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Smartdop 45
Operating Manual
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Hadeco Smartdop 45 Operating Manual

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Page 2
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
3-2-3. Mode Setting Details ........................................................................................21
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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
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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.
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(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.
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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
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2. Quick start
For the first time of use and in case the unit has been not used for a while, fully charge the
internal battery.
2-1. Turning the unit ON / OFF
(1) Connect the probe to the probe connector so that
the polarity mark will be placed under
mark as shown in the right (12 o’clock).
(2) Press the power button to turn the unit OFF.
(3) When Smartdop is turned ON first time, the
message as shown in the picture right will
appear, press Enter button to proceed.
(4) When battery is low, low battery indicator
appears as shown in the right. Smartdop can be
used for a few more minutes. Recharge the
battery as soon as possible for further use.
Low battery
Polarity mark
Power button
Enter button
Right button
Back button
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(5) AUTOMATIC POWER OFF
When the AUTO-OFF mode is ON, if the unit is left on, the power is automatically
shut off after following time passes:
(a) 35 minutes when in measurement. (Only Fetal Heart Rate WAVE mode)
(b) 15 minutes when in measurement. (Except Fetal Heart Rate WAVE mode)
(c) 5 minutes when no signal.
(d) 10 minutes when on freeze mode.
Note: If Automatic shut-off functions while on Freeze mode, Smartdop will revert to
Freeze mode and display the frozen waveform on LCD by turning the unit on.
2-2. Charging / Discharging battery
(1) Turn the unit off and plug the AC adaptor to the
unit to charge battery. The charging indicator will
go solid orange while charging is in progress.
Note: Use the designated adaptor, see "§
6-3.Specifications".
(2) When the battery is fully charged, the charging
indicator will go solid green. Unplug the AC
adaptor.
(3) Discharging battery:
Using and charging the battery repeatedly
without fully discharging may cause a shorter full
charge battery life. Fully discharge battery before
charging every once in a while as follows:
• Turn the unit off and plug the AC adaptor.
• Press Back Button and hold it, and press
Enter button to display battery level.
• While holding Back Button, press Right button
to discharge the battery.
Charging indicator
AC adaptor connector
Enter button
Right button
Back button
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• The “DISCHARGE” will be displayed on the
LCD.
• After the discharging completed, charge
process will start automatically and the
“DISCHARGE” will disappear, then charging
indicator will go solid orange.
Note: It takes about 3 hours to fully charge battery.
Battery life is 300 full charges. Contact your dealer for replacing battery.
2-3. Checking battery level
Battery level indicator shows upper right of the menu
screen.
(1) Turn the unit on and press Enter button to display
the menu.
(2) Battery level indicator shows the battery level in 4
steps as shown right.
(3) Charge the battery when in low.
Low battery indicator
When the battery is low, the low battery indicator will
be shown on bottom right of LCD. Recharge the
battery.
See "2-2. Charging / Discharging Battery"
If battery gets extremely low, the message shown
right will appear upon turning it on to indicate
memory data have been cleared for waveform data,
Battery level indicator
Low battery indicator
70%
Full
Low
30%
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Date setting, and Patient data excluding other Menu
mode settings.
(1) Press Enter button to go to Measurement mode
and charge the battery.
2-4. Setting printer paper
(1) Press Cover Open Button to open the paper
cover and remove the roll shaft.
(2) Insert the roll shaft into the paper roll.
(3) Set them in the paper compartment as shown in
the right. Pull the paper edge out a few inches
and close the paper cover tightly.
Cover Open Button
Roll shaft
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2-5. Measuring blood velocity
This section explains the fundamental use of measuring blood velocity. Refer to “3.
Appearance and Mode Settings” for various uses.
(1) Connect the probe to the probe connector so that
the polarity mark will be placed under
mark as shown in the right (12 o’clock).
(2) Put ultra ultrasonic gel on the probe top or patient
skin.
(3) Press the power button to turn the unit on. Turn
the volume control to maximum.
If you wish to enter the patient data, see “3-2-3-j.
Patient Data Input”.
(4) Put the probe on the measurement area and
move it slowly to locate the point where the
maximum Doppler sounds are heard. An ideal
probe angle to the vessel is approximately 45 to
60 degrees.
(5) When the waveform becomes rhythmical and
stable, wait more than 5 sec without moving the
probe, and then press the probe button to freeze
the waveform. Press Print Button to print the
waveform of last 5 sec. if necessary.
Note: Probe button function can be selected from Freeze &
Print on PRB-KEY mode setting.
Polarity mark
Power button
Volume control
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(6) Headset (Option) can be used to listen to
Doppler sounds. It will cut off the speaker.
2-6. Measuring fetal heart rate (2 MHz only)
This section explains the fundamental use of measuring fetal heart rate. Refer to “3.
Appearance and Mode Settings” for various uses.
(1) Connect the probe to the probe connector so
that the polarity mark will be placed under
mark as shown in the right (12 o’clock).
(2) Put ultrasonic gel on the probe top or the skin
surface.
(3) Press Power button to turn the unit on. Turn the
volume control to maximum.
(4) If you wish to monitor heart rate waveform, see
“3-2-3-g. DISP (Waveform / Data)” to change the
mode.
(5) Put the probe on the middle of the abdomen at
right angle to the skin surface, and move it
slowly to locate the point where the maximum
heart beat Doppler sounds are heard.
Caution: Verify the fetal heart rate.
(Maternal heart rates match the maternal pulse
rates.)
Headset connector
Polarity mark
Power button
Volume control
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(6) When the heart rate becomes stable, press the
probe button or Right button to freeze it.
Note: If the stable signals are not being detected, the “*”
mark will be shown above “HR”.
(7) Headset (Option) can be used to listen to
Doppler sounds. It will cut off the speaker.
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3. Appearance and mode settings
3-1. Operating controls
3-1-1. Front left view
1. Paper cover: For printer paper.
2. Cover Open Button To open the paper cover.
3. LCD display: Displays waveform, numerical data, heart rate and
menu for mode settings.
4. Speaker: Outputs Doppler sounds.
5. Probe connector: To connect probe
6. Power button: To turn the unit on / off.
7. Volume control: To adjust sound volume.
8. Strap hole: To attach hand strap.
9. Headset: To connect headset. It cuts off the speaker.
2
3
4
5
6
7
8
8
9
10
1
12
13
19
1
<Scroll Button>
14
15
16
17
18
Back Button
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10. AC adaptor connector: To connect the designated AC adaptor.
11. Keyboard connector: To connect PS2 keyboard, optional.
12. Charging indicator: Indicates battery status.
Orange : Charging
Green : Fully charged
13. Scroll Button: Consists of 5 internal buttons and has following
functions.
14. Up: To select upper menu item.
To increase waveform memory number in Freeze
mode.
