TJF-160R EVIS DUODENOVIDEOSCOPE Operation Manual Feb 2007.pdf
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INSTRUCTIONS
EVIS EXERA DUODENOVIDEOSCOPE
OLYMPUS TJF TYPE 160R
Refer to the endoscope’s companion manual, the “OLYMPUS TJF TYPE 160R
ENDOSCOPE REPROCESSING MANUAL” 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 ...........................
2
Instruction manual.....................................................................................
3
User qualifications ....................................................................................
3
Instrument compatibility ...........................................................................
3
Reprocessing and storage ........................................................................
4
Spare equipment ......................................................................................
4
Repair and modification ...........................................................................
4
Signal words..............................................................................................
5
Warnings and cautions .............................................................................
5
Chapter 1
Checking the Package Contents............................
9
Chapter 2
Instrument Nomenclature and Specifications ......
12
2.1
Nomenclature..................................................................................
12
2.2
Endoscope functions.......................................................................
14
2.3
Specifications..................................................................................
16
Preparation and Inspection ....................................
20
3.1
Preparation of the equipment..........................................................
21
3.2
Preparation and inspection of the endoscope.................................
22
3.3
Preparation and inspection of accessories .....................................
26
3.4
Attaching accessories to the endoscope ........................................
30
3.5
Preparation, inspection and connection of ancillary equipment......
39
3.6
Inspection of the endoscopic system ..............................................
42
Operation .................................................................
46
4.1
Insertion ..........................................................................................
48
4.2
Using endo-therapy accessories.....................................................
53
4.3
Withdrawal of the endoscope..........................................................
58
4.4
Transportation of the endoscope ....................................................
59
Troubleshooting ......................................................
60
5.1
Troubleshooting guide ....................................................................
60
5.2
Returning the endoscope for repair ................................................
64
Chapter 3
Chapter 4
Chapter 5
EVIS EXERA TJF TYPE 160R OPERATION MANUAL
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Contents
ii
Appendix........................................................................................
65
System chart ............................................................................................
65
EMC information .......................................................................................
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EVIS EXERA TJF TYPE 160R 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
EVIS EXERA TJF TYPE 160R 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, video monitor, endo-therapy
accessories such as a biopsy forceps and other ancillary equipment for
endoscopy and endoscopic surgery within the duodenum.
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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EVIS EXERA TJF TYPE 160R 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 “OLYMPUS TJF TYPE 160R
ENDOSCOPE REPROCESSING MANUAL” which 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.
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 injury 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 TJF TYPE 160R OPERATION MANUAL
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Important Information — Please Read Before Use
Reprocessing and storage
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 “OLYMPUS TJF TYPE 160R
ENDOSCOPE REPROCESSING MANUAL”.
After using this instrument, reprocess and store it according to the instructions
given in the endoscope’s 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 user injury and/or
equipment damage can result.
Some problems that appear to be malfunctions may be correctable by referring
to Chapter 5, “Troubleshooting”. If the problem cannot be resolved using the
information in Chapter 5, contact Olympus.
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EVIS EXERA TJF TYPE 160R 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.
•
Never insert or withdraw the endoscope’s insertion tube while
the bending section is locked in position. Patient injury can
result.
•
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 perform angulation control, feed air, perform suction or
insert/withdraw the endoscope’s insertion tube without
viewing the endoscopic image. Patient injury can result.
EVIS EXERA TJF TYPE 160R OPERATION MANUAL
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Important Information — Please Read Before Use
6
•
Do not operate the bending section, feed air or perform
suction, insert or withdraw the endoscope’s insertion tube
while the image is frozen. Patient injury can result.
•
Never use the endoscope unless the distal cover is properly
attached to the distal end. If the distal cover is not attached
correctly, it may fall off the distal end during the examination.
Continuing the examination after the distal cover has fallen
off may cause patient injury by the exposed distal end of the
endoscope. It could also result in thermal injury when used in
combination with high-frequency endo-therapy accessories.
•
Do not touch the light guide of the endoscope connector
immediately after removing it from the light source because it
is extremely hot. Operator or patient injury can result.
•
Do not twist the insertion tube within a narrow tube. This
could cause the distal cover to come off.
•
Never insert/withdraw the insertion tube with excessive force
or while an optimum field of view cannot be obtained.
Otherwise, patient injury could result.
•
Do not pull the universal cord. 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 EVIS video system center OFF before connecting or
disconnecting the videoscope cable from the electrical
connector on the endoscope. Turn the it 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.
EVIS EXERA TJF TYPE 160R 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 or pulling them with excessive
force can break the switches.
•
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.
•
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 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.
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.
•
Using improperly or incompletely reprocessed or stored instruments
may cause patient cross-contamination and infection.
