Kontron SIGMA 110, SIGMA 330 User Manual
IMAGING
SIGMA 110/SIGMA 330
Operator Manual
(Software Version V 5.XX)
© Copyright by KONTRON MEDICAL, 2001
Ref.: DOC31001EN Issue date: 10.12.01 Issue: 4
GENERAL INFORMATION
15.10.01 GENERAL INFORMATION i
ii SIGMA 110/SIGMA 330 15.10.01
I. Copyright
© 2001 by KONTRON MEDICAL SAS
ALL RIGHTS RESERVED
PRINTED IN FRANCE
The information contained in this publication may not be used for any purpose other than that for
which it was originally supplied. The publication may not be reproduced in part or in whole without written consent of KONTRON MEDICAL SAS. In order to maintain and improve standards of
manufacturing, methods of functioning and reliability, KONTRON MEDICAL SAS equipments are
periodically reviewed. For this reason, the content of this publication is subject to change without
any notice.
This product contains KONTRON MEDICAL proprietary software in machine-readable form.
KONTRON MEDICAL SAS retains all its rights, title and interest in the software. Purchase of this
product includes a license to use the software contained in it. The purchaser shall not copy, trace,
disassemble or modify the software, nor cause or allow this software to be copied, traced, disassembled or modified. Transfer of this product by the purchaser will constitute a transfer of this
license, which will not be transferable otherwise.
The equipment described is manufactured by:
KONTRON MEDICAL S.A.S.
Boite Postale 97
78373 PLAISIR CEDEX
FRANCE
Internet: www.kontronmedical.com
Apple, Macintosh, iMac, MacOS, FireWire are registered trademarks of Apple Computer, Inc.
Intel®, Pentium® and Pentium III® are registered trademarks of Intel Corporation.
Linux is a registered trademark of Linus Torvalds.
Matrox® is a registered trademark of Matrox Electronic Systems Ltd.
Microsoft® and Windows® are registered trademarks of Microsoft Corporation.
USB is a registered trademark of USB Implementers Forum, Inc.
SonoWin®, SonoWinlite® and SonoWinbasic® are registered trademarks of Meso.
15.10.01 GENERAL INFORMATION iii
II. Quality, Reliability and Safety
This equipment has been designed with high standards of quality, reliability and safety. KONTRON MEDICAL SAS can however only accept the corresponding manufacturers responsibility
providing the following conditions are met: Electrical installations of the room or building in which
the equipment is to be used must comply with the relevant national regulations. The equipment is
used in accordance with the instructions for use provided by KONTRON MEDICAL SAS (Operator manual). All modifications and repairs to the equipment are carried out by authorized KONTRON MEDICAL personnel, or their agents. The equipment must comply with regulations
specified in the "Safety Informations" section.
Your local KONTRON MEDICAL company or agent is: (To be filled by local KONTRON MEDICAL
company or agent.)
iv SIGMA 110/SIGMA 330 15.10.01
TABLE OF CONTENTS
10.12.01 v
vi SIGMA 110/SIGMA 330 10.12.01
I. Copyright ..........................................................................................iii
II. Quality, Reliability and Safety.......................................................... iv
III. Intended Clinical Use and Safety Information ................................ xv
IV. Compliance with Standards...........................................................xxx
1. INSTRUMENT DESCRIPTION .....................................................1-1
1.1 Introduction.............................................................................................................. 1-3
1.2 SIGMA 110/330 Equipments................................................................................... 1-5
1.3 Physical Description ................................................................................................ 1-7
1.3.1 Electronic Cabinet...................................................................................... 1-11
1.3.2 Control Panel ............................................................................................. 1-11
1.3.3 TV Monitor ................................................................................................. 1-15
1.3.4 Front Panel ................................................................................................ 1-17
1.3.5 Rear Panel................................................................................................. 1-22
1.4 System Controls .................................................................................................... 1-28
1.4.1 Alphanumeric Keys.................................................................................... 1-28
1.4.2 Live Investigation Keys .............................................................................. 1-29
1.4.3 Keys for Frozen Image Study..................................................................... 1-30
1.4.4 Trackball..................................................................................................... 1-31
1.5 Screen Layout ....................................................................................................... 1-33
1.5.1 Ultrasound Screen Layout ......................................................................... 1-33
1.5.2 Menu.......................................................................................................... 1-36
1.5.3 Technical Data Area................................................................................... 1-38
1.6 Display Modes....................................................................................................... 1-42
1.6.1 2D Modes .................................................................................................. 1-42
1.6.2 TM Modes.................................................................................................. 1-42
1.6.3 CW and PW Modes ................................................................................... 1-43
1.6.4 CFM Formats............................................................................................. 1-43
1.7 SIGMA 110 Technical Specifications..................................................................... 1-44
1.7.1 General ...................................................................................................... 1-44
1.7.2 2D (B-Mode) .............................................................................................. 1-46
1.7.3 TM (M-Mode) ............................................................................................. 1-46
1.7.4 Spectral Doppler Mode.............................................................................. 1-47
1.7.5 Digital Archiving: KIPRISM ........................................................................ 1-48
1.7.6 ECG Module (option)................................................................................. 1-48
1.7.7 EasyPrintTM .............................................................................................. 1-49
1.7.8 USB-LinkTM .............................................................................................. 1-49
1.7.9 Peripherals (Optional)................................................................................ 1-49
1.7.10 Inputs/Outputs ........................................................................................... 1-49
1.7.11 Measurement............................................................................................. 1-49
1.7.12 Acoustic Power .......................................................................................... 1-51
1.7.13 Environment............................................................................................... 1-51
1.7.14 Regulation and Safety ............................................................................... 1-51
10.12.01 TABLE OF CONTENTS vii
1.7.15 Dimensions ................................................................................................1-52
1.8 SIGMA 330 Technical Specifications .....................................................................1-53
1.8.1 General ......................................................................................................1-53
1.8.2 2D (B-Mode)...............................................................................................1-55
1.8.3 TM (M-Mode) .............................................................................................1-56
1.8.4 Spectral Doppler Mode ..............................................................................1-56
1.8.5 Colour Doppler Modes ...............................................................................1-58
1.8.6 3D Imaging.................................................................................................1-58
1.8.7 Digital Archiving: KIPRISM.........................................................................1-59
1.8.8 ECG Module (option) .................................................................................1-59
1.8.9 EasyPrintTM...............................................................................................1-59
1.8.10 USB-LinkTM...............................................................................................1-59
1.8.11 Peripherals (Optional) ................................................................................1-60
1.8.12 Inputs/Outputs............................................................................................1-60
1.8.13 Measurement .............................................................................................1-60
1.8.14 Acoustic Power...........................................................................................1-61
1.8.15 Environment...............................................................................................1-62
1.8.16 Regulation and Safety................................................................................1-62
1.8.17 Dimensions ................................................................................................1-62
2. INSTALLATION ............................................................................. 2-1
2.1 Installation Requirements ........................................................................................2-3
2.2 Unpacking ................................................................................................................2-3
2.2.1 Warning........................................................................................................2-3
2.2.2 Unpacking the Instrument ............................................................................2-3
2.3 Checking the Instruments Identification ...................................................................2-3
