FujiFilm SP-900 User manual

897N120838C
Ultrasonic Processor
OPERATION MANUAL
SP-900
Thank you for purchasing our product. Read this
manual carefully before use to avoid unexpected
accidents and to take full advantage of the
product's capabilities.
English
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Important Safety Information
1. Intended use
This product is intended to be used in combination with a FUJIFILM endoscopic
system, a monitor, and other peripheral devices for the visualization of the shapes,
properties or dynamics inside a body using ultrasonic waves to provide image
information for diagnosis in medical facilities under the management of physicians.
Do not use this product for any other purpose.
2. Safety
Read and understand this manual carefully before use. Use the product by
following the instructions provided. Items important for the safe use of this
product are summarized in “Chapter 1 Safety”. Safety precautions associated
with individual operations or procedures are provided separately, indicated by
“ WARNING” or “ CAUTION”.
3. Warnings
Items that must be observed to prevent bodily harm when installing this product are
identied by “ WARNING” or “ CAUTION”. Read and understand the precautions
carefully to ensure that procedures are performed correctly.
WARNING
Read and understand this manual fully before operating this system.
Improper use or operation of the equipment may result in injuries to
patients, physicians, or people in the vicinity.
4. Clinical Procedures
This manual assumes that this product will be used by medical specialists who have
received proper training in endoscopic and ultrasound endoscopic procedures.
This manual does not provide information about clinical procedures. Proper clinical
judgment should be exercised for all clinical procedures.
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Important Safety Information
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5. Inspection Before Use
Make sure to inspect this product before use according to Chapter 6 “Starting/
Closing Exam” to avoid unexpected accidents and take full advantage of the product’s
capabilities.
6. Combination of Equipment
This product may be used in combination with peripherals. To avoid an electric shock
accident, do not use any peripheral other than ones in “3.1.4 Using Equipment in
Combination”.
7. Installation
Only FUJIFILM authorized service personnel is allowed to install this system. No one
except such personnel should install this system.
8. High Voltage
This product contains high-voltage portions. No one except FUJIFILM authorized
service personnel should touch the inside.
Improper use or operation of this product may injure patients, physicians, or people in
the vicinity.
Read this manual thoroughly and carefully before use.
9. Electric Shock
Do not touch the connector on the rear of the equipment and the patient
simultaneously. There is a risk of electric shock.
10. Foreign Matter and Liquid
Foreign matter, water and chemicals entering the equipment may cause a fire or
electric shock. In such a case, stop using the equipment immediately, disconnect the
power plug from the power outlet, and contact your local FUJIFILM dealer.
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Important Safety Information
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11. If Any Abnormality Occurs During Clinical Procedure
If any abnormality occurs with this product during the clinical procedure, refer to
“Chapter 10 Troubleshooting”. Especially, if this product is continuously used with an
abnormal ultrasonic image displayed, the distal end of the endoscopic ultrasonic probe
may generate abnormal heat, causing burn or injury.
12. Loss of Function
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.
If an appropriate ultrasonic image does not appear even after resetting the ultrasonic
processor, turn it off, and then withdraw the endoscopic ultrasonic probe slowly from
the patient.
[Note] Reset: Turn off the ultrasonic processor, and wait for at least 5
seconds. Turn on the ultrasonic processor again.
[Note] For details on how to operate the ultrasonic endoscope, refer to the
operation manual of the ultrasonic endoscope.
