FujiFilm EG-580UR User manual

フジノン 和 文
Ultrasonic Endoscope
EG-580UR
OPERATION MANUAL
This Operation Manual describes details on how to operate the ultrasonic endoscope and cautions
to be observed when operating it. Please read this manual thoroughly before actually operating the
ultrasonic endoscope.
After reading this manual, store it nearby the ultrasonic endoscope so that you can see it whenever
necessary.
202B1262871D
English
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Introduction
Ultrasonic Endoscope EG-580UR is an upper gastrointestinal endoscope intended for
the observation and diagnosis of the esophagus, stomach and duodenum, and for the
observation, diagnosis and endoscopic treatment of submucosal and peripheral organs
at medical facilities under the management of physicians.
This product is not intended for use on children and infants.
This manual provides necessary information for using the ultrasonic 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 ultrasonic 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 ultrasonic endoscope in optimum working condition.
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 © 2015-2016 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.
Ultrasonic Endoscope EG-580UR Operation Manual
Ultrasonic Endoscopes EG-580UT and EG-580UR
Reprocessing Manual
This manual provides necessary information for using the ultrasonic endoscope such as the
equipment overview, operation procedures and precautions to observe.
This manual describes the cleaning, disinfection, sterilization and storage methods of the ultrasonic
endoscope.
[Note] In this manual, the Ultrasonic Endoscope EG-580UR Operation Manual is referred
to as “this manual”, and the Ultrasonic Endoscopes EG-580UT and EG-580UR
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 ultrasonic endoscope.
Chapter 2 Product Overview
This chapter describes the composition of the ultrasonic 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 ultrasonic endoscope.
Chapter 4 Method of Use
This chapter describes a series of operations of the ultrasonic endoscope.
Chapter 5 Troubleshooting
This chapter describes actions should be taken if problems occur in the
ultrasonic endoscope.
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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 ................................................................................11
1.3 Safety............................................................................................12
1.3.1 Infection..........................................................................12
1.3.2 Preventing Electrical Shock............................................15
1.3.3 Treatment with Electrosurgical Instruments...................16
1.3.4 Direct Harm to Human Body..........................................18
1.4 Electromagnetic Compatibility (EMC) ........................................21
1.4.1 Electromagnetic Compatibility (EMC)
Related Standard.............................................................21
1.5 Location of Each Label ................................................................22
1.5.1 Location of Labels ..........................................................22
1.5.2 Symbols ..........................................................................24
1.6 Possible Combinations for Use ....................................................26
1.6.1 Accessories .....................................................................26
1.6.2 Compatible Processor, Light Source and
Ultrasonic Processor .......................................................26
1.6.3 Peripheral Devices ..........................................................26
1.7 Cautions/Warnings .......................................................................27
1.7.1 Abnormalities during Use of This Product.....................27
1.7.2 Transportation and Storage.............................................28
1.7.3 Storage and Management ...............................................28
1.7.4 General Warnings ...........................................................29
Chapter 2 Product Overview.....................................................................................30
2.1 Composition of Standard Set........................................................30
2.2 System Conguration ..................................................................32
2.3 Nomenclature and Functions of Ultrasonic Endoscope ...............34
2.4 Nomenclature and Functions of
Ultrasonic Endoscope Distal End.................................................36
2.5 Nomenclature and Functions of Accessories ...............................37
2.5.1 Forceps Valve .................................................................37
2.5.2 Balloon............................................................................38
2.5.3 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
2.8 Scope Switches.............................................................................45
2.9 Ultrasonic Image ..........................................................................46
Chapter 3 Preparation and Inspection Before Use....................................................47
3.1 Preparing Forceps Valve ..............................................................47
3.1.1 Cleaning and Disinfecting (or Sterilizing)
the Forceps Valve ...........................................................47
3.1.2 Inspecting the Forceps Valve..........................................48
3.1.3 Attaching the Forceps Valve ..........................................48
3.2 Preparing Air/Water Valve and Suction Valve ............................49
3.2.1 Inspecting the Air/Water Valve and Suction Valve........49
3.2.2 Attaching the Air/Water Valve and Suction Valve ........50
3.3 Preparing Peripheral Devices .......................................................51
3.4 Preparing System..........................................................................52
3.4.1 Preparing the System ......................................................52
3.5 Connecting Ultrasonic Endoscope (Attachment).........................54
3.5.1 Connecting the Ultrasonic Endoscope
(Processor, Light Source, Water Tank and
Suction Unit)...................................................................54
3.6 Inspecting Ultrasonic Endoscope .................................................56
3.6.1 Inspecting the Insertion Portion......................................56
3.6.2 Inspecting the Bending Mechanism................................57
3.6.3 Inspecting the Air/Water and Instrument Channels........58
3.6.4 Inspecting the Instrument Channel .................................59
3.7 Inspecting Distal End of Ultrasonic Endoscope...........................60
3.8 Inspecting Ultrasonic Image.........................................................64
3.9 Attaching and Inspecting Balloon ................................................65
Chapter 4 Method of Use..........................................................................................69
4.1 Preparation....................................................................................70
4.1.1 Preparing Necessary Equipment.....................................70
4.1.2 Pretreatment of Patient ...................................................70
4.2 Insertion and Observation ............................................................71
4.2.1 Preparing the Mouthpiece...............................................73
4.2.2 Insertion ..........................................................................73
4.2.3 To Suck Mucus ...............................................................76
4.2.4 If Mucus Adheres to the Distal Objective Lens or
If the Image is Obscured.................................................76
4.3 How to Use Balloon .....................................................................77
4.4 Biopsy...........................................................................................79
4.5 Endoscope Withdrawal.................................................................81
4.6 Removing Balloon........................................................................83
4.7 Pre-cleaning (Primary Cleaning)..................................................84
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Chapter 5 Troubleshooting .......................................................................................85
5.1 Troubleshooting............................................................................85
Main Specication .....................................................................................................93
Service .....................................................................................................................100
Disposal of Electric and Electronic Equipment.......................................................101
Index ........................................................................................................................102
Service Centers ........................................................................................................103
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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. When performing observation,
diagnosis and endoscopic treatment of small intestine, refer to general
contraindications to upper gastrointestinal tract endoscopy and colonoscopy.
