Page 1 DC-55/DC-58 Diagnostic Ultrasound System Operator’s Manual [Basic Volume]...
Page 3 Contents Contents ..........................i Intellectual Property Statement ...................... I Responsibility on the Manufacturer Party..................I Warranty ............................II Exemptions ..........................II Customer Service Department ....................II Important Information ........................III About This Manual ........................III Notation Conventions ........................III Operator’s Manuals ........................IV Hardcopy Manuals ........................
Page 4 Activate & Continue an Exam ..................4-9 Pause & End an Exam ....................4-9 Image Optimization ....................5-1 Imaging Mode ......................... 5-1 B Mode Image Optimization .................... 5-4 M Mode Image Optimization ................... 5-11 Color Mode Image Optimization ..................5-14 Power Mode Image Optimization ..................5-20 PW/CW Doppler Mode ....................5-22 Color M Mode ........................5-29 Anatomical M Mode ......................5-30...
Page 5 11.1 DICOM Preset ........................ 11-2 11.2 Verify Connectivity ......................11-9 11.3 DICOM Services......................11-10 11.4 DICOM Media Storage ....................11-14 11.5 Structured Report ......................11-15 11.6 DICOM Task Management.................... 11-16 12 Setup........................12-1 12.1 System Preset ....................... 12-2 12.2 Exam Mode Preset ......................12-8 12.3 Measurement Preset .....................
Page 7 Contents of this manual are subject to change without prior notice. All information contained in this manual is believed to be correct. Mindray shall not be liable for errors contained herein or for incidental or consequential damages in connection with the furnishing, performance, or use of this manual.
Page 8 PARTICULAR PURPOSE. Exemptions Mindray's obligation or liability under this warranty does not include any transportation or other charges or liability for direct, indirect or consequential damages or delay resulting from the improper use or application of the product or the use of parts or accessories not approved by Mindray or repairs by people other than Mindray authorized personnel.
Page 9 7. Important data must be backed up on external memory media. 8. Mindray shall not be liable for loss of data stored in the memory of this system caused by operator error or accidents. 9. This manual contains warnings regarding foreseeable potential dangers, but you shall also be continuously alert to dangers other than those indicated.
Page 10 Operator’s Manuals You may receive multi-language manuals on compact disc or paper. Please refer to the English manual for the latest information and registration information. The content of the operator manual, such as screens, menus or descriptions, may be different from what you see in your system.
Page 11 Product Difference Product Model B-Profile B-Histogram × √ DC-55 √ √ DC-58...
Page 13 Safety Precautions Safety Classifications  According to the type of protection against electric shock: CLASS I EQUIPMENT  According to the degree of protection against electric shock: Type-BF applied part  According to the degree of protection against harmful ingress of water: The main unit is rated IPX0 The probes are rated IPX7 The foot switch is rated IPX8...
Page 14 Meanings of Signal Words DANGER WARNING CAUTION In this manual, the signal words , NOTE and Tip are used regarding safety and other important instructions. The signal words and their meanings are defined as follows. Please understand their meanings clearly before reading this manual.
Page 15 When using peripherals which are not powered by the ultrasound system's auxiliary output, or peripherals other than those permitted by Mindray, ensure the overall leakage current of peripherals and the ultrasound system meets the requirement of the local medical device electrical regulations (e.g., the touch leakage current should be no more than 500uA as per IEC 60601- 1 Chapter 16), and the responsibility is held by the user.
Page 16 11. Do not use an aftermarket probe other than those specified by Mindray. Such probes may damage the system causing a profound failure, with fire being the worst-case scenario. 12. Do not subject the probes to knocks or drops. Use of a defective probe may lead to electric shock.
Page 17 24. Use detachable power supply cord as mains power breaking device. DO NOT set equipment in place where difficult for disconnection of detachable power supply cord！ 25. Do not modify this equipment without authorization of the manufacturer. 26. Always read and follow carefully the manufacturer instructions on the contrast agent label.
Page 18 You cannot repair the system under this circumstance and must call the Mindray Customer Service Department or a sales representative. There is no risk of high-temperature burns during normal ultrasound examinations.
Page 19 It is necessary to press <End Exam> to end the current scan that is in progress and clear the current Patient Information field. Failure to do so may result in new patient data being combined with the previous patient's data. Do not connect or disconnect the system’s power cord or its accessories (e.g., a printer or a recorder) without turning the system power OFF first.
Page 20 10. If the system is used in a small room, the room temperature may rise. Provide proper ventilation and free air exchange. 11. To dispose of the system or any part thereof, contact the Mindray Customer Service Department or a sales representative. Mindray is not responsible for any system content or accessories that have been discarded improperly.
Page 21 Use disinfection or sterilization solutions recommended in this operator’s manual. Mindray will not be liable for damage caused by other solutions. If you have any questions, please contact the Mindray Customer Service Department or a sales representative.
Page 22 10. Contact with improper gel or cleaner may result in damage to the probe:  DO NOT soak or saturate probes in a strong polar solution such as ethanol, chloride of lime, ammonium chloride, acetone or formaldehyde.  DO NOT bring the probe into contact with solutions or ultrasound gels containing oily mediums such as mineral oil or lanoline.
Page 23 The name, design and meaning of each warning label are described as follows: Warning Labels Meaning a. Do not place the system on a sloped surface. Otherwise the system may slide, resulting in personal injury or the system malfunction. Two persons are required to move the system over a sloped surface.
Page 25 System Overview Intended Use It is intended for use in gynecology, obstetrics, abdominal, pediatric, small organ, cephalic, transcranial, musculo-skeletal, cardiac, vascular, urology, orthopedics, nerve exam. Contraindication The diagnostic ultrasound system is not intended for ophthalmic use. Product and Model Code □...
Page 26 Product Specifications 2.4.1 Imaging Mode B Mode M Mode Anatomical M: Free Xros M, Free Xros CM C Mode Color Power DirPower D Mode Special imaging Smart 3D Static 3D Color M iScape (panoramic imaging) TDI (Tissue Doppler imaging) Stress Echo Stress Echo Tissue Tracking QA 2.4.2...
Page 27 2.4.4 Dimensions and Weight 17 inch monitor: Dimension: 830±5mm (Length) × 510±5mm (Width) × 1145±5mm (Height) 19 inch monitor: Dimension: 830±5mm (Length) × 510±5mm (Width) × 1150±5mm (Height)Weight (including batteries) : <85KG. System Configuration 2.5.1 Standard Configuration  Main unit ...
Page 28 Region Probe model Probe Type Intended Use Applied Abdomen, Pediatric, Small Parts, Musculo- L9-3E Linear Body surface skeletal, Vascular, Nerve Abdomen, Pediatric, Small Parts, Musculo- 7L4B Linear Body surfac skeletal, Vascular Some of the probes have corresponding needle-guided brackets for biopsy. The available probes and the corresponding needle-guided brackets are listed as follows: Biopsy Needle-guided...
Page 29 2.5.3 Options Item Remarks ECG module DC-IN cable ECG module should be configured. Three-cable lead ECG module should be configured. Battery CW module 4D module Gel Warmer Wireless Adapter iScape View DICOM Basic (including: Verify (SCU, SCP), task management, DICOM storage, DICOM print, DICOM storage commitment, DICOM media storage (including DICOM DIR), etc.)
Page 30 Item Remarks TDI (including TVI/TVM/TVD) TDI QA TDI should be configured. Vascular Package should be configured. Smart Volume 4D module should be configured. iWorks Smart NT Obstetrical package should be configured. Stress Echo Cardiac package should be configured. Curved MPR (CMPR) 4D module should be configured.
Page 31 2.5.4 Peripherals Supported Item Model Black/white digital video SONY UP-D897, MITSUBISHI P95DW-N, SONY UP-D898MD, SONY printer UP-X898MD Color digital video printer SONY UP-D25MD Graph/text printer HP Officejet 7000 wide format USB port: 971-SWNOM (2-pedal) Foot switch USB port: 971-SWNOM (3-pedal) Bar code reader SYMBOL LS2208 (1D);...
Page 32 Introduction of Each Unit 2-8 System Overview...
Page 33 Name Function Monitor Displays the images and parameters during scanning. Speaker Sound output. Touch screen panel Operator-system interface or control. Ultrasound gel holder Used for placing the ultrasound gel. Used for placing the general probe (not including pencil probe or Probe holder intra-cavity probe).
Page 34 Name Function Pencil probe holder Used for placing the pencil probe. Probe cable hook Used for fixing the probe cable. Control panel adjusting Used for lifting or swiveling the control panel. lever Keyboard Used for typing characters or entering some functions. Main control panel Operator-system interface or control.
Page 35 I/O Panel Symbol Function <1> USB ports. <2> HDMI High definition multimedia interface. <3> Network port. <4> VGA signal output. <5> S-Video Used for separate video output. <6> Audio signal output port, left channel. Audio signal output port, right channel. <7>...
Page 36 Power Supply Panel Name Function <1> Power outlet Supplies power to optional peripheral devices. <2> Power inlet AC power inlet. Equipotential terminal Used for equipotential bonding which balances the protective earth <3> potentials between the system and other electrical equipment. 2-12 System Overview...
Page 37 Physio Panel Name Function <1> USB port Connects USB device. <2> Pencil probe port Used for connecting a pencil probe. <3> MIC port Used for connecting a microphone. Connects to ECG leads to directly obtain the patient's ECG ECG lead signal input signals.
Page 38 2.10 Control Panel English Name Description Power button <1> Press the button to turn on the system, the system enters the work status and the indicator becomes green. <2> Volume Adjust the volume. <3> <4> <5> Adjust the corresponding functions on the touch screen. <6>...
