Sonoscape SSI-6000 User manual

SSI-6000/SSI-5800/SSI-5500/SSI-5500BW
Digital Color Doppler Ultrasound System
Regulatory Requirement
This product complies with regulatory requirements of the following European di-
rective 93/42/EEC as amended by 2007/47/EC concerning medical devices.
NOTE:
Some options are not available on some models!
SSI-5500BW is the black/white model which does not support color modes (spec-
tral Doppler and color Doppler modes).
P/N: 4701-0061-01B
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SSI-6000/SSI-5800/SSI-5500/SSI-5500BW
Digital Color Doppler Ultrasound System
Revision History
Revision Date Reason for change
1.0 January 2009 Initial release of product.
2.0 June 2010 Software update to version 2.0.4.x
Effective Chapters/Pages
Basic Operator’s Manual
Chapter Page Rev. Number
Cover 2.0
Revision History 2.0
Chapter 01 2.0
Chapter 02 2.0
Chapter 03 2.0
Chapter 04 2.0
Chapter 05 2.0
Chapter 06 2.0
Chapter 07 2.0
Chapter 08 2.0
Chapter 09 2.0
Chapter 10 2.0
Chapter 11 2.0
Chapter 12 2.0
Chapter 12 2.0
Chapter 13 2.0
Chapter 14 2.0
Appendix A 2.0
Appendix B 2.0
P/N: 4701-0061-01B
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SSI-6000/SSI-5800/SSI-5500/SSI-5500BW
Digital Color Doppler Ultrasound System
Contents
1 System Safety and Maintenance 1-1
1.1 Safety Overview . . . . . . . . . . . . . . . . . . . . . . . . . . 1-2
1.2 Symbol Used . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-3
1.3 Biological Safety . . . . . . . . . . . . . . . . . . . . . . . . . . 1-3
1.4 Scanning Patients and Education . . . . . . . . . . . . . . . . . 1-4
1.4.1 Safe Scanning Guideline . . . . . . . . . . . . . . . . . 1-4
1.4.2 Understanding the MI/TI Display . . . . . . . . . . . . . 1-6
1.5 Environmental Requirements . . . . . . . . . . . . . . . . . . . 1-9
1.6 Transport and Storage Environmental Requirements . . . . . . . 1-10
1.7 Electrical Requirements . . . . . . . . . . . . . . . . . . . . . . 1-10
1.8 Electrical Safety . . . . . . . . . . . . . . . . . . . . . . . . . . 1-10
1.9 Transducer Maintenance . . . . . . . . . . . . . . . . . . . . . . 1-11
1.10 System Transportation . . . . . . . . . . . . . . . . . . . . . . . 1-15
1.10.1 Moving the System . . . . . . . . . . . . . . . . . . . . 1-15
1.10.2 Transporting the System . . . . . . . . . . . . . . . . . . 1-15
2 System Specifications 2-1
2.1 System Configuration . . . . . . . . . . . . . . . . . . . . . . . 2-2
2.2 Application and Contraindication . . . . . . . . . . . . . . . . . . 2-3
2.3 Probes and Accessories . . . . . . . . . . . . . . . . . . . . . . 2-4
2.4 Physical Specifications . . . . . . . . . . . . . . . . . . . . . . . 2-5
2.5 Concept of Operation . . . . . . . . . . . . . . . . . . . . . . . 2-6
2.5.1 Screen Layout . . . . . . . . . . . . . . . . . . . . . . . 2-6
2.5.2 Keyboard Layout . . . . . . . . . . . . . . . . . . . . . . 2-7
2.5.3 Keyboard Description . . . . . . . . . . . . . . . . . . . 2-8
2.5.4 General Operation Instructions . . . . . . . . . . . . . . 2-12
3 Starting the System 3-1
3.1 Probe Connection . . . . . . . . . . . . . . . . . . . . . . . . . 3-1
3.2 Boot Up . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-2
3.3 Patient Information . . . . . . . . . . . . . . . . . . . . . . . . . 3-2
3.4 Start Ultrasound Diagnosis . . . . . . . . . . . . . . . . . . . . 3-4
3.4.1 Customized application mode (Create New Exam Mode) . 3-4
3.4.2 Annotation and Bodymark . . . . . . . . . . . . . . . . . 3-4
4 System Setup 4-1
4.1 System Menu . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-2
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SSI-6000/SSI-5800/SSI-5500/SSI-5500BW
Digital Color Doppler Ultrasound System
4.2 File Manager . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-2
4.3 Facility Name . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-4
4.4 Set Date and Time . . . . . . . . . . . . . . . . . . . . . . . . . 4-4
4.5 System Information . . . . . . . . . . . . . . . . . . . . . . . . 4-4
4.6 System Setting . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-5
4.6.1 General Setting . . . . . . . . . . . . . . . . . . . . . . 4-5
4.6.2 Set Printer . . . . . . . . . . . . . . . . . . . . . . . . . 4-6
4.6.3 Set Calculation Menu . . . . . . . . . . . . . . . . . . . 4-7
4.6.4 Set Measurement Method . . . . . . . . . . . . . . . . . 4-7
4.6.5 Annotation Edit . . . . . . . . . . . . . . . . . . . . . . 4-8
4.6.6 Define Quick Key . . . . . . . . . . . . . . . . . . . . . 4-9
4.6.7 Load Default . . . . . . . . . . . . . . . . . . . . . . . . 4-9
4.7 DICOM Setting . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-11
5 B Mode 5-1
5.1 Starting B Mode . . . . . . . . . . . . . . . . . . . . . . . . . . 5-2
5.2 B Mode Image Information . . . . . . . . . . . . . . . . . . . . . 5-2
5.3 Real Time B Mode Operation . . . . . . . . . . . . . . . . . . . 5-3
5.3.1 B Mode Menu . . . . . . . . . . . . . . . . . . . . . . . 5-3
5.3.2 B Gain . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-3
5.3.3 Time Gain Compensation (TGC) . . . . . . . . . . . . . 5-4
