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 manufacturers 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 womans 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 Operators 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 users 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 MIs 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 systems
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

Definition of terms

The Acoustic Intensity generated by an ultrasound probe is usually described as follows:

Ispta
The Spatial Peak Time Average Intensity is an ultrasound intensity averaged over time at the

point in the acoustic field where the pulse average intensity is at maximum.

Isppa

The Spatial Peak Pulse Average Intensity is an ultrasound intensity averaged over the pulse
transmission time at a point in the acoustic field where the pulse average intensity is at maxi­mum.

Imax

The Maximum Intensity is an average intensity during the half-cycle with the greatest amplitude
during the pulse.

Mechan ical I nd ex MI
The Mechanical Index 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.

Therm al In dex TI

The Thermal Index is the ratio between the acoustic power and the power required to raise tissue
temperature by 1°C, estimated on Thermal Models.

Peak rarefactional pressure

The Peak rarefactional pressure (pr in MPa) is temporal peak rarefactional pressure amplitude at
a specified point.

Pulse Intensity Integral

The Pulse Intensity Integral (PII) is time integral of instantaneous velocity for any specific point
and for any specific pulse, integrated over the time in which the envelope of acoustic pressure or
the envelope of hydrophone signal for the specific pulse is non-zero. It is equal to the energy flu­ence per pulse.

15.10.01 GENERAL INFORMATION xxix

IV. Compliance with Standards

SIGMA 110 and SIGMA 330 systems manufactured by KONTRON MEDICAL, entirely comply
with the Council Directive 93/42/EEC of 14 June 1993 concerning medical devices, and bear the
CE Mark.

They are in compliance with

 CE MDD mark
 German K.V. regulation
 IEC 601-1 Class 1 Type B (Electrical Safety)
 IEC 1157 (Acoustic power reporting)
FDA 510 (k)

Consequently, all OEM equipment (video recorders, external TV monitors and other peripherals)
should be:

 connected to the three isolated outputs provided by SIGMA 330 Expert or Excellence cart or

to wall outlets using the proper isolator (see Chapter 6.3, Accessories, on page 6-5 for
ordering).

 marked with CE identification mark and be in compliance with IEC 950 or IEC 601-1 Stand-

ards.

xxx SIGMA 110/SIGMA 330 15.10.01

1. INSTRUMENT DESCRIPTION

15.10.01 INSTRUMENT DESCRIPTION 1-1

1-2 SIGMA 110/SIGMA 330 15.10.01

1.1 Introduction

SIGMA 110 and SIGMA 330 are Ultrasound Diagnostic Systems intended for scanning in multi­application. They both support 2D, TM and spectral Doppler ultrasound modes. SIGMA 330
additionally supports Colour Flow Mapping (CFM).

SIGMA 110/330 can be used in following applications:

Abdominal
 Breast
 Cardiology
 Emergency
 Endocrinology
 Gastro-enterology
 Gynaecology
 Musculoskeletal
 Neonatology
 Obstetrics
 Paediatrics
 Small parts
Urology
Vascular

SIGMA 330 features some unique characteristics in its category:

 Dual Optimization Technique (D.O.T.)
 Auto-adaptive Frequency Adjustment (A.F.A.TM)
 Advanced Tissue Echo Cancellation (A.T.E.C.TM)
EasyPrint
USB-Link

TM

(Option)

TM

(Option)
 PW/CW spectral Doppler (Option)
 CFM (Option)
 Multi-frequency and Multi-technology Transducers (M.M.T.)
 Up to 5 transducers simultaneously connected
 Super High Frequency Transducer (S.H.F.T.)
 Iris colour system for optimal rendering of echo structures
 256 levels grey scale
 Up to 282 images cine-loop
 KIPRISM, digital storage
 Ergonomic design for optimal user comfort
 Remote Control

15.10.01 INSTRUMENT DESCRIPTION 1-3

The SIGMA 110 Family features some unique characteristics in its category:

 Dual Optimization Technique (D.O.T)
 Auto-Adaptive Frequency Adjustment (A.F.A.TM)
 Advanced Tissue Echo Cancellation (A.T.E.C.TM)
EasyPrintTM (Option)
USB-Link

TM

(Option)
 Multi-frequency and Multi-technology Transducers (M.M.T.)
 Up to 5 transducers simultaneously connected
 Super High Frequency Transducer (S.H.F.T.)
 256 levels grey scale
 Ergonomic design for optimal user comfort (E.D.O.)
 PW/CW spectral Doppler (Option)
 Up to 282 images cine-loop (Option)
 KIPRISM, digital storage
 Remote Control (Option)

1-4 SIGMA 110/SIGMA 330 15.10.01

1.2 SIGMA 110/330 Equipments

The table below shows the composition of the SIGMA 110/SIGMA 330 family.

Name Relationship

SIGMA 110 Light SIGMA 110 accepting Annular Sector probes only

SIGMA 110 Master

SIGMA 330 Master SIGMA 330 including colour monitor and Iris features

SIGMA 330 Expert

SIGMA 330 Excellence
without Frame Grabber

SIGMA 330 Excellence
with Frame Grabber

The SIGMA 110/330 systems are available in different language versions.
The following table lists the ordering reference numbers of the SIGMA 110/SIGMA 330 models.

SIGMA 110 accepting Annular Sector probes and Linear/ Convex
probes

SIGMA 330 Master with integrated cart and dual port for Linear/ Con­vex probes

SIGMA 330 Expert with Colour Doppler (CFM) and extended capabili­ties (Picture Archiving and Communication System, etc.)

SIGMA 330 Expert with Colour Doppler (CFM) and extended capabili­ties (3D, Picture Archiving and Communication System, etc.)

Tab l e 1 - 1 : SIGMA 110/330 family

References

Models English French German Italian Spanish Cyrillic

SIGMA 110
Light

SIGMA 110
Master

SIGMA 330
Master

SIGMA 330
Expert

SIGMA 330
Excellence
without frame
grabber board

SIGMA 330
Excellence
with frame
grabber board

480 770 483 788 483 966 484 121 484 318 484 482

482 110 485 012 485 195 485 365 485 543 485 713

482 080 485 209 485 373 485 551 485 721 485 918

482 420 483 818 483 982 484 156 484 334 484 504

483680EN 483680FR 483680GE 483680IT 483680SP 483680CY

483400EN 483400FR 483400GE 483400IT 483400SP 483400CY

Tab l e 1 - 2: Reference numbers of SIGMA 110/SIGMA 330

15.10.01 INSTRUMENT DESCRIPTION 1-5

The following table summarizes the configurations of the SIGMA 110/SIGMA 330 models:

SIGMA 110 SIGMA 330

PRODUCT

Excellence

Light Master Master Expert

w/o FG with FG

Start-up label (SIGMA ...)

Integrated Cart 99 9

Bolero Cart Option Option Option

Probes holder set 999

Handle Option Option Option

Colour monitor, Iris features

Linear/Convex probes

Spectral Doppler

CFM+ Power+ Spectral Doppler Option Option 99

Cine Option Option 99 9 9

ECG Option Option Option Option Option

Remote Control Option Option 99 9 9

Footswitch Option Option Option 99 9

Switchbox

Repetition Monitor Option Option Option Option

PCMCIA Memory Card Flash Flash SRAM 4MB SRAM 4MB SRAM 4MB SRAM 4MB

VHS option Option Option Option Option Option Option

CONFIGURATION

Time Renting Option Option Option Option Option Option

EasyPrint Black & White

EasyPrint Color Option Option 99

USB-Link Option Option Option Option 99

Integrated compact PC and
Flat 15" LCD Monitor for PC

3D-Fetal View option Option

3D-Vascular View option

e

SonoWinlite® option

PAC S

e

SonoWinbasic® option Option Option Option Option Option Option

PAC S

KIPRISM

Cardiology features

c

f

a

d

g

110 Light 110 330 330 330 330

b

999 9 9

Option Option

Option

(external)

Option Option

Option Option Option Option Option Option

9999 9 9

9999 9 9

99 9 9

Option

(external)

99 9

99

Option

Tab l e 1 - 3: System configuration and options

a. Label displayed in the start-up or system information screens.
b. Iris features include colour gamma curves (Rainbow) and colorised screen layout (measurement, technical

data, etc.).

c. Spectral-Doppler option includes PW, CW, Cine review, Angio package and VMean / VMax traces.

d. Requires Cine option.

e. Picture Archiving and Communication Systems. Please contact your local dealer for more information.
f. The complete features of Digital Archiving are obtained with Cine option. Without Cine only the Store feature

is available.

g. Cardiology includes cardiology formats and setups, biometry and measurements, ECG display that requires

ECG module.

1-6 SIGMA 110/SIGMA 330 15.10.01

1.3 Physical Description

The basic SIGMA 1 1 0/330 is a transportable Ultrasound unit which includes the following sub-
assemblies:

 Electronic cabinet containing all electronic modules
 Keyboard panel
 Black and White or colour video monitor
 Stereo audio system for Doppler
 Video Cassette Recorder output
 Black & White and colour Printer output

The SIGMA 1 1 0 Light, SIGMA 1 1 0 Master and the SIG MA 330 Master consist of the basic
SIGMA 110/330 and a transducer holder kit for two transducers and for a bottle of ultrasonic gel.

A front view of these versions and the front panel opened showing the keyboard and screen are
shown in figure 1-1, SIGMA 110 Light, Master and SIGMA 330 Master, on page 1-8.

The SIGMA 330 Expert consists of the basic SIGMA 110/330 system combined with an inte-
grated cart which provides:

 Room for optional Video Cassette Recorder
 Room for optional Printers
 Room for accessories
 Elevating column for user-adaptative height

The pedal on the base of the instrument is used to control the desired position: press the pedal to
lift up; while keeping the pedal depressed, push down the column top part to get it down.

