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DIGI-LITE USER MANUAL
RIMED LTD. Page 1
DIGI-LITE
Transcranial Doppler
User Manual
RIMED LTD.
Email: admin@rimed.com
File no. 23010 Revision 26 Web site: www.rimed.com
Checked By
Signature
Date
Approved By
Signature
Date
Gal Shani
29.04.2018
Alon Mizrachi
29.04.2018
DIGI-LITE USER MANUAL
RIMED LTD. Page 2
DIGI-LITE Transcranial Doppler Operation Manual
Revision 26, April 2018. Software Version 2.3.1.05
This document contains information on the proprietary DIGI-LITE system,
manufactured by Rimed Ltd. Information in this document is subject to change
without notice and does not represent a commitment on the part of Rimed Ltd.
Rimed does not assume liability for damages that may occur as a result of the use
of the information in this manual. No part of this manual may be reproduced or
transmitted in any form for any purpose other than the use of the purchaser of the
DIGI-LITE system.
© Rimed Ltd. Since 1995. All rights reserved.
DIGI-LITE is a trademark of Rimed Ltd. Windows 7/10 is a trademark of
Microsoft Corporation.
Authorized Representative In
Europe
Preissler Medizintechnik
Gmbh
Tel.: +49(0)8341/41425
Augsburger Strasse 75
D-87600 Kaufbeuren
e-mail: info@preissler-
medtech.de
www.preissler-medtech.de
DIGI-LITE USER MANUAL
RIMED LTD. Page 3
Table of Contents
1. Introduction __________________________________________________ 11
1.1. About this manual _____________________________________________ 11
1.2. Explanation of Symbols Used
1.3. Related documentation __________________________________________ 14
1.4. Typographical conventions _______________________________________ 14
1.5. Abbreviations _________________________________________________ 15
2. Indications and contraindications _________________________________ 15
2.1. Indications for use _____________________________________________ 15
2.2. Contraindications _____________________________________________ 15
3. Precautions and warnings ______________________________________ 16
3.1. Warranty and factory service ____________________________________ 16
3.2. Environmental Requirements ____________________________________ 17
3.3. System dimensions and specifications _____________________________ 17
3.4. Standards ___________________________________________________ 17
3.5. Customer responsibility ________________________________________ 17
3.6. Using this manual _____________________________________________ 18
3.7. Electrostatic discharge (ESD) ____________________________________ 19
3.8. Static protection ______________________________________________ 19
3.9. Warnings and cautions _________________________________________ 19
3.10. Ultrasound safety ___________________________________________ 23
3.10.1. Factors affecting ultrasound power output ___________________________ 23
4. Installation and upgrade instructions _____________________________ 24
4.1. Unpacking the system _________________________________________ 24
4.2. Installation of a new system _____________________________________ 25
4.2.1. System components ______________________________________________ 25
4.2.2. Setting up the system _____________________________________________ 27
4.2.3. Checking functionality of the system _________________________________ 29
4.3. Carrying the system from one place to other ________________________ 30
5. Quick tour ____________________________________________________ 31
5.1. System operation _____________________________________________ 31
5.2. The Main screen ______________________________________________ 31
5.3. Touch Screen Options _________________________________________ 36
5.4. Replay _____________________________________________________ 36
5.5. The summary screen __________________________________________ 37
5.6. Patient report ________________________________________________ 39
5.6.1. United Patient Report (Digi-Lite™+IP) ________________________________ 40
5.7. The remote control ____________________________________________ 42
5.8. Keyboard shortcuts ____________________________________________ 45
5.9. Menu bar ___________________________________________________ 46
5.9.1. Patient menu ___________________________________________________ 46
5.9.2. Study type menu ________________________________________________ 48
5.9.3. Setup menu ____________________________________________________ 49
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5.9.4. Functions menu _________________________________________________ 50
5.9.5. Help menu _____________________________________________________ 50
5.10. Right click menu ____________________________________________ 51
5.10.1. Right click on Spectrum window ___________________________________ 51
5.10.2. Right click on M-Mode window ____________________________________ 52
5.10.3. Right click on Summary screen window _____________________________ 52
5.11. Toolbar ___________________________________________________ 53
5.12. Probe, Time display and Analog gain ____________________________ 54
6. Performing Diagnostic Studies ___________________________________ 56
6.1. Turn ON system ______________________________________________ 56
6.2. Define patient ________________________________________________ 56
6.2.1. Define New Patient. ______________________________________________ 56
6.2.2. Load existent patient _____________________________________________ 56
6.2.3. Search for a patient ______________________________________________ 56
6.3. Define the Study ______________________________________________ 56
6.3.1. Define new study type ____________________________________________ 56
6.3.2. Open existent study ______________________________________________ 56
6.4. Examine the blood vessels ______________________________________ 56
6.4.1. Press UNFREEZE _______________________________________________ 56
6.4.2. Press FREEZE __________________________________________________ 57
6.4.3. Repeat step 6.4.1 and 6.4.2 ________________________________________ 57
6.5. Open Summary Screen ________________________________________ 57
6.6. Replay the examination ________________________________________ 57
6.7. Replace the spectrum in the Summary Screen, if needed ______________ 57
6.8. Rename BV , if needed ________________________________________ 57
6.9. Recalculate Clinical Parameters if needed __________________________ 58
6.10. Edit Summary Screen ________________________________________ 58
6.11. Open Patient Report _________________________________________ 58
6.12. Save the examination ________________________________________ 58
6.13. To perform other study for the same patient _______________________ 58
6.14. To perform examination on other patient _________________________ 58
7. Using the DIGI-LITE system _____________________________________ 59
7.1. Entering DIGI-LITE ____________________________________________ 60
7.2. Creating and selecting a patient __________________________________ 60
7.2.1. Adding a new patient _____________________________________________ 60
7.2.2. Loading or searching for an existing patient ___________________________ 63
7.2.3. Deleting a patient ________________________________________________ 67
7.3. Selecting study type, basic operation ______________________________ 69
7.3.1. Intracranial unilateral study type_____________________________________ 70
7.3.2. Extracranial study type ____________________________________________ 71
7.3.3. Peripheral study type _____________________________________________ 71
7.3.4. Monitoring unilateral and bilateral studies type _________________________ 71
7.3.5. Vasomotor Reactivity (VMR) study type _______________________________ 71
7.4. Spectrum examination and modification ____________________________ 72
7.5. MC (manual calculation) cursors saved on Summary Screen and in
Patient Report. ____________________________________________________ 72
7.6. LR (Lindegaard Ratio) _________________________________________ 73
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7.7. Controlling the summary display __________________________________ 73
7.8. Saving patient information and results _____________________________ 74
7.9. Display Patient report __________________________________________ 74
7.10. Backing up and restoring data __________________________________ 78
7.10.1. Making Backup Copies __________________________________________ 78
7.10.2. Restoring backup information _____________________________________ 81
7.11. Printing ___________________________________________________ 82
7.12. Exporting results to other software ______________________________ 82
8. Monitoring Unilateral or Bilateral Studies __________________________ 84
8.1. Selecting Monitoring Unilateral or Bilateral study _____________________ 85
8.2. Monitoring Intracranial Unilateral Layout during Recording _____________ 85
8.3. Monitoring Intracranial Bilateral Layout during Recording ______________ 86
8.4. Monitoring Layout during Replay _________________________________ 88
8.5. Monitoring examination setup ____________________________________ 89
8.6. Performing a Monitoring examination in Unilateral or Bilateral ___________ 92
8.6.1. Beginning a new examination ______________________________________ 92
8.6.2. Performing the examination ________________________________________ 92
8.6.3. Finishing the test ________________________________________________ 92
8.7. Further inspection of the Monitoring examination off line _______________ 92
8.8. Monitoring Post-Processing _____________________________________ 94
8.8.1. Additional Spectrum Window. ______________________________________ 94
8.8.2. Cursors and time delay display. _____________________________________ 94
8.8.3. Add/Delete Emboli _______________________________________________ 95
________________________________________________________________ 97
8.8.4. Add/Delete Event ________________________________________________ 98
________________________________________________________________ 99
8.8.5. Hits Histogram _________________________________________________ 100
8.8.6. New Time Stamp From the Beginning of the Test ______________________ 101
9. Vasomotor Reactivity Test in Unilateral or Bilateral Studies __________ 102
9.1. Selecting Vasomotor Reactivity study _____________________________ 102
9.2. Vasomotor Reactivity test setup _________________________________ 102
9.3. Performing a VMR test examination ______________________________ 103
9.3.1. Beginning a new examination _____________________________________ 103
9.3.2. Control state ___________________________________________________ 103
9.3.3. Test state _____________________________________________________ 103
9.3.4. Finishing the test _______________________________________________ 104
9.4. Further inspection of VMR test examination OFF LINE _______________ 104
10. Evoked Flow Test in Unilateral or Bilateral Studies _______________ 106
10.1. Selecting Evoked Flow study __________________________________ 106
10.2. Evoked Flow test setup ______________________________________ 106
10.3. Performing a Evoked Flow test examination ______________________ 107
10.3.1. Beginning a new examination ____________________________________ 107
10.3.2. Control state _________________________________________________ 107
10.3.3. Test state ___________________________________________________ 107
10.3.4. Finishing the test _____________________________________________ 108
10.4. Further inspection of Evoked Flow test examination OFF LINE _______ 108
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11. Probe Holder use in Monitoring: Technical description ____________ 109
11.1.1. Operation guide ______________________________________________ 110
12. Setup configuration _________________________________________ 113
12.1. Patient report wizard ________________________________________ 113
12.1.1. First window: Report header and general information _________________ 114
12.1.2. Second window: Examination display ______________________________ 116
12.1.3. Third window: Report footer _____________________________________ 117
12.1.4. One Page Report Option _______________________________________ 118
12.2. General Setup _____________________________________________ 120
12.2.1. Basic Configuration ___________________________________________ 120
12.2.2. Hospital details _______________________________________________ 121
12.2.3. DICOM & Worklist ____________________________________________ 122
____________________________________________________________________ 122
12.2.4. Blood vessel configuration ______________________________________ 122
12.2.5. Next function configuration ______________________________________ 125
12.2.6. Summary screen configuration ___________________________________ 127
12.2.7. Economic data saving: _________________________________________ 128
12.2.8. Clinical parameters trends / external channel configuration: ____________ 131
12.2.9. Print settings _________________________________________________ 134
12.2.10. Exporting clinical parameters in monitoring and VMR studies to excel ____ 135
12.3. Studies configuration ________________________________________ 138
12.3.1. Select blood vessels ___________________________________________ 138
12.3.2. Clinical parameters ____________________________________________ 139
12.3.3. HITS setup __________________________________________________ 141
12.4. Save Study _______________________________________________ 142
12.5. Delete Study Layout ________________________________________ 143
13. Functions menu ____________________________________________ 144
14. Calculations _______________________________________________ 149
14.1. Calculation of clinical parameters ______________________________ 149
14.1.1. Intracranial examinations parameters _____________________________ 149
14.1.2 Extracarnial examinations parameters
15. External Signals ____________________________________________ 151
15.1. Digi Lite Analog Output ______________________________________ 151
15.2. Digi Lite Analog Input _______________________________________ 153
15.3. Cleaning and decontamination of 4mhz and 8mhz probes ___________ 153
15.4. Probes Visual Inspection After Cleaning _________________________ 154
16. Sending Data to DICOM Server ________________________________ 155
17. Retrieving Data from the Server with Modality Worklist ____________ 156
18. Packing the system and system components for shipping _________ 157
19. FAQ ______________________________________________________ 158
19.1. The LCD showing white\gray\only light on the screen. ______________ 158
19.2. The LCD is showing black and there is no sound of windows rising. ___ 159
19.3. When I turn on the system I can hear windows rising but the LCD
screen is showing black. ____________________________________________ 160
19.4. When entering the software I receive Error to load DSP\FPGA
massage. _______________________________________________________ 160
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19.5. The background of the printed windows are consuming to much
black ink. How can we remove the background color? _____________________ 160
19.6. There is no sound in one direction of the probe (blue or red)._________ 160
17.7. The TCD software fails or is stuck ________________________________ 161
20. Service Log-File ____________________________________________ 165
21. Guidance and Manufacturer’s Declaration For Electromagnetic
Compability ( EMC ) ______________________________________________ 166
22. Acoustic output report _______________________________________ 171
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List of Figures
Figure 4-1 Back Panel ______________________________________________ 27
Figure 4-2 Bottom Panel ____________________________________________ 28
Figure 4-3 Probes connection ________________________________________ 28
Figure 5-1 Unilateral study main screen buttons __________________________ 31
Figure 5-2 Unilateral study with 8 spectrums _____________________________ 32
Figure 5-3 Unilateral study main screen _________________________________ 32
Figure 5-4 Monitoring Bilateral study ___________________________________ 33
Figure 5-5 Main screen with Blood Vessels List ___________________________ 34
Figure 5-6 Replay __________________________________________________ 36
Figure 5-7 Summary Screen__________________________________________ 38
Figure 5-8 Patient Report ____________________________________________ 39
Figure 5-9 United Report ____________________________________________ 40
Figure 5-10 Manage IP Images Page ___________________________________ 41
Figure 5-11 Remote Control __________________________________________ 43
Figure 5-12 Patient Menu ____________________________________________ 46
Figure 5-13 Studies Menu ___________________________________________ 48
Figure 5-14 Setup Menu _____________________________________________ 49
Figure 5-15 Functions Menu __________________________________________ 50
Figure 5-16 Help Menu ______________________________________________ 50
Figure 5-17 Right Click on Spectrum ___________________________________ 51
Figure 5-18 Right Click on M-Mode ____________________________________ 52
Figure 5-19 Right Click on Summary Screen _____________________________ 52
Figure 5-20 Right Click on Spectrum in Summary Screen ___________________ 53
Figure 5-21 Toolbar ________________________________________________ 53
Figure 7-1 New Patient dialog box _____________________________________ 61
Figure 7-2 Load dialog box ___________________________________________ 63
Figure 7-3 Delete Patient dialog box ___________________________________ 68
Figure 7-4 Studies dialog box _________________________________________ 69
Figure 7-5 Manual Cursors ___________________________________________ 73
Figure 7-6 Patient Report example _____________________________________ 76
Figure 7-7 Backup dialog box _________________________________________ 79
Figure 7-8 Export dialog box _________________________________________ 82
Figure 8-1 Monitoring Layout during Recording ___________________________ 85
Figure 8-2 Monitoring Intracranial Bilateral Layout during Recording ___________ 86
Figure 8-3 Monitoring Taskbar during Recording __________________________ 87
Figure 8-4 Monitoring Layout during Replay _____________________________ 88
Figure 8-5 Monitoring Taskbar during Replay ____________________________ 88
Figure 8-6 Size of Trend Window ______________________________________ 89
Figure 8-7 Events Form _____________________________________________ 89
Figure 8-8 Trends Form _____________________________________________ 91
Figure 8-9 Monitoring Intracranial Unilateral ______________________________ 93
Figure 8-10 Monitoring Intracranial Bilateral ______________________________ 94
Figure 8-11 Cursors and Time delay display _____________________________ 95
Figure 8-12 Add/Delete Emboli. _______________________________________ 96
Figure 8-13 Add Emboli. _____________________________________________ 97
Figure 8-14 Delete Emboli. ___________________________________________ 97
Figure 8-15 Add Event.______________________________________________ 98
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Figure 8-16 Delete Event. ____________________________________________ 99
Figure 8-17 Hits Histogram __________________________________________ 100
Figure 9-1 Size of Trend Window in VMR ______________________________ 102
Figure 9-2 Events Form in VMR study _________________________________ 103
Figure 9-3 VMR Study _____________________________________________ 105
Figure 10-1 Size of Trend Window in Evoked Flow _______________________ 106
Figure 10-2 Events Form in Evoked Flow study __________________________ 107
Figure 10-3 Evoked Flow Study _____________________________________ 108
Figure 11-1 Probe Holder ___________________________________________ 110
Figure 12-1 Patient Report first Dialog box ___________________________ 11507
Figure 12-2 Patient Report second Dialog box _________________________ 11608
Figure 12-3 Patient Report third dialog box ___________________________ 11709
Figure 12-4 Patient Report first Dialog box (one page report option) _________ 1180
Figure 12-5 Patient Report second Dialog box (one page report option) ______ 1191
Figure 12-6 Basic Configuration ____________________________________ 12012
Figure 12-7 Hospital Details Configuration ___________________________ 121120
Figure 12-8 DICOM & Worklist Configuration ___________________________ 1234
Figure 12-9 Blood Vessels Configuration _______________________________ 123
Figure 12-10 Add New Blood Vessel __________________________________ 124
Figure 12-11 Next Function Configuration ______________________________ 125
Figure 12-12 Remote Control Configuration
Figure 12-13 Summary Screen Configuration ___________________________ 127
Figure 12-14 Summary Screen Configurations (Economic Saving) ___________ 128
Figure 12-15 selecting the saving mode per BV on the main screen __________ 129
Figure 12-16 selecting the saving mode per BV on the summary screen (for
the same examination) ______________________________________ 129
Figure 12-17 Channel Configuration first steps __________________________ 131
Figure 12-18 Channel Configuration second steps _______________________ 132
Figure 12-19 Print Configuration _____________________________________ 134
Figure 12-20 Export To Excel ________________________________________ 135
Figure 12-21 Export to Excel Menu Bar ________________________________ 136
Figure 12-22 Export To Excel Saving Bar ______________________________ 137
Figure 12-23 Select Blood Vessels ___________________________________ 139
Figure 12-24 Clinical Parameters Configuration __________________________ 140
Figure 12-25 Hits Setup ____________________________________________ 141
Figure 12-26 Save Study Layout _____________________________________ 142
Figure 13-1 Functions Menu _________________________________________ 144
Figure 13-2 One spectrum without M-Mode _____________________________ 145
Figure 13-3 One spectrum and an M-Mode _____________________________ 146
Figure 13-4 Four spectrums and an M-Mode ____________________________ 146
Figure 13-5 Eight spectrums and an M-Mode ___________________________ 147
Figure 15-1 Analog channels connector pin out __________________________ 151
Figure 15-2. Connector pin number and default function per each channel ____ 152
Figure 15-3 Spectrum windows layout in Unilateral study _________________ 152
Figure 15-4 Spectrum windows layout in Bilateral study __________________ 153
Figure 16-1 Final Patient Report - Dicom Export ________________________ 155
Figure 16-2 Modality Worklist _____________________________________ 11557
Figure 17-1 Voltage in Power Cable __________________________________ 162
Figure 17-2 Voltage in Power Connector ______________________________ 163
Figure 17-3 Block Diagram LCD _____________________________________ 164
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Figure 18-1 Export Log File Menu ___________________________________ 165
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1. Introduction
The DIGI-LITE is a non-invasive, Transcranial Doppler (TCD) system. The
system employs ultrasound energy to perform a variety of studies for the complete
assessment of Extracranial and intracranial circulation. The system utilizes a
number of Doppler probes (2 MHz PW, 4 MHz CW/PW, 8 MHz CW/PW, 16
MHz PW) to allow insonation of most major intracranial and Extracranial blood
vessels.
DIGI-LITE is a computer driven system operating under the Microsoft Windows
7 operating system. For ease-of-use, the DIGI-LITE offers a standard Windows 7
environment. The user interface looks and operates similar to other programs in
Windows 7. You don’t need to learn any special skills or complex computer
terminology to use the program. When you turn on the computer, the intuitive
DIGI-LITE main screen appears, and you can begin working without typing any
prior commands.
DIGI-LITE offers a variety of studies types supporting up to 64 Doppler gates per
probe, starting with unilateral (intracranial, Extracranial and peripheral) study
types for basic diagnosis and examination, bilateral study types for simultaneous
intracranial examination and monitoring of blood flow velocities on both sides of
the head with two 2 MHz PW probes, multi-frequency study types for
simultaneous examination with any combination of two Doppler probes (CW or
PW), and monitoring study types with special trend display of all clinical
parameters as well as up to 8 external analog inputs.
DIGI-LITE allows emboli detection based on multi-layer algorithm, improving
performance and reliability.
1.1. About this manual
This manual is designed for medical professionals using the Rimed DIGI-LITE
Transcranial Doppler system. This manual covers all aspects of user interface and
system operation. It is designed to give operating information for all levels of
users, from beginning to advanced users of the DIGI-LITE system.
Note: The DIGI-LITE Operation Manual assumes that the basic user is a medical
professional familiar with the use of probes for taking blood flow measurements.
Instructions on insonation of blood vessels are beyond the scope of this manual.
See the relevant RIMED publications.
This manual is divided into the following chapters:
Quick Tour (Chapter 5) familiarizes you with the main screen views and the tools
you can use to manipulate the screen. This includes explanations of how
to use the keyboard, remote control and touch screen tools.
Perform Routine Examination (Chapter 6) contains an explanation of the
routine TCD examination.
Using the DIGI-LITE (Chapter 7) contains an explanation of the steps you go
through each time you work with the system. This chapter is the core of
the book, providing step-by-step instructions for all the basic procedures
you use when operating DIGI-LITE.
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Monitoring (Chapter 8) contains information on Monitoring examinations.
Vasomotor Reactivity Test (Chapter 9) contains information on VMR
examinations.
Probe Holder (Chapter 10) contains information on using the probe holder.
Setup (Chapter 11) contains information on customizing the system.
Configuration allows you to control the display and printing features of
the DIGI-LITE system. You may choose to skip this section completely
and use the defaults provided by Rimed.
Functions (Chapter 12) explains the functions menu, supplying an alternative way
to perform screen operations.
Calculations (Chapter 13) explains the calculations of clinical parameters.
External Channels (Chapter 14) explains about external signals that can be input
or output to and from the DIGI-LITE system.
Packing the system and system components for shipping (Chapter 15) contains
details on packing procedure.
FAQ (chapter 16) contains different questions about operating the system.
Service Log File (chapter 17) explains how to send a log file for debugging
problems.
