GIF TYPE xx160 series EVIS EXERA GASTROINTESTINAL VIDEOSCOPE Operation Manual Feb 2007.pdf
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INSTRUCTIONS
EVIS EXERA GASTROINTESTINAL VIDEOSCOPE
OLYMPUS GIF TYPE XP160
OLYMPUS GIF TYPE 160
OLYMPUS GIF TYPE Q160
OLYMPUS GIF TYPE 1TQ160
OLYMPUS GIF TYPE XTQ160
EVIS EXERA COLONOVIDEOSCOPE
OLYMPUS CF TYPE Q160L/I
OLYMPUS CF TYPE Q160AL/I
OLYMPUS PCF TYPE 160AL/I
EVIS EXERA SIGMOIDOVIDEOSCOPE
OLYMPUS CF TYPE Q160S
Refer to the endoscope’s companion manual, the “REPROCESSING MANUAL” whose
cover lists the model of your endoscope, for reprocessing information.
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....................
2
Intended use ............................................................................................
2
Applicability of endoscopy and endoscopic treatment .............................
2
Instruction manual ....................................................................................
3
User qualifications ....................................................................................
3
Instrument compatibility ...........................................................................
3
Reprocessing before the first use/reprocessing and storage after use.....
4
Spare equipment ......................................................................................
4
Repair and modification ...........................................................................
4
Signal words .............................................................................................
4
Warnings and cautions .............................................................................
5
Examples of inappropriate handling .........................................................
7
Chapter 1
Checking the Package Contents............................
9
Chapter 2
Instrument Nomenclature and Specifications ......
12
2.1
Nomenclature..................................................................................
12
2.2
Endoscope functions.......................................................................
22
2.3
Specifications..................................................................................
24
Preparation and Inspection ....................................
32
3.1
Preparation of the equipment..........................................................
33
3.2
Inspection of the endoscope ...........................................................
34
3.3
Preparation and inspection of accessories .....................................
39
3.4
Attaching accessories to the endoscope ........................................
43
3.5
Inspection and connection of ancillary equipment ..........................
45
3.6
Inspection of the endoscopic system ..............................................
48
Operation .................................................................
53
4.1
Insertion ..........................................................................................
56
4.2
Using endo-therapy accessories.....................................................
62
4.3
Withdrawal of the endoscope..........................................................
67
4.4
Transportation of the endoscope ....................................................
68
Chapter 3
Chapter 4
EVIS EXERA GIF/CF/PCF TYPE 160 Series OPERATION MANUAL
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Contents
Chapter 5
ii
Troubleshooting ......................................................
70
5.1
Troubleshooting guide ....................................................................
70
5.2
Withdrawal of the endoscope with an abnormality..........................
74
5.3
Returning the endoscope for repair.................................................
76
Appendix........................................................................................
77
System chart ............................................................................................
77
EMC information........................................................................................
92
EVIS EXERA GIF/CF/PCF TYPE 160 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.
Caution
Endoscope
TYPE BF applied part
Manufacturer
Authorized representative in the European Community
Lot number
Serial number
For US Customers only
For a Symbols Glossary, visit us:
http://www.olympus-global.com/en/common/pdf/symbolsglossary.pdf
EVIS EXERA GIF/CF/PCF TYPE 160 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, documentation equipment, video monitor,
endo-therapy accessories (such as a biopsy forceps) and other ancillary
equipment.
Use the GIF-XP160, GIF-160, GIF-Q160, GIF-1TQ160, GIF-XTQ160 for
endoscopy and endoscopic surgery within the upper digestive tract (including
the esophagus, stomach and duodenum).
Use the CF-Q160L/I, CF-Q160AL/I, PCF-160AL/I for endoscopy and endoscopic
surgery within the lower digestive tract (including the anus, rectum, sigmoid
colon, colon and ileocecal valve).
Use the CF-Q160S for endoscopy and endoscopic surgery within the lower
digestive tract (including the anus, rectum and sigmoid colon).
Do not use these instruments for any purpose other than their intended uses.
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.
2
EVIS EXERA GIF/CF/PCF TYPE 160 Series 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 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.
User qualifications
The operator of this instrument must be a physician or medical personnel under
the supervision of a physician and must have received sufficient training in
clinical endoscopic technique. This manual, therefore, does not explain or
discuss clinical endoscopic procedures. For details on the clinical endoscopic
procedures, the physician and operator are requested to form judgments from
their viewpoints as specialists.
Instrument compatibility
Refer to the “System chart” in the Appendix to confirm that this instrument is
compatible with the ancillary equipment being used. Using incompatible
equipment can result in patient or operator injury and/or equipment damage.
This instrument complies with EMC standard for medical electrical equipment;
edition 2 (IEC 60601-1-2: 2001). 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.
EVIS EXERA GIF/CF/PCF TYPE 160 Series OPERATION MANUAL
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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.
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. This instrument is to be repaired by Olympus
technicians only.
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.
4
EVIS EXERA GIF/CF/PCF TYPE 160 Series OPERATION MANUAL
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Important Information — Please Read Before Use
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. Using improperly or incompletely
reprocessed or stored instruments may cause patient
cross-contamination and/or infection.
