SAEVO EVUS 8 User manual

Cód.: - Rev.:02 77000001436
EVUS 8
OWNER´S
MANUAL
English

MANUAL PRESENTATION
Technical Name: Ultrasound device
Trade Name: Ultrasound Diagnostic Equipment
Model: Evus 8
Brand: Saevo
Responsável Técnico: Daniel R. de Camargo
CREA-SP: 5062199650
ANVISA Registration nº: 10069210070
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
manufacturerauthorized 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 Probe 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 Front Panel ..................................................................................................................................................... 10
2.3.2 Side View ....................................................................................................................................................... 10
2.3.3 Rear Panel .......................................................................................................................................................11
2.3.4 Battery Compartment......................................................................................................................................11
2.3.5 Control Panel.................................................................................................................................................. 12
2.3.6 Basic Screen................................................................................................................................................... 15
3 Preparing the System����������������������������������������������������������������������������������������������������������������������������������������� 17
3.1 Positioning the System .............................................................................................................................................. 17
3.2 Powering the System.................................................................................................................................................. 17
3.2.1 Using the Mains Supply................................................................................................................................. 17
3.2.2 Using the Battery ........................................................................................................................................... 17
3.2.3 Assembling/Disassembling the Battery ......................................................................................................... 18
3.2.4 Status Indicator .............................................................................................................................................. 19
3.3 Powering On/Off the System ..................................................................................................................................... 20
3.4 Adjusting the System ................................................................................................................................................ 20
3.5 Connecting the Probe................................................................................................................................................. 20
3.6 Connecting the Peripheral Device.............................................................................................................................. 21
3.6.1 Connecting the Foot Switch........................................................................................................................... 21
3.6.2 Connecting the Video Printer ......................................................................................................................... 21
3.6.3 Connecting the Network Printer .................................................................................................................... 21
3.6.4 Connecting the USB Printer........................................................................................................................... 22
4 Customizing Your System���������������������������������������������������������������������������������������������������������������������������������� 23
4.1 General System Settings ............................................................................................................................................ 24
4.1.1 General Settings ............................................................................................................................................. 24
4.1.2 Display Settings ............................................................................................................................................. 25

Contents
II
4.1.3 Storage Settings.............................................................................................................................................. 27
4.1.4 Defined-Key Settings..................................................................................................................................... 28
4.2 Peripheral Device Settings......................................................................................................................................... 28
4.3 Defining Annotation Library...................................................................................................................................... 30
4.4 Body Mark Settings ................................................................................................................................................... 31
4.5 Measurement Settings................................................................................................................................................ 31
4.5.1 General Measurement Settings ...................................................................................................................... 32
4.5.2 Application Settings....................................................................................................................................... 33
4.5.3 List Settings.................................................................................................................................................... 36
4.6 Report Settings........................................................................................................................................................... 37
4.7 Configuring DICOM.................................................................................................................................................. 38
4.7.1 Storage Service Settings................................................................................................................................. 38
4.7.2 Commitment Settings..................................................................................................................................... 39
4.7.3 DICOM Worklist Settings.............................................................................................................................. 40
4.7.4 MPPS Settings................................................................................................................................................ 41
4.7.5 Print Service Settings ..................................................................................................................................... 42
4.8 Defining System Defaults .......................................................................................................................................... 44
4.9 Viewing System Information ..................................................................................................................................... 45
4.9.1 General Information....................................................................................................................................... 45
4.9.2 Acoustic Output ............................................................................................................................................. 46
5 Preparing for an Exam �������������������������������������������������������������������������������������������������������������������������������������� 47
5.1 Acquiring Patient Information ................................................................................................................................... 47
5.1.1 Beginning a New Patient................................................................................................................................ 47
5.1.2 Retrieving Archived Information ................................................................................................................... 49
5.1.3 Using DICOM Worklist ................................................................................................................................. 50
5.2 Pausing/Resuming an Exam....................................................................................................................................... 50
5.3 Completing/Discontinuing an Exam.......................................................................................................................... 50
5.3.1 Completing an Exam...................................................................................................................................... 50
5.3.2 Discontinuing an Exam.................................................................................................................................. 51
6 Acquiring Images ����������������������������������������������������������������������������������������������������������������������������������������������� 53
6.1 Selecting a Probe and an Exam Type......................................................................................................................... 53
6.2 Acquiring B-Mode Images......................................................................................................................................... 55
6.2.1 Entering B Mode............................................................................................................................................ 55
6.2.2 Optimizing B-Mode Images........................................................................................................................... 56
6.3 Acquiring Color Flow Images.................................................................................................................................... 60
6.3.1 C Mode........................................................................................................................................................... 60
6.3.2 PDI Mode....................................................................................................................................................... 60
6.3.3 TDI Mode....................................................................................................................................................... 61
6.3.4 Optimizing C/PDI/TDI Mode Images............................................................................................................ 62
6.4 Acquiring M-Mode Images........................................................................................................................................ 65
6.4.1 M Mode.......................................................................................................................................................... 65
6.4.2 Anatomical M-Mode...................................................................................................................................... 66
6.4.3 Optimizing M-Mode Images.......................................................................................................................... 67
6.5 Acquiring Spectral Doppler Images........................................................................................................................... 68
6.5.1 PW Mode ....................................................................................................................................................... 68
6.5.2 CW Mode ....................................................................................................................................................... 70
6.5.3 Optimizing Spectral Doppler Images............................................................................................................. 72
6.6 Acquiring Triplex-Mode Images................................................................................................................................ 75

