FujiFilm EB-530US User manual

フジノン和文
Thank you for purchasing our product. Read this manual carefully before use to avoid
unexpected accidents, and take full advantage of the product's capabilities.
Ultrasonic Endoscope
EB-530US
English
OPERATION MANUAL
(Preparation and Operation)
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Important Safety Information
For the USA Market - CAUTION:
Federal law restricts this device to sale by or on the order of a physician.
1. Intended Use
This product is a medical Ultrasonic Endoscope to be used under the control of doctors
in medical facilities for the observation, diagnosis and medical treatment of tracheae
and bronchi, as well as the inspection of tracheae, bronchi and adjacent organs, using
ultrasonic imaging. Never use this product for any other purpose. This product is not
intended for use on children and infants.
2. Safety
Read and understand this manual carefully before use. Use the Ultrasonic Endoscope
by following the provided instructions. Items important for the safe use of the
Ultrasonic Endoscope are summarized in Chapter 1 “Safety.”
Safety precautions associated with individual operations or procedures are provided
separately, indicated “ WARNING” or “ CAUTION.”
3. Warning
Items that must be observed for safety when performing endoscopy or electrosurgery
are identied 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. About Clinical Procedures
This manual assumes that the product will be used by medical specialists who have
received proper training in ultrasonic endoscopic procedures. It does not provide
information about clinical procedures. Regarding clinical procedures, use proper clini-
cal judgment.
5. When Using this Product for the First Time
This product has not been sterilized. When using it for the rst time, use the level of
disinfection or sterilization suitable to the application, in accordance with Chapter 7
“Cleaning,” Chapter 8 “Chemical Disinfection,” and Chapter 9 “Gas Sterilization.”
Important Safety Information
2
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6. Treatment with Electrosurgical Instruments
This product cannot be used with an electrosurgical instrument for treatment.
7. About Latex Allergy
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.
8. If Any Abnormality Occurs During Clinical Procedure
If any abnormality occurs with the equipment, refer to “Troubleshooting.” Especially,
continued use of the equipment with abnormal images can cause burn and injury by
heat generation from the distal of the Ultrasonic Endoscope.
9. 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.
During treatment, if the endoscopic image disappears, a live image is not displayed
after freeze mode has been cancelled, or the endoscopic image is discolored, stop treat-
ment immediately, remove the treatment tool from the ultrasonic endoscope, and then
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 ultrasonic endoscope slowly from the patient.
Should the endoscopic image disappear during an examination or treatment, and if the
processor and light source are not turned off, it may cause overheating of the distal end
of the ultrasonic endoscope, possibly resulting in mucosal burns or other injury.
During an examination, if the ultrasonic image disappears, or a live image is not
displayed after freeze mode has been cancelled, reset the ultrasonic processor.
During treatment, if the ultrasonic image disappears, or a live image is not displayed
after freeze mode has been cancelled stop treatment immediately, remove the treatment
tool from the ultrasonic endoscope, and then reset the ultrasonic processor.
If an appropriate ultrasonic image does not appear even after resetting the ultrasonic
processor, turn it off, straighten the bending portion, release the angle knobs, and then
withdraw the ultrasonic endoscope slowly from the patient.
[Note] Reset:
To reset the processor and the light source, turn them off, 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.
To reset the ultrasonic processor, turn it off, and wait for at least 5 seconds.•
Turn on the ultrasonic processor again.
