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Bidop ES-100V3
Operating Manual
60 pgs2.17 Mb0

Hadeco Bidop ES-100V3 Operating Manual

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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. Checking battery level and replacing battery. ................................ .......................... 7
3-3. Measuring blood velocity ......................................................................................... 8
3-4. Measuring heart rate (2MHz only) ......................................................................... 12
3-5. 2 MHz BEEP mode ............................................................................................... 14
4. Menu and Mode settings ................................................................................................ 15
4-1. Menu ..................................................................................................................... 15
4-2. Mode setting details .............................................................................................. 19
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
5-4. Warranty ................................................................................................................ 29
6. Supplemental information .............................................................................................. 30
6-1. Basic mode ............................................................................................................. 30
6-2. LCD display ........................................................................................................... 30
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
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.
2
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.
3
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
4
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
Turn down
5
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.
6
3. Quick start
3-1. Turning the unit ON / OFF
(1) Set the alkaline battery in the unit.
(See Ҥ 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.
(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.
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.
Polarity mark
Low battery indicator
7
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.
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.
Low
Full
8
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 Ҥ 4-2-g. DISP" for operation. Also,
see “§6-3. Numerical Data” for the
parameters.
Probe button
9
(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.
10
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.
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.
<Site Screen of Smart-V-Link>
11
Site guidance mode procedures:
(1) Turn the unit off and on and the 1
st
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
monitoring waveform.
Press Back button to get out of “Site
guidance mode” for normal mode
operation.
(3) Press the probe button the 2
nd
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 3
rd
time to store the frozen waveform data on the designated memory number.
(5) The 1
st
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.
Probe button
Probe button
Memory number
Abbreviated site & test name
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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.
(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.
Gel
Skin surface
Probe button
13
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 Ҥ
6-2-2. Heart Rate mode”.
(6) Headset can be used to listen to Doppler sounds. It will cut off the
speaker.
Lower limit
Upper limit
WAVE mode
DATA mode
14
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.
(6) When velocity exceeds the limit, beep
sounds will be heard.
Limit
Skin surface
Gel
15
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.
• Press BACK button to go back to main menu from sub menu or get out of the menu mode.
Press inside
Turn up
Turn down
BACK button
Shuttle Button
16
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
MEMORY READ
1 to 30, FREEZE
b. MEMORY - READ
CLEAR
1 to 30, ALL
c. MEMORY - CLEAR
MODE
COMPOUND SEPARATION
d. MODE
DIR
FORWARD REVERSE
e. DIR TIME
NORMAL , SLOW
f. TIME
FLOW
ON, OFF
v. FLOW
DIAMETER
0.1mm – 20.0mm
w. DIAMETER
OTHERS
LANGUAGE
ENGLISH, DEUTSCH, ITALIANO, ESPANOL, FRANCAIS, TURKCE, POLSKI
m. OTHERS - LANGUAGE FREEZE
MANUAL, AUTO
t. OTHERS - FREEZE
UNIT
cm/s, kHz
n. OTHERS - UNIT
FILTER
ARTERIAL, VENOUS
o. OTHERS - FILTER
SMOOTH
NORMAL, LOW -PASS
p. OTHERS - SMOOTH
DISP
WAVE, DATA
g. DISP
CAL
ON, OFF
q. OTHERS - CAL
BACKLIGHT
ON, OFF,
10 to 60 (10 sec. steps)
r. OTHERS - BACKLIGHT
AUTO-OFF
ON, OFF
s. OTHERS - AUTO-OFF
PRB20MHz
ON, OFF
u. OTHERS - PRB20MHz
Note: PRB20MHz menu is only available when either a 20MHz probe or no probe
is connected.
