Hadeco Smartdop 45 User manual

TABLE OF CONTENTS
Cautions
1. Introduction ......................................................................................................................1
1-1. Features....................................................................................................................1
1-2. Clinical applications...................................................................................................3
1-3. Probe selection .........................................................................................................3
1-4. Contents of package .................................................................................................4
2. Quick start ........................................................................................................................5
2-1. Turning the unit ON / OFF.........................................................................................5
2-2. Charging / Discharging battery..................................................................................6
2-3. Checking battery level...............................................................................................7
2-4. Setting printer paper..................................................................................................8
2-5. Measuring blood velocity...........................................................................................9
2-5. Measuring blood velocity...........................................................................................9
2-6. Measuring fetal heart rate (2 MHz only) ..................................................................10
3. Appearance and mode settings......................................................................................12
3-1. Operating controls...................................................................................................12
3-2. Mode settings..........................................................................................................15
3-2-1. Basic Modes.....................................................................................................15
3-2-2. Menu ................................................................................................................16
a. Menu structure ....................................................................................................16
b. Menu operation ...................................................................................................16
c. Menu for Blood Velocity Measurement mode......................................................18
d. Menu for Blood Velocity Freeze mode ................................................................19
e. Menu for Fetal Heart Rate mode (Measurement and Freeze).............................20
3-2-3. Mode Setting Details ........................................................................................21
a. MEMORY - STORE.............................................................................................21
b. MEMORY - READ ...............................................................................................21
c. MEMORY - CLEAR .............................................................................................22
d. MODE (Baseline mode) ......................................................................................22
e. TIME (Time scale) ...............................................................................................23
f. DIR (Flow direction) .............................................................................................23
g. DISP / OTHERS - DISP (Waveform / Data) ........................................................23
h. UPPER (Upper limit for FHR)..............................................................................24
i. LOWER (Lower limit for FHR) ..............................................................................24
j. PATIENT (Patient data input)................................................................................24
k. OTHERS - LANGUAGE ......................................................................................26
l. OTHERS - UNIT (cm/s / kHz)...............................................................................26
m. OTHERS - FILTER (Arterial / Venous filter)........................................................26
n. OTHERS - SMOOTH (Smoothing filter) ..............................................................26
o. OTHERS - CAL (Calibration)...............................................................................26
p. OTHERS - AUTO-OFF (Automatic shut-off)........................................................26

q. OTHERS - KEYBOARD (External)......................................................................27
r. OTHERS - P.ID PRT (Patient data print) ..............................................................27
s. OTHERS - PRB-KEY (Probe button function) .....................................................27
t. OTHERS - DATE (Date and time setting).............................................................27
u. OTHERS - PRINT (Printer activation) .................................................................27
3-3. LCD display.............................................................................................................28
3-3-1. Blood Velocity Mode.........................................................................................28
3-3-2. Fetal Heart Rate (FHR) mode (Only 2 MHz probe) ..........................................29
3-4. Printing waveforms and data...................................................................................31
3-5. Numerical data ........................................................................................................33
3-6. External outputs ......................................................................................................34
3-7. Symbol list...............................................................................................................34
4. Maintenance ..................................................................................................................35
4-1. Performance check by user ....................................................................................35
4-2. Cleaning..................................................................................................................35
4-3. Warranty..................................................................................................................35
5. Options ..........................................................................................................................36
5-1. Probe selection .......................................................................................................36
5-2. Sterilizable doppler probes......................................................................................36
5-3. Photoplethysmograph .............................................................................................39
5-4. Pneumoplethysmograph .........................................................................................45
6. Technical information .....................................................................................................51
6-1. Principles ................................................................................................................51
6-2. Block diagram .........................................................................................................52
6-3. Specifications ..........................................................................................................53
6-4. Safety standards .....................................................................................................55

