause
stretching or tearing of the wire, which could impair the
movement of the bending section.
1. Operate the angulation control knobs as necessary to guide the distal end
for insertion and observation.
2. The endoscope’s angulation locks are used to hold the angulated distal end
in position.
• When passing an EndoTherapy accessory through the
instrument channel while the angulation is locked, the angle
of the distal end may change. When it is necessary to keep
the angulation stationary, hold the angulation control knobs in
place with your hand.
• When operating the UP/DOWN or RIGHT/LEFT angulation
lock, hold the angulation control knob stationary with your
finger. If this is not done, the angulation will change.
Air/water feeding and suction
• If the sterile water level in the water container is too low, then
air, not water, will be supplied. In this case, turn the airflow
regulator on the light source OFF and add sterile water to the
water container until it reaches the specified water level.
• If air/water feeding does not stop, turn the airflow regulator
on the light source OFF and replace the air/water valve with a
new one.
ULTRASOUND GASTROVIDEOSCOPE GF-UCT180 61
Chapter 4 Operation
• Before using a syringe to inject liquid through the biopsy
valve, detach the valve’s cap from the main body. Then insert
the syringe straight into the valve and inject the liquid. If the
cap is not detached and/or the syringe is not inserted
straight, the biopsy valve could be damaged, which could
reduce the efficacy of the endoscope’s suction system, and
may leak or spray patient debris or fluids, posing an infection
control risk.
• If the biopsy valve is left uncapped during the procedure,
debris or fluids could leak or spray from it, posing an infection
control risk. When the valve is uncapped, place a piece of
sterile gauze over it to prevent leakage.
If the endoscope is cold, condensation may form on the
surface of the objective lens and the endoscopic image may
appear cloudy. In this case, increase the temperature of the
sterile water in the water container to between 40 – 50C
(104 – 122F) and then use the endoscope.
Air/water feeding
1. Cover the air/water valve’s hole to feed air from the air/water nozzle at the
distal end (see Figure 4.3).
2. Depress the air/water valve to the first stage to feed water onto the objective
lens (see Figure 4.3).
Suction valve
Air/water valve
Figure 4.3
62 ULTRASOUND GASTROVIDEOSCOPE GF-UCT180
Chapter 4 Operation
Suction
• Avoid aspirating solid matter or thick fluids; instrument
channel, suction channel, or suction valve clogging can
occur. If the suction valve clogs and suction cannot be
stopped, disconnect the suction tube from the suction
connector on the endoscope connector. Turn the suction
pump OFF, detach the suction valve and remove solid matter
or thick fluids.
• When aspirating, maintain the suction pressure at the lowest
level necessary to perform the procedure. Excessive suction
pressure could cause aspiration of and/or injury to the
mucous membrane. In addition, patient fluids could leak or
spray from the biopsy valve, posing an infection control risk.
• When aspirating, attach the cap to the main body of the
biopsy valve. An uncapped biopsy valve can reduce the
efficacy of the endoscope’s suction system, and may leak or
spray patient debris or fluids, posing an infection control risk.
During the procedure, make sure that the suction bottle does
not fill completely. Aspirating fluids into a full bottle may
cause the suction pump to malfunction.
Depress the suction valve to the first stage to aspirate excess fluid or other
debris obscuring the endoscopic image (see Figure 4.3).
Performing both air feeding and suction at the same time
sometimes makes it easier to remove water droplets from the
objective lens surface.
Observation of the endoscopic image
Do not rely only on the NBI observation mode for primary
detection of lesions or to make a decision regarding any
potential diagnostic or therapeutic intervention.
Refer to the light source’s instruction manual for instructions on how to adjust the
brightness.
ULTRASOUND GASTROVIDEOSCOPE GF-UCT180 63
Chapter 4 Operation
4.2 Observation of the ultrasound image
The sterile deaerated water immersion method
• Completely insert the water feeding valve (MD-744) of the
water supply unit (UWS-1) into the biopsy valve (MAJ-853).
Improper connection may cause water to leak.
• If no balloon is attached, do not depress the suction valve
completely. The balloon channel may be clogged.
1. Position the distal end of the endoscope near the target site and push the
“FREEZE” switch on the ultrasound system to change the ultrasound image
to the REAL-TIME mode.
2. Connect the water supply unit’s water-feeding valve to the biopsy valve of
the endoscope.
3. Depress the water supply unit’s water feeding valve as described in its
instruction manual and supply the necessary amount of sterile deaerated
water.
The balloon method
• Do not inflate the balloon to a diameter of more than 3 cm.
• Do not feed water into the balloon when the water level in the
water container is too low. The balloon may not be inflated
properly.
If the water container is removed from the endoscope while
inflating the balloon, cover the hole in the air/water valve and
depress the valve to the first stage for about 15 seconds. By
doing so, air bubbles can be prevented from entering the
balloon.
64 ULTRASOUND GASTROVIDEOSCOPE GF-UCT180
Chapter 4 Operation
1. Position the distal end of the endoscope near the target site and press the
“FREEZE” switch on the ultrasound system to change the ultrasound image
to the REAL-TIME mode.
2. Cover the small hole in the air/water valve of the endoscope and completely
depress the valve to inflate the balloon.
3. While viewing the ultrasound image, inflate the balloon to the desired size.
Do not inflate the balloon to a diameter greater than 3 cm.
4. Use the endoscope’s angulation mechanism to bring the balloon into full
contact with the intestinal wall. Move the distal end to the target site.
Observation
Keep the ultrasound system in the FREEZE mode, except
during ultrasound observation.
When combined with another electrical instrument, noise
may be displayed on the video monitor.
When the ultrasound image of the target appears, adjust the ultrasound system
as described in its instruction manual to obtain a suitable image.
ULTRASOUND GASTROVIDEOSCOPE GF-UCT180 65
Chapter 4 Operation
4.3 Using EndoTherapy accessories
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 accessories.
• When using EndoTherapy accessories, keep the distance
between the distal end of the endoscope and the mucous
membrane greater than the endoscope’s minimum visible
distance so that the EndoTherapy accessory remains visible
in the endoscopic image. If the distal end of the endoscope is
placed closer than its own minimum visible distance, the
position of the accessory cannot be seen in the endoscopic
image, which could cause serious patient injury and/or
equipment damage. The minimum visible distance depends
on the type of endoscope being used. Refer to Section 2.3,
“Specifications” on page 21.
• When inserting or withdrawing an EndoTherapy accessory,
confirm that its distal end is closed or completely retracted
into the sheath. Slowly insert or withdraw the EndoTherapy
accessory straight into/from the slit of the biopsy valve.
Otherwise, the biopsy valve may be damaged and pieces of it
could fall off.
• If the insertion or withdrawal of EndoTherapy accessories is
difficult, straighten the bending section as much as possible
without losing the endoscopic image. Inserting or
withdrawing EndoTherapy accessories with excessive force
may damage the instrument channel or EndoTherapy
accessories and could cause some parts to fall off and/or
cause patient injury.
• Do not switch between WLI observation mode and NBI
observation mode while using an EndoTherapy accessory.
The endoscopic image may be disturbed while switching
between WLI observation mode and NBI observation mode.
This could cause patient injury, bleeding, and/or perforation.
• If the distal end of an EndoTherapy accessory is not visible in
the endoscopic image, do not open the distal end or extend
the needle of the instrument. This could cause patient injury,
bleeding, perforation, and/or equipment damage.
66 ULTRASOUND GASTROVIDEOSCOPE GF-UCT180
Chapter 4 Operation
• Do not insert EndoTherapy accessories without the forceps
elevator being raised. If they are inserted without the forceps
elevator being raised, the accessory cannot be observed in
the endoscopic image and it may cause patient injury.
• While raising the forceps elevator, do not insert or withdraw
the EndoTherapy accessory with excessive force, open or
close the distal end of the EndoTherapy accessory, or extend
the needle of the instrument. This could damage the
instrument channel and/or the EndoTherapy accessory and
could cause patient injury, bleeding, and/or perforation. If the
EndoTherapy accessory cannot be inserted or withdrawn,
the distal end of the EndoTherapy accessory cannot be
opened or closed, or the needle of the instrument cannot be
extended, move the elevator control lever in the opposite
direction of the “ U” direction to lower the forceps elevator.
• If the forceps elevator cannot be lowered while using an
EndoTherapy accessory, stop the procedure immediately
and take appropriate measures.
• Do not inflate air or a nonflammable gas excessively into the
patient. This could cause gas embolism.
• EUS guided FNA should only be performed when the needle
is visible in the ultrasound image.
• If the ultrasound image disappears while using the needle,
stop the procedure immediately and withdraw the needle
from the tissue.
• When using a biopsy forceps with a needle, confirm that the
needle is not excessively bent. A bent needle could protrude
from the closed cups of the biopsy forceps. Using biopsy
forceps with a protruding needle could damage the
instrument channel and/or cause patient injury.
• When using an injector, be sure not to extend or retract the
needle from the catheter of the injector until the injector is
extended from the distal end of the endoscope. The needle
could damage the instrument channel if extended inside the
channel, or if the injector is inserted or withdrawn while the
needle is extended.
• Although the color code is orange as with GF-UCT180, do
not use EndoTherapy accessories designed for ø 4.2 mm
channel, otherwise the endoscope and/or the EndoTherapy
accessories may be damaged.
ULTRASOUND GASTROVIDEOSCOPE GF-UCT180 67
Chapter 4 Operation
Insertion of EndoTherapy accessories into the endoscope
• Do not insert EndoTherapy accessories forcibly or abruptly.
Otherwise, the EndoTherapy accessory may extend from the
distal end of the endoscope abruptly, which could cause
patient injury, bleeding, and/or perforation.
• When the biopsy valve’s cap is detached from the main body,
it is easier to insert an EndoTherapy accessory into the
instrument channel port (see Figure 3.9 on page 36).
However, the open biopsy valve, after withdrawing an
EndoTherapy accessory, can reduce the efficacy of the
endoscope’s suction system, and it may leak or spray patient
debris or fluids, posing an infection control risk. When not
using an EndoTherapy accessory, attach the cap to the main
body of the biopsy valve.
• When the biopsy valve’s cap is detached from the main body,
it may cause patient debris or fluids to leak or spray from the
endoscope, posing an infection control risk. When the biopsy
valve’s cap has to be detached, place a piece of sterile gauze
over it to prevent leakage.
• Do not let the EndoTherapy accessory hang down from the
biopsy valve. Doing so can create a space between the
accessory and the valve’s slit or hole. This can cause
damage to the valve that can reduce the efficacy of the
endoscope’s suction system, and may leak or spray patient
debris or fluids, posing an infection control risk.
• When inserting an EndoTherapy accessory, hold it close to
the biopsy valve and insert it slowly and straight into the
biopsy valve. Otherwise, the EndoTherapy accessory and/or
biopsy valve could be damaged. This can reduce the efficacy
of the endoscope’s suction system, and may leak or spray
patient debris or fluids, posing an infection control risk.
When using the aspiration needle (NA series), refer to the
instruction manuals for the aspiration needle (NA series).
Otherwise, the instrument channel and/or the EndoTherapy
accessory may become damaged.
68 ULTRASOUND GASTROVIDEOSCOPE GF-UCT180
Chapter 4 Operation
1. Select EndoTherapy accessories compatible with the instrument from the
“System chart” in the Appendix. Refer to the accessories’ instruction
manuals for operating instructions.
2. Move the elevator control lever all the way in the “ U” direction.
3. Hold the UP/DOWN and RIGHT/LEFT angulation knobs stationary.
4. Confirm that the tip of the EndoTherapy accessory is closed or retracted into
its sheath and insert the EndoTherapy accessory slowly and straight into the
slit of the biopsy valve.
Do not open the tip of the EndoTherapy accessory or extend
the tip of the EndoTherapy accessory from its sheath while
the accessory is in the instrument channel. The instrument
channel and/or the EndoTherapy accessory may become
damaged.
5. Hold the EndoTherapy accessory approximately 4 cm from the biopsy valve
and advance it slowly and straight into the biopsy valve using short strokes
while observing the endoscopic image.
When the tip of the EndoTherapy accessory extends
approximately 6 mm from the distal end of the endoscope,
the accessory will appear in the endoscopic image, and/or
ultrasound image.
6. Hold the EndoTherapy accessory approximately 4 cm from the biopsy valve
and advance it slowly and straight into the biopsy valve using short strokes
while observing the endoscopic image. Confirm that the tip of the
EndoTherapy accessory contacts the forceps elevator.
7. Move the elevator control lever in the opposite direction of the “ U”
direction to lower the forceps elevator. Advance the EndoTherapy
accessory slightly and move the elevator control lever in the “ U” direction
confirm that the accessory appears in the endoscopic image.
8. Manipulate the elevator control lever to adjust the height of the elevator (see
Figures 4.4 and 4.5).
ULTRASOUND GASTROVIDEOSCOPE GF-UCT180 69
Chapter 4 Operation
Figure 4.4
Figure 4.5
70 ULTRASOUND GASTROVIDEOSCOPE GF-UCT180
Chapter 4 Operation
Operation of EndoTherapy accessories
Operate the EndoTherapy accessory according to the directions given in its
instruction manual.
Withdrawal of EndoTherapy accessories
• Patient debris might spray when EndoTherapy accessories
are withdrawn from the biopsy valve. To prevent this, hold a
piece of gauze around the accessory and the biopsy valve
during withdrawal.
• Do not withdraw the EndoTherapy accessory if the tip is open
or extended from its sheath; patient injury, bleeding,
perforation, and/or instrument damage may occur.
• Withdraw the EndoTherapy accessory slowly and straight out
of the biopsy valve. Otherwise, the valve’s slit and/or hole
could be damaged. This can reduce the efficacy of the
endoscope’s suction system, and may leak or spray patient
debris or fluids, posing an infection control risk.
• If the EndoTherapy accessory cannot be withdrawn from the
endoscope, close the EndoTherapy accessory and/or retract
it into its sheath, then carefully withdraw both the endoscope
and the EndoTherapy accessory together under endoscopic
observation. Take care not to cause tissue trauma.
Withdraw the EndoTherapy accessory slowly while the tip of the EndoTherapy
accessory is closed and/or retracted into its sheath.
1. Close the tip of the EndoTherapy accessory and/or retract it into its sheath.
2. While lowering the forceps elevator gradually, slowly withdraw the
EndoTherapy accessory.
ULTRASOUND GASTROVIDEOSCOPE GF-UCT180 71
Chapter 4 Operation
High-frequency cauterization treatment
• Performing treatment while the intestines are filled with a
flammable gas could result in an explosion, fire, and/or
serious patient injury. If the intestines contain a flammable
gas, replace it with air or a nonflammable gas such as CO2
before performing high-frequency treatment.
• Not all parts of the endoscope are electrically insulated.
When applying high-frequency current, there is a danger of
unintentional diathermy burns. Always wear electrically
insulating, chemical-resistant gloves.
• Never emit high-frequency current before confirming that the
distal end of the high-frequency EndoTherapy accessory is in
the endoscope’s field of view. Also, confirm that the electrode
section and the mucous membrane in the vicinity of the target
area are at an appropriate distance from the distal end of the
endoscope. If the high-frequency current is emitted while the
distal end of the EndoTherapy accessory is not visible or too
close to the distal end of the endoscope, patient injury,
bleeding, and/or perforation as well as equipment damage
can result.
Prepare, inspect, and connect the electrosurgical unit and electrosurgical
accessories as described in their instruction manuals.
The application of high-frequency current may interfere with
the endoscopic image. This does not indicate a malfunction.
72 ULTRASOUND GASTROVIDEOSCOPE GF-UCT180
Chapter 4 Operation
4.4 Withdrawal of the endoscope
If blood unexpectedly adheres to the surface of the insertion
section of the withdrawn endoscope, carefully check the
condition of the patient.
1. When using the balloon method, aspirate water from the balloon by
depressing the suction valve while covering the hole in the valve.
2. Freeze the ultrasound image.
3. Aspirate the accumulated air, blood, mucous or other debris by depressing
the suction valve to the first stage while covering the hole in the valve.
• Observe the ultrasound image on the video monitor and
confirm that the balloon deflates.
• If the balloon does not deflate even when the suction valve is
completely depressed, turn OFF the switch of the airflow
regulator and remove the air/water valve from the
endoscope. In most cases, the balloon will be automatically
deflated.
• If the balloon does not deflate even when the air/water valve
is removed from the endoscope, tear and deflect the balloon
with the EndoTherapy accessory (for example, biopsy
forceps).
4. Turn the UP/DOWN and RIGHT/LEFT angulation locks to the “F ”
direction to release them.
5. Carefully withdraw the endoscope while observing the endoscopic image.
6. Remove the mouthpiece from the patient’s mouth.
7. If using the balloon method, detach the balloon.
ULTRASOUND GASTROVIDEOSCOPE GF-UCT180 73
Chapter 4 Operation
4.5 Removal of the balloon
• Do not hold the ultrasound transducer when holding the
insertion section. The ultrasonic transducer can be damaged,
resulting in an abnormal ultrasonic image.
• Do not squeeze the ultrasound transducer forcefully. The
ultrasonic transducer can be damaged, resulting in an
abnormal ultrasonic image.
• Do not remove the balloon with equipment such as forceps,
needle holder, or hemostat that may scratch the surface of
the ultrasound transducer. The ultrasonic transducer can be
damaged, resulting in an abnormal ultrasonic image.
• Do not pinch the ultrasound transducer surface and balloon
together when removing the balloon. The ultrasonic
transducer can be damaged, resulting in an abnormal
ultrasonic image.
1. Use a clean, lint-free cloth to gently wipe and dry the balloon surface.
2. Roll up the rear end of the balloon with your fingers (see Figure 4.6).
3. After the removal of the balloon, confirm that the surface of the ultrasound
transducer is free from scratches. In case the ultrasound transducer surface
is scratched, stop using the endoscope and contact Olympus.
Figure 4.6
74 ULTRASOUND GASTROVIDEOSCOPE GF-UCT180
Chapter 4 Operation
4.6 Transportation of the endoscope
Transporting within the hospital
When carrying the endoscope by hand, loop the universal cord, hold the
endoscope connector with the control section in one hand and hold the distal
end of the insertion tube securely, but gently without squeezing, in the other
hand (see Figure 4.7).
Figure 4.7
Transporting outside the hospital
Transport the endoscope in the carrying case.
Always clean, disinfect, or sterilize the endoscope after
removing it from the carrying case. If the endoscope is not
cleaned, disinfected, or sterilized, it could pose an infection
control risk.
• The carrying case cannot be cleaned, disinfected, or
sterilized. Clean and disinfect or sterilize the endoscope
before placing it in the carrying case.
• To avoid damage to the endoscope caused by changes in air
pressure, do not attach the water-resistant cap when
transporting the endoscope.
• Before putting the endoscope in the carrying case, always
make sure that the forceps elevator is not raised. Putting the
endoscope in the carrying case while the forceps elevator is
raised could damage the endoscope.
ULTRASOUND GASTROVIDEOSCOPE GF-UCT180 75
Chapter 5 Reprocessing: General Policy
Chapter 5 Reprocessing: General
Policy
5.1 Instructions
• Chapters 5, “Reprocessing: General Policy” through 8, “Cleaning and
Disinfection Equipment” describe recommended procedures and
equipment for cleaning and disinfecting or sterilizing this instrument.
• This instruction manual contains essential information on reprocessing
this instrument safely and effectively.
• Before reprocessing, thoroughly review the manuals of the reprocessing
chemicals and all equipment that will be used, and reprocess the
equipment as instructed.
• 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, or if a problem that cannot be solved occurs while reprocessing,
contact Olympus.
5.2 Importance of cleaning, disinfection, and
sterilization
The medical literature reports incidents of cross-contamination resulting from
improper cleaning, disinfection, or sterilization. It is strongly recommended that
all individuals engaged in reprocessing closely observe all instructions given in
this manual and the manuals of all ancillary equipment, and have a thorough
understanding of the following items:
• Professional health and safety criteria of your hospital
• Individual cleaning, disinfection, and sterilization protocols
• Structure and handling of endoscopic equipment
• Handling of pertinent chemicals
For the types and conditions of the means of cleaning, disinfection, and
sterilization to be adopted, please make judgments from your professional
viewpoints.
76 ULTRASOUND GASTROVIDEOSCOPE GF-UCT180
Chapter 5 Reprocessing: General Policy
5.3 Precautions
• Some endoscope reprocessors are not designed to
reprocess an elevator wire channel. If the elevator wire
channel cannot be reprocessed by the endoscope
reprocessor, clean, disinfect, and sterilize the endoscope
according to procedures described in Chapter 7, “Cleaning,
Disinfection, and Sterilization Procedures”.
• Failure to properly clean and high-level disinfect or sterilize
endoscope equipment after each procedure can compromise
patient safety. To minimize the risk of transmitting infectious
agents from one patient to another, after each procedure the
endoscope and the equipment must undergo thorough
manual cleaning followed by high-level disinfection or
sterilization, as described in Chapter 7, “Cleaning,
Disinfection, and Sterilization Procedures”. Reprocess not
only the external surface of the endoscope but also all
channels.
• ALL channels of the endoscope, including the elevator wire
channel and balloon channel, MUST be cleaned and
high-level disinfected or sterilized during EVERY
reprocessing cycle, even if the channels were not used
during the previous patient procedure. Otherwise, insufficient
cleaning and disinfection or sterilization of the endoscope
may pose an infection control risk to the patient and/or
operators performing the next procedure with the endoscope.
• After thoroughly brushing or wiping all external surfaces and
the distal end of the endoscope and around the forceps
elevator with a soft brush or lint-free cloth, always visually
confirm that the elevator wire is not broken. If the elevator
wire is broken, patient and/or operator injury could result.
• If the endoscope is not cleaned meticulously, effective
disinfection or sterilization may not be possible. Clean the
endoscope and accessories thoroughly before disinfection or
sterilization to remove microorganisms and organic material
that could reduce the efficacy of disinfection or sterilization.
• Olympus only confirms validation of the endoscope
reprocessors it recommends. When using an endoscope
reprocessor that is not recommended by Olympus, the
manufacturer of the endoscope reprocessor is responsible
for validating compatibility of the reprocessor with the
endoscope models listed in its instruction manual.
ULTRASOUND GASTROVIDEOSCOPE GF-UCT180 77
Chapter 5 Reprocessing: General Policy
• Before using an endoscope reprocessor, confirm that it is
capable of reprocessing the endoscope including all
channels. If you are uncertain as to the ability of your
endoscope reprocessor to clean and high-level disinfect the
endoscope including all channels, contact the endoscope
reprocessor’s manufacturer for specific instructions and/or
information on connectors. Insufficient cleaning and
disinfection or sterilization of the endoscope may pose an
infection control risk to the patient and/or operators
performing the next procedure with the endoscope.
• Patient debris and reprocessing chemicals are hazardous.
Wear personal protective equipment to guard against
dangerous chemicals and potentially infectious material.
During cleaning and disinfection or sterilization, wear
appropriate personal protective equipment, such as eyewear,
face mask, moisture-resistant clothing, and
chemical-resistant gloves that fit properly and are long
enough so that your skin is not exposed. Always remove
contaminated personal protective equipment before leaving
the reprocessing area.
• Thoroughly rinse off the disinfectant solution. Rinse the
external surfaces of the endoscope, channels, and cleaning
equipment thoroughly with clean water to remove any
disinfectant solution residue.
• The disinfection/sterilization room must be adequately
ventilated. Adequate ventilation protects against the buildup
of toxic chemical fumes.
• Store alcohol in an airtight container. Alcohol stored in an
open container is a fire hazard and will lose its efficacy due to
evaporation.
