Eb-580s - Operation Manual
Eb-580s - Operation Manual
Eb-580s - Operation Manual
フジノン和文
Endoscope
EB-580S
OPERATION MANUAL
(Preparation and Operation)
Thank you for purchasing our product. Read this manual carefully before use to avoid
unexpected accidents and to take full advantage of the product's capabilities.
1. Intended Use
2. Safety
Read and understand this manual carefully before use. Use the endoscope by
following the provided instructions. Items important for the safe use of the endoscope
are summarized in Chapter 1 “Safety.”
Safety precautions associated with individual operations or procedures are provided
separately, indicated by “ WARNING” or “ CAUTION.”
3. Warning
Items that must be observed for safety when performing endoscopy or electrosurgery
are identified by “ WARNING” or “ CAUTION.” Perform procedures correctly by
reading and understanding the warning information carefully.
WARNING
Read and understand this manual carefully before
operating the equipment.
Improper operations that will damage the equipment only are identified by
“CAUTION.”
4. Clinical Procedures
This manual assumes that the product will be used by medical specialists who have
received proper training in endoscopic procedures. It does not provide information
about clinical procedures. Regarding clinical procedures, use proper clinical judgment.
This product has not been sterilized. When using it for the first time, use the level
of disinfection or sterilization suitable to the application according to Chapter 7
“Cleaning,” Chapter 8 “Chemical Disinfection,” and Chapter 9 “Gas Sterilization.”
Pay full attention to the oxygen density in the atmosphere where electrosurgical
instruments are used. Before performing electrosurgery, confirm that the tip of the
instrument has well come out of the endoscope distal end.
Before electrosurgery, basic in vitro experiments must be performed to learn how
to tighten the snare properly and how repeated use affects the cutting quality of
endotherapy devices.
8. Loss of Function
[Note] Reset: Turn off the processor and the light source, and wait for at least 5
seconds. Turn on the processor and the light source again, and then light the
lamp by pressing the Lamp button.
Contents
Preface..........................................................................................................................6
Appendix......................................................................................................Appendix-1
Main Specifications.................................................................Appendix-2
Troubleshooting
(Combination with the Processor and the Light Source)........Appendix-8
After-Sales Service................................................................Appendix-12
Disposal of Electric and Electronic Equipment....................Appendix-13
Index......................................................................................Appendix-14
Service Centers......................................................................Appendix-15
Preface
Thoroughly read the operation manuals of the processor, light source and peripherals
used in combination with this product.
In this manual, illustrations and nomenclature of the processor VP-4450HD and the
light source XL-4450 are used for explanation unless otherwise noted.
General Conventions
Convention Description
This chapter summarizes the information necessary for safe use of this
product.
1-1
Chapter 1 Safety
1. Precautions in Using Endoscope
This product is used in combination with the processor and the light source described
below.
• VP-4450HD processor and XL-4450 light source
• VP-3500HD processor and XL-4450 light source
• VP-7000 processor and BL-7000 light source
Prior to using this product, prepare a spare one to avoid unexpected accidents such as
equipment failure. If a replacement is not available, you may not be able to continue
endoscopic procedures.
Make sure to inspect the equipment before use according to the procedures provided in
this manual, to avoid unexpected accidents, and take full advantage of the equipment’s
capabilities.
If the inspection result shows any abnormality, do not use the same equipment.
3) Combination of equipment
The endoscope may be used in combination with peripherals. To avoid electric shock, only
use the peripherals that are described in this operation manual.
Thoroughly read the operation manuals of the peripherals used in combination with this
product.
4) Abnormality in use
If any abnormality is found during its use, perform safety checks and immediately stop
using this product.
5) Maintenance
The equipment will wear out and degrade after repeated use for a long period. In particular,
resin and rubber parts wear out over time or due to chemicals used. Have it checked by
specialists once every six months or once every 100 cases. Also have it checked if there is
anything wrong with the equipment.
Do not disassemble or modify the equipment.
6) Operation of endoscope
The endoscope is a precision instrument. Excessive force or impact on the insertion portion,
flexible portion, or distal end may injure the patient as well as damage the instrument. If any
resistance is sensed during the operation, do not continue operating it forcedly, but insert it
slowly. Do not insert or bend the endoscope without obtaining a clear view on the monitor.
1-2
7) Handling of endoscope
When holding the endoscope, hold it by the control portion. Holding it up by the insertion
portion or LG flexible portion is difficult to hold and may exert an excessive force, resulting
in equipment failure.
Do not apply any impact to the distal end of the endoscope, especially to the lenses. It may
result in abnormal endoscopic images or insufficient airtightness of the endoscope.
When carrying the endoscope, keep the endoscope clean. In addition, put the endoscope
into a clean carrying case to avoid hitting against other objects.
Wear personal protective equipment when handling the endoscope to prevent infection and
electrostatic discharge.
8) Temperature at distal end
Turn off the lamp except during an examination, inspection, etc., when necessary. If the
lamp is left on, the temperature at the distal end may become hot, causing burn injury to the
operator, assistant or patient. Turn on the lamp immediately before starting an examination.
