Angioscan Electronics AngioScan-01 User manual


AngioScan-01 Diagnostic Device of Cardio-Vascular System StateI
© 2014 AngioScan-Electronics LLC
Contents
Chapter I Introduction 2
................................................................................................................................... 2
1Technical Specifications
................................................................................................................................... 2
2Package list
................................................................................................................................... 3
3System Requirements
................................................................................................................................... 3
4 Operating Restrictions
................................................................................................................................... 3
5Warranty
................................................................................................................................... 3
6Developers Information
................................................................................................................................... 5
7Certificate in Regulatory Compliance
................................................................................................................................... 6
8FSR Registration Certificate
................................................................................................................................... 7
9Patent Certificate for Invention
Chapter II AngioScan Software Installation 9
................................................................................................................................... 10
1USB Driver Installation
Chapter III Quick Start 12
................................................................................................................................... 14
1Use of AngioScan with laptop
................................................................................................................................... 15
2Performance of PPG Contour Analysis
................................................................................................................................... 18
3Performance of Occlusion Test
................................................................................................................................... 22
4Performance of Pharmacological Test
Chapter IV AngioScan Medical Tests 27
................................................................................................................................... 27
1PPG Contour Analysis
..........................................................................................................................................................27
Patient preparation requirements
..........................................................................................................................................................28
Test procedure for contour analysis
..........................................................................................................................................................28
Contour test limitations
..........................................................................................................................................................29
Contour analysis test results
.........................................................................................................................................................30HR- HeartRate
.........................................................................................................................................................30AIp - Augmentation Index, peripheral
.........................................................................................................................................................31
AIp75 - Augmentation Index normalized to heart rate of 75 beats per
minute
.........................................................................................................................................................31CT - Pulse wave Contour Type
.........................................................................................................................................................34VA - Vascular Age
.........................................................................................................................................................34Stress Index
.........................................................................................................................................................36SpO2 - Blood oxygen saturation
.........................................................................................................................................................36SI - Stiffness Index
.........................................................................................................................................................38RI- ReflectionIndex
.........................................................................................................................................................39AGI - Aging Index
.........................................................................................................................................................40ED-EjectionDuration
.........................................................................................................................................................41%ED- Ejection Durationpercent
.........................................................................................................................................................41PD-PulseDuration
.........................................................................................................................................................41T1 - Time to 1st Peak
.........................................................................................................................................................41T2 - Time to 2nd Peak
.........................................................................................................................................................42dTpp
.........................................................................................................................................................42QI- QualityIndex
.........................................................................................................................................................43SPa - Systolic Pressure, Aortic
.........................................................................................................................................................43PI-PulseIndex
.........................................................................................................................................................43Level - Signal level

IIСодержание
© 2014 AngioScan-Electronics LLC
.........................................................................................................................................................43SIr - Reference Stiffness Index
.........................................................................................................................................................44TdVMax - Time of maximum blood filling rate
................................................................................................................................... 44
2Occlusion Test
..........................................................................................................................................................46
Patient preparation requirements
..........................................................................................................................................................46
Occclusion test procedure
..........................................................................................................................................................47
Occlusion test results
.........................................................................................................................................................47Occlusion indexes by sensor channel
.........................................................................................................................................................48Occlusion index by pulse wave amplitude
.........................................................................................................................................................49Phase shift
................................................................................................................................... 50
3Pharmacological Test
..........................................................................................................................................................52
Patient preparation requirements
..........................................................................................................................................................52
Pharmacological test procedure
..........................................................................................................................................................53
Pharmacological test limitations
..........................................................................................................................................................53
Pharmacological test results
.........................................................................................................................................................53Pharmacological test index by pulse wave amplitude
.........................................................................................................................................................53Contour analysis results
Chapter V Graphic Interface 55
................................................................................................................................... 56
1AngioScan windows
..........................................................................................................................................................56
Window "Patients Database"
.........................................................................................................................................................59EditNewPatientData
.........................................................................................................................................................60Sorting patients list
.........................................................................................................................................................60Quick search and history of patients selection
.........................................................................................................................................................62Search Database
.........................................................................................................................................................63DeletePatients
.........................................................................................................................................................64EditNewPatientData
.........................................................................................................................................................64Mark Several Records for Group Operations
.........................................................................................................................................................65Patients Database Window Setup
.........................................................................................................................................................66HTML file to save records
.........................................................................................................................................................67DatabaseFilterSetup
.........................................................................................................................................................70Histogrammes
.........................................................................................................................................................71Download Test Results
.........................................................................................................................................................72Export Scan Data
.........................................................................................................................................................73SimulateScan
.........................................................................................................................................................73Recalculate of Scan Results
.........................................................................................................................................................73Thumnails of PPG Contour Analysis Results
.........................................................................................................................................................74Trend Graphs
.........................................................................................................................................................75Transferring Scan Data Between the Patients
..........................................................................................................................................................76
"Measurements" Window
.........................................................................................................................................................78"PPGContourAnalysis"Bookmark
.........................................................................................................................................................82"OcclusionTest"Bookmark
.........................................................................................................................................................87"PharmacologicalTest"Bookmark
..........................................................................................................................................................91
"Console" Window
................................................................................................................................... 91
2AngioScan Main Menu
..........................................................................................................................................................92
"File" Menu
.........................................................................................................................................................93ConfigurationFiles
..........................................................................................................................................................93
"View" Menu
..........................................................................................................................................................93
"Configure" Menu
.........................................................................................................................................................93"AngioScan setup..." Dialog
.........................................................................................................................................93"General"Bookmark
.........................................................................................................................................95"Stand-alonedevice"Bookmark
.........................................................................................................................................96"Advanced" Bookmark
.........................................................................................................................................98"OcclusionTest"Bookmark
.........................................................................................................................................98"PharmacologicalTest"Bookmark
.........................................................................................................................................................98"Environment"Dialog
.........................................................................................................................................98"Fonts"Bookmark
.........................................................................................................................................99"Colors"Bookmark