• Be sure to perform a leakage test on the endoscope prior to
manual cleaning, and do not use the endoscope if a leak is
detected. Use of an endoscope with a leak may cause a
sudden loss of the endoscopic image, damage to the
bending mechanism or other malfunctions.
• Prior to each procedure, confirm that the endoscope has
undergone proper cleaning, disinfection, and sterilization. If it
is determined that the endoscope has not been properly
reprocessed, reprocess it again following the instructions
given in this manual.
78 ULTRASOUND GASTROVIDEOSCOPE GF-UCT180
Chapter 5 Reprocessing: General Policy
• With the cleaning, disinfection, and sterilization methods
stated in this instruction manual, prions, which are
considered to be the pathogenic substance of the
Creutzfeldt-Jakob disease (CJD) cannot be destroyed or
inactivated. When using this instrument on a patient with CJD
or variant Creutzfeldt-Jakob disease (vCJD), be sure to use
this product for such patient only and/or immediately dispose
of this product after use in an appropriate manner. For
methods to handle CJD, please follow the respective
guidelines in your country.
• This instrument is not durable, or does not have sufficient
durability against the respective methods stated in the
guidelines of each country for destroying or inactivating
prions. For information on the durability against each
method, please contact Olympus. If cleaning, disinfection,
and sterilization methods not stated in this instruction manual
are performed, Olympus cannot guarantee the effectiveness,
safety and durability of this instrument. Make sure to confirm
that there is no irregularity before use, and use under
responsibility of a physician. Do not use if any irregularity is
found.
• When aerating or irrigating the endoscope channels, the air
or water pressure must not exceed 0.2 MPa (2 kgf/cm2,
29 psig). Higher pressures may cause damage to the
endoscope.
• When reprocessing an endoscope, confirm that the two
water-resistant caps are securely attached to the endoscope
connector before immersion in reprocessing fluids. If two
water-resistant caps are not securely attached, water,
detergent solution and/or disinfectant solution could enter the
endoscope and damage the equipment.
ULTRASOUND GASTROVIDEOSCOPE GF-UCT180 79
Chapter 5 Reprocessing: General Policy
5.4 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 this manual.
After using this instrument, reprocess and store it according to the instructions
given in this manual. Improper and/or incomplete reprocessing or storage can
present an infection control risk, cause equipment damage, or reduce
performance.
80 ULTRASOUND GASTROVIDEOSCOPE GF-UCT180
Chapter 6 Compatible Reprocessing Methods and Chemical Agents
Chapter 6 Compatible Reprocessing
Methods and Chemical
Agents
6.1 Compatibility summary
Olympus endoscopic equipment is compatible with several methods of
reprocessing. However, certain components and accessories are not compatible
with some methods, which can cause equipment damage. For appropriate
reprocessing methods, refer to see Table 6.1, the recommendations of your
infection control committee and all national and local hospital guidelines and
policies.
Steam sterilization (autoclaving)
Ethylene oxide gas sterilization (gas mixture 20% ethylene oxide
gas/80% CO2 for countries other than the USA)
Ethylene oxide gas sterilization (100% ethylene oxide gas)
ACECIDE disinfectant solution 3
(use OER-A, OER-AW, OER-Pro)
2 – 3.5% glutaraldehyde
70% ethyl or isopropyl alcohol
Detergent solution
Ultrasonic
cleaning
Endoscope 1
Water-resistant cap
(MH-553)
2
Chain for water-resistant
cap (MAJ-1739)
Channel cleaning brush
(BW-20T, BW-7L)
Channel-opening cleaning
brush (MH-507)
Air/water valve (MAJ-1444)
Suction valve (MAJ-1443)
Channel plug (MAJ-621)
Injection tube (MH-946)
Air/water channel cleaning
adapter (MAJ-629)
ULTRASOUND GASTROVIDEOSCOPE GF-UCT180 81
Chapter 6 Compatible Reprocessing Methods and Chemical Agents
Steam sterilization (autoclaving)
Ethylene oxide gas sterilization (gas mixture 20% ethylene oxide
gas/80% CO2 for countries other than the USA)
Ethylene oxide gas sterilization (100% ethylene oxide gas)
ACECIDE disinfectant solution 3
(use OER-A, OER-AW, OER-Pro)
2 – 3.5% glutaraldehyde
70% ethyl or isopropyl alcohol
Detergent solution
Ultrasonic
cleaning
Suction cleaning adapter
(MH-856)
Mouthpiece (MB-142)
Washing tube (MH-974)
Cleaning adapter for
instrument channel port
(MAJ-350)
Biopsy valve (MAJ-853)
Balloon applicator
(MAJ-675)
Balloon (MAJ-213)4
Cleaning brush (MAJ-1534)
Balloon 3 (MAJ-249)
Single use channel
cleaning brush (BW-201T)
Single use channel-opening
cleaning brush (MAJ-1339)
Ultrasonic cable (MAJ-1597)
compatible not compatible
Table 6.1
1 The endoscope is compatible with ultrasonic cleaning only when using an
endoscope reprocessor such as OER, OER-A, OER-AW and OER-Pro
(OER, OER-A, OER-AW and OER-Pro may not be available in some
areas).
2 The water-resistant caps and the chain for water-resistant caps can only
be ultrasonically cleaned if connected to the endoscope that is being
cleaned in an endoscope reprocessor with an ultrasonic cleaning phase.
82 ULTRASOUND GASTROVIDEOSCOPE GF-UCT180
Chapter 6 Compatible Reprocessing Methods and Chemical Agents
3 ACECIDE disinfectant solution is exclusively for an
Olympus-recommended endoscope reprocessor such as OER-A,
OER-AW and OER-Pro (ACECIDE and Acecide-C may not be available in
some areas).
4 This item is not available in the USA.
Alcohol is not a sterilant or high-level disinfectant.
• The endoscope is not compatible with steam sterilization
(autoclaving). Reprocessing using steam sterilization will
result in severe equipment damage.
• The ultrasonic cable is not waterproof. Never immerse it in
disinfectant solution or any other fluids.
• The endoscope is compatible with some endoscope
reprocessors such as the ETD1 system distributed by
Olympus. Refer to the respective instruction manual for
details on operation. For any other details, please contact
Olympus.
1 This product may not be available in some areas.
• EndoTherapy accessories that are marked by the words
“AUTOCLAVE” or “AUTOCLAVABLE”, or accessories with a
green model reference label are compatible with steam
sterilization (autoclaving).
6.2 Detergent solution
Use a medical-grade, low-foaming, neutral pH detergent or enzymatic detergent
and follow the manufacturer’s dilution and temperature recommendations.
Contact Olympus for the names of specific brands that have been tested for
compatibility with the endoscope. Do not reuse detergent solutions.
Excessive detergent foaming can prevent fluid from
adequately contacting internal lumens (e.g., channels).
ULTRASOUND GASTROVIDEOSCOPE GF-UCT180 83
Chapter 6 Compatible Reprocessing Methods and Chemical Agents
6.3 Disinfectant solution
In the U.S., agents used to achieve high-level disinfection are defined as liquid
chemical germicides registered with the U.S. Food and Drug Administration as
“sterilant/disinfectants” that are used according to the time, temperature and
dilution recommended by the disinfectant manufacturer for achieving high-level
disinfection. These conditions usually coincide with those recommended by the
disinfectant manufacturer for 100% kill of mycobacterium tuberculosis.
In general, 2.0 – 3.5% glutaraldehyde solutions, when used according to the
manufacturer’s instructions for achieving high-level disinfection, are compatible
with Olympus endoscopes. Contact Olympus for the names of specific brands
that have been tested for compatibility with this endoscope.
If disinfectant solution is reused, routinely check its efficacy according to the
manufacturer’s recommendations. Do not use solutions beyond their expiration
date.
Alcohol is not a sterilant or high-level disinfectant.
6.4 Rinse water
Once removed from disinfectant solution, the instrument must be thoroughly
rinsed with sterile water to remove any disinfectant residue. If sterile water is not
available, clean, potable tap water or water that has been processed (e.g.,
filtered) to improve its microbiological quality may be used.
When nonsterile water is used after disinfection, wipe the endoscope and flush
the channels with 70% ethyl or isopropyl alcohol, then air-dry all internal
channels to inhibit the growth of residual bacteria. Do not reuse rinse water.
84 ULTRASOUND GASTROVIDEOSCOPE GF-UCT180
Chapter 6 Compatible Reprocessing Methods and Chemical Agents
6.5 Ethylene oxide gas sterilization
This instrument and other accessories listed as compatible with ethylene oxide
gas sterilization in Table 6.1 on page 82 can be sterilized by ethylene oxide gas
and aerated within the parameters given in Tables 6.2 and 6.3. When performing
ethylene oxide gas sterilization, follow the cleaning, disinfection, and sterilization
protocols of your hospital and the instruction manuals of the sterilization
equipment.
• Before sterilization, the instrument must be thoroughly
cleaned and dried. Residual moisture may inhibit sterilization.
• The results of sterilization depend on various factors such as
how the sterilized instrument was packed or the positioning,
method of placing and loading of the instrument in the
sterilization device. Please verify the sterilization effects by
using biological or chemical indicators. Also follow the
guidelines for sterilization issued by medical administrative
authorities, public organizations or the infection management
sections at each medical facility, as well as the instruction
manual for the sterilization device.
• All instruments must be properly aerated following ethylene
oxide gas sterilization to remove toxic ethylene oxide
residuals.
• Exceeding the recommended parameters may cause
equipment damage (see Tables 6.2 and 6.3).
• Disconnect the water-resistant caps from the endoscope
connector before ethylene oxide gas sterilization. If the
water-resistant cap is attached during ethylene oxide gas
sterilization, the air inside the endoscope will expand and
rupture the covering of the bending section and/or damage
the angulation mechanism.
ULTRASOUND GASTROVIDEOSCOPE GF-UCT180 85
Chapter 6 Compatible Reprocessing Methods and Chemical Agents
Parameters for 100% ethylene oxide gas sterilization
cycles
Process phase Parameter Value
Sterilization Temperature 55C (130F)
Vacuum 0.05 – 0.07 MPa
(Absolute pressure) (7.25 – 10.15 psia)
Relative humidity 50 – 80%
Ethylene oxide gas 0.735 – 0.740 mg/cm3
concentration (735 – 740 mg/L)
Exposure time 60 minutes
Aeration Minimum aeration 12 hours in an aeration chamber at
parameters 50 – 57C (122 – 135F) or 7 days at
room temperature
Table 6.2
Parameters for 20% ethylene oxide gas/80% CO2 gas
sterilization cycles, for countries other than the USA
Process phase Parameter Value
Sterilization Temperature 57C (135F)
Relative pressure 0.1 – 0.17 MPa
Relative humidity 55%
Ethylene oxide gas 0.6 – 0.7 mg/cm3
concentration (600 – 700 mg/L)
Exposure time 105 minutes
Aeration Minimum aeration 12 hours in an aeration chamber at
parameters 50 – 57C (122 – 135F) or 7 days at
room temperature
Table 6.3
86 ULTRASOUND GASTROVIDEOSCOPE GF-UCT180
Chapter 6 Compatible Reprocessing Methods and Chemical Agents
6.6 Steam sterilization (autoclaving) of accessories
The accessories listed as compatible with steam sterilization (autoclaving) in
Table 6.1 on page 82 can be sterilized by steam within the parameters given in
Table 6.4. When steam sterilizing, follow the cleaning, disinfection, and
sterilization protocols of your hospital as well as the instructions provided by the
manufacturer of your sterilization equipment.
The results of sterilization depend on various factors such as
how the sterilized instrument was packed or the positioning,
method of placing and loading of the instrument in the
sterilization device. Please verify the sterilization effects by
using biological or chemical indicators. Also follow the
guidelines for sterilization issued by medical administrative
authorities, public organizations or the infection management
sections at each medical facility, as well as the instruction
manual for the sterilization device.
• Do not steam sterilize the endoscope. Steam sterilization
(autoclaving) will severely damage the endoscope.
• Do not exceed a setting temperature of 134C (273F),
equivalent to a maximum temperature of 137C (279F), nor
an exposure time greater than 20 minutes. Otherwise, the
accessories may be damaged.
Process Parameters
Prevacuum Temperature 132 – 134C
(270 – 274F)
Exposure time 5 minutes
Table 6.4 Steam sterilization (autoclaving) exposure parameters
ULTRASOUND GASTROVIDEOSCOPE GF-UCT180 87
Chapter 7 Cleaning, Disinfection, and Sterilization Procedures
Chapter 7 Cleaning, Disinfection, and
Sterilization Procedures
ALL channels of the endoscope, including the elevator wire
channel and balloon channel, MUST be cleaned and
high-level disinfected or sterilized during EVERY
reprocessing cycle, even if the channels were not used
during the previous patient procedure. Otherwise, insufficient
cleaning and disinfection or sterilization of the endoscope
may pose an infection control risk to the patient and/or
operators performing the next procedure with the endoscope.
• Do not coil the endoscope’s insertion section or universal
cord into a diameter of less than 12 cm. The endoscope can
be damaged if coiled too tightly.
• For proper reprocessing results, do not coil the insertion
section or universal cord with a diameter of less than 40 cm.
If the diameter is less than 40 cm, it will be difficult to insert
the channel cleaning brushes (BW-20T, BW-7L), single use
single-ended cleaning brush (BW-400L), single use
combination cleaning brush (BW-412T) and/or the single use
channel cleaning brush (BW-201T).
7.1 Required reprocessing equipment
Preparation of the equipment
Prior to cleaning and disinfection or sterilization, prepare the equipment shown in
Figure 7.1.
Use basins that are at least 40 cm by 40 cm (16” by 16”) in
size and deep enough to allow the endoscope to be
completely immersed.
88 ULTRASOUND GASTROVIDEOSCOPE GF-UCT180
Chapter 7 Cleaning, Disinfection, and Sterilization Procedures
Air/water channel cleaning
adapter (MAJ-629)
Injection tube Single use combination
(MH-946) cleaning brush
Channel plug (BW-412T1) Suction cleaning adapter
(MAJ-621) (MH-856)
Channel cleaning Channel cleaning Washing tube (MH-974) Leakage tester
brush (BW-20T) or brush (BW-7L1) or
(MB-155)
single use channel single use
cleaning brush single-ended cleaning
(BW-201T1) brush (BW-400L1)
Channel-opening cleaning
brush (MH-507) or Cleaning brush Water-resistant cap
single use channel-opening Biopsy valve (MAJ-1534) (MH-553, 2 pcs)
cleaning brush (MAJ-853)
(MAJ-13391)
Cleaning adapter for Suction pump
Maintenance unit Light source
instrument channel (KV-4, KV-5, SSU-2)
(MU-1) (sold separately) (sold separately)
port (MAJ-350) (sold separately)
1 These products may not be available in some areas.
• Detergent solution • Large basin with a • Large basins for • Clean, lint-free cloths
tight-fitting lid for rinsing
detergent and
disinfectant solution
• Clean water • Large basin for rinsing • 500 cm3 (500 ml) • Sterile, cotton swabs
and leakage testing container
• 70% ethyl or • Disinfectant solution • 30 cm3 (30 ml) syringe • 5 cm3 (5 ml) syringe
isopropyl alcohol
• Small containers • Sterile water • Personal protective • Soft-bristled brush
equipment
Figure 7.1
ULTRASOUND GASTROVIDEOSCOPE GF-UCT180 89
Chapter 7 Cleaning, Disinfection, and Sterilization Procedures
Reprocessing equipment parts and functions
For inspection of other equipment than that mentioned below, refer to the
instruction manual for the equipment being used.
Water-resistant cap (MH-553)
The two water-resistant caps are attached to the videoscope cable connector
and the ultrasonic cable connector on the endoscope to protect the connectors
from water penetration during reprocessing. For leakage testing, the venting
connector on the water-resistant cap must be connected to the leakage tester
(MB-155) (see Figure 7.2).
Groove
Venting connector
Seal
Figure 7.2
Channel cleaning brush (BW-20T, reusable)
The channel cleaning brush is used to brush the inside of the instrument
channel, suction channel, and the interior and/or openings of the suction valve,
air/water valve, AW channel cleaning adapter, and biopsy valve (see Figure 7.3).
Metal tip Shaft
Brush head
Figure 7.3
90 ULTRASOUND GASTROVIDEOSCOPE GF-UCT180
Chapter 7 Cleaning, Disinfection, and Sterilization Procedures
Single use channel cleaning brush (BW-201T)
The single use channel cleaning brush is used to brush the inside of the
instrument channel, suction channel, and the interior and/or openings of the
suction valve, AW channel cleaning adapter, and biopsy valve (see Figure 7.4).
Caution sticker (OLYMPUS SINGLE USE ONLY)
Tip
Brush head Shaft
Figure 7.4
Channel cleaning brush (BW-7L/reusable)
/Single use single-ended cleaning brush (BW-400L)
The channel cleaning brush or the single use single-ended cleaning brush is
used to clean the balloon channel (see Figure 7.5).
Metal tip
Shaft
Figure 7.5
ULTRASOUND GASTROVIDEOSCOPE GF-UCT180 91
Chapter 7 Cleaning, Disinfection, and Sterilization Procedures
Channel-opening cleaning brush (MH-507, reusable)
The channel-opening cleaning brush is used to brush the external surface of the
distal end of the endoscope, the suction cylinder, the irrigation port, and the
instrument channel port (see Figure 7.6).
Brush handle
Brush head
Shaft
Figure 7.6
Single use channel-opening cleaning brush (MAJ-1339)
The single use channel-opening cleaning brush is used to brush the external
surface of the distal end of the endoscope, the suction cylinder, the irrigation
port, and the instrument channel port (see Figure 7.7).
Brush head
Handle
Shaft
Figure 7.7
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Cleaning brush (MAJ-1534)
The cleaning brush is used to brush the external surface of the distal end of the
endoscope (see Figure 7.8).
Long bristle row
Short bristle row
Grip section
Figure 7.8
Suction cleaning adapter (MH-856)
The suction cleaning adapter is used to aspirate reprocessing fluids from the
distal end of the endoscope through the instrument channel (see Figure 7.9).
Weighted end
Connecting end
Figure 7.9
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Chapter 7 Cleaning, Disinfection, and Sterilization Procedures
Air/water channel cleaning adapter (MAJ-629)
During precleaning, the air/water channel cleaning adapter is connected to the
air/water cylinder. When the adapter is depressed, water is fed through the
air/water channel. Air is continuously fed when the adapter is not depressed (see
Figure 7.10).
Notice card
Pakings
Piston
Figure 7.10
Use the air/water channel cleaning adapter only during
precleaning.
Injection tube (MH-946)
The injection tube is used to inject detergent solution, disinfectant solution, water
and alcohol into the air/water channel, instrument channel and suction channel
and to flush air through the channels to expel fluids (see Figure 7.11).
Connector plug
Suction channel tube
Notice card
Air pipe port
Suction channel port
Air/water channel port
Air/water channel tube
Suction channel port
(including filter mesh)
Figure 7.11
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Channel plug (MAJ-621)
The channel plug is used to plug the openings of the instrument channel port,
air/water and suction cylinders during cleaning (see Figure 7.12).
Biopsy valve cap
Cylinder plug
Figure 7.12
Washing tube (MH-974)
The washing tube is used to inject detergent solution, disinfectant solution,
water, and alcohol into the elevator wire channel and to flush air through the
channel to expel fluids (see Figure 7.13).
Luer port
Connecting end
Figure 7.13
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Cleaning adapter for instrument channel port (MAJ-350)
The cleaning adapter for instrument channel port is attached to the instrument
channel port during reprocessing so that the endoscope may be connected to
reprocessing equipment (see Figure 7.14).
Notice card
Figure 7.14
Single use combination cleaning brush (BW-412T)
The channel cleaning brush part of the single use combination cleaning brush is
used to brush the inside of the instrument channel, suction channel, and the
interior and/or openings of the suction valve, AW channel cleaning adapter, and
biopsy valve. The channel-opening cleaning brush part of the single use
combination cleaning brush is used to brush the external surface of the distal
end of the endoscope, the suction cylinder, the irrigation port, and the instrument
channel port (see Figure 7.15).
Tip Bristles Shaft Handle Bristles
Channel cleaning Channel-opening
brush part cleaning brush part
Figure 7.15
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Inspection of reusable equipment
For inspection of other equipment than that mentioned below, refer to the
instruction manual for the equipment being used.
All equipment mentioned below is consumable. Should any
irregularity be observed, use a spare instead. Using defective
equipment may make it difficult to effectively reprocess the
endoscope, and could cause endoscope and/or equipment
damage.
Do not immerse the water-resistant cap alone in water.
Moisture remaining on the inner side of the cap may
penetrate the videoscope cable connector and cause
equipment damage.
Inspection of the water-resistant caps (MH-553)
1. Confirm that the inside of the water-resistant caps is dry and free from
debris (see Figure 7.2 on page 90). Wipe with a dry cloth when the inside of
the water-resistant cap is wet or debris is detected.
2. Confirm that the seal inside the water-resistant cap is free from scratches,
flaws, and debris.
3. Check the venting connector for looseness.
Inspection of the suction cleaning adapter (MH-856)
Check for cracks, scratches, flaws, debris and other damage (see Figure 7.9 on
page 93).
Inspection of the air/water channel cleaning adapter
(MAJ-629)
Check for cracks, scratches, flaws, debris and other damage (see Figure 7.10 on
page 94).
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Inspection of the injection tube (MH-946)
1. Confirm that all components of the injection tube are free from cracks,
scratches, flaws and debris (see Figure 7.11 on page 94).
2. Confirm that the filter mesh is in the suction port.
3. Attach the 30 cm3 (30 ml) syringe to the air/water channel port. With the
filter mesh immersed in rinse water, withdraw the syringe plunger and
confirm that rinse water is drawn into the syringe. Depress the plunger and
confirm that rinse water is emitted from the air pipe port. Confirm that water
is not emitted from the suction port.
4. Attach the 30 cm3 (30 ml) syringe to the suction channel port. With the filter
mesh immersed in rinse water, withdraw the syringe plunger and confirm
that rinse water is drawn into the syringe. Depress the plunger and confirm
that rinse water is emitted from the distal end of the suction channel tube.
Confirm that water is not emitted from the suction port.
Inspection of the channel plug (MAJ-621)
Confirm that the cylinder plug and biopsy valve cap are free from cracks,
scratches, flaws and debris (see Figure 7.12 on page 95).
Inspection of the cleaning adapter for instrument channel
port (MAJ-350)
Check for cracks, scratches, flaws, debris and other damage (see Figure 7.14 on
page 96).
Inspection of the washing tube (MH-974)
Check for cracks, scratches, flaws, debris and other damage (see Figure 7.13 on
page 95).
Inspection of the channel cleaning brushes (BW-20T,
BW-7L)
1. Confirm that the brush section and the metal tip at the distal end are
securely in place. Check for loose or missing bristles (see Figure 7.4 on
page 91).
2. Check for bends, scratches and other damage to the shaft.
3. Check for debris on the shaft and/or in the bristles of the brush head.
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Inspection of the channel-opening cleaning brush
(MH-507)
1. Check the brush head for loose or missing bristles (see Figure 7.6 on
page 92).
2. Check for bends, scratches, and other damage to the shaft.
3. Check for debris on the shaft and/or in the bristles of the brush head.
Inspection of the cleaning brush (MAJ-1534)
1. Check the brush head for loose or missing bristles (see Figure 7.8 on
page 93).
2. Check the handle for scratches and other damage.
Inspection of single-use equipment
• All items mentioned below are single-use items. Do not
clean, disinfect, or sterilize the equipment prior to use and/or
after use. Doing so may damage the equipment. Using
damaged equipment may make it difficult to effectively
reprocess the endoscope, and could cause endoscope
and/or equipment damage.