Page 39 English Name Description Press to enter the Cine Review status from non-cine status when <16> Cine there is a multi-frame cine file playing. <17> Body Mark Enter/exit Body Mark. Press to enter M mode, and rotate to adjust M mode gain. While <18>...
Page 40 English Name Description <41> Freeze Freeze/defreeze the image. <42> Save Save the image; user-defined key. <43> User-defined keys, functions of which can be defined in preset. <44> Print Print: user-defined key. Battery status indicator.  Charging status: It illuminates in green when batteries are charged fully. ...
Page 41 Function Back space Insert a space. Caps Lock Switch between upper/lowercase. Activate the Home function: return to start position of the Home comment. Delete Text Delete all comments on the screen. Move the cursor one letter each time, or, select the Direction-control keys surrounding objects in the selectable area.
Page 42  [Fn] key For these combination keys, press <Fn> + key to use the functions indicated with a frame on the key. No. Fn+ Name Function Move the cursor to the end of the row, or the rightmost side of an →...
Page 43 2.11 Symbols This system uses the symbols listed in the following table. Their meanings are explained as follows: Symbol Description Type-BF applied part Caution！ AC (Alternating current) Functional grounding Equipotentiality Power button Foot switch Transducer sockets Pencil probe port Network port USB port Used for VGA output.
Page 44 Symbol Description This product is provided with a CE marking in accordance with the regulations stated in Council Directive 93/42/EEC concerning Medical Devices. The number adjacent to the CE marking (0123) is the number of the EU-notified body certified for meeting the requirements of the Directive. The radio device used in this product complies with the essential requirements and other relevant provisions of Directive 1999/5/EC (Radio Equipment and Telecommunications Terminal Equipment Directive).
Page 45 5. When using peripherals which are not powered by the ultrasound system's auxiliary output, or peripherals other than those permitted by Mindray, ensure the overall leakage current of peripherals and the ultrasound system meets the requirement of the local medical device electrical regulations (e.g., the enclosure leakage current should be...
Page 46 Connecting the Power Cord & Protective Grounding 3.2.1 Connecting Power  The connection method is described as follows: 1. Push the retaining clamp upward, and insert the power plug into the receptacle, as shown in the figure below. 2. Pull the retaining clamp downward to lock the power cord, as shown in the figure above. 3.
Page 47 3.2.2 Equipotential terminal The symbol represents the equipotential terminal that is used for balancing the protective earth potentials between the system and other electrical equipment. 1. Be sure to connect the equipotential wire before inserting the power plug into the receptacle. Be sure to remove the power plug from the receptacle before disconnecting the WARNING: equipotential wire.
Page 48 If the system begins to function improperly, immediately stop scanning. If the system continues to function improperly, fully shut down the system and contact the Mindray Customer Service Department or a sales representative. If you use the system in a persistent improperly functioning state, you may harm the patient or damage the equipment.
Page 49 If you use a probe giving off excessive heat, it may burn the patient. WARNING: If you find anything not functioning properly, this may indicate that the system is defective. In this case, shut down the system immediately and contact Mindray Customer Service Department or sales representative. 3.2.4 Power the System OFF You must follow the correct procedures to power the system off.
Page 50 3.2.5 Standby When the battery is charged to full capacity, the system's standby time is no less than 24 hours.  To enter standby: Open [Setup] → [System] → “General” to set the time for screensaver and standby. If the system is not carrying out an operation, the screensaver appears after the screensaver delay period.
Page 51 Monitor Adjustment 3.3.1 Monitor Position Adjustment Gently hold the bottom edge of the monitor when adjusting its position.  Rotate the monitor  Monitor rotation The monitor can be rotated ±90° .  Tilt the monitor When positioned vertically, the monitor can be tilted 20° backward and can be tilted forward to a horizontal position.
Page 52 3.3.2 Monitor Brightness/Contrast Adjustment Monitoring the brightness and contrast adjustment is one of the most important factors for proper image qualities. If set incorrectly, the gain, TGC, dynamic range or even acoustic output have to be changed more often than necessary to compensate. The adjusting buttons are shown as follows: ...
Page 53 3. Hang the probe cable on the hanger located under the control panel to avoid excessive bending and damage. 4. Only use probes provided by Mindray. Aftermarket probes may result in damage or cause a fire. NOTE: If a probe port is not used for a long period of time, use the dustproof cover to protect the probe port from dust.
Page 54 Lock NOTE: Before inserting the connector into the probe port, inspect the connector pin. If the pin is bent, do not use the probe until it has been inspected/repaired/replaced. 3.5.2 Disconnecting a probe 1. Turn the locking lever 90° counterclockwise to the vertical position. (Shown in the left figure) 2.
Page 55  Function setting The function of the foot switch can be preset. For details, see “12.1.6 Key Configuration.” System Preparation 3-11...
Page 56 Installing a Printer 3.7.1 Installing a Graph/Text Printer  Connecting a local printer Note: Printers listed in “2.5.4 Peripherals Supported” Chapter have drivers installed already. As shown in the figure below, a graph / text printer has a power cord and data cable. The power cord shall be directly plugged into a well-grounded outlet.
Page 57 Note: see the printer’s operation manual to select the port, or try to use the default port of the system. 6. Click [Have Disk…] to find the driver path (the installation type should be WIN7 64), and then click [Next] to install the driver. 7.
Page 58  Print Both report and image can be printed on a graph / text printer. To set the default report printer and its attribute: In "[Setup]→[Print]" screen, select the "Report Print" column in the service list. You can select printer from the driver list next to “Printer” in the lower screen and set the items in the "Property" box.
Page 59 3.7.4 Position the Printer As shown in the following figure, you can open the video printer compartment gate and then place the black/white digital video printer in the video printer compartment. Compartment gate 3.7.5 Installing/ uninstalling Probe/Gel Holder  Installing As shown in the figure below, align the buckle of the holder to the slot at the side of the control panel and then insert the buckle into the slot until the buckle clicks and locks.
Page 60 Basic Screen & Operation 3.8.1 Screen Display The screen displays ultrasound images, parameters, menus and measurement results windows. The following diagram maps out the different areas, such as patient information, image parameter & menu, image area, thumbnail of images saved, help information, soft menu, system status icon, etc.
Page 61  Exam Mode Displays the currently used exam type, e.g. Abdomen.  Probe Model Display the currently-used probe model, or the default model.  Probe parameter area Displays the acoustic power. Including the acoustic power, MI (Mechanical Index) and TI (Thermal Index).
Page 62  System status icon This area displays the relevant system icons, such as USB memory device, printer, network, Chinese/English entry, and current system time, etc.  User-defined key function display region This area displays the function defined for those user-defined keys. For details about user- defined key, see “12.1.6 Key Configuration”.
Page 63  To reposition a dialog box which is not a full-screen dialogue box: 1. Roll the trackball to move the cursor over the title bar of the dialog box. The cursor becomes a . Press the <Set> key. 2. Roll the trackball and position the rectangular graphic in the new desired location. 3.
Page 64 3.8.4 Touch Screen Operation  Mapping mode Operating Operations region Swipe from this area to bottom to enter the mapping mode. Under mapping mode, swipe from this area to right to display the mapping menu. Under mapping mode, this area displays mapping menu, soft menu and tool bar, where you can adjust image parameters, perform measurement, image sending and review.
Page 65  Menu Operations Swipe the touch screen from left (region 2) to right to show the mapping menu. See the figure below. For detailed operations, see Chapter “5.1.2 Image Adjustment”. Touch or flip the menu to the left/right to adjust the image parameters; touch the measurement menu to select measurement tools and start measurement.
Page 66  Operations on Tool Bar Under mapping mode, touch the real-time image on the touch screen (region 3), a  toolbar will display on the top of the touch screen, touch to enter review status. Under mapping mode, open the saved image on the main screen, and touch the ...
Page 67  Non-mapping mode of touch screen The layout of the touch screen varies with the applications or modes. Swipe the touch screen to go to another interface. Learn the interface display and operations by referring to related chapters. 3.8.5 Soft Keyboard Under report, setup, comment adding and iStation screen, the soft keyboard icon displayed on the touch screen.
Page 69 Exam Preparation A patient exam can be started as per the following situations:  New patient information: to start a new patient exam, patient information must first be entered.  New exam: to start a new exam for patient who is already registered, the recorded information can be obtained through either iStation or Worklist.
Page 70 4.1.1 New Patient Information The Patient Info screen is shown as follows: Place the cursor over the desired box. The field box is highlighted and a flashing cursor appears. Information can be entered or selected from the options. You can also change the cursor's position using <Tab>, <Enter> or the up/down controls. Information includes: 1.
Page 71 2. Exam Type  Exam application type You can select from: ABD (Abdomen), OB (Obstetrics), GYN (Gynecology), CARD (Cardiac), VAS (Vascular), URO (Urology), SMP (Small Part), PED (Pediatrics) and BREAST (Breast). Select the exam type tab to enter exam-specific information. ...
Page 72 Exam Type Information Description Para Times of delivery. Ectopic Times of abnormal pregnancy, e.g., extrauterine pregnancy. Aborta Times of abortion. Height Weight After the height and weight are entered, the system will BSA (body automatically calculate the BSA based on the formula which is set surface CARD via “[Setup] →...
Page 73  [New Exam]: clears the current exam information so a new exam can be created for the current patient.  [OK]: saves the patient data entered and exits the screen.  [Cancel]: cancels the patient data entered and exits the screen. 4.1.2 Retrieve Patient Information 4.1.2.1...
Page 74 Button Function Description Review an Click to enter the review screen. Image Patient Click to enter the patient info screen. Information Review Report Click to enter diagnostic report screen. Delete Exam Click to delete the selected record. Backup Exam Click to back up the selected patient record to supported media. Restore Exam Click to import the patient data from an external media.
