Operation/Technical Manual: Full Digital Ultrasonic Diagnostic System
Operation/Technical Manual: Full Digital Ultrasonic Diagnostic System
WED-3000
(Version: V1.5)
Operation/Technical Manual
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4.11 probe work frequency.................................................................................................................... 25
4.12 Frame-related adjustment.............................................................................................................. 25
4.13 M rate adjustment.......................................................................................................................... 26
4.14 Screen cleaning.............................................................................................................................. 26
4.15 Restore factory settings..................................................................................................................26
5 Image processing.................................................................................................................................... 27
5.1 Overview..........................................................................................................................................27
5.2 Cine loop..........................................................................................................................................27
5.3 Static image storage......................................................................................................................... 28
5.4 Image export.................................................................................................................................... 28
5.5 ZOOM............................................................................................................................................... 29
5.6 Upside down.................................................................................................................................... 29
5.7 Turning around.................................................................................................................................29
5.8 Pseudo color procedure....................................................................................................................30
5.9 Bar chart...........................................................................................................................................30
5.10 Image cleaning...............................................................................................................................30
6 Explanation............................................................................................................................................... 32
6.1 Overview..........................................................................................................................................32
6.2 Type the basic information of the patient and hospital.................................................................... 32
6.3 Image explanation............................................................................................................................33
6.4 date and clock adjustment................................................................................................................34
6.5 Language switching......................................................................................................................... 34
6.6 Body mark....................................................................................................................................... 34
7 Measurement........................................................................................................................................... 36
7.1 Ordinary measurement.....................................................................................................................36
7.1.1 Distance measurement.................................................................................................... 36
7.1.2 perimeter/area measurement.......................................................................................... 36
7.1.3 Volume measurement.......................................................................................................38
7.2 Cardiac Measurement (with the mouse).......................................................................................... 38
7.2.1 Left Ventricular Measurement......................................................................................... 38
7.2.2 Aortic Valve Measurement............................................................................................... 40
7.2.3 Mitral Valve Measurement............................................................................................... 41
7.2.4 Pulmonary Valve Measurement...................................................................................... 41
7.2.5 Tricuspid Valve Measurement......................................................................................... 43
7.2.6 Heart Rate Measurement.................................................................................................43
7.2.7 Clear the contents of the report...................................................................................... 44
7.3 Obstetrics calculation.......................................................................................................................44
8 Report........................................................................................................................................................46
9 Check and Maintenance......................................................................................................................... 48
9.1 Service life....................................................................................................................................... 48
9.2 Main unit maintenance.....................................................................................................................48
9.3 Probe maintenance...........................................................................................................................49
9.4 Correct usage of probe.....................................................................................................................50
9.5 Battery information..........................................................................................................................50
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10 Simple Trouble Shooting...................................................................................................................... 52
10.1 Check............................................................................................................................................. 52
10.2 Simple trouble shooting................................................................................................................. 52
11 Transportation and Storage..................................................................................................................53
11.1 Environment requirements on transportation and storage..............................................................53
11.2 Transportation................................................................................................................................ 53
11.3 Storage........................................................................................................................................... 53
Appendix A Acoustic output reporting table.............................................................................................54
Appendix B Obstetrics................................................................................................................................58
Manufacturer Information...........................................................................................................................68
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Preface
Statement
� This publication, including pictures and illustrations, is property of Shenzhen Well.D Medical
� Information in this document is not annotated to change. The manufacture shall not state nor
observe any warranty basing on this point, and definitely give up any implied warranty basing on
� Without previous written permission from the producer, this document must not be photocopied,
� We preserve the right of revision on this document without still further notice.
� Some pictures in this manual, which are schematic diagrams for indication only, may disaccord
with the real object, and then the real object should be regarded as the final.
� is trade marks of Shenzhen Well.D Medical Electronics Co., Ltd. Any abuse of these trade
marks without permission will be sued to assume legal responsibility according to laws.
Manufacturer's warranty
� Shenzhen Well.D Medical Electronics Co., Ltd. assumes the responsibility for equipment security,
reliability and performance only under the preconditions that the disassembly, assembly and
maintenance of the equipment are all performed by its assigned professional and the equipment is
� Shenzhen Well.D Medical Electronics Co., Ltd. ensures a guarantee period within a year and a
half since the delivery day and promises there is no problem with the new equipment in material
and technology. Within the guarantee period, Shenzhen Well.D Medical Electronics Co., Ltd. will
maintain the equipment and replace the parts of non-man-made damages free of charge. But will
� This guarantee is only available for failures occurred when the equipment is operated in
compliance with the operation manual. And the guaranteed equipment can only be used in the
� This guarantee excludes losses or damages caused by external reasons such as thunder struck,
� Shenzhen Well.D Medical Electronics Co., Ltd. shall not be responsible for damages caused by
� When there is problem with the products, please contact Shenzhen Well.D Medical Electronics
Co., Ltd. and explain the equipment model, serial number, date of purchase and the problem.
� To ensure operational safety and long-term stable equipment performance, please read this
operation manual closely and understand the equipment functions, operation and maintenance at
all points before operating the equipment, especially contents of "Warning", "Caution" and
"Note".
� Maloperation or inobservance of the instructions given by manufacturer or its agents may result
� The following convention works through this manual to lay special emphasis on some
information.
� "Warning": Stands for neglect of it will cause severe personal injury, death or realized
property loss.
� "Caution": Stands for neglect of it will cause slight personal injury or property damage.
information is very significant but with no risk. Any warning against dangers shall not be
contained in NOTE.
Safety labels
Type B equipment
Signal output
USB2.0
ClassⅡ equipment
Mouse
Probe socket
-2-
Handle carefully
Temperature limit
Upward
Keep dry
◆ In operation
1. Heat radiation holes are strictly prohibited to be covered.
3. On scanning, if any abnormal case is found, stop scanning immediately and shut down
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the equipment.
5. When operating, do not press the keyboard panel too much, otherwise the equipment
might be damaged.
