GF-UE260-AL5 ULTRASONIC GASTROVIDEOSCOPE Instructions July 2014.pdf
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INSTRUCTIONS
ULTRASONIC GASTROVIDEOSCOPE
OLYMPUS GF TYPE UE260-AL5
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.
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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
Maintenance management .......................................................................
5
Prohibition of improper repair and modification.........................................
6
Signal words .............................................................................................
6
Warnings and cautions .............................................................................
6
Examples of inappropriate handling..........................................................
10
Natural rubber latex medical alert ............................................................
10
Chapter 1
Checking the Package Contents............................
11
1.1
Standard components.....................................................................
11
1.2
Optional components ......................................................................
13
Instrument Nomenclature and Specifications ......
14
2.1
Nomenclature..................................................................................
14
2.2
Endoscope functions.......................................................................
16
2.3
Specifications..................................................................................
18
2.4
Attaching the chain for water-resistant cap (MAJ-1119) .................
20
Preparation and Inspection ....................................
23
3.1
Preparation of the equipment..........................................................
23
3.2
Inspection of the endoscope ...........................................................
25
3.3
Preparation and inspection of accessories .....................................
28
3.4
Attaching accessories to the endoscope ........................................
31
3.5
Inspection and connection of ancillary equipment ..........................
33
3.6
Inspection of the endoscopic system ..............................................
37
3.7
Preparation and inspection of the balloon.......................................
42
Chapter 2
Chapter 3
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Contents
Chapter 4
Operation..................................................................
47
4.1
Insertion ..........................................................................................
49
4.2
Observation of the ultrasonic image................................................
53
4.3
Using endo-therapy accessories.....................................................
55
4.4
Withdrawal of the endoscope..........................................................
58
4.5
Removal of the balloon ...................................................................
59
4.6
Transportation of the endoscope ....................................................
60
Reprocessing: General Policy................................
62
5.1
Instructions......................................................................................
62
5.2
Importance of cleaning, disinfection and sterilization......................
62
5.3
Precautions .....................................................................................
63
5.4
Reprocessing before the first use/reprocessing
and storage after use ......................................................................
66
Chapter 5
Chapter 6
6.1
Compatibility summary....................................................................
67
6.2
Detergent solution ...........................................................................
69
6.3
Disinfectant solution ........................................................................
70
6.4
Rinsing water ..................................................................................
70
6.5
ETO gas sterilization .......................................................................
71
6.6
Steam sterilization (autoclaving) of accessories .............................
73
Chapter 7
ii
Compatible Reprocessing Methods and Chemical
Agents ................................................................................... 67
Cleaning, Disinfection and Sterilization Procedures 74
7.1
Required reprocessing equipment ..................................................
75
7.2
Cleaning, disinfection and sterilization procedures .........................
83
7.3
Precleaning .....................................................................................
84
7.4
Leakage testing...............................................................................
88
7.5
Manual cleaning ..............................................................................
93
7.6
High-level disinfection .....................................................................
106
7.7
Rinsing after high-level disinfection.................................................
109
7.8
Sterilization .....................................................................................
112
7.9
Cleaning, disinfection and sterilization
procedures for reusable parts and reprocessing equipment...........
114
Chapter 8
Cleaning and Disinfection Equipment ................... 122
Chapter 9
Storage and Disposal .............................................. 124
9.1
Storage of the endoscope ...............................................................
124
9.2
Storage of reusable parts and reprocessing equipment .................
125
9.3
Disposal ..........................................................................................
125
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Contents
Chapter 10 Troubleshooting ...................................................... 126
10.1 Troubleshooting guide ....................................................................
126
10.2 Withdrawal of the endoscope with an abnormality..........................
131
10.3 Returning the endoscope for repair ................................................
132
Appendix ....................................................................................... 133
System chart ............................................................................................
133
Inspection of the endoscope after cleaning, disinfection or sterilization in
accordance with IEC 60601-2-37..............................................................
137
Acoustic output table.................................................................................
139
EMC information ......................................................................................