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1.2. Explanation of Symbols Used
DIGI-LITE USER MANUAL
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1.3. Related documentation
Service technicians and individuals who need to perform hardware service or
software installation can refer to Rimed for complete specifications, service,
installation and packaging information.
1.4. Typographical conventions
This manual uses the following typographical conventions:
Arrow brackets <> are used to signify a key on the
keyboard used for a function. This may be a single
key, such as <N>, or a special key, such as <Esc>.
Bold is used to emphasize text, particularly text in a
list which signifies a function, key or menu choice
that appears on the screen.
SMALL CAPITALS are used to denote menu choices or
commands.
1.5. Abbreviations
The terminology used in this manual and on the DIGI-LITE screens is standard
terminology used for Transcranial Doppler analysis. This manual avoids technical
jargon other than that used in the medical profession.
PW: Pulsed Wave
CW: Continuous Wave
BV: Blood Vessel
HITS: High Intensity Transient Signals
FFT: Fast Fourier Transform
MHz: Mega-Hertz
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2. Indications and contraindications
2.1. Indications for use
The instrument is intended for use in the non-invasive evaluation of intracranial
and Extracranial vascular flow velocity irregularities in adults and in children. It is
not intended for fetal use. It is not intended for neonatal use.
2.2. Contraindications
Avoid using the probe on skin
surfaces with recent wounds/
operative cuts. Use all sterility
procedures applicable to your
institution.
Consider the application of long
term monitoring in febrile patients
with caution. Use of Transcranial
Doppler can raise the temperature
of the skull or the surrounding
tissue. While this is not believed to
present a health risk for patients
with normal body temperatures,
use of the device on febrile
patients could elevate brain
temperature above the level of the
fever.
CAUTION
This system and its options should be used no longer than is necessary for the
appropriate diagnostic procedure. In order to minimize exposure to acoustic
energy, switching on only at critical phases of surgery or at special events is
recommended.
CAUTION
ALARA caution: The operator is cautioned to use Doppler power levels as low as
reasonably achievable, and to avoid the use of any power level greater than that
necessary to insure the gathering of adequate Doppler information.
CAUTION
Not intended for fetal use.
CAUTION
Not intended for neonatal use.
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3. Precautions and warnings
3.1. Warranty and factory service
Rimed Ltd. warrants the DIGI-LITE™ equipment, including its electronic boards,
against defective materials or workmanship for a period of one year from the date
of delivery of the system.
Equipment under this warranty is limited to the repair of the DIGI-LITE AND
the electronic cards. In case of any defect or malfunction, the equipment or
components must be returned directly to the Rimed Service Department.
This warranty covers all malfunctions encountered in normal use of the equipment
and does not apply in cases of failure to follow instructions, of loss or damage of
the equipment due to abuse, accident, or mishandling such as liquid immersion,
autoclaving and ETO sterilization.
This warranty is valid on the condition that repairs and service are performed only
by technicians trained by Rimed Ltd.
Rimed Ltd. warrants the ultrasonic probes for a period of 90 days from time of
shipment. The warranty does not apply if damage was caused by abuse,
mishandling, or failure to follow instructions, including, liquid immersion,
autoclaving and ETO sterilization.
In the event of any service or maintenance problem, please contact the Rimed
Service Department directly at:
Tel: 972-9-7484425 or Fax: 972-9-7484417 or E-mail: admin@rimed.com.
If the instrument is being returned for service please send it, protected in its
original package, to:
Rimed Ltd.
25 Hacharoshet st., P.O. Box 2402, Industrial Park
Raanana 4365613
Israel
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3.2. Environmental Requirements
Operating Temperature
+16°C to +40°C (60.8°F to +
104.0°F)
Storage Temperature
-20°C to +70°C (-4°F to +
158°F)
Transport Temperature
-20°C to +70°C (-4°F to +
158°F)
3.3. System dimensions and specifications
Dimensions of main console without monitor: (basic)
Height: 32 cm
Width: 40 cm
Depth: 33 cm
Weight: 7 kg
Power: 100-125 Vac, 50/60 Hz, 3.0 A max. or
200-240 Vac, 50/60 Hz, 1.5 A
Main fuses: 4x20 mm slow blow.
For main console: 2A, (2 fuses) 250V
Classification: Class 1 Type BF
MDD Class IIa
3.4. Standards
The DIGI-LITE equipment fully complies with the following standards:
EN60601-1. Safety for medical diagnostic equipment
EN60601-1-2. Electromagnetic emissions and
immunity compatibility
3.5. Customer responsibility
The DIGI-LITE™ system equipment performs properly only when operated and
maintained as specified in this manual. It is the responsibility of the customer to
use the equipment in accordance with the instruction manuals and equipment
warnings and labels.
Paragraphs no. 4 and 15 in this manual: ("Installation and upgrade instructions"
and "Packing the system and system components for shipping") contain
instructions for unpacking and packing the equipment. Paragraph no. 4
"Installation and upgrade instructions", contains instructions for carrying the
system.
Caution:
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It is essential to ship the equipment to Rimed using the original packing materials,
including the wooden pallet.
Caution:
If the system is moved from one place to another it is essential to insert it into its
original dedicated carrying case.
If the product is found to be defective it should not be used. The system should not
be operated if any parts are missing or damaged. Parts which are visibly broken,
worn out, warped, or contaminated must be replaced immediately with new parts
supplied by Rimed Ltd. No components should be replaced with parts from any
other manufacturer. If the customer suspects a part may be defective, it is the
customer’s responsibility to contact Rimed Ltd.
Rimed Ltd. is responsible for parts supplied in accordance with the warranty. If
the customer requires repair or replacement of parts beyond the warranty period,
the customer should consult Rimed regarding service and replacement of parts.
Rimed is responsible for the software originally installed on the system. When the
user wishes to install additional software, it is recommended to consult with
Rimed’s technical department.
This can prevent software conflicts and assure optional performance. Rimed will
not be responsible for software installations that were not confirmed.
The systems are scanned for software viruses. As new software viruses appear
constantly, Rimed cannot be responsible for virus damage when additional
software or files are used. The user should be responsible for using updated
Antivirus software in such cases.
The owner of the product has sole responsibility for any malfunction resulting
from improper use or maintenance, including service by someone other than an
authorized Rimed service representative. The owner of the product is also solely
responsible for any malfunction caused by use of parts not manufactured by or
authorized by Rimed Ltd., including parts that are altered without authorization of
a Rimed service representative.
3.6. Using this manual
This manual contains safety precautions and interfacing procedures.
WARNING
The WARNING label identifies conditions or practices that may present danger to
the patient or user.
CAUTION
The CAUTION label identifies conditions or practices that could result in damage
to the equipment
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3.7. Electrostatic discharge (ESD)
Objects become charged as a result of being separated. Atoms near any surface
will transfer electrons and upon separation, end up with either a surplus of
electrons, known as a negative charge, or a deficiency in electrons, known as a
positive charge. Objects can be charged easily to potentials as high as 30,000
volts, by such simple acts as walking or sliding. Materials that easily transfer
electrons between atoms are known as conductors and are said to have “free”
electrons. Materials which do not easily transfer electrons are known as insulators.
Both conductors and insulators may be “charged” with static electricity.
When a conductor is charged, the free electrons give it the ability to discharge
rapidly when it comes near another conductor with a different potential. The
potential required for a spark, noticeable by most people, is about 3,000 volts.
ESD has become a problem in electronics, as electronic circuits have become
smaller.
CAUTION
When using CMOS chips, some devices may be damaged by ESD events caused
by potentials as low as 30 volts and up to 30,000 volts. At the lower voltages,
people do not notice this level of electricity.
3.8. Static protection
CAUTION
In order to avoid damage to the CMOS ICs in the electronic board, care needs to
be taken to guard against electrostatic discharge. Anyone handling internal
hardware, specifically circuit boards, must use electrostatic protection to prevent
damage to the hardware. The technician should not handle any circuit boards
without using an electrostatic protective wrist strap and using a work surface mat.
Static shielding bags are used to cover electronic boards during shipping. Every
card sent for repair or replacement to Rimed Ltd. must be enclosed in a static-
shielded bag.
3.9. Warnings and cautions
WARNING
The DIGI-LITE system will operate correctly when used in accordance with the
instructions in this manual. The operator should have a thorough understanding of
these instructions before attempting to operate the system. The DIGI-LITE™
system may be operated only by a PHYSICIAN or a TRAINED MEDICAL
TECHNICIAN, with the operator present at all times while the patient is
connected to the system.
WARNING
Electrical shock hazard. Do not remove cover. For service, contact a qualified
service representative.
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WARNING
Switch off all power to the system before attempting any service or maintenance
activity related to cabling or connections.
CAUTION
Switch off all power to the system before connecting or disconnecting any system
components. Failure to turn off the power may result in damage to the system
components.
WARNING
Replacement parts and hardware maintenance should be obtained only from
authorized service representatives of Rimed Ltd. Rimed is not responsible for
malfunctions caused by misuse or improper operation of the system, by improper
or inadequate maintenance, or by repair work or replacement parts obtained from
unauthorized sources
WARNING
Federal Law restricts this device to sale by or on the order of a physician.
CAUTION
This device must be used in accordance with all instructions and labels.
WARNING
Line Power Connection: The DIGI-LITE SHOULD only be plugged into a
grounded (three-prong) hospital-grade outlet. Do not use the system or any
accessory if the power plug or cord appears damaged. The system must be
matched to the power line voltage in use. Line voltage tolerance is +/-10%.
The monitor power cord should be plugged only to the appropriate socket on the
back of the instrument.
CAUTION
Have a service engineer check every year the integrity of the system ground and
leakage current.
WARNING
If you disconnect the cables, make sure to reconnect them in the proper locations.
For a diagram showing the proper locations for the cable connections, refer to
Rimed Service Department.
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CAUTION
Inspect the power cord frequently for signs of fraying or other damage. Do not
operate the system if the power plug or cord is damaged.
CAUTION
Do not substitute unauthorized transducers for the transducers provided with the
system. Transducers (probes) supplied by other manufacturers may not transmit
the correct sound level or quality and may degrade the quality of test.
WARNING
None of the transducers supplied with the DIGI-LITE™ system are intended for
fetal use.
WARNING
Do not switch on any power systems unless all cables have been properly
connected and verified. If there is any doubt contact a Rimed service
representative.
WARNING
Do not use ultrasound intensities greater than 14% for trans-orbital examinations.
CAUTION
If you use additional external monitor, use a color monitor which complies with
EN60950 standards.
CAUTION
Do not attempt to reinstall the system software without consulting a qualified
Rimed service representative first. Reinstalling software may destroy data.
CAUTION
This equipment uses a three-wire power cord which should be connected to a
hospital grade plug (for international applications, EN60601-1 approved plug).
The chassis is earth grounded. For grounding reliability, connect the device to a
hospital grade or hospital only receptacle (for international applications,
EN60601-1 approved plug).
CAUTION
For best results, use only high quality ultrasonic transducer gel.
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WARNING
Do not allow water or other liquids to enter the system. If the system does come in
contact with water, shut the system down, disconnect the system from the power
cable and contact your Rimed service representative.
CAUTION
Always handle transducers with care.
CAUTION
Do not drop or bang the transducers.
CAUTION
Clean the probes with a clean cloth or tissue paper at the end of each day to
remove remains of gel.
WARNING
Do not immerse transducers in water or any other fluids.
CAUTION
Problems caused by interference from outside systems are indicated by vertical
lines of different frequencies on the screen. In these cases, move the system away
from the source of the disturbance. If problems continue, contact the Rimed
service representative.
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3.10. Ultrasound safety
Ultrasound works by sending a pulse of ultrasound energy to the human tissue,
waiting for parts of the pulse to be reflected back. The transducer is able to send
the pulses and receive the ultrasound echo. Ultrasound waves dissipate energy in
the form of heat and can therefore cause tissue warming. This effect is extremely
low when using the Transcranial Doppler. However, it is important to control and
limit patient exposure to ultrasound pulses. Authorities and governing bodies in
the field of ultrasound have issued statements saying that there are no known
adverse effects from the use of diagnostic ultrasound; however, exposure levels
should always be limited to As Low as Reasonably Achievable (the ALARA
principle).
In practice: after obtaining a good quality signal, reduce power to the minimal
setting while still keeping sufficient quality. Remember to reduce power whenever
examining a certain blood vessel for a longer period.
3.10.1.Factors affecting ultrasound power output
Ultrasound exposure can be limited by adjusting the system. The following factors
can be controlled to affect ultrasound power output:
Ultrasonic power: The power control adjusts the power of the ultrasonic signal.
Increasing the power setting increases the duty cycle of the transmitted
wave, resulting in a higher ultrasonic output at the transducer. The
power is expressed in terms of percentage of maximum system output
which is restricted so as not to exceed the recommended FDA
guidelines.
Pulse Duration: The sample volume is the axial length of the area from which the
Doppler signals are obtained. For a larger sample volume, the transducer
produces a longer pulse burst, and the ultrasound output power increases
accordingly.
Pulse Rate: The pulse rate, or range, represents the pulse repetition frequency,
that is, the number of pulses bursts per second. At a higher range setting,
there will be a higher ultrasound output.
This manual contains specific instructions on adjusting these factors when
performing diagnostics.
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4. Installation and upgrade instructions
4.1. Unpacking the system
When unpacking the system, remove all parts carefully. The system arrives in a
box, on a wooden pallet used for shipping. The box, packing material and wooden
pallet are necessary when shipping the system back to Rimed in case of
malfunction. Thus, the packing material should be kept in case it becomes
necessary to send the equipment back for service.
To unpack the system, proceed as follows.
1. Cut the plastic bands holding the box to the pallet. Cut open or remove the
packing tape on the top of the box.
2. Lift off the upper foam guard. Underneath are the accessory attachments
to the instrument, including the keyboard, probes, remote control and AC
power cable (may be omitted in some countries). These components are
fitted into a middle foam guard which is custom-designed specifically for
these parts.
3. Carefully lift the instrument out of the box and place it on a table or
working surface where it is to be installed.
4. Underneath the instrument are the remaining CDs, including the licensed
copy of Microsoft Windows package. Make sure to remove all CDs,
literature, and any other components that are packaged under the
instrument.
5. Keep the foam guards and box in case the equipment needs to be shipped
back to Rimed for service.
Once you have removed the equipment from the packaging, proceed to inspect it
to make sure no damage was incurred during shipping. Assemble the system
according to the directions and diagram shown in the following sections.
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4.2. Installation of a new system
4.2.1. System components
Once you have unpacked the system, make sure that you have all of the
components and that they have not been damaged during shipping. If parts are
missing or damaged, contact the service department of Rimed Ltd.
The Digi-Lite have two configurations, Unilateral and Bilateral.
The basic system for Digi-Lite Unilateral configuration includes the following
components:
Main Console
Mini Keyboard
Mouse
Remote control
2 MHz Probe
CDs and documentation for Windows 7
CD containing the Rimed DIGI-LITE™ software
CD containing Rimed DIGI-LITE™ User Manual
CD containing Computer and Touch Screen drivers
Dedicated Carrying Box
The basic system for Digi-Lite Bilateral configuration includes the following
components:
Main Console
Mini Keyboard
Mouse
Remote control
2 MHz Probe 2 pcs.
Probe Holder LMY-3
CDs and documentation for Windows 7
CD containing the Rimed DIGI-LITE™ software
CD containing Rimed DIGI-LITE™ User Manual
CD containing Computer and Touch Screen drivers
Dedicated Carrying Box
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In addition to the basic standard components listed above, several optional
components are also available. Check the items that should be included along with
the basic system according to the customer order. Following are the possible
options that may be ordered with the DIGI-LITE™ system.
4 MHz Probe
8 MHz Probe
16 MHz Probe
Probe Holder LMY-3
Foot-Switch.
Dedicated cart
Dedicated Carrying Case
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4.2.2. Setting up the system
The DIGI-LITE™ system comes complete with all software loaded. If no damage
was incurred during shipping, it is necessary to attach all the components to the
main console. Figure 4-1 shows the back panel with all connectors.
Figure 4-1 Back Panel
Remote Control is connected to the back panel as shown in Figure 4-1.
;USB to connect printer, or mouse, or CD-RW, or disk on key or other
Analog channels to connect analog input and output channels
Figure 4-2 shows the bottom panel with all connectors.
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Figure 4-2 Bottom Panel
Keyboard is connected to the PS2 Keyboard/Mouse port.
Mouse: The mouse can be connected to the PS2 Keyboard/Mouse port or to USB
or to COM1.
Monitor is connected to the bottom panel, as shown in Figure 4-2. Used to connect external
monitor.
LAN: to connect to Local Network
Figure 4-3 Probes connection
Probes are connected on the left side of the console (when facing the front of the
console). The probes are color coded for simple assembly. Figure 4-3
shows the probe connections for the system. Pay attention to the
differences between the probes: The 2MHz, 4 and 8 MHz probes have
Lemo connectors. To connect, align the red dots on the probe’s
connector and on the panel. Then push the connector. To disconnect,
pull the sliding sleeve on the connector towards you.
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4.2.3. Checking functionality of the system
If you are unable to boot the system, and it appears that the hard disk drive or the
information on the hard drive may be damaged, contact Rimed Ltd.
Once the system is set up, perform the following system checks to make sure it is
functioning properly. This check should be done by a Rimed representative or a
user who is already familiar with the system.
The following acceptance tests should be performed on all systems. Turn on the
power of the system.
1. Go to the Unilateral Default study screen, 2 MHz. With a 2 MHz probe in
the default state, check the signal at the depth of 55 mm, 60 mm, or 70 mm.
Check that you receive good M-Mode and spectrum signals on the vessels
and that the sound is clean.
2. In Unilateral Default study press on Add Spectrum icon and check the
signal. Change the depth according to the signal and make sure that you
receive a good signal for each one of the different depths on screen.
3. Repeat step 2 for up to 8 spectrums.
4. Go to the Extracranial Default study screen Extracranial probe of 4 MHz
PW. Perform a blood vessel check. Check that you receive good spectrum
and M-Mode signals on the vessels and that the sound is clean.
5. In Extracranial Default study press on Add Spectrum icon and check the
signal. Change the depth according to the signal and make sure that you
receive a good signal for each one of the different depths on screen.
6. Repeat step 5 for up to 8 spectrums
7. Go to the Extracranial Default study screen Extracranial probe of 4 MHz
CW. Perform a blood vessel checks. Check that you receive good spectrum
signals on the vessels and that the sound is clean.
8. Go to the Extracranial Default study screen Extracranial probe of 8 MHz
PW. Perform a blood vessel check. Check that you receive good spectrum
and M-Mode signals on the vessels and that the sound is clean.
9. Go to the Extracranial Default study screen Extracranial probe of 8 MHz
CW. Perform a blood vessel checks. Check that you receive good spectrum
signals on the vessels and that the sound is clean.
If the system is bilateral, perform the following additional acceptance tests.
1. Go to the Monitoring Unilateral or Bilateral Default study. Check the
blood flow of two different vessels simultaneously in the bilateral mode
using two 2 MHz probes.
2. Change the depth for one probe. Make sure that this does not influence the
spectrum frequency of the other probe. Change the depth of the second
probe. Make sure this does not influence the spectrum of the first probe.
Repeat for the other Doppler parameters.
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3. In Monitoring Unilateral or Bilateral Default study press on Add Spectrum
icon and check the signal. Change the depth according to the signal and
make sure that you receive a good signal for each one of the different depths
on screen.
Note: achieving 4 or more spectrums in different depths are not easy,
depending on vessel anatomy. If not successful, change depths so that you see
spectrums in part of the windows.
4.3. Carrying the system from one place to other
When carrying the system from one place to other it's essential to insert it into the
original carrying case and to take special care of the screen.
Pay attention to place the system into the carrying case as follows:
Place the system with its back panel turning to the case back side and the screen
turning to the thicker side of the case cover.
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5. Quick tour
The Quick Tour chapter gives an overview of how the system works and how to
manipulate the various operational mode study types and screens. It gives an
overview on how to control the results displayed by DIGI-LITE.
5.1. System operation
The DIGI-LITE system allows you to record and display the blood flow spectrum
for various Extracranial and intracranial blood vessels. The system works in two
basic states: Freeze and Unfreeze. When the screen is in the Unfreeze state, you
see the display of the blood flow being insonated. In the Freeze state, no input is
received and the probes are not active.
When you switch from Freeze to Unfreeze, you immediately get the display of
whatever the probe detects, whether the probe is directed at a blood vessel or not.
When you switch from Unfreeze to Freeze, the resulting spectrum and M-Mode
are the registered for that particular examination.
5.2. The Main screen
When you turn on the DIGI-LITE system, you enter the main screen. The main
screen contains areas which show the blood flow being examined and calculated
parameters of the blood flow. Additionally, the main screen contains selections
and buttons which allow control of the program’s function. See figure 5-1.
Figure 5-1 Unilateral study main screen buttons
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Figure 5-2 Unilateral study with 8 spectrums
Figure 5-3 Unilateral study main screen
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Figure 5-4 Monitoring Bilateral study
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Figure 5-5 Main screen with Blood Vessels List
The Functional Region: The functional region relates to on screen items which
can be accessed or controlled by the user.
Patient Name, Study Name, Date and time: The patient bar is the blue bar at the
top of the screen which includes the following items: System name,
Patient Name and Study Name at the left side; and the date and hour at
the right side. The patient name is displayed as defined in the patient
details window. If no patient name is entered, “Undefined” appears as
the default name.
Menu Bar: The menu bar is the white bar at the top of the screen which includes
the following items: Patient, Studies, Setup, Functions and Help. Upon
clicking on any of these items on touch screen or with the mouse, or
pressing MENU and then RTN (RETURN) on the remote control, the
respective menu of each item is displayed for user selection. The menu
bar contains all the system’s items and is used for system configuration
and operations which are not typically part of a routine examination.