4-1-3. MENU for Blood Velocity Freeze mode
Menu
Sub Menu
Selections
Reference in §4-2
MEMORY STORE
1 to 30, FREEZE
a. MEMORY - STORE
READ
1 to 30, FREEZE
b. MEMORY - READ
CLEAR
1 to 30, ALL
c. MEMORY - CLEAR
MODE
COMPOUND SEPARATION
d. MODE
DIR
FORWARD REVERSE
e. DIR
17
DISP
WAVE, DATA
g. DISP
FLOW
ON, OFF
v. FLOW
DIAMETER
0.1mm – 20.0mm
w. DIAMETER
OTHERS LANGUAGE
ENGLISH, DEUTSCH, ITALIANO, ESPANOL, FRANCAIS, TURKCE, POLSKI
m. OTHERS - LANGUAGE FREEZE
MANUAL, AUTO
t OTHERS - FREEZE
BACKLIGHT
ON, OFF,
10 to 60 (10 sec. steps)
r. OTHERS - BACKLIGHT
AUTO-OFF
ON, OFF
s. OTHERS - AUTO-OFF
4-1-4. MENU for Heart Rate mode (Measurement and Freeze)
Menu
Sub Menu
Selections
Reference in §4-2
MEMORY STORE
1 to 30, FREEZE
a. MEMORY - STORE
READ
1 to 30, FREEZE
b. MEMORY - READ
CLEAR
1 to 30, ALL
c. MEMORY - CLEAR
DISP
WAVE, DATA, BEEP
g. DISP
SOUND
ON, OFF
h. SOUND
UPPER
60 to 220 (every 5 BPM)
i. UPPER
LOWER
60 to 220 (every 5 BPM)
j. LOWER
OTHERS LANGUAGE
ENGLISH, DEUTSCH, ITALIANO, ESPANOL, FRANCAIS, TURKCE, POLSKI
m. OTHERS - LANGUAGE BACKLIGHT
ON, OFF,
10 to 60 (10 sec. steps)
r. OTHERS - BACKLIGHT
AUTO-OFF
ON, OFF
s. OTHERS - AUTO-OFF
Note1: STORE menu is available when on WAVE & freeze mode only.
Note2: When on Freeze mode, DISP mode can’t be changed.
18
4-1-5. MENU for 2MHz BEEP Measurement mode
Menu
Sub Menu
Selections
Reference in §4-2
MEMORY READ
1 to 30, FREEZE
b. MEMORY - READ
CLEAR
1 to 30, ALL
c. MEMORY - CLEAR
DISP
WAVE, DATA, BEEP
g. DISP
DISP/BEEP
WAVE, DATA
g. DISP
LIMIT-1
0 – 120cm/s or 0.0kHz – 12.0kHz
k. LIMIT-1
LIMIT-2
MAX, AVE
l. LIMIT-2
OTHERS
LANGUAGE
ENGLISH, DEUTSCH, ITALIANO, ESPANOL, FRANCAIS, TURKCE, POLSKI
m. OTHERS - LANGUAGE UNIT
cm/s, kHz
n. OTHERS - UNIT
BACKLIGHT
ON, OFF,
10 to 60 (10 sec. steps)
r. OTHERS - BACKLIGHT
AUTO-OFF
ON, OFF
s. OTHERS - AUTO-OFF
4-1-6. MENU for 2MHz BEEP Freeze mode
Menu
Sub Menu
Selections
Reference in §4-2
MEMORY STORE
1 to 30, FREEZE
a MEMORY - STORE
READ
1 to 30, FREEZE
b. MEMORY - READ
CLEAR
1 to 30, ALL
c. MEMORY - CLEAR
DISP
WAVE, DATA, BEEP
g. DISP
DISP/BEEP
WAVE, DATA
g. DISP
OTHERS LANGUAGE
ENGLISH, DEUTSCH, ITALIANO, ESPANOL, FRANCAIS, TURKCE, POLSKI
m. OTHERS - LANGUAGE BACKLIGHT
ON, OFF,
10 to 60 (10 sec. steps)
r. OTHERS - BACKLIGHT
AUTO-OFF
ON, OFF
s. OTHERS - AUTO-OFF
Button functions limited to Heart Rate mode;
・ Shuttle (up & down): To restart waveform monitoring when on WAVE mode. ・ Shuttle (up): To start and stop manual counting of heart rate when
on DATA mode. See “§ 6-2-2. Heart Rate mode” for details.
・ Shuttle (down): To show next page of monitoring waveform when on
Freeze mode.
・ BACK: To freeze and unfreeze the waveform & heart rate.
19
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 Shuttle Button up and down.
Note: The memory number with "*" indicates
memory area where other data have been
already stored.
(2) Press Shuttle Button to store the data into
the memory and it will go back to frozen waveform automatically.
