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User Manual - Arteriograph start

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1. System Upert Prinind pat Liisi nate Fast name Faih rime Logn meme user HT Add Hew 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 19 4 Performing a single 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 8096 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
2. cscscccccccsssecccceesseccecseesececsecaeseeeeseaaeceessuaaeceessaueneeeessaaaeeeeses 19 3 3 FIISESESD R BEF SR a pai do a E 19 Performing a single blood pressure measurement ss 20 4 1 xiii DE AA ON dore eines T EN 20 4 2 Performing the measurement ccccsssseccccsesecccccesecceceuaeseececsauseeceesaeeeececssuusseceessuuseceesseasecessauaaeeees 20 4 3 ACOEBSBICSISIISIS aan de MEIN NUI EE rM nee ie De T rM 21 Performing pulse wave recording and analysis 22 5 1 Hemodynamic parameters measured by the Arteriograph 22 5 2 sz SOU TP C HH 23 5 3 misse P 24 5 4 Performing the A aS Uh Ie NETTE OE TE TOO o TOT 26 5 4 1 Device and measurement setup csssecccccesssececceessceeceeseeseceecseasececseeaseceeessaeseceessuaaeceesauaeeeesaes 26 SCOMUMEEES edocuit ER 28 5 4 2 1 How to select an existing patient siennes 28 5 4 2 1 1 How to modify a patient s data is 28 542 12 Howto search TOM apateni aeos cisasastue e reixto npe vut dcoh us lavi etx e vasta pu Desk rad PLI ae 28 5 4 2 2 How to enter a new patient s data ss 29 5 4 3 Medical Examination with Medexpert TensioClinic Arteriograph esee 30 5 4 4 Quality control of the measurement sise 32 5 4 4 1 Quality control index the SD PWVao ss 32 5 4 4 2 Quality control by visual inspection ss 32 54 5 Howtoanalyse the Ga
3. 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 should be noted that errors can occur due to patient movement causing artefacts in the reading In case the Device cannot measure blood pressure e g due to 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 motion measuring will be disrupted What to do Plug in the adapter and follow the instructions of Section 2 5 Go to Control Panel Telephones and Modems Modems 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 in
4. 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 on line Help of Windows or the Windows User Manual Arteriograph is an unregistered trademark of Medexpert 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 ETO CU CTO MNT E OO DO DER 7 1 1 PUG SE eumd FE MEM NIIS UNUM DEN E EIDEM NN NNI INTE 7 1 2 Contents OF the MAnUal Se Op ORE aei vu can non annees near CEU UR cU QUID SEE 7 1 3 General IDTOLiablOH see pea aid ee aan vase
5. as follows Cuff type Bladder dimensions 01 02 34x 8 cm 26 x 8 cm 62 x 9 cm 52 x9 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 intense 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 CB LR61 5V AA LR6 1 5V AA QD IG LR6 1 5v AA LR6 1 5V AA COL Figure 3 11 34 43 cm 26 33cm 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 56V LCD for a
6. see Section 5 4 2 1 1 F5 Confirmation 2 Arm circumference 26 cm Suggested cuff type 2 bls 26x6cm Operators name ARTERIOGRAM E 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 the end of the e
7. Medexpert 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 imm Systolic blood pressure measured on the ankle mmHg OMS E 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 Axtencgraph You are logged in as ARTERIOGRAM cep 7 File View Took Infeemation c E 17 4 SBS stant X Z3 med ia rep AD waters Y aes comperon 2 Bowie 0 Reset e Ariomma anim 535 D ES Curra Fady reme Teszi Feu nara Boteg Date of Beth 61 01 1975 PEER 51 2 11 7 270 ms 125 ms x A j 53 cm 85 m s else i 0 21 ms 28 7 mmHg 111 7 mmHg 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 31 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 measure
8. RF X communications equipment should be used no closer to any part of the TL1 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 Veg 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 P NOTE1 At80 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 measured field st
9. dii Step 7 When the automatic installation procedure is finished the following screen appears Click Finish to exit the Wizard and start the Arteriograph Software oe Completing the Arteriograph Setup Wizard Setup has fined inatialing Senogneh en your cometer The inp sa mon rey be Vari ery eS m irai allons acer Chock Finish to ext Setup J Larch Aimoa _Firah 16 3 2 The software at a glance To start the Program double click the Arteriograph icon on your desktop or use the Al Windows Start Menu to navigate to the program in the Program Files l 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 Enter your login name I Cancel BEN S medexpert www medexpert hu Manufactured by TensioMed Kft ui K r str 2 d 1103 Budapest Hungary The 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 83 TensioMed Arteriograph You are logged in as ARTERIDGRAM EM medexpert gt iem SES Bs aser ss pro gre Se YP I 2 faie Rebel B A