2.4 Checking the Delivery ..............................................................................................2-4
2.5 Transport...............................................................................................................2-6
2.6 Installation of SIGMA 330 Expert and SIGMA 330 Excellence................................2-7
2.6.1 Installation of the integrated cart ..................................................................2-7
2.6.2 Installation of the flat panel monitor .............................................................2-8
2.6.3 Installation of the integrated compact PC (SIGMA 330 Excellence only).....2-8
2.7 Power Source Connection .....................................................................................2-10
2.7.1 Input Power Source....................................................................................2-10
2.7.2 Output Power Source .................................................................................2-11
2.8 Connecting a Probe ...............................................................................................2-12
2.8.1 SIGMA 330 Expert and SIGMA 330 Excellence Probe Assignment..........2-12
2.8.2 SIGMA 110 Light/Master and SIGMA 330 Master Probe Assignment....... 2-13
2.8.3 Probe Connection ......................................................................................2-13
2.9 Connection of Peripherals......................................................................................2-15
2.9.1 Electrical safety with peripherals................................................................2-15
2.9.2 Recommended Peripherals........................................................................2-17
2.9.3 Archiving on Personal Computer................................................................2-17
2.9.4 Connection of B&W Video Printer..............................................................2-18
2.9.5 Connection of Colour Video Printer............................................................2-19
viii SIGMA 110/SIGMA 330 10.12.01
2.9.6 Video Recorder (VCR)............................................................................... 2-20
2.9.7 ECG Module .............................................................................................. 2-22
2.9.8 Colour Monitors ......................................................................................... 2-23
2.9.9 Black & White Monitor ............................................................................... 2-25
2.9.10 Printer ........................................................................................................ 2-26
2.9.11 Connection with medical grade isolators ................................................... 2-32
2.9.12 Connection with S-Video Distributor.......................................................... 2-33
3. OPERATING INSTRUCTIONS......................................................3-1
3.1 Operating Precautions............................................................................................. 3-3
3.2 Switching the Instrument ON................................................................................... 3-4
3.2.1 Switching ON SIGMA 110 and SIGMA 330 Master..................................... 3-4
3.2.2 Switching ON SIGMA 330 Expert................................................................ 3-4
3.2.3 Switching SIGMA 330 Excellence ON ......................................................... 3-4
3.2.4 Initialization of SIGMA ................................................................................. 3-5
3.3 Switching the Instrument OFF................................................................................. 3-6
3.3.1 Switching OFF SIGMA 110 and SIGMA 330............................................... 3-6
3.3.2 Switching OFF SIGMA 330 Excellence ....................................................... 3-6
3.4 Menus...................................................................................................................... 3-7
3.4.1 Notes ........................................................................................................... 3-7
3.4.2 Menu Key Conventions................................................................................ 3-7
3.4.3 Menu Types ................................................................................................. 3-7
3.4.4 Menu Display ............................................................................................... 3-7
3.4.5 Menu Items .................................................................................................. 3-8
3.5 Probes ................................................................................................................... 3-11
3.5.1 Probe Selection ......................................................................................... 3-11
3.5.2 Menu Display ............................................................................................. 3-11
3.6 Setup .................................................................................................................... 3-13
3.6.1 Setup Menu ............................................................................................... 3-13
3.6.2 Loading a Setup......................................................................................... 3-13
3.6.3 Saving a Setup .......................................................................................... 3-13
3.6.4 Deleting a Setup ........................................................................................ 3-14
3.6.5 Preferences ............................................................................................... 3-14
3.6.6 PCMCIA CARD.......................................................................................... 3-23
3.6.7 System Info................................................................................................ 3-23
3.7 Major Modes.......................................................................................................... 3-25
3.7.1 2D Mode .................................................................................................... 3-25
3.7.2 TM (Time Motion) ...................................................................................... 3-31
3.7.3 PW Doppler ............................................................................................... 3-34
3.7.4 CW Doppler ............................................................................................... 3-39
3.7.5 CFM Mode ................................................................................................. 3-42
3.7.6 3D imaging................................................................................................. 3-46
3.8 Print .......................................................................................................................3-47
3.9 Cine Mode............................................................................................................. 3-48
3.9.1 Storing Pictures ......................................................................................... 3-48
10.12.01 TABLE OF CONTENTS ix
3.9.2 Displaying Pictures.....................................................................................3-49
3.9.3 Cine Auto-Replay .......................................................................................3-49
3.10 Magnifier in 2D and CFM Mode.............................................................................3-50
3.11 Digital Archiving: KIPRISM ....................................................................................3-51
3.11.1 Image Storage and Freeze Menu...............................................................3-51
3.11.2 Archive: Display of Stored Images .............................................................3-52
3.11.3 Using the Memory Card on PC ..................................................................3-54
3.11.4 Patient Report and Patient ID with KIPRISM .............................................3-55
3.12 Annotations............................................................................................................3-59
3.12.1 Entering Annotation Mode..........................................................................3-59
3.12.2 Exiting the Annotation Mode ......................................................................3-59
3.12.3 Manual Text Annotation..............................................................................3-60
3.12.4 Labels.........................................................................................................3-60
3.12.5 Arrows ........................................................................................................3-64
3.13 Body Markers.........................................................................................................3-65
3.13.1 Displaying Body markers............................................................................3-65
3.13.2 Moving Body Markers.................................................................................3-66
3.13.3 Deleting Body markers...............................................................................3-66
3.13.4 Medical.......................................................................................................3-66
3.13.5 Deleting All Annotations.............................................................................3-66
3.14 Measurements .......................................................................................................3-67
3.14.1 Generalities ................................................................................................3-67
3.14.2 Starting a Measurement.............................................................................3-68
3.14.3 2D Measurement........................................................................................3-68
3.14.4 CFM Measurement ....................................................................................3-75
3.14.5 TM Measurement.......................................................................................3-77
3.14.6 Doppler Measurement................................................................................3-82
3.15 Biometry and Report..............................................................................................3-90
3.15.1 Biometry Pictograms..................................................................................3-90
3.15.2 Patient Information .....................................................................................3-90