When turning off the processor, also turn off the light source. If the light source remains
on after turning off the processor, the ALC (automatic light control) does not function and
the maximum amount of light is emitted. As a result, the distal end of the endoscope may
become hot, causing burn injury to the operator, assistant or patient.
9) Electromagnetic interference
This equipment has been tested and found to comply with the limits for medical devices
defined in EN 60601-1-2:2007. These limits are designed to provide reasonable protection
against harmful interference in a typical medical installation. However, it is possible that it
may cause harmful interference to other devices in the vicinity, if it is installed and used in
accordance with the instructions. Also, there is no guarantee that interference will not occur
in a particular installation. Therefore, if this equipment does cause harmful interference
to other devices, which can be determined by turning the equipment off and on, the user is
encouraged to try to correct the interference by one or more of the following measures:
• Change the orientation or position of any affected device.
• Increase the spacing between devices.
• Consult the manufacturer or dealer of the device.
If the problem cannot be solved with the above measures, stop using this product and
consult the manufacturer or your local FUJIFILM dealer for help.
WARNING
Do not place any objects that emit strong electromagnetic waves near
this product. Otherwise, malfunction of this product may occur.
1-3
CAUTION
Noise may appear on the monitor of this product due to the effect of
electromagnetic waves. In this case, turn off the device emitting the
electromagnetic waves or move the device away from this product.
This product has not been sterilized. When using it for the first time, perform cleaning,
disinfection and sterilization suitable for the application.
After using it, clean and disinfect/sterilize it according to the procedures in the manual
(Cleaning, Disinfection and Storage). Inadequate cleaning may result in infection. Carefully
clean the insertion portion and all the channels especially.
Wear personal protective equipment during chemical washing and disinfection to protect
your skin and to prevent infection.
When using this product for a patient with Creutzfeldt-Jakob disease (especially variant
Creutzfeldt-Jakob disease), use it exclusively for a patient with the same disease, or
properly discard this product after use. Since the cleaning, disinfection and sterilization
methods described in the manual (Cleaning, Disinfection and Storage) of this product
cannot eliminate the causal agents of Creutzfeldt-Jakob disease, the product could be a
source of infection. For the treatment of Creutzfeldt-Jakob disease, refer to the guidelines
for it available.
3. Disposal
This product has heavy metal parts. When disposing of this product, comply with local
laws and regulations in your area. Determine whether or not the product is to be treated as
a biohazard, then handle and dispose of accordingly.
1-4
4. Repair or Inspection
Contact your local FUJIFILM dealer when this product is returned for repair or inspection.
In addition, be sure to clean and disinfect (or sterilize) this product before returning for
repair or inspection. A returned product which is not cleaned and disinfected (or sterilized)
may increase infection control risks.
1-5
1-6
end of endoscope and the tip of the treatment equipment. Energize the high-frequency
power supply after bringing the tip of the treatment equipment into the field of view. Set the
output power of the high-frequency power supply and treatment equipment below the rated
output. Also, set the output power to the minimum within the required range. If the output
power is inappropriate, it may cause damage to tissues in the body cavity, thermal injury,
bleeding or perforation.
Do not use an electrosurgical instrument when supplying flammable gas. There is a risk of
ignition. If necessary, use non-flammable gas such as carbon dioxide. Do not use excessive
non-flammable gas.
Wear electrically insulating gloves when using an electrosurgical instrument or accessory.
If not worn, there is a risk of thermal injury or electric shock.
Always keep pacemaker users away from electrosurgical instruments. The operation of
the pacemaker will be malfunctioned by the electrosurgical instruments.
When using diathermic treatment equipment, suck mucus adhered to the tissues in the body
cavity first and then energize the instrument. If the equipment is energized when in contact
with mucus, it may cause thermal injury.
Before electrosurgery, basic in vitro experiments must be performed to learn how to
tighten the snare properly and how repeated use affects the cutting quality of therapeutic
accessories.
Do not forcibly advance or withdraw the endoscope into/from the patient. It may cause
damage to the body lumen, bleeding or perforation.
In the case of transnasal insertion, bleeding in the nasal cavity may occur. If this happens,
stop bleeding properly. When withdrawing the endoscope, observe the nasal cavity and
ensure that no bleeding is found. Even if no bleeding is found, do not let the patient blow
his/her nose strongly. It may cause bleeding.
If an excessive force is applied to the endoscope due to patient's sneezing, the endoscope
may be damaged. If this happens, bleeding or perforation may occur, or endoscope
withdrawal may become impossible. If any abnormality is found during its use, perform
safety checks and immediately stop using this product.
Do not apply excessive force of the endoscope against the body lumen wall. It may cause
bleeding or perforation.
Do not use this product using maximum light intensity from the light source. When this
product projects light at the maximum brightness for 2-3 minutes, temperature at the distal
end may exceed 41°C and reach 50°C. If the surface temperature exceeds 41°C, thermal
injury to the patient may occur. Always use this product with minimum illumination,
minimum time and appropriate distance to perform the procedure.
