Table of Contents Cautions 1. Introduction ... 1 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. Charging battery ... 6 3-2. Software installation... 6 4. Testing ... 8 4-1. Starting operation ... 8 4-2. Automatic Arterial Testing (Oscillometry) ... 9 4-3. Further segmental studies ... 13 4-4. Doppler Arterial Testing... 15 4-5. PPG Venous Reflux ... 19 4-6. Foot Temperature ... 21 5. Menu ... 23 5-1. SaveFile ... 23 5-2. Search Files... 23 5-3. New File ... 24 5-4. Print Report ... 25 5-5. Patient Information ... 25 5-6. Symptoms/ Diagnosis ... 25 5-7. Default Data... 26 5-8. Option Screen... 26 6. Maintenance ... 28 6-1.Performance check by user ... 28 6-2.Cleaning ... 28 6-3.Warranty ... 28 7. Supplemental information ... 29 7-1. Symbol List ... 29 7-2. Contents of package ... 29 7-3. Options ... 30 8. Technical information ... 30 8-1.Principles ... 30 8-2.Block diagram ... 32 8-3.Specifications ... 33 8-4.Safty standards ... 34
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. Device placement: Take care of storage and operating environments. (1) Do not place it near water. (2) Do not put anything where disconnecting power supply of the unit could be obstructed. (3) Do not place it where atmospheric pressure, temperature, humidity, ventilation, sunlight, dust, salt, sulfur and so forth will not affect the unit adversely. (4) Pay attention to the stability conditions to avoid too much inclination, vibration, shock and so on during transportation and installation of the unit. (5) Do not place it where chemicals are stored or where gas may be generated. (6) Do not place it where the unit tends to fall. (7) Do not place it on or adjacent other electronic device. 5. Before use: (1) Make sure that the computer works properly for Smart-XT-Link. (2) Make sure that the unit operates safely and correctly by implementing simple check before use mentioned in "§ 6-1. Performance check by user". (3) Make sure that all cables and components are connected correctly and safely. (4) Using it with other equipment together may cause a misdiagnosis or danger to patient due to a malfunction. (5) Double-check that all the cables and components do not obstruct any external connection to the patient. (6) Do not sterilize the main unit by gas, autoclave or so on to prevent any damage. 6. Operation: (1) Do not use the unit simultaneously with either electric cautery, cardioverter, other ultrasonic device or mobile phone. (2) Be careful not to exceed time and volume of diagnosis treatment required. (3) Always watch so the unit and patient are not under abnormal conditions. (4) When any abnormality is found on the unit or the patient, take proper action such as stopping use of the unit in a manner safe for the patient. (5) In case of emergency or unexpected situations, take the following action(s) to stop the inflation of the cuffs: • Press STOP button on the front panel of the unit. • Disconnect the tubing of cuff from the unit. • Turn the unit off. (6) Do not let the patient touch the unit. (7) Use the designated components only.
(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. 7. After use: (1) Do not apply excessive force to disconnect the cables by pulling them too strongly. (2) Clean the unit, tubing, probes and AC adaptor and place them in right place for the next use. 8. Storage: (1) Follow the caution # (1) to (5) of section #4 in the previous page. (2) Clean the unit, components, cables and probes and place them in right place for the next use. (3) When using the unit next time, perform the maintenance to make sure it works properly and safety. 9. Maintenance: (1) Do the periodical maintenance by following the procedures mentioned in “§6-1. Performance check by user”. (2) The maintenance must be done at least once a year. 10. Probes: (1) Clean the probe using damp cloth before use. Using alcohol or thinner may damage the probe. (2) The probe transducer tip is very thin and delicate. Please handle with great care and use the probe cap when not in use. 11. Ultrasonic gel: (1) Do not apply ultrasonic gel to the Doppler probe body other than the tip of probe (2) Using other materials such as baby oil and cream may damage the probe. (3) The ultrasonic gel enclosed is non-sterile and do not use it for surgeries. (4) Incidence of allergy: Discontinue use of gel if an allergic reaction occurs. 12. Battery: (1) When battery is low, the power indicator blinks in green. If it’s extremely low, the unit will not operate. Charge the battery. (2) Battery life is 300 full charges. When full charged life becomes obviously short, contact your dealer for replacing battery. 13. For transportation of the unit, it should be packed properly to protect against shock. 14. Repair services: (1) When the unit gets out of order, contact the dealer for repair from whom you purchased the unit. (2) Only authorized people should perform the repair services. 15. Do not disassemble the unit.