3.15.3 Biometry Patient Study...............................................................................3-90
3.15.4 Report ........................................................................................................3-91
3.15.5 Starting a Study..........................................................................................3-91
3.15.6 Radiology Study.........................................................................................3-92
3.15.7 Obstetrics/Gynaecology Study...................................................................3-93
3.15.8 Vascular Study ...........................................................................................3-94
3.15.9 Cardiology Study........................................................................................3-94
3.16 ECG (Option) .........................................................................................................3-95
3.17 EasyPrint Options...............................................................................................3-96
3.17.1 Printing of images ......................................................................................3-96
3.17.2 Printing of Report .......................................................................................3-98
3.18 USB-Link Option.................................................................................................3-99
3.18.1 Overview ....................................................................................................3-99
3.18.2 Compatibility...............................................................................................3-99
3.18.3 Usage example with Windows® 2000........................................................3-99
3.18.4 Read data from a computer .....................................................................3-101
x SIGMA 110/SIGMA 330 10.12.01
3.18.5 Copy data to the computer ...................................................................... 3-101
3.18.6 Interface with PACS ................................................................................. 3-102
3.18.7 Limitations................................................................................................ 3-102
3.19 SonoWin® Lite and SonoWin® Basic PACS ....................................................... 3-103
3.19.1 Overview.................................................................................................. 3-103
3.19.2 Start a Study............................................................................................ 3-104
3.19.3 Save images, reports and patient information ......................................... 3-105
3.19.4 Transfer data to SonoWin®...................................................................... 3-106
3.19.5 Data Assignment ..................................................................................... 3-109
3.20 Integrated PC (SIGMA 330 Excellence) .............................................................. 3-110
3.20.1 Overview.................................................................................................. 3-110
3.20.2 SAFETY PRECAUTIONS........................................................................ 3-110
3.20.3 Entering PC remote control mode ........................................................... 3-111
3.20.4 PC remote control features description ................................................... 3-111
3.20.5 Leaving PC remote control mode ............................................................ 3-111
3.20.6 Keyboard in PC mode.............................................................................. 3-111
3.20.7 Errors and warnings................................................................................. 3-114
3.20.8 PC power on............................................................................................ 3-114
3.20.9 PC power off............................................................................................ 3-114
3.20.10 3D VascularView and 3D FetalView ................................................. 3-115
3.20.11 PACS option............................................................................................. 3-115
3.20.12 Connection to a Network ......................................................................... 3-115
3.20.13 Installation of peripherals......................................................................... 3-115
4. MAINTENANCE ............................................................................4-1
4.1 Cleaning .................................................................................................................. 4-3
4.1.1 Probes ......................................................................................................... 4-3
4.1.2 TV Monitor ................................................................................................... 4-3
4.1.3 EYE-Q 300M Monitor................................................................................... 4-3
4.1.4 Keyboard...................................................................................................... 4-3
4.1.5 Instrument.................................................................................................... 4-4
4.2 Disinfection .............................................................................................................. 4-5
4.3 Repairs and Maintenance........................................................................................ 4-8
4.3.1 User Maintenance........................................................................................ 4-8
4.3.2 Manufacturer Maintenance .......................................................................... 4-9
4.4 Product Recycling and Disposal............................................................................ 4-10
5. TROUBLESHOOTING ..................................................................5-1
5.1 Handle Error and Warning Messages ..................................................................... 5-3
5.2 Introduction and Rules............................................................................................. 5-4
5.2.1 Rules............................................................................................................ 5-4
5.2.2 Definition...................................................................................................... 5-4
5.2.3 Remarks ...................................................................................................... 5-4
5.3 Status Messages..................................................................................................... 5-5
10.12.01 TABLE OF CONTENTS xi
5.3.1 ECG .............................................................................................................5-5
5.3.2 Measurement and Biometry .........................................................................5-7
5.3.3 Transmit Voltage Indicator ............................................................................5-8
5.4 Warnings..................................................................................................................5-9
5.4.1 Start-up checks ............................................................................................5-9
5.4.2 System Configuration Check......................................................................5-10
5.4.3 Flash card and SRAM................................................................................5-11
5.4.4 Miscellaneous checks ................................................................................5-13
5.5 General Failures and Errors...................................................................................5-18
5.5.1 Error 0: Internal unexpected interrupt ........................................................5-18
5.5.2 Error 1: Can not restore backed up configuration ......................................5-18
5.5.3 Error 2: Tracking problem - Fatal error .......................................................5-19
5.5.4 Error 3: Memory allocation error - Fatal error.............................................5-19
5.5.5 Error 4: Divide by 0 - Fatal error.................................................................5-19
5.5.6 Error 5: Communication error.....................................................................5-19
5.5.7 Error 6: Flash card read error.....................................................................5-19
5.5.8 Error 7: Flash card write error ....................................................................5-19
5.5.9 Error 8: Invalid flash card type....................................................................5-20
5.5.10 Error 9: Ob/Gyn restore error.....................................................................5-20
5.5.11 Error 10: Flashcard not correctly formatted................................................5-20
5.5.12 Error 11: Internal Communication - Fatal error...........................................5-20
5.5.13 Error 12: Cannot program TMPAVG...........................................................5-20
5.5.14 Error 13: CFM Frame Filter LUT Error .......................................................5-21
5.5.15 Error 14: CFM Function LUT Error.............................................................5-21
5.5.16 Error 15: CFM LUT programming time out error ........................................5-21
5.5.17 Error 16: Flashcard removed while printing................................................5-21
5.5.18 Error 17: Internal communication - Fatal error ...........................................5-21
6. OPTIONS AND ACCESSORIES .................................................. 6-1
6.1 Options.....................................................................................................................6-3
6.2 List of Probes...........................................................................................................6-4
6.3 Accessories..............................................................................................................6-5
7. APPENDICES............................................................................... 7-1
Appendix A: Overview .................................................................. 7-3
A.1 Entering the Biometry ......................................................................................7-3
A.2 Exiting the Biometry .........................................................................................7-3
A.3 Make a Measurement from Report ..................................................................7-3