Minimize direct contact of the endoscope tip with mucosal surfaces. Do not allow the distal
end to remain in contact with a patient for 5 minutes or more as thermal energy created by
illumination may cause a burn.
Whenever using the endoscope with other peripheral devices including endotracheal tubes,
etc. strictly adhere to all manufacturers' instructions, cautions and warnings. Failure to
follow the recommendations above can lead to endoscope damage and/or patient injury.
1-7
We recommend use of only those peripheral products specified in this manual to avoid
adverse outcomes such as electric shock when this product is used in combination with
other devices.
Prevent patient’s body from touching electric conductor such as metal part of bed while
using an electrosurgical instrument and an accessory instrument. It could cause thermal
injury to a patient.
Make sure that the patient's vomit or body fluid does not contact the electric conductor such
as metal parts of the bed while using an electrosurgical instrument. Not doing so could
cause electricity to pass through the vomit or body fluid, resulting in thermal injury.
Be careful not to touch the patient while using an electrosurgical instrument. Doing so may
cause thermal injury.
Operate the instruments within specified output range as per the device’s operating
instructions. Leakage current may cause thermal injury.
Perform electrosurgical procedures as per instructions provided in the operation manual for
an electrosurgical instrument.
6.3 Biopsy
When withdrawing the endoscope, slowly pull straight out. Body fluid may be splattered
around due to accidental detachment of the forceps valve, leading to infection.
To avoid the potential for patient injury including perforation, do not apply excessive force
of the endoscope or forceps against mucosal surfaces. Only advance the forceps under
direct visualization.
6.5 Pre-cleaning (Primary Cleaning)
Immediately upon completion of the procedure, it is imperative that pre-cleaning is
performed to begin removal of patient material and ensure that residual debris does not dry
and harden on endoscope and component surfaces.
Chapter 7 Cleaning
7.2 Conditions of Cleaning
Excessive foaming prevents detergent solution from sufficiently contacting the surfaces and
channel walls of the endoscope, and may impair effective cleaning.
Do not reuse clean water and detergent solution that were used for cleaning. If reused,
effective cleaning cannot be achieved, and it may pose an infection risk.
7.4.3 Removing Endoscope from Processor
Immediately after removing the LG connector from the light source, do not touch the light
guide rod with hands since it is extremely hot. There is a risk of burn injury.
7.4.5 Detaching Suction Button and Forceps Valve
The forceps valve and suction button are single patient use items. Do not not reuse them as
continued reuse may present a potential infection risk.
Discard the used suction button and forceps valve. Not doing so may cause infection.
1-8
1-9
In case the cleaning brush is damaged inside the channel, insert a spare brush to remove
the particles of the damaged cleaning brush by pushing them out of the channel. If the
particles are not completely removed even with the spare brush, have the endoscope repaired
immediately. If a damaged brush is left in the channel, the residue may fall out during a
procedure and injure the patient.
7.7 Cleaning and Disinfection Using Automated Endoscope Reprocessors
When cleaning and disinfecting the endoscope using an automated endoscope reprocessor
(AER), use an AER of which the cleaning/disinfection effect has been validated by
FUJIFILM. Use of AERs of which the cleaning/disinfection effect has not been validated by
FUJIFILM could result in unsuccessful cleaning and/or disinfection which could be a source
of infection or may increase risks to patient safety.
When reprocessing two endoscopes (including the combination of this product and another
type of endoscope) at the same time using an AER that is capable of reprocessing multiple
endoscopes at the same time, ensure that the combination of the two endoscopes is compatible
by referring to the manual of the AER. If two endoscopes are reprocessed in an incompatible
combination, it could result in unsuccessful reprocessing which could be a source of infection.
7.7.3 Channel Patency
Prior to automated reprocessing, ensure that all internal endoscope channels are “open” and
unclogged. If any channel is clogged, it could be a source of infection.
Chapter 8 Chemical Disinfection
8.3.2 Channel Disinfection
Confirm that accessories including the cleaning adapter are detached from the endoscope
and immerse them in disinfectant solution. Make sure that the disinfectant solution contacts
all external surfaces of the endoscope and accessories. If the accessories remain attached to
the endoscope during disinfection, the disinfectant solution cannot adequately contact the
connecting portions of the endoscope and accessories.
Flush disinfectant solution into all channels of the endoscope with a syringe until no air
bubbles come out from the distal end of the endoscope. If any air bubbles remain, the
disinfectant solution cannot adequately contact each channel, resulting in inadequate
disinfection.
Using a syringe flush disinfectant solution into all openings and gaps/crevices of the
endoscope and cleaning adapter to remove air bubbles completely. If any air bubbles remain,
the disinfectant solution cannot adequately contact the surface, resulting in inadequate
disinfection.
8.3.3 Rinsing After Disinfection
After rinsing, thoroughly dry the endoscope. Otherwise, bacteria may proliferate and pose an
infection control risk.
Chapter 9 Gas Sterilization
Ensure that all instrument surfaces are dry before attempting ETO gas sterilization. Failure to
do so can result in inadequate sterilization.
