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Preface..............................................................................................................................................................1Statement.......................................................................................................................................................... 1Manufacturer's warranty................................................................................................................................1Matters need Attention....................................................................................................................................2Safety labels...................................................................................................................................................... 2Safety classification..........................................................................................................................................3General tips for equipment operation........................................................................................................... 3General Safety Message.................................................................................................................................. 4Contraindication.............................................................................................................................................. 51 Summary......................................................................................................................................................... 61.1 Brief Introduction...................................................................................................................................... 61.2 Range Of Application................................................................................................................................ 61.3 Appearance................................................................................................................................................. 71.4 Technical Specification.............................................................................................................................. 71.5 Electric principle block diagram..............................................................................................................81.6 Standard configurations............................................................................................................................92 Installation................................................................................................................................................... 102.1 Operation environmental requirements................................................................................................102.2 Connecting probe and main unit............................................................................................................102.3 Equipotential connection.........................................................................................................................112.4 Installation of hook drive........................................................................................................................ 112.5 Foot switch connection (Optional function)..........................................................................................122.6 Li-battery installation (Optional function)........................................................................................... 122.7 Probe slot installation.............................................................................................................................. 132.8 Printer installation (Optional function).................................................................................................133 Operating procedures............................................................................................................................... 143.1 Introduction of keyboard........................................................................................................................ 143.2 Display interface...................................................................................................................................... 153.3 Operation Procedures..............................................................................................................................153.4 System Recovery...................................................................................................................................... 153.5 Laser Printer Installation........................................................................................................................214 Setting........................................................................................................................................................... 224.1 General......................................................................................................................................................224.2 Hospital Information...............................................................................................................................224.3 Typical Case..............................................................................................................................................234.4Obstetrical Algorithm...............................................................................................................................234.5 Dicom Setting:.......................................................................................................................................... 264.6 Save Setting.............................................................................................................................................. 274.7 Other Setting............................................................................................................................................ 284.8 Exit the System.........................................................................................................................................285 Adjust Image Parameters.............................................................................................................................. 295.1 Switch Display Mode............................................................................................................................... 295.2 Freeze Image.............................................................................................................................................305.3 Adjust Gain...............................................................................................................................................305.4 Adjust Displaying Depth......................................................................................................................... 305.5 Adjust Probe Scanning Angle................................................................................................................. 30

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5.6 Focus Adjustment.................................................................................................................................... 305.7 Probe Working Frequency......................................................................................................................305.8 Switch the Probe...................................................................................................................................... 305.9 M Speed Adjustment............................................................................................................................... 315.10 Sound PowerAdjust.............................................................................................................................. 315.11 Frame correlation Adjustment............................................................................................................. 315.12 Line correlation Adjustment.................................................................................................................316 Image Processing and Adjustment................................................................................................................326.1 Tissue Harmonic Image...........................................................................................................................326.2 Pseudo-color Treatment.......................................................................................................................... 326.3Image Turnover.........................................................................................................................................326.4Local Amplification.................................................................................................................................. 336.5Reset........................................................................................................................................................... 336.6 ACUI......................................................................................................................................................... 337 Note...............................................................................................................................................................347.1 Note in Full Screen...................................................................................................................................347.2 Body Sign Setting.....................................................................................................................................347.3 Input Arrow..............................................................................................................................................347.4 Clear Screen............................................................................................................................................. 348 Images and films...........................................................................................................................................358.1 Save Static Images................................................................................................................................... 358.2 Saving Films............................................................................................................................................. 358.3 Loading Films...........................................................................................................................................358.4 Import Patient Information....................................................................................................................369. Settings and reportage of patient information............................................................................................. 379.1 New Patient File....................................................................................................................................... 379.2 Report writing.......................................................................................................................................... 389.3 Preview image.......................................................................................................................................... 399.4 Medical records management.................................................................................................................4010 Measurement...............................................................................................................................................4110.1 General....................................................................................................................................................4110.2 Routine Measurement........................................................................................................................... 41

10.2.1 Distance Measurement......................................................................................................... 4110.2.2 Area Measurement................................................................................................................4110.2.3 Circumference Measurement............................................................................................... 4210.2.4 Angle Measurement..............................................................................................................4310.2.5 Volume Measurement........................................................................................................... 4310.2.6 Other Measurements.............................................................................................................43

10.3 Heart Measurement under Mode M....................................................................................................4410.3.1 Distance Measurement......................................................................................................... 4410.3.2 Heart Rate Measurement...................................................................................................... 44

10.4 Obstetrics Measurement....................................................................................................................... 4410.4.1 Overview...............................................................................................................................4410.4.2 The First Stage......................................................................................................................4410.4.3 The Second Stage................................................................................................................. 4410.4.4 The Third Stage.................................................................................................................... 44

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10.4.5 Generic..................................................................................................................................4510.5 Urinary Measurement........................................................................................................................... 4510.6 Gynecological Measurement.................................................................................................................4510.7 Thyroid Measurement...........................................................................................................................4511 Check and Maintenance.........................................................................................................................4611.1 Service life...............................................................................................................................................4611.2 Main unit maintenance..........................................................................................................................4611.3 Probe maintenance.................................................................................................................................4611.4 Correct usage of probe.......................................................................................................................... 4712 Simple Trouble Shooting........................................................................................................................ 4812.1 Check.......................................................................................................................................................4812.2 Simple trouble shooting.........................................................................................................................4813 Transportation and Storage................................................................................................................... 4913.1 Environment requirements on transportation and storage.............................................................. 4913.2 Transportation........................................................................................................................................4913.3 Storage.................................................................................................................................................... 49Appendix AAcoustic output reporting table.............................................................................................. 50Appendix B EMC...........................................................................................................................................60Appendix C DECLARATION OF RoHS2.0...............................................................................................64

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Important warning information

1、Please be sure to read the instructions on the "warning", "note" and "caution", the contents ofthis manual contains information about the foreseeable potential dangerous warning, attention andcaution, at all times to maintain vigilance, due to neglect or ignore the operation specified in theinstructions for use damage, injury or damage caused by preventive measures, the company is notresponsible for, please be sure to keep this manual properly, don't lost.

2、Strictly forbid teardown modify the any hardware and software of this system。Non-personneldesignated by the Company for maintenance of equipment and re-assemble the consequencesresulting from the Company will not pay any responsibility

3、 This system is intended to provide doctors clinical diagnostic data for reference, not as atreatment for use, not as the device of fetal sex appraisal, the company disclaim all responsibility fordiagnosing process.

4、If necessary, we don't recommend that users use UPS regulated power supply, if the user need toconfigure UPS regulated power supply, please choose products of normal manufacturer or contactour company. please turn off when not use device and UPS power supply, due to the UPS regulatedpower supply failure (short circuit, fire, etc.) caused by this system damage, the company shall not beheld responsible.

5、Connect the other device (e.g., regulated power supply) of this system must be in conformity withthe requirement of electrical safety, due to other equipment failure caused by this system damage andcustomer loss, our company disclaim all responsibility.

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Preface

Statement

This publication, including pictures and illustrations, is property of

. 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.

, the trade mark of . Any abuse of

these trading marks without permission will be sued to assume legal responsibility according to

laws.

Manufacturer's warranty

. 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.

. 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, . 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,

Hangzhou Jupiter Medical Equipment Co., Ltd





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

. shall not be responsible for damages caused by

other devices or arbitrary connection to other devices.

. shall not be responsible for losses, damages or

injuries caused by delayed service request.

When there is problem with the products, please contact

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".

Disoperation 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 labelsEquipment labels explanation:

Type B equipment

Note! Refer to accompanying documents

| Turn-on (general supply)

Disconnect (general supply)

VIDEO

Equipotential

IPX7 Protection against dripping water

USB




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Packing and transportation labels explanation:

Handle carefully

Temperature limit

Upward

Piling layer limit

Keep dry

Protect against heat

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: 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: Continuous operation;

According to the degree of protection against harmful ingress of water as detailed in the current

edition of IEC 529：Main unit is general equipment, the probe is enclosed equipment protected against the

effects of immersion, IPX7.

According to the type of protection against electric shock: ClassⅠ equipment energized from an

external electrical power source equipment;

According to the degree of protection against electric shock: Type B

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

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

JM-W190

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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 MessageSafety of the operator and patients and reliability of the equipment are taken into considerationduring 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 . or its authorized agentfor service.