Important Safety Information
3
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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 Conguration ................................... 2-1
2.1 Composition of Set..................................................................... 2-2
2.2 System Conguration ................................................................. 2-4
Chapter 3 Names and Functions of Parts ............................................................. 3-1
3.1 Ultrasonic Endoscope................................................................. 3-2
3.2 Distal End of Ultrasonic Endoscope .......................................... 3-5
3.3 Ultrasonic Image ........................................................................ 3-6
3.4 Balloon Installation Tool............................................................ 3-6
Chapter 4 Control Portion .................................................................................... 4-1
4.1 How to Operate Bending Mechanism ........................................ 4-2
4.2 Suction Valve, Forceps Inlet and Water Feed Inlet.................... 4-3
4.3 Remote Operating Switches ....................................................... 4-4
4.4 Forceps Valve............................................................................. 4-5
4.5 Suction Button............................................................................ 4-6
Chapter 5 Preparation for Use of Ultrasonic Endoscope ..................................... 5-1
5.1 Preparing Equipment.................................................................. 5-2
5.2 Preparing Suction Button ........................................................... 5-4
5.3 Preparing Forceps Valve ............................................................ 5-5
5.4 Connecting Ultrasonic Endoscope (Installation)........................ 5-7
5.5 Inspection of Ultrasonic Endoscope......................................... 5-11
5.6 Removing Ultrasonic Endoscope ............................................. 5-18
5.7 Attachment and Inspection of Balloon..................................... 5-21
5.8 Inspection of Puncture Needle ................................................. 5-25
5.9 Inspection of Forceps ............................................................... 5-26
Contents
4
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Chapter 6 Method of Use ..................................................................................... 6-1
6.1 Preparation.................................................................................. 6-2
6.2 Insertion and Observation .......................................................... 6-3
6.3 How to Use Balloon ................................................................... 6-8
6.4 Biopsy......................................................................................... 6-9
6.5 Puncture.................................................................................... 6-12
6.6 Pulling Out Ultrasonic Endoscope ........................................... 6-16
6.7 Pre-Cleaning (performed at bedside immediately after use of
Ultrasonic Endoscope) ............................................................. 6-17
Appendix.....................................................................................................Appendix-1
Main Specication..................................................................Appendix-2
Troubleshooting (Combination with EPX-4400 system).......Appendix-8
Troubleshooting (Combination with EPX-2500 system).....Appendix-12
After-Sales Service...............................................................Appendix-16
Disposal of Electric and Electronic Equipment....................Appendix-17
Index.....................................................................................Appendix-18
Service Centers.....................................................................Appendix-19
(Cleaning, Disinfection and Storage)
Chapter 7 Cleaning............................................................................................... 7-1
Chapter 8 Chemical Disinfection......................................................................... 8-1
Chapter 9 Gas Sterilization .................................................................................. 9-1
Chapter 10 Storage............................................................................................... 10-1
Contents
5
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Preface
This manual describes how to use EB-530US.
Conventions Used in This Manual
This manual uses the following conventions to make it easy to understand operations.
General Conventions
Convention Meaning
Indicates a potential danger that may cause harm to people.
WARNING Explains dangerous situations that may cause death or serious
accident if not avoided.
CAUTION Explains situations that may cause slight or moderate levels of
injury if not avoided.
CAUTION Explains situations that may cause damage to equipment
if not avoided.
(1), (2), (3), ... Consecutive numbers in operating procedures indicate the order
in which successive steps in the procedure should be taken.
[Note] Indicates a comment or supplementary information.
Indicates a reference.
Preface
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Chapter 1 Safety
This chapter summarizes the information necessary for safe use of
Ultrasonic Endoscope.
1-1
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Chapter 1 Safety
1. Precautions in Using Ultrasonic Endoscope
1) Applicable processor and light source
This product may be used in the following combinations:
• Processor VP-4450HD, light source XL-4450 and ultrasonic processor SU-8000
• Processor VP-4400, light source XL-4400 and ultrasonic processor SU-8000
• Processor VP-4400, light source XL-4400 and ultrasonic processor SU-7000
• Processor EPX-2500 and ultrasonic processor SU-8000
• Processor EPX-2500 and ultrasonic processor SU-7000
This product complies with the requirements of EN 60601-1:2006 when used
in combination with VP-4450HD, XL-4450 and SU-8000 and those of EN
60601-1:1990+A1:1993+A2:1995 when connected to other equipment.
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 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 operation
manual. Be sure to fully understand the contents of related operation manuals when using
any peripherals.
4) Single use only
Balloon, suction button and forceps valve are intended for single use. To prevent infection,
do not reuse them.
5) Expiration date for use
Do not use any balloon after its expiration date has passed.
Chapter 1 Safety
1-2
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6) Preparation for operation
Use a high-frequency surgical instrument and an Endoscope which can be used with a
high-frequency surgical instrument to provide proper emergency treatment, in cases of
bleeding.
7) Abnormality in use
If any abnormality is noticed during use, carry out safety checks and discontinue use
immediately.
8) Maintenance
The equipment will wear out and degrade after repeated use for a long period. Especially,
the portions such as rubber and resin deteriorate also by chemicals to be used a change with
the passage of time. Have it checked by specialists once every six months or once every 50
cases. Also have it checked if there is anything wrong with the equipment.
