Operating Manual
60 Pages
Preview
Page 1
TABLE OF CONTENTS Cautions 1. Introduction ... 1 1-1. Features ... 1 Venous testing ... 1 1-2. Clinical applications... 2 2. Appearance ... 3 2-1. Front left view ... 3 2-2. Front right view and Probe ... 5 3. Quick start ... 6 3-1. Turning the unit ON / OFF ... 6 3-2. Charging / Discharging battery ... 7 3-4. Setting printer paper... 8 3-5. Measuring blood velocity ... 9 3-5-1. Normal mode ... 9 3-5-2. Site guidance mode ... 10 3-6. Measuring heart rate (2 MHz only) ... 12 3-7. 2 MHz BEEP mode ... 13 4. MENU and Mode settings ... 14 4-1. Menu ... 14 4-1-1. Menu structure ... 14 4-1-2. Menu operation ... 14 4-1-3. Menu for Blood Velocity Measurement mode ... 16 4-1-4. Menu for Blood Velocity Freeze mode ... 17 4-1-5. Menu for Heart Rate mode (Measurement and Freeze) ... 18 4-2. Mode Setting Details ... 19 a. MEMORY - STORE ... 19 b. MEMORY - READ... 19 c. MEMORY - CLEAR ... 20 d. MODE (Baseline mode) ... 20 e. DIR (Flow Direction) ... 20 f. TIME (Time scale)... 21 g. FLOW (Blood volume flow) / h. DIAMETER (Estimated vessel diameter) ... 21 i. PATIENT (Patient data input) ... 21 j. OTHERS - LANGUAGE ... 23 k. OTHERS – FREEZE ... 23 l. OTHERS - UNIT (cm/s / kHz) ... 23 m. OTHERS - FILTER (Arterial / Venous filter) ... 23 n. OTHERS - SMOOTH (Smoothing filter) ... 23 o. DISP (DISP, OTHERS – DISP, DISP/BEEP) ... 23 p. OTHERS - CAL (Calibration) ... 24 q. OTHERS - BACKLIGHT ... 24
r. OTHERS - AUTO-OFF (Automatic shut-off) ... 24 s. OTHERS - P.ID PRT (Patient data print) ... 24 t. OTHERS - PRB-KEY (Probe button function)... 25 u. OTHERS - DATE (Date and time setting) ... 25 v. SOUND (Beep sound for FHR mode) ... 25 w. UPPER (Upper limit for FHR) ... 25 x. LOWER (Lower limit for FHR) ... 25 y. PBR20MHz ... 26 z. LIMIT-1 (For 2MHz BEEP mode) ... 26 aa. LIMIT-2 (For 2MHz BEEP mode) ... 26 5. Maintenance ... 27 5-1. Performance check by user ... 27 5-2. Cleaning ... 27 5-3. Probe sterilization... 27 5-3-1. Sterilizable probes: ... 27 5-3-2. Sterilization ... 28 5-4. Warranty... 30 6. Supplemental information ... 31 6-1. 2 Probe connections: ... 31 6-2. Basic Modes ... 31 6-3. LCD display ... 32 6-3-1. Blood Velocity Mode ... 32 6-3-2. Heart Rate mode (Only for 2 MHz probe) ... 33 6-4. Printing waveforms and data ... 35 6-4-1. How to print ... 35 6-4-2. Print sample ... 35 6-5. Numerical data ... 36 6-6. Extrernal outputs ... 36 6-7. Symbol list ... 37 6-8. Contents in package ... 37 7. Options ... 38 7-1. Probe selection ... 38 7-2. Others ... 39 7-3. Photoplethysmograph ... 40 8. Technical information ... 45 8-1. Principles ... 45 8-2. Block diagram ... 46 8-3. Specifications ... 47 8-4. Safety standards ... 49
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 affect the unit adversely. (4) Pay attention to the stability conditions to avoid too much inclination, vibration, shock and so on during transportation and installation of the unit. (5) Do not place it where chemicals are stored or gas may be generated. (6) Do not place it where the unit tends to fall. 5. Before use (1) Make sure that the unit operates safely and correctly by implementing performance check 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 by gas, autoclave or so on to prevent any damage. (6) Sterilizable probes should be sterilized before use. 6. Operation (1) Do not use the unit simultaneously with either electric cautery, cardioverter, other ultrasonic device or mobile phone. (2) Be cautious not to exceed too much time and volume required for the measurement. (3) Always make sure the unit and patient are not under abnormal conditions. (4) When any abnormality is found on the unit or the patient, take proper action such as stopping use of the unit in a manner safe for the patient.
