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Operation/Technical Manual: Full Digital Ultrasonic Diagnostic System

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0% found this document useful (0 votes)
720 views72 pages

Operation/Technical Manual: Full Digital Ultrasonic Diagnostic System

Uploaded by

Bilal Aloulou
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
Available Formats
Download as PDF, TXT or read online on Scribd
You are on page 1/ 72

Full Digital Ultrasonic Diagnostic System

WED-3000
(Version: V1.5)

Operation/Technical Manual

SHENZHEN WELL.D MEDICAL ELECTRONICS CO. LTD.


Preface........................................................................................................................................................... 1
Statement................................................................................................................................................. 1
Manufacturer's warranty.......................................................................................................................... 1
Matters need Attention.............................................................................................................................2
Safety labels.............................................................................................................................................2
Equipment safety classification............................................................................................................... 3
General tips for equipment operation...................................................................................................... 3
General Safety Message...........................................................................................................................4
EMC statement........................................................................................................................................ 6
Contraindication:................................................................................................................................... 10
1 Summary................................................................................................................................................... 11
1.1 Brief Introduction.............................................................................................................................11
1.2 Range Of Application...................................................................................................................... 11
1.3 Appearance...................................................................................................................................... 12
1.4 Technical Specificatio......................................................................................................................12
1.5 Electric principle block diagram......................................................................................................13
1.6 Standard configurations................................................................................................................... 14
1.7 Optional pieces................................................................................................................................ 14
2 Installation.................................................................................................................................................15
2.1 Operation environmental requirements............................................................................................15
2.2 Installing and disassembling battery................................................................................................15
2.3 Installing and disassembling probes................................................................................................ 16
2.4 Power Supply...................................................................................................................................17
2.4.1 Power supply with adapter...............................................................................................17
2.4.2 Battery Operation.............................................................................................................. 17
2.5 Battery charging...............................................................................................................................18
2.5.1 Charging through main unit............................................................................................. 18
2.5.2 Charging through adaptive line....................................................................................... 18
2.5.3 Charging through auto-charger.......................................................................................19
3 Operating procedures............................................................................................................................. 20
3.1 Introduction of keyboard................................................................................................................. 20
3.2 Display interface.............................................................................................................................. 21
3.3 Operating procedures.......................................................................................................................21
4 Image parameter adjustment................................................................................................................. 22
4.1 Display mode switching...................................................................................................................22
4.2 Image freezing................................................................................................................................. 23
4.3 Gain adjustment............................................................................................................................... 23
4.4 Image brightness adjustment........................................................................................................... 23
4.5 Image smoothing............................................................................................................................. 23
4.6 Gray correction................................................................................................................................ 23
4.7 Dynamic range adjustment.............................................................................................................. 24
4.8 Depth adjustment............................................................................................................................. 24
4.9 Scanning angle adjustment.............................................................................................................. 24
4.10 Focus adjustment........................................................................................................................... 25

-I-
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

- III -
Preface

Statement

� This publication, including pictures and illustrations, is property of Shenzhen Well.D Medical

Electronics Co., Ltd. and under protection of international copyright law.

� 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

any special purpose of selling or making benefit.

� Without previous written permission from the producer, this document must not be photocopied,

reproduced or translated into other languages.

� 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

used strictly in compliance with the operation manual.

� 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

not repair or replace the equipment surface if it is damaged.

� 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

prescribed range given in manual.

� This guarantee excludes losses or damages caused by external reasons such as thunder struck,

earthquake, theft, unsuitable use or abuse and refitting the equipment.

� Shenzhen Well.D Medical Electronics Co., Ltd. shall not be responsible for damages caused by

other devices or arbitrary connection to other devices.


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� Shenzhen Well.D Medical Electronics Co., Ltd. shall not be responsible for losses, damages or

injuries caused by delayed service request.

� 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.

Matters need Attention

� 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

in equipment damage or personal injury.

� 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.

� "Note": to remind user of installation, operation or maintenance information. These

information is very significant but with no risk. Any warning against dangers shall not be

contained in NOTE.

Safety labels

Equipment labels explanation:

Type B equipment

Note! Refer to accompanying documents

Signal output

USB2.0

IPX7 Protection against dripping water

ClassⅡ equipment

Mouse

Probe socket

Packing and transportation labels explanation:

-2-
Handle carefully

Temperature limit

Upward

Piling layer limit

Keep dry

Protect against heat

Equipment safety classification

According to the degree of safety of application in the presence of a flammable anaesthetic

mixture with air or with oxygen or nitrous oxide:


WED-3000 is not suitable for use in the presence of a FLAMMABLE ANAESTHETIC MIXTURE WITH AIR
or WITH OXYGEN OR NITROUS OXIDE.

According to the mode of operation:


WED-3000 is in CONTINUOUS OPERATION.

According to the degree of protection against harmful ingress of water:


The main unit of WED-3000 is ORDINARY EQUIPMENT; the probe is DRIP-PROOF EQUIPMENT.

According to the type of protection against electric shock:


WED-3000 is CLASS II EQUIPMENT powered by external adapter.

According to the degree of protection against electric shock:


WED-3000 is TYPE B EQUIPMENT.

General tips for equipment operation

◆ In operation
1. Heat radiation holes are strictly prohibited to be covered.

2. After closedown, do not switch on the equipment within 2 - 3 minutes.

3. On scanning, if any abnormal case is found, stop scanning immediately and shut down

-3-
the equipment.

