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TensioMed ARTERIOGraph Instructions For Use Manual

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Instruction for use
Arteriograph (version: TL2)
Arteriograph Software
0197
TensioMed Arteriograph-02v14-00
Revised: 16-05-2023

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Summary of Contents for TensioMed ARTERIOGraph

  • Page 1 Instruction for use Arteriograph (version: TL2) Arteriograph Software 0197 TensioMed Arteriograph-02v14-00 Revised: 16-05-2023...
  • Page 4 Copyright © 2022 TensioMed Ltd., Budapest, Hungary. All rights reserved. Under the copyright laws, this manual cannot be reproduced in any form without prior written permission of TensioMed 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.

  • Page 5: Table Of Contents

    4.1 Performing the Arteriograph measurement ....................20 4.2 Acoustic signals ............................21 5. Performing pulse wave recording and analysis ................. 22 5.1 Hemodynamic parameters measured by the Arteriograph ................ 22 5.2 System setup ............................... 24 5.3 Patient preparation ............................. 24 5.4 Performing the measurement ........................

  • Page 6: Introduction And Determination Of The Intended Use Of The Device

    1.2 The purpose of this manual This manual helps you in setting up and starting to use the Arteriograph (version: TL2) device as well as installing and setting up (on Windows 10 or 11 OS) the Arteriograph Software. TensioMed Arteriograph-02v14-00...

  • Page 7: General Information

    1.3 General information • The principle of Arteriograph's operation is based on a patented, innovative solution. The cuff placed on the upper arm first measures the patient's blood pressure using an oscillometric method. After a few seconds, the instrument will re-inflate the cuff to the currently measured diastolic value and then to the so-called “suprasystolic”...

  • Page 8: Guarantee And Life Cycle

    TensioMed Ltd. offers a 2-year warranty for a brand-new device. Any repair and device calibration within or beyond the warranty period are performed by TensioMed Ltd. in the service station of the company (Kossuth Lajos Street 97. Budapest H-1181). The service life of the device is 8 years, and its shelf life is 10 years.

  • Page 9: Warnings And Precautions

    Device use The user of the Arteriograph instrument is expected to be able to read, understand and learn the contents of the user manual. When using the software, it is also an expectation to see and understand the messages and inscriptions of the software.
  • Page 10 Only use with cuffs supplied by TensioMed Ltd! Use of cuffs supplied by a third party can lead to erroneous measurement results.

  • Page 11: The Arteriograph Device

    2. The Arteriograph device This section will give an introduction on the device along with installation information and operation instructions. For detailed specification please see Section 7. 2.1 The device at a glance Figure 1. shows the front view of the device: 1.

  • Page 12: The Accessories Of The Device

    • Three cuffs of different sizes (see below) • Arteriograph software installation CD and flash drive with the instruction for use • Instruction for use The cuff is the Applied Part (AP) of the device that necessarily comes into physical contact with the patient during the intended use of the device to perform its function (see section 5.3 for more...

  • Page 13: Operation Instructions

    Your computer must have active Bluetooth connection capability. The Bluetooth icon appears in the system tray of your PC indicating an active Bluetooth service. For connecting Arteriograph to the PC see Section 5.2. Data transmission can only be performed with the Arteriograph software.

  • Page 14: Arteriograph Software Installation And Setup

    Button and command names ending in “…” indicate that a dialog window will open upon clicking on those items. Arteriograph software allows you to perform arterial function measurement, to print and share the measurement report, and to modify the measurement settings.
  • Page 15 3.1.3 Software Installation For installing the Arteriograph software on the computer, the user must have administrator privileges. Step 1 Insert the CD into the CD tray of your PC or use the provided flash drive. The installation procedure will start automatically. In case it does not, start the installation by double-clicking the setup.exe file on the disc or flash drive with use of...
  • Page 16 The status of the automatic installation procedure can be tracked on a progress bar. If you want to interrupt it, click Cancel. Step 6 When the automatic installation procedure is completed, the following screen appears. Click Finish to exit the Wizard and start the Arteriograph software. TensioMed Arteriograph-02v14-00...

  • Page 17: The Software At A Glance

    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 Arteriograph program. A splash screen appears along with a login dialog window. When you run the software for the first time, simply press OK and the program is initiated with the default “ARTERIOGRAM”...

  • Page 18: The Menu Of The Program

    (deflated stepwise with 10 mmHg) during a blood pressure measurement. Furthermore, you can set both the horizontal and the vertical scale, hide the Toolbar, and get information about the chosen patient. TensioMed Arteriograph-02v14-00...

  • Page 19: The Toolbar Of The Program

    The Tools menu The Tools menu provides the functions to start automatic pulse wave data collection processes with the help of the connected Arteriograph device or interrupt an ongoing data collection process. Previous versions of databases can be converted and imported into the new database format.