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. Connection to computer: (1) Any connected computer is not allowed to be in the patient area according to EN60601-1. (2) Use the computer confirming with EN60601-1 to connect to the unit. (3) Connection of the connected computer to a network that includes other equipment such as network printer could result in previously unidentified risks to patients, or operators and the user of the unit should identify, analyze, and control such risks. (4) Subsequent changes to network could introduce new risks and require new analysis; and changes to network include: (a) Connection of additional items to network (b) Disconnecting items from network (c) Update of equipment connected to network (d) Upgrade of equipment connected to network
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. Please read this manual carefully to acquaint yourself with the unit operation. This medical device can be used for the purposes mentioned in "Clinical Applications" for patients in hospitals and clinics.
1-1. Features One button operation for up to 6-site automatic blood pressure measurements by oscillometry & PPG for ABI, TBI, and PV-Arterial studies. Up to 6-site semi-automatic blood pressure measurements by Doppler & PPG for ABI & TBI along with Doppler and PV arterial studies. Segmental blood pressures for up to 14 sites with rolling basis operation PPG Venous reflux study with dual PPG probes. Foot temperature study available with optional temperature probe. All tests controlled & stored by computer with Smart-XT-Link for Windows that includes capabilities to print waveform data and export to DICOM.
1-2. Clinical applications To diagnose peripheral vascular disease: ABI and TBI studies Blood pressure segmental studies PV arterial studies Bi-directional Doppler lower extremity studies PPG toe pressure & venous reflux studies Foot temperature studies
1-3. System requirements MAIN UNIT: SOFTWARE: COMPUTER
Smartdop XT Smart-XT-Link for 6 ports for Windows OS: CPU clock: Display:
Windows Vista/ 7/ 8.1 Celeron 1GHz or more 800 x 600 dots or more 256 colors or more Minimum memory requirements: RAM: 1 GBytes or more HDD: 40 MBytes or more USB: USB2.0 or more
2. Appearance 2-1. Smartdop XT Front view
2 7 8 9
Inflation ports for right side Inflation ports for left side PPG probe connector for right side Doppler probe connector PPG probe connector for left side Foot temperature probe connector Stop button
2 3 4 5 6
10 Probe holder
To connect extender tubes for right side cuffs To connect extender tubes for left side cuffs To connect right PPG probe To connect Doppler probe, option To connect left PPG probe To connect foot temperature probe, option To stop testing and dump all cuffs immediately while in measurement To indicate battery charging status as follows; Orange LED: Charging battery with AC adaptor LED turns off: When battery fully charged (See “§3-1. Charging battery” for details.) To indicate the power status as follows; Green LED: Unit turned on Green LED blinking: Low battery LED turned off: Unit turned off To place optional Doppler/ temperature probe when not in use
11 Speaker To output sounds Note: Sound volume can be adjusted on each testing screen of Smart-XT-Link software.
Power switch ON: OFF:
To turn the unit ON and OFF
AC adaptor connector Serial port
To connect designated AC adaptor To connect computer with designated USB cable
2-2. Probes PPG probe Model: PG-01
Doppler probe (Option) Model: BT*M05S8C (A)
Temperature probe (Option) Model: TP-01
16 17 18 19 20
Doppler probe button Doppler transducer Probe cap Temperature probe button Temperature transducer
To detect toe PPG waveforms for toe and transmetatarsal pressures To freeze and unfreeze the waveform To detect blood velocity To protect the transducer tip when not in use To record the foot temperature To detect foot temperature 4
2-3. Smart-XT-Link for 6 ports for Windows Main screen
Menu bar Launcher icons
Menu bar Save File Search Files New File Print Report Patient Information Symptoms/Diagnosis Default Data Options
To save data file To search data files to open To create new patient file To print report or export it to PDF file To input patient data To input symptoms and diagnosis for patient To input and/or revise Default Data: Facility data, Performing Studies and Requesting Physician To set optional settings for CommPort, Language, DICOM®, data folder and others
Launcher icons Automatic Arterial Testing
PPG Venous Reflux
Doppler Arterial Testing
3. Getting started 3-1. Charging battery (1) Turn the unit off and plug the AC adaptor to it to charge the battery. The Charge indicator will turn to orange while charging is in progress. (2) When the battery is fully charged, the orange Charge indicator will be turned off. Unplug the AC adaptor. Note: When the battery is low, the green Power indicator blinks. Use the designated AC adaptor for charging.
