Hadeco Bidop ES-100V3 Operating Manual
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Hadeco Bidop ES-100V3 Operating Manual

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Summary of Contents for Hadeco Bidop ES-100V3

  • Page 3: Table Of Contents

    TABLE OF CONTENTS Cautions 1. Introduction ........................1 1-1. Features ........................2 1-2. Clinical applications ....................3 2. Appearance ........................4 2-1. Front view ........................ 4 2-2. Back side view and Probe ..................5 3. Quick start ........................6 3-1. Turning the unit ON / OFF ..................6 3-2.
  • Page 4 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.
  • Page 5 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.
  • Page 6 (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.
  • Page 7 (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.

  • Page 8: Introduction

    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.

  • Page 9: 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.

  • Page 10: Clinical Applications

    1-2. Clinical applications • Detections of arterial and venous blood flow velocity for vascular disease Probes to be used: BT2M20S8C (2 MHz) BT4M05S8C (4 MHz) BT5M05S8C (5 MHz) BT8M05S8C (8 MHz) BT10M5S8C (10 MHz) PEAK & MEAN blood velocity determinations Detection of arterial and venous blood flow velocity for vascular disease...

  • Page 11: Appearance

    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.

  • Page 12: Back Side View And Probe

    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.

  • Page 13: Quick Start

    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 Polarity mark the polarity mark will be placed under mark.

  • Page 14: Checking Battery Level And Replacing Battery

    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.

  • Page 15: Measuring Blood Velocity

    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.
  • Page 16 (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.

  • Page 17: 3-3-2.Site Guidance Mode

    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-V-...
  • Page 18 Site guidance mode procedures: Turn the unit off and on and the 1 guidance with memory number and abbreviated site & test name will appear as shown in the right. Memory number Note: The first memory number available will be selected automatically. Abbreviated site &...

  • Page 19: Measuring Heart Rate (2Mhz Only)

    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.
  • Page 20 Upper limit Lower limit WAVE mode DATA 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.

  • Page 21: Mhz Beep Mode

    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.

  • Page 22: Menu And Mode Settings

    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. •...

  • Page 23: Menu For Blood Velocity Measurement Mode

    4-1-2. MENU for Blood Velocity Measurement mode Selections in bold face in the table above are defaults. Menu Sub Menu Selections Reference in §4-2 READ 1 to 30, FREEZE b. MEMORY - READ MEMORY CLEAR 1 to 30, ALL c. MEMORY - CLEAR COMPOUND MODE d.

  • Page 24: Menu For Heart Rate Mode (Measurement And Freeze)

    DISP g. DISP WAVE, DATA FLOW v. FLOW ON, OFF 0.1mm – 20.0mm DIAMETER w. DIAMETER ENGLISH, DEUTSCH, LANGUAGE ITALIANO, ESPANOL, m. OTHERS - LANGUAGE FRANCAIS, TURKCE, POLSKI OTHERS FREEZE t OTHERS - FREEZE MANUAL, AUTO BACKLIGHT ON, OFF, 10 to 60 (10 sec. steps) r.

  • Page 25: Menu For 2Mhz Beep Measurement Mode

    4-1-5. MENU for 2MHz BEEP Measurement mode Menu Sub Menu Selections Reference in §4-2 READ 1 to 30, FREEZE b. MEMORY - READ MEMORY CLEAR 1 to 30, ALL c. MEMORY - CLEAR DISP WAVE, DATA, BEEP g. DISP DISP/BEEP g.

  • Page 26: Mode Setting Details

    4-2. Mode setting details a. MEMORY - STORE (1) STORE menu is available when on freeze mode only. The first memory number available will be selected automatically on STORE. If necessary, change the number where to store waveform data by turning <...

  • Page 27: Memory - Clear

    c. MEMORY - CLEAR (1) Select the memory number you wish to clear the data for. The number with "*" indicates memory area where data have been already stored. (2) Press Shuttle Button and then the confirmation screen with waveform data will be displayed as shown in the right.

