WARNINGS & CAUTIONS ® 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 specifications. CAUTION Federal law restricts this device to sale by or on the order of a licensed healthcare practitioner.
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WARNINGS & CAUTIONS CAUTION Do not use excessive force when disconnecting cables. 30EX accessories. ® CAUTION Use only designated Smartdop 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.
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 FEATURES • Bidirectional Doppler with LCD, cuff inflator, & integrated printer Displays and prints velocity waveforms and numerical data...
Smartdop 30EX ® Basic Operation 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 flow 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.
Smartdop 30EX ® Basic Operation WAVEFORM PATTERN ANALYSIS DOPPLER ARTERIAL WAVEFORMS The Doppler arterial waveforms obtained from the lower extremity may be classified into six categories as an aid in interpretation. TYPE TYPICAL WAVEFORM FINDINGS The contour exhibits a steeply rising upslope at the onset of systole, rapid systolic downslope, and reverse flow (below baseline).
Smartdop 30EX ® Basic Operation WAVEFORM PATTERN ANALYSIS PULSE VOLUME ARTERIAL WAVEFORMS A normal Pulse Volume arterial waveform will display a rapid rise in the upstroke during systole and a sharp peak at maximum amplitude, followed by a gradual downstroke following peak amplitude, and usually the presence of a dicrotic notch.
Smartdop 30EX ® Basic Operation CONTROLS FRONT VIEW 1) PRINTER To print waveforms, systolic pressures, ABI/TBI and velocity/pressure documentation. Outputs Doppler sounds. 2) SPEAKER To adjust sound volume. 3) VOLUME CONTROL For probe placement when not in use. 4) PROBE HOLDER 1 For probe placement when not in use.
Smartdop 30EX ® Basic Operation CONTROLS OPERATION PANEL Indicates the mode selected. 1) MODE LEDs (Mode 1, Mode 2, Arm/Leg, Toe) Illuminates sequentially while the battery is charging. 2) MODE BUTTON To select the mode - Mode 1 (Arterial), Mode 2 (Venous), Arm/Leg Pressure, Toe Pressure.
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Smartdop 30EX ® Basic Operation CONTROLS To inflate the cuff or stop inflation and dump the blood 6) INF/DUMP (FREEZE) pressure cuff (Arm/Leg and Toe modes). BUTTON To freeze / unfreeze the waveform (measurement mode). Menu mode: Moves the cursor right and changes the mode or setting.
Smartdop 30EX ® Basic Operation CONTROLS RIGHT REAR VIEW & PROBE To hold the paper roll in the printer. 1) ROLL SHAFT To connect the Doppler to a computer. 2) COMMUNICATION PORT To connect probe 1. 3) PROBE CONNECTOR 1 To connect probe 2.
Smartdop 30EX ® Basic Operation SETUP & BASIC OPERATION TURNING THE UNIT ON / OFF Connect the probe with the round probe connection mark on the probe connector pointed up (12 o’clock). Press the power button to turn the unit Power ON: Probe connection mark Power OFF:...
Smartdop 30EX ® Basic Operation SETUP & BASIC OPERATION CHECKING THE BATTERY LEVEL Battery level indicator Turn the unit on and press the MENU button to display the Menu screen. The battery level indicator is shown in the upper right corner of the Menu screen.
Smartdop 30EX ® Basic Operation SETUP & BASIC OPERATION INSTALLING THE PRINTER PAPER Turn the Smartdop ® 30EX ON and set the MODE to 1 or 2. Remove the paper roll shaft and set it into the paper roll. Insert and hold the edge of the paper into the paper entry slot located under the printer.
Smartdop 30EX ® Basic Operation SETUP & BASIC OPERATION MEASURING BLOOD VELOCITY This section explains the fundamentals of using the 30EX to measure blood velocity. For detailed ® Smartdop instructions on performing specific tests, see Section 2 Testing Instructions. ® Connect the probe to the Smartdop 30EX with the round probe connection mark on the probe...
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Smartdop 30EX ® Basic Operation SETUP & BASIC OPERATION MEASURING BLOOD VELOCITY (cont.) When the waveform becomes rhythmic and stable, wait 5 seconds or more without moving the probe on Mode 1 or 25 seconds or more on Mode 2. Then, press the INF/DUMP button or probe button (probe button function must be set to FREEZE or FRZ&PRINT) to freeze the waveform.
