Smartdop 30EX Operating Manual Ver 2.6 Sept 2017

m. OTHERS - CALibration ... 28 n. OTHERS - CAL PRINT (Printing Calibration) ... 28 o. OTHERS - BACKLIGHT ... 28 p. OTHERS - AUTO-OFF (Automatic shut-off) ... 29 q. OTHERS - DISCHARGE ... 29 4-3. Shortcut keys ... 30 4-4. External outputs ... 30 4-4-1. Headset ... 30 4-4-2. Communication Port ... 30 4-5. Symbol list ... 31 5. Display and Printing ... 32 5-1. Arterial and venous blood velocity modes ... 32 5-1-1. Waveforms on LCD ... 32 5-1-2. Parameters ... 33 5-1-3. Printing Waveform and Numerical Data ... 33 5-1-4. Print Samples ... 34 5-2. ARM / LEG and TOE pressure modes ... 35 5-2-1. Display Samples in Pressure Measurement Process ... 35 5-2-2. Optional Functions ... 35 5-2-3. Error Messages ... 36 5-2-4. Print Samples ... 36 5-3. PV arterial mode (PV-AC) ... 37 5-3-1. Waveforms on LCD ... 37 6. Maintenance ... 38 6-1. Performance check by user ... 38 6-2. Cleaning ... 38 6-3. Warranty ... 39 7. Options ... 39 7-1. Probe selection: ... 39 7-2. Others: ... 40 7-3. Photoplethysmograph ... 40 7-3-1. PPG (Photoplethysmography) Probe Assemblies ... 40 7-3-2. PPG - Arterial Pulse Waveform Studies ... 40 7-3-3. PPG - Venous Reflux Study ... 41 7-3-4. Menu for PPG... 44 7-3-5. PPG Mode Settings ... 44 7-4. Pneumoplethysmograph ... 45 7-4-1. PV (Pneumoplethysmography) Probe Assemblies ... 45 7-4-2. PV - Measurement of Maximum Venous Outflow ... 45 7-4-3. Menu for PV ... 47 7-4-4. PV Mode Setting ... 47 8. Technical Information... 48 8-1. Principles ... 48 8-2. Block diagram ... 49 8-3. Specifications ... 50 8-4. Safety standards ... 52

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 Follow the requirements for storage and operating environments. (1) Do not place it near water. (2) Dot not place it where atmospheric pressure, temperature, humidity, ventilation, sunlight, dust, salt, sulfur and so forth will affect the unit adversely. (3) Pay attention to the stability conditions to avoid too much inclination, vibration, shock and so on during transportation and installation of the unit. (4) Do not place it where chemicals are stored or gas may be generated. (5) Do not place it where the unit tends to fall. (6) Do not place it on or adjacent other electronic devices. 5. Before use (1) Make sure that the unit operates safely and correctly by implementing performance check mentioned in "§ 6-1. 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 and non-sterilizable probe to prevent any damage. 6. Operation (1) Do not use the unit simultaneously with either electric cautery, cardioverter, other ultrasonic device or mobile phone. (2) Be careful not to exceed time and volume of diagnosis treatment required. (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) In case of emergency or unexpected situations, take the following action(s) to stop the inflation of the cuff: • Press INF/DUMP button to dump the pressure. • Disconnect the tubing from the unit. • Turn the unit off. (6) Do not let the patient touch the unit. (7) Use the designated components only.

