enf_type_gp_rhino-laryngofiberscope_instructions_de.pdf
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INSTRUCTIONS
RHINO-LARYNGOFIBERSCOPE
OLYMPUS ENF TYPE GP
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
Instruction manual ....................................................................................
2
User qualifications ....................................................................................
2
Instrument compatibility ...........................................................................
2
Reprocessing and storage ........................................................................
3
Repair and modification ...........................................................................
3
Signal words .............................................................................................
3
Warnings and cautions..............................................................................
4
Examples of inappropriate handling..........................................................
7
Chapter 1
Checking the Package Contents............................
8
Chapter 2
Instrument Nomenclature and Specifications ......
9
2.1
Nomenclature..................................................................................
9
2.2
Endoscope functions.......................................................................
10
2.3
Specifications..................................................................................
11
Preparation and Inspection ....................................
12
3.1
Preparation of the equipment..........................................................
13
3.2
Preparation and inspection of the endoscope.................................
14
3.3
Preparation and inspection of accessories .....................................
15
3.4
Attaching accessories to the endoscope ........................................
16
3.5
Preparation, inspection and connection of ancillary equipment......
17
3.6
Inspection of the endoscopic system ..............................................
19
Operation .................................................................
20
4.1
Insertion ..........................................................................................
21
4.2
Withdrawal of the endoscope..........................................................
24
4.3
Transportation of the endoscope ....................................................
24
Reprocessing: General Policy................................
26
5.1
Instructions......................................................................................
26
5.2
Precautions .....................................................................................
27
Chapter 3
Chapter 4
Chapter 5
RHINO-LARYNGOFIBERSCOPE ENF-GP
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Contents
Chapter 6
6.1
Compatibility summary....................................................................
29
6.2
Detergent solution ...........................................................................
30
6.3
Disinfectant solution ........................................................................
31
6.4
Rinsing water ..................................................................................
31
6.5
ETO gas sterilization .......................................................................
32
6.6
Steam sterilization (autoclaving) of accessories .............................
34
Chapter 7
ii
Compatible Reprocessing Methods and Chemical
Agents....................................................................... 29
Cleaning, Disinfection and Sterilization Procedures
................................................................................... 36
7.1
Required reprocessing equipment ..................................................
36
7.2
Cleaning, disinfection and sterilization procedures .........................
38
7.3
Precleaning .....................................................................................
39
7.4
Leakage testing...............................................................................
40
7.5
Manual cleaning ..............................................................................
42
7.6
High-level disinfection .....................................................................
44
7.7
Rinsing after high-level disinfection.................................................
45
7.8
Sterilization .....................................................................................
46
7.9
Cleaning, disinfection and sterilization procedures for reusable parts
........................................................................................................
47
Chapter 8
Cleaning and Disinfection Equipment ...................
51
Chapter 9
Storage .....................................................................
52
Chapter 10 Troubleshooting ......................................................
53
10.1 Troubleshooting guide ....................................................................
53
10.2 Returning the endoscope for repair.................................................
54
Appendix........................................................................................
55
System chart ............................................................................................
55
RHINO-LARYNGOFIBERSCOPE ENF-GP
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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.
TYPE BF applied part
Endoscope
Manufacturer
Authorized representative in the European Community
RHINO-LARYNGOFIBERSCOPE ENF-GP
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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,
documentation equipment, display monitor and other ancillary equipment for
endoscopic diagnosis within the nasal and nasopharyngeal lumen.
Do not use this instrument for any purposes other than their intended uses.
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
instruments as instructed.
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 and/or equipment damage.
2
RHINO-LARYNGOFIBERSCOPE ENF-GP
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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 Chapter 5, “Reprocessing: General Policy” through Chapter 8, “Cleaning and
Disinfection Equipment”.
After using this instrument, reprocess and store it according to the instructions
given in Chapter 5 through Chapter 9. Improper and/or incomplete reprocessing
or storage can present an infection control risk, cause equipment damage or
reduce performance.
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 10, “Troubleshooting”. If the problem cannot be resolved using the
information in Chapter 10, contact Olympus.
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.
RHINO-LARYNGOFIBERSCOPE ENF-GP
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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.
4
•
Never operate the bending section, perform suction, insert or
withdraw the endoscope’s insertion tube without viewing the
endoscopic image. Patient injury can result.
•
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 into all patients. Before proceeding, always be
sure to confirm that transnasal insertion is possible with the
patient. Otherwise, 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, patient injury can result or the
endoscope could become lodged and be difficult to withdraw.
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.