•
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.
EVIS EXERA TJF TYPE 160R OPERATION MANUAL
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Important Information — Please Read Before Use
•
Inserting and using endo-therapy accessories without a clear
endoscopic view may cause burns or perforation.
•
Patient injury may be caused by:
inserting or withdrawing the endoscope, feeding air or
applying suction without a clear endoscopic view
withdrawing the endoscope with the angulation controls
locked
forcefully pulling, twisting or rotating the angulated
bending section
8
EVIS EXERA TJF TYPE 160R 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 “OLYMPUS TJF TYPE 160R
ENDOSCOPE REPROCESSING MANUAL”.
EVIS EXERA TJF TYPE 160R OPERATION MANUAL
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Chapter 1 Checking the Package Contents
Endoscope
Mouthpiece
(MB-142, 2 pcs)
Channel plug (MH-944)
Biopsy valve
(MB-358, 10 pcs)
Injection tube (MH-946)
Channel cleaning brush
(BW-20T)
Distal cover
(MAJ-311, 2 pcs)
Suction valve
(MH-443, 2 pcs)
Air/water valve
(MH-438, 2 pcs)
Water-resistant cap
(MH-553)
Channel-opening
cleaning brush (MH-507)
Washing tube (MH-974)
Suction cleaning adapter
(MH-856)
AW channel cleaning adapter
(MH-948)
Operation manual
10
Reprocessing manual
Instruction manual
(Distal cover)
EVIS EXERA TJF TYPE 160R OPERATION MANUAL
Instructions (Caution
for attaching the
distal cover)
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Chapter 1 Checking the Package Contents
EVIS EXERA TJF TYPE 160R OPERATION MANUAL
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Chapter 2 Instrument Nomenclature and Specifications
Chapter 2 Instrument Nomenclature
and Specifications
2.1
Nomenclature
The endoscope’s main body is illustrated with its valves and distal cover
detached.
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
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Chapter 2 Instrument Nomenclature and Specifications
8. Suction valve (MH-443)
9. Air/water valve (MH-438)
7. UP/DOWN angulation lock
12. Remote switches
6. UP/DOWN angulation control knob
18. Elevator control lever
17. RIGHT/LEFT
angulation
control knob
Control
section
Suction cylinder
16. RIGHT/LEFT
angulation lock
Air/water cylinder
Grip section
15. Color code
14. Elevator channel plug
Biopsy valve (MB-358)
10. Instrument channel port
Boot
Working length
Distal cover
(MAJ-311)
Insertion tube
13. Insertion tube
limit mark
12. Remote switches
Distal end
11. Bending section
Top view
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Chapter 2 Instrument Nomenclature and Specifications
2.2
Endoscope functions
1. Suction connector
The suction connector connects the endoscope to the suction tube of the
suction pump.
2. S-cord connector mount
The 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.
3. 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.
4. 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.
5. Electrical connector
The electrical connector connects the endoscope to the EVIS video system
center via the videoscope cable. This endoscope contains a memory chip
that stores information about the endoscope and communicates this
information to the CV-160. For more details, refer to the instruction manual
of the CV-160.
6. UP/DOWN angulation control knob
When turned in the “ U” direction, the bending section moves UP; when
turned in the “D ” direction, the bending section moves DOWN.
7. UP/DOWN angulation lock
Pushing the lever in the “F ” direction frees angulation. Pushing the lever
in the opposite direction locks the bending section at any desired position.
8. Suction valve
The suction valve is depressed to activate suction. The valve is also used to
remove any remaining fluid or debris adhering to the objective lens.
9. Air/water valve
The hole in the air/water 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 remaining fluid or debris adhering to the objective lens.
10. Instrument channel port
The instrument channel port functions as:
channel for the insertion of endo-therapy accessories
suction channel
fluid feed channel (from a syringe via the biopsy valve)
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Chapter 2 Instrument Nomenclature and Specifications
11. Bending section
The bending section moves the distal end of the endoscope when the
UP/DOWN and RIGHT/LEFT angulation control knobs are operated.
12. Remote switches 1 to 4
The functions of the remote switches 1 to 4 can be selected on the EVIS
video system center. When selecting the functions, refer to the instruction
manual for the EVIS video system center.
13. Insertion tube limit mark
The insertion tube limit mark shows the maximum point to which the
endoscope may be inserted into the patient’s body.
14. Elevator channel plug
The elevator channel plug is used for connection of the washing tube to
clean and disinfect the elevator channel.
15. Color code
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.
Orange : TJF-160R
16. 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.
17. RIGHT/LEFT angulation control knob
When turned in the “R ” direction, the bending section moves RIGHT;
when turned in the “ L” direction, the bending section moves LEFT.