To move cursor up on the on-screen keyboard.
15. Right: To move cursor right on the on-screen keyboard.
To go to submenu.
16. Down: To select lower menu item.
To decrease waveform memory number in Freeze
mode.
To move cursor down on the on-screen keyboard.
17. Left: To move cursor left on the on-screen keyboard.
To go back to main menu from submenu or get out
from menu.
18. Enter: To go to menu mode.
To perform the selected command on the menu.
19. Print / Back Button: To activate / deactivate the printer.
To go back to previous screen.
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3-1-2. Front right view and Probe
1. Probe holder: For probe placement when not in use.
2. Communication port: To connect computer. (USB)
3. Probe: Multi-probe selection of 2, 4, 5, 8 and 10 MHz
4. Probe button: To freeze and unfreeze the waveform.
To activate and deactivate the printer.
Note: The function is defined in the menu PRB-KEY. See “3-2-3-s, OTHERS - PRB-KEY” for
the details.
5. Probe cap: To protect the probe transducer tip when probe is not
in use.
4
5
3
2
1
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3-2. Mode settings
Note: For the mode settings for options, see “§ 5-2-5. Menu for PPG” and “§ 5-3-5. Menu for
PV”.
3-2-1. Basic Modes
Smartdop has following five Basic Operation Modes:
• Blood Velocity - Measurement For measuring blood velocity
• Blood Velocity - Freeze For observing waveforms and numerical data
• Fetal Heart Rate - Measurement For measuring fetal heart rate
• Fetal Heart Rate - Freeze For observing heart rate and graph
• Menu For changing other mode settings
Changing Basic Mode with probe connection (Blood Velocity / Fetal Heart Rate)
Connecting 4, 5, 8 or 10 MHz probe sets on Blood Velocity mode automatically.
Connecting 2 MHz probe sets on Fetal Heart Rate mode automatically.
Optional operation modes are available by connecting optional PPG and PV probes. See
" 5. Options".
Changing mode with probe button (Measurement / Freeze)
Press the probe button to go to freeze mode and
press again to get back to measurement mode.
(When PRB-KEY is Freeze mode.)
With 2 MHz probe, Fetal Heart Rate mode, pressing
Right button also changes the mode alternatively.
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3-2-2. Menu
Using Scroll Button, various mode settings are changeable on Menu mode. Some menus
have sub menus. Refer to following Menu structure and Menu operation first.
a. Menu structure
b. Menu operation
(1) Press Enter to show MENU depending on Basic
Mode.
(2) Select the mode by pressing Up and Down
buttons and selected mode will be highlighted.
Press Enter once or twice to change the mode
setting.
2 MHz only
PPG DC only
<Scroll Button>
Back Button
Up
Right
Down
Left
Enter
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(3) For MEMORY, PATIENT and OTHERS in
MENU, pressing Enter or Right button shows
sub menu for further mode settings.
(4) For MEMORY sub menus and LANGUAGE,
press Up or Down button again for the selection
of memory number or language.
(5) Press Left button to go back to main menu from
submenu or get out of the menu mode.
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c. Menu for Blood Velocity Measurement mode
Menu Sub Menu Selections Reference in §3-2-3.
STORE 1 to 30, FREEZE a. Memory - Store
READ 1 to 30, FREEZE b. Memory - Read
MEMORY
CLEAR 1 to 30, ALL c. Memory - Clear
MODE (waveform)
Compound Separate
d. Mode
TIME scale
Normal Slow
e. Time
DIR, direction
Forward Reverse
f. DIR
PATIENT data ID, NAME, SEX, AGE, DATE, SITE, MEMO j. Patient
LANGUAGE
ENGLISH, DEUTSCH,
ITALIANO, ESPANOL,
FRANCAIS
k. Others - Language
UNIT
cm/s, kHz
l. Others - Unit
FILTER
80Hz, 200Hz
m. Others - Filter
SMOOTHING
5Hz, 10Hz
n. Others - Smooth
DISP, display mode
WAVE, DATA
g. Others - DISP
CALibration
ON, OFF
o. Others - CAL
AUTO-OFF
ON, OFF
p. Others - Auto- off
KEYBOARD
ENGLISH, JAPANESE
q. Others - keyboard
P.ID PRT
(Patient data print)
ON, OFF
r. Others - P.ID PRT
PRB-KEY
(Probe button)
PRT & FRZ, PRINT, FREEZE
s. Others - PRB - KEY
OTHERS
DATA MMM.DD,YYYY HH:MM:SS t. Others - Date
Note: Selections in bold face in the table above are default settings.
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d. Menu for Blood Velocity Freeze mode
Menu Sub Menu Selections Reference in §3-2-3.
STORE 1 to 30, FREEZE a. Memory - Store
READ 1 to 30, FREEZE b. Memory - Read
MEMORY
CLEAR 1 to 30, ALL c. Memory - Clear
MODE (waveform)
Compound Separate
d. Mode
DIR, direction
Forward Reverse
f. DIR
DISP, display mode
WAVE, DATE
g. DISP
PATIENT date ID, NAME, SEX, AGE, DATE, SITE, MEMO j. Patient
LANGUAGE
ENGLISH, DEUTSCH, ITALIANO,
ESPANOL, FRANCAIS
k. Others - Language
AUTO-OFF
ON, OFF
p. Others - Auto- off
KEYBOARD
ENGLISH, JAPANESE
q. Others - keyboard
P.ID PRT
(Patient data print)
ON, OFF
r. Others - P.ID PRT
PRB-KEY
(Probe button)
PRT & FRZ, PRINT, FREEZE
s. Others - PRB - KEY
DATA MMM.DD,YYYY HH:MM:SS t. Others - Date
OTHERS
PRINT u. Others - Print
Note: Selections in bold face in the table above are default settings.
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e. Menu for Fetal Heart Rate mode (Measurement and Freeze)
Menu Sub Menu Selections Reference in §3-2-3.
STORE 1 to 30, FREEZE a. Memory - Store
READ 1 to 30, FREEZE b. Memory - Read
MEMORY
CLEAR 1 to 30, ALL c. Memory - Clear
DISP, display mode
WAVE, DATE
g. DISP
UPPER limit 60 to 220 (every 5 BPM) h. Upper
LOWER limit 60 to 220 (every 5 BPM) i. Lower
PATIENT date ID, NAME, SEX, AGE, DATE, SITE, MEMO j. Patient
LANGUAGE
ENGLISH, DEUTSCH, ITALIANO,
ESPANOL, FRANCAIS
k. Others - Language
AUTO-OFF
ON, OFF
p. Others - Auto- off
KEYBOARD
ENGLISH, JAPANESE
q. Others - keyboard
P.ID PRT
(Patient data print)
ON, OFF
r. Others - P.ID PRT
PRB-KEY
(Probe button)
PRT & FRZ, PRINT, FREEZE
Others - PRB - KEY
DATA MMM.DD,YYYY HH:MM:SS t. Others - Date
OTHERS
PRINT u. Others - Print
Note: PRINT is only available when in WAVE & Freeze mode. DISP mode is not changeable
when on freeze mode. Selections in bold face in the table above are default settings.