10. 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 crossed battery icon 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 CFF state the device cannot be operated either manually or by PC To turn it on the button must be pressed twice again 2 5 System Infrared communication setup For installing the driver of the IrDA adapter please perform the following steps the same description can be found in the Installation Users Manual Attention Please note that the IrDA adapter must not be plugged in the PC before or during installation To complete the driver installation the computer must be restarted Insert the IrDA driver CD into the CD tray of your PC The installation starts automatically
11. in the following way when an active i e enabled on the PC infrared communication adapter moves in the Device s efficient range the Device and the PC will automatically connect The sign If cH shown by the Figure on the right appears on the LCD No actual data transmission takes place yet An icon appears in the system tray of the PC indicating a detected infrared connection By default it is accompanied with a Windows sound effect Data transfer can only be initiated with use of the Medexpert 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 examination is performed while the
12. 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 ee Aiea 29 5 4 3 Medical Examination with Medexpert Arteriograph Bre START To start a single measurement select PW read under Tools or press the START button ig on the toolbar Em 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 KEN Start Frequency 5 min 3 Stop 7 Save results automatically Number of remaining measurements 3 core 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 s characteristics
13. 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 suspected 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 1 The name of the Device 2 Push button for entering two commands to control the Device as per Section 2 4 3 Symbols standing for the above two commands 4 LCD 1 4 i A Arteriograph Vascular age 3 V1 assessment Ut LL SYS mmHg DiA mmHg PULSE min IWIN medexpert Er Mia Ser BP 1x P O
14. N OFF 2x a a Figure 1 Figure 2 shows the rear view of the device 5 Battery socket cover removed 6 Device label 7 Pneumatic connector Figure 2 Figure 3 shows the device label The meanings of the symbols are the following 10 11 12 13 14 15 16 17 Name of the Device Name of the Manufacturer Range of ambient operating temperature Manufacturing serial number Applicable nominal range of supply voltage with the batteries Year of manufacturing Safety classification of electric shock protection Classification Patient side BF Warning on the importance of reading this User Manual thoroughly Certification mark as a guarantee of the Device s conformity with EU requirements S 8 S 9 TensioClinic reves a 10 18 EN asser CEoir d LC is Made in Hungary 16 sy TL 1 A d _ DC4 8 6V un 12 i ual NL Figure 3 Type ID of the Device See Figure 4 for the side view of the Device 18 Infrared communication window 18 Figure 4 10 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 Atape measure for measuring the jugulum symphysis distance e IrDA adapter kit IrDA adapter Driver CD USB extension cable e Apouch with an integrated console for holding the IrDA adapter e A User Manual The cuff sizes are
15. Please choose your preferred language Click Next to run the procedure Click Install to begin the installation and to exit the install program Restart the computer to complete the install procedure Without restarting the PC the driver will not work properly All open data should be saved before restart aS dd 12 6 After restart plug in the IrDA adapter Do not plug in the adapter before or during the installation 7 The IrDA device is ready to communicate The Device communicates with the PC using standard infrared protocol IrDA with a transmission rate of 115 200bps We recommend the IrDA communication to be set up by a person experienced in wireless communication For connecting Arteriograph to the PC see Section 5 2 Data transmission can only be initialized with the Arteriograph Software 13 3 The software 3 1 Medexpert Arteriograph Software installation and setup 3 1 1 Preliminary information about the software The Medexpert Arteriograph Software Medexpert 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 Medexpert 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 I
