FujiFilm EI-580BT User manual

Video Endoscope
EI-580BT
OPERATION MANUAL
This Operation Manual describes details on how to operate the video endoscope and cautions to be
observed when operating it. Please read this manual thoroughly before actually operating the video
endoscope.
After reading this manual, store it nearby the video endoscope so that you can see it whenever
necessary.
202B1263075
English
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Introduction
Video Endoscope EI-580BT is a medical endoscope intended for the observation,
diagnosis and endoscopic treatment of the esophagus, stomach, duodenum, small
intestine, ileocecal region, large intestine, sigmoid colon and rectum at medical
facilities under the management of physicians.
This manual provides necessary information for using the endoscope, such as the
equipment overview, operation procedures and precautions to observe.
The Reprocessing Manual describes precautions and the cleaning, disinfection and
storage methods for the endoscope.
If you are a rst-time user of this product, be sure to read this manual before actual
operation. Also, after reading this manual, store it close to this product for future
reference to keep the endoscope in optimum working condition.
In this manual, illustrations and nomenclature of the video processor VP-4450HD and
the light source XL-4450 are used for explanation unless otherwise noted.
Trademarks
The company names and product names described in this manual are trademarks or registered trademarks
of FUJIFILM Corporation or its subsidiaries.
Other holders’ trademarks
All other company names and product names described in this manual are trademarks or registered
trademarks of their respective owners.
Copyright © 2015 FUJIFILM Corporation. All rights reserved.
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Introduction
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CAUTION
1 No part or all of this manual may be reproduced in any form without prior
permission.
2 The information contained in this manual may be subject to change without
prior notice.
3 FUJIFILM Corporation shall not be liable for malfunctions and damages
caused by installation, relocation, remodeling, maintenance, and repair
performed by dealers other than those specied by FUJIFILM Corporation.
4 FUJIFILM Corporation shall not be liable for malfunctions and damages of
FUJIFILM Corporation products due to products of other manufacturers not
supplied by FUJIFILM Corporation.
5 FUJIFILM Corporation shall not be liable for malfunctions and damages
caused by remodeling, maintenance, and repair using repair parts other than
those specied by FUJIFILM Corporation.
6 FUJIFILM Corporation shall not be liable for malfunctions and damages
resulting from negligence of the precautions and operating methods contained
in this manual.
7 FUJIFILM Corporation shall not be liable for malfunctions and damages
resulting from use under environment conditions outside the range specied
for this product, such as the power supply, installation environment, etc., as
described in this manual.
8 FUJIFILM Corporation shall not be liable for malfunctions and damages
resulting from natural disasters, such as res, earthquakes, oods, lightning,
etc.
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
Reprocessing Manual. There is a risk of being a source of infection.
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Introduction
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Endoscope Manuals
Manage and store the Operation Manual and Reprocessing Manual of this product as a
set.
Video Endoscope EI-580BT Operation Manual
Video Endoscope EI-580BT Reprocessing Manual
This manual provides necessary information for using the video endoscope such as the equipment
overview, operation procedures and precautions to observe.
This manual describes the cleaning, disinfection, sterilization and storage methods of the video
endoscope.
[Note] In this manual, the Video Endoscope EI-580BT Operation Manual is referred to
as “this manual”, and the Video Endoscope EI-580BT Reprocessing Manual as
“Reprocessing Manual”.
How to Read This Manual
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.
WARNING Explains dangerous situations that may cause death or serious
injury if not avoided.
CAUTION Explains situations that may cause injury if not avoided.
CAUTION Explains situations that may cause damage to equipment
if not avoided.
(1), (2), (3), ...
Indicates consecutive numbers in operating procedures for the
order in which successive steps in the procedure should be
taken.
[Note] Indicates a comment or supplementary information.
Indicates a reference.
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Endoscope Manuals
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Contents at a Glance
Chapter 1 Precautions
This chapter describes the warnings and cautions for safe operation of
the endoscope.
Chapter 2 Product Overview
This chapter describes the composition of the endoscope set of
accessories and system conguration.
