Koven Smartdop 45 User manual

GTIN: 00894912002135

WARNINGS & CAUTIONS
CAUTION Use the Smartdop®45 under normal operating conditions, according to the instructions
provided in this operation manual and under the operating conditions stated in the product
specications.
CAUTION Federal law restricts this device to sale by or on the order of a licensed healthcare
practitioner.
CAUTION The Smartdop®45 has not been evaluated for safety and compatibility in the MR
environment. The Smartdop®45 has not been tested for heating or migration in the MR
environment.
CAUTION Perform ultrasound testing/procedures prudently using the principle of ALARA (As Low As
Reasonably Achievable).
CAUTION Use ultrasound gel. Other materials such as baby oil or cream may produce incorrect
sounds or damage the probe.
WARNING The ultrasound gel included with purchase is non-sterile and should only be used
noninvasively.
WARNING Discontinue use of ultrasound gel if an allergic reaction occurs.
CAUTION The probe transducer tip is thin and delicate. Please handle with care and use the probe cap
when not in use.
WARNING If any abnormality is found on the unit or patient, discontinue use in a manner safe to the
patient.
CAUTION Make sure all cables are property connected before use.
CAUTION Do not drop or place in an area where the unit may fall.
CAUTION Do not use simultaneously with an electrocautery debrillator, other ultrasonic device or a
mobile phone.
CAUTION Do not use in an area where a strong electromagnetic eld is present. Doing so may cause
incorrect measurements.
CAUTION Do not place near water or other liquid, where atmospheric pressure, temperature, humidity,
ventilation, sunlight, dust, salt sulfur, etc. may cause damage or where chemicals are stored
or gas may be generated.
CAUTION Protect the unit from vibration and shock during transport.
CAUTION Do not use excessive force when disconnecting cables.
CAUTION Use only designated Smartdop® 45 accessories.
CAUTION The Doppler box should not have direct contact with the patient or be placed in the sterile
area. The Doppler box cannot be sterilized or reprocessed.
WARNING The Doppler box and noninvasive probes should be cleaned following any patient contact.
CAUTION Do not submerge the Doppler box or probe in any liquid.
CAUTION Clean probes with a recommended probe cleaner before use.
CAUTION Do not perform any modications to the unit.
CAUTION Repairs should only be performed by authorized personnel.

TABLE OF CONTENTS
SECTION 1 (Basic Operation)
Warnings & Cautions
Introduction ................................................................................................................................1
Indications for Use ......................................................................................................................1
Features ......................................................................................................................................1
1. Indications for Use, Contraindications, & Applications ....................................................2
1-1 Doppler Arterial & Venous Applications .........................................................................…2
1-2 PPG (Photoplethysmography) Arterial & Venous Applications .........................................2
1-3 Fetal Applications ..............................................................................................................2
1-4 Air Emboli Monitoring ........................................................................................................2
2. Lower Extremity Doppler Arterial Waveform Pattern Analysis ........................................3
3. Controls
3-1 Front Left View .............................................................................................................. 4-5
3-2 Front Right View & Probe ..................................................................................................6
4. Setup & Operation
4-1 Turning the Unit ON / OFF ................................................................................................7
4-2 Checking the Battery Level ...............................................................................................8
4-3 Charging the Battery .........................................................................................................9
4-4 Discharging the Battery .....................................................................................................9
4-5 Installing Printer Paper ....................................................................................................10
5. Basic Operation
5-1 Measuring Blood Velocity ...........................................................................................11-12
5-2 PPG: Arterial Pulse Waveform Studies ...........................................................................13
5-3 Measuring Fetal Heart Rate (FHR) .................................................................................14
5-4 Fetal Heart Rate (FHR) Monitoring .................................................................................15
5-5 Air Emboli Monitoring ......................................................................................................16
6. Mode & Menu Settings
6-1 Menu
6-1-1 Menu Structure .......................................................................................................17
6-1-2 Menu Operation ......................................................................................................18
6-1-3 Menu for Blood Velocity Measurement...................................................................19
6-1-4 Menu for Blood Velocity Freeze Mode ...................................................................20
6-1-5 Menu for PPG (Photoplethysmography)(Measurement & Freeze) ........................21
6-1-6 Menu for 2.25 MHz Fetal / Beep Mode ..................................................................22
6-2 Mode Setting Details
6-2-1 MEMORY - STORE ................................................................................................23
6-2-2 MEMORY - READ ..................................................................................................24
6-2-3 MEMORY - CLEAR ................................................................................................24
6-2-4 MODE (Baseline Mode) .........................................................................................25
6-2-5 DIR (Flow Direction) ...............................................................................................25
6-2-6 TIME (Time Scale) ..................................................................................................25
6-2-7 FLOW (Blood Volume Flow) / DIAMETER (Est. Vessel Diameter) ........................26
6-2-8 PATIENT (Patient Data Input) ........................................................................... 26-27
6-2-9 OTHERS - LANGUAGE .........................................................................................28
6-2-10 OTHERS - FREEZE .............................................................................................28
6-2-11 OTHERS - UNIT ...................................................................................................28
6-2-12 OTHERS - FILTER (Arterial / Venous Filter) ........................................................28
6-2-13 OTHERS - SMOOTH (Smoothing Filter) ..............................................................28
6-2-14 DISP / OTHERS - DISP (Waveform / Data) .........................................................29
6-2-15 OTHERS - CAL (Calibration) ................................................................................29
6-2-16 OTHERS - BACKLIGHT .......................................................................................29
6-2-17 OTHERS - AUTO OFF (Automatic Shut O󰀨) ........................................................30