4. The patient is prohibited to touch any non-applied part of 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.

4. Put the probe into the special case.

General Safety Message

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

Shenzhen Well.D Medical Electronics Co., Ltd. or their authorized agent.

5. If it is needed to connect the equipment with other company’s' electronic or mechanical

devices , please contact Shenzhen Well. D Medical Electronics Co,. Ltd. before

connection.

6. Equipment operation, storage and transportation environment


Environmental requirements on normal operation:
a) Environment temperature range: +10℃~ +40℃
b) Relative humidity range: 30%~ 75%
c) Atmosphere pressure range: 70KPa~ 106Kpa
Environment requirements on equipment storage and transportation:
a) Environment temperature range: -5℃~+40℃
b) Relative humidity range: <80%(20℃)

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

correctly for recovery processing.

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

adapter to reduce risk.

12. Shenzhen Well.D Medical Electronics Co., Ltd. shall not take any responsibility for any

risk resulted from unauthorized re-fitment by the users.

13. To disconnect the equipment from the power supply network by unplug the adapter from

the power supply network.

14. Refer to appendix B for sound output parameters.

-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.

-6-
-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.

- 10 -
1 Summary

1.1 Brief Introduction

� This equipment is high resolution linear/convex Veterinary Ultrasound Scanner. It adopts

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

technology promise more lasting battery operation.

� 7 inches TFT-LCD display and field programmable gate array (FPGA) and surface

mounted technology (SMT) make this equipment compact and light in weight.

� Jet molding enclosure with hand-held structure.

� The equipment consists of main unit, probe and adapter. Standard configuration is

C1-11/50R/3.5MHz convex probe, Optional probes: C1-12/20R/5.0MHz micro-convex

probe, L1-5/7.5MHz HF linear probe, EC1-7/13R/6.5MHz endo-vaginal probe.

1.2 Range Of Application


The device is suitable for ultrasonic examination on abdominal and pelvic cavity organs.

- 11 -
1.3 Appearance

Front sketch

Side interfaces sketch

Top knobs sketch

1.4 Technical Specificatio


MODEL WED-3000

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

Detect Depth(mm) ≥80 ≥140 ≥60 ≥90


≤3 (Depth≤80)
Lateral ≤1 (Depth≤60) ≤5 (80< ≤1 (Depth≤40) ≤3 (Depth≤60)
Resolution Depth≤130)
(mm)
Axial ≤1 (Depth≤80) ≤1 (Depth≤80) ≤1 (Depth≤40) ≤1 (Depth≤60)

Blind zone(mm) ≤3 ≤6 ≤5 ≤5
Geometric Horizont ≤5 ≤7.5 ≤5 ≤7.5
position al
precision Vertical ≤5 ≤5 ≤5 ≤5

- 12 -
Monitor size 7 Inch TFT LCD

Display mode B、B+B、4B、B+M、M

Image gray scale 256 Scale

Image storage 64 Frame

Dynamic range 0-192dB(Adjustment range 64-192dB)

Cine loop ≥400 Frame

Scan depth 70mm~240mm

Image flip Up/down, left/right


Focus Focus Number, Focus position
Body mark 40
Image Process Pseudo color, GAMA, Image Smoothen, Histogram
Probe Frequency Adjustable(3 point each probe)
Angle Show, Adjustable
Distance, Circumference, area, volume, Gestational age,
Measure
expected date
Date, clock, name, PID, age, Sex, hospital name, doctor,
Character display
full-screen character editor

Output report Support

Interface 2*USB2.0,VIDEO,MOUSE
Battery Continuous work ≥3Hours
Size L(265mm)*W(46mm)*H(153mm)

Net weight 800g

Power 45W

1.5 Electric principle block diagram

- 13 -
1.6 Standard configurations

� Main unit

� power adapter

� Battery

� C1-11/50R/3.5MHz Convex probe

� Adapter power supply cord

� Coupling gel 250ml

� Manual

� Final examination report

� Packing List

1.7 Optional pieces

� C1-12/20R/5.0MHz Micro-convex probe

� L1-5/7.5MHz HF linear probe

� EC1-7/13R/6.5MHz Endo-vaginal probe

� Printer

� CD

� High speed USB cable

Warning:

Please use the spare parts specified above. The manufacturer shall not bear the

responsibility of safety problem, unexpected EMC performance drop caused by

arbitrary adoption of non-specified spare parts.

- 14 -
2 Installation

2.1 Operation environmental requirements

� Environment temperature range: +10℃~+40℃

� Relative humidity range: 30%~75%

� Atmosphere pressure range: 70KPa~106Kpa

� Power supply: a.c.100V~240V,50Hz±1Hz/60Hz±1Hz

� 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;

Keep the equipment well-ventilated, damp proof and dustproof.

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

methods described in “Installation


Installation””.

Warning:

If there is breakage at unpacking check, it is banned to use the device to ensure

security.

manufacturer..
The probe should be protected from felling off or crashing and the manufacturer

2.2 Installing and disassembling battery

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).

Disassemble battery: It is the reverse process of installation (refer to figure).

- 15 -
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.
- 16 -
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.

2.4 Power Supply


The equipment provides two automatic switch-over modes to supply power: adapter and built-in battery.

2.4.1 Power supply with adapter

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.

2.4.2 Battery Operation

1. Install the battery correctly on the main unit.


2. Switch on the power switch on the left side of the equipment. When the main unit is power on, the
power indicator will turn on.
3. The equipment can start operation.

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.

- 17 -
Warning:
It is prohibited to use any other power supply except the standard adapter as the
external power supply for the main unit.