Smartdop 30EX ® Basic Operation MODE & MENU SETTINGS BASIC MODE SETTINGS The Smartdop® 30EX has the following 6 basic mode settings: Mode Type of Test How to Select Mode 1 Arterial (AC) Press the MODE button Blood Velocity (measurement mode only) Mode 2 Venous (DC) Press the MODE button...
Smartdop 30EX ® Basic Operation MODE & MENU SETTINGS MENU 5-3-1 MENU OPERATION Press the MENU button to enter Menu mode. The available menu options will appear on the LCD screen. Scroll through the available menu options using the buttons on the front control panel to navigate the menu.
Smartdop 30EX ® Basic Operation MODE & MENU SETTINGS MENU (Cont.) Press the MENU button to go to Menu mode. The LED on the MENU button will be lit. 5-3-2 MENU FOR BLOOD VELOCITY MEASUREMENT MODE For measuring blood flow velocity waveforms and numerical data. Connect a 5, 8 or 10 MHz probe to select the menu.
Smartdop 30EX ® Basic Operation MODE & MENU SETTINGS MENU (Cont.) 5-3-3 MENU FOR BLOOD VELOCITY FREEZE MODE For observing blood flow velocity waveforms and numerical data. Press the probe button or the INF/DUMP button to select the menu; press again to exit. Menu Submenu Selections...
Smartdop 30EX ® Basic Operation MODE & MENU SETTINGS MENU (Cont.) 5-3-4 MENU FOR PRESSURE MODE (MEASUREMENT & FREEZE) For measuring blood systolic pressures, performing Ankle Brachial Index (ABI) and Toe Brachial Index (TBI) studies and calculating ABI and TBI ratios. Press the ARM/LEG or TOE mode to select the menu.
Smartdop 30EX ® Basic Operation MODE & MENU SETTINGS MENU (Cont.) 5-3-5 MENU FOR PPG (PHOTOPLETHYSMOGRAPHY) (MEASUREMENT & FREEZE) For measuring and observing PPG waveforms. Connect the PPG probe to select measurement. Press the probe button or INF/DUMP button to select freeze; press again to exit. Menu Sub Menu Selections...
Smartdop 30EX ® Basic Operation MODE & MENU SETTINGS MENU (Cont.) 5-3-6 MENU FOR PV-AC (PULSE VOLUME ARTERIAL) MODE (MEASUREMENT & FREEZE) For measuring and observing PV arterial waveforms and calculating PVR study results. Press the probe select button until both LED’s are lit. Press the INF/DUMP button to select freeze;...
Smartdop 30EX ® Basic Operation MODE & MENU SETTINGS MENU (Cont.) 5-3-8 MEMORY - STORE MEMORY-STORE is used to save waveform data into memory to view or print at a later time. MEMORY - STORE is available in Freeze mode only. See 5-2-1 “Measurement / Freeze Mode”...
Smartdop 30EX ® Basic Operation MODE & MENU SETTINGS MENU (Cont.) 5-3-9 MEMORY - READ MEMORY-READ is used to view previously stored waveform data. Press the MENU button to go to Menu mode. Scroll up (PRINT button) or down (LEG/TOE button) until MEMORY is highlighted.
Smartdop 30EX ® Basic Operation MODE & MENU SETTINGS MENU (Cont.) 5-3-10 MEMORY - CLEAR (cont.) indicate numbers which contain saved data. Scroll up (PRINT button) or down (LEG/TOE button) until the memory number you would like to clear is highlighted. Highlight “ALL”...
Smartdop 30EX ® Basic Operation MODE & MENU SETTINGS MENU (Cont.) 5-3-12 DISP / OTHERS - DISP (Waveform/Data) DISP is used to change the LCD display from Waveform to Data. DISP is available in blood flow velocity measurement and freeze modes. When in measurement mode, DISP is a submenu of OTHERS in the menu.