RHINO-LARYNGOFIBERSCOPE ENF-GP
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Important Information — Please Read Before Use
•
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.
•
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.
•
Although the illumination light emitted from the endoscope’s
distal end is required for endoscopic observation and
treatment, it may also cause alteration of living tissues such
as protein denaturation of liver tissue and perforation of the
intestines by inappropriate using.
Observe the following warnings on the illumination.
− Always set the minimum required brightness.
The brightness of the image on a video monitor may differ
from actual brightness at the distal end of endoscope.
Especially, operating the electrical shutter function of a
video system, pay attention to the brightness level setting
of the light source.
When a light source and a video system are compatible
with the automatic brightness control function, be sure to
use the function of the light source. The automatic
brightness control function can keep the illumination light
properly.
Refer to the instruction manual of the light source and the
video system for details.
− Do not continue observation in proximity to tissue or keep
the distal end of the endoscope in contact with a living
tissue for a long time.
− When discontinuing the use of the endoscope, be sure to
turn the light source OFF or activate the light shield
function (standby mode etc.) so that the endoscope does
not irradiate unnecessary light.
RHINO-LARYNGOFIBERSCOPE ENF-GP
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Important Information — Please Read Before Use
6
•
If the endoscopic image dims during use, this may be a sign
that blood or mucus is adhered to the light guide on the distal
end of endoscope.
Carefully withdraw the endoscope from patient and remove
the blood or mucus in order to obtain optimum illumination
and to ensure the safety of examination.
If you continue to use the endoscope in such a condition, the
distal end temperature may rise and cause mucosa burns. It
may also cause patient and/or operator injury.
•
Be sure to prepare another endoscope to avoid that the
examination be interrupted due to equipment failure or
malfunction.
•
Do not coil the insertion tube with a diameter of less than
10 cm. Equipment damage can result.
•
Do not strike the distal end of the insertion tube or allow it to
strike other objects. The objective lens surface of the distal
end is particularly fragile, and vision 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 bending
section’s covering may stretch or break and cause water
leaks.
•
The eyepiece section cannot be removed. Do not attempt to
rotate it by force.
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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 given below.
•
Using improperly reprocessed or stored instruments may cause patient
cross-contamination and/or infection.
•
Applying prolonged suction with the distal end in contact with the
mucosal surface may cause bleeding or suction lesions.
•
Patient injury may be caused by
− inserting or withdrawing the endoscope without a clear
endoscopic image
− withdrawing the endoscope with the angulation controls
locked
− forcefully pulling, twisting or rotating the angulated
bending section
RHINO-LARYNGOFIBERSCOPE ENF-GP
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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 Chapter 5, “Reprocessing: General Policy” through Chapter 8, “Cleaning and
Disinfection Equipment”.
Endoscope
ETO cap
(MB-156)
8
Light guide adapter
(MAJ-900)
RHINO-LARYNGOFIBERSCOPE ENF-GP
Instruction manual
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Chapter 2 Instrument Nomenclature and Specifications
Chapter 2 Instrument Nomenclature
and Specifications
2.1
Nomenclature
Eyepiece section
3. Eyepiece frame (viewfinder)
4. Diopter adjustment ring
Light guide
2. UP/DOWN angulation
control lever
Serial number
Control section
ETO cap
(MB-156)
Venting connector
Boot
Insertion
tube/working length
1. Bending section
Distal end
RHINO-LARYNGOFIBERSCOPE ENF-GP
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Chapter 2 Instrument Nomenclature and Specifications
2.2
Endoscope functions
1. Bending section
The bending section moves the distal end of the endoscope when the
UP/DOWN angulation control lever is operated.
2. UP/DOWN angulation control lever
When turned in the “U” direction, the bending section moves UP; when
turned in the “D” direction, the bending section moves DOWN.
3. Eyepiece frame (viewfinder)
The viewfinder contains an index mark indicating the UP direction of the
bending section.
4. Diopter adjustment ring
The diopter adjustment ring adjusts the operator’s focus. This does not
affect focusing for photography.
10
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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
(0.7 – 1.1 kgf/cm2)
(10.2 – 15.4 psia)
Transportation and
storage
environment
Ambient temperature
–47 to 70°C (–52.6 to 158°F)
Relative humidity
10 – 95%
Atmospheric pressure
700 – 1060 hPa
(0.7 – 1.1 kgf/cm2)
(10.2 – 15.4 psia)
Specifications
Optical system
Insertion tube
Field of view
85°
Depth of field
5 – 50 mm
Distal end outer diameter
ø 3.4 mm
Insertion tube outer
diameter
Bending section
ø 3.6 mm
Working length
300 mm
Angulation range
UP 130°, DOWN 130°
Total length
550 mm
Medical Devices
Directive
This device complies with the
requirements of Directive 93/42/EEC
concerning medical devices.