In addition to the SIGMA 330 Expert features, the SIGMA 330 Excellence includes a flat screen
associated with an integrated personal computer for 3D imaging and patient data management.

15.10.01 INSTRUMENT DESCRIPTION 1-7

Figure 1 -1 : SIGMA 110 Light, Master and SIGMA 330 Master

1-8 SIGMA 110/SIGMA 330 15.10.01

Figure 1 -2: SIGMA 330 Expert

15.10.01 INSTRUMENT DESCRIPTION 1-9

Figure 1 -3: SIGMA 330 Excellence

1-10 SIGMA 110/SIGMA 330 15.10.01

1 .3.1 Electronic Cabinet

The electronic cabinet includes the required circuitry to perform complete functions.



Power Supply



Processor which controls the main system functions and the user interface.



Transmitter/receiver modules for both linear/convex and sector transducers.



Scan Converter



Digital processing and filtering



Spectral-Doppler



Colour Flow Mapping

1 .3.2 Control Panel

The Control Panel is connected to the main electronic board through a serial line. Its ergonomics
allows the user to communicate easily with the system.

The keyboard includes a backlight that allows the system to be used in semi-darkness.
The Control Panel includes:

 23 function keys
 10 menu function keys. Their current functions are displayed on the corresponding

MENU on the screen.

 1 incremental potentiometer (softpot). Its current function is displayed in the correspond-

ing MENU on the screen.
 1 potentiometer for 2D or TM gain adjustment.
 1 potentiometer for spectral gain adjustment in CFM, PW and CW.
 1 potentiometer for depth selection.
 5 sliders (rectilinear potentiometers) for gain equalization.
 1 alphanumerical keyboard with standard upper case characters and useful graphic

characters.
 1 trackball with corresponding function keys.
 1 Power ON/OFF button
 1 Remote control

15.10.01 INSTRUMENT DESCRIPTION 1-11

1.3.2.1 Keyboard

The controls located on the keyboard are listed below and shown in figure 1-4, Keyboard, on
page 1-13.

1. Remote control unit location

2. Power ON/OFF key

3. Potentiometer joined to function menus

4. Alphanumerical keys

5. MENU key

6. Menu function keys joined to menus displayed on screen

7. MENU PREVIOUS/NEXT keys

8. Time Gain Compensation (TGC)

9. Function keys

10. 2D/TM gain

11. CFM/PW/CW gain

12. Depth

13. FREEZE key

14. Validation (SET) keys joined to the trackball, 3 independent keys

15. Trackball

1-12 SIGMA 110/SIGMA 330 15.10.01

2

1

3 4 5 6 87

9

10

11

Figure 1 -4: Keyboard

12

1315 14

15.10.01 INSTRUMENT DESCRIPTION 1-13

1.3.2.2 Remote Control Unit

It allows the remote control for main scanning parameters, freeze and image printing.
The main advantages of the remote control are:

 System control in any inadequate examination condition.
 Usage in operating room, because it can be easily disinfected.
 Operation in difficult environment.
 Group demonstration or lesson.

7 8 9 10 13

11 12

6

5

4

3

2

1

Figure 1 -5: Remote Control Unit

The different keys available on the remote controller are the following:

1. MAGNIFY: Magnify the ultrasound image by a factor 2

2. SCROLL SP (+/-): Scrolling in Trace Modes

3. DEPTH (+/-): Depth change

4. ON/OFF: Power ON/OFF

5. BASELINE (+/-): Baseline shift in PW/CW and CFM mode

6. FREQ (+/-): Freq +/- in 2D, frequencies in PW/CW and CFM

7. VELOCITY (+/-): Velocity in PW/CW and CFM modes

8. CW: CW mode switch

9. PRINT: Equivalent to PRINT1 on the keyboard

10. 2D, CFM, PW, TM: Mode switch

11. FREEZE key

12. GAIN (+/-): 2D gain in 2D, SP gain in Doppler, CFM gain in CFM

13. Trackball keys

The 3 keys SCROLL SP, BASELINE and VE L OCI TY, access directly to the corresponding Dop-
pler parameters described in Chapter 3.7.3.2, PW Live Menu, on page 3-36. For changing the
selected parameter, use (-) and (+) keys.

1-14 SIGMA 110/SIGMA 330 15.10.01

For example, to modify the scroll speed:

1. Press SCROLL SP key to select the parameter.

2. Press (-) key to decrease the scroll speed or press (+) key to increase it.

The DEPTH key accesses directly to the corresponding 2D parameter described in Chapter

3.7.1.2, 2D Live Menu, on page 3-28. For changing the parameter, proceed as described
above.

MAGN. and FREQ are toggle keys described in Chapter 3.7.1.2, 2D Live Menu, on page 3-28.
In PW/CW mode FREQ. corresponds directly to the frequency item displayed in the Doppler

Menu on screen described in Chapter 3.7.3.2, PW Live Menu, on page 3-36 and Chapter

3.7.4.2, CW Live Menu, on page 3-41
The (-GAIN+) key modifies the overall gain according to the active mode. Press the left side of

the key to decrease the gain or press the right side to increase it.
The trackball function of the control panel is replaced by 4 arrows and a button located in the

centre. Use the arrows for moving in the four directions and press the button for validating the
operation.

The keys PRINT, TM, 2D, SELECT, CFM, PW, CW and FREEZE, access directly to the corre-
sponding functions described in Chapter 1.4, ÚSystem ControlsÛ, on page 1-28.

The Remote Control Unit is powered by two 1.5 V batteries (see Chapter 6.3, Accessories, on
page 6-5 for ordering).

1.3.3 TV Monitor

1.3.3.1 General

SIGMA 110 units are equipped with a high quality 10" Black & White monitor to display images
and information.

SIGMA 330 units are equipped with a high quality 10" colour monitor to display images and infor­mation.

The monitor is integrated into the instrument housing.

1.3.3.2 Controls

If the image is not satisfactory, check whether all controls are in the correct position for an opti­mum adjustment. The location of the controls is described in figure 1-6, SIGMA 110 Light,
SIGMA 110 Master and SIGMA 330 Master front view, on page 1-17.

15.10.01 INSTRUMENT DESCRIPTION 1-15

This page is intentionally left blank

1-16 SIGMA 110/SIGMA 330 15.10.01

1 .3.4 Front Panel

1.3.4.1 SIGMA 110 Light, Master and SIGMA 330 Master Front View

The following items are shown in figure 1-6, SIGMA 110 Light, SIGMA 110 Master and SIGMA
330 Master front view, on page 1-17:

1. Audio volume adjustment

2. Brightness adjustment for video screen

3. Contrast adjustment for video screen

4. Loudspeakers

5. Remote control receiver

6. Location dedicated to Remote Control Unit
(Remote Control Unit is optional with SIGMA 110)

7. Video screen

8. Receptacle for bottle of gel

9. Probe holder

10. Keyboard

1

2

7

8

3

9

4

5

6

4

10

Figure 1 -6: SIGMA 110 Light, SIGMA 110 Master and SIGMA 330 Master front view

15.10.01 INSTRUMENT DESCRIPTION 1-17

1.3.4.2 SIGMA 330 Expert Front View

The following items are shown in figure 1-8, SIGMA 330 Expert front view, on page 1-19:

1. Audio volume adjustment

2. Brightness adjustment for video screen

3. Contrast adjustment for video screen

4. Loudspeakers

5. Remote control receiver

6. Remote Control Unit

7. Keyboard

8. Cabinet for optional Video Printer

9. Cabinet for optional Video Cassette Recorder

10. Cabinet for accessories

11. Control pedal for carrying up/down the column

12. Video screen (colour monitor)

Figure 1 -7: SIGMA 330 Expert front view (closed)

1-18 SIGMA 110/SIGMA 330 15.10.01

1

12

2

3

4

5

6

7

8

9

10

4

11

Figure 1 -8: SIGMA 330 Expert front view

15.10.01 INSTRUMENT DESCRIPTION 1-19

1.3.4.3 SIGMA 330 Excellence Front View

The following items are shown in figure 1-9, SIGMA 330 Excellence front view, on page 1-21:

1. Additional high resolution flat screen

2. Compact personal computer integrated in the lower cabinet

1-20 SIGMA 110/SIGMA 330 15.10.01

1

2

Figure 1 -9: SIGMA 330 Excellence front view

15.10.01 INSTRUMENT DESCRIPTION 1-21

1.3.5 Rear Panel

1.3.5.1 SIGMA 330 Expert Rear Panel

1. Fuses (Electronic cabinet - top part)

2. Switch ON/OFF (Electronic cabinet - top part)

3. Mains plug (Electronic cabinet - top part)

4. Equalization potential terminal (Chassis Ground)

5. Probe holder

6. Guide for probe cable

7. Handle

8. Connectors for Linear/Curved Probes

9. Fuses (SIGMA 110/330 cart - bottom part)

10. Switch ON/OFF (SIGMA 110/330 cart - bottom part)

11. Mains plug (SIGMA 110/330 cart - bottom part)

12. Equalization potential terminal (Chassis Ground)

13. Equalization potential terminal (Chassis Ground)

14. Connector panel

15. Connector for Doppler Pencil Probes

16. Receptacle for bottle of gel

17. Connectors for Annular Sector Probes

18. Air filter grid

19. Identification labels:
 at the top: (CE mark, model, reference, serial number, revision number)
 at the bottom: (model, reference, serial number)

Output power: 3 outlets for peripherals (see Chapter 2.7.2, Output Power Source, on page
2-11)

