GIF-2TH180 EVIS EXERA II GASTROINTESTINAL VIDEOSCOPE Operation Manual April 2010.pdf
Page 1
INSTRUCTIONS
EVIS EXERA II GASTROINTESTINAL VIDEOSCOPE
OLYMPUS GIF TYPE 2TH180
Refer to the endoscope’s companion manual, the “OLYMPUS GIF TYPE 2TH180
REPROCESSING MANUAL”, for reprocessing information.
USA: CAUTION: Federal law restricts this device to sale by or on the order of a
physician.
Page 3
Contents
Contents
Symbols.........................................................................................
1
Important Information — Please Read Before Use....................
2
Intended use ............................................................................................
2
Applicability of endoscopy and endoscopic treatment .............................
2
Instruction manual.....................................................................................
3
User qualifications ....................................................................................
3
Instrument compatibility ............................................................................
4
Reprocessing before the first use/reprocessing and storage after use ....
4
Spare equipment ......................................................................................
4
Maintenance management .......................................................................
4
Prohibition of improper repair and modification ........................................
5
Signal words .............................................................................................
5
Warnings and cautions .............................................................................
5
Examples of inappropriate handling..........................................................
9
Chapter 1
Checking the Package Contents............................
10
Chapter 2
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..........................................................
24
3.2
Inspection of the endoscope ...........................................................
25
3.3
Preparation and inspection of accessories .....................................
28
3.4
Attaching accessories to the endoscope ........................................
33
3.5
Inspection and connection of ancillary equipment ..........................
36
3.6
Inspection of the endoscopic system ..............................................
39
Operation .................................................................
45
4.1
Insertion ..........................................................................................
48
4.2
Using EndoTherapy accessories ....................................................
54
4.3
Withdrawal of the endoscope..........................................................
61
4.4
Transportation of the endoscope ....................................................
61
Chapter 3
Chapter 4
EVIS EXERA II GIF TYPE 2TH180 OPERATION MANUAL
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Contents
Chapter 5
ii
Troubleshooting ......................................................
63
5.1
Troubleshooting guide ....................................................................
63
5.2
Withdrawal of the endoscope with an irregularity............................
68
5.3
Returning the endoscope for repair.................................................
70
Appendix........................................................................................
71
System chart ............................................................................................
71
EMC information........................................................................................
81
EVIS EXERA II GIF TYPE 2TH180 OPERATION MANUAL
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Symbols
Symbols
The meaning(s) of the symbol(s) shown on the component packaging, the back
cover of the instruction manual, and/or the instrument are as follows:
Refer to instructions.
Caution
Endoscope
TYPE BF applied part
Single use only
Lot number
Manufacturer
Authorized representative in the European Community
Serial number
EVIS EXERA II GIF TYPE 2TH180 OPERATION MANUAL
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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 Olympus video system
center, light source, documentation equipment, monitor, EndoTherapy
accessories (such as a biopsy forceps), and other ancillary equipment for
endoscopy and endoscopic surgery within the upper digestive tract (including
the esophagus, stomach, and duodenum).
Do not use this instrument for any purpose other than its intended use. Select
the endoscope to be used according to the objective of the intended procedure
based on the full understanding of the endoscope’s specifications and
functionality as described in this instruction manual.
Applicability of endoscopy and endoscopic treatment
If there are official standards on the applicability of endoscopy and endoscopic
treatment that are defined by the hospital’s administrators or other official
institutions, such as academic societies on endoscopy, follow those standards.
Before starting endoscopy and endoscopic treatment, thoroughly evaluate its
properties, purposes, effects, and possible risks (their nature, extent and
probability). Perform endoscopy and endoscopic treatment only when its
potential benefits are greater than its risks.
Fully explain to the patient the potential benefits and risks of the endoscopy and
endoscopic treatment as well as any examination/treatment methods that can be
performed in its place, and perform the endoscopy and endoscopic treatment
only after obtaining the consent of the patient.