Do not disassemble or modify the equipment.
9) Operation of Ultrasonic Endoscope
Ultrasonic Endoscope is a precision instrument. Unnatural force or impact on the insertion
portion, exible portion, or distal end may injure the inside of the patient as well as damage
the instrument. If you feel any abnormal resistance, do not force the Ultrasonic Endoscope
to insert and pull out. Please operate the Ultrasonic Endoscope slowly.
Do not perform the insertion, withdrawal, or bending without keeping a eld of view.
A forward-oblique viewing direction is employed with this product and there is a
difference between the inserting direction and viewing direction. Be sure to understand the
characteristics of the equipment upon use.
10) Handling of Ultrasonic Endoscope
When holding Ultrasonic Endoscope, hold it by the control portion. Handling it up by the
insertion portion or LG exible portion is difcult to hold and may exert an unnatural force,
resulting in instrument failure.
Wear protective gear when handling an Ultrasonic Endoscope to prevent infection and static
charges.
11) Handling of balloon
If the balloon is inflated while it is in patient’s air passage, the air flow may become
blocked. Before using the balloon, thoroughly check the balloon position in the air passage
and the water ow rate to the balloon.
Chapter 1 Safety
1-3
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12) Temperature at distal end
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.
13) Electromagnetic interference
This equipment has been tested and found 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 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.•
Noise may appear on the monitor of this equipment 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 equipment.
This equipment complies with the requirements of EN 60601-1-2:2001+A1:2006 when
connected to VP-4400, XL-4400, EPX-2500 and SU-7000.
2. Cleaning and Disinfection/Sterilization
This product has not been sterilized. When using it for the rst time, perform cleaning,
disinfection and or 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 including the balloon water feed channel
especially.
Wear protective gear during chemical cleaning and disinfection 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 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.
Chapter 1 Safety
1-4
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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
infective waste, depending on the usage state.
4. Indication symbol
This symbol, developed by Eucomed [Note], indicates that this specic type of medical device
contains dibutyl phthalate (DBP). Its amount is so minuscule that it has little effect on
patients’ health.
[Note] The URL of Eucomed is as follows; http://www.eucomed.be/
5. “ Warning” and “ Caution” Messages Appearing in Individual Chapters
Chapter 5 Preparation for Use of Ultrasonic Endoscope
Do not use the abnormal equipment. The use of abnormal equipment will cause wrong
diagnosis or injury.
5.4 Connecting Ultrasonic Endoscope
Do not touch the LG connector tip until it cools down (approximately 5 minutes). Touching
the LG connector with hands immediately after use of the Endoscope may cause a burn
injury.
<Combination with the VP-4400 and XL-4400 or VP-4450HD and XL-4450>
Set a suction pressure at 53kPa or less. Ultrasonic Endoscope may adhere to mucous
membrane, resulting in damage to the mucous membrane.
<Combination with the EPX-2500 system>
Set a suction pressure at 53kPa or less. Ultrasonic Endoscope may adhere to mucous
membrane, resulting in damage to the mucous membrane.
5.5.3 Inspecting Suction, Water Feed and Forceps Channel
Firmly attach the forceps valve to the forceps inlet of the Ultrasonic Endoscope. There is a
risk of infection.
5.5.5 Inspecting Objective Lens
Turn off the light before inspecting the lens. Viewing the light of light guide directly may
damage your eyes.
5.7 Installation and Inspection of Balloon
Use a disinfected and sterilized balloon installation tool. There is a risk of infection.
Do not use a balloon on patients allergic to latex. It may cause an anaphylactic reaction.
Chapter 1 Safety
1-5
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5.8 Inspection of Puncture Needle
Do not use the puncture needle with an abnormally bent or deformed needle. There is a risk
of bleeding or wrong puncturing.
Chapter 6 Method of Use
Do not use force during insertion or withdrawal of the Ultrasonic Endoscope. Slowly
advance the instrument under direct visualization. Since this product is a precision
instrument, excessive force or impact on the insertion portion, exible portion, or distal end
may cause patient injury as well as damage to the instrument. Do not advance or angulate
the Ultrasonic Endoscope without obtaining a clear endoscopic view on the monitor.
6.2 Insertion and Observation
When a balloon is not used, t the cap on the balloon water feed inlet. There is a risk of
infection.