3-2. Software installation 3-2-1. Installing Smart-XT-Link (1) Insert the Smart-XT-Link for 6 ports CD-ROM into the drive of your computer. (2) Installer dialog box will appear automatically, otherwise open My Computer and double-click the CD-ROM drive in which Smart-XT-Link CD is inserted, and double-click Setup.exe to install Smart-XT-Link software. Follow the instructions of the installer. (3) When installation process is completed, Smart-XT-Link will start automatically with Default Data screen.
3-2-2. Installing USB Cable Driver (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: Windows Vista (4) When Found New Hardware is shown, click Locate and install driver software (recommended). (5) If Found New Hardware - Unknown Device is shown, click Don't search online. (6) Windows Security Window alerts you that the publisher of the driver cannot be verified. Click Install this driver software anyway. (7) The USB cable driver will be installed. (8) When completion dialog is shown, click Close. (9) If another "Found New Hardware" pops up after completing up to step #8, repeat step #4 to 8. After the end of work, set the COM port of Smart-XT-Link. (Refer to the section "§5-8. Options".)
Windows 7 and 8.1 (4) A shortcut for "Windows 7 and 8 Driver Installation" will be created automatically on the desktop when Smart-XT-Link installation is completed. Click it and follow the instructions.
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 HadecoSmart-XT-Link6 Ver1.0Uninstall Smart-XT-Link6 Ver1. on Program menu to uninstall Smart-XT-Link. Note: Smart-XT-Link does not support both Windows power options of Sleep and Suspend and thus disable the options while using the software.
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.
(5) Type the patient information or you may do it later. (6) Click Save to save the information and it will go to Main Screen. (7) Click Options and do Search Comm once to search for COM port where the unit is connected and Smart-XT-Link will show the COM port #. Do the other settings desired on Option Screen. (See section “§5-8. Option Screen” for more details.) (8) Click Return to Main Screen.
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. Preparations (1) Get the necessary components ready as the following example for 6 sites:
VC-10: 4 pcs. For brachia and ankles DVC-1.9: 2 pcs. For great toes 2 tubing each color x 3 sets; White for Arm, Green for Ankle/PT, Black for Great toe (Tubing with blue mark at both ends are for the right side) PG-01 x 2 pcs.
PPG Clip x 2 pcs.
Cuffs (Option) Tubing
(2) Click Automatic Arterial Testing launcher icon on Main Screen. (3) Settings Click Settings button on Automatic Arterial Testing screen and set the Auto-testing order as follows.
Auto-testing order: No.1: Arm (R/L) - Great Toe (R/L) - Ankle (R/L) No.2: Arm (R/L) - Ankle (R/L) - Great Toe (R/L) Default setting is No.1. Click Save to set the settings. 9
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. Check the Mute check box to mute the sound volume.
Select R or L. Slider
Note: No sounds during oscillometry testing. (5) Removing waveform window(s) To remove waveform window(s) you do not use, click each trash can next to the window, clicked can becomes fat , and then click Remove button to proceed. Remove button
buttons to get the removed window(s) back.
4-2-2. Starting Automatic Arterial Testing (1) Wrap cuffs snugly on each side of brachium, ankle, and great toe. Note: Use appropriately sized cuffs for each patient. (2) Hook up each color coded tubing between cuff and the inflation port with the same color as tubing’s for each site. (3) Connect 2 PPG probes to the unit and affix each PPG transducer with clear side against the pad of each great toe with PPG probe clip. Note: PPG probe is used for taking great toe pressures.