Classification: Class II a
Year of manufacture
71012345
The year of manufacture is given in the
second digit of the serial number.
Degree of protection
against electric
TYPE BF applied part
shock
RHINO-LARYNGOFIBERSCOPE ENF-GP
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Chapter 3 Preparation and Inspection
Chapter 3 Preparation and Inspection
12
•
Before each case, prepare and inspect this instrument as
instructed below. Inspect other equipment to be 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 10,
“Troubleshooting”. If the irregularity is still suspected after
consulting Chapter 10, 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 Chapter 5,
“Reprocessing: General Policy” through Chapter 8, “Cleaning
and Disinfection Equipment”.
RHINO-LARYNGOFIBERSCOPE ENF-GP
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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 the “System
chart” in the Appendix) and personal protective equipment, such as eye wear, a
face mask, moisture-resistant clothing and chemical-resistant gloves, before
each use. Refer to the respective instruction manual for each piece of
equipment.
Endoscope
Light source
• Paper towels
Light guide adapter
• Trays
• Personal protective
Light guide cable
• Lint-free cloth
equipment
Figure 3.1
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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 Chapter 5,
“Reprocessing: General Policy” through Chapter 8, “Cleaning and Disinfection
Equipment”.
Inspection of the endoscope
1.
Inspect the control section for excessive scratching.
2.
Inspect the boot and the insertion tube near the boot for bends, twists or
other irregularities.
3.
Inspect the surface of the insertion tube for dents, bulges, swelling, peeling
or other irregularities.
4.
Carefully run your fingertips over the entire length of the insertion tube.
Inspect for any protruding objects or other irregularities (see Figure 3.2).
Figure 3.2
14
5.
Inspect the bending section’s covering for sagging, swelling, cuts, holes or
other irregularities.
6.
Gently hold the midpoint of the bending section and a point 5 cm from the
distal end. Push and pull gently to confirm that there is no play.
7.
Inspect the objective lens at the distal end of the endoscope’s insertion tube
for scratching, cracks, stains, gaps around the lens or other irregularities.
8.
Confirm that the diopter adjustment ring turns smoothly and that the
eyepiece section is attached securely to the control section. Confirm that the
eyepiece is free of defects, such as scratches or deformations.
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Chapter 3 Preparation and Inspection
When cleaning or wiping the eyepiece lens surface, do not
use abrasive cleansers because they may scratch the lens
surface.
9.
Wipe the eyepiece section and light guide using a clean, lint-free cloth
moistened with 70% ethyl or isopropyl alcohol.
Inspection of the bending mechanism
Perform the following inspections while the bending section is straight.
Inspection of operation
3.3
1.
Move the UP/DOWN angulation control lever slowly in each direction until it
stops. Confirm that the bending section moves smoothly and correctly and
that maximum angulation can be achieved.
2.
Move the UP/DOWN angulation control lever slowly to its neutral position.
Confirm that the bending section returns smoothly to an approximately
straight condition.
Preparation and inspection of accessories
Prepare the light guide adapter.
Inspection of the light guide adapter
Inspect the light guide adapter (MAJ-900) for damage.
RHINO-LARYNGOFIBERSCOPE ENF-GP
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Chapter 3 Preparation and Inspection
3.4
Attaching accessories to the endoscope
Attaching the light guide adapter
1.
Attach the light guide adapter to the light guide fitting on the endoscope (see
Figure 3.3).
2.
Rotate the light guide adapter clockwise until it stops.
Light guide
Light guide adapter
Figure 3.3
16
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Chapter 3 Preparation and Inspection
3.5
Preparation, inspection and connection of
ancillary equipment
Preparation and inspection of ancillary equipment
Prepare and inspect the light source according to its instruction manual.
Connection of the endoscope and ancillary equipment
•
Only use Olympus light guide cables
A3093/A3293/WA03200A with this endoscope. If another
light guide cable is used, the control section of the
endoscope may become too hot and cause operator and/or
patient burns.
•
The distal end of the endoscope may exceed 41°C (106°F)
and reach 50°C (122°F) due to intense endoscopic
illumination. Surface temperatures over 41°C (106°F) may
cause mucosal burns. Always use the minimum level of
illumination necessary for adequate viewing. Whenever
possible, avoid close stationary viewing and do not leave the
distal end of the endoscope close to mucous membranes for
a long time.