• Do not store the equipment outside its packaging. Doing so
could allow the equipment to become damaged. Before use,
inspect the bristles for any damage. If the bristles are
crushed, gently straighten them with your fingers. Using a
brush with crushed bristles may make it difficult to effectively
reprocess the endoscope.
• Before use, inspect the equipment for any irregularities.
Should any irregularity be observed, use a spare instead.
Using defective equipment may result in ineffectual
reprocessing, and could cause endoscope and/or equipment
damage.
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Inspection of the single use channel cleaning brush
(BW-201T)
1. Remove the packaging immediately before use (see Figure 7.16).
2. Confirm that the tip and bristles at the distal end are securely in place.
Check for loose or missing bristles.
3. Check for bends, scratches and other damage to the shaft.
4. Check for debris on the shaft and/or in the bristles of the brush.
Tip
Brush head Shaft
Packaging
Figure 7.16
Inspection of the single use channel-opening cleaning
brush (MAJ-1339)
1. Open the packaging immediately before use (see Figure 7.17).
2. Check for loose or missing bristles.
3. Check for bends, scratches, and other damage to the shaft.
4. Check for debris on the shaft and/or in the bristles of the brush head.
Brush head Handle
Packaging Shaft
Figure 7.17
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Inspection of the single use combination cleaning brush
(BW-412T)
1. Remove the brush from its packaging just prior to use (see Figure 7.18).
2. Confirm that the channel cleaning brush part and the tip at the distal end are
securely attached.
3. Check the channel cleaning brush and the channel-opening cleaning brush
parts for loose or missing bristles.
4. Check the bristles of the channel cleaning brush and the channel-opening
cleaning brush parts for any damage. If the bristles are crushed, gently
straighten them with your fingertips.
5. Check the shaft for bends, scratches, and other damage. Do not reprocess
the single use combination cleaning brush prior to use. The brush may be
damaged.
Brush head
Handle
Tip
Shaft
Packaging
Figure 7.18
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7.2 Cleaning, disinfection, and sterilization
procedures for the endoscope
After the procedure, clean, disinfect, and sterilize the endoscope according to
the procedure described below.
Endoscope reprocessing summary chart
Withdrawal of the endoscope
Precleaning (Section 7.3)
Leakage testing (Section 7.4)
Manual cleaning (Section 7.5)
High-level disinfection Sterilization
(Section 7.6) (Section 7.8)
Rinsing after high-level
disinfection (Section 7.7)
Storage and Disposal
(Chapter 9)
ALL channels of the endoscope, including the elevator wire
channel and the balloon channel, MUST be cleaned and
high-level disinfected or sterilized during EVERY
reprocessing cycle, even if the channels were not used
during the previous patient procedure. Otherwise, insufficient
cleaning and disinfection or sterilization of the endoscope
may pose an infection control risk to the patient and/or
operators performing the next procedure with the endoscope.
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7.3 Precleaning
If the endoscope is not immediately precleaned after each
procedure, residual organic debris will begin to solidify and it
may be difficult to effectively reprocess the endoscope.
Preclean the endoscope at the bedside in the procedure room immediately after
each procedure. These steps are to be performed when the suction pump is still
connected to the endoscope. During precleaning, wear appropriate personal
protective equipment.
Equipment needed
Prepare the following equipment, and wear appropriate protective equipment.
• Personal protective equipment
• Clean, lint-free cloth
• 500 cm3 (500 ml) containers
• Detergent solution
• Clean water
• Air/water channel cleaning adapter (MAJ-629)
• Washing tube (MH-974)
• 5 cm3 (5 ml) syringe
Preparation
1. Turn the ultrasound center, video system center and light source OFF.
2. Prepare a 500 cm3 (500 ml) container of detergent solution at the
temperature and concentration recommended by the detergent
manufacturer.
3. Prepare clean water in a 500 cm3 (500 ml) container.
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Wipe down the insertion section
• Handle the insertion section carefully. Tightly gripping or
sharply bending the insertion section or bending section can
stretch or severely damage the insertion section and the
covering of the bending section.
• Do not hold the ultrasound transducer when holding the
insertion tube. The ultrasound transducer damage can result
and/or the ultrasound image will be abnormal.
• Do not squeeze the ultrasound transducer forcefully. The
ultrasound transducer damage can result and/or the
ultrasound image will be abnormal.
1. Remove and discard the balloon as described in Section 4.5, “Removal of
the balloon” on page 74, to ensure proper cleaning of the endoscope.
2. Wipe the entire insertion section with a clean, lint-free cloth soaked in
detergent solution. Wipe from the boot at the control section toward the
distal end.
3. Gently wipe the ultrasound transducer surface.
Aspirate detergent solution
Monitor the suction bottle on the suction pump carefully to
ensure that it does not overflow. Otherwise, suction pump
damage could result.
1. Turn the suction pump ON.
2. Attach the biopsy valve cap.
3. Immerse the distal end of the insertion section in detergent solution.
Depress the suction valve to the first stage and aspirate detergent solution
into the channel for 30 seconds.Then depress the suction valve completely
and aspirate detergent solution into the balloon channel for 30 seconds (see
Figure 7.19).
4. Remove the distal end of the insertion section from the detergent solution.
Depress the suction valve to the first stage and aspirate air for 10 seconds.
Then depress the suction valve completely and aspirate air for 10 seconds.
5. Turn the suction pump OFF.
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Suction valve
Detergent solution
Figure 7.19
Flush water and air into the air/water channel
Do not use the air/water channel cleaning adapter for patient
examinations. It will cause continuous insufflation and could
result in patient injury.
To prevent clogging of the air/water nozzle, always use the
air/water channel cleaning adapter to clean the air/water
channel after each use.
1. Prepare clean water in a 500 cm3 (500 ml) container.
2. Turn the light source ON.
3. Depress the air/water valve completely to feed water into the balloon
channel and wash away any liquid that remained in the balloon channel.
4. Switch “OFF” the airflow regulator on the light source.
5. Remove the air/water valve from the endoscope and place it in a container
of detergent solution (see Figure 7.20).
Water may drip from the air/water valve or cylinder when the
air/water valve is detached. The water dripping from the
air/water valve or cylinder is clean (i.e., sterile water in the
water container). If water is dripping from the air/water valve
or cylinder, hold the control section higher than the water
container during water feeding.
6. Attach the air/water channel cleaning adapter to the air/water cylinder of the
endoscope (see Figure 7.20).
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Chapter 7 Cleaning, Disinfection, and Sterilization Procedures
7. Switch the airflow regulator to maximum output (“HIGH” or “3”).
8. Immerse the distal end of the insertion tube in the water (see Figure 7.19).
9. Depress the air/water channel cleaning adapter to feed water through the
channels for about 30 seconds. Release the adapter to feed air through the
channels for 10 seconds or more.
10. Turn the light source, the EVIS video system center and the ultrasound
imaging system OFF.
Air/water channel cleaning adapter
Figure 7.20
Flush detergent solution and air into the elevator wire channel
1. Connect the washing tube to the elevator channel plug (see Figure 7.21).
Elevator channel plug
Washing tube
Figure 7.21
2. Immerse the distal end of the insertion section in the clean water.
3. Use the 5 cm3 (5 ml) syringe, to slowly flush detergent solution through the
elevator wire channel several times until no air bubbles exit the distal end
(see Figure 7.22).
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4. Use the 5 cm3 (5 ml) syringe to slowly flush clean water through the elevator
wire channel several times (see Figure 7.22).
5. Use the 5 cm3 (5 ml) syringe to slowly flush air through the elevator wire
channel several times until a steady stream of air bubbles exit the distal end
(see Figure 7.22).
5 cm3 (5 ml) syringe Washing tube
Elevator channel
Elevator wire channel plug
Endoscope connector
Figure 7.22
Disconnect the endoscope, reusable parts and reprocessing
equipment
Do not touch the light guide of the endoscope connector
immediately after removing it from the light source because it
is extremely hot. Operator or patient injury may result.
1. Disconnect the ultrasonic cable from the endoscope’s ultrasonic cable
connector.
2. Disconnect the videoscope cable from the endoscope’s videoscope cable
connector.
3. Disconnect the suction tube from the suction connector of the endoscope
connector.
4. Disconnect the metal tip of the water container from the air/water supply
connector of the endoscope connector. Then, attach the metal tip to the tip
receptacle on the lid of the water container as described in the water
container’s instruction manual.
5. Disconnect the endoscope connector from the light source.
6. Transport the endoscope to the reprocessing area.
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7. Detach the air/water channel cleaning adapter, suction valve, and biopsy
valve from the endoscope and place them in a container of detergent
solution.
8. Disconnect the washing tube from the endoscope.
7.4 Leakage testing
After precleaning, perform leakage testing on the endoscope to ensure that it is
waterproof.
Equipment needed
Prepare the following equipment, and wear appropriate personal protective
equipment.
• Personal protective equipment
• Large basin
• Clean water
• Maintenance unit or (MU-1 or
light source CLV-180, CLV-160, CLV-U40)
• Leakage tester (MB-155)
• Water-resistant cap (2 pcs) (MH-553)
Attaching the water-resistant caps (MH-553)
• The ultrasonic cable connector and the electrical connector
of the endoscope are not waterproof. Before immersing or
leakage testing the endoscope, always attach the
water-resistant caps. Otherwise, equipment damage may
result.
• If the exterior of the ultrasonic cable connector and/or the
videoscope cable connector is scratched, the connector may
no longer be waterproof and the seal inside the
water-resistant cap may become scratched. If the ultrasonic
cable connector or the electrical connector is scratched,
contact Olympus.
• Never immerse the water-resistant caps unless they are
attached to the endoscope. Water remaining inside the
water-resistant caps can be transferred to and damage the
ultrasonic cable connector and/or the videoscope cable
connector.
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• Always use a dry water-resistant cap. Any water remaining
on the water-resistant cap may cause damage to the
endoscope, maintenance unit or light source.
1. Confirm that the inside of the water-resistant cap is dry and free from debris.
Wipe with a dry, lint-free clean cloth if the inside of the water-resistant cap is
wet or there is debris.
2. Align the EW character (see Figures 7.23 (a) and 7.24 (a)) on the
water-resistant caps with mark 2 on the electrical connector housing and the
ultrasonic cable connector housing. When using a manual disinfector, align
the KC/TD character (see Figures 7.23 (b) and 7.24 (b)) on the
water-resistant caps with mark 2 on the electrical connector housing and the
ultrasonic cable connector housing.
3. Align the pin on the electrical connector and the ultrasonic cable connector
with the grooves on the water-resistant caps.
4. Push the water-resistant caps into position and rotate each of them
clockwise until they stop (approximately 45).
Mark 2 (yellow) Mark 2 (yellow)
Water-resistant
cap
2. 2.
Rotate Rotate
3. 3.
4. 4.
(a) When performing leakage (b) When using a manual disinfector
testing, cleaning, disinfection
or using an endoscope
reprocessor
Figure 7.23
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Mark 2 (red) Mark 2 (red)
Water-resistant
cap
2. 2.
Rotate Rotate
3. 3.
4. 4.
(a) When performing leakage (b) When using a manual disinfector
testing, cleaning, disinfection
or using an endoscope
reprocessor
Figure 7.24
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Performing the leakage test
• During leakage testing, a continuous series of bubbles
emerging from a location on the endoscope indicates a leak
at that location. This means that water will be able to
penetrate the inside of the endoscope. If you locate a leak,
remove the endoscope from the water and contact Olympus.
• Never connect or disconnect the water-resistant cap or the
leakage tester’s connector cap while immersed. Doing so
could allow water to enter the endoscope and equipment
damage can result.
• Rotate the leakage tester’s connector cap until it stops. If it is
not fully and properly attached, the endoscope’s interior will
not be pressurized and accurate leakage testing will be
impossible.
• When connecting the leakage tester’s connector cap to the
water-resistant cap’s venting connector, make sure that the
inside of the leakage tester’s connector cap and the outside
of the water-resistant cap’s venting connector are completely
wiped and dry. Water remaining on either component may
penetrate the inside of the water-resistant cap and could
cause endoscope malfunction.
When the leakage tester connector is in place, the covering
of the bending section will expand as the air pressure inside
the endoscope increases. This is normal.
1. Fill a basin with clean water. Use a basin that is at least 40 cm by 40 cm (16”
by 16”) in size and deep enough to allow the endoscope to be completely
immersed.
2. Insert the leakage tester connector into the output socket of the
maintenance unit or the light source (see Figure 7.25) and turn the
maintenance unit or the light source ON. Set the light source’s airflow
regulator switch to its maximum level.
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Leakage tester connector
Maintenance unit 2.
or light source
Water-resistant
4.
cap (MH-553)
Leakage tester
connector cap
Venting connector
Figure 7.25
3. Confirm that the leakage tester is emitting air by gently depressing the pin
located inside the leakage tester’s connector cap.
4. Connect the leakage tester’s connector cap to either one of the two venting
connectors that are in the water-resistant caps of the video cable connector
and the ultrasonic cable connector (see Figure 7.25).
5. With the leakage tester connected, immerse the entire endoscope in water
and observe for approximately 30 seconds while angulating the bending
section. Confirm that there is no location on the endoscope from that a
continuous series of bubbles emerges.
6. Remove the endoscope from the basin with the leakage tester attached.
7. Turn the maintenance unit or the light source OFF.
8. Disconnect the leakage tester from the maintenance unit or the light source.
Always disconnect the leakage tester connector from the
light source or maintenance unit before disconnecting the
leakage tester’s connector cap from the venting connector.
Failure to do this will not allow the endoscope to
depressurize properly. This may damage the endoscope.
9. Wait 30 seconds, or until the covering of the bending section contracts to its
pre-expansion size. Disconnect the leakage tester’s connector cap from the
venting connector.
10. Thoroughly dry the leakage tester.
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7.5 Manual cleaning
To prevent a water leak, do not apply excessive force when
cleaning the endoscope.
After completing the leakage test, perform manual cleaning according to the
procedures described below.
In case of excessive bleeding and/or delayed reprocessing, perform “Presoak for
excessive bleeding and/or delayed reprocessing after each procedure” on
page 131 and follow the procedure described below.
Reusable parts that are normally reprocessed with the
endoscope
• Channel plug (MAJ-621)
• Injection tube (MH-946)
• Water-resistant cap (2 pcs) (MH-553)
• Chain for water-resistance caps (MAJ-1739)
• Washing tube (MH-974)
• Cleaning adapter for instrument (MAJ-350)
channel port
Equipment needed
Prepare the following equipment and wear appropriate personal protective
equipment.
• Personal protective equipment
• Soft brush
• 30 cm3 (30 ml) syringe
• Clean, lint-free cloths
• Large basins
• Detergent solution
• Clean water
• Suction pump
• Suction cleaning adapter (MH-856)
• Channel cleaning brush (BW-20T),
Single use channel cleaning brush (BW-201T) or
Single use combination cleaning brush (BW-412T)
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Chapter 7 Cleaning, Disinfection, and Sterilization Procedures
• Channel-opening cleaning brush (MH-507),
Single use channel-opening cleaning brush (MAJ-1339) or
Single use combination cleaning brush (BW-412T)
• Channel cleaning brush (BW-7L)
• Cleaning brush (MAJ-1534)
• Single use single-ended cleaning brush (BW-400L)
• Channel plug (MAJ-621)
• Injection tube (MH-946)
• Cleaning adapter for (MAJ-350)
instrument channel port
• Washing tube (MH-974)
• 5 cm3 (5 ml) syringe
• To prevent damage to the endoscope, never immerse it
together with objects other than the equipment listed above.
• Reuse of detergent may cross-contaminate equipment and
compromise the safety of personnel cleaning the endoscope.
Do not reuse detergent.
Preparation
1. Fill a basin with fresh detergent solution at the temperature and
concentration recommended by the detergent manufacturer. Use a basin
that is at least 40 cm by 40 cm (16” by 16”) in size and deep enough to
completely immerse the endoscope.
2. Fill a basin with clean water. Use a basin that is at least 40 cm by 40 cm (16”
by 16”) in size and deep enough to completely immerse the endoscope.
Cleaning the external surface
After thoroughly brushing or wiping all external surfaces and
the distal end of the endoscope with a soft brush or lint-free
cloth, always visually confirm that the elevator wire is not
broken. If the elevator wire is broken, patient and/or operator
injury could result.
Do not wipe the ultrasonic transducer forcefully. The
ultrasonic transducer damage can result and/or the ultrasonic
image will be abnormal.
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1. Immerse the endoscope in the detergent solution.
2. With the endoscope immersed, use a soft brush or lint-free cloth to
thoroughly brush or wipe all external surfaces of the endoscope. Pay
particular attention to the air/water nozzle opening and the objective lens,
and ensure that all surfaces of the distal end are thoroughly cleaned (see
Figure 7.26).
Ultrasound transducer
Lint-free cloth
Air/water nozzle
opening
Objective lens
Figure 7.26
Brushing around the forceps elevator and instrument channel
outlet
• After thoroughly brushing around the forceps elevator with a
soft brush, always visually confirm that the elevator wire is
not broken. If the elevator wire is broken, patient and/or
operator injury could result.
• To avoid splattering detergent solution while brushing, keep
the endoscope submerged.
Using a stiff brush or excessive force when brushing may
scratch the distal end and result in water leakage, cause the
elevator wire to come off the distal end, bend or kink the
elevator wire so that the forceps elevator will no longer work.
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1. Turn the elevator control lever all the way in the opposite direction of the
“ U” direction. perform the following brushing in the detergent solution.
2. While holding the distal end, brush the groove of the interior of the forceps
elevator with the cleaning brush (MAJ-1534) until all debris is removed (see
Figure 7.27).
Forceps elevator
Cleaning brush
(MAJ-1534)
Figure 7.27
3. Look at the left side of the instrument channel opening from the distal end,
brush the interior of this part with the cleaning brush (MAJ-1534) until all
debris is removed (see Figure 7.28).
Cleaning brush
(MAJ-1534)
Figure 7.28
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4. Look at the right side of the instrument channel opening from the distal end,
brush the interior of this part with the cleaning brush (MAJ-1534) until all
debris is removed (see Figure 7.29).
Cleaning brush
(MAJ-1534)
Figure 7.29
5. Move the elevator control lever in the “ U” direction to raise the forceps
elevator.
6. While holding the distal end, brush both sides of the forceps elevator and
the opposite side of the groove of the forceps elevator with the cleaning
brush (MAJ-1534) until all debris is removed (see Figure 7.30).
Forceps elevator
Cleaning brush
(MAJ-1534)
Figure 7.30
7. Brush the distal end of the endoscope, using the cleaning brush
(MAJ-1534).
8. Move the elevator control lever all the way in the opposite direction of the
“ U” direction to lower the forceps elevator.
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Flushing the interior of the forceps elevator
1. Immerse the distal end in detergent solution, operate the elevator control
lever to raise and lower the forceps elevator 3 times.
2. With the forceps elevator raised, flush the interior of the forceps elevator
with detergent solution using the 30 cm3 (30 ml) syringe (see Figure 7.31).
Forceps elevator
Figure 7.31
Brushing the channels
• Be sure to brush the inside of the instrument channel and
suction channel. Otherwise, insufficient cleaning and/or
disinfection of the endoscope may pose an infection control
risk to the patient and/or operators performing the next
procedure with the endoscope.
• To avoid splattering detergent solution when the channel
cleaning brush (BW-20T), the single use channel cleaning
brush (BW-201T), or the single use combination cleaning
brush (BW-412T) is pulled out, keep the endoscope
submerged.
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• The channel cleaning brush (BW-20T) is a consumable. The
single use channel cleaning brush (BW-201T) and the single
use combination cleaning brush (BW-412T) are single-use
items. Repeated use may cause the brush head to become
bent or kinked, which could cause it to come off during use.
Confirm that the channel cleaning brush (BW-20T), the
single use channel cleaning brush (BW-201T), or the single
use combination cleaning brush (BW-412T) is free from any
damage or other irregularities before and after use. If a part
of the brush comes off inside the endoscope, immediately
retrieve it and carefully confirm that no parts remain inside
the channel of the endoscope by passing a new cleaning
brush or other EndoTherapy accessory through the channel.
Any parts left in the channel can drop into the patient during
the procedure.
Depending on the location, the missing part may not be
recoverable by passing a new brush or other EndoTherapy
accessory through the channel. In this case, contact
Olympus.
• Clean only one endoscope and/or accessories with a single
use channel cleaning brush (BW-201T), a single use
channel-opening cleaning brush (MAJ-1339), a single use
combination cleaning brush (BW-412T), a single use
single-ended cleaning brush (BW-400L) and dispose of the
brushes immediately after use. Using a single use channel
cleaning brush (BW-201T), a single use channel-opening
cleaning brush (MAJ-1339), a single use combination
cleaning brush (BW-412T), a single use single-ended
cleaning brush (BW-400L) on more than one endoscope
and/or accessories may make it difficult to effectively
reprocess the endoscope and/or accessories, and could
cause endoscope, accessories and/or equipment damage.
• Gently withdraw the channel cleaning brush (BW-20T), the
single use channel cleaning brush (BW-201T), the single use
combination cleaning brush (BW-412T), or the single use
single-ended cleaning brush (BW-400L) from the instrument
channel or suction channel. Make sure that the shaft does
not rub against the external opening of the suction cylinder.
This could damage the brush and/or wear a groove in the
opening, leading to impaired suction and liquid leakage.
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• Do not attempt to pass the channel cleaning brush (BW-20T),
the single use channel cleaning brush (BW-201T), the single
use combination cleaning brush (BW-412T), or the single use
single-ended cleaning brush (BW-400L) from the distal end
of the insertion section and/or suction connector. It may get
caught, making retrieval impossible.
While the endoscope is submerged, brush the instrument and the suction
channel, suction cylinder, instrument channel port, balloon channel and irrigation
port according to the following procedures (see Figure 7.32).
Suction cylinder
A
B
C
E
B
B
Instrument
channel port
D
C
A A
Suction
connector
Figure 7.32
Brushing the instrument channel in the insertion tube and
suction channel in the control section (location A)
1. Immerse the endoscope in the detergent solution to avoid splattering.
2. Straighten the endoscope’s bending section. Grip the channel cleaning
brush (BW-20T), the single use channel cleaning brush (BW-201T), or the
single use combination cleaning brush (BW-412T) at a point 3 cm from the
bristles.
3. Insert the channel cleaning brush (BW-20T), the single use channel
cleaning brush (BW-201T), or the single use combination cleaning brush
(BW-412T) into the center opening of the suction cylinder as illustrated by A
in Figure 7.32. Using short strokes, feed the brush through the insertion tube
until it emerges from the distal end of the endoscope.
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4. Clean the bristles with your fingertips in the detergent solution. Carefully pull
the brush out through the channel and back out of the suction cylinder.
5. Clean the bristles in the detergent solution again.
6. Repeat until all debris is removed.
Brushing the suction channel in the universal cord
(location B)
1. Grip the channel cleaning brush (BW-20T), the single use channel cleaning
brush (BW-201T), or the single use combination cleaning brush (BW-412T)
at a point 3 cm from the bristles.
2. Insert the channel cleaning brush (BW-20T), the single use channel
cleaning brush (BW-201T), or the single use combination cleaning brush
(BW-412T) straight into the opening of the suction cylinder as illustrated by
B in Figure 7.32. Using short strokes, feed the brush through the universal
cord until it emerges from the suction connector on the endoscope
connector.
3. Clean the bristles with your fingertips in the detergent solution. Carefully pull
the brush out through the channel and back out of the suction cylinder.