5.3.4 Depth . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-4
5.3.5 Focal Zones . . . . . . . . . . . . . . . . . . . . . . . . 5-5
5.3.6 Tissue Acoustic Characteristics . . . . . . . . . . . . . . 5-5
5.3.7 Dynamic Range . . . . . . . . . . . . . . . . . . . . . . 5-6
5.3.8 Grayscale curve . . . . . . . . . . . . . . . . . . . . . . 5-6
5.3.9 Persistence . . . . . . . . . . . . . . . . . . . . . . . . 5-7
5.3.10 Chroma . . . . . . . . . . . . . . . . . . . . . . . . . . 5-7
5.3.11 Sector Width and Position . . . . . . . . . . . . . . . . . 5-7
5.3.12 Line Density . . . . . . . . . . . . . . . . . . . . . . . . 5-7
5.3.13 Compound Imaging . . . . . . . . . . . . . . . . . . . . 5-8
5.3.14 Frequency Range . . . . . . . . . . . . . . . . . . . . . 5-8
5.3.15 Image Orientation . . . . . . . . . . . . . . . . . . . . . 5-8
5.3.16 Adaptive Image Fusion . . . . . . . . . . . . . . . . . . 5-9
5.3.17 uScan Function . . . . . . . . . . . . . . . . . . . . . . 5-9
5.3.18 Acoustic Output Power . . . . . . . . . . . . . . . . . . 5-9
5.3.19 Trapezoidal Imaging . . . . . . . . . . . . . . . . . . . . 5-9
5.3.20 Zoom . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-10
5.4 Cine Mode Operation . . . . . . . . . . . . . . . . . . . . . . . 5-10
5.4.1 Grayscale curve . . . . . . . . . . . . . . . . . . . . . . 5-10
5.4.2 Chroma . . . . . . . . . . . . . . . . . . . . . . . . . . 5-10
5.4.3 Image Orientation (Left/Right) . . . . . . . . . . . . . . . 5-10
5.4.4 Read Previously Saved Image . . . . . . . . . . . . . . 5-11
5.4.5 Select Image Sequence . . . . . . . . . . . . . . . . . . 5-11
5.4.6 Cine Playback . . . . . . . . . . . . . . . . . . . . . . . 5-11
P/N: 4701-0061-01B
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SSI-6000/SSI-5800/SSI-5500/SSI-5500BW
Digital Color Doppler Ultrasound System
5.4.7 Saving Image/Cine . . . . . . . . . . . . . . . . . . . . 5-11
5.5 Dual and Quad Display Formats . . . . . . . . . . . . . . . . . . 5-12
5.5.1 Dual Display Format . . . . . . . . . . . . . . . . . . . . 5-12
5.5.2 Quad Display Format . . . . . . . . . . . . . . . . . . . 5-13
5.6 Tissue Harmonic Imaging (THI) . . . . . . . . . . . . . . . . . . 5-13
6 CDI Mode 6-1
6.1 Starting CDI Mode . . . . . . . . . . . . . . . . . . . . . . . . . 6-2
6.2 Color Image Information . . . . . . . . . . . . . . . . . . . . . . 6-2
6.3 CDI Mode Operation . . . . . . . . . . . . . . . . . . . . . . . . 6-2
6.3.1 CDI Menu . . . . . . . . . . . . . . . . . . . . . . . . . 6-2
6.3.2 Adjust CDI Sample Box . . . . . . . . . . . . . . . . . . 6-3
6.3.3 Pulse Repetition Frequency . . . . . . . . . . . . . . . . 6-3
6.3.4 Wall Filter . . . . . . . . . . . . . . . . . . . . . . . . . 6-3
6.3.5 CDI Gain . . . . . . . . . . . . . . . . . . . . . . . . . . 6-4
6.3.6 Persistence . . . . . . . . . . . . . . . . . . . . . . . . 6-4
6.3.7 Color Map . . . . . . . . . . . . . . . . . . . . . . . . . 6-4
6.3.8 CDI Power . . . . . . . . . . . . . . . . . . . . . . . . . 6-4
6.3.9 Baseline . . . . . . . . . . . . . . . . . . . . . . . . . . 6-5
6.3.10 Sector Width and Position . . . . . . . . . . . . . . . . . 6-5
6.3.11 B Reject . . . . . . . . . . . . . . . . . . . . . . . . . . 6-5
6.3.12 CDI Frequency . . . . . . . . . . . . . . . . . . . . . . 6-5
6.3.13 Image Orientation (Left/Right) . . . . . . . . . . . . . . . 6-6
6.3.14 Flow Invert . . . . . . . . . . . . . . . . . . . . . . . . . 6-6
6.3.15 Line Density . . . . . . . . . . . . . . . . . . . . . . . . 6-6
6.4 Cine Mode . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-6
6.4.1 C Map . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-7
6.4.2 B Reject . . . . . . . . . . . . . . . . . . . . . . . . . . 6-7
6.4.3 Flow Invert . . . . . . . . . . . . . . . . . . . . . . . . . 6-7
6.4.4 Cine Playback . . . . . . . . . . . . . . . . . . . . . . . 6-7
7 DPI Mode 7-1
7.1 Starting DPI Mode . . . . . . . . . . . . . . . . . . . . . . . . . 7-1
7.2 DPI Image Information . . . . . . . . . . . . . . . . . . . . . . . 7-2
7.3 DPI Mode Operation . . . . . . . . . . . . . . . . . . . . . . . . 7-2
7.3.1 DPI Menu . . . . . . . . . . . . . . . . . . . . . . . . . 7-2
7.3.2 Adjust DPI Sample Box . . . . . . . . . . . . . . . . . . 7-3
7.3.3 Pulse Repetition Frequency . . . . . . . . . . . . . . . . 7-3
7.3.4 Wall Filter . . . . . . . . . . . . . . . . . . . . . . . . . 7-3
7.3.5 DPI Gain . . . . . . . . . . . . . . . . . . . . . . . . . . 7-4
7.3.6 Persistence . . . . . . . . . . . . . . . . . . . . . . . . 7-4
7.3.7 Color Map & Directional DPI . . . . . . . . . . . . . . . . 7-4
7.3.8 DPI Power . . . . . . . . . . . . . . . . . . . . . . . . . 7-5
7.3.9 Sector Width and Position . . . . . . . . . . . . . . . . . 7-5
7.3.10 B Reject . . . . . . . . . . . . . . . . . . . . . . . . . . 7-5
7.3.11 DPI Frequency . . . . . . . . . . . . . . . . . . . . . . . 7-5
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SSI-6000/SSI-5800/SSI-5500/SSI-5500BW
Digital Color Doppler Ultrasound System
7.3.12 Image Orientation (Left/Right) . . . . . . . . . . . . . . . 7-6
7.3.13 Line Density . . . . . . . . . . . . . . . . . . . . . . . . 7-6