16. V 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 Active infrared port Although the Program can start in a less powerful environment in that case we cannot take responsibility for its fast and reliable operation 14 3 1 3 Software Installation For installing the Medexpert SW on the computer the user must have administrator privileges After the installation is completed please visit our website www Medexpert com for the latest software upgrades Installation instructions for those can also be found on our site Insert the CD into the CD tray of your PC The installation procedure will start Step 1 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 3 This file does not have a valid digital signature that verifies its Q publisher You should only run software from publishers you trust How can decide what software to run Step 2 To start the Setup Wizard choose a preferred language for
17. aet 8 6 4 e Aix brachial 75 rr Mix aortic 75 2 8 x J bom m Lower Dents eiroeulatban jection duratkan 280 mutes ABI En 320 mi D OS Ge 1 30 34 O0 0X ap 44 30 34 d 70 73 de d G6 d 10 Age 43 Arterial age A0 S yiri D 30th percentile Age year 608 90th percentile p m s E ce Sh percentile L J cn the basis of approsimately T0000 meaiohaments performed im Central 8G Eurocean pope tisse TenileMedT Software v 3 000 BETA TeramMedT Softwar v 3000BET jO TUO114 001198 IO TLOLI4 00119 43 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 i
18. al This manual helps you in setting up and starting to use the Medexpert Arteriograph TL1 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 infrared communication The electromagnetic compatibility between the Device 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 AN Attention Federal Law restricts this device to use by or on the order of a physician I or other licensed practitioner US only a 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
19. 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 26 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 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 proper port numb
20. arniky rm Hornzontal ans d z r Date Fusl name pressure measurement Furthermore you can set the scale both Wii venicai aus compression sl horizontally and vertically hide the Toolbar and get information about ein the currently studied patient Patient info The Tools Menu The Tools Menu enables you to start automatic pulse wave data em rere lesged ina ATENIOSRAM File View Tesis Irdermatinn collection by means of the Arteriograph Device as well as interrupt an J w 7 ongoing data collection process Previous versions of databases can be cone Conve previous database andimpot dts converted and imported into the new database format furthermore E p 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 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 The results block The calculated hemodynamic parameters are displayed here when an analysis of measurement data is performed automatically or manually 18 3 2 5 Patient details field The na
21. ba serre naen N ANAE ane uH Op e YIN SPI STET EE neue 35 5 4 5 1 TOO WOK Visa MS CUI Oll so ciuitati ndn pd dh rU a tela dora Do en 0 38 5 4 5 2 Oscillation amplitudes during blood pressure measurement sssessseseserssrreresressrreserrrresn 39 5 4 5 3 Vascular age asses NO a nano eee ee nn te DIES ae dun TUE A0 5 4 6 The measurement Report cccccsssseccccccesseccccaesecccceeeseececeeeececesaueseceeseeaseceeseuaeceesseaseceesagaseees 40 5 4 6 1 d NNNM 41 5 4 6 2 PMT ARC OTE a mixed UU Pat UC DIU EE 42 5 4 6 3 How to send a Report in PDF format ses 45 5 4 7 Exporting th measurement data ssi beet Peas ocu Deu case d Desi ba DES Ui Uv bre M ebrbn Descente 45 6 548 Backup and restore the database sen sserete eee pe vt e tob IS ESSE nine PUT eto eres QUE VERS EE EXER doa 5 4 8 1 BACROD AAA E EO ESTEE 5 4 8 2 Rectore datana E EU EE 5 4 8 3 Iniport previels AAA ni he Re teu te iv omes UNI D Gad e hid MPOUDICS IO OCG esse ER re 220 NN malt D le 25 20 doit Rad EET TECNICA SPECIFICATION agaaa NI D Ne RNA ni cui 7 1 Electromagnetic compatibility sisi 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 manu
22. ct 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 zl d data Restore 5 D Se Dan CCleaner nokia Start Cancel LACE 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 vs no ET medexpert 1 An information window appears when the restoration is successfully completed r E51 Information e 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 Ml Information A Data import has been successfuly done CO 2 lt lt I 48
23. 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 evaluation By doing so the current time will disappear from the display and then e The LCD test pattern is displayed XN A Be Dae Be e The supply voltage is checked 560V e The Device calibrates itself by setting the zero pressure CAL Q 20 The measurement starts with the inflation of the cuff This procedure 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 67 v 69 LG 96 PLL 66 OF When the Device is active a gentle acoustic signal is emitted when its button is pressed dow