TABLE OF CONTENTS
6-2-18 OTHERS - P.ID PRT (Patient Data Print) .............................................................30
6-2-19 OTHERS - PRB-KEY (Probe Button Function) ....................................................30
6-2-20 OTHERS - DATE (Date and Time Setting) ...........................................................30
6-2-21 OTHERS - PRB20MHZ (20 MHz Probe Selection) ..............................................31
Mode Settings for Optional PPG Probe
6-2-22 AC/DC (Arterial/Venous) .......................................................................................31
6-2-23 COUNT .................................................................................................................31
Mode Settings for Optional 2.25 MHz Probe
6-2-24 DISP (Display Mode) ............................................................................................31
6-2-25 SOUND (Beep Sound for FHR Mode) ..................................................................32
6-2-26 UPPER (Upper Limit for FHR) ..............................................................................32
6-2-27 LOWER (Lower Limit for FHR) .............................................................................32
6-2-28 DISP / BEEP (Display for Beep Mode) .................................................................32
6-2-29 LIMIT-1 (Limit for Beep Mode) ..............................................................................33
6-2-30 LIMIT-2 (Maximum/Average for Beep Mode) .......................................................33
6-2-31 OTHERS - UNIT (Beep mode Unit) ......................................................................33
7. LCD Display
7-1 Blood Velocity
7-1-1 Waveforms .............................................................................................................34
7-1-2 Numerical Data .......................................................................................................35
7-2 Fetal Heart Rate Mode
7-2-1 Displaying Real Time FHR (Data Mode) ................................................................35
7-2-2 Monitoring FHR in Graph (Wave Mode) .................................................................36
8. Printing Waveforms & Data
8-1 Mode Settings Inuencing the Printed Chart ...................................................................37
8-2 How to Print ............................................................................................................... 37-38
8-3 Print Sample ....................................................................................................................38
9. Numerical Data ...................................................................................................................39
10. External Outputs
10-1 Headset .........................................................................................................................40
10-2 Communication Port ......................................................................................................40
11. Maintenance ........................................................................................................................41
12. Symbol List .........................................................................................................................41
13. Operating Principles .........................................................................................................42
14. Block Diagram ...................................................................................................................43
15.Specications .....................................................................................................................44
16. Operation Storage & Transport Environments .................................................................45
17. System Includes .................................................................................................................45
18. Cleaning ..............................................................................................................................46
19. Disposal of Device ..............................................................................................................47
20. Warranty ..............................................................................................................................47
21. Safety Standards ........................................................................................................... 48-50
SECTION 2 (Vascular Testing Instructions)
1. Ankle Brachial Index .................................................................................................... 51-52
2. Segmental Blood Pressures ....................................................................................... 53-54
3. Venous Compression Studies ..................................................................................... 55-56
4. PPG Toe Pressures & Toe Brachial Index (TBI) ......................................................... 57-58
5. PPGVenousReux ...................................................................................................... 59-60

Section1
Section1
Basic Operation

Smartdop®45BasicOperation
Thank you for choosing the
Smartdop®45…
e Smartdop® 45 is a bidirectional Doppler with LCD display and integrated printer
used for the detection of arterial and venous blood ow in extremities and fetal heart
sounds. Please read this manual carefully to acquaint yourself with the proper
operation.
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Smartdop and Smart-V-Link are registered trademarks ® of Koven Technology, Inc.
FEATURES
• Bidirectional hand held Doppler with LCD and integrated printer
Displays real-time waveforms, numerical data and heart rate
Prints frozen waveforms, numerical data, monitored heart rate and patient data
• Microprocessor based
Various mode settings available for optimal measurement with the LCD menu and unique scroll button
30 waveform memory storage for waveform, numerical data, heart rate, and patient data
• Convenient probe activation button
Freezes and/or prints waveform and numerical data for documentation purposes
• AutomaticPower“o󰀨”
• USB computer interface
Optional communication cable and Smart-V-Link®software are available
Store waveforms and numerical data to a computer for data analysis and electronic storage
• Optional PPG (Photoplethysmography) probe available for expanded arterial and
venous testing
NOTE
If using the Smartdop®45 with the optional Smart-V-Link®documentation software, please
refer to the Smart-V-Link®operation manual for instructions on downloading waveforms and
performing tests with the Doppler and software.
Manufactured by:
Hadeco, Inc.
2-7-11 Arima, Miyamae-ku, Kawasaki, 216-0003 Japan
CAUTION
Use the Smartdop®45 under normal operating conditions, according to the instructions
provided in this operation manual and under the operating conditions stated in the product
specications.
CAUTION
Federal law restricts this device to sale by or on the order of a licensed healthcare practitioner.
RX only.
CAUTION
The Smartdop®45 has not been evaluated for safety and compatibility in the MR environment.
The Smartdop®45 has not been tested for heating or migration in the MR environment.
CAUTION
Perform ultrasound testing/procedures prudently using the principle of ALARA (As Low As
Reasonably Achievable).

