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1. 6 Troubleshooting Problem No communication No arterial function parameters are displayed No print preview The PDF report cannot be opened Database import cannot be completed Cannot send e mail successfully Error messages Error codes as shown on the LCD and their explanation are specified below It Possible causes Communication adapter is not connected The device is not recognized by the PC No or low batteries in the device The device was turned off Loose cuff Arrhythmia Tremor No printer have been installed to the PC Adobe Reader is not installed to the PC Not the proper database was opened or the database was damaged No e mail client is installed to the PC What to do Plug in the adapter and follow the instructions of Section 2 5 Go to Control Panel Bluetooth Devices and check whether the device is present If not follow the instructions of Section 5 2 Replace the batteries Turn on the device by pressing its button twice Tighten the cuff The method cannot reliably assess arterial function parameters in arrhythmic patients If possible try to terminate tremor Install a printer or use the built in virtual printer of Windows Download and install the latest version of Adobe Reader Import the database by following the instructions of Section 5 4 8 3 Install an e mail client and set it to be the default one Example should be noted th
2. s characteristics see Section 5 4 2 1 1 E Confirmation 2 Arm circumference 26 cm Suggested cuff type 2 bls 26x8cm Operators name ARTERIOGRAM o A med The measurement process starts with the SW connecting to the Arteriograph device The scanning of the active ports and the communication process can be tracked on the monitor While this communication is in progress CONNECT See Section 5 4 1 will appear on the LCD of the Device After a short time measurement will start automatically by performing a blood pressure measurement in the first phase During measurement the recorded pulse wave curves can be tracked on the screen In the second phase the pulse wave recording for pulse waveform analysis is performed e First the Device will inflate back to the diastolic pressure level and register the pulse waves for a previously determined duration 8 sec by default e Second the Device inflates further to the suprasystolic pressure level by default to the measured systolic value 35mmHg occluding the brachial artery completely in this way and registers the pulse waves for a previously determined duration 8 sec by default The time and pressure offset values can be modified through the system settings function in the above described manner See Section 5 4 1 During the measurement there is a real time data transfer enabling the user to see the recorded oscillatory waves on the screen At t
3. You ane logged in as ATER F e y Togh e l 7 E 4 BS START pm 7 med E Y a ap aati Copa bei I Lier B dec pa Y Fi u Liane 2 Earl rurea D a Time Far ra gt ade at Det LH T HUM HU 23 1 55 229 x 230 ma 12 ma i ei Mali Pad Pe vy u un We q dd yr 4 8 m s 1 85 ms LE 7 mmHg 117 7 ma Movement artefacts Movement artefacts distort the waveforms and lead either to not analysable measurements or to results with inflated variation How to recognize the baseline of the recording undulates or some pulse waves noticeably differ from the others How to avoid emphatically ask the patient not to move Manual evaluation see Section 5 4 5 can help to find a regular sequence in the suprasystolic measurement phase DB Temoltes Lnerogrer You are logged in e ARTESIOGRAM iu Vie Vom Took I 7 AR stant a Y mod n Fy 11 A Le ere min po rem ar E pere Eees 6 AID as 5 P 0 Emna E rh ram Das Tma Fed raro sin 14 o 150 Y we gar 5 4 5 How to analyse the data Select a patient and an examination thereof you intend to analyse You have two evaluation options available automatic and manual The former is fast and convenient Automatic evaluation will take E Automatic analysis 5 39 D CEA place immediately after a patient s examination is selected The same can be achieved by clicking first on Automatic analysis S35 for supr
4. 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 Notes Notes Notes UN putting precision first Arteriograph Medexpert Arteriograph User Manual 2011 Medexpert Ltd All rights reserved
5. Print the Report 40 5 4 6 3 How to send a Report in PDF format 43 5 4 7 Export the measurement data ss 43 6 5 4 8 Backup and restore the database 00 000onnsoseennsssrerrrsssrerssssrerssssrerossereesssreresssrereesssreresseree 5 4 8 1 Backup E A eee 5 4 8 2 Restore datan id cie 5 4 8 3 Import previous database nase een een IFOUDIESNOOLNG ns ee ee Technical Specilicallon una pen eo 7 1 Electromagnetic compatibility ss 1 Introduction 1 1 Preface Thank you for choosing Medexpert Arteriograph This state of the art device and method enables recording and analysing arterial pulse waves in an exceptionally easy reliable and accurate way With this entirely new implementation of oscillometric method a complete arterial function evaluation can be achieved 1 2 Contents of the manual This manual helps you in setting up and starting to use the Medexpert Arteriograph TL2 device as well as installing and setting up the Medexpert Arteriograph Software up to versions 3 0 0 0 Attention Before first use please read and understand this document carefully gt 1 3 General information e When active the Device does not cause any electromagnetic disturbance and its immunity to environmental effects is also sufficient The measurement data are downloaded into the PC through wireless Bluetooth communication The electromagnetic compatibility between the Dev
6. TCrep_TestElisabeth 26032007 07 43 pdf As a next step the default e mail client if there is any is loaded automatically with the generated pdf file attached to a new letter 5 4 7 Export the measurement data Formerly saved measurement results see Section 5 4 5 can be exported into a formatted text E file by choosing Export data under the Tools menu or clicking the Export data button on the toolbar Step 1 Select a User whose patients measurement you would like to export by clicking the checkbox next to it The Select all option is a quick way to select all the listed users All the registered users are listed in this window Selection is confirmed by clicking on the arrow Export data 1 Step Hanse nalad uzena Select all Ga API TOME Mhecairent Naghain Ha 1 Step 2 Select the patients whose measurements you would like to export by clicking on its row All the patients belonging to the selected user are listed here in alphabetical order of the family name In case there is a great number of patients a particular patient can be found by using the built in search function For a quick search click anywhere in the patient list and type in the initials of the family name of the given patient The built in search is not case Step 3 Step 4 Step 5 sensitive Multiply selection can be done in the common Windows way using Ctrl or Shift while clicking The Select all option is a quick way to select all the
7. The Information Menu Med Arteriograph You are logged in as ARTERIOGRAM The most important information about the manufacturer and the mes e Manufacturer and software version information software can be accessed through the Information menu The menu gt also includes this User s Manual 200 ms cm Y axis compression 2 Baseline Family name First name 3 2 2 The Toolbar of the Program The toolbar can be found under the menu bar and contains icons which allow direct access to the major functions of the program The Toolbar can be displayed or hidden by the Toolbar command of the View Menu 3 2 3 The examinations window All the previous if there are any examinations of the selected patient are listed here by the date and time of recording 3 2 4 Theresults block The calculated hemodynamic parameters are displayed here when an analysis of measurement data is performed automatically or manually 3 2 5 Patient details field The name and date of birth of the patient are displayed in this field 3 2 6 The measurement data window During the measurement the data are displayed here real time in the form of non calibrated pressure curves oscillations as recorded by the device The recorded and saved pressure waves can be opened and displayed at any later time The User can also select to display the amplitudes of the oscillometric curves throughout the blood pressure measurement phase or the estimated
8. are computed during the measurement Sys Brachial systolic blood pressure mmHg Dia Brachial diastolic blood pressure mmHg HR Heart Rate beat min MAP Mean Arterial Pressure mmHg As calculated from the brachial systolic and diastolic blood pressure MAP diastolic blood pressure systolic diastolic blood pressure 3 PP Brachial Pulse Pressure mmHg PP is the difference between the systolic and diastolic blood pressure in mmHg ABI Ankle Brachial Index Dimensionless index The ratio of the ankle systolic blood pressure and brachial systolic blood pressure values Aix brachial brachial augmentation index Augmentation index The difference between the amplitudes of the late backward systolic wave P2 and the early forward systolic wave P over the pulse pressure PP and multiplied with 100 Aix P P PP 100 Aix aortic central augmentation index Calculated on the basis of a very strong R gt 0 9 linear relationship between the brachial and central augmentation index ED Ejection Duration of the left ventricle ms It is the period of the mechanical systole i e the time span between the opening and closing of the aortic valves RT Return time ms The RT is the time of the pulse wave travelling from the aortic root to the bifurcation and back PWVao aortic pulse wave velocity m s The velocity of the pulse wave in the aorta This is calculated from the travelled