1-10
Aeration procedures must be performed immediately after ETO gas sterilization in order to
remove potentially harmful gas residuals from contacting patients. No or incomplete aeration
can potentially harm patients.
Chapter 10 Cleaning, Disinfection and Sterilization of Endoscopic Accessories
10.1 Cleaning, Disinfecting (or Sterilizing) Forceps Valve
The forceps valve is intended for single use. To prevent infection, do not reuse it.
When disinfecting the forceps valve, it must be completely immersed in a disinfectant
solution. Remove air bubbles completely. If any air bubbles remain, effective disinfection
cannot be achieved and an inadequately cleaned and disinfected (or sterilized) forceps valve
may be an infection risk.
10.2 Cleaning and Sterilizing Suction Button
The suction button is intended for single use. To prevent infection, do not reuse it.
Chapter 11 Storage
Do not store this product in a carrying case. Storage of this product in a carrying case and
subsequent clinical use may increse infection risks.
1-11
1-12
This chapter describes the composition of the endoscope set and system
configuration.
2-1
The endoscope set is provided in a carrying case. The set consists of the following items.
2-2
Endoscope (1)
Operation Manual
Preparation and Operation (1)
Cleaning, Disinfection and Storage (1)
Cleaning Adapter
CA-500C (1)
2-3
2.2 System Configuration ( Combination with the Processor and the Light Source)
You may use this product with various peripherals that can be connected to it. These
peripherals are available separately. Extension makes the following possible.
Endoscope
Light Source
XL-4450
BL-7000
Processor
VP-4450HD
VP-3500HD
VP-7000
Foot Switch
FS1
Forceps/Endotherapy Device Data Keyboard
DK-4450E
DK-3500
DK-7000
Cart
2-4
[Note] The devices described here may have already been discontinued. For details on the
devices used in combination with this product, contact your local FUJIFILM dealer.
LCD Monitor
CDL1576A
CDL1909A
RADNANCE24 (NDS)
Video Printer
UP-51MD-120V, 230V-(SONY)
UP-51MDU-120V-(SONY)
UP-21MD (SONY)
UP-55MD (SONY)
CP900E-230V-(MITSUBISHI)
CP900UM-120V-(MITSUBISHI)
DVD Recorder
LQ-MD800 (Panasonic)
DVO-1000MD (SONY)
2-5
2-6
This chapter describes the names and functions of endoscope parts and the
composition of the main unit.
3-1
LG flexible portion
Contains light guide and cables.
Suction connector
Accepts tube from suction unit.
Control portion
Provides a grip for holding the endoscope,
and also contains parts for operating the
endoscope.
Ventilation connector
Connects to the air leak tester or ventilation adapter.
3-2
Waterproof cap
Shields the electric contacts
from the exposure to fluids.
LG connector
Connects to the scope socket on the light source.
Video connector
Connects to the video connector
socket on the processor.
Distal end
Contains objective lens, light guide, forceps outlet.
Suction is performed with the buttons on the control
portion.
Insertion portion (applied part)
This portion is inserted into body cavities and
contains the distal end, bending portion and
flexible portion.
Objective lens
Forceps outlet
Light guide
Enlarged view of distal end
3-3
<Symbols>
Symbol Description
Do not re-use /
Single patient use only
Lot number
Serial number
Date of manufacture
Manufacturer
Temperature limitation
Keep dry
Non-sterile
CE marking
Degree of waterproof
Humidity limitation
3-4
The control portion contains the angle lever for operating the bending
mechanism and valves for suction, etc.
This chapter describes the operations and functions of these parts.
4-1
1 Angle lever
A direction
D
U
B side A side
B direction
U
4-2
2 Suction Valve
3 Forceps Inlet
2
Opening for passing through endoscopic accessory.
Normally, the forceps valve is attached.
4-3
4-4
WARNING
The forceps valve is a single patient use item. DO NOT reuse it as
continued reuse may present a potential infection risk.
The forceps valve consists of a valve body and a lid. It has the function of preventing the
leak or flowback of air.
6 Valve Body
7 Lid
6
4-5
WARNING
The suction button is a single patient use item. DO NOT reuse it as
continued reuse may present a potential infection risk.
8 Suction Button
9 Suction Connector
9
8
The suction tube part of the suction unit is connected to
the suction connector.
4-6
5-1
WARNING
Make sure to inspect the equipment before use according to the
procedures provided in this manual to avoid unexpected accidents and
to take full advantage of the equipment’s capabilities. If the inspection
result shows any abnormality, do not use the same equipment.
CAUTION
Do not use the endoscope if it has failed its pre-inspection check.
Doing so can negatively affect the functionality of the instrument or
increase risks to patient safety.
WARNING
Ensure that the forceps valve is properly attached to the forceps inlet. If
this product is used without the forceps valve attached, body fluid may
flow back and it could be a source of infection.
5-2
The forceps valve is provided without sterilization and must be cleaned and disinfected
(or sterilized) prior to use following the instructions of the Operation Manual (Cleaning,
Disinfection and Storage).
The forceps valve is a single-use product. Do not reuse it to avoid infection.
