JF-TE3 DUODENOFIBERSCOPE Operation Manual March 2007.pdf
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INSTRUCTIONS
GASTROINTESTINAL FIBERSCOPE
OLYMPUS GIF TYPE XPE3
OLYMPUS GIF TYPE E3
COLONOFIBERSCOPE
OLYMPUS CF TYPE E3L/I
OLYMPUS PCF TYPE E3L/I
DUODENOFIBERSCOPE
OLYMPUS JF TYPE TE3
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
GIF/CF/PCF/JF TYPE E3 Series OPERATION MANUAL
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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 ....................................................................................
3
Instrument compatibility ............................................................................
4
Reprocessing before the first use/reprocessing and storage after use ....
4
Spare equipment ......................................................................................
4
Maintenance management........................................................................
5
Prohibition of improper repair and modification ........................................
5
Signal words .............................................................................................
5
Warnings and cautions..............................................................................
6
Examples of inappropriate handling ..........................................................
9
Chapter 1
Checking the Package Contents ............................
10
Chapter 2
Instrument Nomenclature and Specifications ......
12
2.1
Nomenclature..................................................................................
12
2.2
Endoscope functions.......................................................................
16
2.3
Specifications ..................................................................................
18
Preparation and Inspection ....................................
23
3.1
Preparation of the equipment..........................................................
23
3.2
Inspection of the endoscope ...........................................................
24
3.3
Preparation and inspection of accessories .....................................
29
3.4
Attaching accessories to the endoscope.........................................
34
3.5
Inspection and connection of ancillary equipment ..........................
43
3.6
Inspection of the endoscopic system .............................................
45
Operation..................................................................
49
4.1
Insertion ..........................................................................................
51
4.2
Using EndoTherapy accessories ....................................................
57
4.3
Withdrawal of the endoscope..........................................................
64
4.4
Transportation of the endoscope ....................................................
65
Troubleshooting ......................................................
66
5.1
Troubleshooting guide ....................................................................
66
5.2
Withdrawal of the endoscope with an abnormality..........................
70
5.3
Returning the endoscope for repair.................................................
71
Chapter 3
Chapter 4
Chapter 5
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GIF/CF/PCF/JF TYPE E3 Series OPERATION MANUAL
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Contents
Appendix .......................................................................................
73
System chart ............................................................................................
73
EMC information .......................................................................................
94
GIF/CF/PCF/JF TYPE E3 Series OPERATION MANUAL
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Contents
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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
Type BF applied part
Endoscope
Manufacturer
Authorized representative in the European Community
Lot number
Serial number
GIF/CF/PCF/JF TYPE E3 Series 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 light source,
photographic equipment, EndoTherapy accessories such as biopsy forceps and
other ancillary equipment.
Use the GASTROINTESTINAL FIBERSCOPE GIF-XPE3, GIF-E3 for endoscopy
and endoscopic surgery within the upper digestive tract (including the
esophagus, stomach and duodenum).
Use the COLONOFIBERSCOPE CF-E3L/I, PCF-E3L/I for endoscopy and
endoscopic surgery within the lower digestive tract (including the anus, rectum,
sigmoid colon, colon and ileocecal valve).
Use the DUODENOFIBERSCOPE JF-TE3 for endoscopy and endoscopic
surgery within the duodenum.
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 risks (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 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” 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
If there is an official standard on user qualifications to perform endoscopy and
endoscopic treatment that is defined by the medical administration or other
official institutions, such as academic societies on endoscopy, follow that
standard. If there is no official qualification standard, the operator of this
instrument must be a physician approved by the medical safety manager of the
hospital or person in charge of the department (department of internal medicine,
etc.).
GIF/CF/PCF/JF TYPE E3 Series OPERATION MANUAL
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Important Information — Please Read Before Use
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.
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.
4
GIF/CF/PCF/JF TYPE E3 Series OPERATION MANUAL
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Important Information — Please Read Before Use
Maintenance management
The probability of failure of the endoscope and ancillary equipment increases as
the number of procedures performed and/or the total number of operating hours
increases. 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 irregularity
should not be used, but should be inspected by following Section 5.1,
“Troubleshooting guide” on page 66. If the irregularity is still observed 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 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.
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Important Information — Please Read Before Use
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 light guide 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 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 operate the bending section, feed air or perform
suction, insert or withdraw the endoscope’s insertion tube,
use EndoTherapy accessories without viewing the
endoscopic image. Patient injury, bleeding, and/or perforation
can result.
GIF/CF/PCF/JF TYPE E3 Series OPERATION MANUAL
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Important Information — Please Read Before Use
•
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 uncovered distal end of
the endoscope. It could also result in thermal injury when
used in combination with high-frequency EndoTherapy
accessories (for JF-TE3 only).
•
Never insert or withdraw the insertion tube abruptly or
suddenly with excessive force. Patient injury, bleeding and/or
perforation can 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.
•
Do not touch the light guide of the light guide connector
section immediately after removing it from the light source
because it is extremely hot. Operator or patient burns can
result.