9. characteristic point on the curve see Section 5 4 5 Diastolic record This part contains the parameters resulting from the analysis of the pulse wave curves recorded at the diastolic pressure step There are also two graphs showing a section of the pulse wave curves and a single curve the last wave if several waves are selected for analysis The DRA SAI and DAI parameters can be defined only if an ED value is available from the previous phase Suprasystolic record Footer Institutional and operator data on the left hand side if set Section 5 4 6 1 Manufacturer s data complemented with the version number of the SW on the right hand side Suprasystolic record The first part of this page contains the quality control of the measurement A section of pulse wave curves recorded on the suprasystolic pressure step are shown in a graph to enable visual control over the quality of the waveforms The value of SD PWVao is also represented here Pulse Wave Velocity measurement This part highlights the measured aortic pulse wave velocity and return time values PWV Arterial Age Assessment The current measurement is placed in an age PWVao graph with smoothed reference percentile curves see Section 5 4 5 3 The point of the measurement is coloured according to the ranges in the graph legend The estimated arterial age of the patient is also given here in decades except for pooling over the vascular age of 60 A more precise es
10. could be found in the suprasystolic 17 m s ble measurement sequence The SD appears in red colour in the Results field to ms warn the User on the quality problem The results of the analysis should be ppao 59 5 mmHg rejected and the measurement should be repeated 5 4 4 2 Quality control by visual inspection Although the SD PWVao performs considerably well in detecting erroneous measurements further visual inspection can help categorizing the type of the error Consequently it can be avoided when repeating the measurement By visual inspection disturbances can also be detected in measurements that were categorized to be of good quality by the SD PWVao parameter Improper cuff size or tightness In this case no early and late systolic wave can be differentiated on the pulse wave form Due to the larger cuff size or the looser fit the cuff system loses its sensitivity to pick up higher frequency components of the oscillatory waves This often leads to recording small amplitudes which case is always indicated by the software with a warning message How to recognize no reflected component can be seen on the wave How to avoid use a smaller cuff or tighten the cuff according to the instructions see Section 5 3 F TercioMed Artenograph You are logged in as ARTERIOGRAM o a File View Took Infeemation e gt am 4 sm Em EN mede u x oy AD mater Y ges comprero 2 Badr D gt Reset a Mina arab 5 P D kb Cavas Disc
11. distance measured as the suprasternal notch pubic bone distance of the pulse wave in the aorta divided by the measured transit time RT 2 SD PWVao m s A parameter informing about the quality of the measurement The PWVao is calculated from each pulse recorded and the standard deviation is featured For more details see Section 5 4 4 1 SBPao central systolic blood pressure mmHg Calculated on the basis of the physiological relationship between diastolic BP mean arterial BP peripheral and central Aix and central SBP PPao central pulse pressure mmHg The difference between aortic systolic and diastolic BP values DRA Diastolic Reflection Area Dimensionless index DRA provides information about the quality of diastolic filling in the coronary arteries taking into consideration the duration of the diastole and the area between the expected theoretical diastolic pressure curve without reflection and the truly measured diastolic curve with reflection SAI Systolic Area Index SAl is the systolic part of the area under the entire pulse curve DAI Diastolic Area Index DAI is the diastolic part of the area under the entire pulse curve 5 2 System setup After installation connect Arteriograph to the PC by following the instructions of the enclosed Bluetooth Operation manual The passkey of the device is OOOO The device should not be farther than 10 metres from the PC for optimal operation Attention T
12. i till TensioMed TensioClinic 40 C TL2 X S N COSA case 4 13 12 11 10 Figure 2 15 1 2 2 The accessories of the Device Arteriograph has the following accessories e 4pcs AA size alkaline batteries e Three D ring cuffs of different sizes see below e Medexpert Arteriograph Software installation CD e A tape measure for measuring the jugulum symphysis distance e Bluetooth adapter kit Bluetooth adapter Driver CD Operation manual e A protective pouch for the device e A User s Manual The cuff sizes are as follows Cuff type Bladder dimensions 01 02 34 x 8 cm 26 x 8 cm 62x9cm 52x9 cm 2 3 Installing the Device Arteriograph is a battery operated device e Insert 4 durable alkaline AA batteries into the Device with taking care of the right polarity see Figure 3 e Or insert 4 AA sized rechargeable Ni MH or NiCd batteries as per the above instruction Please note that new batteries must be pre charged o For problem free operation minimum 1 500 mAh chargeable Ni MH or NiCd batteries Note The clock circuits of the Device are fed by integrated NiCd HA 35 battery cells therefore the operation of the clock is independent from the AA battery supply gt are recommended Attention If you do not intend to use the Device for a longer period of time remove the batteries and store them in a dry and cool place out of little children s reach Do not expose them to inten
13. in the same way as in a normal automatic analysis r m F TercioMed Arterograph You are logged in as ARTERIOGRAM File View Toot Information gt r Am cy u Ar t Da RES START an HU med x maic mes COMPAR 2 Rawr 0 mS Davor a e Fay rare Teszt it nam Beteg Dale of Det 01 01 1975 t 52 0 11 3 270 ms j 125 ms i N N N em 38 pin do E J REN 10 fern E Mes gest NTE 8 5 m s AT et Le 0 00 ms 28 6 mmHg 111 6 mmHg e Incase a pulse wave of only a single heartbeat is highlighted of either those that were registered at the suprasystolic or those registered at the diastolic pressure level it will appear in a separate window displayed on the millimetre net Please note that in this case SD PWVao cannot be calculated The said separate window can have two kinds of content o The one highlighted pulse wave at the suprasystolic pressure step is represented by a green curve There are four markers shown on the curve the meaning of those can be found below r 7 F TersioMed Arteriograph You are logged in as ARTERIOGRAM el File Wew Toot Information Ae Ses sas Ls ZM medexport Y K oat pr ZU mam Y aan Comp 2 Rare 0 Reset A Atomai aah 535 D ii Capa er Fand rare Toszt Port name Beteg Date of Beth 01 01 1975 Aix brach 121 52 0 11 3 83 265 ms j mel N 5 ms A 125 me A 53 o
14. on When the button is on the control tools appear With use of these the sec CoC cursor can be moved in small or big steps Note The Cursor feature is only available at the default X axis step of 200 ms cm Note The oscillatory signals are not calibrated and therefore should not be considered to represent true pressure values The above mentioned functions are illustrated in the picture below If TersioMed Arteriograph You are logged in as ARTERIOGRAM eee ee ABS Bm Les EE medoxport fl X mat step 200 malen Y ae compeatti n 2 Rene 0 Reset El san anus 535 D Ci Gas 0 1 E ad PATIENT DETAILS Fay rare Teszt Date Tise Feit name Beteg Date of Bem 01 01 1975 005201 0914 gus ale Herbie ime 4000 fru akude 240 es 182 mmHg Aix brachint 181 52 0 Aux aorls n3 x 9 265 ms A _ _ _ R 9 1 PA 125 ms jH PA fo UG SY j ha zu 0 PE 53 cm 30 gu HOG HUB o Ocio van iiti DR A set PWVao 8 5 m or Loris 60 ms PPao 28 6 mmHg ShPao 111 6 mmHg U Pulsa wyra Aang ponssuam values Asteri age assessment 5 4 5 2 Oscillation amplitudes during blood pressure measurement By clicking on the Amps pressure values tab of the measurement window the maximum amplitudes of the oscillations recorded during the blood pressure measuring phase appear The same function can be accessed by selecting the Amps pressur
15. patients a particular patient can be found by using the search function of the software For a quick search click anywhere in the patient list and type in the initials of the family name of the given patient The quick search is not case sensitive An advanced search can be done by name or date of birth with use of the Search for function Select Name Date of Birth or ID and type in the name date or ID you want to find into the Search for field This function is case sensitive When searching by name the search is made in both the first and last names and even a part of the name can be searched for not necessarily including the initial of the name 5 4 2 2 How to enter a new patient s data N If you want to enter a new patient into the database select the New patient command in the File menu or click on the New patient button see on the left on the Toolbar For entering a new patient only the date of birth the height the patient s jugulum symphysis JUG SY distance and the upper arm circumference are required to be filled out The jugulum symphysis distance and the upper arm circumference can be measured by means of the tape measure provided as an accessory see Section 5 3 The former data is necessary for calculating the pulse wave velocity while the latter one is needed for calculating the proper cuff size After filling out the arm circumference field the suggested cuff type and its size wil
16. sortic 75 28 i 3 Lower hmb circulation jection dutathon ABI ED 320 ms 200 mice 4 es tinn 19 20 M 0 M ag ee Mi ee ee M i 100 Apr FE Arterial age 40 50 years Sth percentile Age vari gt 508 lt 90th percentile Par Jeria abih percentile ion the basis of apprommat ts 10000 Henne performed mm Cintra Luroce n pope rise TeriiofiedT Software 5 1000 BETA 10 T10114 00115 TeniioMiedT Softwar v 3 0 0000 BETA JON TLOLI4A 00115 Page 1 Page 2 Patient details The data specified when entering the patient s data are shown here including a user defined parameter and its value provided it is set Section 5 4 1 The space for missing or undefined data will remain blank Risk profile The previously entered risk profile see Section 5 4 2 2 appears here Medication The list of medications entered previously see Section 5 4 2 2 appears here Measurement data This part contains the date and time of the examination the name of the operator and the mandatory patient data Suprasystolic record Peripheral and central hemodynamic parameters are listed here excluding pulse wave velocity The calculated Ankle Brachial Index ABI is also represented here if this option was selected see Section 5 4 1 A characteristic pulse wave is shown with the points of the Return Time RTS35 and Dicrotic notch Ejection Duration ED indicated on it The return time does not necessarily fall to a