Smartdop 30EX ® Basic Operation MODE & MENU SETTINGS MENU (Cont.) 5-3-13 WAVEFORM WAVEFORM is used to scroll between page 1 and page 2 of the waveform on the LCD in Blood Velocity and PV Arterial modes or to switch between the full and magnified view of the waveform in Pressure Mode.
Smartdop 30EX ® Basic Operation MODE & MENU SETTINGS MENU (Cont.) 5-3-14 OTHERS - LANGUAGE LANGUAGE is used to change the LCD language preference. Press the MENU button to go to Menu mode. Scroll up (PRINT button) or down (LEG/TOE button) until OTHERS is highlighted.
Smartdop 30EX ® Basic Operation MODE & MENU SETTINGS MENU (Cont.) 5-3-17 OTHERS - CAL PRINT (Printing Calibration) CAL PRINT is used to print the 4-step calibration after the velocity waveform. CAL PRINT is available in Mode 1 and Mode 2. Press the MENU button to go to Menu mode.
Smartdop 30EX ® Basic Operation MODE & MENU SETTINGS MENU (Cont.) 5-3-19 OTHERS - RESET RESET is used to reset the Doppler menu to the original default settings. Press the MENU button to go to Menu mode. Scroll up (PRINT button) or down (LEG/TOE button) until OTHERS is highlighted.
Smartdop 30EX ® Basic Operation MODE & MENU SETTINGS MENU (Cont.) 5-3-22 GUIDANCE GUIDANCE enables / disables testing instructions to appear on the LCD. It is available in ARM/ LEG and TOE pressure modes during measurement. Press the MENU button to go to Menu mode. Scroll up (PRINT button) or down (LEG/TOE button) until GUIDANCE is highlighted.
Smartdop 30EX ® Basic Operation MODE & MENU SETTINGS MENU (Cont.) 5-3-25 P.CLEAR P.CLEAR is used to clear the pressure data. It is available in ARM/LEG and TOE pressure modes. Press the MENU button to go to Menu mode. Scroll up (PRINT button) or down (LEG/TOE button) until P.CLEAR is highlighted.
Smartdop 30EX ® Basic Operation LCD DISPLAY BLOOD VELOCITY MODE 6-1-1 WAVEFORMS Smartdop 30EX automatically adjusts the baseline to best position. There are 4 ® baseline positions: bottom, 1/4 from the bottom, center, and 3/4 from the bottom. The waveform amplitude is automatically adjusted. The amplitude scale (velocity or frequency per division) is displayed in the upper left corner of the LCD.
Smartdop 30EX ® Basic Operation LCD DISPLAY PRESSURE MODES (ARM/LEG and TOE MODES) While in pressure mode, Smartdop® 30EX automatically calculates arm, leg and toe systolic pressures. In addition, Smartdop® 30EX automatically calculates and prints ABI and TBI ratios. See Section 2 of this manual for detailed instructions on using the pressure mode to perform ABI, TBI and Segmental Pressure studies.
Smartdop 30EX ® Basic Operation LCD DISPLAY PRESSURE MODES (ARM/LEG and TOE MODES) (Cont.) 6-2-2 ERROR MESSAGES If an error occurs during blood pressure measurement, one of the following error messages will appear on the LCD. (Reserved) Waveform error Pressure exceeded 300 mmHg Systolic pressure not found Exceeded time limit Cuff pressure did not increase...
Smartdop 30EX ® Basic Operation PRINTING WAVEFORMS & DATA HOW TO PRINT Waveforms can be printed while in Freeze mode only. Press the PRINT button. NOTE Pressing the probe button also activates the printer when the probe button function is set to either PRINT or FRZ&PRINT.
Smartdop 30EX ® Basic Operation PRINTING WAVEFORMS & DATA PRINT SAMPLES Mode 1 (Arterial) Time scale 0.2 sec/div. (approx. 25 mm/s) Combined forward and reverse 0.2 sec. 5 sec. max. Mode 2 (Venous) Time scale 1 sec/div. (approx. 5 mm/s) Separation of arterial and venous flow velocity 1 sec.
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Smartdop 30EX ® Basic Operation PRINTING WAVEFORMS & DATA PRINT SAMPLES (Cont.) Arm/Leg and Toe Pressure Modes (press print button less than 1 second). Arm only Leg only Toe only Arm & Leg Arm & Toe Arm, Leg, & Toe (Save the arm pressure last) Arm/Leg and Toe Pressure Modes (press print button longer than 2 seconds).