1-22 SIGMA 110/SIGMA 330 15.10.01

1

2

19

18

3

17

16

4

5

15

6

7

6

14

8

9

13

10

11 12

Figure 1 -1 0: SIGMA 330 Expert rear panel

15.10.01 INSTRUMENT DESCRIPTION 1-23

1.3.5.2 SIGMA 330 Excellence Rear Panel

1. Fuses (Electronic cabinet - top part)

2. Switch ON/OFF (Electronic cabinet - top part)

3. Mains plug (Electronic cabinet - top part)

4. Equalization potential terminal (Chassis Ground)

5. Probe holder

6. Guide for probe cable

7. Handle

8. Connectors for Linear/Curved Probes

9. Fuses (SIGMA 110/330 cart - bottom part)

10. Switch ON/OFF (SIGMA 110/330 cart - bottom part)

11. Mains plug (SIGMA 110/330 cart - bottom part)

12. Equalization potential terminal (Chassis Ground)

13. Equalization potential terminal (Chassis Ground)

14. Connector panel

15. Connector for Doppler Pencil Probes

16. Receptacle for bottle of gel

17. Connectors for Annular Sector Probes

18. Air filter grid

19. Identification labels:
 at the top: (CE mark, model, reference, serial number, revision number)
 at the bottom: (model, reference, serial number)

Output power: 3 outlets for peripherals (see Chapter 2.7.2, Output Power Source, on page
2-11)

1-24 SIGMA 110/SIGMA 330 15.10.01

1

19

2

18

3

17

4

16

5

6

15

7

6

14

8

13

9

10

12

11

Figure 1 -1 1 : SIGMA 330 Excellence rear panel

15.10.01 INSTRUMENT DESCRIPTION 1-25

1.3.5.3 SIGMA 110 Light, Master and SIGMA 330 Master Rear Panel

1. Fuses (see Chapter 2.7.1, Input Power Source, on page 2-10)

2. Switch ON/OFF

3. Mains plug

4. Probe holder

5. Bottle of gel receptacle

6. Equalization potential terminal (Chassis Ground)

7. Identification label (CE mark, model, reference, serial number, revision number)

8. Connector for Linear/Curved Probes (Master)

9. Air filter grid

10. Connectors for Annular Sector Probes

11. Connector for Doppler Pencil Probes

12. Connector panel

1 7

2

3

4

5

10

11

6

12

8

9

Figure 1 -1 2: SIGMA 110 Light, Master and SIGMA 330 Master rear panel

1-26 SIGMA 110/SIGMA 330 15.10.01

1.3.5.4 Connector Panel

1 2 3 4 5 6 7 10 11 12

Figure 1 -1 3: Connector panel

Before connecting any equipment to these connectors read carefully, "Chapter III.1, Intended
Clinical Use, on page -xv" and Chapter III.2, Safety Information, on page -xviii.

1. Service connector

2. Video printer 2 remote control

3. Video printer 1 remote control

4. Remote Power Switch

5. Line Printer (parallel Port)

6. Serial Interface COM1, ECG

7. Keyboard

8. USB Port

9. Monitor

8

9

10. Video printer

11. SVHS VCR & Audio Input/Output

12. Foot switch

15.10.01 INSTRUMENT DESCRIPTION 1-27

1.4 System Controls

Definition of the control keys shown in figure 1-4, Keyboard, on page 1-13:

1 .4.1 Alphanumeric Keys

Alphanumeric keys access to all upper case characters. Useful graphic characters are accessed
with using of the SHIFT key.

1.4.1.1 ESC Key

The ESCape key is a generic key that:

 leaves any menu and return to the previous one.
 aborts any string (entry and restore the previous one, if possible).
 is available as often as possible to give user possibility to correct its manipulation errors.
 aborts current measurement.
 returns to previous study sheet or exits report when first sheet is displayed.

1.4.1.2 POWER ON/OFF Key

The POWER key switches ON or OFF system power. For Power OFF a confirmation menu is dis-
played, with a key for action aborting. This is to prevent a user manipulation error.

1.4.1.3 MENU Key

The MENU key is a toggle key displaying and hiding the menu of current functions. This menu is
depending on the current state and mode.

The (<) PREVIOUS and (>) NEXT keys located close right of the function keys, are used to
access the next/previous menu page if other menu pages are available.

0

2

MENU

F1

F6

F2

F7

F3

F8

F4

F9

F5

F10

1.4.1.4 F1 to F10 Keys

Select functions displayed in menu on the screen. If it is an action-function, the action is immedi­ately performed.

If it is an adjustment function (this can be recognized by the symbol on screen), the user has
to make an adjustment using the potentiometer on the left of the function keys.

1.4.1.5 ID Key

The ID key calls the starting page and menu for entering new patient information, laboratory and
operator identification.

1-28 SIGMA 110/SIGMA 330 15.10.01

1.4.1.6 PROBE

The PROBE key displays the probe MENU showing the names of the connected probes. User
can select the operating probe. On probe selection, the corresponding probe setups are loaded
and live image starts.

1.4.1.7 SETUP Key

The SETUP key displays a menu giving an user action choice on setups and preferences.



Load SETUP: replaces working parameters of current probe by parameters saved in the
SETUP.



Save SETUP: Save working parameters of current probe as preset values.



Preferences: Date & Time, Doppler Scale (m/s or kHz), Printer Selection, Patient ID, Tech­nical Data, Cine Mode and Refresh setup.

1.4.2 Live Investigation Keys

1.4.2.1 FREEZE Key

The FREEZE key is a toggle key starting and stopping image scanning. This key is always ena­bled. Action on freeze key displays menu of current mode on the screen. When the report is dis­played, action on freeze key exits report and displays live ultrasound image.

This key includes a relief mark for easy tactile recognition.

1.4.2.2 PRINT1 and PRINT2 Keys

The PRINT1 and PRINT2 key control video printers.
The PRINT1 key is always enabled and attached to a B&W video printer.
The PRINT2 key can be configured for colour video printer or for digital archiving (KIPRISM).

The configuration can be done with the SETUP menu.
Just before start printing, the live image is frozen and any menu removed from the screen. Just

after printing, previous system state is automatically restored.

1.4.2.3 2D Key

The 2D key sets the system in 2D mode (not all probes are 2D compatible).

1.4.2.4 TM Key

The TM key sets the system in TM mode (not all probes are 2D compatible).

1.4.2.5 CFM Key

The CFM key sets the system in CFM mode (only if linear probes are attached to the system,
mechanical probes can not be used for CFM).

This key exists only on SIGMA 330 systems + option CFM.

15.10.01 INSTRUMENT DESCRIPTION 1-29

1.4.2.6 PW Key

The PW key sets the system in PW mode.

1.4.2.7 CW Key

The CW key sets the system in CW mode. (not all probes are CW compatible, see table i, Probe
applications, on page -xvi)

1.4.2.8 MAGNIFY Key

The MAGNIFY key is used to display an ultrasound image area magnified by a factor 2 in live or
freeze mode in 2D/CFM mode.

1.4.2.9 SELECT Key

The SE LECT key acts when 2 or more images are displayed on the screen. It freezes current
image pad, if needed, and sets in live mode the next one.

1.4.2.10 GAIN Pots

The GAIN pots change the gain of the current image (2D, TM, CFM, PW or CW). It has no action
in freeze mode. Out of the gain range limits, the system emits a sound beep to warn the user.
The gain pot which is currently active, is backlighted.

1.4.2.11 TGC Pots

The TGC (Time Gain Control) is achieved by 5 sliders (rectilinear potentiometers). Five zones
are vertically defined on the image. Each slider corresponds to one of the 5 zones and adjusts
the gain in this one. TGC acts only in 2D and TM.

1.4.2.12 DEPTH Pot

The DEPTH pot changes depth of current image (2D or TM). It has no action in freeze mode. Out
of the depth range limits, a beep sounds to warn the user.

1.4.3 Keys for Frozen Image Study

1.4.3.1 BODYMRK

The BODYMRK key displays the current body marker set according to the current medical appli-
cation

1.4.3.2 ANNOTATE

The ANNOTATE key displays or hides the annotation menu on the screen and automatically
freezes image. Annotation menu enables annotation writing, displays cursors or body markers on
the screen.

1-30 SIGMA 110/SIGMA 330 15.10.01

1.4.3.3 MEASURE

The MEASURE key displays or hides the measurement menu on the screen and automatically
freezes ultrasound image.

1.4.3.4 REPORT

The REPORT key enters or exits the report screen and automatically freezes image. When exit-
ing report, the system returns to frozen ultrasound image display.

1.4.4 Trackball

The trackball and the 3 trackball buttons are linked together. These buttons have different func­tions:

Upper right keyUpper left key

Lower key

The actions associated to those keys are:



Upper left key is used to select the next available action in the action list,



Upper right key is used to select the previous available action in the action list,



Lower key is used to select the position cursor.

Action lists are managed in a circular manner: if the upper right (upper left) key is pressed and if
the current selected action is the last one (the first one) then the next selected action will be the
first (last) action of the actions list.

This convention is used for each mode except for:

 Measurement,
Biometry,
 Annotation,
 Pop-up menus,
 KIPRISM (see, Chapter 3.11.2.3, Principles of Selection and Validation, on page 3-53)
 PC Mode (see, Chapter 3.20.4, PC remote control features description, on page

3-111)

Some functions are linked to the trackball:

 Magnify and Zoom: moves zoomed or magnified area.
 Annotation/add text: set position of cursor.
 Annotation/Arrow mark: set arrow position on image.
 Measures.

15.10.01 INSTRUMENT DESCRIPTION 1-31

 Patient menu.
 Report.

The trackball is not attached to several functions simultaneously (except in PW live mode).
The trackball is attached to the last selected function. When the current function ends, the track-

ball attachment returns to the previous one.

1.4.4.1 Positioning of the Cursor

In any imaging mode, live and freeze, the user can move a "Position Cursor" on the screen to
point to a region of interest.

Press the lower key to display the cursor and move it using the trackball.
Press the lower key again to erase the cursor and return to previous function.