Contents
III
6.6.1 B+C/TDI +M.................................................................................................................................................. 75
6.6.2 B + C/PDI/TDI + PW..................................................................................................................................... 76
6.6.3 B+C/PDI+CW................................................................................................................................................ 77
7 Elastography Imaging���������������������������������������������������������������������������������������������������������������������������������������� 79
7.1 Acquiring Elastography Images................................................................................................................................. 79
7.2 Optimizing Elastography Images............................................................................................................................... 80
7.2.1 Strain Map...................................................................................................................................................... 80
7.2.2 Strain Process................................................................................................................................................. 80
7.2.3 Transparency .................................................................................................................................................. 81
7.2.4 Contrast ......................................................................................................................................................... 81
7.2.5 Persistence ..................................................................................................................................................... 81
7.2.6 Frequency....................................................................................................................................................... 81
7.3 Working with Elastography Images........................................................................................................................... 81
8 Using 3D �������������������������������������������������������������������������������������������������������������������������������������������������������������� 83
8.1 Acquiring 3D Images................................................................................................................................................. 83
8.2 Working with 3D Images ........................................................................................................................................... 84
8.2.1 Adjusting ROI ................................................................................................................................................ 84
8.2.2 Setting Display Format .................................................................................................................................. 85
8.2.3 Reviewing Cine.............................................................................................................................................. 85
8.2.4 Setting Render Mode ..................................................................................................................................... 86
8.2.5 Cropping Reviews.......................................................................................................................................... 86
8.2.6 Moving/Rotating/Magnifying Images............................................................................................................ 87
8.2.7 Optimizing 3D Image..................................................................................................................................... 88
8.2.8 Observing reviews by the slice ...................................................................................................................... 88
8.2.9 Setting the Scan Mode ................................................................................................................................... 89
8.2.10 Adjusting Z Angle/Z Scale............................................................................................................................. 89
8.2.11 Restoring the Image ......................................................................................................................... 90
8.2.12 Customizing Presets ......................................................................................................................... 90
9 Using 4D �������������������������������������������������������������������������������������������������������������������������������������������������������������� 91
9.1 Acquiring 4D Images................................................................................................................................................. 91
9.1.1 Entering the Real-Time 4D Imaging.............................................................................................................. 91
9.1.2 Acquiring Dynamic 3D Image....................................................................................................................... 92
9.2 Working with 4D Images ........................................................................................................................................... 92
10 Working with Images��������������������������������������������������������������������������������������������������������������������������������������� 93
10.1 Imaging Features........................................................................................................................................................ 93
10.1.1 Imaging Reverse ............................................................................................................................................ 93
10.1.2 Split Screen Display....................................................................................................................................... 93
10.1.3 M-Tuning ....................................................................................................................................................... 94
10.1.4 Harmonic Imaging ........................................................................................................................................ 95
10.1.5 Panoramic Imaging ........................................................................................................................................ 95
10.2 Magnifying an Image................................................................................................................................................. 97
10.3 Freezing an Image...................................................................................................................................................... 97
10.4 Using Cine.................................................................................................................................................................. 97
10.4.1 Reviewing Cine ............................................................................................................................................. 97
10.4.2 Cutting Cine ................................................................................................................................................... 98
10.5 Annotations and Body Marks .................................................................................................................................... 98
10.5.1 Annotating an Image with Typed Words........................................................................................................ 98