(8) Do not use the components for other devices. (9) Use the unit under the operating environments specified on the specifications. (10) Use the unit as specified in the operation manual. (11) Do not use the unit in a strong electromagnetic field or it may cause incorrect measurements. 7. After use (1) Return all switches to the conditions before use and 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 (1) to (5) of section #4 Device placement in the previous page. (2) Clean the unit, AC adaptor, cables and probes and place them in right place for the next use. (3) When using the unit next time, perform the maintenance to make sure it works properly and safety. 9. Maintenance (1) Do the periodical maintenance by following the procedures mentioned in "§ 6-1. 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. 11. Ultrasonic gel (1) Do not apply ultrasonic gel to the probe body other than the tip of probe. (2) Using other materials such as baby oil and cream may damage the probe. (3) The ultrasonic gel enclosed is non-sterile and do not use it for surgeries. (4) Incidence of allergy: Discontinue use of gel if any allergic reaction occurs. 12. Battery (1) When battery is extremely low, the LCD display will not operate. Also there will be no speaker sounds. Charge the battery. (2) Battery life is 300 full charges. When full charging life is obviously short, contact your dealer for replacing battery. 13. For transportation of the unit, it should be packed properly to protect against shock. 14. Repair services (1) When the unit gets out of order, contact the dealer for repair from whom you

purchased the unit. (2) Only authorized persons should perform the repair services. 15. Do not disassemble the unit. 16. Destruction (1) In case of destruction of the unit, follow the instructions for disposal of the destruction appointed by each country or local government. (2) Do not place battery in a fire or it may cause an explosion and injury. 17. Any connected computer is not allowed to be in the patient area according to IEC60601-1.

1. Introduction Thank you very much for choosing the Smartdop 30EX. The Hadeco Smartdop 30EX is a uniquely designed bi-directional Doppler with backlit LCD display and Doppler blood pressure monitor capability. It detects arterial and venous blood flows in extremities as well as blood pressures of brachial, ankle and toe, calculates ABI and TBI and fetal heart sounds. Please read this manual carefully to acquaint yourself with the unit 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 DOPPLER WITH BACKLIT LCD and PRINTER Displays and prints velocity waveforms in bi-directional & dual separation channel and numerical data.  DOPPLER BLOOD PRESSURE RECORDER Full auto system with built-in cuff inflator Shows instructions on LCD for measuring pressures if desired. Calculates and prints ABI /TBI and velocity/pressure documentation.  TWO PROBE COMBINATIONS (for 2, 4, 5, 8, 10 MHz, PPG and PV) The unit has dual probe connectors and selection switch. Convenient for measuring pressures for TBI using with PPG.  Hadeco DESIGNED SMART MICROPROCESSOR Various mode settings are available for optimal measurement with the menu displayed on the LCD. 30 waveform memory.  BUILT-IN PULSE VOLUME with automatic cuff inflator.  CONVENIENT PROBE ACTIVATION BUTTON Freezes waveform as well as FREEZE button. Inflates and dump cuff as well as INF/DUMP button. Button function can be changed on probe key mode setting, PRB-KEY.  USB COMPUTER INTERFACE Transfers waveforms and numerical data to computer for data storage.

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Communication cable and Windows software are optional.  PPG and PV-MVO PROBES optionally available Expands arterial & venous testing.

1-2. Clinical applications Detections of fetal heart rate Evaluation of fetal heart rate and sounds throughout pregnancy except where fetal heart is not developed sufficiently during the first trimester.

Detections of arterial and venous blood flow velocity and pressures for vascular disease  ABI and TBI studies  Bi-directional lower extremity studies.  PEAK & MEAN blood velocity determinations.  Peripheral vascular procedures.  Blood pressure segmental studies.  Venous compressions.  Penile & digit systolic pressures.  Toe pressure & venous reflux studies (PPG).  PV - Arterial studies Note: The Smartdop 30EX and associated Doppler probes, inflatable cuffs, and optional photoplethysmography probe are not intended for use in contact with blood or mucous membrane.

CONTRAINDICATIONS Do not use the Smartdop 30EX for ophthalmic or periordical studies as the acoustic intensity is higher than the level recommended by authorities for use on and around the eye.

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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. BT2M20S8C (2MHz): BT4M05S8C (4 MHz): BT5M05S8C (5 MHz): BT8M05S8C (8 MHz): BT10M5S8C (10 MHz):

Fetal heart rate Deep peripheral blood velocity and flow Deep peripheral blood velocity and flow Superficial blood velocity and flow Superficial blood velocity and flow

Note: One of these probes comes with Smartdop as a standard component. Other probes are available as optional components.