3. The equipment has already been regulated into its optimal performance. Do not adjustany 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. or their authorized agent.

5. If it is needed to connect the equipment with other company’s' electronic or mechanicaldevices ， please contact . before connection.

6. Equipment operation, storage and transportation environmentEnvironmental requirements on normal operation:a) Environment temperature range: 0℃～+40℃b) Relative humidity range: ≤80%c) Atmosphere pressure range: 70KPa～106KPaEnvironment requirements on equipment storage and transportation:d) Environment temperature range: -20℃～+55℃e) Relative humidity range: <80%（20℃）

7. Do not hit the fragile TFT-LCD display. If it cracks, deal carefully with it in case the liquidcrystal gets into eyes or mouths.

8. Must not hit the inner chargeable Li-ion battery nor throw it into fire in case it trigger anexplosion； Do not short circuit the battery output electrodes in case the battery bedamaged; and please use the original binding charger to charge the battery. More over,because used battery will cause environment pollution, please handle the batterycorrectly for recovery processing.

9. Must not disassemble the power supply adapter. If failures happen, it should be handledby the professional; the charging output can only be used for charging the battery of theequipment, any improper use on other battery may cause explosion, fire and otherunexpected hazards.

10. Must not short circuit the output of the adapter，a long term short circuit shall result inadapter damage.

11. Please use standard power cord as the input line of the network power supply for theadapter to reduce risk.

12. . shall not take any responsibility for anyrisk resulted from unauthorized re-fitment by the users.

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





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the power supply network.14. Refer to appendix A for sound output parameters.

Contraindication★ This equipment is not suit for contain-gas viscera, such as lung examine.。★ Suggesting not to examine the wounded or urgent inflammation part, it could Cause

across infect.★ Below patient forbided to use vagina and recta probe:

Vagina colpitis, such as colpitis, and sexual illness; discoverture people; vaginaabnormality; menses; vagina shrink; vagina ultrasound examine difficulty person; vaginableeding; placenta front sufferer.

WarningWhen works in strong electromagnetic environment exceeding its statement,

its image might be interfered and the diagnoses could be influenced. At this time, pleasestop operating until the EMC interference is removed.

WarningWhen works at the state of overlapping or paralleling with other equipments,

there might be unexpected EMC problems； If it must work close to other equipments,please observe carefully and check if some equipment is influenced by unexpected EMcoupling.

WarningReplacement of non-standard probe parts may cause unexpected EMC problem.

NOTEAccessory equipment connected to the analog and digital interfaces must be certified

according to the respective IEC standards (e.g. IEC 60950 for data processing equipmentand IEC 60601-1-1 for medical equipment). Furthermore, all configurations shall complywith the valid version of the system standard IEC 60601-1-1. Everybody who connectsadditional 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 validversion of the system standard IEC60601-1. IF in doubt, consult the technical servicedepartment or your local representative.

JM-W190

JM-W190

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1 Summary

1.1 Brief Introduction

is a high resolution convex/linear array scanning ultrasound diagnostic system ,whichutilizing the PC control and digital scan converter(DSC) while adopting multiple technologiessuch as digital beam forming (DBF) , real-time dynamic aperture (RDA), dynamic receiveapodization (DRA), dynamic receive focusing (DRF), dynamic frequency scan (DFS), 8-TGC as wellas frame correlation , and it can support various linear and convex array probes with a wide rangeof frequency.

It provides five display modes as B、B+B、B+M、M、4B and gray scale of 256 levels. It provides such functions as real-time, freeze, magnification, up and down flip, left and right flip,

edge enhancement, ACUI and so on. It allows the continuous playback and single frame play of 500 frames at most, while static

pictures of 1000 frames can be stored and recalled at most. The patient data can be saved whilesaving the pictures.

It provides multiple level regulations for scanning depth, scanning angle, THI, acoustic outputpower, frame correlation factors, focus position, line correlation factors, pseudo color.

It functions at display of date and time; annotation of name, sex, age of patients, doctor andhospital’s name; full screen annotation. It allows to changing in Chinese and English operatinginterface, to input in Chinese or English input mode, and to choose the arrow mark as well as 40body posture marks.

It possesses abundant software such as routine measurement (including distance, area and girth,angle and volume),heart measurement (including distance ,time, slope , heart rate)and obstetricmeasurement ( to estimate the gestational weeks ,expected date of confinement and fetus weightby BPD、CRL、GS、FL、HC、AC)

This device has the DICOM3.0 port, thus can transmit the picture in the DICOM format. It alsoprovides the color video output, thus it can be connected with the external display with the bigscreen .In addition, the device has the high speed USB2.0 port, thus the picture can be saved intothe portable storage device and it can be connected with an external video printer. There is abuilt-in memory with high-capacity which can save a large amount of pictures.

The device has an injection moulding envelop and the usage of non-industrial frequencytransformer switching power supply, programmable parts and surface mounting technology (SMT)make the whole unit highly compact, small in volume and light in weight.

1.2 Range Of Application

The machine is used in abdominal, Obstetric, Cardiac, small parts sonography.

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1.3 Appearance

1.4 Technical Specification

ProbeC5-2/50R/3.5

MHz

convex array

l3-1/7.5MhzHF linear

c1-6/20R/5.0MHz

micro convex

ec1-1/13R/6.5MHz

endo-vaginal

ec1-6/10R/6.5MHz

endo-vaginal

c3-1/60R/3.5MHz

convex array

Display depth (mm) 250 (max)

Maximal detect depth (mm) ≥140 ≥50 ≥80 ≥40 ≥40 ≥ 160

Resolution(mm)

Lateral

≤3(depth≤80)≤4

(80＜depth≤130)

≤2(depth≤40)

≤2(depth≤40)

≤2(depth≤30)

≤2(depth≤30)

≤3(depth≤80)

≤4(80＜depth≤

130)

Axial≤2

(depth≤80)

≤1(depth≤50)

≤1(depth≤40)

≤1(depth≤40)

≤1(depth≤40)

≤2(depth≤80)

Blind zone(mm) ≤7 ≤3 ≤5 ≤4 ≤4 ≤7Geometricpositionprecision

Horizontal ≤20 ≤10 ≤20 ≤10 ≤10 ≤20

Vertical ≤10 ≤5 ≤10 ≤5 ≤5 ≤10

Monitor size 15 Inch TFT LCD

Display mode B, B+B, B+M, M, 4B

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Image gray scale 256 Scale

Cine loop ≥600Frame

Image storage ≥1000Frame

Image flip Up/down, left/right

Image Process THI, Pseudo color, Zoom, ACUI

Focus Focus position

Measure Distance, circumference, area, volume, heart, GA, FW, EDD

Character display Date, clock, name, PID, age, Sex, hospital name, doctor,

Notation full-screen character editor, posture mark, Position indication

USB port USB2.0: 4PCS

power consumption (MAX) 100VA

Net weight 10.5kg

Size 210mm×408mm×401mm

1.5 Electric principle block diagram

APROBE

CPROBE

PROBESELECT

T/RSWITCHES

AFE FPGA

USB 2.0

PCKeyboard and Mouse LCD

BPROBE

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1.6 Standard configurations

Mainframe

Optional pieces: C5-2 convex array probe, l3-1/7.5Mhz HF linear, c1-6/20R/5.0MHz

micro convex, ec1-1/13R/6.5MHz endo-vaginal, ec1-6/R10/6.5MHz endo-vaginal,

c3-1/ R60/3.5MHz convex array probe

PS cable

2 pieces of fuse tube F2AL250V

Coupling gel 250ml

User Manual

Final examination report

Packing List

Optional pieces: Monitor, Video printer, three regional

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

responsibility of safety problem, unexpected EMC performance drop caused byarbitrary adoption of non-specified spare parts.

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2 Installation

2.1 Operation environmental requirements

Environment temperature range: 0℃ ～+40℃

Relative humidity range: ≤80%

Atmosphere pressure range: 70kPa～106kPa

Power supply: a.c.100V～240V,50Hz/60Hz

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”.