24. e acsmistoeni 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 pressure values option under View menu By using this feature the quality of blood pressure measurement can be evaluated visually I TercioMed Arteriograph You are logged in as ARTERIOGRAM E Dev AGS racer ts GY medoxport fl Y Axes Curgention 2 sararan PATIENT DETAILS Fandy rere Teszt Date Te Fert name Beteg Date of Det 01 01 1375 a 121 pu T Y 7 Li 7 T 100 150 ZU 0 30 prets 96 30 60 mmr 0 so Pilot wat Amps peaccute vues Peters age atseitimert 39 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 7596 of the observations can be found Age specific percentile curves show certain percentiles in different ages Note The reference cur
25. ectromagnetic 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 t 8 kV air tile If floors are covered with synthetic material the relative humidity should be at least 30 96 feces RS IEC 61000 4 4 1 kV for input output lines IEC 61000 4 5 2 kV line s to earth Voltage dips short interruptions 596 Ur Not applicable and voltage variations on power gt 95 dip in Ux supply input lines for 0 5 cycle IEC 61000 4 11 40 Ur 60 dip in Ur for 5 cycles 70 Ur 3096 dip in Ur for 25 cycles 596 Ux gt 95 dip in Uz for 5s Power frequency If image distortion occurs it may be 50 60 Hz necessary to position the TL1 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 Ur is the AC mains voltage prior to application of the test level 52 Electromagnetic immunity The TL1 device is intended for use in the electromagnetic environment specified below The customer or the user of the TL1 device should assure that it is used in such an environment Immunity test IEC 60601 test level Compliance level Electromagnetic environment guidance Portable and mobile
26. en 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 Make to start the backup process Also select the destination directory for the backup file Fr Backup and restore database Backup Place of backup file Make zl c packard bell Restore g cA Advancedinstallers ar SA bg BG C2 catroot Ca catroot2 com config Ca csZ da DK de DE Dism x C c lo 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 2 E Confirmation a Backup file already exists Do you want to overwrite it An information window appears if the backup is successfully completed E Information Qo Backup completed 47 5 4 8 2 Restore data In the Backup field sele
27. 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 Characteristic 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 p 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 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 Q 2 F1 Confirmation 3 Results already exist Overwrite rmm E This even allows saving results different from the ones calculated by the automatic evaluation When an examination is opened it appear
28. er can be checked under Control Panel Telephones and modems Modems 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 5 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 CLIMMECT text CONNECT will be displayed on the LCD of the Device while communicatio
29. flection SAI Systolic Area Index SAI is the systolic part of the area under the entire pulse curve DAI Diastolic Area Index 96 DAI is the diastolic part of the area under the entire pulse curve 5 2 System setup Enable the infrared communication on the PC see Section 2 5 Place the Device by directing its infrared window towards the infrared port of the PC Please make sure that the infrared window of the Device and the IrDA adapter plugged into the PC are facing each other nothing blocks the path of the ray and that the device and the adapter are on the same level The distance between the Device and the sensor cannot be more than 1 m Then once the device moves into the operating range of the infrared communication adapter the Device automatically connects to the PC To ensure optimal conditions for IrDA communication please use the supplied pouch with integrated console for holding the IrDA adapter see Figure 6 Insert the device into the pouch with its infrared window pointing towards the console The IrDA adapter can be fastened on the console with use of the velcro strip attached on each item Attention Direct light either sunlight or artificial light or mirroring surfaces e g glass table can cause infrared communication malfunction Other infrared devices e g mobile phone operating in the range of the system also may cause error 23 Console Figure 6 Infrared communication takes place