Button functions limited to Fetal Heart Rate mode
1 Right To freeze and unfreeze the waveform & heart rate.
2 Up / Down To restart waveform monitoring when on WAVE mode.
3 Left To show next page of monitoring waveform when on Freeze mode.
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3-2-3. Mode Setting Details
See "§ 3-2-2-b. Menu operation" for button operation on Menu mode.
Do the mode setting once and subsequent Smartdop use will revert to this mode.
However, if battery gets extremely low, memory data will be cleared for waveform data,
Date setting, and Patient data excluding other Menu mode settings.
a. MEMORY - STORE
(1) The first memory number available will be
selected automatically on STORE. If necessary,
change the number where to store waveform
data and patient data by pressing Up and
Down.
Note: The memory number with "*" indicates memory
area where other data have been already stored.
(2) Press Enter to store the data into the memory
and it will go back to waveform display.
Note: If other data have been already stored in memory
number storing, a confirmation of "OVERWRITE?" will be shown. Press Enter to overwrite, or Left to cancel for selecting other memory number available.
b. MEMORY - READ
(1) Select the memory number where you wish to
read waveform data and patient data from by
pressing Up and Down.
(2) Press Enter button to show the waveform.
(3) Press Up and Down to show next waveform if
necessary.
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Note: Any frozen waveform is stored temporarily in
memory area of FREEZE separated from regular 30 memory. It can be re-shown by reading from memory FREEZE and won't be erased until next waveform is frozen or unit is turned off.
c. MEMORY - CLEAR
(1) Select the memory number you wish to clear
the data. The memory number with "*" indicates
memory area where data have been already
stored.
(2) Press Enter and then the confirmation screen
with waveform data will be displayed as shown
in the right. Press Enter to clear the memory, or
press Left to cancel.
(3) To clear all the data except FREEZE in the
memory at once, select and press on ALL and
follow the instruction.
d. MODE (Baseline mode)
(1) Press Enter to change the baseline mode as
follows:
Compound mode: Combined forward and reverse components
Separate mode: Separation of forward from reverse component
Compound mode Separate mode
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e. TIME (Time scale)
(1) Press Enter to change the time scale as follows:
Normal: For arteries (2.56 sec/screen)
Slow: For veins (12.8 sec/screen)
f. DIR (Flow direction)
(1) Press Enter button to change waveform polarity as follows:
Forward: Flow toward probe is processed as positive component.
Reverse: Flow away from probe is processed as positive component.
g. DISP / OTHERS - DISP (Waveform / Data)
(1) Press Enter to change the Display mode as follows:
Blood Velocity mode
WAVE: Displays waveforms.
DATA: Displays numerical data
See “3-3-1. Blood Velocity mode” for more details.
Fetal Heart Rate mode
WAVE: Monitoring waveform
DATA: Numerical data
See ”3-3-2. Fetal Heart Rate mode” for more details.
Note: Display mode cannot be changed when on Freeze mode. When on measurement mode
with WAVE mode, pressing Up or Down restarts the monitoring.
Forward mode Reverse mode
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h. UPPER (Upper limit for FHR)
If heart rate exceeds the upper limit for more than 30 sec, LCD will start flashing for
warning.
(1) Press Up and Down to select the upper limit in 5 BPM steps and press the button to
fix it.
i. LOWER (Lower limit for FHR)
If heart rate gets below lower limit for more than 30 sec, LCD will start flashing for
warning.
(1) Press Up and Down to select the lower limit in 5 BPM steps and press the button
to fix it.
j. PATIENT (Patient data input)
The patient data can be input. This setting contains ID, NAME, SEX, AGE, examination
DATE, anatomical SITE and MEMOrandum.
Save the patient data on Measurement mode and it will apply to all of future
measurement data until it's changed so that you won't have to input the same data for the
same patient again. If it is done on Freeze mode, the patient data will apply only to the
stored/FREEZE data selected.
(1) Prior to the patient data input, go to
OTHERS-DATE menu and set the date and time
for an initial setting.
Scroll to the item where you wish to input and
press Enter to display data input screen. With
SEX, pressing Enter changes Male to Female or
vice versa.
DATE data can be changed on PATIENT menu
when on FREEZE mode only.
Upper limit
Lower limit
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(2) Scroll to the letter you wish and press Enter to
type it. Pressing Back Button or entering
Backspace ( ) deletes the letter you typed
previously.
(3) After entering the data, press and hold
Print/Back for longer than 1 sec to save the data
or scroll to (Back) and press Enter to do it.
(4) Press Left to get out of Patient Data screen.
When using external PS2 keyboard:
(1) Press any key on the keyboard to open Patient Data screen.
(2) Use cursor keys to select item and input the data by typing letters.
(3) Press Esc or End to save the data and get out of Patient Data screen.
Copy / Paste / Clear of the data
You can copy and paste the patient data to the other patient data area when on FREEZE
mode mainly for your convenience.
(1) Press Back Button while Patient Data screen is
displayed.
(2) Scroll to the edit command and press Enter.
(3) COPY will copy all items of the patient data to
clipboard.
(4) PASTE will paste the clipboard data to the other
patient data area. It overwrites the existing data.
All items except DATE will be pasted at once.
(5) CLEAR will delete the patient data.
(6) PASTE and CLEAR commands require the
confirmation as shown right. Press Enter to
proceed or press Left to cancel.
(7) Press Back Button to go back to Patient Data.
Screen keyboard
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k. OTHERS - LANGUAGE
(1) Press Up and Down to select the language in which menus and messages are
written. And press Enter to fix it.
l. OTHERS - UNIT (cm/s / kHz)
(1) Press Enter to change the unit of blood flow as follows:
cm/s: Blood flow velocity
kHz: Doppler frequency shift
m. OTHERS - FILTER (Arterial / Venous filter)
The high-pass filter cuts off Doppler signals with lower frequencies than filtering
frequency (200 or 80 Hz) for optimal audibility.
(1) Press Enter to change the filter as follows:
200 Hz: For arteries
80 Hz: For veins
n. OTHERS - SMOOTH (Smoothing filter)
(1) Press Enter to change smoothing frequency as follows:
10 Hz: For normal signals
5 Hz: For noisy signals
o. OTHERS - CAL (Calibration)
(1) Press Enter to change CAL mode as follows:
ON: Displays 4 step (3, 2, 1, 0, -1 kHz)
calibration waveform.