Clip PPG probe
(4) Click Auto Start button and auto-testing will start on both sides simultaneously in the order selected in Auto-testing order. 10
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. Note: For legs, PV testing is performed prior to each blood pressure testing. (5) When all tests are completed, the dialog box as shown below will appear.
Click OK to close it and ABI and TBI will be calculated automatically during the tests. After all testing is completed, Smartdop will dump all cuffs with beeping automatically. Note: ABI = (Ankle pressure) / (Brachial pressure) TBI = (Toe pressure) / (Brachial pressure)
Enlarging waveform Right click one of PV waveform windows to enlarge it and the Individual waveform screen will appear for waveform analysis. Click Delete to delete the waveform. Click Print to print out the waveform data. Click Return to go back to previous screen.
Right click here.
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. (2) Select Take pressure in pull-down menu to start testing. Select Take pressure
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. 14 sites button
Note: The green inflation ports for ankles will be used for the segmental testing at high thigh, above knee, below knee, and transmetatarsal/DP as well as ankle/PT.
(2) Click Settings button and set the Auto-testing order and click Save to set the settings. (3) Sound adjustment See the step# (7) in the “§4-2-1. Preparations” for sound adjustment. (4) Removing waveform window(s) See the step# (8) in the “§4-2-1. Preparations” for removing the window(s).
4-3-2. Starting segmental studies (1) Wrap cuffs, tubing and PPG probes ready for the testing sites. (2) Click Auto Start button to start auto-testing and follow the guidance to proceed.
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. Note: On Doppler Arterial Testing, ankle cuff is used for taking transmetatarsal/DP pressure as shown in the right.
(3) When all tests are completed, the dialog box as shown right will appear. Click OK to close it. Smartdop will dump all cuffs automatically while beeping.
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. Preparations (1) Get the necessary components ready as the following example for 6 sites: VC-10: 4 pcs. For brachia and ankles DVC-1.9: 2 pcs. For great toes 2 tubing each color x 3 sets; White for Arm, Green for Ankle/PT, Black for Great toe Tubing (Tubing with blue mark at both ends are for the right side) PG-01 x 2 pcs. PPG probe PPG Clip x 2 pcs. PPG clip Doppler probe BT8M05S8C x 1pc. (Option) Ultrasonic gel (TSUBAKIYA) for Doppler testing (Option) Cuffs (Option)
(2) Click Doppler Arterial Testing launcher icon on Main Screen. (3) Settings Click Settings button on Doppler Arterial Testing screen and set Doppler-test settings as follows.
Waveforms: Select Doppler or PV which is used for waveform testing. Auto-testing order: Select the Auto-testing order desired from following 4 orders: No 1 2 3 4
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) – Ankle/PT (R/L) Arm (R/L) - Ankle/PT (R/L) – Great Toe (R/L)
Default setting differs depending on which Doppler or PV is used for waveform testing as follows; When Doppler is used for waveform testing: No.1 When PV is used for waveform testing: No.3
Operational settings: Auto Freeze / Decision Check the check box to freeze the waveform and save the testing data automatically when waveform becomes stable. Click Save to set the settings. 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 cuffs. (4) Sound adjustment See the step# (7) in the “§4-2-1. Preparations” for the details. (5) Removing waveform window(s) See the step# (8) in the “§4-2-1. Preparations” for removing the window(s).
