Angioscan Electronics AngioScan-01 User Manual Download Page 2

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AngioScan-01 Diagnostic Device of Cardio-Vascular System State

Contents

................................................................................................................................... 2

1 Technical Specifications

................................................................................................................................... 2

2 Package list

................................................................................................................................... 3

3 System Requirements

................................................................................................................................... 3

4 Operating Restrictions

................................................................................................................................... 3

5 Warranty

................................................................................................................................... 3

6 Developers Information

................................................................................................................................... 5

7 Certificate in Regulatory Compliance

................................................................................................................................... 6

8 FSR Registration Certificate

................................................................................................................................... 7

9 Patent Certificate for Invention

Chapter II

AngioScan Software Installation

................................................................................................................................... 10

1 USB Driver Installation

Chapter III

Quick Start

................................................................................................................................... 14

1 Use of AngioScan with laptop

................................................................................................................................... 15

2 Performance of PPG Contour Analysis

................................................................................................................................... 18

3 Performance of Occlusion Test

................................................................................................................................... 22

4 Performance of Pharmacological Test

Chapter IV

AngioScan Medical Tests

................................................................................................................................... 27

1 PPG Contour Analysis

.......................................................................................................................................................... 27

Patient preparation requirements

.......................................................................................................................................................... 28

Test procedure for contour analysis

.......................................................................................................................................................... 28

Contour test limitations

.......................................................................................................................................................... 29

Contour analysis test results

......................................................................................................................................................... 30

HR - Heart Rate

......................................................................................................................................................... 30

AIp - Augmentation Index, peripheral

......................................................................................................................................................... 31

AIp75 - Augmentation Index normalized to heart rate of 75 beats per
minute

......................................................................................................................................................... 31

CT - Pulse wave Contour Type

......................................................................................................................................................... 34

VA - Vascular Age

......................................................................................................................................................... 34

Stress Index

......................................................................................................................................................... 36

SpO2 - Blood oxygen saturation

......................................................................................................................................................... 36

SI - Stiffness Index

......................................................................................................................................................... 38

RI - Reflection Index

......................................................................................................................................................... 39

AGI - Aging Index

......................................................................................................................................................... 40

ED - Ejection Duration

......................................................................................................................................................... 41

%ED - Ejection Duration percent

......................................................................................................................................................... 41

PD - Pulse Duration

......................................................................................................................................................... 41

T1 - Time to 1st Peak

......................................................................................................................................................... 41

T2 - Time to 2nd Peak

......................................................................................................................................................... 42

dTpp

......................................................................................................................................................... 42

QI - Quality Index

......................................................................................................................................................... 43

SPa - Systolic Pressure, Aortic

......................................................................................................................................................... 43

PI - Pulse Index

......................................................................................................................................................... 43

Level - Signal level

Summary of Contents for AngioScan-01

Page 1: ......

Page 2: ...of Occlusion Test 22 4 Performance of Pharmacological Test Chapter IV AngioScan Medical Tests 27 27 1 PPG Contour Analysis 27 Patient preparation requirements 28 Test procedure for contour analysis 2...

Page 3: ...t 60 Quick search and history of patients selection 62 Search Database 63 DeletePatients 64 EditNewPatientData 64 Mark Several Records for Group Operations 65 Patients Database Window Setup 66 HTML fi...

Page 4: ...t AngioScan Database 107 Database Backups 107 2 Program 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 108 13...

Page 5: ...Chapter I...

Page 6: ...umentation 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...

Page 7: ...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 comp...

Page 8: ...4 2014 AngioScan Electronics LLC Introduction...

Page 9: ...Introduction 5 2014 AngioScan Electronics LLC 1 7 Certificate in Regulatory Compliance...

Page 10: ...6 2014 AngioScan Electronics LLC Introduction 1 8 FSR Registration Certificate...

Page 11: ...Introduction 7 2014 AngioScan Electronics LLC 1 9 Patent Certificate for Invention...

Page 12: ...Chapter II...

Page 13: ...nstaller 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...

Page 14: ...y 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...

Page 15: ...Chapter III...

Page 16: ...n 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 c...

Page 17: ...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 ope...

Page 18: ...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 Us...

Page 19: ...veness 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 smo...