17. vascular age of the patient based on the arterial function assessment 3 3 First step Register a user If the program is used by several users with different groups of patients it may be necessary that users can access their own respective patients data only after login To this end a new user will have to register in the database by specifying the name and login Arteriograph SW can be used with the default login of ARTERIOGRAM it is however highly recommended to create and use your own user login Registration of a new user To register a new user open the Options window under the Tools menu and select the Users tab To enter a new user click on Add New and then enter the first and family names of the user and specify a login name user ID Click Add to register the new user in the database or click Cancel to interrupt the registration The new user can log in with the login name specified Note The registered users data cannot be edited planen System Utert Printed spart Uiii rime Fast name Faih ame Lagni mare eses 101 User Ent o CO How to delete registered users To delete registered users select Options under Tools and click on the Users tab in the pop up window The Delete button can be used for deleting a pre selected item from the users list In case the list contains only one user the Delete function will not be available 4 Performing a sin
18. Arteriograph User Manual Medexpert Arteriograph TL2 Medexpert Arteriograph Software Arteriograph Medexpert Arteriograph Medexpert Arteriograph Software Copyright 2011 Medexpert Ltd Budapest Hungary All rights reserved Under the copyright laws this manual cannot be reproduced in any form without prior written permission of Medexpert Ltd Every effort has been made to ensure that the information in this manual is accurate Succeeding models and manuals are subject to change without notice Medexpert is not responsible for printing or clerical errors This Manual is produced on the assumption that the operator is an experienced user of the Windows 2000 XP Vista 7 Operating Systems If the operator is not familiar with Windows operations please refer to the online Help of Windows or the Windows User Manual Arteriograph is an unregistered trademark of TensioMed Ltd Other company and product names mentioned herein may be trademarks of their respective companies Head office and service Medexpert Ltd T rr kk u 5 7 1037 Budapest HUNGARY Hungary Phone 36 1 250 4490 Fax 36 1 250 3795 Web www medexpert hu E mail arterialcare medexpert hu Contents 1 o A A E AES 7 1 1 e ee ee ee o 7 1 2 Contents Of the Mana rra 7 1 3 Genera lito Mal Olor ia rer 7 1 4 GUITAR TEE dd 7 1 5 Warnings and precautions cccccsssseccccsssessececcaessececseuseccecauuseceessuaecees
19. In the Backup field select Restore to start the restoration process Also select the destination directory for the backup file r Backup and restore database Backup Place of backup file Make E d data Restore DA DUO CCleaner nokia Start Cancel O 88 edexper A confirmation window pops up for approving the restoration Simply press No to cancel the process To start the restoration click on Yes F1 Confirmation a Are you sure you want to restore the database Cyes J no ET medexpert E An information window appears when the restoration is successfully completed r EN Information eo Data restore completed 5 4 8 3 Import previous database If you have a previous version of Arteriograph database on your computer the Convert previous database and import data command under Tools menu helps to convert the measurements into the new database format Select the patient list pat file in the Regisztratumok folder under the previous installation directory by default C TensioClinic Regisztratumok and click Open to start the import procedure Note Only a database in the original installation folder can be imported Note For a large database the conversion can take several minutes The status of the procedure is shown by a progress bar Successful conversion is confirmed by a pop up window Information a A Data import has been successfuly done
20. Writer Status Ready Print to file Preferences Location CE Find Printer Page Range Al Number of copies 1 11 2 2 3 3 ne The print preview screen appears El Pres mr W 5 i kar With use of the toolbar on this screen the following functions can be accessed Zoom tool J m The print preview page can be zoomed to fit the screen height Zoom to fit to fit the screen width Zoom to width and to the original size 100 Navigation tool This tool can be used to navigate to the First page Previous page Next q gt ee gt en page or to the Last page of the medical report Search tool Y With use of these tools a search can be performed by page number Go to page or by a keyword Search for text Copy tool The current page of the report can be copied to clipboard with this tool Print tool A printer can be selected an set up with use of the first icon The page can be printed with the previously determined settings by clicking on the second icon Load Save tool a The Report can also be saved in a file by clicking on Save report The destination a directory and the name of the saved file can be selected in a pop up dialog window The report can be saved as e qrp file This procedure generates a QuickReport file qrp which can be viewed only in the Medexpert SW e pdf file This creates an Adobe Acrobat file which can be opened without the use of the Medexpert SW This fea
21. an 35 mmHg e Offset of diastolic pressure level determines the value which is added to the measured diastolic pressure in order to obtain the pressure step where the Device will record diastolic pulse wave data volume curve Zero 0 is the default setting which means that data will be collected at the pressure step corresponding to the measured diastolic value Diagnostic examinations should not deviate from this value e Data transfer time at dia and sys pressure level determines the time span in seconds of pulse wave data collection at the above specified pressure levels The default value is 8 sec Diagnostic examinations may deviate from this value in the 7 10 sec range e Data interface GDT The GDT interface enables data transfer between medical devices and general practice IT systems according to the standard produced by the German Quality Assurance Software QMS A practice software system that supports GDT is required for the communication For setting up the GDT interface please read and follow the GDT interface manual located on the Arteriograph installation CD e Calculation of Ankle Brachial Index if selected Ankle Brachial Index is calculated For this the ankle systolic blood pressure has to be measured before the pulse wave recording see Section 5 4 3 e Communication port A default communication port number can be defined here This way the user can avoid the more time consuming process of automatic port search The pro
22. analysis 21 5 1 Hemodynamic parameters measured by the Arteriograph 21 5 2 SYSTEN SET U EEE 22 5 3 Patient prepara O IN ne aa 22 5 4 Performing the measurement sise 24 5 4 1 Device and measurement setup sise 24 S542 Selecta MVE ccena ee eg 26 5 4 2 1 How to select an existing patient 26 5 4 2 1 1 How to modify a patient s data 26 5 4 2 1 2 How to search for a patient ss 26 5 4 2 2 How to enter a new patient s data 27 5 4 3 Medical Examination with Medexpert Arteriograph een 28 5 4 4 Quality control of the measurement ss 30 5 4 4 1 Quality control index the SD PWVao sise 30 5 4 4 2 Quality control by visual inspection 30 5 4 5 HOw to analyse the data ss 33 5 4 5 1 Tools for visual inspection ss 36 5 4 5 2 Oscillation amplitudes during blood pressure measurement 37 5 4 5 3 Vascular age assessment ss 38 5 4 6 The measurement Report u ra 38 5 4 6 1 Edit the Report case IA 39 5 4 6 2
23. asystolic data and then on button D for diastolic data after the results have been displayed Most of the hemodynamic parameters described above Section 5 1 will appear in the results window under the list of examinations During the automatic analysis the algorithm will analyse pulse waves of several heartbeats and calculate the mean of the results as well as the standard deviation of the PWVao SD PWVao However if there is only one evaluable pulse wave no SD PWVao can be calculated For manual evaluation you have to go to the end of the whole measurement sequence by using the horizontal scroll bar at the bottom of the graphic area The pulse wave curves recorded at the suprasystolic pressure step are located at the end of the measurement sequence You can use the mouse for selecting arbitrarily any or several pulse wave recorded at the diastolic and suprasystolic pressure steps Curves can be selected even from those recorded in the blood pressure measuring phase but only that were recorded above the measured systole or in a 10 mmHg range of the measured diastole To select a series of pulse waves or a single one highlight hold down the left mouse button while moving the mouse those from the beginning to the end of the sequence Only pulses i e heart cycles that are highlighted in their entirety are included in the analysis see the picture below e When several pulse waves are selected for manual analysis the results are displayed
24. at errors can occur due to patient movement causing artefacts in the reading In case the Device cannot measure blood pressure e g due to motion measuring will be disrupted Er 32 The codes of the error flags indicated by the Device shall mean the following 1 measuring time exceeded The Device could not measure the patient s blood pressure within the pre set time 3 low battery Measuring was disrupted because of low battery 31 cuff missing The cuff is not connected to the Device 32 33 34 35 90 99 100 101 102 110 111 112 113 115 cuff clogged air leakage the cuff is not on the arm measuring disrupted Device error Faulty measuring result motion no pulse detected Faulty measuring result Faulty measuring result Faulty measuring result The rubber hose of the cuff is blocked or something is choking the hose The cuff or the Device leaks While connected to the Device the cuff is not put on the patient For some reason e g the user presses the button measuring is disrupted Blood pressure measuring failed for some Device error or the battery is low The calculated results cannot be considered as a real blood pressure value or the patient is having arrhythmia The measuring conditions e g the patient s movement interfere with the process of measuring For some reason the D