Tool Bar (Icons): The icon bar is located below the white menu bar. The icons
represent frequently-used functions, and can be activated by clicking on
them on the touch screen or with the mouse. The function of each icon is
displayed in a “balloon” form when the cursor points at the icon. See
chapter 5.9 for details. At the right side the following are displayed:
Probe changer button, Spectrum Time and Rimed logo. Probe changer
button is used to change the probe. Time button is used to display
spectrum window time and to change it, if necessary.
Spectrum Windows: The spectrum window, the black window in the center of
the screen, is the most important part of the screen. The spectrum
window is used for display of the blood flow velocity spectrum, the
corresponding spectrum envelopes, the zero line, and the 64 spectrum
color codes. To the left of the spectrum window there is a white display
region of the Y axis and a picture of the direction of the blood flow
relative to the probe. If more than two spectrum windows are open, only
one spectrum is displayed big and the others are displayed as small
spectrums in right and left side of the big spectrum and M-Mode
windows see Figure 5-2
Units: The Units button is located right below the direction indicator and displays
the current unit selected. Units can be either in KHz or Cm/s. To toggle
between these two options simply click on the "Units" button. In
addition to changing the Y axis scale, toggling of the units also displays
the clinical parameters in the new unit selected. See Figure 5-3
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M-Mode Windows: The M-Mode window is used to display the blood flow
energy level along the ultrasound beam at straight line. It is used for
quicker find the insonation window, for blood vessel localization and
identification and for more accurate emboli detection. The M-Mode
window displays Doppler signal energy as function of time and depth. It
is a 3D graph: horizontal - X AXIS is time, vertical -Y AXIS is depth
and color encoded -Z AXIS is Doppler power and direction. Red colors
family represent blood flow direction to the probe and blue colors
family, direction away from the probe. Black color represents no flow.
The white dotted line in the M-Mode and the arrow located in the right
side of the M-Mode represent the depth of the selected spectrum (the big
spectrum whose signal is heard on speakers). See Figure 5-3
System Variables: The system variables are located in boxes just above the
spectrum window. These variables can be controlled through the remote
control or keyboard, and are used to improve insonation. If continuous
wave (CW) probes are used the pulse wave (PW) variables are not
displayed. See chapter 5.6 and 6.5 for details. In the right side are
displayed the name of the current blood vessel, to the left, and the
current probe on its right. The probe type is accompanied with a colored
square which identifies the activated probe. Above this is displayed the
Heart Rate value. See Figure 5-3
Clinical Parameters The clinical parameters are located in boxes to the right of
the spectrum screen. These parameters are the outcome of calculations
automatically performed on the blood flow spectrum. If no blood flow is
detected by the system the boxes remain empty. If only reverse flow is
detected, the parameter values appear with a minus sign (). If both
forward and reverse flows are detected, both parameters appear in each
box, with the top number relating to the forward flow and bottom
number corresponding to the reverse flow. See Figure 5-3
Docking windows: At the right side of the working screen there are 2 docking
windows. The docking windows can be fixed to remain open by sticking
in the small stab in its right top corner. The docking windows are as
follows: Selected Blood Vessels List, HITS Histogram and Events list
(in monitoring studies).The blood vessel list displays the selected blood
vessels for the present study. If a PW probe is defined for a particular
vessel, then the insonated depth is displayed. Blood vessels which have
already been insonated appear in blue in the list. The user may select any
blood vessel by clicking on its name in the list. See Figure 5-3
Scrolling after "freezing" diagnostic examination: When the user reach a point
(by navigating with the arrows) in the examination that he wants to save (Rather
then the default point - the "end" point after freeze), he can right click (the mouse
should be over the spectrum image) and choose "Update Summary Image". The
new data will be auto populating to the clinical parameters, Summary screen
images, and the patient reports images and table.
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5.3. Touch Screen Options
The Transcranial Doppler System has a Touch Screen option in order to change
the parameters by touching the screen directly. Each parameter has two options: in
order to increase the user should press the label, and in order to decrease the user
should press the number. These Touch Screen options are functional during
unfreeze or in freeze before the examination was done and are not functional in
load state.
DEPTH: Increase or decrease insonation depth of selected gate.
GAIN: Increase or decrease spectrum gain.
SCALE: Increase or decrease spectrum scale size.
PWR (Power): Increase or decrease power of insonation.
SMPL VOL (Sample Volume): Increase or decrease the sample volume
width of insonation.
FILTER: Increase or decrease spectrum filters value.
5.4. Replay
In Replay state the system will display the spectrum and M-Mode windows with the
examination that was done on the selected BV:
Figure 5-6 Replay
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Start Replay: begin to replay the current displayed examination
(spectrum, sound and M-Mode as during examination real time).
Stop Replay: stop to replay the examination. The spectrum and M-Mode will
freeze.
Stop Replay: stop to replay the examination. The spectrum and M-Mode will
freeze.
To replay the examination done on other blood vessel, open the Blood Vessels List
docking window and press on other blood vessel name.
Start Recording: After starting a replay (on the icon) the recording
icon appears. Clicking on it starts the recording of an WMV file (Windows Media
Video) and it will blink with red and black while the recording is active. Additional
click on it will stop the recording and an option to save the file will appear.
5.5. The summary screen
For each study type (except monitoring) there is a dedicated summary screen. The
summary screen includes all the insonated spectrums, and an anatomical picture in
the center of the screen. All right sided vessels are displayed on the right hand side
of the screen, and all left sided vessels on the left. Vessels which have no
particular side, such as the basilar artery, are displayed in the middle below the
anatomic picture.
There is no limit to the number of spectrums from a particular vessel that can be
stored in the summary screen. If more than 5 spectrums are stored on one side, the
user needs to scroll the screen using the scroll bar on the right in order to view the
rest of the spectrums.
The order of display is according to the predefined blood vessel list shown in the
spectrum screen. The spectrum display order is such that always right sided
vessels are displayed at the same level of their corresponding left sided vessels.
You can move a spectrum to other location in the same side, by drugging it.
To return to the spectrum screen press the “Return” icon (the picture of back
arrow). To replay or view any particular spectrum in more detail, simply double
click on the selected spectrum and it opens in the spectrum screen.
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Figure 5-7 Summary Screen
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Expand clinical parameters: gives the option to display 3 or 6 clinical
parameters in summary screen
Return: to return to spectrums screen.
Examination Notes: To add notes to the current examination.
Patient Report: To display the patient report of the current examination.
5.6. Patient report
The patient report contains general information about hospital, operator and
patient together with examination details, pictures and clinical parameters. All this
information can be displayed or only part of it, according to user configuration.
For more details on user configuration options, see “Setup Configuration”.
Figure 5-8 Patient Report
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5.6.1. United Patient Report (Digi-Lite+IP)
Another unique option in our TCD system is the possibility to merge between the
DL final patient report and the IP images.
In order to do the merge you will need first of all to enter to the TCD software and
choose setupreport generator wizardpress nextpress nextchoose in the
next window the option 2 images per page and then press next and then press
finish. When asked to press OK.(See figure 5-9)
Figure 5-9 United Report
Steps:
1. Go to the TCD software create New Patient and do a test in order to create
Summary Screen for the patient then save the test.
2. Go to the IP software and create New Patient (the same name you created in the
TCD test) then do a test and save it with quick save option in the button
toolbar (number 9 ).
3. Go back to the TCD software and load the test that you made in stage 1.
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4. Go to the final patient report (from the summary screen press on the
button) and go to the page where you see the headline is Manage DIGI-LITE IP
images (See figure 5-10)
Figure 5-10 Manage IP Images Page
press the button and then press on the + icon and add the images from the test
that you have done in stage 2.
5. After you arrange the images press on the save button in the dialog box.
6. After you finish to do all changes please press on the SAVE ICON near to
the DICOM EXPORT in the upper toolbar.
7. you will get a message that says the report was saved.
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5.7. The remote control
The remote control allows you to perform important on-line system functions,
especially those needed to obtain and manipulate insonated blood velocity
spectrums. Although all of the remote control functions can be also performed
using the on-screen features or the keyboard, the remote control is designed to
allow you to operate the system without having to be next to the computer. This is
particularly useful when examining the patient. There are two types of remote
controls, both presented below, first the new remote control and then the previous
version:
Rename
Freeze
Event
Gain
Depth
Mousepad
Mouse Buttons
Optional Keys
Scale
Zero Line
Envelope
Volume
Next Function
Direction
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Figure 5-11 Remote Control
The new version of the remote control provides five groups of remote control
functions.
o User Programmable keys
o Doppler parameters
o Frequently used functions
o Main system functions
o Mouse functions
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User Programmable keys
New version:
The new remote control has two buttons F1, F2 that can be assigned with any
function from the list below throughout the setup. The options are: Print, Record
WMV, Next BV, Previous BV, HITS Detection, Add Spectrum, Send to
DICOM, Export Image, PU and Return BV.
Previous Version
F1- NEXT FUNCTION: Perform next function as defined by the user
F4- Mute sound volume
Doppler parameter keys
The Doppler parameter keys control the Doppler parameters operation. Each
parameter has two keys: + to increase, and to decrease. Excluding the zero line
option, these keys are functional during unfreeze or in freeze before the
examination was done and are not functional in load state.
SCALE (Y axis scale): Increase or decrease the frequency scale (range
or PRF).
VOL (Volume): Increase or decrease speaker sound volume.
GAIN: Increase or decrease spectrum gain.
DEPTH: Increase or decrease insonation depth of selected gate (PW:
probes only).
FREEZE: Toggle between FREEZE and UNFREEZE states
ZERO: Increase or decrease the zero line position of the selected gate.
SMPL VOL (Sample Volume): Increase or decrease the sample volume
width of insonation (PW: probes only)
PWR (Power): Increase or decrease power of insonation (PW: probes
only).
Frequently used function keys
CHN (Channel): This key is used to toggle between the open windows
displayed in study types with more than one window (both
during freeze and unfreeze).
RVRS: This key is used to reverse the direction of the flow on the
spectrum during unfreeze.
PROB: This key is used to change probe (1 MHz, 2 MHz, 4 MHz, 8
MHz).
HITS: Activates/ deactivates automatic emboli detection function.
Main function keys
This group of keys is used to perform main system functions.
ESC: This is equivalent to the keyboard <Esc> key, and is used to exit
the summary screen display or the cursor mode.
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RTN: This is the equivalent of the keyboard <Return> key, and is used
to confirm selections from the screen menus.
FREEZE: This key is equivalent to the <Space> bar on the keyboard,
and is used to toggle between the freeze and unfreeze states.
5.8. Keyboard shortcuts
Selected important system functions can be performed, in addition to operation of
the remote control or on-screen functions, also using dedicated keyboard keys.
The selection of keyboard keys functions was done to facilitate system operation.
The user is not required to memorize the function of each key. However, it is
recommended that the user remembers the functions of frequently used functions.
Most key functions are logical, i.e. <M> for Mute, etc. There are two main groups
of keyboard functions: those that are active during the freeze state and those that
are active only during unfreeze state. Several keys are functional during both
periods.
Key
Function in Freeze state
Function in Unfreeze state
SPACE
Toggle to Unfreeze state
Toggle to Freeze state
ALT SHIFT I
Change Current Probe
Change Current Probe
CTRL C,
Toggle display spectrum
Toggle display spectrum
M
Mute (Silence the speakers)
Mute (Silence the speakers)
ALT SHIFT O
Toggle between open windows
Toggle between open windows
CTRL H
Emboli (toggle activation of
emboli)
Emboli (toggle activation of
emboli)
Alt
Select Menu
X
Toggle display of peak mode
envelope
Ctrl X
Toggle display of reverse mode
envelope
Z
Toggle display of peak
envelope
Ctrl Z
Toggle display of reverse
envelope
Esc
Remove cursor and distribution,
return to spectrum screen (or
load screen) from summary
screen.
F1
Depth down
Depth down
F2
Depth up
Depth up
F3
Gain down
Gain down
F4
Gain Width up
Gain Width up
F5
Scale down
Scale down
F6
Scale up
Scale up
F7
Power down
Power down
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F8
Power up
Power up
F9
Sample volume down
Sample volume down
F10
Sample volume up
Sample volume up
F11
Filter down
Filter down
F12
Filter up
Filter up
1
Zero line down
Zero line down
2
Zero line up
Zero line up
+
Volume up
Volume up
Volume down
Volume down
5.9. Menu bar
DIGI-LITE provides commands encompassing all system functions in the five
menus displayed in the menu bar at the top of the screen. Each menu provides a
related set of functions.
5.9.1. Patient menu
Patient menu provides operations for patient file creation, modification, search and
delete. It also provides backup, export and some printer functions. In some
windows programs these functions are referred to as “file” functions. (See figure
5-12)00
Figure 5-12 Patient Menu
New: Creates a new patient file, opening the Patient Details dialog box. Make sure
you have saved any previously recorded data before choosing this
option. (chapter 6.3.1)
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Load: Allows you to load (open) the information for any patient stored in the
database. When you select this option, the Load Patient dialog box
opens. (Chapter 6.3.2)
Work List: Allows you to load examinations to preform over scheduled
patients. The Worklist window is displayed.
Search: Allows you to search patients according to different entries. When you
select this option, the Load Patient dialog box opens. (Chapter 6.3.2)
Delete: Allows you to delete a patient from the database. When you select this
option, the Delete Patient dialog box opens.
Export: Provides options for you to export the patient information for use with
other software packages. You can export picture files or text files. You
can export trends to excel software.
Backup: Allows you to backup patient data to an external device. You must insert
a diskette into the floppy drive to use this option.
Restore: Recovers or loads patient information from an external device. You may
use this option when looking for old patient files that were deleted.
Print Preview: This is used to preview the examination as it will be printed in
Print Screen mode
Print: Prints in Print Screen mode.
Printer Setup: Allows configuration of the printed paper (orientation, size, etc.)
Exit DIGI-LITE( MAIN MENU): Exits the DIGI-LITE program and enters the
program manager of the Windows operating system.
CAUTION
If you exit the DIGI-LITE program, do not reopen the program before
shutting down Windows and restarting the TCD machine.
Exit Windows: You should select this option before shutting down the computer.
CAUTION
Use software shut down and avoid turning the unit off without exiting
windows. Explain this to all users of the instrument. Otherwise, the
windows environment can be damaged.
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5.9.2. Study type menu
Study type allows you to select the preferred operation mode. The study types are
discussed in detail in “Selecting study types”. See Figure 5-13
Figure 5-13 Studies Menu
Intracranial Unilateral: This study type is used for intracranial unilateral
examination with one probe.
Extracranial: This study type is used for Extracranial examination with one probe.
Peripheral: This study type is used for peripheral examination with one probe
Monitoring Intracranial Unilateral: This study type is used for continuous
monitoring in unilateral study and recording of TCD parameters. (Chapter 8)
Monitoring Intracranial Bilateral: This study type is used for continuous
monitoring in bilateral study and recording of TCD parameters. (Chapter 8)
VMR Unilateral: This study type is used to perform vasomotor reactivity tests
in unilateral study and calculates VMR parameter. Chapter 9 gives full
information about this study type.
VMR Bilateral: This study type is used to perform vasomotor reactivity tests in
bilateral study and calculates VMR parameter. Chapter 9 gives full information
about this study type.
Evoked Flow Unilateral: This study type is used to perform Evoked Flow tests
in unilateral study and calculates flow change parameter. Chapter 10 gives full
information about this study type.
Evoked Flow Bilateral: This study type is used to perform Evoked Flow tests in
Bilateral study and calculates flow change parameter. Chapter 10 gives full
information about this study type.
CAUTION
Remember that exposure levels should always be limited to as low as reasonably
achievable (the ALARA Principle).
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5.9.3. Setup menu
Figure 5-14 Setup Menu
Setup allows you to set custom configurations for the DIGI-LITE system. You
normally do not use these functions during diagnostics, but rather when you want
to change how the system is setup. Using the setup menu is discussed in Setup
Configuration. (Chapter 11)
Report Generator Wizard: This wizard is used to configure the patient report.
General: This menu is used to configure general system parameters.
Studies: This menu is used to configure each one of the studies separately.
Save Study Layout: This option enables to save a favorite layout by the user.
Delete Study Layout: This option enables to delete a layout by the user.
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5.9.4. Functions menu
Functions are used to perform operations on the spectrum being displayed.
Figure 5-15 Functions Menu
Actually, the functions menu can replace icon operation, if the user prefers menus.
As usual with Windows software, you can use the keyboard, clicking Alt + the
underlined letter, to open a specific menu. Continue pressing the “ALT” key,
while clicking on other letters as needed to open submenus. (See figure 5-15)
Using the functions menu is discussed in chapter 12.
5.9.5. Help menu
Help provides version information on DIGI-LITE and an on-line help system. The
on-line help provides most of the material contained in this user manual. (See
figure 5-16)
Figure 5-16 Help Menu
Content: Opens the on-line help menu content.
Index: Opens the index of all the items in the software.
Search: Gives the possibility to search specific items.
What is this? : This menu is used to display help of an item by pointing at it with
the mouse.
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About: Gives the copyright information and version number of your DIGI-LITE
system, displayed at the bottom left corner.
5.10. Right click menu
In addition to the menu bar, the DIGI-LITE provides also right click commands for
the important software items. The right click menu is specific per item, and it
contains the most used actions in the specific situation. The options in the menus
are enabled or not, according to system state.
5.10.1.Right click on Spectrum window
By clicking the right mouse button on a specific spectrum window the following
menu will appear.
Figure 5-17 Right Click on Spectrum
Update Summary Image: Adds the spectrum to the Summary Screen. Active in
Freeze state, after the examination was done, or in LOAD state.
Single Spectrum: Closes multiple spectrums to one in a single click.
Insert Cursors: Insert cursors to the spectrum. Active in Freeze state, after the
examination was done, or in LOAD state.
Insert Notes: Insert notes related to the spectrum. Active in Freeze state, after the
examination was done, or in LOAD state.
M-Mode: Open/ Close (toggle) M-Mode window related to the spectrum. Always
active.
HITS Detection: Enable/ Disable (toggle) HITS detection function for the
spectrum. Always active.
Export : Send spectrum to: Active in Freeze state, after the examination was
done, or in LOAD state.
Next BV: Examine the next blood vessel from the blood vessels list, or display the
examination done on next blood vessel. Active in Freeze state.
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Print: Send the spectrum to print in order to print it according to print
configuration. Active in Freeze state, after an examination was done, or
in LOAD state.
Close: Close the spectrum window. Active always.
5.10.2.Right click on M-Mode window
By clicking the right mouse button on a specific spectrum window the following
menu will appear.
Figure 5-18 Right Click on M-Mode
Close: Close the M-Mode window. Active always.
5.10.3.Right click on Summary screen window
By clicking the right mouse button on the summary screen on the picture in the
middle of the screen, the following menu will appear. Summary Screen is active in
Freeze state, after an examination was done, or in LOAD state.
Figure 5-19 Right Click on Summary Screen
Save Examination: Save the current summary screen
Report: Opens patient report for the current summary screen. The following
options are available:
Patient Report: Opens patient report for the current summary screen.
The following options are available:
Examination Summary: Print summary screen:
Insert Notes: Insert notes related to the spectrum. Active in Freeze state, after the
examination was done, or in LOAD state.
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By clicking the right mouse button on the summary screen on a specific
spectrum, the following menu will appear
Figure 5-20 Right Click on Spectrum in Summary Screen
Replay: Enlarge the selected spectrum and go to replay state.
Delete Spectrum: Remove the selected spectrum from the actual summary screen.
This feature is applicable for the main screen while a recorded BV is
selected.
5.11. Toolbar
The most commonly used items in the menu are shown in the toolbar. (See figure
5-21) Instead of selecting items from the menus, you can simply click on the icon
in the toolbar to perform the same function. When you hold the cursor above any
of the icons, DIGI-LITE displays a bubble giving a quick description of the icon.
This section describes the icons in order of appearance on the toolbar. The toolbar
appears to the right of the patient name. In this illustration, the patient’s name is
Smith John.
Figure 5-21 Toolbar
Freeze/Unfreeze Button: Instead of click on the spectrum image you
can now use this new button
Study type: The Study type icon is pictured as a register. Clicking on this
icon opens the Study type dialog box. (See chapter 7.3)
New Patient: Pictured as a man face. Clicking on this icon is the same as
selecting NEW from the PATIENT menu. (See chapter 7.2.1)
Load: The Load icon is pictured as an open folder. Clicking on this icon is
equivalent to selecting LOAD from the PATIENT menu. (See chapter
7.2.2)
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Print: The Print icon is pictured as a printer. Clicking this icon is
equivalent to selecting PRINT from the FUNCTIONS menu. (See chapter
7.10)
Cursors: The Cursors icon is pictured as a black screen with two pairs of
cursors. Clicking this icon is equivalent to selecting CURSORS on the
FUNCTIONS menu. (See chapter 13)
Notes: The Notes icon is pictured as a notepad. This is the equivalent to
selecting NOTES from the FUNCTIONS menu. (See chapter 12)
Summary screen: The summary screen icon is pictured as a minimized
summary screen with a big probe and red arrow in the middle. Upon
clicking on this icon the spectrum display changes into the summary
screen display. To return from the summary screen display back to the
spectrum display press the ESC key.
Next: pictured as a curved arrow. Clicking this icon will perform NEXT
FUNCTION as selecting NEXT FUNCTION from the FUNCTIIONS.
HITS: The HITS icon is pictured as a red blood vessel with a small white
embolus in the blood stream. Clicking this icon is equivalent to selecting
HITS from the FUNCTIONS menu. (See section 11.3.3)
Add Spectrum: The Add Spectrum icon is pictured as a minimized
spectrum with a big red plus sign at its left top corner. Clicking this icon
is equivalent to selecting Add Spectrum from the FUNCTIONS menu. (See
chapter 12)
M-Mode: The M-Mode icon is pictured as a minimized M-Mode
display. It is a toggle function that display or close M-Mode display.
Clicking this icon is equivalent to selecting M-Mode from the
FUNCTIONS menu. (See chapter 12)
Scroll Option: This buttons enables to scroll through the spectrum
window.
Dicom: This button sends the image spectrums to PACS server in Dicom
format.
