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Hadeco Smartdop XT Operating Manual

6 ports with smart-xt-link
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Summary of Contents for Hadeco Smartdop XT

  • Page 2: Table Of Contents

    1-1. Features ........................1 1-2. Clinical applications ....................1 1-3. System requirements ....................1 2. Appearance ........................2 2-1. Smartdop XT ......................2 2-2. Probes ........................4 2-3. Smart-XT-Link for 6 ports for Windows ..............5 3. Getting started ......................... 6 3-1.
  • Page 3 Cautions Please read the following important points carefully before you operate the unit. 1. Only skilled people should operate the unit. 2. Use the unit for intended use described in "§1-2. Clinical applications". 3. Do not apply any modification to the unit. 4.
  • Page 4 (8) Do not use the components for other devices. (9) Use the unit under the operating environments specified on the specifications. (10) Use the unit as specified in the operating manual. (11) Do not use the unit in a strong electromagnetic field or it may cause incorrect measurements.
  • Page 5 16. Destruction: (1) In case of destruction of the unit, follow the instructions for disposal of the destruction appointed by each country or local government. (2) Do not throw battery in a fire or it may cause an explosion and injury. 17.

  • Page 7: Introduction

    1. Introduction Thank you very much for choosing the Smartdop XT. The Hadeco Smartdop XT is a fully automatic total vascular testing system for ABI and TBI studies that works with a Windows software Smart-XT-Link including automated blood pressure & pulse volume measurement capabilities for up to 6 sites with simple one-button operation as well as up to 14 sites with rolling basis segmental testing.

  • Page 8: Appearance

    2. Appearance 2-1. Smartdop XT Front view Inflation ports for right To connect extender tubes for right side cuffs side Inflation ports for left side To connect extender tubes for left side cuffs PPG probe connector To connect right PPG probe...
  • Page 9 Side view Speaker To output sounds Note: Sound volume can be adjusted on each testing screen of Smart-XT-Link software. Rear view SmartdopXT Power switch To turn the unit ON and OFF OFF: AC adaptor connector To connect designated AC adaptor Serial port To connect computer with designated USB cable...

  • Page 10: Probes

    2-2. Probes PPG probe Model: PG-01 Doppler probe (Option) Model: BT*M05S8C (A) *Frequency Temperature probe (Option) Model: TP-01 PPG transducer To detect toe PPG waveforms for toe and transmetatarsal pressures Doppler probe button To freeze and unfreeze the waveform Doppler transducer To detect blood velocity Probe cap To protect the transducer tip when not in use...

  • Page 11: Smart-Xt-Link For 6 Ports For Windows

    2-3. Smart-XT-Link for 6 ports for Windows Main screen Menu bar Launcher icons Menu bar Save File To save data file Search Files To search data files to open New File To create new patient file Print Report To print report or export it to PDF file Patient Information To input patient data Symptoms/Diagnosis...

  • Page 12: Getting Started

    (1) Set the Smart-XT-Link for 6 ports V1.0 CD-ROM on your CD-ROM drive. (2) If automatic installer Smart-XT-Link for 6 ports Ver1.0 installation pops up, click on Cancel. (3) Connect the Smartdop XT to your computer by using the USB cable enclosed. The following procedures depend on your Windows version as follows:...
  • Page 13 3-2-3. Uninstalling Smart-XT-Link (1) Before uninstalling Smart-XT-Link, copy all the waveform data saved on the WaveData folder for future reference. The initial WaveData is located in C: \Hadeco \SXTLink6_1.0\. (Default) (2) Select Hadeco\Smart-XT-Link6 Ver1.0\Uninstall Smart-XT-Link6 Ver1. on Program menu to uninstall Smart-XT-Link.

  • Page 14: Testing

    4. Testing 4-1. Starting operation (1) Connect the USB cable to the unit. Caution: Use the designated USB cable, Model #: USB-CB5. (2) Connect the other side of the cable to USB port of the computer. (3) Turn the unit on. (4) Start Smart-XT-Link and Patient Information screen will appear.