25. by PC To turn it on the button must be pressed twice again 2 5 System Bluetooth communication setup In case your PC does not have a built in Bluetooth at least v2 0 install the supplied Bluetooth communication adapter by reading and following the instructions of the enclosed Bluetooth operation manual If necessary ask for the help of your system administrator After successful installation a Bluetooth icon appears in the system tray of the PC indicating an active Bluetooth service For connecting Arteriograph to the PC see Section 5 2 Data transmission can only be initialized with the Arteriograph Software 3 The software 3 1 Medexpert Arteriograph Software installation and setup 3 1 1 Preliminary information about the software The Medexpert Arteriograph Software Arteriograph SW is a Windows based software The common Windows mouse operations are to be used in the program left single click double click drag etc Button and command names ending in indicate that a dialog window will open upon clicking on those items Arteriograph SW allows you to perform arterial function measurement to print and share the measurement report and to modify the measurement settings 3 1 2 Minimum system requirements e Pentium IV PC 256MB memory 2GB available HDD capacity CDROM 1024 768 resolution e Windows 2000 operating system with Service Pack 4 Windows XP with Service Pack 2 Windows Vista or Windows 7 installed e Act
26. cation is in progress Successful data download will be confirmed on the PC Note The downloaded settings cannot be cancelled They can be overwritten through re programming 5 4 2 Select a patient 5 4 2 1 How to select an existing patient E After logging in to the program use the Open command in the File menu or click on the Open 5 button see on the left on the toolbar for displaying the list of the patients that belong to the user logged in Find and select the patient you are interested in by double clicking on the row which contains the patient s details or by highlighting the row with a single click and then click on OK The selected patient s fullname and date of birth are displayed in the Patient Details block under the Toolbar In addition the patient s previous examinations will also appear in a list if there are any FI TenuoMed Arteriograph You are logged im at ARTERIOGRAM fie View Tools information Des BRA 5 fas Les GY medexpert fl K ands step AD malen vw Y sn compression 2 v Darie Preset 5 Atomatic ana 55 D LA Canu E narnrustiorn N Hard re Teszt Date Time Fest nar Beteg Date of Beth 01 01 1975 5 4 2 1 1 How to modify a patient s data Select the patient as described above whose data you wish to modify by a single click in the Patients List and press Edit Click on OK to save the modified data 5 4 2 1 2 How to search for a patient In case there is a great number of
27. dexpert Arteriograph using the simple blood pressure measurement function see Section 4 In the latter case please use the appropriate cuff size the same rules apply as for arm cuffs see Section 4 1 Calculation of Ankle Brachial Index ome Su Systolic blood pressure measured on the ankle mmHg Com lo After the measurement is completed the automatically calculated blood pressure and arterial function data appear in the Results field see Section 3 2 while the recorded pulse wave curves are displayed in the Data window see Section 3 2 F TersioMed Arteriograph You are logged in as ARTERIOGRAM a ON File View Took Infeemation gt E 17 4 SBS stant Ea EN med H dep AD waters Y ges Bonner 2 Padre 0 Reset a Brahma nahm SJ D ES Curra Far nme Test Fest rere Boteg Date of Beth 01 01 1975 ae 51 2 5 11 7 5 270 ms 125 ms A A j 53 cm 0 5 m s m e a 1m i 0 21 ma 28 7 mmHg 111 7 mmttg Every examination is saved automatically An already saved examination can be deleted by selecting the row which contains its date and time in the Examinations list and then pressing the Delete button on the keyboard 5 4 4 Quality control of the measurement Conditions movement arrhythmia respiration etc disturbing the measuring process may distort the shape of the recorded pulse wave which may result in false hemodynamic parameter values After the measurement is completed its qual
28. e values option under View menu By using this feature the quality of blood pressure measurement can be evaluated visually IF TersioMed Arteriograph You are logged in as ARTERIOGRAM S Das SG fas Cas UE meaoxport il Y ges Conmgretnon 2 v Eeamunnaorn PATIENT DETAILS Fady name Teszt Date Tem Fest name Beteg Date of Beth 01 01 1975 ETE RE 121 83 36 30 Y 7 Y 7 T Y Y Y Y T Y Y 7 Y T Y Y Y Y T Y 7 Y 7 T 0 0 100 150 20 20 30 prets Pulte waren Ampt piacnse valias Fell age Ansmann 5 4 5 3 Vascular age assessment By clicking on the Vascular age assessment tab of the measurement window the estimated vascular age of the measured patient can be displayed The same function can be accessed by selecting the Vascular age assessment command under View menu This tab shows the Age PWVao relationship with smoothed reference percentile curves Note Percentile is a value below which a certain percentage of the known measurements fall e g the 75 percentile is the value below which 75 of the observations can be found Age specific percentile curves show certain percentiles in different ages Note The reference curves were derived from a healthy central European population including approx 10 000 subjects The current measurement is indicated with a coloured dot in the graph with the colour depending on which range the measured PWVao value falls The ranges are as follows e Normal green colo
29. ear on the third page of the print out Note The report is assigned to a specific examination and can be modified later For other measurements of the patient this medical advice will not be saved or displayed To display institutional data on the printed Report select Options under Tools In the dialog box choose the Printed Report tab where you can specify the following e Doctor s identification data e Department details e Operator s name Department details along with the doctor s name and registration number will appear in the footer of the printed Report These data are user specific and therefore will appear on the report of every patient of the user The Operator s name will appear in the Study data section of the printed report It is measurement specific therefore can be modified for each measurement By default the Operator s name is the login name of the User The Operator s name for the default user ARTERIOGRAM cannot be modified Con IS E m0 5 4 6 2 Print the Report gt You can print out a Report by choosing Print preview and print under the File menu or clicking the Print preview and print button on the toolbar A Print options dialog window appears where printer selection and printer settings can be made and other common print options can be set Click OK to continue Print 1 WE General Select Printer Add Printer Fax Eh Microsoft XPS Document
30. ection X axis step Horizontal axis The scale of the horizontal time axis of the pulse wave curve as displayed on the millimetre net can be set from 10 ms cm to 1 600 ms cm in the pre defined steps This function can be accessed directly from the toolbar X axis step or by selecting a value under Horizontal axis in the View menu anis step 200 meter Y axis compression Vertical axis compression Here the vertical amplitude axis of the pulse wave curve as displayed on the millimetre net can be set The set value indicates the vertical compression rate of the curve In case the set value is 1 the curve will be displayed in full size This function can be accessed directly from the toolbar Y axis step or by selecting a value under Vertical axis compression in the View menu Y asi compression Baseline shift The pulse wave curve on the millimetre net can be moved upwards or downwards relative to the zero line The original position can be restored by clicking on the Reset button Baseline U Reset View pressure curve To display the actual cuff pressure values press the View pressure curve button on the toolbar When it is on the baseline cuff pressure can be seen during the whole measurement on the millimetre net Cursor EE Lasa Use the Cursor function for reading the co ordinates of the oscillatory signal pulse i waves and the value of the baseline cuff pressure if the View pressure curve function is
31. ed field strength in the location in which the TL2 device is used exceeds the applicable RF compliance level above the TL2 device should be observed to verify normal operation If abnormal performance is observed additional measures may be necessary such as re orienting or relocating the TL2 device Over the frequency range 150 kHz to 80 MHz field strengths should be less than 3 V m Recommended separation distances between portable and mobile RF communications equipment and the TL2 device The TL2 device is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled The customer or the user of the TL2 device can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment transmitters and the TL2 device as recommended below according to the maximum output power of the communications equipment Separation distance according to frequency of transmitter Rated maximum output m power of transmitter 150 kHz 80 MHz 80 MHz 800 MHz 800 MHz 2 5 GHz d 3 5 3 vP d 3 5 3 vP d 7 3 vP For transmitters rated at a maximum output power not listed above the recommended separation distance d in metres 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
32. evice does not detect the cardiac pulses The signals are insufficient for blood pressure calculation Artefacts arrhythmia The calculated results cannot be considered as a real blood pressure value The most likely reason is noisy measurement signals The pulse rate cannot be calculated or cannot be considered as a real value 7 Technical Specification Power supply Four AA long life alkaline batteries or rechargeable batteries Protection against electric shock Internal supply by batteries Grade of protection against electric shock BF type on patient s side Display Liquid Crystal Display LCD Data storage EEPROM Data transmission Radio Bluetooth PC Interface Bluetooth Communication Adapter PC system requirements Windows XP with Service Pack 2 or newer OS installed Ambient temperature 10 40 C Dimensions 116 x 94 x 47mm Weight incl batteries 250g Blood pressure measuring method Oscillometric Sampling frequency 200Hz Blood pressure measuring limits 30 280mmHg Static accuracy 3mmHg or 2 of the measured value Stability 2 years Measuring accuracy Systolic 91 91 out of 99 comparative checks fall within 5 mmHg For 33 patients out of 33 2 of 3 comparative checks fall within 5 mmHg 0 of 33 patients did not have a value within 5 mmHg after 3 measurements Diastolic 97 98 out of 99 comparative checks fall within 5 mmHg For 33 patients 33 2 of 3 comparative checks within 5 mmH