Smartdop 30EX ® Basic Operation PRINTING WAVEFORMS & DATA NUMERICAL VELOCITY Mode 1 (Arterial) Parameters Abbrs. Systolic velocity [cm/s] Mean velocity [cm/s] Heart rate [bpm] Mode 2 (Venous) Parameters Abbrs. Systolic velocity [cm/s] Mean velocity [cm/s] NOTE Computations are based on the following parameters. If the heart rate cannot be calculated because of an over +/-25% irregularity due to Arrhythmia or a venous waveform, “HR***”...
Smartdop 30EX ® Basic Operation EXTERNAL OUTPUTS HEADSET When using an external headset (not provided), sound to the speaker will be cut off. 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, or to create a report of standardized testing modules.
Smartdop 30EX ® Basic Operation 10. SYMBOL LIST Symbols Descriptions Symbols Descriptions Type BF applied part Freeze Headset Mode button USB connector Print button AC adaptor connector Menu button Probe connector Arm button Caution Leg/Toe button Power ON Probe selection button Federal law restricts Power Off...
Smartdop 30EX ® Basic Operation 11. OPERATING PRINCIPLES 30EX bidirectional Doppler is designed to obtain blood flow velocities through ® The Smartdop the use of ultrasound, which is transmitted from the probe to the patient’s body and reflected by the blood (hemocyte, etc.). The unit amplifies the high frequency oscillation output and then supplies it to the transmitter transducer.
Smartdop 30EX ® Basic Operation 14. OPERATION, STORAGE & TRANSPORT OPERATING ENVIRONMENT • 10 to 37°C • 85% humidity or less with no condensation CAUTION Do not drop or place in an area where the unit may fall. CAUTION Do not use simultaneously with an electrocautery defibrillator, other ultrasonic device or a mobile phone.
Smartdop 30EX ® Basic Operation 16. CLEANING Clean the Doppler & probes after use. DOPPLER BOX To clean the Doppler box, wipe down with a damp cloth, then with a soft dry cloth. Take care not to allow water to penetrate the unit. CAUTION The Doppler box should not have direct contact with the patient or be placed in the sterile area.
Smartdop 30EX ® Basic Operation 17. DISPOSAL OF DEVICE Please follow local ordinances or regulations for proper disposal of the device, accessories & packaging. Do not place the battery in fire. Doing so may cause an explosion and/or injury. 18. WARRANTY The Doppler box is guaranteed for a period of 2 years from the date of purchase when used under normal conditions.
Smartdop 30EX ® Basic Operation 19. SAFETY STANDARDS The Smartdop ® 30EX conforms to the following standards: Manufacturing standard: IEC60601-1 Protection class against electric shock : Class II device : Internally powered equipment Protection grade against electric shock : Type BF applied part Leak current: Based on IEC60601-1 Items...
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Smartdop 30EX ® Basic Operation Guidance and Manufacturer’s Declarations (cont.) Electromagnetic Immunity 30EX is intended for use in the electromagnetic environment specified below. The user of The Smartdop ® 30EX should assure that it is used in such an environment. ®...
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Smartdop 30EX ® Basic Operation Guidance and Manufacturer’s Declarations (cont.) Electromagnetic Immunity (cont.) 30EX is intended for use in the electromagnetic environment specified below. The user of The Smartdop ® 30EX should assure that it is used in such an environment. the Smartdop ®...
Smartdop 30EX ® Vascular Testing Instructions ANKLE BRACHIAL INDEX (ABI) The Ankle Brachial Index is the ratio of the highest systolic pressure at the arm to the systolic pressure at the ankle. This simple test is performed much like taking a standard blood pressure, except that a Doppler is used instead of a stethoscope.
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Smartdop 30EX ® Vascular Testing Instructions ANKLE BRACHIAL INDEX (ABI) (Cont.) To see a magnified view of the waveform, press and hold the MODE button, then press the LEG/TOE button. Press again to return the full waveform view. Or, use the WAVEFORM option in the menu.