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Important Safety Information
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Contents
Important Safety Information ....................................................................................2
Preface .....................................................................................................................8
Chapter 1 Safety....................................................................................................12
Chapter 2 Ultrasonic Output Power.......................................................................16
2.1 ALARA (As Low As Reasonably Achievable) ..............................16
2.2 Effects of Ultrasonic Waves on Living Body................................. 17
2.3 Controlling Ultrasonic Output Power ............................................ 18
Chapter 3 SP-900 System Conguration...............................................................19
3.1 Components of SP-900 System................................................... 19
3.1.1 Components of SP-900 System....................................... 19
3.1.2 Standard System Conguration (Example)......................20
3.1.3 System Expansion (Example)..........................................21
3.1.4 Using Equipment in Combination..................................... 22
3.2 Names and Functions of Parts..................................................... 23
3.2.1 SP-900 .............................................................................23
3.2.2 Foot Switch FS1 (Optional)..............................................25
3.3 Names and Functions of Keys on Control Pad CP-900 ............... 26
3.4 Screen Conguration ...................................................................28
3.4.1 Screen Conguration of SP-900 ......................................28
3.5 RS-900 (Scanner) ........................................................................29
Chapter 4 Basic Operations...................................................................................30
4.1 Power-on and Power-off ..............................................................31
4.1.1 Power-on..........................................................................31
4.1.2 Logoff ...............................................................................32
4.1.3 Power-off..........................................................................33
4.2 Entering Comments .....................................................................34
4.2.1 Entering Text....................................................................34
4.2.2 Correcting Text ................................................................35
4.2.3 Moving in Text Block........................................................37
4.2.4 Deleting Text....................................................................38
4.2.5 Deleting All Texts .............................................................39
Chapter 5 Initial Settings........................................................................................40
5.1 User Setting Mode .......................................................................40
5.1.1 Setup Items in “User Menu” Screen................................. 40
5.2 Initialization of External Storage Device....................................... 45
5.3 Security Function .........................................................................47
5.3.1 Changing Login Password ...............................................48
Chapter 6 Starting/Closing Exam ..........................................................................50
6.1 Preparation...................................................................................50
6.2 Initial Settings............................................................................... 52
6.3 Inspection Before Use.................................................................. 55
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6.4 Registration of Patient Data .........................................................57
6.4.1 Details of the “Patient Information Entry” Screen ........... 58
6.5 Preparation for Ultrasound Examination ......................................59
6.6 Acquiring Ultrasonic Image ..........................................................61
6.7 Gain Adjustment...........................................................................63
6.8 Dynamic Range............................................................................63
6.9 Ending Exam................................................................................ 64
Chapter 7 Function of B Mode...............................................................................65
7.1 B-mode.........................................................................................65
7.2 B-mode Functions ........................................................................65
7.2.1 Gain Adjustment ..............................................................66
7.2.2 Switching Display Range .................................................66
7.3 Image Rotation............................................................................. 67
7.4 Center Moving Modes .................................................................. 67
7.5 Mirror Image................................................................................. 68
7.6 Dynamic Range Adjustment.........................................................69
7.7 STC Adjustment ...........................................................................69
7.8 MAP Adjustment ..........................................................................69
7.9 Measuring Distance .....................................................................70
7.10 Measuring Circumference and Area ............................................72
7.11 P in P............................................................................................74
7.11.1 Operation of PinP.............................................................75
Chapter 8 Recording and Replaying Images......................................................... 76
8.1 Cine Memory................................................................................ 76
8.2 Storing Exam Images................................................................... 77
8.2.1 Overview ..........................................................................77
8.2.2 Storing Images in Internal Storage Device ......................77
8.3 Printing Images with Color Printer (Remote System)...................78
8.3.1 Printer Connection ...........................................................78
8.3.2 Setting Printing Function..................................................79
8.3.3 Exporting Image...............................................................79
8.3.4 Printing Image..................................................................80
8.4 Printing Images with Digital Printer ..............................................81