1-4. Contents in package Main unit ... 1 Probe... 1 AC adaptor (GMPU18UI-3) ... 1 Ultrasonic gel (AQUAULTRA BASIC)... 1 Paper... 1 Blood pressure cuff (VC-12) ... 1 Tubing ... 1

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2. Appearance 2-1. View Front Right View

1 2 3 4

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9 6 7 8 1. Printer:

5. Probe holder #1: 6. Probe connector #1:

To print velocity wave forms, systolic pressures, ABI / TBIs and velocity / pressure documentations and PPG / PV waveforms. Outputs Doppler sounds. To adjust sound volume. For probe placement when not in use. Probe holder #2 can be removed by removing the 2 screws. Fix them to the unit. For probe placement when not in use. To connect probe #1.

7. Headset:

To connect headset. It cuts off the speaker.

8. Inflation inlet: 9. LCD display:

To connect the tubing for the blood pressure cuff. Displays waveform, numerical data, and menu for mode settings.

2. Speaker: 3. Volume control: 4. Probe holder #2:

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Operating Panel 10

11

12

13

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17 10. Mode LEDs: 11. MODE button:

12. PRINT button: Up

13. MENU button:

16

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Indicate the mode selected. (Mode 1, Mode 2, ARM/LEG, TOE) Illuminate sequentially while charging battery. To select the mode of either the arterial Mode 1, venous Mode 2, ARM/LEG pressure or TOE pressure mode. See “§ 4-1-1. Basic Modes” for details. When optional PPG/PV probe is connected, Mode 1 and Mode 2 correspond to AC and DC modes respectively. To activate and deactivate the printer. Menu mode To move the cursor up. To go to menu mode. See “§ 4-2. Menu Mode” for details. To turn backlight on/off.

14. Probe selection button: Enter

To select the probe intended to use from the connected probes. The LED corresponding to the probe number will illuminate. To select PV Arterial mode and both of LED will illuminate. When displaying stored waveforms on Freeze mode: To increase memory #. To decreases memory # Menu mode To fix the mode or value. To change the mode or setting. 5

15. INF/DUMP button: Freeze Right

To freeze / unfreeze the waveform. Measuring pressure To inflate / dump the blood pressure cuff.

To move cursor (systolic pressure point) to the right. Menu mode To move the cursor right. To change the mode or setting. 16. LEG/TOE button: Down

Measuring pressure To store and display the measured pressure value as a leg or toe pressure. (Freeze mode) To display ABI or TBI (Measurement mode) To erase measured pressure data by pressing longer than 2 sec. (Measurement mode) To magnify the view of waveform.

Measuring blood velocity To change the Display mode. (Waveform / Numerical data) Menu mode To move the cursor down. 17. ARM button: Left

Measuring pressure To store and display the measured pressure value as an arm (brachial) pressure. (Freeze mode) To display ABI or TBI. (Measurement mode) To erase measured pressure data by pressing longer than 2 sec. (Measurement mode) To move cursor (systolic pressure point) to the left Menu mode To go back to previous menu or to get out of menu mode.

means to press and hold MODE button before pressing each button.

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Back Right View and Probe

18 22

20

19

21

25

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18. Roll shaft:

To set paper roll.

19. Communication port:

To connect computer. (USB)

20. Probe connector #2:

To connect probe #2.

21. AC adaptor connector:

To connect the designated AC adaptor.

22. Power switch:

To turn on/off the unit.

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ON OFF 23. Probe: 24. Probe button:

Multi-probe selection of 2, 4, 5, 8 and 10 MHz To freeze and unfreeze the waveform. To activate and deactivate cuff inflator.