A.4 Importing Measurements in Report .................................................................7-4
Appendix B: Report Menu............................................................. 7-5
Appendix C: Patient Information ................................................... 7-7
C.1 First Page ........................................................................................................7-7
C.2 Second Page ...................................................................................................7-9
xii SIGMA 110/SIGMA 330 10.12.01
Appendix D: Cardiology Study..................................................... 7-11
D.1 Left Ventricle Study ....................................................................................... 7-12
D.2 Mitral Valve Study ......................................................................................... 7-18
D.3 Aortic Valve Study ......................................................................................... 7-22
D.4 Right Ventricle Study .................................................................................... 7-26
Appendix E: Vascular Study........................................................7-31
E.1 Description .................................................................................................... 7-31
E.2 Stenosis Percentage ..................................................................................... 7-31
E.3 Equations ...................................................................................................... 7-33
Appendix F: Ob/Gyn Studies.......................................................7-37
F.1 2D Sheet ....................................................................................................... 7-37
F.2 TM/SP Sheet ................................................................................................. 7-41
F.3 Foetal Information Sheet ............................................................................... 7-43
F.4 Setup Sheet .................................................................................................. 7-44
F.5 User Table Sheet .......................................................................................... 7-47
F.6 Curve View .................................................................................................... 7-48
Appendix G: Reference Tables for Ob/Gyn .................................7-49
G.1 Biparietal Diameter (BPD) ............................................................................. 7-49
G.2 Chorion Diameter (ChD) from Rempen ........................................................ 7-57
G.3 Femur Length (FML) ..................................................................................... 7-58
G.4 Humerus Length (HuL) ................................................................................. 7-65
G.5 Transabdominal Diameter (TAD) from Merz ................................................. 7-67
G.6 Thoracic Diameter (THD) from Hansmann .................................................. 7-68
G.7 Anterior Posterior Diameter (APD) ................................................................ 7-69
G.8 Crown Rump Length (CRL) .......................................................................... 7-71
G.9 Gestational Sac (GES) .................................................................................. 7-76
G.10 Abdominal Circumference (AC) .................................................................... 7-78
G.11 Head Circumference (HC) ............................................................................ 7-81
G.12 Binocular Distance (BOD) from Jeanty ......................................................... 7-84
G.13 Occipital Frontal Diameter (OFD) from Merz ................................................ 7-84
Appendix H: Radiology Study......................................................7-85
H.1 Description .................................................................................................... 7-85
H.2 Equations ...................................................................................................... 7-86
Appendix I: Measurement Interface ...........................................7-89
I.1 Doing a Measurement from Report ............................................................... 7-89
I.2 Importing Measurements in Report ............................................................... 7-91
Appendix J: Print Preview...........................................................7-93
J.1 Edit the Printable Report ............................................................................... 7-93
10.12.01 TABLE OF CONTENTS xiii
J.2 Print the Report on an External Printer ..........................................................7-94
J.3 Save the Report on a Flashcard ....................................................................7-94
Appendix K: KIPRISM / SonoWin® Basic Conversion Tables.... 7-95
K.1 Overview ........................................................................................................7-95
K.2 Cardiology Measurements .............................................................................7-95
K.3 Vascular measurements ..............................................................................7-102
K.4 Obstetric and Gynaecology .........................................................................7-104
K.5 Radiology Study ..........................................................................................7-108
K.6 Multiple associations ...................................................................................7-109
Appendix L: Body Markers ....................................................... 7-111
L.1 Vascular .......................................................................................................7-111
L.2 Radiology .....................................................................................................7-111
L.3 Obstetrics/ Gynaecology .............................................................................7-112
L.4 Cardiology ...................................................................................................7-112
Appendix M:Acoustic Output Tables ........................................ 7-113
M.1 Track3 Summary Tables .............................................................................7-113
M.2 Definition of Terms ......................................................................................7-114
M.3 Acoustic Output Tables ...............................................................................7-116
xiv SIGMA 110/SIGMA 330 10.12.01
III. Intended Clinical Use and Safety Information
This system complies with the Medical Device Directive (MDD) 93/42/EEC, according to which
KONTRON MEDICAL has classified this device as a Class 1 Type B device.
Note for U.S. Customers
U.S Federal Law restricts this device to sale, distribution and use by or on the order of a
physician.
III.1 .Intended Clinical Use
The SIGMA 110 / 330 is intended for visualization by ultrasound of internal organs, for medical
diagnostic purposes only. It must be operated by qualified and trained Physician or "Sonographer".
The particular organs visualized, and the methods of visualization, depend on the particular
transducer used, and the imaging mode employed.
Modes are used in two senses in this manual: Imaging Modes refer to the method of depicting
the organs visualized, and are explained below. It is also used to indicate various operational
modes, such as freeze, zoom, cine, etc. In general, it is obvious when a non-imaging mode
is referred to. In the manual they are explained when they are first used.
The principal imaging modes of the SIGMA 110/330 and their abbreviations, which are used
throughout this manual, are as follows:
2D: Two-dimensional representation of a slice in the body, often called B-mode.
TM: Often called just M-Mode, the ultrasound beam is stationary (giving an A-scan), but the
time axis moves, with the result that moving organs can be easily visualized.
PW: Pulse Wave Doppler, which permits determining the velocity of blood or another organ in the
interior of the body.
CW: Continuous Wave Doppler, which determines the velocity of flow or movement of all ele-
ments within the range of the probe.
CFM: Colour-flow mapping, which superimposes a map of the velocity of moving organs or blood
on top of a 2D scan (B-scan) of the organs.
The SIGMA 110/330 does not permit composite modes (two modes produced at the same
time). However, two modes can be made sequentially and then displayed next to each other on
the same screen. If two modes are displayed together, this is called a double-pad mode. If only
one is displayed, it is called a single-pad mode.
15.10.01 GENERAL INFORMATION xv
These are all real-time displays. However, an image can be frozen at a particular point in time
to produce a static display so that it may be studied in more detail later.
Imaging modes are explained in more detail in Chapter 3.7, Major Modes, on page 3-25
The following table lists the SIGMA 110 / 330 probes and their intended clinical use:
PROBE TYPE
3.5 MHz CV 3.5 Abdominal, Ob/Gyn 2D/TM/PW/CFM
3.5 MHz MC 3.5
6.5 MHz MC 6.5
5.0 MHz LV 5
7.5 MHz LV 7.5
7.5 MHz LVS 7.5
6.5 MHz EV 6.5 Ob/Gyn, Urology 2D/TM/PW
6.5 MHz MR 6.5
6.5 MHz VMC 6.5 Ob/Gyn, Urology 2D/TM/PW/CFM
3.5 MHz GP 3.5
5.0 MHz GP 5.0
7.5 MHz GP 7.5
14 MHz PV 14
PEN 2 MHz 2
PEN 4 MHz 4 Vascular PW/CW
PEN 8 MHz 8 Vascular PW/CW
TCD 2 MHZ 2 Transcranial Doppler PW
Nominal Frequency
(MHz)
Convex Linear Probes
Cardiology, Transcranial
Linear Probes
Pediatrics, Perivascular
Pediatrics, Perivascular,
Pediatrics, Perivascular,
Endocavitarian Probes
Endorectal multiplane for
Annular Sector Probes
Cardiology, Abdominal,
Perivascular, Small Parts,
Breast, Muskuloskeletal
Pencil Probes
PROBE
APPLICATIONS
Abdominal,
Vascular/Angiology
Pediatrics, Cardiology,
Vascular/Angiology
Abdominal, Obstetrics,
Small Parts
Small Parts
Urology
Ob/Gyn
Abdominal, Ob/Gyn
Cardiology, Pediatrics
Vascular, Small parts,
Neonatology
Cardiovascular
MODES
2D/TM/PW/CFM
2D/TM/PW/CFM
2D/TM/PW/CFM
2D/TM/PW/CFM
2D/TM/PW/CFM
2D/TM/PW
2D/TM/PW/CW
2D/TM/PW/CW
2D/TM/PW/CW
2D/TM/PW
PW/CW
Tab l e i : Probe applications
Details on the various applications are below.
xvi SIGMA 110/SIGMA 330 15.10.01
Abdominal / Gynaecology / Urology Application
The probe applies ultrasound energy through the patient abdomen to obtain an image of the
abdominal organs to detect abnormalities (imaging) and assess the blood velocity, flow and patency of abdominal vessels through the Doppler modalities.