(5) Do not let the patient touch the unit. (6) Use the designated components only. (7) Do not use the components for other devices. (8) Use the unit under the operating environments specified on the specifications. (9) Use the unit as specified in the operation manual. (10) Do not use the unit in a strong electromagnetic field or it may cause incorrect measurements. 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, AC adaptor, 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) When using the unit next time, perform the maintenance to make sure it works properly and safety. 9. Maintenance and inspection (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 damp cloth before use. Using alcohol or thinner may damage the probe. (2) The probe transducer tip is very thin and delicate. Please handle with great care and use the probe cap when not in use. (3) Optional sterilizable probe (reusable) can be sterilized in the manner described in § 5-3.Probe sterilization. (4) 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 such as baby oil and cream may damage the probe.
(3) The ultrasonic gel enclosed is non-sterile and do not use it for surgeries. (4) Incidence of allergy: Discontinue use of gel if any allergic reaction occurs. 12. Battery (1) When battery is extremely low, the LCD display will not operate. Also there will be no speaker sounds. Charge the battery. (2) Battery life is 300 full charges. When full charging life is obviously short, contact your dealer for replacing battery. 13. For transportation of the unit, it should be packed properly to protect against shock. 14. Repair services (1) When the unit gets out of order, contact the dealer for repair from whom you purchased the unit. (2) Only authorized persons should perform the repair services. 15. Do not disassemble the unit. 16. Destruction (1) In case of destruction of the unit, follow the instructions for disposal of the destruction appointed by each country or local government. (2) Do not place battery in a fire or it may cause an explosion and injury. 17. Any connected computer is not allowed to be in the patient area according to EN60601-1.
1. Introduction Thank you very much for choosing the Smartdop 45. The Hadeco Smartdop 45 is a uniquely designed bi-directional handheld Doppler with LCD display and fast printer. The Smartdop displays velocity waveforms, numerical data and heart rate. Also it prints them out. Please read this manual carefully to acquaint yourself with the Smartdop operation. This medical device can be used by doctor for the purposes mentioned in "1-2. Clinical applications" for patient in hospital and clinic. For the use with computer, refer to the operating manual for Windows linking software optional.
1-1. Features BI-DIRECTIONAL HANDHELD DOPPLER WITH BACKLIT LCD DISPLAY and FAST PRINTER Displays real-time velocity waveforms, numerical data and heart rate. Prints frozen waveform, numerical data and monitored heart rate as well as patient data. HADECO DESIGNED SMART MICROPROCESSOR Various mode settings are available for optimal measurement with the menu displayed on the LCD and unique Scroll Button. 30 waveform memory CONVENIENT PROBE ACTIVATION BUTTON Freezes and prints waveform and numerical data for notation. Button function can be changed on probe key mode setting, PRB-KEY. MULTIPROBE SELECTION of 2, 4, 5, 8, 10 and 20MHz. 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 Venous testing
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1-2. Clinical applications Detection of heart rate Probe to be used:
BT2M20S8C (2 MHz)
Detection of arterial and venous blood flow velocity for vascular
disease Probes to be used:
BT2M20S8C (2MHz) 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.
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2. Appearance
1 2
2-1. Front left view
3
4
<Scroll Button> Back Button
19 13
14 UP 15
12
Right
18
11
Enter
9
17 Left
5
10 7 8
16 Down
6
8
1. Paper cover:
For printer paper
2. Cover Open Button
To open the paper cover
3. LCD display:
Displays waveform, numerical data, heart rate and menu for mode settings
4. Speaker:
Outputs Doppler sounds
5. Probe connector #1:
To connect probe
6. Power button:
To turn the unit on / off
7. Volume control:
To adjust sound volume
8. Strap hole:
To attach hand strap
9. Headset:
To connect headset. It cuts off the speaker
10. AC adaptor connector:
To connect the designated AC adaptor
11. Probe connector #2:
To connect probe See §7-2. Others for 2nd probe holder option.