OFF: Measurement mode
p. OTHERS - AUTO-OFF (Automatic shut-off)
(1) Press Enter to change the mode.
For the explanation of Automatic shut-off, refer to 2-1. Turning the unit ON / OFF.
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q. OTHERS - KEYBOARD (External)
(1) Press Enter to change the keyboard.
ENGLISH: 104 English keyboard PS2
JAPANESE: 109 Japanese keyboard PS2
Note: Only PS2 keyboard is available.
r. OTHERS - P.ID PRT (Patient data print)
(1) Press Enter to change the mode as follows:
ON: Prints with patient data.
OFF: Prints without patient data.
s. OTHERS - PRB-KEY (Probe button function)
(1) Press Enter to change the probe button function
as follows:
PRT&FRZ: Freezes and prints.
PRINT: Prints and goes to Monitoring mode as follows:
FREEZE: Freezes
Note: When on FHR - DATA mode, only FREEZE is functional no matter what is selected on
the PRB-KEY mode.
t. OTHERS - DATE (Date and time setting)
(1) Press Enter to go to Date Setting screen.
(2) Scroll item with Right and Left, and adjust it with
Up and Down.
(3) Press Enter to fix it or press Back Button to
cancel.
u. OTHERS - PRINT (Printer activation)
(1) Press Enter to activate the printer.
Note: Pressing Print Button also activates printer. Press Print the second time to deactivate
printer.
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3-3. LCD display
3-3-1. Blood Velocity Mode
Waveforms
(1) The base line is automatically located at optimal position for each waveform.
Smartdop has 4 base lines, the bottom, 1/4 from the bottom, the center, and 3/4
from the bottom.
(2) The waveform amplitude is automatically adjusted for optimal observation.
(3) The amplitude scale (velocity or frequency per division) is displayed on top left of
LCD.
(4) When pressing probe button to freeze the
waveform, Smartdop will stop monitoring
sequence and will display frozen waveform with
“FREEZE”.
(5) The read out waveform is displayed with
memory number, e.g. "#01" on top right of LCD.
Compound mode
Memory number
Separate mode
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Numerical data
Following numerical parameters are displayed on DATA mode.
See “3-5. Numerical Data” for the meaning of abbreviations and the definitions of
parameters.
3-3-2. Fetal Heart Rate (FHR) mode (Only 2 MHz probe)
Displaying heart rate at the moment (DATA mode)
(1) Heart rate is displayed based on a 4 beat average once the Smartdop gets
sufficient data to calculate.
(2) The heart mark " " tracks heart beat while in measurement. The heart mark
also indicates the speed of heart movements in 3 different sizes as follows:
Fast Medium Slow
(3) When calculated heart rate is not stable, the asterisk (*) will show above “HR”.
Unit: cm/s Unit: kHz
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Monitoring heart rate in graph (WAVE mode, Monitoring mode)
(1) The measurement range of heart rate is 60 to 220 BPM.
(2) Heart rate at the moment is displayed on bottom left of LCD.
(3) Heart mark indicates the same way as DATA
mode. See previous page.
(4) Two dotted lines indicate Upper and Lower
limits of heart rate. If it gets out of limits for
more than 30 sec, LCD will start flashing for
warning.
(5) When on freeze mode by pressing probe or
Right button, the latest monitoring waveform
of up to 33 minutes can be shown over 4
pages on LCD with FREEZE indicator. Turn
Shuttle Button down to show next page.
(Approx. 8 minutes a page)
(6) The read out waveform from memories is
displayed with memory number, e.g. "#01" on
top right LCD.
Heart rate
220 200
Asterisk is displayed when calculated heart rate is not stable.
Heart rate at the moment
Max. Min.
Page number
Freeze indicator
Memory number
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3-4. Printing waveforms and data
3-4-1. The mode settings influencing printed chart
The following mode settings influence the printed waveform and data. Smartdop prints
depending on the present mode settings. Change modes before printing if desired.
Note: Refer to the description of each mode in “ 3-2-3. Mode Setting Details”.
Mode Abbrev. Selection
a. Baseline mode MODE Compound, Separate
b. Time scale TIME Normal, Slow
c. Flow direction DIR Forward, Reverse
d. Language LANGUAGE English, Deutsch, Italiano, Español,
Français
e. Unit UNIT cm/s, kHz
f. Filter FILTER 80Hz, 200Hz
g. Smoothing filter SMOOTH 5 Hz, 10 Hz
h. Waveform / Data DISP Wave, Data
i. Patient data print P.ID PRT ON, OFF
3-4-2. How to print
Printing waveform and data is available on Freeze
mode and Patient Data Input mode.
(1) Press Print button or execute PRINT command on
the menu mode to print waveforms. Also, pressing
probe button makes print when PRB-KEY is on
PRT&FRZ or PRINT mode.
(2) Smartdop prints following waveforms and then
stops printing automatically.
Blood Velocity mode
TIME is Normal: Waveform of the 5 sec before freezing
TIME is Slow: Waveform of the 25 sec before freezing
Print button
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FHR mode
Monitoring mode: Waveform of up to the 33 minutes before freezing
(3) Press Print button or execute PRINT command the
second time to deactivate the printer.
3-4-3. Print sample
Note: See “3-5. Numerical Data” for the meaning of abbreviations and the definitions of
Numerical data.
Unit
Time scale
Direction
Waveform
mode
Probe
Frequency
Patient data area
Numerical data area
Waveform
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3-5. Numerical data
Parameters Abbrs. Definitions
Systolic velocity [cm/s] or
Systolic Doppler shift [kHz]
S
Mean velocity [cm/s] or
Mean Doppler shift [kHz]
MN
Diastolic velocity [cm/s] or
diastolic Doppler shift [kHz]
D
Minimum velocity [cm/s] or
minimum Doppler shift [kHz]
MIN
Resistance Parameter RP RP=(S-D) / S
RP=1 if waveform goes below base line.
Pulsatility Index PI PI=(Peak-to-peak) / MN
PI
99.99
S/D ratio SD SD=S / D
Heart rate [BPM] HR
Samples displayed on LCD
Unit: cm/s
Unit: kHz
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3-6. External outputs
3-6-1.Headset
Connect the headset when necessary. The headset cuts off the speaker.
See 3-1. Operating Controls.
3-6-2. Communication port (3.5 mm jack)
To observe the waveform in high resolution on a PC monitor or to store the waveform
and numerical data into a computer for future reference as well as an entire report for
standardized testing modules.
(1) Connect a computer with dedicated communication cable (option).
(2) Press the Power Button to turn the unit on.
(3) Run the communication software (option) on your computer.
Note: For software operation, refer to the software operating manual.