2.5 Battery charging


There are 3 ways to charge the battery.

2.5.1 Charging through main unit

1. Install the battery correctly into the main unit.

2. Insert the plug of “ ” of the adapter into the “DC14V/3A” interface on the rear.

3. Connect power cord of “ ”of the adapter to the AC. EPS.


4. Whenever the main unit is power on or off, the “Charging/Volume” indicator light turns on, it means
the battery is charged through adapter; when the lights turn on, it means the battery is fully
charged(refer to figure).

Charging through main unit


Tip:
To prolong the battery operation time, please finish charging when the indicator lights
show that the battery is full.

2.5.2 Charging through adaptive line

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

the charging terminal of the battery.

3. Connect power cord of " " of the adapter to the AC EPS.

- 18 -
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).

Charging through adaptive line


2.5.3 Charging through auto-charger

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).

Charging through auto-charger


Tips:
The input voltage of the auto-charger is DC9 14V/1.5A.
DC9~14V/1.5A.
The output voltage of the auto-charger is DC12.6V/1A.
The operations and storage environment are the same as those of the main unit.

- 19 -
3 Operating procedures

3.1 Introduction of keyboard

Power indicator Display area

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

Freeze the image or display the measuring mark.

Middle button

End the measurement and display the result of volume measurement.

Right button

● Determine the start and end position of the cursor, and switch the start cursor and end cursor in the

distance measurement mode.

● Determine the start position of the cursor and complete the measurement of perimeters and areas in

the free arm type measurement of perimeters and areas.

● Be equal to the role of button in the elliptical type measurement of perimeters and areas.

- 20 -
3.2 Display interface

Hospital name Patient name Patient age Patient gender System date, time probe type

Probe frequency
Doctor name

Current scanning angle Focous, focal distance


Medical record number
Scanning direction mark

Frame correlation value overall gain

Brightness, image smoothing, grey correction


Near field, far field
gray scale band

Dynamic range, frame frequency

Probe raster

Battery capacity indicator

Status indicator of cineloop Depth display

3.3 Operating procedures

1. Switch on the power button“ ”.

2. Press any button to enter the B-type ultrasonic scan interface.

3. Type the basic information of the patient.

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,

then the real-time image can be observed on the screen.

5. Freeze the image, and conduct measurement on the image.

6. Create a report, print the report and image by the connected video printer.

- 21 -
4 Image parameter adjustment

4.1 Display mode switching

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

default mode when the equipment is power on)

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.

B+M/M mode switching

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

is displayed on the screen.

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

to switch the real-time and freeze states of four images.

B BB B+M

M 4B

Attention:

When you call up the menu, please exit the menu before switching the display mode.
- 22 -
4.2 Image freezing

Press “ ”button to switch real-time state and freeze state. “FROZEN” on the bottom of screen is the

freeze mark.

4.3 Gain adjustment

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.

4.4 Image brightness adjustment

Press 7 or 8 button in real-time state to lighten “B” on top right of the screen, then press ▲5 and ▼6

button to adjust the brightness.

Press to exit.

4.5 Image smoothing

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,

which listed as IM0, IM1, IM2.

Press to exit.

Common image Image after smoothing

4.6 Gray correction

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.

- 23 -
Tip:

When an external monitor is applied, the image might be properly displayed only by gray scale

correction.

4.7 Dynamic range adjustment

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

the adjustment range is 64-192dB.

Press to exit.

4.8 Depth adjustment

Press to exit the parameter adjustment state on the right of screen.

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

type. The following table is presented as a reference.

Probe type C1-11/50R/3.5MHz L1-5/7.5MHz C1-12/20R/5.0MHz EC1-7/13R/6.5MHz

depth
90~240 40~90 80~150 50~120
(mm)

Depth 90 Depth 180 Depth 240

4.9 Scanning angle adjustment

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,

please refer to the following table.

Press to exit.

Probe type C1-11/50R/3.5MHz EC1-7/13R/6.5MHz C1-12/20R/5.0MHz

angle 70º visual and adjustable 152º visual and adjustable 96º visual and adjustable

- 24 -
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

focal distance is 4 cm.

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.

4.11 probe work frequency

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:

C1-11/50R/3.5MHz convex array probe —— 2.0MHz, 2.5MHz, 3.5MHz, 5.0MHz

C1-12/20R/5.0MHz convex probe—— 4.0MHz , 4.5MHz, 5.0MHz, 5.5MHz

L1-5/7.5MHz High frequency linear-array probe —— 6.0MHz , 6.5MHz, 7.5MHz, 8.5MHz

EC1-7/13R/6.5MHz Endo-vaginal probe —— 5.5MHz、6.5MHz、7.5MHz

Press to exit.

4.12 Frame-related adjustment

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:

If the frame-related adjustment is conducted in the BM mode, “Frame Related


Related”” on the right of

the screen should be lightened in B or BB mode before entering the adjustment mode.

4.13 M rate adjustment

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.

4.14 Screen cleaning

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.

4.15 Restore factory settings

Press “FUNC/4”→“8” button in real-time scanning mode,The total gain, the near field, far field and

brightness values will be restored to the default.

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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

number. Press button to exit the menu.

-----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

5.2 Cine loop

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.

Operate as the following steps:

1. Start the equipment into real-time scanning mode, and allow the equipment to conduct the cine

loop image collection, the collect time is about 30 seconds.

2. Freeze the image, press “FUNC/4”→“0”button in turn to playback, and the image is played in a

continuous loop. The playback state “120/408 → ”is displayed on the

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

“FUNC/4”→“0”button in turn again to back to auto repeat mode.