AngioScan-01 Diagnostic Device of Cardio-Vascular System StateIII
© 2014 AngioScan-Electronics LLC
.........................................................................................................................................100"KeyMappings"Bookmark
.........................................................................................................................................100"Toolbar"Bookmark
.........................................................................................................................................100"Misc"Bookmark
..........................................................................................................................................................101
"Tools" Menu
.........................................................................................................................................................102"Calculator"Dialog
.........................................................................................................................................................103"Test statistics" Dialog
.........................................................................................................................................................103"ImportDatabaseReport"Dialog
..........................................................................................................................................................103
"Windows" Menu
..........................................................................................................................................................103
"Help" Menu
.........................................................................................................................................................104About AngioScan
.........................................................................................................................................................104"Check for updates..." Dialog
Chapter VI Appendix 106
................................................................................................................................... 106
1Information about AngioScan Database
..........................................................................................................................................................107
Database Backups
................................................................................................................................... 107
2Program Messages
..........................................................................................................................................................107
5002
..........................................................................................................................................................107
12129
..........................................................................................................................................................107
13002
..........................................................................................................................................................107
13006
..........................................................................................................................................................107
13009
..........................................................................................................................................................108
13012
..........................................................................................................................................................108
13015
..........................................................................................................................................................108
13017
..........................................................................................................................................................108
13025
..........................................................................................................................................................108
13027
..........................................................................................................................................................108
13032
..........................................................................................................................................................108
13033
..........................................................................................................................................................108
13043
.........................................................................................................................................................10813034
..........................................................................................................................................................109
13072
..........................................................................................................................................................109
13074
..........................................................................................................................................................109
13083
..........................................................................................................................................................109
13087
..........................................................................................................................................................109
13088
..........................................................................................................................................................109
13091
..........................................................................................................................................................109
13092
..........................................................................................................................................................109
13093
..........................................................................................................................................................110
13104
..........................................................................................................................................................110
13105
..........................................................................................................................................................110
13108
..........................................................................................................................................................110
13109
..........................................................................................................................................................110
13111
..........................................................................................................................................................110
13112
..........................................................................................................................................................111
13113
..........................................................................................................................................................111
13114
..........................................................................................................................................................111
13115
..........................................................................................................................................................111
13116
..........................................................................................................................................................111
13119
..........................................................................................................................................................111
13121
..........................................................................................................................................................111
13123
..........................................................................................................................................................111
"New users are found in the memory" Dialogue
..........................................................................................................................................................111
"Choose registration method" Dialogue
..........................................................................................................................................................112
"New test data found in memory" Dialogue
..........................................................................................................................................................112
"User Registration" Dialogue
Index 114