In addition, if the general condition of the patient is extremely critical, or if
there are any risks involved in performing the endoscopic examination of
ileus, gastrointestinal perforation, respiratory disease, cardiovascular disease,
Crohn's disease, acquired hemophilia, stenosis, large ulcer, tumor, etc.,
perform endoscopy only when the benefits outweigh the risks. 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.
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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.
4. Degree of waterproof : IEC 60529 IPX7 (with US waterproof cap attached)
[Note] Use in combination with the VP-4450HD processor, XL-4450 light source and
SU-1 ultrasonic processor.
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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 ultrasonic endoscope’s all surfaces including
channels as per provided reprocessing instructions.
Wear personal protective equipment during a procedure as well as
during cleaning and disinfection (or sterilization) to protect your eye
and 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 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 ultrasonic
endoscope. Not doing so may cause backflow of body fluids and
increase a risk of infection.
Use a disinfected (or sterilized) balloon attachment tool. There is a risk
of infection.
During ultrasonic procedures in which a balloon is not used, do not
fully depress the suction valve and do not attempt to aspirate patient
material into/through the balloon evacuation channel. Doing so can
result in partial or complete clog of the narrow balloon evacuation
channel, especially if the ultrasonic endoscope is not cleaned
immediately after each procedure and if not reprocessed as per
FUJIFILM recommendations. Once the balloon evacuation channel is
clogged, it cannot be cleaned, disinfected or sterilized properly and can
be a source of infection.
If the lid of the forceps valve needs to be open during a procedure, put
sterile gauze around the forceps valve before opening the lid. If sterile
gauze is not applied, body uid may be splattered, leading to infection.
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WARNING
Slowly insert an endotherapy device (e.g. forceps) or syringe straight
into the ultrasonic endoscope. Also, when withdrawing it, slowly pull
straight out. If it is inserted or withdrawn quickly, body fluid may be
splattered around due to breakage or accidental detachment of the
instrument, leading to infection.
Do not perform procedures 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 and balloon are intended for single use. To prevent
infection, do not reuse them.
Discard the forceps valve and balloon after use. Used forceps valve
and balloon 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) valve
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) ultrasonic endoscope
at a clean state. If personal protective equipment such as gloves is
contaminated, the contaminants adhere to the ultrasonic endoscope
and it can be a source of infection.
When removing the balloon, wear personal protective equipment and
slowly remove the balloon. There is a risk 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 ultrasonic 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.
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1.3.3 Treatment with Electrosurgical Instruments
WARNING
This product is not intended to stop bleeding with diathermic treatment
equipment. Prepare an endoscope and diathermic treatment
equipment that can be used with it, so as to take necessary actions in
emergencies such as bleeding.
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.
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 repeated use affects the cutting quality of therapeutic
accessories.
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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. Not doing so could cause thermal injury to a patient.
Do not energize the electrosurgical instruments when the electrically
active portion of diathermic treatment equipment and the metal part
at the distal end of the ultrasonic endoscope are in contact with each
other. Thermal injury or scope damage may occur.
Do not apply the current under the circumstance that patient’s clothing
is wet when using electrosurgical instruments. 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.
When using diathermic treatment equipment, maintain enough distance
between the distal end of the ultrasonic 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.
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1.3.4 Direct Harm to Human Body
WARNING
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 in blood pressure and shock. If such symptoms
are observed, stop the use of this product immediately and take
appropriate measures.
Do not use this product with an endoscopic CO2regulator. If used, air
bubbles may be generated in the sterile water inside the water tank
and enter the balloon channel. This could prevent water discharge from
the balloon and disable deation of the balloon.
Do not use a balloon on patients allergic to latex. There is a risk of an
anaphylactic reaction.
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 ultrasonic endoscope or endotherapy
device against mucosal surfaces. Only advance the endotherapy
device while viewing the endoscopic image.
Use the air/water channel cleaning adapter CA-609 only for cleaning
the air/water channel. If it is used during a procedure, continuous air
supply may occur and cause patient injury.
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CAUTION
Take extreme care when inserting the ultrasonic endoscope into the
oral cavity. Otherwise, it may cause pain to the patient.
Do not forcibly advance or withdraw the ultrasonic endoscope into/
from the patient. It may cause damage to the body lumen, bleeding or
perforation.
Do not angulate the bending section forcibly or operate it quickly. It
may cause damage to the body lumen, bleeding or perforation.
During an observation, do not perform close observation for an
extended period of time. Use the ultrasonic 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 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.
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CAUTION
When the ultrasonic endoscope projects light at high brightness and
transmission of ultrasonic waves for a long time, the temperature may
exceed 41°C at the distal end. Turn off the lamp and stop transmission
of ultrasonic waves (Freeze the ultrasonic processor) when you hang
the ultrasonic endoscope on the cart hanger.
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.
Set the suction pressure between 40 and 53 kPa. If the suction
pressure is too high, the ultrasonic 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 ultrasonic endoscope. Turn off the lamp before
inspecting the objective lens. Viewing the light from the light guide
directly may damage your eyes.
If the balloon or other parts fall into a body cavity due to a malfunction
of the device, immediately stop the procedure and retrieve the parts by
following appropriate measures. There is a risk of damaging the inside
of the body cavity.
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