4. Press “ ”button to exit the cine loop.

Tip:

BB”” button to switch different windows during the playback in BB mode.


Press “BB

wouldn’’t
If the image scanning way, probe or display mode is changed, the cine loop operation wouldn

work until ordinary scanning is conducted for 30 seconds.


- 27 -
The cine loop time will be changed by the change of angle. The current playback information is

displayed on the bottom left of the screen.

5.3 Static image storage

storage::
Local storage

The equipment offers storage space for 64 static images, and the date wouldn’t lost when the power-down.

Store image by the following steps:

1. First scan and freeze an image.

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.

3. Press “freeze” button to back to the real-time scanning state.

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

the image saving.

STORAGE IS FULL. ERASE NO.01?


1. YES 2. NO

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

saving finishes, the serial number disappears.

5.4 Image export

FUNC/4
1. Press “FUNC/4
FUNC/4”→“2”button in turn to display the following dialog box:
- 28 -
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.

5.6 Upside down

FUNC/4
Press “FUNC/4
FUNC/4”→“4” continuously in non-4B mode to realize the upside down of image.

5.7 Turning around

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.

- 29 -
5.8 Pseudo color procedure

FUNC/4
Press “FUNC/4
FUNC/4”→“6” in turn to display following dialog box:

PLEASE ENTER COLOR:

1.IMAGE 2.CHAR 3.BACKGROUND

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.

Press to exit the dialog box.

5.9 Bar chart

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.

5.10 Image cleaning

FUNC/4
Press “FUNC/4
FUNC/4”→“9”in turn to display the following dialog box:

ERASE ALL STORAGE?


1.YES 2.NO

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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

disappear when the cleaning is completed.

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

software version number. Press button to exit the menu.

-----V1.10-----
0. NAME
1. PID
2. AGE
3. SEX
4. COMMENT
5. TIME
6. HOSP
7. DOCT
8. BODY MARK
9. LANGUAGE

6.2 Type the basic information of the patient and hospital

Type the basic information according to the following method.

NAME

Press “ ”→“0”in turn to display the following dialog box:

PLEASE ENTER NAME:


0-A 1-B 2-C 3-D 4-E

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

typing. If you want to give up the typing, press directly.

PATIENT ID

Press “ ”→“1”in turn to display the following dialog box:

PLEASE ENTER PID


- 32 -
Only number can be used in the ID, and the maximum characters number is 8. Press to confirm the

typing. If you want to give up the typing, press directly.

AGE

Press “ ”→“2”in turn to display the following dialog box:

PLEASE ENTER AGE:


Age is composed by three numbers, and the input method is the same with the method which “ID” adapts.

GENDER

Press“ ”→“3”in turn to display the following dialog box:

PLEASE ENTER SEX:


1.MALE 2.FEMALE

Press the corresponding number to select.

HOSPITAL

Press“ ”→“6”in turn to display the following dialog box:

PLEASE ENTER HOSP:


The input method is the same with the method which “NAME” adapts, and the maximum character number

is 18.

DOCTOR

Press“ ”→“7”in turn to display the following dialog box:

PLEASE ENTER DOCT:


The input method is the same with the method which “NAME” adapts, and the maximum character number

is 14.

6.3 Image explanation

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.
- 33 -
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

6.5 Language switching

Press “ ”→“9”in turn into interface language switching dialog box:

PLEASE ENTER LANGUAGE:


1.CHINESE 2.ENGLISH

Press corresponding number to switch the current language.

6.6 Body mark

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

Body front (M) Body front (F) Body back

Body left side Body right side


2. Obstetric

Mother (F) Fetus


3. Head

- 34 -
4. Heart

5. Others

- 35 -
7 Measurement

7.1 Ordinary measurement


7.1.1 Distance measurement
1. First freeze the image.

2. +/9
Press “+/9
+/9”or the left button of mouse to display the measurement cursor.

3. Move the cursor to measurement start point.

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)

5. Press middle button of mouse to end the measurement.

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”

to clear the measurement mark and measurement result.

Distance measurement chart

7.1.2 perimeter/area measurement


Free measurement

1. First clean the origin date on the screen.

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.

4. Move the cursor to measurement start point.

5. Press “ ” or right button of mouse, move the cursor to end point through the edge of measure

areas to form a closed path.

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.

Free measurement chart

Elliptical method measurement

1. First freeze the image.

2. Clean the origin date on the screen.

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.

5. Move sample frame to measure area.

6. Press or right button of mouse, adjust the size by direction button.

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

the right of screen. Clear screen first if you want to re-measure.

Elliptical measurement chart

- 37 -
7.1.3 Volume measurement
Triaxial method

1. Measure the distance of 3 groups or more according to distance measurement.

2. FUNC/4
Press “FUNC/4
FUNC/4”or middle button of mouse to display volume value.

“Vm1”on the right of screen indicates the current volume value.

Elliptical method

Measure the perimeter/area value of two groups by elliptical method, the current volume value“Vm1”

would be displayed on the right of screen.

Volume measurement chart

7.2 Cardiac Measurement (with the mouse


mouse))

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.

Press button to exit the menu.