Do not sharply twist or bend during operation. It may cause damage inside body cavities.
Before attempting to clinically use this Ultrasonic Endoscope with an endotracheal tube,
select an appropriate size tube whose inner diameter has sufcient clearance between the
endotracheal tube and the Ultrasonic Endoscope to avoid restriction of oxygen ow which
may impair patient breathing.
The endotracheal tube should pass easily over the Ultrasonic Endoscope’s insertion tube -
never force an endotracheal tube onto the Ultrasonic Endoscope and never apply excessive
pressure or force when attempting to pass or withdraw the Ultrasonic Endoscope.
Do not insert the Ultrasonic Endoscope through the nose. There is a risk of bleeding.
Do not allow the distal end to touch the same part for 5 minutes or more. Energy of illumi-
nation may burn.
Do not look directly at the illuminated light guide. It may damage your eyes.
In order to inject solution by using a syringe, rmly and deeply insert the syringe straight
into the forceps valve. Chemical solutions might splatter.
If the balloon or parts fall into a body cavity due to equipment failure or for other reasons,
immediately stop the inspection and properly retrieve the parts in question. It may cause
damage inside body cavities.
Whenever using the Ultrasonic 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 Ultrasonic Endoscope
damage and/or patient injury.
6.3 How to Use Balloon
Do not use a balloon on patients allergic to latex. It may cause an anaphylactic reaction.
Do not feed more than 1 mL of water into the balloon. There is a risk of suffocation.
Do not feed more than 1 mL of water into the balloon. There is a risk of aspiration.
Chapter 1 Safety
1-6
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6.4 Biopsy
Do not press forceps against the trachea or broncho wall with undue force. It may cause
perforation or bleeding.
Do not insert the forceps if you cannot obtain a endoscopic image. Do not insert the forceps
into the Ultrasonic Endoscope if you cannot see the forceps outlet on the endoscopic image.
It may cause perforation or bleeding.
6.5 Puncture
Wear protective gear. There is a risk of infection.
Do not insert the puncture needle into the Ultrasonic Endoscope if you cannot see the
forceps outlet on the endoscopic image. Do not perform puncture if you cannot see the
puncture needle on the endoscopic image. Operate the puncture needle while checking
the endoscopic and ultrasonic images. Do not insert the puncture needle into the forceps
inlet while the bending portion of the Ultrasonic Endoscope is bent. Do not insert a bent
puncture needle into the forceps inlet. Stop puncturing immediately if you cannot obtain an
endoscopic or ultrasonic image. It may cause perforation or bleeding.
6.7.3 Removing Ultrasonic Endoscope from Processor
Do not touch the LG connector tip until it cools down (approximately 5 minutes). Touching
the LG connector with hands immediately after use of the Endoscope may cause a burn
injury.
Chapter 7 Cleaning
7.1 Methods of Cleaning
Be sure to clean and disinfect or otherwise sterilize all the channels after every case,
regardless of whether used or not. There is a risk of infection.
7.4 Manual Cleaning (cleaning in sink)
In case the cleaning brush is damaged during a cleaning process, remove any residue from
inside the tube. A damaged cleaning brush could be a source of infection.
7.4.2 Remove Suction Button and Forceps Valve
Do not reutilize an already used suction button and forceps valve. There is a risk of being a
source of infection.
7.4.9 Cleaning Entire Ultrasonic Endoscope
Remove the balloon before cleaning, disinfecting or sterilizing the Ultrasonic Endoscope.
There is a risk of infection.
After cleaning, rinse off any remaining chemical with water. Cleaning liquid might ow
into a patient’s body.
7.5 Cleaning and Sterilizing Biopsy Forceps
Close the cap before putting the forceps in a sterile pack. Sterility might not be maintained
if the sterile pack is ruptured.
Chapter 1 Safety
1-7
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Chapter 8 Chemical Disinfection
8.1 Methods of Chemical Disinfection
Be sure to clean and disinfect or otherwise sterilize all the channels after every case,
regardless of whether used or not. Remove the balloon before cleaning, disinfecting or
sterilizing the Ultrasonic Endoscope. There is a risk of infection.
8.4.1 Injecting Sterile Water
After immersing in the chemical solution, rinse off remaining chemical solution with sterile
water. Disinfectant might ow into a patient’s body.