Note: If other data have been already stored in memory number storing, a
confirmation of "OVERWRITE?" will be shown. Press Shuttle Button to
overwrite, or BACK to cancel it for selecting other memory number
available.
b. MEMORY - READ
(1) Select the memory number where you
wish to read waveform data by turning Shuttle Button up and down.
(2) Press Shuttle Button to show the
waveform. To show next waveform stored, press Shuttle up and down.
Note: Any frozen waveform is stored temporarily in memory area of FREEZE
separated from regular 30 memories. It can be re-shown by reading from
memory FREEZE and won't be erased until next waveform is frozen or
unit is turned off.
< On normal mode>
< On site guidance mode>
20
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. Press Shuttle Button to clear the memory, or press BACK button to cancel.
(3) To clear all the data except FREEZE in
the memory at once, select and press on ALL and follow the instruction.
d. MODE (Baseline mode)
(1) Press Shuttle Button to change the baseline mode as follows:
• Compound mode: Combined forward and reverse components
• Separate mode: Separation of forward from reverse component
e. DIR (Flow direction)
(1) Press Shuttle Button to change waveform polarity as follows:
• Forward: Flow toward probe is processed as positive component.
• Reverse: Flow away from probe is processed as positive component.
Compound
Separate
Forward
Reverse
21
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>
• WAVE: Waveform
• DATA: Numerical data
• BEEP: 2MHz BEEP mode
<DISP/BEEP>
• WAVE Waveform for 2MHz BEEP mode
• DATA Numerical data for 2MHz BEEP mode
Note: On heart rate mode, display mode cannot be changed when on Freeze
mode. When on heart rate measurement mode with WAVE mode, turning
Shuttle button up & down to restart the monitoring.
h. SOUND (Beep sound for HR)
Set SOUND mode for ON to activate beep sounds when heart rate gets out of upper and lower limits during the test except 1st 30 sec.
(1) Press Shuttle Button to change beep sound ON / OFF.
i. UPPER (Upper limit for HR)
In case heart rate exceeds the upper limit during the test except 1st 30 sec., LCD will start flashing.
(1) Turn Shuttle Button up and down to select the upper limit in 5 BPM
steps and press the button to set it.
j. LOWER (Lower limit for HR)
In case heart rate gets below lower limit during the test except 1st 30sec., LCD will start flashing.
22
(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.
(1) Turn Shuttle Button up and down to select the limit in 1 cm/s (0.1 kHz)
steps and press the button to set it.
l. LIMIT-2 (Maximum / Average for 2MHz BEEP mode)
(1) Press Shuttle Button to change the mode as follows:
• MAX: Beeps when maximum velocity exceeds limit.
• AVE: Beeps when average velocity exceeds limit.
m. OTHERS - LANGUAGE
(1) Turn Shuttle Button up and down to select the language you wish for
menus and messages, and press the button to set it.
n. OTHERS - UNIT (cm/s / kHz)
(1) Press Shuttle Button to change the unit of blood flow as follows:
• cm/s: Blood flow velocity
• kHz: Doppler-shifted frequency
o. OTHERS - FILTER (Arterial / Venous filter)
The high-pass filter cuts off Doppler signals with lower frequencies than filtering frequency (200 or 80 Hz) for optimal audibility.
(1) Press Shuttle Button to change the filter as follows:
• ARTERIAL: For arteries (200 Hz)
• VENOUS: For veins (80 Hz)
p. OTHERS - SMOOTH (Smoothing filter)
(1) Press Shuttle Button to change smoothing frequency as follows:
• NORMAL: For normal signals (10 Hz)
• LOW-PASS: For noisy signals (5 Hz)
23
q. OTHERS - CAL (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.
(1) Turn Shuttle Button up and down to select the time and press the
button to set it.
• ON: Turns backlight always on.
• OFF: Turns backlight always off.
• 10 ... 60: Auto-off time with 10 sec. steps
BACKLIGHT can be also turned ON / OFF by pressing BACK button longer than 2 sec. When BACKLIGHT is set for Auto-off, backlight goes off in auto-off time of no operation and any button operation will turn the light on again.
s. OTHERS - AUTO-OFF (Automatic shut-off)
(1) Set it for ON / OFF for auto-off on / off.