18. Elevator control lever
When this lever is moved in the “ U” direction, the forceps elevator is
raised. When turned in the opposite direction, the forceps elevator is
lowered.
EVIS EXERA TJF TYPE 160R 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)
Standard storage
Ambient temperature
environment (e.g.
Relative humidity
within the hospital)
Atmospheric pressure
5 – 40C (41 – 104F)
10 – 95%
700 – 1060 hPa
(0.7 – 1.1 kgf/cm2)
(10.2 – 15.4 psia)
Transportation
Ambient temperature
environment
Relative humidity
(conditions during
Atmospheric pressure
transportation and
short-term storage)
–47 to 70C (–52.6 to 158F)
10 – 95%
700 – 1060 hPa
(0.7 – 1.1 kgf/cm2)
(10.2 – 15.4 psia)
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Chapter 2 Instrument Nomenclature and Specifications
Specifications
Endoscope functions
Model
Optical system
TJF-160R
Field of view
100
Direction of view
Insertion tube
Backward
Sideviewing 5
Depth of field
5 – 60 mm
Distal end outer diameter
ø 13.5 mm
Distal end enlarged
1. Air/water nozzle
2. Objective lens
3. Light guide lens
4. Forceps elevator
5. Instrument channel outlet
3.
4.
2.
5.
1.
Insertion tube outer
diameter
Instrument channel
ø 11.3 mm
Working length
1240 mm
Channel inner diameter
ø 4.2 mm
Minimum visible distance
10 mm
Direction from which
endo-therapy accessories
enter and exit the
endoscopic image
Air flow rate
25 cm3/s
Note: Standard when CLV-160
(high air pressure) is used.
Bending section
Angulation range
Total length
EVIS EXERA TJF TYPE 160R OPERATION MANUAL
UP 120
DOWN 90
RIGHT 110
LEFT 90
1550 mm
17
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Chapter 2 Instrument Nomenclature and Specifications
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
18
2012345
The year of manufacture is given in the
second digit of the serial number.
TYPE BF applied part
EVIS EXERA TJF TYPE 160R OPERATION MANUAL
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Chapter 2 Instrument Nomenclature and Specifications
EVIS EXERA TJF TYPE 160R OPERATION MANUAL
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Chapter 3 Preparation and Inspection
Chapter 3 Preparation and Inspection
20
•
Before each case, prepare and inspect this instrument as
instructed below. Inspect other equipment used with this
instrument as instructed in their respective instruction
manuals. Should the slightest irregularity be suspected, do
not use this instrument and see Chapter 5,
“Troubleshooting”. If the irregularity is still suspected after
consulting Chapter 5, contact Olympus. Damage or
irregularity may compromise patient or user safety and may
result in more severe equipment damage.
•
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 “OLYMPUS TJF TYPE
160R ENDOSCOPE REPROCESSING MANUAL”.
EVIS EXERA TJF TYPE 160R OPERATION MANUAL
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Chapter 3 Preparation and Inspection
3.1
Preparation of the equipment
Prepare the equipment shown in Figure 3.1 (for compatibility, see “System chart”
in the Appendix) and personal protective equipment, such as eye wear, face
mask, moisture-resistant clothing and chemical-resistant gloves, before each
use. Refer to the respective instruction manuals for each piece of equipment.
Video monitor
Video system center
Light source
Endo-therapy accessories
Suction pump
Water container
Biopsy valve
Mouthpiece
Distal cover
Endoscope
• Paper towels
• Trays
• Lint-free cloths
• Personal protective equipment
Figure 3.1
EVIS EXERA TJF TYPE 160R OPERATION MANUAL
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Chapter 3 Preparation and Inspection
3.2
Preparation and inspection of the endoscope
Clean and disinfect or sterilize the endoscope as described in its companion
reprocessing manual.
Inspection of the endoscope
1.
Inspect the control section and the endoscope connector for excessive
scratching, deformation, loose parts or other irregularities.
2.
Inspect the boot and the insertion tube near the boot for bends, twists or
other irregularities.
3.
Inspect the external surface of the entire insertion tube including the
bending section and the distal end for dents, bulges, swelling, scratching,
holes, sagging, transformation, bends, adhesion of foreign bodies, dropout
of parts, any protruding objects or other irregularities.
4.
Holding the insertion tube gently with one hand, carefully run your fingertips
over the entire length of the insertion tube in both directions (see Figure
3.2). Confirm that no objects or metallic wire protrude from the insertion
tube. Also confirm that the insertion tube is not abnormally rigid.
Figure 3.2
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EVIS EXERA TJF TYPE 160R OPERATION MANUAL