Eb-580s - Operation Manual

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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.

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Important Safety Information

Important Safety Information

1. Intended Use

This product is a medical endoscope intended for observation, diagnosis, and


endoscopic treatment of the trachea and bronchus at medical facilities under
management of physicians. Do not use this product for any other purpose.

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 use or operation of the equipment may


injure patients, physicians, or people in the vicinity.

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.

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Important Safety Information

5. When Using the Endoscope for the First Time

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.”

6. If Any Abnormality Occurs During Clinical Procedure

If any abnormality occurs with the equipment, refer to “Troubleshooting.” In


particular, continuing to use this product even after it displays abnormal images may
cause overheating of the distal end, resulting in burns or other injury.

7. Treatment with Electrosurgical Instruments

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

During an examination, if the endoscopic image disappears, a live image is not


displayed after freeze mode has been cancelled, or the endoscopic image is discolored,
reset the processor and light source.
If an appropriate image does not appear even after resetting the processor and light
source, turn them off, straighten the bending portion, release the angle lever, and then
withdraw the endoscope slowly from the patient.
During an examination, if an abnormality occurs on the endoscopic image (if it
disappears, becomes darker or brighter, etc.), the imaging section may be damaged.
Reset the processor and light source. If an appropriate image does not appear even
after resetting, turn them off, straighten the bending portion, release the angle lever,
and then withdraw the endoscope slowly from the patient.
Continued use of the endoscope may cause overheating of the distal end, possibly
resulting in burn injury.

[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.

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Contents

Contents

(Preparation and Operation)

Important Safety Information.......................................................................................2

Preface..........................................................................................................................6

Conventions Used in This Manual................................................................................6

Chapter 1 Safety.................................................................................................... 1-1

Chapter 2 Composition of Set and System Configuration.................................... 2-1


2.1 Composition of Set...................................................................... 2-2
2.2 System Configuration
(Combination with the Processor and the Light Source)............ 2-4

Chapter 3 Names and Functions of Parts.............................................................. 3-1

Chapter 4 Control Portion..................................................................................... 4-1


4.1 Operating Bending Mechanism................................................... 4-2
4.2 Suction Valve and Forceps Inlet................................................. 4-3
4.3 Scope Switches............................................................................ 4-4
4.4 Forceps Valve.............................................................................. 4-5
4.5 Suction Button............................................................................. 4-6

Chapter 5 Preparation for Use of Endoscope........................................................ 5-1


5.1 Preparing Forceps Valve............................................................. 5-2
5.2 Preparing Suction Button............................................................ 5-5
5.3 Preparing Equipment................................................................... 5-6
5.4 Connecting Endoscope................................................................ 5-7
5.5 Inspection of Endoscope............................................................. 5-9

Chapter 6 Method of Use...................................................................................... 6-1


6.1 Preparation.................................................................................. 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

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

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Contents

(Cleaning, Disinfection and Storage)

Chapter 7 Cleaning................................................................................................ 7-1

Chapter 8 Chemical Disinfection.......................................................................... 8-1

Chapter 9 Gas Sterilization................................................................................... 9-1

Chapter 10 Cleaning, Disinfection and Sterilization of Endoscopic Accessories... 10-1

Chapter 11 Storage................................................................................................ 11-1

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Preface

Preface

This manual describes how to use EB-580S..

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.

Conventions Used in This Manual

This manual uses the following conventions for easier understanding.

General Conventions
Convention Description

Indicates a potential danger that may cause harm to people.


Explains dangerous situations that may cause death or serious
WARNING injury if not avoided.

CAUTION Explains situations that may cause injury if not avoided.


Explains situations that may cause damage to equipment if not
CAUTION
avoided.
Indicates consecutive numbers in operating procedures for the order
(1), (2), (3), ...
in which successive steps in the procedure should be taken.
[Note] Indicates a comment or supplementary information.
Indicates a reference.

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Chapter 1 Safety

This chapter summarizes the information necessary for safe use of this
product.

1-1

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Chapter 1 Safety

Chapter 1 Safety
1. Precautions in Using Endoscope

1) Compatible processor and light source

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

2) Preparation and inspection before use

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.

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Chapter 1 Safety

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.

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Chapter 1 Safety

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.

Use the cable specified in the Installation Manual of the processor


for this product. Use of other cables may cause an increase in
electromagnetic emission or decrease in electromagnetic immunity of
this product.

2. Cleaning and Disinfection/Sterilization

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.

