Hadeco Smartdop 30EX User manual

GTIN: 00894912002098

CAUTION Use the Smartdop®30EX 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®30EX has not been evaluated for safety and compatibility in the MR
environment. The Smartdop®30EX 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 only the designated adaptor that came with your Smartdop®30EX or contact Koven
Technology for parts & accessories.
CAUTION To avoid possible damage to the printer, never pull paper in the opposite direction as the
paper feed. To properly remove paper, cut the paper at the roll side and pull the remaining
paper out through the top of the unit.
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.
WARNING In case of emergency or unexpected situations, stop cu󰀨 ination by pressing the INF/DUMP
button on the front panel, disconnect the tubing from the unit, and turn the unit o󰀨.
CAUTION Make sure all cables are property connected and there are no obstructions to any external
connections to the patient, 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.
WARNINGS & CAUTIONS

CAUTION Do not use excessive force when disconnecting cables.
CAUTION Use only designated Smartdop® 30EX 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.
WARNINGS & CAUTIONS

TABLE OF CONTENTS
Warnings & Cautions
SECTION 1 (Basic Operation)
Introduction ...................................................................................................................1
Features ..........................................................................................................................1
1. Indications for Use, Contraindications, & Applications
1-1 Detection of Arterial and Venous Blood Flow Velocity ..........................................2
1-2 PPG & PV Arterial & Venous Studies....................................................................2
2. Waveform Pattern Analysis
2-1 Doppler Arterial Waveforms .................................................................................3
2-2 Pulse Volume Arterial Waveforms .........................................................................4
3. Controls
3-1 Front View .............................................................................................................5
3-2 Operation Panel .................................................................................................6-7
3-3 Right Rear View & Probe ......................................................................................8
4. Setup & Basic Operation
4-1 Turning the Unit ON / OFF ....................................................................................9
4-2 Checking the Battery Level .................................................................................10
4-3 Charging the Battery ..........................................................................................10
4-4 Installing the Printer Paper.................................................................................. 11
4-5 Measuring Blood Velocity...............................................................................12-13
5. Mode & Menu Settings
5-1 Basic Mode Settings ...........................................................................................14
5-2 Other Modes
5-2-1 Measurement / Freeze Mode .....................................................................14
5-2-2 Display Mode..............................................................................................14
5-3 Menu
5-3-1 Menu Operation..........................................................................................15
5-3-2 Menu for Blood Velocity Measurement Mode.............................................16
5-3-3 Menu for Blood Velocity Freeze Mode .......................................................17
5-3-4 Menu for Pressure Mode (Measurement & Freeze) ...................................18
5-3-5 Menu for PPG (Photoplethysmography)(Measurement & Freeze) ............19
5-3-6 Menu for PV-AC (Pulse Volume Arterial) Mode (Measurement & Freeze) ...20
5-3-8 MEMORY-STORE ......................................................................................21
5-3-9 MEMORY-READ ........................................................................................22
5-3-10 MEMORY-CLEAR ...............................................................................22-23
5-3-11 DIR (ow direction) ...................................................................................23
5-3-12 DISP / OTHERS-DISP (Waveforms/Data) ...............................................24

TABLE OF CONTENTS
5-3-13 WAVEFORM ..................................................................................................25
5-3-14 OTHERS-LANGUAGE...................................................................................26
5-3-15 OTHERS - PRB-KEY .....................................................................................26
5-3-16 OTHERS - CALIBRATION .............................................................................26
5-3-17 OTHERS - CAL PRINT (Printing Calibration)......................................................27
5-3-18 OTHERS - BACKLIGHT ................................................................................27
5-3-19 OTHERS - AUTO OFF ...................................................................................27
5-3-20 OTHERS - RESET .........................................................................................28
5-3-21 OTHERS - DISCHARGE ..........................................................................28
5-3-22 GUIDANCE ..............................................................................................29
5-3-23 CURSOR ..................................................................................................29
5-3-24 P.DISPLAY................................................................................................29
5-3-25 P.CLEAR ..................................................................................................30
5-3-26 COUNT .....................................................................................................30
5-4 Shortcut Keys ...........................................................................................................31
6. LCD Display
6-1 Blood Velocity Modes
6-1-1 Waveforms .................................................................................................32
6-1-2 Numerical Data...........................................................................................32
6-2 Pressure Modes (Arm/Leg and Toe Modes)
6-2-1 Display Samples.........................................................................................33
6-2-2 Error Messages ..........................................................................................34
6-3 Battery Indicators
6-3-1 Battery Level Indicator................................................................................34
6-3-2 Low Battery Indicator..................................................................................34
6-4 PV-AC (Pulse Volume Arterial)............................................................................34
7. Printing Waveforms & Data
7-1 How to Print ........................................................................................................35
7-2 Print Samples.................................................................................................36-37
7-3 Numerical Velocity ..............................................................................................38
7-4 4-Step Calibration ...............................................................................................38
8. External Outputs
8-1 Headset...............................................................................................................39
8-2 Communication Port ...........................................................................................39
9. Maintenance ...........................................................................................................39
10. Symbol List ............................................................................................................40
11. Operating Principles ..............................................................................................41
12.Block Diagram .......................................................................................................42