7.4 Cine Mode Operation . . . . . . . . . . . . . . . . . . . . . . . 7-6
7.4.1 Color Map . . . . . . . . . . . . . . . . . . . . . . . . . 7-6
7.4.2 B Reject . . . . . . . . . . . . . . . . . . . . . . . . . . 7-6
7.4.3 Cine Playback . . . . . . . . . . . . . . . . . . . . . . . 7-7
8 TDI Mode 8-1
8.1 Starting TDI Mode . . . . . . . . . . . . . . . . . . . . . . . . . 8-2
8.2 TDI Image Information . . . . . . . . . . . . . . . . . . . . . . . 8-2
8.3 TDI Mode Operation . . . . . . . . . . . . . . . . . . . . . . . . 8-2
8.3.1 TDI Menu . . . . . . . . . . . . . . . . . . . . . . . . . 8-2
8.3.2 Adjust TDI Sample Box . . . . . . . . . . . . . . . . . . 8-3
8.3.3 Pulse Repetition Frequency . . . . . . . . . . . . . . . . 8-3
8.3.4 Wall Filter . . . . . . . . . . . . . . . . . . . . . . . . . 8-3
8.3.5 TDI Gain . . . . . . . . . . . . . . . . . . . . . . . . . . 8-4
8.3.6 Persistence . . . . . . . . . . . . . . . . . . . . . . . . 8-4
8.3.7 Color Map . . . . . . . . . . . . . . . . . . . . . . . . . 8-4
8.3.8 TDI Power . . . . . . . . . . . . . . . . . . . . . . . . . 8-4
8.3.9 Baseline . . . . . . . . . . . . . . . . . . . . . . . . . . 8-5
8.3.10 Sector Width and Position . . . . . . . . . . . . . . . . . 8-5
8.3.11 B Reject . . . . . . . . . . . . . . . . . . . . . . . . . . 8-5
8.3.12 TDI Frequency . . . . . . . . . . . . . . . . . . . . . . . 8-5
8.3.13 Image Orientation (Left/Right) . . . . . . . . . . . . . . . 8-6
8.3.14 Flow Invert . . . . . . . . . . . . . . . . . . . . . . . . . 8-6
8.3.15 Line Density . . . . . . . . . . . . . . . . . . . . . . . . 8-6
8.4 Cine Mode Operation . . . . . . . . . . . . . . . . . . . . . . . 8-6
8.4.1 C Map . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-7
8.4.2 B Reject . . . . . . . . . . . . . . . . . . . . . . . . . . 8-7
8.4.3 Flow Invert . . . . . . . . . . . . . . . . . . . . . . . . . 8-7
8.4.4 Cine Playback . . . . . . . . . . . . . . . . . . . . . . . 8-7
9 M Mode 9-1
9.1 Starting M Mode . . . . . . . . . . . . . . . . . . . . . . . . . . 9-1
9.2 M Mode Operation, M Trace Inactive . . . . . . . . . . . . . . . 9-2
9.2.1 Adjust M Mode Cursor Line . . . . . . . . . . . . . . . . 9-2
9.3 M Mode Operation, M Trace Active . . . . . . . . . . . . . . . . 9-3
9.3.1 M Gain . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-3
9.3.2 Sweep Speed . . . . . . . . . . . . . . . . . . . . . . . 9-3
9.3.3 Power . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-4
9.3.4 Chroma . . . . . . . . . . . . . . . . . . . . . . . . . . 9-4
9.3.5 Video Invert . . . . . . . . . . . . . . . . . . . . . . . . 9-4
9.3.6 M Process . . . . . . . . . . . . . . . . . . . . . . . . . 9-4
9.3.7 Display Format . . . . . . . . . . . . . . . . . . . . . . 9-5
9.4 Cine Mode Operation . . . . . . . . . . . . . . . . . . . . . . . 9-5
P/N: 4701-0061-01B
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SSI-6000/SSI-5800/SSI-5500/SSI-5500BW
Digital Color Doppler Ultrasound System
10 Spectral Doppler Mode 10-1
10.1 Activation of Spectral Doppler Mode . . . . . . . . . . . . . . . . 10-2
10.1.1 B/CDI/DPI/TDI Operation in Spectral Doppler Mode . . . 10-3
10.1.2 2D Refresh . . . . . . . . . . . . . . . . . . . . . . . . 10-4
10.1.3 Display Format . . . . . . . . . . . . . . . . . . . . . . 10-5
10.2 PW Mode Operation . . . . . . . . . . . . . . . . . . . . . . . . 10-5
10.2.1 Sample Volume Gate Adjustment . . . . . . . . . . . . . 10-5
10.2.2 Activation of PW Spectral Display . . . . . . . . . . . . . 10-5
10.2.3 Pulse Repetition Frequency (PRF) . . . . . . . . . . . . 10-5
10.2.4 Wall Filter (WF) . . . . . . . . . . . . . . . . . . . . . . 10-6
10.2.5 Spectral Doppler Gain . . . . . . . . . . . . . . . . . . . 10-6
10.2.6 Steer Angle . . . . . . . . . . . . . . . . . . . . . . . . 10-6
10.2.7 Flow Invert . . . . . . . . . . . . . . . . . . . . . . . . . 10-6
10.2.8 Spectral Doppler Frequency . . . . . . . . . . . . . . . . 10-7
10.2.9 Sweep Speed . . . . . . . . . . . . . . . . . . . . . . . 10-7
10.2.10 Baseline . . . . . . . . . . . . . . . . . . . . . . . . . . 10-7
10.2.11 PW Power . . . . . . . . . . . . . . . . . . . . . . . . . 10-7
10.2.12 Angle Correction . . . . . . . . . . . . . . . . . . . . . . 10-8
10.2.13 Dynamic Range (DYN) . . . . . . . . . . . . . . . . . . 10-8
10.2.14 Chroma . . . . . . . . . . . . . . . . . . . . . . . . . . 10-8
10.2.15 Video Invert . . . . . . . . . . . . . . . . . . . . . . . . 10-8
10.3 CW Mode Operation . . . . . . . . . . . . . . . . . . . . . . . . 10-9
10.3.1 Activation of CW Mode (PW↔CW) . . . . . . . . . . . . 10-9
10.3.2 CW Cursor Position . . . . . . . . . . . . . . . . . . . . 10-9
10.3.3 Flow Invert . . . . . . . . . . . . . . . . . . . . . . . . . 10-9
10.3.4 Sweep Speed . . . . . . . . . . . . . . . . . . . . . . . 10-9
10.3.5 CW Power . . . . . . . . . . . . . . . . . . . . . . . . . 10-9
10.3.6 Dynamic Range (DYN) . . . . . . . . . . . . . . . . . . 10-10
10.3.7 Chroma . . . . . . . . . . . . . . . . . . . . . . . . . . 10-10
10.3.8 Video Invert . . . . . . . . . . . . . . . . . . . . . . . . 10-10