Before disposing of this product or an endoscopic accessory, perform cleaning and


disinfection (or sterilization) according to the procedure described in the operation manual.
There is a risk of being a source of infection.

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Chapter 1 Safety

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.

5. “ Warning” and “ Caution” Messages Appearing in Individual Chapters

Chapter 4 Forceps Valve


4.4 Forceps Valve
The forceps valve is a single patient use item. DO NOT reuse it as continued reuse may
present a potential infection risk.
4.5 Suction Button
The suction button is a single patient use item. DO NOT reuse it as continued reuse may
present a potential infection risk.
Chapter 5 Preparation for Use of Endoscope
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.
Insert the AC plug into a hospital grade receptacle. When carrying or connecting the
endoscope, take care to keep it clean. Not doing so may cause electric shock.
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.
Store the endoscope under the storage conditions described in “Main Specifications.” Use
the endoscope under the operating conditions described in "Main Specifications."
5.1 Preparing Forceps Valve
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.
Attach a properly disinfected (or sterilized) forceps valve. If the forceps valve is not cleaned
or disinfected (or sterilized) properly, it can create a risk of infection to patients and/or
end-users.
Be sure to inspect the forceps valve before attachment. If any abnormality is found during
inspection, do not use the product. It could be a source of infection.
5.1.2 Inspecting the Forceps Valve
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.

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Chapter 1 Safety

5.1.3 Attaching the Forceps Valve


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 Connecting Endoscope
Attach the suction button and forceps valve securely. Not doing so can create a risk of
infection.
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.
Do not exceed a suction (negative) pressure of 53 kPa. Avoid aspiration of the mucous
membrane into the forceps channel to avoid potential patient injury.
5.5.4 Inspecting the Distal End
Turn off the lamp before inspecting the objective lens. Viewing the light from the light
guide directly may damage your eyes.
Chapter 6 Method of Use
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.
Wear personal protective equipment when using the endoscope. Otherwise, it may cause
infection.
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.
Do not supply an excessive amount of air or gas during a procedure as doing so could cause
perforation or rupture of the digestive tract wall, or an embolism. Do not overinsufflate
during any clinical procedure to minimize the potential for pneumatic perforation.
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 Insertion and Observation
Do not operate the bending portion quickly. It may cause damage to the body lumen.
Before attempting to clinically use this endoscope with an endotracheal tube, select
an appropriate size tube whose inner diameter has sufficient clearance between the
endotracheal tube and the endoscope to avoid restriction of oxygen flow which may impair
patient breathing.
The endotracheal tube should pass easily over the endoscope’s insertion tube - never force
an endotracheal tube onto the endoscope and never apply excessive pressure or force when
attempting to pass or withdraw the endoscope.
When using diathermic treatment equipment, maintain enough distance between the distal

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Chapter 1 Safety

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.

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Chapter 1 Safety

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.

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Chapter 1 Safety

7.5 Transporting Endoscope for Cleaning and D


‌ isinfection (or Sterilization)
When transporting the endoscope after use, do not hit it against whatever is in the vicinity and
prevent the residual fluid adhered to the endoscope from being splattered around. Doing so
may cause infection.
7.6 Manual Cleaning (Cleaning in Sink)
Carefully inspect all cleaning brushes for abnormalities and/or damage prior to use. Check
the brushes integrity after every brushing to ensure that they are not damaged and no brush
fragment remains inside the channel. Retained brush fragments could be a potential source of
infection and/or cause patient injury.
In case the cleaning brush is damaged during cleaning, remove any residue from inside the
channel using a spare brush. If residue is not completely removed even with the spare brush,
have the endoscope repaired immediately. If residue remains inside the channel, it could be a
source of infection.
Before using any cleaning brush for the valve, channel or forceps inlet, remove any debris
from the bristles on the brush. This will avoid reintroduction of patient material into the
channels/lumens.
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.
7.6.1 Air Tightness Test
Do not store the air leak tester together with the medical equipment that has been cleaned and
disinfected. Store the air leak tester in a place out of reach of persons except for physicians
and healthcare professionals. If the air leak tester is touched carelessly, it may cause infection.
7.6.3 Brushing
Be sure to thoroughly brush the inside of the forceps channel, forceps inlet, suction channel
and suction valve of the endoscope. Insufficient brushing may pose an infection control risk.
Carefully inspect all cleaning brushes for abnormalities and/or damage prior to use. Check
the brushes integrity after every brushing to ensure that they are not damaged and no brush
fragment remains inside the channel. Retained brush fragments could be a potential source of
infection and/or cause patient injury.
In case the cleaning brush is damaged during cleaning, remove any residue from inside the
channel using a spare brush. If residue is not completely removed even with the spare brush,
have the endoscope repaired immediately. If residue remains inside the channel, it could be a
source of infection.
Before using any cleaning brush for the valve, channel or forceps inlet, remove any debris
from the bristles on the brush. Not doing so may cause reintroduction of patient material into
the channels/lumens and it could be a source of infection.
To avoid splashing the detergent solution when the brush is pulled out from the endoscope,
keep the endoscope immersed in the detergent solution while brushing. Splashed detergent
solution may pose an infection control risk to the operators or may damage the skin.