33. g 0 of 33 patients did not have a value within 5 mmHg after 3 measurements Average deviation from auscultatory measurements Korotkov sounds systolic diastolic 0 4 0 3 mmHg Standard deviation systolic diastolic 2 7 2 3 mmHg Pressure sensor Piezo resistive Inflation Automatic motor driven pump Safety Maximum cuff pressure 280mmHg Deflation Automatic stepwise 7 1 Electromagnetic compatibility Electromagnetic emissions The TL2 device is intended for use in the electromagnetic environment specified below The customer or the user of the TL2 device should assure that it is used in such an environment ss Emissionstest Compliance Electromagnetic environment guidance RF emissions The TL2 device uses RF energy only for its internal CISPR 11 function Therefore its RF emissions are very low and are not likely to cause any interference in nearby electronic equipment The TL2 device is suitable for use in all establishments CISPR 11 including domestic establishments and those directly Harmonic emissions Not applicable connected to the public low voltage power supply IEC 61000 3 2 network that supplies buildings used for domestic Voltage fluctuations flicker emissions Not applicable purposes IEC 61000 3 3 Electromagnetic immunity The TL2 device is intended for use in the electromagnetic environment specified below The customer or the user of the TL2 device should assure that it is used in such an environmen
34. g 120mmHg lt 40 lt 120 mmHg Fixed initial inflation pressure mmHg 160 Offset of diastolic pressure level Date and time of the device 120mmHg lt 0 lt 120 mmHg Downloading into the device Data transfer time at dia and sys pressure level 1 lt 8 lt 10 Set default sec Data Interface GDT GDT Directory Browse Local Name TSM_ARG2 Local Short Name TARG Remote Name Remote Short Name Calculation of Ankle Brachial Index Communication port COM 28 User defined parameter Print preview Program language Date format Set English dd mmyyy v o M In the pop up window the following parameters can be set in the System tab e Initial inflation pressure is the value Arteriograph inflates the cuff to when starting a blood pressure measurement This can be set as a fixed or a relative value In this latter case the Device adds 50 mmHg to the mean arterial pressure MAP value measured previously and inflates the cuff to this pressure The relative value is the default setting e Offset of systolic pressure level determines the value which is added to the measured systolic pressure in order to obtain the suprasystolic pressure step where the Device will record pulse wave data 35mmH g is the default setting which means that data will be collected at a pressure level of the measured systolic value 35mmHg For diagnostic examinations this value should not be set lower th
35. gle blood pressure measurement The Medexpert Arteriograph device can be used as a simple automatic blood pressure meter For this function no computer is needed 4 1 Patient preparation Sitting position is recommended for standard blood pressure measurement The patient should be comfortably seated with the legs uncrossed and the back and arm supported The cuff on the upper arm should be at the level of the heart Allow the patient to sit in a relaxed state for at least 5 minutes before the measurement Ensure optimal room temperature and eliminate excessive background noise Choose a cuff of appropriate size by considering the followings e The length of the inflatable bladder of the cuff should be at least 80 of upper arm circumference e The width of the inflatable bladder of the cuff should be at least 40 of upper arm length Please read and follow the latest guidelines on blood pressure measurement 4 2 Performing the measurement To operate Arteriograph first install the device see Section 2 3 There is a single push button Section 2 1 available for operating the Device The measured values and the status of the Device are shown on the LCD e The Device is ready for operation if the current PC time D 09 39 appears on the LCD By pressing the button shortly manual blood pressure measuring will start Note In this case the Device performs blood pressure measurement without arterial function e g PWVao Aix evalua
36. he end of the examination the Device transmits the blood pressure values to the PC as well The SW displays the followings systolic and diastolic blood pressure values heart rate MAP pulse pressure and the entire registered pulse wave curve T aber If you want to interrupt the measurement use the Abort command An Abort button appears automatically next to the PW button when starting a measurement and the same command can be found under the Tools menu Please note that this function only disrupts the data collection procedure of the software and does not affect the operation of the Device To interrupt a measurement on the device the push button of the Medexpert Arteriograph must also be pressed once If the Calculation of Ankle Brachial Index was selected See Section 5 4 1 a dialog window appears after the suprasystolic pulse wave recording phase is completed Enter the formerly measured ankle systolic blood pressure here and press OK The calculated value will appear under the blood pressure values in the Results field see Section 3 2 If calculation of ABI is not needed or the ankle blood pressure could not be measured press Cancel Measurement of the ankle blood pressure is advised to be performed preceding the pulse wave recording For measuring systolic blood pressure on the ankle use of Doppler technique is suggested However if it is not available blood pressure measurement can also be performed on the ankle with Me
37. her running Windows applications and click Next O Welcome to the Arteriograph Setup Wizard The ll otal Tre sah 3 00 0 bea gi pour Beamter hi ee al you ieee al ee een ee Canin Step 4 Select the components to be installed from the drop down list The type of installation can either be Full or Upgrade When the preferred component is selected click Next de Setup Arteriograph Sele Lomporenida Wech components rodea be rise T Sapo the comporeris pou man io etal char re pou de nol mini lo patel Check Med when pou ore ready bo comino sac Ness cancel Step 5 The following screen offers you to create an icon on the desktop This task can be deselected Click Next to start the installation process y Select Additional Tasks Wish addboral asie a be parform d Desg ds addon iska ou wold ce Setup In plom de inst sn Anenegraph then bak Hat Addon ora J Crate dedo icon smak nees Cancel Step 6 The status of the automatic installation procedure can be tracked on a progress bar If you want to interrupt it click Cancel This procedure also includes the driver installation of the hardware key see Section 3 1 4 8 Setup Arteriograph betaling Messe wet whe Setup rails AROSA on your DOUE Estrie fies Crogan Mes Teno Med A erograch one di Step 7 When the automatic installation procedure is finished the following screen appears Click Finish to exit the Wizard and start
38. hol consumption should be avoided o The patient should not sleep during the measuring phase o At least a ten minute period of physical and mental rest is required before the examination o Any circumstance e g noise phone ringing persons movement in the examining room that may disturb the patient s calm must be avoided o Should White Coat Effect be detected the measurement must be repeated several times with a few minutes intervals or the examination should be repeated in another time 5 4 Performing the measurement To start the Program double click the Arteriograph icon on the desktop or use the Windows Start Menu to navigate to the program Log in to the software with the previously specified user name see Section 3 3 When started for the first time the Program logs in the user with the default ARTERIOGRAM login name On every login after that however the user name must be specified In case a wrong or non existent user name is given the Program will offer the default name E Warning A Login is incorrect Do you wish to enter with the standard login name ca A 5 4 1 Device and measurement setup Before starting the measurement changing or checking setup parameters may be needed For setting up the Device select Options under the Tools menu F Options Initial inflation pressure Offset of systolic pressure level Previous BP value 35mmH
39. ice and the PC is guaranteed see Section 7 1 for details e To ensure the optimal performance and precise operation the Device should be maintained at the manufacturer s service every second year e The cuff and the Device itself can be cleaned with a wet cloth by making sure that no liquid enter into the Device e The manufacturer s products must be handled stored packaged protected and shipped in compliance with the general quality requirements N Attention Federal Law restricts this device to use by or on the order of a physician or other licensed practitioner US only u 1 4 Guarantee Medexpert Ltd offers a two year guarantee period for the Device Any repair within or beyond the guarantee period will be performed by Medexpert Ltd at the company s site as indicated above 1 5 Warnings and precautions Patient safety The device has an integrated safety mechanism which prevents the cuff pressure to exceed 300 mmHg If however the inflation continues above this value or the pressurization lasts too long unplug the tube of the cuff from the device and remove the cuff from the subject Do not use the device on an arm which is being injected with intravenous injection Do not use On neonates Device use Only use with cuffs supplied by Medexpert Ltd Use of cuffs supplied by a third party can lead to erroneous measurement results Confirm blood pressure measurement with auscultation when erroneous results are s