Perivascu lar Ap plication
The probe applies ultrasound energy through the neck or extremities of a patient to obtain an
image of the carotid artery, or other peripheral vessels, that can be used to detect abnormalities
or obstructions in the vessel. In Doppler modes, the probe applies ultrasound energy through the
neck or extremities of a patient to assess the blood velocity, flow or lack of flow and patency of
peripheral vessels.
Small Parts Application
The probe applies ultrasound energy through the skin to obtain an image or a Doppler flow visualization of small organs such as the thyroid (neck), testicles (scrotal sac) and breast.
Cardiology Application
The probe applies ultrasound energy through the chest wall to obtain an image of the heart for
purpose of assessing cardiac abnormalities. In Doppler modes, the probe applies energy through
the chest wall to determine the velocity and direction of blood in the heart and in the vessels.
Obstetrics / Fetal Application
The probe applies ultrasound energy through a pregnant womans abdomen to obtain an image
of the fetus to detect structural abnormalities or to visualize and measure anatomical and physiological parameters of the fetus for the purpose of assessing fetal growth. In Doppler modes, the
probe applies energy through the patient abdomen to detect placental or fetal flow abnormalities.
Note
The user should always follow the ALAR A (As Low As Reasonably Achievable) principle,
but especially in Obstetrics / Fetal applications. Use the lowest amount of acoustic output
power for the shortest duration of time to obtain the necessary clinical diagnostic information.
Neonatology Application
The probe applies ultrasound energy through the neonatal head fontanelles to visualize brain
structures (imaging) or flow (Doppler) to detect structural or functional abnormalities.
WARNING: This system is not to be used for transorbital or any other ophtalmic applications.
Transcranial Doppler
The probe applies ultrasound energy through the adult patient skull to, visualize flow (Pulsed
Wave Doppler) to detect functional abnormalities.
15.10.01 GENERAL INFORMATION xvii
WARNING: This system is not to be used for transorbital or any other ophtalmic applications.
The main features of the probes are shown in the table below:
Frequency
PROBE
TYPE
Range
(FL to F H
Scanning
in MHz)
Angle
(degree)
3.5 MHz CV 2 - 5 45 - 60 - 70 1.2 0.7 - 86.4 x 12
3.5 MHz MC 2 - 5 30 - 90 - 70 1.5 0.7 - 38.2 x 11
6.5 MHz MC 4 - 9 30 - 90 - 45 0.6 0.4 - 33.4 x 6.5
5.0 MHz LV 3 - 7 - 63 50 1.0 0.5 - 86.4 x 11
7.5 MHz LV 4 - 10 - 50 20 0.6 0.3 - 59.4 x 4.5
7.5 MHz LVS 4 - 12 - 38 25 0.5 0.3 - 38.4 x 6.5
6.5 MHz EV 4 - 9 90 - 140 - 25 0.7 0.4 9 -
6.5 MHz MR 4 - 9 90 - 110 - 25 0.7 0.4 8 -
6.5 MHz VMC 4 - 9 45 - 111 - 45 0.6 0.4 - 33.4 x 6.5
3.5 MHz GP 2 - 5 45 - 90 - 70 1.6 0.8 16 -
5.0 MHz GP 3 - 7 45 - 90 - 40 0.8 0.5 11.4 -
7.5 MHz GP 5 - 10 40 - 90 - 20 0.4 0.3 7 -
14 MHz PV 8 - 16 40 - 15 0.3 0.2 5.5 -
TCD 2 MHZ 2 - - 45 3 - 15 -
PEN 2 MHz 2 - - 45 3 - 13 -
PEN 4 MHz 4 - - 30 2 - 9 -
PEN 8 MHz 8 - - 20 2 - 6 -
Width
(mm)
Convex
Linear
Endocavitarian
Annu lar Sector
Pencil
Focal
Point
(mm)
Resolution Ceramics
lateral
(mm)
axial
(mm)d (mm)
L x W
(mm)
Tab l e i i : Probe Features
III.2.Safety Information
In this manual a WAR NI NG pertains to possible injury to a patient and/or the sonographer. A
CAUTION describes the precaution which are necessary to protect the equipment.
Be sure that you understand and observe each of cautions and warnings.
xviii SIGMA 110/SIGMA 330 15.10.01
III.2.1 . Electrical Safety
As defined in EN60601-1 (IEC Standard 601-1, safety of Medical Electrical Equipment), this
equipment is classified as Class I, type B (probes), while the ECG module has a Class CF
degree of protection.
WAR NINGS
The system must be properly grounded to prevent shock hazards. Protection is provided by
grounding the chassis with a three wire cable and plug; the system must also be powered
through a properly grounded receptacle.
Electrical shock hazard. Do not remove any panel. Refer servicing and internal adjustments
to qualified KONTRON personnel only.
For continued protection against risk of fire, replace fuses only with fuses of the same type
and rating (see Chapter 2.7, Power Source Connection, on page 2-10).
The equipment is not suitable for use in the presence of a flammable anaesthetic mixture with
air, oxygen or nitrous oxide. Do not use the system in the presence of flammable anaesthetics. Explosion is a hazard under such conditions.
The system not watertight and provides a class IP(X)0 degree of protection to liquids; do not
expose the system to rain or moisture. Avoid placing liquid containers on the system.
Remove probes and electrocardiography leads from patient contact before applying a high
voltage defibrillation pulse.
Like any other ultrasound equipment, the SIGMA 110/330 uses high frequency signals which
could interfere with pacemakers. You should be aware of this small potential hazard and
immediately turn off the unit if interference in the pacemaker operation is noted or suspected.
If you drop or strike a probe, do not use it until a measurement of the electrical leakage cur-
rent has demonstrated that a electrical safety has not been compromised. It is also necessary
to insure that the probe has not been cracked or damaged so that it produces erroneous
scans.
Do not immerse the entire probe in liquids to clean it. The probe is not watertight and immer-
sion may compromise the electrical safety features of the probe. Carefully follow the cleaning
instructions in this manual.
Take all appropriate precautions to avoid impact damage to the sensitive face of the probe.
The use of products not approved by KONTRON MEDICAL such as oil, Methylene blue, ether
or some disinfectants could cause permanent damage to the sensitive part of the transducer.
Only the KONTRON MEDICAL supplied gel (KONTRON supply part number 100 250, ultra-
sonic gel) is recommended by KONTRON MEDICAL for coupling the transducer to the skin.
The use of an agent other than the approved gel may adversely affect the quality of the
images and produce substandard results.