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Chapter 1 Safety

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.

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Chapter 1 Safety

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.

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Chapter 1 Safety

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Chapter 2 Composition of Set and System
Configuration

This chapter describes the composition of the endoscope set and system
configuration.

2.1 Composition of Set........................................................2-2


2.2 System Configuration (‌ Combination with the Processor
and the Light Source)....................................................2-4

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Chapter 2 Composition of Set and System Configuration

Chapter 2 Composition of Set and System Configuration

2.1 Composition of Set

The endoscope set is provided in a carrying case. The set consists of the following items.

[Note] Figures in parentheses indicate quantities.

Carrying Case (1) Ventilation Adapter


AD-7 (1)

Cleaning Brush Cleaning Brush


WB7024FW (1) WB11003FW (1)

Forceps Valve Suction Button


FOV-DV7 (10) SB-500B/D (20)

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Chapter 2 Composition of Set and System Configuration

Endoscope (1)

Operation Manual
Preparation and Operation (1)
Cleaning, Disinfection and Storage (1)

Waterproof Cap (1)

Forceps Inlet Cleaning Adapter (with a Cap) (1)


CA-503B/C

Valve Set (1)

Valve Adapter (1)


Syringe (1)

Cleaning Adapter
CA-500C (1)

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Chapter 2 Composition of Set and System Configuration

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.

• Recording video images


• Printing still images

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

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Chapter 2 Composition of Set and System Configuration

[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.

Electrosurgical Unit [Note 1]


ICC 200 (ERBE)
VIO300D (ERBE)

[Note 1] ‌For details, refer to the manual of


the electrosurgical instrument.

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)

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Chapter 2 Composition of Set and System Configuration

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Chapter 3 Names and Functions of Parts

This chapter describes the names and functions of endoscope parts and the
composition of the main unit.

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Chapter 3 Names and Functions of Parts

Chapter 3 Names and Functions of Parts

The endoscope consists of the following parts.

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.

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Chapter 3 Names and Functions of Parts

Waterproof cap
Shields the electric contacts
from the exposure to fluids.

LG connector
Connects to the scope socket on the light source.

Light guide rod


Connects to the light source.

Video connector
Connects to the video connector
socket on the processor.

Flexible portion Bending portion


Connects bending portion and control portion. Bends when inserted. This portion bends by
The endoscope can be inserted into the body operating the lever on the control portion.
cavity up to this portion.

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.

Imaging section (inside)

Objective lens

Forceps outlet
Light guide
Enlarged view of distal end

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Chapter 3 Names and Functions of Parts

<Symbols>

Symbol Description

Do not re-use /
Single patient use only

Lot number

Serial number

Date of manufacture

Manufacturer

Consult instructions for use

Authorised representative in the European Community

Temperature limitation

Keep dry

Non-sterile

CE marking

Degree of waterproof

Type BF applied part

WEEE marking [Note]

Humidity limitation

Atmospheric pressure limitation

Super CCD model

[Note] This product shall not be treated as household waste.

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Chapter 4 Control Portion

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 Operating Bending Mechanism.....................................4-2


4.2 Suction Valve and Forceps Inlet...................................4-3
4.3 Scope Switches..............................................................4-4
4.4 Forceps Valve................................................................4-5
4.5 Suction Button...............................................................4-6

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Chapter 4 Control Portion

Chapter 4 Control Portion

4.1 Operating Bending Mechanism

1 Angle lever

Used to angulate the bending portion upward or


downward.

When the angle lever is slanted toward A side, the


1 bending portion is bent upward (A direction).
When the angle lever is slanted toward B side, the
bending portion is bent downward (B direction).

A direction
D
U

B side A side
B direction
U

Lever position when the bending portion is straight.