4. Clean the bristles in the detergent solution again.
5. Repeat until all debris is removed.
Brushing the balloon channel (location C)
1. Grip the channel cleaning brush (BW-7L) or the single use single-ended
cleaning brush (BW-400L) at a point 3 cm from the bristles.
2. Insert the channel cleaning brush (BW-7L) or the single use single-ended
cleaning brush (BW-400L) straight into the opening of the suction cylinder
as illustrated by C in Figure 7.32. Using short strokes, feed the brush until it
reaches the distal end near the balloon attachment groove.
It can be confirmed whether the brush has reached the distal end by looking
at the tip of brush through the groove of the balloon water suction port
(Rough standard of brush insertion length: 150 cm from point).
3. Pull the brush out through the channel and clean the bristles with your
fingertips in the detergent solution.
4. Repeat until all debris is removed.
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Brushing the suction cylinder (location D)
When inserting the channel-opening cleaning brush
(MH-507), the single use channel-opening cleaning brush
(MAJ-1339), or the single use combination cleaning brush
(BW-412T) into the suction cylinder, do not forcibly insert the
brush beyond the middle of the brush section. Otherwise, the
brush may become stuck in the suction cylinder.
1. Insert the channel-opening cleaning brush (MH-507), the single use
channel-opening cleaning brush (MAJ-1339), or the single use combination
cleaning brush (BW-412T) into the suction cylinder as illustrated by D in
Figure 7.32 on page 120 until half of the brush section is inserted.
2. Turn the inserted brush once.
3. Pull the brush out and clean the bristles with your fingertips in the detergent
solution.
4. Repeat until all debris is removed.
Brushing the instrument channel port (location E)
1. Insert the channel-opening cleaning brush (MH-507), the single use
channel-opening cleaning brush (MAJ-1339), or the single use combination
cleaning brush (BW-412T) into the instrument channel port until the brush
handle touches the channel opening as illustrated by E in Figure 7.32 on
page 120.
2. Turn the inserted brush once.
3. Pull the brush out and clean the bristles with your fingertips in the detergent
solution.
4. Repeat until all debris is removed.
5. Insert the channel-opening cleaning brush into the other instrument channel
port and repeat Steps 1 through 3 until all debris is removed.
6. Reprocess the channel-opening cleaning brush (MH-507) as described in
Section 7.9, “Cleaning, disinfection, and sterilization procedures for
reusable parts and reprocessing equipment” on page 139.
7. Dispose of the single use channel-opening cleaning brush (MAJ-1339) or
the single use combination cleaning brush (BW-412T) in an appropriate
manner.
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If the single use channel-opening cleaning brush is not
properly disposed of, it could pose a risk of contamination
and/or infection.
The channel cleaning brush (BW-20T) or the single use
channel cleaning brush (BW-201T) are used to brush the
accessories of the endoscope as described in Section 7.9,
“Cleaning, disinfection, and sterilization procedures for
reusable parts and reprocessing equipment” on page 139.
8. Remove the endoscope from the detergent solution.
Aspirating detergent solution into the instrument channel and
the suction channels
1. Attach the suction valve (MAJ-1443) to the suction cylinder of the
endoscope.
2. Attach the cleaning adapter for instrument channel port to the instrument
channel port.
3. Attach the suction cleaning adapter to the cleaning adapter for instrument
channel port (see Figures 7.33 and 7.34).
4. Connect the suction tube from the suction pump to the suction connector on
the endoscope. Turn the suction pump ON.
5. Immerse both the endoscope’s distal end and the weighted end of the
suction cleaning adapter in the detergent solution.
6. Depress the suction valve to the first stage and aspirate detergent solution
for approximately 30 seconds.
7. Remove both the endoscope’s distal end and the weighted end of the
suction cleaning adapter from the detergent solution.
8. Depress the suction valve to the first stage and aspirate air for
approximately 30 seconds.
9. Immerse the endoscope’s distal end in the detergent solution again.
10. Depress the suction valve completely and aspirate detergent solution for
approximately 30 seconds.
11. Remove the endoscope’s distal end from the detergent solution.
12. Depress the suction valve completely and aspirate air for approximately
30 seconds.
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13. Turn the suction pump OFF.
14. Disconnect the suction tube and remove the suction valve and the suction
cleaning adapter.
15. Reprocess the suction tube, the suction cleaning adapter and suction valve
as described in Section 7.9, “Cleaning, disinfection, and sterilization
procedures for reusable parts and reprocessing equipment” on page 139.
Suction cleaning
adapter
Weighted end
Figure 7.33
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Chapter 7 Cleaning, Disinfection, and Sterilization Procedures
Suction cleaning Cleaning adapter for the
Weighted adapter instrument channel port
end
Suction Instrument
port channel port
Suction
Balloon channel Instrument channel valve
Suction
cylinder
Endoscope connector Universal cord
Suction
Suction connector channel
Suction tube
Suction pump
Suction bottle
Figure 7.34
Alcohol is flammable. Handle with care.
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Chapter 7 Cleaning, Disinfection, and Sterilization Procedures
Flushing detergent solution into the air/water and balloon
channels
1. Attach the channel plug’s biopsy valve cap to the cleaning adapter for
instrument channel port (see Figure 7.35).
2. Lower the channel plug’s cylinder plug onto the air/water and suction
cylinders and slide the plug until it stops (see Figure 7.35).
Cylinder plug Air/water cylinder
Suction cylinder
Biopsy valve cap
Cleaning adapter for the
instrument channel port
Instrument
channel port
Figure 7.35
3. Attach the injection tube’s connector plug to the air and water supply
connectors on the endoscope connector (see Figures 7.36 and 7.37).
4. Attach the injection tube’s air pipe port to the air pipe on the endoscope
connector (see Figures 7.36 and 7.37).
5. Attach the injection tube’s suction channel tube to the suction connector on
the endoscope connector (see Figures 7.36 and 7.37).
6. Immerse the suction port of the injection tube in the detergent solution.
Syringe
Suction channel tube Air/water
channel tube
Suction port
Air pipe port
Connector plug Detergent solution
Figure 7.36
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Chapter 7 Cleaning, Disinfection, and Sterilization Procedures
7. Attach the 30 cm3 (30 ml) syringe to the injection tube’s air/water channel
port (see Figure 7.37).
8. Inject 150 cm3 (150 ml) of detergent solution into the air/water channel and
the balloon channel.
9. Detach the channel plug, the cleaning adapter for instrument channel port
and injection tube from the endoscope, and leave all items immersed.
Channel plug
Air channel Air/water cylinder
Water channel
Suction
cylinder
Air/water nozzle Balloon channel
Connector plug
Water supply
connector
Air supply connector
Universal cord
Air pipe port
Air pipe Suction connector
Injection tube
Suction port
Air/water
channel port
Suction channel port
Syringe
Figure 7.37
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Flushing detergent solution into the elevator wire channel
1. Connect the washing tube to the elevator channel plug (see Figure 7.38).
Elevator channel plug
Washing tube
Figure 7.38
2. Use the 5 cm3 (5 ml) syringe to inject 15 cm3 (15 ml) of detergent solution
into the elevator wire channel via the washing tube (see Figure 7.39).
5 cm3 (5 ml) syringe Washing tube
Elevator channel
plug
Elevator wire channel
Endoscope connector
Figure 7.39
3. Disconnect the washing tube from the endoscope and immerse it in
detergent solution.
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Soaking the endoscope and all reprocessing equipment in
detergent solution
1. Using a lint-free cloth, wipe all debris from the endoscope’s external
surfaces while the endoscope is immersed in the detergent solution.
2. Cover the basin with a tight-fitting lid to minimize the diffusion of detergent
vapors.
3. Soak the endoscope and all reprocessing equipment for the amount of time
and at the temperature and concentration recommended by the detergent
manufacturer.
4. Remove the endoscope and all reprocessing equipment from the detergent
solution.
5. Inspect all reprocessing equipment. If debris remains, ultrasonically clean at
33 – 48 kHz for 5 minutes.
6. Place the endoscope and all reprocessing equipment in clean water and
gently agitate them to thoroughly rinse.
Removing detergent solution from all channels
1. Attach the channel plug, the cleaning adapter for instrument channel port
and the injection tube to the endoscope. Place the suction port in clean
water. Attach the channel plug’s biopsy valve cap to the cleaning adapter for
instrument channel port (see Figure 7.40).
2. Attach the 30 cm3 (30 ml) syringe to the suction channel port and inject
150 cm3 (150 ml) of clean water into the suction channel and the balloon
channel (see Figures 7.37 and 7.40).
3. Attach the 30 cm3 (30 ml) syringe to the injection tube’s air/water channel
port and inject 150 cm3 (150 ml) of clean water into the air/water channel
and the balloon channel (see Figures 7.37 and 7.40).
4. Connect the washing tube to the elevator channel plug (see Figure 7.38).
5. Attach the 5 cm3 (5 ml) syringe to the washing tube and flush the elevator
wire channel with 5 cm3 (5 ml) of clean water (see Figure 7.39).
6. Remove the endoscope, together with all equipment, from the water.
7. Cover the distal end and control section of the endoscope with a clean,
lint-free cloth.
8. Using the 30 cm3 (30 ml) syringe, flush the air/water, balloon, and suction
channels with 150 cm3 (150 ml) of air, respectively, via the injection tube
(see Figures 7.37 and 7.40).
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Chapter 7 Cleaning, Disinfection, and Sterilization Procedures
9. Use the 5 cm3 (5 ml) syringe, to flush the elevator wire channel with 10 cm3
(10 ml) of air via the washing tube (see Figure 7.39).
10. Remove the clean, lint-free cloth from the distal end and the control section
of the endoscope.
11. Detach the channel plug, the cleaning adapter for instrument channel port
and injection tube from the endoscope.
12. Detach the washing tube from the endoscope.
Channel plug Suction cylinder
Instrument channel
Balloon channel
Suction channel
Universal cord
Suction
channel tube
Suction connector
Suction port
Injection tube
Air/water
channel port
Syringe
Suction channel port
Figure 7.40
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Dry external surfaces
1. Using a clean, lint-free cloth, wipe and dry the external surfaces of the
endoscope and all equipment thoroughly.
2. Inspect the endoscope and all equipment for residual debris. Should debris
remain, repeat the procedures given in this section.
Presoak for excessive bleeding and/or delayed reprocessing
after each procedure
Follow the steps below only in case of excessive bleeding
and/or delayed reprocessing; unnecessary immersions
should be avoided. Consecutive extended immersions may
damage the endoscope.
1. Fill a basin with detergent solution at the temperature and concentration
recommended by the detergent manufacturer. Use a basin that is at least
40 cm by 40 cm (16” by 16”) in size and deep enough to allow the
endoscope to be completely immersed.
2. Carefully coil the endoscope’s insertion tube and universal cord, and
completely immerse the endoscope in the detergent solution.
3. Fill all channels with the detergent solution following the procedures
described in this section.
4. Remove only reprocessing equipment from the detergent solution.
5. Cover the basin with a tight-fitting lid to minimize the diffusion of detergent
vapors.
6. Soak the endoscope for 10 hours at the temperature and concentration
recommended by the detergent manufacturer.
7. Remove the endoscope from the detergent solution.
8. After soaking the endoscope, manually clean it following the procedures
described in this section.
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7.6 High-level disinfection
All disinfection steps should be performed with the
endoscope and all equipment completely immersed in
disinfectant solution. If the equipment is connected to the
endoscope while they are immersed, or any part of the
equipment is not immersed completely, disinfectant solution
may not adequately contact all surfaces of the equipment.
After manual cleaning, disinfect the endoscope according to the procedures
described below.
Equipment needed
Prepare the following equipment and wear appropriate personal protective
equipment.
• Personal protective equipment
• Clean, lint-free cloths
• Large basin with a tight-fitting lid
• Disinfectant solution
• 30 cm3 (30 ml) syringe
• 5 cm3 (5 ml) syringe
• Channel plug (MAJ-621)
• Injection tube (MH-946)
• Washing tube (MH-974)
• Cleaning adapter for instrument (MAJ-350)
channel port
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Preparation
1. Fill a basin with disinfectant solution at the temperature and concentration
recommended by the disinfectant manufacturer. Use a basin that is at least
40 cm by 40 cm (16” by 16”) in size and deep enough to completely
immerse the endoscope.
2. Connect the cleaning adapter for the instrument channel port to the
endoscope.
3. Attach the channel plug and the injection tube to the endoscope. Attach the
channel plug’s biopsy valve cap to the cleaning adapter for instrument
channel port (see Figures 7.35 and 7.36).
4. Connect the washing tube to the elevator channel plug (see Figure 7.38).
Flushing disinfectant solution into all channels
Completely remove all air bubbles from all channels. Air
bubbles may inhibit disinfection of the channel surface.
Removal of air bubbles can be facilitated by forcefully
injecting disinfectant solution into the channels.
1. Immerse the endoscope and all equipment in the disinfectant solution.
2. Confirm that the suction port of the injection tube is immersed in disinfectant
solution.
3. Using the 30 cm3 (30 ml) syringe, flush at least 150 cm3 (150 ml) of
disinfectant solution through the air/water and suction channels respectively.
Confirm that no bubbles exit the distal end of the endoscope.
4. Using the washing tube and the 5 cm3 (5 ml) syringe, flush 15 cm3 (15 ml)
of disinfectant solution through the elevator wire channel. Confirm that no
bubbles exit the distal end of the endoscope.
5. While immersed in disinfectant solution, raise the forceps elevator and flush
the vicinity of the forceps elevator with disinfectant solution using the 30 cm3
(30 ml) syringe.
6. With the endoscope, channel plug, injection tube, cleaning adapter for the
instrument channel port and washing tube completely immersed in
disinfectant solution, disconnect all equipment from the endoscope. Leave
the endoscope and all equipment immersed in the disinfectant solution.
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Soaking the endoscope and all equipment in disinfectant
solution
All disinfection steps should be performed with the
endoscope and all equipment completely immersed. If the
equipment is disconnected while not immersed, disinfectant
solution may not adequately contact all surfaces. As a result,
the effectiveness of disinfection may be reduced.
1. With the endoscope and all equipment completely immersed in the
disinfectant solution, disconnect all equipment from the endoscope. Leave
the endoscope and all equipment immersed in the disinfectant solution.
2. Immerse the distal end in disinfectant solution, and move the elevator
control lever in the “U” direction to slope the forceps elevator.
3. If air bubbles adhere to the surfaces of the endoscope and/or equipment,
wipe them away using a clean, lint-free cloth.
4. Cover the basin with a tight-fitting lid to minimize the diffusion of disinfectant
vapors.
5. Soak the endoscope and all equipment in disinfectant solution for the
amount of time and at the temperature and concentration recommended by
the disinfectant manufacturer.
Removing the endoscope and all equipment from disinfectant
solution
1. Before removing the endoscope from the disinfectant solution, connect the
channel plug, injection tube, cleaning adapter for the instrument channel
port and washing tube to the endoscope. Attach the channel plug’s biopsy
valve cap to the cleaning adapter for the instrument channel port.
2. Remove the injection tube’s suction port from the disinfectant solution.
3. Attach the 30 cm3 (30 ml) syringe to the injection tube’s air/water channel
port and flush the air/water channel with 150 cm3 (150 ml) of air.
4. Attach the 30 cm3 (30 ml) syringe to the injection tube’s suction channel port
and flush the suction channel with 150 cm3 (150 ml) of air.
5. Attach the 5 cm3 (5 ml) syringe to the washing tube and flush the elevator
wire channel with 15 cm3 (15 ml) of air.
6. Remove the endoscope and all equipment from the disinfectant solution.
7. Disconnect all equipment from the endoscope.
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Chapter 7 Cleaning, Disinfection, and Sterilization Procedures
7.7 Rinsing after high-level disinfection
After reprocessing, purge the channels of the endoscope to
thoroughly dry them. Otherwise, bacteria may proliferate in
the channels and pose an infection control risk to the patient
and/or operators performing the next procedure with the
endoscope.
After high-level disinfection, rinse the endoscope according to the procedures
described below.
Use water of appropriate microbiological quality. Once removed from disinfectant
solution, the instrument must be thoroughly rinsed with sterile water to remove
any disinfectant residue. If sterile water is not available, fresh potable tap water
or water that has been processed (e.g., filtered) to improve its microbiological
quality may be used with 70% ethyl or isopropyl alcohol rinse (see “Nonsterile
water rinse and alcohol flush” on page 137). Consult with your hospital’s
infection control committee.
Equipment needed
Prepare the following equipment, and wear appropriate personal protective
equipment.
• Personal protective equipment
• Sterile, lint-free cloths
• Sterile large basin with tight-fitting lid
• Sterile water for sterile water rinse
• Suction pump (with sterile suction tube)
• 30 cm3 (30 ml) syringe
• 5 cm3 (5 ml) syringe
• Channel plug (MAJ-621)
• Injection tube (MH-946)
• Washing tube (MH-974)
• Cleaning adapter for instrument (MAJ-350)
channel port
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If sterile water is not available, prepare the following equipment.
• Clean water for nonsterile water rinse
• Small basin with a tight-fitting lid
• Sterile cotton swabs
• 70% ethyl or isopropyl alcohol
Alcohol is flammable. Handle with care.
Sterile water rinse
1. Fill a basin with sterile water. Use a basin that is at least 40 cm by 40 cm
(16” by 16”) in size and deep enough to allow the endoscope to be
completely immersed.
2. Immerse the endoscope, channel plug, injection tube and cleaning adapter
for the instrument channel port in the sterile water. Using a sterile, lint-free
cloth, thoroughly rinse and wipe all external surfaces.
3. Connect the cleaning adapter for the instrument channel port, the channel
plug, and the injection tube to the endoscope. Place the suction port in
sterile water.
4. Attach the 30 cm3 (30 ml) syringe to the injection tube’s air/water channel
port and inject 150 cm3 (150 ml) of sterile water into the air/water channel
and the balloon channel.
5. Attach the 30 cm3 (30 ml) syringe to the suction channel port and inject
150 cm3 (150 ml) of sterile water into the suction channel and the balloon
channel.
6. Attach the washing tube to the elevator channel plug.
7. Using the 5 cm3 (5 ml) syringe, inject 15 cm3 (15 ml) of sterile water into the
elevator wire channel.
8. Remove the endoscope, together with all equipment, from the water.
9. Using the 30 cm3 (30 ml) syringe, flush the air/water and suction channels
with 150 cm3 (150 ml) of air.
10. Using the 5 cm3 (5 ml) syringe, flush the elevator wire channel with 15 cm3
(15 ml) of air.
11. Disconnect the injection tube only. Connect a sterile suction tube from the
suction pump to the suction connector on the endoscope. Turn the suction
pump ON and aspirate air for at least 15 seconds.
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12. Turn the suction pump OFF and disconnect all equipment from the
endoscope.
13. Use a sterile, lint-free cloth to thoroughly wipe and dry the external surfaces
of the endoscope and all equipment.
14. Store the components following the instructions as described in Chapter 9,
“Storage and Disposal”.
Flushing the channels with 70% ethyl or isopropyl alcohol
after rinsing them with sterile water facilitates drying inside
the channels.
Nonsterile water rinse and alcohol flush
1. Fill a small container with 70% ethyl or isopropyl alcohol.
2. Inject nonsterile water and air following the procedure given in “Sterile water
rinse” on page 136.
3. Immerse the suction port of the injection tube in the alcohol. Using the
30 cm3 (30 ml) syringe, flush the air/water and suction channels with
150 cm3 (150 ml) of the alcohol, respectively.
4. Remove the suction port of the injection tube from the alcohol. Flush the
air/water and suction channels with 150 cm3 (150 ml) of air.
5. Using the 5 cm3 (5 ml) syringe, flush the washing tube with 15 cm3 (15 ml)
of the alcohol through the elevator wire channel.
6. Using the 5 cm3 (5 ml) syringe, flush the washing tube with 15 cm3 (15 ml)
of air through the elevator wire channel.
7. Disconnect all equipment from the endoscope.
8. Remove all equipment and the endoscope from the basin.
9. Use a sterile, lint-free cloth to thoroughly wipe and dry the external surfaces
of the endoscope and all equipment.
10. Use a sterile, lint-free cloth moistened with alcohol to thoroughly wipe the
external surfaces of the endoscope and all equipment.
11. Connect the cleaning adapter for instrument channel port, channel plug and
injection tube to the endoscope. Using the 30 cm3 (30 ml) syringe, flush the
air/water channel with 150 cm3 (150 ml) of air.
12. Using the washing tube and the 5 cm3 (5 ml) syringe, flush 15 cm3 (15 ml)
of air through the elevator wire channel.
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13. Disconnect the injection tube only. Connect a clean suction tube from the
suction pump to the suction connector on the endoscope and aspirate air for
15 seconds.
14. Disconnect all equipment from the endoscope.
15. Use sterile cotton swabs to dry the inside of the air/water cylinder, suction
cylinder, and instrument channel port.
16. Store the components following the instructions as described in Chapter 9,
“Storage and Disposal”.
7.8 Sterilization
Ethylene oxide gas sterilization
As an alternative to high-level disinfection, the endoscope can be sterilized by
ethylene oxide gas. After performing manual cleaning and drying as described in
Section 7.3, “Precleaning” on page 103 and Section 7.5, “Manual cleaning” on
page 113, follow the procedures given below.
• Exceeding the recommended parameters may cause
equipment damage.
• If ethylene oxide gas sterilization is performed while the
water-resistant caps are attached, the covering of the
bending section can be damaged.
1. Dry the endoscope before ethylene oxide gas sterilization.
2. Remove the water-resistant caps before ethylene oxide gas sterilization
(see Figure 7.41).
3. Seal the instrument in a package appropriate for ethylene oxide gas
sterilization according to your hospital’s protocol.
4. Sterilize the package according to the recommended ethylene oxide gas
exposure parameters as described in Section 6.5, “Ethylene oxide gas
sterilization” on page 85 and the sterilizer manufacturer’s instructions.
5. Aerate the components following the minimum aeration parameters
specified in Section 6.5, “Ethylene oxide gas sterilization” on page 85.
6. Store the components following the instructions given in Chapter 9, “Storage
and Disposal”.
138 ULTRASOUND GASTROVIDEOSCOPE GF-UCT180
Chapter 7 Cleaning, Disinfection, and Sterilization Procedures
Water resistant cap (MH-553)
Figure 7.41
7.9 Cleaning, disinfection, and sterilization
procedures for reusable parts and reprocessing
equipment
All reusable parts and reprocessing equipment must be
cleaned and high-level disinfected or sterilized after each
use. Otherwise, an infection control risk to the patient and/or
operators can result.
This section includes cleaning, disinfection, and sterilization procedures for the
reusable parts and reprocessing equipment listed below.
• Air/water valve (MAJ-1444)
• Suction valve (MAJ-1443)
• Air/water channel cleaning adapter (MAJ-629)
• Mouthpiece (MB-142)
• Biopsy valve (MAJ-853)
• Channel-opening cleaning brush (MH-507)
• Channel cleaning brush (BW-20T, BW-7L)
• Suction cleaning adapter (MH-856)
• Balloon applicator (MAJ-675)
• Cleaning brush (MAJ-1534)
ULTRASOUND GASTROVIDEOSCOPE GF-UCT180 139
Chapter 7 Cleaning, Disinfection, and Sterilization Procedures
Equipment needed
Prepare the following equipment, and wear appropriate personal protective
equipment.
• Personal protective equipment
• Small basins with tight-fitting lids
• Clean water
• Detergent solution
• Channel cleaning brush or (BW-20T, BW-7L)
single use channel cleaning brush (BW-201T)
• Soft brush
• Clean, lint-free cloths and/or sponges
• 30 cm3 (30 ml) syringe
• Disinfectant solution
• Sterile water for sterile water rinse
• Sterile, lint-free cloths
If sterile water is not available, prepare the following equipment.