10.3.9 Display Format . . . . . . . . . . . . . . . . . . . . . . 10-10
10.3.10 Pulse Repetition Frequency (PRF) . . . . . . . . . . . . 10-10
10.3.11 Wall Filter (WF) . . . . . . . . . . . . . . . . . . . . . . 10-10
10.4 Spectral Doppler Cine Mode Operation . . . . . . . . . . . . . . 10-10
11 3D Mode∗11-1
11.1 Starting 3D Mode . . . . . . . . . . . . . . . . . . . . . . . . . 11-2
11.2 3D Mode Menu . . . . . . . . . . . . . . . . . . . . . . . . . . . 11-2
11.3 3D Mode Operation . . . . . . . . . . . . . . . . . . . . . . . . 11-3
11.3.1 Display Format . . . . . . . . . . . . . . . . . . . . . . 11-3
11.3.2 Rotate and Zoom . . . . . . . . . . . . . . . . . . . . . 11-3
11.3.3 Clear & Restore ROI . . . . . . . . . . . . . . . . . . . . 11-4
11.3.4 Crop . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11-4
11.3.5 ROI Box Adjustment . . . . . . . . . . . . . . . . . . . . 11-4
11.3.6 Render Mode . . . . . . . . . . . . . . . . . . . . . . . 11-4
P/N: 4701-0061-01B
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Digital Color Doppler Ultrasound System
11.3.7 Auto Rotate . . . . . . . . . . . . . . . . . . . . . . . . 11-4
11.3.8 Trace Cut . . . . . . . . . . . . . . . . . . . . . . . . . 11-5
11.3.9 Clip Plane . . . . . . . . . . . . . . . . . . . . . . . . . 11-6
11.3.10 Opacity Setting . . . . . . . . . . . . . . . . . . . . . . 11-6
11.3.11 Multi-Slice . . . . . . . . . . . . . . . . . . . . . . . . . 11-6
11.3.12 Color Map . . . . . . . . . . . . . . . . . . . . . . . . . 11-6
11.3.13 Scan Method . . . . . . . . . . . . . . . . . . . . . . . 11-6
11.3.14 Z Scale (For Scan Method = Lin) . . . . . . . . . . . . . 11-6
11.3.15 Z Angle (For Scan Method = Sec) . . . . . . . . . . . . . 11-7
12 4D Mode∗12-1
12.1 Starting 4D Mode . . . . . . . . . . . . . . . . . . . . . . . . . 12-1
12.2 4D Mode Menu . . . . . . . . . . . . . . . . . . . . . . . . . . . 12-2
12.3 4D Mode Operations . . . . . . . . . . . . . . . . . . . . . . . . 12-2
12.3.1 Adjustment of Sample Box & Cut Off Line . . . . . . . . . 12-2
12.3.2 Cine Review . . . . . . . . . . . . . . . . . . . . . . . . 12-3
12.3.3 Rescan . . . . . . . . . . . . . . . . . . . . . . . . . . 12-3
12.3.4 Image Quality . . . . . . . . . . . . . . . . . . . . . . . 12-3
12.3.5 Stabilization . . . . . . . . . . . . . . . . . . . . . . . . 12-4
13 Transducers 13-1
13.1 Transducer Information . . . . . . . . . . . . . . . . . . . . . . . 13-1
13.1.1 Supported Transducers and Intended Applications . . . . 13-1
13.1.2 Acoustic Output . . . . . . . . . . . . . . . . . . . . . . 13-2
13.2 Environmental Requirements . . . . . . . . . . . . . . . . . . . 13-2
13.3 Preparation and Usage of the Probe . . . . . . . . . . . . . . . . 13-2
13.3.1 Inspection . . . . . . . . . . . . . . . . . . . . . . . . . 13-2
13.3.2 Probe Connection . . . . . . . . . . . . . . . . . . . . . 13-3
13.3.3 Preparation for Scanning . . . . . . . . . . . . . . . . . 13-3
13.3.4 Scanning . . . . . . . . . . . . . . . . . . . . . . . . . . 13-4
13.4 Probe Maintenance: Cleaning and Disinfection . . . . . . . . . . 13-4
13.4.1 Probe immersion level . . . . . . . . . . . . . . . . . . . 13-4
13.4.2 Cleaning Instructions . . . . . . . . . . . . . . . . . . . 13-5
13.4.3 Disinfection Instructions . . . . . . . . . . . . . . . . . . 13-5
14 System Maintenance 14-1
14.1 Guidance for Service . . . . . . . . . . . . . . . . . . . . . . . . 14-1
14.2 Manufacturer Responsibility . . . . . . . . . . . . . . . . . . . . 14-2
14.3 Contact Information . . . . . . . . . . . . . . . . . . . . . . . . 14-2
A Description of Symbols A-1
B Information of EU Representative B-1
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Chapter 1
System Safety and Maintenance
Contents
1.1 Safety Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-2
1.2 Symbol Used . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-3
1.3 Biological Safety . . . . . . . . . . . . . . . . . . . . . . . . . . 1-3
1.4 Scanning Patients and Education . . . . . . . . . . . . . . . . . . 1-4
1.4.1 Safe Scanning Guideline . . . . . . . . . . . . . . . . . 1-4
1.4.2 Understanding the MI/TI Display . . . . . . . . . . . . . 1-6
1.5 Environmental Requirements . . . . . . . . . . . . . . . . . . . . 1-9
1.6 Transport and Storage Environmental Requirements . . . . . . . . 1-10
1.7 Electrical Requirements . . . . . . . . . . . . . . . . . . . . . . . 1-10
1.8 Electrical Safety . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-10
1.9 Transducer Maintenance . . . . . . . . . . . . . . . . . . . . . . 1-11
1.10 System Transportation . . . . . . . . . . . . . . . . . . . . . . . 1-15
1.10.1 Moving the System . . . . . . . . . . . . . . . . . . . . 1-15
1.10.2 Transporting the System . . . . . . . . . . . . . . . . . . 1-15
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Digital Color Doppler Ultrasound System
1.1 Safety Overview
This section discusses measures to ensure the safety of both the operator and
patient.
To ensure the safety of both operator and patient, please read the relevant details in
this chapter carefully before operating this system. Disregarding the WARNINGS