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Chapter 4 Control Portion

4.2 Suction Valve and Forceps Inlet

2 Suction Valve

The suction button is attached.

3 Forceps Inlet
2
Opening for passing through endoscopic accessory.
Normally, the forceps valve is attached.

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Chapter 4 Control Portion

4.3 Scope Switches

4 Recording Switch (RC Switch)


4
This is the remote switch for capturing an image for a
video printer.
This switch can be manipulated to capture images even
while an image is frozen with the freeze switch.
5

5 Freeze Switch (FR Switch)

This is the remote switch for freezing or capturing an


image. The displayed image is frozen while this button
is being depressed. Image freezing is canceled a few
seconds after it is released.
If this switch is depressed again while the image is still
frozen, a trigger signal is output to the device connected
to the hard copy device.

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Chapter 4 Control Portion

4.4 Forceps Valve

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

The valve body is a part that reduces the leakage or


backflow of air when an endotherapy device is used. It is 7
mounted on the opening of the forceps inlet.

7 Lid
6

The lid functions as a valve for preventing the leak or


backflow of air. It should normally be kept closed.

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Chapter 4 Control Portion

4.5 Suction Button

WARNING
The suction button is a single patient use item. DO NOT reuse it as
continued reuse may present a potential infection risk.

The suction button is attached to the suction valve.


This button is used to perform suction from the forceps outlet at the distal end.
The suction button SB-500B/D has not been sterilized.
When using the suction button SB-500B/D, carry out cleaning and sterilization.

8 Suction Button

Suction is performed while this button is depressed.

9 Suction Connector
9

8
The suction tube part of the suction unit is connected to
the suction connector.

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Chapter 5 Preparation for Use of Endoscope

This chapter describes the system necessary for endoscopy.

5.1 Preparing Forceps Valve...............................................5-2


5.1.1 Cleaning and Disinfecting (or Sterilizing) t‌he
Forceps Valve....................................................5-3
5.1.2 Inspecting the Forceps Valve.............................5-3
5.1.3 Attaching the Forceps Valve..............................5-4
5.2 Preparing Suction Button..............................................5-5
5.2.1 Cleaning and Sterilizing the Suction Button......5-5
5.2.2 Attaching Suction Button...................................5-5
5.3 Preparing Equipment.....................................................5-6
5.4 Connecting Endoscope..................................................5-7
5.5 Inspection of Endoscope...............................................5-9
5.5.1 Inspecting the Insertion Portion.........................5-9
5.5.2 Inspecting Bending Mechanism.......................5-10
5.5.3 Inspecting Suction and Forceps Channel.........5-10
5.5.4 Inspecting the Distal End.................................5-12

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Chapter 5 Preparation for Use of Endoscope

Chapter 5 Preparation for Use of Endoscope

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.

Insert the AC plug into a hospital grade receptacle. When carrying or


connecting the endoscope, take care to keep it clean. Not doing so
may cause electric shock.

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.

Store the endoscope under the storage conditions described in “Main


Specifications.” Use the endoscope under the operating conditions
described in "Main Specifications."

5.1 Preparing Forceps Valve

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.

Attach a properly disinfected (or sterilized) forceps valve. If the forceps


valve is not cleaned or disinfected (or sterilized) properly, it can create
a risk of infection to patients and/or end-users.

Be sure to inspect the forceps valve before attachment. If any


abnormality is found during inspection, do not use the product. It could
be a source of infection.

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Chapter 5 Preparation for Use of Endoscope

5.1.1 Cleaning and Disinfecting (or Sterilizing) t‌he Forceps Valve

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)

5.1.2 Inspecting the Forceps Valve

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.

Forceps valve (FOV-DV7)

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Chapter 5 Preparation for Use of Endoscope

5.1.3 Attaching the Forceps Valve

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.

(1) Attach the forceps valve to the forceps inlet of the


endoscope.

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Chapter 5 Preparation for Use of Endoscope

5.2 Preparing Suction Button

5.2.1 Cleaning and Sterilizing the Suction Button

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).

“10.2 Cleaning and Sterilizing Suction Button” in Operation Manual (Cleaning,


Disinfection and Storage)

5.2.2 Attaching Suction Button

Align the suction button with the “ ” position indicator,


and insert the arm into the endoscope.

Rotate the suction connector in the direction of the arrow.

To remove the suction connector, return it to the position


indicator, and pull out the entire button.

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Chapter 5 Preparation for Use of Endoscope

5.3 Preparing Equipment

(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.

(3) Prepare the suction unit.