13.Specications .........................................................................................................43
14.Operation, Storage & Transport Environments ...................................................44
15.System Includes .....................................................................................................44
16.Cleaning ..................................................................................................................45
17.Disposal of Device ..................................................................................................46
18.Warranty ..................................................................................................................46
19.Safety Standards ...............................................................................................47-49
SECTION 2 (Testing Instructions)
1. Ankle Brachial Index .........................................................................................50-53
2. Segmental Blood Pressures ...........................................................................54-56
3. Venous Compression Studies ..............................................................................57
4. PPG Toe Pressures & Toe Brachial Index (TBI) .............................................58-60
5. PPGVenousReux ...........................................................................................61-62
6. Pulse Volume recordings (PVRs) .........................................................................63
TABLE OF CONTENTS

Section1
Section1
Basic Operation

Thank you for choosing the
Smartdop®30EX…
e Smartdop® 30EX is a bidirectional Doppler with LCD display, integrated printer
and automatic cu inator. It is used for the detection of arterial and venous blood
ow in extremities. Please read this manual carefully to acquaint yourself with the
proper operation.
Smartdop and Smart-V-Link are registered trademarks ® of Koven Technology, Inc.
FEATURES
• BidirectionalDopplerwithLCD,cu󰀨inator,&integratedprinter
Displays and prints velocity waveforms and numerical data
Automatic cu󰀨 ination / deation
Automatically calculates and prints ABI / TBI and velocity / pressure
• Convenient probe activation button
Freezes and/or prints waveform and numerical data for documentation purposes
Inates and/or dumps the cu󰀨
• Automatic Power “OFF”
To conserve battery life
• USB computer interface & optional software
Transfers waveforms and numerical data to a computer for data storage & EMR’s
USB communication cable and Smart-V-Link®software are optional
• 30 Waveform Memory
Save patient waveforms and numerical data for later use or download to the optional Smart-V-Link®software
• Optional PPG (Photoplethysmography) probe available for expanded arterial and
venous testing
NOTE
If using the Smartdop®30EX 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®30EX 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®30EX has not been evaluated for safety and compatibility in the MR environment.
The Smartdop®30EX 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).
1

Smartdop®30EXBasicOperation
1. INDICATIONS FOR USE, CONTRAINDICATIONS, &
APPLICATIONS
INDICATIONS FOR USE
The Smartdop® 30EX intended for use in the noninvasive evaluation of peripheral vascular
pathology in patients by detecting arterial and venous blood ow in extremities.
CONTRAINDICATIONS
Not intended for use in ophthalmic or periorbital studies as the acoustic intensity is higher than
the level recommended for use on and around the eye.
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 Pressure studies • Penile & digit systolic pressures
• Venous compressions
1-2 PPG (PHOTOPLETHYSMOGRAPHY) AND PULSE VOLUME (PV) ARTERIAL &
VENOUS APPLICATIONS
(PPG applications require the optional PG-21 Photoplethysmography probe, supplied
separately)
• PPG toe pressures & Toe Brachial Index (TBI)
• PPG venous reux
• Pulse Volume Recordings (PVR)
2
NOTE
The Smartdop®30EX has built-in
pulse volume capabilities. No
additional PV module is required
to perform pulse volume arterial
studies.
NOTE
The Smartdop® 30EX and associated Doppler probes, cus, and photoplethysmography
(PPG) probe are not intended to be placed in contact with blood or mucous membranes.
NOTE
The Smartdop®30EX is not recommended for fetal use.

Smartdop®30EXBasicOperation
2. WAVEFORM PATTERN ANALYSIS
2-1 DOPPLER ARTERIAL WAVEFORMS
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.
3