See “§3-1. Turning the unit ON / OFF” for more details.
t. OTHERS - FREEZE
(1) Set FREEZE for AUTO to freeze the waveform automatically when it
becomes stable. Set it for MANUAL for freezing waveform manually.
u. OTHERS - PRB20MHz
For 20MHz probe, set 20MHz mode for ON before connecting the probe.
4 step calibration
24
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.
(2) Set the estimated vessel diameter by turning Shuttle button Up &
Down for anywhere between 0.1 and 20.0 mm at 0.1 mm intervals and Bidop will calculate and show blood volume flow of numerical data MAX (Maximum) and MN (Mean) on DATA display.
Note: Set DISP mode for DATA to display numerical data and press BACK button
to show flow MAX and MN on 2nd page of numerical data as shown below.
2nd page of numerical data
1st page of numerical data
Blood volume flow data
Indication of next / previous page
25
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.
(3) Turn the unit on and make sure if the LCD displays normally.
5-2. Cleaning
PROBE:
Remove the Doppler gel from the probe head after use. Clean the probe using damp cloth and then wipe with a soft dry cloth, but take great care that any water may not penetrate into the probe. If using disinfectant, please consult in advance with the manufacturer.
MAIN UNIT:
To clean the main unit, use a damp cloth and then wipe with a soft dry cloth, but take great care that any water may not penetrate into the unit. Check the unit by maintenance procedures mentioned in “5-1. § Performance check by user”.
5-3. Probe sterilization
5-3-1. Sterilizable probes (Amplifier required)
Small pencil 8MHz: VRP-08 10MHz: VRP-10 20MHz: VRP-20 Long 8MHz: LRP-08 10MHz: LRP-10 Flat 8MHz: FDP-08 Autoclavable 8MHz: ACP-08 Curved pencil 10MHz: CRP-10H* 20MHz: CRP-20H* 20MHz: CRP-20H1N*
26
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. They must be sterilized before use as follows:
Sterilization limits:
All sterilizable probes except ACP and FDP probe: Up to 50 times ACP probe: Up to 5 times by steam autoclave FDP probe: Up to 5 times
Note: Do not exceed sterilization limits or it may cause damage to probes.
Cautions:
1. Except ACP probe, do not sterilize probes by steam autoclave nor put them in washer disinfector or it will damage probes.
2. ACP probe should be sterilized by steam autoclave as described in section "Instructions for sterilization" below.
Instructions for sterilization:
Point of preparation: No particular requirements. Preparation for cleaning: No particular requirements.
Cleaning:
Automated: Do not do automated cleaning of probes other than ACP
probe.
27
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
STERRAD® by Johnson & Johnson, K.K. sterilization
system as follows:
・ STERRAD®50 ・ STERRAD®100S (only short cycle) ・ STERRAD®200 (only short cycle) ・ STERRAD®NX (only standard cycle) ・ STERRAD®100NX (only standard cycle)
Do not put liquid, powder & cellulose inside sterilization
equipment or it may reduce effectiveness of sterilization
because these substances absorb hydrogen peroxide.
Eliminate water on surface of probe because it may
reduce effectiveness of sterilization.
Sterilization should be performed in accordance with
instructions of the sterilization equipment.
ACP probe: Steam autoclave
• 30 minutes at 121 °C
• 4 minutes at 134 °C
Do not expose probes to temperatures exceeding 134 °C
Sterilization should be performed in accordance with
instructions of the sterilization equipment. Drying:
Sterilizable probes except ACP probe:
No particular requirements.
ACP probe: Dry it well after the sterilization. Maintenance: No particular requirements. Inspection and Function Testing:
No cracks nor contaminations in appearance.
28
Connect the probe to main unit and make sure if you
hear Doppler sounds properly when you rub probe tip. 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 remains the responsibility of the processor to ensure that the processing as actually performed using equipment, materials and personal in the processing facility achieve the desired result. This requires validation and routine monitoring of process. Likewise any deviation by the processor from the instruction provided should be evaluated for effectiveness and potential adverse consequences.
29
5-4. Warranty
Guarantee period: * Frequency
Main unit
Two(2) years
Probe
BT*M05S8C(A), BF8M15S8A, BP*M05S8A, VRP-*, LRP-*, BDP*MS8, PG-21,
One(1) year 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.