◆ After operation
1. Power off the equipment.
2. Pull out the plug from power supply socket instead of pulling the cable.
3. Clean off the couplant on the probe with soft medical sterilized cotton ball.
Safety of the operator and patients and reliability of the equipment are taken into consideration
during designing and producing, the following safety precaution must be implemented:
1. The equipment shall be operated by qualified operating staff or under their instructions.
2. Do not open the equipment and change the parameters without permission. If necessary,
please turn to for Shenzhen Well.D Medical Electronics Co., Ltd. or its authorized agent
for service.
3. The equipment has already been regulated into its optimal performance. Do not adjust
any preset control or switch unless operate as per instructions in the manual.
4. If there is equipment failure, please shut down the equipment at once and contact for
devices , please contact Shenzhen Well. D Medical Electronics Co,. Ltd. before
connection.
7. Do not hit the fragile TFT-LCD display. If it cracks, deal carefully with it in case the liquid
-4-
crystal gets into eyes or mouths.
8. Must not hit the inner chargeable Li-ion battery nor throw it into fire in case it trigger an
explosion ; Do not short circuit the battery output electrodes in case the battery be
damaged; and please use the original binding charger to charge the battery. More over,
because used battery will cause environment pollution, please handle the battery
9. Must not disassemble the power supply adapter. If failures happen, it should be handled
by the professional; the charging output can only be used for charging the battery of the
equipment, any improper use on other battery may cause explosion, fire and other
unexpected hazards.
10. Must not short circuit the output of the adapter, a long term short circuit shall result in
adapter damage.
11. Please use standard power cord as the input line of the network power supply for the
12. Shenzhen Well.D Medical Electronics Co., Ltd. shall not take any responsibility for any
13. To disconnect the equipment from the power supply network by unplug the adapter from
-5-
EMC statement
WED--3000 shall not affect the basic performance of radio service and other equipments and can
WED
work well in its stated electromagnetic environment.
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-7-
-8-
Warning
When WED-3000 works in strong electromagnetic environment exceeding its statement,
its image might be interfered and the diagnoses could be influenced. At this time,
please stop operating until the EMC interference is removed.
Warning
When WED-3000 works at the state of overlapping or paralleling with other equipments,
there might be unexpected EMC problems
problems;If If it must work close to other equipments,
please observe carefully and check if some equipment is influenced by unexpected EM
coupling.
Warning
Replacement of non-standard probe parts may cause unexpected EMC problem.
-9-
NOTE
Accessory equipment connected to the analog and digital interfaces must be certified
according to the respective IEC standards (e.g. IEC 60950 for data processing
equipment and IEC 60601-1-1 for medical equipment). Furthermore, all configurations
shall comply with the valid version of the system standard IEC 60601-1-1. Everybody
who connects additional equipment to the signal input or signal output part configures
a medical system, and is therefore responsible that the system complies with the
requirements of the valid version of the system standard IEC60601-1. IF in doubt,
consult the technical service department or your local representative.
Contraindication:
It is suggested not to probe the part with wound or acute inflammation to avoid cross infection.
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1 Summary
micro-computer control and digital scan converter (DSC), digital beam-forming (DBF),
real time dynamic aperture (RDA), real time dynamic receiving apodization, real time
Dynamic receiving focusing (DRF), Digital frequency Scan (DFS), frame correlation
technologies to endue its image with clarity, stability and high resolution.
� There are five display modes: B, B+B, B+M, M and 4B; And 256 gray scale.
� The system can process real time image display, freeze, save, load, up and down flip, left
and right flip, capacity cine loop; Multi-level scanning depth, dynamic range, Scan angle,
frame correlation factor regulation and focus number, focus position, etc.
� Date, clock display; name, sex, age, hospital annotation; Distance, circumference, area,
volume and heart rate measurement; the system offers 256 gray scale and 40 Body
marks.
� Video output offers connection to external video image printer and large-screen display
and other equipments. High speed USB port provides real time image transfer to the PC.
� Combined power supply mode of AC adapter and built-in chargeable battery, 3 battery
charging modes and the low power consumption and advanced power management
� 7 inches TFT-LCD display and field programmable gate array (FPGA) and surface
mounted technology (SMT) make this equipment compact and light in weight.
� The equipment consists of main unit, probe and adapter. Standard configuration is
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1.3 Appearance
Front sketch
EC1-7/13R/6. C1-12/20R/5.
L1-5/7.5MHz C1-11/50R/3.
Probe 5MHz 0MHz
HF linear 5MHz convex
endo-vaginal micro-convex
Blind zone(mm) ≤3 ≤6 ≤5 ≤5
Geometric Horizont ≤5 ≤7.5 ≤5 ≤7.5
position al
precision Vertical ≤5 ≤5 ≤5 ≤5
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Monitor size 7 Inch TFT LCD
Interface 2*USB2.0,VIDEO,MOUSE
Battery Continuous work ≥3Hours
Size L(265mm)*W(46mm)*H(153mm)
Power 45W
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1.6 Standard configurations
� Main unit
� power adapter
� Battery
� Manual
� Packing List
� Printer
� CD
Warning:
Please use the spare parts specified above. The manufacturer shall not bear the
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2 Installation
� Avoid strenuous vibration during operation; Keep away from equipments with high
electric field, high magnetic field and high voltage; avoid strong sunlight on the display;
Note:
Check according to the "packing list" after uncasing and make sure that there is no
shipping damage, and then install the equipment according to requirements and
Warning:
security.
manufacturer..
The probe should be protected from felling off or crashing and the manufacturer
Install battery: Set the battery into the battery slot and move the battery release key on its side to top
till the battery is inserted completely and then release the key (refer to figure).
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2.3 Installing and disassembling probes
Install probes:
The probe jack lies in the bottom of the right side of the equipment. Adjust the probe plug
mark position and insert it, turn the plug lock sleeve counter-clockwise. There is only one plug
jack which is also compatible for those optional probes (refer to figure).
1 2
Disassemble probes:
It is the reverse process of installation.
Warning:
instructions,,
Installation and disassembly of the probe must comply with the operation instructions
must not twiddle the sheath around the plug (refer to figure).
Warning:
Do not by all means unplug or plug the probe connector at state of log on in case the
probe and main unit be damaged.
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2000 times of efficient connection and disconnection of the probes are
guaranteed.Once the probe is connected with the main unit, do not unplug nor plug it
at discretion in case poor contact happen.