Chapter 3 Preparation and Inspection
Before Use
This chapter describes the inspection and preparation methods to be
performed for using the endoscope.
Chapter 4 Method of Use
This chapter describes a series of operations of the endoscope.
Chapter 5 Troubleshooting
This chapter describes actions should be taken if problems occur in the
endoscope.
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Contents at a Glance
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Contents
Introduction..................................................................................................................3
Endoscope Manuals .....................................................................................................5
How to Read This Manual ...........................................................................................5
Contents at a Glance ....................................................................................................6
Chapter 1 Precautions ...............................................................................................10
1.1 For Safe Operation .......................................................................10
1.2 Classication ................................................................................10
1.3 Safety............................................................................................11
1.3.1 Infection..........................................................................11
1.3.2 Preventing Electrical Shock............................................14
1.3.3 Treatment with Electrosurgical Instruments...................14
1.3.4 Direct Harm to Human Body..........................................16
1.3.5 Balloon Instructions........................................................17
1.4 Electromagnetic Compatibility (EMC) ........................................19
1.4.1 Electromagnetic Compatibility (EMC)
Related Standard.............................................................19
1.5 Location of Each Label ................................................................20
1.5.1 Location of Labels ..........................................................20
1.5.2 Symbols ..........................................................................21
1.6 Possible Combinations for Use ....................................................22
1.6.1 Accessories .....................................................................22
1.6.2 Compatible Video Processor and Light Source..............22
1.6.3 Peripheral Devices ..........................................................23
1.7 Cautions/Warnings .......................................................................24
1.7.1 Abnormalities during Use of This Product.....................24
1.7.2 Transportation and Storage.............................................25
1.7.3 Storage and Management ...............................................25
1.7.4 General Warnings ...........................................................26
Chapter 2 Product Overview.....................................................................................28
2.1 Composition of Standard Set........................................................28
2.2 System Conguration ..................................................................30
2.2.1 Combination with VP-4450HD ......................................30
2.2.2 Combination with VP-7000............................................32
2.3 Nomenclature and Functions of Endoscope.................................34
2.4 Nomenclature and Functions of Endoscope Distal End...............36
2.5 Nomenclature and Functions of Accessories ...............................37
2.5.1 Forceps Valve .................................................................37
2.5.2 Cleaning Adapter ............................................................38
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2.6 Operating Bending Section ..........................................................40
2.6.1 Operating the Bending Section.......................................40
2.6.2 Angle Lock Function ......................................................42
2.7 Control Valves..............................................................................44
2.7.1 Suction Valve..................................................................44
2.7.2 Air/Water Valve..............................................................44
2.8 Scope Switches for Images and Recording ..................................45
Chapter 3 Preparation and Inspection Before Use....................................................46
3.1 Preparing Forceps Valve ..............................................................46
3.1.1 Cleaning and Disinfecting (or Sterilizing)
the Forceps Valve ...........................................................47
3.1.2 Inspecting the Forceps Valve..........................................47
3.1.3 Attaching the Forceps Valve ..........................................47
3.2 Preparing Air/Water Valve and Suction Valve ............................48
3.2.1 Inspecting the Air/Water Valve and Suction Valve........48
3.2.2 Attaching the Air/Water Valve and Suction Valve ........49
3.3 Preparing and Inspecting Over-tube and Balloon ........................50
3.3.1 Preparing and Inspecting Necessary Equipment ............50
3.3.2 Attaching the Over-tube .................................................52
3.3.3 Mounting the Endoscope Balloon ..................................52
3.3.4 Attaching the Fixing Rubber ..........................................54
3.3.5 Attaching the Hood (Only When Necessary) .................57
3.3.6 Inspecting the Balloon ....................................................59
3.4 Connecting Balloon Controller ....................................................60
3.4.1 Connecting the Balloon Controller.................................60
3.4.2 Inspecting the Balloon (Balloon Controller) ..................61
3.5 Preparing System..........................................................................63
3.5.1 Preparing Peripheral Devices .........................................63