Probe
Except European Union Countries
TP-01
One(1) year
CRP-*H, CRP-20H1N, NRP-*H
Six(6) months
NRP-10HF,NRP-20H1NF
Three(3) months
Single use probe
Either one year from the date of purchase or out of box failure
The guarantee period is after the date of purchase when used under normal condition. In the event of any trouble during the warranty period, please contact the dealer from who you purchased the unit. In case the warranty period is over, please consult the dealer for a charged service.
30
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
• 2 MHz BEEP - Measurement For precordial blood velocity
• 2 MHz BEEP - Freeze For observing waveforms and
numerical data
• Menu For changing other mode settings
Changing mode with probe button (Measurement / Freeze)
Press the probe button to go to freeze mode and press it again to get back to measurement mode.
Note: If the probe button is pressed longer than 2
sec., the unit will turn OFF.
With 2 MHz probe, you can also change mode (Measurement / Freeze) by pressing BACK button of the unit.
6-2. LCD display
6-2-1. Blood Velocity mode
Waveforms:
(1) The base line is automatically located at optimal position for each
waveform. Bidop has 4 base lines, the bottom, 1/4 from the bottom, the center, and 3/4 from the bottom.The waveform amplitude is automatically adjusted for optimal observation.
31
(2) The amplitude scale (velocity or frequency per division) is displayed
on top left of LCD.
(3) When pressing probe button to freeze
the waveform, Bidop will stop monitoring and will display frozen waveform with “FREEZE”.
Memory number is shown on top right of LCD for waveform read from MEMORY, e.g. "#01"
Numerical data:
Following numerical parameters are displayed on DATA mode.
Amplitude scale
Slow mode (25.6 sec./screen)
Unit: cm/s
Unit: kHz
Amplitude scale
Division
Compound mode
Separate mode
Memory number
32
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.
(1) The heart mark " " tracks heart beat while in measurement. The
heart mark also indicates the speed of heart movements in 3 different size sizes as follows:
(2) When calculated heart rate is not stable, the asterisk (*) will show
above “HR”.
Manual counting mode:
(1) Turn Shuttle up and hold to start
manual counting and "M" and the time passed will be shown on the top right while on manual counting mode.
(2) Count 10 heartbeats and release
Shuttle and the heart rate manually counted will be shown.
Fast Medium Slow
33
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.
(3) Heart mark indicates the same way as DATA mode. See previous
page.
(4) Two dotted lines indicate Upper and Lower limits of heart rate. If it gets
out of limits during the test except 1st 30 sec., LCD will start flashing.
(5) When on freeze mode by pressing
probe or BACK button, the latest monitoring waveform of up to 33 minutes can be shown over 4 pages on LCD with FREEZE indicator. Turn Shuttle Button down to show next page. (Approx. 8 minutes a page)
(6) Memory # is shown on top right of
LCD waveform read from MEMORY as shown in the right.
Page number
Freeze indicator Max
Min.
Memory number
Measuring time
Monitoring waveform Upper limit
Lower limit
Heart rate
220
200
100
60
Asterisk is displayed when
calculated heart rate is not stable.
Heart rate at the moment
34
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.
(4) When pressing probe button to freeze the waveform, Bidop will stop
monitoring and will display frozen waveform with “FREEZE”.
Amplitude scale
Limit-1
MAX waveform
AVE waveform (dotted line) will be displayed when on AVE
mode for LIMIT-2
LIMIT-2
Base line
35
6-3. Numerical data
Parameters
Abbrs.
Definitions
Systolic velocity [cm/s] or systolic Doppler shift [kHz]
S
Mean velocity [cm/s] or mean Doppler shift [kHz]
MN
Diastolic velocity [cm/s] or diastolic Doppler shift [kHz]
D
Minimum velocity [cm/s] or minimum Doppler shift [kHz]
MIN
Resistance Parameter
RP
RP = (S -D) / S RP = 1 if waveform goes blow base line.
Pulsatility Index
PI
PI = (S - MIN) / MN PI < 99.99
S/D ratio
SD
SD = S / D
Heart rate [BPM]
HR
Max volume flow
MAX
Mean volume flow
MN
Vessel diameter
DIAM
Samples displayed on LCD;
Unit: cm/s
Unit: kHz
36
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. (3) Run Smart-V-Link (option) on your computer.
Note: For software operation, refer to the software operating manual.