Warning:

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

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

2.2 Connecting probe and main unit

Check the power supply too see if it is in the expected range (AC100V-240V，50Hz/60Hz), then connect

the equipment and the power socket with the cable.

Connect probe:①Insert the probe

②Locking the probe along this

direction

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2.3 Equipotential connection1) In the hospital, doctors and patients in the midst of a dangerous influence of compensation current

beyond the control. In the medical room, as the connection equipment generates compensationdue to its having different potential from accessible conductive parts, the safest solution is toestablish a set of uniform equipotential network, and medical devices are connected with theequipotential network in the medical room a through angled socket.

2) The power outlet of the equipment should be a standard three-pin power outlet, whose protectionground (terminal) should be connected to the protective earth conductor of the power supplysystem.

3) If the power outlet has no protection or is not connected to the protective earth conductor of thepower supply system, "protective ground" must be provided. The user shall use a metal wire withcross-sectional area of not less than 1.0mm 2, one end of which is connected to the protective earthrod, and the other connected to a ground wire.

NoteLaying the ground wire shall be conducted by the user according to relevant

standards or under the guidance of an experienced electrician.

NoteThe equipment should stay away from the power generators, X-ray machines,radio stations and transmission lines to avoid electromagnetic noise whenscanning, approaching image these objects may cause anomaly of images, and theequipment is strongly recommended to use separate circuit and grounded safetyoutlet. When this equipment and other electronic or electrical equipment share apower supply, this may generate poor images.

2.4 Installation of hook drive

Figure 2-20 Installation schematic of hook driveThe drawing above is a schematic of the hook drive, in which the threaded end of the hook drive is

mounted into the threaded hole at the top right of the mainframe and is tightened.

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2.5 Foot switch connection (Optional function)

Figure 2-19 Foot switch schematicConnect the connecting end of the foot switch to RS-232 port of the mainframe, and tighten the

port occlusion.

2.6 Li-battery installation (Optional function)

Figure 2-6 Right view of mainframe

Figure 2-7 Li-battery schematic

Li-battery slot

Li-batterycathode

Li-batteryanode

Li-battery buckle

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Figure 2-8

Figure 2-9

2.7 Probe slot installationThe probe slots are on the upper right of the machine, as shown as the following figure:

Note: Don’t pull out plug repeatedly, avoid damaging the machine.

2.8 Printer installation (Optional function)supports USB-port and TV-port printers. After installation of connection, enter the

Windows interface of the machine, and set up the driver according to the use instruction of the printer.

Open the Li-battery slot cover, pullthe Li-battery outward, with itscathode upward, its anode downwardand nameplate facing the back of themainframe, as shown in the figure onthe left, and insert the Li-battery.

After insertion of the battery, thebattery buckle on the left will pop out,and if required to take out theLi-battery, move the buckle in thedirection of arrow, and remove thebattery by pulling the Li-batterybuckle.

Slot cover

JM-W190

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3 Operating procedures

3.1 Introduction of keyboard

The standard PC keyboard：

～：English character keys

In the annotation mode or a dialog box pressing this keys, displaying the corresponding

characters on the cursor position.

: Space key

In the annotation mode or a dialog box pressing the key, the cursor input space.

: Backspace character key

In the annotation mode or dialog box, press the key, can be deleted one by one input

characters.

～ : Digital character keys.

Note:

When the pointer on the screen was disappeared, you could press “Pointer” key to find it.

Keyboard(alphanumerickeys)

TGC

Function keys

Trackballl

Pointer keyl

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3.2 Display interface

3.3 Operation Procedures

1. Turn on the power switch on the back of the machine ,then Press key on the up side

of the machine’s keyboard (at least 3 seconds)to start the device;

2. The system will automatically enter the B ultrasound diagnosis interface;

3. Select the proper probe, examine type, and adjust the various parameters

4. Apply medical ultrasonic coupling agent on the sound window surface of probe, press it on

scanning place, and the real time images will be displayed on screen;

5. Freeze the image, and start measuring operation on it;

6. Press REPORT key and input the basic information of patient, then save;

7. Press Print key or Click REPORT to generate and print reports.

8. Press Pointer key to hide or show the cursor.

3.4 System Recovery

1、When your computer fails to boot or the system crashed, please follow relevant operationsteps to recover the system.

2、System recovering steps: Link the standard PC keyboard, turn on the system and press the key “F11” on the

Parametersdisplaying area

Control Panel

Imagesdisplaying area

System setting

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keyboard continuously，till enter the “Bootmenu” Interface. As shown as figure 3.1:

Figure 3.1

Choose “OK”→ “True Image” on the screen consequently and wait till enteredSystem recovery interface. As shown as figure 3.2:

Figure 3.2 Choose “Recovery” on the left side of the screen and then choose “Refresh Backups”

on the top right of the screen, wait for the automatic searching. As shown as followfigures 3.3、3.4、3.5:

Figure 3.3

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Figure 3.4

Figure 3.5 Click the “Disk Recovery” → “Next” → “Next” on the screen consequently. As

shown as figures 3.6、3.7:

Figure 3.6

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Figure 3.7 Tick “Disk1” and then click “Next”. As shown as figure 3.8:

Figure 3.8 Click “Next” →“Next” →“Proceed” consequently and then shows the processing

bar. As shown as figures 3.9、3.10、3.11:

Figure 3.9

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Figure 3.10

Figure 3.11 Choose the “Restart the computer when the operation is completed”, and then

waiting for the processing bar 100% completed. The computer will be restartedautomatically which need 15 seconds or you can click “Restart” to restart thecomputer, and system recovery is finished. As shown as figures 3.12、3.13:

Figure 3.12

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Figure 3.13Note: When finishing the above operations, Activation is required to complete a key recovery.Activate steps:

1、 Double-click the APP , enter the “Acronis True Image 2014 Premium” screen, as

shown as figure 3-14:

Figure 3-142、 Click “Tool and utilities”→ “Acronis Startup Recovery Manager”and then

enter the “Acronis Startup Recovery Manager” screen.3、 If the interface displays “Activate”, click it to activate the system, as shown as

figure 3-15; if it displays “Deactivate” which can’t activate it and exit it. As shownas figure 3-16:

Figure 3-15

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Figure 3-16

4、 Activate successfully, it will appear figure 3-17, exit it can finish system recovery.

Figure 3-17

3.5 Laser Printer Installation

For details about installation, see the Printer Manual.

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4 Setting

4.1 General

Click to open SETTING window, and click on upper right to close.

Setting consists: Hospital Information, Typical Case, Obstetrical Algorithm, Dicom Settings,Save Setting and Other Setting.

4.2 Hospital Information

Hospital Name, Telephone and Address refer to the information of examining hospital, wherein,the hospital name will be included in the reporting page automatically.The diagnosis doctor and examine doctor in examine file can be added or deleted via Doctor Listhere, and the exam result can be added or deleted via the Examine Result here.

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4.3 Typical Case

Note: This function has been forbiddened.

4.4Obstetrical Algorithm

Preset the algorithm before obstetrical measurement in this window.Beside of modifying obstetrical algorithm presets, there are three more blocks, respectivelyGestational Age Table, Fetus Growth Curve and Fetus Physiology Score.

Gestational Age Table:

Click to enter, there are mainly two parts: preset obstetrical list and user

edit mode, respectively as shown in the figure below:Note: Non-professionals are forbidden to change User Edit area.

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Preset Obstetrical List User Edit ModeMove the cursor to corresponding obstetrical list and click, there are 31 sheets of obstetrical list, wherein,**User refers to user edit mode, * * (mm) for the measured values, WEEKS (W.D) for gestational age,SD (days) for the upper and lower deviation the number of days which are shown as follow:

BPD(Tokyo Method) AC(Hadlock Method) HL(Hansmann Method)

BPD(Hadlock Method) AC(Korean Method) HL(Jeanty Method)

BPD(Korean Method) AC(Merz Method) HL(Osaka Method)

BPD(Hansmann Method) AD(Hansmann Method) OFD(Hansmann Method)

BPD(Merz Method) CRL(Tokyo Method) FTA(Osaka Method)

FL(Tokyo Method) CRL(Korean Method)

FL(Hadlock Method) CRL(Hansmann Method)

FL(Korean Method) CRL(Robinson Method)

FL(Merz Method) GS(Tokyo Method)

HC(Hadlock Method) GS(Korean Method)

HC(Korean Method) GS(Hansmann Method)

HC(Hansmann Method) GS(Hellman Method)

HC(Merz Method) AFI(Korean Method)

Fetus Growth Curve:

Click and enter, as shown in the figure below:

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The system includes totally 31 types of fetus growth curves for users’ reference, which can be

exit by clicking .