Page 20: ...ire 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 Measurement...

Page 21: ...Quick Start 17 2014 AngioScan Electronics LLC To save test results in database click Save toolbar button The dialogue will appear where one can enter a comment to the scan...

Page 22: ...ot 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 If in Measurements wind...

Page 23: ...Quick Start 19 2014 AngioScan Electronics LLC 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...

Page 24: ...f until the pressure is 220 240 mmHg and maintain this pressure throughout the occlusion phase During the test graphs in measurements window will look like it is shown on the following picture Occlusi...

Page 25: ...Quick Start 21 2014 AngioScan Electronics LLC To save test results in database click Save window toolbar button The dialogue will appear where it is possible to enter a commentary to the scan...

Page 26: ...ow toolbar If in Measurements window the Pharmacological Test 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 r...

Page 27: ...a recording will start Approximately 1 minute after the start of the test the patient can take the medicine which effect is test s subject Duration of pharmacological test is to be defined by physicia...

Page 28: ...24 2014 AngioScan Electronics LLC Quick Start To save results in the database click Save window toolbar button The dialogue will appear where it is possible to enter a commentary to the scan...

Page 29: ...Quick Start 25 2014 AngioScan Electronics LLC...

Page 30: ...Chapter IV...

Page 31: ...in the supine or seated position The patient s hands should be placed at the heart level The test results recorded in the supine or a seated position have marked differences This is due to the change...

Page 32: ...he optical sensor on the index finger of the right hand such that the sensor cable is on the same side of the finger as the finger nail The sensor connected to Channel 1 Ch1 on the device should be pl...

Page 33: ...SIr Reference Stiffness Index RI Reflection Index AIp Augmentation Index AIp75 Augmentation Index at HR 75 AGI Aging Index VA Vascular Age ED Ejection Duration PD Pulse Duration ED Ejection Duration...

Page 34: ...lysis Augmentation index AIp is expressed as a percentage of the pulse pressure This parameter reflects the contribution of the reflected pressure waves to the arterial blood pressure and identifies t...

Page 35: ...n the heart rate This is due to the fact that the first harmonic of the pulse wave uses most up to 60 70 of the total energy of the heart muscle contraction Therefore the first harmonic and therefore...

Page 36: ...ation of pulse waves and is typical for the elderly patients with hypertension and an increased stiffness of arteries The pulse wave types in this situation are of types A or B This form of pulse wave...

Page 37: ...pulse wave is characterized by the maximum of the reflected wave in the middle of systole and the point of projection on the curve is almost the same as the global maximum of the pulse wave This type...

Page 38: ...tem In addition it is useful in communicating with patients since it allows one to easily explain the state of the patient s cardiovascular system The vascular age index is used widely Takazawa A simi...

Page 39: ...ients with chronic heart failure type 2 diabetes and alcohol heart damage vanRavenswaaij Arts et al 1993 Heart rate variability is used to stratify the risk of sudden death in patients with severe car...

Page 40: ...rt failure diabetes mellitus severe heart rhythm disturbances 4 1 4 7 SpO2 Blood oxygen saturation Oxygen saturation of hemoglobin oxygen is a vital index the value of which is determined by Pump func...

Page 41: ...the pulse wave velocity increases which is reflected in the increase in the stiffness index When the aorta is elastic the stiffness index in the range of 5 to 8 m c and in cases of increasing the rig...

Page 42: ...n as well as in the prognosis of these patients Laurent et al 2006 4 1 4 9 RI Reflection Index Reflection Index RI is used to assess the contribution of the reflected component to the pulse wave This...

Page 43: ...derivative of the pulse wave at Korpas et al 2009 The age index AGI is calculated as the difference between the amplitude of the early negative peak and those of the other components to the amplitude...

Page 44: ...increases the duration of the cardiac cycle decreases as well as does the duration of the systole The faster is the pulse the shorter is the systole For example when the heart rate is 60 beats per min...

Page 45: ...significantly it can lead to poor perfusion of the myocardium which is a risk factor of heart muscle damage 4 1 4 13 PD Pulse Duration The duration of the pulse wave is determined from the start of th...