6-5. Symbol list
Symbols
Description
Symbols
Description
Type BF
applied part
Back button
Headset
Shuttle button
Power
ON / OFF
Manufacturer
Serial port
Authorized representative
in Europe
Volume control
6-6. Contents in package
• Main unit ............. 1
• Probe .................. 1
• Carrying case ...... 1
• Ultrasonic gel (AQUAULTRA BASIC) .. 1
• Battery ................................................. 1
37
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:
8MHz: VRP-08 10MHz: VRP-10 20MHz: VRP-20
Long:
8MHz: LRP-08 10MHz: LRP-10
Flat:
8MHz: FDP-08
Autoclavable:
8MHz: ACP-08
38
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. Others
• Neck strap (Except European Union Countries)
• Smart-V-Link software with communication cable
39
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.
7-3-1. PPG (Photoplethysmography) Probe Assembly Single-channel photoplethysmography (PPG) probe
AC Coupling: Arterial pulse waveform studies, Toe pressure DC Coupling: Venous reflux study
7-3-2. PPG - Arterial Pulse Waveform Studies Purpose:
Arterial pulse waveform studies by photoplethysmography are performed to determine the presence or absence of pulsatile flow and to assess the state of perfusion in the tissue area immediately beneath the sensor site. When used with a suitable cuff and manometer, the method permits the measurement of systolic blood pressure in the fingers and toes.
Model PG-21
To the main unit
Probe Button
PPG probe head
40
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.
(3) Check that the face of the PPG sensor is free of stains.
Clean it if necessary.
(4) Make certain that room temperature is comfortable and, especially,
that the skin surface where the probe is to be mounted is warm. Cold
constricts superficial blood vessels and thus jeopardizes the accuracy
of PPG measurements.
Examination Procedure: (1) Apply the sensor with the clear side against the skin surface, and fix it
in place using Velcro straps, PPG clip (Option) or double-sided clear
tape.
(2) The gain is automatically adjusted and the
PPG waveform is shown on the LCD.
High-pitched sounds following heartbeats
can be heard from speaker and mute it
with volume control if desired.
(3) When the waveform gets stable and rhythmic, press probe button to
freeze the waveform.
(4) If you wish to store the data on the
memory, see Ҥ 4-2-a. MEMORY -
STORE”.
41
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.
Select MODE and press Shuttle to set for
DC mode.
(3) COUNT represents number of foot exercise during study and if
desired, press Shuttle on COUNT and turn it up and down to change
the number.
Press BACK to get out of the COUNT sub menu.
(4) Check that the face of the PPG sensor is free of stains. Clean it if
necessary.
(5) Make certain that room temperature is comfortable and that the skin
surface of the lower limb is warm. Cold constricts superficial blood
vessels and thus jeopardizes the accuracy of PPG measurements.
Examination Procedure: (1) Have the patient sit on an examination table so that the feet are off
the floor.
(2) Apply the sensor, with the clear side against the skin surface, to the
medial malleolus over the posterior tibial vein. Fix the sensor in place
with double-sided clear tape.
(3) Press probe button to begin the measurement process.
42
(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
waveform and calculate recovery times.
Note: "1/2" is the half recovery time for returning to 50% of refilling amplitude
where middle vertical dotted line is shown.
(7) If you wish to store the data on the
memory, see Ҥ 4-2-a. MEMORY -
STORE”.
(8) Press the probe button to get out of the
freeze mode.
43
7-3-4. Menu for PPG
Menu
Sub Menu
Selections
Reference in §4-2.
MEMORY STORE
1 to 30, FREEZE
a. MEMORY - STORE
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. MODE
COUNT
1 to 20 (DC mode only)
7-3-6. COUNT
OTHERS
LANGUAGE
ENGLISH, DEUTSCH, ITALIANO, ESPANOL, FRANCAIS, TURKCE, POLSKI
m. OTHERS - LANGUAGE
FREEZE
MANUAL, AUTO
t. OTHERS-FREEZE
BACKLIGHT
ON, OFF, 10 to 60 (10 sec. steps)
r. OTHERS - BACKLIGHT
AUTO-OFF
ON, OFF
s. OTHERS - AUTO-OFF
Note1: STORE menu is available when on freeze mode only.
Note2: MODE is selectable when in Measurement mode.