4-4-2. Starting Doppler Arterial Testing (1) Wrap cuffs snugly on each site of brachium, ankle and great toe. Note: Use appropriately sized cuffs for each patient. (2) Hook up each color coded tubing between cuff and the inflation port with the same color as tubing’s for each site. Toe cuff
(3) Connect 1 Doppler and 2 PPG probes to the unit and affix each PPG transducer with clear side against the pad of each great toe with PPG probe clip. (4) Click Auto Start button to start Auto-testing and dialog box as shown in the right will appear. 16
Clip PPG probe
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. (6) When taking blood pressures except great toe, follow the guidance with site name shown on upper left of monitoring screen to perform the testing. Note: All the PV testing is performed prior to blood pressure testing. Note: For Doppler testing, put ultrasonic gel on tip of Doppler probe. Place the probe to the artery with an angle of 45 to 60 degrees and move it slowly to locate the point where the maximum sounds are heard. Adjust sound volume if necessary. Note: Smartdop always restart Auto-testing by re-clicking Auto Start from where any testing has been cancelled. (7) When all tests are completed on Doppler Arterial Testing screen, the dialog box as shown right will appear. Click OK to close it and ABI and TBI will be calculated automatically during tests. After all testing is completed, Smartdop will dump all cuffs automatically while beeping. Note: ABI = (Ankle pressure) / (Brachial pressure) TBI = (Toe pressure) / (Brachial pressure)
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. See “Manual testing” in the “§4-2-2. Starting Automatic Arterial Testing” for more details.
4-4-3. 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. See “§4-3. Further segmental studies” for Automatic Arterial Testing.
4-4-4. Monitoring screen Each of monitoring screens will show up while performing Doppler blood pressure testing or individual waveform testing of blood velocity, PV and PPG on Doppler Arterial Testing screen as follows:
<Pressure Monitor for Doppler>
<Velocity, PV, and PPG waveforms>
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. (3) Click Settings button on the screen and set PPG Venous Reflux settings as follows. Test mode: Select either “Single test” or “Dual test” for testing right and left legs separately or simultaneously, respectively. Count: Type the number of times for patient dorsiflexes. 1/2RT: Check the checkbox to show the 1/2RT half recovery time values on the screen, returning to 50% of refilling amplitude where vertical dotted line is shown. Click Save to set all the settings.
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. (3) Apply the PPG transducer with the clear side against the skin surface to the medal malleolus over the posterior tibial vein. Fix the PPG transducer in place with tape. (4) Click one of Monitoring buttons or waveform windows to start monitoring the waveform. (5) When patient is ready, click Start Test button to start venous reflux study. (6) Ask patient to flex his foot synchronizing with beep sound as many as count number being set on the settings. Click Cancel to cancel testing if necessary. When an appropriate waveform returns to the base-line amplitude, it will automatically freeze and save the waveform and show Recovery Time. (7) Repeat steps # (4) to (5) on the other side or on the second test. Note: Beep sound is heard from the speaker of computer. Note: Click Second test to add second test window(s) on the screen if necessary.
Fix PPG transducer with tape.
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. (2) Click Foot Temperature launcher icon on Main Screen. (3) Click Settings button on Foot Temperature screen and set the settings as follows. Unit: Select either Celsius (°C) or Fahrenheit (°F) for temperature unit. Extra temperatures: Check the checkbox to show extra temperature boxes on the screen.
Note: Site name for each extra temperature box can be changed by typing in. Click Save to set all the settings. Delete all data: Click it to delete all temperature data on the screen.
Type the site name here.
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. (4) Press the probe button to measure and show the temperature in the box and it will automatically go to the next temperature box turning into light blue. Note: Hit space bar or Enter to skip to the next box without taking temperature OR click the box where you wish to measure for. (5) Repeat steps # (3) to (4) for the next site until all testing is completed. Note: After using temperature probe, wipe the probe using with a soft dry cloth. Take great care that any water may not penetrate into the probe.
Typing foot temperatures: (1) Click the temperature box where you wish to type one in taken by an external thermometer and it will turn into light blue.
(2) Type the foot temperature in the box and press Enter.
Specifications: Temperature measuring method: non-contact Accuracy: ± 0.5°C (measurement range 10 to 40 °C), when operating temperature is 0 to 40°C Display Resolution: 0.1°C FOV: 4:1 (object distance: measuring range) Emissivity: 0.98 Less than 4cm Object 1cm
5. Menu 5-1. SaveFile
(1) Click SaveFile on Main Screen to open SaveFile window with a file name of Patient ID, or name if ID is not typed, along with extension "XT2". Note: Default data folder can be specified on Option Screen. (2) Change the file name if necessary and click Save to save testing data. Note: If the check box of Export to DICOM on Option Screen is being checked, Smart-XT-Link will automatically export all the report images of each test module to DICOM.