3-7. Symbol list
* Caution must be observed to avoid damage to the unit. Refer the operating manual carefully.
Symbols Description Symbol Description
Type BF applied part
USB connector
Headset
Volume control
Print button
Charging indicator
AC adaptor connector
Keyboard connector
Caution*¹
Back button
Power button
Manufacturer
Authorized
representative in Europe
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4. Maintenance
4-1. Performance check by user
Perform the following performance checks at least once a year:
(1) Make sure if there is no damage and/or crack on the main unit and probe.
(2) Shake the main unit and make sure if there are no sounds inside from internal
components coming out.
(3) Turn the unit on and make sure if the LCD displays normally.
4-2. Cleaning
Probe
Remove the Doppler gel from the probe head after use.
Clean the probe using damp cloth and then wipe with a soft dry cloth, but take great care
that any water may not penetrate into the probe.
If using disinfectant, consult in advance with the manufacturer.
Main unit
To clean the main unit, use a damp cloth and then wipe with a soft dry cloth, but take
great care that any water may not penetrate into the unit. Check the unit by maintenance procedures mentioned in "§ 4-1.Performance check by
user" before using the unit.
4-3. Warranty
Guarantee period: *: Frequency
Main unit
Two(2) years
BT*M05S8C(A), BF8M15S8A, BP*M05S8A, VRP-*,
LRP-*, FDP-08, ACP-08*¹, BDP-*
One(1) year
CRP-*H, NRP-*H Six(6) months
Probe
NRP-*HF Three(3) months
The guarantee period is after the date of purchase when used under normal condition. In the event of any trouble during the warranty period, please contact the dealer from who
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36
you purchased the unit. In case the warranty period is over, please consult the dealer for a charged service.
*1: Guarantee period of ACP-08: either one year from the date of purchase or within 5
times of autoclave sterilization.
5. Options
5-1. Probe selection
Standard Doppler probes: 2, 4, 5, 8 and 10 MHz (with curled or straight cable)
Flat type Doppler probes: 2, 8 MHz
Sterilizable Doppler probes: 8, 10, & 20 MHz (Amplifier required)
Vascular, lapaloscopic, neurovascular, cardiovascular
Amplifier Model BDP*MS8 (*: Frequency 8, 10, & 20 MHz)
PPG probe: Model PG-21
PPG/PV probe: Model PGV-20 (switchable single channel)
Cuffs: DVC-1.9, DPC-2.5, VC-10, VC-12
Sphyg
Tubing: 120 cm
3-way stopcock
Smart-V-Link software with communication cable
Smart-Fetal-Link software with communication cable
Headset
5-2. Sterilizable doppler probes
VRP: Vascular, LRP: Lapaloscopic, NRP: Neurovascular,
CRP: Cardiovascular, FDP: Flat, ACP: Autoclavable (up to 5 times)
5-2-1. Sterilization
Only sterilizable probes can be sterilized. Do not sterilize other type of probes including
amplifiers as well as main unit.
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Warnings
Sterilizable probes are not sterilized before shipment.
They must be sterilized before use as follows:
Sterilization limits
1. All sterilizable probes except ACP probe: Up to 50 times
2. ACP probe: Up to 5 times (steam autoclave)
Note. Do not exceed sterilization limits or it may cause damage to probes.
Caution
1. Except ACP probe, do not sterilize probes by steam autoclave nor put them in
washer disinfector or it will damage probes.
2. ACP probe should be sterilized by steam autoclave as described in section
"Sterilization" below.
Instructions for sterilization
Point of preparation: No particular requirements.
Preparation for cleaning: No particular requirements.
Cleaning: Automated Do not do automated cleaning of probes other than ACP probe.
Manual Do not soak probes into medicinal solution. Wipe any
contamination from probes with damp cloth.
Disinfection: Not applicable
Sterilization:
Sterilizable probes except ACP probe Low temperature plasma sterilization (Hydrogen peroxide low
temperature plasma sterilization), under 60 degrees (C).
Do not put liquid, powder & cellulose inside sterilization
equipment or it may reduce effectiveness of sterilization
because these substances absorb hydrogen peroxide.
Eliminate water on surface of probe because it may reduce
effectiveness of sterilization.
Sterilization should be performed in accordance with
instructions of the sterilization equipment.
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ACP probe
Steam autoclave;
30 minutes under 115 degrees (C)
20 minutes under 121 degrees (C)
10 minutes under 134 degrees (C)
Do not expose the instrument to temperatures exceeding 134
degrees (C).
Sterilization should be performed in accordance with
instructions of the sterilization equipment.
Drying:
Sterilizable probes except ACP probe
No particular requirements.
ACP probe
Dry it well after the sterilization.
Maintenance: No particular requirements.
Inspection and Function Testing:
No cracks nor contaminations in appearance.
Connect the probe to main unit and make sure if you hear Doppler
sounds properly when you rub probe tip.
Packaging: No particular requirements.
Storage: No particular requirements.
Manufacturer contact:
Hadeco, Inc.
2-7-11 Arima, Miyamae-ku, Kawasaki, 216-0003, Japan
Tel: +81-44-877-4361
Fax: +81-44-855-7301
The instructions provided above have been validated by the medical device
manufacturer as being CAPABLE of preparing a medical device for reuse. It remains the
responsibility of the processor to ensure that the processing as actually performed using
equipment, materials and personal in the processing facility achieve the desired result.
This requires validation and routine monitoring of process. Likewise any deviation by the
processor from the instruction provided should be evaluated for effectiveness and
potential adverse consequences.
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5-3. Photoplethysmograph
With the PG-21 and PGV-20 (PPG mode), Smartdop senses the reflection of light from the
hemoglobin of the red blood cells in surface vessels by utilizing infrared light.
Basically, “How to use photoplethysmograph” is described in this section. For other
matters such as Cautions, Technical information and Interpretations of test result, refer to
the Operating Manual that comes with your PPG probe.
5-3-1. PPG (Photoplethysmography) Probe Assemblies
Single-channel photoplethysmography (PPG) probe
Model PG-21
Switchable dual-modality (PPG/PV) single-channel probe
Model PGV-20
5-3-2. Clinical Applications
AC Coupling: Arterial pulse waveform studies, Toe pressure
DC Coupling: Venous reflux study
To the main unit
PPG/PV mode switch
PPG probe head
To the main unit
PPG probe head
Probe button
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5-3-3. PPG - Arterial Pulse Waveform Studies
Purpose
Arterial pulse waveform studies by photoplethysmography are performed to determine
the presence or absence of pulsatile flow and to assess the state of perfusion in the
tissue area immediately beneath the sensor site. When used with a suitable cuff and
manometer, the method permits the measurement of systolic blood pressure in the
fingers and toes.