• Small basin with a tight-fitting lid
• 70% ethyl or isopropyl alcohol
• Single use combination cleaning brush (BW-412T)
• Single use single-ended cleaning brush (BW-400L)
Manual cleaning
• Make sure that the items immersed in detergent solution do
not contact one another.
• Make sure not to scratch the seals on the air/water valve and
air/water channel cleaning adapter with brushes, etc.
1. Fill a basin with clean water. Use a basin that is deep enough to completely
immerse all equipment.
2. Fill a basin with the detergent solution at the temperature and concentration
recommended by the detergent manufacturer. Use a basin that is deep
enough to completely immerse all equipment.
140 ULTRASOUND GASTROVIDEOSCOPE GF-UCT180
Chapter 7 Cleaning, Disinfection, and Sterilization Procedures
3. Detach the biopsy valve’s cap from the main body, before immersing in the
detergent solution (see Figure 7.42).
Slit
Cap Main body
Figure 7.42
4. Immerse all equipment in the detergent solution. Using a clean, soft brush or
lint-free cloth, meticulously clean all external surfaces in detergent solution.
5. Clean the bristles of the cleaning brushes (BW-20T, BW-7L and MH-507) or
the single use single-ended cleaning brush (BW-400L) thoroughly while the
brushes are immersed.
6. While immersed, depress and release the pistons of the air/water valve,
suction valve and air/water channel cleaning adapter.
7. Using the channel cleaning brush (BW-20T, BW-7L), the single use channel
cleaning brush (BW-201T), the single use combination cleaning brush
(BW-412T), or the single use single-ended cleaning brush (BW-400L)
thoroughly brush the hole of the suction valve and air/water valve, the
openings of biopsy valve and balloon applicator until no debris can be seen
(see Figures 7.43 and 7.44). Clean the bristles of the brush while it is
immersed in detergent solution.
Suction valve Channel cleaning brush (BW-20T),
single use channel cleaning brush
(BW-201T),
single use combination cleaning
brush (BW-412T)
Hole
Suction valve (MAJ-1443)
Figure 7.43
ULTRASOUND GASTROVIDEOSCOPE GF-UCT180 141
Chapter 7 Cleaning, Disinfection, and Sterilization Procedures
Channel cleaning
brush (BW-7L),
single use Hole
single-ended cleaning
brush (BW-400L)
Air/water valve
Air/water valve (MAJ-1444)
Figure 7.44
8. To clean the suction cleaning adapter, attach the 30 cm3 (30 ml) syringe and
flush the tube thoroughly with detergent solution.
9. Soak all equipment for the amount of time and at the temperature
recommended by the detergent manufacturer.
10. Remove all equipment from the detergent solution and place it in clean
water.
11. Inspect all equipment. If debris remains, ultrasonically clean at 38 – 47 kHz
for 5 minutes.
12. While immersed, depress and release the pistons of the air/water valve,
suction valve and air/water channel cleaning adapter.
13. Attach the 30 cm3 (30 ml) syringe to the suction cleaning adapter and flush
the tube with the clean water.
14. Remove all equipment from the clean water.
15. Attach the 30 cm3 (30 ml) syringe to the suction cleaning adapter and flush
air to remove the clean water.
16. Use a clean, lint-free cloth to thoroughly wipe and dry the external surfaces
of all equipment.
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Chapter 7 Cleaning, Disinfection, and Sterilization Procedures
High-level disinfection
• Completely remove all air bubbles from all equipment,
including inner channels. Air bubbles remaining on the
equipment prevent proper disinfection.
• All disinfection steps should be performed with all equipment
completely immersed. If any part of the equipment is not
immersed completely, disinfectant solution may not
adequately contact all surfaces.
1. Fill a basin with disinfectant solution at the temperature and concentration
recommended by the disinfectant manufacturer. Use a basin that is deep
enough to completely immerse all equipment.
2. Immerse all equipment in the disinfectant solution.
3. Use a lint-free cloth and/or 30 cm3 (30 ml) syringe, to wipe and/or flush all
surfaces with the disinfectant solution to remove all air bubbles.
4. Use the 30 cm3 (30 ml) syringe, to flush the interior and recessed parts of all
equipment while immersed. Ensure that all air bubbles are expelled.
5. While immersed, depress and release the pistons of the valves and
air/water channel cleaning adapter. Ensure that all air bubbles are expelled.
6. Use the 30 cm3 (30 ml) syringe, to flush the recessed parts of the biopsy
valve with disinfectant solution while the valve is immersed. Ensure that all
air bubbles are expelled.
7. Rub the bristles of the channel cleaning brush and channel-opening
cleaning brush to remove all air bubbles.
8. Use the 30 cm3 (30 ml) syringe to flush the inside of the suction cleaning
adapter thoroughly with disinfectant solution while immersed in the
disinfectant solution. Ensure that all air bubbles are expelled.
9. Cover the basin with a tight-fitting lid to minimize the diffusion of disinfectant
vapor. Soak all equipment in disinfectant solution for the amount of time and
at the temperature and concentration recommended by the disinfectant
manufacturer.
10. Remove the suction cleaning adapter from the disinfectant solution. Hold
the adapter and tilt it to expel the disinfectant solution remaining in the
adapter.
11. Remove all equipment from the disinfectant solution.
ULTRASOUND GASTROVIDEOSCOPE GF-UCT180 143
Chapter 7 Cleaning, Disinfection, and Sterilization Procedures
Rinsing after high-level disinfection
After high-level disinfection, rinse all equipment according to the procedures
described below.
Use water of appropriate microbiological quality. Once removed from disinfectant
solution, the instrument must be thoroughly rinsed with sterile water to remove
any disinfectant residue. If sterile water is not available, fresh, potable tap water
or water that has been processed (e.g., filtered) to improve its microbiological
quality may be used in conjunction with 70% ethyl or isopropyl alcohol rinse (see
“Nonsterile water rinse and alcohol flush” on page 137). Consult with your
hospital’s infection control committee.
Alcohol is flammable. Handle with care.
Sterile water rinse
1. Fill a small basin with sterile water. Use a basin that is deep enough to
completely immerse all equipment.
2. Immerse all equipment in the sterile water.
3. Gently agitate the equipment to thoroughly rinse it.
4. Use the 30 cm3 (30 ml) syringe to flush the interiors and recessed parts of
all equipment with sterile water while immersed. Ensure that all air bubbles
are expelled.
5. While immersed, depress and release the pistons of the air/water valve,
suction valve, and air/water channel cleaning adapter. Ensure that all air
bubbles are expelled.
6. Rub the bristles of the channel cleaning brush and channel-opening
cleaning brush to remove all air bubbles.
7. Attach the 30 cm3 (30 ml) syringe to the suction cleaning adapter and flush
the adapter with 30 cm3 (30 ml) of sterile water while immersed. Ensure that
all air bubbles are expelled.
8. Remove the suction cleaning adapter from the sterile water. Hold the
adapter and tilt it to expel the sterile water remaining in the adapter.
9. Use the 30 cm3 (30 ml) syringe, to flush air to dry the inside of the suction
cleaning adapter.
10. Remove all equipment from the sterile water.
11. Use a sterile, lint-free cloth to thoroughly wipe and dry all external surfaces.
12. Dry all equipment.
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Chapter 7 Cleaning, Disinfection, and Sterilization Procedures
13. Store the components following the instructions given in Chapter 9, “Storage
and Disposal”.
Flushing the channels with 70% ethyl or isopropyl alcohol
after rinsing them with sterile water facilitates drying inside
the channels.
Nonsterile water rinse and alcohol flush
1. Fill a small basin with clean water. Use a basin that is deep enough to
completely immerse all equipment.
2. Immerse all equipment in clean water and perform Steps 3 through 11 as
described in “Sterile water rinse” on page 144.
3. Fill a small basin with 70% ethyl or isopropyl alcohol.
4. Immerse all equipment in the alcohol.
5. Gently agitate the equipment in the alcohol.
6. Use the 30 cm3 (30 ml) syringe, to flush the interiors and recessed parts of
all equipment with alcohol to remove all air bubbles.
7. While immersed, depress and release the pistons of the air/water valve,
suction valve, and air/water channel cleaning adapter. Ensure that all air
bubbles are expelled.
8. Rub the bristles of the channel cleaning brush and channel-opening
cleaning brush to remove all air bubbles.
9. Attach the 30 cm3 (30 ml) syringe to the suction cleaning adapter and flush
the adapter with 30 cm3 (30 ml) of alcohol to remove all air bubbles.
10. Remove the suction cleaning adapter from the alcohol. Hold the adapter
and tilt it to expel the alcohol remaining in the adapter.
11. Use the 30 cm3 (30 ml) syringe to flush air to dry the inside of the suction
cleaning adapter.
12. Remove all equipment from the alcohol.
13. Use a sterile, lint-free cloth, to thoroughly wipe and dry all external surfaces.
14. Dry all equipment thoroughly.
15. Store the components following the instructions as described in Chapter 9,
“Storage and Disposal”.
ULTRASOUND GASTROVIDEOSCOPE GF-UCT180 145
Chapter 7 Cleaning, Disinfection, and Sterilization Procedures
Sterilization
Some components are compatible with several sterilization
methods. However, certain components are not compatible
with some methods, which can cause equipment damage.
In this section, the sterilization methods for the equipment compatible with
ethylene oxide gas sterilization or steam sterilization (autoclaving) listed in Table
6.1 on page 82, are described below.
The channel plug (MAJ-621), the injection tube (MH-946), the cleaning adapter
for instrument channel port (MAJ-350) and washing tube (MH-974) that have
been cleaned and disinfected with the endoscope can also be sterilized by the
procedures described below.
Ethylene oxide gas sterilization
Follow the procedures described in Section 7.8, “Sterilization” on page 138.
Steam sterilization (autoclaving)
After cleaning as described in “Manual cleaning” on page 140, steam sterilize
(autoclave) the equipment according to the procedures described below.
• Before taking the equipment package out of the autoclave, let
it cool down to room temperature. Otherwise, it may cause
burns.
• Effective sterilization will not be possible if items are packed
tightly together in the autoclave; always pack items loosely.
• Inspect each equipment package for openings, tears, or
other damage. If the equipment package is open or
damaged, seal the equipment in a new package and
resterilize it as described below.
• Allow the packages to dry within the autoclave, using the
autoclave’s drying cycle (if available) or by opening the door
of the autoclave and allowing the packages to air-dry.
Handling a wet package can compromise its sterility.
Sudden changes in temperature may damage the
instruments.
146 ULTRASOUND GASTROVIDEOSCOPE GF-UCT180
Chapter 7 Cleaning, Disinfection, and Sterilization Procedures
1. Seal the individual parts or equipment separately in packages appropriate
for steam sterilization (autoclaving) according to your hospital’s protocol.
2. Steam sterilize the packages according to the recommended steam
sterilization (autoclaving) exposure parameters as described in Section 6.6,
“Steam sterilization (autoclaving) of accessories” on page 87 and the
sterilizer manufacturer’s instructions.
3. Following steam sterilization (autoclaving), let all components gradually cool
down to room temperature.
4. Store the components following the instructions as described in Chapter 9,
“Storage and Disposal”.
7.10 Care of the ultrasonic cable (MAJ-1597)
Equipment needed
• Clean, lint-free cloth
• Neutral detergent
• 70% ethyl or isopropyl alcohol
Care
1. If the cable is soiled with blood or other potentially infectious materials, wipe
off all gross debris using a soft, lint-free cloth moistened with neutral
detergent.
2. To remove dust, dirt and other non-patient debris, wipe the cable’s surface
with a soft, lint-free cloth moistened with 70% ethyl or isopropyl alcohol.
3. Make sure that the cable is completely dry.
Alcohol is not a sterilant or high-level disinfectant.
• Never apply water to the ultrasonic cable. Equipment
damage can result.
• The ultrasonic cable is not waterproof. Never immerse it in
disinfectant solution or any other fluids.
ULTRASOUND GASTROVIDEOSCOPE GF-UCT180 147
Chapter 8 Cleaning and Disinfection Equipment
Chapter 8 Cleaning and Disinfection
Equipment
The endoscope is compatible with some endoscope reprocessors recommended
by Olympus. Refer to the instruction manual for the endoscope reprocessor for
details on operation.
• Thoroughly clean the endoscope as described in Chapter 7,
“Cleaning, Disinfection, and Sterilization Procedures” before
reprocessing the endoscope in an endoscope reprocessor. If
an endoscope that has not been thoroughly manually
cleaned is placed into the endoscope reprocessor, debris
attached to the endoscope may impair the cleaning and
disinfection capabilities of the reprocessor, and the
endoscope can pose an infection control risk to the patient
and/or operators who perform the next procedure with it.
Note that if the instrument is not precleaned immediately
after the procedure, patient debris may solidify, which could
impair proper cleaning and disinfection of the endoscope.
Refer to the endoscope reprocessor’s instruction manual for
details on proper connection of the endoscope to the
reprocessor and operation of the reprocessor.
• Olympus only confirms validation of endoscope reprocessors
it recommends. When using an endoscope reprocessor that
is not recommended by Olympus, the endoscope
reprocessor’s manufacturer is responsible for validation of
the reprocessor with the endoscope models listed in this
instruction manual.
• Before using an endoscope reprocessor, confirm that it is
capable of reprocessing the endoscope including all
channels. If you are uncertain as to the ability of your
endoscope reprocessor to clean and high-level disinfect the
endoscope including all channels, contact the endoscope
reprocessor’s manufacturer for specific instructions and/or
information on connectors. Insufficient cleaning and
disinfection or sterilization of the endoscope may pose an
infection control risk to the patient and/or operators
performing the next procedure with the endoscope.
148 ULTRASOUND GASTROVIDEOSCOPE GF-UCT180
Chapter 8 Cleaning and Disinfection Equipment
• When cleaning and disinfecting an endoscope in an
endoscope reprocessor, use connectors that are specifically
compatible with the endoscope model. Otherwise, insufficient
cleaning and disinfection or sterilization of the endoscope
may occur, which could pose an infection control risk to the
patient and/or operators performing the next procedure with
the endoscope. The applicable connectors for each
endoscope model should be listed in the instruction manual
for the endoscope reprocessor. If your endoscope model is
not listed in that instruction manual, please contact the
manufacturer of the endoscope reprocessor.
• Some endoscope reprocessor are not designed to reprocess
an elevator wire channel. If the elevator wire channel cannot
be reprocessed by the endoscope reprocessor, clean,
disinfect, and sterilize the endoscope according to
procedures described in Chapter 7, “Cleaning, Disinfection,
and Sterilization Procedures”.
• If using the endoscope reprocessor (EW-30, OER, OER-Pro,
OER-AW), the GF-UCT180 can not be reprocessed with any
other endoscopes. Only one unit of the GF-UCT180 can be
reprocessed. GF-UCT180 can be reprocessed only one by
one. Otherwise, insufficient cleaning and/or disinfection of
the endoscope may pose an infection control risk to the
patient and/or operators performing the next procedure with
the endoscope.
• If using the endoscope reprocessor recommended by
Olympus, be sure to attach the appropriate
cleaning/connecting tube and retaining rack (see Table 8.1).
Otherwise, insufficient cleaning and disinfection of the
endoscope may pose an infection control risk to the patient
and/or operators performing the next procedure with the
endoscope. The applicable connectors for the endoscope
model should be listed in the instruction manual for the
endoscope reprocessor or in Table 8.1. If the endoscope and
endoscope reprocessor is not listed in the instruction manual
or in Table 8.1, please contact Olympus.
ULTRASOUND GASTROVIDEOSCOPE GF-UCT180 149
Chapter 8 Cleaning and Disinfection Equipment
Cleaning/connecting tube Retaining rack
OER 1
MAJ-33, MAJ-41, MAJ-43 –
EW-30 1
OER-A 1 MAJ-825, MAJ-838 MAJ-840
OER-AW1 MAJ-1501, MAJ-1517 MAJ-840
OER-Pro1 MAJ-1501, MAJ-1517 MAJ-840
Table 8.1
1 These products may not be available in some areas.
OER-Pro OER-AW
GF-UCT180 Group31 Group31
Table 8.2
1 Group shows the endoscopes that can be reprocessed with this
endoscope, and it is defined by the “List of Conpatible
Endoscopes/Connecting Tubes” of OER-Pro and OER-AW. Refer to the
“List of Compatible Endoscopes/Connecting Tubes” for endoscopes that
can be reprocessed with this endoscope before using OER-Pro and
OER-AW.
Be sure to attach all required connectors to the endoscope and accessories. For
details concerning appropriate connectors, refer to the instructions of the AER
manufacturer.
Manually clean and disinfect or sterilize any endoscopes and accessories which
are not compatible withe the AER.
150 ULTRASOUND GASTROVIDEOSCOPE GF-UCT180
Chapter 9 Storage and Disposal
Chapter 9 Storage and Disposal
• After reprocessing, keep the endoscope and accessories
separate from any contaminated equipment. If the clean
endoscope and accessories become contaminated between
procedures, they could present an infection control risk to the
patient and/or operators in the subsequent procedure.
• To prevent contamination of the reprocessed endoscope and
accessories, be sure to keep the storage cabinet clean.
• The storage cabinet must be clean, dry, well ventilated and
maintained at ambient temperature. Storing the endoscope in
direct sunlight, at high temperatures, in high humidity or
exposed to ozone, X-rays and/or ultraviolet-rays may
damage the endoscope and/or present an infection control
risk.
• Prior to storage, detach all removable parts from the
endoscope. It will allow air to circulate through the internal
lumens of the endoscope and will assist drying.
• Do not store the endoscope in the carrying case. Use the
carrying case only for shipping the endoscope. Routinely
storing the endoscope in a humid, nonventilated
environment, such as the carrying case, may present an
infection control risk.
• The package containing the balloons also contains a
deoxidizer to maintain a deoxygenated condition until the
package is opened. After the package is opened, the
balloons will gradually deteriorate. To minimize deterioration,
always keep the package sealed.
ULTRASOUND GASTROVIDEOSCOPE GF-UCT180 151
Chapter 9 Storage and Disposal
9.1 Storage of the endoscope
When storing the endoscope, make sure that the forceps
elevator is not raised or it is not strike any objects. This could
damage forceps elevator.
1. Detach all equipment (the air/water valve, suction valve, biopsy valve, and
water-resistant cap) from the endoscope.
2. Confirm that all surfaces of the endoscope (especially the interior of the
channels, the distal end, lens, and electrical contacts) are completely dry.
3. Place the endoscope’s angulation locks in the “F ” position.
4. Hang the endoscope in the storage cabinet with the distal end hanging
freely. Make sure that the insertion section hangs vertically and as straight
as possible.
9.2 Storage of the balloon
Do not store the sterile package containing the instrument in
place where it will be damaged, wet or improperly sealed.
Otherwise, the sterility of the instrument may be
compromised and pose an infection control risk.
Store the balloon at room temperature, in a clean and dry environment. Do not
store it in direct sunlight. If you have any questions about any information in this
manual, contact Olympus.
9.3 Storage of reusable parts and reprocessing
equipment
1. Confirm that all reusable parts and reprocessing equipment are dry.
2. Store all reusable pars loosely in a storage cabinet.
3. Store all reprocessing equipment in a container, then place the container in
the storage cabinet.
152 ULTRASOUND GASTROVIDEOSCOPE GF-UCT180
Chapter 9 Storage and Disposal
9.4 Storage of the ultrasonic cable
The storage cabinet must be clean, dry, well ventilated, and
maintained at ambient temperature. Storing the ultrasonic
cable in direct sunlight, at high temperatures, in high
humidity, or exposed to X-rays and/or ultraviolet-rays may
damage the ultrasonic cable.
1. Make sure the ultrasonic cable is completely dry before storage.
2. The ultrasonic cable should be stored without being tightly coiled or twisted.
9.5 Disposal
When disposing of this endoscope or any of its components, follow all applicable
national and local laws and guidelines.
ULTRASOUND GASTROVIDEOSCOPE GF-UCT180 153
Chapter 10 Troubleshooting
Chapter 10 Troubleshooting
If the endoscope is visibly damaged, does not function as expected, or is found
to have irregularities during the inspection described in Chapter 3, “Preparation
and Inspection”, do not use the endoscope. Contact Olympus.
Some problems that appear to be malfunctions may be correctable by referring
to Section 10.1, “Troubleshooting guide” on page 154. If the problem cannot be
resolved by the described remedial action, stop using the endoscope and send it
to Olympus for repair.
Olympus does not repair accessory parts. If an accessory part becomes
damaged, contact Olympus to purchase a replacement.
• Never use the endoscope on a patient if any irregularity is
observed. Damage or irregularity in the instrument may
compromise patient or user safety and may result in more
severe equipment damage.
• If any parts of the endoscope fall off inside the patient body
due to equipment damage or failure, stop using the
endoscope immediately and retrieve the parts in an
appropriate way.
Should any irregularity in the function of the endoscope and/or endoscopic
image be observed during use, stop the examination immediately and carefully
withdraw the endoscope from the patient as described in Section 10.2,
“Withdrawal of the endoscope with an irregularity” on page 159.
10.1 Troubleshooting guide
The following table shows the possible causes of and countermeasures against
troubles that may occur due to equipment setting errors or deterioration of
consumables.
Troubles or failures due to other causes than those listed below should be
serviced. As repair performed by persons who are not qualified by Olympus
could cause patient or user injury and/or equipment damage, be sure to contact
Olympus for repair following the instructions given in Section 10.3, “Returning
the endoscope for repair” on page 161.
154 ULTRASOUND GASTROVIDEOSCOPE GF-UCT180
Chapter 10 Troubleshooting
Endoscope functions
Angulation
Irregularity
Possible cause Solution
description
Resistance is The angulation lock(s) is Rotate angulation lock(s) in the
encountered when engaged. “F ” direction.
rotating angulation
control knob(s).
Air/water feeding
Irregularity
Possible cause Solution
description
No air feeding. The air pump is not Press the “LOW”, “MED”, “HIGH”
operating. button on the light source as
described in the light source’s
instruction manual.
The air/water valve is Replace it with a new one.
damaged.
No water feeding. The air pump is not Press the “LOW”, “MED”, “HIGH”
operating. button on the light source as
described in the light source’s
instruction manual.
There is no sterile water in Add sterile water to fill the container
the water container. to the specified water level.
The air/water valve is Replace it with a new one.
damaged.
The air/water valve The air/water valve is dirty. Remove the air/water valve.
is sticky. Reprocess the air/water valve and
then attach it again.
The air/water valve is Replace it with a new one.
damaged.
The air/water valve An incorrect air/water valve Use a correct air/water valve.
cannot be is used.
attached. The air/water valve is Replace it with a new one.
damaged.
ULTRASOUND GASTROVIDEOSCOPE GF-UCT180 155
Chapter 10 Troubleshooting
Suction
Irregularity
Possible cause Solution
description
The suction is The biopsy valve is not Attach it correctly.
absent or attached properly.
insufficient. The biopsy valve is Replace it with a new one.
damaged.
The suction pump is not set Adjust the suction pump’s setting as
properly. described in its instruction manual.
The suction valve is Replace it with a new one.
damaged.
The suction valve The suction valve is dirty. Remove the suction valve.
is sticky. Reprocess the suction valve and
attach it again.
The suction valve is Replace it with a new one.
damaged.
The suction valve The suction valve is Replace it with a new one.
cannot be damaged.
attached. An incorrect suction valve Use a correct suction valve.
is used.