8.4.1 Digital Printer Connection ................................................81
8.4.2 Setting Printing Function..................................................82
8.4.3 Digital Printer Settings .....................................................82
8.4.4 Exporting Image...............................................................84
8.4.5 Printing Image..................................................................84
8.5 Reviewing Exam Images..............................................................85
8.5.1 Searching Exam Images (Setting Search Conditions).....85
8.5.2 Searching Exam Images (Search Results) .....................87
8.5.3 Enlarging Exam Images...................................................87
8.5.4 Printing Images ................................................................88
8.6 Copying Exam Images to External Storage Device .....................90
8.7 Deleting Exam Image Data ..........................................................93
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Contents
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Chapter 9 Storage and Maintenance..................................................................... 95
9.1 Maintenance.................................................................................95
9.2 Maintenance of SP-900, RS-900 and CP-900 .............................96
9.3 Method of Storage........................................................................97
9.4 Before Bringing This Product for Service ..................................... 98
9.5 Replacing Fuse ............................................................................99
9.6 Monthly Inspection .....................................................................100
9.7 Storage.......................................................................................102
9.8 Moving Cart................................................................................ 103
Chapter 10 Troubleshooting ................................................................................105
10.1 Troubleshooting .........................................................................105
10.2 Error Messages.......................................................................... 107
Chapter 11 System Installation............................................................................111
11.1 Operating Conditions .................................................................111
11.1.1 Environment...................................................................111
11.1.2 Power Supply.................................................................112
11.2 Installation of SP-900 System (Initial Installation) ...................... 113
11.2.1 Installation of the Standard System with an Endoscopic
System Added to It.........................................................114
11.2.2 Installation for System Expansion..................................126
11.2.3 Connection with SU-8000 ..............................................128
11.2.4 Connection with SU-1 ....................................................135
11.3 Connecting Power Supplies ....................................................... 141
11.3.1 Power Connection for Using Equipment in
Combination...................................................................141
11.3.2 Power Connection on the Cart.......................................142
11.3.3 Basic Information on Power Cord ..................................143
11.4 Preparation Before Use..............................................................144
11.4.1 Moving and Fixing..........................................................144
11.4.2 Connecting Power Supply and Potential Equalization
Terminal .........................................................................145
11.4.3 Adjusting Monitor ........................................................... 146
Main Specications...............................................................................................147
Index .....................................................................................................................156
Software Used in This Product .............................................................................157
After-Sales Service ...............................................................................................158
Disposal of Electric and Electronic Equipment .....................................................159
Service Centers ....................................................................................................160
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Contents
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Preface
This manual describes how to use the ultrasonic processor SP-900 as well as how to
record images using peripherals.
The SP-900 system is composed of the main unit, control pad, endoscopic ultrasonic
probe and scanner, and is used in combination with an ultrasonic endoscope, medical
endoscopic system, monitor, color printer, etc.
For how to connect and operate these devices, refer to their operation manuals.
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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Preface
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Terms used in this manual
SP-900 System
In narrow denition, includes the ultrasonic processor SP-900, control pad CP-900,
scanner RS-900 and endoscopic ultrasonic probe in the P series or PB2020-M.
In the broad denition, includes a set of equipment (standard system and expanded
system) including various connected peripheral devices in addition to the narrow
denition.
Endoscopic ultrasonic probe
An endoscopic ultrasonic probe used with the SP-900 system.
Active
The screen on which the menus are selectable.
Live mode
The live image provided by ultrasound scanning is displayed on the screen.
Freeze mode
An image displayed on the screen remains still and the [FREEZE] key is pressed.
Press (Keyboard)
It allows various key operations.
Some keys, when pressed, enable the operation to be activated while others activate
the mode allocated to the key.
Select
It means selecting a function by pressing the [SET] key.
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Preface
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B-mode
The B-mode screen is displayed.
“7.1 B-mode”
Measurement menu
It indicates the menus displayed when [MEASURE] key is pressed during the freeze
mode.
“7.9 Measuring Distance”
“7.10 Measuring Circumference and Area”
Image
It indicates an image actually displayed on the screen.
Frame
It indicates an image obtained when scanned once.
Frame rate
It indicates the number of frames obtained per second. The frame rate changes
according to the scanning conditions.
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Preface
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Symbols and marks
The meanings of the symbols and marks used in this product are as follows.