5.12. Probe, Time display and Analog gain
At the right side of the toolbar there are 2 dialog boxes: Probe and Display speed.
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Probe: Displays the actual active probe and enables
changing probes. Each probe is represented by a color displayed here in
a small rectangle. The same appears on the probe connector. The probe
is characterized by its frequency (2MHz in this case) and type (PW or
CW).
Display Speed (seconds): Determines how many seconds of the
ultrasound spectrum are shown on the screen. This box enables changing
display speed. from 2.5 seconds in unilateral and 1 second in bilateral.
Analog gain: Determines the analog gain for the probe. There are 4
analog gain levels (from 1 to 4). 1 is for minimal gain and 4 for maximal
gain. This box enables changing analog gain to receive the best spectrum
signal: if the signal is too weak choose 4, and if it’s too strong, choose 1.
The default is 2 and is recommended for regular signals.
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6. Performing Diagnostic Studies
This paragraph contains a brief description of a general diagnostic examination,
according to system existent setup. The setup can be factory setup or changed by
each user according to his needs. After defining the setup, the users can perform
different diagnostic examinations.
6.1. Turn ON system
6.2. Define patient
Define patient by using one of the following three ways:
6.2.1. Define New Patient.
Define New patient as detailed in para.7.2.1 Adding a new patient
6.2.2. Load existent patient
Load existent patient as detailed in Para. 7.2.2 Loading or searching for an
existent patient
6.2.3. Search for a patient
Search for a patient according to specific characteristics, as detailed in Para. 7.2.2
Loading or searching for an existent patient
6.3. Define the Study
6.3.1. Define new study type
Define new study type as detailed in Para. 7.3 Save Study
6.3.2. Open existent study
Open existent study as detailed in Para. 7.3 Selecting study type
6.4. Examine the blood vessels
Examine the blood vessels according to the blood vessel list defined for the
selected study, as follows:
6.4.1. Press UNFREEZE
Press UNFREEZE and find the first blood vessel in the blood vessels list (for
blood vessel list see para.11.3.1 Select blood vessels), as follows:
6.4.1.1.For faster finding and identification of the blood vessel, use M-Mode
window
Search the depth with maximum energy in the vicinity of the predefined depth of
the first blood vessel. Press on screen to automatically change the depth of the
active spectrum.
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6.4.1.2.Find the Doppler variables for the best insonation
If necessary change GAIN, DEPTH, ANALOG GAIN, SCALE, POWER,
SAMPLE VOLUME, FILTER to receive the best signal and the lower noise
possible.
6.4.1.3.Keep the probe in the best location for few seconds
Keep the probe in the best location, as found in the precedent step, for few
seconds. The time is according to active spectrum time defined in setup (see Para.
5.2 Main screen). When at least a full spectrum window of good and stable signal,
with clinical parameters is displayed, you can press FREEZE.
6.4.2. Press FREEZE
Press FREEZE and then press Next Blood Vessel (see Para. 12 Functions).
6.4.3. Repeat step 6.4.1
and 6.4.2
Repeat step 6.4.1 and 6.4.2 for all the blood vessels in the blood vessels list
In order to save time it is possible to press only once for two actions: Next bv and
UNFREEZE .in order To do this the user must define the function Next Function
to perform these two functions automatically (see Para. 11.2.4 Next Function)
6.5. Open Summary Screen
If you want to edit the examination, open the Summary Screen after performing
the examination on all the blood vessels in the list. In the Summary Screen you
can delete or move examinations.
6.6. Replay the examination
Right click on the spectrum to replay. Press PLAY
6.7. Replace the spectrum in the Summary Screen, if needed
If during examination replay you want to replace the spectrum that was initially in
the Summary Screen, perform as follows:
Replay the examination
Press PAUSE when you see the best spectrum. The replay will
stop
Right click on spectrum and press Update Summary Image
This option is available also after loading a study.
6.8. Rename BV, if needed
If after performing insonation or loading a recorded study you decide to rename
the BV to a different one, it is possible with right clicking the BV and "Rename"/
using the "Rename" function in the remote control.
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6.9. Recalculate Clinical Parameters if needed
If during examination replay you want to replace the automatic clinical parameters
calculations by clinical parameters manually calculated, perform as follows:
Replay the examination
Press PAUSE when you see the best spectrum. The replay will
stop
Press on MC (Manual Calculations) button. The software will
prompt you to insert CURSORS
Insert CURSORS
Put one horizontal CURSOR on Peak Systole level and the other
on End Diastole level
Press MC Button again. The software will replace the old
automatic clinical parameters with the new manually calculated
clinical parameters
Right click on spectrum and press Update Summary Image
This option is available also after loading a study.
6.10. Edit Summary Screen
Repeat the steps 6.5, 6.6 or 6.7 for all the blood vessels in the examination, if
necessary
6.11. Open Patient Report
Add Indications and Interpretations, if needed.
Print or export the patient report.
6.12. Save the examination
6.13. To perform other study for the same patient
To perform other study for the same patient, repeat steps 6.3 to 6.11 for next
study.
6.14. To perform examination on other patient
To perform examination on other patient, repeat steps 6.2 to 6.11 for next patient.
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7. Using the DIGI-LITE system
To use DIGI-LITE, the normal sequence of events is as follows (for a diagnostic
examination):
1. Turn on the computer.
2. Choose a study type.
3. Select or define a patient.
4. Insonate the blood vessels, following the order in selected BV’s list.
5. View the blood vessel summary screen and add your diagnostics, remarks
or comments.
6. Save and Print the results.
These steps and other optional procedures are described in detail in this chapter.
CAUTION
Always handle transducers with care.
CAUTION
Do not drop or bang the transducers.
CAUTION
Clean the probes with a clean cloth or tissue paper at the end of each day to
remove remains of gel. Gel that dries on the plastic might damage it.
WARNING
Do not immerse transducers in water or any other fluids.
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7.1. Entering DIGI-LITE
To start the DIGI-LITE application, simply turn on your computer. The monitor
automatically displays the test working screen of the DIGI-LITE.
The DIGI-LITE operates under Microsoft Windows 7 operating system
Configuring the system
The DIGI-LITE system contains a number of dialog boxes which allow you to
configure the system display and printout.
For a full description of all the configuration dialog boxes and parameters, see
SETUP CONFIGURATION (Chapter 11).
7.2. Creating and selecting a patient
The Patient menu is used to handle all functions that deal with patient
management, such as saving, loading and deleting of files or patients, and handling
of the patients’ database.
7.2.1. Adding a new patient
1. To add a new patient, Select New from the Patient Menu. The Patient
Details form, shown below, appears. (see figure 7-1)
2. Fill in the relevant patient information by typing on the keyboard. You
must fill in an identification number. All other fields are optional.
3. You move from one field to the next by pointing the mouse or pressing the
tab button.
4. At the bottom side of the form there is an area with clinical details that
you may want to fill in for the patient.
5. When you complete the form click on the OK button.
6. You can now proceed to record spectrum information for the patient. (ID#
is mandatory field and must be filled. All other fields are optional).
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Figure 7-1 New Patient dialog box
The following fields appear in the Patient Details form.
ID #: The patient’s identification number. This can consist numbers or letters. No
hyphens, spaces. You must enter an ID number for all patients. The
system will not accept an ID which already exists and will give an alert.
Last Name: The patient’s family name. If you don’t enter a name, a star will
appear instead of the name.
Middle Name: The patient’s middle name.
First Name: The patient’s first name. This can be made up of any letter
characters.
Title: One of the following titles can be entered: Mr., Miss., Mrs., Ms., Dr., Prof
or no title.
Sex: Male or female click box.
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Birth Date: The patient’s birth date in the format: day - month - year or
day/month/year. It is necessary to enter the year in a 4-digit format. The
patient’s age is automatically calculated and placed in the age box.
Age: Patient’s age will be calculated automatically from the birth date. If you
don’t type a birth date, you can type the age directly in this box.
Tel #: The patient’s telephone number. Any character is accepted as part of the
telephone number. The following telephone numbers can be written:
telephone at home, telephone at work and mobile telephone.
Address: The patient’s address. Any characters can be typed in this box.
E-Mail address: The e-mail address. Any characters can be typed in this box.
Clinical details:
Referred by: The name of the doctor who referred the patients. Any characters
can be typed in this box.
Reason for Examination: The symptoms leading to the present examination. Any
characters can be typed in this box. You can use this field to record
changes in the patient’s status. If on entering a new patient you write a
short summary of clinical history and status, and you add information
anytime you re-examine the patient, a very useful record is formed.
Clinical History: You can mark characteristics relevant to the patient’s clinical
history and risk factors. To mark events, simply select the event with the
mouse and click on it. A check mark appears in the small box next to the
event.
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7.2.2. Loading or searching for an existing patient
You may wish to add or modify information for an existing patient, perform
another Doppler examination for an existing patient, display examination, display
patient report or search patients according to specific characteristics. To do so,
you use the Search/Load Patient function. (See figure 7-2)
Figure 7-2 Load dialog box
The Search/Load Patient dialog box contains two areas: Search functions at the
left side and Load functions at the right side. It contains the following fields and
buttons:
Load area:
Name: Name selection field. Contains a list of patients in the database, listed by
name in alphabetical order with the family name first followed by first
name.
ID #: ID selection field. Contains a list of patients in the database, in numerical
order.
Patient Details: Pressing this button allows you to view the patient details.
Examinations: Displays list of all the examinations saved for the selected patient
with the following examinations information: date, time, location, study
type and comments entered by physician for the examination.
Examined Blood Vessels: Displays the blood vessels names and Doppler probe
type of the blood vessels examined and saved (for the examination
highlighted in the Examination List).
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Examined Gates: Displays the Doppler probe type and depth of the blood vessels
examined and saved (for the examination highlighted in the Examination
List).
The column headings in this field are:
HD: Shows if the examination is saved on the hard disk. A ‘+’ (Plus)
sign means that it is on the hard disk. A ‘-’ (minus) means that the
examination was erased from the hard disk.
Date: Date of examination (Day-Month-Year format).
Time: Time of examination.
Location: The location to which a backup copy was saved. The options
are:
blank - no backup was done.
(fixed) - to the hard disk of the instrument.
(Removable) - to an external memory
device (such as a read-write CD-Rom).
Search patient area:
In this area you can search patients according to the following characteristics:
Search patient: To search patient by:
Last Name
First Name
Id. Number
Patient Details: To search patient by:
Sex
Age: find patients in specific age range
Referred by: search by name of the doctor who
referred the patient
Reason: search by reason of examination
Examination: To search patient by:
Date: find examinations done between two dates
Type: search by type of examination done on this
patient (e.g. Intracranial Unilateral, Extracranial
etc...)
Location: search according to the location of the
examination (in the hard disk, on CD-RW, etc...)
Other: search by words appearing in the patient’s
details
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Clinical History: Search patient by clinical history as inserted in
New Patient clinical details
Blood Vessels: Search patient according to what blood vessels
were examined.
Viewing Records from the Database
1. To load details on an existing patient, select LOAD from the PATIENT
menu or click on the icon that looks like an open folder.
The Load Patient form, shown above, appears. (See figure 7-2)
2. Click on the arrow next to the NAME field. A list of all patient names is
displayed. Use the up and down arrows on the scroll bar to scroll the
patient name list and click on the name of the patient whose records you
want to recall. When you select a patient, a list of all previous
examinations is displayed in the dedicated fields below the name. To
search for a specific patient, you can type the first few characters of the
last name of the patient to highlight the first matching name.
If you prefer, you can search by ID#, using the same procedure.
3. You move from one field to the next by pointing the mouse or pressing the
tab button.
4. If you want to view or modify the patient details, click on the Patient
Details button. The form described above (Figure 7-1).
5. You can view previous spectrum examinations of the patient by double-
clicking on the relevant line.
6. When you have selected the patient and examination you want, click on
the Show Examination, Show Blood Vessel, Show Gate or OK button,
depending on what you wish to display.
Click “Show Examination” if you want to view the complete summary screen.
Click “Show Examined Blood Vessels” if you want to view the examinations
(spectrums and M-Modes) recorded for a specific blood vessel.
Click “Show Examined Gates” if you want to view the spectrum recorded for a
specific gate (depth).
Click “OK” if you want to start a new examination for that specific patient.
The new examination will be added to that patient’s database. (See also below)
You can now proceed to record or review spectrum information for the patient.
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Displaying examination summary screen
You can view the summary information directly from the Load Patient dialog box,
as follows.
1. On the Load Patient dialog box, select the patient using the Name or ID
field.
2. From the “examination list” windows, double-click on the examination
you wish to view. The summary screen for that examination appears.
Alternately, you can click the “Show examination” button.
3. You can perform any of the regular summary screen options from this
screen.
4. To return to the Select Patient dialog box press on LOAD icon.
Displaying a single blood vessel examination
After highlighting an examination, double click on a specific blood vessel name
from the “Examined blood vessels” list on the middle. Alternately, highlight and
click the “Show Blood Vessel” button.
Displaying a single gate examination
After highlighting an examination and a blood vessel name, double click on a
specific depth from the “Examined gates” list on the right. Alternately, highlight
and click the “Show gate” button.
Opening a new examination file for an existing patient:
When a patient comes back for examination, the correct procedure should be:
1. On the Load Patient dialog box, find the patient’s name (or his/her ID).
2. Click the <OK> button.
3. You can start a new examination; it will be saved and filed together with
other examinations already done for this patient.
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Modifying Examinations in the Database
Deleting an examination
You can delete the results of one or more of the examinations for a particular
patient. Note that once you have removed this data from the database, you cannot
restore it unless you have made a back up.
1. On the Load Patient dialog box, select the patient using the Name or ID
field.
2. From the “examination list” window, click on the examination you wish to
delete.
3. Click on the Delete Examination button.
4. Confirm that you want to delete this examination information.
7.2.3. Deleting a patient
You can delete a patient from the database. Deleting a patient also erases all
examination data relevant to that patient. You cannot recover deleted data unless
you have made a backup. See Backing up and restoring data in chapter 7.9.
To delete a patient:
1. Select DELETE from the PATIENT menu. The delete patient data form
appears (See figure 7-3)
2. Select the NAME or ID# of the patient to be deleted. You select from the
list by clicking the arrow next to the NAME or ID# field, and clicking on
the patient.
3. Once you select a patient, all the other fields in the dialog box show the
details of the patient.
4. The system prompts for you to confirm your action.
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Figure 7-3 Delete Patient dialog box
The Delete Patient dialog box contains the following fields.
Name: Name selection field. Contains a list of patients in the database, listed by
name in alphabetical order with the family name first, followed by first
name.
ID #: ID selection field. Contains a list of patients in the database, in numerical
order.
Delete Patient: This button is used to delete a patient from the patient database.
All patient details and previous examinations are deleted with the
patient.
Close: This button confirms the delete process and exits the dialog box.
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Selecting study type, basic operation
The STUDY TYPE menu helps the user to select the current working operation mode
or study type of the system. The study types are for unilateral or bilateral diagnosis
or monitoring. Each study type has a default configuration defined at factory and
can have also customized studies defined by the users.
Figure 7-4 Studies dialog box
When recording the examinations using the various study types, you should
perform the following steps.
1. From the STUDY TYPE menu (See figure 7-4), select one of the study types
described below.
2. The display screen for that study type appears. For unilateral study types
the display screen shows only spectrums and M-Mode belonging to one
spectrum screen. For bilateral study types, the screen is divided in half,
and each half contains the spectrums and M-Mode belonging to other
probe. The CHN button on the remote control or the <T> key on the
keyboard or mouse, allow you to toggle between the open windows on
screen (spectrums and M-Modes). The selected window is distinguished
by its blue frame
3. Press the <Space> bar (on the keyboard) or the Freeze button (on the
remote control) to begin spectrum examination with the selected probe.
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4. When the signal shown on the spectrum is stable and appears on the
display in a satisfactory manner, press the <Space> bar or the Freeze
button to freeze the spectrum.
5. If you wish you can unfreeze and re-record (according to system setup).
6. The active spectrum window has blue frame, and the inactive spectrum
windows have gray frames. The sound relates to the active spectrum
window.
7. Return to step 1 to record spectrums for other blood vessels.
8. When you have finished recording all the spectrums needed the
examination is complete. You can display a summary screen, modify
screens, save the spectrum, or print the patient report, as described in the
appropriate sections of this manual.
Note: Whenever you record the spectrum of any blood vessel, it is automatically
added or not to the appropriate summary screen, according to Summary Screen
setup. See Summary screen setup on (11.2.5).
CAUTION
Remember that exposure levels should always be limited to as low as reasonably
achievable (the ALARA Principle).
7.2.4. Intracranial unilateral study type
Intracranial Unilateral study type is used for single probe examinations of the
intracranial circulation. This option is useful for a careful examination of arteries
comprising the Circle of Willis, the Vertebral and Basilar arteries, and the
Ophthalmic arteries. Although a 2 MHz PW probe is the default choice for all
arteries (except the Ophthalmic, which may be insonated with an 8 MHz CW
probe as well), you can select other probes for this exam. You can display up to
seven clinical parameters to the right of the selected spectrum. Up to 8 spectrums
can be displayed for simultaneous examination at up to 8 different depths with a
single 2 MHz PW probe. This option is used to allow comparison of blood flow
velocities at up to 8 different depths (such as at a stenosis and proximal or distal to
it), or to capture the movement of a cerebral emboli. Control of the spectrum in
each window is performed independently of the spectrum in the other window.
Pressing the CHN button on the remote control or <T> on the keyboard toggles
between the two spectrum windows. The spectrum of the active window is shown
in blue, and the inactive windows are shown in gray. The sounds are from the
active spectrum window.
An M-Mode window can be displayed for fast screening of intracranial blood
vessels, finding and identifying of blood vessels, visualization of the emboli
movement and improvement of emboli detection.
A dedicated summary screen of the intracranial circulation is included with this
study type.
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7.2.5. Extracranial study type
Extracranial study type is used for single probe examinations of the arteries of the
neck (primarily CCA, ICA, ECA). The preferred probes to examine these arteries
are 4 MHz or 8 MHz PW or CW probes. You can also use 2 MHz PW probe.
You can display up to seven clinical parameters to the right of the spectrum. If the
probes are used in PW mode, than an M-Mode window can be displayed and up to
8 different depths, in the same manner as in Intracranial study type.
A dedicated summary screen of the Extracranial circulation is included with this
study type.
7.2.6. Peripheral study type
Peripheral study type is used for examinations of blood vessels in the upper and
lower limbs. The controls and display of this study type are similar to those in
Unilateral study type. All probes may be used for Peripheral study type. The
preferred probes to examine these arteries are 4 MHz or 8 MHz PW or CW
probes. You can also use 2 MHz PW probe. You can display up to seven clinical
parameters to the right of the spectrum. If the probes are used in PW mode, than
an M-Mode window can be displayed and up to 8 different depths, in the same
manner as in Intracranial study type.
A dedicated summary screen of the peripheral circulation is included with this
study type.
7.2.7. Monitoring unilateral and bilateral studies type
Monitoring is used for continuous monitoring and recording of TCD parameters.
Chapter 8 gives full information about working with this mode.
CAUTION
Remember that exposure levels should always be limited to as low as reasonably
achievable (the ALARA Principle).
7.2.8. Vasomotor Reactivity (VMR) study type
The vasomotor reactivity test mode performs vasomotor reactivity tests and
calculates VMR parameter. The VMR parameter is calculated in real time
during the test, and can be recalculated also off line, after the test was
finished. Chapter 9 gives full information about working with this mode.
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7.3. Spectrum examination and modification
Once you have created a new patient or loaded an existing patient, and
selected the study type, you can proceed with the examination of the patient.
1. Select the probes for insonating the blood vessel.
2. Begin recording by toggling the Freeze button to start the spectrum.
3. Insonate the vessel by viewing the display on the M-Mode screen
and choosing the best spectrum depth according to M-Mode display.
Adjust the control variables to get the best insonation.
4. When the best signal was get and it’s stable, select the HITS option
if you wish to record HITS.
5. When the display shows a satisfactory spectrum, toggle Freeze to
freeze the spectrum on the screen.
6. You may save the spectrum if you wish.
7. If you want to record another blood vessel, select new vessel from
the BV list or use the Next function, repeat this procedure until all
required blood vessels were examined.
8. Click the “Summary Screen” icon.
The summary screen, described in the next section, shows a
comprehensive display of all the results of a set of examinations.
9. Save results.
10. Print a patient report, if needed.
7.4. MC (manual calculation) cursors saved on Summary Screen and
in Patient Report.
Go to Intracranial Unilateral Study, makes Unfreeze/Freeze, adds cursors to the
screen, clicks MC and gets new numbers for Peak, Mean etc. Then go to Summary
Screen. The summary screen images updates according to this screen.
Now Cursor Lines is added on the image in Summary Screen and in Final Patient
Report) (see figure 7-5).
The same happens with M.C marks.
This enables the doctor to notice what calculation was done automatically & what
manually.
This option is available also after loading a study.
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Figure 7-5 Manual Cursors
7.5. LR (Lindegaard Ratio)
This clinical parameter after calculated is presented in the main screen Under
the L.R. button and in the Lindegaard Ratio window, the Summary Screen and the
Patient Report. It can be calculated only after having measurements of both the
MCA and ICA on the same side. It takes the maximum mean value of each vessel
and divides them. (mean velocity of MCA / mean velocity of ICA). After receiving
values from those BVs, manual L.R. calculation can be performed inside the L.R.
function.
7.6. Controlling the summary display
There are three default summary displays: Extracranial vessels, intracranial
vessels, and peripheral vessels. The blood vessel spectrums shown for each
summary are automatically configured with the system. However, if you want to
customize which spectrums to send to summary screen or which blood vessels are
shown in the displays, you can do so using the Setup options: General- Summary
Screen configuration and Studies- Select blood vessels.
Manual
Calculation
Lines
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Once you have recorded the blood vessels you want for the patient, you can view
all of the displays as one summary display.
To display the summary screen (after performing the examination):
1. Click on the summary icon or select SUMMARY from the FUNCTIONS
menu.