40. inaon h Fat rne Tesrt Date Ime Feu nara Reteg Date of Beth 01 01 1975 Pulse ware Ampt precia valuas Actecial aga accacemant Arrhythmia The oscillatory measurement method is highly affected by arrhythmia In such cases the beat to beat variance of the pulse wave forms renders the analysis inaccurate How to recognize the heart beats do not show regularity How to avoid this condition cannot be affected by the examiner Manual evaluation see Section 5 4 5 can help to find a regular sequence in the suprasystolic measurement phase Y rocked Arerogriah You se logged in m ARTIRIRAM eee Fie Wee Took L m Des PRA imm Las HE mea n d ni ar i AA Bose a Rami E E Essais i arai FRS Dime Te Fact rarer Cas of Eo Ol 1 re 65 2 5 46 i 296 ma i It 13 ma EE cm LR ne J in A cpt ee ss ms Im ms 56 h mmHg 162 6 matig Pubs por Anpa pe a uc A eee Tremor or mechanical vibration Tremor introduces an unwanted high frequency noise into the measurement This often leads to unrecognizable and not evaluable waveforms How to recognize the measurement is noisy a sawtooth like signal is superimposed to the pulse waves How to avoid tremor cannot be affected by the examiner Make sure however that the patient is isolated from external mechanical vibration e g do not place the patient s arm onto a vibrating machine like a PC D fensotted artenograph
41. ity should be checked to decide whether the result of the subsequent analysis can be accepted 5 4 4 1 Quality control index the SD PWVao SD PWVao see Section 5 1 is the standard deviation of the PWVao values calculated from the pulse waves that could be analysed by the algorithm of the software This variable shows how much the PWVao data of each analysed pulse curve differ therefore reflects on the identity of the recorded pulse wave forms Large deviation of the measured data shows some disturbance in the measurement Normal SD ve JUG SY i 51 cm 54 If the SD PWVao is greater than or equal to O and less than or equal to 1 0 m s ue HR the measurement is considered to be of good quality ST ea 2 ABI 1 08 PPao 54 3 mmHg High SD RT 36 If the SD PWVao SD is greater than 1 0 m s the measurement is considered 1 to be of unacceptable quality and the results of the current analysis should be a i rejected The SD appears in red colour in the Results field to warn the User on 1m s An the quality problem For advanced users the use of manual evaluation see IA Section 5 4 5 can help to find a good quality sequence in the suprasystolic prac N j 40 1 mmH measurement phase If manual evaluation is still not acceptable the mm measurement should be repeated No SD AT 107 80 ms JUG SY dy If the automatic analysis calculated arterial function data but no SD PWVao lem then only one evaluable pulse curve
42. ive Bluetooth v2 0 port Although the Program can start in a less powerful environment in that case we cannot take responsibility for its fast and reliable operation 3 1 3 Software Installation For installing the Arteriograph SW on the computer the user must have administrator privileges After the installation is completed please visit our website www medexpert hu for the latest software upgrades Installation instructions for those can also be found on our site Step 1 Insert the CD into the CD tray of your PC The installation procedure will start automatically In case it does not start the installation by double clicking the setup exe file on the disc with use of a file manager program Should a security warning pop up simply press Run to start the installation Open File Security Warning The publisher could not be verified Are you sure you want to run this software CE Name E settclin3000b exe Publisher Unknown Publisher Type Application From E settclin3000b exe CAN ca run software from publishers you trust This file does not have a valid digital signature that verifies its X publisher You should only How can decide what software to run Step 2 To start the Setup Wizard choose a preferred language for installation and click OK Select Setup Language x Select the language to use during the installation A Step 3 The wizard starts with a welcome screen Please close all the ot
43. l automatically appear next to it Note To achieve good measurement quality always use the cuff suggested by the software The cholesterol unit can be selected from a drop down list mmol l or mg dl The Comment field is advised to be filled out with important information on the measuring conditions e g the measuring position pregnancy Fill out the Risk profile field with information on the known cardiovascular risk factors such as family history duration and frequency of smoking etc Cos Address 5 4 3 Medical Examination with Medexpert Arteriograph MES START To start a single measurement select PW read under Tools or press the START button e on the toolbar W To start a scheduled sequence of measurements click the Repeated Measurements RE button on the toolbar In the dialog window the length of the test and the measurement frequency can be set To start the measurements click Start The measurement process can be interrupted by pressing the Stop button Repeated measurements Length of test 7 KEN Start Frequency 5 min 3 Stop 7 Save results automatically Number of remaining measurements 3 Cancel es medexpert When starting a measurement a confirmation window will pop up with some important measurement information If the listed data are correct press Yes to start the measurement process If these data need to be modified press No and edit the patient
44. listed subjects Selection is confirmed by clicking on the arrow 2 Step Please select patientis Select all Tet Beleg Palo of Bethy C8 OM 145 Adder Esport al manzuremaeia oS By setting a time range here only those measurements that were performed in the specified range will be exported By selecting Export all measurements every measurement of the formerly selected patients will be exported Click Export to start the process 2081 juut HE fx E l 3 3 i 7 A 16 W i gt 16 N H M F E Saa 3 Step amp 5 E Flense smi 1 M 1106 20 J Fram AMM Ey Ta nu Export Export all messurements et NE mec Y The status of the export process is shown by a progress bar In case of a large database the process can take several minutes Export data Export patients data Export measurements When the export is completed a message window will pop up confirming on the successful save SS Information les eo File saved successfully IE 8 000 The save destination of the completed text file can be selected The exported file is a tab delimited text file which can easily be opened or imported in common spreadsheet applications e g Microsoft Excel or statistical packages e g SPSS SAS Note The exported text file contains each measurement in a different row Several measurements for one patient are listed under each other If the result were no
45. m 8 UN aes al 8 5 m s ATH ms 78 6 mmt ig ER l Cursor 4 Clove 111 6 mmHg Pulte wee Ampt Geecouee vales Actor age atoetemert o When selecting only one pulse wave at the pressure step corresponding to the diastolic value several curves appear in the window the original pulse wave represented by a red curve the systolic component green and the diastolic wave component black The curve shows two markers indicating from left to right the locations of the peak of the systolic wave and the start of the diastolic wave r TA F TerioMed Arterograph You are lagged in as ARTERIOGRAM a file View Tools Information Dala ACA E Sas La BM medoxpor I K moat tep ZU mam Y aes Companion 2 arre Reset 8 Astonia arabe 5 35 D ii Caves vor Fady name Teszt Feit name Beteg Date of Beth 01 01 1975 attexstart 121 300 ms RA 66 393 N ENI pad AR A u j Al NL J Zu 33 8 X N l A gt e 66 2 een e gt l Cu 4 Chow Pula w Text peca o valves Asiana age accecemert With use of the tools in the separate window the single pulse wave can further be examined The curve can be enlarged and reduced in size within pre set limits see the relevant value of this in the upper left hand corner of the window Furthermore you can examine the curves from point to point by means of a cursor that can be activated The window can be closed separately Charac
46. mination is performed while the patient is seated indicate this fact in the Comment field of the SW when the patient s data are entered e Place the cuff in a way that the hose is in anterior position e To avoid the irritation of the skin a long sleeved shirt made of some thin material can be worn under the cuff e Connect the hose of the cuff to the air connector of the Device For this push the plug on the hose into the air connector of the device and twist the plug slightly until it securely clicks Make sure that the cuff is properly attached by checking the tightness of the connection e Measure the suprasternal notch pubic bone distance Jug Sy with use of the supplied tape measure Note The suprasternal notch jugulum pubic bone symphysis distance should be measured in a Straight line Measuring on the body surface can lead to overestimation e g in case of obese patients e Ensure optimal measuring conditions o Speaking muscle movements especially the movement of arm muscles must be avoided as these activities significantly increase the measuring time may result in measurement failure or may reduce the precision rate thereof Muscle movements tremor distort the form of the measured pulse wave and render its evaluation impossible o Within 3 hours before the examination the patient should not consume a greater amount of food drink coffee or smoke Additionally within 10 hours before the examination alco
47. nd mobile RF communications equipment should be used no closer to any part of the TL2 device including cables than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter Recommended separation distance Conducted RF 3 Ver d 1 2VP IEC 61000 4 6 150 kHz 80 MHz Radiated RF 3 V m d 1 2VP 80 MHz 800 MHz IEC 61000 4 3 80 MHz 2 5 GHz d 2 3VP 800 MHz 2 5 GHz where P is the maximum output power rating of the transmitter in watts W according to the transmitter manufacturer and d is the recommended separation distance in metres m Field strengths from fixed RF transmitters as determined by an electromagnetic site survey should be less than the compliance level in each frequency range Interference may occur in the vicinity of equipment marked with the following symbol W NOTE 1 At 80 MHz and 800 MHz the higher frequency range applies NOTE 2 These guidelines do not apply in all situations Electromagnetic propagation is affected by absorption and reflection from structures objects and people 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 measur