Fetus Physiology Score:

Click and enter, as shown in the figure below:

Choose corresponding scores in the fetal breath movement, fetal movement, fetal tone andamniotic fluid index options according to physical development conditions of fetus and

click .

Note: Fetal physiology score just only for reference. Non-professionals are forbidden to change.

- 26 -

4.5 Dicom Setting:

DICOM Overlay Information is used to set whether characters information will be loaded or

not during saving DICOM images.

Window Center and Window Width is used to set up the contrast and brightness during

saving DICOM images.

When auto send is checked on, the film files will be DICOM transmitted

when they are being saved.

The Dicom Transmitting function is added for pictures in the form of .dcm can be adjusted

with its gray scale, which is helpful to doctor diagnosis.

Dicom transmission refers to transmission of pictures in .dcm forms between two machines

installed with Dicom protocol, and the specific settings are included in the Dicom Setting

area. Dicom settings are required both for transmitting end and receiving end, the receiving

end number and server end number must be same. (tips: Can only transmit .DCM format

images)

Dicom transmission requires receiving end and transmitting end, this machine can be used

as both. When it is used as receiving end, the received parameters can be set in receiving end

setting, and the local receiving function should be started; if the local receiving is disabled,

the transmitting fails. If the machine is used as transmitting end, specific settings are shown

as follow:

1) Set the parameters on transmitting end;

- 27 -

2) Click , open the interface shown as follow.

3) Click and pop up the dialogue frame, then select open;

4) Click , send .dcm pictures to receiving end, and Successfully Sent

dialogue frame pops up;

5) Click .

4.6 Save Setting

After customer saving route is checked, the system will remind the users to select route when theimages are saved every time.

It is also possible to modify default saving route, and click .Cine Frame Count, Save Frequency and Delay set by move the pointer.The images can be saved with optional form, including .bmp, jpg formsThe film forms include .seq, DCM (DICOM) and avi.The video output can be chose with local or global.

Click after set.

- 28 -

4.7 Other Setting

Language bar can be used to set the displaying language of entire software. Report Icon is for report title image.

4.8 Exit the System

Click , and following dialogue frame appears:

Click to stop the device and put it into standby status;

Click to exit B-ultrasound interface and enter into windows operation

system.

- 29 -

5 Adjust Image Parameters

5.1 Switch Display Mode

Switch to Mode B

Press key B-Gain, the current image is switched to real time single B mode (device start default

mode).

Switch to Mode BB

Press key BB, the current image is switched to double B mode, the screen displays both real time

and frozen images. Press key BB again to switch the real time and frozen status of the two

images.

Switch to B+M Mode

Press key BM, and the current image is switched to B+M mode, the screen displays a type B and

a type M real time images at same time, and the sampling line on type B image can be moved

horizontally by trackball.

Switch to Mode M

Under Mode B+M, press key BM again to switch the current image to Mode M, the screen

displays a type M image.

Switch to Mode 4B

Under Mode B and BB, press key 4B to switch the current image to 4B mode. The screen

displays four type B images including one real time mode. Continue to press key 4B to switch the

real time and frozen status of the four images.

B BB B+M

M 4B

- 30 -

5.2 Freeze Image

Press key FREEZE to switch real time and frozen status.

Note: Frozen images and measurements, do not short time continuous pressing the " freeze " key, so as to

avoid error operation caused no reaction apparatus.

5.3 Adjust Gain

The Total Gain: 32dB on right side of screen is the current gain, which is adjusted by dialingB-Gain left and right. The close/middle/remote fields can be adjusted via the 8 sections ofTGC on keyboard.

5.4 Adjust Displaying Depth

Under real time mode (only in B mode), dial Depth left and right to change the currentdisplaying depth (or scale). The current depth display is on right side of screen, and theadjustment scope changes along with probe type.

Depth 90 Depth 180 Depth 240

5.5 Adjust Probe Scanning Angle

This function is currently not available, reserved. Please contact us, if need.

5.6 Focus Adjustment

Focus Position

Dial FocPosi left and right in real time scanning status to move the focus vertically andchange its position.

Notice:

Images near focus indicator have better focusing. It is possible to change the focus position

to direct the focus to interested area.

5.7 ProbeWorking Frequency

Press key Freq, then dial Value left and right in real time scanning status to switch thefrequency of currently working probe, and the current working frequency will be displayedon upper right corner of screen, such as Frequency: 35MHz.

5.8 Switch the Probe

The device is connected with 2or 3 probes at the same time , the automatically identifiedplug port A is default working probe after start, and the probe type is displayed on upperright corner of screen, such as Probe: R60A. Press key Probe, there will be a menu withprobes and exam type. Moving the pointer to choose the one exam type you want.

- 31 -

5.9 M Speed Adjustment

Under real time B+M and M mode, click “Mspeed” button to adjust the brush speed of typeM images on screen. The current scanning speed will be displayed on left side of screen,such as M speed: 6ms.

5.10 Sound PowerAdjust

This function is currently not available, reserved. Please contact us, if need.

Notice:

Ultrasonic waves may do harm to human body, and long time radiation with high power must be avoided.

Be careful when using the function. The probe may heat up when the power of ultrasonic wave is added.

5.11 Frame correlation Adjustment

Under real time mode, click “FrameAVG” button to adjust the frame correlation images onscreen. The current scanning frame correlation will be displayed on left side of screen, suchas FramAvg: 2.

5.12 Line correlation Adjustment

Under real time mode, click “LineAVG” button to adjust the line correlation images onscreen. The current scanning line correlation will be displayed on left side of screen, such asLineAvg: 2.

- 32 -

6 Image Processing and Adjustment

6.1 Tissue Harmonic Image

During real time scanning status, continuously click to enable/disable tissue

harmonic image. Tissue harmonic weave status will be indicated on right side of screen:Tissue Harmonic: ON.

Able Tissue Harmonic Disable Tissue Harmonic

Notice:

Tissue harmonic is only valid under abdomen probe.

6.2 Pseudo-color Treatment

On the right side of screen, you can click “Pseudo” button continuously to change thescanning area color. There are 8 kinds of colors.

6.3Image Turnover

Turning Over Up and Down

Press key U/D continuously to turn over the image up and down.

Turning Over Lift and Right

Under B or BB mode real time scanning status, Press key L/R continuously to turn theimage over left and right. The on upper left side of screen is the image scanningdirection indication.

- 33 -

6.4Local Amplification

Press key ZOOM, and move cursor to image area, the cursor changes to【十】. Press mouseleft and select area via trackball, then the image of the area is amplified and displayed in thecenter of screen, which can be moved by trackball. Press key ZOOM again to exit localamplification.

Press ZOOM and adjust knob ParamAdju to amplify or shrink the image, and the amplifiedrate is indicated on upper left side of image in real time. Press “ZOOM” to exit.

6.5Reset

Click the " " button at the bottom right of the screen，All parameters can be

restored to the factory defaults .

6.6 ACUI

During real time scanning status, continuously click the "ACUI" button at the bottom left ofthe screen to enable/disable the function of ACUI. The AUCI status will be indicated onright side of screen: ACUI: ON. Using ACUI function will make the image more clear andprecise, which is the biggest highlight of this machine. The highest quality of image willmake you more comfort and make the diagnosis more efficient.

- 34 -

7 Note

7.1 Note in Full Screen

Press key TEXT, Input note content and then click anywhere in image area to finish noting.

Press to delete wrongly input words.

Press Ctrl+Shift to shift input method.

In order to move the note content, click it on screen until it becomes green and cursor changes to

direction icon, and then move the content and click again.

To delete comment content, Press right key to choose the comment content, then press Delete.

7.2 Body Sign Setting

Sequentially press key BODY Body Mark, and body signs are indicated on right side of screen.

Click corresponding icons to show body signs on lower right corner or screen. Different body

marks are decided on different exam type you choose before. There are 121 kinds of body marks

in total.