-----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

7.2.1 Left Ventricular Measurement


By measuring the diastolic period and systolic period: posterior wall of the right ventricular, anterior wall
of the interventricular septum, posterior wall of the interventricular septum, endocardium of the posterior
wall of the left ventricular, epicardium; to calculate the diastolic period and systolic period respectively:
thickness of the left cardiac wall, diameter of the right ventricular, diameter of the left ventricular, thickness
of the posterior wall of the left ventricular, thickness of the interventricular septum, volume of the left
ventricular, heartbeat flow, ECG output, systolic fraction and ejection fraction.
Operation Procedure:

- 38 -
1. Enter the B/M mode, and move the mouse to change the position of the sampling lime. Press the

key when the proper M mode image appears;


2. FUNC/3
Press the“FUNC/3
FUNC/3”key and the cardiac measurement menu will appear;
3. Press the“0”key to select “LV<VF>”, a vertical time bar will appear in the M image;
4. Move the time bar to the end of the diastolic period and press the left key, mark the anterior wall of the
right ventricular (D1) with the left key. Some mark points of the diastolic period are described as
follows and mark the following several points with the same method:
D2——Posterior Wall of the Right Ventricular in the Diastolic Period
D3——Anterior Wall of the Interventricular Septum in the Diastolic Period
D4——Posterior Wall of the Interventricular Septum in the Diastolic Period
D5——Endocardium of the Posterior Wall of the Left Ventricular in the Diastolic Period
D6——Epicardium in the Diastolic Period
5. (D6) After marking, the second time bar will appear, move the time bar to the end of the diastolic
period and press the left key and mark the anterior wall of the right ventricular (S1) of the systolic
period with the left key. Some mark points of the diastolic period are described as follows and mark
the following several points with the same method:
S2——Posterior Wall of the Right Ventricular in the Systolic Period
S3——Anterior Wall of the Interventricular Septum in the Systolic Period
S4——Posterior Wall of the Interventricular Septum in the Systolic Period
S5——Endocardium of the Posterior Wall of the Left Ventricular in the Systolic Period
S6——Epicardium in the Systolic Period
6. (S6)After the marking finishes, the measurement results will display on the right side of the screen
automatically.

Left
Ventricular
Measurement

RHWD—Thickness of the Right Cardiac Wall in the Diastolic Period (mm)


RHWS—Thickness of the Right Cardiac Wall in the Systolic Period (mm)
RVD—Right Ventricular Diameter in the Diastolic Period (mm)
RVS—Right Ventricular Diameter in the Systolic Period (mm)
LVDD—Left Ventricular Diameter in the Diastolic Period (mm)
LVDS—Left Ventricular Diameter in the Systolic Period (mm)
PLVWD—Thickness of the Posterior Wall of the Left Ventricular in the Diastolic Period (mm)
- 39 -
PLVWS—Thickness of the Posterior Wall of the Left Ventricular in the Systolic Period (mm)
IVSD—Thickness of the Interventricular Septum in the Diastolic Period (mm)
IVSS—Thickness of the Interventricular Septum in the Systolic Period (mm)
LVEDV—Left Ventricular Volume at the end of the Diastolic Period (ml)
LVESV—Left Ventricular Volume at the end of the Systolic Period (ml)
SF—Systolic Fraction (%)
EF—Ejection Fraction (%)
SV—Heartbeat Volume (ml)
CO—ECG Output (ml)
7.2.2 Aortic Valve Measurement
Calculate the aortic valve diameter, open size of the aortic valve and the ratio between the aortic valve and

left atrium to study the aortic valve.

Operation Procedure:

1. Enter the B/M mode and move the mouse to change the position of the sampling line. Press the“ ”

key when proper M mode image appears;


2. FUNC/3
Press the“FUNC/3
FUNC/3”key and the cardiac measurement menu will appear;
3. Press the“1”key to select “AV”, and a vertical time bar will appear in the M image;
4. Move the time bar to the end of the diastolic period and press the Left key, mark the anterior wall of
the aortic valve (D1) and the posterior wall of the aortic valve (D2) with the Left key, the second time
bar will appear after the marking;
5. Move the time bar to the open point of the aortic valve and press the Left key, mark the anterior lobe
of the aortic valve (O1) and posterior lobe of the aortic valve (O2) with the same method, the third
time bar will appear after the marking;
6. Move the time bar to the close point of the aortic valve and press the Left key, mark the posterior wall
of the aortic valve (C1) and posterior lobe arterial wall (C2);
7. When all the measurements finish, the calculation results of the aortic valve will display on the right
side of the screen.

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“ ”

key when the proper M mode image appears;


2. FUNC/3
Press the“FUNC/3
FUNC/3”key and the cardiac measurement menu will appear;
3. Press the“2”key to select “MV”, move the cursor to the Q wave position of the M mode image area
and press the left key, mark “D”;
4. Mark the following mitral valve waves with the same method;
E: E Wave
F: F Wave
5. After the marking finishes, the measurement results will display on the right side of the screen
automatically.

Mitral Valve
Measurement

DE<EX>—Distance from Point D to E on the Y Axis (mm)


EF<EX>—Distance from Point E to F on the Y Axis (mm)
DE<TM>—DE Time (second)
EF<TM>—EFTime (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)
7.2.4 Pulmonary Valve Measurement
In this measurement, it is a characteristic calculation parameter. Calculate the pulmonary valve according to

the following point marking position.


- 41 -
A: Maximum Downward Position of the Valve of the Atrial Systolic Period
B: Start Point of the Ventricular Systolic Period
C: Maximum Open Point of the Lobule
E1: Start Point of the Ventricular Diastolic Period
E2: Complete Close Point of the Valve
F: Start Point of the Atrial Systolic Period
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.