1-32 SIGMA 110/SIGMA 330 15.10.01

1.5 Screen Layout

1 .5.1 Ultrasound Screen Layout

Colour/Grey scale

General information, date & time

Technical data

Meas. result

Zoom indicator

AFA indicator

Tilt

icon

Menu keys M1-M10

Figure 1 -1 4: Screen Layout

1.5.1.1 General information and Date & Time

In this area following information are displayed:

 the laboratory references
 the operator name
 the patient name
 the current date and time

Patient Name

print
icon

ECG message

Mag.

icon

OperatorLaboratory

Date

Body
Mark.

Time

general information fields

According to the user preferences (set in the setup menu), the content of the general information
fields can be displayed or not. These fields are set in the Patient ID form.
The content of the laboratory and the operator fields are saved in the Non Volatile RAM and dis­played at each start-up.

15.10.01 INSTRUMENT DESCRIPTION 1-33

1.5.1.2 Colour/Grey Scale

According to the current mode (2D or CFM mode), the colour and/or the grey scales are dis­played on the left part of the screen. The display rules of both scales are the following:

 scales are never displayed in full TM mode
 scales are displayed in all the other modes when no overlapping between the scales and

the ultrasound image is possible.

 scales have an height of 128 pixels in single 2D or CFM and 80 pixels in the other

modes.



The grey scale
From the 128 (CFM mode) or 256 (2D mode) ultrasound possible grey levels only 16 are
displayed in the grey scale.
Remark: in CFM mode the displayed grey scale has the half of the width of the grey scale
displayed in 2D.



The colour scale
The colour scale is only displayed in CFM modes (single or multi-pad modes) and is always
associated to the grey scale (when colour scale is displayed, grey scale also displayed). In
this mode, two different types of colour scales can be displayed.

 the 128 colour levels are displayed in Power and Velocity mode
 if imaging of turbulence is activated in Velocity mode 32 colour levels and 96 turbulence

levels distributed into 128 colours are displayed.

The colour baseline shift has no influence on the number of displayed colours, which is always
equal to 128 levels.

Colou r & Grey scale desi gn

+31

Baseline

Wall filter
marker

Colour Threshold

Grey scale Colour scale

Unit

-31

cm/s

Velocity
Range

1.5.1.3 Technical Data

See Chapter 1.5.3, Technical Data Area, on page 1-38.

1.5.1.4 Measurement Results

See Chapter 3.14, Measurements, on page 3-67.

1-34 SIGMA 110/SIGMA 330 15.10.01

1.5.1.5 Icons

Four types of icons can be displayed on the SIGMA screen:

the freeze symbol icon displayed when the system is frozen

the magnify icon displayed when the 2D or CFM image is magnified

the tilt icon

the print icon

displayed with tiltable probes (6.5 EV). This symbol indicates the
current scanned part

temporary displayed when the user press on one of the two print
keys

1.5.1.6 Zoom Indicator

On the left side of the menu the range scale is drawn. This scale locates
the zoomed part of the 2D image. By moving the trackball up or down
the current displayed area will be moved and the zoom range indicator
will be modified.

Zoom range

indicator

1.5.1.7 ECG

Menu and ECG pads are always displayed one above the other. The menu is always displayed.

Menu

The colour of the ECG trace is CYAN with a colour monitor and WHITE with a B/W monitor.

1.5.1.8 Auto Frequency Adjustment (AFA)

The Auto Frequency Adjustment marker (A.F.A.) shows the current ultrasound
working frequency bandwidth of the transducer in 2D. This working frequency

5

MHz

bandwidth depends on actual selected scan depth and on the Freq+/Freq- setting.
For each transducer, depth and frequency setting, A.F.A selects the optimal fre­quency bandwidth of the transducer.
A.F.A. is available in single 2D mode and Freeze mode.
AFA display is selectable in the Preferences Menu.

15.10.01 INSTRUMENT DESCRIPTION 1-35

1

MHz

1.5.2 Menu

1.5.2.1 Function Key Menu

Function Keys on the keyboard are named F1 to F10 and Menu Items on the screen M1 to M10
to get understanding of the following description easier.

MP, as Menu Potentiometer, is for the incremental potentiometer.
MK is for the MENU key.
(<) is for the PREVIOUS key
(>) is for the NEXT key.
Function Keys F1 to F10 are respectively attached to the corresponding Menu Items
M1 to M10 (e.g. pressing F1 acts on M1)

0

2

MENU

F1

F6

F2

F7

F3

F8

F4

F9

F5

F10

Figure 1 -1 5: Function Keys

A specific menu exists for each mode. The current menu is automatically displayed when enter­ing mode. For example, pressing 2D key enters 2D mode and displays 2D menu. MK key is used
to display or hide menu. (<) (>) keys are used to access previous/next menu page when more
than one is available.

There are two types of displayed menu: single or double.



Single Menu is displayed on 1 line and consists of 5 Menu Items M1 to M5.

M1 M2 M4 M5M3

F1

F2

F3

F4

F5

F1

F2

F3

F4

F5

Figure 1 -1 6: Single Menu Display

For Single Menu the Fi and Fi' keys have the same action. Press indifferently F1 or F1' to select
M1 menu item.



Double Menu is displayed on 2 lines and consists of 10 Menu Items M1 to M10.

1-36 SIGMA 110/SIGMA 330 15.10.01

M1 M2 M4

M3

M5

F1

F6

M7 M6

F2

F7

M8 M9 M10

F3

F8

F4

F9

F5

F10

Figure 1 -1 7: Double Menu Display

1.5.2.2 PopUp Menu Used for Labels and Body markers

When activating label or body marker menu, a list is displayed in place of the technical and
measurement data. More details on labels and body marker management are available in
Appendix L, Body Markers, on page 7-111

15.10.01 INSTRUMENT DESCRIPTION 1-37

1.5.3 Technical Data Area

This chapter describes technical data of SIGMA 110/330 in the different modes.
In multi-pad mode, the common parameters (i.e. Gamma, Smooth, ...) are the ones of the active

pad.

1.5.3.1 Technical Data Formats

Most of parameter values are preceded by a character label so that the user can easily identify
their meaning. In the following sections the different value formats are described: xx means that 2
characters are displayed.



Non labelled data

 Probe: probe name (including its working frequency).
 Application: the probe medical application.
 Sub-Application in CFM mode1: name of the selected CFM Sub-Application (Liver &

Vein, Kidney, Abdom. Artery, Periph. Artery, Periph. Vein and Fetal Heart) or the scan­ning method (Scan Fast or Scan Normal in Cardio).

Depth: xx cm
Quality: Freq+ or Freq-
 Doppler frequency (SPFreq): x MHz
 Doppler mode: CW or PW
 CFM frequency (CFMFreq): x.xMH z
 Frame rate in 2D and CFM mode: xx fps



Labelled data

2D Gain: BGainxx
Gamma: Gamma x
Rainbow: Rainb x
Enhance: Enh x
 Reject: Rej x
 Smooth: Smoothx
 Zoom Factor: Mag x.x
Gate size: Gatexxmm
 Spectral Wall filter: WxxxxH z
 Vector: Ve c + x x °
 Doppler Gain: DGainxx
 Spectral Energy: En -xxdB
 CFM Gain: CGainxx
 Resolution: Res Low, Res Med or Res Hi
 Persistence: Pers x

1. The parameter Sub-application is different from the biometry Medical Application. The later is only relevant
to annotation, body marker, measurement and biometry modules.

1-38 SIGMA 110/SIGMA 330 15.10.01

 Colour Map: ColMapx
 CFM Energy: En -xxdB
 Thermal Index1: TISx. x or TIB x. x (or MI x.x when the probe is a

pencil probe or TIC x.x when the probe is a TCD2
probe).

 Mechanical Index: MI xx.x

1.5.3.2 2D and [2D]/TM Technical Data

The techdata for the 2D and [2D]/TM modes are organized as described below:

Probe
Depth
Quality
Enhance
Gamma
Zoom Factor
TI/MI

Probe
xx cm
Freq+
Enh x
Gamma x
Mag x.x

TI xx.x

Appl. name
BGainxx
Smooth x
Rej x
Rainb x
xx fps

Application
2D Gain
Smooth
Reject
Rainbow
Frame Rate

The Zoom Factor field is optional: it contains the zoom or the magnify factor and will only be dis­played if Mag or Zoom is on.

1.5.3.3 2D/[TM] Technical Data

These ones contains the 2D data (except the Zoom Factor) and the TM data:

Probe
Depth
Quality
Enhance
Gamma

TI/MI

Probe
xx cm
Freq+
Enh x
Gamma x

TI xx.x

Appl. name
BGainxx
Smooth x
Rej x
Rainb x
xx fps

Application
2D Gain
Smooth
Reject
Rainbow
Frame Rate

1.5.3.4 TM Technical Data

In this mode, only the information relevant to the TM single pad are displayed:

Probe
Depth
Quality
Enhance
Gamma

TI/MI

Probe
xx cm
Freq+
Enh x
Gamma x

TI xx.x

Appl. name
BGainxx

Rej x
Rainb x

Application
2D Gain

Reject
Rainbow

1.5.3.5 Double 2D and Quad 2D Modes

In these modes the technical data window contains the information concerning the active image.
See Chapter 1.5.3.2, 2D and [2D]/TM Technical Data, on page 1-39.

