Hadeco Smartdop 30EX User manual

TABLE OF CONTENTS
Cautions
1. Introduction ......................................................................................................................1
1-1. Features....................................................................................................................1
1-2. Clinical applications...................................................................................................2
1-3. Probe selection .........................................................................................................3
1-4. Contents in package .................................................................................................3
2. Appearance .....................................................................................................................4
2-1. View ..........................................................................................................................4
3. Quick start........................................................................................................................8
3-1. Turning the unit ON...................................................................................................8
3-2. Charging / Discharging battery..................................................................................9
3-3. Checking battery level...............................................................................................9
3-4. Setting printer paper................................................................................................10
3-5. Measuring Blood Velocity........................................................................................11
3-6. Ankle brachial pressure index (ABI)........................................................................12
3-7. Toe brachial pressure index (TBI)...........................................................................15
3-8. PV –Arterial studies................................................................................................16
3-9. Measuring Fetal Heart Rate ....................................................................................17
3-9-1. Functions..........................................................................................................17
3-9-2. Operating panel................................................................................................17
3-9-3. OPERATION ....................................................................................................18
4. Mode settings ................................................................................................................19
4-1-1. Basic Modes.....................................................................................................19
4-1-2. Measurement / Freeze Mode ...........................................................................19
4-2. Menu mode .............................................................................................................20
4-2-1. Menus ..............................................................................................................20
4-2-2. Menu Operation................................................................................................21
4-2-3. Menu for Blood Velocity Measurement Mode...................................................22
4-2-4. Menu for Blood Velocity Freeze Mode .............................................................22
4-2-5. Menu for Pressure Mode..................................................................................23
4-2-6. Menu for PV-AC Mode .....................................................................................23
4-2-7. Menu Mode Details ..........................................................................................24
a. MEMORY - STORE ............................................................................................24
b. MEMORY - READ...............................................................................................24
c. MEMORY - CLEAR.............................................................................................25
d. DIR (Flow direction) ............................................................................................25
e. DISP / OTHERS - DISP (Waveform / Data)........................................................25
f. WAVEFORM (Freeze mode only)........................................................................26
g. GUIDANCE.........................................................................................................26
h. P.CLEAR (Clearing blood Pressure data)...........................................................27
i. CURSOR (Mode for adjusting systolic pressure point).........................................27
j. P.DISP (Displaying/erasing Pressure value)........................................................27
k. OTHERS - LANGUAGE ......................................................................................27
l. OTHERS - PRB-KEY (Probe button function)......................................................28

m. OTHERS - CALibration ......................................................................................28
n. OTHERS - CAL PRINT (Printing Calibration)......................................................28
o. OTHERS - BACKLIGHT......................................................................................28
p. OTHERS - AUTO-OFF (Automatic shut-off) .......................................................29
q. OTHERS - DISCHARGE.....................................................................................29
4-3. Shortcut keys ..........................................................................................................30
4-4. External outputs ......................................................................................................30
4-4-1. Headset............................................................................................................30
4-4-2. Communication Port.........................................................................................30
4-5. Symbol list...............................................................................................................31
5. Display and Printing.......................................................................................................32
5-1. Arterial and venous blood velocity modes...............................................................32
5-1-1. Waveforms on LCD ..........................................................................................32
5-1-2. Parameters.......................................................................................................33
5-1-3. Printing Waveform and Numerical Data ...........................................................33
5-1-4. Print Samples ...................................................................................................34
5-2. ARM / LEG and TOE pressure modes ....................................................................35
5-2-1. Display Samples in Pressure Measurement Process.......................................35
5-2-2. Optional Functions ...........................................................................................35
5-2-3. Error Messages ................................................................................................36
5-2-4. Print Samples ...................................................................................................36
5-3. PV arterial mode (PV-AC) .......................................................................................37
5-3-1. Waveforms on LCD ..........................................................................................37
6. Maintenance ..................................................................................................................38
6-1. Performance check by user ....................................................................................38
6-2. Cleaning..................................................................................................................38
6-3. Warranty .................................................................................................................39
7. Options ..........................................................................................................................39
7-1. Probe selection: ......................................................................................................39
7-2. Others: ....................................................................................................................40
7-3. Photoplethysmograph .............................................................................................40
7-3-1. PPG (Photoplethysmography) Probe Assemblies............................................40
7-3-2. PPG - Arterial Pulse Waveform Studies ...........................................................40
7-3-3. PPG - Venous Reflux Study .............................................................................41
7-3-4. Menu for PPG...................................................................................................44
7-3-5. PPG Mode Settings..........................................................................................44
7-4. Pneumoplethysmograph .........................................................................................45
7-4-1. PV (Pneumoplethysmography) Probe Assemblies...........................................45
7-4-2. PV - Measurement of Maximum Venous Outflow.............................................45
7-4-3. Menu for PV .....................................................................................................47
7-4-4. PV Mode Setting ..............................................................................................47
8. Technical Information.....................................................................................................48
8-1. Principles ................................................................................................................48
8-2. Block diagram .........................................................................................................49
8-3. Specifications..........................................................................................................50
8-4. Safety standards .....................................................................................................52