  • Page 20: The Real-Time Data Display

    A new user will have to register in the database by specifying their first name, family name and user ID. The Arteriograph software is recommended, however, to be used with the default login name “ARTERIOGRAM”.
  • Page 21 To delete registered users, select Setup… under the Tools menu and click on the Users tab in the pop-up window. The Delete button can be used for removing a pre-selected item from the user list. If the list contains only one user, the Delete function will not be available. TensioMed Arteriograph-02v14-00...

  • Page 22: Performing A Simple Blood Pressure Measurement

    4. Performing a simple blood pressure measurement 4.1 Performing the Arteriograph measurement To operate Arteriograph, first prepare the device (see Section 2.3). There is a single push button (Section 2.1) available for two functions: • pressing the button once: starting a simple blood pressure measurement/ halting an already started blood pressure measurement.

  • Page 23: Acoustic Signals

    Thereafter the time is displayed again, which indicates that the device is ready for another manual or programmed measurement. 4.2 Acoustic signals When the device is active, a soft acoustic signal is emitted when its button is pressed down. TensioMed Arteriograph-02v14-00...

  • Page 24: Performing Pulse Wave Recording And Analysis

    5. Performing pulse wave recording and analysis Pulse wave recording can only be initialised by the Arteriograph software that is running on a Windows operating system, using a medium with wireless Bluetooth connection to the Arteriograph device (in this case the button of the device is not used to start the measurement)! The oscillatory signals recorded during the whole measurement process are displayed real-time on the screen.
  • Page 25 Pressurising the cuff to the diastolic blood pressure volumetric signals can be obtained. The area under the curve is taken as 100%, and then it is divided into systolic (SAI) and diastolic (DAI) area and expressed as the percentage of the total (100%). TensioMed Arteriograph-02v14-00...

  • Page 26: System Setup

    Data transfer can only be initiated with use of the Arteriograph software. 5.3 Patient preparation We have extensive experience with the application of Arteriograph in the 3-90 age group, as our database of tens of thousands of patients has shown that the measurement can be performed in such a wide age range.
  • Page 27 PWVao and Aix in the sitting and lying position regarding the values of these parameters (Hypertens Res. 2011 Feb; 34 (2): 202-8), we recommend a supine position during the Arteriograph examination, because it is more stable from a hemodynamical perspective.

  • Page 28: Performing The Measurement

    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 username (see Section 3.3).

  • Page 29: Device And Measurement Setup

    In the pop-up window the following parameters can be set on the System tab: • 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. During the second measurement the device adds 50 mmHg to the mean arterial pressure (MAP) value measured previously and inflates the cuff to this pressure.
  • Page 30 To configure the GDT interface, please read carefully and follow the instructions in the GDT Interface Manual on the Arteriograph Installation CD. If the "AUTO PDF" function is selected, the GDT communication automatically saves the test report in pdf format in a directory called PDF.

  • Page 31: Select A Patient

    Select the patient (as described above) whose data you wish to modify (by a single click in the Patient list) and press Edit. Click on OK to save the modified data. 5.4.2.3 How to search for a patient The search function of the software is helpful to find a single patient even in larger databases. TensioMed Arteriograph-02v14-00...
  • Page 32 The Comment field is advised to be filled out with important information about the patient or 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 medical history (anamnesis), duration and frequency of smoking, etc. TensioMed Arteriograph-02v14-00...

  • Page 33: Medical Examination With Arteriograph

    No and edit the patient characteristics (see Section 5.4.2.2.). The measurement process starts with the software connecting to the Arteriograph device. First the discovery of the device and active ports, and then the communication process can be tracked on the screen.
  • Page 34 Tools menu. Please note that this function only halts 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 Arteriograph shall be pressed once instead.

  • Page 35: Quality Control Of The Measurement

    For this reason, please follow the instructions given below. 1. Select the problematic measurement with the high standard deviation. TensioMed Arteriograph-02v14-00...
  • Page 36 Experienced users can use the manual evaluation to search for appropriate waves on the suprasystolic part of the measurement (see 5.4.4.). If the manual evaluation would not provide better (<0.7 m/s) SD, the measurement should be repeated! High SD TensioMed Arteriograph-02v14-00...
  • Page 37 If there is no second systolic wave on the pressure curves recorded on the suprasystolic section Arteriograph can only provide arterial function data when the first (direct) and second (reflected) systolic waves can be detected separately on the pressure curves recorded at the suprasystolic cuff pressure.
  • Page 38 How to recognize: the measurement is noisy; a sawtooth signal is superimposed on 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). TensioMed Arteriograph-02v14-00...