30. he patient s arm onto a vibrating machine like a PC E Tenzched rire You me logged in as ARTI EIOOGRAM F e Wy Togh B T am Des ES E mo ED enter Ci T dep DINNER EC X mu a 1 m y med m E asir beer B db aeuum o P a A F andy rama Dals Tie Fer rere aie af eh ZAUA 106 7 23 1 22 3 X 250 m3 125 ma Gt cm a m s 195 ms LE 7 mma 117 Z maHa 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 M Teniees7 Anenograph You ae logged in e ARTERIOGRAM emt uma f e Vw Took p LE Ww 4 sw t E med Hg K ai res min Bec cree rr gt me tem B ense nme it 0 Euni where D s Tma Fest nam se airt 14 on SE 34 5 4 5 Howto 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 535 D i place immediately after a patient s examination is selected The same can be achieved by clicki
31. idt siap Wma Y ane Compreicson Ravine Reset E fudtomatac anys SH D t3 Gave i eagran Fac rare Teszt Date Tee Veit name Beteg Date of Beth 01 01 1375 Aix bract 121 52 0 11 3 X 265 ms 1 125 ms A 53 em Baas HS TE Van 8 5 m s ones stan PY DU ms 28 6 mmHg A A lc i oo 111 6 mmHg Pulte wave Ampt peeccure vales Astany age acoeisment 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 36 Fr m F TeraioMed Arterograph You are logged in as ARTERIOGRAM Die View Toots Information oes BRS m bes Cas BW medexport i X oat tiep ZU0ma cm Y es Corentin Ramin Resm Atoms aubin SH D t3 Ciapa bor Far rere Teszt Feit name Beteg Date of Det 0 01 1375 alex n 121 300 ms RA 66 93 96 SE 4 fi a NE NS w A TNT i J l T re 33 8 JU SH SU e A n Tw Jl u 662 X I ee M 60 a VA l c 4 Diote vite wya Ampt peeccure values Adaria age acoeisment With use of the tools in the separate window the single pulse wave can further be examined The curve can be
32. installation and click OK Select Setup Language I fem Select the language to use during the installation English M Step 3 The wizard starts with a welcome screen Please close all the other running Windows applications and click Next Ts 3 Welcome to the Arteriograph Setup Wizard Le Terza Mesd Peleriegeaghs 4 000 0 bela on your pc TS aen 15 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 E Setup Arteriograph Sele Comporerds rech comparanda sies bel be erties Sealed the cuam pou wand io etal clear Hus components yeu do nol mant lo irata Click Nesd wher you Bre ready bo continue Full ntalo eme j 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 B Setup Arterioquaph Select Fekitinnol Tasks Wh addbonal tage should ba performed Select de sobre teak you weld os Setup lo percer while installing Prienegeaph then click Hat Acker acra J Create a desig aon simi ie Seal Step 6 The status of the automatic installation procedure can be tracked on a progress bar If you want to interrupt it click Cancel If Setup Arteriograph dris adus Bese wot while Cen piratas Ana on your DIGIE Estracirng fes CXProgram Mes Tenaio Mes Arierograch orine
33. ion 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 53 54 55 us medexpert putting precision first Arteriograph Medexpert Arteriograph User Manual 2011 Medexpert Ltd All rights reserved
34. jects Selection is confirmed by clicking on the arrow 2 Shep Please select patientis Select nli Tet Beleg alis of Euh I9 001 1885 Adder Esport all manzurgmanesiag ot 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 2001 jmut E ime ts F ton Y amp T B ow on 14 i2 ib 17 13 15 A Hn s f M M 3 Step Plense ari CO Mac 208 106 30 v From SR EJ Ta SDE AI Export all measurements ES RS Figen 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 datz Export patients data Export measurements When the export is completed a message window will pop up confirming on the successful save Information imm Sem e File saved successfully 46 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 not saved for a giv
35. mHg 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 mem us c 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 35 mmHg to the systolic 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
36. me 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 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 Medexpert 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 plns
37. me of the examination in the pre set date and time format e g TCrep TestElisabeth 26032007 07 43 pdf As a next step the default e mail client if there is any on the PC is loaded automatically with the generated pdf file attached to a new letter 5 4 7 Exporting the measurement data EX Formerly saved measurement results see Section 5 4 4 can be exported into a formatted text 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 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 45 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 listed sub
