Bidop ES-100V3 Operating Manual Ver 3.1 May 2018

n. OTHERS - UNIT (cm/s / kHz) ... 22 o. OTHERS - FILTER (Arterial / Venous filter) ... 22 p. OTHERS - SMOOTH (Smoothing filter) ... 22 q. OTHERS - CAL (Calibration) ... 23 r. OTHERS - BACKLIGHT ... 23 s. OTHERS - AUTO-OFF (Automatic shut-off)... 23 t. OTHERS - FREEZE ... 23 u. OTHERS - PRB20MHz ... 23 v. FLOW (Blood volume flow) / w. DIAMETER (Estimated vessel diameter) ... 24 5. Maintenance ... 25 5-1. Performance check by user ... 25 5-2. Cleaning ... 25 5-3. Probe sterilization ... 25 5-3-1. Sterilizable probes (Amplifier required) ... 25 5-3-2. Sterilization ... 26 5-4. Warranty ... 29 6. Supplemental information ... 30 6-1. Basic mode ... 30 6-2. LCD display ... 30 6-2-1. Blood Velocity mode ... 30 6-2-2. Heart Rate mode (Only 2 MHz probe) ... 32 6-2-3. 2 MHz BEEP mode ... 34 6-3. Numerical data ... 35 6-4. External outputs ... 36 6-5. Symbol list ... 36 6-6. Contents in package... 36 7. Options ... 37 7-1. Probe selection... 37 7-2. Others ... 38 7-3. Photoplethysmograph ... 39 7-4. Foot Temperature (Except European Union Countries)... 44 8. Technical information ... 46 8-1. Principles ... 46 8-2. Block diagram... 46 8-3. Specifications ... 46 8-4. Safety standards ... 48

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 not affect the unit adversely. (4) Pay attention to the stability conditions such as inclination, vibration, and shock during transportation and installation work. (5) Do not place it where chemicals are stored, or where gas may be generated. (6) Do not place it where the unit tends to fall. (7) Do not place it on or adjacent other electronic device. 5. Before use: (1) Make sure that the unit operates safely and correctly by following the maintenance procedures mentioned in "§ 5-1. 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, non-sterilizable probes and amplifiers to prevent any damage. (6) Sterilizable probes (optional) should be sterilized before use. (See §5-3. Probe sterilization) 6. Operation (1) Do not use the unit simultaneously with an 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 operating the unit in a manner safe to the patient. (5) Do not let the patient touch the unit. (6) Use the designated components only such as the probe. (7) Do not use the components for other devices. (8) Use the unit under the operating environments specified on the specifications. (9) Use the Bidop as specified in the Operating manual. (10) Do not use the unit in a strong electromagnetic field or it may cause incorrect measurement. 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, 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) Clean the unit, 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 "§ 5-1. Performance Check by user". (2) The maintenance must be done at least once a year. 10. Probes (1) Clean the probe using dump 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 “§5-3. Probe sterilization”. 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 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 an allergic reaction occurs. 12. Battery (1) When battery is extremity low, the LCD display will not operate. Also there will be no speaker sounds. Replace the battery. (2) Use a 9 volt alkaline square type battery. A non-alkaline may cause a shortage of power. (3) When not using the unit for a long time, remove the battery. 13. 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. 14. Do not disassemble the Bidop. 15. Destruction (1) In case of destruction of the unit, follow the instructions for disposition of the destruction appointed by each country or local government. (2) Do not place battery in fire or it may cause an explosion and injury. 16. 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 Bidop ES-100V3. The Hadeco Bidop ES-100V3 is a uniquely designed bi-directional pocket Doppler with LCD display. It detects arterial and venous blood flows in extremities. The Bidop displays velocity waveform and numerical data. Please read this manual carefully to acquaint yourself with the Bidop 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, please refer to the operating manual for Windows linking software optional.

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1-1. Features • BI-DIRECTIONAL HAND HELD DOPPLER WITH LCD DISPLAY Displays real-time waveforms, numerical data on backlit LCD. • Hadeco DESIGNED SMART MICROPROCESSOR Various mode settings are available for optimal measurement with the menu displayed on the LCD and unique side Shuttle Button. 30 waveform memories. • CONVENIENT PROBE ACTIVATION BUTTON Freezes waveform and numerical data for notation. Turns Bidop ON and OFF. • MULTIPROBE SELECTION of 2, 4, 5, 8, 10 and 20 MHz • USB COMPUTER INTERFACE Stores waveforms and numerical data in your computer for data analyzing and filing. Communication cable and Smart-V-Link Windows software are optional. • PHOTOPLETHYSMOGRAPH (PPG) PROBE OPTIONAL Expands arterial & venous testing.