  • Page 39: How To Analyse The Data

    Curves can be selected even from the waveforms recorded in the blood pressure measuring phase, but only those which were recorded above the measured systole or in a ±10 mmHg range of the measured diastole. TensioMed Arteriograph-02v14-00...
  • Page 40 (Dicrotic notch), respectively. The 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 align with the other characteristic points. TensioMed Arteriograph-02v14-00...
  • Page 41 The secondary data display can be closed separately. The new 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. TensioMed Arteriograph-02v14-00...
  • Page 42 When the button is on, the cursor control tools appear. Using these, the cursor can be moved in single or multiple steps. Note: The cursor feature is only available at the default X axis step of 200 ms/cm. TensioMed Arteriograph-02v14-00...
  • Page 43 The same function can be accessed by selecting the Amps – pressure values option under the View menu. By using this feature, the quality of the blood pressure measurement can be evaluated visually. TensioMed Arteriograph-02v14-00...

  • Page 44: The Measurement Report

    The following functions are only enabled if an examination of a patient has been selected. 5.4.6.1 Edit the report To add or edit information (notes) to 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 TensioMed Arteriograph-02v14-00...
  • Page 45 5.4.6.2 Print the report 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. TensioMed Arteriograph-02v14-00...
  • Page 46 Using 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 the clipboard with this tool. TensioMed Arteriograph-02v14-00...
  • Page 47 The patient’s previously saved reports can be selected and displayed by clicking on Load Report in the Print preview dialog box. Close The Print preview screen can be closed by using this button. The report printed by the Arteriograph software will contain the following: TensioMed Arteriograph-02v14-00...
  • Page 48 The DRA, SAI, and DAI parameters can be obtained 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 software on the right-hand side. TensioMed Arteriograph-02v14-00...
  • Page 49 The measured PWV value is depicted on a colour scale, which facilitates this distinction further. Note: In each case, a medical doctor’s expertise is required to evaluate the findings of the whole measurement. Do not attempt to interpret the measurement results and diagnose the patient without this knowledge! TensioMed Arteriograph-02v14-00...
  • Page 50 This page provides a concise description of the parameters depicted on the measurement report. This information contains the definition, normal (healthy) value range and problems regarding abnormal values of the parameters, literature references and any other important information. TensioMed Arteriograph-02v14-00...
  • Page 51 Medical Report. This page includes only the patient details and the edited medical report, as noted by the operator. Note: The report is always printed out in A4 size. It contains only the previously entered information and the results measured or calculated during the analyses. TensioMed Arteriograph-02v14-00...

  • Page 52: Export The Measurement Data

    A selection of any number of the patients can be performed by ticking their respective checkboxes. The Select all option is a quick way to select all the listed patients. Selection is confirmed by clicking on the second arrow. TensioMed Arteriograph-02v14-00...
  • Page 53 When the export is completed, the directory should be selected where the completed text file will be saved. 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 most of the statistical packages (e.g. SPSS, SAS) TensioMed Arteriograph-02v14-00...

  • Page 54: Backup And Restore The Database

    If you approve overwriting, simply click on Yes. To select a backup directory, double-click on it. Please note that the C:\ root directory cannot be used as a backup directory! An information window pops up if the backup is successfully completed. TensioMed Arteriograph-02v14-00...
  • Page 55 Upon successful completion an information window can be seen. 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.

  • Page 56: Troubleshooting

    Import the database by following selected, or the database was cannot be completed the instructions of Section 5.4.8.3. damaged. Cannot send e-mail No mailing application is installed Install a mailing application and set successfully to the PC. it as default. TensioMed Arteriograph-02v14-00...
  • Page 57 Invalid measurement result The calculated results cannot be considered as real blood pressure values. (The most likely reason is noisy measurement signals.) Unacceptable measurement result The pulse rate cannot be calculated or cannot be considered as a real value. TensioMed Arteriograph-02v14-00...

  • Page 58: Technical Specification

    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: 300 mmHg; Maximum measurement time: 180 seconds Deflation: Automatic, stepwise TensioMed Arteriograph-02v14-00...

  • Page 59: Electromagnetic Compatibility

    7.1 Electromagnetic compatibility Electromagnetic emissions The Arteriograph device is intended for use in the electromagnetic environment specified below. The customer or the user of the device should assure that it is used in such an environment. Emissions test Compliance Electromagnetic environment - guidance...
  • Page 60 Electromagnetic immunity The Arteriograph device is intended for use in the electromagnetic environment specified below. The customer or the user of the device should assure that it is used in such an environment. Immunity test IEC 60601 test level Compliance level Electromagnetic environment —...

  • Page 61: Use Specification

    7.2 Use Specification Intended medical indication Non-invasive determination of brachial blood pressure, heart rate, and central hemodynamic parameters in a medical office. Only a medical professional is allowed to evaluate the measurement results! Assessing the hemodynamic parameters affected by various factors of the patients’...

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