gif-x260_and_cf-x260_series_evis_lucera_gastrointes.pdf
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INSTRUCTIONS
EVIS LUCERA GASTROINTESTINAL VIDEOSCOPE
OLYMPUS GIF-N260
OLYMPUS GIF-XP260
OLYMPUS GIF-XQ260
OLYMPUS GIF-Q260
OLYMPUS GIF-H260
OLYMPUS GIF-H260Z
EVIS LUCERA COLONOVIDEOSCOPE
OLYMPUS CF-Q260AL/I
OLYMPUS CF-Q260DL/I
OLYMPUS CF-H260AL/I
OLYMPUS CF-H260AZL/I
OLYMPUS PCF-Q260AL/I
Refer to the endoscope’s companion manual, the “REPROCESSING MANUAL” whose
cover lists the model of your endoscope, for reprocessing information.
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Contents
Contents
Symbols.........................................................................................
1
Important Information — Please Read Before Use....................
2
Intended use ............................................................................................
2
Applicability of endoscopy and endoscopic treatment ..............................
3
Instruction manual ....................................................................................
3
User qualifications ....................................................................................
4
Instrument compatibility ...........................................................................
4
Reprocessing before the first use/reprocessing and storage after use.....
5
Spare equipment ......................................................................................
5
Maintenance management .......................................................................
5
Prohibition of improper repair and modification ........................................
5
Signal words..............................................................................................
6
Warnings and cautions .............................................................................
6
Examples of inappropriate handling..........................................................
12
Chapter 1
Checking the Package Contents............................
13
Chapter 2
Instrument Nomenclature and Specifications ......
18
2.1
Nomenclature..................................................................................
18
2.2
Endoscope functions.......................................................................
30
2.3
Specifications..................................................................................
33
2.4
Attaching the chain for water-resistant cap (MAJ-1119) .................
46
Preparation and Inspection ....................................
49
3.1
Preparation of the equipment..........................................................
50
3.2
Inspection of the endoscope ...........................................................
52
3.3
Preparation and inspection of accessories .....................................
58
3.4
Attaching accessories to the endoscope ........................................
62
3.5
Inspection and connection of ancillary equipment ..........................
65
3.6
Inspection of the endoscopic system ..............................................
69
Operation .................................................................
75
4.1
Insertion ..........................................................................................
79
4.2
Using endo-therapy accessories.....................................................
88
4.3
Withdrawal of the endoscope..........................................................
94
4.4
Transportation of the endoscope ....................................................
95
Chapter 3
Chapter 4
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Contents
Chapter 5
Troubleshooting ......................................................
97
5.1
Troubleshooting guide ....................................................................
97
5.2
Withdrawal of the endoscope with an abnormality..........................
102
5.3
Returning the endoscope for repair.................................................
105
Appendix........................................................................................ 107
ii
System chart ............................................................................................
107
EMC information........................................................................................
133
EVIS LUCERA GIF/CF/PCF TYPE 260 Series OPERATION MANUAL
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Symbols
Symbols
The meaning(s) of the symbol(s) shown on the package with the components,
the back cover of this instruction manual and/or this instrument are as follows:
Refer to instructions.
Endoscope
TYPE BF applied part
Manufacturer
Authorized representative in the European Community
EVIS LUCERA GIF/CF/PCF TYPE 260 Series OPERATION MANUAL
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Important Information — Please Read Before Use
Important Information — Please Read
Before Use
Intended use
These instruments have been designed to be used with an Olympus video
system center, light source, endoscope position detecting unit (for CF-Q260DL/I
only), magnification controller (for CF-H260AZL/I only), documentation
equipment, monitor, endo-therapy accessories such as a biopsy forceps and
other ancillary equipment.
Use the EVIS LUCERA GASTROINTESTINAL VIDEOSCOPE GIF-N260 for
transoral or transnasal endoscopy and endoscopic surgery within the upper
digestive tract (including the esophagus, stomach and duodenum).
Use the EVIS LUCERA GASTROINTESTINAL VIDEOSCOPE GIF-XP260,
GIF-XQ260, GIF-Q260, GIF-H260, GIF-H260Z for endoscopy and endoscopic
surgery within the upper digestive tract (including the esophagus, stomach and
duodenum).