Even after starting the endoscopy and endoscopic treatment, continue to
evaluate the potential benefits and risks, and immediately stop the
endoscopy/treatment and take proper measures if the risks to the patient
become greater than the potential benefits.
2
EVIS EXERA II GIF TYPE 2TH180 OPERATION MANUAL
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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 that will be used during the procedure and use the
equipment as instructed.
Note that the complete instruction manual set for this endoscope consists of this
manual and the “REPROCESSING MANUAL” with your endoscope model listed
on the cover. It also accompanied the endoscope at shipment.
Keep this and all related instruction manuals in a safe, accessible location.
If you have any questions or comments about any information in this manual,
please contact Olympus.
Terms used in this manual
NBI (Narrow Band Imaging) observation mode:
This is an observation mode using narrowband light.
Normal light observation mode (or WLI (White Light Imaging) observation
mode):
This is an observation mode using standard white light illumination.
User qualifications
If there are official standards for user qualifications to perform endoscopy and
endoscopic treatment that are defined by the hospital’s medical administrators or
other official institutions, such as academic societies on endoscopy, follow those
standards. If there are no official qualification standards, the operator of this
instrument must be a physician approved by the medical safety manager of the
hospital or person in charge of the department (department of internal medicine,
etc.).
The physician should be capable of safely performing the planned endoscopy
and endoscopic treatment following guidelines set by the academic societies on
endoscopy, etc., and considering the difficulty of endoscopy and endoscopic
treatment. This manual does not explain or discuss endoscopic procedures.
EVIS EXERA II GIF TYPE 2TH180 OPERATION MANUAL
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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: 2001). However, when connected with an
instrument that complies with the EMC standard for medical electrical
equipment, edition 1 (IEC 60601-1-2: 1993), the whole system complies with
edition 1.
Reprocessing before the first use/reprocessing and
storage after use
This instrument was not cleaned, disinfected, or sterilized before shipment.
Before using this instrument for the first time, reprocess it according to the
instructions given in the endoscope’s companion “REPROCESSING MANUAL”
with your endoscope model listed on the cover.
After using this instrument, reprocess and store it according to the instructions
given in the endoscope’s companion reprocessing manual. Improper and/or
incomplete reprocessing or storage can pose an infection control risk, cause
equipment damage, or reduce performance.
Spare equipment
Be sure to prepare another endoscope to avoid interruption of the examination
due to equipment failure or malfunction.
Maintenance management
The probability of failure of the endoscope and ancillary equipment increases as
the number of procedures performed and/or the total operating hours increase.
In addition to the inspection before each procedure, the person in charge of
medical equipment maintenance in each hospital should inspect the items
specified in this manual periodically. An endoscope with an observed irregularity
should not be used, but should be inspected by following Section 5.1,
“Troubleshooting guide” on page 63. If the irregularity is still observed after
inspection, contact Olympus.
4
EVIS EXERA II GIF TYPE 2TH180 OPERATION MANUAL
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Important Information — Please Read Before Use
Prohibition of improper repair and modification
This instrument does not contain any user-serviceable parts. Do not
disassemble, modify, or attempt to repair it; patient or operator injury and/or
equipment damage may result.
Equipment that has been disassembled, repaired, altered, changed, or modified
by persons other than Olympus’ own authorized service personnel is excluded
from Olympus’ limited warranty and is not warranted by Olympus in any manner.
Signal words
The following signal words are used throughout this manual:
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.
•
After using this instrument, reprocess and store it according
to the instructions given in the endoscope’s companion
“REPROCESSING MANUAL” with your endoscope model
listed on the cover. Using improperly or incompletely
reprocessed or stored instruments may cause patient
cross-contamination and/or infection.
EVIS EXERA II GIF TYPE 2TH180 OPERATION MANUAL
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Important Information — Please Read Before Use
6
•
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.
•
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 due to
unintended retroflexion of the bending section. 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.