[Note] For information on how to clean and disinfect (or sterilize) the forceps valve, refer
to the Operation Manual (Cleaning, Disinfection and Storage).
“10.1 Cleaning and Disinfecting (or Sterilizing) Forceps Valve” in Operation Manual
(Cleaning, Disinfection and Storage)
WARNING
Ensure that a properly disinfected or sterilized forceps valve is
attached to the forceps inlet. Not doing so can create a risk of infection
to patients and/or end-users.
The forceps valve is intended for single use. If any abnormality is found, do not use the
product, and use a new disinfected (or sterilized) forceps valve.
(1) Visually check that the slit in the cap (a) and hole in
the main body (b) of the forceps valve are free from
abnormalities such as tears, cracks, discoloration, etc. a b
(2) Attach the lid to the main body of the forceps valve.
5-3
WARNING
Ensure that a properly disinfected or sterilized forceps valve is
attached to the forceps inlet. Not doing so can create a risk of infection
to patients and/or end-users.
5-4
The suction button is provided without sterilization and must be cleaned and or sterilized
prior to use following the instructions of the Operation Manual (Cleaning, Disinfection and
Storage).
The suction button is a single-use product. Do not reuse it to avoid infection.
[Note] For information on how to clean and sterilize the suction button, refer to the
Operation Manual (Cleaning, Disinfection and Storage).
5-5
(1) Move the cart with the processor and light source to the
place where the endoscope is to be used.
[Note]
Refer to the Installation Manual of the processor/light
source to install the peripherals onto the cart.
(2) After turning off the main switch on the cart, plug the
power cord from the cart into a hospital grade receptacle.
[Note]
For details on the suction unit, refer to the manual of the
suction unit.
Collection
canister
Suction
unit
5-6
WARNING
Attach the suction button and forceps valve securely. Not doing so can
create a risk of infection.
CAUTION
Immediately after removing the LG connector from the light source, do
not touch the light guide rod with hands since it is extremely hot. There
is a risk of burn injury.
(1) Before attaching the LG connector to the light source, Light incident distal face
visually check that there is no dirt on the light incident
distal face and no cracks on the glass of the light incident
distal face.
(3) Insert the video connector of the endoscope into the 500
system scope connector socket on the processor.
[Note]
Place the waterproof cap on the edge of the tray.
5-7
(5) Connect the suction tube between the suction unit and
suction connector of the endoscope.
5-8
(2) Hold the flexible portion with both hands and allow it to
go over its full length in such a way that the apex of the
semicircle with a diameter of about 200 mm gradually
begins to slide. Check that the portion bends fully and
there is no local difficulty in bending it.
[Note]
Do not forcibly twist or bend too sharply the flexible
portion by hand. It may cause a failure.
[Note]
Do not forcibly twist or bend too sharply the bending
portion by hand. It may cause a failure.
5-9
(1) Turn the angle lever upward and downward until it stops.
Check that the bending portion moves smoothly.
(2) Check that releasing the angle lever unbends the bending
portion a little.
(1) Turn on the suction unit, cart, processor and light source.
Keep the lamp off.
5-10
[Note]
Visually check that the forceps valve has been properly
attached to the forceps inlet of the endoscope.
[Note]
Do not use the forceps valve after its expiration date has
elapsed.
(4) Insert the forceps from the forceps inlet and check that the
tip of the forceps projects smoothly from the forceps outlet
at the distal end.
5-11
CAUTION
Turn off the lamp before inspecting the objective lens. Viewing the light
from the light guide directly may damage your eyes.
[Note]
Check that the objective lens and its surroundings are free
from cracks.
Also, check the following:
• The cover of the distal end is securely fixed.
• The light guides are free from cracks and are securely
fixed.
• The side surface of the distal end is free from scratches,
peeling and abnormal bulging.
[Note]
If the distal adhesives are missing, peeling, deteriorated
or if any lens is damaged or missing, contact your local
FUJIFILM dealer.
[Note]
To clean the lens, wipe it lightly with gauze or similarly
soft cloth soaked in lens cleaner or ethanol.
5-12
(3) Turn on the lamp and observe the endoscopic image on the
monitor. Check if the image is clearly displayed without
fogging or blur.
[Note]
If the objective lens is still fogged even after wiping with
gauze, the airtightness of the endoscope is insufficient.
Perform air tightness test with an air leak tester LT-7F.
5-13
5-14
6.1 Preparation....................................................................6-3
6.1.1 Preparing Necessary Equipment........................6-3
6.1.2 Pretreatment of Patient.......................................6-3
6.2 Insertion and Observation.............................................6-4
6.3 Biopsy..........................................................................6-11
6.4 Withdrawal..................................................................6-14
6.5 Pre-cleaning (Primary Cleaning).................................6-15
6-1
WARNING
Make sure to inspect the equipment before use according to the
procedures provided in this manual to avoid unexpected accidents and
to take full advantage of the equipment’s capabilities. If the inspection
result shows any abnormality, do not use the same equipment.
Biopsy forceps are critical devices that must be sterilized prior to use.
Inadequately sterilized forceps can present an infection control risk.
Discard the forceps valve and suction button after use. Used forceps
valve and suction button could be a source of infection.