Warning:
The probe should be protected from felling off or crashing and the manufacturer
assumes no responsibility for the kind of hazard.
Warning:
Must not touch the contact pin in the probe connector.
Warning:
Please handle the equipment carefully.
1. Check the input power cord plug of the adapter to see if it matches the EPS outlet.
2. Check the EPS to see if it is in the specified range and the power cord to see if it is connected well.
3. Check the adaptor to see if it works well: Plug the power cord into the AC input outlet, switch on the
power switch of the outlet, if the DC output indicating light turns on green, it works well.
4. Shut the power switch of the outlet.
5. Insert the DC output plug of the adapter into the DC14V/3A outlet in the rear of the equipment, switch
on the outlet.
6. Press the power switch, the main unit is power on and the power indicator light turns on, that means the
adapter operate well.
Note:
At power off state, there is still certain power consumption with the main unit. If the
main unit can not be turned on when pressing down the switch, that is to say the
battery is running up and needs charging.
Note:
When the main unit charging/volume indicator light is flashing, that is the battery is
running up and it should be charged as soon as possible.
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Warning:
It is prohibited to use any other power supply except the standard adapter as the
external power supply for the main unit.
2. Insert the plug of “ ” of the adapter into the “DC14V/3A” interface on the rear.
1. Take out the battery from the main unit or take out the spare battery.
2. Connect the round end of the adaptive line to the " " terminal of the adapter, and the flat end to
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4. When the " " indicator light on the adapter turns into red, the battery is in charging; when the
" " indicator light turns into green, the battery is fully charged. (Refer to figure).
1. Take out the battery from the main unit or take out the spare battery.
2. Connect the flat end marked with an arrow of the auto-charger to the charging terminal of the battery.
3. Plug the other end of the auto-charger into the cigar lighter socket.
4. When the "Charging" indicator light on the adapter turns into red, the battery is in charging; when the
"Charging" indicator light turns into green, the battery is fully charged. (Refer to figure).
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3 Operating procedures
Power switch
Freezes button
Probe socket
Function button
Mouse
As a supplement of computer operation, mouse can make the measurement faster and more convenient. PC
mouse of which the left button, middle button and right button have specific functions is applied to the
equipment.
Left button
Middle button
Right button
● Determine the start and end position of the cursor, and switch the start cursor and end cursor in the
● Determine the start position of the cursor and complete the measurement of perimeters and areas in
● Be equal to the role of button in the elliptical type measurement of perimeters and areas.
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3.2 Display interface
Hospital name Patient name Patient age Patient gender System date, time probe type
Probe frequency
Doctor name
Probe raster
Press “ ” to type the information including name, PID, age, gender, hospital, doctor.
4. Spread ultrasonic coupling agent on the probe acoustic shadow surface, and close to the scanning area,
6. Create a report, print the report and image by the connected video printer.
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4 Image parameter adjustment
B mode switching
B/0
Press “B/0
B/0”button in the real-time scanning mode to switch current image to real-time single B mode. (The
BB mode switching
BB/1
Press “BB/1
BB/1” button to switch the current image to double B mode. Real-time image and freeze image are
displayed on the screen. Press “BB”button continuously to switch the real-time and freeze states of two
images.
BM/2
Press “BM/2
BM/2” button to switch the current image to B+M mode. B type and M type real-time images can be
displayed on the screen at the same time. The sample line of B type image can be moved around by mouse
and arrow button. Press this button again to switch the current image to M mode, and then an M type image
4B mode switching
FUNC/3
Press “FUNC/3
FUNC/3”to switch the current image to 4B mode in the B type, BB type real-time scanning mode.
FUNC/3
Four B type images are displayed, one of which is in a real-time state. Press“FUNC/3
FUNC/3”button continuously
B BB B+M
M 4B
Attention:
When you call up the menu, please exit the menu before switching the display mode.
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4.2 Image freezing
Press “ ”button to switch real-time state and freeze state. “FROZEN” on the bottom of screen is the
freeze mark.
Press 7 or 8 button in real-time state to active gain, near field and far field on top right of the screen.
Then press ▲5 and ▼6 button to adjust gain value. The gain adjustment range is 0-62, and the near field
and far field adjustment range is 0-30. The pre-set gain value is 27.
Press to exit.
Press 7 or 8 button in real-time state to lighten “B” on top right of the screen, then press ▲5 and ▼6
Press to exit.
Press 7 or 8 button in real-time state to active this function. The “IM” on the right of screen is
lightening. Then press ▲5 and ▼6 button to adjust sharpen level, there are three levels can be chosen,
Press to exit.
Press 7 or 8 button in real-time state to active this function. The “GY” on the right of screen is
lightening. Then press ▲5 and ▼6 button to adjust the gray scale of image. The adjustment range is
GY0-GY7.
Press to exit.
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Tip:
When an external monitor is applied, the image might be properly displayed only by gray scale
correction.
Press 7 or 8 button in real-time state to active this function. The “DR” on the right of screen is
lightening. Then press ▲5 and ▼6 button to adjust the dynamic range. The dynamic range is 0-192dB, and
Press to exit.
Press ▲5 and ▼6 button in the B type real-time mode to switch the current scanning depth. The current
depth is displayed on the bottom right of screen. The depth adjustment range changes with different probe
depth
90~240 40~90 80~150 50~120
(mm)
Press 7 or 8 button in real-time state to active this function. The “Angle” on the right of screen is
lightening. Then press ▲5 and ▼6 button to switch the scanning angle. When mentioning probe angle,
Press to exit.
angle 70º visual and adjustable 152º visual and adjustable 96º visual and adjustable
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4.10 Focus adjustment
Focus number
Press 7 or 8 button in real-time B mode or BB mode state to light “Focus” on the top right of screen,
+/9
and then press “+/9
+/9”button repeatedly to switch the focal point number to one or two. Meanwhile, the
current focal point number is displayed on the right of screen, such as “focus: 2 D4”, “D4” means that the
Press to exit.
Attention:
When the focus is set to 2, the current image frame frequency would be reduced.
Focal position
Press 7 or 8 button in real-time B mode or BB mode state to light “focus” on the top right of screen,
and then press ▲5 and ▼6 button to move the focus up and down, and change the focal position.