•
Never operate the bending section, feed air or perform
suction, insert or withdraw the endoscope’s insertion section,
or use EndoTherapy accessories without viewing the
endoscopic image or while the endoscopic 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.
•
If it is difficult to insert the endoscope, do not forcibly insert
the endoscope; stop the endoscopy. Forcible insertion can
result in patient injury, bleeding, and/or perforation.
•
Never insert or withdraw the endoscope’s insertion section or
use EndoTherapy accessories while the image is magnified.
Patient injury, bleeding, and/or perforation can result (when
using the image magnification function of the video system
center).
•
Do not touch the light guide on the endoscope connector
immediately after removing it from the light source because it
is extremely hot. Operator or patient burns can result.
EVIS EXERA II GIF TYPE 2TH180 OPERATION MANUAL
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Important Information — Please Read Before Use
•
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.
•
Do not rely on the NBI observation mode alone for primary
detection of lesions or to make a decision regarding any
potential diagnostic or therapeutic intervention.
•
During the endoscopic treatment, keep the insertion section
and the bending section as straight as possible. If there is a
loop or a bend on the insertion section or the bending
section, the operation can not be performed as intended, and
patient injury, bleeding, and/or perforation can 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 electrical
connector. CCD damage may result.
•
Do not apply shock to the distal end of the insertion section,
particularly the objective lens surface at the distal end. Visual
irregularities may result.
•
Do not twist or bend the bending section with your hands.
Equipment damage may result.
•
Do not squeeze the bending section forcefully. The covering
of the bending section may stretch or break and cause water
leaks.
•
Turn the video system center ON only when the videoscope
cable is connected to both the video system center and the
electrical 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.
EVIS EXERA II GIF TYPE 2TH180 OPERATION MANUAL
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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 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.
•
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.
This endoscope contains a memory chip that stores
information about the endoscope and communicates this
information to the video system center CV-180.
8
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Important Information — Please Read Before Use
Examples of inappropriate handling
Details on clinical endoscopic technique are the responsibility of trained
specialists. Patient safety in endoscopic examinations and endoscopic treatment
can be ensured through appropriate handling by the physician and the medical
facility. Examples of inappropriate handling are described below.
•
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.
•
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.
1 Narrow Band Imaging. For more details, refer to the
instruction manual for the video system center CV-180.
EVIS EXERA II GIF TYPE 2TH180 OPERATION MANUAL
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Chapter 1 Checking the Package Contents
Chapter 1 Checking the Package
Contents
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 described in the endoscope’s companion “REPROCESSING
MANUAL” with your endoscope model listed on the cover.
10
EVIS EXERA II GIF TYPE 2TH180 OPERATION MANUAL
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Chapter 1 Checking the Package Contents
Packaged for the USA, Canada, Australia, and New Zealand
Endoscope
Single use channel
cleaning brush
(BW-201T, 3 pcs)1
Water-resistant cap
(MH-553)
AW channel cleaning
adapter (MH-948)
Injection tube (MH-946)
Single use channel-opening
cleaning brush
(MAJ-1339, 3 pcs)1
Biopsy valve (MAJ-419)
Channel connection tube
(MAJ-420)
Auxiliary water tube (MAJ-855)
1
Single use combination cleaning
brush (BW-412T, 3 pcs)1
Air/water valve
(MH-438, 2 pcs)
Suction valve
(MH-443, 2 pcs)
Chain for water-resistant cap
(MAJ-1119)
Caps for biopsy
valve (10 pcs)
Mouthpiece
(MB-142, 2 pcs)
Operation manual
Channel plug (MH-944)
Reprocessing manual
These products may not be available in some areas.