Contents
IV
10.5.2 Annotating an Image with Arrows ................................................................................................................. 98
10.5.3 Body Mark ..................................................................................................................................................... 98
10.5.4 Deleting Annotations and Body Marks .......................................................................................................... 99
10.6 Using ECG ................................................................................................................................................................. 99
10.6.1 Basic Procedures of ECG Operation............................................................................................................ 100
10.6.2 Optimizing Parameters................................................................................................................................. 100
10.6.3 Reviewing ECG ........................................................................................................................................... 101
11 Managing Images/Data ���������������������������������������������������������������������������������������������������������������������������������� 103
11.1 Storing an Image ...................................................................................................................................................... 103
11.1.1 Storing an Image Automatically .................................................................................................................. 103
11.1.2 Storing an Image Manually.......................................................................................................................... 103
11.2 Viewing an Image/Cine............................................................................................................................................ 103
11.2.1 Viewing the Current Image/Cine ................................................................................................................. 104
11.2.2 Retrieving an Image ..................................................................................................................................... 104
11.3 Sharing Data............................................................................................................................................................. 105
11.4 Backing up Data....................................................................................................................................................... 105
11.4.1 Backing up Data to the USB Drive .............................................................................................................. 105
11.4.2 Backing up Data to DVD ............................................................................................................................. 105
11.5 Importing Data to the System .................................................................................................................................. 106
12 Working with DICOM����������������������������������������������������������������������������������������������������������������������������������� 107
12.1 Verifying Connectivity............................................................................................................................................. 107
12.2 DICOM Storage ....................................................................................................................................................... 107
12.3 DICOM Print............................................................................................................................................................ 108
12.4 DICOM Worklist..................................................................................................................................................... 108
12.5 MPPS ....................................................................................................................................................................... 109
12.6 Storage Commitment ................................................................................................................................................110
12.7 DICOM Queue..........................................................................................................................................................111
13 Probes and Biopsy ����������������������������������������������������������������������������������������������������������������������������������������� 113
13.1 Probe .........................................................................................................................................................................113
13.1.1 Available Probes............................................................................................................................................113
13.1.2 Probe Usage ..................................................................................................................................................114
13.1.3 Cleaning the Probe........................................................................................................................................115
13.1.4 Disinfecting or Sterilizing the Probe.............................................................................................................116
13.1.5 Sterilizing the Probe......................................................................................................................................118
13.1.6 Disinfecting and Sterilizing the Probe Cable................................................................................................118
13.1.7 Storage and Transportation ...........................................................................................................................119
13.2 Biopsy .......................................................................................................................................................................119
13.2.1 Available Biopsy Brackets ........................................................................................................................... 120
13.2.2 Assembling the Biopsy Bracket................................................................................................................... 121
13.2.3 Preparing for a Biopsy ................................................................................................................................. 123
13.2.4 Verifying the Biopsy Bracket....................................................................................................................... 124
13.2.5 Performing a Biopsy .................................................................................................................................... 124
13.2.6 Cleaning the Biopsy Bracket........................................................................................................................ 125
13.2.7 Sterilizing the Biopsy Bracket ..................................................................................................................... 125
13.2.8 Storage ......................................................................................................................................................... 126
14 System Maintenance �������������������������������������������������������������������������������������������������������������������������������������� 127
14.1 Cleaning the System................................................................................................................................................. 127

Contents
V
14.2 Maintenance Checks ................................................................................................................................................ 128
14.3 Troubleshooting ....................................................................................................................................................... 129
14.4 Equipment Disposal ................................................................................................................................................. 129
14.5 Precautions for the Reduction of the Environment Impact...................................................................................... 129
14.6 Precautions in Case of Destruction of the System ................................................................................................... 129
14.7 Customer Service ..................................................................................................................................................... 130
Appendix A Specifications���������������������������������������������������������������������������������������������������������������������������������� 131
Appendix B EMC Guidance and Manufacturer’s Declaration ���������������������������������������������������������������������� 132
Appendix C In Situ, Derated, and Water Value Intensities ���������������������������������������������������������������������������� 135
Appendix D Recommended Coupling Gel, Cleaner and Disinfectant ����������������������������������������������������������� 136
D.1 Coupling Gel............................................................................................................................................................ 136
D.2 Cleaner ..................................................................................................................................................................... 137
D.3 Disinfectant .............................................................................................................................................................. 137
Appendix E Acoustic Output Data �������������������������������������������������������������������������������������������������������������������� 139

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