3.5.2 Preparing the System ......................................................63
3.6 Connecting Endoscope (Attachment)...........................................65
3.6.1 Connecting the Endoscope
(Video Processor and Light Source)...............................65
3.6.2 Connecting the Water Tank and Suction Unit................67
3.7 Inspecting Endoscope...................................................................68
3.7.1 Inspecting the Insertion Portion......................................68
3.7.2 Inspecting the Bending Mechanism................................69
3.7.3 Inspecting the Air/Water Supply and
Suction Channels ............................................................69
3.7.4 Inspecting the Balloon Air Feed Inlet.............................71
3.7.5 Inspecting the Instrument Channel .................................71
3.8 Inspecting Distal End of Endoscope ............................................72
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Chapter 4 Method of Use..........................................................................................74
4.1 Preparation....................................................................................76
4.1.1 Preparing Necessary Equipment.....................................76
4.1.2 Pretreatment of the Patient..............................................76
4.2 Insertion and Observation ............................................................77
4.2.1 Peroral Insertion..............................................................79
4.2.2 Transanal Insertion .........................................................83
4.2.3 To Suck Mucus ...............................................................87
4.2.4 If Mucus Adheres to the Distal Objective Lens or
If the Image is Obscured.................................................87
4.3 Treatment......................................................................................88
4.4 Endoscope Withdrawal.................................................................89
4.5 Removing Hood, Over-tube and Balloon.....................................91
4.5.1 Removing the Hood (Only When Used) ........................91
4.5.2 Removing the Balloon ....................................................92
4.5.3 Removing the Over-tube.................................................92
4.6 Pre-cleaning (Primary Cleaning)..................................................93
Chapter 5 Troubleshooting .......................................................................................94
5.1 Troubleshooting............................................................................94
Main Specication ...................................................................................................103
Service .....................................................................................................................109
Disposal of Electric and Electronic Equipment.......................................................110
Index ........................................................................................................................111
Service Centers ........................................................................................................112
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Chapter 1 Precautions
1.1 For Safe Operation
Before using this product, read this section carefully so that you can operate it correctly.
Whenever you operate this product, be sure to observe those precautions. Failure to do so
may cause you to subject to injuries or property damage to occur.
The institution is responsible for the use and maintenance of this product.
In addition, this product should not be used by persons other than doctors or
suitably trained staff.
Be sure to prepare a spare endoscope against unexpected accidents such
as the failure of this product. Otherwise, you may not be able to continue the
endoscopic procedure. If the spare endoscope is not available, prepare other
alternative means such as abdominal surgery.
This product is intended for use by medical professionals who have received
proper training in endoscopic procedures. This manual does not provide
information about clinical procedures or any aspects of endoscopic techniques.
Do not modify this product or its components, and do not disassemble, repair
or in any other way reverse-engineer these products. Even if you nd a defect,
do not attempt to repair these products yourself. FUJIFILM Corporation shall
not be liable for any defects or device failures caused by such modications,
disassembly, repairs or reverse-engineering.
1.2 Classication
<Classication of Medical Electrical Equipment>
1. Type of protection against electric shock : Class I equipment
(power supply: protected ground fault
receptacle)
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 ammable gas atmosphere.
[Note] Use in combination with the VP-4450HD video processor and XL-4450 light
source or with the VP-7000 video processor and BL-7000 light source.
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1.3 Safety
Read the following precautions before using this product to ensure proper handling.
1.3.1 Infection
WARNING
This product has not been cleaned or disinfected (or sterilized). It
must be cleaned and disinfected (or sterilized) for the rst time prior
to use and after any subsequent use as per instructions provided in
the Reprocessing Manual. Prior to reuse, this product must be pre-
cleaned, cleaned and disinfected (or sterilized) according to the
procedures given in the Reprocessing Manual. Inadequate cleaning
may compromise successful disinfection or sterilization, increasing the
risk of infection.
Meticulously clean the endoscope’s all surfaces including channels as
per provided reprocessing instructions.
Wear personal protective equipment during clinical procedures as well
as during cleaning and disinfection (or sterilization) to protect your eye
and skin and to prevent infection.
Wear personal protective equipment when using the endoscope.
Otherwise, it may cause 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 Reprocessing Manual 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 local guidelines.