Sequentially press BODY Remove Body Mark to delete body signs.

7.3 Input Arrow

Sequentially press BODY Arrow, the cursor changes to +. Click anywhere in image area, and

drive the arrow to expected length, and lick again to input arrow. Repeat to make more arrows.

7.4 Clear Screen

Press CLEAR to clear the measuring mark, notes and body signs etc. information in image area.

- 35 -

8 Images and films

8.1 Save Static Images

Images can be saved in .bmp, .jpg = forms, see details in Save Settings.

1. In real time or frozen status, continuously press key Grab to save the current image in memory.Image preview window is indicated on right side of screen, and 5 current images can be saved atmax.

2. Click on the screen, the personal file occurs, edit patient’s information and click Set

to build a new personal document;3. After operations above, the saving route of saved image is: D:\Data\Patient-Image\us\ Case

Number.Notice:

Restart the software and save image, the images saved last time will be covered. Right click in the menu Image Preview on right side of screen to select Clear and selected

image is removed. It is also possible to clear all.

8.2 Film Replay After startup and entered into real time scanning status, the device collects the current

images into memory, and press FREEZE after about 30S to freeze the image. Press knob Cine to start film replay, the images will be displayed in cycle. Current replay

status is displayed on lower right corner of image, for example:“Frame XXX/XXX”, “XXX/XXX” respectively represent current frame and total framenumber.

Please press knob Cine to suspend replay, and adjust the knob to realize single frame reply.Press again and switch back to automatic recycling replay status. Press key FREEZE andreturn to current active status.

8.2 Saving Films

Film saving forms: the films can be saved in .seq, DICOM and AVI form. See SavingSettings for detail.

Film saving route:

Click to pop up saving route selection dialogue frame.

Notice:

Please do not try other operations during film saving

8.3 Loading Films

If there are film files on hard disk, choose in right menu, and select

corresponding file in dialogue frame popped up. Click open button to display automatically.

- 36 -

(Note the file type)

If film files in DICOM form are loaded, press left button in image area, and move trackball to set

image brightness.

8.4 Import Patient Information

Notice:

Before importing, ensure the patients’ information is backed up according to 8.5.

Since Welld.mdb files include all the word information of patients, these files refresh every time a

patient’s file is newly added or existed case is modified. So consider twice before importing

patients’ information.

1. Without replacing hard disk, all the data in windows disk D will remain unchanged after thesystem is upgraded or resumed, the data in disk D will be recalled after repeatedupgrade/reset. Under such condition, the patients’ information is not required to be importedor resumed. If it is needed, ensure there is no newly added case or case data is unchangedafter backup, and then import information (with following method). Otherwise, the modifiedor newly added data will permanently lost unless you do not need them, please do rememberthis！

2. When the hard disk is replaced or formatted, backup patients’ information needs to beimported: First resume the system, and then copy the corresponding Data files (Typical caseor Setting), saved images and data base (patients’ information) in disk or movable memorydevice to windows disk D and cover original files, then enter into B-ultrasonic system. Press

REPORT on keyboard or click on main interface to enter into file interface. At this

time, New，Delete etc. operations are available.

- 37 -

9. Settings and reportage of patient information

9.1 New Patient File

1. Click to set up a new patient file. After the basic information edited, Click Set. The new

file is set up successfully, as shown below:

9-1 New patient’s fileThe check number can’t be edited, which is automatically generated in the system according tochronological order.

2. Click to improve the patient medical record as shown below:

9-2 Patient registrationThis interface is used to improve or revise patient information. Type, inspection item, date, and

other items are optional in the drop-down box. After the confirmation, click . Patient

registration is successful.

Click to enter the system main interface for ultrasound image acquisition.

- 38 -

9.2 Report writing

1. Select and click the clinically significant image to save under the current patient name. Then, click

to enter the report. Write a report as follows:

9.3 Report writing2. The image column in the left side is to display the ultrasound image for the patient. If the image

saved exceeds the current display range, then both up and down arrows can be used foradjustment.

3. Need to write words in and .

4. The report allows you to add up to six images which can be selected

at .

5. Method to add an image: Select the image needed in the left image column, click the white areabelow the corresponding image. Make a tick on the small box at the left side of the image todisplay the final report page.

6. Method of operating an image: Select any image on the left-side image column or report image

column, right-click the mouse to pop out or . Now theimage can be operated as shown.

7. After the report writing is completed, click at the right corner to the

final report as shown below:

- 39 -

9-5 Final reportThe report can automatically add a page if the number of items increases, so as to ensure that all

information in the report page is displayed.

9.3 Preview image

Double-click any image on the left-side image column to enter the image preview interface asshown below:

- 40 -

9-6 Preview image

Here, select the image added to the report, click to confirm its addition. Clickto directly save it in the U disk. The image not added to the report is displayed as "not added

to the report"; otherwise, displayed as "already added to the report."

9.4 Medical records management

is used to inquire, export, and delete a patient record. The interface is shown asfollows:

9.7 Medical records managementBy setting the time and data of the check, you can find the ultrasound medical record of the

patient in this time. By selecting any medical record, you can do operations, for example, open, export,and delete etc. Also, by setting the other item, you can find the accurate information of the patient.

- 41 -

10 Measurement

10.1 General

The device can give multiple measurements to multiple items, with six measuring marks: ,, △, □, ◇ and ○.

The device provides more than 10 measuring items. Adjust knob EXAM to selectcorresponding examine type, and press keyMEASURE to enter.

Press key MEASURE, system automatically enter into measurement status under currentexamine type and displaying mode, it also displays measuring menu.

10.2 Routine Measurement

10.2.1 Distance Measurement

1. Choose examine type as abdomen and press key MEASURE to sequentially selectGENERIC DISTANCE on right side of screen;

2. Move icon十 to start point by trackball, and left click to confirm;3. Move icon 十 by trackball and click left to confirm, at this time the cursor changes to

single arrow, and the measuring value is automatically displayed on lower left corner.4. Adjust measurement: move the cursor via trackball near to start/end point, press mouse left

when the icon becomes hand form, and move trackball to adjust. Press left key to confirmafter adjustment.

5. If it needs to continuously measure multiple groups of distance values, move the cursor tostart point by trackball and left click to confirm. At the same time, cursor changes into crossicon十, and then repeat step 3.

10.2.2 Area Measurement

Trace Method:1. Select examine type as abdomen, and press key MEASURE. Sequentially select GENERIC

AREA on right side of screen;2. Move cross icon十 to start point by track ball and click left;3. Drive icon pen type to trace, click L to confirm and finish the measurement, the tracing real

line change to imaginary line, the measured value will be displayed on lower left corner;4. Repeat step 1 to 3 to continuously measure multiple groups of area values.

Distance Measurement Diagram

- 42 -

Ellipse Method:1. Select examine type as abdomen, and press key MEASURE. Sequentially select GENERIC

AREA on right side of screen;2. Move cross icon十 to start point by track ball and click left;3. Move cross icon 十 until ellipse trace appears, drive to proper position and click left to

confirm the other point. At this time the cursor is still cross icon, and drive the icon to alterthe size of ellipse and finally press left to end the measurement. Measured value is indicatedon lower left corner;

4. Click the nodes or arc of ellipse with cursor, move trackball and press left key to change thesize of ellipse;

5. If it needs to continuously measure multiple groups of area values, move the cursor to startpoint and click left to confirm, the cursor becomes cross icon, and repeat step 3 and 4.

10.2.3 Circumference Measurement

Trace Method:1. Select examine type as abdomen, and press key MEASURE. Sequentially select GENERIC

CIRCUMFERENCE on right side of screen;2. Move cross icon十 to start point by track ball and click left;3. Drive icon pen type to trace, click L to confirm and finish the measurement, the tracing real

line change to imaginary line, the measured value will be displayed on lower left corner;4. Repeat step 1 to 3 to continuously measure multiple groups of area values.