Use the EVIS LUCERA COLONOVIDEOSCOPE CF-Q260AL/I, CF-H260AL/I,
PCF-Q260AL/I, CF-H260AZL/I, CF-Q260DL/I for endoscopy and endoscopic
surgery within the lower digestive tract (including the anus, rectum, sigmoid
colon, colon and ileocecal valve).
Do not use these instruments for any purpose other than their intended uses.
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.
2
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Important Information — Please Read Before 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.
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.
Note that the complete instruction manual set for this endoscope consists of this
manual and the “REPROCESSING MANUAL” whose cover lists the model of
your endoscope. 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
Special light observation:
This is an observation using filtered light.
NBI (Narrow Band Imaging) observation:
This is a special light observation using the narrow band observation light.
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Important Information — Please Read Before Use
Normal light observation (WLI (White Light Imaging) observation):
This is the ordinary observation using the RGB light.
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 society 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 safety 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.
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.
4
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Important Information — Please Read Before Use
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 manual, the “REPROCESSING
MANUAL” whose cover lists the model of your endoscope.
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.
Spare equipment
Be sure to prepare another endoscope to avoid that the examination will be
interrupted 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 which an irregularity is
suspected should not be used, but should be inspected by following Section 5.1,
“Troubleshooting guide” on page 97. If the irregularity is still suspected 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 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.
EVIS LUCERA GIF/CF/PCF TYPE 260 Series OPERATION MANUAL
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Important Information — Please Read Before Use
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
•
After using this instrument, reprocess and store it according
to the instructions given in the endoscope’s companion
reprocessing manual whose cover lists the model of your
endoscope. 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. If performing
high-frequency cauterization treatment becomes necessary
while the patient wears a metallic object, it may cause burns
on the patient in areas around the metallic object.
•
Do not strike, bend, hit, pull, twist, or drop the endoscope’s
distal end, insertion tube, bending section, control section,
universal cord, or endoscope connector of the endoscope
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.
EVIS LUCERA GIF/CF/PCF TYPE 260 Series OPERATION MANUAL
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Important Information — Please Read Before Use
•
When performing transnasal insertion of the GIF-N260,
please follow the cautions below.
− The shape and size of the nasal cavity and its suitability
for transnasal insertion may vary from patient to patient.
No endoscope, including this one, can always be inserted
transnasally with all patients. Before proceeding, always
be sure to confirm that transnasal insertion is possible
with the patient by always considering both the size of the
patient’s nasal cavity as well as the size of the
endoscope’s insertion tube. Otherwise, operator and/or
patient injury can result or the endoscope could become
lodged and be difficult to withdraw.
− Transnasal insertion is accompanied by the risk of
inflammation of the nasal cavity. If this happens, the nasal
passage will be constricted, making it more difficult to
withdraw the endoscope. In this case, do not use force to
withdraw the endoscope because patient injury such as
bleeding or perforation may result.
− Transnasal insertion is accompanied by the risk of
bleeding in the nasal cavity. Be sure to be prepared to
deal with any bleeding. When withdrawing the
endoscope, observe the inside of the nasal cavity to
ensure that there is no bleeding. Even when the
endoscope has been withdrawn without bleeding, do not
allow the patient to blow his or her nose strongly because
this could cause it to start bleeding.
− Before transnasal insertion, apply the appropriate
pretreatment and lubrication to the patient to enlarge the
nasal cavity. Otherwise, operator and/or patient injury can
result or the endoscope could become lodged and be
difficult to withdraw. When applying a pretreatment agent
through a tube, insert the tube into the same path as the
path planned for the endoscope insertion. Otherwise, the
treatment will have no effect. The effects of the
pretreatment agent and lubricant will decrease the longer
the procedure lasts. Apply the pretreatment agent or
lubricant as required during the procedure – for example,
when withdrawal seems to be difficult.
− Transnasal insertion of the endoscope should be
performed carefully. If resistance to insertion is felt, or the
patient reports pain, stop insertion immediately.