EVIS EXERA II GIF TYPE 2TH180 OPERATION MANUAL
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Chapter 1 Checking the Package Contents
Packaged for countries other than the USA, Canada, Australia, and New Zealand
Endoscope
Channel cleaning brush
(BW-20T)
Water-resistant cap
(MH-553)
AW channel cleaning
adapter (MH-948)
Injection tube (MH-946)
Channel-opening cleaning
brush (MH-507)
Air/water valve
(MH-438, 2 pcs)
Suction valve
(MH-443, 2 pcs)
Biopsy valve (MAJ-419)
Caps for biopsy valve
(10 pcs)
Auxiliary water tube (MAJ-855)
Operation manual
12
Mouthpiece
(MB-142, 2 pcs)
Channel connection tube (MAJ-420)
Channel plug (MH-944)
Reprocessing manual
EVIS EXERA II GIF TYPE 2TH180 OPERATION MANUAL
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Chapter 1 Checking the Package Contents
EVIS EXERA II GIF TYPE 2TH180 OPERATION MANUAL
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Chapter 2 Instrument Nomenclature and Specifications
Chapter 2 Instrument Nomenclature
and Specifications
2.1
Nomenclature
Universal cord
2. Auxiliary water inlet
1. Suction connector
Auxiliary water inlet cap
(MAJ-215)
6. Electrical connector
Air pipe
3. S-cord connector mount
4. Air supply connector
4. Water supply connector
Light guide
Product name (model) and serial number
Contact pins
5. Endoscope connector
14
EVIS EXERA II GIF TYPE 2TH180 OPERATION MANUAL
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Chapter 2 Instrument Nomenclature and Specifications
9. Suction valve (MH-443)
8. UP/DOWN angulation lock
10. Air/water valve (MH-438)
Suction cylinder
7. UP/DOWN angulation control knob
18. RIGHT/LEFT angulation
control knob
Air/water cylinder
17. RIGHT/LEFT
angulation lock
11. Biopsy valve (MAJ-419)
Grip section
16. Color code
(yellow (A, left),
orange (B, right))
Boot
Control
section
Suction switchover lever
12. Instrument channels
Instrument channel ports
13. Insertion section limit mark
Insertion section
15. Remote switches
1 to 4
Distal end
14. Bending section
Top view
Insertion tube
EVIS EXERA II GIF TYPE 2TH180 OPERATION MANUAL
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Chapter 2 Instrument Nomenclature and Specifications
2.2
Endoscope functions
1. Suction connector
Connects the endoscope to the suction tube of the suction pump.
2. Auxiliary water inlet
Connect the auxiliary water tube here. Feed water from this inlet through the
auxiliary water channel when necessary, (e.g., when blood adheres to the
mucous membrane in the patient’s body cavity). When the auxiliary water
inlet is not being used, make sure that it is covered by the auxiliary water
inlet cap.
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. When the endoscope is used with the
electrosurgical unit ESG-100, it is not necessary to use the S-cord. Connect
the fitting part of the chain for water-resistant cap to this mount, as required
(see Section 2.4 on page 20).
4. 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.
5. Endoscope connector
Connects the endoscope to the output socket of the light source and
transmits light from the light source to the endoscope.
6. Electrical 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-180. For more details, refer to the instruction manual for the
CV-180.
7. 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.
8. 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.
9. Suction valve (MH-443)
This valve is depressed to activate suction. The valve is used to remove any
fluids, debris, flatus, or air from the patient.
16
EVIS EXERA II GIF TYPE 2TH180 OPERATION MANUAL
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Chapter 2 Instrument Nomenclature and Specifications
10. Air/water valve (MH-438)
The hole in this valve is covered to insufflate air and the valve is depressed
to feed water for lens washing. It also can be used to feed air for removing
any fluids or debris adhering to the objective lens.
11. Biopsy valve (MAJ-419) with suction switchover lever
When the lever is turned so that “A” is facing upward and the suction valve
is depressed, suction is performed only through the ø 2.8 mm instrument
channel (channel A, left). When the lever is turned so that “AB” is facing
upward and the suction valve is depressed, suction is performed through
both instrument channels simultaneously.