Preparation
(1) Connect the PPG probe to the main unit, and
turn it on.
Note: With the PGV-20 probe, set the PPG/PV mode
switch to the PPG mode beforehand.
(2) Press Enter button to display MENU and make
sure MODE is on AC mode. If it's been set for
DC mode, press Enter on MODE to change to
AC.
Press Left to get out of the MENU mode.
(3) Check that the face of the PPG sensor is free of
stains. Clean it if necessary.
(4) Make certain that room temperature is
comfortable and, especially, that the skin
surface where the probe is to be mounted is
warm. Cold constricts superficial blood vessels
and thus jeopardizes the accuracy of PPG
measurements.
Power button
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Examination Procedure
(1) Apply the sensor with the clear side against the
skin surface, and fix it in place using Velcro
straps or double-sided clear tape.
(2) If you wish to input patient data, see “3-2-3-j.
PATIENT”.
(3) The gain is automatically adjusted and the PPG
waveform is shown on the LCD.
(4) When the waveform gets stable and rhythmic,
press Right or probe button to freeze the
waveform. Press Print Button to print the
waveform of last 5 sec. if necessary.
(5) If you wish to save the data on the memory, see
“ 3-2-3-a. MEMORY - STORE”.
5-3-4. PPG - Venous Reflux Study
Purpose
The venous reflux study is performed to assess valvular competence by measuring the
amount of time required for venous refilling after calf veins have been emptied through
exercise.
Preparation
(1) Connect the PPG probe to the main unit, and
turn it on.
Power button
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Note: With the PGV-20 probe, set the PPG/PV mode
switch to the PPG mode beforehand.
(2) Press Enter button to display MENU. Scroll to
MODE and press Enter to change from AC to
DC mode.
(3) COUNT represents number of foot exercise
during study and if desired, press Enter on
COUNT and press Up and Down to change the
number.
Press Left to get out of the MENU mode.
(4) Check that the face of the PPG sensor is free of
stains. Clean it if necessary.
(5) Make certain that room temperature is
comfortable and that the skin surface of the
lower limb is warm. Cold constricts superficial
blood vessels and thus jeopardizes the
accuracy of PPG measurements.
Examination Procedure
(1) Have the patient sit on an examination table so
that the feet are off the floor.
(2) Apply the sensor, with the clear side against the
skin surface, to the medial malleolus over the
posterior tibial vein.
Fix the sensor in place with double-sided clear
tape.
(3) If you wish to input patient data, see “3-2-3-j.
PATIENT”.
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(4) Press Right or probe button to begin the
measurement process.
(5) Ask the patient to flex the foot specified number
on COUNT following the foot animation on LCD.
The exercise should be forceful, especially
when lifting the foot upward.
(6) After flexing, instruct the patient to relax the foot
and avoid all movement.
(7) The test is completed when the waveform
returns to the baseline and Smartdop will
automatically freeze the waveform.
Press Print Button to print the waveform if
necessary.
(8) If you wish to save the data on the memory, see
“3-2-3-a. MEMORY - STORE”.
(9) Press the Right to get out of the freeze mode.
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5-3-5. Menu for PPG
Menu Sub Menu Selections Reference in §3-2-3
STORE 1 to 30, FREEZE a. Memory - Store
READ 1 to 30, FREEZE b. Memory - Read
MEMORY
CLEAR 1 to 30, ALL c. Memory - Clear
MODE(Coupling)
AC, DC
5-3-6. Mode
COUNT 1 to 20 5-3-6. Count
PATIENT data ID, NAME, SEX, AGE, DATE, SITE, MEMO j. Patient
LANGUAGE
ENGLISH, EUTSCH,ITALIANO,
ESPANOL, FRANCAIS
k. Others - Language
AUTO-OFF
ON, OFF
p. Others – Auto-off
KEYBOARD
ENGLISH, JAPANESE
q. Others – Keyboard
P.ID PRT
(Patient data print)
ON, OFF
r. Others – P.ID PRT
PRB-KEY (Probe button) PRT & FRZ, PRINT, FREEZE s. O t h er s – P RB -K E Y
DA TE
MMM. DD, YYYY HH:MM:SS t. O t h er s – Date
OTHERS
PRINT u. Others – Print
Note: MODE is selectable when in Measurement mode, and PRINT is available when in
Freeze mode. COUNT is used for DC mode when in Measurement mode.
5-3-6. PPG Mode settings
MODE (AC / DC) (Only available in Measurement mode)
(1) Press Enter to change mode as follows:
AC: For arterial testing
DC: For venous reflux study
COUNT (Only available in DC - Measurement mode)
Set the number for foot exercise.
(1) Press Enter on COUNT and press Up and Down to change the number. Press Enter
to fix it.
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5-4. Pneumoplethysmograph
With the PGV-20 (PV mode), Smartdop senses volume changes in a limb or digit by
measuring the pressure changes in a recording cuff.
Basically, “How to use pneumoplethysmograph” is described in this section. For other
matters such as Cautions, Technical information and Interpretations of test result, refer to
the Operating Manual comes with your PV probe assembly.
5-4-1. PV (Pneumoplethysmography) Probe Assemblies
Switchable dual-modality (PPG/PV) single-channel probe
Model PGV-20
5-4-2. Clinical Applications
AC Coupling: PV Arterial studies
DC Coupling: Measurement of maximum venous outflow
5-4-3. PV - Arterial Studies
Purpose
Pneumoplethysmography is useful in detecting arterial occlusive conditions in the lower
limbs through analysis of waveform patterns. The method is sufficiently sensitive for
digital studies. PV also offers an alternative to Doppler techniques for segmental blood
pressure studies. Pneumoplethysmography is particularly useful for patients in whom
vessel calcification prevents accurate Doppler signal processing and occlusion-cuff
pressure measurements.
To the main unit
To the cuff
PPG/PV mode switch
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Preparation
(1) Connect the PV probe to the main unit, and turn
it on.
Note: With the PGV-20 probe, set the PPG/PV mode
switch to the PV mode beforehand.
(2) Press Enter button to display MENU and make
sure MODE is on AC mode. If it's been set for
DC mode, press Enter on MODE to change to
AC. Press Left to get out of the MENU mode.
Examination Procedure
(1) Place the patient in supine position with the leg and hip rotated outward. Use pillows
to support the leg and hip comfortably.
(2) Wrap cuffs of appropriate width around the thigh at the groin, above the knee, below
the knee, and at the ankle on both limbs. Avoid wrapping cuffs tightly. The fit should
be snug but comfortable.
(3) Connect a 3-way stopcock to the inlet of the PV interface box. Interconnect the
stopcock, tubing, cuff, and sphygmomanometer as shown in the diagram below.
(4) Turn the stopcock so that air is routed from the
sphygmomanometer to the cuff.