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1-2. Clinical applications •

Detections of arterial and venous blood flow velocity for vascular disease Probes to be used:

* *

BT2M20S8C BT4M05S8C BT5M05S8C BT8M05S8C BT10M5S8C

(2 MHz) (4 MHz) (5 MHz) (8 MHz) (10 MHz)

PEAK & MEAN blood velocity determinations Detection of arterial and venous blood flow velocity for vascular disease

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2. Appearance 2-1. Front view

1. Probe connector:

To connect probe.

2. Headset:

To connect headset. It cuts off the speaker.

3. Serial port:

To connect computer. (USB)

4. Volume control:

To adjust sound volume.

5. Shuttle Button:

To turn the unit ON/OFF, press it inside. To select menu, turn it up or down. To set the mode or execute command, press it inside. To display next memory data, turn it up and down.

Press inside

Turn up

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Turn down

6. BACK button:

To quit menu mode. To go back to previous menu. To change Display mode from WAVE to DATA and vice versa. To get out of Site guidance mode.

7. Speaker:

Outputs Doppler sounds.

8. LCD display:

Displays waveform, numerical data, Heart Rate and menu for mode settings. See “§ 6-2. LCD Display” for details.

2-2. Back side view and Probe

9. Probe holder:

For probe placement when not in use.

10. Strap holes:

To connect neck strap (Option).

11. Battery cover:

For battery placement.

12. Probe button:

To turn the unit ON. To freeze the waveform & numerical data when power is ON. To turn the unit OFF, press it longer than 2 sec.

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3. Quick start 3-1. Turning the unit ON / OFF (1) Set the alkaline battery in the unit. (See “§ 3-2. Checking battery level and replacing battery”.) (2) Connect the probe to the Bidop so that the polarity mark will be placed under mark.

Polarity mark

(3) Press the probe button or shuttle button to turn the unit ON. Press button the second time longer than 2 sec. to turn it OFF.

Low battery: When battery is low, low battery indicator appears. Replace the battery for further use. Low battery indicator

Automatic shut-off: When the AUTO-OFF is ON, if the unit is left on, the power is automatically shut off after following time passes: (a) 15 minutes when in measurement. (35 min. for FHR waveform mode) (b) 2 minutes when no signal. (c) 5 minutes when on freeze mode. Note: If Automatic shut-off functions while on Freeze mode, Bidop will revert to Freeze mode and display the frozen waveform on LCD by turning the unit on. 6

Error message: In case any inappropriate probe is connected to the unit, error message as shown right will be displayed.

3-2. Checking battery level and replacing battery. (1) Turn the unit on and press Shuttle button to display Menu and battery level indicator will be shown on top right of MENU. It shows 4 levels as shown below.

Full

Low

When battery is low, replace the battery with new one as follows. (2) When you replace battery, turn the unit off and open the battery cover as shown right.

(3) To prevent any damage to the battery terminal, please insert the battery to battery box as shown right.

(4) Use a 9 volt ALKALINE square type battery. A non-alkaline may cause a shortage of power. Set the battery in the unit ensuring that the positive and negative terminals correspond to the + and - marks on the label in battery box, respectively. Note: Use the battery composed in the package as a standard component for performing operation check only. 7

3-3. Measuring blood velocity 3-3-1. Normal mode This section explains the fundamental use of measuring blood velocity. Refer to “§ 4. MENU and Mode settings” for various uses. (1) Put ultrasonic gel on the probe top or patient skin.

(2) 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°. (3) When the waveform becomes rhythmical and stable, wait more than 5 sec. without moving probe and press the probe button to freeze the waveform. Note: Pressing probe button longer than 2 sec. will turn the unit OFF.

(4) To get numerical data, press BACK button or go to menu and change the DISP mode to DATA. Note: See “§ 4-2-g. DISP" for operation. Also, see “§6-3. Numerical Data” for the parameters. 8

Probe button

(5) Headset can be used to listen to Doppler sounds. It will cut off the speaker. To store the data: If you wish to store the waveform and numerical data on the memory, do the following procedures; 1. Press the Shuttle Button to display MENU and press it again on MEMORY to go to MEMORY menu. 2. Press the Shuttle button on STORE and next memory number available for storage will be displayed as shown in the right. Turn Shuttle Button up and down to change the memory number, if necessary. 3. Press the Shuttle button to store the data.

To display stored data; 1. Press the Shuttle button to go to MEMORY menu. 2. Press the Shuttle button on READ and select the memory number with "*" by turning the Shuttle Button up and down. 3. Press the Shuttle button to show the waveform. To show next waveform, turn the Shuttle button up and down.

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LCD Backlighting time; LCD backlighting time can be adjusted on BACKLIGHT mode setting. See “§4-2-r. OTHERS – BACKLIGHT” for details. Press BACK button longer than 2 sec. to turn it ON / OFF instantly during testing.