•
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 becoming 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 pull the universal cord during an examination. The
endoscope light guide 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 of than 12 cm. Equipment damage can
result.
•
Do not attempt to bend the endoscope’s insertion tube with
excessive force. Otherwise, the insertion tube may be
damaged.
•
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 hand.
Equipment damage may result.
GIF/CF/PCF/JF TYPE E3 Series OPERATION MANUAL
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Important Information — Please Read Before Use
8
•
Do not squeeze the bending section forcefully. The covering
of the bending section may stretch or break and cause water
leaks.
•
Do not hit or bend the electrical contacts on the endoscope
light guide connector. The connection to the light source may
be impaired and faulty contact can result.
•
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.
GIF/CF/PCF/JF TYPE E3 Series OPERATION MANUAL
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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 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 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.
GIF/CF/PCF/JF TYPE E3 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 described in the endoscope’s companion manual, the
“REPROCESSING MANUAL” whose cover lists the model of your endoscope.
10
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Chapter 1 Checking the Package Contents
Endoscope
Biopsy valve (MB-358, 10 pcs)
Mouthpiece (MA-474, MB-142,
for GIF-XPE3, 1 pc each)
Mouthpiece (MB-142,
for GIF-E3, JF-TE3, 2 pcs)
Elevator-wire-channel cleaning
tube (MB-109, for JF-TE3 only)
All-channel irrigator with
30 cm3 (30 ml) syringe (CW-3)
Channel-opening cleaning
brush (MH-507)
Operation manual
Channel cleaning brush
(BW-20T)
ETO cap (MB-156)
Reprocessing manual
Distal cover
(MAJ-411,
for JF-TE3 only)
GIF/CF/PCF/JF TYPE E3 Series OPERATION MANUAL
Channel cleaning adapter
(MB-19)
AW channel cleaning
adapter (MB-107)
Lubricant (silicone oil)
(MB-146)
11
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Chapter 2 Instrument Nomenclature and Specifications
Chapter 2 Instrument Nomenclature
and Specifications
2.1
Nomenclature
GIF-XPE3, GIF-E3, CF-E3L, CF-E3I, PCF-E3L, PCF-E3I
1. Light guide connector
Universal cord
2. S-cord connector mount
Air pipe
3. Suction connector
Light guide
4. Venting connector
Serial number
5. Water container connector
Electrical contacts
12
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Chapter 2 Instrument Nomenclature and Specifications
9. Eyepiece section
10. Suction valve (MB-197)
11. Air/water valve (MB-196)
8. UP/DOWN angulation lock
7. Diopter adjustment ring
6. UP/DOWN angulation control knob
Control
section
Suction cylinder
16. RIGHT/LEFT angulation
control knob
Air/water cylinder
15. RIGHT/LEFT angulation lock
Grip section
Biopsy valve (MB-358)
12. Instrument channel
14. Color code
Instrument channel port
Boot
Working length
Eyepiece contact
Top view
Distal end
Insertion tube
13. Bending section
GIF/CF/PCF/JF TYPE E3 Series OPERATION MANUAL
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Chapter 2 Instrument Nomenclature and Specifications
JF-TE3
Universal cord
1. Light guide connector
2. S-cord connector mount
Air pipe
Light guide
3. Suction connector
4. Venting connector
Serial number
5. Water container connector
Electrical contacts
14
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Chapter 2 Instrument Nomenclature and Specifications
9. Eyepiece section
19. Elevator channel plug
8. UP/DOWN angulation lock
10. Suction valve (MB-197)
11. Air/water valve (MB-196)
7. Diopter adjustment ring
17. Elevator control lever
6. UP/DOWN angulation
control knob
Control
section
16. RIGHT/LEFT
angulation control
knob
Suction cylinder
Air/water cylinder
15. RIGHT/LEFT
angulation lock
Grip section
Biopsy valve (MB-358)
14. Color code
12. Instrument channel
Instrument channel port
Boot
18. Forceps
elevator
Working length
Distal cover
(MAJ-411)
Eyepiece contact
Distal end
Top view
Insertion tube
GIF/CF/PCF/JF TYPE E3 Series OPERATION MANUAL
13. Bending section
15
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Chapter 2 Instrument Nomenclature and Specifications
2.2
Endoscope functions
1. Light guide connector
Connects the endoscope to the output socket of the light source and
transmits light from the light source to the endoscope.
2. 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. For instructions on how to connect the S-cord, refer to
the instruction manual for the electrosurgical unit.
3. Suction connector
Connects the endoscope to the suction tube of the suction pump.
4. Venting connector
Install the ETO cap before performing Ethylene oxide gas sterilization.
5. Water container connector
Connects the endoscope to the water container via the water container tube,
in order to supply water to the distal end of the endoscope.
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. Diopter adjustment ring
This ring adjusts the operator’s focus. This does not affect focussing for
photography.
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. Eyepiece section
There is a permanent marker in the field of view indicating which direction
corresponds to the bending section moving UP. As the endoscope is turned
in different directions, this marker is important for maintaining the safety of
the procedure.