[Note]
For details on the suction unit, refer to the manual of the
suction unit.

Collection
canister

Suction
unit

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Chapter 5 Preparation for Use of Endoscope

5.4 Connecting Endoscope

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.

Do not exceed a suction (negative) pressure of 53 kPa. Avoid


aspiration of the mucous membrane into the forceps channel to avoid
potential patient 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.

(2) Insert the LG connector of the endoscope into the


endoscope socket on the light source.

(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.

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Chapter 5 Preparation for Use of Endoscope

(4) Connect the dedicated connector cap to the connector


socket not in use.

(5) Connect the suction tube between the suction unit and
suction connector of the endoscope.

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Chapter 5 Preparation for Use of Endoscope

5.5 Inspection of Endoscope

5.5.1 Inspecting the Insertion Portion

(1) Visually check the insertion portion (distal end, bending


portion and flexible portion) for abnormalities such as
flaws or dents and for sharp edges on protrusions that may
injure the patient.

Confirm that the resin parts at each end of the bending


portion sheath are intact. If the adhesive surfaces are
rough, pitted or flaking, return the instrument to your local
FUJIFILM dealer.

(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.

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Chapter 5 Preparation for Use of Endoscope

5.5.2 Inspecting Bending Mechanism

(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.

5.5.3 Inspecting Suction and Forceps Channel

(1) Turn on the suction unit, cart, processor and light source.
Keep the lamp off.

(2) Prepare a cup of sterile water.

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Chapter 5 Preparation for Use of Endoscope

(3) While immersing the distal end of the endoscope in water,


check that the water is sucked in when the suction button
is pressed and the suction stops when the finger is released
from the button.

[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.

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Chapter 5 Preparation for Use of Endoscope

5.5.4 Inspecting the Distal End

CAUTION
Turn off the lamp before inspecting the objective lens. Viewing the light
from the light guide directly may damage your eyes.

(1) Make sure that the lamp is turned off.


Be sure that the objective lens and light guides on the
distal end of the endoscope are not disengaged, but remain
fixed. Look the distal end from an angle to check no dirt or
foreign substances adhering to the objective lens.

[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.

(2) If any dirt or foreign matter is adhered to the lens, clean it


off.

[Note]
To clean the lens, wipe it lightly with gauze or similarly
soft cloth soaked in lens cleaner or ethanol.

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Chapter 5 Preparation for Use of Endoscope

(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.

“7.6.1 Air Tightness Test” in Operation Manual (Cleaning,


Disinfection and Storage)

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Chapter 5 Preparation for Use of Endoscope

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Chapter 6 Method of Use

This chapter outlines how to operate the equipment, according to the


general procedures.
Regarding clinical procedures, use proper clinical judgment.

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

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Chapter 6 Method of Use

Chapter 6 Method of Use

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.

Wear personal protective equipment when using the endoscope.


Otherwise, it may cause infection.

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.

Do not supply an excessive amount of air or gas during a procedure as


doing so could cause perforation or rupture of the digestive tract wall,
or an embolism. Do not overinsufflate during any clinical procedure to
minimize the potential for pneumatic perforation.

[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.

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Chapter 6 Method of Use

6.1 Preparation

6.1.1 Preparing Necessary Equipment

Prepare the accessories and forceps, etc. to be used.

6.1.2 Pretreatment of Patient

Use pretreatment that suits the purpose of examination.

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Chapter 6 Method of Use

6.2 Insertion and Observation

WARNING
Do not operate the bending portion quickly. It may cause damage to
the body lumen.

Before attempting to clinically use this endoscope with an endotracheal


tube, select an appropriate size tube whose inner diameter has
sufficient clearance between the endotracheal tube and the endoscope
to avoid restriction of oxygen flow which may impair patient breathing.

The endotracheal tube should pass easily over the endoscope’s


insertion tube - never force an endotracheal tube onto the endoscope
and never apply excessive pressure or force when attempting to pass
or withdraw the endoscope.

When using diathermic treatment equipment, maintain enough distance


between the distal 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.

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Chapter 6 Method of Use

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.

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.

CAUTION
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.

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Chapter 6 Method of Use

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.

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.

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Chapter 6 Method of Use

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.

When attempting to use the endoscope with an endotracheal tube,


before applying lubricant ensure that the endotracheal tube slides
smoothly over the endoscope without resistance.

Ensure that the endoscope's distal bending portion is straight - never


angulate the endoscope while it is within the endotracheal tube.

Do not use if either endoscope or endotracheal tube is damaged or


compromised.