1. Only one of the thermal or the mechanical index will be displayed at a time.

15.10.01 INSTRUMENT DESCRIPTION 1-39

1.5.3.6 2D/SP, 2Di/SP Technical Data

These technical data contains the 2D data and also the PW ones:

Appl. name
BGainxx
Smooth x
Rej x
Rainb x
TI xx.x

DGainxx
Vec+xx°
En -xxdB
TI xx.x

a

Probe
xx cm
Freq+
Enh x
Gamma x
Mag x.x

PW
x.x MHz
WxxxxHz
Gatexxmm

Probe
Depth
Quality
Enhance
Gamma

Zoom Factor

PW/CW
SPFreq
SPWall Filter

GateSize
TIx/MI

a. Zoom mode only
b. PW mode only
c. only displayed when image is active and live

b

c

1.5.3.7 CFM and [CFM]/TM Technical Data

The most relevant CFM information are displayed here:

Probe
Sub-Application
Depth
Resolution
CFMFreq
Color Map
2D Gain

Zoom Factor

b

TIx

a

Probe
Subappl. name
xx cm
Res Low
x.x MHz
ColMapx
BGain xx
Mag x.x
TI xx.x

Appl. name

CGainxx
Pers x
xx fps
En -xxdB

Application
2D Gain
Smooth
Reject
Rainbow
Frame Rate

Doppler Gain
Vector
SP Energy

Application

CFM Gain
Persistence
Frame Rate
CFM Energy

a. only if Mag or Zoom is on
b. in live mode only

When Color Off is pressed, the 2D technical data are displayed (See Chapter 1.5.3.2, 2D and
[2D]/TM Technical Data, on page 1-39).

1.5.3.8 CFM/[TM] Technical Data

See Chapter 1.5.3.3, 2D/[TM] Technical Data, on page 1-39

1-40 SIGMA 110/SIGMA 330 15.10.01

1.5.3.9 [CFM]/SP Technical Data

The CFM information is inserted in the 2D/SP techdata:

Probe
Sub-Application
Depth
Resolution
CFMFreq
Color Map
2D Gain

PW/CW
SPFreq.
SPWall Filter

GateSize
TI/MI

a. PW mode only
b. in live mode only

a

b

Probe
Subappl. name
xx cm
Res Low
x.x Mhz
ColMapx
BGainxx

PW
x.x MHz
WxxxxHz
Gatexxmm
TI xx.x

Appl. name

CGainxx
Pers x
xx fps
En -xxdB

DGainxx
Vec+xx°
En -xxdB

Application

CFM Gain
Persistence
Frame Rate
CFM Energy

Doppler Gain
Vector
SP Energy

When the Color Off key is pressed, the 2D/SP technical data are displayed (Chapter 1.5.3.6,
2D/SP, 2Di/SP Technical Data, on page 1-40).

1.5.3.10 CFM/[SP] Technical Data

Chapter 1.5.3.6, 2D/SP, 2Di/SP Technical Data, on page 1-40

15.10.01 INSTRUMENT DESCRIPTION 1-41

1.6 Display Modes

1.6.1 2D Modes

2D (si n gle 2D) 2D+ 2D (dual) Qu ad 2D

zoomed
area

zoomed
image area

magnified
zone

Mech anical zoom

1 .6.2 TM Modes

Magnified 2D

Figure 1 -1 8: 2D Display Modes

2D or CF M+ TM

Figure 1 -1 9: TM Display Modes

Linear zoom

only the zoomed area is displayed

TM

1-42 SIGMA 110/SIGMA 330 15.10.01

1.6.3 CW and PW Modes

2D+ CW

2D or CF M+ PW

2Di+ CW

2Di or CF Mi+ PW

Figure 1 -20: CW and PW Display Modes

Remark: the CFM+CW modes are not available because the CFM is only possible with linear
probes and the CW mode only with mechanical or pencil probes.

1 .6.4 CFM Formats

CFM

only the zoomed areas are displayed

Linear zoom

Magnified CFM

magnified

zone

Figure 1 -21 : CFM Display

These formats are only available for linear transducers. It is composed of 2 images displayed one
over the other: the 2D image (on the back) and the Colour Flow Mapping image (on the front)

15.10.01 INSTRUMENT DESCRIPTION 1-43

1.7 SIGMA 1 10 Technical Specifications

1.7.1 General

The SIGMA 110 is a 2D, TM and spectral Doppler transportable ultrasound scanner for general
purpose applications:

Abdominal
 Breast
 Cardiology
 Emergency
 Endocrinology
 Gastro-enterology
 Gynaecology
Obstetrics
 Paediatrics
 Small parts
 Musculoskeletal
 Neonatology
Urology
 Vascular

SCANNING TECHNIQUES

 Electronic linear scanning
 Electronic convex scanning
 Annular array sector scanning
 Doppler Pencil probes

DISPLAY MODES

 Real time 2D (B-Mode) display modes:

 Single 2D format
 Double 2D format
 Quad 2D format
 2D panoramic zoom (for mechanical probes only)
 2D scroll zoom (for LINEAR/CONVEX probes only)
 2D magnification

 TM (M-Mode) display modes:

 Quasi Duplex 2D + TM: 2D (50% screen) + TM (50% screen)
 Full screen TM

 CW display modes:

 Quasi Duplex 2D + CW: 2D (50% screen) + CW (50% screen)
 2Di (icon) + CW

 PW display modes:

1-44 SIGMA 110/SIGMA 330 15.10.01

 Quasi Duplex 2D + PW: 2D (50% screen) + PW (50% screen)
 2Di (icon) + PW

MONITOR

 Black & White monitor, 10" diagonal
 640 x 480 pixels resolution
 Direct management of brightness and contrast
 includes loudspeakers and control knob for volume

KEYBOARD

 Six languages: English, French, German, Italian, Spanish and Russian (Cyrillic)
 Backlightening of all keys and knobs
 Ten software controlled function keys for menu selection
 Full alphanumeric capabilities
 B/W video printer remote control
 Trackball for focus point setting, TM, CW/PW line steering, annotations positioning,

measurements, cine-mode review and arrow pointing
 Layout removable for cleaning operation
 Trackball removable for cleaning operation

INFRARED REMOTE CONTROL (option)

 Ensure system control in any inadequate examination condition
 Allow the remote control for scanning parameters, freeze and image printing
 Dedicated place on keyboard

SCREEN LAYOUT

 Patient identification field including patient name clinic name, operator name, time and

date
 Technical data field showing all pertinent imaging parameters
 Measurement field displaying the last ten measurement results
 Menu field activated by the corresponding function key
 Freeze mode indicator
 Cine-loop memory index (option)
 Annotation arrows and user defined annotations with trackball controlled positioning
 Image orientation indicator
 Over 51 body markers with scan plane indication
 Dot lines for TM/CW/PW beam orientation
 Real time ECG trace display
 Biopsy channel indication with automatic calibration of depth, probe type, left/right

guides and angle up/down orientation

SE TTIN GS

 Default settings related to the medical application and transducer for image quality opti-

mization
 User settings memorized in the system as well as on a flash card

15.10.01 INSTRUMENT DESCRIPTION 1-45

1.7.2 2D (B-Mode)

SCANNING SECTOR

 Angle: 40, 45, 60, 75, 90, 110 and 140° for Annular Sector (Probe dependent)
 Angle: 30, 45, 60, 75, 90 and 110° for Convex Array (Probe dependent)
 Depth: 2 cm to 24 cm, up to 10 depths (Probe dependent)
 Nominal frequency range: 2 to 14 MHz (Probe dependent)

FRAME RATE

 Up to 200 fps (probe and medical application dependent)
 Depending on depth, angle and medical application

SIGNAL PROCESSING

 Large bandwidth: 1.5 - 18 MHz
 Overall Gain: 32 steps
 Time Gain Compensation: 5 sliders
 Dynamic focusing on reception
 Up to four focus zones on transmission
 Automatic adjustment of reception bandwidth for each depth
 Contour enhancement: 7 positions application dedicated
 Dynamic range control (reject): 4 positions to increase the contrast and reduce weak

echoes
 Frame filter: 4 non linear smoothing filters + OFF position
 Automatic Frequency Adjustment (A.F.A.) for standard and less echogenic patient

(Freq+/Freq-)
 Grey scale optimization thanks to 8 Gamma curves (probe dependent)

IMAGE PRESENTATION

 Single, Double and Quad image representation
 Freeze mode
 Left/right
Up/Down
 Video inversion

RESOLUTION

 512 x 512 pixels on screen for 2D image display
 256 grey levels

IMAGE MEMORY (option)

 Cine Mode: up to 282 images (probe and medical application dependent)

1.7.3 TM (M-Mode)

SIGNAL PROCESSING

 Same as 2D mode

IMAGING PARAMETERS

 Scrolling speed:

1-46 SIGMA 110/SIGMA 330 15.10.01

 2, 3, 5, 8 sec./screen (full screen)
 1, 1.5, 2.5, 4 sec./screen (2D + TM)

M LINE STEERING

 Trackball controlled over complete 2D sector

DISPLAY

 2D (50% screen) + TM (50% screen)
 Full screen TM

IMAGE MEMORY

 Cine Mode:

 up to 16 trace screens in full TM
 up to 5 trace screens in 2D + TM

1.7.4 Spectral Doppler Mode

AVAI L AB L E MO D E S

 Steerable PW
 Steerable CW

SIGNAL PROCESSING

 Multi-frequency Doppler mode: 2, 3, 4 and 8 MHz (probe dependent)
 Velocity range:

 PW: +/-1 kHz to +/- 10 kHz
 CW: +/-1 kHz to +/- 20 kHz
 +/- 10 cm/sec. to +/- 3.5 m/s (PW), +/- 7.2 m/sec. (CW), full scale, depending on

probe and operating frequency
 High pass wall filter: 10 cut-off frequencies adjustable between 50 to 1000 Hz
 Grey scale optimization with 8 post-processing curves (probe dependent)
 Spectrum gain control: 11 selections between 0 and 30 dB
 120 dB dynamic range for best sensitivity
 256 point FFT, computing time of 0.2 ms
 Doppler transmit power control: 8 selections between 0 dB and -21 dB
 Doppler angle correction: from -80 to 80 °
 Scrolling speed:

 2, 3, 5, 8 sec./screen (full screen)
 1, 1.5, 2.5, 4 sec./screen (2D + SP)

 Adjustable audio volume

PW GATE

 PW gate adjustable for sample volumes between 1 and 15 mm (8 selections)
 PW gate adjustable with the trackball between 0 and maxi depth of the image format

DISPLAY

 2D (50% screen) + Doppler (50% screen)
 2D icon + Doppler

15.10.01 INSTRUMENT DESCRIPTION 1-47

 Base line shift: 9 positions for optimal signal display, avoiding spectrum aliasing
V
V

real time trace display

MEAN

and V

MAX+

MAX-

real time trace display

 Quasi duplex automatic refresh: 4 levels, according to scrolling speed

IMAGE MEMORY

Cine Mode:

 up to 16 trace screens in full Doppler
 up to 5 trace screens in 2D + Doppler

ACOUSTIC POWER OUTPUT

 Fulfils acoustic output display standards
 Complies with FDA acoustic output limits
 Automatic power output adjustment versus medical application for optimal Doppler per-

formance (ALARA)

 User selectable Doppler transmit power attenuation:

8 positions between 0 dB and -21 dB

1.7.5 Digital Archiving: KIPRISM

 Digital archiving on Memory Card: the number of ultrasound images which can be

stored, is depending on memory card capacity

 up to 32 images on 4 megabytes memory card
 up to 64 images on 8 megabytes memory card
etc.