38. ment is completed its quality 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 TA JUG S Y i 51 cm 54 If the SD PWVao is greater than or equal to 0 and less than or equal to 1 0 m s eee HR the measurement is considered to be of good quality ST ea a a ABi 1 08 PPao 54 3 mmHg High SD RT 38 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 Pis rejected The SD appears in red colour in the Results field to warn the User on 1m s B the quality problem For advanced users the use of manual evaluation see pm Section 5 4 5 can help to find a good quality sequence in the suprasystolic prac i 40 1 mmH measurement phase If manual evaluation is still not acceptable the idis measurement should be repeated No SD RT 107 80 ms JUG SY iy If the automatic analysis calculated arterial function data but no SD PWVao gt eml then
39. n 21 5 Performing pulse wave recording and analysis Pulse wave registration can only be initialized by Medexpert SW that is running on a PC with wireless infrared 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 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 96 Augmentation index The difference between the amplitudes of the late backward systolic wave P2 and the early forward systolic wave P4 over the pulse pressure PP and multiplied with 100 Aix P5 P4 PP 100 Aix aortic central augmentation index 96 Calculated on the basis of a very strong R gt 0 9 linear rela
40. n Fes e Anh aneyim 535 D i Cave Csseansions Far rome Text Dae Tine Fett nume Rnteg Date of Bih 91 01 1975 Pulse wave Ampt piaccute values Aden age accecamert 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 Bl TenzcMed Anerogragh You ane logged in ai AKTIIGOGRAM eim Fie Vane Took LA m c r ig 4 Zax ijt Te EN mee m ammi went ax Y Twy p cope 4 o Be Farid B8 Sion andes 505 D Eurre i F arai Pun Date Tms Fest rare Dane or Bt erm 1972 7 rs A amp x E J 246 ma 195 ms BE cm RE ER UNES veu t ss m LAT ma 5 amp amp mmHg IE b mast Pium eee A DENT VUES aoc GE eee 33 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 t
41. n 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 27 5 4 2 Select a patient 5 4 2 1 How to select an existing patient B After logging in to the program use the Open command in the File menu or click on the Open E 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 full name 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 TenuoMed Artenograph You are logged im at ARTERIOGRAM De View Tools nfcemation c C 171 4 zm ORs v HE mede t E X ads step JADmu G v Y sn compresion 2 Darie Preset t Automatic ans 535 D L amp Cana E xm sont Y bar ne Teszt Dae Terme Feu name Brieg Date of Bet 61 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 patien
42. ndicated on it The return time does not necessarily fall to a characteristic point on the curve see Section 5 4 4 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 5 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 4 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 exce
43. ng first on Automatic analysis S35 for suprasystolic 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 f
44. nts 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 51 7 1 Electromagnetic compatibility Electromagnetic emissions The TL1 device is intended for use in the electromagnetic environment specified below The customer or the user of the TL1 device should assure that it is used in such an environment Emissonstet Compliance Electromagnetic environment guidance RF emissions The TL1 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 TL1 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 TL1 device is intended for use in the electromagnetic environment specified below The customer or the user of the TL1 device should assure that it is used in such an environment El
45. oided 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 Anycircumstance 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 25 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 E3 Warning A Login is incorrect Do you wish to enter with the standard login name clo OOE 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 35mmHg 120mmHg lt 40 lt 120 m
46. only one evaluable pulse curve could be found in the suprasystolic 35Im sl bs 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 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 32 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 TersioMed Artencgraph You are logged in as ARTERIOGRAM Die View Took Infeemation c E 17 4 BS stant te ES med H an vey AD water Y ges comprermon 2 Parce
47. or manual analysis the results are displayed in the same way as in a normal automatic analysis F m F TerioMeod Arterograph You are logged in as ARTERIOGRAM E File View Toot Information Am cy LES AA t r EE xm START HU med x maic mes COmprecon 2 B atrbre 0 ut 535 Gava mat cen Fay reme Teszt 1t nam Beteg Dae of Det 01 01 1375 t 52 0 113 270 ms j h 125 ms i i A N J E cm 38 E i E V S a 12 395 s UBER TIT 8 5 m s LT Pe Le 0 00 ms 8 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 35 The said separate window can have two kinds of content o Theone highlighted pulse wave at the suprasystolic pressure step is represented by a green curve There are four markers shown on the curve and these markers indicate the location of the incident wave s highest point the location of the first reflected wave s foot and peak and the point of dicrotic notch ED value i e the closing of the aorta valve r 8 F TeesioMed Arteriograph You are logged in as ARTERIOGRAM Die View Toots Information Des SOS S tan Ci BM meaoxport fl K