[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.

If transnasal insertion is difficult, endoscope withdrawal may also become difficult.


Regarding the propriety of transnasal insertion, use proper clinical judgment.

6-7

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Chapter 6 Method of Use

(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.

(3) Apply clean lubricant (Xylocaine jelly or the like) to the


insertion portion as required.

[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

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Chapter 6 Method of Use

[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.

Adjust the brightness with the level button on the light


source.

(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.

<To suck phlegm, mucus, blood, etc.>

Bring the distal end of the endoscope close to the objects


to be sucked, and suck them by pressing the suction
button.

6-9

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Chapter 6 Method of Use

<To perform spray anesthesia>

Perform the spray anesthesia from forceps inlet to prevent


coughing reaction.

6-10

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Chapter 6 Method of Use

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.

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.

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

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Chapter 6 Method of Use

(2) Check the opening and closing functions of the forceps.

Slowly insert the forceps straight into the forceps inlet


while observing the image.

[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.

(4) Bring the forceps closer to the biopsy site slowly.

6-12

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Chapter 6 Method of Use

(5) Take a biopsy specimen by manipulating the angle lever


and letting the forceps in and out.

(6) Remove the forceps slowly and take out the biopsy
specimen.

6-13

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Chapter 6 Method of Use

6.4 Withdrawal

(1) Unbend the bending portion until it is almost straight by


operating the angle lever.

(2) Pull the endoscope out slowly.


Remove the mouthpiece.

6-14

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Chapter 6 Method of Use

6.5 Pre-cleaning (Primary Cleaning)

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).

“7.4 Pre-cleaning (Primary Cleaning)” in Operation Manual (Cleaning, Disinfection and


Storage)

6-15

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Chapter 6 Method of Use

6-16

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Appendix

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

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Appendix

Main Specifications

<Classification of Medical Electrical Equipment>

1. Type of protection against electric shock : Class I equipment


(power supply: protective earth plug)
2. Degree of protection against electric shock : Type BF applied part
3. Degree of explosion protection : Use is prohibited in an oxygen-rich environment or
in a flammable gas atmosphere.
[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.

<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>

Temperature +10 to +40°C


Humidity 30 to 85%RH (no dew condensation)
Pressure 70 to 106 kPa (within range of atmospheric pressure)

Appendix-2

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Appendix

<Storage Environment>

Temperature -20 to +60°C


Humidity 10 to 85%RH (no dew condensation)
Pressure 70 to 106 kPa (within range of atmospheric pressure)

<Transport Environment>

Temperature -20 to +60°C


Humidity 10 to 85%RH (no dew condensation)
Pressure 70 to 106 kPa (within range of atmospheric pressure)

<Term of Validity/Period for Use (Durability)>

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”

<Compatible Processor and Light Source>

Processor VP-4450HD
VP-3500HD
VP-7000
Light Source XL-4450
BL-7000

<Consumable Supplies (Supplied with the Endoscope)>

Forceps valve FOV-DV7


Suction button SB-500B/D
Cleaning brush WB7024FW
WB11003FW
Cleaning adapter CA-500C

<Air Leak Tester (Optional Item)>

Air leak tester LT-7F

Appendix-3

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Appendix

<Compatible Endotherapy Devices>

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

<Image Size> <Direction of Forceps>

<Medical Device Directive>

This product complies with the requirements of


European Directive 93/42/EEC.
Classification : Class II a

Appendix-4

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Appendix

<Electromagnetic Compatibility (EMC) Information>

EB-580S is intended for use in the electromagnetic environments specified below.


The customer or the user of this product should assure that it is used in such an environment.

Electromagnetic emission compliance information and guidance


Emission standard Compliance Guidance
This product uses RF (Radio Frequency) energy
RF emissions only for its internal function. Therefore, its RF
Group I
EN 55011 emissions are very low and are not likely to cause
any interference in nearby electric equipment.

Radiated emissions This product is intended for use in medical


Class A [Note 1]
EN 55011 facilities and commercial facilities.
Harmonic emissions If this product is used in domestic establishments,
Class A [Note 1] electromagnetic interference may occur on any
EN 61000-3-2
equipments.
Voltage fluctuations/
In this case, it is recommended to use this
flicker emissions Applicable
product according to Chapter 1 “Safety.”
EN 61000-3-3
[Note 1] The class is Class B when this product is used in combination with the VP-7000 processor
and the BL-7000 light source.

