SP-900 Ultrasonic Processor Operation Manual

Important Safety Information

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 identified 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

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

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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Contents

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 Configuration... 19 3.1 Components of SP-900 System... 19 3.1.1 Components of SP-900 System... 19 3.1.2 Standard System Configuration (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 Configuration... 28 3.4.1 Screen Configuration 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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Contents

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

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 Specifications... 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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Preface

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

Terms used in this manual SP-900 System In narrow definition, 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 definition, includes a set of equipment (standard system and expanded system) including various connected peripheral devices in addition to the narrow definition.

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

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

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. 897N120838C

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Chapter 1 Safety

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 fibrillation. (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

(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

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 fire 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

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, fire, 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, fire, 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 2 Ultrasonic Output Power

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 finishes 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

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

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 606012-37.

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Chapter 3 SP-900 System Configuration

Chapter 3 SP-900 System Configuration 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)

Control Pad CP-900 (1)

Scanner RS-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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Chapter 3 SP-900 System Configuration

3.1.2

Standard System Configuration (Example) The standard system configuration 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 RS-900

Control Pad CP-900 [Note]

Ultrasonic Processor SP-900

LCD Monitor CL-22 CL-24 RADIANCE24 CCL220/AR CCL244/AR Scanner Arm

Cart

[Note] Connect the control pad CP-900 to the ultrasonic processor SP-900 only.

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