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.
- 42 -
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)

7.2.6 Heart Rate Measurement


Operation Procedure:

1. Enter the B/M mode, move the mouse to change the position of the sampling line, press the key

when proper M mode image appears;


2. FUNC/3
Press the “FUNC/3
FUNC/3” key and the cardiac measurement menu will appear;
3. Press the“5”key to select “HR”, a vertical time bar appears in the M image;
4. Move the time bar to the first wave peak and press the left key, the second time bar appears;
5. Move the time bar to the third wave peak and press the left key;
6. The measurement finishes and the measurement results will display on the right side of the screen.

- 43 -
Heart Rate
Measurement

TM—Time (second)
HR— Heart Rate (times/minute)
7.2.7 Clear the contents of the report

Press →“FUNC/3” and select “7.NEWPATIENT” to clear report.

7.3 Obstetrics calculation


The equipment can calculate gestation age, expected date of delivery according to 7 parameters such as
BPD, FL, AC , HC, CRL,GS, first day of the last menses. Therein, BPD can be used to calculate fetus
weight.

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

corresponding obstetrical table data display on screen right.

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.

Select "6. LMP", a reminder displays

- 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

delivery is on February 21,2007.


Note
In expected date of delivery calculation, the system date must be correct.

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.

Set Obstetrics formula

Press “7” to select "7. OBTABLE ", The remind box is given bellow:

PLEASE ENTER OBTABLE:


1.TOKYO 2.HADLOCK

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

store the last measurement results.

When the corresponding measurement finishes, press“ ”→“FUNC/3


FUNC/3” →“6”key, The report menu
FUNC/3

will display:

1.ABDOMEN 2.CARDIAC 3. OB 4. UROLOGY

Enter the corresponding number key to enter the related report and press any key to exit this menu.

Abdominal Report, Urological Report:

Cardiac Report:

- 46 -
Obstetrics Report:

Press “ ” to exit the report.

Tips:
You can press the key on the report interface and then annotate information in the

annotation box, Press “ exit..


” to exit

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

9.1 Service life

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:

The Discard the device according to local law.

Do not discard it mixing with other household garbage.

Warning
Warning:

The manufacturer shall not assume the responsibility of risks caused by using the

device beyond its service life.

9.2 Main unit maintenance

� Instrumentation environment should accord with "Operation environmental requirement".

� If device enclosure needs cleaning,shutdown the device first and then wipe with alcohol sponges.

� Device should not turn on and off frequently.

� 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

“Transportation and storage environmental requirements".

Caution
Caution:

Please refer to instructions prescribed by the manufacturer closely when using

detergents.

Be careful with cleaning of the display, because it is very easy to scratch and spoil.

Please wipe it with dry soft cloth.

Please do not clean the inner base of the device.

Please do not place the device in liquid.

Do not leave any detergent on the device surface.

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

ensure it is good incase liquid ingression spoil the inner components.

R50/3.5MHz L40/7.5MHz R20/5.0MHz R13/6.5MHz

� Probe and host machine once tie, be request not to take down at will , for fear probe pin and

socket's contract badness.

Note:

Probe might be damaged due to long time covered coupling gel.

Clean the probe head after every use.

Do not clean the probe with a surgical brash neither soft brash. Only soft cloth can be

used to clean it.

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

deface the probe's protective foil.

Must not place the probe in liquid or detergent.

Must keep the equipment or probe from any type of liquid's infiltration.

Must not clean device or probe by airing or heating.

- 49 -
9.4 Correct usage of probe

In order to prolong probe's service life and obtain optimum performance , follow these

instructions:

1. Periodic inspection on probe cable, socket and acoustic window.

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.

4. Never heat the probe.

5. Never bend or pull probe cable, otherwise the internal connection should be broken.

6. Use couplant only on probe header and then clean probe.

7. Inspect probe acoustical window, enclosure and cable seriously after probe cleaning.

Never use the probe again if any crack or breakage is found.

9.5 Battery information

1. The equipment is fitted with rechargeable li-ion battery.

2. For optimum efficiency, the new battery must be charged and discharged (regular

service,not enforced discharging) two or three rounds completely.

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.

6. Extreme environment temperature (overcooling or overheating) will influence battery

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).

8. Don't try demounting battery.

9. Don't short circuit the battery.

10. Do not throw the battery into the fire or heat it, otherwise it would trigger an explosion.

11. Do not souse or wet the battery.

12. Do not incorrectly connect the positive and negative polarity.

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.

17. Must not bead the battery terminals.

18. Must not decompound the battery in any way.

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

different capacity, models and types.

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

immediately and stop using it any longer.

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),

must not switch on the equipment.

� 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.

10.2 Simple trouble shooting

S.N Simple failure Solutions

When power on, PS


1. Check if 14V of adapter works well;
1 indicator light does not turn on
2. Check if battery needs charging.
and no display on screen.
1.Check if 14V output of the adapter is
stable;
2.Check if there is electric or magnetic
2 Noisy display of image
fiend interference around the equipment;
3.Check if the probe plug and jack are
connected properly.

1. Adjust STC (Overall, near field, far field


3 Unclear display of image gain);
2. Clear the screen optical filter.

- 52 -
11 Transportation and Storage

11.1 Environment requirements on transportation and storage


Environment temperature range:-5℃~+40℃
Relative humidity range:<80%(20℃)

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.

Keep it well ventilated, do not expose it to strong sunlight or caustic gases.

- 53 -
Appendix A Acoustic output reporting table
B mode

frequency: 6.5MHz

Trans ducer Model: L1-5

Manufactured By: SHENZHEN WELL.D MEDICAL ELECTRONIC CO.,LTD.