Page 46: ...interval the more elastic is the aorta The parameter has a diagnostic value only when its values are either zero or negative pulse waves of types C and B The parameter has no diagnostic value when th...

Page 47: ...ary and renal blood flow occurs These factors lead to an increased risk of heart attack and kidney failure Prognostic significance of central blood pressure has been proven in several large studies ev...

Page 48: ...ents undergoing percutaneous coronary intervention Halcox et al 2009 In these diseases and conditions endothelial dysfunction is often a cause and a marker of local inflammation and a high prothrombot...

Page 49: ...thelial function Physiological effects of brachial artery occlusion can be described as follows After releasing the cuff pressure the blood flow in the brachial artery increases dramatically by 300 80...

Page 50: ...d intense exercise has to be terminated one day before the test 3 Immediately prior to the test the subject should rest for 15 minutes in a warm darkened and quiet room 4 During the test the subject s...

Page 51: ...ange in the amplitude of pulse wave amplitude before and after occlusion is calculated The change in the amplitude characterizes the change in blood volume in small resistive arteries and arterioles 2...

Page 52: ...litude of the reference channel is made The physiological significance of this occlusion index is to assess endothelial function in small resistive arteries and arterioles When the endothelial functio...

Page 53: ...of post occlusion nitric oxide production on the smooth muscle of large arteries brachial and radial arteries Phase shift is determined by the time delay with which the pulse waves travel in the occlu...

Page 54: ...collected the Angioscan software prompts the operator to administer a stimulus After the stimulus has been delivered the pulse wave data is collected continuously to assess the effect of the stimulus...

Page 55: ...the drug diminishes To study the details of the impact of the drug a contour analysis is carried out Contour analysis of the baseline pulse waves indicates that RI is 32 0 and AIp75 is 16 8 By the 7t...

Page 56: ...the anatomic differences in the brachiocephalic area 5 The test should be conducted in a warm darkened and quiet room 4 3 2 Pharmacological test procedure Pharmacological test procedure consists of t...

Page 57: ...his parameter is the ratio of the average amplitude of the pulse waves in the time interval after pharmacological stimulus the pink area on the pharmacological test graph to the average amplitude of t...

Page 58: ...Chapter V...

Page 59: ...terface can be either in Russian or in English Please see languages settings in Configure menu Expert Mode AngioScan program can operate in Expert and User modes In User mode some advanced functions a...

Page 60: ...sensors of both channels are used during the test occlusion test and none of them is put on finger status of channels can randomly change It is not malfunction of device 5 1 AngioScan windows Main wi...

Page 61: ...ng at window in the bottom part there is a More toolbar button Local menus are different for top and bottom parts Many commands can be performed with the help of hot keys which names are displayed in...

Page 62: ...in HTML file Data filter Histograms Operations with test results data In the bottom of the database window there is a list of test results performed for patient selected marked by blue background on t...

Page 63: ...alog toolbar Enter patient s data in the open dialog Fields in bold must to be filled in except Patient ID field The patient s height is indicated in centimeters After entering data click the OK butto...

Page 64: ...or example if you choose age as a sorting criteria the patients of one age will be sorted according to their names 5 1 1 3 Quick search and history of patients selection Quick search On the left toolb...

Page 65: ...e sequence of patients selected for test To receive the list click the arrow next to the quick search field To select a patient click the line with his name in the list The patients are sorted accordi...

Page 66: ...string for a search In the list Search in mark where to search the entered substring In the list Search direction specify the direction of search In the list Match coincidence select how to compare a...

Page 67: ...all lines containing fields meeting search conditions Then it is possible to perform group operations with all marked records For example one can delete or save as a table in HTML file 5 1 1 5 Delete...

Page 68: ...Edit new patient data dialog Editing patient data is not available when records filter is switched on 5 1 1 7 Mark Several Records for Group Operations If you mark several entries in the window you ca...

Page 69: ...with the cursor by holding Shift key To mark all records use Ctrl A keys combination 5 1 1 8 Patients Database Window Setup With the help of Settings toolbar button one can specify fields and their o...

Page 70: ...able directly in the window by dragging fields headings with the mouse 5 1 1 9 HTML file to save records This function allows to save one or several entries in the form of table in HTML file The saved...