or violation of relevant rules may result in personal injury or even loss of life for
operator or patient.
Users should observe the following PRECAUTIONS:
•This system complies with Type BF general equipment, and the EN60601-1
standard.
•Do not modify this system in any way. Necessary modifications must be
made only by the manufacturer or its designated agents.
•This system has been fully adjusted at the factory. Do not adjust any fixed
adjustable parts.
•In the event of a malfunction, turn off the system immediately and inform the
manufacturer or its designated agents.
•The power cable of the system should only be connected to a grounded
power socket. Do not remove the ground cable for any reason.
•Only connect this system, either electronically or mechanically, with devices
that comply with the EN60601-1 standard. Recheck the leakage current
and other safety performance indices of the entire system to avoid potential
system damage caused by leakage from a current superposition.
•The system does not incorporate any specialized protective measures in the
event it is configured with high-frequency operation devices. The operator
should use CAUTION in these types of applications.
•The system should be installed only by personnel authorized by the manu-
facturer. Do not attempt to install the system yourself.
•Only an authorized service engineer may perform maintenance.
•Only a qualified operator, or someone under qualified supervision, should
use the system.
•Do not use this system in the presence of flammable substances or an ex-
plosion may occur.
•Do not continuously scan the same part of a patient or expose the patient to
prolonged scanning. Doing so may harm the patient.
•When using the system for ultrasound testing, use only qualified ultrasound
gel that complies with system standards.
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•Do not use the switch at the back of the unit for normal shut down. Always
use the power-on button in the keyboard area
•Do not unplug probe when the system is in active operation. Doing so may
damage the probe. Always go to EXAM screen when need to remove the
probe.
•To prevent from arm or neck injury, the operator should not stay at the same
position for too long during patient scanning without taking break.
•Do not put liquid on top of the main unit.
•For proper disposal of this product, please contact our service department.
1.2 Symbol Used
Refer to Appendix A.
1.3 Biological Safety
This product, as with all diagnostic ultrasound equipment, should be used only for
valid reasons and should be used both for the shortest period of time and at the
lowest power settings necessary ( ALARA - As Low As Reasonably Achievable)
to produce diagnostically acceptable images.
The AIUM offers the following guidelines:
Clinical Safety Quoted from AIUM
Approved March 26, 1997
Diagnostic ultrasound has been in use since the late 1950s. Given
its known benefits and recognized efficacy for medical diagnosis, in-
cluding use during human pregnancy, the American Institute of Ultra-
sound in Medicine herein addresses the clinical safety of such use:
There are no confirmed biological effects on patients or instrument
operators caused by exposures from present diagnostic ultrasound
instruments. Although the possibility exists that such biological effects
may be identified in the future, current data indicate that the benefits
to patients of the prudent use of diagnostic ultrasound outweigh the
risks, if any that may be present.
Heating:
Elevating tissue temperature during obstetrical examinations creates medical con-
cerns. At the embryo development stage, the rise in temperature and the length of
time exposed to heat combine to determine potential detrimental effects. Exercise
CAUTION particularly during Doppler/Color exams.
The Thermal Index (TI) provides a statistical estimate of the potential temperature
elevation (in centigrade) of tissue temperature. Three forms of TI are available:
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TIS, for soft tissue exposures; TIB, for instances when bone lies near the beam
focus; and TIC, for the heating of bone situated close to the transducer.
Cavitation:
Cavitation may occur when sound passes through an area that contains a cavity,
such as a gas bubble or air pocket (in the lung or intestine, for example). During
the process of cavitation, the sound wave may cause the bubble to contract or res-
onate. This oscillation may cause the bubbles to explode and damage the tissue.
The Mechanical Index (MI) has been created to help users accurately evaluate the
likelihood of cavitation and the related adverse effects.
1.4 Scanning Patients and Education
The Track-3 or IEC60601-2-37 output display standard allows users to share the
responsibility for the safe use of this ultrasound system. Follow these usage guide-
lines for safe operation:
•In order to maintain proper cleanliness of the transducers, always clean them
between patients.
•Always use a new disinfected sheath on all EV/ER probes during every
exam.
