SAEVO FT 412 User manual

Cód.: - Rev.:01 77000001433
FT 412
OWNER´S
MANUAL
English

MANUAL PRESENTATION
Technical Name: Ultrasound device
Trade Name: Ultrasound Diagnostic Equipment
Model: FT 412
Brand: Saevo
Responsável Técnico: Daniel R. de Camargo
CREA-SP: 5062199650
ANVISA Registration nº: 10069210072
Alliage S/A Industrias Médico Odontológico
Rodovia Abrão Assed, Km 53 - CEP 14097-500
Ribeirão Preto - SP - Brazil
Phone: [phone]

Statement
The manufacturer owns the intellectual property rights to this manual, and also maintains the contents of this manual as
confidential information. This manual is a reference for the operation, maintenance and cleaning of this product and does not
convey any license under the patent rights of the manufacturer, nor the rights of others.
This manual contains the information protected by copyrights or patents. Reproduction, amendment or translation of this
manual in any manner whatsoever without the written permission of the manufacturer is strictly prohibited.
All information contained in this manual is believed to be correct. The manufacturer shall not be liable for errors contained
herein or for incidental or consequential damages in connection with the furnishing, performance or use of this manual. The
manufacturer does not assume any liability arising out of any infringements of patents or other rights of third parties.
This manual is based on the maximum configuration and therefore some contents may not apply to your product.
This manual is subject to change without prior notice and legal obligation.
Manufacturer’s Responsibility
The manufacturer is responsible for the effects on safety, reliability and performance of this product, only if all the following
requirements are met.
●All installation operations, expansions, changes, modifications and repairs of this product are conducted by the
manufacturer authorized personnel.
●The use or application of the product or the use of parts or accessories is approved by the manufacturer.
●The electrical installation of the relevant room complies with the applicable national and local requirements.
●The product is used in accordance with the instructions for use.
Documentation
The manufacturer provides the documentation consisting of various manuals:
●The basic user manual describes the basic functions and operating procedures of the system.
●The advanced user manual provides information about the measurements and calculations available in each mode.
Understand the meanings of the following items clearly before reading this manual.
Item Meaning
!
Indicates a potentially hazardous situation which, if not avoided, could result in death or serious injury.
Indicates a potentially hazardous situation which, if not avoided, may result in malfunction or damage of
the system.
Indicates a potentially biological hazardous situation which, if not avoided, may result in disease
transmission.
NOTE Indicates precautions or recommendations that should be used in operating the system.
Boldfaced
Word
Indicates controls on the control panel, or on-screen objects such as menu items or keys.

Item Meaning
Click Move the cursor to the controls on the display and press the conrm key on the control panel.
>Select a menu item or a key following the path.

I
Contents
1 Safety ��������������������������������������������������������������������������������������������������������������������������������������������������������������������� 1
1.1 Intended Use ................................................................................................................................................................ 1
1.2 Safety Precautions........................................................................................................................................................ 1
1.2.1 Electrical Safety ............................................................................................................................................... 1
1.2.2 Mechanical Safety............................................................................................................................................ 2
1.2.3 Accessories Caring........................................................................................................................................... 3
1.2.4 Biohazard Considerations ................................................................................................................................ 3
1.3 Acoustic Power Principle............................................................................................................................................. 3
1.3.1 Biological Safety.............................................................................................................................................. 4
1.3.2 ALARA............................................................................................................................................................ 4
1.3.3 Mechanical and Thermal Indices ..................................................................................................................... 4
1.3.4 Transducer Surface Temperature Limits .......................................................................................................... 5
1.3.5 Imaging Functions that Change Acoustic Output ............................................................................................ 5
1.4 Safety Symbols ............................................................................................................................................................ 5
2 System Overview ������������������������������������������������������������������������������������������������������������������������������������������������� 9
2.1 System Configuration .................................................................................................................................................. 9
2.2 Physical Specifications ................................................................................................................................................ 9
2.3 System Components..................................................................................................................................................... 9
2.3.1 Peripheral Device Panel ................................................................................................................................. 10
2.3.2 Control Panel...................................................................................................................................................11
2.3.3 Key Panel ....................................................................................................................................................... 13
2.3.4 Basic Screen................................................................................................................................................... 15
3 Preparing the System����������������������������������������������������������������������������������������������������������������������������������������� 17
3.1 System Assembly ....................................................................................................................................................... 17
3.2 System Moving/Positioning....................................................................................................................................... 18
3.3 Connecting and Powering on the System .................................................................................................................. 18
3.3.1 Using the Mains Supply................................................................................................................................. 18
3.3.2 Using the Battery ........................................................................................................................................... 19
3.3.3 Indicators........................................................................................................................................................ 19
3.4 Powering On/Off the System ..................................................................................................................................... 20
3.5 Adjusting the System ................................................................................................................................................ 21
3.5.1 Adjusting the Monitor Arm............................................................................................................................ 21
3.5.2 Adjusting the Display Monitor ...................................................................................................................... 21
3.6 Connecting the Probe................................................................................................................................................. 22
3.7 Connecting the Peripheral Device.............................................................................................................................. 23
3.7.1 Connecting the Foot Switch........................................................................................................................... 23
3.7.2 Connecting the Video Printer ......................................................................................................................... 23
3.7.3 Connecting the Network Printer .................................................................................................................... 23
3.7.4 Connecting the USB Printer........................................................................................................................... 24
4 Customizing Your System���������������������������������������������������������������������������������������������������������������������������������� 25
4.1 General System Settings ............................................................................................................................................ 25
4.1.1 General Settings ............................................................................................................................................. 25
4.1.2 Display Settings ............................................................................................................................................. 27