[Note] Body fluid may be splattered around due to patient's coughing. It could be a source
of infection if personal protective equipment is not worn.
[Note] Always observe the patient closely. If the patient has symptoms suggestive of an
embolism or perforation, discontinue the endoscopic procedure immediately and
give proper medical treatment.
CAUTION
Do not use force during insertion or withdrawal of the endoscope.
Slowly advance the instrument under direct visualization. Since this
product is a precision instrument, excessive force or impact on the
insertion portion, flexible portion, or distal end may cause patient injury
as well as damage to the instrument. Do not advance or angulate the
endoscope without obtaining a clear endoscopic view on the monitor.
6-2
6.1 Preparation
6-3
WARNING
Do not operate the bending portion quickly. It may cause damage to
the body lumen.
6-4
WARNING
When using diathermic treatment equipment, suck mucus adhered to
the tissues in the body cavity first and then energize the instrument. If
the equipment is energized when in contact with mucus, it may cause
thermal injury.
CAUTION
Do not forcibly advance or withdraw the endoscope into/from the
patient. It may cause damage to the body lumen, bleeding or
perforation.
Do not apply excessive force of the endoscope against the body lumen
wall. It may cause bleeding or perforation.
Do not use this product using maximum light intensity from the light
source. When this product projects light at the maximum brightness for
2-3 minutes, temperature at the distal end may exceed 41°C and reach
50°C. If the surface temperature exceeds 41°C, thermal injury to the
patient may occur. Always use this product with minimum illumination,
minimum time and appropriate distance to perform the procedure.
6-5
CAUTION
Whenever using the endoscope with other peripheral devices
including endotracheal tubes, etc. strictly adhere to all manufacturers'
instructions, cautions and warnings. Failure to follow the
recommendations above can lead to endoscope damage and/or patient
injury.
Make sure that the patient's vomit or body fluid does not contact
the electric conductor such as metal parts of the bed while using an
electrosurgical instrument. Not doing so could cause electricity to pass
through the vomit or body fluid, resulting in thermal injury.
6-6
CAUTION
Do not directly apply Xylocaine spray to the insertion portion. It may
cause deterioration of the outer surface.
Do not use olive oil as a lubricant for insertion. It may cause swelling of
the outer surface.
[Note] In cases with bleeding, use the light save function of the light source (processor).
Patient's blood adhering to light guide at the distal end of endoscope may be
coagulated by the energy of illumination. For details on how to use the light save
function, refer to the operation manual of light source (processor).
[Note] If any steam like smoke appears in the endoscopic image, or if the endoscopic image
becomes dark, blood or other substances may adhere to the light guide at the distal
end of endoscope. Withdraw the endoscope from the patient immediately, remove
foreign matter, make sure that the light guide has no abnormality, and then use the
endoscope again. If foreign matter is not removed, the temperature at the distal
end of endoscope may rise, causing damage to the endoscope or burn injury to the
patient or operator.
6-7
(1) When inserting the endoscope orally, have the patient hold
the mouthpiece in the mouth.
[Note]
When you use the endotracheal tube insert the
endotracheal tube to the patient in advance.
(2) Turn on the power to the processor and light source, and
turn on the lamp by pressing the lamp ON/OFF button.
[Note]
Do not apply Xylocaine spray or olive oil directly to the
insertion portion.
[Note]
Do not forcibly twist or bend too sharply the flexible
portion by hand. It may cause a failure.
6-8
[Note]
Do not forcibly twist or bend too sharply the bending
portion by hand. It may cause a failure.
(4) Insert the distal end of the endoscope from the oral cavity
to the pharynx or from the nasal cavity to the nasopharynx
under constant observation.
(5) Turn the angle lever to steer the distal end of the
endoscope to the area to be observed.
[Note]
In case that the bending portion does not return or cannot
be pulled out easily because it is inverted inside the narrow
lumen, do not pull it out forcibly.
6-9
6-10
6.3 Biopsy
WARNING
When withdrawing the endoscope, slowly pull straight out. Body fluid
may be splattered around due to accidental detachment of the forceps
valve, leading to infection.
CAUTION
If resistance is encountered while advancing forceps (or other
accessory device) within the forceps channel, stop and withdraw the
accessory. Repeat again but do not apply excessive force to avoid
damaging the forceps channel.
[Note] The distal end of the endoscope may move. Insert the forceps slowly.
[Note] The forceps may not pass through the bending portion smoothly. In such a case,
slightly unbend the bending portion and try to insert it again.
(1) Steer the distal end of the endoscope to the biopsy site.
6-11
[Note]
The forceps may not pass through the bending portion
smoothly. In such a case, slightly unbend the bending
portion and try to insert it again.
[Note]
If the forceps handle is held tightly, the forceps may not
be inserted smoothly or the maximum bending angle may
decrease. If this happens, decrease the holding force.
(3) When the distal end of the forceps comes into the field of
view, stop insertion temporarily.
6-12
(6) Remove the forceps slowly and take out the biopsy
specimen.