  • Page 15: Automatic Arterial Testing (Oscillometry)

    4-2. Automatic Arterial Testing (Oscillometry) Automatic Arterial Testing includes ABI, TBI and PV-Arterial studies for up to 6 sites with simple one-button operation. PPG and oscillometry are used for taking blood pressures on great toes, ankles and Arms, respectively. <Automatic Arterial Testing screen> 4-2-1.
  • Page 16 Delete all data: Click Delete all data to delete all waveform data on the screen. Dump all cuffs: Click Dump all cuffs to dump all cuff. (4) Sound adjustment Click Sound button and select R or L side from where PV waveform sounds come out from the speaker and move the slider to adjust the sound volume.
  • Page 17 When each testing is completed, the blood pressure value and pulse volume (PV) waveform will be shown in blood pressure box and waveform window, respectively, as shown below. Blood pressure value Pulse volume (PV) waveform Note: Auto start button will change to Stop button while in testing. Click Stop button to stop the testing.
  • Page 18 Manual testing Each site can be manually tested as follows: Manual testing of PV waveform: (1) Click the PV waveform window where you wish to test manually and Smartdop will start PV testing. Manual testing of blood pressure testing: (1) Click the pressure icon where you wish to test manually.

  • Page 19: Further Segmental Studies

    4-3. Further segmental studies If desired, further blood pressure segmental studies can be performed with the Smartdop on rolling basis operation for up to 14 sites on both Automatic Arterial Testing and Doppler Arterial Testing screens. 4-3-1. Preparations (1) Click button on the testing screen to show 14 each of blood pressure box and waveform window.
  • Page 20 Red star mark(s) appears to let you know for which site(s) you should get the cuff(s) ready. Note: PPG probe must be used for taking great toe and transmetatarsal pressures. Note: Auto start button changes to Stop button while in testing. Click Stop button to stop the testing.

  • Page 21: Doppler Arterial Testing

    4-4. Doppler Arterial Testing Doppler Arterial Testing includes ABI, TBI and PV-Arterial studies for up to 6 sites with semi-automatic simple operation. PPG and Doppler probes are used for taking blood pressures on great toes, ankles and Arms, respectively. <Doppler Arterial Testing screen> 4-4-1.
  • Page 22 Waveforms: Select Doppler or PV which is used for waveform testing. Auto-testing order: Select the Auto-testing order desired from following 4 orders: Auto-testing order for Doppler Arterial Testing Arm (R/L) – Great toe (R) - Ankle/PT (R) - Great toe (L) - Ankle/PT (L) Arm (R/L) - Ankle/PT (R) - Great toe (R) - Ankle/PT (L) - Great toe (L) Arm (R/L) - Great Toe (R/L) –...
  • Page 23 Red star mark(s) appears to let you know for which site(s) you should get the cuff(s) ready. (5) Click OK or hit Space bar to start auto-testing. Note: Auto start button changes to Stop button while in testing. Click Stop button to stop the testing.
  • Page 24 Enlarging waveform PV/ blood velocity waveforms: Right click one of waveform windows. See “Enlarging waveform” of “§4-2-2. Starting Automatic Arterial Testing”. Blood pressure waveforms: Right click one of pressure icons and click Show Waveform to enlarge the waveform. Click Show Waveform Manual testing Each site can be manually tested in the same manner as other testing.

  • Page 25: Ppg Venous Reflux

    4-5. PPG Venous Reflux PPG Venous reflux study is performed to assess valvular competence by measuring the time required for venous refilling after calf veins have been emptied through exercise. 4-5-1. Preparations (1) Prepare the following components;  PPG probe: PG-01 x 2 pcs. (2) Click PPG Venous Reflux launcher icon on main screen to go to PPG Venous Reflux screen.
  • Page 26 Delete all data: Click it to delete all waveform data on the screen. (4) Sound adjustment See the step# (7) in the “§4-2-1. Preparations” for sound adjustment. 4-5-2. Starting PPG Venous Reflux study (1) Connect 2 PPG probes to the unit. (2) Have the patient sit on an examination table so that feet are off floor.

  • Page 27: Foot Temperature

    4-6. Foot Temperature This screen is to record several temperatures on each foot through temperature probe as well as typing in manually through keyboard. Extra temperature boxes are available for other sites. 4-6-1. Preparations (1) Prepare 1 temperature probe, optional, for foot temperature testing.
  • Page 28 4-6-2. Operation Measuring foot temperatures: (1) Connect temperature probe, optional, to the unit (2) Go to Foot Temperature screen and temperature box for right toe will be selected and turn to light blue automatically. (3) Get the probe tip close to the measuring site less than 4 cm as shown in the right.