Chapter
I

2
© 2014 AngioScan-Electronics LLC
Introduction
1 Introduction
1. The User Guide (UG) is designed for customers and engineers working with AngioScan-01
Diagnostic Complex of Cardio-Vascular System State (further "AngioScan device" or
"AngioScan").
2. The User Guide contains all necessary information about operation and technical characteristics of
the device, about its preparation for work and exploitation rules. The information is important for use of
all technical options of the device and its right exploitation.
3. The device is designed for use by specialists after they study the User Guide.
4. As the device is being updated all the time, there might be some slight changes not reflected in the
present User Guide.
1.1 Technical Specifications
General Technical Specifications
The complex corresponds to technical requirements TU 9442-001-30577-000009020-2008, GOST Р
50444 and to design documentation's set.
The complex runs under IBM PC with minimum system requirements:
-Operating System - Windows 98/NT/2000/XP;
-Processor - Pentium III 500 MHz and over;
-Random Access Memory (RAM) 128 MB;
-Video Card SVGA Hi-Color 1024ґ768 8 MB or more;
-Color printer;
-Not less than 800 MB of free hard disk space;
-One free serial port and two USB ports;
-CD-ROM.
Basic parameters and dimensions
Number of channels for receiving and registering of two input signals - 2;
Primary transmitter is based on optoelectronic pair;
Range of input voltages, LEV, 5 - 100;
Channel noise level must not exceed mV, 100;
Frequency range of input signals, Hz, 0.5-130;
Unevenness of amplitude-frequency characteristics should be %, -30 to +5;
Supply voltage, V, 220. Power supply of primary conversion is to be done via personal computer;
The power consumed by the complex must not exceed VA 1.5;
Overall dimensions of the converter unit are, mm:
- Width - 60;
- Length - 75;
- Height - 15.
Weight of the unit converter is, kg, 0.5.
1.2 Package list
AngioScan-01
device
1
Photoplethysmograp
hy sensor
2
Interconnecting
cable (mini USB)
1
Basic Software (CD-
ROM)
1

Introduction 3
© 2014 AngioScan-Electronics LLC
Instruction manual
1
1.3 System Requirements
AngioScan software runs under the following operating systems:
Operating
System
32-bit
64-bit
Windows XP
Windows Vista
Windows 7
Windows 8
1.4 Operating Restrictions
1. As there might be significant temperature fluctuations in stocks and working premises, received from
the stock AngioScan device should be kept packed for several hours (not less than 2 hours) in normal
conditions.
2. If AngioScan device was stored in high humid area, it should be kept packed for 6 hours in normal
conditions.
3. When unpacking AngioScan device, check its completeness in accordance with the specification.
4. The tests should be performed 1 minute or more later, after switching on the AngioScan device
connected to computer via USB port.
1.5 Warranty
"AngioScan-Electronics" Ltd. guarantees an excellent performance of AngioScan-01 device for 24
months since the date of sale to a consumer, if all conditions and rules of exploitation, transportation
and storage are observed as specified in instruction manual. During the warranty period, the
manufacturer provides free repair of the device in case of any malfunction being the fault of the
manufacturer.
1.6 Developers Information
"AngioScan- Electronics" LLC.
16, Baumanskaya, Moscow, 105005 , Russia
Tel.+7(495)662-1150
E-mail: [email protected]
Web: www.angioscan.ru/en

4
© 2014 AngioScan-Electronics LLC
Introduction

Introduction 5
© 2014 AngioScan-Electronics LLC
1.7 Certificate in Regulatory Compliance

6
© 2014 AngioScan-Electronics LLC
Introduction
1.8 FSR Registration Certificate

Introduction 7
© 2014 AngioScan-Electronics LLC
1.9 Patent Certificate for Invention

Chapter
II

AngioScan Software Installation 9
© 2014 AngioScan-Electronics LLC
2AngioScan Software Installation
Severalversionsof AngioScan software can be installed on one PC. Software updates are available via
Internet.
When updating the software, the installer checks already installed versions of AngioScan software and
proposes to transfer working environment of existing version to the updated one. Workingenvironment
contains AngioScan setting files. The user's database is one for all AngioScan software versions, it
cannot be changed during the installation of a new version neither deleted during the uninstallation.
Onwards you will be proposed to delete old AngioScan software versions.

10
© 2014 AngioScan-Electronics LLC
AngioScan Software Installation
2.1 USB Driver Installation
The driver will be installed automatically during the AngioScan software installation. In case of error,
window of driver's installer will remain on screen.
AngioScan device can be connected or disconnected from computer. It is preferable to connect the
device to computer after software and driver installation, as in this case "Found New Hardware" dialogue
will not appear. If the device is connected before software installation, the "Found New Hardware"
dialogue will appear. Close the dialogue without performing any action.
It might take some time (several seconds) to connect USB device after driver installation so that the
system could initialize device's parameters. During that time the device will not operate.
If the driver is already installed, the system will check its version. If the installed driver has later version
than the being installed one, the system will not perform any action. Otherwise the installed driver will be
updated.
Usually, the system restart is not needed after driver installation. However, in case it is needed to restart
the system,
the corresponding messages will show up.
Driver installer is available after software installation as well: there is an icon "USB Device Driver
Installer" in AngioScan folder. If the problems occur during driver installation, this installer will help to
manage them.