Page 75 4.1.2.2 Worklist Worklist is an option. To use Worklist function, you have to configure DICOM Basic and DICOM Worklist options. When the DICOM basic package is configured and the Worklist server has been set, click [Worklist] in the Patient Info screen to query or import the patient data. (For details about the Worklist server setting, see the DICOM chapter.) Worklist can retrieve patient data of two kinds of protocols: DICOM and HL7.
Page 76 Select Exam Mode and Probe If the exam mode is changed during a measurement, all measurement CAUTION: calipers on the image will be cleared. The general measurement data will be lost, but application measurement data will be stored in the reports. ...
Page 77 Activate & Continue an Exam 4.4.1 Activate an Exam On the iStation screen, select an exam record which was completed within 24 hours and click [Activate Exam] from the menu which appears. Or click [Active Exam] on the iStation or Review screen to activate the exam.
Page 79 Image Optimization The images displayed in this system are for WARNING: reference only. Mindray is not responsible for the correctness of diagnostic results. In Dual-B imaging mode, the measurement results of the merged image may be inaccurate. Therefore, the results are provided for reference only, not for confirming diagnoses.
Page 80 3. Parameter adjusting area: displays the parameters in the current imaging mode or function.  Parameter magnitude setting: touch to increase/decrease the value.  ON/OFF setting: some of the parameters can only be set to ON or OFF. ON activates the function, and when the function is activated the key is highlighted in green.
Page 81 ON/OFF setting: some of the parameters only can be set at ON or OFF, ON is to activate  the function, and when the function is activated, the menu item is highlighted in green. Functional item: touch to go to the corresponding function. ...
Page 82 B Mode Image Optimization B mode is the basic imaging mode that displays real-time images of anatomical tissues and organs. 5.2.1 Basic Procedures for B Mode Imaging 1. Enter the patient information. Select an appropriate probe and exam mode. 2. Press <B> on the control panel to enter B mode. 3.
Page 83 5.2.3 B Mode Image Optimization Image Quality Description To switch between the fundamental frequency and harmonic frequency, and select the corresponding frequency type. The real-time frequency value is displayed in the image parameter area in the top-right corner of the screen, and if harmonic frequency is used “F H”...
Page 84 Description The system compensates the signals from deeper tissue by segments to optimize the image. There are 8-segment TGC sliders on the control panel corresponding to the areas of the image. Operations To increase the gain compensation in an area of interest, move the TGC slider to the right.
Page 85 Imaging Adjustment Description More information can be obtained without moving the probe or changing the sampling position. FOV (Field 1. To change the scan range, touch [FOV] on the touch screen to enter the FOV of View) range and FOV position adjustment status. 2.
Page 86 iClear Description The function is used to enhance the image profile so as to distinguish the image boundary for optimization. Operations Adjust using the [iClear] item or mapping-menu on the touch screen. The system provides 7 levels of iClear adjustment: off represents no iClear effect, and the bigger the value the stronger the effect.
Page 87 Image Merge Description In the Dual-split mode, when the images of the two windows have the same probe type, depth, invert status, rotation status and magnification factor, the system will merge the two images so as to extend the field of vision. Operations Turn the function on or off using the [Auto Merge] item or the mapping-menu item on the touch screen.
Page 88 Operations Touch [H Scale] or the mapping-menu item on the touch screen to display or hide the scale. Dual Live Description Display different image effects of one probe for better observation. Operation Touch [Dual Live] item or the mapping-menu item on the touch screen to turn the function on/off.
Page 89 M Mode Image Optimization 5.3.1 Basic Procedures for M Mode Imaging 1. Select a high-quality image during B mode scanning, and adjust to position the area of interest in the center of the B mode image. 2. Press <M> on the control panel, and roll the trackball to adjust the sampling line. 3.
Page 90 5.3.3 M Mode Image Optimization Gain Description To adjust the gain of M mode image. The real-time gain value is displayed in the image parameter area in the top-right corner of the screen. Operations Rotate the <M> knob clockwise to increase the gain, and counter-clockwise to decrease it.
Page 91 Edge Enhance Description This function is used to enhance the image profile so as to distinguish the image boundary for optimization. Operations Adjust using the [Edge Enhance] item or the mapping-menu item on the touch screen. There are 3 levels of edge enhance adjustment available: the bigger the value the stronger the effect.
Page 92 Color Mode Image Optimization The Color mode is used to detect color flow information, and the color is designed to judge the direction and speed of blood flow. Generally, the color above the color bar indicates the flow towards the probe, while the color below the color bar indicates the flow away from the probe.
Page 93 ROI Adjustment Description This function adjusts the width and position of the ROI in Color mode. Operations When the ROI box is a dotted line, roll the trackball to change the size. When the ROI box is a solid line, roll the trackball to change the position. Press <Set>...
Page 94 Line Density Description Line density determines the quality and information of the image. Operations Adjust using the [Line Density] item or the mapping-menu item on the touch screen. 4 levels of line density are provided: H, L, UH, M. Effects The higher the line density, the higher the resolution.
Page 95 Scale Description This function is used to adjust the speed range of the color flow, which is adjusted using the PRF in the system. The real-time PRF value is displayed in the image parameter area in the top-right corner of the screen. Operations Adjust through the [Scale] item or the mapping-menu item on the touch screen.
Page 96 WF (Wall Filter) Description It filters out low-velocity signals to provide effective information, and this function is used to adjust the filtered frequency. The real-time value is displayed in the image parameter area in the top-right corner of the screen. Operations Select using the [WF] item or the mapping-menu item on the touch screen.
Page 97 ITouch (Auto Image Optimization) Description To optimize image parameters as per the current tissue characteristics for a better image effect. Operations Press <iTouch> on the control panel to turn the function on. HR Flow (High Resolution Flow) Description This function enhances the micro vessel imaging effect, and can be used to analyze the tissue blood supply condition.
Page 98 Power Mode Image Optimization Power mode provides a non-directional display of the blood flow in terms of intensity as opposed to flow velocity. DirPower (Directional Power mode) provides additional information of the flow direction toward or away from the probe. 5.5.1 Basic Procedures for Power Mode Imaging 1.
Page 99 Color Map Description This feature indicates the display effect of the Power image. The maps in the Power mode image are grouped into two categories: Power maps and Directional Power maps. Operations To select from among the maps, turn the knob under [Color Map] on the touch screen or adjust through the mapping-menu item.
Page 100 PW/CW Doppler Mode PW (Pulsed Wave Doppler) mode or CW (Continuous Wave Doppler) mode is used to provide blood flow velocity and direction utilizing a real-time spectrum display. The horizontal axis represents time, while the vertical axis represents Doppler frequency shift. PW mode provides a function for examining flow at one specific site for its velocity, direction and features.
Page 101 5.6.2 PW/CW Mode Image Parameters In PW/CW mode scanning, the image parameter area in the top-right corner of the screen displays the real-time parameter values as follows: Parameter Angle Meaning Frequency Gain SV Size Angle Wall Filter Position Parameter Angle Meaning Frequency Gain...
Page 102 5.6.3 PW/CW Mode Image Optimization Gain Description This function is intended to adjust the gain of the spectrum map. The real-time gain value is displayed in the image parameter area in the top-right corner of the screen. Operations Rotate the [PW] knob clockwise to increase the gain, and counter-clockwise to decrease it.
Page 103 Scale Description This function is used to adjust the speed range of the flow, which is adjusted using the PRF in the system. The real-time PRF value is displayed in the image parameter area in the top-right corner of the screen. Operations Rotate the knob under the [Scale] item on the touch screen or through the mapping-menu item .
Page 104 Sensitivity To change the trace area, adjust through [Trace Sensitivity] item or the mapping- menu item on the touch screen. There are 5 levels of sensitivity adjustment, the bigger the value the higher the sensitivity. Operations In real-time scanning, the results displayed are derived from the calculation of the latest cardiac cycle.
Page 105 Tint Map Description This function provides an imaging process based on color difference rather than gray distinction. Operations Adjust through the [Tint Map] item or the mapping-menu item on the touch screen to select the map. There are 8 color effect maps available. Gray Map Description This function applies the gray correction to obtain optimum images.
Page 106 Angle Description This function is used to adjust the angle between Doppler vector and flow to make the velocity more accurate. The real-time adjusting angle value is displayed on the right part of the spectrum map. Operations Rotate the <Angle/Steer> knob on the control panel to adjust it. The adjustable angle range is -89~89°, in increments of 1°.
Page 107 Color M Mode Color M mode provides information about color flow or tissue on the M mode images to indicate the cardiac motion state. It is highly sensitive to the flow or tissue movement. The Color M mode includes Color Flow M mode and Color Tissue M mode. CM mode is not available for linear probes.
Page 108 Anatomical M Mode Anatomical M Mode and Color Anatomical M mode images are CAUTION: provided for reference only, not for confirming diagnoses. Compare the image with those of other machines, or make diagnoses using non-ultrasound methods. For an image in the traditional M mode, the M-mark line goes along the beams transmitted from the probe.
Page 109 Display/Hide the M-mark Line Description There are 3 M-mark lines available, each with “A”, “B” or “C” at the one end as identification and an arrow at the other end to mark the direction. M-mark Line Perform the selection using the [Show A], [Show B] or [Show C] item on the touch Selection screen or the mapping-menu, and the corresponding image will be displayed on the screen once the related item is selected.
Page 110 5.8.2.1 Basic Procedures for Free Xros CM 1. In 2D real-time imaging mode, adjust the probe and image to get the desired image, then fix the probe. 2. Press [TDI] user-defined key to enter TDI imaging and acquire the necessary images. 3.