•
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.
•
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
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.
•
Never perform flexibility adjustment, operate the bending
section, feed air or perform suction, insert or withdraw the
endoscope’s insertion tube without viewing the endoscopic
image. Never use endo-therapy accessories without viewing
the endoscopic image. Patient injury can result.
EVIS EXERA GIF/CF/PCF TYPE 160 Series OPERATION MANUAL
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Important Information — Please Read Before Use
6
•
Never perform flexibility adjustment, operate the bending
section, feed air or perform suction, insert or withdraw the
endoscope’s insertion tube while the image is frozen. Never
use endo-therapy accessories while the image is frozen.
Patient injury can result.
•
Regardless of the flexibility of the endoscope’s insertion tube,
never insert or withdraw it with excessive force. Otherwise,
patient injury could 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 into 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.
•
Turn the video system center OFF before connecting or
disconnecting the videoscope cable from the electrical
connector on the endoscope. Turn the switch ON or OFF
only when the videoscope cable is connected to both the
video system center and 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.
EVIS EXERA GIF/CF/PCF TYPE 160 Series OPERATION MANUAL
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Important Information — Please Read Before Use
•
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 flexibility is at the stiffest position.
Otherwise, the insertion tube may be damaged.
•
The endoscope contains a memory chip that stores
information about the endoscope and communicates this
information to the CV-160. Although the memory chip is
durable, damage will prevent data from being backed up on
it. When data are lost or damaged, contact Olympus.
•
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.
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 and/or perforation.
•
Applying prolonged suction with the distal end in contact with the
mucosal surface may cause bleeding or suction lesions.
•
Retroflexing the endoscope within the esophagus or duodenal bulb may
cause mucosal trauma or impaction of the endoscope (for GIF models
only).
EVIS EXERA GIF/CF/PCF TYPE 160 Series OPERATION MANUAL
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Important Information — Please Read Before Use
8
•
Inserting, withdrawing and using endo-therapy accessories without a
clear endoscopic image may cause burns 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.
EVIS EXERA GIF/CF/PCF TYPE 160 Series 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 given in the endoscope’s companion manual, the
“REPROCESSING MANUAL” whose cover lists the model of your endoscope.
Endoscope
Channel cleaning brush
(BW-20T)
Channel cleaning brush
(BW-17K for GIF-XTQ160 only)
Injection tube (MH-946)
EVIS EXERA GIF/CF/PCF TYPE 160 Series OPERATION MANUAL
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Chapter 1 Checking the Package Contents
Channel-opening cleaning
brush (MH-507)
Mouthpiece
(MA-474, MB-142 for
GIF-XP160, 1 pc. each)
Suction valve
(MH-443, 2 pcs.)
Suction cleaning adapter
(MH-856)
Forceps Suction Plug (T-Plug)
(MH-405 for GIF-XTQ160 only)
Instruction Manual
(Forceps Suction Plug,
for GIF-XTQ160 only)
10
AW channel cleaning
adapter (MH-948)
Mouthpiece (MB-142 for GIF-160,
GIF-Q160, GIF-1TQ160,
GIF-XTQ160, 2 pcs.)
Water-resistant cap
(MH-553)
Biopsy valve
(MB-358, 10 pcs.)
Air/water valve
(MH-438, 2 pcs.)
Channel plug (MH-944)
Auxiliary water tube
(MAJ-855 for endoscopes with
auxiliary water feeding only)
Operation manual
Instructions (Leaflet type, for
CF-Q160AL/I, PCF-160AL/I only)
Reprocessing manual
Instructions
(Leaflet type, for
GIF-XTQ160 only)
EVIS EXERA GIF/CF/PCF TYPE 160 Series OPERATION MANUAL
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Chapter 1 Checking the Package Contents
EVIS EXERA GIF/CF/PCF TYPE 160 Series OPERATION MANUAL
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Chapter 2 Instrument Nomenclature and Specifications
Chapter 2 Instrument Nomenclature
and Specifications
2.1
Nomenclature
GIF-XP160, GIF-160, GIF-Q160
Universal cord
1. Suction connector
5. Electrical connector
2. S-cord connector mount
Air pipe
3. Air supply connector
3. Water supply connector
Light guide
Product name and serial number
Electrical contacts
4. Endoscope connector
12
EVIS EXERA GIF/CF/PCF TYPE 160 Series OPERATION MANUAL
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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
6. UP/DOWN angulation control knob
16. RIGHT/LEFT angulation
control knob
Control
section
15. RIGHT/LEFT angulation lock
Grip section
Suction cylinder
Air/water cylinder
14. Color code
Boot
Biopsy valve (MB-358)
10. Instrument channel port
11. Insertion tube limit mark
Working length
Distal end
13. Remote switches
Top view
12. Bending section
Insertion tube
EVIS EXERA GIF/CF/PCF TYPE 160 Series OPERATION MANUAL
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Chapter 2 Instrument Nomenclature and Specifications
GIF-1TQ160, CF-Q160L/I, CF-Q160S
Universal cord