Press to exit.
Tip
Tip:
The focusing of image near the focus indicator is better, and you can change the focus
number and focal position, so that the focus will point to the interest areas.
Press 7 or 8 button in real-time state to light “frequency” on the top right of screen, and then press
▲5 and ▼6 button to adjust frequency. The current frequency will be displayed on the top right of screen,
such as “frequency: 3.5 MHz”. Frequency range of every kinds of probe is listed as following:
Press to exit.
Press 7 or 8 buttons in real-time B mode, BB, 4B mode states to active frame-related adjustment.
“FMAVG” on the right of screen is lighting. Press ▲5 and ▼6 button to change the frame size, and the
result will be displayed on the right of screen, such as “FMAVG: 0.55”. The adjustment range is 0.20-0.95.
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Press to exit.
Tip:
the screen should be lightened in B or BB mode before entering the adjustment mode.
Press“+/9”button in real-time B+M, M mode to adjust the refresh rate of M-type image on the screen. The
current scan rate is displayed on the bottom of screen, such as “ST=2.50S”. There are four levels listed as
3.00S, 2.50S, 2.00S, 1.25S to adjust in B+M mode, and four levels listed as 6.00S, 5.00S, 4.00S, 2.50S to
adjust in M mode.
B/0
Clear the screen measurement mark and measurement result by pressing “B/0
B/0”button in freeze state.
Clear the screen measurement mark and measurement result by pressing button in real-time scanning
mode.
Press “FUNC/4”→“8” button in real-time scanning mode,The total gain, the near field, far field and
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5 Image processing
5.1 Overview
FUNC/4
Press “FUNC/4
FUNC/4”button to display the menu which including some image processing functions, then press
the corresponding number to enter. The “V1.10” on the top of menu presents current software version
-----V1.10-----
0. CINE LOOP
1. SAVE
2. SVLOAD
3. ZOOM
4. UP-DOWN
5. LEFT-RIGHT
6. COLOR
7. AREA-VOLM
8. HISTOGRAM
9. ERASE
First of all, save all pieces of static image in temporary memory (the data in temporary memory will be lost
when the power is off), then play these static image continuously to realize the function of cine loop.
1. Start the equipment into real-time scanning mode, and allow the equipment to conduct the cine
2. Freeze the image, press “FUNC/4”→“0”button in turn to playback, and the image is played in a
bottom left of the screen. “120/408” present current frame and total frame separately.
3. Press ▲5 and ▼6 button during the playback to realize frame step play. Press
Tip:
wouldn’’t
If the image scanning way, probe or display mode is changed, the cine loop operation wouldn
storage::
Local storage
The equipment offers storage space for 64 static images, and the date wouldn’t lost when the power-down.
2. FUNC/4
Press “FUNC/4
FUNC/4”→“1”button in turn to save the image. The prompt “SAVING……05”displayed
on top left of screen indicates that the image saving is conducting, any other operation is
forbidden. And the prompt will disappear when the saving is completed.
The image memory can number the image(01-64) automatically. If 01-20 is used, it would save from 21 the
next time. When the memory is full (save over 64 images), the following dialog box would display during
Prompt whether the image NO.01 should be overwritten, you may choose yes or not.
Tip:
When the memory is full, you may export one image, and then conduct image saving. The system
would prompt whether clear or save from the removed image number.
storage::
U disk storage
U disk into the host and press “ ” → “ FUNC/3 ” → “ 8 ” key, the current stored image serial
number automatically displays at top left corner of the image area. Such as "SAVING......001". When image
FUNC/4
1. Press “FUNC/4
FUNC/4”→“2”button in turn to display the following dialog box:
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PLEASE ENTER STORAGE NO.:
■
2. Type the memory number(such as “01”, press “ ”to delete if there is wrong type.), then
press “ ”to export the first saved image. On the bottom left of screen it displays 01/64 to
present current image number and memory capacity. Now press ▲5 or ▼6 to export other
images in turn.
3. Press “ ”to back to real-time scanning mode, and repeat the above steps to export other
images.
5.5 ZOOM
FUNC/4
At real time or freeze state, press “FUNC/4
FUNC/4”→“3” button in turn to display or close sampling windows.
▼6 ,7 , 8 key. Press “
Move “sampling window” by Mouse or ▲5,▼ B/0
”→“B/0
B/0”in turn to exit.
FUNC/4
Press “FUNC/4
FUNC/4”→“4” continuously in non-4B mode to realize the upside down of image.
FUNC/4
FUNC/4”→“55” continuously in real-time scanning state of B, BB, 4B mode to realize the turning
Press “FUNC/4
around of image. The which on top left of screen is the indicator of image scanning direction.
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5.8 Pseudo color procedure
FUNC/4
Press “FUNC/4
FUNC/4”→“6” in turn to display following dialog box:
Press BB/1 continuously to set image pseudo color circularly, which listed as: black, white, red, yellow,
blue.
Press BM/2 continuously to set the character color circularly, which listed as: white, yellow.
Press FUNC/3 continuously to set the background color circularly, which listed as: gray, blue.
FUNC/4
Press “FUNC/4
FUNC/4”→“8”in turn to call out sample frame after the image is frozen. Move the frame to the
interest image area, Use“9”and key to adjust the size of the sample frame, press “ ” to
conduct measurement. Meanwhile the statistics coordinate and statistics result are displayed on the bottom
right of screen.
In the coordinates, X axis presents gray value and Y axis presents pixels number.
In the statistics result, PT presents pixels number of the sample frame, GM and PM present the
corresponding gray value and pixels number of the highest point in the statistics chart.
B/0
Press “B/0
B/0” to exit the bar chart statistics.
FUNC/4
Press “FUNC/4
FUNC/4”→“9”in turn to display the following dialog box:
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BB/1
Press “BB/1
BB/1” to confirm the image cleaning. The prompt “ERASING... ...”displayed on top left of screen
indicates that the image cleaning is conducting, any other operation is forbidden. And the prompt will
BM/2
Press “BM/2
BM/2”to stop the image cleaning.