141
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Contents
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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 ultrasonic connector
Release the ultrasonic connector
Ultrasonic endoscope
Single use only
Do not resterilize
Use by (expiration date)
Sterilized using ethylene oxide
Sterilization lot number
Lot number
Non-sterile
Keep away from sunlight
ULTRASONIC GASTROVIDEOSCOPE GF-UE260-AL5
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Symbols
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
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Important Information — Please Read Before Use
Important Information — Please Read
Before Use
Intended use
This instrument has been designed to be used with an diagnostic ultrasound
system (ALOKA CO., LTD), video system center, light source, documentation
equipment, video monitor, endo-therapy accessories and other ancillary
equipment for endoscopic ultrasonic imaging of the gastrointestinal wall, bile and
pancreatic ducts, 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 risk (their natures, extent and
probability). Perform endoscopy and endoscopic treatment only when its
potential benefits are greater than its risks.
Fully explain to the patient the potential benefits and risks of the endoscopy and
endoscopic treatment as well as any examination/treatment methods that can be
performed in its place, and perform the endoscopy and endoscopic treatment
only after obtaining the consent of the patient.
Even after starting the endoscopy and endoscopic treatment, continue to
evaluate the potential benefits and risks, and immediately stop the
endoscopy/treatment and take proper measures if the risks to the patient
become greater than the potential benefits.
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Important Information — Please Read Before Use
Instruction manual
This instruction manual contains essential information on using this instrument
safely and effectively. Before use, thoroughly review this manual and the
manuals of all equipment which will be used during the procedure and use 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, please
contact Olympus.
Terms used in this manual
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 is an official standard on user qualifications to perform endoscopy and
endoscopic treatment that is defined by the medical administration or other
official institutions, such as academic societies on endoscopy, follow that
standard. If there is no official qualification standard, the operator of this
instrument must be a physician approved by the medical safety manager of the
hospital or person in charge of the department (department of internal medicine,
etc.).
The physician should be capable of safely performing the planned endoscopy
and endoscopic treatment following guidelines set by the academic societies on
endoscopy, etc., and considering the difficulty of endoscopy and endoscopic
treatment. This manual does not explain or discuss endoscopic procedures.
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Important Information — Please Read Before Use
Instrument compatibility
Refer to 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 the EMC standard for medical electrical
equipment, edition 2 (IEC 60601-1-2: 20001) and 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 Chapters 5 through 9. 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 re-sterilize a balloon.
Maintenance management
The probability of failure of the endoscope and ancillary equipment increases as
the number of procedure 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 which an irregularity is
suspected should not be used, but should be inspected by following the Section
10.1, “Troubleshooting guide”. If the irregularity is still suspected after inspection,
contact Olympus.
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Important Information — Please Read Before Use
Prohibition of improper repair and modification
This instrument does not contain any user-serviceable parts. Do not
disassemble, modify or attempt to repair it; patient or operator injury and/or
equipment damage can result.
Equipment which has been disassembled, repaired, altered, changed or
modified by persons other than Olympus’ own authorized service personnel is
excluded from Olympus’ limited warranty and is not warranted by Olympus in
any manner.
Signal words
The following signal words are used throughout this manual:
Indicates a potentially hazardous situation which, if not
avoided, could result in death or serious injury.
Indicates a potentially hazardous situation which, if not
avoided, may result in minor or moderate injury. It may also
be used to alert against unsafe practices or potential
equipment damage.
Indicates additional helpful information.
Warnings and cautions
Follow the warnings and cautions given below when handling this instrument.
This information is to be supplemented by the warnings and cautions given in
each chapter.
6
•
Never use high frequency endo-therapy accessories,
because the distal end of this instrument is not insulated.
Using high-frequency accessories places the patient at the
risk of an electric shock.
•
After using this instrument, reprocess and store it according
to the instructions given in Chapters 7 through 9. Using
improperly or incompletely reprocessed or stored instruments
may cause patient cross-contamination and/or infection.