Page 111 5.9.1 Basic Procedures for TDI Imaging  Press user-defined key for TDI on the control panel in real-time scanning to enter the modes(Assign a key as user-defined TDI: the setting path is "[Setup]→ [System] →[Key Config]", see “12.1.6 Key Configuration” chapter for details), or touch [TDI] on the touch screen directly: ...
Page 112 5.9.4 TDI Quantitative Analysis (QA) TDI Quantitative Analysis results are provided for reference only, not CAUTION: for confirming diagnoses. Compare the results with those of other machines, or make diagnoses using non-ultrasound methods. TDI QA is applied for TVI original data analysis, for evaluating the velocity change of the same cardiac muscle with cardiac cycles.
Page 113 5.9.4.1 TDI QA Screen Description TDI QA Screen (using the Speed – Time curve as an example) 1 - TVI Cineloop window Sample area: indicates the sampling position of the analysis curve. The sample area is color- coded, 8 (maximum) sample areas can be indicated. 2 - B Cineloop window Tip: ...
Page 114 5.9.4.2 Basic TDI QA Procedures Setting the ROI This function is used for setting the TDI QA target. Up to eight ROIs can be saved on the reference image, with the corresponding eight traces plotted simultaneously on the graph. Each ROI display has a different color, and its corresponding trace data is plotted with the same color.
Page 115  Delete an ROI Press the <Clear> key to clear the last ROI. Touch [Delete All] on the touch screen to clear all ROIs. The corresponding traces for the deleted ROIs are erased from the plot. Press <Clear> to delete the last added ellipse ROI. ...
Page 116 5.10 3D/4D NOTE: 3D/4D imaging is largely environment-dependent, so the images obtained are provided for reference only, not for confirming diagnoses. 5.10.1 Overview Ultrasound data based on three-dimensional imaging methods can be used to image any structure where a view cannot be achieved with the standard 2D-mode and to improve the understanding of complex structures.
Page 117 image Cut plane  ROI size and position Roll the trackball to change the ROI size and position. Press the <Set> key to toggle between setting the size (dotted line) and position (solid line).  Curved VOI adjustment Roll the trackball to change the curved VOI position. Press the <Set> key to switch between the changing ROI and curved VOI states.
Page 118 A window B window C window 3D window (VR)  On the touch screen, the current window’s icon is highlighted, as shown below. Window A is the currently activated window. A, B and C sectional images correspond to the following sections of the 3D image. ...
Page 119 Tip: the upper part of the 3D image in the 3D window corresponds to the orientation mark on the probe. If the fetal posture is head down (toward the mother’s feet), and the orientation mark is toward the mother’s head, then the fetus posture is head down in the 3D image. The 3D image can be rotated by touching [180°] on the touch screen to show the fetus head-up.
Page 120 5.10.2 Note Before Use 5.10.2.1 3D/4D Image Quality Conditions NOTE: In accordance with the ALARA (As Low As Reasonably Achievable) principle, try to shorten the sweeping time after a good 3D image is obtained. The quality of images rendered in 3D/4D mode is closely related to the fetal condition, angle of a B tangent plane and scanning technique (only for Smart 3D).
Page 121 5.10.3 Static 3D Static 3D provides single frame image acquisition of 3D images. During scanning, the probe performs the scanning automatically. Only probe D7-2E and DE10-3E supports Static 3D imaging. 5.10.3.1 Basic Procedures for Static 3D Imaging To perform Static 3D imaging: 1.
Page 122 Touch the cross cursor on the VOI curve and move the cursor with finger to adjust VOI curve. Cross cursor on the VOI curve For setting the ROI, be sure to:  Set the ROI on the 2D image with the largest section area of the fetal face. ...
Page 123 5.10.3.2 Static 3D Acquisition Preparation Description of parameters: Type Parameter Description Function: to set the range for imaging. Angle Range: 10-80°. Parameter Function: to adjust the image quality by changing the line adjusting density. Image quality can affect the imaging speed: the better Quality the image quality, the longer the time.
Page 124 MPR Viewing In the actual display, different colors for the window box and the section line are used to identify the MPR A, B and C.  Window A is blue, and the lines (representing MPR A) displayed in the other two windows are also blue.
Page 125 View Direction a. Up/Down b. Down/Up c. Left/Right d. Right/Left e. Front/Back f. Back/Front Touch [Up/Down], [Left/Right] or [Front/Back] on the second page of the touch screen to select the direction of the above Figure a, c and e. Touch [Flip] on the touch screen to view in the opposite direction to the current direction, as shown in Figures b, d and e.
Page 126 3. Roll the trackball to adjust the VOI position, size and curved VOI, and press <Set> to switch between the adjusting status. Or rotate the <4D> knob on the control panel to adjust the relative position of MPRs so as to slice through the VR. ...
Page 127 Parameter Description Function: to set the brightness of VR. Brightness Range: 0%-100%. 0% represents the minimum brightness, while 100% represents the maximum. Function: to set the contrast of VR. Contrast Range: 0%-100%. Tint Switch tint map on/off. Selection: Off, 1-8. To quickly rotate the VR.
Page 128 Rotate an Image The system supports the following rotation modes:  Axial rotation  Auto rotation  Axial rotation Axial rotation rotates the currently activated image around the X-, Y- or Z-axis.  Procedures a) Select the current image. b) Rotate the corresponding knobs to make the image rotate: ...
Page 129  Rotate the <Zoom> knob to increase or decrease the magnification factor.  Under touch screen mapping mode, zoom the image by pinching the two fingers on the touch screen. Sync This function switches the view direction perpendicular to the current active plane, so as to get a better view of VR.
Page 130 Comments and Body Marks  Function: Add comments and body marks to the MPR and VR.  Operation: The operation is the same as adding comments and body marks in B image mode. Image Editing  Function Image editing is a more elaborate function than VOI adjusting for optimizing the 3D image by clipping (removing) the obscured part of the region of interest.
Page 131 The image cutting parameters are described as follows: Type Parameters Description Contour Allows you to trace the portion of the image you want to cut. Displays a box which can be used to define the portion of the Rect. image you want to cut. Applies to softer or smoother boundary within a small range of Soft eraser the image.
Page 132 5.10.4.1 Basic Procedures for 4D Imaging 1. Select the appropriate 4D-compatible probe and exam mode. Make sure there is sufficient gel on the probe for scanning. 2. Obtain a 2D image as described in the Static 3D imaging procedure. 3. Press to enter 4D imaging preparation status.
Page 133 5.10.4.5 3D/4D Fast Switching In 4D real-time imaging mode, press to quickly switch to VR viewing status, where you can obtain the same image of a better quality. In 3D imaging viewing mode, press to quickly switch to 4D image real-time imaging status, where you can obtain the same image in dynamic mode.
Page 134 5.10.5.2 Smart 3D Acquisition Preparation In Smart 3D mode, you need to set the scan method in addition to the other items in Static 3D mode. The other parameters are the same as those for Static 3D. For details, see “5.10.3.2 Static 3D Acquisition Preparation.”...
Page 135 5.10.5.3 Smart 3D Image Viewing In VR viewing, the system supports the following functions:  Render setting.  B-mode parameter adjustment.  Setting the display format.  Viewing MPR.  Image zooming.  Rotation.  Image editing.  VR parameter adjustment. ...
Page 136 5.10.6.1 Basic Procedures for iPage 1. Acquire 3D/4D data.  Single-frame VR: STIC/4D mode: freeze the system, then roll the trackball to select the image. Static 3D: an image frame is acquired automatically after the acquisition is completed.  Multi-frame 3D images: acquire multiple 3D images in 4D imaging mode. 2.
Page 137 <1> A plane (the current <2> B plane <3> C plane reference image) <4> Central slice line (current <5> Slice line <6> Space between two slice active slice) lines <7> Y-axis <8> X-axis <9> Slice position (to the central slice) <10>...
Page 138 For details, see the descriptions in Static 3D.  Image zooming Same as Static 3D image zooming.  Hide/show reference image The system displays 3 standard sectional images (A plane, B plane, C plane) on the left side indicating the position of the slice lines. Touch to hide the 3 reference images, then slices are displayed on the whole image area.
Page 139 5.10.7 iLive iLive brings you a better imaging experience by adding a light rendering effect to the traditional method. It supports the global lighting mode as well as the partial scattering mode, allowing human tissue texture to be revealed more clearly. iLive is an option, and is available under Smart 3D, Static 3D and 4D modes.
Page 140 5.10.7.1 Operation Controls Adjustable parameters for iLive are on the second page of the touch screen.  Shading Adjusts the effect of shadowing and scattering. When the selected level is 0, the rendered image will be bright and sharp, and the shadow border will be clear while the area of the shadow will be relatively small.
Page 141  Grad View After this function is activated, VR details will be revealed and enhanced. Other operation controls and adjusting methods are similar to those in 3D/4D mode. Other Operations iLive does not support Inversion mode.  Zoom Same as in 3D/4D mode. ...
Page 142 images, enter iScape mode from B+Power mode), or touch [iScape View] on the touch screen directly: 3. Optimize the B mode (Power mode) image: In the acquisition preparation status, touch the [B] ([Power]) page tab to select B mode (color) image optimization.
Page 143  Always keep the probe perpendicular to the skin's surface. Do not rock, rotate or tilt the probe during the scan.  The system accommodates a reasonable range of motion velocity. Do not make abrupt changes in motion speed.  Deeper scans generally require reduced acquisition speed.
Page 144 5.11.3.4 Measurement, Comments and Body Marks In iScape image viewing status, you can perform measurement, comments and body marks. The operations are the same as in B mode. NOTE: 1. The measurement accuracy for spliced images may be degraded - exercise caution when measurements are performed on an iScape image.