TIS TIB
Index label MI Non-scan Non- TIC
Scan Aaprt≤1cm2 Aaprt>1
1cm2
1cm scan

Maximum index value 0.507 0.043 - - - Note

Pra (MPa) 1.170

P (mW) 6.8 - - #

Min.of [Pα(zs), Izpta,αzs)] (mW) -

Zs (cm) -

Associated Zbp (cm) -

acoustic Zb (cm)
parameters Z at max. Ipi,α (cm) 2.30

deq (Zb) (cm) -

fawf (MHz) 5.331 5.331 - - - #

X (cm) 4.00 - - - #
Dim of Aaprt
Y (cm) 0.90 - - - #

td (μsec) 0.334

prr (Hz) 4800


Other
pr at max. Ipi (MPa) 1.786
information
deq at max. Ipi (cm) -

Ipa,α at max. MI (W/cm2) 79.16

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

Trans ducer Model: C1-11

Manufactured By: SHENZHEN WELL.D MEDICAL ELECTRONIC CO.,LTD.

TIS TIB
Index label MI Non-scan Non- TIC
Scan Aaprt≤1cm2 Aaprt>1
1cm2 scan

Maximum index value 0.463 0.063 - - - Note

Pra (MPa) 0.799

P (mW) 27.3 - - #

Min.of [Pα(zs), Izpta,αzs)] (mW) -

Zs (cm) -

Associated Zbp (cm) -

acoustic Zb (cm)
parameters Z at max. Ipi,α (cm) 3.80

deq (Zb) (cm) -

fawf (MHz) 2.982 2.982 - - - #

X (cm) 6.16 - - - #
Dim of Aaprt
Y (cm) 1.45 - - - #

td (μsec) 0.589

prr (Hz) 6490


Other
pr at max. Ipi (MPa) 1.181
information
deq at max. Ipi (cm) -

Ipa,α at max. MI (W/cm2) 25.76

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

Trans ducer Model: C1-12

Manufactured By: SHENZHEN WELL.D MEDICAL ELECTRONIC CO.,LTD.

TIS TIB
Index label MI Non-scan Non- TIC
Scan Aaprt≤1cm2 Aaprt>1
1cm2 scan

Maximum index value 0.349 0.042 - - - Note

Pra (MPa) 0.732

P (mW) 6.3 - - #

Min.of [Pα(zs), Izpta,αzs)] (mW) -

Zs (cm) -

Associated Zbp (cm) -

acoustic Zb (cm)
parameters Z at max. Ipi,α (cm) 2.80

deq (Zb) (cm) -

fawf (MHz) 4.389 4.389 - - - #

X (cm) 3.12 - - - #
Dim of Aaprt
Y (cm) 1.00 - - - #

td (μsec) 0.312

prr (Hz) 4800


Other
pr at max. Ipi (MPa) 1.119
information
deq at max. Ipi (cm) -

Ipa,α at max. MI (W/cm2) 36.7

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

Trans ducer Model: EC1-7

Manufactured By: SHENZHEN WELL.D MEDICAL ELECTRONIC CO.,LTD.

TIS TIB
Index label MI Non-scan Non- TIC
Scan Aaprt≤1cm2 Aaprt>1
1cm2 scan

Maximum index value 0.378 0.029 - - - Note

Pra (MPa) 0.802

P (mW) 3.4 - - #

Min.of [Pα(zs), Izpta,αzs)] (mW) -

Zs (cm) -

Associated Zbp (cm) -

acoustic Zb (cm)
parameters Z at max. Ipi,α (cm) 2.10

deq (Zb) (cm) -

fawf (MHz) 4.510 4.510 - - - #

X (cm) 2.64 - - - #
Dim of Aaprt
Y (cm) 0.90 - - - #

td (μsec) 0.526

prr (Hz) 4800


Other
pr at max. Ipi (MPa) 1.112
information
deq at max. Ipi (cm) -

Ipa,α at max. MI (W/cm2) 21.2

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

HC WEEKS S.D HC WEEKS S.D


mm w. d. ±days mm w. d. ±days
56 12.0 8 210 23.1 11
63 12.3 8 217 23.5 11
70 12.6 8 224 24.3 15
77 13.2 8 231 25.1 15
84 13.5 8 238 25.6 15
91 14.1 8 245 26.4 15
98 14.4 8 252 27.3 15
105 15.0 8 259 28.1 15
112 15.3 8 266 29.0 15
119 15.6 8 273 29.6 15
126 16.3 8 280 30.5 21
133 16.6 8 287 31.4 21
140 17.2 8 294 32.4 21
147 17.6 8 301 33.3 21
154 18.3 11 308 34.3 21
161 18.6 11 315 35.2 19
168 19.4 11 322 36.3 19
175 20.0 11 329 37.3 19
182 20.4 11 336 38.4 19
189 21.1 11 343 39.4 19
196 21.6 11 350 40.5 19
203 22.3 11

- 58 -
Femur length (FL)
Table Set1: Tokyo University Method

FL WEEKS S.D FL WEEKS S.D


mm w. d. ±days mm w. d. ±days
8 12.3 10 42 24.5 24
10 13.0 10 44 25.2 25
12 13.4 10 46 26.0 25
14 14.1 10 48 27.0 25
16 14.5 10 50 28.0 25
18 15.2 10 52 29.0 30
20 16.0 10 54 29.5 30
22 16.4 10 56 30.2 30
24 17.1 10 58 31.3 32
26 17.6 10 60 33.0 38
28 18.4 14 62 34.0 42
30 19.2 17 64 35.0 46
32 20.5 17 66 36.5 50
34 21.5 18 68 38.0 57
36 22.3 19 70 40.0 64
38 23.0 21 72 40.2 64
40 24.0 22