•Continuously move the probe, rather than staying in a single spot, to avoid
elevated temperatures in one part of the patient’s body.
•Move probe away from the patient when not actively scanning.
•Understand the meaning of the TI, TIS, TIB, TIC, and MI output display, as
well as the relationship between these parameters and the thermal/cavitation
bioeffect to the tissue.
•Expose the patient to only the very lowest practical transmit power levels for
the shortest possible time to achieve a satisfactory diagnosis (ALARA - As
Low As Reasonably Achievable).
1.4.1 Safe Scanning Guideline
1. Ultrasound should only be used for medical diagnosis and only by trained
medical personnel.
2. Diagnostic ultrasound procedures should be done only by personnel fully
trained in the use of the equipment, in the interpretation of the results and
images, and in the safe use of ultrasound (including education as to potential
hazards).
3. Operators should understand the likely influence of the machine controls, the
operating mode (e.g. B-mode, color Doppler imaging or spectral Doppler)
and probe frequency on thermal and cavitation hazards.
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Digital Color Doppler Ultrasound System
4. Select a low setting for each new patient. Output should only be increased
during the examination if penetration is still required to achieve a satisfactory
result, and after the Gain control has been moved to its maximum value.
5. Maintain the shortest examination time necessary to produce a useful diag-
nostic result.
6. Do not hold the probe in a fixed position for any longer than is necessary. It
should be removed from the patient whenever there is no need for real-time
imaging or spectral Doppler acquisition. The freeze frame and Cine loop
capabilities allow images to be reviewed and discussed without exposing
the patient to continuous scanning.
7. Do not use endo-cavity probes if there is noticeable self heating of the probe
when operating in the air. Although applicable to any probe, take particular
care during trans-vaginal exams during the first eight weeks of gestation.
8. Take particular care to reduce output and minimize exposure time of an em-
bryo or fetus when the temperature of the mother is already elevated.
9. Take particular care to reduce the risk of thermal hazard during diagnostic
ultrasound when exposing: an embryo less than eight weeks after gestation;
or the head, brain or spine of any fetus or neonate.
10. Operators should continually monitor the on-screen thermal index (TI) and
mechanical index (MI) values and use control settings that keep these set-
tings as low as possible while still achieving diagnostically useful results.
In obstetric examinations, TIS (soft tissue thermal index) should be moni-
tored during scans carried out in the first eight weeks after gestation, and
TIB (bone thermal index) thereafter. In applications where the probe is very
close to bone (e.g. trans-cranial applications), TIC (cranial thermal index)
should be monitored.
MI> 0.3 There is a possibility of minor damage to
neonatal lung or intestine. If such expo-
sure is necessary, reduce the exposure
time as much as possible.
MI> 0.7 There is a risk of cavitation if an ul-
trasound contrast agent containing gas
micro-spheres is being used. There is
a theoretical risk of cavitation without the
presence of ultrasound contrast agents.
The risk increases with MI values above
this threshold.
TI> 0.7 The overall exposure time of an embryo
or fetus should be restricted in accor-
dance with Table 1.1 below as a refer-
ence.
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Digital Color Doppler Ultrasound System
TI Maximum exposure time (minutes)
0.7 60
1.0 30
1.5 15
2.0 4
2.5 1
Table 1.1: Maximum recommended exposure times for an embryo or fetus
11. Non-diagnostic use of ultrasound equipment is not generally recommended.
Examples of non-diagnostic uses of ultrasound equipment include repeated
scans for operator training, equipment demonstration using normal subjects,
and the production of souvenir pictures or videos of a fetus.
For equipment of which the safety indices are displayed over their full range
of values, the TI should always be less than 0.5 and the MI should always
be less than 0.3. Avoid frequent repeated exposure of any subject.
Scans in the first trimester of pregnancy should not be carried out for the sole
purpose of producing souvenir videos or photographs, nor should their pro-
duction involve increasing the exposure levels or extending the scan times
beyond those needed for clinical purposes.
12. Diagnostic ultrasound has the potential for both false positive and false neg-
ative results. Misdiagnosis is far more dangerous than any effect that might
result from the ultrasound exposure. Therefore, diagnostic ultrasound should
be performed only by those with sufficient training and education.
1.4.2 Understanding the MI/TI Display
Track-3 follows the Output Display Standard for systems which include fetal Doppler
applications. The acoustic output will not be evaluated on an application-specific
basis, but the global maximum de-rated Ispta must be ≤720 mW/cm2 and either
the global maximum MI must be ≤1.9 or the global maximum de-rated Isppa must
be ≤190 W/cm2. An exception is for ophthalmic use, in which case the TI=max
(TIS_as, TIC) is not to exceed 1.0; Ispta.3 ≤50mW/cm2, and MI ≤0.23. Track-3
gives the user the freedom to increase the output acoustic power for a specific
exam, and still limit output acoustic power within the global maximum de-rated
Ispta ≤720 mW/cm2 under an Output Display Standard.
For any diagnostic ultrasonic systems, Track-3 provides an Output Indices Display
Standard. The diagnostic ultrasound systems and its operator’s manual contain the
information regarding an ALARA (As Low As Reasonably Achievable) education
program for the clinical end-user and the acoustic output indices, MI and TI.
The MI describes the likelihood of cavitation, and the TI offers the predicted maxi-
mum temperature rise in tissue as a result of the diagnostic examination.
In general, a temperature increase of 2.5oC must be present consistently at one
spot for 2 hours to cause fetal abnormalities. Avoiding a local temperature rise
above 1oC should ensure that no thermally induced biologic effect occurs.
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Digital Color Doppler Ultrasound System
When referring to the TI for potential thermal effect, a TI equal to 1 does not mean
the temperature will rise 1 degree C. It only means an increased potential for ther-
mal effects can be expected as the TI increases. A high index does not mean that
bioeffects are occurring, but only that the potential exists and there is no consider-
ation in the TI for the scan duration, so minimizing the overall scan time will reduce
the potential for effects. These operator control and display features shift the safety
responsibility from the manufacturer to the user. So it is very important to have the
Ultrasound systems display the acoustic output indices correctly and the education
of the user to interpret the value appropriately.