  • Page 28: Time (Time Scale)

    f. TIME (Time scale) (1) Press Shuttle Button to change the time scale as follows: • Normal: For arteries (2.56 sec./screen) • Slow: For veins (25.6 sec./screen) g. DISP (DISP, OTHERS – DISP, DISP/BEEP) (1) Press Shuttle Button to change the Display mode as follows: <DISP>...

  • Page 29: Limit-1 (Limit For 2Mhz Beep Mode)

    (1) Turn Shuttle Button up and down to select the lower limit in 5 BPM steps and press the button to set it. k. LIMIT-1 (Limit for 2MHz BEEP mode) In case maximum or average blood velocity exceeds the limit, beep sound will be heard.

  • Page 30: Others - Cal (Calibration)

    q. OTHERS - CAL (Calibration) 4 step calibration (1) Press Shuttle Button to change the CAL mode as follows: • ON: Displays 4 step (3, 2, 1, 0, -1 kHz) calibration waveform. • OFF: Measurement mode r. OTHERS - BACKLIGHT LCD backlighting time can be adjusted on BACKLIGHT mode.

  • Page 31: Flow (Blood Volume Flow) / W. Diameter (Estimated Vessel Diameter)

    v. FLOW (Blood volume flow) / w. DIAMETER (Estimated vessel diameter) Blood volume flow will be calculated on blood velocity measurement & freeze modes when FLOW is set for ON. (1) Press Shuttle Button to set FLOW mode for ON and DIAMETER menu will be shown as shown below.

  • Page 32: Maintenance

    5. Maintenance 5-1. Performance check by user Perform the following performance checks at least once a year: (1) Make sure if there is no damage and/or crack on the main unit and probe. (2) Shake the main unit and make sure if there are no sounds inside from internal components coming off.

  • Page 33: Sterilization

    Bayonet 10MHz: NRP-10H* 20MHz: NRP-20H* Flexible 10MHz: NRP-10HF* 20MHz: NRP-20H1NF* Single use 10MHz: NDP-10H* 20MHz: NDP-20H* *: Except European Union Countries. 5-3-2. Sterilization Only sterilizable probes can be sterilized. Do not sterilize other type of probes including amplifiers as well as main unit. Warnings: Sterilizable probes are not sterilized before shipment.
  • Page 34 Manual: Do not soak probes into medicinal solution. Wipe any contamination from probes with damp cloth. Disinfection: Not applicable Sterilization: Sterilizable probes except ACP probe: Low temperature plasma sterilization (Hydrogen peroxide low temperature plasma sterilization), under 60°C. Sterilization system is compatible with only the ®...
  • Page 35 Packaging: No particular requirements. Storage: No particular requirements. Manufacturer contact: Hadeco, Inc. 2-7-11 Arima, Miyamae-ku, Kawasaki, 216-0003, Japan Tel : +81-44-877-4361 Fax : +81-44-855-7301 The instructions provided above have been validated by the medical device manufacturer as being CAPABLE of preparing a medical device for reuse. It...

  • Page 36: Warranty

    5-4. Warranty Guarantee period: * Frequency Main unit Two(2) years Probe BT*M05S8C(A), BF8M15S8A, One(1) year BP*M05S8A, VRP-*, LRP-*, BDP*MS8, PG-21, ACP-08 Either one year from the date of purchase or within 5 times of autoclave sterilization. FDP-08 Either 3 months from the date of purchase or within 5 times of sterilization.

  • Page 37: Supplemental Information

    6. Supplemental information 6-1. Basic mode Eight Basic Operation Modes: • Blood Velocity - Measurement For measuring blood velocity • Blood Velocity - Freeze For observing waveforms and numerical data • Heart Rate - Measurement For measuring heart rate • Heart Rate - Freeze For observing heart rate and graph •...
  • Page 38 (2) The amplitude scale (velocity or frequency per division) is displayed on top left of LCD. Amplitude scale Division Compound mode Separate mode Amplitude scale Slow mode (25.6 sec./screen) (3) When pressing probe button to freeze the waveform, Bidop will stop monitoring and will display frozen waveform with “FREEZE”.