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12. Charging indicator:
Indicates battery status. Orange: Charging Green: Fully charged
13. Scroll Button: Consists of 5 internal buttons and has following functions; 14. Up:
To select upper menu item. To increase waveform memory number in Freeze mode. To move cursor up on the on-screen keyboard.
15. Right:
To move cursor right on the on-screen keyboard. To go to sub-menu.
16. Down:
To select lower menu item. To decrease waveform memory number in Freeze mode. To move cursor down on the on-screen keyboard.
17. Left:
To move cursor left on the on-screen keyboard. To go back to main menu from sub-menu or get out from menu. To turn backlight on/off.
18. Enter:
To go to menu mode. To perform the selected command on the menu.
19. Print / Back Button:
To activate / deactivate the printer. To go back to previous screen. To get out of Site guidance mode .
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2-2. Front right view and Probe
1
2
5
4
3
1. Probe holder:
For probe placement when not in use.
2. Communication port:
To connect computer. (USB)
3. Probe:
Multi-probe selection of 2, 4, 5, 8 and 10 MHz
4. Probe button:
To freeze and unfreeze the waveform. To activate and deactivate the printer. Note: The function is defined in the menu PRB-KEY.
5. Probe cap:
See “§4-2-t, OTHERS - PRB-KEY” for the details. To protect the probe transducer tip when probe is not in use.
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3. Quick start For the first time of use and in case the unit has been not used for a while, fully charge the internal battery.
3-1. Turning the unit ON / OFF (1) Connect the probe to the probe connector so that the polarity mark
Polarity mark
will be placed under
mark as shown in the right (12 o’clock).
Power button Press the power button to turn the unit ON. Smartdop will show a moment what probe is connected as shown in the right. In case no probe is connected, it will show “NC” for no connection as shown in the right.
NC
Automatic power OFF: When the AUTO-OFF mode 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) 5 minutes when no signal. (c) 10 minutes when on freeze mode.
Note: If Automatic shut-off functions while on Freeze mode, Smartdop will revert to Freeze mode and display the frozen waveform on LCD by turning the unit on.
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3-2. Charging / Discharging battery Charging battery: (1) Turn the unit off and plug the AC adaptor to the unit to charge battery. The charging indicator will
Charging indicator
go solid ORANGE while charging is in progress. Note: Use the designated AC adaptor. Model name: GMPU18EI-3
(2) When the battery is fully charged, the charging indicator will go solid GREEN. Unplug the AC adaptor. AC adaptor connector Discharging battery: Using and charging the battery repeatedly without fully discharging may cause a shorter full charge battery life. Fully discharge battery before charging every once in a while as follows:
(1) Turn the unit off and plug the AC adaptor.
(2) Press and hold Back button and press Enter and
Back
then Right to start discharging the battery. “DISCHARGE” will appear on LCD while
Up
Left
discharging and disappear when completed. Charging process will start automatically and
Right
charging indicator will go solid ORANGE.
Down Enter
Note: It takes about 3 hours to fully charge battery. Battery life is 300 full charges.
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3-3. Checking battery level (1) Turn the unit on and press Enter button to display the menu.
Battery level indicator
(2) Battery level indicator shows the battery level in 4 steps as shown right. (3) Charge the battery when in low. Full
30% 30%
70%
Low Low
Low battery indicator
3-4. Setting printer paper (1) Press Cover Open Button to open the paper
Roll shaft
cover and remove the roll shaft.
(2) Insert the roll shaft into the paper roll.
(3) Set them in the paper compartment as shown in the right. Pull the paper edge out a few inches over LCD and close the paper cover completely.
Cover Open Button
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30%
3-5. Measuring blood velocity 3-5-1. Normal mode This section explains the fundamental use of testing blood velocity. Refer to “4. Menu and Mode Settings” for various uses. (1) Put ultrasonic gel on the probe top or patient skin.
Put the probe on the testing area and move it slowly to locate the point where the maximum Doppler sounds are heard. An ideal probe angle to the vessel is approximately 45 to 60 degrees.
(2) When the waveform becomes rhythmical and stable, wait more than 5 sec without moving the probe, and press the probe button to freeze the waveform. Press Print Button to print the waveform of last 5 sec if necessary.