[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

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Appendix

Electromagnetic immunity compliance information and guidance


EN 60601-1-2 Compliance
Immunity test Guidance
Test level level
Floors should be wood, concrete, or
Electrostatic discharge (ESD) ± 6kV: contact ceramic tile. If floors are covered with
Same as left
EN 61000-4-2 ± 8kV: air synthetic material, the relative humidity
should be at least 30%.

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.

Surge ± 1kV: Line to line Main power quality should be that of a


Same as left
EN 61000-4-5 ± 2kV: Line to earth typical commercial or hospital.

< 11.5V (> 218.5V dip)


For 0.5 cycle
Main power quality should be that of a
Voltage dips, short 92V (138V dip) typical commercial or hospital. If the
interruptions and voltage For 5 cycle user of this product requires continued
variations on power supply Same as left operation during power mains
input lines 161V (69V dip) interruptions, it is recommended
EN 61000-4-11 For 25 cycle that this product is powered from an
uninterruptible power supply or battery.
< 11.5V (> 218.5V dip)
For 5 sec
It is recommended to use this product
Power frequency (50/60 Hz)
by maintaining enough distance from
magnetic field 3 A/m Same as left
any equipment that operates with high
EN 61000-4-8
current.

Appendix-6

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Appendix

Electromagnetic immunity compliance information and guidance

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.

Recommended separation distance

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

Where “P” is the maximum output power rating of the


Radiated RF 3V/m 3V/m[E1]
transmitter in watts (W) according to the transmitter
EN 61000-4-3 80MHz to 2.5GHz
manufacturer and “d” is the recommended separation
distance in meters (m).

This product complies with the requirements of


EN 60601-1-2: 2007.
However electromagnetic interference may occur on this
product under electromagnetic environment that exceeds
its noise level.

Electromagnetic interference may occur in the vicinity of


equipment marked with the following symbol.

Electromagnetic immunity compliance information and guidance

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

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Appendix

Troubleshooting (‌ Combination with the Processor and the Light Source)

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

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Appendix

Problem Cause Remedy


An image disappears 1) The imaging section is damaged. 1) If the problem occurred during
during a procedure. treatment [Note 1], stop treatment and remove
the endotherapy device from the endoscope.
Then, reset [Note] the processor and the light
source. If the problem occurred during an
examination, reset [Note] the processor and
the light source. If an appropriate image
does not appear even after resetting, turn
them off, straighten the bending section to
unlock, release the angle knobs, withdraw
the endoscope slowly from the patient, and
then contact your local FUJIFILM dealer.
2) The endoscope connection is incomplete. 2) Reconnect the endoscope.
“5.2 Connecting the Endoscope”
3) The system is malfunctioning due to static 3) 4)
charges, etc. If the problem occurred during
4) The video signal cable has shorted out or treatment [Note 1], stop treatment and remove
broken. the endotherapy device from the endoscope.
Then, reset [Note] the processor and the light
source. If the problem occurred during an
examination, reset [Note] the processor and
the light source. If an appropriate image
does not appear even after resetting, turn
them off, straighten the bending section to
unlock, release the angle knobs, withdraw
the endoscope slowly from the patient, and
then contact your local FUJIFILM dealer.
A live image is not The system is malfunctioning due to static If the problem occurred during treatment [Note 1],
displayed after image charges, etc. stop treatment and remove the endotherapy
freezing is cancelled device from the endoscope. Then, reset [Note]
during a procedure. the processor and the light source. If the
problem occurred during an examination,
reset  [Note] the processor and the light source.
If an appropriate image does not appear
even after resetting, turn them off, straighten
the bending section to unlock, release the
angle knobs, withdraw the endoscope slowly
from the patient, and then contact your local
FUJIFILM dealer.