Otherwise, operator and/or patient injury can result or the
endoscope could become lodged and be difficult to
withdraw.
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Important Information — Please Read Before Use
− If it becomes impossible to withdraw the transnasally
inserted endoscope, pull its distal end out of the mouth,
cut the flexible tube using wire cutters, and after ensuring
that the cut section will not injure the body cavity or nasal
cavity of the patient, withdraw the endoscope carefully.
Therefore, always prepare wire cutters in advance.
8
•
Never perform angulation control forcibly or abruptly. Never
forcefully pull, twist or rotate the angulated bending section.
Patient injury, bleeding and/or perforation can result. It may
also become impossible to straighten the bending section
during an examination.
•
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 perform flexibility adjustment, operate the bending
section, feed air or perform suction, insert or withdraw the
endoscope’s insertion tube, or use endo-therapy accessories
without viewing the endoscopic image. Patient injury,
bleeding and/or perforation can result.
•
Never perform flexibility adjustment, operate the bending
section, feed air or perform suction, insert or withdraw the
endoscope’s insertion tube, or use endo-therapy accessories
while the image is frozen. Patient injury, bleeding and/or
perforation can result.
•
Regardless of the flexibility of the endoscope’s insertion tube,
never insert or withdraw the insertion tube abruptly or with
excessive force. Patient injury, bleeding and/or perforation
can result.
•
The bending section will never bend to the RIGHT or LEFT
direction but to the UP or DOWN direction. To insert or
withdraw, operate the endoscope by considering the direction
in which the bending section is angulated. Never apply
excessive force to the RIGHT or LEFT direction when
inserting or withdrawing the endoscope. Patient injury,
bleeding and/or perforation can result (for GIF-N260 only).
•
Never insert or withdraw the endoscope’s insertion tube, use
endo-therapy accessories while the image is magnified.
Patient injury, bleeding and/or perforation can result (when
using the GIF-H260Z, CF-H260AZL/I or using the image
magnification function of the video system center).
•
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.
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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.
•
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.
•
When combining the endoscope with a splinting tube, there is
the risk of perforation or bleeding due to entanglement of the
mucous membrane, or of the tube to become separated from
the endoscope and remaining in the body. Before use, be
sure to read the instruction manual for the splinting tube to
fully understand its characteristics.
•
Do not rely on the NBI imaging modality alone for primary
detection of lesions or to make a decision regarding any
potential diagnostic or therapeutic intervention.
•
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 touch the electrical contacts inside the electrical
connector. CCD damage may result.
•
Do not apply shock to the distal end of the insertion tube,
particularly the objective lens surface at the distal end. Visual
abnormalities 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.
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Important Information — Please Read Before Use
10
•
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.
•
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 attempt to bend the endoscope’s insertion tube with
excessive force unless its flexibility is set to the most-rigid
position. Otherwise, the insertion tube may be damaged (for
endoscopes with flexibility adjustment only).
•
Do not pull the magnification control cable 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. The magnification control cable will
be pulled out from the endoscope’s zoom connector and the
endoscopic image will not zoom in or out (for CF-H260AZL/I
only).
•
Turn the magnification controller OFF before connecting or
disconnecting the magnification control cable from the
endoscope’s zoom connector. Failure to do so can result in
equipment damage (for CF-H260AZL/I only).
•
Do not pull the UPD cable 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. The UPD cable will be pulled out from the UPD
scope connector and the scope model will not be visible (for
CF-Q260DL/I only).
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Important Information — Please Read Before Use
•
Turn the endoscope position detecting unit (UPD) OFF
before connecting or disconnecting the UPD cable from the
UPD scope connector. Turn the UPD ON or OFF only when
the UPD cable is connected to the UPD scope connector.
Failure to do so can result in UPD damage (for CF-Q260DL/I
only).
•
To check the electromagnetic influence 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.
•
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.
This endoscope contains a memory chip that stores
information about the endoscope and communicates this
information to the video system center CV-260SL, 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 described below;
12
•
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.
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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 manual, the
“REPROCESSING MANUAL” whose cover lists the model of your endoscope.