  • Page 39: Heart Rate Mode (Only 2 Mhz Probe)

    See “§ 6-3. Numerical Data” for the meaning of abbreviations and the definitions of parameters. Note: When calculated heart rate is not stable, an asterisk (*) will show left side of “HR” 6-2-2. Heart Rate mode (Only 2 MHz probe) Numerical heart rate (DATA mode): Heart rate is displayed based on a 4 beat average once the Bidop gets sufficient data to calculate.
  • Page 40 Monitoring heart rate in graph (WAVE monitoring mode): (1) The measurement range of heart rate is 60 to 220 BPM. (2) Numerical heart rate is displayed on bottom left of LCD. Monitoring waveform Heart rate Upper limit Lower limit Measuring time Asterisk is displayed when calculated heart rate is not stable.

  • Page 41: Mhz Beep Mode

    6-2-3. 2 MHz BEEP mode Waveforms (DISP/ BEEP: WAVE): (1) The base line is fixed 1/4 from the bottom. (2) The waveform amplitude is automatically adjusted depending on limit. (3) The amplitude scale (velocity or frequency per division) is displayed on top left of LCD.

  • Page 42: Numerical Data

    6-3. Numerical data Parameters Abbrs. Definitions Systolic velocity [cm/s] or systolic Doppler shift [kHz] Mean velocity [cm/s] or mean Doppler shift [kHz] Diastolic velocity [cm/s] or diastolic Doppler shift [kHz] Minimum velocity [cm/s] or minimum Doppler shift [kHz] RP = (S -D) / S Resistance Parameter RP = 1 if waveform goes blow base line.

  • Page 43: External Outputs

    6-4. External outputs 6-4-1. Headset Connect the headset when necessary and it cuts off the speaker. 6-4-2. Communication port (3.5 mm jack) It is for Smart-V-Link for Windows for comprehensive vascular testing and data storage. (1) Connect a computer with designated communication cable (option). (2) Press the Power Button to turn the unit on.

  • Page 44: Options

    7. Options 7-1. Probe selection The frequency of diagnostic ultrasound is inversely proportional to depth of penetration. Use those probes depending on your applications. Standard Doppler probe: Standard: 2MHz: BT2M20S8C 4MHz: BT4M05S8C 5MHz: BT5M05S8C 8MHz: BT8M05S8C 10MHz: BT10M5S8C Flat: 2MHz: BF2M20S8A 8MHz: BF8M15S8A Sterilizable probe: (Amplifier required) Small pencil:...

  • Page 45: Others

    Curved pencil: 10MHz: CRP-10H* 20MHz: CRP-20H* 20MHz: CRP-20H1N* Bayonet: 10MHz: NRP-10H* 20MHz: NRP-20H* Flexible: 10MHz: NRP-10HF* 20MHz: NRP-20H1NF* Single use: 10MHz: NDP-10H* 20MHz: NDP-20H* Amplifier: 8MHz: BDP8MS8 10MHz: BDP10MS8 20MHz: BDP20MS8 PPG probe: PG-21 Temperature Probe: TP-02* *: Except European Union Countries. 7-2.

  • Page 46: Photoplethysmograph

    7-3. Photoplethysmograph With the PPG probe, PG-21, Bidop senses the reflection of light from the hemoglobin of the red blood cells in surface vessels by utilizing infrared light. Basically, “How to use photoplethysmograph” is described in this manual. For other matters such as Cautions, Technical information and Interpretations of test result, refer to the Operating Manual that comes with your PPG probe.
  • Page 47 Preparation: (1) Connect the PPG probe to the unit and turn it on. (2) Press Shuttle Button to display MENU and make sure MODE is set for AC mode. If it's been set for DC mode, press Shuttle on MODE to change to AC. Press BACK to get out of the MENU mode.
  • Page 48 7-3-3. PPG - Venous Reflux Study Purpose: The venous reflux study is performed to assess valvular competence by measuring the amount of time required for venous refilling after calf veins have been emptied through exercise. Preparation: (1) Connect the PPG probe to the unit and turn it on. (2) Press Shuttle Button to display MENU.
  • Page 49 (4) Ask the patient to flex the foot specified number on COUNT following the foot animation and beep on Bidop. The exercise should be forceful, especially when lifting the foot upward. (5) After flexing, instruct the patient to relax the foot and avoid all movement. (6) The test is completed when the waveform returns to the baseline and Bidop will automatically freeze the...
  • Page 50 7-3-4. Menu for PPG Menu Sub Menu Selections Reference in §4-2. STORE 1 to 30, FREEZE a. MEMORY - STORE MEMORY READ 1 to 30, FREEZE b. MEMORY - READ CLEAR 1 to 30, ALL c. MEMORY - CLEAR MODE AC, DC (Measurement mode only) 7-3-6.