6-13
6.4 Withdrawal
6-14
Pre-cleaning (primary cleaning) means cleaning performed at bedside immediately after use
of the endoscope. Remove the endoscope after pre-cleaning.
CAUTION
Immediately upon completion of the procedure, it is imperative that
pre-cleaning is performed to begin removal of patient material and
ensure that residual debris does not dry and harden on endoscope and
component surfaces.
[Note] For details on pre-cleaning and removal of the endoscope, refer to the Operation
Manual (Cleaning, Disinfection and Storage).
6-15
6-16
Main Specifications.................................................Appendix-2
Troubleshooting ( Combination with the Processor
and the Light Source)..............................................Appendix-8
After-Sales Service................................................Appendix-12
Disposal of Electric and Electronic Equipment....Appendix-13
Index......................................................................Appendix-14
Service Centers......................................................Appendix-15
Appendix-1
Main Specifications
<Applied Part>
Insertion portion
<Specifications>
Model EB-580S
Optical system:
Viewing direction 0° (Forward viewing)
Field of view 120°
Observation range (mm) 2 to 100
Method of illumination Light guide method
Image size Standard
Distal end diameter (mm) 5.3
Flexible portion diameter (mm) 5.1
Maximum diameter of insertion portion (mm) 6.5
Minimum diameter of instrument channel (mm) 2.2 [Note 1]
Bending capability: Up/down 210° / 130°
Working length (mm) [Note 2] 600
Total length (mm) 870
Insertion route Peroral or transnasal
[Note 1] Channel size should not be used as the sole consideration for compatibility of an
accessory.
[Note 2] Use an endotherapy device with a working length of 1200 mm or longer.
<Operating Environment>
Appendix-2
<Storage Environment>
<Transport Environment>
The term of validity (durability) is six years after beginning of use, if proper maintenance
and inspection are performed. “Based on our company’s criteria”
Processor VP-4450HD
VP-3500HD
VP-7000
Light Source XL-4450
BL-7000
Appendix-3
Biopsy forceps:
Fenestrated BF1812SF
Fenestrated with needle BF1812FN
Alligator type BF1812A
Grasping forceps:
V-type GF1812V
Suction button SB-602
Mouthpiece MPC-ST
MPC-P
Appendix-4
[Note] Use in combination with the VP-4450HD/VP-3500HD processor and the XL-4450 light
source, or the VP-7000 processor and the BL-7000 light source.
Appendix-5
Electrical fast transient/burst ± 2kV: for power supply lines Main power quality should be that of a
Same as left
EN 61000-4-4 ± 1kV: for input/output lines typical commercial or hospital.
Appendix-6
EN 60601-1-2 Compliance
Immunity test Guidance
Test level level
Portable and mobile RF communications equipment
should be used no closer to any part of this product,
including cables, than the recommended separation
distance calculated from the equation applicable to the
frequency of the transmitter.
3.5
d= √P
V1
3.5
d= √P 80 to 800MHz
E1
Conducted RF 3Vrms d=
7
√P 800MHz to 2.5GHz
EN 61000-4-6 150kHz to 80MHz 3V[V1] E1
The customer or the user of this product can help prevent electromagnetic interference by maintaining a minimum
distance between portable and mobile RF communications equipment (transmitter) and this product as recommended
below, according to the maximum output power of the communications equipment.
Rated maximum output Separation distance related to frequency of the transmitter (m)
power of transmitter P 150kHz to 80MHz 80 to 800MHz 800MHz to 2.5GHz
(W) d=1.2√P d=1.2√P d=2.3√P
0.01 0.12 0.12 0.23
0.1 0.38 0.38 0.73
1 1.2 1.2 2.3
10 3.8 3.8 7.3
100 12 12 23
Appendix-7
If the endoscope should fail during use, follow these instructions to troubleshoot it.
Problem Cause Remedy
No images come out. 1) The cart, monitor or processor is unplugged 1) Plug the cart, monitor or processor into the
from the main outlet. main outlet.
2) The cart, monitor or processor is off. 2) Power on the cart, monitor or processor.
The image appears 1) The imaging section is damaged. 1) Reset [Note] the processor and the light
dark. source. If an appropriate image does not
appear even after resetting, turn them off,
straighten the bending portion to unlock,
release the angle knobs, and then withdraw
the endoscope slowly from the patient.
2) The endoscope connection is incomplete. 2) Reconnect the endoscope.
“5.2 Connecting the Endoscope”
3) The brightness level is set to near the 3) Set the brightness level to around 0.
minimum level. Operation manual of the light source
4) The Iris mode is set to “PEAK.” 4) Set the Iris mode to “AVE.”
Operation manual of the light source
5) Dirt is adhered to the lens of endoscope. 5) Supply water to the distal end of endoscope
to remove dirt.
6) The shutter speed is set to “HIGH.” 6) Set the shutter speed to “NORM.”
Operation manual of the processor
7) The maximum light amount is limited by 7) Turn off the light save function of light
the light save function. source.
Operation manual of the light source
8) The Iris timer is activated. 8) Release the timer by pressing the FR switch
of endoscope.