48. ort 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 appear 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 41 5 4 6 2 Print the Report E 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
49. p dialog window Note This procedure generates a QuickReport file qrp which can be viewed only in the TensioMed SW 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 Medexpert Software will contain the following FINE i Blood Pressure Meosurement j 1 P x Pulse Wave Analysis JE Arterial ssess CN medexpert Arteriagraph report adit Weis AL LA medexpert Arteriograph report ant A ell Api A sims Name Postal code 1035 Country code HU Name iD 007 10 DO City Budapest Date of Birth 1949 05 09 Date of Beth 1949 04 09 Addrmas Age GI years Gender Male Age 61 years Telaghone 16 1 2554490 _ Gener Male E mail arteriagraphfimedexpert hu Welghi BMI LO kg 318 kgm Quality control Risk profite 50 0 14 m family history of CVD f oe j mii E Medication 250 ma 10 nene Pulse Wave Velocity measurement PY BO m RT 147 mi Measurement data PWY Anmerial Age Assessment Date 2011 04 01 1005 Haight iB cm Anm ciie Jiem Right TV ao Operator ARTERIOGRAM dug 58cm Cull size 2 Suprasystalic record a BT M Wrachial Mead Pressure Central Hemodynamics wu and Pulse Wave Analyiri Sya 122 mmHg amp B8P aa 111 2 mmHg Dia Bl mmHg PF 41 mmHg PPaa 30 2 mmHg j MAP 95 mmHg i HR 63 min Ai brazhial 55 5 5 Aix
50. patient is seated indicate this fact in the Comment field of the SW when the patient s data are entered 24 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 alcohol consumption should be av
51. pt for pooling over the vascular age of 60 A more precise estimation 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 5 1 This page includes only the patient details and the edited medical report 44 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 ti
52. rdiac 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 50 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 Wireless infrared PC Interface IrDA 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 296 of the measured value Stability 2 years Measuring accuracy Systolic 91 9196 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 9896 out of 99 comparative checks fall within 5 mmHg For 33 patients 33 2 of 3 comparative checks within 5 mmHg 0 of 33 patie
53. rength in the location in which the TL1 device is used exceeds the applicable RF compliance level above the TL1 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 TL1 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 TL1 device The TL1 device is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled The customer or the user of the TL1 device can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment transmitters and the TL1 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 the separat
54. s en NOE Ege UE E EU net e Mise EDU NU KE dT GI Fed QUM ODE V 7 1 4 GUT Bana a a E a einen 7 1 5 Warnings and precautions ccccsssseecccccssecccccueseccccceesecccesuaecceseseuueccesseeseecessaeseceessuaeeceessuagaeeeesauaasess 8 The Medexpert TensioClinic Arteriograph device ss 9 2 1 MA IC A RII a Om 9 2 2 Theaccessories OF the DEVICE oa racacacesscndanoaannreweamedannnnncateenindae dnetutvciteanntneasowsvanivtenedentut oiedanntneaseasvanvapeansad 11 2 3 SAAB ER DRM eate SEU E ramas ta a a ee no 11 2 4 D AUTOMNE CCT 01S Eee te Om OI 12 2 5 System Infrared communication setup nennen enne nnn nnne estne ns 12 DA SOA RTT m 14 3 1 Medexpert TensioClinic Software installation and setup 14 3 1 1 Preliminary information about the software ss 14 3 1 2 Minimum system FequiFetmiglits sssrin sacre rrisin ER EERE EDI d VnE EET EF UIT CERO ERREUR A EF inside RENE UK eA 14 Seles DOW Sie Instalati amm 15 3 2 MUMS OT EV Gl AE GAN TTE OO OTT 17 3 2 1 WHE Menu of the PFOBE ATi sn anse lasers IE ssbateiousaant dondseaicasenwailodeniesansaneddoadsansaceansaiees 18 322 The Toolbarot the PORTA e aet tuse astres Guo MUR EN EN 18 3 2 9 The examinations WINDOW secexscrsutkunsoi veketk os priytevxs SEV eq Rus ch Ex MURUS FRUDEF S AU nee te VT ITO FU p xq VP races cernes 18 Sele WNT SST US NO ETE m 18 9 2 9 Paden deroil DIC os carat essaie a ee EDD SINE SUME a ie NUM NI E 19 3 2 06 The measurement data window
55. s 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 37 5 4 5 1 Tools for visual inspection 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 mem 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 0 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 press
