FujiFilm PB2020-M User manual

202B1263042
Endoscopic Ultrasonic Probe
OPERATION MANUAL
PB2020-M
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.
English
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Introduction
The medical endoscopic ultrasonic probe PB2020-M is intended for ultrasonographic
observation and diagnosis of the trachea, bronchus, esophagus, stomach, duodenum,
and large intestine via the instrument channel of a FUJIFILM endoscope in medical
facilities under the management of a physician. Do not use this product for any other
purpose.
This manual provides necessary information for using the endoscopic ultrasonic probe,
such as the equipment overview, operation procedures and precautions to observe, as
well as the cleaning, disinfection and storage methods.
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 product 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 © 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, perform cleaning and disinfection (or sterilization)
according to the procedure described in this manual. There is a risk of being a
source of infection.
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Introduction
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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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How to Read This Manual
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Contents at a Glance
Chapter 1 Precautions
This chapter describes the warnings and cautions for safe operation of
this product.
Chapter 2 Names and Functions of Parts
This chapter describes the names and functions of this product.
Chapter 3 Inspection Before Use
This chapter describes the inspection to be performed for using this
product.
Chapter 4 Method of Use
This chapter describes a series of operations of this product.
Chapter 5 Cleaning
This chapter describes the recommendations for cleaning of this
product.
Chapter 6 Disinfection
This chapter describes the recommendations for disinfection of this
product.
Chapter 7 Sterilization
This chapter describes the recommendations for sterilization of this
product.
Chapter 8 Storage
This chapter describes the method and conditions of storage.
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Contents at a Glance
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Contents
Introduction ...............................................................................................................3
How to Read This Manual ........................................................................................5
Contents at a Glance................................................................................................6
Chapter 1 Precautions.............................................................................................9
1.1 For Safe Operation.........................................................................9
1.2 Classication ..................................................................................9
1.3 Safety ...........................................................................................10
1.3.1 Infection ...........................................................................10
1.3.2 Preventing Electrical Shock .............................................12
1.3.3 Direct Harm to Human Body ............................................13
1.4 Electromagnetic Compatibility (EMC) ..........................................15
1.4.1 Electromagnetic Compatibility (EMC)
Related Standard .............................................................15
1.5 Location of Each Label................................................................. 16
1.5.1 Location of Label..............................................................16
1.5.2 Symbols ...........................................................................17
1.6 Possible Combinations for Use ....................................................18
1.6.1 Peripheral Devices...........................................................18
1.7 Cautions/Warnings.......................................................................19
1.7.1 Abnormalities During Use of This Product ....................... 19
1.7.2 Transportation and Storage .............................................19
1.7.3 General Warnings ............................................................20
Chapter 2 Product Overview..................................................................................21
2.1 Components of This Product........................................................21
2.2 Names and Function of Parts.......................................................22
Chapter 3 Inspection Before Use...........................................................................23
3.1 Inspecting Endoscopic Ultrasonic Probe...................................... 24
3.2 Removing Air Bubbles..................................................................25
3.3 Inspecting for Combination ..........................................................27
Chapter 4 Method of Use.......................................................................................29
4.1 Inserting Endoscopic Ultrasonic Probe and
Performing Ultrasound Examination ............................................30
4.2 Withdrawal of Endoscopic Ultrasonic Probe ................................33
Chapter 5 Cleaning................................................................................................35
5.1 Method of Cleaning ......................................................................35
5.2 Detergent Solution .......................................................................36
5.3 Necessary Equipment and Materials ...........................................37
5.4 Pre-cleaning .................................................................................38
5.4.1 Wiping ..............................................................................38
5.5 Manual Cleaning ..........................................................................39
5.5.1 Cleaning of Endoscopic Ultrasonic Probe........................ 39
5.5.2 Rinsing of Endoscopic Ultrasonic Probe..........................41
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Chapter 6 Chemical Disinfection ...........................................................................43
6.1 Method of Chemical Disinfection..................................................43
6.2 Disinfectant Solution ....................................................................44
6.3 Chemical Disinfection of Endoscopic Ultrasonic Probe ...............45
6.4 Rinsing of Endoscopic Ultrasonic Probe After Disinfection.......... 47
6.5 Rinsing of Endoscopic Ultrasonic Probe After Disinfection.......... 48
Chapter 7 Sterilization ...........................................................................................49
7.1 Methods of Sterilization................................................................49
7.2 Ethylene Oxide Gas Sterilization.................................................. 50
7.3 EOG (Ethylene Oxide Gas) Sterilization ......................................51
Chapter 8 Storage .................................................................................................52
Main Specication...................................................................................................53
Disposal of Electric and Electronic Equipment .......................................................58
Index .......................................................................................................................59
Service Centers ......................................................................................................60
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Contents
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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 of this product against unexpected accidents such
as the failure of this product. Otherwise, you may not be able to continue the
endoscopic procedure.