  • Page 51: Foot Temperature (Except European Union Countries)

    7-4. Foot Temperature (Except European Union Countries) With optional temperature probe (TP-02), Bidop can detect foot temperature. Model TP-02 Temperature probe button Temperature transducer 7-4-1. Foot temperature study (1) Connect the temperature probe to the unit and turn the unit on. Foot temperature screen will be shown as shown in the right.
  • Page 52 7-5-2. Menu for Foot temperature Menu Sub-menu Selections Reference in §.4-2 UNIT °C, °F 7-4-1-(2) ENGLISH, DEUTSCH, ITALIANO, m. OTHERS - LANGUAGE LANGUAGE ESPANOL, FRANCAIS, TURKCE, POLSKI OTHERS BACKLIGHT ON, OFF, 10 to 60 (10 sec. steps) r. OTHERS - BACKLIGHT AUTO-OFF ON, OFF s.

  • Page 53: Technical Information

    8. Technical information 8-1. Principles Model ES-100V3 Bidop is designed to obtain various blood flow velocity through the ultrasound which is transmitted from probe to patient body and is reflected by the blood (hemocyte, etc.). The unit amplifies the high frequency oscillation output and then supplies it to the transmitter transducer.

  • Page 54: Specifications

    8-3. Specifications Probes: Model Freq. Ispta* (in situ) [mW/cm BT2M20S8C 2 MHz 80 or less BT4M05S8C 4 MHz 390 or less BT5M05S8C 5 MHz 390 or less BT8M05S8C 8 MHz 390 or less BT10M5S8C 10 MHz 390 or less * Ispta: Special Peak-Temporal Average Intensity. Battery: DC 9 volts, Alkaline square type battery Battery life:...

  • Page 55: Safety Standards

    Storage and transport environment: 0 to 50 °C 85% humidity or less with no condensation Dimensions: Main unit: 78 (W) x 141 (L) x 27 (H) mm (Probe holder not included) Probe: 20 (Diam.) x 105 (L) mm Weight: 220 grams (including battery, probe not included) Manufacturing date: The first 2 digits and following 2 digits of the serial number represent the year and month of...
  • Page 56 Voltage fluctuations/ Not applicable flicker emissions IEC61000-3-3 Guidance and manufacturer’s declaration – electromagnetic immunity The ES-100V3 is intended for use in the electromagnetic environment specified below. The customer or the user of the ES-100V3 should assure that it is used in such an environment. Immunity test IEC60601 test level Compliance level...
  • Page 57 Conducted RF 3Vrms 3Vrms d = 1,2√P 80 to 800MHz IEC61000-4-6 150kHz to 80MHz, 150kHz to 1kHZ 80%AM 80MHz, d = 2,3√P 800MHz to 2,5GHz Modulation 1kHZ 80%AM where P is the maximum output power 6Vrms in ISM Modulation rating of the transmitter in watts (W) according to the transmitter manufacturer bands(I/O cables<...
  • Page 59 For European Union Countries: European Authorized Representative ICHIYAMA GmbH Benderstraße 130, 40625 Düsseldorf, Germany Tel: 0211-298538 Fax: 0211-299257...
  • Page 60 Manufactured by Hadeco, Inc. 0123 May, 2018 2-7-11 Arima, Miyamae-ku, Printed in Japan Kawasaki, Kanagawa 080-00156-3.1 216-0003 Japan...

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