RF: De-rating factor
In Situ intensity and pressure cannot currently be measured. Therefore, the acous-
tic power measurement is normally done in the water tank, and when soft tissue
replaces water along the ultrasound path, a decrease in intensity is expected. The
fractional reduction in intensity caused by attenuation is DENOTED by the de-rating
factor RF,
RF=(−.a·f·z)
Where a is the attenuation coefficient in dB cm-1 MHz-1, f is the transducer center
frequency, and z is the distance along the beam axis between the source and the
point of interest.
De-rating factor RF for the various distances and frequencies with attenuation co-
efficient 0.3dB cm-1 MHz-1 in homogeneous soft tissue is listed in the following
table. An example is if the user uses 7.5MHz frequency, the power will be at-
tenuated by .0750 at 5cm, or 0.3x7.5x5=-11.25dB. The De-rated Intensity is also
referred to as ’.3’ at the end (e.g. Ispta.3).
Distance Frequency (MHz)
(cm) 1 3 5 7,5
1 0,9332 0,8128 0,7080 0,5957
2 0,8710 0,6607 0,5012 0,3548
3 0,8128 0,5370 0,3548 0,2113
4 0,7586 0,4365 0,2512 0,1259
5 0,7080 0,3548 0,1778 0,0750
6 0,6607 0,2884 0,1259 0,0447
7 0,6166 0,2344 0,0891 0,0266
8 0,5754 0,1903 0,0631 0,0158
I’=I*RF Where I’ is the intensity in soft tissue, I is
the time-averaged intensity measured in water.
Tissue Model
Tissue temperature elevation depends on power, tissue type, beam width, and
scanning mode. Six models are developed to mimic possible clinical situations.
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Digital Color Doppler Ultrasound System
Thermal
Models
Composition Mode Specification Typ. app
1TIS Soft tissue Unscanned Large aperture
(>1cm)
Liver PW
2TIS Soft tissue Unscanned Small aperture
(<1cm)
Pencil probe
3TIS Soft tissue Scanned Evaluated at sur-
face
Breast color
4TIB Soft tissue and
bone
Scanned Soft tissue at sur-
face
Muscle color
5TIB Soft tissue and
bone
Unscanned Bone at focus Fetus head
PW
6TIC Soft tissue and
bone
Unscanned /
Scanned
Bone at surface Trans cranial
Soft tissue
Describes low fat content tissue that does not contain calcifications or large gas-
filled spaces.
Scanned: (auto-scan)
Refers to the steering of successive burst through the field of view, e.g. B and color
mode.
UnScanned
Emission of ultrasonic pulses occurs along a single line of sight and is unchanged
until the transducer is moved to a new position. For instance, the PW, CW and M
mode.
TI
TI is defined as the ratio of the In Situ acoustic power (W.3) to the acoustic power
required to raise tissue temperature by 1oC (Wdeg),
T I =W./W deg
Three TIs corresponding to soft tissue (TIS) for abdominal; bone (TIB) for fetal and
neonatal cephalic; and cranial bone (TIC) for pediatric and adult cephalic, have
been developed for applications in different exams.
An estimate of the acoustic power in milliwatts necessary to produce a 1°Ctemperature
elevation in soft tissue is:
W deg =/ f c
for model 1 to 4, where fc is the center frequency in MHz.
W deg = ·K·D
for model 5 and 6, where K (beam shape factor) is 1.0, D is the aperture diameter in
cm at the depth of interest
MI
Cavitation is more likely to occur at high pressures and low frequencies in pulse
ultrasound wave in the tissue, which contains the bubble or air pocket (for instance,
the lung, intestine, or scan with gas contrast agents). The threshold under optimum
conditions of pulsed ultrasound is predicted by the ratio of the peak pressure to the
square root of the frequency.
MI =Pr 0/pf c
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Digital Color Doppler Ultrasound System
Pr’ is the de-rated (0.3) peak rare-fractional pressure in Mpa at the point where PII is
the maximum, and fc is the center frequency in MHz. PII is the Pulse Intensity Integral
that the total energy per unit area carried by the wave during the time duration of the
pulse.
The peak rare-fractional pressure is measured in hydrophone maximum negative
voltage normalized by the hydrophone calibration parameter.
Display Guideline
For different operation modes, different indices must be displayed. However, only
one index needs to be shown at a time. Display is not required if maximum MI
is less than 1.0 for any setting of the operating mode, or if maximum TI is less
than 1.0 for any setting of the operating mode. For TI, if the TIS and TIC are
both greater than 1.0, the scanners need not be capable of displaying both indices
simultaneously. If the index falls below 0.4, no display is needed. The display
increments are no greater than 0.2 for index value less than one and no greater
than 1.0 for index values greater than one (e.g. 0.4, 0.6, 0.8, 1, 2, 3).
Display and Report in Different Mode
For B-Scan Mode
Only display and report MI, and start from 0.4 if maximum MI > 1.0
For Color Mode
Only display and report TIS or TIB and start from 0.4 if maximum TI > 1.0
For Doppler Mode
Only display and report TIS or TIB and start from 0.4 if maximum TI > 1.0
Below is a simple guideline for the user when TI exceeds one limit exposure time
to 4(6-TI) minutes based on the National Council on Radiation Protection. Ex-
posure Criteria for Medical Diagnostic Ultrasound: I. Criteria Based on Thermal
Mechanisms. Report No.113 1992:
Operator Control Features
The user should be aware that certain operator controls may affect the acoustic
output. It is recommended to use the default (or lowest) output power setting and
compensate using Gain control to acquire an image. Other than the output power
setting in the soft-menu, which has the most direct impact on the power; the PRF,
image sector size, frame rate, depth, and focal position also slightly affect the
output power. The default setting is normally around 70% of the allowable power
depending on the exam icon.