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 modifications, 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 SP-900 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 this manual. Prior
to reuse, this product must be pre-cleaned, cleaned and disinfected (or
sterilized) according to the procedures given in this manual. Inadequate
cleaning may compromise successful disinfection or sterilization,
increasing the risk of infection.
Meticulously clean all the surfaces of this product as per provided
reprocessing instructions. Not doing so may pose an infection risk.
Wear personal protective equipment (such as goggles, facemask,
chemical-resistant and waterproof gloves, antifouling protective clothing,
cap and shoe covers) during an examination and treatment as well as
during reprocessing to protect your eye and skin and to prevent infection.
Not doing so 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
this manual 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.
Use a cleaned and disinfected (or sterilized) endoscopic ultrasonic probe.
An inadequately cleaned and disinfected (or sterilized) probe may pose
an infection risk.
Carry a cleaned and disinfected (or sterilized) endoscopic ultrasonic
probe at a clean state. If personal protective equipment such as gloves
is contaminated, the contaminants adhere to this product and it can be a
source of infection.
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WARNING
Be sure to wear sterile gloves when inspecting this product. Not doing so
may contaminate this product and pose an infection risk.
In clinical procedures in which this product that has been sterilized is
used, exercise caution not to contaminate this product when placing it
temporarily. Not doing so may pose an infection risk.
Slowly insert this product straight into the 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.
Slowly pull this product out of the end holder. If it is withdrawn quickly
from the end holder, body fluid may be splattered around, posing an
infection risk.
Be sure to clean and disinfect (or sterilize) this product as per instructions
as per instructions in this manual after every case. If this product is
not disinfected (or sterilized), it may pose an infection risk or cause an
accident.
If the image often becomes dark during observation, air bubbles may be
on the transducer inside the ultrasound head. However, do not remove air
bubbles once this product is inserted. Body uid adhered to this product
may be splattered, posing an infection risk.
Do not withdraw this product sharply. In so doing, body uids adhered to
this product may be splattered, posing an infection risk.
This product is not compatible with cleaning and disinfection with
an automated endoscope reprocessor. If an automated endoscope
reprocessor is used, effective cleaning and disinfection cannot be
achieved, and it may pose an infection risk.
Excessive foaming prevents detergent solution from sufciently 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.
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WARNING
After cleaning, rinse off any remaining detergent solution with clean water.
If detergent solution remains, the chemical disinfection to be performed at
the next step will lose its effectiveness.
After immersing this product in disinfectant solution, remove air bubbles
completely. If any air bubbles remain, effective disinfection cannot be
achieved.
When immersing this product in disinfectant solution, immerse the entire
unit. If not properly immersed, effective chemical disinfection cannot be
achieved.
When this product is immersed in the chemical solution, remove air
bubbles on the surface. Not doing so may pose an infection risk.
Proceed with gas sterilization after vaporizing water out of this product.
If gas sterilization is performed while moisture remains in this product,
sterilization of wet parts will be incomplete.
When performing ethylene oxide gas sterilization of this product,
ensure that the surfaces are dry before attempting ethylene oxide gas
sterilization. If any moisture remains in this product, sterilization of undried
parts will be incomplete and it could be a source of infection.
When performing ethylene oxide gas sterilization of this product, detach
the connector cap from the probe connector. If sterilization is performed
while the connector cap is placed on the probe connector, sterilization will
be incomplete and may pose an infection risk.
1.3.2 Preventing Electrical Shock
WARNING
Connect the power plug to the protective earth receptacle. Not doing so
may cause an electric shock.
This product is not intended to be used with an electrosurgical unit. If
used with an electrosurgical unit, it may cause burn injury to the patient or
end-user.
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1.3.3 Direct Harm to Human Body
WARNING
To avoid the potential for patient injury including perforation and bleeding,
do not apply excessive force of this product against walls of the bronchus
and digestive tract. Only advance this product under direct visualization.