Page 71: ...rowser will automatically open An example of the table in HTML file 5 1 1 10 Database Filter Setup Records Filter is an advanced option allowing to display only those entries that match with specified...

Page 72: ...isplayed Insert Condition button opens the dialog where you can set a filtering condition On the top side of the window you can set a field of database records according to which the filtration will b...

Page 73: ...it will be as it is shown in the picture below for text fields one can specify criteria of matching with substring and for date field to choose a date In the bottom input field which view depends on...

Page 74: ...conditions it might be useful to prioritize the comparison Insert and Insert buttons that put conditions into the brackets are designed for this purpose When the filter is switched on all entries are...

Page 75: ...patients of a corresponding height For example it is well seen in the picture that there is one registered patient with a height of 150 centimeters and 9 patients with the height of 178 centimeters 5...

Page 76: ...of text file for further analysis in PowerGraph program as well as to export data of one or several tests to another AngioScan database for example for sending data to another computer To perform the...

Page 77: ...nd helps to recalculate one or several scan results saved in database In the process of AngioScan software development data processing algorithms can be changed and thus reprocess will be required for...

Page 78: ...to change the size of the pictogram by choosing it in Picture size group Open button downloads selected in the list picture to Measurements window without closing the dialog Thereby it is possible to...

Page 79: ...ll be selected corresponding to the position of the cursor To change to size of the picture select it in Picture Size menu item Thumbnails button is available for trends of PPG contour analysis and op...

Page 80: ...ve similar toolbars as well as local menus Every tab has a field where the receiving from sensor signal is displayed in real time mode if the device is connected to computer and the sensor is put on p...

Page 81: ...aph of the received from the sensor signal will be displayed in oscilloscope field of the window If there is no recording of the signal it means that AngioScan operates in signal monitoring mode Meanw...

Page 82: ...ring stops To resume the signal monitoring remove the sensor from patient s finger and put it on again to change the patient or click Restart button There are all commands corresponding to toolbar but...

Page 83: ...the bottom part of the window To switch between them select the corresponding tab Pulse Waves Graphs The displayed signal has undergone several levels of filtration during the processing The horizont...

Page 84: ...de If you move the cursor to a parameter the tooltip with its full name will appear By clicking the arrows near the beats field one can change the number of selected pulse wave By clicking the arrows...

Page 85: ...rresponding to the column s location on horizontal axis For example the histogram above shows that 54 pulse waves with duration of 0 85 seconds 71 beats per minute were accumulated during the test The...

Page 86: ...lusion Test Bookmark See the medical description of the test in Occlusion Test section The description of measured parameters see in Measured Parameters of Occlusion Test General rules of test perform...

Page 87: ...signal amplitude decreases during the occlusion test The horizontal axis chows time in minutes When the test finishes graphs are automatically scaled stretched along the horizontal axis After the test...

Page 88: ...the bottom right corner shows the pulse waves in a large size and superimposed upon each other that allows to visually compare their shape and phase shift The yellow graph displays the 1st wave channe...

Page 89: ...intervals As a result of test two lists of Contour Analysis parameters for each channel are created The first list shows the average parameters values taken an interval before the Occlusion test blue...

Page 90: ...utomatic recalculation of measured parameter values is performed Recalculation of Test Results The calculation of occlusion indexes is based on evaluation of signal parameters before and after the Occ...

Page 91: ...ice cannot reliably perform the pulse waves selection PPG Contour Analysis Tab displays the results of Contour Analysis after activation To return to Occlusion Test click its header Export of all puls...

Page 92: ...de of the window and test results are shown on the right The horizontal axis shows time in minutes After the test finishes the graph is automatically scaled stretched along the horizontal axis It is p...

Page 93: ...he values of parameters displayed either in In the right part of the tab there are parameter values displayed either as absolute values or as values differences Show Absolute values Show Differences W...

Page 94: ...f mouse cursor in the window The same is performed when clicking twice on the selected point of the chart PPG Contour Analysis Tab activates and displays the results of contour analysis To go back to...

Page 95: ...ed message is highlighted by a specified background colour To select another message click it and use the cursor control keys Local Menu The local menu of the window contains the following commands an...