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Important Information — Please Read Before Use
•
Never perform angulation control forcibly or suddenly. Never
forcefully pull, twist or rotate the angulated bending section.
Patient injury, bleeding and/or perforation can result.
•
Never insert or withdraw the endoscope’s insertion tube while
the bending section is locked in position. Patient injury,
bleeding and/or perforation can result.
•
Never insert or withdraw the insertion tube abruptly or with
excessive force. Patient injury, bleeding and/or perforation
can result.
•
Do not touch the light guide of the endoscope connector
immediately after removing it from the light source because it
is extremely hot. Operator or patient burns can result.
•
Before each use or after a change of viewing modes/settings,
check to ensure the view observed through the endoscope
provides a live image (rather than a stored one) and has the
correct image orientation. Otherwise, patient injury, bleeding,
and/or perforation could result.
•
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.
•
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.
•
This endoscope is not intended for fetal use.
•
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.
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Important Information — Please Read Before Use
•
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.
8
•
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 into a diameter
of less than 12 cm. Equipment damage can result and/or the
ultrasonic image will be abnormal.
•
Do not coil the ultrasonic cable into a diameter of less than
12 cm. Equipment damage can result.
•
Do not touch the electrical contacts inside the electrical
connector. CCD damage can result.
•
Do not apply shock to the distal end of the insertion tube,
particularly the ultrasonic transducer and the objective lens
surface at the distal end. This could cause abnormalities in
the visual and/or ultrasonic images.
•
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.
•
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 OFF before connecting or
disconnecting the videoscope cable from the electrical
connector on the endoscope. Turn the video system center
ON or OFF only when the videoscope cable is connected to
both the video system center and the electrical connector on
the endoscope. Failure to do so can result in equipment
damage, including destruction of the CCD.
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Important Information — Please Read Before Use
•
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 may 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 attempt to bend the endoscope’s insertion tube with
excessive force. Otherwise, the insertion tube may be
damaged.
•
Do not touch the electrical contacts in the ultrasonic
connector. Equipment damage can result.
•
Do not pull, twist or tightly coil the ultrasonic cable. Noise can
develop in the ultrasonic image.
•
To prevent unnecessary patient exposure to ultrasonic
radiation, follow the ‘as-low-as-reasonably achievable’
(ALARA) principle when using Olympus ultrasonic
equipment. Freeze the image whenever you are not actively
viewing the “live” ultrasonic image. When the equipment is in
the FREEZE mode, no ultrasonic energy is emitted.
•
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.
•
It is highly desirable that a backup endoscope 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 CV-260.
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Important Information — Please Read Before Use
Examples of inappropriate handling
Details on clinical endoscopic technique are the responsibility of trained
specialists. Patient safety in endoscopic examinations and endoscopic treatment
can be ensured through appropriate handling by the physician and the medical
facility. Examples of inappropriate handling are given 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 and/or withdraw the endoscope. 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 endo-therapy 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.
Natural rubber latex medical alert
Balloons used with this instrument contain natural rubber latex which may cause
allergic reactions in some patients.
Do not use the balloon on a latex-sensitive patient. Instead, perform the
procedure using “The sterile de-aerated water immersion method” described in
Section 4.2, “Observation of the ultrasonic image”.
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Chapter 1 Checking the Package Contents
Chapter 1 Checking the Package
Contents
1.1
Standard components
Match all items in the package with the components shown below. Inspect each
item for damage. If the instrument is damaged, a component is missing or you
have any questions, do not use the instrument; immediately contact Olympus.
This instrument was not 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”.
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Chapter 1 Checking the Package Contents
Endoscope
Air/water valve
(MAJ-1444)
Balloon 2
(MH-303, non-sterile, 20 pcs.)
Suction valve
(MAJ-1443)
Injection tube
(MH-946)
Balloon applicator
(MAJ-864)
Mouthpiece
(MB-142, 2 pcs.)
Channel plug
(MAJ-621)
Channel-opening cleaning brush
(MH-507)
Suction cleaning adapter
(MH-856)
Channel cleaning brush
(BW-20T)
Biopsy valve (MB-358, 10 pcs.)
