Hadeco Smartdop XT User manual

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 Ҥ6-1.
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
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: Smartdop XT
SOFTWARE: Smart-XT-Link for 6 ports for Windows
COMPUTER
OS: Windows Vista/ 7/ 8.1
CPU clock: Celeron 1GHz or more
Display: 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
2. Appearance
2-1. Smartdop XT
Front view
1
Inflation ports for right
side
To connect extender tubes for right side cuffs
2
Inflation ports for left side
To connect extender tubes for left side cuffs
3
PPG probe connector
for right side
To connect right PPG probe
4
Doppler probe connector
To connect Doppler probe, option
5
PPG probe connector
for left side
To connect left PPG probe
6
Foot temperature probe
connector
To connect foot temperature probe, option
7
Stop button
To stop testing and dump all cuffs immediately
while in measurement
8
Charge indicator
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.)
9
Power indicator
To indicate the power status as follows;
Green LED: Unit turned on
Green LED blinking: Low battery
LED turned off: Unit turned off
10
Probe holder
To place optional Doppler/ temperature probe
when not in use
10
1
2
3
4
5
6
7
8
9

3
Side view
11
Speaker
To output sounds
Note: Sound volume can be adjusted on each testing screen of Smart-XT-Link software.
Rear view
12
Power switch
ON: OFF:
To turn the unit ON and OFF
13
AC adaptor connector
To connect designated AC adaptor
14
Serial port
To connect computer with designated USB
cable
11.
12
13
14
SmartdopXT

4
2-2. Probes
PPG probe
Model: PG-01
Doppler probe (Option)
Model: BT*M05S8C (A) *Frequency
Temperature probe (Option)
Model: TP-01
15
PPG transducer
To detect toe PPG waveforms for toe and
transmetatarsal pressures
16
Doppler probe button
To freeze and unfreeze the waveform
17
Doppler transducer
To detect blood velocity
18
Probe cap
To protect the transducer tip when not in use
19
Temperature probe button
To record the foot temperature
20
Temperature transducer
To detect foot temperature
19
20
16
17
18
15

5
2-3. Smart-XT-Link for 6 ports for Windows
Main screen
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
To input symptoms and diagnosis for patient
Default Data
To input and/or revise Default Data: Facility data,
Performing Studies and Requesting Physician
Options
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
Menu bar
Launcher icons

6
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".)

7
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 Hadeco\Smart-XT-Link6 Ver1.0\Uninstall 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.

8
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.

9
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.
4-2-1. Preparations
(1) Get the necessary components ready as the following example for 6 sites:
Cuffs
(Option)
VC-10: 4 pcs.
For brachia and ankles
DVC-1.9: 2 pcs.
For great toes
Tubing
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)
PPG probe
PG-01 x 2 pcs.
PPG clip
PPG Clip x 2 pcs.
(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.
<Automatic Arterial Testing screen>

10
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 Ror Lside 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.
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.
Click & buttons to get the removed window(s) back.
4-2-2. Starting Automatic Arterial Testing
(1) Wrap cuffs snuglyon 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.
(4) Click Auto Start button and auto-testing will start on both sides simultaneously
in the order selected inAuto-testing order.
Select Ror L.
Slider
Trash can
Remove button
Clip
PPG probe
Toe cuff

11
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.
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.
Blood pressure
value
Pulse volume (PV) waveform
Right click here.

12
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

13
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 AutomaticArterial 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.
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 theAuto-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.
14 sites button

14
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.