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Smartdop 30EX ® Vascular Testing Instructions ANKLE BRACHIAL INDEX (ABI) (Cont.) Apply ultrasound gel to the posterior tibial artery and place the Doppler probe on the skin. Hold the probe on the posterior tibial artery at a 45 to 60 degree angle against flow (see figure C). Adjust the probe angle until best sounds are heard and a steady waveform appears on the LCD.
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Smartdop 30EX ® Vascular Testing Instructions ANKLE BRACHIAL INDEX (ABI) (Cont.) Calculating the ABI To calculate the Ankle Brachial Index ratio, divide the ankle pressure by the highest arm pressure or refer to the charts on the Pressure Index Guide provided with your Doppler. Ankle systolic pressure ABI = Arm systolic pressure...
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Smartdop 30EX ® Vascular Testing Instructions SEGMENTAL BLOOD PRESSURES Segmental pressure studies are performed with the same method as an Ankle Brachial Index, but incorporate additional cuffs wrapped above and below the knee, and optionally at the high thigh, in additional to the ankle.
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Smartdop 30EX ® Vascular Testing Instructions SEGMENTAL BLOOD PRESSURES (Cont.) When the waveform is steady and the INF/DUMP LED begins to blink, hold the probe in place and press the INF/DUMP or probe button to activate the automatic cuff inflator. The Smartdop ®...
Smartdop 30EX ® Vascular Testing Instructions SEGMENTAL BLOOD PRESSURES (Cont.) Interpreting the Results Observe pressure differences between adjacent cuff sites on the same leg. Pressure differences between cuff sites are used to localize the disease. Pressure differences between two adjacent levels of less than 20 mmHg is considered normal within limits.
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Smartdop 30EX ® Vascular Testing Instructions VENOUS COMPRESSION STUDIES Venous compressions are auditory tests consisting of 2 maneuvers. These are, compression of the metatarsal arch to verify augmentation followed by compression of the calf muscle to verify valvular competence. Venous compressions are performed to detect enlarged veins due to the presence of malfunctioning valves.
Smartdop 30EX ® Basic Operation PPG TOE PRESSURES & TOE BRACHIAL INDEX (TBI) Requires the optional PPG (Photoplethysmography) probe {PG-21}, supplied separately. PPG (Photoplethysmography) toe pressure studies and related TBI’s (Toe Brachial Index) are performed to assess the vascular condition of the foot by obtaining systolic pressures at the toe.
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Smartdop 30EX ® Vascular Testing Instructions PPG TOE PRESSURES & TOE BRACHIAL INDEX (TBI) (Cont.) T ake the systolic pressure at the toe After taking the arm pressures and documenting the PPG waveform, press the MODE button to select Toe pressure mode (the TOE LED will be lit).
Smartdop 30EX ® Vascular Testing Instructions PPG TOE PRESSURES & TOE BRACHIAL INDEX (TBI) (Cont.) Press the INF/DUMP button to return to the monitoring screen and repeat the test on the other foot. NOTE If you would like to print the pressure results, before pressing INF/DUMP to return to the monitoring screen, press the PRINT button less than 1 second to print numerical data only or longer than 2 sec-...
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Smartdop 30EX ® Vascular Testing Instructions VENOUS REFLUX Requires the optional PPG (Photoplethysmography) probe {PG-21}, supplied separately. Venous reflux studies use a PPG probe affixed adjacent to the Posterior Tibial artery. The patient is asked to dorsiflex the foot, which acts as a pump for venous augmentation. Recovery time is the time required for refilling of the vein to occur.
Smartdop 30EX ® Vascular Testing Instructions VENOUS REFLUX (Cont.) Allow the sensor to equilibrate. Then, press the PRINT button or the probe button to begin the test. Ask the patient to dorsiflex the foot the specified number of times, following the foot animation on the LCD.
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Smartdop 30EX ® Vascular Testing Instructions PULSE VOLUME RECORDINGS (PVRs) PVRs use pulse volume (pneumoplethysmography) to identify changes in leg blood volume. Rather than temporarily occluding blood flow, the cuffs are only inflated slightly so that blood continues to flow. Blood pulses in the arteries cause the vessels to expand which changes the air volume in the cuff.