[Note] If the image still appears dark even
after performing 4) to 7), slowly withdraw the
endoscope and clean the distal end.
The highlight portion 1) The imaging section is damaged. 1) Reset [Note] the processor and the light
of an image is too source. If an appropriate image does not
bright. appear even after resetting, turn them off,
straighten the bending portion to unlock,
release the angle knobs, and then withdraw
the endoscope slowly from the patient.
2) The brightness level is set to near the 2) Set the brightness level to around 0.
maximum level. Operation manual of the light source
3) The Iris mode is set to “AVE.” 3) Set the Iris mode to “PEAK.”
Operation manual of the light source
[Note] Reset: Turn off the processor and the light source, and wait for at least 5 seconds. Turn on the processor and the
light source again, and then light the lamp by pressing the Lamp button.
Appendix-8
[Note] Reset: Turn off the processor and the light source, and wait for at least 5 seconds. Turn on the processor and the
light source again, and then light the lamp by pressing the Lamp button.
[Note 1] During treatment with a snare, withdraw the snare after loosening it enough.
Appendix-9
[Note] Reset: Turn off the processor, and wait for at least 5 seconds. Turn on the processor again, and then light the lamp
by pressing the Lamp button.
[Note 1] During treatment with a snare, withdraw the snare after loosening it enough.
Appendix-10
Appendix-11
After-Sales Service
1) If the equipment does not work properly, check it first by reading this manual again and
follow all instructions.
2) If the equipment is still not working well, contact your local FUJIFILM dealer.
We will repair your equipment free of charge according to the provisions of the warranty.
The warranty period is one year after date of purchase.
We will make a paid repair at your request if the equipment is found possible to restore
the normal function by repair. When contacting our service representative, provide the
following information.
Model name :
Serial number :
Description of failure : as detailed as possible
Date of purchase :
Appendix-12
This symbol on the product, or in the manual and/or on this packaging, indicates that this
product shall not be treated as household waste.
Instead it should be taken to an applicable collection point for the recycling of electrical and
electronic equipment.
By ensuring this product is disposed of correctly, you will help prevent potential negative
consequences to the environment and human health, which could otherwise be caused by
inappropriate waste handling of this product.
The recycling of materials will help to conserve natural resources. For more detailed
information about recycling of this product, contact your local FUJIFILM dealer.
In Countries outside the EU: If you wish to discard this product, contact your local
authorities and ask for the correct way of disposal.
Appendix-13
Index
<A> <M>
Aeration................................................................ 9-3 Maintenance......................................................... 1-2
Angle lever........................................................... 4-2 Monitor................................................................. 2-5
<B> Mouthpiece........................................................... 6-8
Bending mechanism............................................. 4-2 <N>
Bending portion.................................................... 3-3 Neutral detergent.................................................. 7-3
<C> <O>
Cart....................................................................... 2-4 Operating environment...........................Appendix-2
Caution.................................................................2, 6 <P>
CDL1576A........................................................... 2-5 Preparations.......................................................... 5-2
CDL1909A........................................................... 2-5
<R>
Chemical disinfection.......................................... 8-2
Recording switch.................................................. 4-4
Cleaning............................................................... 7-2
<S>
Clinical procedures..................................................2
Safety................................................................... 1-2
Control portion..................................................... 3-2
Storage............................................................... 11-2
CP900E................................................................ 2-5
Storage environment...............................Appendix-3
CP900UM............................................................ 2-5
Suction button...................................................... 4-6
<D>
Suction connector.......................................... 3-2, 4-6
Distal end............................................................. 3-3
Suction tube................................................... 4-6, 5-8
DK-3500............................................................... 2-4
<U>
DK-4450E............................................................ 2-4
UP-21MD............................................................. 2-5
DK-7000............................................................... 2-4
UP-51MD............................................................. 2-5
<E>
UP-51MDU.......................................................... 2-5
Enzymatic detergent............................................. 7-3
UP-55MD............................................................. 2-5
EOG.............................................................. 9-3, 9-4
<V>
Ethylene oxide gas........................................ 9-3, 9-4
Ventilation adapter........................................ 3-2, 9-6
<F>
Ventilation connector........................................... 3-2
Flexible portion.................................................... 3-3
Video connector................................................... 3-3
Forceps inlet......................................................... 4-3
VP-3500HD......................................................... 2-4
Forceps valve................................................ 4-3, 4-5
VP-4450HD......................................................... 2-4
Freeze switch........................................................ 4-4
VP-7000............................................................... 2-4
<G>
<W>
Gas sterilization.................................................... 9-2
Warning................................................................2, 6
<I> Waterproof cap..................................................... 3-3
Insertion portion................................................... 3-3
<X>
<L> XL-4450............................................................... 2-4
LG connector........................................................ 3-3
LG flexible portion............................................... 3-2
Appendix-14
Service Centers
Contact our regional representative below or the distributor from which you purchased the product.
<Europe>
<USA>
<Australia>
<Asia>
If you are not a resident of the regions above, contact the distributor from which you purchased the product.
Appendix-15
202B1263154B
160720-3.0-DT-E2
FB89A Printed in Japan