(5) If you wish to input patient data, see “ 3-2-3-ｊ.
PATIENT”.
Sphyg
Cuff
Extender tubing
3-way stopcock
To Main unit
PV interface box
Power button
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(6) Inflate the cuff to 60 mmHg. Then, turn the
stopcock so that it blocks the sphyg and routs
cuff pressure to the PV interface box.
(7) The gain is automatically adjusted and the PV
waveform is shown on the LCD.
(8) When the waveform gets stable and rhythmic,
press the Right to freeze the waveform. Press
Print Button to print the waveform of last 5 sec. if
necessary.
(9) If you wish to save the data on the memory, see
“ 3-2-3-a. MEMORY - STORE”.
(10) Deflate the cuff and repeat steps #3 through #10
of this section for each cuff on each limb.
5-4-4. PV - Measurement of Maximum Venous Outflow
Purpose
Because deep venous occlusion cannot be diagnosed reliably on the basis of presenting
signs and symptoms, pain and swelling being frequently due to other causes, objective
screening tests are of value in confirming or ruling out suspected venous obstructions in the
lower extremities. The test consists of first inducing temporary venous pooling by means of
a constricting thigh cuff followed by measurement of the rapidity of emptying when the
constricting cuff is suddenly vented. Measurement of maximum venous outflow is
frequently employed as an adjunct to Doppler venous compression studies.
Preparation
(1) Connect the PV probe to the main unit, and turn
the unit on.
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(2) Press Enter button to display MENU. Scroll to
MODE and press Enter to change from AC to DC
mode.
Examination Procedure
(1) Place the patient in supine position with the leg and hip rotated outward. Use pillows
to support the leg and hip. It is important that the patient is comfortable and relaxed.
(2) Wrap a wide occluding cuff at mid-thigh and a sensing cuff at mid-calf.
(3) Connect a 3-way stopcock to the inlet of PV interface box. Interconnect the stopcock,
tubing, cuff and sphygmomanometer as shown below.
(4) Turn the stopcock so that air is routed from the sphygmomanometer to the
sensing cuff at mid-calf.
(5) If you wish to input patient data, see “3-2-3-ｊ.
PATIENT”.
(6) Inflate the sensing cuff to 40 mmHg. Wait 10
seconds to allow time for settling and deflate the
cuff to 15 mmHg.
(7) Turn the stopcock so that it blocks sphyg and routes cuff pressure to the PV interface
box.
(8) Disconnect the sphyg from the stopcock and attach it to the occluding cuff at the
thigh.
(9) Press Right to begin the measurement process.
Sphyg
Cuff
Extender
3-way stopcock
To Main unit
PV interface box
Cuf
f
Extender
Sphyg
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(10) Inflate the occluding cuff at the thigh to at least
60 mmHg. Pressures in the cuff are plotted on
the screen. The graph will indicate a gradual
increase in waveform amplitude signifying that
venous outflow is blocked by the occluding cuff.
(11) After 90 seconds, disconnect the sphyg from
the occluding cuff. The pressures on the screen
will drop back to the baseline.
(12) Smartdop will automatically stop the
measurement process, and then freeze the
waveform. Press Print Button to print the
waveform if necessary.
(13) If you wish to save the data on the memory, see
“ 3-2-3-a. MEMORY - STORE”.
(14) Press the Right to get out of the freeze mode.
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5-4-5. Menu for PV
Menu Sub Menu Selections Reference in §3-2-3
STORE 1 to 30, FREEZE a. Memory - Store
READ 1 to 30, FREEZE b. Memory - Read
MEMORY
CLEAR 1 to 30, ALL c. Memory - Clear
MODE(Coupling)
AC, DC
5-3-6. Mode
PATIENT data ID, NAME, SEX, AGE, DATE, SITE, MEMO j. Patient
LANGUAGE
ENGLISH, EUTSCH,ITALIANO,
ESPANOL, FRANCAIS
k. Others - Language
AUTO-OFF
ON, OFF
p. Others – Auto-off
KEYBOARD
ENGLISH, JAPANESE
q. Others – Keyboard
P.ID PRT
(Patient data print)
ON, OFF
r. Others – P.ID PRT
PRB-KEY
(Probe button)
PRT & FRZ, PRINT, FREEZE
s. Others – PRB-KEY
DATE MMM. DD, YYYY HH:MM:SS t. Others – D a t e
OTHERS
PRINT u. Others – Print
Note : MODE is selectable when in measurement mode, and PRINT is available when in
Freeze mode.
5-4-6. PV Mode setting
MODE (AC / DC) (Only Measurement mode)
(1) Press Enter to change mode as follows:
AC: For arterial testing
DC: For measurement of maximum venous outflow
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6. Technical information
6-1. Principles
Model Smartdop 45 is designed to obtain various blood flow velocity through the
ultrasound which is transmitted from probe to patient body and is reflected by the blood
(hemocyte, etc.).
The unit amplifies the high frequency oscillation output and then supplies it to the
transmitter transducer. It is converted to ultrasound by the transducer and the ultrasound
is transmitted to external objects. The ultrasound moves straight through biophysical
object, and is reflected by the moving object (blood flow, fetal heartbeat etc.).
The reflected ultrasound is received by the receiving transducer and is converted into
electric signals again.
The converted signals are amplified and then detected. After removing unnecessary noise
from the signals and improving S/N ratio at the filter circuit, the Doppler shift signals are
amplified and are converted to audible sounds through a speaker or a headset.
Simultaneously, the Doppler shift signals are applied to the CPU and converted to blood
flow velocity waveform signals which can be displayed and printed.
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52
6-2. Block diagram
Page 59
53
6-3. Specifications
Probes: Model Freq. Ispta* (in situ) [mW/cm²]
BT2M20S8C 2 MHz 80 mW/cm² or less
BT4M05S8C 4 MHz 390 mW/cm² or less
BT5M05S8C 5 MHz 390 mW/cm² or less
BT8M05S8C 8 MHz 390 mW/cm² or less
BT10M5S8C 10 MHz 390 mW/cm² or less
*Ispta : Spatial Peak - Temporal Average Intensity
Power: Ni-MH rechargeable battery pack or AC adaptor
Input: AC 100-240V- 0.3A (max), 50/60 Hz
Output: DC 12V, 500mA or more
Consumption: DC 12 V, 300 mA
Recharge: Approx. 3 hours by the AC adaptor
Full charge life: 2.5 hours or more if used with freeze mode.
Battery life: Approx. 2 years, 300 full charges
Automatic shut-off No signal: 5 min. Freeze: 10 min.
Others: 15 min. (only FHR WAVE mode: 35 min.)