Contents
II
4.1.3 Storage Settings.............................................................................................................................................. 28
4.1.4 Defined-Key Settings..................................................................................................................................... 29
4.2 Peripheral Device Settings......................................................................................................................................... 30
4.3 Defining Annotation Library...................................................................................................................................... 31
4.4 Body Mark Settings ................................................................................................................................................... 32
4.5 Measurement Settings................................................................................................................................................ 33
4.5.1 General Measurement Settings ...................................................................................................................... 33
4.5.2 Application Settings....................................................................................................................................... 34
4.5.3 List Settings.................................................................................................................................................... 37
4.6 Report Settings........................................................................................................................................................... 38
4.7 Configuring DICOM.................................................................................................................................................. 39
4.7.1 Storage Service Settings................................................................................................................................. 39
4.7.2 Commitment Settings..................................................................................................................................... 40
4.7.3 DICOM Worklist Settings.............................................................................................................................. 41
4.7.4 MPPS Settings................................................................................................................................................ 42
4.7.5 Print Service Settings ..................................................................................................................................... 43
4.8 Defining System Defaults .......................................................................................................................................... 44
4.8.1 Loading System Defaults ............................................................................................................................... 45
4.8.2 Creating System Defaults............................................................................................................................... 45
4.8.3 Export or Import System Defaults ................................................................................................................. 45
4.9 Viewing System Information ..................................................................................................................................... 46
4.9.1 General Information....................................................................................................................................... 46
4.9.2 Acoustic Output ............................................................................................................................................. 46
5 Preparing for an Exam �������������������������������������������������������������������������������������������������������������������������������������� 49
5.1 Acquiring Patient Information ................................................................................................................................... 49
5.1.1 Beginning a New Patient................................................................................................................................ 49
5.1.2 Retrieving Archived Information ................................................................................................................... 51
5.1.3 Using DICOM Worklist ................................................................................................................................. 52
5.2 Pausing/Resuming an Exam....................................................................................................................................... 52
5.2.1 Pausing an Exam............................................................................................................................................ 52
5.2.2 Resume an Exam............................................................................................................................................ 52
5.3 Completing/Discontinuing an Exam.......................................................................................................................... 52
5.3.1 Completing an Exam...................................................................................................................................... 52
5.3.2 Discontinuing an Exam.................................................................................................................................. 53
6 Acquiring Images ����������������������������������������������������������������������������������������������������������������������������������������������� 55
6.1 Selecting a Probe and an Exam Type......................................................................................................................... 55
6.2 Acquiring B-Mode Images......................................................................................................................................... 57
6.2.1 Entering B Mode............................................................................................................................................ 57
6.2.2 Optimizing B-Mode Images........................................................................................................................... 57
6.3 Acquiring Color Flow Images.................................................................................................................................... 62
6.3.1 CFM Mode..................................................................................................................................................... 62
6.3.2 PDI Mode....................................................................................................................................................... 63
6.3.3 TDI Mode....................................................................................................................................................... 63
6.3.4 Optimizing CFM/PDI/TDI Mode Images...................................................................................................... 64
6.4 Acquiring M-Mode Images....................................................................................................................................... 67
6.4.1 M Mode.......................................................................................................................................................... 67
6.4.2 Anatomical M-Mode...................................................................................................................................... 68
6.4.3 Optimizing M-Mode Images.......................................................................................................................... 69