48. per port number can be checked under Control Panel gt Bluetooth devices If this field is left blank the software performs an automatic port search when starting the measurement This process may take up to one minute e User defined parameter One new parameter can be added to the patient s data set through this function Enter the name of the parameter into the input field the parameter will be displayed in the Patient details field on the print out see 5 4 6 2 and press Set Note A new parameter can be added to a patient s data only once and cannot be modified or deleted later The new parameter wil automatically be added to all the patients in the database After setting it into either a new patient s data or an existing patient s data the patient characteristics will feature this newly specified parameter as well Non Device specific settings e Program language the language of the Arteriograph SW can be selected The change only takes place upon the next SW start e Date format one of the following date formats can be selected Year month day day month year and month day year Default settings can be restored by clicking on Default Settings The settings must be downloaded into the Device to take effect For this use the Downloading into the Device button The download of the settings to the Device can be tracked on the screen The CONKT text CONNECT will be displayed on the LCD of the Device while communi
49. program window appears with the following components For a better understanding the picture below shows the program window after a completed measurement Menu bar Toolbar Examinations window Results field Patient details field Data window DAS e SS x E TersioMed Arteriograph You are logged in as ARTERIOGRAM File SS Tools Information z en 200 mub Y ass compresi n 2 Eee u Rebel 6 Autom anak 5 35 Tear Beteg Fary repre Fast name E PATIENT Data Tine Date of Bath Soil ie 83 1 25 ms E N 53 cm E i 85 o s lt Le Ma 0 21 ms ee 7 mmHg 1 1 7 mmHg Pubs wave dings postie values Aulenal age acperimeni 3 2 1 The Menu of the Program 01 01 1975 lor Des Bea S Bee el CB medexpont fl D BE Cura lt 5 The menu bar of the software can be found under the title bar and contains the menu items through which all the major functions of the program can be accessed The File Menu The basic functions of Arteriograph SW can be accessed through the File menu You can enter new patients open edit or delete existing database records save the result of an analysis furthermore edit print and send medical reports as well as log out and exit The View Menu The View Menu enables you to choose to display the pulse waves recorded or the maximum amplitudes of the oscillatory signals at each cuff pressure step deflated stepwise with 10 mmHg during blood pre
50. ransmission inhibiting objects e g metal objects can cause signal weakening and consequently malfunction in the communication The use of the supplied protective pouch does not affect the transmission signal strength When an active Bluetooth device e g a PC tries to add Arteriograph the sign shown on the right appears on the LCD No actual data transmission takes place B uel INK yet Adding Arteriograph is only possible by entering its passkey see above Data transfer can only be initiated with use of the Arteriograph SW 5 3 Patient preparation Wrap the cuff around the dominant upper arm When doing this procedure please consider the followings e Use the cuff suggested by the software see Section 5 4 2 e Make sure that the cuff is tightened properly without causing harm to the patient The cuff should fit the patient s arm evenly Tightness is sufficient if your finger cannot or can only hardly be inserted under the cuff e Make sure that the patient s skin is not pinched by the cuff Note If the cuff is too loose or big the SW does not provide measurement results and gives an error message Small amplitudes The cuff should not contact the patient s chest during the measurement because the respiratory movements may cause pressure alterations and artefacts in the cuff According to the guidelines for measuring arterial function routinely the supine position is recommended for measurements In case the exa
51. se heat because it may cause a short circuit Regarding both rechargeable and alkaline batteries the policies of use and waste collection as governed by detailed environmental and labour safety requirements are to be considered amp LR6 1 5V AA LR6 1 5V AA EL LES LR6 1 5v AA O LR61 5V AA amp L Figure 3 34 43 cm 26 33 cm 18 25 cm Once the batteries are inserted in the Device the following checks are performed automatically e Voltage control of the batteries The measured value appears on the 50V LCD for a few seconds The supply voltage is sufficient if the measured value is between 6 0 V and 5 4 V for alkaline batteries and between 4 8 V and 4 6 V for rechargeable batteries e f the voltage drops below 4 4V the batteries must be replaced A LOwbot t warning symbol of low battery appears on the LCD e The Device is ready for operation if the current PC time appears on D 09 39 the LCD 2 4 Operation instructions There is a single push button available for operating the Device Section 2 1 The patient can use the only push button for issuing a total of two commands 1 By pressing the button shortly manual blood pressure measuring will start Note In this case the Device performs blood pressure measurement without any arterial function e g PWVao Aix evaluation 2 The Device can be turned off by pressing the button twice In OFF FF state the device cannot be operated either manually or
52. seuseceessuuseeeessugaeeeessagaeees 8 The Medexpert Arteriograph device 9 2 1 The device at a 2 Ace een on aa 9 2 2 The accessories of the Device sise 10 2 3 installing the Device ae ee da eee ee eee eee 10 2 4 Operation instructions ar NAS 11 2 5 System Bluetooth communication setup 11 TNS OT AE ee ee euere 12 3 1 Medexpert Arteriograph Software installation and Setup oocccccocccnnonccncnnnnccnnnnacononacnonnnos 12 3 1 1 Preliminary information about the software cccccooocccncconocccnncncnnnconnnonanocnnnonononnnnonanononos 12 3 1 2 Minimum system requirements ss 12 3 1 3 Software Installation near 13 SIE AVS TU A KV a ee ee het 15 3 2 The software at a elder innatas 15 32 1 The Menu of the Program een 16 3 2 2 The Toolbar of the Program ss 17 3 2 3 The examinations window ss 17 3 2 4 The results e o a nn a ea ine o OOO nee 17 3 2 5 Patient details Held assim een 17 3 2 6 The measurement data window ss 17 3 3 First step Register a user seen rer ER 18 Performing a single blood pressure measurement nennen 19 4 1 Panent preparato De ee Ne a een 19 4 2 Performing the measurement sisi 19 4 3 Acoustic signals ann un een an 20 Performing pulse wave recording and
53. ssure measurement Furthermore you can set the scale both horizontally and vertically hide the Toolbar and get information about the currently studied patient TemiohMird Arterisgraph You are legged in a ARTERIOGRAM Eile Wiw Toch Information New patient Open Sivi nls Eda report Print preview and prat Send POF report Exit Ciria M Cirle Dile Fi a im a 3 Oe START x pompei E B ls Fanta rare Fit nan F TensioMed Artenograph You are logged in as ARTERIOGRAM File View Jools Information Y Pulse wave Amps pressure values X ai Arterial age assessment Exar Honor tal aus Date Y Toolbar Patient info 4 Vertical aus compression Ctre Fl ES START K Ct F2 Cents 3 we 2 B a F arniky nam Fasi name 7 The Tools Menu FA TersioMed Arteriograph You are logged in as ARTERIOGRAM The Tools Menu enables you to start automatic pulse wave data collection by means of the Arteriograph Device as well as interrupt an ongoing data collection process Previous versions of databases can be converted and imported into the new database format furthermore exports and backups of the actual database can be created All the Program and Device settings can also be accessed and modified through this Menu Pir Nica Tools Imlermatinn 1 PIN read a N oda php x Convert previous database and import data Erama Dae Tims Expert data 7
54. t f Electromagnetic environment Immunity test IEC 60601 test level Compliance level Electrostatic discharge ESD 6 KV contact 6 kV contact Floors should be wood concrete or ceramic IEC 61000 4 2 8 KV air 8 kV air tile If floors are covered with synthetic material the relative humidity should be at least 30 feces A ee IEC 61000 4 4 1 kV for input output lines IEC 61000 4 5 2 kV line s to earth Voltage dips short interruptions lt 5 U Not applicable and voltage variations on power gt 95 dip in Ur supply input lines for 0 5 cycle IEC 61000 4 11 40 Ur 60 dip in Ur for 5 cycles 70 Ur 30 dip in Uy for 25 cycles lt 5 Ur gt 95 dip in Ur for5s Power frequency If image distortion occurs it may be 50 60 Hz necessary to position the TL2 device further magnetic field from sources of power frequency magnetic IEC 61000 4 8 fields or to install magnetic shielding The power frequency magnetic field should be measured in the intended installation location to assure that it is sufficiently low NOTE Uy is the AC mains voltage prior to application of the test level Electromagnetic immunity The TL2 device is intended for use in the electromagnetic environment specified below The customer or the user of the TL2 device should assure that it is used in such an environment Immunity test IEC 60601 test level Compliance level Electromagnetic environment guidance Portable a
55. t saved for a given measurement the exported text file will only contain the patient characteristics and the blood pressure measurement data in that row 5 4 8 Backup and restore the database To protect your measurements against accidental data loss the database should regularly be backed up For this use the Backup command under Tools menu The Backup and restore dialog window appears where you can set whether to make or to restore a database The destination directory can also be selected 5 4 8 1 Backup data In the Backup field select Create to start the backup process Also select the destination directory for the backup file FE Backup and restore database Backup Place of backup file O Make E c packard bell gt Restore gt C Advancedinstallers ar SA bg BG catroot Ca catroot2 com config cs CZ da DK de DE Dism a emre MEE In case there is a previously saved backup file in the selected database a confirmation window pops up for overwriting the file If you don t want to overwrite it press No and rename the previous backup file or choose another destination directory If you approve overwriting simply click on Yes EAN Confirmation Q Backup file already exists Do you want to overwrite it An information window appears if the backup is successfully completed EAN Information eo Backup completed 5 4 8 2 Restore data