56. stall 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 Ere 3e The codes of the error flags indicated by the Device shall mean the following The Device could not measure the patient s blood pressure Measuring was disrupted because of low battery The cuff is not connected to the Device 1 measuring time exceeded within the pre set time 3 low battery 31 cuff missing 49 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 patients movement interfere with the process of measuring For some reason the Device does not detect the ca
57. tionship 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 distance measured as the suprasternal notch pubic bone distance of the pulse wave in the aorta divided by the measured transit time RT 2 22 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 re
58. 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 4 Print x General Select Printer ah Add Printer Fax i5 Microsoft XPS Document Writer Status Ready Print to file Preferences Location Comment Find Printer Page Range Al Number of copies 1 11 2 2 3 3 Cem The print preview screen appears With use of the toolbar on this screen the following functions can be accessed Zoom tool 1 7 B 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 r dm m 8 pag pag page or to the Last page of the medical report Search tool With use of these tools a search can be performed by page number Go to page or by a keyword Search for text Ld 42 Copy tool T 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 e u with the previously determined settings by clicking on the second icon Load Save tool x The Report can also be saved in a file by clicking on Save report The destination directory and the name of the saved file can be selected in a pop u
59. ts 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 28 5 4 2 2 How to enter a new patient s data L3 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 will automatically appear
60. ure can be seen during the whole measurement on the millimetre net Cursor CEE Cursor 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 on Sai When the button is on the control tools appear With use of these the s di E81 Ded D 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 38 The above mentioned functions are illustrated on the picture below I TercioMed Arteriograph You are logged in as ARTERIOGRAM eee JAS ABS By fas Lis EE medoxport fl X m t step Wma Y aves compresi n 2 Baten 0 Reset Bl amne mms 535 D Ci Gas OS E varmabon PATIENT DETAILS Fay rame Teszt Date Te Feit name Beteg Date of But 01 01 1975 LEA mu ipit tiep 725 mendo erm me 234090 ni akude 240 memes 152 mmHg Aix brachint 181 52 0 Aux aorin 113 x 9 265 ms i f fe R 3 1 y 125 ms jH F fo IGS j en V ae 53 cm 30 dui Mel HUB Mir ane bibit LH JA p PWVao 8 5 m orn Loris 60 ms PPao 28 6 mmHg 5BHPnn 111 6 mmHg Puits wyra Jumps pessum values Asteri ag
61. utomate anii 535 E aai PATIENT DETAIL F amik name Teszi Fast name Beteg Date of Brih 01 01 1975 51 2 Aim morti 117 8 270 ms f RT 9B P d 125 ms j i i JuG s d I E vx i E Tun t j a 53 cm H E X ew AAA PF pa 1 5 m s punc 0 21 ms 28 7 mmHg a iN EF 111 7 mmHg Fuine verve amps patine values Autenal age actesimend 17 3 2 1 The Menu of the Program 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 Medexpert SW can be accessed through the File 7 er trees Sum Elle View Toch Information menu You can enter new patients open edit or delete existing aaa cen ll Best LE pa ai 7 database records save the result of an analysis furthermore edit print Save ess cw preme 1 Ed report I I se and send medical reports as well as log out and exit amp iw Send PDF report Exit The View Menu F TensioMed Artenograph You are logged in as ARTERIOGRAM The View Menu enables you to choose to display the pulse waves 77 777 recorded or the maximum amplitudes of the oscillatory signals at each cen Nssran LE Amps pressure values en Ba 2 cuff pressure step deflated stepwise with 10 mmHg during blood cuer Exar F
62. ves 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 colour 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 Took Information ec ral eae ES fase LES EA mode mes COmpretcon y F D FI TersioMed Arteriograph You are logged in as ARTERIOGRAM mi Fay rame Teszt Port name Beteg Dae of Bet 01 01 1375 PWVao PA Im MS o 2 3 2 90th pescentile 50 and lt 90th percentile n r on the hace of apposuit 10000 mecnm s pedore in Caria E uropean popisi hd SUh 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 40 5 4 6 1 Edit the Report m To edit the Report press the Edit rep
63. xamination 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 30 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

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