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6 Explanation
6.1 Overview
Press “ ” in freeze mode to display explanation menu which including image explanation
functions, then press the corresponding number to enter. The “V1.10” at the top of menu presents current
-----V1.10-----
0. NAME
1. PID
2. AGE
3. SEX
4. COMMENT
5. TIME
6. HOSP
7. DOCT
8. BODY MARK
9. LANGUAGE
NAME
There are 26 letters and some special characters in the prompt box, press 7 , 8 to page up or down to
display other characters. Press the number to display corresponding character in the cursor position. Up to
15 letters are allowed to type. Press to delete the wrong character. Press to exit after the
PATIENT ID
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Only number can be used in the ID, and the maximum characters number is 8. Press to confirm the
AGE
Age is composed by three numbers, and the input method is the same with the method which “ID” adapts.
GENDER
HOSPITAL
The input method is the same with the method which “NAME” adapts, and the maximum character number
is 18.
DOCTOR
The input method is the same with the method which “NAME” adapts, and the maximum character number
is 14.
Press “ ”→“4”in turn into the image explanation function. There will be 26 letters and some special
characters, +/9 button on the bottom of screen. Page up or down to display other characters. Move the
cursor to the explanation areas by direction button or mouse. Press the corresponding number button to type
the characters. Press “ ”to confirm the typing. If you want to give up the typing, press
directly.
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6.4 date and clock adjustment
Press “ ”→“5”in turn to enter the date and clock adjustment dialog box:
YY-MM-DD
■
HH-MM-SS
Type method: for example now is nine thirty-five thirty second on January 1st, 2010, then type
100101093530. Press to complete the typing and exit, the following box is listed as a reference.
YY-MM-DD
100101
HH-MM-SS
093530
Body mark
Press “ ”→“8” in turn in freeze state, and relative body mark could be displayed on the bottom of
screen. Press direction button continuously to display other body mark. There are 16 body marks can be
B/0
chosen. Press “B/0
B/0” to clear body mark. The brief description of body mark is listed as following.
1. Abdomen
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4. Heart
5. Others
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7 Measurement
2. +/9
Press “+/9
+/9”or the left button of mouse to display the measurement cursor.
4. Press “ ” or the right button of mouse, and move the cursor to measurement end point. (press
“ ” or the right button of mouse to switch the start and end cursor)
Repeat steps 2-5 to measure continuously. Up to 4 groups of measurement is allowed. If you want to
continue the measurement after 4 groups, the original data would be overwritten. The current measure
B/0
result would be displayed on the right of screen. The distance rate is listed as “D1/D2, D3/D4”. Press “B/0
B/0”
2. FUNC/4
Press “FUNC/4
FUNC/4”→“7”in turn to display following dialog box:
PLEASE ENTER:
1.FREEHAND 2.ELLIPSE
3. Press “1” to choose free method, and the measure cursor is displayed on the screen.
5. Press “ ” or right button of mouse, move the cursor to end point through the edge of measure
6. Press “ ” or right button of mouse to complete the measurement. If the curve is unclosed, the
- 36 -
system would form a closed path automatically according to the shortest distance.
FUNC/4
Press the left button of mouse or press “FUNC/4
FUNC/4”→“7”in turn, repeat steps 4-6 to measure continuously.
Up to 2 groups of measurement is allowed. The result would be displayed on the right of screen. “C1/C2,
B/0
A1/A2”are perimeter rate, area rate. Press “B/0
B/0”to re-measure.
3. FUNC/4
Press “FUNC/4
FUNC/4”→“7”in turn to display following dialog box:
PLEASE ENTER:
1.FREEHAND 2.ELLIPSE
4. Press “2” to choose elliptical method, and the elliptical sample frame is displayed on the screen.
7. Press or right button of mouse, adjust the sample frame direction by direction button.
8. Press or right button of mouse, repeat steps 5-7 to re-adjust sample frame.
FUNC/4
Press left button or “FUNC/4
FUNC/4”→“7”in turn, repeat steps 5-8 to measure continuously. Up to 2 groups of
measurement is allowed. Press the middle button to end the measurement. The result would be displayed on
- 37 -
7.1.3 Volume measurement
Triaxial method
2. FUNC/4
Press “FUNC/4
FUNC/4”or middle button of mouse to display volume value.
Elliptical method
Measure the perimeter/area value of two groups by elliptical method, the current volume value“Vm1”
FUNC/3
Obtain the satisfied image under the B/M or M mode and freeze. Press the“FUNC/3
FUNC/3” key and the cardiac
measurement menu will appear, The “V1.10” at the top of menu presents current software version number.
-----V1.10-----
0. LV<VF> 0. Left Ventricular
1. AV 1. Aortic Valve
2. MV 2. Mitral Valve
3. PV 3. Pulmonary Valve
4. TV 4. Tricuspid Valve
5. HR 5. Heart Rate
6. REPORT
7. NEWPATIENT
- 38 -
1. Enter the B/M mode, and move the mouse to change the position of the sampling lime. Press the
Left
Ventricular
Measurement
Operation Procedure:
1. Enter the B/M mode and move the mouse to change the position of the sampling line. Press the“ ”
Aortic Valve
Measurement
AO—The Aortic Root Diameter at the end of the Diastolic Period (mm)
LA—Diameter of the Left Ventricular at the end of the Systolic Period (mm)
- 40 -
AVO—Distance between the Aortic Anterior Lobe and Posterior Lobe and the Open Point of the
Aortic Valve (mm)
LAR—Left Atrium/Aorta Ratio
LVET—Left Ventricular Ejection Time (second)
7.2.3 Mitral Valve Measurement
The research of the mitral valve allows the user to estimate the D-E and E-F displacement, D-E and E-F
slope, D-E and E-F time on the D wave, E wave and F wave under the M mode and BM mode.
Operation Procedure:
1. Enter the B/M mode and move the mouse to change the position of the sampling line, press the“ ”
Mitral Valve
Measurement
Pulmonary Valve
Measurement
A<DEP>——Depth:
The distance from point F to point A is the distance from the start point of the atrial systolic
period to the maximum downward position of the pulmonary valve. The distance from point F to
A on the Y axis is the maximum movement range of the pulmonary valve in the atrial systolic
period.