2. You can add comments to the summary screen, using the write icon or
function.
3. If you wish, you can print the summary screen (use the patient icon)
4. If you wish, you can display the patient report (use the patient report icon)
5. If you wish, you can change the order of the BV's to be displayed by
dragging them in the summary screen. This is also available after loading
a study.
6. To return to the spectrum display, press return icon.
7.7. Saving patient information and results
It is possible to save patient and spectrum information. To save the information
recorded during the examination, simply press on the Save icon in the summary
screen window.. DIGI-LITE saves only the information currently displayed on the
screen.
7.8. Display Patient report
The patient report contains general information about hospital, operator and
patient together with examination details, pictures and clinical parameters (figure
7-6). All this information can be displayed or only part of it, according to user
configuration. For more details on user configuration options, see “Setup
Configuration”. (Chapter 11)
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Figure 7-6 Patient Report example
The patient report for a specific examination can be open from two different
places:
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In summary screen display press on Patient report icon. After
performing an examination, open summary screen, configure it by
deleting or moving spectrums, save it, and then press on patient
report icon. The patient report of the examination will be
displayed according to the setup. It can be printed, saved, exported
to other applications or sent by email. It can be saved on different
formats, as: Acrobat -*.PDF, Microsoft Excel - *.xls, Microsoft
Word- *.doc or Rich Text Format - *.rtf.
After you have performed full examination you can enter to the summery
screen and then to the Final patient report and as you can see there is a
button to export the report
Then in the export report window you can see you can chose in which
format you want to save the report and save it in your Disk On Key
In addition, there is an easy option to export the report to PDF by
the next icon
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If you want to display the patient report of a saved examination,
press LOAD icon, choose the patient and select the examination,
then press on Report icon. The selected patient and examination
patient report will be displayed according to patient report
configuration.
7.9. Backing up and restoring data
Examination files take up a lot of disk memory. When many patients were
examined or long monitoring sessions done, you need to remove them. Backup is
used to make copies that can be archived in a safe place for future needs. When
you need to review a patient’s examination that no longer exists on the HD, you
will use the restore function.
7.9.1. Making Backup Copies
Backup is most often used to move large amounts of examinations. It can also be
used to copy single examinations for any purpose. For backing up efficiently, it is
recommended to use an instrument such as a read-write CD-ROM, network disks
or any other storage devices. They can be commercial instruments that connect
externally to a PC. As this line of products is changing quite fast, contact Rimed’s
customer support for the latest recommendations. (Consult with Rimed technical
support regarding electrical safety standards when using commercial accessories).
To backup data, perform the following procedure:
1. If you are using an external device, verify that it is properly installed and
connected.
2. Select Backup from patient menu. The “Backup patient” dialog box appears.
(See figure 7-7).
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Figure 7-7 Backup dialog box
The backup function can work in the default mode for routine backups. This is
very simple and straight forward. If you want to modify it, some options are
available.
Periodical, routine backup:
The Backup patient data opens with the following setting:
Mode for Backup: By date (the system automatically sets the default date for
'today', thus selecting all the examinations made during this day).
Location: system defaults (files will be put under TCD/Backup directories on the
media that you choose).
Choose a drive for backup (lower left corner of
the dialog box. [-c-] if you want to backup on the
hard disk, [-d-] for an external drive ([-d-] is
available only if an external device is connected)
or other drives if the system is connected to a
network.
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Choose “copy” or “move”. click “Copy” If you
want to leave the examinations on the hard disk.
If you want to delete them after backup, click
“Move”. If you clicked “Move”, the system
warns you that all the examinations will be
deleted. Confirm by clicking OK, or cancel.
The system shows a warning: “Ready to start
backup . Estimated time ____h ____m ____s.
Confirm by clicking OK. The time estimate may
not be very accurate, depending on the media you
use. Anyhow, it will give you a good idea. If you
want to use the instrument soon and backup
would take a long time, you can cancel and start
again later, at a more convenient time. You can
also see the size of selected files (written under
the patient’s list). Once you click OK, an
advancing blue bar will show the percentage of
files that have been backed up.
3. A message appears: “compression successfully finished”. Confirm by
clicking OK.
4. Click “CLOSE” to exit the backup dialog box.
WARNING
If the hard disk is almost full. The back-up procedure might fail. Make a
habit of routine periodical backups (depending on number of examinations
saved) to keep enough free space on the hard disk.
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Backup options:
Mode for backup:
If you want to make backup copies of all examinations present on the
HD (even those that were backed-up) choose “ALL” in “Mode for
Backup”.
If you want to make backup copies for examinations made during
specific dates (range or a specific day) choose "By date" in "Mode For
Backup". This will automatically select all the examinations made
during those dates.
If you want to select specific files for backup, choose “User Defined”.
Then choose by the Patient’s names (or #Ids). Click twice on each
patient name for which you need backup. The list of examinations for
that patient will appear on the right side. Highlight the examinations you
want to backup. Repeat for other patients.
Proceed as before - “Copy” or “Move”. Confirm when needed, “Close” to
exit.
CAUTION
It is important to label the CD (use the number given by the system), or
list the patients by Name or ID number on the diskette itself, when you
are storing information which you plan to erase from the DIGI-LITE
computer. Make sure that you keep careful track of where all data is
stored and that the date is written on the diskette.
7.9.2. Restoring backup information
You use this function to retrieve old files that were backed-up and erased from the
system. Choose “Restore” from the patient menu.
Once you select Patient - Restore, the restore patient data dialog box appears. In
the system default mode:
1. Select drive to restore
2. Under patient’s list, choose the name you are looking for. Click twice on it,
high-light the examinations you want to restore (under examinations list).
3. Click OK. A warning shows you the estimated time. Confirm by clicking
OK if time limits permit.
4. A Blue bar shows the advancement of the restoring process.
5. Confirm “Decompression successful” by clicking OK.
Restore Options:
Locate: Choosing locate enables you to restore from directories
different than the default one (if backup was done to another
directory). Browse through the desired drive and directory from the
“Select directory to restore” dialog box.
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7.10. Printing
There are three different ways to print examinations:
1. Print screen: You can print the results by selecting PRINT from the
PATIENT menu or clicking on the PRINT icon.
2. Print selected spectrum windows in predefined layout: right click on
spectrum window that you want to print. The selected windows will
be printed in the predefined layout. Refer to section (11.2.8) “Print
Settings” to learn how to configure printing.
3. Print Patient report: select print from Patient Report in order to print
the patient report as predefined by the user in setup.
7.11. Exporting results to other software
The export function helps you exchange data with other programs that you use.
Theoretically you can even install them on the same platform. However, since
sometimes there can be a conflict between different programs, you must contact
Rimed and confirm that the specific software can be installed. If the combination
was already checked, an authorized permit will be sent to you. Otherwise, Rimed
can not be held responsible for any damages that might occur.
The export options are:
Pictures: Exports the spectrum or summary screens as picture files. Pictures can
be sent in standard format like .jpg, bmp.
Select the export function needed. Under the field “File Name”, enter the patient’s
name (or according to your choice) with an appropriate extension (*.jpg for
picture, *.txt for text files). After clicking OK, the file will be saved (as default)
under c:\export. Later you can open it using suitable software, for analysis or any
other use. You can also choose another directory for saving the exported files. See
figure 7-8 for an example of an Export screen.
Figure 7-8 Export dialog box
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Export Trends to excel: Exports all the trends in monitoring studies to excel file
for research purposes. See “Exporting clinical parameters in monitoring and VMR
studies to excel” (section 11.2.9)
Export Log Fie: Exports a log file for services issues. See Chapter 17.
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8. Monitoring Unilateral or Bilateral Studies
The monitoring studies of the DIGI-LITE system allow you to monitor blood flow
velocity over an extended period of time. Using a dedicated probe holder which
can be attached to the patient’s head, you can monitor blood flow over a period of
hours, recording information about events occurring during the monitoring period.
You perform monitoring just as you do any other kind of insonation. The
difference is that you are in monitoring study type rather than on one of the other
study types shown on the STUDY TYPE menu. See figure 8-1 for a typical
monitoring screen.
You can perform Post-processing on the study you just recorded in order to add
or delete Events or HITS in offline and also have the tools using the cursors and
additional spectrum window to analyze the results.
WARNING
Remember that exposure levels should always be limited to as low as reasonably
achievable (the ALARA Principle).
WARNING
While monitoring patients for long periods, switching on (Unfreeze) only at
critical phases of surgery (or follow-up period) is preferred to continuous
monitoring.
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8.1. Selecting Monitoring Unilateral or Bilateral study
Enter Monitoring test using menu bar Studies, or Change study icon in
toolbar.
Monitoring examination is done in Unfreeze Real time and can be further
inspected in LOAD off line state.
8.2. Monitoring Intracranial Unilateral Layout during Recording
Figure 8-1 Monitoring Layout during Recording
The upper half of the monitoring screen is almost identical to the spectrum screens
you already know. Notice the two “Tape Buttons” added to the icon row. After
you unfreeze, you use them to control recording: (A record examination is saved
automatically to the hard disk). See figure 8-2
The lower part of the monitoring screen displays the trend windows. In the trend
window, you see how different parameters (derived from spectrum calculations or
from external instruments) change during the examination period.
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8.3. Monitoring Intracranial Bilateral Layout during Recording
Figure 8-2 Monitoring Intracranial Bilateral Layout during Recording
In this study type the user can insonate in both channels simultaneously by using
the probe holder (Chapter 10) and see the result in one screen. See figure 8-2
The upper half of the monitoring screen is almost identical to the spectrum screens
you already know. Notice the three “Tape Buttons” added to the icon row. After
you unfreeze, you use them to control recording: (A record examination is saved
automatically to the hard disk).
The lower part of the monitoring screen displays the trend windows. In the trend
window, you see how different parameters (derived from spectrum calculations or
from external instruments) change during the examination period.
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Figure 8-3 Monitoring Taskbar during Recording
HITS: The HITS icon is pictured as a red blood vessel with a small
white embolus in the blood stream
Spectrum Window: Add spectrum window ( you can add only 1
additional spectrum window)
Trend Window: Add / Remove trend window
Red Circle: Start Recording.
Black Square: Stop Recording (you will have 3 options: Save, Don't
Save, Continue Recording).
Final Patient Report: To display the patient report of the current
examination ( Events/Hits Pictures Only)
Examination Clock: The actual time of the examination:
hour, minutes and seconds
Right click menu on Trends: Size of Trend Window: Determines the display
size of the trend window in minutes.
CAUTION
This system and its options should be used no longer than is necessary for the
appropriate diagnostic procedure. In order to minimize exposure to acoustic
energy, switching on only at critical phases of surgery or at special events is
recommended.
CAUTION
ALARA caution: The operator is cautioned to use Doppler power levels As Low
As Reasonably Achievable, and to avoid the use of any power level greater than
that necessary to insure the gathering of adequate Doppler information.
To optimize the monitoring software for your needs, use the setup monitoring
options, described below.
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8.4. Monitoring Layout during Replay
Figure 8-4 Monitoring Layout during Replay
Figure 8-5 Monitoring Taskbar during Replay
Replay Examination: Replay the examination beginning with the time
displayed (spectrum, m-mode, trends and sound)
Scroll back the Examination: Scroll back the spectrum, m-mode and
trends from the time displayed. The time gradients are equal to the spectrum
window size.
Scroll forward the Examination: Scroll forward the spectrum, m-mode
and trends from the time displayed. The time gradients are equal to the spectrum
window size.
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Black Vertical Lines: Pause / Resume replay.
Scroll Bar: Scroll to any point during the examination at replay mode
8.5. Monitoring examination setup
The following characteristics of the Monitoring examinations can be changed:
Size of Trend Window: To change the size of trends right click on
TRENDS window and choose the option TIME DISPLAY. The
TRENDS window time will change according to the selection
Figure 8-6 Size of Trend Window
Setting Monitoring events: You can configure the predefined events which
you may want to place as markers during the monitoring period. The
events list allows you to define new events for monitoring. Choose
SetupStudiesStudy name clicking the "Event" tab (See figure 8-
7).
Figure 8-7 Events Form
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To add an event, type in the new name and click the “Add” button. Repeat as
needed, and then click OK. To delete an event, highlight the event and click on the
Remove button. Then click OK.
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Start Play Event before and after- this option is controlling on the time period of the
selected event. (By default we use 2 seconds).
Setup the study trends - As a helper to create flexibility in the trend component, we
have implemented the ability to select the trends that you will like to see in a given
study. This window is very strait forward and will be very friendly and familiar to the
expert user. It's using the same logic of adding clinical parameters/ blood vessels for
study. You will see the next screen after going from the main menu to
SetupStudiesStudy name clicking the "Trend" tab. (See figure 8-8)
Figure 8-8 Trends Form
In the image we can see that the user chose to see 5 trends in the trend window at the
"Monitoring intracranial Bilateral" study. 4 are a familiar clinical parameter and on
external channel (The 8th one).
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8.6. Performing a Monitoring examination in Unilateral or Bilateral
8.6.1. Beginning a new examination
To begin a new examination, press the UNFREEZE button (the recording will
start automatically) and Perform a good insonation.
To monitor with two Doppler spectrum windows, you have to add the
additional window before starting the examination.
8.6.2. Performing the examination
During the examination the following actions can be done:
Add predefined events. To do this press on the specific event
(one click) - in the EVENTS LIST. The name of the event
will appear in the EVENTS HISTORY with the time of
appearance. A yellow vertical line will appear on TRENDS
window at the same time
Enable/disable HITS. After enabling HITS an automatic
HITS event will appear in HITS HISTORY window and a
correspondent yellow line in TRENDS
Add/ remove M-MODE
Pause/continue the recording
8.6.3. Finishing the test
After the test was finished, press “STOP RECORDING” and save the examination.
8.7. Further inspection of the Monitoring examination off line
You can inspect the recorded Monitoring examination off line. To do this,
load a saved Monitoring Unilateral or Bilateral examination and then you
can perform any of the following actions (See figure 8-9):
Choose an event from the EVENTS HISTORY. To do this
double click on the event in the EVENTS HISTORY
window
Pay attention that when you choose an event it’s in PAUSE
state, so if you want to REPLAY, you have to press on
PAUSE/CONTINUE icon.
Choose to replay the whole examination or from a specific
event
Choose to scroll the spectrum back or forward
Choose to change the size of Trend Window
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Figure 8-9 Monitoring Intracranial Unilateral
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8.8. Monitoring Post-Processing
8.8.1. Additional Spectrum Window.
In order to detect if an Emboli is real or not you can use this tool to see different Depths of
the same insonation that you have made.
You must use this option before starting recording. (You will have the option to close the
M-Mode window or the Trend Window)
This option is used in Monitoring Unilateral and Bilateral studies.
Figure 8-10 Monitoring Intracranial Bilateral
Spectrum Window: Add spectrum window ( For each channel you can have up
to 2 spectrum windows simultaneously)
Cursors: The Cursors icon is pictured as a black screen with two pairs of cursors
8.8.2. Cursors and time delay display.
Another tool to help determining a real emboli or artifact is the cursors option and time
delay display.
After finishing recording the study and loading the study, you can add the cursors using the
button mentioned above.
Two cursors are added, each cursor contains the time stamp from the beginning of the test .
One of the cursors contains the time delay between the cursors.
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Figure 8-11 Cursors and Time delay display
8.8.3. Add/Delete Emboli
After determining artifact emboli or new emboli that wasn't automatically detected by the
system you can add or/and delete Emboli using the cursors in replayed monitoring study.
(See figure 8-12).
To add emboli put the main cursor (not the doted one) on the emboli that was not
automatically detected by the system in the upper main window and right click on the
cursors and press Add Hit. - The HIT event will automatically be shown in the event list, the
HIT counter will be increased by 1, yellow bar will be added to the trend window and a
green mark will be shown in the added spot. After you finish editing press on the SAVE
button. (See figure 8-13)
To delete emboli put the main cursor (not the doted one) on the automatically detected
emboli that was detected by the system (marked by orange marker) in the upper main
window and right click on the cursors and press Delete Hit. - The HIT event will
automatically remove from the event list, the HIT counter will be decrease by 1 , yellow bar
will be added to the trend window and the orange mark will be removed after you
confirmed. After you finish editing press on the SAVE button. (See figure 8-14)
Time delay Display
Cursors
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Figure 8-12 Add/Delete Emboli.
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Figure 8-13 Add Emboli.
Figure 8-14 Delete Emboli.
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8.8.4. Add/Delete Event
After loading monitoring study from the Data Base. You have the ability to Add or /and
Delete an event in offline mode.
To add Event play the monitoring study till you get to the preferred spectrum picture and
press pause button. Right click on the upper main window and then choose from the popup
menu Add Event, in the next popup window you will need to choose Event from the
predefined Event list or Enter new event name and press Ok.
New event is now added to the event list and yellow bar is added to the trend window
After you finish editing press on the SAVE button (See figure 8-15)
To delete Event double click on the event you want to delete from the event list. Right click
on the upper main window and then choose from the popup menu Delete Event you wll need
to confirm and then press Ok.
Your event will be deleted from the event list and yellow bar will be removed from the trend
window.
After you finish editing press on the SAVE button (See figure 8-16)
Figure 8-15 Add Event.
New event
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Figure 8-16 Delete Event.
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8.8.5. Hits Histogram
In order to see the energy and the amount of hits from each channel you can use the Hits
Histogram table that is located at the docking window in Hits tab.
Figure 8-17 Hits Histogram
Hits Tab
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8.8.6. New Time Stamp From the Beginning of the Test
Figure 8-18 Time Stamp
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9. Vasomotor Reactivity Test in Unilateral or Bilateral
Studies
9.1. Selecting Vasomotor Reactivity study
Enter Vasomotor Reactivity (VMR) test using menu bar Studies, or Change
study icon in toolbar.
VMR test is performed in a similar way as Monitoring: the examination is
done in Unfreeze Real time.
The examination can be further inspected in LOAD OFF LINE state.
9.2. Vasomotor Reactivity test setup
Vasomotor Reactivity Test setup is based on Monitoring Unilateral or
Bilateral.
Size of Trend Window: The size of trends can be changed in the same way
as in Monitoring mode.
Figure 9-1 Size of Trend Window in VMR
Setting VMR events: The predefined events can be configured in the same
way as in Monitoring studies. The difference is that in VMR there
are two new predefined events: Baseline velocity and Test velocity.
As in Monitoring, you can define and add new events. Choose
SETUP- STUDIES-VMR and press the Events tab. The “EVENTS
setup” form appears.
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Figure 9-2 Events Form in VMR study
9.3. Performing a VMR test examination
9.3.1. Beginning a new examination
To begin a new examination, press the UNFREEZE button. Perform a good
insonation, and press “RECORDING”.
9.3.2. Control state
At this stage the patient is in the control state and breaths normally. When a steady
state velocity is achieved, press on the event named “BASELINE VELOCITY” in the
PREDEFINED EVENTS area.
9.3.3. Test state
Perform the test, either by injecting drugs, breathing CO2 or breathe holding. The
velocity will increase. Wait until the velocity achieves a new steady state value. At this
moment press on the predefined event “TEST VELOCITY”. The VMR parameter is
automatically calculated using the velocity values selected by you in steps 9.3.2
“Control state” and 9.3.3 ”Test state”. You can end the test, or continue it by
performing different additional maneuvers and see the behavior of the velocity.
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9.3.4. Finishing the test
After the test was finished, press “STOP RECORDING” and “FREEZE”.
9.4. Further inspection of VMR test examination OFF LINE
You can inspect the recorded VMR unilateral or bilateral examination off
line. To do this, load a saved VMR test examination and then you can
perform any of the following actions (See figure 9-3):
Choose an event from the EVENTS HISTORY: BASELINE
VELOCITY or TEST VELOCITY or other. To do this
double click on the event in the EVENTS HISTORY
window
Pay attention that when you choose an event it’s in PAUSE
state, so if you want to REPLAY, you have to press on
PAUSE/CONTINUE icon.
Open the Patient Report to view the events created, patient
details/history and enter the Indication and Interpretation.
Choose to replay the whole examination or from a specific
event
Choose to scroll the spectrum back or forward
Choose to change the size of Trend Window
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Figure 9-3 VMR Study
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10. Evoked Flow Test in Unilateral or Bilateral Studies
10.1. Selecting Evoked Flow study
Enter Evoked Flow test using menu bar Studies, or Change study icon in
toolbar.
Evoked flow test is performed in a similar way as Monitoring: the
examination is done in Unfreeze Real time.
The examination can be further inspected in LOAD OFF LINE state.
10.2. Evoked Flow test setup
Evoked Flow Test setup is based on Monitoring Unilateral or Bilateral.
Size of Trend Window: The size of trends can be changed in the same way
as in Monitoring mode.
Figure 10-1 Size of Trend Window in Evoked Flow
Setting Evoked Flow events: The predefined events can be configured in
the same way as in Monitoring studies. The difference is that in
Evoked Flow there are two new predefined events: Start
Stimulation and Stop Stimulation. As in Monitoring, you can
define and add new events. Choose SETUP- STUDIES-Evoked
Flow and press the Events tab. The “EVENTS setup” form appears.
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Figure 10-2 Events Form in Evoked Flow study
10.3. Performing an Evoked Flow test examination
10.3.1.Beginning a new examination
To begin a new examination, press the UNFREEZE button. Perform a good
insonation, and press “RECORDING”.
10.3.2.Control state
At this stage the patient is in the control state and breaths normally. When a start
stimulating the brain the user need to press on “Start Stimulation” in the
PREDEFINED EVENTS area.
10.3.3.Test state
Perform the test by stimulating the brain. There will be a change in the flow. Wait until
you will see a change in the flow, at this moment press on the predefined event “Stop
Stimulation”. The Flow Change is automatically calculated in the upper right of the
trend window using the peak values selected by you in steps 10.3.2 “Control state” and
10.3.3 ”Test state”. You can end the test, or continue it by performing different
additional maneuvers and see the behavior of the peak values.
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10.3.4.Finishing the test
After the test was finished, press “STOP RECORDING” and “FREEZE”.