The cart available with the SIGMA 330 Expert and SIGMA 330 Excellence provides insulated
plugs and connectors to manage optional hard copy devices (VCR, printers). Follow the
instructions in this manual to install such a device. Wrong connections may compromise the
electrical safety of the system.
Never connect additional peripherals directly to wall outlets; use a medical grade isolating
transformer which must comply with IEC 601-1 specifications. Wrong connections may com-
promise the electrical safety of the system.
KONTRON MEDICAL provides a medical grade isolating transformer and isolating accesso-
ries on request, see Chapter 6.3, Accessories, on page 6-5 for ordering.
15.10.01 GENERAL INFORMATION xix
Never connect Network (RJ-45) directly to the system; use a medical grade network isolator
which must comply with IEC 601-1 specifications. Wrong connections may compromise the
electrical safety of the system.
KONTRON MEDICAL provides a medical grade isolator on request, see Chapter 6.3, Accessories, on page 6-5 for ordering.
CAUTIONS
In order to prevent an overheating, ensure that the ventilation openings are not covered and
keep the SIGMA 110/330 rear panel away from a vertical wall.
To prevent further damage to your system and the accessories, power off the unit if it does not
start up correctly.
Never expose the probes to gas, heat or unauthorized liquid sterilization procedures (see
probe cleaning instructions). These methods can permanently damage the probe.
Do not connect or disconnect an active probe during live scanning; the system must be in
freeze mode or turned off to connect or disconnect a probe.
Carefully follow the Operators Manual instructions to clean or disinfect a probe.
Safety Symbols
The International Electrotechnical Commission (IEC) has defined a set of graphic symbols for
use on medical electronic equipment. The following symbols are used on KONTRON MEDICAL
systems:
ON (Power)
OFF (Power)
AC line input
Protective earth (ground)
Equalization potential terminal
Type CF isolated E.C.G input, defibrillator proof (IEC 601 - 1)
Type B equipment (IEC 601 - 1)
This symbol generally means "Attention". Please consult the equipment documentation carefully before using any function labelled
with this symbol
xx SIGMA 110/SIGMA 330 15.10.01
III.2.2. Environmental Safety
Electro-Magnetic Compatibility
This system complies with the EN60601-1-2 (Electro-Magnetic Compatibility). It is a Class B
device.
Ultrasound units are designed to receive radio frequency (RF) energy and are, therefore, susceptible to other RF sources. As an example, other medical devices, information technology
products or TV/Radio transmitters may all cause interference with the ultrasound system.
In the presence of RF interference, the physician must evaluate the image degradation and its
diagnostic impact.
Electrostatic discharge (ESD)
An electrostatic discharge is a short transient current flow. It may happen if electrostatically
charged people touches a part of ultrasound system. ESD may causes white or black dots in
2D or TM mode, coloured dots in CFM and can be heard or seen as dots in Doppler mode.
The effects created by ESD are not at all correlated with the ultrasound information. There-
fore, they may be well differentiated from the true ultrasound echo.
Burst
Bursts are short transient pulses on the mains power line. They may cause white or black
dots in 2D or TM mode, coloured dots in CFM and can be heard or seen as dots in Doppler
mode. The effects created by bursts are not correlated with the ultrasound information. There-
fore, they may be well distinguishable from the true ultrasound echo.
Immunity restriction
Electromagnetic fields in the environment of the ultrasound system may cause white or black
patterns in 2D or TM mode, coloured patterns in CFM and can be seen as horizontal lines in
Doppler mode. Especially in the Doppler modes (CW and PW), some lack of immunity may
be observed in a narrow frequency band of 20 kHz at the used frequency and its multiples.
Typically, the transducer acts like the reception antenna and the effects are stronger when it is
applied to patient. In any case, the effects are not correlated with the ultrasound information;
therefore, they may be well distinguishable from the true ultrasound echo.
Electro-Surgical Units (ESUs)
Electro surgical units or other devices that introduce radio frequency electromagnetic fields or
currents into the patient, may interfere with the ultrasound image. An electro surgical device in
use during ultrasound imaging will greatly distort the 2D image and render Doppler modalities
useless.
Information about Reusing/Recycling
In this system, the packing materials are reusable and recyclable; the unit casings (plastic) and
most of the cart components (plastic) are also recyclable.
The SIGMA 110 and SIGMA 330 contains electronic boards, batteries and tubes. Before you dispose the system, these boards, batteries and tubes must be removed and discarded according
to local regulations or recycled where facilities exist. Contact your local KONTRON MEDICAL
company or agent for further informations.
For battery disposal contact your local waste disposal facility.
15.10.01 GENERAL INFORMATION xxi
III.2.3. Biocompatibility and Infection Control
Item s i n co ntact wi th p ati en t
The probe and electrode materials that are in contact with patients, comply with the European
applicable requirements (EN10993). No negative reactions to these materials have been
reported.
Note
KONTRON probes and electrodes do NOT contain Latex.
Infection Control
Since probes and electrodes are intended to be used on intact skin, the use of this system has a
very limited probability of being able to propagate infections; basic procedures as described later
in this manual are sufficient for infection control.
III.2.4. Ultrasound Safety
In trod u ction
KONTRON MEDICAL has adopted the more recent requirements and recommendations established by the USA Food and Drug Administration and by the American Institute for Ultrasound in
Medicine. The SIGMA 110/330 therefore, equipped with the Acoustic Output Display feature to
provide the user with real-time, on-line information on the actual power of the system.
The following sections describe the rationale of this methodology. KONTRON MEDICAL recommends the use of the ALARA principle (see below), which is extensively covered in this manual.
Additionally to this operator manual you get the AIUM manual "Medical Ultrasound Safety" which
covers the following topics more in detail: Bioeffects and biophysics, prudent use and implementing ALARA. Read it carefully before using the SIGMA 110/330.
Clinical Safety
In the USA, in more than three decades of use, there has been no report of injury to patients or
operators from medical ultrasound equipment.
Ameri can In stitute for U ltrasound in Medicine (AIU M)
Statement on Clinical Safety: October 1 982, Revised March 1 993 and October 1 993
Diagnostic ultrasound has been in use for over 25 years. Given its known benefits and recognized efficacy for medical diagnosis, including use during human pregnancy, the American Institute of Ultrasound in Medicine herein addresses the clinical safety of such use:
No confirmed biological effects on patients or instrument operators caused by exposure at
intensifies typical of present diagnostic ultrasound instruments have been reported.
Although the possibility exists that such biological effects may be identified in the future,
current data indicate that the benefits to patients deriving from the prudent use of diagnostic
ultrasound outweigh the risks, if any, that may be present.
xxii SIGMA 110/SIGMA 330 15.10.01
The ALAR A (As Low As Reasonably Achievable) principle is the guideline for prudent use; dur-
ing an exam, the user should use for the shortest duration the least amount of acoustic output to
obtain the necessary clinical information for diagnostic purposes.