A<DEP>Depth=AY-FY (mm)
AY is point A on the Y axis, and FY is point F on the Y axis.
EF<SL>——Slope:
When the initial blood flow from the atrium, E1 is the start point of the ventricular diastolic
period and F is the inflow start point of the atrial systolic period.
EF<SL>Slope=(FY-E1Y)/(FX-E1X)(mm/second)
FY is point F on the Y axis, E1Y is point E1 on the Y axis, FX is point F on the X axis and E1X is
point E1 on the X axis.
BC<DS>——Diameter:
BC is the open part of the pulmonary valve in the ventricular systolic period and the part on the Y
axis the movement distance of lobule when the pulmonary valve open to the maximum.
BC<DS> diameter =CY-BY (mm)
CY is point C on the Y axis, and BY is point B on the Y axis.
BC<SL>——Slope:
BC<SL>Slope= (CY-BY)/ (CX-BX) (mm/second)
CY is point C on the Y axis, BY is point B on the Y axis, CX is point C on the X axis and BX is
point B on the X axis.
RVET——Ejection Time of the Right Ventricular:
Ejection time of the right ventricular is the time from point B to E2 of the opening of the
pulmonary valve.
RVET=E2X-BX (second)
E2X is point E2 on the X axis, and BX is point B on the X axis.
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7.2.5 Tricuspid Valve Measurement
Tricuspid valve measurement is similar to mitral valve measurement, and the following three points are
used for:
D: Open point of the tricuspid valve and the end of the systolic period of the right ventricular
E: Maximum Point of the Tricuspid Valve Orifice
F: The tricuspid valve closes completely
Mark the above points with the method described above, when the marking finishes, the measurement
results will display on the right side of the screen automatically.
Tricuspid Valve
Measurement
DE<EX>— Distance from point D (right ventricular in the front of the tricuspid valve orifice) to point
E (maximum tricuspid valve orifice) (mm)
EF<EX>—Distance from point E to point F on the Y axis (mm)
DE<TM>—DE time (second)
EF<TM>—EF time (second)
DE<SL>—Slope= (Point E on the Y axis–Point D on the Y axis)/ (Point F on the X axis – Point D on
the X axis) (mm/second)
EF<SL>—Slope= (Point E on the Y axis–Point F on the Y axis) / (Point F on the X axis – Point E on
the X axis) (mm/second)
1. Enter the B/M mode, move the mouse to change the position of the sampling line, press the key
- 43 -
Heart Rate
Measurement
TM—Time (second)
HR— Heart Rate (times/minute)
7.2.7 Clear the contents of the report
At freeze state, Press key to display obstetrics table menu and press button to exit the menu.
TOKYO
0. BPD-FW
1. FL
2. AC
3. HC
4. CRL
5. GS
6. LMP
7. OBTABLE
For BPD, FL, CRL and GS, Measure the distance according to distance measurement method, the
For AC, HC, Measure as per Ellipse measurement method for circumference and area, the device will
automatically calculate the related data and display them on screen right.
- 44 -
PLEASE ENTER LMP: MM—DD
■
This reminder ask to put in the first date of the pregnant woman's last menses in the date format MM-DD.
For example: May 11, put in 05-11. When the correct date is put, measuring result will displays at "EDD"
on screen right in the format of YY-MM-DD, for example 07-02-21 means that the expected date of
The default standard pregnancy period in the system is 40 weeks. In last menses method
measuring, if the time interval between the input date and the system date exceeds 40 weeks, the
inward date will not be accepted and need to be put in again.
Under the condition of item 1, if the inward date is bigger than the current system date, it will be
regarded as the date of the last year.
Press “7” to select "7. OBTABLE ", The remind box is given bellow:
Table TOKYO is suitable for Asian, and Table HADLOCK is suitable for European.
Tips:
Head circle (HC)
(HC)、、 abdomen circle (AC) only have the Hadlock form
form,, this equipment does Not
provide the HC, AC form under the Tokyo formula
- 45 -
8 Report
The equipment will store the patient information, diagnosis annotation, measurement result and hospital,
data, time, doctor and some other information in the report page with the diagnosis. The abdominal, cardiac,
obstetrics and urological reports will generate automatically according to different measurement items, and
will display:
Enter the corresponding number key to enter the related report and press any key to exit this menu.
Cardiac Report:
- 46 -
Obstetrics Report:
Tips:
You can press the key on the report interface and then annotate information in the
In the obstetrics report 1, 2, 3 means that biparietal diameter (BPD), femur length (FL),
Crown-rump length (CRL) and gestational sac (GS) can be measured at most for three times,
and AVG is the average value of the three measurement results. TOTAL-AVG is the average
value of the gestational age (GA) and expected date of delivery (EDD).
In the obstetrics report, fetal weight (BPD, AC) is calculated through the biparietal diameter
(BPD) and abdominal circumference (AC), and when the measured BPD and AC are unequal to
zero, fetal weight will display here automatically.
- 47 -
9 Check and Maintenance
Bases on the manufacturer’s design, production related files, this model’s use life is six years. The
Product’s material will gradually aging, if the product continually use over the designed use life, it
may bring the problem of the performance reduced and fault rate raise.
Note
Note:
Warning
Warning:
The manufacturer shall not assume the responsibility of risks caused by using the
� If device enclosure needs cleaning,shutdown the device first and then wipe with alcohol sponges.
� When the device does not work for a long time, pack the device according to the instructions on
the packing. Store it properly in the warehouse. The storage environment should accord with
Caution
Caution:
detergents.
Be careful with cleaning of the display, because it is very easy to scratch and spoil.
Though there will be no chemical reaction between the device enclosure and most of
those detergents, We still suggest no detergent in cleaning lest the device surface is
spoiled.
- 48 -
9.3 Probe maintenance
� Probe is an expensive and frangible part. Never hit it or drop it on floor. When diagnoses
pauses, put the probe in its case and press key to keep it in a state of "Frozen".
� See to use medical ultrasound coupling gel during diagnosis. Degree of protection
against harmful ingress of water is IPX7. For the probes, water should not immerge over
the probe acoustic window (refer to figure). Regularly check the probe enclosure to
� Probe and host machine once tie, be request not to take down at will , for fear probe pin and
Note:
Do not clean the probe with a surgical brash neither soft brash. Only soft cloth can be
Do not press the probe on the patient too long to avoid discomfort.