  • Page 29: Menu

    (1) Click Search Files on Main Screen to open Search Files screen and it will show Smart-XT-Link data files stored on the data folder specified on Option Screen. (Default: C\Hadeco\SXTLink6_1.0\WaveData) (2) Select the file you wish to open and double-click on it or click Open to proceed.

  • Page 30: New File

    Folder selection: (a) Click other folder on folders pane where you wish to search files and the folder path and Smart-XT-Link files found will be shown on “Search In" path box and files pane, respectively. (b) Click the up arrow to go to upper folder.

  • Page 31: Print Report

    5-4. Print Report (1) Click Print Report on Main Screen to open the Print Report screen. (2) Choose the printer and check each check box of the reports you wish to print out. Select Entire Report if you wish to print all the reports. (3) Click Print to print out report(s), Preview to see print preview, or PDF to create PDF report file.

  • Page 32: Default Data

    5-7. Default Data Default data saved on this screen can be used in the pull-down menus on Patient Information screen. (1) Type each default data for Facility, Address, Telephone number, Performing Studies and Requesting Physician. Select the data and overtype other word and then click Change to revise. Select the data and click Delete to delete it.
  • Page 33 (c) Data Folder Click the button "..." and select the folder where you wish to save Smart-XT-Link files regularly and then click OK. The folder path will be shown in the path box and it will be used on Search Files and Save File as a default folder. (d) Export to DICOM Check it to export the report images to DICOM when data file is saved.

  • Page 34: Maintenance

    6. Maintenance 6-1.Performance check by user Perform the following performance checks at least once a year: (1) Make sure if there is no damage and/or crack on the unit including all components. (2) Perform entire tests on either Automatic or Doppler Arterial Testing and make sure the unit works properly and provides appropriate test results.

  • Page 35: Supplemental Information

    7. Supplemental information 7-1. Symbol List Symbol Description Symbol Description Power ON Power OFF AC adaptor Connector Serial port Stop button Temperature probe connector Type BF Caution* applied part Manufacturer * Caution must be observed to avoid damage to the unit. Refer the operating manual carefully. 7-2.

  • Page 36: Options

    7-3. Options  Cuffs: Refer the following cuff size as example; Cuff Site name VC-10, VC-12 Brachia, above knees, below knees, ankles and high thighs VC-1.9 Great toes VC-7.5 Transmetatarsi  Probes: Doppler probe: Freq. 4MHz, 5MHz, 8MHz or 10MHz Temperature probe: Model: TP-01 ...
  • Page 37 The cuff pressure at the first signal is the systolic pressure. After confirming a return of the rhythmical blood flow signals, the CPU opens the air valve to dump the cuff pressure and converted to systolic pressure waveform signals which can be displayed.

  • Page 38: 8-2.Block Diagram

    8-2.Block diagram Doppler Sound Volume circuit Sound circuit Power PPG/PV Doppler Probe amplifier Sound Transducer Comparator Phase detection High frequency -Amplifier circuit Chargin AC adaptor Battery g circuit NiMH Power LED Power circuit Charging LED PPG Probe / PV 1 STOP PPG Probe switch...

  • Page 39: 8-3.Specifications

    8-3.Specifications Power: Ni-MH rechargeable battery pack or AC adaptor AC adaptor: Model #: DPS54-M Input: AC 100-240V, 50Hz/ 60Hz Output: DC 15V, 4A or more Consumption: DC 15V, 1.75 A Recharge time Approx. 4 hours by the AC adaptor Full charge life: Approx.

  • Page 40: 8-4.Safty Standards

    Guidance and manufacturer’s declaration – electromagnetic emissions The Smartdop XT is intended for use in the electromagnetic environment specified below. The customer or the user of the Smartdop XT should assume that it is used in such an environment. Emissions test...
  • Page 41 Guidance and manufacturer’s declaration – electromagnetic immunity The Smartdop XT is intended for use in the electromagnetic environment specified below. The customer or the user of the Smartdop XT should assure that it is used in such an environment. Immunity test...
  • Page 42 If the measured field strength in the location in which the Smartdop XT is used exceeds the applicable RF compliance level above, the Smartdop XT should be observed to verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as reorienting or relocating the Smartdop b Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m.
  • Page 44 Manufactured by Hadeco, Inc. 2-7-11 Arima, Miyamae-ku, Kawasaki, April, 2015 Kanagawa, 216-0003 Japan 080-00198-1.0...

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