12. Instrument channels
The instrument channels function 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. 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.
16. Color code
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.
Yellow (A):
ø 2.8 mm instrument channel (channel A, left).
Orange (B):
ø 3.7 mm instrument channel (channel B, right).
17. 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.
18. 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.
EVIS EXERA II GIF TYPE 2TH180 OPERATION MANUAL
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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
Model
GIF-2TH180
140
Optical system Field of view
Direction of view
Insertion
section
Forward viewing
Depth of field
2 – 100 mm
Distal end outer
diameter
ø 12.2 mm
Distal end enlarged
1. Air/water nozzle
2. Light guide lens
3. Objective lens
4. Instrument channel A outlet (ø 2.8 mm)
5. Instrument channel B outlet (ø 3.7 mm)
6. Auxiliary water channel
1.
UP
RIGHT
5.
DOWN
Insertion tube outer
diameter
Insertion section
working length
18
ø 12.6 mm
1030 mm
EVIS EXERA II GIF TYPE 2TH180 OPERATION MANUAL
3.
2.
LEFT
4.
6.
Page 23
Chapter 2 Instrument Nomenclature and Specifications
Instrument
channel
Channel inner
diameter
Minimum visible
distance
Direction from which
EndoTherapy
accessories enter
and exit the
endoscopic image
A: ø 2.8 mm
B: ø 3.7 mm
A: 3 mm from the distal end
B: 5 mm from the distal end
A
B
Airflow rate
25 cm3/s
Note: Standard when CLV-180 (high air
pressure) is used.
Bending
section
Angulation range
UP 210, DOWN 90,
RIGHT 100, LEFT 100
Total length
1350 mm
NBI observation mode1
Available
1 For more details, refer to the instruction manual for the CV-180.
Medical
Devices
Directive
EMC
This device complies with the requirements
of Directive 93/42/EEC concerning medical
devices.
Classification: Class II a
Applied standard:
IEC 60601-1-2: 2001
This instrument complies with the standards
listed in the left column.
CISPR 11 of emission:
Group 1, Class B
This instrument complies with the EMC
standard for medical electrical equipment,
edition 2 (IEC 60601-1-2: 2001). 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
Degree of
protection
against
electric shock
2001234
The last digit of the year of manufacture is
the second digit of the serial number.
TYPE BF applied part
EVIS EXERA II GIF TYPE 2TH180 OPERATION MANUAL
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Chapter 2 Instrument Nomenclature and Specifications
2.4
20
Attaching the chain for water-resistant cap
(MAJ-1119)
•
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.
•
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 the 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 it is connected to an
endoscope that is being cleaned in an endoscope
reprocessor with an ultrasonic cleaning phase (such as OER,
OER-A, OER-AW).
•
The chain for water-resistant cap and the water-resistant cap
itself cannot be ethylene oxide 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 ethylene
oxide gas sterilization.
•
The chain for water-resistant cap and the water-resistant cap
itself cannot be steam sterilized (autoclaved); doing so can
damage them severely.
EVIS EXERA II GIF TYPE 2TH180 OPERATION MANUAL
Page 25
Chapter 2 Instrument Nomenclature and Specifications
Notch
Chain part
Connecting plate
Fitting part
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 (see Figure 2.2).
Connecting plate
Notch
Pin
Venting connector
Water-resistant cap
Figure 2.2
EVIS EXERA II GIF TYPE 2TH180 OPERATION MANUAL
21
Page 26
Chapter 2 Instrument Nomenclature and Specifications
5.
Place the hole on the fitting part over the endoscope’s S-cord connector
mount (see Figure 2.3).
Fitting part
Hole
S-cord connector
mount
Figure 2.3
6.
Confirm that the fitting part is securely attached to the foot of the S-cord
connector mount and can be smoothly rotated.
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.
22
EVIS EXERA II GIF TYPE 2TH180 OPERATION MANUAL