Ellipse Method:

Area Measurement Diagram(Trace)

Area Measurement Diagram(Ellipse)

- 43 -

1. Select examine type as abdomen, and press key MEASURE. Sequentially select GENERIC

CIRCUMFERENCE on right side of screen;2. Move cross icon十 to start point by track ball and click left;3. Move cross icon 十 until ellipse trace appears, drive to proper position and click left to

confirm the other point. At this time the cursor is still cross icon, and drive the icon to alterthe size of ellipse and finally press left to end the measurement. Measured value is indicatedon lower left corner;

4. Click the nodes or arc of ellipse with cursor, move trackball and press left key to change thesize of ellipse;

5. If it needs to continuously measure multiple groups of area values, move the cursor to startpoint and click left to confirm, the cursor becomes cross icon, and repeat step 3 and 4.

10.2.4 Angle Measurement

1. Select examine type as abdomen, and press key MEASURE. Sequentially select GENERIC Angle.2. Click at three points in the picture with the trackball, then the angle value shaped from the threepoints will be displayed on the left side of the screen automatically.

Angle measurement

10.2.5 Volume Measurement

The volume is measured in three axis method. Continuously measure three groups of distancevalues according to distance measuring method above, and the system automatically calculate thevolume and indicate it on lower left corner.

Shown as follow:

10.2.6 Other Measurements

Distance narrow rate measurement: continuously measure two groups of distance values and

Volume MeasurementDiagram

- 44 -

the system automatically calculate distance narrow rate and indicate it on lower left ofimage.

Area narrow rate measurement: continuously measure two groups of area values and thesystem automatically calculate area narrow rate and indicate it on lower left of image.

10.3 Heart Measurement under Mode M

10.3.1 Distance Measurement

Distance Measurement could follow 10.2.1 distance measurement steps;

10.3.2 Heart Rate Measurement

Heart rate is based on two periods of cardiograms, and measured in following steps:1. Select examine type as Heart, acquire satisfactory image and freeze under mode B/M or M,

sequentially pressMeasure Generic Heart Rate;2. Move “+” by trackball to start point and click left to confirm;3. Move “+” by trackball to start point and click left to finish the measurement, the data

displays on the left bottom of the screen.4. If need to continuously measure multiple groups of heart rate values, click L key and repeat

step 2 and 3.

10.4 Obstetrics Measurement

10.4.1 Overview

Press “Probe”, choose examine part “Obstetrics”, click “Set” and press “Measure” to enter. Obstetrics Measurement includes The First Stage, The Second Stage, The Third Stage

and Generic.

10.4.2 The First Stage

The First Stage includes BPD, FL, HC, AC, CRL, FTA, NT, YS, GSDL, GSDW, GSDH; BPD, FL, CRL, NT, YS, GSDL, GSDW, GSDH could follow 10.2.1 distance measurement steps; HC, AC could follow 10.2.2 area’s ellipse measurement steps; FTA could follow 10.2.2 area’s trace measurement steps;

10.4.3 The Second Stage

The Second Stage includes BPD, FL, HC, AC, CRL, IOD, NT, CER, CMAG, APTD, APD, FTA,NSF, LV, FIB, TIB, LFT, RFT, HL, RAD, ULN, OFD, OOD, AFI;

BPD, FL, CRL, IOD, NT, CER, CMAG, APTD, APD, NSF, LV, FIB, TIB, LFT, RFT, HL, RAD, ULN,OFD, OOD, AFI could follow 10.2.1 distance measurement steps;

HC, AC could follow 10.2.2 area’s ellipse measurement steps; FTA could follow 10.2.2 area’s trace measurement steps;

10.4.4 The Third Stage

The Third Stage includes BPD, FL, HC, AC, CRL, IOD, CER, CMAG, APTD, APD, FTA, NSF, LV,FIB, TIB, LFT, RFT, HL, RAD, ULN, OFD, OOD, AFI;

BPD, FL, CRL, IOD, CER, CMAG, APTD, APD, NSF, LV, FIB, TIB, LFT, RFT, HL, RAD, ULN,OFD, OOD, AFI could follow 10.2.1 distance measurement steps;

- 45 -

HC, AC could follow 10.2.2 area’s ellipse measurement steps; FTA could follow 10.2.2 area’s trace measurement steps;

10.4.5 Generic

Generic includes Distance, Area, Circumference, Angle, Volume which could follow 10.2 genericmeasurements.

10.5 Urinary Measurement

Press “Probe”, choose “urinary” and click “Set”, at last press “Measure” to enter; Urinary measurement includes Antigen, Prostate-Volume, TransZone-Volume,

Bladder-Volume, Urine-Volume, L-Renal-Volume, R-Renal-Volume; Click “Antigen” and occur display frame, import the urinary data and click “OK”. Prostate-Volume, TransZone-Volume, Bladder-Volume, Urine-Volume, L-Renal-Volume,

R-Renal-Volume which could follow 10.2.5 volume measurements.

10.6 Gynecological Measurement

Press “Probe”, choose “gynecological” and click “Set”, at last press “Measure” to enter; Gynecological measurement includes generic and gynecological; Generic includes Distance, Area, Circumference, Angle, Volume which could follow 10.2 generic

measurements. Gynecological includes Uterus-Volume, Cervix-Volume, Right-Ovarium-Volume,

Left-Ovarium-Volume, Endometr, L1-Follide-Volume, L2-Follide-Volume, L3-Follide-Volume,L4-Follide-Volume, R1-Follide-Volume, R2-Follide-Volume, R3-Follide-Volume, R4-Follide-Volumewhich could follow 10.2.5 volume measurement.

10.7 Thyroid Measurement

Press “Probe”, choose “thyroid” and click “Set”, at last press “Measure” to enter; Thyroid measurement includes generic and thyroid; Generic includes Distance, Area, Circumference, Angle, Volume, Stenosis Diameter, Stenosis Area

which could follow 10.2 generic measurements. Thyroid includes L-Thyroid-Volume, R-Thyroid-Volume, Thyroid-Isthmus; Thyroid-Isthmus

measurement could follow 10.2.1 distance measurement; L-Thyroid-Volume and R-Thyroid-Volumemeasurement could follow 10.2.5 volume measurement.

- 46 -

11 Check and Maintenance

11.1 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：Discard the device according to local law.Do not discard it mixing with other household garbage.

Warning：The manufacturer shall not assume the responsibility of risks caused by using the device beyondits service life.

11.2 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：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.

11.3 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 14mm. Regularly check the probe enclosure to ensure it is good incase liquid

ingression spoil the inner components.

- 47 -

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:Don’t use extender, ethylene oxide or any other organic solvent which tend to deface the probe's

protective foil.Don’t 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.

11.4 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.

- 48 -

12 Simple Trouble Shooting

12.1 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.

12.2 Simple trouble shooting

No. Malfunction phenomena Troubleshooting1 Open power switch of the device, with

no signal appeared on the screen andthe indicator light is not on.

1. Examine power supply;2. Examine supply line and plug;3. Examine whether the fuse is burned-out;4. Examine the lightness adjusting knob ofthe monitor.

2 Discontinuous striae and snow appearon the screen.

1. Examine power supply: strike fire interfereof the other devices;2. Environmental examination: Electric andmagnetic field interfere;3. Examine power and probe plugs: whetherthey are well connected.

3 Unclear image display 1.Adjust the brightness and contrast knobs onthe front panel;2.Adjust the 8 level TGC and the total gainknob on the front panel;3.Clean the screen optical filter.

4 Unclear near field 1. Adjust the total gain knob on the frontpanel and the 8 level TGC;2. Adjust the focus position to the near field;

5 Unclear far field 1. Adjust the total gain knob on the frontpanel and the 8 level TGC;2. Adjust the focus number, space andposition to set the focus in the far field.

- 49 -

13 Transportation and Storage

13.1 Environment requirements on transportation and storageEnvironment temperature range：-20℃～+55℃Relative humidity range：<80%（20℃）

13.2 Transportation

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.

13.3 Storage

Equipment should be taken out from the packing when storage time exceeds six months，power on it forfour hours, and then pack it correctly and keep it in a warehouse. The device must not be piled, and do notplace it closely against the floor, walls or roof.