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Chapter 1 Checking the Package Contents
GIF-N260
Endoscope
GIF-XP260, GIF-XQ260, GIF-Q260, GIF-H260
Endoscope
GIF-H260Z
Endoscope
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Chapter 1 Checking the Package Contents
CF-Q260AL/I, CF-H260AL/I, PCF-Q260AL/I
Endoscope
CF-H260AZL/I
Endoscope
CF-Q260DL/I
Endoscope
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Chapter 1 Checking the Package Contents
Channel cleaning brush (BW-20T)
Water-resistant cap (MH-553)
Injection tube (MH-946)
Channel-opening cleaning
brush (MH-507)
AW channel cleaning
adapter (MH-948)
Suction valve
(MH-443) (2 pcs)
Air/water valve
(MH-438) (2 pcs)
Biopsy valve
(MB-358) (10 pcs)
Suction cleaning adapter
(MH-856)
Auxiliary water tube
(MAJ-855) (for GIF-H260Z only)
Operation manual
16
Channel plug (MH-944)
Chain for water-resistant cap (MAJ-1119)
Mouthpiece
(MB-142 for GIF-XQ260,
GIF-Q260, GIF-H260,
GIF-H260Z) (2 pcs)
Reprocessing manual
Mouthpiece
(MA-474, MB-142 for
GIF-N260, GIF-XP260)
(1 pc each)
Instructions (leaflet type,
for endoscopes with
flexibility adjustment only)
EVIS LUCERA GIF/CF/PCF TYPE 260 Series OPERATION MANUAL
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Chapter 1 Checking the Package Contents
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Chapter 2 Instrument Nomenclature and Specifications
Chapter 2 Instrument Nomenclature
and Specifications
2.1
Nomenclature
GIF-N260
Universal cord
1. Suction connector
5. Electrical connector
26. Chain connector
Air pipe
3. Air supply connector
Light guide
3. Water supply connector
Product name and serial number
Electrical contacts
4. Endoscope connector
18
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Chapter 2 Instrument Nomenclature and Specifications
9. Air/water valve (MH-438)
8. Suction valve (MH-443)
7. UP/DOWN angulation lock
Suction cylinder
6. UP/DOWN angulation control knob
Control
section
Air/water cylinder
Grip section
14. Color code
Biopsy valve (MB-358)
Boot
10. Instrument channel
Instrument channel port
11. Insertion tube limit mark
Working length
Distal end
13. Remote switches
12. Bending section
Top view
Insertion tube
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Chapter 2 Instrument Nomenclature and Specifications
GIF-XP260, GIF-XQ260, GIF-Q260, GIF-H260
1. Suction connector
5. Electrical connector
26. Chain connector (for GIF-XP260 only)
Air pipe
Universal cord
3. Air supply connector
3. Water supply connector
Light guide
Product name and serial number
Electrical contacts
4. Endoscope connector
1. Suction connector
5. Electrical connector
2. S-cord connector mount
(except GIF-XP260)
Air pipe
3. Air supply connector
3. Water supply connector
Light guide
Product name and serial number
Electrical contacts
4. Endoscope connector
20
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Chapter 2 Instrument Nomenclature and Specifications
9. Air/water valve (MH-438)
8. Suction valve (MH-443)
7. UP/DOWN angulation lock
Suction cylinder
6. UP/DOWN angulation control knob
16. RIGHT/LEFT angulation control knob
Control
section
15. RIGHT/LEFT angulation lock
Air/water cylinder
Grip section
14. Color code
Biopsy valve (MB-358)
Boot
10. Instrument channel
Instrument channel port
11. Insertion tube limit mark
Working length
Distal end
13. Remote switches
12. Bending section
Top view
Insertion tube
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Chapter 2 Instrument Nomenclature and Specifications
GIF-H260Z
Universal cord
19. Auxiliary water inlet
1. Suction connector
Auxiliary water inlet cap
(MAJ-215)
5. Electrical connector
Air pipe
2. S-cord connector mount
3. Air supply connector
3. Water supply connector
Light guide
Product name and serial number
Contact pins
4. Endoscope connector
22
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