10. Suction valve (MB-197)
This valve is depressed to activate suction. The valve is used to remove any
fluid, debris, flatus, or air.
16
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Chapter 2 Instrument Nomenclature and Specifications
11. Air/water valve (MB-196)
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 for feed air to removing
any fluid or debris that is adhering to the objective lens.
12. Instrument channel
The instrument channel functions as the following:
− channel for the insertion of EndoTherapy accessories
− suction channel
− fluid feed channel (from a syringe via the biopsy valve)
13. Bending section
This section moves the distal end of the endoscope when the UP/DOWN
and RIGHT/LEFT angulation control knobs are operated.
14. Color code
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 of the accessories.
• Blue
• Yellow
GIF-XPE3
GIF-E3, CF-E3L/I, PCF-E3L/I, JF-TE3
15. 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.
16. RIGHT/LEFT angulation control knob
When this knob turned in the “R ” direction, the bending section moves
RIGHT. When the knob is turned in the “ L” direction, the bending section
moves LEFT.
17. Elevator control lever
When this lever is moved in the direction of the grip section, the forceps
elevator is raised. When the lever is moved in the direction of the eyepiece
section, the forceps elevator is lowered.
18. Forceps elevator
The elevator moves EndoTherapy accessories when the elevator control
lever is operated.
19. Elevator channel plug
This plug is used for connection of the elevator-wire-channel cleaning tube
to clean and disinfect the elevator channel.
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Chapter 2 Instrument Nomenclature and Specifications
2.3
Specifications
Environment
Operating
environment
Ambient
temperature
10 – 40°C (50 – 104°F)
Relative humidity
30 – 85%
Atmospheric
pressure
700 – 1060 hPa
Standard storage
Ambient temperature
environment (e.g.
Relative humidity
within the hospital)
Atmospheric pressure
(0.7 – 1.1 kgf/cm2)
(10.2 – 15.4 psia)
5 – 40°C (41 – 104°F)
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)
18
–47 to 70°C (–52.6 to 158°F)
10 – 95%
700 – 1060 hPa
(0.7 – 1.1 kgf/cm2)
(10.2 – 15.4 psia)
GIF/CF/PCF/JF TYPE E3 Series OPERATION MANUAL
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Chapter 2 Instrument Nomenclature and Specifications
Specifications
Endoscope functions
Model
GIF-XPE3
GIF-E3
100°
120°
Optical system Field of view
Direction of view
Forward viewing
Depth of field
Insertion tube
3 – 100 mm
Distal end outer
diameter
Distal end
enlarged
ø 7.9 mm
1. Air/water nozzle
1. Air/water nozzle
2. Light guide lens
2. Light guide lens
3. Objective lens
3. Objective lens
4. Instrument channel
4. Instrument channel
1.
UP
RIGHT
DOWN
Channel inner
diameter
Minimum visible
distance
3.
1.
UP
LEFT
RIGHT
2.
4.
DOWN
ø 7.9 mm
Working length
Instrument
channel
2.
LEFT
3.
Insertion tube
outer diameter
ø 9.8 mm
4.
ø 9.8 mm
1025 mm
ø 2 mm
ø 2.8 mm
3 mm from the distal
end
2 mm from the distal
end
Direction from
which
EndoTherapy
accessories enter
and exit the
endoscopic
image
Air flow rate
25 cm3/s
Note: Standard when CLV-U40 (high air
pressure) is used
Bending
section
Angulation range
Total length
GIF/CF/PCF/JF TYPE E3 Series OPERATION MANUAL
UP 210°,
DOWN 90°,
RIGHT 100°,
LEFT 100°
1345 mm
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Chapter 2 Instrument Nomenclature and Specifications
Model
Optical
system
Field of view
CF-E3L
CF-E3I
PCF-E3L
PCF-E3I
140°
120°
Direction of view
Forward viewing
Depth of field
Insertion tube
5 – 100 mm
Distal end outer
diameter
Distal end
enlarged
ø 13.8 mm
ø 12 mm
1. Air/water nozzle
1. Air/water nozzle
2. Light guide lens
2. Light guide lens
3. Objective lens
3. Objective lens
4. Instrument channel
4. Instrument channel
UP
2.
RIGHT
3.
3.
LEFT
1.
UP
RIGHT
LEFT
1.
4.
Insertion tube
outer diameter
Working length
Instrument
channel
Channel inner
diameter
Minimum visible
distance
4.
DOWN
ø 12.9 mm
DOWN
ø 11.8 mm
L: 1680 mm
I: 1330 mm
ø 3.2 mm
2 mm from the distal
end
3 mm from the distal
end
Direction from
which
EndoTherapy
accessories enter
and exit the
endoscopic
image
Air flow rate
30 cm3/s
Note: Standard when CLV-U40 (high air
pressure) is used.
Bending
section
Total length
20
Angulation range
2.
UP 180°,
DOWN 180°,
RIGHT 160°,
LEFT 160°
L: 2000 mm
I: 1650 mm
GIF/CF/PCF/JF TYPE E3 Series OPERATION MANUAL