Contents
III
6.5 Acquiring Spectral Doppler Images........................................................................................................................... 70
6.5.1 PW Mode ....................................................................................................................................................... 70
6.5.2 CW Mode ....................................................................................................................................................... 72
6.5.3 Optimizing Spectral Doppler Images............................................................................................................. 74
6.6 Acquiring Triplex-Mode Images................................................................................................................................ 77
6.6.1 B+CFM/TDI +M............................................................................................................................................ 77
6.6.2 B+CFM/PDI/TDI +PW.................................................................................................................................. 78
6.6.3 B+CFM/PDI+CW .......................................................................................................................................... 80
7 Elastography Imaging���������������������������������������������������������������������������������������������������������������������������������������� 81
7.1 Acquiring Elastography Images................................................................................................................................. 81
7.2 Optimizing Elastography Images............................................................................................................................... 82
7.2.1 Strain Map...................................................................................................................................................... 82
7.2.2 Strain Process................................................................................................................................................. 82
7.2.3 Transparency .................................................................................................................................................. 83
7.2.4 Contrast ......................................................................................................................................................... 83
7.2.5 Persistence ..................................................................................................................................................... 83
7.2.6 Frequency....................................................................................................................................................... 83
7.3 Working with Elastography Images........................................................................................................................... 83
8 3D Imaging ��������������������������������������������������������������������������������������������������������������������������������������������������������� 85
8.1 Acquiring 3D Images................................................................................................................................................. 85
8.2 Working with 3D Images ........................................................................................................................................... 86
8.2.1 Adjusting ROI ................................................................................................................................................ 86
8.2.2 Setting Display Format .................................................................................................................................. 87
8.2.3 Setting Render Mode ..................................................................................................................................... 87
8.2.4 Cropping Reviews with Trace ....................................................................................................................... 88
8.2.5 Moving/Rotating/Magnifying Images............................................................................................................ 88
8.2.6 Optimizing 3D Image..................................................................................................................................... 89
8.2.7 Observing Reviews by the Slice .................................................................................................................... 89
8.2.8 Setting the Scan Mode ................................................................................................................................... 90
8.2.9 Adjusting ZAngle/ZScale .............................................................................................................................. 90
8.2.10 Restoring the Image ......................................................................................................................... 91
8.2.11 Customizing Presets ......................................................................................................................... 91
9 4D Imaging���������������������������������������������������������������������������������������������������������������������������������������������������������� 93
9.1 Acquiring 4D Images................................................................................................................................................. 93
9.1.1 Entering the Real-Time 4D Imaging.............................................................................................................. 93
9.1.2 Acquiring Dynamic 3D Image....................................................................................................................... 94
9.2 Working with 4D Images ........................................................................................................................................... 94
10 Working with Images��������������������������������������������������������������������������������������������������������������������������������������� 95
10.1 Imaging Features........................................................................................................................................................ 95
10.1.1 Imaging Reverse ............................................................................................................................................ 95
10.1.2 Split Screen Display....................................................................................................................................... 95
10.1.3 m-Tuning........................................................................................................................................................ 96
10.1.4 Harmonic Imaging ......................................................................................................................................... 96
10.1.5 Panoramic Imaging ........................................................................................................................................ 97
10.2 Magnifying an Image................................................................................................................................................. 99
10.3 Freezing an Image...................................................................................................................................................... 99
10.4 Using Cine.................................................................................................................................................................. 99