Probe button
Note1: Probe button function can be selected from PRINT, FRZ & PRINT or FREEZE on PRB-KEY mode setting. See “§.4-2-t. OTHERSPBR-KEY” for details. Note2: If FREEZE mode is set for AUTO, Smartdop will freeze the waveform automatically when the waveform becomes stable. See “§.4-2-k. OTHERS-FREEZE” for details.
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(3) Headset (Option) can be used to listen to Doppler sounds. It will cut off the speaker.
Headset connector LCD Backlighting time: LCD backlighting time can be adjusted on BACKLIGHT mode setting. See the section “§.4-2-q. OTHERS - BACKLIGHT” for details. Press LEFT button to turn it ON / OFF instantly during testing.
3-5-2. Site guidance mode This mode allows you to easily proceed multiple Smart-V-Link testing by just pressing probe button without connecting Smart-V-Link. 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.
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<Site Screen of Smart-V-Link>
Site guidance mode procedures: (4) 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.
Memory number Abbreviated site & test name
(5) Press the probe button to start monitoring
Probe button
waveform. Press Back button to get out of “Site guidance mode” for normal mode operation. (6) Press 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. (7) Press probe button the 3rd time to store the frozen waveform data on the designated memory number. (8) The 1st guidance for the next testing will appear as shown in the right. Repeat steps #(5) to #(8) until all testing is completed.
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Probe button
3-6. Measuring heart rate (2 MHz only) This section explains the fundamental use of measuring heart rate. Refer to “4. Menu and Mode Settings” for various uses. (1) Connect the 2MHz probe to the unit and turn the unit ON. (2) Press Enter to display MENU and set DISP mode for WAVE or DATA. If necessary, change the upper and lower limits by pressing UP & Down between 60 and 220 BPM at 5 BPM intervals and press Enter to set them. See “§4-2- w. UPPER” and “§4-2-x. LOWER” for details. (3) Put ultrasonic gel on the probe top or the skin surface. (4) Put the probe on the middle of the abdomen, as shown in the right, and move it slowly to locate the point where the maximum heart beat Doppler sounds are heard. Caution: Verify the heart rate. (5) When the heart rate becomes stable, press the probe button or Right button to freeze it. In case FHR exceeds the upper and lower limits, LCD will start flashing for warning and also, beep sounds will be heard if SOUND mode is set for ON. See “§4-2- v. SOUND” for details.
Upper limit
Lower
WAVE mode
DATA mode (6) Headset (Option) can be used to listen to Doppler sounds. It will cut off the speaker.
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3-7. 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 2MHz probe to the unit and turn the unit ON.
(2)
Press Enter 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 pressing Up & Down between 0 and 120 cm/s at 1 cm/s intervals and press Enter to set it.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, as shown in the right, and move it slowly to locate the point where the maximum Doppler sounds are heard.
(6)
When velocity exceeds the limit, beep sounds will be heard.
Limit
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4. MENU and Mode settings Note: For the mode settings for options, see “§ 7-3-5. Menu for PPG”.
4-1. Menu By using Scroll buttons, various mode settings can be selected on Menu mode. Some of the menus consist of sub-menu(s).
4-1-1. Menu structure
2MHz only
4-1-2. Menu operation To show MENU: Press Enter to show MENU. Left
Up Right
Enter Down <Buttons on left side of Smartdop 45>
To select the mode: Select the mode by pressing Up & Down buttons and selected mode will be highlighted. Press Enter once or twice to change the mode setting.
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To go to sub-menus: MEMORY, PATIENT and OTHERS consist of sub-menus.
Sub-menus
Press Enter to go to sub-menus. Press Right to show lower sub-menus. On lower sub-menu of either MEMORY or LANGUAGE, press Up & Down to select memory number or language, respectively. Press Left once or twice to go back to main
Lower sub-menus
menu or to get out of menu mode. FLOW / DIAMETER menu: Setting FLOW for ON activates DIAMETER menu for volume flow calculations. See “§4-2-g. FLOW / 4-2- h. DIAMETER” for details.