RHINO-LARYNGOFIBERSCOPE ENF-GP
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Chapter 3 Preparation and Inspection
1.
Connect the light guide cable to the light guide adapter (see Figure 3.4).
2.
Rotate the attachment ring of the light guide cable clockwise until it stops.
Light guide adapter (MAJ-900) is constructed by main body
and LG adapter (A0460). LG adapter (A0460) must be
screwed off from main body when connect the light guide
cable (WA03200A).
Main body
Light guide cable
WA03200A
LG adapter Light guide cable
A3093, A3293
(A0460)
MAJ-900
Figure 3.4
3.
Insert the light guide connector into the output socket of the light source
(see Figure 3.5).
4.
Turn the light source on, and adjust the brightness level according to the
light source’s instruction manual.
Light source
Light guide connector
Figure 3.5
18
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Chapter 3 Preparation and Inspection
3.6
Inspection of the endoscopic system
Inspection of the endoscopic image
1.
Turn the light source ON as described in its instruction manual. If you are
using an EVIS universal light source, set the mode switch to “OES”.
2.
Adjust the brightness level as appropriate.
3.
Turn the diopter adjustment ring until the fiber pattern is clear. Confirm that
an object approximately 8 mm from the objective lens can be seen clearly.
If the object cannot be seen clearly, wipe the objective lens
and the eyepiece lens using a clean, lint-free cloth moistened
with 70% ethyl or isopropyl alcohol.
RHINO-LARYNGOFIBERSCOPE ENF-GP
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Chapter 4 Operation
Chapter 4 Operation
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. It only describes basic operation and
precautions related to the operation of this instrument.
20
•
Anytime you suspect an abnormality in an endoscope
function, stop the examination immediately and slowly
remove it while viewing the endoscopic image. Using a
defective endoscope may cause patient injury.
•
If the endoscopic image should unexpectedly disappear, stop
the examination immediately. Without touching the
angulation control lever, carefully withdraw the endoscope
from the patient.
•
If the angulation control mechanism or any other part of the
system is not functioning properly, stop the procedure
immediately; do not operate the angulation control lever
unless absolutely necessary. Then carefully withdraw the
endoscope while observing the endoscopic image. If the
endoscope cannot be withdrawn from the patient smoothly,
do not attempt to forcibly withdraw it; leave it inside the
patient and immediately contact Olympus. Forcibly
withdrawing the endoscope may cause patient injury.
•
Wear personal protective equipment to guard against
dangerous chemicals and potentially infectious material.
During operation, wear appropriate protective equipment,
such as eye wear, a face mask, chemical-resistant clothing
and moisture-resistant gloves that fit properly and are long
enough so that your skin is not exposed.
RHINO-LARYNGOFIBERSCOPE ENF-GP
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Chapter 4 Operation
4.1
Insertion
Holding and manipulating the endoscope
The control section of the endoscope is designed to be held in the left hand. The
UP/DOWN angulation control lever can be operated using the left thumb. The
right hand is free to manipulate the insertion tube (see Figure 4.1).
Figure 4.1
Insertion of the endoscope
1.
If necessary, apply a medical-grade, water-soluble lubricant to the insertion
tube.
•
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 into all patients. Before proceeding, always be
sure to confirm that transnasal insertion is possible with the
patient. Otherwise, operator and/or patient injury can result
or the endoscope could become lodged and be difficult to
withdraw.
•
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.
RHINO-LARYNGOFIBERSCOPE ENF-GP
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Chapter 4 Operation
Do not apply olive oil or products containing petroleum-based
lubricants (e.g. vaseline). These products may cause
stretching and deterioration of the bending section’s
covering.
2.
Turn the illumination on.
3.
Always view the endoscopic image when passing the distal end of the
endoscope through the nose or mouth.
Do not allow the insertion tube to bend in a radius of 10 cm or
less at the junction of the boot. Insertion tube damage can
occur (see Figure 4.2).
> 10 cm
Figure 4.2
Angulation of the distal end
If the angulation control mechanism or any other part of the
system is not functioning properly, stop the procedure
immediately; do not operate the angulation control lever
unless absolutely necessary. Then carefully withdraw the
endoscope while observing the endoscopic image. If the
endoscope cannot be withdrawn from the patient smoothly,
do not attempt to forcibly withdraw it; leave it inside the
patient and immediately contact Olympus. Forcibly
withdrawing the endoscope may cause patient injury.
Operate the angulation control lever as necessary to guide the distal end for the
insertion and observation.
22
RHINO-LARYNGOFIBERSCOPE ENF-GP