Rating plate
Symbols
Symbol Description Symbol Description
Serial number WEEE marking [Note]
Date of manufacture Humidity limitation
Manufacturer Atmospheric pressure
limitation
Authorised representative in
the European Community (Blue) Refer to instructions for use
Temperature limitation Alternating current
Keep dry Fuse
CE marking Potential equalization
terminal
Type BF applied part
[Note] This product shall not be treated as household waste.
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Preface
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Chapter 1 Safety
1. Precautions for use
(1) Application to heart
This product is in accordance with the degree of protection against electric shock for
type BF equipment. Do not bring the endoscopic ultrasonic probe connected to this
product into contact with the heart. Neglect of this may cause serious hazards such as
ventricular brillation.
(2) Protection from cardioverter
This product does not provide protection from a cardioverter.
When using the cardioverter while using this product, remove the endoscopic
ultrasonic probe out of a patient to make sure that this product is not in contact with
the patient. Neglect of this may cause an electric shock.
(3) 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 this product before use according to the procedures provided in
this manual to avoid unexpected accidents and take full advantage of the equipment's
capabilities. In particular, defected images may lead to a misdiagnosis. As a result of
the inspection, if any defect is found in any device, do not use the device.
(4) Combination of equipment
This product may be used in combination with peripherals. To avoid an electric shock
accident, do not use any peripheral other than ones listed in “3.1.4 Using Equipment in
Combination”.
(5) Maintenance
Have this product checked by FUJIFILM authorized service personnel once every six
months. This product will wear out and deteriorate after repeated use for a long period.
Also have it checked if any defect is found in this product.
Do not disassemble or modify this product.
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Chapter 1 Safety
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(6) Temperature at distal end
When ultrasound waves are emitted over an extended time, the temperature of the
distal end of ultrasonic endoscope may reach 42.0ºC at maximum.
Stop emitting the ultrasound waves and (freeze the ultrasonic image) when the
endoscopic ultrasonic probe is not used.
(7) Electromagnetic interference
This product has been tested and confirmed to comply with the limits for medical
devices to the EN 60601-1-2:2007. These limits are designed to provide reasonable
protection against harmful interference in a typical installation at medical facilities.
However, it is possible that this product may cause harmful interference to other
devices in vicinity, even if it is installed and used in accordance with the instructions of
this product. Also, there is no guarantee that interference will not occur in a particular
installation. Therefore, if this product does cause harmful interference to other devices,
that can be determined by tuning this product 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 product due to the interference of
electromagnetic waves. In this case, turn off the device emitting the electromagnetic
waves or move the device away from this product.
(8) Distortion of images due to load on endoscopic ultrasonic probe
If a load is applied to the endoscopic ultrasonic probe, distortion of images or an error
in distance measurement result may occur. Fully understand the endoscopic ultrasonic
probe’s properties before use.
2. Disposal
This product is equipped with a lithium manganese dioxide battery. 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.
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Chapter 1 Safety
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3. “ WARNING” and “ CAUTION” Messages Appearing in Each Chapter
Chapter 6 Starting/Closing Exam
Do not use the equipment in flammable gas atmosphere. Doing so may cause
explosion.
Use the rated voltage only. Plug the power plug into a medical outlet with a ground
terminal. Connect the power plug to the protective earth receptacle. Only FUJIFILM
authorized service personnel are permitted to open the covers. Not adhering to these
instructions may cause electric shock.
6.6 Acquiring Ultrasonic Image
Do not perform scanning when the endoscopic ultrasonic probe is not visible. Do not
let the endoscopic ultrasonic probe press against the inner surface of the body cavity.
Doing so may cause perforation or damage to mucous.
Chapter 9 Storage and Maintenance
9.1 Maintenance
Do not open covers of this product. Only FUJIFILM authorized service personnel are
permitted to open the covers. Doing so may pose a risk of electric shock.
Keep liquids such as alcohol and water from entering this product. Not doing so may
cause re or equipment failure.