10.4. Further inspection of Evoked Flow test examination OFF LINE
You can inspect the recorded Evoked Flow unilateral or bilateral
examination off line. To do this, load a saved Evoked Flow test examination
and then you can perform any of the following actions (See figure 10-3):
Choose an event from the EVENTS HISTORY: Start
Stimulation Or Stop Stimulation or other. To do this double
click on the event in the EVENTS HISTORY window
Pay attention that when you choose an event it’s in PAUSE
state, so if you want to REPLAY, you have to press on
PAUSE/CONTINUE icon.
Choose to replay the whole examination or from a specific
event
Choose to scroll the spectrum back or forward
Choose to change the size of Trend Window
Figure 10-3 Evoked Flow Study
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11. Probe Holder use in Monitoring: Technical
description
The probe holder is used to attach the ultrasonic probes to the skull for continuous
monitoring. Proper use will enable stable signal acquisition for long periods. The
device is built of two separate parts. One is the frame; the second is the connecting
set for the probes.
WARNING
Remember that exposure levels should always be limited to as low as reasonably
achievable (the ALARA Principle).
WARNING
While monitoring patients for long periods, switching on (Unfreeze) only at
critical phases of surgery (or follow-up period) is preferred to continuous
monitoring.
Using the probe holder is easy if you keep in mind the following steps:
1. Attach the probe (or probes)
2. Put the frame on the patient’s head
3. Locate the temporal window
4. Lock the probe in place
5. Repeat for the other side
The frame is placed on the patient’s head. The connecting set enables positioning
of the probe on the patient’s skin, in the area where the ultrasonic window is
usually found. It is made of two arms: The first connects to the frame, the second
to the first arm. Both can rotate freely relative to the frame and to each other. Once
the probe is in the correct position and a signal is obtained, eccentric locks will
keep the arms in that position.
The probe is connected to the end of the second arm with a ball and socket
mechanism. This allows for changing the probe’s angle - to optimize the Doppler
signal. A third eccentric lock keeps that angle constant
Tips for use: It is very helpful to locate the temporal window before attempting to
put on the probe holder. Marking the area can help if the examination
is done a few hours prior to surgery.
Cleaning and disinfection: All parts can be cleaned and disinfected.
Recommended cleaning instructions are using water and mild soap for general
cleaning, followed by sterilization with FDA approved disinfecting solutions.
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Figure 11-1 Probe Holder
11.1.1.Operation guide
1. Connecting the probe:
Take off the handle from the probe.
Connect the probe to the screw protruding out of the device’s handle (Tip: screw it out
enough to be manipulated easily).
Make sure to tighten this screw against the probe’s surface.
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2. Frame adjustment:
Open the frame to its full extent (both horizontally and vertically).
Rimed suggests to take off the large rubber padding. A thin adhesive padding can be
ordered and put on the frame. This increases stability as it reduces empty spaces
between the frame and the skull.
Put the probe holder on the patient’s head, knob facing forward.
The back of the frame should rest low relative to the skull, to increase stability.
The front of the frame should be adjusted on the forehead, with the temporal ultrasonic
window in mind (too low would hide the window; too high decreases stability).
Remove hair that is caught between the frame and the skin.
Tighten the front knob, communicating with the patient. You need his/ her cooperation,
so check in advance that it is not painful. When the patient is unconscious, use the
minimal tension that gives good stability.
Tighten the upper knob, just enough to make good contact with the skull. Don’t over-
tighten, as this tends to “pull” the frame off the head and decreases stability.
3. Locating the TCD signal
Using sufficient quantities of ultrasonic gel apply the probe to the temporal window and
search for a signal.
Best results are achieved when the signal was located and marked before.
When starting to look for the signal, adjust the probe’s pressure against the skin to a
minimum. This would allow easy movement and “natural” searching.
After the best signal has been found, increase the probe’s pressure. Don’t overdo it the
probe should feel stable, but avoid causing pain. Remember that this pressure will be
held for a long period of time.
4. Locking
Locking on the signal is simple just move the small lever fully from unlocked position
to lock.
However, before attempting to lock, you should feel that the probe “holds itself”. Avoid
exerting pressure on the probe before locking the elasticity of the frame will move it
from the optimal position. This is best learned by experimenting on you and colleagues
before rushing with the device to the operating room.
If after locking the signal changed and is not optimal, release the lever (with experience,
you can release it only halfway) while holding the probe in position. Adjust the signal
again and lock in place.
Additional operating tips:
Removing the mechanism on one side:
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When only unilateral monitoring is needed (during carotid endarterectomy, for
example), you can take off the mechanism from the other side. To do this, make
sure that the locking lever is in the unlocked position. Then unscrew the large,
notched cap that is connected to the frame. Put the mechanism in a secure place
until needed again.
Before re-connecting, check that the lever is in the unlocked position. Screw the
cap in place, until friction is felt. Do not over-tighten, as this can damage the unit
and will not add to stability.
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12. Setup configuration
The Setup Configuration menu allows the user to configure all system settings for
routine system operation.
The DIGI-LITE has a very powerful and user friendly setup menu, that gives the
possibility to change almost all the system’s characteristics, providing the
flexibility of using the system in multiple and various applications by different
users.
DIGI-LITE comes from the factory with a default configuration. However, if you
want to, you can customize the configuration to meet your needs. The setup
contains three main setup categories:
1. Patient Report Wizard: to configure the patient report
2. General Setup: to configure general system parameters
3. Studies Setup: to configure specific parameters for each
study separately
4. Save Study: to save a customized study as it was defined by
the user
12.1. Patient report wizard
To reach the Patient report wizard dialog box select SETUP-PATIENT REPORT
WIZARD from the SETUP menu. (See figure 12-1)
The patient report can contain details on hospital, patient and examinations. Each
user can configure the patient report according to his needs and choose what
information to display and what not.
There is a very friendly wizard that will help you to configure the patient report
according to your needs.
The wizard contains three dialog windows with configuration details. At the right
side of each window there are check boxes for each detail that can be inserted or
not to the patient report. To choose what information will appear in the report,
mark the appropriate box. At the left side there is a preview of the report, as it
looks, according to the actual chosen configuration. To configure the patient
report, fill each one of the three dialogs and then press NEXT. After filling the last
dialog press FINISH.
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The three dialog windows are:
12.1.1.First window: Report header and general
information
The first window contains the report header and the following general details:
Date display: mark this if you want to display examination date
Hospital details: mark this if you want to display hospital details
Hospital logo: mark this if you want to display hospital logo
Title display: mark this if you want to display the title: “TCD
Examination…”
Patient details: Full or Minimal: If you choose Full: all the details
will appear in the report. If you choose Minimal: only partial
information will appear.
Patient History: mark this if you want to display the patient
clinical history (as it was written in New patient form)
Examination history: mark this if you want to display a list of all
the examinations that were done for the selected patients in the
past
One Page Report: 1 page patient report. It includes only patient
details & clinical parameters table & signature that all & it
occupies one page only. For choosing 1 page Patient report you
should go to Setup -> Report Generator Wizard. Choose One-page
report checkbox. Patient History and Examinations History
deactivated. In Patient Details Minimal radio-button is checked
automatically.
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Figure 12-1 Patient Report first Dialog box
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12.1.2.Second window: Examination display
The second window contains two check boxes that define examination display
configuration, as follows:
Summary Screen: mark this if you want to display the summary
screen of the actual examination with all the spectrums appearing
in the summary screen
Table Report: mark this if you want to display a table containing
information on the actual examination with the clinical parameters
for each blood vessel, as appears in the summary screen, but
without the spectrums’ pictures
Mark both Summary Screen and Table Report: if you want to
display both in the patient report
If you don’t mark any of the two options, no pictures and no
clinical parameters will appear for the actual examination
Figure 12-2 Patient Report second Dialog box
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12.1.3.Third window: Report footer
The third window is the report footer and it contains operator and doctor’s
comments and signature for the actual examination. All these comments will be
written after the specific examination was done, and you want to build the patient
report. It contains the following three check boxes:
Indication: mark this if you want to display indications for the
actual examination
Interpretation: mark this if you want display interpretations for the
actual examination
Signature: mark this if you want to add doctor’s manual signature
to the patient report for validation. The signature can be added
only manually, after printing the report.
Figure 12-3 Patient Report third dialog box
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12.1.4. One Page Report Option
The one-page Report option includes only patient details & clinical parameters
table & signature that all & it occupies one page only. For choosing 1 page Patient
report you should go to Setup -> Report Generator Wizard. Choose One-page
report checkbox. Patient History and Examinations History deactivated. In Patient
Details Minimal radio-button is checked automatically. (See figure 12-4)
Figure 12-4 Patient Report first Dialog box (one page report option)
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Click on “Next” button. Summary Screen checkbox deactivated. Table report
checkbox deactivated also but always checked. (See figure 12-5)
Figure 12-5 Patient Report second Dialog box (one page report
option)
Click on “Next” button. Indication, Interpretation and Signature checkboxes
deactivated. But Signature checkbox always checked.
After creation of “one page report” has finished in Full Patient Report will appear
all changes.
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12.2. General Setup
To reach the General Setup dialog box select SETUP-GENERAL SETUP from the
SETUP menu. (See figure 12-6). The SETUP dialog box contains two areas: setup
explorer area with general setup items in the left side and configuration details for
the specific item in the right side. The setup item can be accessed either by
choosing the item from the SETUP menu, or by opening the SETUP menu and
selecting the item in the explorer left side.
12.2.1.Basic Configuration
The Basic Configuration dialog box contains parameters which determine how the
spectrums are displayed on your screen. It also contains sound parameters. To
reach the Basic Configuration dialog box select BASIC CONFIGURATION from the
SETUP- GENERAL SETUP menu. (See figure 12-6)
Figure 12-6 Basic Configuration
FFT Size: Sets the resolution of FFT spectrum analysis. A higher number gives a
higher level of detail. The recommended default is 256 points.
Enable Blood Vessels Default Depth: This check box gives the option either to
enable predefined depth for each blood vessel, or to keep the same depth
when performing insonation on next blood vessel. If you check this box,
the depth will change according to predefined values when changing
blood vessel. If you don’t check this box the depth will remain the same
giving the possibility to scan the blood vessels without skipping any part
of it. In this last case the depth will be manually changed only by the
user.
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Depth table: This table gives the possibility to define depth step and M-Mode
depth range for each one of the PW probes. You can set Minimum Depth
and Depth step, and the software will calculate Maximum Depth
according the following formula: Min Depth + Step * 64 = Max Depth
(all in millimeters). If you want wider depth range increase the step. The
default steps are 1 mm for 2, 4 and 8 MHz and 0.2 mm for 16 MHz
probes.
Sound Volume: Choose to hear sound either thru Loudspeaker or Headphones.
When headphone is selected the loudspeakers are silenced (mute
condition) and the opposite. Also sets the default sound volume, on a
scale of 0 (mute) to 20 (maximal volume), in the loudspeakers and
headphone.
12.2.2.Hospital details
The Hospital Details dialog box is used to input hospital information to be printed
as a header with each patient report printout. These details are optional, and used
only when this option is activated in the Patient Report wizard first screen. To
reach the hospital details dialog box select “Hospital details” from SETUP-
GENERAL SETUP menu. (See figure 12-7)
Figure 12-7 Hospital Details Configuration
Hospital / Institute Name: Hospital name.
Department Name: Department name.
Doctor Name: Name of responsible doctor.
Operator Name: DIGI-LITE operator name.
Notes: Other notes or information written by the user
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Hospital Logo: Hospital or any other logo may be entered here. Click on the
Browse button and select the Hospital logo picture in any standard
picture format.
12.2.3.DICOM & Worklist
The DICOM & Worklist tab is used to input server information to retrieve or send
data from/to the hospital server. The DICOM is used to push screenshots or the
Patient Report with DICOM protocol. The Worklist is used to retrieve a list of
patients. (See figure 12-8)
Figure 12-8 DICOM & Worklist Configuration
DICOM Setup: Please note that in order to be able to send data to DICOM server
and see appropriate menu items, you must set IP address and port of your
DICOM server inside the DICOM Setup. In order to confirm that all the
parameters are correct press on the ECHO Button.
Worklist Setup: Please note that in order to be able to retrieve data of patients
from the server and see appropriate menu items, you must set the IP
address and the port of your modality worklist server inside the Worklist
Setup. After that press Accept.
12.2.4.Blood vessel configuration
Blood vessel configuration allows the user to configure default settings for each
selected blood vessel. To reach the blood vessel defaults dialog box select “Blood
vessel defaults” from SETUP- GENERAL SETUP menu. (See figure 12-9)
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Figure 12-9 Blood Vessels Configuration
At the left side there is a list that displays all the blood vessels selected in the
study configuration for all the studies. It is possible to add new blood vessel or to
delete existent blood vessel.
Add new blood vessel. To add a vessel that is not shown in one of the
available vessels lists, click on the Add button (+ in the top of the blood vessel
list). A dialog box opens for you to type in the name of the vessel you want to add
(see Figure 12-10). You can also use this function if you use different names for
the cerebral blood vessels. Take care to use the exact spelling (including spaces
etc.) for arteries on both sides (to keep the summary screen well organized).
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Figure 12-10 Add New Blood Vessel
Blood Vessel Name: Fill in the name of the new blood vessel that you want to
define.
Side: Choose one of the following 4 options for blood vessel side: Left (only),
Right (only), Both Sides or Middle.
Location: Choose the location of the blood vessel from the options: Extracranial,
Intracranial or Peripheral.
Default Parameters for Selected Blood Vessels: Sets the default probe type,
depth, power, frequency scale, gain, sample volume width, filter, units,
angle, zero line position and direction of flow for each blood vessel
selected from the list. To set up the next vessel simply click on it, and
the settings for the previous vessel are saved. When a probe type of
either 4 MHz CW or 8 MHz CW is selected, the depth, width and power
are not activated. The angle is an estimation of the angle (in degrees)
between the ultrasound beam and the blood vessel, for calculations of
blood velocity from the Doppler equation for pulse wave mode. For
intracranial applications the default is 0 degrees. For Extracranial
applications the default is 45 degrees.
Display Spectrum: Determines whether the screen displays the blood flow
spectrum. If a V mark is not clicked, only the envelope will appear, but
no spectral display.
Display Envelopes: The type of envelope shown as default for each vessel. More
than one envelope may be selected.
Use Envelops For Clinical Parameters Display: Determines whether the screen
displays the clinical parameters only when the envelops are displayed, as
selected by the user in Display Envelopes check boxes (see details
above). If a V mark is not clicked, both forward and reverse flow clinical
parameters are displayed if the software detects both flows.
HITS Detection threshold: Sets the threshold intensity (in db) above the
background flow for emboli detection algorithm.
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WARNING
Do not use ultrasound intensities greater than 36% for trans-orbital examinations.
12.2.5.Next function configuration
Next function configuration allows the user to configure the next function as a
preprogrammed function that enables fast and automatic performance of several
actions using one click. To reach the next function dialog box select “Next
function” from SETUP- GENERAL SETUP menu. (See figure 12-11).
Figure 12-11 Next Function Configuration
Available functions: This list contains the available functions that can be
performed after pressing on Next function.
Next function by order of execution: This list contains the functions that were
selected to be can be performed after pressing on Next function. To add
new function in this list select the function in the Available functions list
and press ADD. To remove a function in this list select the function and
press REMOVE.
12.2.6.Remote Control
Next function configuration allows the user to configure the next function as a
preprogrammed function that enables fast and automatic performance of several
actions using one click. To reach the next function dialog box select “Next
function” from SETUP- GENERAL SETUP menu. (See figure 12-11).
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Figure 12-12 Remote Control Configuration
Available functions: This list contains the available functions that can be
performed with F1, F2.
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12.2.7.Summary screen configuration
Summary screen configuration allows the user to configure what spectrums will be
sent to the summary screen. To reach the summary screen dialog box select
“Summary Screen” from SETUP- GENERAL SETUP menu. (See figure 12-12).
Figure 12-13 Summary Screen Configuration
Add all open spectrums: Choose this option if you want to send to the summary
screen all the examined spectrums. This is useful if you make several
measurements for the same blood vessel.
Add only selected spectrum: Choose this option if you want to add only the
selected spectrum for each examination. This can be for the same blood
vessel or not. This option is useful if you don’t want to add all the
examined gates to the summary screen.
Customize multiple tests on same blood vessel and depth: Choose this option if
you want more customization for the case that several measurements are
done for the same blood vessel (in different depths, for example). One of
the following three options can be chosen:
Replace old: Choose this if you want to have only one recording
for each blood vessel. In this case the previous examination will be
replaced by the new one.
Add new:
Ask for each test: A dialog box will appear after going to freeze
state (from the second measurement to the same blood vessel). You
can choose to replace the previous examination, add the new one, or
discard the new one.
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Save only summary images: choose this option if you want to save space disk.
This option only saves the images without any replay. (see section
12.2.6)
12.2.8.Economic data saving:
As you can see in the next image, in the "General setup" "Summery screen", there is a
new check box with the caption of "Save only summary images (No replay option)". As it
title suggest, checking this option will cause that by default, only the last image of an
examination, the images that will be shown at the summary screen and the patient report
will by saved. After you save the examination you will not be able to "replay" this blood
vessel but only to watch the static images.
Figure 12-14 Summary Screen Configurations (Economic Saving)
- Overwrite the default behavior
No matter what was your choice in the previous window, you can always overwrite it. After
you perform "Unfreeze" on a specific blood vessel you will see that a new icon will pop up
to the left of the BV name (see figure 12-14). An icon with a floppy disk means that the
"Replay Data" will be saved for this BV. If you see a "Stop" warning sing on the floppy
disk that means no replay data will be saved.
Clicking the icon will change its "Value".
There is also an option to do the same, by performing the same operation but from the
summary screen window (see figure 12-15). This is very useful when the user ending the
procedure and go to the summary screen. Now he can select the most interesting part of the
examination (The ones that there a good chance he would like to replay).
Important note: Notice that at any case, if you don't delete the BV from the summary screen
you will always be able to see it statically by reload the examination from the HD.
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Figure 12-15 selecting the saving mode per BV on the main screen
Figure 12-16 selecting the saving mode per BV on the summary
screen (for the same examination)
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At "Replay" mode you will see an indication (Again, by using the same "Floppy disk" icons
at the same location) that will point out if you can replay this BV. Notice that if the replay
data was not saved, the ability to replay the BV includes the buttons, the space bar and the
remote control button will be blocked.
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12.2.9.Clinical parameters trends / external channel configuration:
The user can configure the trends/channels by using the "General setup" "Channel configuration"
screen. This allows the user to configure some parameters. In case of a channel that represent a
clinical parameter channel (see figure 12-16) the first 4 channels it will like this:
Figure 12-17 Channel Configuration first steps
According to the number (1,2,3,4,5) :
1) The name of the channel/trend. In case of clinical parameters this name is hard coded
and can not be replaced.
2) Minimum and maximum values That will be the values that you expect to see in the
examination. The values that you enter are will influence directly on the scale of the
trends. Values outside of the ranges will not be showed at all.
3) Color simply enable you to choose the color of the trend in the window
4) Alarm this option will allow (in the future) invoking an alarm when the values of
the parameter are out of predetermined values that you enter in this window. In this
version the option is disabled and there no use to enter any values.
5) The entry point for the channels setup.
In case of selecting External channel you will able to set additional parameters
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Figure 12-18 Channel Configuration second steps
1) Channel name in case of external channel you can modify the name of the channel. As
mentioned before you will see it in the trend window. You will also see this name in the
study-trends setup (see later in this document).
2) Channel number actually this one is hard wired, but will help you to remember the physical
channel that wired to the logical name you gave it
3) Linear scaling this important setting allows you to determine how the analog signal from
your device will be normalized to the expect values in the trend window.
- Calibration: This step transforms the graph to one with the correct numbers. It is
done separately for each external instrument. Calibration ends when the numbers on the
Digi-Lite trends are the same as the numbers on the external instruments. The following
instructions relate to calibrating trends from blood pressure measurements, as an
example.
To calibrate an external channel, follow the step described below (an example of values
derived from a blood pressure monitor are given)
1) Check (setup general setup- channel Configuration: ExternalChannelName ) that the linear
scaling shows 1 * X + 0. If it shows 0 * X + 0, nothing will be showed except a straight line.
2) Start recording in monitoring mode. In the trend window, a signal from the external
instrument should appear. If you see only a straight line at zero, stop and enter setup again.
Change the linear scaling to -1 instead of 1. This will change the wave phase in 180.
3) Write down the minimum and maximum values shown on the external instrument. Calculate
the difference d1= Extmax- Extmin.
4) Stop recording. Load the examination from memory. Measure minimum and maximum values
for the trend graph. Calculate the difference d2 = Trendmax - Trendmin.
5) Calculate: a =
2
1
d
d
.
6) Insert the value of “a” instead of “1” in linear scaling.
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7) Start the recording again. Write down a single reproducible value (maximum blood pressure,
for example).
8) Stop recording. Load. Measure the same value. Calculate b = Ext - Trend.
9) Insert “b” in linear scaling (in the right-side box, instead of the previous o).
10) Check again. Now the numbers should fit.
Numerical Example:
1) Suppose that a blood pressure measuring instrument shows BP of 120/80 mmHg. In step 3,
you calculate d1 = 120 - 80 = 40.
2) On the trend window, you measure 50/30. In step 4, you calculate d2 = 50 - 30 = 20.
3) Step 5 gives a =
20
40
2
1=
d
d
= 2.
4) After changing the setup so that the linear scaling is 2 * x + 0, you get on the trend window a
graph showing 100/60. If systolic BP remains at 120(g), you get in step 8: b = 120 -
100 = 20.
5) After changing the setup so that the linear scaling is 2 * x + 20, both instruments should show
a BP of 120/80.
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12.2.10.Print settings
Print settings are used to configure printing operations. To reach the Print
Configuration dialog box select “Print Configuration” from SETUP- GENERAL
SETUP menu. (See figure 12-18).