Note3: COUNT is used for DC mode when in Measurement mode.
7-3-5. PPG Mode settings MODE (AC / DC) (Only available in Measurement mode):
(1) Select MODE with Shuttle Button. (2) Press it to change mode as follows:
AC: For arterial testing DC: For venous reflux study
COUNT (Only available in DC - Measurement mode):
Set the number for foot exercise. (1) Press Shuttle button on COUNT
and turn it up and down to change the number.
(2) Press it to fix it.
44
7-4. Foot Temperature (Except European Union Countries)
With optional temperature probe (TP-02), Bidop can detect foot temperature.
Model TP-02
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.
(2) Select the temperature unit on UNIT
menu for either Celsius (°C) or Fahrenheit (°F).
(3) Get the probe tip close to the
measurement site less than 4 cm as shown in the right.
(4) Press the probe button to measure and
show the temperature on the LCD.
Note: Comprehensive foot temp. study can be
organized with Smart-V-Link for Windows, optional.
Temperature probe button
Temperature transducer
45
7-5-2. Menu for Foot temperature
Menu
Sub-menu
Selections
Reference in §.4-2
UNIT
°C, °F
7-4-1-(2)
OTHERS LANGUAGE
ENGLISH, DEUTSCH, ITALIANO, ESPANOL, FRANCAIS, TURKCE, POLSKI
m. OTHERS - LANGUAGE
BACKLIGHT
ON, OFF, 10 to 60 (10 sec. steps)
r. OTHERS - BACKLIGHT
AUTO-OFF
ON, OFF
s. OTHERS - AUTO-OFF
Specifications:
Temperature measuring method: non-contact Accuracy: ± 0.5°C (measurement range 10 to 40 °C),
when operating temperature is 0 to 40°C Display Resolution: 0.1°C FOV: 4:1 (object distance: measuring range) Emissivity: 0.98
Object 1cm
Less than 4cm
46
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. It is converted to ultrasound by the transducer and the ultrasound is transmitted to external objects. The ultrasound moves straight through biophysical object, and is reflected by the moving object (blood flow etc.). The reflected ultrasound is received by the receiving transducer and is converted into electric signals again. The converted signals are amplified and then detected. After removing unnecessary noise from the signals and improving S/N ratio at the filter circuit, the Doppler shift signals are amplified and are converted to audible sounds through a speaker or a headset. Simultaneously, the Doppler shift signals are applied to the CPU and converted to blood flow velocity waveform signals which can be displayed.
8-2. Block diagram
Analog circuit
Pre-amplifier
USB circuit
CPU
RAM+ROM
LCD
Battery
Power supply
Headset
Probe
Power
amplifier
47
8-3. Specifications
Probes: Model Freq. Ispta* (in situ) [mW/cm2] 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: Approx. 2.5 hours (When using with alkaline battery and
backlight off.) Automatic shut-off No signal: 2 min. Freeze: 5 min. Others: 15 min. (only FHR WAVE mode: 35 min.) Frequency range: 80 / 200 Hz to 5 kHz Mode settings: Memory, Waveform, Direction, Time scale, Others Waveform memory: 30 waveforms LCD display: 128 x 64 dots, STN LCD with backlight Bi-directional waveform (normal & slow mode)
Numerical data (Systolic, diastolic & mean velocities, RP,
PI, SD, HR) Heart rate: 30 to 300 BPM, accuracy of ±3% Low battery indicator
Velocity accuracy: ±10% or less comparing with internal phantom testing. Speaker output: 300 mW or more External outputs: Headset, serial port (USB)
Electrical safety: Conform to IEC60601-1 Internally powered equipment Type BF applied part.
Operating environment: 10 to 37 °C 85% humidity or less with no condensation
48
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 manufacturing, respectively.
The serial number is located inside of the battery
compartment and it consists of 4 to 8 digits and may start with “Serial number” or “SN”.
Examples:
03020001: Feb/2003 0401: Jan/2004
* Specifications subject to change
8-4. Safety standards
The unit confirms to the following standards: IEC60601-1 (1) Protection class against electric shock : Internally powered equipment
Protection grade against electric shock : Type BF applied part
(2) Guidance and manufacturer's declaration - electromagnetic emissions and
immunity: IEC60601-1-2:2014(4th Edition)
Guidance and manufacturer’s declaration – electromagnetic emissions
The ES-100V3 is intended for use in the electromagnetic environment specified below. The customer or the user of the ES-100V3 should assume that it is used in such an environment.