1.5 Environmental Requirements
The following environmental conditions are within system tolerances for operation:
Relative Humidity: 30%∼75%, no condensation
Temperature: 10°C∼40°C
Atmosphere Pressure: 700∼1060hPa
Strong radiation sources or powerful electromagnetic waves (e.g. electromagnetic
waves from radio broadcasting) may result in image ghosting or noise. The system
should be isolated from such radiation sources or electromagnetic waves.
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1.6 Transport and Storage Environmental Requirements
The following environmental conditions for transport and storage are within system
tolerances:
Temperature: -20°C∼55°C
Relative Humidity: 20% ∼90 %, no condensation
Pressure: 700∼1060hPa
1.7 Electrical Requirements
Power Requirements:
110-120VAC
220-230VAC
Power Consumption:
330VA
Main unit voltage
Maintain a fluctuation range of less than ±10% or the system may be
damaged.
Grounding
Before connecting the power cable, connect the attached ground pro-
tection cable to a specialized grounding device.
 Note:
•Please ensure that the power requirements are satisfied. Only use power lines
that meet the system guidelines—failure to follow these procedures may result
in system damage.
•Voltage level may vary in different geographic locations. Adjust the voltage
rating on the rear panel according to your local voltage level.
•Use only the power button on the side panel to turn on or off the unit. Mains
power switch on the rear panel should be always ON unless prior to transport
or maintenance or service of the equipment.
1.8 Electrical Safety
Only trained health professionals should operate this system. This equipment com-
plies with the following standards:
•The equipment conforms with the following regulations for electrical safety,
–IEC 60601-1: 1988+A1:1991+A2:1995, Medical Electrical Equipment
Part 1: General Requirements For Safety, Class I, BF, continuous op-
eration
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Digital Color Doppler Ultrasound System
–IEC 60601-2-37: 2001 + A1:2004 + A2:2005, Medical Electrical Equip-
ment Part 2-37: Particular Requirements For The Safety Of Ultrasonic
Medical Diagnostic And Monitoring Equipment
•The equipment conforms with the following EMC/EMI standards: IEC60601-
1-2: 2001+A1: 2004, Class A (CE)
•Degrees of protection against harmful liquid:
For the main sys-
tem:
IPX0
For the trans-
ducer:
IPX7, from the acoustic window to the junction line
(Figure 13.1);
and IPX1 for other parts that may contact with the
patient, excluding the transducer connector.
For maximum safety, adhere to these guidelines:
• Proper grounding of the system is critical to avoid electrical shock. For pro-
tection, ground the system with a three-conductor cable, and plug the sys-
tem into a hospital-grade receptacle or outlet.
• Do not remove or entangle the grounding wire.
• Do not remove the protective covers of the system. These covers protect
users from hazardous voltages. Only authorized service technicians can
make replacements of the parts inside the system.
• Never use this system while inflammable gas is present!
• Devices must be powered from a receptacle marked “hospital grade” be-
fore being connected to the system directly. In case “hospital grade” re-
ceptacles are not available, use isolation transformers instead.
1.9 Transducer Maintenance
The transducers/probes provided with the system are durable and have reliable
performance. These precision instruments should be inspected daily and handled
with care. Please observe the following PRECAUTIONS:
• Do not drop the transducer on the hard surface. This can damage the trans-
ducer elements and compromise the electrical safety of the transducer.
• Avoid kinking or pinching the transducer cable.
• Use only approved ultrasound coupling gels.
• Follow the instructions for cleaning and disinfecting the probes.
Disinfecting Surface Transducers
• Disconnect the transducer from the system.
• Wipe all surfaces with isopropyl alcohol solution and air dry.
• Clean all surfaces of the probe and cable with soft cloth.
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• Allow the transducer to air dry prior to storage or further use.
The following statement from AIUM outlines instructions for cleaning the intracavi-
tary transducer:
Guidelines for Cleaning and Preparing Endocavitary Ultrasound
Transducers between Patients from AIUM
Approved June 4, 2003
The purpose of this document is to provide guidance regarding the clean-
ing and disinfection of transvaginal and transrectal ultrasound probes.
All sterilization/disinfection represents a statistical reduction in the num-
ber of microbes present on a surface. Meticulous cleaning of the instrument
is the essential key to an initial reduction of the microbial/organic load by at
least 99%. This cleaning is followed by a disinfecting procedure to ensure
a high degree of protection from infectious disease transmission, even if a
disposable barrier covers the instrument during use.
Medical instruments fall into different categories with respect to poten-
tial for infection transmission. The most critical level of instruments are
those that are intended to penetrate skin or mucous membranes. These
require sterilization. Less critical instruments (often called “semi-critical” in-
struments) that simply come into contact with mucous membranes such as
fiber optic endoscopes require high-level disinfection rather than sterilization.
Although endocavitary ultrasound probes might be considered even less
critical instruments because they are routinely protected by single use dis-
posable probe covers, leakage rates of 0.9% - 2% for condoms and 8%-81%
for commercial probe covers have been observed in recent studies. For max-
imum safety, one should therefore perform high-level disinfection of the probe
between each use and use a probe cover or condom as an aid in keeping
the probe clean.
There are four generally recognized categories of disinfection and steril-
ization.
Sterilization is the complete elimination of all forms or microbial life
including spores and viruses.
Disinfection, the selective removal of microbial life, is divided into
three classes:
•High-Level Disinfection -Destruction/removal of all microorganisms ex-
cept bacterial spores.
•Mid-Level Disinfection - Inactivation of Mycobacterium Tuberculosis,
bacteria, most viruses, fungi, and some bacterial spores.
•Low-Level Disinfection - Destruction of most bacteria, some viruses
and some fungi. Low-level disinfection will not necessarily inactivate
Mycobacterium Tuberculosis or bacterial spores.
The following specific recommendations are made for the use of intracavitary ul-
trasound transducers.
Users should also review the Centers for Disease Control and Prevention docu-
ment on sterilization and disinfection of medical devices to be certain that their
procedures conform to the CDC principles for disinfection of patient care equip-
ment.
1. CLEANING
P/N: 4701-0061-01B
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