Page 145 5.12 Stress Echo Stress Echo is an option. The following probes under certain exam modes support stress echo function:  Cardiac exam modes: P4-2/P7-3 Stress echo data are provided for reference only, not for confirming CAUTION: diagnoses. 5.12.1 Overview The Stress Echo feature allows you to capture and review cardiac loops for multiple-phase (multiple-stage) Stress Echo protocols.
Page 146 Acquired phase/view Current stage/view Hints Saved loops Soft menu 3. According to the help information in the bottom of the screen, if an ROI is displayed, adjust the ROI size and position. Press <Update> key on the control panel to confirm the ROI. Tip: When you confirm the ROI size by pressing <Update>, you cannot adjust the ROI size during acquisition.
Page 147 When acquisition is complete for each stage, the system advances to the next stage. If the stage is non-continuous, the system displays the stage views. When image acquisition is completed for all views and continuous stages, the system switch to Select Mode. 6.
Page 148 Description of select mode controls: Mode Phase/view selection Cine controls Other controls Soft menu Touch screen controls: Selection Description Stages: XX Rotate the corresponding knob under the button to select a stage. Views: XX Rotate the corresponding knob under the button to select a view. Acquire/ To switch the mode status.
Page 149 Selection Description Decreases or increases playback speed. Text “On”/“Off” Function that turns the screen graphic text “On” or “Off.” The function is the same as the Labels on/off icon at the top of the screen. Information includes: name of level, name of view, heart rate, time stamp acquisition, timers, frame slider, loop ID, clip control.
Page 150 2. To exclude a phase or view from display, select the blue box to the left of each required phase and/or view. The system inserts a red X into each selected box, like 3. Select [Display Selected] on the touch screen. The system displays the selected phases for each selected view side by side.
Page 151 1. Select a colored number in the bottom-right area of the screen. The meanings and colors used in segments are listed in the table below. Score Meaning Color Normal Green Hypokinesis Yellow Severe Hypokinesis Khaki Akinesis Blue Dyskinesis Aneurysm Purple 2.
Page 152 5.12.5 Maintenance and Protocol 5.12.5.1 Maintenance Select “<F10 Setup>->[Stress Echo]->[Maintenance]” to enter the screen. Item Function Description Acquire mode Set the type of ROI: manual ROI or full-screen. Overlay Select the items to be labeled on each loop. WMS score type Set the chamber segment division method.
Page 153 5.12.5.2 Protocol Edit You can create, edit and delete Stress Echo protocols using the Protocol Editor dialog box. Access the Protocol Editor dialog box by clicking [Protocol] in [Setup]->[Stress Echo]->[Protocol], or clicking [Edit] on the Select Protocol screen as shown in the figure below: Item Function Description Protocol name...
Page 154 Item Function Description New stage Create a stage for the current protocol. Quit Remove the Protocol Editor dialog box. Creating a Stress Echo Protocol To create a stress echo protocol: 1. Click the [New Protocol] button to the right of the Protocol Editor dialog box. 2.
Page 155  Entering Indications or Comments for the Reports You can enter an indication for display in Stress Echo reports. To enter an indication: 1. Press <Report> on the control panel to open the report. 2. Use the keyboard to enter text in the Indication dialog box and then click [OK]. 5.13 Elastography Elastography images are provided for reference only, not for CAUTION:...
Page 156 Operation When the ROI box is solid line, roll the trackball to change its position. When the ROI box is a dotted line, roll the trackball to change the size. Press <Set> to switch between the solid line and the dotted line status. Smooth Description To adjust the smooth feature of the Elasto image.
Page 157 5.14 Tissue Tracking Quantitative Analysis (QA) Apart from the TDI imaging function, the system also provides a tissue tracking QA function for myocardial movement evaluation. Using the tissue tracking QA function, the ultrasound system will scan each pixel position by frame within the cardiac cycle, then use the region matching method and auto-correlation searching method to trace each spot and calculate the movement, so as to determine myocardial motion in a more quantitative way.
Page 158 5.14.2 Tissue Tracking QA Screen Description 1 - Displays the image used to generate the trace curve 2 - Displays the ECG trace 3 - Displays the measurement and calculation results: EDV: maximum value of the end diastolic volume during the trace. EDA: maximum value of the end diastolic area (Left Ventricular) during the trace.
Page 159 The system also displays the TPSD value on the Bull’s Eye graph: Time to Peak Standard Deviation (TPSD): ∑ − TPSD | ∈ Where the standardized value of time to peak data: . (N is the number of time to peak data) Average standardized value of time to peak data: 4 - Display curve: Velocity/Displacement/Strain/Strain Rate.
Page 160 5.14.4 Myocardial Boundary Tracing  The system provides two kinds of tracing methods for two kinds of sections:  Long axis section (A4C, A2C, ALAX): the 3-point method and manual tracing method are both available.  3-point method As shown in the following figure, after pressing <Set> to place 3 points clockwise on the image, the system generates the trace automatically.
Page 161 View Selection Before tracing, touch the corresponding button to select the view.  [A4C]: apical four-chamber view.  [A2C]: apical two-chamber view.  [ALAX]: apical long axis view.  [PSAX B]: short axis base view.  [PSAX M]: short axis mid view. ...
Page 162 5.14.6 Bull’s Eye After tracking, the system displays a Bull’s Eye graph for judging the reverse movement or scope of myocardium. 1. Touch [Bull’s Eye] on the touch screen to turn the function on: You can acquire:  Time to peak value and peak value of the 17 segments; ...
Page 163 Display & Cine Review Splitting Display The system supports dual-split and quad-split display format. However, only one window is active.  Dual-split: press the key on the control panel to enter dual-split mode. Under Dual-split mode, press <Freeze> to freeze the image and then use to switch between the two images.
Page 164 Tip:  Spot zoom can only be achieved on real-time images.  The size and position of the sample volume box change along with the scanning depth and area. 6.2.2 Pan zoom To use the function, use the knob on the control panel. 1.
Page 165 6.3.2 Imaging Display Format Switching When Frozen Image display format switching in freeze mode follows these principles:  2D+PW (press <Freeze> in 2D+PW imaging mode) If the imaging mode before freezing is 2D (frozen) + PW (real time) or 2D (real time) + PW (frozen), then in freeze mode, you can switch between 2D (frozen) + PW (activated) or 2D (activated) + PW (frozen) by pressing the <Update>...
Page 166 6.4.2 Cine Review in 2D Mode (B/B+Color/B+Power/B+TVI/B+TEI)  Manual Cine Review: After entering cine review in 2D mode, roll the trackball to review the cine images on the screen one by one. Or under touch screen mapping mode, touch the touch screen and swipe left and right to review the images.
Page 167 e) In auto cine review, pressing the knob under [Auto Play] on the touch screen or rolling the trackball will stop the auto cine review and enter the manual cine review. f) Click [Jump to First]/[Jump to Last] to review the first or last image. Tip: you can perform cine review on each image window in the dual/quad splitting mode, and set the auto review region for each window.
Page 168 Image Compare 6.5.1 Image Compare under Review Mode You can perform image compare through the path:  Thumbnail area in the main screen;  iStation screen (press <iStation> to enter);  Review screen (press <Review> to enter). 1. In the above condition, press <Cursor> to show the cursor and click the target image file. 2.
Page 169  Retrospective saving saves specified images which were captured before the current moment. Images stored in the cine memory are saved to the system's hard drive.  Prospective saving saves specified images which are captured later than the current moment. Images are saved to both the cine memory and the system's hard drive. The live capture time can be set.
Page 171 Physiological Signal A physiological input panel is available for this system. The physiological module consists of two channels: ECG and DC IN. DC IN is capable of handling external ECG signals from other ECG signal devices. The scanned image displayed is synchronized with the ECG traces. So ECG signals can be used as a time reference in an ultrasound exam (mainly in cardiology exams).
Page 172 7.1.1 ECG Operation Basic Procedures 1. Connect the device.  Turn off the system power supply, and connect the ECG cable to the ECG port on the physio panel of the machine.  Turn on the system power supply. Place the ECG electrodes on the patient’s body (as shown in the following figures). Right Right Left...
Page 173 Tips:  The trigger mark is displayed in both freeze mode and live mode.  The marks in Dual trigger are different in color.  Trigger function is unavailable if the ECG trace is disappeared. Only the live 2D image can be triggered.
Page 174 Parameter Description The physio parameters are described as follows: Parameter Description ECG Source Select ECG source. Function: to set the amplitude of the trace. Method: click [Gain] on the soft menu, or press/rotate the corresponding knob. Gain Each adjustment takes you to the next setting. Value: 0-30, in increments of 1.
Page 175 Measurement You can perform measurements on zoomed images, cine reviewing images, real-time images or frozen images. For measurement details, see the [Advanced Volume]. Be sure to measure areas of interest from the most optimal WARNING: image plane to avoid misdiagnosis arising from inaccurate measurement values.
Page 176 General Measurements 8.2.1 2D General Measurements 2D general measurements are general measurements on images in B, Color, Power or iScape imaging modes. The measurements listed below can be performed: Measurement Function Tools Distance Measures the distance between two points of interest. Measures the distance between the probe surface and the probing point Depth along the ultrasound beam.
Page 177 8.2.3 Doppler General Measurements Doppler general measurements are general measurements on PW/CW-mode images. The measurements listed below can be performed: Measurement Function Tools Time Measures the time interval between any two points. N intervals (n≤8) are measured to calculate a PW mode derived HR value in Beats Per Minute (BPM).
Page 178 Measurement Accuracy Table 1 2D Image Measurements Parameter Range Error Distance Full Screen Within ±3% Area (ellipse, circle) Full Screen Within ±7% Trace Area Full Screen Within ±7% Circ Full Screen Within ±10% Angle Full Screen Within ±3% Volume Full Screen Within ±10 % Table 2 Basic Time Motion Measurements Parameter...