Ultrasound Bioeffects
Although diagnostic ultrasound has an excellent history of safety, it has been known for a long
time that ultrasound, at certain levels, can alter biological systems.
The AIUM Bioeffects Committee describes two fundamental mechanisms by which ultrasound
may induce biological effects: non-thermal or mechanical mechanisms and thermal effects.
Non-thermal bioeffects, also, referred to as mechanical bioeffects, seem to be caused by the
alternate expansion and contraction of tissue induced when ultrasound pressure waves pass
through or near gas. The majority of these non-thermal interactions, also known as cavitation,
deal with the generation, growth, vibration and possible collapse of micro bubbles within the tissue. The occurrence of cavitation depends on a number of factors, such as the ultrasonic pressure and frequency, the ultrasonic field (focused or unfocused, pulsed or continuous), the nature
and state of the tissue and boundaries. Mechanical bioeffects are a threshold phenomenon,
occurring only when a certain level of output is exceeded. However, the threshold level varies
depending on the tissue. The potential for mechanical effects is thought to increase as peak rarefactional pressure increases, but decrease as the ultrasound frequency increases.
Although there have been no adverse mechanical bioeffects in humans from diagnostic ultrasound exposure, it is not possible to specify thresholds at which cavitation will occur in mammals.
Therm al Bi oeffects are the rise in temperature of tissue when exposed to acoustic energy. The
acoustic energy is absorbed by body tissue; absorption is the conversion of this energy into heat.
If the rate of energy deposition in a particular region exceeds the ability to dissipate the heat, the
local temperature will rise. The rise in temperature will depend on the amount of energy, the volume of exposure, and the thermal characteristics of the tissue.
On-Screen Real-Time Acoustic Output Display
Until recently, application-specific output limits established by the USA Food and Drug Administration (FDA) and the users knowledge of equipment controls and patient body characteristics
have been the means of minimizing exposure. Now, more information is available through a new
feature, named the Acoustic Output Display. The Output Display provides users with information
that can be specifically applied to ALARA. It eliminates some of the guess work and provides
both an indication of what may actually be happening within the patient (i.e. the potential for bioeffects), and what occurs when system control settings are changed. This makes it possible for
the user to get the best image possible while following the ALARA principle and thus to maximize
the benefits/risks ratio.
The SIGMA 110/330 incorporates a real-time acoustic output display according to the AIUM/
NEMA Standard for Real-Time Display of Thermal and Mechanical Acoustic Output Indices on
Diagnostic Ultrasound Equipment publication, adopted in 1992 by both institutions. This Output
Display Standard is intended to provide on-screen display of these two indices, which are related
to ultrasound thermal and cavitation mechanisms, to assist the user in making informed risk (i.e.
patient exposure) / benefit (diagnostically useful information) decisions. Considering the type of
15.10.01 GENERAL INFORMATION xxiii
exam, patient conditions and the case study level of difficulty, the system operator decides how
much acoustic output to apply for obtaining diagnostically useful information for the patient; the
thermal and mechanical indices real-time display is intended to provide information to the system
operator throughout the examination so that exposure of the patient to ultrasound can be reasonably minimized while maximizing diagnostic information.
For systems with an Output Display, the FDA currently regulates only the maximum output. The
SIGMA 110/330 has been designed to automatically default to the proper range of intensity levels for a particular application. However, within the SIGMA 110/330 limits, the user may override
the application specific limits, if clinically required. The user is responsible for being aware of the
output level that is being used. The SIGMA 110/330 real-time output display provides the user
with relative information about the intensity level.
The Mechanical Ind ex
The Mechanical Index (MI) is defined as the Peak Rarefactional Pressure in MPa (derated by a
tissue attenuation coefficient of 0.3 dB/cm/MHz) divided by the square root of the probe central
frequency in MHz.
With the MI, the user can keep the potential for mechanical bioeffects as low as reasonably
achievable while obtaining diagnostically adequate images. The higher the index, the larger the
potential. However, there is no level that indicates when Bioeffects is actually occurring: The
Index is not intended to give an alarm but are an aid in implementing the ALARA principle.
The Th erm al I ndex
The purpose of the Thermal Index (TI) is to keep the user aware of conditions that may lead to a
temperature rise under certain defined assumptions. It is the ratio between the total acoustic
power to the power required to raise tissue temperature by 1°C, estimated on Thermal Models.
There are currently three Thermal Indices (each based on a specific Thermal Model) used to
estimate temperature rise whether at the surface, within the tissues, or at the point where the
ultrasound is focusing on bone:
1. The Soft Tissue Thermal Index (TIS) provides information on temperature increase within soft
homogeneous tissue.
2. The Cranial Bone Thermal Index (TIC) indicates temperature increase of bone at or near the
surface, as may occur during a cranial exam.
3. The Bone Thermal Index (TIB ) provides information on temperature increase of bone at or
near the focus after the beam has passed through soft tissue.
As with the Mechanical Index, the Thermal Indices are relative indicator of temperature rise: a
higher value represents a higher temperature rise; they indicate that the possibility for an
increase in temperature exists and they provide a relative magnitude that can be used to implement ALARA.
The SIGMA 1 1 0/330 Acoustic Outpu t Display
xxiv SIGMA 110/SIGMA 330 15.10.01
The SIGMA 110/330 displays the Acoustic Output Indices during live scanning to the right of the
screen, together with the transmit power setting and other technical data. The following abbreviations are used:
I n d ex A b b r ev i at i o n
Mechanical Index MI
Soft Tissue Thermal Index TIS
Cranial Bone Thermal Index TIC
Bone Thermal Index TIB
The Output Display is organized to provide meaningful information to implement ALARA without
distracting the user with unnecessary data. Each time a user selects a new probe a choice of
applications is provided (Radio, Vasc., Ob/Gyn, Cardio); depending on the selection, the system
will default the appropriate indices.
Note
Index values below 0.4 are displayed by this system as <0.4. Indices are displayed in 0.2
increments
To optimize ALARA, index values equal or higher than 0.4 are displayed even if the maximal index value does not exceed 1.0.
The SIGMA 110/330 does not provide combination modes (i.e. modes used simultaneously,
such as real-time 2D and Doppler), but can display a tracing (Doppler or TM-Mode) with a
reference 2D (frozen or periodically updated). The index for the active mode is indicated.
Th e SI G MA 1 1 0/330 Ou tp u t Defau lt S etti n gs
System default settings depend upon the probe, the mode of operation and the application which
is selected after selecting a probe. The SIGMA 110/330 defaults the transmit power to obtain output levels that are below the historic Ispta limits established by the FDA for the selected application.
Methodology and Accuracy of Display
The displayed indices values must be interpreted as relative information to help the user to
achieve the ALARA principle.