Smartdop®45BasicOperation
Smartdop®45BasicOperation
1. INDICATIONS FOR USE, CONTRAINDICATIONS, &
APPLICATIONS
INDICATIONS FOR USE
The Smartdop® 45 is used for the detection of arterial and venous blood ow in extremities as
well as fetal heart sounds. It displays and prints bidirectional velocity waveform, numerical data
and fetal heart rate with heart beat indicator.
CONTRAINDICATIONS
None known.
APPLICATIONS
(Refer to section 2 for Noninvasive Arterial & Venous testing instructions)
1-1 DOPPLER ARTERIAL & VENOUS APPLICATIONS
• Ankle Brachial Index (ABI) studies • Systolic pressures
• Peripheral vascular procedures • Blood ow velocity
• Segmental studies • Penile & digit systolic pressures
• Venous compressions
1-2 PPG (PHOTOPLETHYSMOGRAPHY) ARTERIAL & VENOUS APPLICATIONS
(Requires optional PG-21 Photoplethysmography probe, supplied separately)
• PPG toe pressures & Toe Brachial Index (TBI)
• PPG venous reux
1-3 FETAL APPLICATIONS
(Requires optional fetal probe, supplied separately)
• Evaluation of fetal heart rate and sounds throughout pregnancy except during rst
trimester, where fetal heart is not su󰀩ciently developed.
1-4 AIR EMBOLI MONITORING
(Requires optional BF2M20S8A at monitoring probe, supplied separately)
• Monitoring for the detection of venous air embolism
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Smartdop®45BasicOperation
2. LOWER EXTREMITY DOPPLER ARTERIAL
WAVEFORM PATTERN ANALYSIS
The Doppler arterial waveforms obtained from the lower extremity may be classied into six
categories as an aid in interpretation.
TYPE TYPICAL WAVEFORM FINDINGS
0 The contour exhibits a steeply rising upslope at the onset of systole,
rapid systolic downslope, and reverse ow (below baseline). Dop-
pler sounds are loud and sharp. Normal peak forward velocity = 30
+/- 10 cm at the dorsalis pedis artery.
I The contour demonstrates a strong but diminished systolic compo-
nent and loss of reverse ow. The width of systolic pulse is broad-
ened. The Doppler sounds are diminished very little as compared
to the type “O” pattern.
II The contour shows prolongation of both the upstroke and the down-
stroke and diminished waveform amplitude (attening). Doppler
sounds are heard during systole and continuing through all or most
of diastole.
III The contour exhibits slowly rising velocity during systole, and the
amplitude of the waveform is reduced. Doppler sounds are not
sharp even during systole.
IV The amplitude of the waveform and the Doppler sounds is greatly
reduced.
V The amplitude of the waveform is extremely reduced. The contour
is hardly recognizable as an arterial blood ow waveform. The
Doppler sounds are very faint.
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Smartdop®45BasicOperation
Smartdop®45BasicOperation
5. CONTROLS
5-1 FRONT LEFT VIEW
1) PAPER COVER Place paper inside
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 1 To connect the 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 a headset (not provided).
Cuts o󰀨 sound to the speaker.
10) AC ADAPTOR CONNECTOR To connect the designated AC adaptor.
Scroll Button
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3. CONTROLS
3-1 FRONT LEFT VIEW

Smartdop®45BasicOperation
3. CONTROLS
3-1 FRONT LEFT VIEW (Cont.)
11) PROBE CONNECTOR 2 To connect a second probe (press the probe
button to select)
12)CHARGING INDICATOR Indicates battery charging status.
Orange: Charging
Green: Fully charged
13)SCROLL BUTTON Consists of 5 internal buttons having the
following functions:
14)UP To scroll up through menu items
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 the sub-menu
16)DOWN To scroll down through menu items
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 return to the main menu from the sub-
menu or exit from the menu
18)ENTER To go to the menu
To perform the selected command on the
menu
19)PRINT / BACK BUTTON To activate / deactivate the printer.
To return to the previous screen
To exit Site Guidance mode (For use with
Smart-V-Link®Vascular software only. See
the Smart-V-Link®Operation Manual for
details)
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