Page 179 Parameter Range Error Single window display: Within ±7% (not Trace Area Section A/B/C including Smart 3D mode) Single window display: Within ±10% (not Circ Section A/B/C including Smart 3D mode) Single window display: Within ±5% (not Angle Section A/B/C including Smart 3D mode) Volume Section A/B/C Within ±20 % (not including Smart 3D mode)
Page 181 Comments and Body Marks Comments Comments can be added to an ultrasound image to bring attention, notate or communicate information observed during the examination. You can add comments to: zoomed images, cine review images, real-time images, frozen images. You can type comments as characters, insert pre- defined comments from the comments library or insert arrow markers.
Page 182 9.1.2 Touch Screen Display in Comments The system can be configured with comment text libraries including Abdomen, Cardiology, GYN (Gynecology), OB (Obstetrics), Urology, SMP (Small Part), Vascular, PED (Pediatric), Nerve Blocks and emergency medicine. In comments status, you can enter the comment text using the screen menu or touch screen.
Page 183 9.1.3 Adding Comments  Typing comment characters 1. To set the comment location: Roll the trackball or press the direction keys on the keyboard to move the cursor to the desired comment location. 2. To type alphanumeric characters: You can enter characters using the keyboard. ...
Page 184  Tracing (1) In comment status, touch [Trace] on the touch screen to activate the trace function. The current image is also displayed on the touch screen. (2) Control Panel operation: a) Roll the trackball to the desired position and press <Set> to confirm the start point. b) Roll the trackball to move the cursor along the edge of the desired region and trace the outline of the region.
Page 185 9.1.6 Deleting Comments  Deleting Comment Characters, Texts or Arrows 1. Move the cursor to the comment to be deleted. 2. Press the <Set> key to select the comment. 3. Press the <Backspace>, <Del.> or <Clear> key to delete the comment. ...
Page 186  Save Probe If the probe mark direction and position is determined for the current body mark being added, touch [Save Probe] to save the current probe mark direction and position for the body mark. 9.2.2 Adding Body Marks 1. Enter Body Mark status. Use the knob under [Library] to select the body mark category. 2.
Page 187 External storage media is recommended for archiving images. 2. The system's patient database space is limited. Back up or clear patient data regularly. 3. Mindray is not responsible for lost data if you DO NOT follow the recommended backup procedures. 10.1 Patient Information Management 10.1.1...
Page 188 The system can save FRM files as BMP, JPG, TIFF, PNG or DCM files, or save CIN files as AVI or DCM files by Send To function in iStation screen. For details, please refer to “10.2.12 Sending Image Files” chapter. ...
Page 189 The image thumbnail will appear in the thumbnail area on the bottom of the screen. When you move the cursor over the thumbnail, its filename and suffix will be displayed. You can set the clip saving length in the path: [Setup] → [System] → [General]. 10.2.5 Quickly Saving Full Screen Images to the System ...
Page 190 Setting method (take “Save Image” as an example, add the auxiliary functions “Send Image to DICOM Storage” and “Send Image to USB disk”): 1. Set the user-defined key through the path: [Setup]→ [System]→ [Key Config]. Select a key in the Key Function field on the left side and select “Save Image”...
Page 191 The Review screen is shown as follows:  To exit Review:  Click [Exit] on the Review screen  Press <ESC> or press <Review> again. Functions in the Review screen:  Exam History: You can select more than one exams of one patient in iStation screen to check the patient exam history.
Page 192 To change the thumbnail size.  Other operations:  [New Exam]: click to create a new exam for the selected patient and open the Patient Info screen.  [Activate Exam]: activate the currently-selected exam (already ended) and enter the image scanning screen. ...
Page 193 10.2.11 iVision The iVision function is used to demonstrate the stored images. Image files are played one by one according to file names (including system-relevant and PC-compatible format images). To perform image demonstration: 1. Enter the iVision screen: Press the user-defined key for iVision (setting path: [Setup] → [System] → [Key Config.]) 2.
Page 194 [Add Catalog]: to add a catalog of files to the list. [Delete]: to delete selected files or catalogs from the file list. [Clear]: to clear all the files or catalogs in the file list. [Export]: to export selected directories/files to external storage devices. Click [Export] to bring up the Browse dialog box, select the path and click [OK].
Page 195  For video printers, send images to the video printer connected to the system. For graph/text printers, send images to the default graph/text printer.  For MedTouch/MedSight devices, single-frame image will be saved in PNG format, and multi-frame image will be saved in AVI format. Note: if the transferred AVI file cannot be played normally on PC, please try to transfer the multi- frame cine file in MPEG format (set [Setup]->[General]->”AVI File Encode Format”...
Page 196 To export reports: (1) Check “Export Report” on the screen. (2) Select the report type to be exported. (3) Click [OK] to confirm. You can select the paper size for the report print in the path: [Setup] → [Print].  Report printing Use a connected graph/text printer to print a report.
Page 197 10.4 iStation - Patient Data Management Patient data includes basic patient information, exam information, image files and reports. You can search, view, backup, send, restore or delete patient data in iStation.  To Enter iStation  Press the <iStation> key on the control panel, or ...
Page 198 10.4.2 Searching a Patient 1. Select the data source: Click [Data Source]Select the patient data's data source; the system patient database is the default. 2. Set search conditions by Name, ID, DOB, Exam Date in the “Item” drop-down list. 3. Enter the keyword according to the “Item” selected.. 4.
Page 199  Send Exams The system supports sending data to external memory devices, print or iStorage. You can use this function to export the exam data to external devices (in PC data or DICOMDIR data format) and then import to PC or restore to the ultrasound system to review the data. 1.
Page 200 (2) Click [Exit] to exit the Recycle Bin screen. NOTE: If there are more than 200 records in recycle bin, the system will ask you to clear the bin or not. Mindray recommends you clear the recycle bin regularly. 10-14 Patient Data Management...
Page 201 4. Select PC transfer format to send the report. 5. Click [OK] to start sending. To use iStorage function, you need UltraAssist software in 2.0 version (with V1.0 network protocol); consult Mindray service engineer for details. 10.6 Print 10.6.1 Print Setting For printer connection and driver installation, please refer to “3.7 Installing a Printer”...
Page 202 2. Click the icon on the top right side of the image, and select the printer in the dialog box which appears. 3. Click [OK] to start printing. See the accompanying printer manuals for more details. 10.6.3 Report Printing Both reports and images can be printed on a graph/text printer. 1.
Page 203 10.8 Patient Task Management Click in the bottom-right corner of the screen to bring up the following dialog box: The system supports following types of task management:  Storage Task: displays the DICOM storage task.  DICOM Print Task: displays the DICOM print task. ...
Page 204 When the task management icon displays as , it means no task is underway or has failed.  DICOM Service Setting On the Storage Task and DICOM Print Task page, click [Service Setting] to enter the DICOM service setting screen. For details, see the DICOM chapter. ...
Page 205 3. Enter the password and click [Log in].  To change users: 1. To log out the current user and change to another user, click in the bottom-right corner of the screen to bring up the dialog box. 2. Click [Change User] to bring up the Login dialog box. 3.
Page 206 10.10 V-Access The ultrasound system can be used to log on to a remote server to check or modify patient data on the server. 1. Set the user-defined key via the path: [Setup] → [System] → [Key Config]. Select a key in the Key Function field on the left side, and select “V Access”...
Page 207 DICOM/HL7 NOTE: Before using DICOM, read the DICOM CONFORMANCE STATEMENT electronic file provided with the device. The chapter is restricted to the preset, connection verification and DICOM services of the DICOM- configured ultrasound machine, and does not include SCP configurations such as PACS/RIS/HIS. The DICOM package is optional.
Page 208 11.1 DICOM Preset 11.1.1 IP Preset See “Appendix D Wireless LAN” for details. 11.1.2 DICOM Local Preset 1. Enter the DICOM local preset screen using the path: [Setup] → [DICOM/HL7]. 2. Enter AE Title, Port and PDU according to the actual situation, then click [Save] to exit the screen.
Page 209 Name Description You can ping other machines after entering the correct IP address. Ping You can also select a server in the Device list to ping it. Device List Displays the added device. Set DICOM Provides server settings of DICOM service. For details, see the following Service chapters.
Page 210 11-4 DICOM/HL7...
Page 211 DICOM storage preset items are described as follows: Name Description After setting the servers in the DICOM Preset screen, the Device names will appear in the drop-down list. Select the name of the storage server. Service Name The default is xxx-Storage, user-changeable. Application Entity title.
Page 212  Images of PW/M/TVM/TVD mode (B image is frozen), the system will save/transfer the images files in frame rate of 6. 11.1.3.2 Print Service Preset 1. On the DICOM Service screen, click the [Print] page tab to enter the Print page. 2.
Page 213 Name Description See copies of printed files. You can select from 1 to 5, or Copies directly enter the number. The system supports RGB (color printing) and Settings MONOCHROME2 (black and white printing). Please select the type the printer supports. Film Orientation Select from between LANDSCAPE and PORTRAIT.
Page 214 11.1.3.3 DICOM Worklist Preset 1. On the DICOM Service screen, click the [Worklist] page tab to enter the Worklist page. 2. Select a device and enter the correct AE Title, port, etc. 3. Click [Add] to add the service to the Service List. The DICOM Worklist service parameters are similar to those described in DICOM Storage Preset.
Page 215 11.1.3.7 HL7Query Preset HL7 protocol, enacted by Health Level Seven organization in 1987, is a 7 layer (application layer) based on the OSI model (Open System Interconnection) released by ISO (International Standard Organization).HL7 is used to rule and manage communications between HIS/RIS system and devices, as well as reduce the intercommunication cost.