[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

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Appendix

Problem Cause Remedy


An image is suddenly 1) The imaging section is damaged. 1) 2) 3)
discolored during a 2) The system is malfunctioning due to static If the problem occurred during treatment [Note 1],
procedure. charges, etc. stop treatment and remove the endotherapy
3) The video signal cable has shorted out or device from the endoscope. Then, reset [Note]
broken. the processor and the light source. If the
problem occurred during an examination,
reset  [Note] the processor and the light source.
If an appropriate image does not appear
even after resetting, turn them off, straighten
the bending section to unlock, release the
angle knobs, withdraw the endoscope slowly
from the patient, and then contact your local
FUJIFILM dealer.
Images appear 1) The imaging section is damaged. 1) Reset [Note] the processor and the light
garbled. 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) Not connected correctly 2) Connect properly.
3) The video signal cable has shorted out or 3) Reset [Note] the processor and the light
broken. 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.
No suction 1) Pump is switched off. 1) Switch on the pump.
2) Pump is not connected. 2) Connect the pump.
3) No forceps valve is attached. 3) Attach a forceps valve.
4) The suction button is damaged. 4) Replace with a new suction button.
Low suction volume 1) The suction button is damaged. 1) Replace with a new suction button.
2) The forceps valve is degraded. 2) Replace with a new forceps valve.
3) The suction tube is not attached properly. 3) Reattach the suction tube.
4) The forceps valve is not attached properly. 4) Reattach the forceps valve.
The suction button 1) Foreign matters or blood is adhered to the 1) Disconnect the suction tube. After pulling
does not return to the suction button. out endoscope, detach the button and clean
original position. or replace it.
2) The suction button is damaged. 2) Replace with a new suction button.

[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

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Appendix

Problem Cause Remedy


The endotherapy 1) The endotherapy device (such as biopsy 1) Close the endotherapy device for insertion.
device cannot be forceps) is left open.
inserted. 2) The handle of the endotherapy device (such 2) Loosen the grip to insert the endotherapy
as biopsy forceps) is held firmly. device.
3) The endotherapy device (such as biopsy 3) Reduce the angle of the bending portion
forceps) has difficulty being inserted due to slightly and then insert it.
bending.
4) Improper size is used. 4) Use an endotherapy device with an
appropriate size.
The endotherapy 1) The endotherapy device (such as biopsy 1) Close the endotherapy device and pull it out
device cannot be forceps) is left open. from the endoscope.
withdrawn. 2) The handle of the endotherapy device (such 2) Loosen the grip and pull out the
as biopsy forceps) is held firmly. endotherapy device from the endoscope.
3) The endotherapy device (such as biopsy 3) Reduce the angle of the bending portion
forceps) has difficulty being inserted due to slightly and then pull out the endotherapy
bending. device from the endoscope.
4) An abnormality occurs in the endotherapy 4) Withdraw the tip of the endotherapy device
device. to the forceps outlet of the endoscope, and
then slowly pull out the endoscope and
endotherapy device together.
5) Improper size is used. 5) Withdraw the tip of the endotherapy device
to the forceps outlet of the endoscope, and
then slowly pull out the endoscope and
endotherapy device together.
[Note] Use an endotherapy device with an
appropriate size.
Images cannot be 1) The image recorder is not connected. 1) Connect the image recorder.
captured in the image 2) Not connected correctly. 2) Reconnect the image recorder to ensure
recorder. correct connection.
The bending portion The bending control mechanism is Discontinue use immediately, and contact your
cannot return to malfunctioning. local FUJIFILM dealer or the nearest service
neutral position. center without forcing the bending portion out
of position. Forcing the bending portion out
of position could cause damage to the body
cavity.

Appendix-11

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Appendix

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.

3) Repairs during the warranty period

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.

Note that the warranty is void in the following cases:


a. Damage caused by fire or natural disaster such as storms or floods.
b. Troubles caused by careless handling or misuse of the product on the part of the user.
c. Troubles caused by repair or modification by an unauthorized person.

4) Repairs after the warranty period

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

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Appendix

Disposal of Electric and Electronic Equipment

Disposal of Used Electrical and Electronic Equipment (Applicable in the


European Union and other European countries with separate collection systems)

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

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Appendix

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

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Appendix

Service Centers

Contact our regional representative below or the distributor from which you purchased the product.

<Europe>

FUJIFILM Europe GmbH


http://www.fujifilm.eu/eu/
See our website to locate our representative in your country.

<USA>

FUJIFILM Medical Systems U.S.A., Inc.


http://www.fujifilmendoscopy.com/
(800) 385-4666

<Australia>

FUJIFILM Australia Pty Ltd.


http://www.fujifilm.com.au/
1800 060 209

<Asia>

FUJIFILM (Singapore) Pte. Ltd.


http://www.fujifilm.com.sg/
6380-5540

If you are not a resident of the regions above, contact the distributor from which you purchased the product.

Appendix-15

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FUJIFILM Corporation
26-30, Nishiazabu 2-chome, Minato-ku, Tokyo 106-8620, Japan

FUJIFILM Europe GmbH


Heesenstrasse 31, 40549 Duesseldorf, Germany

202B1263154B
160720-3.0-DT-E2
FB89A Printed in Japan

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