Figure 12-19 Print Configuration
Printing Layout: Allows selection of preferred printing layout. Spectrum screens
may be printed either 1, 2, 4, or 6 per page.
After sending a spectrum screen for printing, a message appears:
“Spectrum sent to print buffer”. Only when the last spectrum is sent, the
printer will start printing.
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12.2.11.Exporting clinical parameters in monitoring and
VMR studies to excel
This option working In monitoring Unilateral, Bilateral and VMR Unilateral,
Bilateral studies this feature is implemented
Please follow the screens bellow
From main-menu enter the tcd system
go to setupgeneralexport to excel
Figure 12-20 Export To Excel
Choose your preferred interval of sampling 2 sec, 30sec or 1 min and after that
press the OK button
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12.2.11.1. Perform a test in one of your preferred studies (mentioned above)
12.2.11.2.After recording the examination is finished perform the following steps
to receive the excel file
12.2.11.3.Go to PatientExportExport trends to excel
Figure 12-21 Export to Excel Menu Bar
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12.2.11.4. Save the excel file (identify the file by patient name and date) in an
external device (such as disk on key)
Figure 12-22 Export To Excel Saving Bar
12.2.11.5. After saving the test in the disk on key you will be able to open the file
using Microsoft-excel in any personal computer
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12.3. Studies configuration
1. To reach the Study Configuration dialog box select SETUP- STUDIES
from the SETUP menu. (See figure 12-22).
2. In the left side of the SETUP dialog click on the study you want to
customize: default or customized: Intracranial, Extracranial or Peripheral.
3. Then click on a tab at the top of the right side of the SETP dialog box to
choose the item to be configured, as detailed above:
12.3.1.Select blood vessels
Select blood vessels configuration allows the user to define blood vessels for each
type of study by order of examination. The blood vessels selected appear in blood
vessels list and on the summary screen for that type of study.
You can customize the blood vessel list as follows:
1. First select the study to be configured in the SETUP explorer side (left
panel)
2. To reach the Select Blood Vessels dialog box press on first tab (the
leftmost) in the right panel of the selected study dialog box
3. The right panel will display the Select blood Vessels dialog box (figure
12-22)
4. The right panel contains the following information: in the left side:
Available BVs: a list with the names of all the defined blood vessels. The
list in the right side: BVs Order: shows the blood vessels which are
displayed in the selected study by order of appearance.
5. To add a blood vessel to the study display, select the name of the blood
vessel in the list Available BVs, then click Add.
6. To remove a blood vessel from the study display, select the name of the
blood vessel in the list BVs Order, then click Remove.
7. To change the order of the blood vessels displayed, use the “Move Up”
and “Move Down” buttons.
8. When you have finished configuring the study, click OK to activate the
changes, or “Cancel” to cancel the changes.
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Figure 12-23 Select Blood Vessels
Intracranial/Extracranial/Peripheral: Choosing one of these options shows
different lists of available blood vessels in Available BVs list, from
which specific arteries can be chosen and moved to the right column.
BVs Order: A list of the blood vessels by order of appearance for routine
examination in the spectrum screen or display in the summary screen.
This list determines the preset order of examination when you go back
to the examination screen the blood vessel list will be arranged
according to this order.
12.3.2.Clinical parameters
Clinical Parameters dialog box allows you to select the clinical parameters to be
displayed and the order of appearance on the screen.
You can customize the clinical parameters as follows:
1. First select the study to be configured in the SETUP explorer side (left
panel)
2. To reach the Clinical Parameters dialog box press on second tab (from the
left) in the right panel of the selected study dialog box
3. The right panel will display the Clinical Parameters configuration dialog
box (See figure 12-23).
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4. The right panel contains the following information: in the left side:
Available Clinical Parameters: a list with the names of all the available
blood vessels. The list in the right side: Clinical Parameters By Order of
Appearance: shows the clinical parameters that are displayed in the selected
study by order of appearance.
5. To add a clinical parameter to the study display, select the name of the
parameter in the list Available Clinical Parameters, then click Add.
6. To remove a clinical parameter from the study display, select the name of
the parameter in the list Clinical Parameters By Order of Appearance, then
click Remove.
7. To change the order of the clinical parameters displayed, use the “Move
Up” and “Move Down” buttons.
8. When you have finished configuring the study, click OK to activate the
changes, or “Cancel” to cancel the changes.
Figure 12-24 Clinical Parameters Configuration
Available Parameters: Displays all clinical parameters available.
Clinical Parameters by order of appearance: Displays all clinical parameters
displayed on screen for the selected study.
 Add: To add a parameter for display, select one or more parameters from the
available parameters list and click on the  Add button.
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Remove: To remove a parameter from one of the display lists, select one or
more parameters and click on the Remove  button. If the display lists
are already full, parameters must be removed first in order to allow
selection of a new parameter to be added.
Move Up/Move Down: These 2 buttons are used to move a selected parameter in
the display lists up or down the list. This will change the order of
appearance on the screen.
12.3.3.HITS setup
The HITS setup dialog box is used to define parameters that are related to
detection and counting of High Intensity Transient signals (HITS). To see it,
choose SETUP- GENERAL-HITS SETUP.
Figure 12-25 Hits Setup
HITS Threshold: This variable sets the threshold level for HITS detection. The
threshold, in dB, relates to the difference in the Doppler intensity
between the intensity of the suspected HITS event and the intensity of
the average blood flow spectrum prior to the suspected HITS event. A
low threshold may result in artifacts recognized as HITS, while a high
threshold may miss low energy embolic signals. For normal operation a
threshold in the range of 10dB is recommended.
Histogram Steps: The number of HITS (suspected embolic events) can be
displayed on a histogram as a function of HITS intensity levels above the
blood intensity, in dB. This option allows the user to set the step sizes
(in dB) in the histogram display.
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While performing HITS detection, the following is recommended:
1. Achieve a reasonable signal: Adjust the gain so that the peak
envelopes follow the signal well. Intensity colors should be in
mid-range (not too faint, not too bright).
2. Adjust the range so that the signal captures about tow thirds of
the window height, leaving enough dynamic range for high
velocity signals.
3. Reduce Thump to minimum (3 cm/sec or 100 Hz). This is best
done through Setup-Blood Vessel defaults, so that you do not
have to remember changing thump each time you enable HITS
detection. To change thump on real time, use the “1” or “2”
keyboard buttons (“1” to decrease, “2” to increase).
12.4. Save Study
To reach the Save Study dialog box select SETUP-SAVE STUDY LAYOUT from
the SETUP menu. (See figure 12-25)
Figure 12-26 Save Study Layout
To define a new study, perform as follows:
1. First select an existent study (default or custom) in the STUDIES menu.
2. Then add or remove spectrums or M-Mode windows until you reach the
desired layout.
3. Then press on SETUP- SAVE STUDY Layout. The SAVE STUDY dialog
box will open (see figure 12-24).
4. The study type that you are in will be written.
5. Write the name of the new study in STUDY NAME.
6. Click OK to save the new defined study or “cancel” to cancel the changes.
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12.5. Delete Study Layout
For delete some layout you should go to Setup -> Delete Study Layout. Once
“Delete Study Layout” window is opened, choose required Study from which you
want to Delete Layout, choose necessary Layout and click on Delete button. If you
are currently using layout that you want to delete, then you can not do it. First, you
need to go to any other layout and then begin the process of removal. Default
layout can’t be deleted.
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13. Functions menu
Functions are used to perform operations on the actual displayed screen. See
figure 13-1.
Figure 13-1 Functions Menu
Actually, the functions menu can replace icon operation, if the user prefers menus.
As usual with Windows software, you can use the keyboard, clicking Alt + the
underlined letter, to open a specific menu. Continue pressing the “ALT” key,
while clicking on other letters as needed to open submenus.
Add Spectrum: Add new spectrum to the current display. The new spectrum will
be at the same depth as the current selected spectrum. The screen layout
change according to the number of windows, as follows:
1. One spectrum without M-Mode: one big spectrum will appear on the
entire screen (see Figure 13-2)
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Figure 13-2 One spectrum without M-Mode
2. One or two spectrums with M-Mode: a spectrum in the upper side and an
M-Mode in the lower side of the screen (see Figure 13-3)
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Figure 13-3 One spectrum and an M-Mode
3. Three or four spectrums with M-Mode: a big spectrum in the upper left
side, an M-Mode in the lower left side and small spectrums in the right
side of the screen (see Figure 13-4)
Figure 13-4 Four spectrums and an M-Mode
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4. From five to eight spectrums with M-Mode: a big spectrum in the center
upper side, an M-Mode in the center lower side and small spectrums in the
left and right sides of the screen (see Figure 13-5)
Figure 13-5 Eight spectrums and an M-Mode
M-Mode: Toggle (add or remove) M-Mode display. The M-Mode will always be
associated to the selected spectrum, his depth indication line will
indicate the depth of this spectrum and the width indicator is according
to selected spectrum width. The M-Mode will appear below the selected
spectrum.
Cursors: Inserts a grid on the spectrum screen. This is useful when you want to
perform calculations related to the spectrum. The cursors option can be
activated while in the freeze state in the spectrum screen. When you
select this option, two sets of cursors appear on the screen, horizontal
and vertical. In each pair, one cursor is solid (master cursor) and the
second is dotted.
Pressing the up/down or right/left arrows moves the solid lined cursor.
To move the second cursor click on one of the two new icons those
appear next to the patient’s name: horizontal or vertical. This toggles
between the two cursors. The cursors can also be moved simply by
clicking on the cursor you want to move and dragging it with the mouse
to another position.
The cursor’s position is shown in a window next to the end of the cursor
line. The difference between each pair of cursors is also displayed.
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The spectrum energy distribution is shown in a separate window on the
right hand side of the screen. The energy distribution relates to the
master vertical cursor, and the display changes with each cursor
movement.
The values of E1 and E2 (in dB) shown above the distribution window
relate to the position of the two horizontal cursors. In bilateral and
multigate mode study types two pairs of cursors appear in each spectrum
window, and cursor movement is done simultaneously in both windows.
Similarly, two distribution windows, one per spectrum window, are
shown
Notes: Allows you to write text in the form of a short report or diagnosis which is
saved and/or printed with the spectrum screen or summary screen. This
option opens a window where you can enter text. You can return to this
window at any time in order to add, modify or delete previously inserted
text.
HITS detection: Enables the HITS detection algorithm, which records, marks and
counts the HITS events detected in the spectrum. HITS (High Intensity
Transient Signals) are usually considered as micro-emboli flowing in the
blood stream. HITS detection is available only for 2 MHz PW probes.
When active, the HITS counter is updated every time the system
recognizes HITS. In addition, when HITS is enabled, a histogram is
displayed at the right hand side of the screen. The histogram displays the
number of HITS as a function of HITS energy above the mean blood
flow energy. The toolbar also displays the Reset and Pause buttons
which pause and reset the HITS counter.
Next BV: Displays the next blood vessel in the series.
Previous BV: Shows the previous Blood Vessel
Summary: The summary button brings you to the summary screen of the current
mode study type. To return from the summary screen display back to the
spectrum display press the Return button.
CAUTION
Remember that exposure levels should always be limited to as low as reasonably
achievable (the ALARA Principle).
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14. Calculations
14.1. Calculation of clinical parameters
There are two sets of calculated clinical parameters, one for PW mode and one for
CW mode. All parameters are averaged over the number of cardiac cycles that are
displayed on the screen. The accuracy of the calculations is +/- 5%.
14.1.1.Intracranial examinations parameters
Peak: Maximal systolic frequency/velocity in KHz or cm/s.
Mean: Mean frequency/velocity calculated for ten cardiac cycles over the
envelope of the spectrum. The envelope designates maximal
frequency/velocity at any given time; therefore, Mean represents the
average maximal frequency/velocity over the cardiac cycle. If a
horizontal line was to be drawn at the calculated mean
frequency/velocity level, then the area of the envelope above the mean
should equal the area below the mean. Mean is measured in KHz or
cm/s.
DV: DV stands for the diastolic velocity, which is calculated as the minimal
end-diastolic velocity of the spectrum envelope in KHz or cm/s.
PI PI represents Gosling’s pulsatility index, and is calculated based on the
envelope parameters to define the pulsatility nature of the blood flow
velocity.
PI = (Peak - DV) / Mean.
RI RI represents Pourcelot’s resistance index, and is also calculated based
on the envelope parameters to define the pulsatility nature of the blood
flow velocity and changes in distal resistance.
RI = (Peak - DV) / Peak
S/D S/D, or the systolic to diastolic flow ratio, is another way to describe the
pulsatility nature of the blood flow velocity and changes in distal
resistance.
S/D = Peak / DV
HR HR, or heart rate, indicates the number of cardiac beats per minute.
HITS HITS, or high intensity transient signals, is the total count of such
signals within the blood velocity spectrum. To differentiate HITS, which
are considered as micro-emboli, from artifacts, HITS are identified as
high energy signals with energy above the background blood energy,
short in duration, unidirectional, and appearing anywhere in the
spectrum.
LR L.R. or Lindegaard Ratio, indicates the ratio of blood flow velocity in
two different arteries - The MCA and the ICA.
L.R. =Mean_velocity(MCA) / Mean_velocity(ICA)
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14.1.2.Extracarnial examinations parameters
Peak: Maximal systolic frequency/velocity in KHz or cm/s.
Mode: Frequency/velocity of the FFT cell with maximal energy during peak
systole in KHz or cm/s.
Average: Frequency/velocity of the FFT cell with the average energy, calculated
during peak systole in KHz or cm/s.
DV: DV stands for the diastolic velocity, which is calculated as the minimal end-
diastolic velocity of the spectrum envelope in KHz or cm/s.
PI: PI represents Goslings’ pulsatility index, and is calculated based on the
envelope parameters to define the pulsatility nature of the blood flow
velocity.
PI = (Peak - DV) / Mean
RI: RI represents Pourcelot’s’ resistance index, and is also calculated based on the
envelope parameters to define the pulsatility nature of the blood flow
velocity and changes in distal resistance.
RI = (Peak - DV) / Peak
S/D: S/D, or the systolic to diastolic flow ratio, is another way to describe the
pulsatility nature of the blood flow velocity and changes in distal
resistance.
S/D = Peak / DV
HR: HR, or heart rate, indicates the number of cardiac beats per minute.
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15. External Signals
15.1. Digi Lite Analog Output
o Analog output range (0 - 4.096) V.
o Number of separated analog outputs 8 channel
o Permissible load impedance per each channel not less than 2kOhm
o Output voltage value is calculated according to equation
SCALE
VEL
vOUT *096.4=
,
o Velocity is calculated from signal voltage according to equation:
096.4
*vOUT
SCALEVEL =
o Where SCALE chosen scale in cm/s, VEL current positive
velocity value cm/s.
o Analog channels connector DB25F (same to PC connector for parallel printer)
o The DB25F connector pin out image is shown below in Fig. 14-1.
113
25 14
Figure 15-1 Analog channels connector pin out
o Analog channels connector pin-out:
GND pins 14, 15, 19…25.
Analog output pins 9...13, 16, 17, 18.
o Default function of analog output channels is positive envelope per each spectrum
window. The connector pin number and default function per each channel is shown in
the table below Figure 15-2.
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Analog
output
channel #
Connector pin
#
Unilateral mode
Bilateral mode
0
13
Spectrum window 1
Probe A (Green) spectrum
window 1
1
12
Spectrum window 2
Probe A (Green) spectrum
window 2
2
11
Spectrum window 3
3
10
Spectrum window 4
4
9
Spectrum window 5
Probe B (Yellow) spectrum
window 1
5
16
Spectrum window 6
Probe B (Yellow) spectrum
window 2
6
17
Spectrum window 7
7
18
Spectrum window 8
Figure 15-2. Connector pin number and default function per each
channel
o The spectrum windows layouts are shown in Fig.15-3 and Fig.15-4
Spectrum 1
Spectrum 2
Spectrum 3
Spectrum 4
Spectrum 5
Spectrum 6
Spectrum 7
Spectrum 8
M-Mode
Spectrum i
Figure 15-3 Spectrum windows layout in Unilateral study
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M-Mode
Spectrum 1
Spectrum 2
M-Mode
Spectrum 1
Spectrum 2
Figure 15-4 Spectrum windows layout in Bilateral study
15.2. Digi Lite Analog Input
Analog signal input range from minus 5V till +5V relative GND (pins 14, 15,
19…25).
Number of separated analog inputs 8 channels. Inputs via connector Fig. 15-1
Channel #1 pin 1, Channel #2 pin 2, Channel #8 pin 8.
Positive full scale number + 32767, negative full scale number minus 32768
Displayed range should be scaled via general setup.
15.3. Cleaning and decontamination of 4mhz and 8mhz probes
The sterilization that recommended by the manufacturer is:
1. The preferred sterilization method is ethylene oxide gas at low
temperature up to max 55° Celsius at low pressure up to max. 5. 5
bar.
2. Also certain aqueous disinfectants and alcohol impregnated wipes
are most preferred for disinfecting.
3. Further the probes tested with 10 cycles of high pressure ETO
sterilization at 55° Celsius and 5,5 bar for 30minutes. After
measuring the probes before and after sterilization there was no
damage at the probes.
The measurements showed: all acoustic and electric data were
unchanged and identical to the data before the sterilization tests.
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The concluding to sterilize on these two ways come after checking
the probes in different procedures that not recommended.
1. In general, due to the combination of plastics, rubber or rubber
like items, together with various internal metals and electronic parts
the preferred decontamination by the DHSS method (not steam)
cannot be used.
2. The probes were totally immersed in fungicidal, virucidal aqueous
solutions as:
Gigasept 5% for 1 hour and for 16 hours
Gigasept 10% for 1 hour and for 2 hours
Buraton 1% for 1 hour and for 4 hours
Buraton 2% for 1 hour and for 16 hours
In each case the plastic housing and acoustic windows of the probes
had slightly softened at their surfaces. After rinsing with water and
drying them carefully, and after about 1 hour, they had returned to
their former hardness.
Some liquid had entered via cables, connectors and buckling pieces.
Putting the probes into the heater at 60° Celsius for abt.1 to 2 hours
will get the liquid out.
Thereafter the measurements showed all acoustic and electric data
unchanged and identical to the data of before the immersion tests.
However, the requirements to meet the safety standards concerning
patient applied parts do not allow total immersion in aqueous
solutions e.g. as described herein.
15.4. Probes Visual Inspection After Cleaning
Visual inspection of the probes including the cable and the connector after
the cleaning and decontamination procedure: carry out checking by sight for
damage and wear or tear. The coating of the probe must not be damaged (if
needed check by sight under a microscope).
In case of no damage is seen, test the probe with Digi-Lite Doppler
device for a signal.
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16. Sending Data to DICOM Server
Enter in the SETUP-GENERAL-DICOM & Worklist the following parameters of
the DICOM setup (IP address of the PACS, Port Number of the PACS, AE Title of
the PACS, and the local AE of the system.). See Figure 12-8
Figure 16-1 Final Patient Report - DICOM Export
After you have filled the DICOM setup and checked if the connection is good
(press on ECHO button and verify you get the message "Echo test PASS"),
Then you are able to use the button in the final patient
Report in order to send the report to the PACS. See Figure 16-1
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17. Retrieving Data from the Server with Modality
Worklist
Enter in the SETUP-GENERAL-DICOM & Worklist the following parameters of
the Worklist Setup (IP address of the PACS, Port Number of the PACS, AE Title
of the PACS, and the local AE of the system.). See Figure 12-8
Figure 16-2 Modality Worklist
After you have filled the Worklist Setup and pressed "Accept", Then you are able
to use the Worklist. On the top menu bar press "Patient" "Work List".
(See Figure 16-2)
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18. Packing the system and system components for
shipping
Rimed ships the DIGI-LITE™ system in a box measuring 45 cm X 40 cm X 30
cm, on a wooden pallet used for shipping. This box includes three foam guards for
protecting the components, plus a separate foam guard for the probes. It is
essential to ship the equipment to Rimed using the original packing materials,
including the wooden pallet.
Caution:
If you do not have all of the original packing materials, contact Rimed Ltd.
To pack the system in its original box, proceed as follows.
1. Carefully place the console in the foam guard.
2. Place the middle foam guard on top of the system console. It should fit snugly, with
the compartments on the upper side.
3. Place the system console in the box guard, if there is any extra material you want to
send to Rimed, put it in the extra space on the foam guard above the console.
4. Place the probes in the special foam guard provided for that purpose.
5. In the middle foam guard, place the remote control, power cable, keyboard, probes
and foot switch
6. Close the box and seal it with packing tape.
7. Place the box on a wooden shipping pallet and secure the box to the
pallet with plastic bands.
The system is now ready to be shipped.
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19. FAQ
19.1. The LCD showing white\gray\only light on the screen.
1) connect external monitor
2) press DEL key and turn on the system to get in the BIOS
3) go to "ADVANCED CHIPSET FEATURES" line and press ENTER
4) go to "BOOT DISPLAY" line and press ENTER
5) go with the arrows to CRT+LVDS and press ENTER
6) go to "PANEL TYPE" line and press ENTER
7) go to 1024X768 LVDS and press ENTER
8) PRESS F10 and y
9) press ENTER
10) press ENTER
11) the system will get in to the win xp then to the rimed software- -IF NOT YOU WILL NEED TO
REPLACE HD-CONTACT RIMED FOR SPARE PARTS
12) get out from the win software by clicking PATIENT- EXIT
13) on the WIN XP desktop click the icon of the LCD that you have on the win bar that is on the right side
of the win clock
14) go to GRAPHICS OPTIONS line and press ENTER
15) go to OUTPUT TO line and press it
16) click on INTEL (R) DUAL DISPLAY CLONE
17) and click MONITOR+NOTEBOOK
18) you will see the external monitor working and the lcd as well IF YOU DON'T SEE THE LCD
SCREEN (PLEASE SEE IF STAGE 19 IS OK IF NOT YOU WILL NEED TO REPLACE THE LCD
CABLE PLEASE CONTACT RIMED FOR SPARE PARTS
19) if after restarting the system you get in the bios and see that the data that your changes has been saved
it’s ok .if not you will need to replace the bios battery in the motherboard
20) if all this stages doesn’t help you will need to replace Motherboard- - CONTACT RIMED FOR SPARE
PARTS
DIGI-LITE USER MANUAL
RIMED LTD. Page 159
19.2. The LCD is showing black and there is no sound of windows rising.
1) When turning the system on dose the light in the main switch is on, does the fans working?