Warning:
Must not use extender, ethylene oxide or any other organic solvent which tend to
Must keep the equipment or probe from any type of liquid's infiltration.
- 49 -
9.4 Correct usage of probe
In order to prolong probe's service life and obtain optimum performance , follow these
instructions:
2. Shutdown the device first and then connect or disconnect the probe.
3. Do not drop probe or flint body,and never hit the probe acoustic window, otherwise probe
should be damaged.
5. Never bend or pull probe cable, otherwise the internal connection should be broken.
7. Inspect probe acoustical window, enclosure and cable seriously after probe cleaning.
2. For optimum efficiency, the new battery must be charged and discharged (regular
3. The battery can be charged and discharged for hundred times,but it will be worn-out.
When the work time shortens apparently, please replace it with a new one.
4. Be sure to use electricity charger appointed by Shenzhen Well.D Electronics CO., Ltd.
(i.e. AC adapter) to charge the battery. Do not connect the battery to the electricity
charger (AC adapter) when charging is not needed. Do not connect the battery to the
electricity charger (AC adapter) longer than 10 hours; otherwise the battery life may
shorten. The fully charged battery will discharge by itself if it is long-time out of use.
5. The battery should be charged and discharged once in every 3 months to prevent it
unuseful.
charging effect. Must not charge the battery near the ignition source or under extreme hot
condition! Do not use or store battery near source of heat (such as fire or heater)! If find
the battery is leaking or smelling, move the battery away from the naked flame
immediately.
- 50 -
7. Don’t go on using non-serviceable battery and electricity charger (AC adapter).
10. Do not throw the battery into the fire or heat it, otherwise it would trigger an explosion.
13. Do not directly connect the battery to wall outlet or car-lit socket.
14. Must not short circuit the positive and negative polarity of the battery with led or other
metal objects. Must not transport nor store the battery with necklace, hair pin or other
metal objects.
15. Must not pierce battery shell with nail or other sharp objects, must not hammer nor step
on the battery.
16. Must not hit, cast the battery and avoid mechanical shock on it.
19. Must not place the battery in microwave oven or pressure vessels.
20. Must not combine the battery with primary battery (such as dry battery) or battery with
21. Do not use the battery if it is smelling, heating, straining, discolored or with other
abnormal phenomena and remove it from the current consumer or electricity charger
22. Do deal carefully with the discarded battery according to local related waste handling
regulations.
- 51 -
10 Simple Trouble Shooting
10.1 Check
� Check if the power supply is ok or not, main unit power cable is connected well or not. When the
supply voltage surpasses the equipment specified voltage range (AC100V-240V, 50Hz/60Hz),
� Check if the probe and main unit are connected well or not.
� Check power cable and probe lines regularly and replace the damaged or broken one if found.
- 52 -
11 Transportation and Storage
11.2 Transportation
11.2
Signs on the packing box conform to 《 Iconograph and sign of packing, storage and
transportation》(GB/T191-2008). Simple shockproof establishment is fitted within the box,which
apply to aviation, railway, highway or steamship transportation. Keep dry, avoid inversion and
collision.
11.3 Storage
11.3
Equipment should be taken out from the packing when storage time exceeds six months,power on
it for four hours, and then pack it correctly and keep it in a warehouse. The device must not be
piled, and do not place it closely against the floor, walls or roof.
- 53 -
Appendix A Acoustic output reporting table
B mode
frequency: 6.5MHz
TIS TIB
Index label MI Non-scan Non- TIC
Scan Aaprt≤1cm2 Aaprt>1
1cm2
1cm scan
P (mW) 6.8 - - #
Zs (cm) -
acoustic Zb (cm)
parameters Z at max. Ipi,α (cm) 2.30
X (cm) 4.00 - - - #
Dim of Aaprt
Y (cm) 0.90 - - - #
td (μsec) 0.334
Depth 40mm
Operating
Focal Position 2D3
control
conditions
Note: 1. Information need not be provided for any formulation of TIS not yielding the maximum value of
TIS for that mode.
2. Information need not be provided regarding TIC for any transducer assembly not intended for
transcranial or neonatal cephalic uses.
3. Information on MI and TI need not be provided if the equipment meets both exemption clauses
given in 51.2 aa) and 51.2 dd).
- 54 -
Acoustic output reporting table
B mode
frequency: 2.5MHz
TIS TIB
Index label MI Non-scan Non- TIC
Scan Aaprt≤1cm2 Aaprt>1
1cm2 scan
P (mW) 27.3 - - #
Zs (cm) -
acoustic Zb (cm)
parameters Z at max. Ipi,α (cm) 3.80
X (cm) 6.16 - - - #
Dim of Aaprt
Y (cm) 1.45 - - - #
td (μsec) 0.589
Depth
Operating
Focal Position
control
conditions
Note: 1. Information need not be provided for any formulation of TIS not yielding the maximum value of
TIS for that mode.
2. Information need not be provided regarding TIC for any transducer assembly not intended for
transcranial or neonatal cephalic uses.
3. Information on MI and TI need not be provided if the equipment meets both exemption clauses
given in 51.2 aa) and 51.2 dd).
- 55 -
Acoustic output reporting table
B mode
frequency: 5.0MHz
TIS TIB
Index label MI Non-scan Non- TIC
Scan Aaprt≤1cm2 Aaprt>1
1cm2 scan
P (mW) 6.3 - - #
Zs (cm) -
acoustic Zb (cm)
parameters Z at max. Ipi,α (cm) 2.80
X (cm) 3.12 - - - #
Dim of Aaprt
Y (cm) 1.00 - - - #
td (μsec) 0.312
Depth
Operating
Focal Position
control
conditions
Note: 1. Information need not be provided for any formulation of TIS not yielding the maximum value of
TIS for that mode.
2. Information need not be provided regarding TIC for any transducer assembly not intended for
transcranial or neonatal cephalic uses.
3. Information on MI and TI need not be provided if the equipment meets both exemption clauses
given in 51.2 aa) and 51.2 dd).