Cautions
Please read the following important points carefully before you operate the unit.
1. Only skilled persons should operate the unit.
2. Use the unit for measuring blood flow.
3. Do not apply any modification to the unit.
4. Device placement
Follow the requirements for storage and operating environments.
(1) Do not place it near water.
(2) Dot not place it where atmospheric pressure, temperature, humidity, ventilation,
sunlight, dust, salt, sulfur and so forth will affect the unit adversely.
(3) Pay attention to the stability conditions to avoid too much inclination, vibration,
shock and so on during transportation and installation of the unit.
(4) Do not place it where chemicals are stored or gas may be generated.
(5) Do not place it where the unit tends to fall.
(6) Do not place it on or adjacent other electronic devices.
5. Before use
(1) Make sure that the unit operates safely and correctly by implementing
performance check mentioned in "§ 6-1. Performance check by User".
(2) Make sure that all cables are connected correctly and safely.
(3) Using it with other equipment together may cause a misdiagnosis or danger to
patient due to a malfunction.
(4) Double-check that all the cables do not obstruct any external connection to the
patient.
(5) Do not sterilize the main unit and non-sterilizable probe 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 make sure 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 cuff:
• Press INF/DUMP button to dump the pressure.
• Disconnect the tubing 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 operation manual.
(11) Do not use the unit in a strong electromagnetic field or it may cause incorrect
measurements.
7. After use
(1) Return all switches to the conditions before use and turn the unit off the way
specified.
(2) Do not pull the cable(s) too much while disconnecting or it may cause damage.
(3) Clean the unit, AC adaptor, cables and probes and place them in right place for
the next use.
8. Storage
(1) Follow the caution (1) to (5) of section #4 Device placement in the previous page.
(2) Clean the unit, AC adaptor, 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 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 any allergic reaction occurs.
12. Battery
(1) When battery is extremely low, the LCD display will not operate. Also there will be
no speaker sounds. Charge the battery.
(2) Battery life is 300 full charges. When full charging life is 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 persons 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 place battery in a fire or it may cause an explosion and injury.
17. Any connected computer is not allowed to be in the patient area according to
IEC60601-1.

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1. Introduction
Thank you very much for choosing the Smartdop 30EX.
The Hadeco Smartdop 30EX is a uniquely designed bi-directional Doppler with backlit LCD
display and Doppler blood pressure monitor capability. It detects arterial and venous blood
flows in extremities as well as blood pressures of brachial, ankle and toe, calculates ABI
and TBI and fetal heart sounds.
Please read this manual carefully to acquaint yourself with the unit operation.
This medical device can be used by doctor for the purposes mentioned in "§ 1-2. Clinical
applications" for patient in hospital and clinic.
For the use with computer, refer to the operating manual for Windows linking software
optional.
1-1. Features
BI-DIRECTIONAL DOPPLER WITH BACKLIT LCD and PRINTER
Displays and prints velocity waveforms in bi-directional & dual separation channel and
numerical data.
DOPPLER BLOOD PRESSURE RECORDER
Full auto system with built-in cuff inflator
Shows instructions on LCD for measuring pressures if desired.
Calculates and prints ABI /TBI and velocity/pressure documentation.
TWO PROBE COMBINATIONS (for 2, 4, 5, 8, 10 MHz, PPG and PV)
The unit has dual probe connectors and selection switch.
Convenient for measuring pressures for TBI using with PPG.
Hadeco DESIGNED SMART MICROPROCESSOR
Various mode settings are available for optimal measurement with the menu displayed
on the LCD. 30 waveform memory.
BUILT-IN PULSE VOLUME with automatic cuff inflator.
CONVENIENT PROBE ACTIVATION BUTTON
Freezes waveform as well as FREEZE button.
Inflates and dump cuff as well as INF/DUMP button.
Button function can be changed on probe key mode setting, PRB-KEY.
USB COMPUTER INTERFACE
Transfers waveforms and numerical data to computer for data storage.

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Communication cable and Windows software are optional.
PPG and PV-MVO PROBES optionally available
Expands arterial & venous testing.
1-2. Clinical applications
Detections of fetal heart rate
Evaluation of fetal heart rate and sounds throughout pregnancy except where fetal heart is
not developed sufficiently during the first trimester.
Detections of arterial and venous blood flow velocity and pressures for
vascular disease
ABI and TBI studies
Bi-directional lower extremity studies.
PEAK & MEAN blood velocity determinations.
Peripheral vascular procedures.
Blood pressure segmental studies.
Venous compressions.
Penile & digit systolic pressures.
Toe pressure & venous reflux studies (PPG).
PV - Arterial studies
Note: The Smartdop 30EX and associated Doppler probes, inflatable cuffs, and optional
photoplethysmography probe are not intended for use in contact with blood or mucous
membrane.
CONTRAINDICATIONS
Do not use the Smartdop 30EX for ophthalmic or periordical studies as the acoustic
intensity is higher than the level recommended by authorities for use on and around the
eye.

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1-3. Probe selection
The frequency of diagnostic ultrasound is inversely proportional to depth of penetration.
The Smartdop has 5 interchangeable probes with different frequencies. Use those probes
depending on your applications.
BT2M20S8C (2MHz): Fetal heart rate
BT4M05S8C (4 MHz): Deep peripheral blood velocity and flow
BT5M05S8C (5 MHz): Deep peripheral blood velocity and flow
BT8M05S8C (8 MHz): Superficial blood velocity and flow
BT10M5S8C (10 MHz): Superficial blood velocity and flow
Note: One of these probes comes with Smartdop as a standard component. Other probes are
available as optional components.
1-4. Contents in package
Main unit ................................................ 1
Probe....................................................... 1
AC adaptor (GMPU18UI-3)..................... 1
Ultrasonic gel (AQUAULTRA BASIC)...... 1
Paper....................................................... 1
Blood pressure cuff (VC-12).................... 1
Tubing..................................................... 1