If not check the fuses or the power cable.
2) Connect an external screen and turn on the system while you are pressing the Del button down. Do
you see the bios screen?
If you see the Bios screen continue with the first question in the beginning of this
document.
3) Open the system by unscrewing the four screws from two sides of the system.
4) Check the voltages in the power supply, but first disconnect the DC power cable.
5) You will find the schematic chart and power table in the end of this document. If one of the outputs
is not in the boundaries of limitation you will need to replace the power supply.
6) If the power supply is in the limits reconnect the DC power cable and check the power in the
connectors of the hard drive, motherboard and the DHW card.
7) If one of the outputs is not in the boundaries of limitation replace the DC power cable.
8) If the power is in its limits unscrew rimed card and the motherboard and disconnect the
motherboard from Rimed DHW card.
9) Use an insulation plate to place the motherboard on and turn the power on.
10) If the screen is showing windows you will need to replace the DHW card.
11) If the screen is still black disconnect the hard drive and see if the screen showing the dos screen.
12) If yes replace the hard drive
13) If not replace the motherboard.
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19.3. When I turn on the system I can hear windows rising but the
LCD screen is showing black.
* see figure 17-3
19.4. When entering the software I receive Error to load DSP\FPGA
massage.
1) Reboot the system
2) If the massage is still showing close the system and check the connection between the DHW,
passive back plane and computer board.
3) If the massage is still showing check if you see any question mark in the device manger.
4) If you see an exclamation mark on the device inside the JUNGO directory try replacing the passive
back plane.
5) If it dose not help try to replace the DHW card.
6) If that dose not help replace the motherboard.
19.5. The background of the printed windows are consuming to
much black ink. How can we remove the background color?
1) Go to setup general print.
2) Mark the option no background.
3) In order to print without the background select the spectrum window you want to print by pressing
on it with right button and choose print.
4) Make sure that in setup general print. The option layout is on one if not you will need to
choose more windows to print as chosen in the layout option.
19.6. There is no sound in one direction of the probe (blue or red).
1) Open the system by removing the 4 screws from the two sides of the system.
2) Check that there is a shortcut between the two pins of each speaker cable when the cable is still
connected to rimed card.
3) If there is no shortcut between the pins of one of the speakers replace the faulty cable
DIGI-LITE USER MANUAL
RIMED LTD. Page 161
17.7. The TCD software fails or is stuck
1) Restart WINDOWS
2) Restart computer.
3) Close all the other applications when running TCD software.
4) Check if there is enough free space in your HARD DISK.
5) If there is less than 40MB free it is recommended to free up disk space. In order to know the
amount of free HARD DISK:
6) Double click “MY COMPUTER, click the disk “C”
7) On the “FILE” menu, click “PROPERTIES”.
8) If there isn’t enough free space, perform the following steps:
9) Empty the “RECYCLE BIN” – on the “DESKTOP”, double click the “RECYCLE BIN”. If you
don’t need the files listed, click the “FILE” menu, and then click “EMPTY RECYCLE BIN”
10) Use “SCANDISK” to check for errors on HARD DISK. Perform steps 2.5.1 and 2.5.2 from above.
In the window “C – PROPERTIES click TOOLS choose THOROUGH
AUTOMATICALLY FIX ERRORS after the procedure finished, delete “LOST FILES “ if you
are asked by the computer.
11) Back up and remove or uninstall from the disk unneeded files or software.
12) Look in directory “C:\WINDOWS\TEMP” (use “MY COMPUTER” or “WINDOWS
EXPLORER”). You can delete all the files beginning with “~”. Also you can delete all the other
unneeded files.
13) In DL software back up examinations to storage media, like CD-WR, or other. Use in “DL”
software the menu “PATIENT BACKUP MOVE EXAMINATION”.
14) For more details on freeing HARD DISK space, see WINDOWS HELP click “START – HELP”
15) Reinstall TCD software:
16) Reinstall DL software. Download latest DL software version from RIMED INTERNET site:
www.rimed.com menu “distributor entrance”. To download the software you need username:
login, and password: user. In the Web site press on download and download the latest software/
17) Check if there is a HARDWARE problem in your system:
18) Click “START – SETTINGS CONTROL PANEL” – double click on “SYSTEM”- open
“DEVICE MANAGER”
19) There is a list with all the hardware devices of the system. See if there is a yellow circled
exclamation point through an icon. If yes, this means the hardware has a problem.
20) In order to know what the problem is, select the device and press “PROPERTIES”.
21) If there is a faulty HARDWARE device, try to reinstall the device.
22) See WINDOWS “HELP” and “TROUBLESHOOT” for more details.
23) If there are problems to save, backup or restore examinations:
24) Check if there is enough free space in HARD DISK. If not, free space. For more details see par. 6.5
above.
25) Reinstall TCD software (first the same version, then, if the problem was fixed, you can upgrade the
software version).
DIGI-LITE USER MANUAL
RIMED LTD. Page 162
Figure 17-1 Voltage in Power Cable
No
Color
Max
V
Min
V
1
Red
5.2V
4.8V
2
Black
GND
GND
3
Blue
12.2V
11.8V
4
Yellow
N.C
N.C
DIGI-LITE USER MANUAL
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No'
Pin no'
Voltage
1
1
5V
2
2
5V
3
3
5V
4
4
GND
5
5
GND
6
6
GND
7
7
GND
8
8
12V
9
9
12V
10
10
-12V
11
11
12V
Figure 17-2 Voltage in Power Connector
Pin
1
DIGI-LITE USER MANUAL
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Figure 17-3 Block Diagram LCD
DIGI-LITE USER MANUAL
RIMED LTD. Page 165
20. Service Log-File
In order to improve our service and to find out where the
software is stuck we added a detailed log file that collects the
user clicks the sequence of operation and it will show the log file
using the following procedure:
From main-menu enter the tcd system
Patientexportexport log file
Save the file name "log file" in disk on key and send it by mail
to alon@rimed.com
Figure 18-1 Export Log File Menu
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21. Guidance and Manufacturer’s Declaration For
Electromagnetic Compability ( EMC )
for the DIGI-LITE according to EN 60601-1-2:2007
(Tables 1, 2, 4 and 6)
Table 1
Guidance and manufacturer's declaration electromagnetic emissions DIGI-LITE
The DIGI-LITE is intended for use in the electromagnetic environment specified below; The customer or the user of the DIGI-LITE
should assure that it is used in such an environment.
Emissions
test
Compliance
Electromagnetic environment -
guidance
RF emissions
CISPR 11
Group 1
The DIGI-LITE uses RF energy only for its internal function.
Therefore, its RF emissions are very low and are not likely to
cause any interference in nearby electronic equipment.
RF emissions
CISPR11
Class A
Digi-Lite is suitable for use in all establishments other than domestic,
and may be used in domestic establishments and those directly
connected to the public low-voltage power supply network that
supplies buildings used for domestic purposes, provided the following
warning is heeded:
Warning: This equipment/system is intended for use by healthcare
professionals only.
This equipment/system may cause radio interference or may be
necessary to take mitigation measures, such as re-orienting or
relocating Digi-Lite or shielding the location.
Harmonic emissions
IEC 61000-3-2
Class A
Voltage fluctuations/
flicker emissions
IEC 61000-3-3
Complies
DIGI-LITE USER MANUAL
RIMED LTD. Page 167
Table 2
Guidance and manufacturer's declaration electromagnetic immunity DIGI-LITE
The DIGI-LITE is intended for use in the electromagnetic environment specified below; The customer or the user of the DIGI-LITE
should assure that it is used in such an environment.
Immunity test
IEC 60601-1-2
Test level
Compliance
level
Electromagnetic
environment - guidance
Electrostatic discharge (ESD)
IEC
61000-4-2
±6 kV
contact
±8 kV air
±6 kV contact
±8 kV air
Floors should be wood, concrete
or Ceramic tile. If floors are
covered with synthetic material,
the relative humidity Should be at
least 30 %.
Electrical fast
transient/burst
IEC 61000-4-4
±2 kV for power
supply lines
±1 kV for input/output
lines
±2 kV for power
supply lines
Νot Applicable
Mains power quality should be that of a
typical public low-voltage power supply
network that supplies buildings used for
domestic purposes, commercial or hospital
Environment.
Surge
IEC 61000-4-5
±1 kV differential
mode
±2 kV
common
mode
±1 kV differential
mode
±2 kV common
mode
Mains power quality should be that of a
typical public low-voltage power supply
network that supplies buildings used for
domestic purposes, commercial or hospital
Environment.
DIGI-LITE USER MANUAL
RIMED LTD. Page 168
Voltage dips, short
interruptions and voltage
variations on power supply
input lines
IEC 61000-4-11
.
<5 %UT
(>95 %dip in
UT)
for 0,5 cycle
40 %UT
(60 %dip in
UT)
for 5 cycles
<5 %UT
70 %UT
(30 %dip in
UT)
for 25 cycles
<5 %UT
<5 %UT
(>95 %dip in
UT)
for 5 s
<5 %UT
(>95 %dip in
UT)
for 0,5 cycle
40 %UT
(60 %dip in
UT)
for 5 cycles
<5 %UT
70 %UT
(30 %dip in
UT)
for 25 cycles
<5 %UT
<5 %UT
(>95 %dip in
UT)
for 5 s
Mains power quality should be that of a
typical public low-voltage power supply
network that supplies buildings used for
domestic purposes, commercial or hospital
Environment.
If the user of the DIGI-LITE requires
continued operation during power mains
interruptions; it is recommended that
DIGI-LITE be powered from an
uninterruptible power Supply or a battery.
Power frequency (50/60
Hz) magnetic field
IEC 61000-4-8
3 A/m
3 A/m
Power frequency magnetic fields should be
at levels characteristic of a typical public
low-voltage power supply network that
supplies buildings used for domestic
purposes, commercial or hospital
Environment.
NOTE: UT is the a.c. mains voltage prior to application of the test level.
DIGI-LITE USER MANUAL
RIMED LTD. Page 169
Table 4
Guidance and manufacturer's declaration electromagnetic immunity DIGI-LITE
The DIGI-LITE is intended for use in the electromagnetic environment specified below; The customer or the user of the DIGI-LITE
should assure that it is used in such an environment.
Immunity
test
IEC 60601-1-2
Test level
Compliance
level
Electromagnetic environment - guidance
Conducted RF
IEC 61000-4-6
Radiated RF
IEC 61000-4-3
3 Vrms
150 k Hz to 80
MHz
3 V/m
80 MHz to 2,5
GHz
3
Vrms
3 V/m
Portable and mobile RF communications equipment
should be used no closer to any part of the
DIGI-LITE, including cables, than the
recommended separation distance calculated from the
equation applicable to the frequency of the transmitter
.
Recommended separation distance
d = 1.17P
d = 1.17P 80 M Hz t o 800 MHz
d= 2.34P 800 MHz t o 2,5 GHz
where P i s the maximum output power rating of the
transmitter in watts (W)according to the transmitter
manufacturer and d i s the recommended separation
Distance in meters (m).
Field strengths from fixed R F transmitters, as
determined by an electromagnetic site survey ,a should be
less than t he compliance level in each frequency
range .b
Interference may occur in t he vicinity of equipment
marked with the following symbol:
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RIMED LTD. Page 170
NOTE 1 At 80 MHz and 800 MHz, the higher frequency range applies.
NOTE 2 These guidelines may not apply in all situations .Electromagnetic propagation is affected by absorption
And reflection from structures objects and people.
a
Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless) telephones and land mobile radios,
amateur radio, AM and FM radio broadcast and TV broadcast cannot be predicted theoretically with accuracy. To assess the electromagnetic
environment due to fixed RF transmitters, an electromagnetic site survey should be considered. If the measured field strength in the location in
which the DIGI-LITE is used exceeds the applicable RF compliance level above, the DIGI-LITE should be observed to verify normal operation. If
abnormal performance is observed, additional measures may be necessary, such as re-orienting or relocating the DIGI-LITE.
b
Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m.
Table 6
Recommended separation distances between
portable and mobile RF communications equipment and the DIGI-LITE
The DIGI-LITE is intended f or us e in an electromagnetic environment in which radiated RF disturbances are
Controlled. The customer or the user of t DIGI-LITE can help prevent electromagnetic interference by maintaining
a minimum distance between port able and m obi le RF communications equipment (transmitters)and the DIGI-LITE
as recommended below, according t o t he maximum out put power of t he communications equipment .
Rated maximum output power
of transmitter
Watts [W]
Separation distance according to frequency of transmitter
Meters [m]
150kHz to 80MHz
d =
1.17
P
80MHz to 800MHz
d =
1.17
P
800MHz to 2.5GHz
d=
2.34
P
0.01
0.12
0.12
0.24
0.1
0.37
0.37
0.74
1
1.17
1.17
2.34
10
3.7
3.7
7.4
100
11.7
11.7
23.4
For transmitters rated at a maximum output power not listed above, the recommended separation distance d in meters
(m) can be estimated using the equation applicable to the frequency of the transmitter, where P is the maximum output
power rating of the transmitter in watts (W) according to the transmitter manufacturer.
NOTE 1 At 80 MHz and 800 MHz, the separation distance for the higher frequency range applies.
NOTE 2 These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection
from structures, objects, and people.
DIGI-LITE USER MANUAL
RIMED LTD. Page 171
22. Acoustic output report
The following tables indicate the acoustic output for the system and transducer
combinations. These tables are organized by transducer model and imaging mode.
The acoustic output for this ultrasound system has been measured and calculated in
accordance with “Acoustic Output Measurement and Labeling Standard for Diagnostic
Ultrasound Equipment” (AIUM - NEMA 1993).
The system does not exceed a spatial peak temporal average intensity (ISPTA) of 420
mW/cm2 for all imaging modes. (For either the Ophthalmic examination, the acoustic output
is limited to the following values: ISPTA does not exceed 17 mW/cm2; TI does not exceed
1.0, and MI does not exceed 0.057.)
Additionally, one means for meeting the ALARA principle (“as low as reasonably
achievable.”) is to set the MI or TI values to a low index value and then modifying this level
until a satisfactory image or Doppler mode is obtained. For more information on MI and TI,
see BS EN 60601-2-37:2007: Annex CC.
All intensity parameters are measured in water. Since water does not absorb acoustic energy,
these water measurements represent a worst case value. Biological tissue does absorb acoustic
energy. The true value of the intensity at any point depends on the amount, type of tissue, and
the frequency of the ultrasound passing through the tissue. The intensity value in the tissue, In
Situ, has been estimated.
DIGI-LITE USER MANUAL
RIMED LTD. Page 172
Acoustic output reporting table
Transducer Model 2MHz
Operation Mode: PW Doppler
Applications Transcranial
DIGI-LITE USER MANUAL
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Transducer Model 2MHz
Operation Mode: PW Doppler
Applications Ophthalmic Power 7%
DIGI-LITE USER MANUAL
RIMED LTD. Page 174
Transducer Model 2MHz
Operation Mode: PW Doppler
Applications Ophthalmic Power 14%
DIGI-LITE USER MANUAL
RIMED LTD. Page 175
Transducer Model 4MHz
Operation Mode: PW Doppler
Applications Peripheral Vessel
DIGI-LITE USER MANUAL
RIMED LTD. Page 176
Transducer Model 4MHz
Operation Mode: CW Doppler
Applications Peripheral Vessel
DIGI-LITE USER MANUAL
RIMED LTD. Page 177
Transducer Model 8MHz
Operation Mode: PW Doppler
Applications Peripheral Vessel
DIGI-LITE USER MANUAL
RIMED LTD. Page 178
Transducer Model 8MHz
Operation Mode: CW Doppler
Applications Peripheral Vessel
DIGI-LITE USER MANUAL
RIMED LTD. Page 179
Index
A
Abbreviations, 10
About command, 43
B
Back Panel
schematic, 22
Backing up data, 59, 68
Backup command, 39
Basic Configuration dialog box, 95, 96, 97,
99, 100, 107
Basic system components, 21
Bitmap, 71, 75, 76
Blood vessel configuration, 97
Blood Vessel Defaults dialog box, 97
BV
definition, 10
C
Calculation of clinical parameters, 122
Change probe
remote control key, 36
CHN/INFLT
remote control key, 36
Clinical parameters, 30
calculation, 122
Clinical parameters display
configuration, 112
Configuraiton
hospital details, 96
Configuration
basic, 95
blood vessel, 97
HITS, 114
print, 107, 110
study, 111
Configuring the system, 52
Connectors
back panel, 22
Contents command, 42, 43, 44, 45
Continuous Wave
calculation, 123
Conventions
typographical, 9
Cursors
icon, 45
Cursors command, 120
CW
definition, 10
D
Delete command, 39
Delete Patient dialog box, 60
DEPTH
remote control key, 31, 36
Depth down
shortcut key, 37
Depth up
shortcut key, 37
Display clinical parameters, 112
Display Clinical Parameters dialog box, 112
E
Electrostatic Discharge
caution, 14
Emboli
shortcut key, 37
Entering INTRA-VIEW, 52
ESC
remote control key, 36
Events Lise dialog box, 77, 81
Examination details
displaying, 58
Export command, 39
Extracranial mode, 63
F
F. RNG
remote control key, 36
FFT
definition, 10
Flush Printer command, 39
Foot switch
connector location, 22
Freeze
remote control key, 36
FREEZE
remote control key, 36
Frequency range
remote control key, 36
Frequency range down
shortcut key, 37
Frequency range up
shortcut key, 37
Frequently used function keys
remote control, 36
Functions menu, 42, 117
G
GAIN
remote control key, 31, 36
Gain down
shortcut key, 37
Gain up
shortcut key, 37
H
Hardware installation. See Installation,
Unpacking, See Installation, Unpacking
Help menu, 42
HITS
definition, 10
icon, 46
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HITS Configuration dialog box, 114
HITS configuration, 114
HITS detection command, 121
Hospital details configuration, 96
Hospital Details dialog box, 96, 98
I
Insonation depth
remote control key, 31, 36
Insonation power
remote control key, 31, 36
Insonation width
remote control key, 31, 36
Installation, 20
Intracranial unilateral mode, 62
Introduction, 8
K
Keyboard shortcuts, 37
L
Load command, 38
Load patient
icon, 45
Load Patient dialog box, 55
LOGGING ON, 52
M
Main function keys
remote control, 36
Main screen, 26
Main spectrum screen, 26
Manual
about, 8
Mean envelope peak
shortcut key, 37
Mean envelope reverse
shortcut key, 37
Menus, 38
MHz
definition, 10
Mode
icon, 45
Mode menu, 40
Monitoring, 72
N
Name
Patient Name, 29
New command, 38
New patient, 52
New Patient
icon, 45
Next BV command, 117, 120, 121
O
Operation, 26
Operation modes
setting, 61
Optional components, 21
Overview, 8
P
Packing list, 21
Packing the system, 13, 128
Parameters
clinical parameters, 30
Patient
adding, 52
deleting, 59
examination, 64
new, 52
saving profile and specturm, 66
Patient details
modifying, 55
Patient Details form, 53
Patient menu, 38
Patient Name, 29
Peak envelope
shortcut key, 37
Peak mean envelope display
shortcut key, 37
Power down
shortcut key, 37
Power up
shortcut key, 38
Precautions and warnings, 12
Print
icon, 45
PRINT
remote control key, 36
Print configuration, 107, 110
Print Details command, 39
Printing results, 70
Probe change
remote control key, 36
Probes
color coding, 23
connector locations, 23
Pulse Wave
calculation, 122
PW
definition, 10
PWR
remote control key, 31, 36
Q
Quick tour, 26
R
Remote control, 35
buttons, 35
Remote Control
connector location, 22
Remove cursor
shortcut key, 37
Restore command, 39
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RIMED LTD. Page 181
Restoring data, 59, 68
Return to spectrum screen
shortcut key, 37
Reverse envelope
shortcut key, 37
Reverse mean envelope
shortcut key, 37
Reverse spectrum flow
remote control key, 36
Rimed Ltd.
address, 12
telephone number, 12
RTN
remote control key, 36
S
Selected BVs, 30
Service department
address, 12
telephone number, 12
Setting up the system, 22
Setup configuration, 88
Setup menu, 41
Sound volume
remote control key, 36
Spectrum
examination, 64
modification, 64
Spectrum gain
remote control key, 31, 36
Spectrum parameter keys
remote control, 31, 36
Spectrum screen, 29, 30
shortcut key, 37
Standards compliance, 13
Study configuration, 111
Study Configuration dialog box, 88, 95, 111,
112, 115
Summary command, 121
Summary screen, 33
controls, 65
icon, 46
System components, 21
System dimensions and specifications, 12
System operation, 26
System testing, 24
System use, 51
System variables, 30
T
Table of Contents, 3
Toggle windows
remote control key, 36
Toolbar, 45
Typographical conventions, 9
U
Ultrasound Power Output
factors affecting, 19
Ultrasound Safety, 19
Unfreeze
remote control key, 36
Units button, 29
Unpacking, 20
Using the INTRA-VIEW system, 51
V
Variables
system variables, 30
VOL
remote control key, 36
Volume
remote control key, 36
Volume down
shortcut key, 38
Volume up
shortcut key, 38
W
Warnings, 12
Warnings and Cautions, 15
warranty
exceptions, 12
Warranty, 12
WDT
remote control key, 31, 36
Width down
shortcut key, 37
Width up
shortcut key, 37
Write
icon, 46
Write command, 121
Z
ZERO
remote control key, 36
Zero line down
shortcut key, 38
Zero line position
remote control key, 31, 36
Zero line up
shortcut key, 38
DIGI-LITE USER MANUAL
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