3-3-2. Site guidance mode This mode allows you to easily proceed multiple Smart-V-Link testing by just pressing probe button without connecting Smart-VLink. Register Abbreviated site & test names on the unit through Smart-V-Link to activate this mode. Once the names are registered, the unit will show each of names at the beginning of each testing to let you know where to test next. <Site Screen of Smart-V-Link>

Preparation for site guidance mode: (1) Connect the unit to the computer with the USB cable and start

Smart-V-Link. (2) Go to Site Screen and input abbreviated site & test name for each

waveform memory and then store the names on the unit. (3) Go to MEMORY menu and clear ALL memory data on the unit

before newly starting the site guidance mode. See the section “§.4-1-4. Site” on Smart-V-Link, V4.1 or over, operating manual for more details.

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Site guidance mode procedures: (1) Turn the unit off and on and the 1st

guidance with memory number and abbreviated site & test name will appear as shown in the right. Note: The first memory number available will be selected automatically.

(2) Press the probe button to start

Memory number Abbreviated site & test name

Probe button

monitoring waveform. Press Back button to get out of “Site guidance mode” for normal mode operation. (3) Press the probe button the 2nd time to

freeze the waveform when it becomes stable and the 2nd guidance “STORE?” as shown in the right will appear.

(4) Press probe button the 3rd time to store

the frozen waveform data on the designated memory number.

(5) The 1st guidance for the next testing will

appear as shown in the right. Repeat steps #(5) to #(7) until all testing is completed. Press probe button when the message shown right is displayed upon completion of all testing and the unit will get out of site guidance mode.

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Probe button

3-4. Measuring heart rate (2MHz only) This section explains the fundamental use of measuring heart rate. Refer to “§ 4. Menu and Mode settings” for various uses. (1) Connect the 2 MHz probe to the Bidop and turn the unit ON. (2) Press the Shuttle button to display MENU and set DISP mode for WAVE or DATA. If necessary, change the upper and lower limits by turning the Shuttle button up and down between 60 and 220 BPM at 5 BPM intervals and press the Shuttle button to set them. See “§4-2-i. UPPER” and “§4-2j. LOWER” for details. (3) Put ultrasonic gel on the probe top or patient skin surface. (4) Put the probe on the measurement area and move it slowly to locate the point where the maximum sounds are heard.

Gel Skin surface

(5) When the heart rate becomes stable, press the probe button, or BACK button while using waterproof probe, to freeze it. In case FHR exceeds the upper and lower limits, LCD will start flashing and also, beep sounds will be heard if SOUND mode is set for ON. See “§4-2-h. SOUND” for details.

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Probe button

Upper limit Lower limit

DATA mode

WAVE mode

To store the monitoring waveform data on the memory, follow the step “To store the data” in “§3-3-1. Normal mode”. Note1: Numerical heart rate can’t be stored on the memory. Note2: If the asterisk (*) is shown above the frozen heart rate as a calculation error indicator, press probe button and do the testing again. Manual counting mode is available if heart rate cannot be calculated, see “§ 6-2-2. Heart Rate mode”. (6) Headset can be used to listen to Doppler sounds. It will cut off the speaker.

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3-5. 2 MHz BEEP mode 2 MHz BEEP mode is available when 2 MHz probe is connected and it displays blood velocity waveform and beeps when velocity exceeds the limit. (1) Connect the 2 MHz probe to the Bidop and turn the unit ON. (2) Press Shuttle Button to display MENU and set DISP mode for BEEP. LIMIT-1 and LIMIT-2 menu will be shown as shown in the right. (3) Change the LIMIT-1 by turning the Shuttle button Up & Down between 0 and 120 cm/s at 1 cm/s intervals and press the Shuttle button to set it. Set LIMIT-2 for MAX or AVE as follows; MAX: To beep when max velocity exceeds upper limit. AVE: To beep when average velocity exceeds upper limit. (4) Put ultrasonic gel on the probe top or the skin surface.

(5) Put the probe on the measurement area and move it slowly to locate the point where the maximum sounds are heard. Gel

(6) When velocity exceeds the limit, beep sounds will be heard. Limit

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Skin surface

4. Menu and Mode settings 4-1. Menu By using Shuttle buttons, various mode settings can be selected on Menu mode. Some of the menus consist of sub-menu(s). 4-1-1. Menu operation • Press Shuttle Button inside to show MENU depending on Basic mode. • Select the mode by turning Shuttle Button up and down and selected mode will be highlighted. Press it once or twice to change the mode setting. • For MEMORY and OTHERS in MENU, pressing Shuttle Button shows sub menu for further mode settings.

BACK button Shuttle Button

• Press BACK button to go back to main menu from sub menu or get out of the menu mode.

Press inside

Turn up

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Turn down