Liquid leaks out of The biopsy valve is Replace it with a new one.
the biopsy valve. damaged.
The biopsy valve is not Attach it correctly.
attached properly.
Image quality or brightness
Irregularity
Possible cause Solution
description
An image is An incompatible video Use a compatible video system
abnormal. system center is being center.
used.
An incompatible light Use a compatible light source.
source is being used.
There is no video Not all power switches are Turn all power switches ON.
image. ON.
An image is not The objective lens is dirty. Feed water to remove mucus, etc.
clear.
An image is The light source is not set Adjust the light source’s setting as
excessively dark or properly. described in its instruction manual.
bright.
156 ULTRASOUND GASTROVIDEOSCOPE GF-UCT180
Chapter 10 Troubleshooting
EndoTherapy accessories
Irregularity
Possible cause Solution
description
An EndoTherapy An incompatible Refer to the “System chart” in the
accessory does not EndoTherapy accessory is Appendix and select a compatible
pass through the being used. EndoTherapy accessory. Confirm
instrument channel that the color code on the
smoothly. EndoTherapy accessory matches
that on the endoscope. Although
the color code of the GF-UCT180 is
orange, do not use EndoTherapy
accessories designed for a
Ø 4.2 mm or Ø 6.0 mm channel,
use only EndoTherapy accessories
designed for a o 3.7 mm channel.
The elevator The elevator wire or the Clean and disinfect or sterilize the
control lever does elevator wire channel is elevator wire channel as described
not operate dirty. in Chapter 7, “Cleaning,
smoothly. Disinfection, and Sterilization
Procedures” that has the model
number of your endoscope on the
cover.
Others
Irregularity
Possible cause Solution
description
The remote switch does The wrong remote Operate the correct remote
not work. switch is operated. switch.
The remote switch Set the remote switch function
function has been set correctly as described in the video
incorrectly. system center’s instruction
manual.
ULTRASOUND GASTROVIDEOSCOPE GF-UCT180 157
Chapter 10 Troubleshooting
Ultrasound function (display monitor image)
Irregularity
Possible cause Solution
description
Echo appears where Multiple echoes Move the endoscope’s distal end
there is no object. generated from an to another position and check to
object with strong see if the echo in question moves
reflection. to a greater degree than other
echoes. If this happens, multiple
echoes have coalesced and
disturbed the ultrasound image.
Keep the endoscope’s distal end
away from any object with strong
reflection.
Balloon water feeding
Irregularity
Possible cause Solution
description
No water is fed into the The air/water and/or Reprocess the valve.
balloon and/or no suction valve is dirty.
aspiration.
The balloon water Reprocess the channel.
channel is dirty.
There is not enough • Fill the container with enough
water in water container sterile deaerated water.
when inflating/aspirating • Cover the hole of the air/water
the balloon. valve and depress the valve to
the first stage for about
15 seconds.
After this procedure, completely
depress the valve until the
balloon inflates (It generally
takes about 30 seconds).
The balloon channel is Reprocess the channel.
obstructed.
The balloon supply port Remove the thread from the
is obstructed by the balloon water supply port. Tie the
sterile cotton thread. cotton thread at the balloon
attachment groove.
158 ULTRASOUND GASTROVIDEOSCOPE GF-UCT180
Chapter 10 Troubleshooting
10.2 Withdrawal of the endoscope with an irregularity
If an irregularity occurs while the endoscope is in use, take proper measures as
described in either “Withdrawal when the WLI and NBI endoscopic images
appear on the monitor”, “Withdrawal when EITHER the WLI or the NBI
endoscopic image does not appear on the monitor”, “Withdrawal when all
endoscopic images do not appear on the monitor or a frozen image cannot be
restored” below. After withdrawal, return the endoscope for repair as described
in Section 10.3, “Returning the endoscope for repair” on page 161.
If the endoscope or EndoTherapy accessory cannot be
withdrawn from the patient smoothly, do not attempt to
forcibly withdraw it. Should any irregularity be observed,
immediately contact Olympus. Forcibly withdrawing the
endoscope or EndoTherapy accessory may cause patient
injury, bleeding, and/or perforation.
Withdrawal when the WLI and NBI endoscopic images appear
on the monitor
1. Turn all equipment OFF except the video system center, light source,
monitor, and suction pump.
2. When the NBI endoscopic image is displayed, switch to the WLI endoscopic
image by operating the video system center and light source.
3. When using an EndoTherapy accessory, close the tip of the EndoTherapy
accessory and/or retract it into its sheath. Then withdraw the EndoTherapy
accessory slowly while lowering the forceps elevator gradually.
4. Aspirate accumulated air, blood, mucus, or other debris by depressing the
suction valve to the first stage.
5. Turn the UP/DOWN and RIGHT/LEFT angulation locks in the “F ”
direction to release them.
6. Carefully withdraw the endoscope while observing the endoscopic image.
Remove the mouthpiece from the patient’s mouth.
ULTRASOUND GASTROVIDEOSCOPE GF-UCT180 159
Chapter 10 Troubleshooting
Withdrawal when EITHER the WLI or the NBI endoscopic
image does not appear on the monitor
1. Turn all equipment OFF except the video system center, light source,
monitor, and suction pump.
2. Operate the video system center and the light source to switch to the
endoscopic image that is still displayed.
3. Follow the procedure of Step 3 above in “Withdrawal when the WLI and NBI
endoscopic images appear on the monitor”. Carefully withdraw the
endoscope under the visible observation mode when the WLI endoscopic
image is not displayed.
Withdrawal when all endoscopic images do not appear on the
monitor or a frozen image cannot be restored
1. Turn all equipment OFF except the video system center, light source,
monitor, and suction pump.
2. Turn the video system center and light source OFF and then ON again. If
the WLI or NBI endoscopic image appears or the frozen image is restored,
follow the procedure given in “Withdrawal when EITHER the WLI or the NBI
endoscopic image does not appear on the monitor”, beginning from Step 2.
If all endoscopic images still do not appear or the frozen image cannot be
restored, perform the following steps.
3. Turn the video system center, light source, monitor, suction pump OFF.
4. When using an EndoTherapy accessory, withdraw the EndoTherapy
accessory slowly while the tip of the EndoTherapy accessory is closed
and/or retracted into its sheath while lowering the forceps elevator gradually.
5. Turn the UP/DOWN and RIGHT/LEFT angulation locks in the “F ”
direction to release them.
6. Turn the UP/DOWN and RIGHT/LEFT angulation control knobs to their
respective neutral positions (see Figure 3.4 on page 32).
7. Release the angulation control knobs and carefully withdraw the
endoscope. Remove the mouthpiece from the patient’s mouth.
160 ULTRASOUND GASTROVIDEOSCOPE GF-UCT180
Chapter 10 Troubleshooting
10.3 Returning the endoscope for repair
Thoroughly clean and high-level disinfect or sterilize the
endoscope before returning it for repair. Improperly
reprocessed equipment poses an infection control risk to
each person who handles the endoscope within the hospital
or at Olympus.
Olympus is not liable for any injury or damage that occurs as
a result of repairs attempted by non-Olympus personnel.
Before returning the endoscope for repair, contact Olympus. With the
endoscope, include a description of the malfunction or damage and the name
and telephone number of the individual at your location who is most familiar with
the problem. Also include a repair purchase order.
When returning the endoscope for repair, follow the instructions given in
“Transporting outside the hospital” on page 75.
ULTRASOUND GASTROVIDEOSCOPE GF-UCT180 161
Chapter 10 Troubleshooting
162 ULTRASOUND GASTROVIDEOSCOPE GF-UCT180
Appendix A: System Chart
Appendix A: System Chart
The recommended combinations of equipment and accessories that can be
used with this instrument are listed below. Some items may not be available in
some areas. New products released after the introduction of this instrument may
also be compatible for use in combination with this instrument. For further
details, contact Olympus.
If combinations of equipment other than those shown below
are used, the full responsibility is assumed by the medical
treatment facility.
ULTRASOUND GASTROVIDEOSCOPE GF-UCT180 163
Appendix A: System Chart
Suction pumps
Endoscope Water supply unit
GF-UCT180 (for ultrasonic endoscope)
KV-4, KV-5 SSU-2 (UWS-1)
Biopsy valve
(MAJ-853)
Ultrasonic cable
(MAJ-1597)
ALOKA
Diagnostic ultrasound
system Balloon
SSD-10 (MAJ-213)
Universal endoscopic
ProSound 71 Balloon 3
ultrasound center
ProSound F751 (MAJ-249)
(EU-ME1)
Balloon applicator
Mouthpiece (MAJ-675)
(MB-142)
Videoscope cable
EXERA II (MAJ-1430) Videoscope cable
EXERA (MAJ-843)
Videoscope cable 100
(MD-6801, MD-1481, or
MH-9761)
EVIS EXERA
EVIS EXERA II video system center
video system center Water container
(CV-1451, CV-160) (MH-884, MAJ-901)
(CV-180, CV-1651)
EVIS video system center
(CV-140)
EVIS EXERA II EVIS EXERA light source
light source (CLV-160, CLE-1451)
(CLV-180, CLE-1651) EVIS universal light source
(CLV-U40)
1 These products may not be available in some areas.
164 ULTRASOUND GASTROVIDEOSCOPE GF-UCT180
Appendix A: System Chart
Electrosurgical units
EndoTherapy accessories
See next page.
UES-20, UES-30
Electrosurgical accessories
See next page.
PSD-30, PSD-60
ESG-100
ULTRASOUND GASTROVIDEOSCOPE GF-UCT180 165
Appendix A: System Chart
Cleaning and disinfection equipment
Channel cleaning brush Channel cleaning brush Single use combination
(BW-7L1) or (BW-20T) or cleaning brush
single use single-ended single use channel cleaning (BW-412T1)
cleaning brush (BW-400L1) brush (BW-201T1)
Channel-opening cleaning brush Cleaning brush
(MH-507) or (MAJ-1534)
single use channel-opening
cleaning brush (MAJ-13391)
Leakage tester
(MB-155)
Suction cleaning adapter
(MAJ-222)
Water-resistant cap
(MH-553)
Endoscope washer (EW-301),
Endoscope reprocessor (OER1,
OER-A1, OER-AW1, OER-Pro1)
Ultrasonic cleaner
(KS-2, ENDOSONIC)
Maintenance unit
(MU-1)
Air/water valve Suction valve
(MAJ-1444) (MAJ-1443)
Air/water channel
cleaning adapter
(MAJ-629)
Suction cleaning adapter
(MH-856)
Cleaning adapter for
instrument channel port
(MAJ-350)
Injection tube Channel plug
(MH-946) (MAJ-621) Washing tube (MH-974)
1 These products may not be available in some areas.
166 ULTRASOUND GASTROVIDEOSCOPE GF-UCT180
Appendix A: System Chart
EndoTherapy accessories
Please not that some of the accessories may not be available in some areas.
Biopsy forceps
Alligator type with
With needle Rat tooth Alligator type
rat tooth
Endoscope
GF-UCT180 FB-13Q-1 FB-39Q-1, FB-40Q-1 FB-45Q-1 FB-46Q-1
Biopsy forceps (fenestrated)
Elongated cups with
Standard With needle Rat tooth
needle
Endoscope
FB-19N-1, FB-26N-1,
GF-UCT180 FB-24Q-1 FB-50Q-1 FB-37U-1
FB-28R-1
Disposable biopsy
Biopsy forceps (fenestrated)
forceps
Alligator jaws and Alligator jaws and
Alligator jaws and
rat tooth (swinging rat tooth with needle
rat tooth Alligator jaws-step
type/elongated (swinging type/
(swinging type)
cups) elongated cups)
Endoscope
GF-UCT180 FB-53Q-1 FB-54Q-1 FB-55Q-1 FB-212U
Disposable biopsy forceps Grasping forceps
Alligator jaws-step
Oval Oval with needle Rat tooth
with needle
Endoscope
GF-UCT180 FB-222U FB-232U FB-242U FG-14P-1
ULTRASOUND GASTROVIDEOSCOPE GF-UCT180 167
Appendix A: System Chart
Grasping forceps
Rubber tips
Basket type Flower basket type Tripod type
(non-latex)
Endoscope
FG-16U, FG-18Q-1,
GF-UCT180 FG-301Q FG-20P-1 FG-45U-1
FG-22Q-1, FG-23Q-1
Rotatable
Grasping forceps Disposable grasping forceps
grasping forceps
Rat tooth with
Pentapod type Flower basket type Basket type
alligator type
Endoscope
GF-UCT180 FG-46U-1 FG-401Q FG-402Q, FG-403Q FG-44NR-1
Washing pipe Disposable hot biopsy forceps
Hot biopsy forceps
Standard type Alligator jaws-step Oval
Endoscope
GF-UCT180 PW-1V-1 FD-5U FD-210U FD-230U
Disposable
Mechanical lithotriptor mechanical
Heat probe
lithotriptor
Basket type Slide type Slide type
Endoscope
BML-202Q,
GF-UCT180 CD-21Z, CD-120U BML-2Q-1 BML-4Q-1 BML-203Q,
BML-204Q
168 ULTRASOUND GASTROVIDEOSCOPE GF-UCT180
Appendix A: System Chart
Measuring device Aspiration needle
Straight type Disposable Reuseable
Endoscope
GF-UCT180 M1-2U NA-200H-8022 NA-11J-KB
Electrosurgical accessories
Electrosurgical snare
Crescent Hexagonal Oval Mini oval
Endoscope
GF-UCT180 SD-5U-1, SD-7P-1 SD-6U-1, SD-8P-1 SD-9U-1, SD-11U-1 SD-12U-1, SD-13U-1
Electrosurgical snare Disposable electrosurgical snare
Mini Oval
Oval (with thorns) Ex-mini oval Mini oval
(with thorns)
Endoscope
SD-210U-10, SD-210U-15,
GF-UCT180 SD-16U-1 SD-17U-1
SD-240U-10 SD-240U-15
Disposable electrosurgical snare
Oval Crescent Oval (with spiral)
Endoscope
SD-210U-25,
GF-UCT180 SD-221U-25 SD-230U-20
SD-240U-25
ULTRASOUND GASTROVIDEOSCOPE GF-UCT180 169
Appendix B: Inspection of the endoscope after cleaning, disinfection or sterilization in accordance with IEC 60601-2-37
Appendix B: Inspection of the
endoscope after cleaning, disinfection or
sterilization in accordance with
IEC 60601-2-37
After cleaning, disinfection or sterilization this instrument, check the parts or
accessories that can be contaminated through contact with the patient, with body
fluids, or with expired gases according to the “Method of inspection” listed below.
Inspection of the endoscope after cleaning, disinfection or
sterilization
Timing of Pertinent parts,
Method of inspection
inspection components or functions
After precleaning Waterproof See section 7.4, “Leakage testing” on page 108.
After cleaning, Inspection of the endoscope See “Inspection of the endoscope” in Section 3.2, “Inspection
disinfection or of the endoscope”, on page 30.
sterilization Bending mechanisms See “Inspection of the bending mechanisms” in Section 3.2,
“Inspection of the endoscope”, on page 31.
Forceps elevator mechanism See “Inspection of the forceps elevator mechanism” in
Section 3.2, “Inspection of the endoscope”, on page 33.
Air/water valve See “Inspection of the air/water and suction valves” in Section
3.3, “Preparation and inspection of accessories”, on page 34.
Suction valve See “Inspection of the air/water and suction valves” in Section
3.3, “Preparation and inspection of accessories”, on page 34.
Biopsy valve See “Inspection of the biopsy valve” in Section 3.3,
“Preparation and inspection of accessories”, on page 36.
Mouthpiece See “Inspection of the mouthpiece” in Section 3.3,
“Preparation and inspection of accessories”, on page 37.
Attaching the suction valve See “Attaching the suction valve” in Section 3.4, “Attaching
accessories to the endoscope”, on page 38.
Attaching the air/water valve See “Attaching the air/water valve” in Section 3.4, “Attaching
accessories to the endoscope”, on page 39.
Attaching the biopsy valve See “Attaching the biopsy valve” in Section 3.4, “Attaching
accessories to the endoscope”, on page 39.
Connection of the suction See “Connection of the endoscope and ancillary equipment”
tube in Section 3.5, “Inspection and connection of ancillary
equipment”, on page 43.
170 ULTRASOUND GASTROVIDEOSCOPE GF-UCT180
Appendix B: Inspection of the endoscope after cleaning, disinfection or sterilization in accordance with IEC 60601-2-37
Timing of Pertinent parts,
Method of inspection
inspection components or functions
After cleaning, Connection of the water See “Connection of the endoscope and ancillary equipment”
disinfection or container in Section 3.5, “Inspection and connection of ancillary
sterilization equipment”, on page 43.
Connection of the videoscope See “Connection of the endoscope and ancillary equipment”
cable in Section 3.5, “Inspection and connection of ancillary
equipment”, on page 43.
Connection of the ultrasonic See “Connection of the endoscope and ultrasonic cable” in
cable Section 3.5, “Inspection and connection of ancillary
equipment”, on page 45.
Endoscopic image See “Inspection of the endoscopic image” in Section 3.6,
“Inspection of the endoscopic system”, on page 46.
Remote switches See “Inspection of the remote switches” in Section 3.6,
“Inspection of the endoscopic system”, on page 47.
Air feeding function See “Inspection of the air-feeding function” in Section 3.6,
“Inspection of the endoscopic system”, on page 47.
Objective lens cleaning See “Inspection of the objective lens cleaning function” in
function Section 3.6, “Inspection of the endoscopic system”, on
page 48.
Water feeding function into See “Inspection of the water feeding function into the balloon”
the balloon in Section 3.6, “Inspection of the endoscopic system”, on
page 48.
Suction function See “Inspection of the suction function” in Section 3.6,
“Inspection of the endoscopic system”, on page 49.
Aspiration from the balloon See “Inspection of aspiration from the balloon water suction
port” in Section 3.6, “Inspection of the endoscopic system”, on
page 49.
Instrument channel and See “Inspection of the instrument channel and forceps
forceps elevator elevator” in Section 3.6, “Inspection of the endoscopic
system”, on page 50.
Ultrasound image See “Inspection of the ultrasound image with the Olympus
universal endoscopic ultrasound center EU-ME1” and
“Inspection of the ultrasound image with the ALOKA
diagnostic ultrasound system” in Section 3.6, “Inspection of
the endoscopic system”, on page 50 and 52.
Balloon See Section 3.7, “Preparation and inspection of the balloon”
on page 52.
ULTRASOUND GASTROVIDEOSCOPE GF-UCT180 171
Appendix C: EMC Information
Appendix C: EMC Information
Guidance and manufacturer’s declaration —
Electromagnetic emissions
This model is intended for use in the electromagnetic environment specified
below. The customer or the user of this model should assure that it is used
in such an environment.
Emissions test Compliance Electromagnetic environment — Guidance
RF emissions Group 1 This instrument uses RF (Radio Frequency) energy only for its
CISPR 11 internal function. Therefore, its RF emissions are very low and are not
likely to cause any interference in nearby electronic equipment.
Radiated emissions Class B This instrument’s RF emissions are very low and are not likely to
CISPR 11 cause any interference in nearby electronic equipment.
Main terminal
conducted emissions
CISPR 11
Harmonic emissions Class A This instrument’s harmonic emissions are low and are not likely to
IEC 61000-3-2 cause any problem in the typical commercial power supply connected
to this instrument.
Voltage Complies This instrument stabilizes its own radio variability and has no effect
fluctuations/flicker such as flicker in lighting apparatus.
emissions
IEC 61000-3-3
172 ULTRASOUND GASTROVIDEOSCOPE GF-UCT180
Appendix C: EMC Information
Guidance and manufacturer’s declaration —
Electromagnetic immunity
This model is intended for use in the electromagnetic environment specified
below. The customer or the user of this model should assure that it is used
in such an environment.
Immunity test IEC 60601 test level Compliance level Electromagnetic environment — Guidance
Electrostatic Contact: Same as left Floors should be made of wood, concrete, or
discharge (ESD) 2, 4, 6 kV ceramic tile that hardly produces static. If
IEC 61000-4-2 Air: floors are covered with synthetic material that
2, 4, 8 kV tends to produce static, the relative humidity
should be at least 30%.
Electrical fast 2 kV Same as left Mains power quality should be that of a typical
transient/burst for power supply lines commercial (original condition feeding the
IEC 61000-4-4 1 kV facilities) or hospital environment.
for input/output lines
Surge Differential mode: Same as left Mains power quality should be that of a typical
IEC 61000-4-5 0.5, 1 kV commercial or hospital environment.
Common mode:
0.5, 1, 2 kV
Voltage dips, short < 5% UT Same as left Mains power quality should be that of a typical
interruptions, and (> 95% dip in UT) commercial or hospital environment. If the
voltage variations for 0.5 cycle user of this instrument requires continued
on power supply operation during power mains interruptions, it
40% UT
input lines is recommended that this instrument be
(60% dip in UT)
IEC 61000-4-11 powered from an uninterruptible power supply
for 5 cycle or a battery.
70% UT
(30% dip in UT)
for 25 cycle
< 5% UT
(> 95% dip in UT)
for 5 seconds
Power frequency 3 A/m Same as left It is recommended to use this instrument by
(50/60 Hz) maintaining enough distance from any
magnetic field equipment that operates with high current.
IEC 61000-4-8
Definition: UT is the a.c. mains voltage prior to application of the test level.
ULTRASOUND GASTROVIDEOSCOPE GF-UCT180 173
Appendix C: EMC Information
Guidance and manufacturer’s declaration —
Electromagnetic immunity
This model is intended for use in the electromagnetic environment specified
below. The customer or the user of this model should assure that it is used
in such an environment.
Portable and mobile RF communications equipment should be used no
closer to any part of this model, including cables, than the recommended
separation distance calculated from the equation applicable to the frequency
of the transmitter.
Compliance
Immunity test IEC 60601 test level Electromagnetic environment — Guidance
level
Recommended separation distance
Conducted RF 3 Vrms 3 V (V1) 3.5
(150 kHz – 80 MHz) d = --------- P
IEC 61000-4-6 V1
Recommended separation distance
Radiated RF 3 V/m 3 V/m (E1) 3.5
(80 MHz – 2.5 GHz) d = --------- P
IEC 61000-4-3 E1
80 MHz – 800 MHz
7
d = ----- P
E1
800 MHz – 2.5 GHz
Definition: Where “P” is the maximum output power rating of the transmitter in watts (W) according to
the transmitter manufacturer and “d” is the recommended separation distance in meters (m).
• At 80 MHz and 800 MHz, the higher frequency range applies.
• These guidelines may not apply in all situations.
Electromagnetic propagation is affected by absorption and
reflection from structures, objects and people.
• This instrument complies with the requirements of
IEC 60601-1-2: 2007. However, under electromagnetic
environment that exceeds its noise level, electromagnetic
interference may occur on this instrument.
• Electromagnetic interference may occur in the vicinity of
high-frequency electrosurgical equipment and/or other
equipment marked with the following symbol:
174 ULTRASOUND GASTROVIDEOSCOPE GF-UCT180
Appendix C: EMC Information
• Field strength from fixed RF transmitters as determined by an
electromagnetic site surveya) should be less than the
compliance level in each frequency rangeb).
a) Field strength from fixed transmitters, such as base
stations for radio (cellular/cordless) telephones and
land mobile radios, amateur radio, AM and FM radio
broadcast and TV broadcast cannot be predicted
theoretically with accuracy. To assess the
electromagnetic environment due to fixed RF
transmitters, an electromagnetic site survey should be
considered. If the measured field strength in the
location in which this model is used exceeds the
applicable RF compliance level above, this model
should be observed to verify normal operation. If
abnormal performance is observed, additional
measures may be necessary, such as re-orienting or
relocating this model.
b) Over the frequency range 150 kHz to 80 MHz, field
strength should be less than 3 V/m.
