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