Smartdop XT (6ports) Operating Manual April 2015

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

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2. Appearance 2-1. Smartdop XT Front view

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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

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Charge indicator

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Power indicator

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10 Probe holder

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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

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Side view

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11 Speaker To output sounds Note: Sound volume can be adjusted on each testing screen of Smart-XT-Link software.

Rear view

SmartdopXT

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Power switch ON: OFF:

To turn the unit ON and OFF

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AC adaptor connector Serial port

To connect designated AC adaptor To connect computer with designated USB cable

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2-2. Probes PPG probe Model: PG-01

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Doppler probe (Option) Model: BT*M05S8C (A)

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*Frequency

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Temperature probe (Option) Model: TP-01

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PPG transducer

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Doppler probe button Doppler transducer Probe cap Temperature probe button Temperature transducer

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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

Foot Temperature

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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".)

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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.

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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.

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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:

PPG probe

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

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

Trash can

Click

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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.

Toe cuff

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.

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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

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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.

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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.

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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.

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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