ULTRASOUND GASTROVIDEOSCOPE GF-UCT180 175
Appendix C: EMC Information
Recommended separation distances between portable and
mobile RF communications equipment and this model
This model is intended for use in an electromagnetic environment in which
radiated RF disturbances are controlled. The customer or the user of this
model can help prevent electromagnetic interference by maintaining a
minimum distance between portable and mobile RF communications
equipment (transmitters) and this model as recommended below, according
to the maximum output power of the communications equipment.
Separation distance according to frequency of transmitter (m)
Rated maximum output (calculated as V1=3 and E1=3)
power of transmitter 150 kHz – 80 MHz 80 MHz – 800 MHz 800 MHz – 2.5 GHz
P (W)
d = 1.2 P d = 1.2 P d = 2.3 P
0.01 0.12 0.12 0.23
0.1 0.38 0.38 0.73
1 1.2 1.2 2.3
10 3.8 3.8 7.3
100 12 12 23
Others: For transmitters rated at a maximum output power not listed above, the recommended
separation distance ‘d’ in metres (m) can be estimated using the equation applicable to
the frequency of the transmitter, where ‘p’ is the maximum output power rating of the
transmitter in watts (W) according to the transmitter manufacturer.
• At 80 MHz and 800 MHz, the separation distance for the
higher frequency range applies.
• These guidelines may not apply in all situations.
Electromagnetic propagation is affected by absorption and
reflection from structures, objects and people.
176 ULTRASOUND GASTROVIDEOSCOPE GF-UCT180
Appendix D: Acoustic Output Information in Accordance with the FDA Guidance: “Information for Manufacturers
Appendix D: Acoustic Output
Information in Accordance with the FDA
Guidance: “Information for
Manufacturers Seeking Marketing
Clearance of Diagnostic Ultrasound
Systems and Transducers”
Symbol key
MI Mechanical Index
TISscan Soft Tissue Thermal Index in an auto-scanning mode
TISnon-scan Soft Tissue Thermal Index in a non-autoscanning mode
TIB Bone Thermal Index
TIC Cranial Thermal Index
TI type The applicable thermal index type
TI value The thermal index value
Aaprt Area of the active aperture (square centimeters)
pr.3 Derated peak rarefactional pressure associated with the transmit
pattern giving rise to the value reported under MI (megapascals)
W0 Ultrasonic power except for TISscan, in which case it is the ultrasonic
power passing through a one centimeter window (milliwatts)
W.3 (Z1) Derated ultrasonic power at axial distance z1 (milliwatts)
ITA.3 (Z1) Derated spatial peak, temporal average intensity at axial distance z1
(milliwatts per square centimeter)
z1 Axial distance corresponding to the location of max [min (W.3 (Z), ITA.3
(Z) × 1 cm2)] where Z Zbp (centimeters)
zbp 1.69 Aaprt
(centimeters)
zsp For MI, the axial distance at which Pr.3 is measured for TIB, the axial
distance at which TIB is a global maximum (i.e., zsp = zB.3)
(centimeters)
[email protected] Axial distance corresponding to the maximum of the derated
spatial-peak pulse intensity integral (megapascals)
ULTRASOUND GASTROVIDEOSCOPE GF-UCT180 177
Appendix D: Acoustic Output Information in Accordance with the FDA Guidance: “Information for Manufacturers
deq (Zsp) Equivalent beam diameter as a function of axial distance z, and equal
to [(4/) (W0/ITA(z))] 0.5, where ITA(z) is the temporal-average intensity
as a function of z (centimeters)
fc Center frequency (MHz). For MI, fc is the center frequency associated
with the transmit pattern giving rise to the global maximum reported
value of MI. For TI, for combined modes involving transmit patterns of
unequal center frequency, fc is defined as the overall ranges of center
frequencies of the respective transmit patterns
Dim. of Aaprt Active aperture dimensions for azimuthal (x) and elevational (y)
planes (centimeters)
PD Pulse duration (microseconds) associated with the transmit pattern
giving rise to the reported value of MI
PRF Pulse repetition frequency associated with the transmit pattern giving
rise to the reported value of MI (Hz)
pr@PIImax Peak rarefactional pressure at the point where the free-field,
spatial-peak pulse intensely integral is a maximum (megapascals)
deq@PIImax Equivalent beam diameter at the point where the free-field,
spatial-peak pulse intensity integral is a maximum (centimeters)
FL Focal length, or azimuthal (x) and elevational (y) lengths, if different
(centimeters)
IPA.3@MImax Derated pulse-average intensity at the point of global maximum
reported MI (watts per square centimeter)
ISPTA.3 Derated spatial peak temporal average intensity (milliwatts per square
centimeter)
Derated ISPTA Derated spatial peak temporal average intensity (milliwatts per square
centimeter)
PII Pulse intensely integral
178 ULTRASOUND GASTROVIDEOSCOPE GF-UCT180
Appendix D: Acoustic Output Information in Accordance with the FDA Guidance: “Information for Manufacturers
Acoustic output table with ALOKA diagnostic
ultrasound system
Acoustic output table for default settings when combined
with SSD-10
Transducer Model: GF-UCT180
Acoustic Output MI TIS TIB TIC
Maximum Value 0.36 0.11 0.21 0.18
Operating mode Mflow B/Bflow PWD B/Bflow
DVA% (%) 70 70 48 70
Function Off Off Off Off
B/W Frequency Select (MHz) n/a 7.5 MHz n/a 7.5 MHz
B/W Focus n/a F9 n/a F9
B/W-Range (cm) 12.0 12.0 n/a 12.0
B/W Line Density n/a HIGH n/a HIGH
B/W Scan Area (%) n/a 100 n/a 100
Doppler Image Select n/a n/a STD n/a
Doppler Frequency Select (MHz) n/a n/a 6 MHz n/a
Operator Doppler Focus n/a n/a F12 n/a
Controls Doppler Velocity Range (cm/sec) n/a n/a 39.8 n/a
Color Image Select STD STD n/a STD
Color Doppler Frequency Select (MHz) 5 MHz 5 MHz n/a 5 MHz
Flow Focus F13 F13 n/a F13
Color Velocity Range (m/sec) 0.12 0.12 n/a 0.12
Color Line Density n/a LOW n/a LOW
Color Average n/a MID n/a MID
Flow Filter n/a #4 n/a #4
Flow Scan Area (%) n/a 49 n/a 49
Triplex Velocity Range n/a n/a n/a n/a
ISPTA.3 (mW/cm2) 34 7.0 68 7.0
ULTRASOUND GASTROVIDEOSCOPE GF-UCT180 179
Appendix D: Acoustic Output Information in Accordance with the FDA Guidance: “Information for Manufacturers
Acoustic output table for track3 when combined with
SSD-10
Transducer Model: GF-UCT180 Operating Mode: PWD-mode
TIS TIB
Index label MI TISnon-scan Non- TIC
TISscan
Aaprt<=1 Aaprt>1 scan
Maximum Index Value 0.88 – 0.71 – 1.7 0.96
p r. (MPa) 2.0
W0 (mW) – 20 24 26
min of [W(z 1), I TA.(z 1)] (mW) –
z1 (cm) –
Assoc. z bp (cm) –
Acoustic z sp (cm) 1.4
Param. [email protected] (cm) 1.4
d eq(z sp) (cm) 0.19
ƒc (MHz) 5.3 – 7.4 – 5.3 5.3
Dim of A aprt X (cm) – 0.74 – 0.74 0.74
Y (cm) – 0.50 – 0.50 0.50
PD (µsec) 0.47
PRF (Hz) 5210
p r @PII max (MPa) 2.5
Other Info. d eq @ PII max (cm) 0.18
Focal Length FL x (cm) – 4.3 – 4.3
FL y (cm) – 1.0 – 1.0
I pa. @MImax (W/cm2) 209
DVA% (%) 100 – 89 – 97 100
Function CHE B – eF ExPHD – eF ExPHD eF ExPHD
B/W Frequency Select (MHz) n/a n/a n/a n/a n/a n/a
B/W Focus n/a n/a n/a n/a n/a n/a
B/W-Range (cm) n/a n/a n/a n/a n/a n/a
B/W Line Density n/a n/a n/a n/a n/a n/a
B/W Scan Area (%) n/a n/a n/a n/a n/a n/a
Doppler Image Select PENET – PENET – PENET PENET
Doppler Frequency Select (MHz) 5 MHz – 7.5 MHz – 5 MHz 5 MHz
Doppler Focus F5 – F15 – F11 F16
Operator
Doppler Velocity Range (cm/sec) 19.9 – 36.2 – 76.0 39.8
Controls
Color Image Select n/a n/a n/a n/a n/a n/a
Color Doppler Frequency
(MHz) n/a n/a n/a n/a n/a n/a
Select
Flow Focus n/a n/a n/a n/a n/a n/a
Color Velocity Range (m/sec) n/a n/a n/a n/a n/a n/a
Color Line Density n/a n/a n/a n/a n/a n/a
Color Average n/a n/a n/a n/a n/a n/a
Flow Filter n/a n/a n/a n/a n/a n/a
Flow Scan Area (%) n/a n/a n/a n/a n/a n/a
Triplex Velocity Range n/a n/a n/a n/a n/a n/a
Display TISmax 0.71
Display TIBmax 1.7
180 ULTRASOUND GASTROVIDEOSCOPE GF-UCT180
Appendix D: Acoustic Output Information in Accordance with the FDA Guidance: “Information for Manufacturers
Transducer Model: GF-UCT180 Operating Mode: Mflow-mode
TIS TIB
Index label MI TISnon-scan Non- TIC
TISscan
Aaprt<=1 Aaprt>1 scan
Maximum Index Value 0.88 – 0.76 – 1.7 0.89
p r. (MPa) 2.0
W (mW) – 22 22 24
min of [W(z 1), I TA.(z 1)] (mW) –
z1 (cm) –
Assoc. z bp (cm) –
Acoustic z sp (cm) 1.2
param. [email protected] (cm) 1.4
d eq(z sp) (cm) 0.19
ƒc (MHz) 5.3 – 7.4 – 5.1 5.3
Dim of A aprt X (cm) – 0.74 – 0.74 0.74
Y (cm) – 0.50 – 0.50 0.50
PD (µsec) 0.47
PRF (Hz) 5210
p r @PII max (MPa) 2.5
Other Info. d eq @ PII max (cm) 0.18
Focal Length FL x (cm) – 4.6 – 4.3
FL y (cm) – 1.0 – 1.0
I pa. @MImax (W/cm2) 209
DVA% (%) 100 – 100 – 100 100
Function CHE B – eF ExPHD – Off eF ExPHD
B/W Frequency Select (MHz) n/a n/a n/a n/a n/a n/a
B/W Focus n/a n/a n/a n/a n/a n/a
B/W-Range (cm) 4.0 – 2.0 – 2.0 2.0
B/W Line Density n/a n/a n/a n/a n/a n/a
B/W Scan Area (%) n/a n/a n/a n/a n/a n/a
Doppler Image Select n/a n/a n/a n/a n/a n/a
Doppler Frequency Select (MHz) n/a n/a n/a n/a n/a n/a
Doppler Focus n/a n/a n/a n/a n/a n/a
Operator
Doppler Velocity Range (cm/sec) n/a n/a n/a n/a n/a n/a
Controls
Color Image Select PENET – PENET – PENET PENET
Color Doppler Frequency
(MHz) 5 MHz – 7.5 MHz – 5 MHz 5 MHz
Select
Flow Focus F5 – F16 – F9 F16
Color Velocity Range (m/sec) 0.20 – 0.80 – 0.61 0.94
Color Line Density n/a n/a n/a n/a n/a n/a
Color Average n/a n/a n/a n/a n/a n/a
Flow Filter n/a n/a n/a n/a n/a n/a
Flow Scan Area (%) n/a n/a n/a n/a n/a n/a
Triplex Velocity Range n/a n/a n/a n/a n/a n/a
Display TISmax 0.76
Display TIBmax 1.7
ULTRASOUND GASTROVIDEOSCOPE GF-UCT180 181
Appendix D: Acoustic Output Information in Accordance with the FDA Guidance: “Information for Manufacturers
Acoustic measurement uncertainty
Uncertainty
Quantity
(95% confidence)
W0 12.22%
PII 25.62%
Pr 13.19%
Fc 2.39%
Acoustic output table when combined with Olympus
universal endoscopic ultrasound center EU-ME1
Acoustic output table
ISPTA.3 62
TI type TIS, TIB
TI value 0.83
MI 0.99
IPA.3 @MImax 377
Global maximum derated ISPTA and MI values when
combined with the EU-ME1
Imaging mode Derated ISPTA MI
B mode 15 0.99
Color flow mode 46 0.97
Power flow mode 62 0.94
Acoustic measurement precision and uncertainty
Quantity Uncertainty (%)
Pr 17
W0 44
fc 17
PII 41
MI 20
ISPTA.3 48
182 ULTRASOUND GASTROVIDEOSCOPE GF-UCT180
Appendix D: Acoustic Output Information in Accordance with the FDA Guidance: “Information for Manufacturers
Clinical measurement accuracy with ALOKA
diagnostic ultrasound system
When combined with SSD-10
Measurement feature General
Round-off accuracy
accuracy
Distance in B-mode 0.01 cm <10 cm distance
3%
0.1 cm >10 cm distance
Area by trace in B-mode 0.01 cm2 <100 cm2 area
6%
0.1 cm2 >100 cm2 area
Circumference by trace 0.01 cm <10 cm distance
6%
B-mode 0.1 cm >10 cm distance
Area by ellipses in B-mode 0.01 cm2 <100 cm2 area
5%
0.1 cm2 >100 cm2 area
Volume in B-mode 7% 0.01 cm3 <100 cm3 area
Excrusion in M-mode 0.01 cm <10 cm distance
3%
0.1 cm >10 cm distance
Time interval in M-mode 1 ms <1000 ms time
3%
0.1 s >1000 ms time
Velocity in Doppler mode 10% 0.1 cm/sec
Heart rate 1BPM or 5% 1 beat per minute
Clinical measurement accuracy when combined with
Olympus universal endoscopic ultrasound center
EU-ME1
Measurement Feature Accuracy Maximum measurement range
Length 5% 20 – 40 mm
Direction 5% 20 mm
Circumference 10% 20 – 40 mm
Area 10% 20 – 40 mm
ULTRASOUND GASTROVIDEOSCOPE GF-UCT180 183
Appendix E: Acoustic Output Information Accordance with IEC 60601-2-37
Appendix E: Acoustic Output
Information Accordance with
IEC 60601-2-37
Acoustic output table with ALOKA diagnostic
ultrasound system
The terms used in the acoustic output table are as follows:
Acoustic attenuation coefficient
Aaprt –12 dB output beam area
A eq (z) Normalizing coefficient
D eq Equivalent aperture diameter
d –6 Pulse beam width
deq Equivalent beam diameter
ƒawƒ Acoustic working frequency
Ipa Pulse-average intensity
Ipa, Attenuated pulse-average intensity
Ipi Pulse-intensity integral
Ipi, Attenuated pulse-intensity integral
Ita (z) Temporal-average intensity
Ita , ( z ) Attenuated temporal-average intensity
Izpta (z) Spatial-peak temporal-average intensity
Izpta, ( z ) Attenuated spatial-peak temporal-average intensity
MI Mechanical index
P Output power
P Attenuated output power
P1 Bounded output power
pi Pulse pressure squared integral
184 ULTRASOUND GASTROVIDEOSCOPE GF-UCT180
Appendix E: Acoustic Output Information Accordance with IEC 60601-2-37
pr Peak-rarefactional acoustic pressure
p r, Attenuated peak-rarefactional acoustic pressure
prr Pulse repetition rate
TI Thermal index
TIB Bone thermal index
TIC Cranial-bone thermal index
TIS Soft-tissue thermal index
TIS scan Soft tissue thermal index in an auto-scanning mode
TIS non – scan Soft tissue thermal index in a non-autoscanning mode
td Pulse duration
X, Y –12 dB output beam dimensions
z Distance from the source to a specified point
zb Depth for TIB
zbp Break-point depth
zs Depth for TIS
fc Center frequency (MHz). For MI, fc is the center frequency
associated with the transmit pattern giving rise to the global
maximum reported value of MI. For TI, for combined modes
involving transmit patterns of unequal center frequency, fc is
defined as the overall ranges of center frequencies of the
respective transmit patterns
PII Pulse intensely integral
Acoustic measurement uncertainty
Uncertainty
Quantity
(95% confidence)
P 12.22%
PII 25.62%
Pr 13.19%
Fc 2.39%
ULTRASOUND GASTROVIDEOSCOPE GF-UCT180 185
Appendix E: Acoustic Output Information Accordance with IEC 60601-2-37
Acoustic output table when combined with SSD-10
Transducer Model: GF-UCT180 Operating Mode: B-mode
Table 201.103 – Acoustic output reporting table
TIS TIB
Index label MI Non-scan Non- TIC
Scan
Aaprt1cm2 Aaprt>1cm2 scan
Maximum Index Value 0.84 0.69 – – – 0.76
p r, (MPa) 2.0
P (mW) 27 – – 20
Min of [P(z s), I ta,(z s)] (mW) –
zs (cm) –
Associated z bp (cm) –
acoustic zb (cm) –
parameters z at max. Ipi, (cm) 1.2
d eq(z b) (cm) –
ƒ awf (MHz) 5.4 5.3 – – – 4.4
Dim of A aprt X (cm) 1.2 – – – 0.72
Y (cm) 0.50 – – – 0.50
td (µsec) 0.29
prr (Hz) 6940
p r at max. I pi (MPa) 2.3
Other
d eq at max. I pi (cm) –
information
I pa, at max.MI (W/cm ) 2 313
Focal Length FL x (cm) 2.8 – – 0.56
FL y (cm) 1.0 – – 1.2
DVA% (%) 100 100 – – – 100
Function CHE A Penet CHE B – – – CHE A Penet
B/W Frequency Select (MHz) 5.4 MHz 5.4 MHz – – – 4.3 MHz
B/W Focus F4 F9 – – – F2
B/W-Range (cm) 8.0 4.0 – – – 4.0
B/W Line Density HIGH HIGH – – – HIGH
B/W Scan Area (%) 25 25 – – – 25
Doppler Image Select n/a n/a n/a n/a n/a n/a
Doppler Frequency Select (MHz) n/a n/a n/a n/a n/a n/a
Operating
Doppler Focus n/a n/a n/a n/a n/a n/a
control
Doppler Velocity Range (cm/sec) n/a n/a n/a n/a n/a n/a
conditions
Color Image Select n/a n/a n/a n/a n/a n/a
Color Doppler Frequency Select (MHz) n/a n/a n/a n/a n/a n/a
Flow Focus n/a n/a n/a n/a n/a n/a
Color Velocity Range (m/sec) n/a n/a n/a n/a n/a n/a
Color Line Density n/a n/a n/a n/a n/a n/a
Color Average n/a n/a n/a n/a n/a n/a
Flow Filter n/a n/a n/a n/a n/a n/a
Flow Scan Area (%) n/a n/a n/a n/a n/a n/a
Triplex Velocity Range n/a n/a n/a n/a n/a n/a
NOTE1 Data should only be entered in one of the columns related to TIS.
NOTE2 Information need not be provided regarding TIC for any TRANSDUCER ASSEMBLY not intended for transcranial or
neonatal cephalic uses.
NOTE3 If the requirements of 201.12.4.2a are met, it is not required to enter any data in the columns related to TIS, TIB or TIC.
NOTE4 If the requirements of 201.12.4.2b are met, it is not required to enter any data in the columns related to MI.
NOTE5 Focal Length is a NOMINAL value.
186 ULTRASOUND GASTROVIDEOSCOPE GF-UCT180
Appendix E: Acoustic Output Information Accordance with IEC 60601-2-37
Transducer Model: GF-UCT180 Operating Mode: B/M-mode
Table 201.103 – Acoustic output reporting table
TIS TIB
Index label MI Non-scan Non- TIC
Scan
Aaprt1cm2 Aaprt >1cm2 scan
Maximum Index Value 0.84 0.45 – – 0.096 0.56
p r, (MPa) 2.0
P (mW) 22 – 0.91 18
Min of [P(z s), I ta,(z s)] (mW) –
zs (cm) –
Associated z bp (cm) –
acoustic zb (cm) 0.51
parameters z at max. I (cm) 1.2
pi,
d eq(z b) (cm) 0.18
ƒ awf (MHz) 5.4 4.4 – – 4.4 4.3
Dim of A aprt X (cm) 1.1 – – 0.31 1.2
Y (cm) 0.50 – – 0.50 0.50
td (µsec) 0.29
prr (Hz) 5510
p r at max. I pi (MPa) 2.3
Other
d eq at max. I pi (cm) 0.17
information
I pa, at max.MI (W/cm 2) 313
Focal Length FL x (cm) 2.3 – – 4.3
FL y (cm) 1.2 – – 1.2
DVA% (%) 100 100 – – 99 99
Function CHE A Penet CHE A Penet – – CHE A Penet CHE A Penet
B/W Frequency Select (MHz) 5.4 MHz 4.3 MHz – – 4.3 MHz 4.3 MHz
B/W Focus F4 F7 – – F12 F12
B/W-Range (cm) 4.0 4.0 – – 4.0 4.0
B/W Line Density HIGH HIGH – – HIGH HIGH
B/W Scan Area (%) 25 25 – – 25 25
Doppler Image Select n/a n/a n/a n/a n/a n/a
Doppler Frequency Select (MHz) n/a n/a n/a n/a n/a n/a
Operating
Doppler Focus n/a n/a n/a n/a n/a n/a
control
Doppler Velocity Range (cm/sec) n/a n/a n/a n/a n/a n/a
conditions
Color Image Select n/a n/a n/a n/a n/a n/a
Color Doppler Frequency Select (MHz) n/a n/a n/a n/a n/a n/a
Flow Focus n/a n/a n/a n/a n/a n/a
Color Velocity Range (m/sec) n/a n/a n/a n/a n/a n/a
Color Line Density n/a n/a n/a n/a n/a n/a
Color Average n/a n/a n/a n/a n/a n/a
Flow Filter n/a n/a n/a n/a n/a n/a
Flow Scan Area (%) n/a n/a n/a n/a n/a n/a
Triplex Velocity Range n/a n/a n/a n/a n/a n/a
NOTE1 Data should only be entered in one of the columns related to TIS.
NOTE2 Information need not be provided regarding TIC for any TRANSDUCER ASSEMBLY not intended for transcranial or
neonatal cephalic uses.
NOTE3 If the requirements of 201.12.4.2a are met, it is not required to enter any data in the columns related to TIS, TIB or TIC.
NOTE4 If the requirements of 201.12.4.2b are met, it is not required to enter any data in the columns related to MI.
NOTE5 Focal Length is a NOMINAL value.