Ensure that the forceps valve is properly attached to the instrument
channel inlet. If this product is used without the forceps valve attached,
body uid may ow 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.
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WARNING
The forceps valve 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 increase a risk of
infection.
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.
The lid of the forceps valve must be closed when using the endoscope.
Not doing so may cause backow of body uids and increase a risk of
infection.
If the lid of the forceps valve needs to be open during an examination
or treatment, put sterile gauze around the forceps valve before opening
the lid. If sterile gauze is not applied, body fluid may be splattered,
leading to infection.
Be sure to attach a balloon and Over-tube when using the endoscope.
If not attached, body uid may ow back and it could be a source of
infection.
Do not use the balloon or Over-tube after its expiration date has
elapsed. Doing so may pose an infection risk.
The lter and tube of the tube kit are consumables. Replace them once
a month or once every 10 cases, whichever comes rst. If body uid
ows back into the tube, replace the tube kit. Not doing so may pose
an infection risk.
When removing the hood, Over-tube and balloon, wear personal
protective equipment and slowly remove them. Not doing so may pose
an infection risk.
Do not release your finger suddenly from the suction valve during
suction. Doing so may cause body fluid to splatter and pose an
infection risk.
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WARNING
Slowly insert an endotherapy device (e.g. forceps) or syringe straight
into the endoscope. Also, when withdrawing it, slowly pull straight
out. If it is inserted or withdrawn quickly, body uid may be splattered
around due to breakage or accidental detachment of the instrument,
leading to infection.
Do not perform examinations with an endotherapy device hung over
the forceps valve. Doing so may cause backflow of body fluids and
increase a risk of infection.
The forceps valve, setting tool ST-05B, balloon and Over-tube are
intended for single use. To prevent infection, do not reuse them.
Discard the forceps valve, balloon and Over-tube after use. Used
forceps valve, balloon and Over-tube could be a source of infection.
Use a cleaned and disinfected (or sterilized) air/water valve and
suction valve. An inadequately cleaned and disinfected (or sterilized)
accessory may pose an infection risk.
Use a cleaned and disinfected (or sterilized) endotherapy device. An
inadequately cleaned and disinfected (or sterilized) endotherapy device
may pose an infection risk.
When supplying water, use sterile water. If sterile water is not used, it
can create a risk of infection.
Carry a cleaned and disinfected (or sterilized) endoscope at a clean
state. If personal protective equipment such as gloves is contaminated,
the contaminants adhere to the endoscope and it can be a source of
infection.
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1.3.2 Preventing Electrical Shock
WARNING
Insert the AC plug into a hospital grade receptacle. Not doing so may
cause an electric shock accident.
Use an electrosurgical instrument conforming to EN 60601-2-2. Refer
to the manual of the electrosurgical instrument for how to operate the
electrosurgical instrument.
Connect the electrosurgical instruments and electrosurgical generators
in accordance with each operation manual. Incorrect connection may
cause electric shock and/or burns.
CAUTION
The endoscope may be used in combination with peripherals. To avoid
an electric shock accident, do not use any peripherals than the ones
specied in this manual.
1.3.3 Treatment with Electrosurgical Instruments
WARNING
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 eld 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-ammable gas
such as carbon dioxide. Do not use excessive non-ammable gas.
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WARNING
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 rst 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
We recommend use of only those peripheral products specied 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 uid, 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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1.3.4 Direct Harm to Human Body
WARNING
Use the air/water channel cleaning adapter CA-611 only for cleaning
the air/water channel. If it is used during an examination or treatment,
continuous air supply may occur and cause patient injury.
Do not supply an excessive amount of air or gas during the procedure
as doing so could cause an embolism. Do not overinsufate during any
clinical procedure to minimize the potential for pneumatic perforation.
To avoid the potential for patient injury including perforation, do not
apply excessive force of the endoscope or endotherapy device against
mucosal surfaces. Only advance the endotherapy device under direct
visualization.
Do not angulate the bending section or insert the endoscope while
an endotherapy device is out of the distal end. Doing so may cause
the endotherapy device to be pressed against the mucosal surfaces,
resulting in bleeding or perforation.