Page 216 11.3 DICOM Services If all the DICOM presets on the DICOM Service Preset screen are completed, you are ready for the Storage, Print, Worklist (HL7 Query), MPPS, Storage Commitment and Query/Retrieve applications. 11.3.1 DICOM Storage DICOM Storage is used to send images to the DICOM storage server for storage. ...
Page 217 c) Click [Exit] to exit the page and return to the Setup menu, then click [Save] on the Setup menu to make the preset take effect. (3) Press the key to send to DICOM storage.  To send images to storage after an exam ends (1) Open “[Setup]→...
Page 218 1. Define the short key. For details, see “10.2.8 Auxiliary Output Function”. 2. Set a default printer server. a) Enter the DICOM Service Preset screen via “[Setup]→ [DICOM Preset] → [DICOM Service].” b) Click [Print] to open the Print page. c) Select a Print server in the Service List and click [Default].
Page 219 2. Select an exam (a suspended exam or an inactive exam) (images are stored in the exam record). Click the [Send Exam] button in the menu which appears to open the Send To dialog box. 3. Click to select “DICOM” in the Target box on the left side, then select the DICOM storage server in the Storage Server box on the right side.
Page 220 3. Select the server in the “Server and Service” area (both the source and the destination). 4. Enter the query information, such as Patient ID, Patient Name, Accession #, Exam Date or key words. Click [Clear] to empty the entered query information. 5.
Page 221 Media Storage 1. Select patient records in the iStation screen. 2. Click [Send Exam] in the menu which appears to open the dialog box. 3. Select the destination to “DICOMDIR” and DICOM Format as well as compression mode. 4. Click [OK] to begin the storage. If the backup is successful, a tick will appear in the Backup list in the iStation screen.
Page 222 (3) Perform measurements. (4) Save the images. (5) End the exam. (6) Open the iStation screen, select the patient exam, and click the corresponding [Send Exam] button in the menu which appears in order to open the Send To dialog box. (7) Click to select “DICOM”...
Page 223 CD/DVD or USB memory device. When the preset data is changed, be sure to save the preset data CAUTION: according to the methods described in this chapter. Mindray is not responsible for the loss of preset data. ...
Page 224 12.1 System Preset The system automatically enters the [System] screen after you enter Setup. Page Description To set the hospital name, language, time zone, time format and system Region date/time. To set patient information, exam setup, patient management, storage, system General dormancy, display and so on.
Page 225 12.1.1 Region Open the Region page via [Setup] → [System] → [Region]. Item Description To set the hospital-relevant information such as name, Hospital Information address, telephone, and so on. To select a language (input) for the system. Available languages are Chinese, English, French, German, Italian, Portuguese, Russian, Spanish, Polish, Czech, Turkish, Language Norwegian, Serbian, Finnish (can be entered only), Danish...
Page 226 12.1.2 General Open the page via [Setup] → [System] → [General]. Type Item Description Info displays in an To select whether to display the available patient image banner information items on the screen. Patient Info H&W Unit To set the unit for patient height and weight. Surface Formula To set the surface formula.
Page 227 Type Item Description Analog Output To select the format for analog signal (video output/ S-Video) Mode output: NTSC or PAL. Clip Length To set the cine length and heart cycle. Prospective Cine To set the cine length for prospective live capture. Length Retrospective Cine To set the cine length for retrospective live capture.
Page 228 Type Item Description Reset Config. Probe To set the default probe model for the system. Freeze Status after Freeze To set the system status after the image is frozen. Config. To set the steer mode in B + Color + PW imaging mode. C&PW: select to adjust the sample volume in color mode Steer and sample line in PW mode together.
Page 229  Key function setting You can set the functions for <Save>, <Print>, user-defined keys (including F3, F4, F5, F6, F12 and P) and two-finger gesture. See “3.8.4 Touch Screen Operation” for details about two- finger gesture operation. To assign a function to a key: a) Click to select the desired key in the Key Function column on the left side of the page.
Page 230 12.1.7.1 Access Control For access control details, see “10.9 Administration.” 12.1.8 Scan Code Preset See “Appendix B Barcode Reader” chapter for details. 12.2 Exam Mode Preset Open “[Setup] → [Exam Mode]” to enter the screen. You can assign available exam modes for probes. 1.
Page 231 12.3 Measurement Preset For details about Measurement Preset, see the [Advanced Volume]. 12.4 Comment Preset You can preset the custom comments library for current exam mode. The comments in the library are provided by the system or user-defined ones. 1. Select “<F10 Setup>->[Comment]” to enter Comment Preset: 2.
Page 232 Click [<<] to withdraw all items in Selected Items.  Delete a user-defined item in the Available Items box: Select a user-defined item in the Available Items box, and click [<]. You can only delete the user-defined items rather than the items in the system library. After a user-defined item is deleted, it will not be available.
Page 233 12.8 Print Preset This screen is used to set up the printer and image printing. Click [Print] in the preset menu to enter.  Printer setting The printer settings include print service and print driver.  Print Service Setting  Add Service: click to begin adding print services.
Page 234 12.9 Network Preset Parameters for transferring are set here. For details of local IP setting, see “Appendix D Wireless LAN”. 12.9.1 iStorage Preset You can send exam data or images to the iStorage server and perform analysis using UltraAssist. For details about this feature, see the UltraAssist manual. ...
Page 235  Click [Uninstall] to begin uninstalling a previously-installed option. Please contact the Mindray Customer Service Department or a sales representative for details. 12.10.2 Exporting Setup Data This function is used to write all setup data of the system into a disk for backup. The format of the data file is .PDP.
Page 236 1. Click [Import] to open the Load Data screen. 2. Select the imported file. 3. Click [OK], a progress bar will appear and the setup data is imported to the specified path. 4. To restore the factory setup data, click [Load Factory] on the right side of the screen. You can use [Export All], [Import All], or [Load Factory] at the bottom of the screen to export/import all setup data of the system or restore all factory setup data of the system.
Page 237 Probes and Biopsy 13.1 Probes NOTE: For details of storage times and conditions for disinfected probes and brackets, refer to the Technical standard for Disinfection of Medical and Health Structures. The system supports the following probes: 3C5A P4-2 P7-3 7L4A D7-2E L14-6NE CW5s...
Page 238 V11-3 CW2s V11-3B C6-2 DE10- P10-4E L9-3E 7L4B 13-2 Probes and Biopsy...
Page 239 13.1.1 Probe Functions by Part The basic structures and corresponding functions of probes are basically the same. <2> <1> <3> <4> <5> Name Function <1> Probe head Converts the electrical signal to an ultrasonic signal, focusing the sound beams in a given direction while it receives the reflected ultrasonic signal and converts it to an electrical signal for transmission over the cable.
Page 240 13.1.2 Orientation of the Ultrasound Image and the Probe Head The orientation of the ultrasound image and the probe are shown below. The “Mark” side of the ultrasound image on the monitor corresponds to the mark side of the probe. Check the orientation prior to the examination (using a linear probe as an example).
Page 241 Inspection before examination Connection to the ultrasonic diagnostic system Examinations Biopsy procedure Disconnection to the ultrasonic diagnostic system Sterilization of the needle- guided bracket Wiping off the ultrasound gel Inspection after use Washing the transducer with water Storage Draining/drying Immersion into disinfectant Removing the transducer from disinfectant Rinsing the transducer in sterile water...
Page 242 Operating procedures (with no biopsy function): Inspection before examination Connection to the ultrasonic diagnostic system Examinations Disconnection to the ultrasonic diagnostic system Wiping off the ultrasound gel Washing the transducer with water Draining/drying Disinfection Immersion into disinfectant Removing the transducer from disinfectant Rinsing the transducer into sterile water Draining/drying...
Page 243 13.1.4 Wearing the Probe Sheath A legally-marketed probe sheath must be installed over the probe before performing intra-cavitary and intra-operative examinations. Protective barriers may be required to minimize disease transmission. Probe sheaths are available for use in all clinical situations where infection is a concern.
Page 244 13.1.5 Probes Cleaning and Disinfection After completing each examination, clean and disinfect (or sterilize) the probes as required. When biopsy procedures have been performed, be sure to sterilize the needle-guided bracket. Fail to do so may result in the probe and the needle-guided bracket to becoming sources of infection. Please follow the instructions in the manual for cleaning.
Page 245 Disinfecting by Immersion 1. Wear sterile gloves to prevent infection. 2. Clean the transducer before disinfecting it. MINDRAY recommends the following solutions to disinfect the transducer.  Refer to the instructions provided by the chemical manufacturer concerning concentration of the disinfectant solution, method of disinfection and dilution and cautions during use.
Page 246 Strain relief Probe handle NOTE: Observe the graph here carefully to immerse the transducer. Only soak parts of the transducer below the strain relief. Repeated disinfection will eventually damage the probe, please check the probe performance periodically. Compatible Disinfectants For the disinfectants information, please refer to Disinfectant Quick Reference. 13.1.6 Environment Working condition Use the probes in the following ambient conditions:...
Page 247 Ambient Atmospheric Relative humidity Probe temperature pressure 0℃～40℃ 30%～85%RH（no 700hPa～1060hPa V11-3B condensation） 0℃～40℃ 20%～85%RH（no 700hPa～1060hPa L9-3E condensation） 0℃～40℃ 20%～85%RH（no 700hPa～1060hPa C6-2 condensation） 0℃～40℃ 30%～85%RH（no 700hPa～1060hPa P4-2 condensation） 10℃～40℃ 30%～85%RH（no 700hPa～1060hPa P7-3 condensation） 0℃～40℃ 20%～85%RH（no 700hPa～1060hPa 7L4B condensation） P10-4E 30%～85%RH （no 0℃～40℃...