Note: The function is defined in the menu PRB-KEY. See § 4-2-7-l. OTHERS -PRB-KEY” for details. 25. Probe cap:

To protect the probe transducer tip when probe is not in use.

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3. Quick start For the first time of use and in case the unit has not been used for a while, fully charge the internal battery.

3-1. Turning the unit ON (1) Connect the probe to the probe connector so that the arrow mark will be placed under the Probe connector mark .

Arrow mark (2) Press the power switch to turn the unit ON.

Power ON:

Power OFF:

Power switch

Note: When battery is low, low battery indicator appears as shown right. The unit can be used for a few more minutes however, we recommend recharging battery as soon as possible for further use. Low battery indicator

AUTOMATIC SHUT-OFF: When the AUTO-OFF is ON, if the unit is left on without AC adaptor connected, the power is automatically shut off after following time passes: (a) 5 minutes when no signal. (b) 15 minutes when on measurement. (c) 10 minutes when on freeze mode. Note: If automatic shut-off functions while on freeze mode, the unit will resume the waveform on freeze mode by turning the unit on.

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3-2. Charging / Discharging battery Charging battery: (1) Turn the unit off and plug the AC adaptor to the unit to charge battery. The Mode LEDs will illuminate sequentially (one after another) while charging is in progress. Note1: Use the designated AC adaptor. Model name: GMPU18UI-3

AC adaptor connector

Note2: Charging battery with AC adaptor while in use may cause unnecessary power-supply noise. When the battery is fully charged, the Mode LEDs will be turned off. Unplug the AC adaptor.

Mode LEDs

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. See “§ 4-2-7-q. OTHERS -DISCHARGE” how to do it.

3-3. Checking battery level Battery level indicator shows upper right of the menu screen.

Battery level indicator

(1) Turn the unit on and press MENU button to display the menu. When battery is low, low battery indicator will be shown on bottom right of LCD as shown in the right. Charge the battery when in low.

Note: Battery level indicator shows the battery level in 4 steps as shown right.

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Low battery indicator Full

30%

70%

Low

3-4. Setting printer paper (1) Remove the roll shaft and set it into the paper roll. Insert and hold the paper edge into the paper entry under the printer and press the PRINT button.

(2) Press the button again when sufficient paper comes out. Pull the paper edge out a few inches and cut it at the paper guide. Put the roll shaft with the paper back on the roller guide. Note: Cut the paper straight before inserting the paper for loading it easily. Apply slight fingertip pressure to the paper at beginning of insertion.

Caution: Do not pull paper in a direction opposite to the direction of paper feed (printing and auto loading). It may cause malfunction of the printer. In cases removing paper from printer, cut the paper at the roll side and pull the remaining paper out in the direction of paper feed. Also paper feed problems like paper jam or wrinkled paper hit by printer head or something may cause malfunction of the printer. Insert the paper correctly by following the steps mentioned above.

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3-5. Measuring Blood Velocity This section explains typical operation of measuring blood velocity. Refer to “§ 5-1. Arterial and venous blood velocity modes” and “§ 4-2. Menu Mode” for mode settings of various uses. (1) Connect the probe to the probe connector. See the step# (1) in the “§.3-1. Turning the unit ON” for the details. (2) Put ultrasonic gel on tip of probe or patient skin. (3) Turn the unit on and turn the volume control to maximum. Make sure the probe selection LED illuminating corresponds to the connector you connected probe. If not, press probe selection button to change it.

Power switch Probe connector #2

(4) Press MODE button to select Mode 1 for arteries or Mode 2 for veins.

(5) 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.

Wait more than 5 sec for MODE 1 (OR up to 25 sec for MODE 2) without moving probe after the maximum Doppler sounds, press probe button (or INF/DUMP button) to freeze the waveform. Press PRINT button to print the waveform, if necessary.

Probe button

Note: Function of the probe button can be selected from Freeze, Print, and Freeze & Print on PRBKey mode settings. See “§4-2-7-l.OTHERS - PRB-KEY (Probe button function)”.