 Transfer on Personal Computer via memory card (PCMCIA standard, DOS format)

1.7.6 ECG Module (option)

FORMATS

 for all single or dual pad formats

INPUT

 Isolated input, type CF, Defibrillator proof (IEC 601-1)
 through serial port, 240 x 8 bit / second, QRS trigger available
 ECG Gain: 1000 (1V / 1 mV)
 Heart rate: up to 180 bpm
 Recovery time after defibrillator shock: > 5 sec

B MODE TRIGGER

 in single and dual B mode available, trigger moment may be set by user.
 For dual pad modes two independent triggers can be set.

DISPLAY and CINE REVIEW

 Display trace (on video screen)
 Indication of time relationship between 2D mode image and ECG trace by marker on

ECG trace. Cine review on trace modes is also available.

1-48 SIGMA 110/SIGMA 330 15.10.01

1.7.7 EasyPrint

 Direct output to inkjet printer
 Compatible with HP PCL level III

TM

1.7.8 USB-Link

TM

 Digital transfer of images and report text files to Personal Computer through USB cable
 Compatibility: refer to Chapter 3.18.2, Compatibility, on page 3-99.

1 .7.9 Peripherals (Optional)

The following peripherals can be connected to the system:

 VCR (VHS and S-VHS)
 B/W video printer
 Parallel DeskJet printer (PC compatible) for images (EasyPrintTM) and report printout
 B/W monitor

1.7.10 Inputs/Outputs

 S-VHS/VHS (including audio) input/output for VCR connection, PAL/NTSC compatible,

video playback automatically fed to the monitor
 Black & White video composite output for B/W video printer connection
 Double footswitch (Freeze/ Print/ Select image)
 Memory card connector (PCMCIA) dedicated to software upgrade, user setup storage

and digital archiving (KIPRISM)
 RGB video output for external monitor and color video printer
 Parallel port for images and report printout
 Serial port for peripheral devices
 USB port for data transfer to PC

1.7.11 Measurement

CALIPE RS

 Trackball controls the multiple callipers
 Complete measurement capabilities on frozen images
 2D: distance, surface and circumference of area, surface and circumference of ellipse,

angle; distance and area ratio
 TM: distance, time, slope, heart rate, distance and time ratio, LV studies
 PW/CW: speed gradient, frequency, time, acceleration, integral, PI & RI, RI, heart rate,

speed, gradient and time ratio
 Specific measurements for OB/GYN
 Up to 10 result lines on screen

15.10.01 INSTRUMENT DESCRIPTION 1-49

ANNOTATIONS

 Annotation collection
 Text, arrows, body markers

PATIE N T RE POR T

 Automatic selection of relevant measurement from patient report
 Comprehensive report for each medical application: Radio, Vasc., Ob/Gyn, Pediatry,

Cardio.

 Peripheral vascular: stenosis percentage, continuity equation, resistance index, steno-

sis index, pulsatility index, spectral broadening index, flow volume, frequency

 Abdominal: volume 1 to 4 (user-defined), cardiac output, diameter, continuity equation
 Pediatric: hip angles
 Ob/Gyn: extensive measurements capabilities including BPD, FML, CRL, BOD, ABD,

THD, AC, GES, HC, OFD, APD, TAD, Foetal Weight, Estimated Birth Date

 Cardio: left ventricular volumetry using Simpson, area length single and bi-plane formu-

las, systolic and diastolic volume using Teichholz rule, shortening fraction, myocardial
mass and mass index, left ventricular circumference, ejection fraction, cardiac output
and index, stroke volume and index, mean velocity, pressure and mean pressure gradi­ent, pressure half time and valve area, time to peak velocity in systole, right and left ven­tricular ejection time and pre-ejection period, right ventricular systolic pressure,
continuity equation, QP/QS

 All applications: body surface area (BSA)

ME ASUR EME NT ACCURACY

Mode: Parameters: Typical accuracy:

 Distance  < +/- 3%

 1 mm, when 3% of the measured

2D

Angle

value is less than 1 mm

< +/- 2.5 °

 Distance  < +/- 1%

 0.5 mm, when 1% of the meas-

TM

SP

Time

 Slope

Speed

Frequency

 Gradient

ured value is less than 0.5 mm

< +/- 1%

< +/- 2%

< +/- 5% of max. displayed velocity

< +/- 5% of max. displayed frequency

< +/- 10%

HR

Time

 Acceleration

 Heart rate computed by ECG

< +/- 1%

< 10%

+/- 1 bpm

Tab l e 1 - 4: Measurement Accuracy

1-50 SIGMA 110/SIGMA 330 15.10.01

1 .7.1 2 Acoustic Power

SIGMA 110 complies with the FDA Standards.
Acoustic power depends on Medical Application.

I

SPPA

< 190 W/cm2 (Medical Application independent)
Im < 310 W/cm2 (Medical Application independent)
I

in situ, in mW/cm

SPTA

MEDICAL

APPLICATION

I

In situ, in mW/cm

SPTA

 Accuracy of MI display: +/- 30 %
 Accuracy of TI display: +/- 50 %

1.7.13 Environment

TE MPE R ATU RE

 Operating temperature: 10 °C to 40 °C (50 °F to 104 °F)
 Storage temperature: -20 °C to 40 °C (-4 °F to 104 °F)

HUMIDITY

 Operating humidity: 30% to 80%, non condensing

2

CARDIO VASC. RADIO, OB/GYN

2

< 430 < 720 < 94

Tab l e 1 - 5: Acoustic Intensity

 Storage humidity: 30% to 95%, non condensing

ATMOSPHERIC PRESSURE

 Operating pressure: 700 mbar to 1060 mbar
 Storage pressure: 500 mbar to 1060 mbar

ELECTRICAL SPECIFICATIONS

 Input voltage: 100 - 127 V~ and 200 - 240 V~
 Mains frequency: 50 - 60 Hz
 Consumption: 340 VA

ELECTROMAGNETIC FIELD

 Maximum field strength without degradation of performance: 1 V/m

1.7.14 Regulation and Safety

 CE MDD mark
 German K.V. regulation
 IEC 601-1 Class 1 Type B (Electrical Safety)
 IEC 1157 (Acoustic power reporting)
 FDA 510 (k)

15.10.01 INSTRUMENT DESCRIPTION 1-51

1 .7.15 Dimensions

 Height: 380 mm
 Width: 470 mm
Depth: 526 mm
 Weight: 29 kg

1-52 SIGMA 110/SIGMA 330 15.10.01

1.8 SIGMA 330 Technical Specifications

1 .8.1 General

The SIGMA 330 is a 2D, TM, Spectral Doppler and Color Flow Mapping ultrasound scanner for
general purpose applications:

Abdominal
 Breast
 Cardiology
 Emergency
 Endocrinology
 Gastro-enterology
 Gynaecology
 Musculoskeletal
 Neonatology
 Obstetrics
 Paediatrics
 Small parts
Urology
Vascular

SCANNING TECHNIQUES

 Electronic linear scanning
 Electronic convex scanning
 Annular array sector scanning
 Doppler Pencil Probes

DISPLAY MODES

 Real time 2D (B-Mode) display modes:

 Single 2D format
 Double 2D format
 Quad 2D format
 2D panoramic zoom (for AS probes only)
 2D scroll zoom (for LINEAR/CONVEX probes only)
 2D magnification

1

3D

 3D-Fetal View
 3D-Vascular View

TM

TM

 TM (M-Mode) display modes:

 Quasi Duplex 2D + TM: 2D (50% screen) + TM (50% screen)
 Full screen TM

1. SIGMA 330 Excellence only

15.10.01 INSTRUMENT DESCRIPTION 1-53

 CW display modes:

 PW display modes:

 CFM display modes:

 Colorised 2D, TM, PW & CW mode display

MONITOR

 Colour monitor

 Quasi Duplex 2D + CW: 2D (50% screen) + CW (50% screen)
 2Di (icon) + CW

 Quasi Duplex 2D + PW: 2D (50% screen) + PW (50% screen)
 2Di (icon) + PW

 Single CFM
 Quasi Duplex CFM + PW: CFM (50% screen) + PW (50% screen)
 CFMi (icon) + PW

 10" diagonal
 640 x 480 pixels resolution
 PAL/NTSC compatible
 Direct management of brightness and contrast
 includes loudspeakers and control knob for volume

 LCD flat panel colour monitor

 15" diagonal
 800 x 600 pixels resolution

KEYBOARD

 Six languages: English, French, German, Italian, Spanish and Russian (Cyrillic)
 Backlightening of all keys and knobs
 Ten software controlled function keys for menu selection
 Full alphanumeric capabilities
 B/W and colour video printer remote control
 Trackball for TM, CW/PW line steering, PW gate positioning, CFM colour window resiz-

ing and positioning, focus point setting, annotation positioning, measurements and cine-

mode review
 Layout removable for cleaning operation
 Trackball removable for cleaning operation