Emissions test
compliance
Electromagnetic environment - guidance
RF emissions CISPR 11
Group 1
The ES-100V3 use RF energy only for its internal function. Therefore, its RF emissions are very low and are not likely to cause any interference in nearby electronic equipment.
RF emissions CISPR 11
Class B
The ES-100V3 is suitable for use in all establishments other than domestic and those directly connected to the public low­voltage power supply network that supplies buildings used for domestic purposes.
Harmonic emissions IEC61000-3-2
Not applicable
49
Voltage fluctuations/ flicker emissions IEC61000-3-3
Not applicable
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
Electromagnetic environment -
guidance
Electrostatic discharge(ESD)
IEC61000-4-2
±8kV contact ±2kV, ±4kV, ±8kV,
±15kV air
±8kV contact ±2kV, ±4kV,
±8kV, ±15kV air
Floors should be wood, concrete or ceramic tile. If floors are converted with synthetic material, the relative humidity should be at least 30 %.
Electrical fast transient/burst
IEC61000-4-4
±2kV for power supply lines(100KHz)
±1kV for input/output lines
Not applicable Surge IEC61000-4-5
±1kV differential mode ±2kV common mode
Not applicable
Voltage dips, short interruptions and voltage variations on power supply input lines
IEC61000-4-11
Dip to 0% for 1 cycles @ 0°phase angle Dip to 70% for 25/30 cycles @ 0°phase angle
Dropout to 0% for
0.5cycle @ 0°, 45°, 90°, 135°, 180°, 225°, 270°&315°
Interrupts 100% for 250/300 cycles
Not applicable
Power frequency (50Hz) magnetic field IEC61000-4-8
30 A/m
30 A/m
Power frequency magnetic fields should be at levels characteristic of a typical location in a typical commercial or hospital environment.
NOTE UT is the a.c. mains voltage prior to application of the test revel.
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
Electromagnetic environment - guidance
Portable and mobile RF communications equipment should be used no closer to any part of the ES-100V3, including cables, than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter.
Recommended separation distance d = 1,2√P
50
Conducted RF IEC61000-4-6
Radiated RF IEC61000-4-3
3Vrms 150kHz to 80MHz, 1kHZ 80%AM Modulation 6Vrms in ISM bands(I/O cables< 3m excluded) Patient coupled ports tested with current clamp
3V/m, 80Mhz to 2,7GHz, 1kHz 80%AM modulation Table-9 (IEC60601-1-2:2014)
3Vrms 150kHz to 80MHz, 1kHZ 80%AM Modulation 6Vrms in ISM bands(I/O cables< 3m excluded) Patient coupled ports tested with current clamp
3V/m, 80Mhz to 2,7GHz, 1kHz 80%AM modulation Table-9 (IEC60601-1­2:2014)
d = 1,2√P 80 to 800MHz d = 2,3√P 800MHz to 2,5GHz
where P is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer and d is the recommended separation distance in meters (m).
Field strength from fixed RF transmitters, as determined by an electromagnetic site survey, a should be less than the compliance level in each frequency range. b
Interference may occur in the vicinity of the equipment marked with the following symbol:
NOTE 1 At 80 MHz and 800 MHz, the separation distance for the higher frequency range applies. NOTE 2 These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects and people.
a Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless) telephones
and land mobile radios, amateur radio, AM and FM radio broadcast and TV broadcast cannot be predicted theoretically with accuracy. To assess the electromagnetic environment due to fixed RF transmitters, an electromagnetic site survey should be considered. If the measured field strength in the location in which the ES-100V3 is used exceeds the applicable RF compliance level above, the ES-100V3 should be observed to verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as reorienting or relocating the ES-100V3.
b Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m.
For European Union Countries:
European Authorized Representative
ICHIYAMA GmbH
Benderstraße 130, 40625 Düsseldorf, Germany
Tel: 0211-298538 Fax: 0211-299257
Manufactured by
Hadeco, Inc.
2-7-11 Arima, Miyamae-ku, Kawasaki, Kanagawa 216-0003 Japan
May, 2018
Printed in Japan
080-00156-3.1
0123
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