17. Auxiliary water inlet
1. Suction connector
5. Electrical connector
Auxiliary water inlet cap
(MAJ-215)
Air pipe
2. S-cord connector mount
3. Air supply connector
3. Water supply connector
Light guide
Product name and serial number
Electrical contacts
4. Endoscope connector
14
EVIS EXERA GIF/CF/PCF TYPE 160 Series OPERATION MANUAL
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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
6. UP/DOWN angulation control knob
16. RIGHT/LEFT angulation
control knob
15. RIGHT/LEFT angulation lock
Grip section
Control
section
Suction cylinder
Air/water cylinder
14. Color code
Boot
Biopsy valve (MB-358)
10. Instrument channel port
11. Insertion tube limit mark
Working length
Distal end
13. Remote switches
Top view
12. Bending section
Insertion tube
EVIS EXERA GIF/CF/PCF TYPE 160 Series OPERATION MANUAL
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Chapter 2 Instrument Nomenclature and Specifications
GIF-XTQ160
Universal cord
17. Auxiliary water inlet
1. Suction connector
5. Electrical connector
Auxiliary water inlet cap
(MAJ-215)
Air pipe
2. S-cord connector mount
3. Air supply connector
3. Water supply connector
Light guide
Product name and serial number
Electrical contacts
4. Endoscope connector
16
EVIS EXERA GIF/CF/PCF TYPE 160 Series OPERATION MANUAL
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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
6. UP/DOWN angulation control knob
16. RIGHT/LEFT angulation
control knob
Suction cylinder
15. RIGHT/LEFT angulation lock
Control
section
Air/water cylinder
Grip section
Biopsy valve
(MB-358)
14. Color code
Boot
Forceps Suction Plug
(T-Plug) (MH-405)
10. Instrument channel port
11. Insertion tube limit mark
Working length
Distal end
13. Remote switches
Top view
12. Bending section
Insertion tube
EVIS EXERA GIF/CF/PCF TYPE 160 Series OPERATION MANUAL
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Chapter 2 Instrument Nomenclature and Specifications
CF-Q160AL/I
Universal cord
17. Auxiliary water inlet
1. Suction connector
5. Electrical connector
Auxiliary water inlet cap
(MAJ-215)
Air pipe
2. S-cord connector mount
3. Air supply connector
3. Water supply connector
Light guide
Product name and serial number
Electrical contacts
4. Endoscope connector
18
EVIS EXERA GIF/CF/PCF TYPE 160 Series OPERATION MANUAL
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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
6. UP/DOWN angulation control knob
16. RIGHT/LEFT
angulation control
knob
15. RIGHT/LEFT angulation lock
Control
section
Suction cylinder
Air/water cylinder
Grip section
14. Color code
Mark
18. Flexibility adjustment ring
Biopsy valve (MB-358)
Mark
10. Instrument channel port
Boot
11. Insertion tube limit mark
Working length
Insertion tube
Distal end
13. Remote switches
Top view
12. Bending section
EVIS EXERA GIF/CF/PCF TYPE 160 Series OPERATION MANUAL
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Chapter 2 Instrument Nomenclature and Specifications
PCF-160AL/I
Universal cord
1. Suction connector
5. Electrical connector
2. S-cord connector mount
Air pipe
3. Air supply connector
3. Water supply connector
Light guide
Product name and serial number
Electrical contacts
4. Endoscope connector
20
EVIS EXERA GIF/CF/PCF TYPE 160 Series OPERATION MANUAL
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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
6. UP/DOWN angulation control knob
16. RIGHT/LEFT
angulation control
knob
15. RIGHT/LEFT angulation lock
Control
section
Suction cylinder
Air/water cylinder
Grip section
14. Color code
Mark
18. Flexibility adjustment ring
Biopsy valve (MB-358)
Mark
10. Instrument channel port
Boot
11. Insertion tube limit mark
Working length
Insertion tube
Distal end
13. Remote switches
Top view
12. Bending section
EVIS EXERA GIF/CF/PCF TYPE 160 Series OPERATION MANUAL
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Chapter 2 Instrument Nomenclature and Specifications
2.2
Endoscope functions
1. Suction connector
This connector connects the endoscope to the suction tube of the suction
pump.
2. S-cord connector mount
This 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.
3. Water supply connector and air supply connector
These connectors connect the endoscope to the water container via the
water container tube, to supply water to the distal end of the endoscope.
4. Endoscope connector
This connector connects the endoscope to the output socket of the light
source and transmits light from the light source to the endoscope.
5. Electrical connector
This connector connects the endoscope to the video system center via the
videoscope cable. The endoscope contains a memory chip that stores
information about the endoscope and communicates this information to the
video system center CV-160. For more details, refer to the instruction
manual of the CV-160.
6. 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.
7. 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.
8. Suction valve (MH-443)
This valve is depressed to activate suction. The valve is used to remove any
fluid, debris, flatus or air from the patient.
9. 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 to remove any
fluid or debris adhering to the objective lens.
22
EVIS EXERA GIF/CF/PCF TYPE 160 Series OPERATION MANUAL