When either one of the following occurs, immediately stop using and unplug this
product, and then contact your local FUJIFILM dealer.
- When this product receives a strong shock like falling off.
- When liquid such as water enters this product or spills out.
- When this product does not work properly.
- When the chassis of this product is cracked, split up or broken.
- When the performance of the power cord, guide cord and other cords is degraded.
9.5 Replacing Fuse
Do not replace the fuse. If the fuse needs to be replaced, contact your local FUJIFILM
dealer.
9.8 Moving Cart
Move the cart by two people. Not doing so may cause the cart to tip over and result in
personal injury.
Move the cart by three people in uneven places. Not doing so may cause the cart to
tip over and result in personal injury.
Remove the water tank before moving the cart. Not doing so may cause the cart to tip
over due to spilt water and result in personal injury.
Remove the endoscope before moving the cart. Not doing so may cause damage to
the endoscope.
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Chapter 1 Safety
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Remove the endoscopic ultrasonic probe before moving the cart. Not doing so may
cause damage to the endoscopic ultrasonic probe.
Chapter 11 System Installation
11.1.1 Environment
Do not use this product in flammable gas atmosphere. Doing so may cause an
explosion.
11.1.2 Power Supply
Use the rated voltage. Otherwise, re, electric shock or equipment failure may result.
Connect the power plug to the protective earth receptacle directly. Use the peripherals
that are compliant with medical safety standards. Not doing so may pose a risk of
electric shock.
11.4.1 Moving and Fixing
Move the cart by two people. Not doing so may cause the cart to tip over and result in
personal injury.
Move the cart by three people in uneven places. Not doing so may cause the cart to
tip over and result in personal injury.
Remove the water tank before moving the cart. Not doing so may cause the cart to tip
over due to spilt water and result in personal injury.
Remove the endoscope before moving the cart. Not doing so may cause damage to
the endoscope.
Remove the endoscopic ultrasonic probe before moving the cart. Not doing so may
cause damage to the endoscopic ultrasonic probe.
11.4.2 Connecting Power Supply and Potential Equalization Terminal
The power supply should be used at the rated voltage. Otherwise, re, electric shock
or equipment failure may result.
Connect the power plug to the protective earth receptacle directly. Use the peripherals
that are compliant with medical safety standards. Doing so may pose a risk of electric
shock.
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Chapter 1 Safety
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Chapter 2 Ultrasonic Output Power
Prior to using SP-900, be sure to read the information on the ultrasonic output power
mentioned below.
2.1 ALARA (As Low As Reasonably Achievable)
As far as you observe the instructions to use SP-900 correctly, you will not be
harmed regardless of an ultrasonic frequency, irradiation time or strength, but it
is recommended to conduct an inspection with the minimum degree of ultrasonic
irradiation which allows you to obtain necessary diagnostic information. This concept
of operation is called ALARA (As Low As Reasonably Achievable).
This concept is to minimize the ultrasonic output power and inspection time without
lowering the ultrasonic diagnostic accuracy and the resolution.
Against the benefits obtained from an endosonography, an operator has to put an
emphasis on reducing an inspection risk.
For this reason, it is recommend to follow the steps below:
• Use ultrasonic waves to diagnose only when you have a correct medical basis to use
them.
• Every time you start an inspection, press [PATIENT ENTRY] key to reset the data.
• Use an endoscopic ultrasonic probe provided with the resolution and the depth of
focus suitable for diagnosis.
• In order to reduce an ultrasonic irradiation time, a medical physician should collect
necessary clinical data and use a technique which nishes an inspection as quickly
as possible. As for fetuses, particularly embryos, do not irradiate them with ultrasonic
waves because they are very susceptible to ultrasonic energy.
The concept of ALARA and the possible biological effects of ultrasonic waves are also
obtainable from “Medical Ultrasound Safety” issued by the AIUM (American Institute of
Ultrasound in Medicine).