Channel cleaning brush
(BW-7L, 2 pcs.1)
Single use single-ended
cleaning brush
(BW-400L, 3 pcs.1)
Water-resistant cap
(MH-553)
Chain for water-resistant cap
(MAJ-1119)
Air/water channel cleaning adapter
(MAJ-629)
Water-resistant cap
(MAJ-896)
Instruction manual
1 These products may not be available in some areas.
12
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Chapter 1 Checking the Package Contents
1.2
Optional components
The item listed below is optional, 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-UE260-AL5
MAJ-233
Table 1.1
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Chapter 2 Instrument Nomenclature and Specifications
Chapter 2 Instrument Nomenclature
and Specifications
2.1
Nomenclature
Ultrasonic cable
Universal cord
13. Ultrasonic
connector
14. Suction
connector
11. Water supply
connector and air
supply connector
15. Electrical
connector
12. Endoscope
connector
16. Chain
connector
Electrical contacts
Water-resistant cap
(MAJ-896)
14
Water-resistant cap
(MH-553)
Air pipe
Light guide
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Chapter 2 Instrument Nomenclature and Specifications
3. Suction valve
(MAJ-1443)
2. UP/DOWN angulation lock
4. Air/water valve
(MAJ-1444)
5. UP/DOWN angulation
control knob
6. RIGHT/LEFT angulation
control knob
7. RIGHT/LEFT
angulation lock
Control
section
Suction cylinder
Air/water cylinder
Grip section
10. Color code (blue)
Biopsy valve
(MB-358)
Boot
Instrument channel
8. Instrument channel port
Insertion tube limit mark
Working length
Distal end
9. Bending section
1. Remote switches 1 to 4
Insertion tube
Ultrasonic
transducer
Top view
Balloon water feeding
and aspiration ports
are in this groove
Balloon attachment
groove
Light guide lens
Nozzle
Instrument
channel outlet
Objective lens
Detail of distal end
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Chapter 2 Instrument Nomenclature and Specifications
2.2
Endoscope functions
1. Remote switches 1 to 4
The functions of the remote switches 1 to 4 can be selected on the video
system center. When selecting the functions, refer to the instruction manual
for the video system center.
2. UP/DOWN angulation lock
Moving the lock in the “F
” direction frees angulation. Moving the lock in
the opposite direction locks the bending section at any desired position.
3. Suction valve
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 the
water from the balloon through the balloon channel.
4. Air/water valve
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.
5. UP/DOWN angulation control knob
When the 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.
6. RIGHT/LEFT angulation control knob
When the 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.
7. RIGHT/LEFT angulation lock
Turning the lock in the “F
” direction frees angulation. Turning the lock in
the opposite direction locks the bending section at any desired position.
8. Instrument channel port
The instrument channel port functions as:
channel for the insertion of endo-therapy accessories
de-aerated water feed channel (from the water supply unit
or a syringe via the biopsy valve)
9. Bending section
The bending section moves the distal end of the endoscope when the
UP/DOWN and RIGHT/LEFT angulation control knobs are operated.
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Chapter 2 Instrument Nomenclature and Specifications
10. Color code (blue)
The color code is used to quickly determine the compatibility of
endo-therapy accessories. The endoscope can be used with endo-therapy
accessories that have the same color code.
11. Water supply connector and air supply connector
The water supply connector and the air supply connector connect the
endoscope to the water container via the water container tube, to supply
water and pressurized air to the distal end of the endoscope.
12. Endoscope connector
The endoscope connector connects the endoscope to the output socket of
the light source and transmits light from the light source to the endoscope.
13. Ultrasonic connector
The ultrasonic connector connects the endoscope to the diagnostic
ultrasound system.
14. Suction connector
The suction connector connects the endoscope to the suction tube of the
suction pump.
15. Electrical connector
The electrical connector connects the endoscope to the video system center
via the videoscope cable.
16. Chain connector
This connector connects the fitting part of the chain for water-resistant cap.