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

- 50 -

Appendix A Acoustic output reporting tableB modeNominal frequency: 3.5MHzTransducer Model: C5-2Manufactured By: ,

Notes:

（a）This probe is not intended for transcranial or neonatal cephalic use;

Index label MI

TIS TIB

TICScan

Non-scan Non-scanAaprt≤1cm2 Aaprt＞1cm2

Maximum index value 0.85 0.98 - - - （a）

Associatedacoustic

parameters

Pra (MPa) 1.46

P (mW) 115.2 - - #

Min.of [Pα(zs), Izpta,αzs)] (mW) -

Zs (cm) -

Zbp (cm) -

Zb (cm) -

Z at max. Ipi,α (cm) 5.30

deq (Zb) (cm) -

fawf (MHz) 2.91 2.91 - - - #

Dim of Aaprt

X (cm) 1.64 - - - #

Y (cm) 1.30 - - - #

Other

information

td (μsec) 0.52

prr (Hz) 3787

pr at max. Ipi (MPa) 2.48

deq at max. Ipi (cm) -

Ipa,α at max. MI (W/cm2) 207.9

Operatingcontrol

conditions

F-PIN 1 1 - - - #

Power,% 80 80 - - - #

Angle,° 30 30

Focus position 7 7


- 51 -

Acoustic output reporting tableM mode (Inc B mode)Nominal frequency: 3.5MHzTransducer Model: C5-2Manufactured By:

Notes:（a）This probe is not intended for transcranial or neonatal cephalic use;

Index label MI

TIS TIB

TICScan


Maximum index value 0.89 0.49 - 0.036- 0.11 （a）

Associatedacoustic

parameters

Pra (MPa) 1.51

P (mW) 82.0 - 4.7 #

Min.of [Pα(zs), Izpta,αzs)] (mW) 2.61

Zs (cm) 2.94

Zbp (cm) 2.94

Zb (cm) 5.07


deq (Zb) (cm) 0.35

fawf (MHz) 2.91 2.91 - 2.90 2.90 #

Dim of Aaprt

X (cm) 2.35 - 2.34 2.34 #

Y (cm) 1.30 - 1.30 1.30 #

Other

information

td (μsec) 0.53

prr (Hz) 4166


deq at max. Ipi (cm) 0.34


Operatingcontrol

conditions

F-PIN 1 1 - 1 1 #

Power,% 80% 80% - 80% 80% #

Angle,° 30 30 30 30 #

Focus position 7 7 - 7 7 #

M Speed, S 1.25 1.25 - 1.25 1.25 #


- 52 -

Acoustic output reporting tableB modeNominal frequency: 3.5MHzTransducer Model: c3-1Manufactured By:


Index label MI

TIS TIB

TICScan



Associatedacoustic

parameters

Pra (MPa) 1.46

P (mW) 115.2 - - #


Zs (cm) -

Zbp (cm) -

Zb (cm) -


deq (Zb) (cm) -

fawf (MHz) 2.91 2.91 - - - #

Dim of Aaprt

X (cm) 1.64 - - - #

Y (cm) 1.30 - - - #

Other

information

td (μsec) 0.52

prr (Hz) 3787




Operatingcontrol

conditions

F-PIN 1 1 - - - #

Power,% 80 80 - - - #

Angle,° 30 30

Focus position 7 7


- 53 -

Acoustic output reporting tableM mode (Inc B mode)Nominal frequency: 3.5MHzTransducer Model: c3-1Manufactured By: ,


Index label MI

TIS TIB

TICScan


Maximum index value 0.89 0.49 - 0.036- 0.11 （a）

Associatedacoustic

parameters

Pra (MPa) 1.51

P (mW) 82.0 - 4.7 #

Min.of [Pα(zs), Izpta,αzs)] (mW) 2.61

Zs (cm) 2.94

Zbp (cm) 2.94

Zb (cm) 5.07


deq (Zb) (cm) 0.35

fawf (MHz) 2.91 2.91 - 2.90 2.90 #

Dim of Aaprt

X (cm) 2.35 - 2.34 2.34 #

Y (cm) 1.30 - 1.30 1.30 #

Other

information

td (μsec) 0.53

prr (Hz) 4166




Operatingcontrol

conditions

F-PIN 1 1 - 1 1 #

Power,% 80% 80% - 80% 80% #

Angle,° 30 30 30 30 #

Focus position 7 7 - 7 7 #

M Speed, S 1.25 1.25 - 1.25 1.25 #


- 54 -

Acoustic output reporting tableB modeNominal frequency: 4.5MHzTransducer Model: c1-6Manufactured By: ,


Index label MI

TIS TIB

TICScan



Associatedacoustic

parameters

Pra (MPa) 1.26

P (mW) 10.0 - - #


Zs (cm) -

Zbp (cm) -

Zb (cm) -


deq (Zb) (cm) -

fawf (MHz) 3.87 3.87 - - - #

Dim of Aaprt

X (cm) 0.52 - - - #

Y (cm) 0.79 - - - #

Other

information

td (μsec) 0.43

prr (Hz) 4784




Operatingcontrol

conditions

F-PIN 1 1 - - - #

Power,% 80 80 - - - #

Angle,° 90 90

Focus position 6 6 - - - #


- 55 -

Acoustic output reporting tableM mode (Inc B mode)Nominal frequency: 4.5MHzTransducer Model: c1-6Manufactured By:


Index label MI

TIS TIB

TICScan


Maximum index value 0.66 0.22 0.025 - 0.05 （a）

Associatedacoustic

parameters

Pra (MPa) 1.29

P (mW) 11.6 1.35 1.35 #


Zs (cm) -

Zbp (cm) -

Zb (cm) 2.68


deq (Zb) (cm) 0.31

fawf (MHz) 3.86 3.86 3.88 - 3.88 #

Dim of Aaprt

X (cm) 0.63 0.63 - 0.63 #

Y (cm) 0.79 0.80 - 0.80 #

Other

information

td (μsec) 0.43

prr (Hz) 4807




Operatingcontrol

conditions

F-PIN 1 1 1 - 1 #

Power,% 80% 80% 80% - 80% #

Angle,° 90 90 90 - 90 #

Focus position 6 6 6 - 6 #

M Speed, S 1.25 1.25 1.25 - 1.25 #


- 56 -

Acoustic output reporting tableB modeNominal frequency: 7.0MHzTransducer Model: l3-1Manufactured By:


Index label MI

TIS TIB

TICScan



Associatedacoustic

parameters

Pra (MPa) 1.30

P (mW) 24.0 - - #


Zs (cm) -

Zbp (cm) -

Zb (cm) -


deq (Zb) (cm) - -

fawf (MHz) 5.70 5.70 - - - #

Dim of Aaprt

X (cm) 1.02 - - - #

Y (cm) 0.71 - - - #

Other

information

td (μsec) 0.28

prr (Hz) 5649




Operatingcontrol

conditions

F-PIN 1 1 - - - #

Power,% 80% 80% - - - #



- 57 -

Acoustic output reporting tableM-mode (Inc B mode)Nominal frequency: 7.0MHzTransducer Model: l3-1Manufactured By:


Index label MI

TIS TIB

TICScan



Associatedacoustic

parameters

Pra (MPa) 1.34

P (mW) 22.1 1.06 1.06 #


Zs (cm) -

Zbp (cm) -

Zb (cm) 2.47


deq (Zb) (cm) 0.20

fawf (MHz) 5.70 5.70 5.70 - 5..70 #

Dim of Aaprt

X (cm) 1.01 1.00 - 1.00 #

Y (cm) 0.70 0.70 - 0.70 #

Other

information

td (μsec) 0.28

prr (Hz) 5681




Operatingcontrol

conditions

F-PIN 1 1 1 - 1 #

Power,% 80% 80% 80% - 80% #


M Speed, S 1.25 1.25 1.25 - 1.25 #


- 58 -

Acoustic output reporting tableB modeNominal frequency: 6.0MHzTransducer Model: ec1-6Manufactured By:


Index label MI

TIS TIB

TICScan



Associatedacoustic

parameters

Pra (MPa) 1.38

P (mW) 10.0 - - #


Zs (cm) -

Zbp (cm) -

Zb (cm) -


deq (Zb) (cm) -

fawf (MHz) 4.66 4.66 - - - #

Dim of Aaprt

X (cm) 0.63 - - - #

Y (cm) 0.79 - - - #

Other

information

td (μsec) 0.31

prr (Hz) 4807




Operatingcontrol

conditions

F-PIN 1 1 - - - #

Power,% 80 80 - - - #

Angle,° 120 120



- 59 -

Acoustic output reporting tableM-mode (Inc B mode)Nominal frequency: 6.0MHzTransducer Model: ec1-6Manufactured By:


Index label MI

TIS TIB

TICScan



Associatedacoustic

parameters

Pra (MPa) 1.41

P (mW) 10.2 0.62 0.62 #


Zs (cm) -

Zbp (cm) -

Zb (cm) 2.36


deq (Zb) (cm) 0.26

fawf (MHz) 4.66 4.66 4.61 - 4.61 #

Dim of Aaprt

X (cm) 0.62 0.62 - 0.62 #

Y (cm) 0.80 0.79 - 0.79 #

Other

information

td (μsec) 0.31

prr (Hz) 4807




Operatingcontrol

conditions

F-PIN 1 1 1 - 1 #

Power,% 80% 80% 80% - 80% #

Angle,° 120 120 120 - 120 #


M Speed, S 1.25 1.25 1.25 - 1.25 #


- 60 -

Appendix B EMCEXAMPLE OF GUIDANCE AND MANUFACTURER’S DECLARATION

Guidance and manufacturer’s declarationGuidance and manufacturer’s declaration – electromagnetic emissionsThe MACHINE is intended for use in the electromagnetic environment specified below.The customer or the user of the MACHINE should assure that it is used in such anenvironment.Emissions test Compliance Electromagnetic environment –

guidanceRF emissionsCISPR 11

Group 1 The MACHINE uses RF energy only forits internal function. Therefore, its RFemissions are very low and are not likelyto cause any interference in nearbyelectronic equipment.

RF emissionsCISPR 11

Class A

Harmonic emissionsIEC 61000-3-2

Not Applicable

Voltage fluctuations/flickeremissionsIEC 61000-3-3

Not Applicable

- 61 -

Guidance and manufacturer’s declaration – electromagnetic immunityThe MACHINE is intended for use in the electromagnetic environment specified below.The customer or the user of the MACHINE should assure that it is used in such anenvironment.Immunity test IEC 60601

test levelCompliancelevel

Electromagneticenvironment–guidance

Electrostaticdischarge (ESD)IEC 61000-4-2

±6 kV contact±8 kV air

±6kV Contact±8kV Air

Floors should be wood,concrete or ceramic tile. Iffloors are covered withsynthetic material, the relativehumidity should be at least30 %. If ESD interfere with theoperation of equipment,counter measurements suchas wrist strap, grounding shallbe considered.

Electrical fasttransient/burst IEC61000-4-4

±2 kV forpower supplylines ±1 kV Forinput/outputlines

±2 kV for Powersupply lines

Mains power quality should bethat of a typical commercial orhospital environment.

Surge IEC61000-4-5

±1 kVdifferentialmode ±2 kVcommon mode

±1kVdifferentialmode±2kV commonmode

Mains power quality should bethat of a typical commercial orhospital environment.

Voltage dips, shortInterruptions andVoltage variationson power supplyinput lines IEC61000-4-11

<5 % UT(>95 % dip inUT)for 0.5cycle40 % UT(60 % dip inUT)for 5 cycles70 % UT(30 % dip inUT)for 25cycles<5 % UT(>95 % dip inUT) for 5 sec

<5% UT for 0.5cycle40% UT for 5cycles70% UT for 25cycles<5% UT for 5 s

Mains power quality should bethat of a typical commercial orhospital environment. If theuser of the MACHINErequires continued operationduring power mainsinterruptions, it isrecommended that theMACHINE be powered froman uninterruptible powersupply or a battery.

Power frequency(50/60 Hz) magneticfield IEC 61000-4-8

3 A/m 3 A/m Power frequency magneticfields should be at levelscharacteristic of a typicallocation in a typicalcommercial or hospitalenvironment.

NOTE UT is the a.c. mains voltage prior to application of the test level.

- 62 -

Guidance and manufacturer’s declaration-electromagnetic immunity-For EQUIPMENT and SYSTEM that are not LIFE-SUPPORTING

Guidance and manufacturer’s declaration-electromagnetic immunityThe MACHINE Full Digital Ultrasonic Diagnostic System is intended for use in the electromagneticenvironment specified below. The customer or the user of the MACHINE Full Digital Ultrasonic DiagnosticSystem should assure that it is used in such an environment.Immunitytest

IEC 60601test level

Compliance level

Electromagnetic environment-guidance

ConductedRFIEC61000-4-6

Radiated RFIEC61000-4-3

3Vrms150kHz to 80MHz

3V/m80 MHz to2.5GHz

1V

3V/m

Portable and mobile RF communications equipment should beused no closer to any part of the MACHINE Full DigitalUltrasonic Diagnostic System, including cables, than therecommended separation distance calculated from the equationapplicable to the frequency of the transmitter.

Recommended separation distance

Where p is the maximum output power rating of the transmitterin watts (W) according to the transmitter manufacturer and d isthe recommended separation distance in meters(m)b

Field strengths from fixed RF transmitters, as determined by anelectromagnetic site survey, should be less than the compliancelevel in each frequency range b

Interference may occur in the vicinity of equipment marked withthe following symbol:

NOTE 1 At 80 MHz and 800 MHz, the higher frequency range applies.NOTE 2 These guidelines may not apply in all situations. Electromagnetic is affected by absorption fromstructures, objects and people.a Field strengths from fixed transmitters, such as base stations for radio(cellular/cordless) telephones andland mobile radios, amateur radio, AM and FM radio broadcast and TV broadcast cannot be predictedtheoretically with accuracy. To assess the electromagnetic environment due to fixed RF transmitters, anelectromagnetic site survey be considered. If the measured field strength in the location in which the MACHINEFull Digital Ultrasonic Diagnostic System is used exceeds the applicable RF compliance level above, theMACHINE Full Digital Ultrasonic Diagnostic System should be observed to verify normal operation. If abnormalperformance is observed, additional measures may be necessary, such as reorienting or relocating theMACHINE Full Digital Ultrasonic Diagnostic System.b Over the frequency range 150kHz to MHz, field strengths should be less than 3V/m.

- 63 -

Recommended separation distances between portable and mobileRF communications equipment and the EQUIPMENT or SYSTEM-For EQUIPMENT and SYSTEMS that are not LIFE_SUPPORTING

Recommended separation distances betweenportable and mobile RF communications equipment and the MACHINE Full Digital

Ultrasonic Diagnostic SystemThe MACHINE Full Digital Ultrasonic Diagnostic System is intended for use in anelectromagnetic environment in which radiated RF disturbances are controlled. The customeror the user of the MACHINE Full Digital Ultrasonic Diagnostic System can help preventelectromagnetic interference by maintaining a minimum distance between portable andmobile RF communications equipment (transmitters) and the MACHINE Full DigitalUltrasonic Diagnostic System as recommended below, according to the maximum outputpower of the communications equipment.

Rated maximumoutput oftransmitter

W

Separation distance according to frequency of transmitter

0.01 0.35 0.12 0.23

0.1 1.1 0.38 0.73

1 3.5 1.2 2.3

10 11 3.8 7.3

100 35 12 23

For transmitters rated at a maximum out power not listed above the recommended separationdistance d in meters (m) can be estimated using the equation applicable to the frequency ofthe transmitter, where P is the maximum output power rating of the transmitter in watts (W)according to the transmitter manufacturer.

Note 1 At 80 MHz and 800 MHz, the separation distance for the higher frequency rangeapplies.

Note 2 These guidelines may not apply in all situations, electromagnetic propagation isaffected by absorption and reflection from structures, objects and people.

Appendix C DECLARATION OF RoHS2.0Area in conformity with the ROHS Directive 2011/65/EU--- the European Parliament and of thecouncil of 8 June 2011 on the restriction of the use of certain hazardous substances in electricaland electronic equipment.

The above-mentioned products carries the CE marking and complies with the requirement forrestricted substances ,the requirement for restricted substances and maximum concentrationvalues tolerated by weight in homogeneous materials in the Directive 2011/65/EU isas follows:

Lead (Pb) (0.1%)Mercury (Hg) (0.1%)Cadmium (Cd) (0.01%)hexavalent chromium (Cr(VI)) (0.1%)Polybrominated biphenyls (PBB) (0.1%)

Polybrominated diphenyl ethers (PBDE) (0.1%)

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