8.5 Cleaning and Disinfection Using Cleaning and Disinfection Devices
Use cleaning and disinfection devices appropriate for this Ultrasonic Endoscope. There is a
risk of infection.
Chapter 9 Gas Sterilization
Clean, disinfect and sterilize all the channels after every case, regardless of whether used
or not. Remove the balloon before cleaning, disinfecting or sterilizing the Ultrasonic
Endoscope. Applying gas sterilization to wet parts presents incomplete sterilization.
Proceed gas sterilization after vaporizing water out of Ultrasonic Endoscope. There is a
risk of infection.
Proceed aeration after gas sterilization. Gas remaining in Ultrasonic Endoscope after gas
sterilization is harmful to human body.
Chapter 10 Storage
Do not store Ultrasonic Endoscope in a carrying case. Storage of Ultrasonic Endoscope in
a carrying case may cause infection.
Chapter 1 Safety
1-8
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Chapter 2 Composition of Set and System
Conguration
This chapter describes the composition of Ultrasonic Endoscope set and
system conguration.
2.1 Composition of Set.......................................................2-2
2.2 System Conguration ...................................................2-4
2.2.1 Combination with VP-4450HD or VP-4400 and
SU-8000 ............................................................2-4
2.2.2 Combination with VP-4400 and SU-7000........2-6
2.2.3 Combination with EPX-2500 system and
SU-8000 ............................................................2-8
2.2.4 Combination with EPX-2500 system and
SU-7000 ..........................................................2-10
2-1
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Chapter 2 Composition of Set and System Conguration
Composition of Set2.1
The Ultrasonic Endoscope set is provided in a carrying case. The set consists of the
following items.
[Note] Figures in parentheses indicate quantities.
Carrying Case (1)
Forceps Valve
FOV-BU1 (10)
Ventilation Adapter
AD-7 (1)
Cleaning Brush
WB3503FW (1)
Cleaning Brush
WB3212FW2 (1)
Chapter 2 Composition of Set and System Conguration
2-2
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Operation Manual
Preparation and Operation (1)
Cleaning, Disinfection and Storage (1)
Tube for Suction Channel
WA-002 (1)
Cleaning Brush (for Valve)
WB11002FW2 (1)
Forceps Inlet Cleaning Adapter (with a Cap)
WA-003 (1)
Cleaning Adapter
CA-500BU (1)
Ultrasonic Endoscope (1)
Suction Button
SB-500B/D (20)
US Waterproof Cap
WA-7000 (1)
Balloon Installation Tool
BA-BU1 (1)
Syringe (1) Valve Adapter
WA-001 (1)
Dry Adapter
WA-004 (1)
Chapter 2 Composition of Set and System Conguration
2-3
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System Conguration2.2
You may use the EB-530US with various peripherals attached to it. These peripherals are
available separately. Extension makes the following possible.
Recording of video images•
Printer output•
Combination with VP-4450HD or VP-4400 and SU-80002.2.1
Ultrasonic Endoscope
EB-530US
Endoscopic Accessory
Balloon
Foot Switch
FS1
Airtightness Tester
LT-7 Cart
Light Source
XL-4450
XL-4400
Ultrasonic Processor
SU-8000
Processor
VP-4450HD
VP-4400
Data Keyboard
DK-4450E
DK-4400E
Chapter 2 Composition of Set and System Conguration
2-4
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[Note] For details on the connections of peripherals other than those listed here, please
contact your local dealer.
Printer
UP-51MD (SONY)
UP-55MD (SONY)
UP-21MD (SONY)
CP900UM(120W) (MITSUBISHI)
CP900DW (MITSUBISHI)
Monitor
CDL1576A
CDL1909A
RADIANCE24 (NDS)
Monitor
CDL1576A
CDL1909A
RADIANCE24 (NDS) [Note]
[Note] Only when using the VP-4450HD
Keyboard
CP-8000
Foot Switch
FS1
Chapter 2 Composition of Set and System Conguration
2-5
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Combination with VP-4400 and SU-70002.2.2
Ultrasonic Endoscope
EB-530US
Endoscopic Accessory
Balloon
Foot Switch
FS1
Airtightness Tester
LT-7 Cart
Light Source
XL-4400
Ultrasonic Processor
SU-7000
Processor
VP-4400
Data Keyboard
DK-4400E
Chapter 2 Composition of Set and System Conguration
2-6
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