DIAMETER menu
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4-1-3. Menu for Blood Velocity Measurement mode Menu
MEMORY
Sub-menu
Selections
Reference in §4-2
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
DIR
Forward
Reverse
e. DIR
TIME
Normal
Slow
f. TIME
FLOW
ON, OFF
g. FLOW
DIAMETER
0.1mm – 20.0mm
h. DIAMETER
PATIENT
Separate
ID, NAME, SEX, AGE, DATE, SITE, MEMO LANGUAGE
d. MODE
i. PATIENT
ENGLISH, DEUTSCH, ITALIANO, j. OTHERS - LANGUAGE ESPANOL, FRANCAIS
OTHERS
FREEZE
MANUAL, AUTO
k. OTHERS - FREEZE
UNIT
cm/s, kHz
l. OTHERS - UNIT
FILTER
ARTERIAL, VENOUS
m. OTHERS - FILTER
SMOOTH
NORMAL, LOW-PASS
n. OTHERS - SMOOTH
DISP
WAVE, DATA
o. OTHERS - DISP
CAL
ON, OFF
p. OTHERS - CAL
BACKLIGHT
ON, OFF, 60sec, 50sec, 40sec,
q. OTHERS - BACKLIGHT
30sec, 20sec, 10sec AUTO-OFF
ON, OFF
r. OTHERS - AUTO-OFF
P.ID PRT
ON, OFF
s. OTHERS - P.ID-PRT
PRB-KEY
FRZ&PRINT, PRINT, FREEZE
t. OTHERS - PRB - KEY
DATE
MMM.DD,YYYY HH:MM:SS
u. OTHERS - DATE
PRB20MHz
ON, OFF
x. PRB20MHz
Note1: Selections in bold face in the table above are default settings. Note2: PRB20MHz menu is only available when either a 20MHz probe or no probe is connected.
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4-1-4. Menu for Blood Velocity Freeze mode Menu
MEMORY
Sub-menu
Selections
Reference in §4-2
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
DIR
Forward
DISP
WAVE, DATA
v. DISP
FLOW
ON, OFF
g. FLOW
DIAMETER
0.1mm – 20.0mm
h. DIAMETER
PATIENT
Separate Reverse
ID, NAME, SEX, AGE, DATE, SITE, MEMO LANGUAGE
d. MODE e. DIR
i. PATIENT
ENGLISH, DEUTSCH, ITALIANO, j. OTHERS - LANGUAGE ESPANOL, FRANCAIS
FREEZE
MANUAL, AUTO
k. OTHERS - FREEZE
BACKLIGHT
ON, OFF, 60sec, 50sec, 40sec,
q. OTHERS - BACKLIGHT
30sec, 20sec, 10sec
OTHERS
Note:
AUTO-OFF
ON, OFF
r. OTHERS - AUTO-OFF
P.ID PRT
ON, OFF
s. OTHERS - P.ID-PRT
PRB-KEY
PRT & FRZ, PRINT, FREEZE
t. OTHERS - PRB - KEY
DATE
MMM.DD,YYYY HH:MM:SS
u. OTHERS - DATE
Selections in bold face in the table above are default settings.
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4-1-5. Menu for Heart Rate mode (Measurement and Freeze) Menu
Sub-menu
Selections
Reference in §4-2
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
LIMIT-1
0 – 120cm/s or 0.0 – 12.0kHz
z. LIMIT-1
LIMIT-2
MAX, AVE
aa. LIMIT-2
SOUND
ON, OFF
v. SOUND
UPPER
60 to 220 (every 5 BPM)
w. UPPER
LOWER
60 to 220 (every 5 BPM)
x. LOWER
MEMORY
PATIENT
ID, NAME, SEX, AGE, DATE, SITE, MEMO LANGUAGE
i. PATIENT
ENGLISH, DEUTSCH, ITALIANO, j. OTHERS - LANGUAGE ESPANOL, FRANCAIS
BACKLIGHT
ON, OFF, 60sec, 50sec, 40sec,
q. OTHERS - BACKLIGHT
30sec, 20sec, 10sec OTHERS AUTO-OFF
ON, OFF
r. OTHERS - AUTO-OFF
P.ID PRT
ON, OFF
s. OTHERS - P.ID-PRT
PRB-KEY
PRT & FRZ, PRINT, FREEZE
t. OTHERS - PRB - KEY
DATE
MMM.DD,YYYY HH:MM:SS
u. OTHERS - DATE
Note: Selections in bold face in the table above are default settings.