CAUTION
During an observation, do not perform close observation for an
extended period of time. Use the endoscope with a minimum
necessary amount of brightness and time while maintaining an
appropriate distance. When the shutter speed is set to "HIGH", take
care not to set the brightness level too high. Thermal energy created
by illumination may cause burn injury. For details on the settings, refer
to the operation manual of the light source and video processor in use.
If the brightness level is high, the temperature at the distal end may
exceed 41°C. Do not allow the distal end to remain in contact with the
same site for an extended period of time. It may cause burn injury.
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.
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CAUTION
Set the suction pressure between 40 and 53 kPa. If the suction
pressure is too high, the endoscope may adhere to mucous membrane,
resulting in damage to the mucous membrane.
Do not look directly into the light coming from the light guide at the
distal end of the endoscope. Turn off the lamp before inspecting the
objective lens. Viewing the light from the light guide directly may
damage your eyes.
1.3.5 Balloon Instructions
WARNING
When using the Over-tube and balloon, the operator should conduct
sufficient basic experiments outside the body and learn the degree
of ination of the balloon before using it. If the balloon is swollen too
much, the intestinal tract might be damaged.
This product is used with a product that contains natural rubber as
a material. Natural rubber may rarely cause allergy symptoms, such
as itching, reddening, hives, swelling, fever, dyspnea, asthma-like
symptoms, drop of blood pressure and shock. If such symptoms are
observed, stop use immediately and take appropriate measures.
Do not use the TS-13101 Over-tubes and BS-2 balloons on patients
allergic to latex. Doing so can create a risk of an anaphylactic reaction/
shock.
Connect the endoscope and the Over-tube to the balloon controller
properly. Before insertion, make sure that the balloon operates as
intended. Otherwise, it may cause an injury.
Do not supply excessive amount of air or gas during the procedure.
Doing so may result in perforation or rupture of the digestive tract wall.
Do not inate the balloon in the pharynx or esophagus. Doing so can
create a risk of suffocation.
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WARNING
Insert and withdraw the endoscope or Over-tube slowly. Slowly insert
the Over-tube so as not to have the intestinal tract caught in a gap
between the endoscope and Over-tube. When holding the Over-
tube, take care not to fold or crush the air feed inlet (clear tube). Do
not press the endoscope or Over-tube strongly onto the walls of the
digestive tract. Do not insert or withdraw the endoscope or Over-tube
with the balloon inated. It may damage to the walls of the digestive
tract, causing perforation.
Make sure that water never enters the balloon air feed inlet (clear tube)
of the Over-tube or the balloon air feed inlet of the endoscope. Ination
or deflation of the balloon with the balloon controller may become
impossible, damaging the walls of the digestive tract.
Use of devices such as endoscopic/enteroscopy overtubes may be
associated with potential complications including but not limited to
mucosal trauma, pancreatitis and/or hyperamylasemia. Users are
encouraged to closely monitor patients for such complications during
and after procedures and to appropriately treat patients as required.
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1.4 Electromagnetic Compatibility (EMC)
To avoid electromagnetic interference in the operational environment, read the following
precautions and properly handle this product and other devices in the vicinity.
1.4.1 Electromagnetic Compatibility (EMC) Related Standard
This product has been tested and conrmed to comply with the limits for medical devices
dened in EN 60601-1-2:2007. These limits are designed to provide reasonable protection
against harmful electromagnetic interference in a typical installation at medical facilities.
However, there is a possibility that this product may cause harmful electromagnetic
interference to other devices in the vicinity, even if it is used according to the video
processor instructions. Also, there is no guarantee that interference will not occur in a
particular installation. If this product does cause harmful electromagnetic interference to
other devices, that can be determined by turning the processor off and on, we recommend
that you may 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 other devices.
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.
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.
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1.5 Location of Each Label
The positions where the labels are afxed on this product are shown below. The relevant
safety signs are also described.
1.5.1 Location of Labels
<Control Portion>
Model Label
Instrument Channel Diameter Label
<LG Connector>
LG Connector Label
Label for the Serial Number
Label for the Year of Manufacture
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