56. teristic points of the pulse wave curve are marked in this window Blank blue circles represent the first and reflected wave peaks and the ejection duration Dicrotic notch respectively Filled red dot represents the calculated return time The return time is calculated as the time difference between specific characteristic points of the curve therefore it does not necessarily fall to a characteristic point itself 2 1 time 200 ms amplitude 113 5 Note Results of the evaluation are not saved automatically For saving the results into the database the Save results command should be used This allows the examiner to save the results of only those measurements that are of good enough quality to be exported later E The findings of the evaluation can be saved into the database by selecting Save results in the File menu or by clicking the Save results button on the toolbar Any previous result will be overwritten E Confirmation 2 Results already exist Overwrite ve Co ecto er This even allows saving results different from the ones calculated by the automatic evaluation When an examination is opened it appears with the formerly saved arterial stiffness results If no result is saved the software displays the results of the automatic evaluation However in this latter case no values will be exported with the Export command see Section 5 4 7 5 4 5 1 Tools for visual insp
57. the Arteriograph Software ko El Completing the Arteriograph Setup Wizard Stop hae fined inataling A erogreh en your camgar The apps pay ba launched by ears Pa eed ale ona Click Finish to ext Setup Ji Launch Asa Firah 3 1 4 The hardware key For copy protection purposes the software is supplied with a hardware key Before starting the software and during its run the hardware key must be plugged in a USB port of your computer As the software installation wizard installs the driver of the hardware key automatically the hardware key is ready for use Note Without the hardware key the software will not start and an error message will appear Attention Do not remove the hardware key while the software is running as it causes the software to freeze out gt 3 2 The software at a glance To start the Program double click the Arteriograph icon on your desktop or use the Windows Start Menu to navigate to the program in the Program Files A splash screen appears along with a login dialog window When started for the first time simply press OK and the Program logs in the user with the default ARTERIOGRAM login name On every login after that however the user name must be specified Arteriograph for professional users Y Login Dialog Enter pour login name OK I Cancel Ea CA www medexpert hu Manufactured by TensioMed Kft ud K r str 2 d 1103 Budapest Hungary The
58. timation of the patient s arterial age can be seen on the SD PWVao parameter graph which is a simplified visualization of the reference percentile values for the patient s age It shows the patient s position relative to the reference population The measured value is indicated in the graph also showing the estimated arterial age at the top Page 3 optional Medical Report Printed only if the Edit report function was used see Section 5 4 6 1 This page includes only the patient details and the edited medical report Note The Report is always printed out in A4 size It will contain only as much information as was entered previously or was calculated in the course of the analyses which also means that a Report can be printed out with only the patient s data appearing Note Cut off critical values for the different parameters can be found in the available scientific literature addressing vascular age and arterial function 5 4 6 3 How to send a Report in PDF format You can convert the above detailed Report to PDF format by Send PDF Report under the File menu and simply e mail it After the command is selected the program converts the Report to PDF format automatically The generated pdf file can be saved to a selected destination with the following file name Tcrep_fullname_date_time pdf where fullname is the name of the patient and date and time are the date and time of the examination in the pre set date and time format e g
59. tion By doing so the current time will disappear from the display and then e The LCD test pattern is displayed REX A Be Dae Be e The supply voltage is checked 56V e The Device calibrates itself by setting the zero pressure CAL O The measurement starts with the inflation of the cuff This procedure A B I is indicated by an arrowhead pointing upwards During deflation an arrowhead pointing downwards indicates the procedure When measurement is completed the Device displays the systolic and diastolic values and then the heart rate The measuring process can be disrupted any time by a single press on the button The text OFF will appear and remain visible for about 5 seconds on the display Thereafter the time is displayed again which indicates the ready to operate status for another manual or programmed measurement 4 3 Acoustic signals v 69 LG Y PUL 68 OF When the Device is active a gentle acoustic signal is emitted when its button is pressed down 5 Performing pulse wave recording and analysis Pulse wave registration can only be initialized by Arteriograph SW that is running on a PC with wireless Bluetooth data transmission link to the Device in this case the button of the device should not be used The oscillatory signals recorded during the whole measuring process are displayed real time on the PC screen 5 1 Hemodynamic parameters measured by the Arteriograph The following hemodynamic parameters
60. ture is equivalent to the Send PDF Report function see Section 5 4 6 3 The patient s previously saved Reports can be selected and displayed by clicking on Load Report in the Print preview dialog box Close Close The Print preview screen can be closed by using this button The Report printed out by the Arteriograph Software will contain the following TS ann F Blood Pressure Measurement rn expe sri Pulse Wowe Analysis expert Y expert ON mede tel Arteriogra ph report ond Pulse Wowe Analysis Y mede i if Arteriograph report ond Arterial Age Assessment ME Atend Name Postal code 1035 Country code HU Name ID 007 ich oy City Hud pert Date of Birth 194905409 Date of Path 1495 05 09 Addrots Age 61 years Gender Male eel bho ana epg Gender Male E mail srtenograph medenpent hu Weight BMA 110 ig 31 8 kg m Quality control Risk profile 50 0 14 mis farnily history of CVD A er TAE J be ner nnn MN BE Medication BC Pere o 10 mans Pulse Wave Velocity measurement Pury BO ms AT 147 ms Measurement data PWV Arterial Age Assesoment Date 2011 04 01 10 05 Haight lB cm Armin Jiem Aight Piso Operator ARTERIOGRAK iag Si SSom Cuff sive 2 m 4 Suprarystole record ia a AT EH rachael Dad Pronto Central Hemodynamics sl and Pulse Wave Analy n Sy 122 mmHg SAPO 111 2 mmHg Dia 81 metia PP 41 mmHg Pac 30 2 mmHg j MAP 95 menda ken 63 min HA Aix brachial 555 Aix sortie 9 6 T Abs brachial 75 B22 Aix
61. ur The measured value is lower than or equal to the 50 percentile for that specific age group e Elevated yellow colour The measured value is higher than the 50 percentile but lower than or equal to the 90 percentile for that specific age group e High red colour The measured value is higher than the 90 percentile for that specific age group File View Tools Information ec rg Pa ES sm LES EA mode mes Comet y r al FI TercioMed Arteriograph You are lagged in as ARTERIOGRAM a F andy rare Teszt Feit name Beteg Date of Bet 01 01 1975 PWVao PA Im a a 4 5 gt y e gt o Mth percentle 50 and lt Sth percentile ES r on the hace of paana 10000 remarca paianed in Cardin ropas popisi hd o Uh percentile 5 4 6 The measurement Report The Report is a printed summary of the measurement results It includes patient details all the calculated hemodynamic parameters characteristic pressure curves and vascular age assessment The following functions are only enabled if an examination of a patient has been selected 5 4 6 1 Edit the Report TA To edit the Report press the Edit report button on the toolbar or select the Edit report command under the File menu In the report window you can enter your medical advice treatment suggestion which can be saved by clicking on Save The current date can be inserted to the report by using the Insert date button The edited Report will app
62. uspected Do not use a microwave device e g mobile phone near the unit during measurement Do not use the device when it is exposed to mechanical vibration e g in vehicles Prevent the device to be exposed to direct sunlight to get in contact with liquid or from excessive mechanical impact Do not disassemble the device 2 The Medexpert Arteriograph device This section will give an introduction on the device along with installation information and operation instructions 2 1 The device at a glance Figure 1 shows the front view of the device The name of the Device Air connector LCD Push button for entering two commands to control the Device as per Section 2 4 Symbols standing for the above two commands a ES Arteriograph Vascular age assessment is BLUELIN SYS mmHg DIA mmHg PULSE min BP 10 ON OFF 2x0 B Figure 1 Figure 2 shows the device label The meanings of the symbols are the following 6 Name of the Device 7 Name of the Manufacturer 8 Range of ambient operating temperature 9 Manufacturing serial number 10 Applicable nominal range of supply voltage with the batteries 11 Year of manufacturing 12 Safety classification of electric shock protection Classification Patient side BF 13 Warning on the importance of reading this User Manual thoroughly 14 Certification mark as a guarantee of the Device s conformity with EU requirements 15 Type ID of the Device

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