Frequency range: 80 / 200 Hz to 5 kHz
Mode settings: Memory, Waveform, Direction, Time scale, Others
Waveform memory: 30 waveforms
LCD display: 128 x 64 dots, STN LCD
Bi-directional waveform (normal & slow mode)
Numerical data (Systolic, diastolic & mean velocities, RP, PI, SD,
HR)
Heart rate: 30 to 300 BPM, accuracy of ±5%
Battery level and low battery indicators
Printer: Paper: 58 mm (W) x 25 m/roll (L), Thermal
Resolution: 384 dots/line
Print speed: 25 mm/s
Velocity accuracy: ±10% or less comparing with internal phantom testing.
Speaker output: 250 mW or more
Page 60
54
External outputs: Headset, USB port
Electrical safety: Conform to IEC60601-1
Internally powered equipment
Type BF applied part.
Operating environment:
10 to 40 degrees Centigrade
85% humidity or less with no condensation
Storage and transport environment:
0 to 50 degrees Centigrade
85% humidity or less with no condensation
Dimensions: Main unit: 92 (W) x 210 (D) x 60 (H) mm
(Probe holder not included)
Probe: 20 (Diam.) x 105 (L) mm
Weight: 560 grams (including battery & probe)
Manufacturing date: The first 2 digits and following 2 digits of the serial number
represent the year and month of manufacturing, respectively.
The serial number is located inside of the printer paper
compartment and it consists of 4 to 8 digits and may start with
“Serial number” or “SN”.
Examples:
03020001: Feb/2003
0401: Jan/2004
* Specifications subject to change
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55
6-4. Safety standards
The unit confirms to the following standards:
Manufacturing standard: IEC60601-1
(1) Protection class against electric shock : Class II device
: Internally powered equipment
Protection grade against electric shock : Type BF applied part
(2) Guidance and manufacturer's declaration - electromagnetic emissions and immunity
Guidance and manufacturer’s declaration – electromagnetic emissions
The Smartdop 45 is intended for use in the electromagnetic environment specified below. The
customer or the user of the Smartdop 45 should assume that it is used in such an environment.
Emissions test compliance Electromagnetic environment - guidance
RF emissions
CISPR 11
Group 1 The Smartdop 45 use RF energy only for its internal
function. Therefore, its RF emissions are very low and are
not likely to cause any interference in nearby electronic
equipment.
RF emissions
CISPR 11
Class A
Harmonic
emissions
IEC61000-3-2
Class A
Voltage
fluctuations/ flicker
emissions IEC61000-3-3
Complies
The Smartdop 45 is suitable for use in all establishments
other than domestic, and may be used connected to the
public low-voltage power supply network that supplies
buildings used for domestic purposes provided the following
warning in needed:
Warning: This equipment/system is intended for use by
healthcare professions only. This equipment/system may
cause radio interference or may be necessary to take
mitigation measures, such as re-orienting or relocating the
Smartdop 45 or shielding the location.
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56
Guidance and manufacturer’s declaration – electromagnetic immunity
The Smartdop 45 is intended for use in the electromagnetic environment specified below. The customer or
the user of the Smartdop 45 should assure that it is used in such an environment.
Immunity test IEC60601 test level Compliance level Electromagnetic environment
- guidance
Electrostatic
discharge(ESD)
IEC61000-4-2
±6 kV contact
±8 kV air
±6 kV contact
±8 kV air
Floors should be wood,
concrete or ceramic tile. If
floors are converted with
synthetic material, the relative
humidity should be at least
30%.
Electrical fast
transient/burst
IEC61000-4-4
±2 kV for power supply
lines
±1 kV for input/output
lines
±2 kV for power supply
lines
±1 kV for input/output
lines
Mains power should be that of
a typical commercial or
hospital environment.
Surge
IEC61000-4-5
±1 kV differential mode
±2 kV common mode
±1 kV differential mode
±2 kV common mode
Mains power should be that of
a typical commercial or
hospital environment.
Voltage dips, short
interruptions and
voltage variations on
power supply input
lines
IEC61000-4-11
< 5% U
T
(> 95% dip in UT)
for 0,5 cycles
40% U
T
(60% dip in U
T
)
for 5 cycles
70% U
T
(30% dip in U
T
)
for 25 cycles
< 5% U
T
(> 95% dip in U
T
)
for 5 s
< 5% U
T
(> 95% dip in UT)
for 0,5 cycles
40% U
T
(60% dip in U
T
)
for 5 cycles
70% U
T
(30% dip in U
T
)
for 25 cycles
< 5% U
T
(> 95% dip in U
T
)
for 5 s
Mains power should be that of
a typical commercial or
hospital environment.
Power frequency
(50/60Hz) magnetic
field
IEC61000-4-8
3 A/m 3 A/m Power frequency magnetic
fields should be at levels
characteristic of a typical
location in a typical
commercial or hospital
environment.
NOTE UT is the a.c. mains voltage prior to application of the test revel.
Page 63
57
Guidance and manufacturer’s declaration – electromagnetic immunity
The Smartdop 45 is intended for use in the electromagnetic environment specified below. The customer or the user of the Smartdop 45 should assure that it is used in such an environment.
Immunity test IEC60601 test level Compliance
level
Electromagnetic environment - guidance
Conducted RF IEC61000-4-6
Radiated RF IEC61000-4-3
3Vrms 150 kHz to 80 MHz
3V/m 80 MHz to 2,5 GHz
3 V
3 V/m
Portable and mobile RF communications equipment should be used no closer to any part of the Smartdop 45, including cables, than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter.
Recommended separation distance
d = 1,2 √P
d = 1,2 √P 80 to 800 MHz
d = 2,3 √P 800 MHz to 2,5 GHz
where P is the maximum output power rating
of the transmitter in watts (W) according to
the transmitter manufacturer and d is the
recommended separation distance in meters (m).
Field strength from fixed RF transmitters, as determined by an electromagnetic site survey,
a
should be less than the
compliance level in each frequency range.
b
Interference may occur in the vicinity of the equipment marked with the following symbol:
ｓｓｓNOTE 1 At 80 MHz and 800 MHz, the separation distance for the higher frequency range applies. NOTE 2 These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects and people.
a Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless) telephones
and land mobile radios, amateur radio, AM and FM radio broadcast and TV broadcast cannot be predicted theoretically with accuracy. To assess the electromagnetic environment due to fixed RF transmitters, an electromagnetic site survey should be considered. If the measured field strength in the location in which the Smartdop 45 is used exceeds the applicable RF compliance level above, the Smartdop 45 should be observed to verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as reorienting or relocating the Smartdop 45.
b Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m.
Page 64
Manufactured by
Hadeco, Inc.
2-7-11 Arima, Miyamae-ku, Kawasaki, 216-0003 Japan
SD45 OM E-24
June, 2013
Printed in Japan
080-00095-2.4
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