Contents
IV
10.4.1 Reviewing Cine ............................................................................................................................................. 99
10.4.2 Cutting Cine ................................................................................................................................................ 100
10.5 Annotations and Body Marks .................................................................................................................................. 100
10.5.1 Annotating an Image.................................................................................................................................... 100
10.5.2 Body Mark ................................................................................................................................................... 101
10.5.3 Deleting Annotations and Body Marks ........................................................................................................ 101
10.6 Using ECG ............................................................................................................................................................... 101
10.6.1 Basic Procedures of ECG Operation............................................................................................................ 102
10.6.2 Optimizing Parameters................................................................................................................................. 102
10.6.3 Reviewing ECG ........................................................................................................................................... 103
11 Managing Images/Data ���������������������������������������������������������������������������������������������������������������������������������� 105
11.1 Storing an Image ...................................................................................................................................................... 105
11.1.1 Storing 2D Image ......................................................................................................................................... 105
11.1.2 Storing 3D/4D Image ................................................................................................................................... 105
11.2 Viewing an Image .................................................................................................................................................... 105
11.2.1 Viewing a Current Image ............................................................................................................................. 105
11.2.2 Retrieving an Image ..................................................................................................................................... 106
11.3 Sharing Data............................................................................................................................................................. 106
11.4 Backing up Data....................................................................................................................................................... 107
11.4.1 Backing up Data to the USB drive............................................................................................................... 107
11.4.2 Backing up Data to DVD ............................................................................................................................. 107
11.5 Importing Data to the System .................................................................................................................................. 107
12 Working with DICOM����������������������������������������������������������������������������������������������������������������������������������� 109
12.1 Verifying Connectivity............................................................................................................................................. 109
12.2 DICOM Storage ....................................................................................................................................................... 109
12.3 DICOM Print.............................................................................................................................................................110
12.4 DICOM Worklist.......................................................................................................................................................110
12.5 MPPS ........................................................................................................................................................................111
12.6 Storage Commitment ................................................................................................................................................112
12.7 DICOM Queue..........................................................................................................................................................113
13 Probes and Biopsy ������������������������������������������������������������������������������������������������������������������������������������������ 115
13.1 Probe .........................................................................................................................................................................115
13.1.1 Available Probes............................................................................................................................................115
13.1.2 Probe Usage ..................................................................................................................................................116
13.1.3 Cleaning the Probe........................................................................................................................................117
13.1.4 Disinfecting and Sterilizing the Probe ..........................................................................................................118
13.1.5 Disinfecting and Sterilizing the Probe Cable............................................................................................... 120
13.1.6 Storage and Transportation .......................................................................................................................... 121
13.2 Biopsy ...................................................................................................................................................................... 121
13.2.1 Available Biopsy Brackets ........................................................................................................................... 122
13.2.2 Assembling the Biopsy Bracket................................................................................................................... 122
13.2.3 Preparing for a Biopsy ................................................................................................................................. 125
13.2.4 Verifying the Biopsy Bracket....................................................................................................................... 125
13.2.5 Performing a Biopsy .................................................................................................................................... 125
13.2.6 Cleaning the Biopsy Bracket........................................................................................................................ 126
13.2.7 Sterilizing the Biopsy Bracket ..................................................................................................................... 127
13.2.8 Storage ......................................................................................................................................................... 127

Contents
V
14 System Maintenance �������������������������������������������������������������������������������������������������������������������������������������� 129
14.1 Cleaning the System................................................................................................................................................. 129
14.2 Maintenance Checks ................................................................................................................................................ 130
14.3 Troubleshooting ....................................................................................................................................................... 130
14.4 Replacing the Fuse................................................................................................................................................... 131
14.5 Equipment Disposal ................................................................................................................................................. 131
14.6 Precautions for the Reduction of the Environment Impact...................................................................................... 131
14.7 Precautions in Case of Destruction of the System ................................................................................................... 132
14.8 Customer Service ..................................................................................................................................................... 132
Appendix A Specifications���������������������������������������������������������������������������������������������������������������������������������� 133
Appendix B EMC Guidance and Manufacturer’s Declaration ���������������������������������������������������������������������� 134
Appendix C In Situ, Derated, and Water Value Intensities ���������������������������������������������������������������������������� 137
Appendix D Recommended Coupling Gel, Cleaner and Disinfectant ����������������������������������������������������������� 138
D.1 Coupling Gel............................................................................................................................................................ 138
D.2 Cleaner ..................................................................................................................................................................... 139
D.3 Disinfectant .............................................................................................................................................................. 139
Appendix E Acoustic Output Data �������������������������������������������������������������������������������������������������������������������� 140

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