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
(1) Follow the requirements for storage and operating environments.
(2) Do not place it near water.
(3) Dot not place it where atmospheric pressure, temperature, humidity, ventilation,
sunlight, dust, salt, sulfur and so forth will 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 gas may be generated.
(6) Do not place it where the unit tends to fall.
5. Before use:
(1) Make sure that the unit operates safely and correctly by implementing
performance check mentioned in "§ 4-1. 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 by gas, autoclave or so on to prevent any damage.
(6) Sterilizable probes should be sterilized before use.
6. Operation
(1) Do not use the unit simultaneously with either electric cautery, cardioverter, other
ultrasonic device or mobile phone.
(2) Be cautious not to exceed too much time and volume required for the
measurement.
(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) Do not let the patient touch the unit.
(6) Use the designated components only.
(7) Do not use the components for other devices.
(8) Use the unit under the operating environments specified on the specifications.
(9) Use the unit as specified in the operation manual.

(10)Do not use the unit in a strong electromagnetic field or it may cause incorrect
measurements.
7. After use:
(1) 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 (2) to (6) of section #4 Device placement in the previous page.
(2) When using the unit next time, perform the maintenance to make sure it works
properly and safety.
9. Maintenance and inspection
(1) Do the periodical maintenance by following the procedures mentioned in "§ 4-1.
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.
(3) Optional sterilizable probe (reusable & disposable) can be sterilized in the manner
described in § 5-2. Sterilizable Doppler probes. However, only one time
sterilization is possible for disposable probe, and do not reuse it.
Except optional ACP probe, do not sterilize probes by steam autoclave.
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 45.
The Hadeco Smartdop 45 is a uniquely designed bi-directional handheld Doppler with LCD
display and fast printer. It detects arterial and venous blood flows in extremities as well as
fetal heart sounds.
The Smartdop displays velocity waveforms, numerical data and fetal heart rate. Also it
prints them out.
Please read this manual carefully to acquaint yourself with the Smartdop 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 HANDHELD DOPPLER WITH LCD DISPLAY and FAST PRINTER
Displays real-time velocity waveforms, numerical data and heart rate.
Prints frozen waveform, numerical data and monitored heart rate as well as patient data.
* HADECO DESIGNED SMART MICROPROCESSOR
Various mode settings are available for optimal measurement with the menu displayed
on the LCD and unique Scroll Button. 30 waveform memory
* CONVENIENT PROBE ACTIVATION BUTTON
Freezes and prints waveform and numerical data for notation.
Button function can be changed on probe key mode setting, PRB-KEY.
* MULTIPROBE SELECTION of 2, 4, 5, 8, 10 and 20 MHz.
(When connecting 20 MHz probe, only kHz (Doppler frequency shift) is available in Unit
mode. See “§ 3-2-3. l. Others - Unit” for the details)
* USB COMPUTER INTERFACE
Stores waveforms and numerical data in your computer for data analyzing and filing.

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Communication cable and Windows software are optional.
* PHOTOPLETHYSMOGRAPH (PPG) AND PNEUMOPLETHYSMOGRAPH (PV)
PROBES OPTIONAL
Expands arterial & venous testing.

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1-2. Clinical applications
1-2-1. Detections of fetal heart rate
Probe to be used BT2M20S8C (2 MHz)
* Evaluation of fetal heart rate and sounds throughout pregnancy except where fetal
heart is not developed sufficiently during the first trimester.
1-2-2. Detections of arterial and venous blood flow velocity for
vascular disease
Probes to be used BT4M05S8C (4 MHz)
BT5M05S8C (5 MHz)
BT8M05S8C (8 MHz)
BT10M5S8C (10 MHz)
*ABI studies
* PEAK & MEAN blood velocity determinations.
* Peripheral vascular procedures.
* Blood pressure segmental studies.
* Venous compressions.
* Penile & digit systolic pressures.
* Flow velocities in recovery room.
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.
Note: One of these probes comes with Smartdop 45 as a standard accessory. Other probes are
available as optional accessories.
BT2M20S8C (2 MHz): Fetal heart rate and sounds
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

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1-4. Contents of package
Main unit 1
Probe 1
AC adaptor 1
Ultrasonic gel 1
Paper 1
Carrying case 1