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(6) Headset can be used to listen to Doppler sounds. It will cut off the speaker. If you wish to save the waveform and numerical data on the memory, see “§ 4-2-7-a. MEMORY STORE”. Headset connector If you retry the measurement, press INF/DUMP button or probe button to get out of the freeze mode.

3-6. Ankle brachial pressure index (ABI) (1) Connect the cuff VC-12 to the tubing and other end of tubing to the inflation inlet as shown in the right.

Inflation inlet (2) Connect the probe to the probe connector #1 or #2. See the step# (1) in the “§.3-1. Turning the unit ON” for the details. (3) Turn the unit on and make sure the probe selection LED illuminating corresponds to the connector you connected probe. If not, press probe selection button to change it. Press MODE button to select ARM/LEG pressure mode. (ARM/LEG LED will illuminate.)

Taking Arm pressure: (4) Wrap the cuff above the elbow and apply the probe to the radial or brachial artery at an angle of approximately 45 to 60 degrees. (5) Move the probe slowly to locate the point where the maximum Doppler sounds are heard and the INF/DUMP LED will blink after a few seconds.

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Note1: Once you locate the point, please keep the probe there until blood pressure is taken. Note2: In case INF/DUMP LED doesn't blink due to low flow or arrhythmia, press INF/DUMP button longer than 2 sec to activate cuff inflator manually in the next step #6. (6) Press INF/DUMP or probe button to inflate the cuff. The unit will stop the inflation at estimated 30 mmHg above the sound cessation and deflate the cuff at 3 to 4 mmHg/sec automatically. Note: In case the inflation doesn't stop automatically, press INF/DUMP or Probe button to stop the inflation. If an error message is displayed in the inflation and deflation processes, press any button other than probe selection button to delete the error message and go back to step #5. The LCD will show the systolic pressure when the first Doppler sound is heard and then the cuff pressure will be dumped automatically.

Press and hold MODE button and press Down (LEG/TOE) to get on MAGNIFIED waveform mode if desired. Do it again to go back to FULL waveform mode. If the systolic pressure is not satisfied, press and hold MODE and press Right / Left to move the cursor (vertical dotted line) to get it adjusted.

(7) Press ARM button to store it as the brachial pressure and the LCD will show it as shown in the right. (8) Press INF/DUMP button to go back to the measurement mode for ankle pressure.

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(9) Wrap the cuff above the ankle and apply the probe to the posterior tibial artery at an angle of approximately 45 to 60 degrees.

Taking Ankle pressure: (10) Take the ankle pressure the same way for the brachial. (Steps #5 to #6 of this section) Press the LEG/TOE button to store it as the ankle pressure and the ABI will be displayed as shown in the right.

(11) Go to the next ankle pressure on the other side. Note: Press the ARM or LEG / TOE button more than 2 sec to clear the pressure data for the next patient.

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3-7. Toe brachial pressure index (TBI) Optional PPG probe (PG-21) is required for this testing. (1) Take the brachial pressure in the same way as ABI. Follow steps #1 to 7 of "§ 3-6 Ankle brachial pressure index (ABI)". (2) Remove arm cuff from tubing and replace with toe cuff, DVC-1.9 or DPC-2.5 for toe pressures. (3) Press MODE button to select toe pressure mode. (TOE LED will illuminate.) (4) Connect PPG probe to the probe connector # 2 with the round polarity mark up on the probe connector (12 o'clock). (5) Press probe selection button to select probe #2. (6) Wrap the cuff around the base of the big toe and affix the PPG probe to the pad of the toe with Velcro strap. (7) Take the toe pressure the same way for the brachial. Press the LEG/TOE button to store it as the toe pressure and the TBI will be displayed as shown right. (8) Go to the next toe pressure on the other side. Note: Press the ARM or LEG/TOE button more than 2 sec to clear the pressure data for the next patient.

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