INFRARED REMOTE CONTROL

 Ensure system control in any inadequate examination condition

1

 Allow the remote control for scanning parameters, freeze and image printing
 Dedicated place on keyboard

SCREEN LAYOUT

 Patient identification field including patient name, clinic name, operator name, time and

date

1. SIGMA 330 Excellence only

1-54 SIGMA 110/SIGMA 330 15.10.01

 Technical data field showing all pertinent imaging parameters
 Measurement field displaying the last ten measurement results
 Menu field activated by the corresponding function key
 Freeze mode indicator
 Cine-loop memory index
 Annotation arrows and user defined annotations with trackball controlled positioning
 Image orientation indicator
 Over 51 body markers with scan plane indication
 Indication of CFM ROI position and size
 Dot lines for TM/CW/PW beam orientation
 Real time ECG trace display
 Biopsy channel indication with automatic calibration of depth, probe type, left/right

guides and angle up/down orientation

 CFM window

SE TTIN GS

 Default settings related to the medical application and transducer for image quality opti-

mization

 User settings memorized in the system as well as on a flash card

1.8.2 2D (B-Mode)

SCANNING SECTOR

 Angle: 40, 45, 60, 75, 90, 110 and 140° for Annular Sector (Probe dependent)
 Angle: 30, 45, 60, 75, 90 and 110° for Convex Array (Probe dependent)
 Depth: 2 cm to 24 cm, up to 10 depths (Probe dependent)
 Nominal frequency range: 2 to 14 MHz (Probe dependent)

FRAME RATE

 Up to 218 fps
 Depending on depth, angle and medical application

SIGNAL PROCESSING

 Large bandwidth: 1.5 - 18 MHz
 Overall Gain: 32 steps
 Time Gain Compensation: 5 sliders
 Dynamic focusing on reception
 Up to four focus zones on transmission
 Automatic adjustment of reception bandwidth for each depth
 Contour enhancement: 7 positions application dedicated
 Dynamic range control (reject): 4 positions to increase the contrast and reduce weak

echoes

 Frame filter: 4 non linear smoothing filters + OFF position

15.10.01 INSTRUMENT DESCRIPTION 1-55

 Automatic Frequency Adjustment (A.F.A.) for standard and less echogenic patient

(Freq+/Freq-)
 Grey scale optimization thanks to 8 Gamma curves (probe dependent)
 Iris colour system

IMAGE PRESENTATION

 Single, Double and Quad image representation
 Freeze mode
 Left/right
Up/Down
 Video inversion

RESOLUTION

 512 x 512 pixels on screen for 2D image display
 256 grey levels

IMAGE MEMORY

 Cine Mode: up to 282 images (probe and medical application dependent)

1.8.3 TM (M-Mode)

SIGNAL PROCESSING

 Same as 2D mode

IMAGING PARAMETERS

 Scrolling speed:

 2, 3, 5, 8 sec./screen (full screen)
 1, 1.5, 2.5, 4 sec./screen (2D + TM)

M LINE STEERING

 Trackball controlled over complete 2D sector

DISPLAY

 2D (50% screen) + TM (50% screen)
 Full screen TM

IMAGE MEMORY

Cine Mode:

 up to 16 trace screens in full TM
 up to 5 trace screens in 2D + TM

1.8.4 Spectral Doppler Mode

AVAI L AB L E MO D E S

 Steerable PW and CW
 Multi-frequency Doppler modes
 Spectral colorization
 Automatic 2D image update when adjusting Doppler cursor position

SIGNAL PROCESSING

1-56 SIGMA 110/SIGMA 330 15.10.01

 Doppler frequencies: 2, 3, 4 and 8 MHz (probe dependent)
 Velocity range:

 PW: +/-1 kHz to +/- 10 kHz
 CW: +/-1 kHz to +/- 20 kHz Doppler shift (PRF/2)
 +/- 10 cm/sec. to +/- 3.5 m/s (PW), +/- 7.2 m/sec. (CW), full scale, depending on

probe and operating frequency
 High pass wall filter: 10 cut-off frequencies adjustable between 50 to 1000 Hz
 Grey scale optimization with 8 post-processing curves (probe dependent)
 Spectrum gain control: 11 selections between 0 and 30 dB
 120 dB dynamic range for best sensitivity
 256 point FFT, computing time of 0.2 ms
 Doppler transmit power control: 8 selections between 0 dB and -21 dB
 Doppler angle correction: from -80 to 80 °
 Scrolling speed:

 2, 3, 5, 8 sec./screen (full screen)

 1, 1.5, 2.5, 4 sec./screen (2D + SP)
 Adjustable audio volume
 Iris colour system

PW GATE

 PW gate adjustable for sample volumes between 1 and 15 mm (8 selections)
 PW gate adjustable with the trackball between 0 and maxi depth of the image format

DISPLAY

 2D (50% screen) + Doppler (50% screen)
 2D icon + Doppler
 Base line shift: 9 positions for optimal signal display, avoiding spectrum aliasing
V
V

real time trace display

MEAN

and V

MAX+

MAX-

real time trace display

 Quasi duplex automatic refresh: 4 levels, according to scrolling speed

IMAGE MEMORY

 Cine Mode:

 up to 16 trace screens in full Doppler

 up to 5 trace screens in 2D + Doppler

ACOUSTIC POWER OUTPUT

 Fulfils acoustic output display standard
 Complies with FDA acoustic output limits
 Automatic power output adjustment versus medical application for optimal Doppler per-

formance (ALARA)

 User selectable Doppler transmit power attenuation: 8 positions between 0 and -21 dB

15.10.01 INSTRUMENT DESCRIPTION 1-57

1 .8.5 Colour Doppler Modes

MODES

 Steerable Color Flow Mapping (CFM) on electronic array probes
 Velocity, Variance and Power mode
 Automatic 2D/CFM image update when adjusting Doppler cursor position

SIGNAL PROCESSING

 Multi frequency CFM mode: 2.5, 3, 5 and 6 MHz (Probe dependent and user selectable)
 High pass wall filter: 6 cut-off frequencies adjustable between 44 to 4400 Hz (depend-

ant on velocity range)
 Colour gain control: 32 positions between 0 and 20 dB
 4 positions colour persistence
 Velocity Ranges: from ± 125 Hz to ±7.5 kHz Doppler shift (PRF/2) or ±1.6 cm/s to

±2.8 m/s full scale, depending on probe, frequency and medical application

CFM WINDOW

 From 10% to full length of 2D sector, trackball controlled resize
 From 10% to full width of 2D sector, trackball controlled resize
 Trackball control of window position within 2D sector

DISPLAY

 Up to 128 colour shades, 8 levels of turbulence
 8 user selectable colour maps for optimum rendering of either low velocities, high veloc-

ities and turbulence
 9 positions of baseline shift
 Turbulence on/off
Colour invert
 Chroma maps for optimum rendering of 2D echo structures
 Up to 64 frames cine memory

ACO U STI C OU TPU T

 Fulfils acoustic output display standard
 Complies with FDA acoustic output limits
 Automatic power output adjustment versus medical application for optimal Doppler per-

formance (ALARA)
 User selectable Doppler transmit power attenuation: 8 positions between 0 dB and - 21

dB

1.8.6 3D Imaging

1

2 highly intuitive user interface packages:



3D - Fetal View (2D reconstruction)



3D - Vascular View  (2D and CFM reconstruction)

 Quick and easy 3D acquisition

1. SIGMA 330 Excellence only

1-58 SIGMA 110/SIGMA 330 15.10.01

 Instantaneous multiplanar 3D reconstruction (MPR)
 3D application specific rendering algorithms
 3D segmentation tools (advanced filter operations)
 Image export to standard PC file format (.bmp and .avi)
 Digital archiving

1.8.7 Digital Archiving: KIPRISM

 Digital archiving on Memory Card:

 up to 32 images on 4 megabytes memory card
 up to 64 images on 8 megabytes memory card

 Transfer on Personal Computer via memory card (PCMCIA standard, DOS format)

 Images in PCX format, report in TXT format
 Up to 15000 color images per archiving media (640 MB)
 DICOM 3.0 compatible (with PACS option)

1.8.8 ECG Module (option)

FORMATS

 for all single or dual screen formats

INPUT

 Isolated input, type CF, Defibrillator proof (IEC 601-1)
 through serial port, 240 x 8 bit / second, QRS trigger available
 ECG Gain: 1000 (1V / 1 mV)
 Heart rate: up to 180 bpm
 Recovery time after defibrillaror shock: > 5 sec

B MODE TRIGGER

 in single and dual B mode available, trigger moment may be set by user.
 For dual pad modes two independent triggers can be set.

DISPLAY and CINE REVIEW

 Display trace (on video screen)
 Indication of time relationship between 2D mode image and ECG trace by marker on

ECG trace. Cine review on trace modes is also available.

1.8.9 EasyPrint

TM

 Direct output to inkjet printer
 Compatible with HP PCL level III

1.8.10 USB-Link

TM

 Digital transfer of images and report text files to Personal Computer through USB cable.
 Compatibility: refer to Chapter 3.18.2, Compatibility, on page 3-99.