- 59 -
Femur length (FL)
Table Set2: Hadlock, F. P. ,et al. Method

FL WEEKS S.D FL WEEKS S.D


mm w. d. ±days mm w. d. ±days
8 12.3 10 46 25.2 15
10 13.0 10 48 26.1 15
12 13.4 10 50 26.6 15
14 14.1 10 52 27.5 15
16 14.5 10 54 28.4 15
18 15.2 10 56 29.4 15
20 16.0 10 58 30.2 21
22 16.4 10 60 31.1 21
24 17.1 10 62 32.1 21
26 17.6 10 64 33.1 21
28 18.4 14 66 34.0 21
30 19.2 14 68 34.6 21
32 20.0 14 70 35.6 21
34 20.5 14 72 36.6 22
36 21.3 14 74 37.6 22
38 22.1 14 76 38.6 22
40 22.6 14 78 39.6 22
42 23.5 14 80 40.6 22
44 24.4 15 82 42.0 22

- 60 -
Crown-rump length (CRL)
Table Set1: Tokyo University Method

CRL WEEKS S.D CRL WEEKS S.D


mm w. d. ±days mm w. d. ±days
6 6.3 7 54 12.4 7
8 6.6 7 56 12.5 7
10 7.1 7 58 13.0 7
12 7.4 7 60 13.1 7
14 7.6 7 62 13.2 7
16 8.1 7 64 13.3 7
18 8.4 7 66 13.4 7
20 9.1 7 68 13.5 7
22 9.2 7 70 13.6 7
24 9.4 7 72 14.0 8
26 9.6 7 74 14.1 8
28 10.2 7 76 14.2 8
30 10.3 7 78 14.3 8
32 10.4 7 80 14.4 8
34 10.6 7 82 14.5 8
36 11.0 7 84 14.6 8
38 11.1 7 86 15.0 8
40 11.3 7 88 15.1 14
42 11.4 7 90 15.2 14
44 11.6 7 92 15.3 14
46 12.0 7 94 15.4 14
48 12.1 7 96 15.5 14
50 12.2 7 98 15.6 14
52 12.3 7 100 16.0 14

- 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

- 62 -
Gestational Sac (GS)
Table Set1: Tokyo University Method

GS WEEKS S.D GS WEEKS S.D


mm w. d. ±days mm w. d. ±days
10 4.0 7 42 9.1 14
12 4.1 7 44 9.3 14
14 4.4 7 46 9.4 14
16 5.0 8 48 10.0 15
18 5.1 8 50 10.1 15
20 5.4 8 52 10.3 15
22 6.0 11 54 10.4 15
24 6.1 11 56 10.6 15
26 6.6 12 58 11.1 16
28 7.1 12 60 11.3 16
30 7.3 12 62 11.4 16
32 7.4 12 64 11.6 16
34 8.0 13 66 11.8 16
36 8.1 13 68 12.1 17
38 8.3 13
40 8.6 13

- 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

BPD WEEKS S.D BPD WEEKS S.D


mm w. d. ±days mm w. d. ±days
16 11.3 7 56 23.0 11
18 11.6 7 58 23.5 11
20 12.0 7 60 24.2 12
22 12.4 7 62 25.0 12
24 13.0 7 64 25.6 12
26 13.6 7 66 26.3 13
28 14.2 7 68 27.3 13
30 14.6 7 70 28.0 13
32 15.2 7 72 29.0 14
34 16.0 8 74 29.5 14
36 16.3 8 76 30.1 15
38 17.0 8 78 31.1 16
40 17.5 8 80 32.1 16
42 18.2 9 82 33.0 18
44 19.0 9 84 34.0 20
46 19.5 10 86 35.5 25
48 20.2 10 88 37.0 25
50 21.0 10 90 39.0 25
52 21.4 10 92 42.0 25
54 22.2 10

- 65 -
Biparietal diameter (BPD)
Table Set2: Hadlock,F.P.,et al.Method

BPD WEEKS S.D BPD WEEKS S.D


mm w. d. ±days mm w. d. ±days
14 11.6 7 60 24.4 16
16 12.2 9 62 25.1 16
18 12.6 9 64 25.6 16
20 13.1 9 66 26.4 16
22 13.4 9 68 27.3 16
24 14.1 9 70 28.1 16
26 14.4 9 72 28.6 16
28 15.0 9 74 29.5 16
30 15.4 9 76 30.4 22
32 16.0 9 78 31.2 22
34 16.4 9 80 32.1 22
36 17.0 9 82 33.0 22
38 17.4 9 84 33.6 22
40 18.1 14 86 34.5 22
42 18.5 14 88 35.4 22
44 19.2 14 90 36.4 24
46 19.6 14 92 37.3 24
48 20.4 14 94 38.2 24
50 21.1 14 96 39.1 24
52 21.6 14 98 40.1 24
54 22.3 14 100 41.1 24
56 23.1 14
58 23.6 14

- 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

Name: Wellkang Ltd.


Add: Suite B, 29 Harley Street LONDON WIG 9QR England, United Kingdom
Tel: +44(20)88168300,88168309,79934346,79276844
Fax: +44(20)76811874
Web: www.CE-marking.com www.CE-marking.org www.CEmarking.org
E-mail: [email protected]

CE mark

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