- 56 -
Acoustic output reporting table
B mode
frequency: 5.5MHz
TIS TIB
Index label MI Non-scan Non- TIC
Scan Aaprt≤1cm2 Aaprt>1
1cm2 scan
P (mW) 3.4 - - #
Zs (cm) -
acoustic Zb (cm)
parameters Z at max. Ipi,α (cm) 2.10
X (cm) 2.64 - - - #
Dim of Aaprt
Y (cm) 0.90 - - - #
td (μsec) 0.526
Depth
Operating
Focal Position
control
conditions
Note: 1. Information need not be provided for any formulation of TIS not yielding the maximum value of
TIS for that mode.
2. Information need not be provided regarding TIC for any transducer assembly not intended for
transcranial or neonatal cephalic uses.
3. Information on MI and TI need not be provided if the equipment meets both exemption clauses
given in 51.2 aa) and 51.2 dd).
- 57 -
Appendix B Obstetrics
Head circumference (HC)
Table Set1: Hadlock,F.P.,et al.Method
- 58 -
Femur length (FL)
Table Set1: Tokyo University Method
- 59 -
Femur length (FL)
Table Set2: Hadlock, F. P. ,et al. Method
- 60 -
Crown-rump length (CRL)
Table Set1: Tokyo University Method
- 61 -
Crown-rump length (CRL)
Table Set2: Hadlock,F.P.,et al.Method
CRL WEEKS S.D CRL WEEKS S.D
mm w. d. ±days mm w. d. ±days
4 6.1 3 68 13.1 6
6 6.3 3 70 13.1 6
8 6.5 3 72 13.3 6
10 7.1 3 74 13.3 6
12 7.3 3 76 13.5 6
14 7.5 3 78 13.6 6
16 8.0 3 80 14.0 6
18 8.2 3 82 14.1 6
20 8.4 4 84 14.2 6
22 8.6 4 86 14.3 6
24 9.1 4 88 14.5 6
26 9.3 4 90 14.6 6
28 9.4 4 92 15.1 6
30 9.6 4 94 15.2 6
32 10.1 5 96 15.3 6
34 10.2 5 98 15.4 6
36 10.4 5 100 15.6 6
38 10.5 5 102 16.1 6
40 10.6 5 104 16.2 6
42 11.1 5 106 16.3 7
44 11.1 5 108 16.5 7
46 11.3 5 110 16.6 7
48 11.4 6 112 17.1 7
50 11.5 6 114 17.2 7
52 11.6 6 116 17.3 7
54 12.0 6 118 17.5 7
56 12.1 6 120 17.6 7
58 12.2 6
60 12.3 6
62 12.4 6
64 12.6 6
66 12.6 6
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Gestational Sac (GS)
Table Set1: Tokyo University Method
- 63 -
Gestational Sac (GS)
Table Set2: Hadlock,F.P.,et al.Method
GS WEEKS S.D GS WEEKS S.D
mm w. d. ±days mm w. d. ±days
6 5.0
8 6.0
10 6.0
12 6.2
14 6.4
16 7.0
18 7.2
20 7.2
22 7.4
24 7.4
26 8.0
28 8.2
30 8.4
32 8.4
34 8.6
36 9.0
38 9.3
40 9.3
42 9.5
44 10.0
46 10.0
48 10.2
50 10.4
52 11.0
54 11.2
56 11.6
58 12.0
60 12.4
62 13.0
64 13.0
- 64 -
Biparietal diameter (BPD)
Table Set1: Tokyo University Method
- 65 -
Biparietal diameter (BPD)
Table Set2: Hadlock,F.P.,et al.Method
- 66 -
Abdominal circumference (AC)
Table Set1: Hadlock,F.P.,et al.Method
AC WEEKS 95% Conf. AC WEEKS 95% Conf.
mm w. d. Limits(d) mm w. d. Limits(d)
100 15.4 13.7-17.5 235 27.5 25.5-29.9
105 16.1 14.2-18.0 240 28.1 26.0-30.4
110 16.4 14.6-18.4 245 28.5 26.5-30.9
115 16.6 15.0-18.8 250 29.1 27.0-31.4
120 17.2 15.4-19.2 255 29.5 27.5-31.9
125 17.6 15.9-19.7 260 30.1 27.1-33.1
130 18.1 16.2-20.2 265 30.4 27.6-33.6
135 18.4 16.6-20.6 270 31.1 28.1-34.1
140 19.1 17.1-21.1 275 31.4 28.6-34.6
145 19.4 17.5-21.5 280 32.1 29.1-35.1
150 20.0 18.0-22.0 285 32.4 29.6-35.6
155 20.3 18.4-22.4 290 33.1 30.1-36.1
160 20.6 18.8-22.8 295 33.4 30.6-36.6
165 21.2 19.3-23.3 300 34.1 31.1-37.1
170 21.5 19.7-23.7 305 34.4 31.6-37.6
175 22.1 20.2-24.2 310 35.1 32.1-38.1
180 22.4 20.6-24.6 315 35.4 32.6-38.6
185 23.1 21.1-25.1 320 36.1 33.6-38.6
190 23.4 21.6-25.6 325 36.4 34.1-39.1
195 24.0 21.8-26.2 330 37.1 34.6-39.6
200 24.4 22.3-26.7 335 37.4 35.1-40.1
205 24.6 22.7-27.1 340 38.0 35.6-40.6
210 25.3 23.2-27.6 345 38.5 36.2-41.2
215 25.6 23.7-28.1 350 39.1 36.7-41.7
220 26.2 24.1-28.5 355 39.5 37.2-42.2
225 26.6 24.6-29.0
230 27.2 25.1-29.5
- 67 -
Manufacturer Information
Name:Shenzhen Well.D Medical Electronics Co., Ltd.
Add: 13/F, New Energy Bldg., Nanhai Ave., Nanshan District, shenzhen 518054, China
Well.d Park, Qinglan 3 Rd., National Biopharmaceutical Industrial Base, Pingshan New Area,
Shenzhen 518118, China
Tel: 0086-755-36900018, 36900019, 36900020
Fax: 0086-755-36900018
Http://www.welld.com.cn, www.welld.net
Email:[email protected]
Authorized representative in EU
CE mark