15.10.01 INSTRUMENT DESCRIPTION 1-59

1.8.11 Peripherals (Optional)

All the following peripherals can be connected to the system:

 VCR (VHS and S-VHS)
 B/W video printer
 Color video printer
 Parallel DeskJet printer (PC compatible) for images (EasyPrintTM) and report printout
 B/W monitor
 Color monitor

1.8.12 Inputs/Outputs

 S-VHS/VHS (including audio) input/output for VCR connection, PAL/NTSC compatible,

video playback automatically fed to the monitor
 Black & White video composite output for B/W video printer connection
 Double footswitch (Freeze / Print/Select image)
 Memory card connector (PCMCIA) dedicated to software upgrade, user setup storage

and digital archiving (KIPRISM)
 RGB video output for external monitor and color video printer
 Parallel port for images and report printout
 Serial port for peripheral devices
 USB port for data transfer to PC

1.8.13 Measurement

CALIPE RS

 Trackball controls the multiple callipers
 Complete measurement capabilities on frozen images
 2D: distance, surface and circumference of area, surface and circumference of ellipse,

angle, volume; distance and area ratio
 TM: distance, time, slope, heart rate; distance and time ratio; LV studies
 PW/CW: speed gradient, frequency, time, acceleration, integral, PI & RI, RI, heart rate;

speed, gradient and time ratio
 CFM: velocity, velocity profile and frequency
 Specific measurements for OB/GYN
 Up to 10 result lines on screen

ANNOTATIONS

 Annotation lists: user-defined
 Text, arrows, body markers

PATIE N T R EPORT

 Automatic selection of relevant measurement from patient report
 Comprehensive report for each medical application: Radio, Vasc., Ob/Gyn, Pediatry,

Cardio.

1-60 SIGMA 110/SIGMA 330 15.10.01

 Peripheral vascular: stenosis percentage, continuity equation, resistance index, steno-

sis index, pulsatility index, spectral broadening index, flow volume, frequency

 Abdominal: volume 1 to 4 (user-defined), cardiac output, diameter, continuity equation
 Pediatric: hip angles
 Ob/Gyn: extensive measurements capabilities including BPD, FML, CRL, BOD, ABD,

THD, AC, GES, HC, OFD, APD, TAD, Foetal Weight, Estimated Birth Date

 Cardio: left ventricular volumetry using Simpson, area length single and bi-plane formu-

las, systolic and diastolic volume using Teichholz rule, shortening fraction, myocardial
mass and mass index, left ventricular circumference, ejection fraction, cardiac output
and index, stroke volume and index, mean velocity, pressure and mean pressure gradi­ent, pressure half time and valve area, time to peak velocity in systole, right and left ven­tricular ejection time and pre-ejection period, right ventricular systolic pressure,
continuity equation, QP/QS

 All applications: body surface area (BSA)

ME ASUR EME NT ACCURACY

Mode: Parameters: Typical accuracy:

 Distance  < +/- 3%

2D

TM

SP

CFM

 1 mm, when 3% of the measured

value is less than 1 mm

Angle

< +/- 2.5 °

 Distance  < +/- 1%

 0.5 mm, when 1% of the meas-

ured value is less than 0.5 mm

Time

Slope

Speed

 Frequency

 Gradient

Time

 Acceleration

Velocity

 Frequency

< +/- 1%

< +/- 2%

< +/- 5% of max. displayed velocity

< +/- 5% of max. displayed frequency

< +/- 10%

< +/- 1%

< 10%

< +/- 10% of the velocity range

< +/- 10% of the frequency range

HR

 Heart rate computed by ECG

+/- 1 bpm

Tab l e 1 - 6: Measurement Accuracy

1 .8.1 4 Acoustic Power

The acoustic power depends on Medical Application.

I

< 190 W/cm2 (Medical Application independent)

SPPA

Im < 310 W/cm2 (Medical Application independent)

15.10.01 INSTRUMENT DESCRIPTION 1-61

I

In situ, in mW/cm2, is shown in the table below

SPTA

MEDICAL

APPLICATION

I

In situ, in mW/cm

SPTA

 Accuracy of MI display: +/- 30 %
 Accuracy of TI display: +/- 50 %

1 .8.1 5 E nviron ment

TE MPE R ATU RE

 Operating temperature: 10 °C to 40 °C (50 °F to 104 °F)
 Storage temperature: -20 °C to 40 °C (-4 °F to 104 °F)

HUMIDITY

 Operating humidity: 30% to 80%, non condensing
 Storage humidity: 30% to 95%, non condensing

ATMOSPHERIC PRESSURE

 Operating pressure: 700 mbar to 1060 mbar
 Storage pressure: 500 mbar to 1060 mbar

CARDIO VASC. RADIO, OB/GYN

2

< 430 < 720 < 94

Tab l e 1 - 7: Acoustic Intensity

ELECTRICAL SPECIFICATIONS

 Input voltage: 100 - 127 and 200 - 240 V~
 Mains frequency: 50 - 60 Hz
 Consumption: 340VA (main unit only), 680 VA (with integrated cart and peripherals)

E LE CTROMAGNE TIC FIE LD

 Maximum field strength without degradation of performance: 1 V/m

1 .8. 1 6 R eg u lation and Safety

 CE MDD mark
 German K.V. regulation
 IEC 601-1 Class 1 Type B (Electrical Safety)
 IEC 1157 (Acoustic power reporting)
 FDA 510 (k)

1 .8.1 7 Dimensions

SIGMA 330 Master

 Height: 380 mm
 Width: 470 mm
 Depth: 526mm
 Weight: 29 kg

1-62 SIGMA 110/SIGMA 330 15.10.01

SIGMA 330 Expert

 Height: 1230 mm (min.) - 1305mm (max.)
 Width: 580 mm
 Depth: 684 mm
 Weight: 90 kg

SIGMA 330 Excellence

 Height: 1230 mm (min.) - 1305 mm (max.)
 Width: 580 mm
 Depth: 684 mm
 Weight: 103 kg

15.10.01 INSTRUMENT DESCRIPTION 1-63

This page is intentionally left blank

1-64 SIGMA 110/SIGMA 330 15.10.01

2. INSTALLATION

10.12.01 INSTALLATION 2-1

2-2 SIGMA 110/SIGMA 330 10.12.01

2.1 Installati on R eq ui rem en ts

Be sure that the site is sufficiently ventilated and do not install the instrument near any important
heat source.

In order to prevent an overheating, ensure that the ventilation openings are not covered and keep
the rear panel away from a vertical wall.

Bring the package relief as close as possible to the required operating location.
It is recommended to provide two people for removing SIGMA 110/330 from its package.

2.2 Unpacking

2.2.1 Warning

Installation must be performed by authorized KONTRON MEDICAL SAS personnel. Any attempt
by unauthorized personnel to install the instrument may invalidate the KONTRON MEDICAL SAS
warranty.
If the instrument is received in damaged conditions, request an immediate inspection by the car­rier and local KONTRON MEDICAL representative.

2.2.2 Unpacking the Instrument

SIGMA 110 and SIGMA 330 instruments are packed in non-returnable packings.

2.2.2.1 SIGMA 110 Light/Master and SIGMA 330 Master

These models are packed in a cardboard box. Remove it carefully.

2.2.2.2 SIGMA 330 Expert and SIGMA 330 Excellence

The upper part (Monitor) is packed in a cardboard box. Remove it carefully.
For SIGMA 330 Excellence, the flat screen and micro-computer are packed in a separate card-

board box. Remove them carefully.
The instrument body (Cart) is packed into a wood crate:



Remove the top and side boards.



Remove the foam protecting the instrument.



Remove the instrument from the pallet.

2.3 Checking the Instruments Identification

The identification label with designation, reference number and serial number is affixed to the
rear panel (see figure 1-10, SIGMA 330 Expert rear panel, on page 1-23, figure 1-11, SIGMA
330 Excellence rear panel, on page 1-25 and figure 1-12, SIGMA 110 Light, Master and SIGMA
330 Master rear panel, on page 1-26).

10.12.01 INSTALLATION 2-3

2.4 Checking the Delivery

Check the contents of the consignment with the delivery note that is supplied with each system. If
parts are missing or damaged, inform your local KONTRON MEDICAL representative.
Following standard parts are supplied with the instrument.
For ordering optional accessories, refer to Chapter 6.3, Accessories, on page 6-5.

Qty. Ref. Designation

1 100 250 250 ml bottle of ultrasound gel

1 411 353 Power cable (EURO/D CEE 22)

1 (or) 487 848 Power cable "North American Hospital Grade" (for US)

1 485 055 Memory card 4 MB (PCMCIA) for SIGMA 110 Light and Master

1 477 729 Memory card 4 MB - SRAM (PCMCIA) for SIGMA 330 Master

1 484 164 Memory card label

1
1

1 (or) DOC31001FR Operator Manual - French (according to system language)

1 (or) DOC31001GE Operator Manual - German (according to system language)

1 (or) DOC31001IT Operator Manual - Italian (according to system language)

1 (or) DOC31001SP Operator Manual - Spanish (according to system language)

1 (or) DOC31001CY Operator Manual - Russian (Cyrillic, according to system language)

1 483 184 Remote control Unit - English (according to system language)

1 (or) 483 176 Remote control Unit - French (according to system language)

1 (or) 483 168 Remote control Unit - German (according to system language)

1 (or) 483 141 Remote control Unit - Italian (according to system language)

1 (or) 483 133 Remote control Unit - Spanish (according to system language)

1 (or) 483 125 Remote control Unit - Cyrillic (according to system language)

2 524 204 Fuse, 5 x 20 mm, T 2 A

2 717 150 Fuse, 5 x 20 mm, T 4 A (according to line voltage)

1 487 090 Notice for NTSC fuses

1 481 033 Remote control cable for Video printer

1 862 169 Coaxial cable (75, BNC/BNC, L = 2 m)

1 487 163 USB cable (A/BM/M 15 Pts, L = 1.8 m)

2 471 059 Air filter

1 426 016 Quality Control form

DOC31001EN
462 489

Operator Manual - English (according to system language)
Medical Ultrasound Safety Guide (for US only)

a

a

a

a

a

a

b

Tab l e 2 - 1 : Supplying list for SIGMA 110 Light/Master and SIGMA 330 Master

a. only for SIGMA 330 Master
b. when USB-Link option is installed

2-4 SIGMA 110/SIGMA 330 10.12.01