Initial data are derived from laboratory measurements based on the AIUM standard. Then the
indices are calculated beginning from these measurements according to the AIUM/NEMA
Standard for Real-Time Display of Thermal and Mechanical Acoustic Output Indices on Diagnostic Ultrasound Equipment publication. Many of the assumptions used for measurements and
calculation are conservative in nature. The measured water tank values are derated using the
conservative attenuation coefficient established by the FDA (0.3 dB/cm/MHz). Over-estimation of
actual In-Situ exposures is thus part of the calculation process.
A number of factors influence the estimation of the accuracy of the displayed indices, the most
significant ones being the variability between probes and the laboratory measurements accuracy
15.10.01 GENERAL INFORMATION xxv
(hydro phone, operator, algorithms, etc.) itself, while variability of the system pulser and efficiency is a minor contributor.
The accuracy of the measurement of the centre frequency is estimated to be ±2%, of the acoustic pressure to be ±16%, of the acoustic power to be ±10% and of the acoustic intensity to be
±32%.
The accuracy estimate, based on the variability range of probes and systems, and on the inherent modelling and the above mentioned measurements errors, ranges from ±30% for the MI
index to ±50% for the TI index.
The SIGMA 1 1 0/330 Maximum Acoustic Output
As per the AIUM standard, the tables in Appendix M: Acoustic Output Tables list the maximum TI
(Thermal Index) and MI (Mechanical Index) values for each probe and mode of operation.
The system screens display the recently adopted MI, which is now considered a better relative
indicator of non-thermal bioeffect mechanisms. The SIGMA 110/330 maximal MI is 1.9 which
FDA has recognized as equivalent to pre-amendments Isppa limits.
The SIGMA 110/330 maximum output for Ispta is limited to the preamendments FDA limit for
peripheral vascular applications, which is 720 mW/cm2.
The maximum output for a given probe can be less than the system limit, since the maximum
depends on a variety of elements (crystal efficiency, mode of operation etc.). It is normally
reached with the Vasc. setup, at minimum depth or maximum PRF and in CFM with the smallest
CFM window size.
All terms are defined in Section III.2.6, Glossary and definition of terms, on page xxviii
The SIGMA 1 1 0/330 Acoustic Output Controls
Control features may be divided into three categories:
1. controls which directly affect the intensity (direct controls)
2. controls which indirectly affect the intensity (indirect controls)
3. controls which do not affect the intensity, such as the gains and the processing curves.
Controls which directly affect the intensity:
the Application selection, which establishes the appropriate range of intensities (see Maxi-
mum Output Section)
the Energy control for Doppler modes, which allows to increase or decrease the output inten-
sity within the range of the selected application.
Controls which indirectly affect the intensity:
This category includes controls which change several aspects of the transmitted ultrasonic field
rather than the intensity. Intensity is affected because of the field variations. Each mode has its
xxvi SIGMA 110/SIGMA 330 15.10.01
own pulse repetition frequency (PRF) and intensity level; moreover, for each mode, a number of
parameters will indirectly affect the transmitted field.
2D
The SIGMA 110/330 allows the user to set the transmit focal point which will affect the indices by
varying the beam profile. Generally, higher MIs will occur with farer focal points. If more than one
transmit focal point is activated, MI values will correspond to the zone with the largest value.
TM
In TM mode, the transmitted field is only affected by the transmit focal point and the frequency. If
M-Mode is displayed with a 2D and the 2D is updated, the system may shows always the index
for the active mode (MI for 2D, TI for TM mode)
CFM
The TI may be increased by any control which increases the system frame rate:
reducing the CFM window size
increasing the CFM PRF
Another variable factor is the CFM frequency; the outcome in terms of transmitted field is marginal and largely unpredictable.
Pu lsed Wave Dopp ler
In PW, the transmit energy is adjusted automatically when changing gatesize or PRF to be constant. Therefore the TI is constant for all settings of gatesize and PRF. The only variable factor
is the Doppler frequency; the outcome in terms of transmitted field is marginal and largely unpredictable.
Continuous Wave Doppler
In CW, the only variable factor is the Doppler frequency. Most probes provide Doppler at more
than one frequency; the outcome in terms of transmitted field is marginal and largely unpredictable. The user can vary the spectral velocity range; this does NOT, however, change the systems
PRF.
Im plementing AL ARA with the SIGMA 1 1 0/330
Prudent use implies that during an exam the user should use for the shortest time the least
amount of acoustic output to obtain the necessary clinical information for diagnostic purposes. In
other words, your goal is to keep the TI and the MI indices as low as possible for the shortest
time while obtaining the necessary clinical information.
This section does not cover the patient and technique factors which may influence the indices
such as the patient body size, the tissue perfusion characteristics, the presence or the absence
of fluid, etc.
select the appropriate application when you select the probe
15.10.01 GENERAL INFORMATION xxvii
depending on the patient characteristics and the type of exam (see Intended Use Section)
select the appropriate probe and frequency
use the system capabilities to preset the SIGMA 110/330 to default each mode according to
your needs or specific applications; this will reduce the need for real-time interactions and
help you obtain useful images quickly thus reducing ultrasound exposure
start scanning with a low output level and optimize the focusing, the gains and all other sys-
tem adjustments; if this is not adequate for diagnostic purposes, then increase the output
level
use the Output Display feature to guide your settings; remember that the indices do not con-
sider TIME exposure: the higher your indices, the shorter should be the patient exposure
Which index when
In cardiology, vascular and general purpose (abdominal, small parts) exams MI is the primary
concern in 2D mode, while TIS is the principle index in CFM and Doppler.
In Ob/Gyn the TIB should be considered when scanning a second or third trimester fetus, while
the TIS is more reliable for earlier exams.
The TIB is a better predictor during neonatal head studies, while the TIC is more significant in
adult transcranial studies.
III.2.5. Measurement Accuracy on SIGMA 1 1 0/330
This is thoroughly discussed in Chapter 1.7.11 on page 1-49 and Chapter 1.8.13 on page 1-60.
III.2.6. Glossary and definition of terms
ÞIn Situß intensities calculations
When determining the possible effects of the ultrasound beam on tissue, the intensity encountered at the tissue site must be calculated. Because of attenuation of the beam within the body,
the intensity at the tissue site (in situ) may be 10 to 100 times less than if it was measured at
the same location in water. The amount of attenuation from experience by an ultrasound beam
as it travels through the body tissue is determined by three factors:
1. Type of tissue along the beam path
2. Frequency of the ultrasound energy
3. Distance covered by the beam
In order to achieve a conservative approximation of attenuation due to these three factors, the
FDA requires the application of the following formula:
Id = Iw exp (-0.23 a f z)
Id is the estimated In Situ intensity at the tissue site
Iw is the intensity measured in water at the distance z, measured in cm
a is the attenuation coefficient expressed in dB/cm/MHz
f is equal to the acoustic frequency in MHz of the ultrasound beam
xxviii SIGMA 110/SIGMA 330 15.10.01
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