5-2. Search Files
(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: CHadecoSXTLink6_1.0WaveData) (2) Select the file you wish to open and double-click on it or click Open to proceed.
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. (c) Check Sub folder check box to include sub folders for searching. (d) Click History to show a list of folder paths you have searched before. Search options: (a) Select Search Type from pull-down menu, and type a search word in the Search For text box. Note: Search Type includes patient name, ID, file name, requesting physician, and test date. (b) Select a file you wish to delete and click Delete to proceed. Advanced operation: (a) Folders pane and files pane can be resized by dragging the splitter bar between the 2 panes. Columns in files pane can also be resized. (b) Click the column name to sort files alphabetically and click it the second time to sort anti-alphabetically. Click here
(c) Right-click on folder in folders pane to show a context menu of Rename, Delete folder and New folder and select the one you wish to proceed. Right click here
5-3. New File Click New File to create a new patient file and Patient Information screen will open. Type all the patient data and click Save to save the information. If previous data has not been saved when New File is clicked, a confirmation dialog box as shown below will appear. Click Yes to save the previous data, No to erase it or Cancel to cancel New File process.
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.
5-5. Patient Information*¹ See the section “§4-1. Starting operation”.
5-6. Symptoms/ Diagnosis*¹
(1) Check the appropriate check boxes and type information in text boxes and then click Save to proceed. Note: “Other 1” to “Other 3” can be overtyped with your own word for Diagnosed Conditions if desired. *1: To open these screens on the testing screen, click Patient information, Symptoms/ Diagnosis buttons on bottom of Automatic Arterial Testing and Doppler Arterial Testing screen. 25
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. (2) Click Save to proceed when the data have been typed.
5-8. Option Screen (d)
(a) CommPort Setting Turn on the unit and connect it to computer. Go to Option Screen and click Search Comm to search COM port connected to the unit. COM port number will be shown next to Search Comm when it’s been found. (b) Language Select Select your language from the pull-down menu and restart Smart-XT-Link to activate the new language.
(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. Set the DICOM folder under the check box where DICOM files should be exported. (e) Auto Power Off To activate the auto-power-off capability and the unit will be automatically shut off when it is left on without AC adaptor connected and the auto-off-time selected from pull-down menu passes. This box is checked as default settings. (f) Gain Unification Check it to unify all the amplitude scales of waveforms in each testing module. (g) Auto-file save Check it to overwrite the data automatically every time any testing is completed. A message “Do SaveFile and Auto-file overwriting will start for each testing” will be displayed as shown below.
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. Simple check before use: (1) Connect the unit to your computer and open Smart-XT-Link. (2) Turn the unit on and make sure the Power LED goes green.
6-2.Cleaning PROBE Remove any dust, stain, and gel from the probe. Clean the probe using damp cloth and then wipe with a soft dry cloth, but take great care that any water may not penetrate into the probe. MAIN UNIT To clean the main unit, use a damp cloth and then wipe with a soft dry cloth, but take great care that any water may not penetrate into the unit. CUFFS The cuffs are intended for use only on intact skin. To clean them, wipe away any dirt or stain using alcohol.
6-3.Warranty The guarantee period is two years for the main unit and one year for the probe after the date of purchase when used under normal conditions. In the event of a problem during the warranty period, please contact your agent. In case the warranty period is over, please consult the dealer for a charged service.
7. Supplemental information 7-1. Symbol List Symbol
AC adaptor Connector
Temperature probe connector
Type BF applied part
Manufacturer * Caution must be observed to avoid damage to the unit. Refer the operating manual carefully.
7-2. Contents of package Main unit ····································· 1 Smart-XT-Link for 6 ports CD-ROM ·· 1 USB cable (USB-CB5) ··················· 1 Operating manual ························· 1 Tubing ········································ 6 AC adaptor (DPS54-M) ·················· 1 Power cable ································· 1 PPG probe (PG-01) ······················· 2 PPG probe holder ························· 2 PPG probe clip ····························· 2
How to use the PPG probe holder 1. Attach the holder to the flat place on the main unit with double-sided tape. 2. Put PPG transducer to the holder as shown below.