Button operation for Heart Rate mode only 1. Right: To freeze and unfreeze the waveform & heart rate. 2. Up & Down:
To restart waveform monitoring when on WAVE mode.
3. Left:
To show next page of monitoring waveform when on Freeze mode.
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4-2. Mode Setting Details a. MEMORY - STORE (1)
The first memory number available will be selected automatically on STORE. If necessary, change the number where to store waveform data and patient data by pressing Up and Down.
< On normal mode>
Note: The memory number with "*" indicates memory area where other data have been already stored. < On site guidance mode> (2)
Press Enter to store the data into the memory and it will go back to waveform display.
Note: If other data have been already stored in memory number storing, a confirmation of "OVERWRITE?" will be shown. Press Enter to overwrite, or Left to cancel for selecting other memory number available. b. MEMORY - READ (1)
Select the memory number where you wish to read waveform data and patient data from by pressing Up & Down.
(2)
Press Enter button to show the waveform.
(3)
Press Up & Down to show next waveform if necessary.
Note: Any frozen waveform is stored temporarily in memory area of FREEZE separated from regular 30 memory. 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.
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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 Enter and then the confirmation screen with waveform data will be displayed as shown in the right. Press Enter to clear the memory, or press Left 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 Enter to change the baseline mode as follows: Compound mode:
Combined forward and reverse components
Separate mode:
Separation of forward from reverse component
Separate mode
Compound mode e. DIR (Flow Direction)
(1) Press Enter 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.
Forward
Reverse
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f. TIME (Time scale) (1)
Press Enter to change the time scale as follows: Normal:
For arteries (2.56 sec/screen)
Slow:
For veins (12.8 sec/screen)
g. FLOW (Blood volume flow) / h. DIAMETER (Estimated vessel diameter) Blood volume flow will be calculated on blood velocity measurement & freeze modes when FLOW is set for ON. (1)
Press Enter to set FLOW mode for ON and DIAMETER menu will be shown as shown below.
Set FLOW ON
(2) Set the estimated vessel diameter by pressing Up & Down for anywhere between 0.1 and 20.0 mm at 0.1 mm intervals and Smartdop 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 Right 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
Indication of next / previous page
i. PATIENT (Patient data input) Patient data contains ID, NAME, SEX, AGE, examination DATE, test SITE and MEMO. Save the patient data on Measurement mode and it will apply to all of future measurement data until it's changed so that you won't have to input the same data for the same patient again. If it is done on Freeze mode, the patient data will apply only to the stored/FREEZE data selected.
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(1) Prior to the patient data input, go to OTHERS-DATE menu and set the date and time for an initial setting. Scroll to the item where you wish to input and press Enter to display data input screen. With SEX, pressing Enter changes Male / Female. DATE can be changed on PATIENT menu when on FREEZE mode only. (2) Scroll to the letter you wish and press Enter to type it. Pressing Back Button or entering Backspace (
Screen keyboard
) deletes the letter you typed
previously. (3) After entering the data, scroll to
(Enter)
and press Enter to save the data. (4) Press Left to get out of Patient Data screen.
Copy / Paste / Clear of the data You can copy and paste the patient data to the other patient data area when on FREEZE mode mainly for your convenience. (1) Press Back Button while Patient Data screen is displayed. (2) Scroll to the edit command and press Enter.
COPY will copy all items of the patient data to clipboard.
PASTE will paste the clipboard data to the other patient data area. It overwrites the existing data. All items except DATE will be pasted at once.
CLEAR will delete the patient data.
PASTE and CLEAR commands require the confirmation as shown in the right.
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Press Enter to proceed or press Left to cancel.