Do not connect the S-cord of the electrosurgical unit here.
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Chapter 2 Instrument Nomenclature and Specifications
2.3
Specifications
Environment
Operating
environment
Ambient temperature
10 – 40C (50 – 104F)
Relative humidity
30 – 85%
Atmospheric pressure
700 – 1060 hPa
(0.7 – 1.1 kgf/cm2)
(10.2 – 15.4 psia)
Transportation
and storage
environment
Ambient temperature
–47 to 70C (–52.6 to 158F)
Relative humidity
10 – 95%
Atmospheric pressure
700 – 1060 hPa
(0.7 – 1.1 kgf/cm2)
(10.2 – 15.4 psia)
Specifications
Endoscope functions
Optical system
Insertion tube
Instrument
channel
Field of view
100
Direction of view
55 Forward Oblique
Depth of field
3 – 100 mm
Distal end outer diameter
ø 13.8 mm
Insertion tube outer diameter
ø 11.8 mm
Working length
1250 mm
Channel inner diameter
ø 2.2 mm
Minimum visible distance
3 mm
Direction from which
endo-therapy accessories enter
and exit the endoscopic image
Air flow rate
Bending
section
Total length
18
20 cm3/s
Note: Standard when
CLV-260 (high air pressure) is
used.
Angulation range
UP 130, DOWN 90
RIGHT 90, LEFT 90
1555 mm
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Chapter 2 Instrument Nomenclature and Specifications
Ultrasonic functions
Display mode
B-mode, M-mode, D-mode,
Flow-mode, Powerflow-mode
Scanning method
Electronic radial array
Scanning direction
Perpendicular to the insertion direction
Frequency
5, 6, 7.5, 10 MHz
Focusing point
Maximum 4 focusing points are available.
(between F1 to F16)
Scanning range
360
Contacting method
Balloon method
Sterile de-aerated water immersion method
Transducer surface
max. temperature
General safety
standard for medical
electrical equipment
43C >
IEC 60601-1: 2005
Medical Devices
Directive
EMC
This instrument, in part or in whole,
may come in contact with its
operators or patients.
This device complies with the
requirements of Directive 93/42/EEC
concerning medical devices.
Classification: Class II a
Applied standards;
IEC 60601-1-2: 2001
IEC 60601-1-2: 2007
IEC 60601-2-37: 2007
This instrument complies with the
standards listed in the left column.
CISPR 11 of emission:
Group 1, Class A
This instrument complies with the
EMC standard for medical electrical
equipment, edition 2 (IEC 60601-1-2:
2001) and edition 3 (IEC 60601-1-2:
2007). However, when 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
1512345
The year of manufacture is given in
the second digit of the serial number.
ULTRASONIC GASTROVIDEOSCOPE GF-UE260-AL5
19
Page 26
Chapter 2 Instrument Nomenclature and Specifications
Degree of protection
against electric
shock
Ingress protection
rating
2.4
20
TYPE BF applied part
IPX7
This instrument complies with the
standards for medical electrical
equipment: IEC 60601-1:2005
IEC 60601-2-37:2007.
Attaching the chain for water-resistant cap
(MAJ-1119)
•
Do not lift the endoscope by the chain for water-resistant cap.
Otherwise, operator and/or patient injury can result, or the
endoscope and/or water-resistant cap may be damaged
when the fitting comes off the chain connector.
•
Only connect the fitting to the chain connector. Connecting
the fitting 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
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 OER)
with an ultrasonic cleaning phase.
•
When attaching the water-resistant cap to the electrical
connector, do not pinch the chain for water-resistant cap
between the electrical 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 ETO gas sterilized; doing so may damage them. If
the water-resistant cap is connected to the endoscope by the
chain, be sure to remove the chain and the water-resistant
cap from the endoscope before ETO gas sterilization.
•
The chain for water-resistant cap and water-resistant cap
cannot be steam sterilized (autoclaved); doing so can
damage them severely.
ULTRASONIC GASTROVIDEOSCOPE GF-UE260-AL5