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Chapter 2 Ultrasonic Output Power
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2.2 Effects of Ultrasonic Waves on Living Body
The following 2 kinds of natures are currently reported on the effects of ultrasonic
waves on the living body.
One is a thermal index (TI) on the living body by absorption of ultrasonic waves
through the tissue, and the other is a mechanical index (MI) on the living body
by cavitation (generation and destruction of bubbles). Note that they reflect the
instantaneous state of the ultrasonic output power and an accumulated effect of
inspection time length is not taken into account.
<Thermal Index (TI)>
This is an index indicating a relative temperature increase by a thermal action. This
thermal action has an effect on the living body. The TI shows a relative ratio to the
ultrasonic output power which causes a temperature increase of 1ºC under certain
conditions simulating the living tissue. As a temperature increase greatly differs
depending on the internal structure of the living body, the TI is divided into 3 kinds;
TIS (Soft-Tissue Thermal Index), TIB (Bone Thermal Index), and TIC (Cranial-Bone
Thermal Index).
TIS: Thermal index for the general soft tissue such as the abdomen and circulatory
organs.
TIB: Thermal index for the cases where the ultrasonic waves pass through the soft
tissue, bringing a focus area close to a bone, such as the head through the
fontanel of a fetus (for the 2nd and 3rd quarter) or a newborn baby.
TIC: Thermal index for the cases where a bone exists immediately below ultrasonic
endoscope such as the case when inspecting from the skull of an infant and an
adult.
The ultrasonic output power is automatically controlled depending on the application.
For obstetrical uses, however, you have to avoid a high TI value, because the WFUMB
(World Federation for Ultrasound in Medicine and Biology) presents the guideline
stating that the tissue of the fetus may be adversely affected if the temperature
increases by 4ºC in 5 minutes.
<Mechanical Index (MI)>
When the sound pressure of negative cycle of the ultrasonic waves exceeds a certain
limit, cavitation occurs. This mechanical action has an effect on the living body.
The MI, an index indicating a possibility of cavitation by ultrasonic waves, is a value
obtained by dividing the maximum negative sound pressure of ultrasonic pulses by
the square root of the frequency. As the frequency increases and the negative sound
pressure decreases, therefore, the MI is reduced, lowering a possibility of cavitation.
If the frequency is 1 MHz and the maximum negative sound pressure is 1 MPa, the
MI will be “1”; making it one of the threshold values to cause cavitation. Particularly
when gas and the soft tissue exist in mixture, such as the lungs radiated at the time of
inspecting the heart and the gas in the bowels at the time of inspecting the abdomen,
it is important to keep the MI low.
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Chapter 2 Ultrasonic Output Power
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2.3 Controlling Ultrasonic Output Power
SP-900 ensures that TI does not exceed 1.0, and MI does not exceed 1.0, in all of the
operation modes. Accordingly, the acoustic output is not described based on EN 60601-
2-37.
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Chapter 2 Ultrasonic Output Power
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Chapter 3 SP-900 System Conguration
3.1 Components of SP-900 System
3.1.1 Components of SP-900 System
The SP-900 system consists of the following components.
Figures in parentheses indicate the number of articles.
Ultrasonic Processor
SP-900 (1)
Scanner
RS-900 (1)
Control Pad
CP-900 (1)
Power Cord [Note] (1)
Operation Manual (1)
[Note] The power cord model CC9-003(BR)(S) is provided to the Brazilian market
only.
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3.1.2 Standard System Conguration (Example)
The standard system conguration consists of the minimum components required for
an examination. Examinations (diagnoses) of ultrasonic images on the monitor can be
conducted.
Endoscopic Ultrasonic Probe
P Series
PB2020-M
Scanner Arm
Control Pad
CP-900 [Note]
LCD Monitor
CL-22
CL-24
RADIANCE24
CCL220/AR
CCL244/AR
Scanner
RS-900
Ultrasonic Processor
SP-900
Cart
[Note] Connect the control pad CP-900 to the ultrasonic processor SP-900 only.
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