Page 96: ...014 AngioScan Electronics LLC Graphic Interface 5 2 1 File Menu ConfigurationFiles Opens a submenu for operations with configurationfiles Exit Closes AngioScan session Or Alt F4 or Alt X keyboard shor...

Page 97: ...nloaded or saved with the help of File 8 Configuration files Besides AngioScan uses session files that contain information about the session and indicate which screen configuration file and option fil...

Page 98: ...lly After restarting AngioScan program it must be set up again Play sounds on occlusion start end Produce a sound signal when to start and to finish the occlusion during the Occlusion test performance...

Page 99: ...er in computer database or for editing of user s data if the patient is already registered You will be asked to enter the name surname date of birth and etc Further the entered first and second names...

Page 100: ...ption is turned on the sounds selected in the list below are switched on Device Memory Information about memory status Apply the Settings Records the settings in device The changes are immediately dis...

Page 101: ...ss of contour analysis the fewer number waves is accumulated the index is not calculated Font size for result lists Allows to set font size of measured test parameters Scan simulation acceleration Sho...

Page 102: ...l the purpose and the consequences of changes Performing tests with wrong settings might give unreliable results or even make impossible any test performance 5 2 3 2 Environment Dialog Here one can cu...

Page 103: ...cription Color scheme Sets name of color scheme It can be printed out or selected from a list of recently used ones Save button saves the scheme to disk Delete button deletes it Colors A list of color...

Page 104: ...ion by right clicking the cell where row with a command and Key 1 or Key 2 column meet 5 2 3 2 4 Toolbar Bookmark Toolbar tab of Environment dialog activates toolbars and buttons of AngioScan windows...

Page 105: ...by a switch with the following positions Overwrite log file after each start Specifies to create a new file for each session and delete the former file if it exists Append messages to logfile Specifi...

Page 106: ...es from one number system to another Result can be copied to the clipboard Dialogitem Description Expression The field for expression or number input Copyas Specifies the format of the result to be co...

Page 107: ...ed by yellow Click Load test result or double click the row with test result to load the results without leaving this dialog 5 2 5 Windows Menu Commands of this menu control the arrangement of windows...

Page 108: ...cuted file version Devicebootloader version Version of device resident software It is displayed only when the device is connected to computer Device target software version Downloadable version of dev...

Page 109: ...Chapter VI...

Page 110: ...fault under the name of common database The common database is not deleted during the uninstallation of AngioScan package and it is not upgraded during the installation of updated versions Thus all An...

Page 111: ...ges 6 2 1 5002 Floating point number is entered In this situation it is necessary to enter an integer 6 2 2 12129 Previous test results for the specified patient are not saved If you perform the actio...

Page 112: ...teristics of pulse waves have a large scatter 6 2 13 13043 The test is completed successfully and a sufficient for analysis number of pulse waves is accumulated The test result can be saved in the dat...

Page 113: ...id directory name It can be set in AngioScan Settings dialogue It is not a fatal error You can continue without creating database backup copies 6 2 18 13088 It is necessary to enter the required infor...

Page 114: ...e about to transfer data of one patient s test results to another patient It might be necessary if the test was performed for a patient selected by mistake as well as after Database import See Test re...

Page 115: ...the user specified has been already registered in computer s database Test results saved in device will be transferred to the already registered user 6 2 34 13123 The message tells about the number of...

Page 116: ...data go to Settings AngioScan Settings Stand alone device tab as well as to patients database dialogue 6 2 37 New test data found in memory Dialogue When connecting stand alone device AngioScan 01P t...

Page 117: ...m analyses the data stored in memory of stand alone device If there are records of users not registered in computer s database AngioScan offers to enter data for each user first name second name date...

Page 118: ...statistics Dialog 103 Toolbar Tab Environment dialog 100 Tools menu 101 View Menu 93 Windows Menu 103 CM settings Stand alone device Tab 95 About AngioScan 104 Add a new patient 59 AngioScan settings...

Page 119: ...ew versions of AngioScan 103 new versions of AngioScan check 104 Patients Database window 56 Quick search database 60 Quick Start 12 Recalculate of Scan Results 73 Record filtering condition 68 Record...

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Angioscan Electronics AngioScan-01, User Manual, Page: 2 / 119

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