When using this product for an endoscope with two instrumaent channels,
do not use an electrosurgical unit at the same time. Doing so may cause
thermal injury to a patient and/or end-user.
Do not hold or scratch this product with metallic forceps, needle, basket,
etc. Doing so may damage the ultrasound head and result in damage to
tissues inside the body cavities or leakage of the ultrasound transmission
medium to the body cavities.
Do not insert this product into an endoscope when a clear endoscopic
image is not obtained on the monitor or when an endoscopic image is
frozen. Doing so may cause damage to tissues in the body cavities,
bleeding, perforation or damage to the equipment.
When using this product under uoroscopy, note that a contrast image
of the region within approx. 5 mm from the distal end of the endoscopic
ultrasonic probe is not obtained. If this product is inserted forcibly, it may
cause bleeding or perforation.
Slowly insert this product into the endoscope. Inserting it quickly may
cause damage to tissues in the body cavity, bleeding or perforation.
This product must be properly aerated after ethylene oxide gas
sterilization to remove toxic components. Gas remaining in this product
after ethylene oxide gas sterilization may harm human body.
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CAUTION
Clean and disinfect (or sterilize) this product in a clean environment.
If dust adheres to this product after cleaning and disinfection (or
sterilization), it may enter the patient's body.
After cleaning, rinse off any remaining detergent solution with water. If
detergent solution remains, chemicals to be used in the subsequent steps
may be diluted or adulterated.
After cleaning, rinse off any remaining detergent solution with clean water.
If detergent solution remains, it may ow into the patient's body.
After cleaning, rinse off any remaining detergent solution with clean water.
If detergent solution remains, the chemical disinfection to be performed at
the next step will lose its effectiveness.
After immersing in chemical solution, rinse off the remaining disinfectant
solution with sterile water. If disinfectant solution remains, it may ow into
the patient’s body.
Proceed with aeration after gas sterilization. If this product is used without
performing aeration, gas remaining in this product after gas sterilization
may harm human body.
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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 confirmed 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 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
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 equipment 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 specied 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 position where the label is afxed on this product is shown below. The relevant
safety signs are also described.
1.5.1 Location of Label
Model Label
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1.5.2 Symbols
Symbol Description
Serial number
Date of manufacture
Manufacturer
Authorised representative in the European Community
(Blue) Refer to instructions for use
Temperature limitation
Keep dry
CE marking
Degree of waterproof
Type BF applied part
WEEE marking [Note]
Humidity limitation
Atmospheric pressure limitation
1Quantity
Application site: Trachea and bronchus
Application site: Upper and lower digestive tract
(Yellow) Ultrasonic frequency: 20 MHz
[Note] This product shall not be treated as household waste.
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1.6 Possible Combinations for Use
1.6.1 Peripheral Devices
WARNING
We recommend use of only those peripheral products specified in this
manual. Read the operation manuals of the peripheral devices used in
combination with this product.
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1.7 Cautions/Warnings
Observe the following cautions when handling this product. Also, there are same
cautions in each chapter.
CAUTION
Do not use this product if it has failed its pre-inspection check. Doing so
can negatively affect the functionality of the instrument or increase risks to
patient safety.
This product is a precision instrument. Unnatural force or impact on the
insertion portion, ultrasound head or connector. If you encounter any
resistance, insert it slowly. Do not insert this product into the endoscope
or bend the endoscope without securing a clear endoscopic view on the
monitor. Not doing so may cause damage to both this product and body
cavities of the patient.
1.7.1 Abnormalities During Use of This Product
WARNING
If any abnormality is noticed during use, carry out safety checks and
discontinue use immediately.
1.7.2 Transportation and Storage
WARNING
Do not store this product in a packaging box. Doing so may cause
infection.
CAUTION
Store this product under the storage conditions described in “Main
Specication.” Use this product in the operating environment described in
“Main Specication.”
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CAUTION
Do not store this product in a place which does not meet the storage
conditions. Doing so may cause equipment failure.
1.7.3 General Warnings
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.
Never use this product for any purposes other than intended use. It may
cause severe harm to patient and/or end-users.
Do not use this product outside the specified operating environment.
Otherwise, it can cause malfunction or equipment failure.
CAUTION
In order to successfully sterilize this product by ethylene oxide gas
sterilization, use the parameters described in “Table 7.2 Conditions of
20% ethylene oxide gas sterilization (chamber type).” Exceeding the
recommended conditions may cause equipment damage.
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