Chapter
III

12
© 2014 AngioScan-Electronics LLC
Quick Start
3 Quick Start
·Install the AngioScan software on your computer without connecting the device to the computer. For
more details about software installation, see AngioScan Software Installation.
·Connect the device to USB-port with a PC cable included in the package. The system will ask you to
install the driver for USB-device found. The driver is located in USB_Driver folder of AngioScan
installation folder.
·Connect the sensors to device connectors. 1st channel sensor is enough for conducting PPG Contour
Analysis and Pharmacological Test , 2 sensors are necessary for Occlusion Test performance. 1st
channel connector is on the left side of the device.
·Run AngioScan program by clicking the icon:
The window of AngioScan program will appear:
There are "Database" and "Measurements" windows in the main window of AngioScan program. There
are tabs with the names of medical tests, that can be performed by AngioScan device, in
"Measurements" window.
It is necessary to select a patient before test performance. If a patient is not registered in Database yet,

Quick Start 13
© 2014 AngioScan-Electronics LLC
it is necessary register them before the test.
Add a new patient to Database.
Go to "Patients Database" window. To do so, click the header or toolbar button of the main window.
"Patients Database" window will activate. Click "New" toolbar button:
The dialogue will open, where it is necessary to enter patient's data. Fields in bold are must-fill (except
"Patient ID" field):

14
© 2014 AngioScan-Electronics LLC
Quick Start
Patient's height is indicated in centimeters.
After filling the dialogue fields click "OK" button. The dialogue will close, the patient will be registered in
the database, and "Measurements" window will activate.
Performance of PPG Contour Analysis
Performance of Occlusion Test
Performance of Pharmacological Test
3.1 Use of AngioScan with laptop
Pleasenote,if AngioScan device isconnectedtolaptopornetbook,laptop’spowersupplymay
causesevereinterferencetothedevice’sphoto-sensor.

Quick Start 15
© 2014 AngioScan-Electronics LLC
Sensor signal with
interference
Sensor signal without
interference
The interference to sensor signal is likely to make the results unreliable, so it is highly recommended to
disconnect a laptop/netbook from the mains supply during the test. Please note, that the power
supply should be disconnected from the outlet, not from the laptop/netbook. If it is impossible to
disconnect the laptop from mains supply, you should place its power supply as far away as possible
from the AngioScan device and its wires.
In AngioScan settings, there is an option "Display warning before test starts if notebook is connected to
the power outlet". The option is set by default and the warning appears before the test starts (the
program automatically recognizes that the operation is being performed on the laptop connected to the
mains supply).
3.2 Performance of PPG Contour Analysis
Requirements for preparing to the test:
The test can be conducted at any time of the day. However, if the purpose of test performance is to
evaluate the effectiveness of the current treatment (for example, hypertension, heart disease, diabetes),
it is better to conduct test in the morning in order to eliminate the influence of circadian daily rhythms.
1. Tobacco smoking, intake of vaso-active drugs, intake of caffeine, alcohol or other stimulants, heavy
physical activity should be stopped one day before the test.
2. The patient should rest in a warm, darkened, quiet room for at least 10 minutes before the test starts.
3. The test should be conducted either in supine or sitting position. The hand should be placed at the
heart level. The test results recorded in sitting or supine positions are different. Especially it concerns
time intervals. This is due to changes in transmural pressure of aorta and arm arteries. During the
dynamic estimation of the contour analysis parameters, the tests should always be performed on one
hand. In this case the right hand is preferred due to the angioarchitectonics features of blood
circulation in brachiocephalic area. The test should be conducted in a warm, darkened, quiet room.
Add a patient to the database, if he has not been not registered yet, or select the registered patient by
double clicking his data.
Activate "Measurements" window by clicking its header or its button at main window toolbar:

16
© 2014 AngioScan-Electronics LLC
Quick Start
If in "Measurements" window the "Contour Analysis" tab is not activated, click it:
Put on the sensor of the 1st channel (the one connected to the left device connector) on index finger of
the right hand so that the sensor's wire was on top. During the standard test the patient should sit in a
relaxed position, the hand with a sensor should be placed on a table. The patient should not move during
the whole test.
In "Measurements" window the graph of patient's pulse waves will be displayed:
Wait for a few seconds until the waves become more stable and then click "Record" toolbar button or
press F9 key. The data recording will start:
When the test is complete the following message will appear:
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