Press Back Button to go back to Patient Data.
j. OTHERS - LANGUAGE (1) Press Up & Down to select the language you wish for menus and messages and press Enter to set it. k. OTHERS – FREEZE (1) Set FREEZE for AUTO to freeze the waveform automatically when it becomes stable. Set it for MANUAL for freezing waveform manually. l. OTHERS - UNIT (cm/s / kHz) (1)
Press Enter to change the unit of blood flow as follows: cm/s:
Blood flow velocity
kHz:
Doppler-shifted frequency
m. 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 Enter to change the filter as follows: ARTERIAL: For arteries VENOUS:
For veins
n. OTHERS - SMOOTH (Smoothing filter) (1) Press Enter to change smoothing frequency as follows: NORMAL:
For normal signals
LOW-PASS: For noisy signals o. DISP (DISP, OTHERS – DISP, DISP/BEEP) (1) Press Enter to change the Display mode as follows: <DISP> WAVE: Waveform DATA:
Numerical data
BEEP:
2MHz BEEP mode
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<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, pressing Up & Down restarts the monitoring. p. OTHERS - CAL (Calibration) (1)
Press Enter to change CAL mode as follows: ON:
Displays 4 step (3, 2, 1, 0, -1 kHz) calibration waveform.
OFF:
Measurement mode
q. OTHERS - BACKLIGHT LCD backlighting time can be adjusted on BACKLIGHT mode. (1)
Press Up & Down to select the time and press Enter 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 Left button on the unit. When BACKLIGHT is set for Auto-off, backlight goes
Left
off in auto-off time of no operation and any button operation will turn the light on again. r. OTHERS - AUTO-OFF (Automatic shut-off) (1)
Set it for ON / OFF for auto-off on / off. See Ҥ3-1. Turning the unit ON / OFF for more details.
s. OTHERS - P.ID PRT (Patient data print) (1) Press Enter to change the mode as follows: ON:
Prints with patient data.
OFF:
Prints without patient data.
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t. OTHERS - PRB-KEY (Probe button function) (1) Press Enter to change the probe button function as follows: PRT&FRZ: Freezes and prints. PRINT:
Prints
FREEZE:
Freezes
Note: When on FHR - DATA mode, printing is not functional even though PRB-KEY mode is set for either PRT&FRZ or PRINT. u. OTHERS - DATE (Date and time setting) (1)
Press Enter to go to Date Setting screen.
(2)
Scroll item with Right and Left, and adjust it with Up & Down.
(3) Press Enter to set it or press Back Button to cancel. v. SOUND (Beep sound for FHR mode) Set SOUND mode for ON to activate beep sounds for warning when heart rate gets out of upper and lower limits during the test except 1st 30 sec. (1) Press Enter to change beep sound ON / OFF. w. UPPER (Upper limit for FHR) In case heart rate exceeds the upper limit during the test except 1st 30 sec, LCD will start flashing for warning. (1) Press Up and Down to select the upper limit in 5 BPM steps and press the button to set it. Upper limit
Lower limit
x. LOWER (Lower limit for FHR) In case heart rate gets below lower limit during the test except 1st 30 sec, LCD will start flashing for warning. (1) Press Up and Down to select the lower limit in 5 BPM steps and press the button to set it.
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y. PBR20MHz For 20MHz probe, set 20MHz mode for ON before connecting the probe. z. LIMIT-1 (For 2MHz BEEP mode) In case maximum or average blood velocity exceeds the limit, beep sound will be heard for warning. aa. LIMIT-2 (For 2MHz BEEP mode) Press Enter to select the mode as follows; MAX:
Beeps when maximum velocity exceeds limit.
AVE:
Beeps when average velocity exceeds limit.
Limit Average waveform
Max waveform
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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 being come 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, 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" before using the unit.
5-3. Probe sterilization 5-3-1. Sterilizable probes: 8MHz:
VRP-08 LRP-08 FDP-08 ACP-08
10MHz:
VRP-10 LRP-10 NRP-10H NRP-10HF
20MHz:
NRP-20H NRP-20H1NF
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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 1. All sterilizable probes except ACP probe: Up to 50 times 2. ACP probe: Up to 5 times (steam autoclave) Note. Do not exceed sterilization limits or it may cause damage to probes. Caution: 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 "Sterilization" below. Instructions for sterilization: Point of preparation: No particular requirements. Preparation for cleaning: No particular requirements. Cleaning: Automated Manual Disinfection:
Do not do automated cleaning of probes other than ACP probe. Do not soak probes into medicinal solution. Wipe any contamination from probes with damp cloth. Not applicable
Sterilization: Sterilizable probes except ACP probe; Low temperature plasma sterilization (Hydrogen peroxide low temperature plasma sterilization), under 60°C. 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.
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