ULTRASOUND GASTROVIDEOSCOPE GF-UCT180 187
Appendix E: Acoustic Output Information Accordance with IEC 60601-2-37
Transducer Model: GF-UCT180 Operating Mode: M-mode
Table 201.103 – Acoustic output reporting table
TIS TIB
Index label MI Non-scan Non- TIC
Scan
Aaprt 1cm2 Aaprt>1cm2 scan
Maximum Index Value 0.84 – 0.074 – 0.30 0.13
p r, (MPa) 2.0
P (mW) – 3.6 3.0 3.6
Min of [P(z s), I ta,(z s)] (mW) –
zs (cm) –
Associated z bp (cm) –
acoustic zb (cm) 1.2
parameters z at max. I (cm) 1.2
pi,
d eq(z b) (cm) 0.16
ƒ awf (MHz) 5.4 – 4.3 – 4.4 4.3
Dim of A aprt X (cm) – 0.74 – 0.55 0.74
Y (cm) – 0.50 – 0.50 0.50
td (µsec) 0.29
prr (Hz) 1000
p r at max. I pi (MPa) 2.3
Other
d eq at max. I pi (cm) 0.15
information
I pa, at max.MI (W/cm 2) 313
Focal Length FL x (cm) – 4.8 – 4.8
FL y (cm) – 1.2 – 1.2
DVA% (%) 100 – 100 – 100 100
Function CHE A Penet – CHE A Penet – CHE A Penet CHE A Penet
B/W Frequency Select (MHz) 5.4 MHz – 4.3 MHz – 4.3 MHz 4.3 MHz
B/W Focus F4 – F15 – F5 F15
B/W-Range (cm) 4.0 – 4.0 – 4.0 4.0
B/W Line Density n/a n/a n/a n/a n/a n/a
B/W Scan Area (%) n/a n/a n/a n/a n/a n/a
Doppler Image Select n/a n/a n/a n/a n/a n/a
Doppler Frequency Select (MHz) n/a n/a n/a n/a n/a n/a
Operating
Doppler Focus n/a n/a n/a n/a n/a n/a
control
Doppler Velocity Range (cm/sec) n/a n/a n/a n/a n/a n/a
conditions
Color Image Select n/a n/a n/a n/a n/a n/a
Color Doppler Frequency Select (MHz) n/a n/a n/a n/a n/a n/a
Flow Focus n/a n/a n/a n/a n/a n/a
Color Velocity Range (m/sec) n/a n/a n/a n/a n/a n/a
Color Line Density n/a n/a n/a n/a n/a n/a
Color Average n/a n/a n/a n/a n/a n/a
Flow Filter n/a n/a n/a n/a n/a n/a
Flow Scan Area (%) n/a n/a n/a n/a n/a n/a
Triplex Velocity Range n/a n/a n/a n/a n/a n/a
NOTE1 Data should only be entered in one of the columns related to TIS.
NOTE2 Information need not be provided regarding TIC for any TRANSDUCER ASSEMBLY not intended for transcranial or
neonatal cephalic uses.
NOTE3 If the requirements of 201.12.4.2a are met, it is not required to enter any data in the columns related to TIS, TIB or TIC.
NOTE4 If the requirements of 201.12.4.2b are met, it is not required to enter any data in the columns related to MI.
NOTE5 Focal Length is a NOMINAL value.
188 ULTRASOUND GASTROVIDEOSCOPE GF-UCT180
Appendix E: Acoustic Output Information Accordance with IEC 60601-2-37
Transducer Model: GF-UCT180 Operating Mode: PWD-mode
Table 201.103 – Acoustic output reporting table
TIS TIB
Index label MI Non-scan Non- TIC
Scan
Aaprt1cm2 Aaprt >1cm2 scan
Maximum Index Value 0.88 – 0.62 – 1.7 0.93
p r, (MPa) 2.0
P (mW) – 17 22 14
Min of [P(z s), I ta,(z s)] (mW) –
zs (cm) –
Associated z bp (cm) –
acoustic zb (cm) 1.2
parameters z at max. I (cm) 1.4
pi,
d eq(z b) (cm) 0.19
ƒ awf (MHz) 5.3 – 7.5 – 5.1 5.2
Dim of A aprt X (cm) – 0.74 – 0.74 0.22
Y (cm) – 0.50 – 0.50 0.50
td (µsec) 0.47
prr (Hz) 5210
p r at max. I pi (MPa) 2.5
Other
d eq at max. I pi (cm) 0.18
information
I pa, at max.MI (W/cm 2) 209
Focal Length FL x (cm) – 3.4 – 0.27
FL y (cm) – 1.0 – 0.84
DVA% (%) 100 – 100 – 100 97
Function CHE B – Off – Off CHE A Std
B/W Frequency Select (MHz) n/a n/a n/a n/a n/a n/a
B/W Focus n/a n/a n/a n/a n/a n/a
B/W-Range (cm) n/a n/a n/a n/a n/a n/a
B/W Line Density n/a n/a n/a n/a n/a n/a
B/W Scan Area (%) n/a n/a n/a n/a n/a n/a
Doppler Image Select PENET – PENET – PENET STD
Doppler Frequency Select (MHz) 5 MHz – 7.5 MHz – 5 MHz 5 MHz
Operating
Doppler Focus F5 – F11 – F9 F1
control
Doppler Velocity Range (cm/sec) 39.8 – 53.1 – 61.3 114
conditions
Color Image Select n/a n/a n/a n/a n/a n/a
Color Doppler Frequency Select (MHz) n/a n/a n/a n/a n/a n/a
Flow Focus n/a n/a n/a n/a n/a n/a
Color Velocity Range (m/sec) n/a n/a n/a n/a n/a n/a
Color Line Density n/a n/a n/a n/a n/a n/a
Color Average n/a n/a n/a n/a n/a n/a
Flow Filter n/a n/a n/a n/a n/a n/a
Flow Scan Area (%) n/a n/a n/a n/a n/a n/a
Triplex Velocity Range n/a n/a n/a n/a n/a n/a
NOTE1 Data should only be entered in one of the columns related to TIS.
NOTE2 Information need not be provided regarding TIC for any TRANSDUCER ASSEMBLY not intended for transcranial or
neonatal cephalic uses.
NOTE3 If the requirements of 201.12.4.2a are met, it is not required to enter any data in the columns related to TIS, TIB or TIC.
NOTE4 If the requirements of 201.12.4.2b are met, it is not required to enter any data in the columns related to MI.
NOTE5 Focal Length is a NOMINAL value.
ULTRASOUND GASTROVIDEOSCOPE GF-UCT180 189
Appendix E: Acoustic Output Information Accordance with IEC 60601-2-37
Transducer Model: GF-UCT180 Operating Mode: Mflow-mode
Table 201.103 – Acoustic output reporting table
TIS TIB
Index label MI Non-scan Non- TIC
Scan
Aaprt 1cm2 Aaprt>1cm2 scan
Maximum Index Value 0.88 – 0.76 – 1.7 0.89
p r, (MPa) 2.0
P (mW) – 22 22 24
Min of [P(z s), I ta,(z s)] (mW) –
zs (cm) –
Associated z bp (cm) –
acoustic zb (cm) 1.2
parameters z at max. I (cm) 1.4
pi,
d eq(z b) (cm) 0.19
ƒ awf (MHz) 5.3 – 7.4 – 5.1 5.3
Dim of A aprt X (cm) – 0.74 – 0.74 0.74
Y (cm) – 0.50 – 0.50 0.50
td (µsec) 0.47
prr (Hz) 5210
p r at max. I pi (MPa) 2.5
Other
d eq at max. I pi (cm) 0.18
information
I pa, at max.MI (W/cm 2) 209
Focal Length FL x (cm) – 4.6 – 4.3
FL y (cm) – 1.0 – 1.0
DVA% (%) 100 – 100 – 100 100
Function CHE B – eF EPHD – Off eF EPHD
B/W Frequency Select (MHz) n/a n/a n/a n/a n/a n/a
B/W Focus n/a n/a n/a n/a n/a n/a
B/W-Range (cm) 4.0 – 2.0 – 2.0 2.0
B/W Line Density n/a n/a n/a n/a n/a n/a
B/W Scan Area (%) n/a n/a n/a n/a n/a n/a
Doppler Image Select n/a n/a n/a n/a n/a n/a
Doppler Frequency Select (MHz) n/a n/a n/a n/a n/a n/a
Operating
Doppler Focus n/a n/a n/a n/a n/a n/a
control
Doppler Velocity Range (cm/sec) n/a n/a n/a n/a n/a n/a
conditions
Color Image Select PENET – PENET – PENET PENET
Color Doppler Frequency Select (MHz) 5 MHz – 7.5 MHz – 5 MHz 5 MHz
Flow Focus F5 – F16 – F9 F16
Color Velocity Range (m/sec) 0.40 – 0.80 – 0.61 0.94
Color Line Density n/a n/a n/a n/a n/a n/a
Color Average n/a n/a n/a n/a n/a n/a
Flow Filter n/a n/a n/a n/a n/a n/a
Flow Scan Area (%) n/a n/a n/a n/a n/a n/a
Triplex Velocity Range n/a n/a n/a n/a n/a n/a
NOTE1 Data should only be entered in one of the columns related to TIS.
NOTE2 Information need not be provided regarding TIC for any TRANSDUCER ASSEMBLY not intended for transcranial or
neonatal cephalic uses.
NOTE3 If the requirements of 201.12.4.2a are met, it is not required to enter any data in the columns related to TIS, TIB or TIC.
NOTE4 If the requirements of 201.12.4.2b are met, it is not required to enter any data in the columns related to MI.
NOTE5 Focal Length is a NOMINAL value.
190 ULTRASOUND GASTROVIDEOSCOPE GF-UCT180
Appendix E: Acoustic Output Information Accordance with IEC 60601-2-37
Transducer Model: GF-UCT180 Operating Mode: B/PWD-mode
Table 201.103 – Acoustic output reporting table
TIS TIB
Index label MI Non-scan Non- TIC
Scan
Aaprt1cm2 Aaprt >1cm2 scan
Maximum Index Value 0.88 – 0.50 – 1.6 0.95
p r, (MPa) 2.0
P (mW) – 14 15 16
Min of [P(z s), I ta,(z s)] (mW) –
zs (cm) –
Associated z bp (cm) –
acoustic zb (cm) 0.37
parameters z at max. I (cm) 1.4
pi,
d eq(z b) (cm) 0.18
ƒ awf (MHz) 5.3 – 7.5 – 5.3 4.3, 5.2
Dim of A aprt X (cm) – 0.74 – 0.31 0.22
Y (cm) – 0.50 – 0.50 0.50
td (µsec) 0.47
prr (Hz) 6640
p r at max. I pi (MPa) 2.5
Other
d eq at max. I pi (cm) 0.16
information
I pa, at max.MI (W/cm 2) 209
Focal Length FL x (cm) – 2.7 – 0.27
FL y (cm) – 1.0 – 0.84
DVA% (%) 100 – 100 – 92 100
Function CHE B – Off – CHE A Std CHE A Std
B/W Frequency Select (MHz) 4.7 MHz – 5 MHz – 4.7 MHz 4.3 MHz
B/W Focus F5 – F16 – F2 F12
B/W-Range (cm) 4.0 – 4.0 – 12.0 4.0
B/W Line Density HIGH – HIGH – HIGH HIGH
B/W Scan Area (%) 25 – 25 – 25 25
Doppler Image Select PENET – PENET – STD STD
Doppler Frequency Select (MHz) 5 MHz – 7.5 MHz – 5 MHz 5 MHz
Operating
Doppler Focus F5 – F8 – F2 F1
control
Doppler Velocity Range (cm/sec) 53.1 – 39.8 – 79.7 133
conditions
Color Image Select n/a n/a n/a n/a n/a n/a
Color Doppler Frequency Select (MHz) n/a n/a n/a n/a n/a n/a
Flow Focus n/a n/a n/a n/a n/a n/a
Color Velocity Range (m/sec) n/a n/a n/a n/a n/a n/a
Color Line Density n/a n/a n/a n/a n/a n/a
Color Average n/a n/a n/a n/a n/a n/a
Flow Filter n/a n/a n/a n/a n/a n/a
Flow Scan Area (%) n/a n/a n/a n/a n/a n/a
Triplex Velocity Range n/a n/a n/a n/a n/a n/a
NOTE1 Data should only be entered in one of the columns related to TIS.
NOTE2 Information need not be provided regarding TIC for any TRANSDUCER ASSEMBLY not intended for transcranial or
neonatal cephalic uses.
NOTE3 If the requirements of 201.12.4.2a are met, it is not required to enter any data in the columns related to TIS, TIB or TIC.
NOTE4 If the requirements of 201.12.4.2b are met, it is not required to enter any data in the columns related to MI.
NOTE5 Focal Length is a NOMINAL value.
ULTRASOUND GASTROVIDEOSCOPE GF-UCT180 191
Appendix E: Acoustic Output Information Accordance with IEC 60601-2-37
Transducer Model: GF-UCT180 Operating Mode: B/Bflow-mode
Table 201.103 – Acoustic output reporting table
TIS TIB
Index label MI Non-scan Non- TIC
Scan
Aaprt 1cm2 Aaprt>1cm2 scan
Maximum Index Value 0.88 0.91 – – – 0.82
p r, (MPa) 2.0
P (mW) 26 – – 27
Min of [P(z s), I ta,(z s)] (mW) –
zs (cm) –
Associated z bp (cm) –
acoustic zb (cm) –
parameters z at max. I (cm) 1.4
pi,
d eq(z b) (cm) –
ƒ awf (MHz) 5.3 5.5, 7.5 – – – 5.1, 5.5
Dim of A aprt X (cm) 1.1 – – – 1.1
Y (cm) 0.50 – – – 0.50
td (µsec) 0.47
prr (Hz) 8730
p r at max. I pi (MPa) 2.5
Other
d eq at max. I pi (cm) –
information
I pa, at max.MI (W/cm 2) 209
Focal Length FL x (cm) 2.7 – – 3.8
FL y (cm) 1.0 – – 0.84
DVA% (%) 100 100 – – – 100
Function CHE B Off – – – Off
B/W Frequency Select (MHz) 4.7 MHz 5 MHz – – – 5 MHz
B/W Focus F5 F15 – – – F14
B/W-Range (cm) 4.0 4.0 – – – 4.0
B/W Line Density HIGH HIGH – – – HIGH
B/W Scan Area (%) 25 25 – – – 25
Doppler Image Select n/a n/a n/a n/a n/a n/a
Doppler Frequency Select (MHz) n/a n/a n/a n/a n/a n/a
Operating
Doppler Focus n/a n/a n/a n/a n/a n/a
control
Doppler Velocity Range (cm/sec) n/a n/a n/a n/a n/a n/a
conditions
Color Image Select PENET PENET – – – PENET
Color Doppler Frequency Select (MHz) 5 MHz 7.5 MHz – – – 5 MHz
Flow Focus F5 F8 – – – F16
Color Velocity Range (m/sec) 0.76 0.50 – – – 0.61
Color Line Density LOW LOW – – – LOW
Color Average HIGH HIGH – – – HIGH
Flow Filter #4 #4 – – – #4
Flow Scan Area (%) 20 20 – – – 20
Triplex Velocity Range n/a n/a n/a n/a n/a n/a
NOTE1 Data should only be entered in one of the columns related to TIS.
NOTE2 Information need not be provided regarding TIC for any TRANSDUCER ASSEMBLY not intended for transcranial or
neonatal cephalic uses.
NOTE3 If the requirements of 201.12.4.2a are met, it is not required to enter any data in the columns related to TIS, TIB or TIC.
NOTE4 If the requirements of 201.12.4.2b are met, it is not required to enter any data in the columns related to MI.
NOTE5 Focal Length is a NOMINAL value.
192 ULTRASOUND GASTROVIDEOSCOPE GF-UCT180
Appendix E: Acoustic Output Information Accordance with IEC 60601-2-37
Transducer Model: GF-UCT180 Operating Mode: Power flow-mode
Table 201.103 – Acoustic output reporting table
TIS TIB
Index label MI Non-scan Non- TIC
Scan
Aaprt1cm2 Aaprt >1cm2 scan
Maximum Index Value 0.88 0.91 – – – 0.82
p r, (MPa) 2.0
P (mW) 26 – – 27
Min of [P(z s), I ta,(z s)] (mW) –
zs (cm) –
Associated z bp (cm) –
acoustic zb (cm) –
parameters z at max. I (cm) 1.4
pi,
d eq(z b) (cm) –
ƒ awf (MHz) 5.3 5.5, 7.5 – – – 5.1, 5.5
Dim of A aprt X (cm) 1.1 – – – 1.1
Y (cm) 0.50 – – – 0.50
td (µsec) 0.47
prr (Hz) 8730
p r at max. I pi (MPa) 2.5
Other
d eq at max. I pi (cm) –
information
I pa, at max.MI (W/cm 2) 209
Focal Length FL x (cm) 2.7 – – 3.8
FL y (cm) 1.0 – – 0.84
DVA% (%) 100 100 – – – 100
Function CHE B Off – – – Off
B/W Frequency Select (MHz) 4.7 MHz 5 MHz – – – 5 MHz
B/W Focus F5 F15 – – – F14
B/W-Range (cm) 4.0 4.0 – – – 4.0
B/W Line Density HIGH HIGH – – – HIGH
B/W Scan Area (%) 25 25 – – – 25
Doppler Image Select n/a n/a n/a n/a n/a n/a
Doppler Frequency Select (MHz) n/a n/a n/a n/a n/a n/a
Operating
Doppler Focus n/a n/a n/a n/a n/a n/a
control
Doppler Velocity Range (cm/sec) n/a n/a n/a n/a n/a n/a
conditions
Color Image Select PENET PENET – – – PENET
Color Doppler Frequency Select (MHz) 5 MHz 7.5 MHz – – – 5 MHz
Flow Focus F5 F8 – – – F16
Color Velocity Range (m/sec) 0.76 0.50 – – – 0.61
Color Line Density LOW LOW – – – LOW
Color Average HIGH HIGH – – – HIGH
Flow Filter #4 #4 – – – #4
Flow Scan Area (%) 20 20 – – – 20
Triplex Velocity Range n/a n/a n/a n/a n/a n/a
NOTE1 Data should only be entered in one of the columns related to TIS.
NOTE2 Information need not be provided regarding TIC for any TRANSDUCER ASSEMBLY not intended for transcranial or
neonatal cephalic uses.
NOTE3 If the requirements of 201.12.4.2a are met, it is not required to enter any data in the columns related to TIS, TIB or TIC.
NOTE4 If the requirements of 201.12.4.2b are met, it is not required to enter any data in the columns related to MI.
NOTE5 Focal Length is a NOMINAL value.
ULTRASOUND GASTROVIDEOSCOPE GF-UCT180 193
Appendix E: Acoustic Output Information Accordance with IEC 60601-2-37
Transducer Model: GF-UCT180 Operating Mode: B/Bflow/D-mode
Table 101 – Acoustic output reporting table
TIS TIB
Index label MI Non-scan Non- TIC
Scan
Aaprt 1cm2 Aaprt>1cm2 scan
Maximum Index Value 0.88 – 0.50 – 1.6 0.90
p r, (MPa) 2.0
P (mW) – 14 15 14
Min of [P(z s), I ta,(z s)] (mW) –
zs (cm) –
Associated z bp (cm) –
acoustic zb (cm) 0.37
parameters z at max. I (cm) 1.4
pi,
d eq(z b) (cm) 0.18
ƒ awf (MHz) 5.3 – 7.5 – 5.3 5.2, 5.4
Dim of A aprt X (cm) – 0.74 – 0.31 0.22
Y (cm) – 0.50 – 0.50 0.50
td (µsec) 0.47
prr (Hz) 11800
p r at max. I pi (MPa) 2.5
Other
d eq at max. I pi (cm) 0.16
information
I pa, at max.MI (W/cm 2) 209
Focal Length FL x (cm) – 2.7 – 0.27
FL y (cm) – 1.0 – 0.84
DVA% (%) 100 – 100 – 92 100
Function CHE B – Off – CHE A Std CHE A Std
B/W Frequency Select (MHz) 4.7 MHz – 5 MHz – 5.4 MHz 4.3 MHz
B/W Focus F5 – F16 – F1 F15
B/W-Range (cm) 4.0 – 4.0 – 10.0 4.0
B/W Line Density HIGH – HIGH – HIGH HIGH
B/W Scan Area (%) 25 – 25 – 25 25
Doppler Image Select PENET – PENET – STD STD
Doppler Frequency Select (MHz) 5 MHz – 7.5 MHz – 5 MHz 5 MHz
Operating
Doppler Focus F2 – F8 – F2 F1
control
Doppler Velocity Range (cm/sec) 106 – 53.1 – 93.8 133
conditions
Color Image Select PENET – PENET – STD STD
Color Doppler Frequency Select (MHz) 5 MHz – 5 MHz – 3.75 MHz 5 MHz
Flow Focus F5 – F16 – F16 F15
Color Velocity Range (m/sec) 0.33 – 0.25 – 0.33 0.33
Color Line Density LOW – LOW – LOW LOW
Color Average HIGH – HIGH – HIGH HIGH
Flow Filter #4 – #4 – #4 #4
Flow Scan Area (%) 20 – 20 – 20 20
Triplex Velocity Range HIGH – HIGH – HIGH HIGH
NOTE1 Data should only be entered in one of the columns related to TIS.
NOTE2 Information need not be provided regarding TIC for any TRANSDUCER ASSEMBLY not intended for transcranial or
neonatal cephalic uses.
NOTE3 If the requirements of 201.12.4.2a are met, it is not required to enter any data in the columns related to TIS, TIB or TIC.
NOTE4 If the requirements of 201.12.4.2b are met, it is not required to enter any data in the columns related to MI.
NOTE5 Focal Length is a NOMINAL value.
194 ULTRASOUND GASTROVIDEOSCOPE GF-UCT180
Appendix E: Acoustic Output Information Accordance with IEC 60601-2-37
Acoustic output table with Olympus universal
endoscopic ultrasound center EU-ME1
GF-UCT180 will not exceed an MI of 1.0, or an ISPTA.3 of 720 mW/cm2 in any
mode. In addition, GF-UCT180 will not exceed a TI of 1.0 in any mode.
ULTRASOUND GASTROVIDEOSCOPE GF-UCT180 195
Appendix E: Acoustic Output Information Accordance with IEC 60601-2-37
196 ULTRASOUND GASTROVIDEOSCOPE GF-UCT180
©2009 OLYMPUS MEDICAL SYSTEMS CORP. All rights reserved.
No part of this publication may be reproduced or distributed without the
express written permission of OLYMPUS MEDICAL SYSTEMS CORP.
OLYMPUS is a registered trademark of OLYMPUS CORPORATION.
Trademarks, product names, logos, or trade names used in this
document are generally registered trademarks or trademarks of each
company.
Manufactured by
2951 Ishikawa-cho, Hachioji-shi, Tokyo 192-8507, Japan
Fax: (042)646-2429 Telephone: (042)642-2111
Distributed by
3500 Corporate Parkway, P.O. Box 610, Center Valley, PA
18034-0610, U.S.A.
Fax: (484)896-7128 Telephone: (484)896-5000
5301 Blue Lagoon Drive, Suite 290 Miami, FL 33126-2097, U.S.A.
Fax: (305)261-4421 Telephone: (305)266-2332
(Premises/Goods delivery) Wendenstrasse 14-18, 20097 Hamburg, Germany
(Letters) Postfach 10 49 08, 20034 Hamburg, Germany
Fax: (040)23773-4656 Telephone: (040)23773-0
KeyMed House, Stock Road, Southend-on-Sea, Essex SS2 5QH, United Kingdom
Fax: (01702)465677 Telephone: (01702)616333
117071, Moscow, Malaya Kaluzhskaya 19, bld. 1, fl.2, Russia
Fax: (095)958-2277 Telephone: (095)958-2245
A8F, Ping An International Financial Center, No. 1-3, Xinyuan South Road,
Chaoyang District, Beijing, 100027 P.R.C.
Fax: (86)10-5976-1299 Telephone: (86)10-5819-9000
Olympus Tower 9F, 446, Bongeunsa-ro, Gangnam-gu, Seoul, Korea 135-509
Fax: (02)6255-3494 Telephone: (02)6255-3210
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GE5999 15 Printed in Japan 20150902 *0000
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