Page 248 Ambient Atmospheric Relative humidity Probe temperature pressure 30%~95%RH（no 3C5A -20℃～55℃ 700 hPa~1060 hPa condensation） 30%~95%RH（no D7-2E -10℃～60℃ 700 hPa~1060 hPa condensation） 30%~95%RH（no L14-6NE -20℃～55℃ 700 hPa~1060 hPa condensation） 30%~95%RH（no V11-3 -20℃～55℃ 700 hPa~1060 hPa condensation） 30%~95%RH（no V11-3B -20℃～55℃ 700 hPa~1060 hPa condensation）...
Page 249 Excessive vibration  Heat generators 2. When the probe is sent to the MINDRAY Customer Service Department or a sales representative for repair, be sure to disinfect it and keep it in the carrying case to prevent infection. 3. Sterilize the carrying case as necessary.
Page 250 If an abnormality is found on the needle-guided bracket, immediately stop using it and contact the MINDRAY Customer Service Department or a sales representative. DO NOT use a needle-guided bracket while scanning is performed.
Page 251 When performing biopsy procedures, only use sterile ultrasound gel that is certified as safe and manage the ultrasound gel properly to ensure that it does not become a source of infection. When performing an operation involving biopsy, wear sterile gloves. Image of the biopsy target and the actual position of the biopsy needle: Diagnostic ultrasound systems produce tomographic...
Page 252 Dispersion of the ultrasound beam Probe Needle Target Ultrasound beam The biopsy needle may not have actually entered the target object even though it appears to have done so in the image. To avoid this, note the points below:  Do not rely only on the needle tip in the image.
Page 253 Needle-guided brackets are available for purchase as optional accessories and are used in combination with the probe. Some probes have corresponding needle-guided brackets and needles. To order needle-guided brackets, contact the MINDRAY Customer Service Department or a sales representative. For biopsy or treatment, ultrasound-guided biopsy procedures can be performed using the probe together with a needle-guided bracket (optional accessory) and a biopsy needle (provided by the user).
Page 254 13-18 Probes and Biopsy...
Page 255  NGB-007 Metal/needle detachable needle-guided bracket: Name Description Support for needle- <1> Used for installing the needle-guided bracket on the probe. guided bracket Tab and groove for the <2> Corresponding to the tab and groove of the probe. needle-guided bracket <3>...
Page 256 Plastic/needle detachable needle-guided bracket: Name Description Support for needle- <1> Used for installing the needle-guided bracket on the probe. guided bracket Used for determining the angle of the biopsy. There are three <2> Angle block angle block specifications. Used for installing biopsy needles. There are five guiding block <3>...
Page 257  NGB-011 Needle guide Needle guide clamping knob Locating Clamp Needle guide hole Locating groove Grip knob Needle guide rack Needle-guided bracket Probe  NGB-021 Retaining Locating Retaining clamp (back) clamp clamp Needle guide (front) Locating bulge Probe Locating groove Locking nut Probes and Biopsy 13-21...
Page 258  NGB-022 Needle fixing nut Groove Lock pin Clamp Needle type dial scale Clamp Angle adjusting base Angle fixing nut Needle guide hole 13.2.2 Basic Procedures for Biopsy Guiding 1. Select the correct needle-guided bracket and needle and install them properly. For details, see “13.2.3 Needle-Guided Bracket Inspection and Installation.”...
Page 259 13.2.3.1 Inspection of the Needle-Guided Bracket Be sure to perform inspections before and after using the needle-guided bracket. If an abnormality is found on the needle-guided bracket, immediately stop using it and contact the MINDRAY Customer Service Department or a sales representative.
Page 260  NGB-006 Metal/needle detachable needle-guided bracket: (1) Put the sterile probe sheath on. (2) Hold the probe in one hand, select the correct needle-guided bracket and hold it with the other hand. Match the groove and tab with the tab and groove of the probe respectively. Mount the bracket onto the probe.
Page 261  NGB-007 Metal/needle detachable needle-guided bracket: (1) Put the sterile probe sheath on. (2) Hold the probe in one hand, select the correct needle-guided bracket and hold it with the other hand. Match the groove and tab with the tab and groove of the probe respectively. Mount the bracket onto the probe.
Page 262 (3) Check manually to confirm that the needle-guided bracket is securely installed on the probe. (4) Select a suitable guiding block and push it into the groove above the angle block, then clamp it tightly. (5) Insert a biopsy needle with the same specification as that of the guiding block into the guiding block hole.
Page 263 (2) Hold the transducer by one hand, select the proper needle-guided bracket, and hold it with the other hand. Match the groove of the bracket with the tab of the transducer. Amount the bracket onto the transducer. (3) Screw the pinch nut of the needle-guided bracket to confirm that the needle-guided bracket is properly installed on the transducer.
Page 264  The biopsy guidezone adjusts along with image adjustments, such as image inversion/rotations, zoom and depth changes.  When the imaging depth and area are changed, the guide line is adjusted.  Exit  Touch [Biopsy Kit XXX] to be OFF or press <F11 Biopsy>. Tips: in real-time status, press <F11 Biopsy>...
Page 265 (2) Separate the residual part of the needle-guide bracket and the transducer from the needle. (3) Screw the pinch nut of the bracket, and remove the needle-guided bracket from the transducer.  NGB-007 Metal needle-guided bracket: (1) Loosen the guiding block's nut and slightly move the guiding block in the direction of the needle’s tail.
Page 266 13.2.6 iNeedle (Needle Visualization Enhancement) During a biopsy, the metal needle attached to the probe pierces the tissue at a certain angle. Due to the needle's acoustic impedance, the ultrasonic beam cannot penetrate the metal needle and a reflecting boundary is formed. As in Figure 1, if the deflection angle is very large, the needle display is not clear.
Page 267 3. After washing, dry the needle-guided bracket using sterile cloth or gauze. Sterilization 1. Wear sterile gloves to prevent infection. 2. Clean the needle-guided bracket before sterilizing it. MINDRAY recommends the following solution or sterilizing system for sterilizing the needle-guided bracket. 3. Follow local regulations when selecting and using disinfectant.
Page 268 2. Between examinations, keep the needle-guided bracket in a sterile environment. 3. If the needle-guided bracket is sent to your MINDRAY representative for repair, be sure to disinfect or sterilize it and keep it in the carrying case to prevent infection.
Page 269 13.2.9 Disposal Be sure to sterilize the needle-guided bracket before disposing of it. Contact your MINDRAY representative when disposing of this device. 13.3 Middle Line Middle Line helps to locate and observe the focus point of lithotripsy wave during lithotripsy treatment.
Page 271 Set the PAL or NTSC during setup. This should be consistent with that on the DVR. Accidental exposure to strong electromagnetic fields may result in image and data loss. Check that the recording was successful as soon as possible. Mindray is not responsible for any data loss.
Page 273 Acoustic Output This section of the operator’s manual applies to the overall system, including the main unit, probes, accessories and peripherals. This section contains important safety information for device operators pertaining to acoustic output and how to control patient exposure through use of the ALARA (as low as reasonably achievable) principle.
Page 274 15.4 MI/TI Explanation 15.4.1 Basic Knowledge of MI and TI Mechanical Bioeffect and Thermal Bioeffect The relationship of various ultrasound output parameters (frequency, acoustic pressure and intensity, etc.) to bioeffects is not fully understood at present. It is recognized that two fundamental mechanisms may induce bioeffects.
Page 275 15.4.2 MI/TI Display TI and MI values are displayed in the top part of the screen in real time. The operator should monitor these index values during examinations and ensure that exposure time and output values are maintained at the minimum amounts required for effective diagnosis. NOTE: If a value of MI or TI exceeds 1.0, the ALARA principle must be practiced.
Page 276 15.6 Acoustic Power Control A qualified operator may use the system controls to limit the ultrasound output and to adjust the quality of the images. There are three categories of system controls relating to output. They are:  Controls that have direct effect on the output ...
Page 277 15.7.2 Limits of Acoustic Output In accordance with the FDA Track 3 requirements, the derating (or attenuated) approach was incorporated into the FDA Acoustic Output Limits, as listed below. The maximum acoustic output level from any probe in any operating mode is expected to fall below these limits. FDA Maximum Acoustic Output Limits for Track 3 (Attenuated Values) Application (mW/cm...
Page 278 15.9 References for Acoustic Power and Safety 1. “Bioeffects and Safety of Diagnostic Ultrasound” issued by AIUM in 1993 2. “Medical Ultrasound Safety” issued by AIUM in 1994 3. “Acoustic Output Measurement Standard for Diagnostic Ultrasound Equipment, Revision 3” issued by AIUM/NEMA in 2004 4.
Page 279 EMC Guidance and Manufacturer's Declaration The system complies with the EMC standard IEC 60601-1-2: 2014. Intended Environments: HOME HEALTHCARE ENVIRONMENT (except for near active HF SURGICAL EQUIPMENT and the RF shielded room of an ME SYSTEM for magnetic resonance imaging). The use of unapproved accessories may diminish system WARNING: performance.
Page 280  Date/time information. TABLE 1 GUIDANCE AND MINDRAY DECLARATION—ELECTROMAGNETIC EMISSIONS The system is intended for use in the electromagnetic environment specified below. The customer or the user of system should assure that it is used in such an environment. ELECTROMAGNETIC ENVIROMENT－...
Page 281 TABLE 2 GUIDANCE AND MINDRAY DECLARATION—ELECTROMAGNETIC IMMUNITY The system is intended for use in the electromagnetic environment specified below. The customer or the user of system should assure that it is used in such an environment. IEC 60601 COMPLIANCE ELECTROMAGNETIC...
Page 282 TABLE 3 GUIDANCE AND MINDRAY DECLARATION—ELECTROMAGNETIC IMMUNITY The system is intended for use in the electromagnetic environment specified below. The customer or the user of system should assure that it is used in such an environment. IMMUNITY IEC 60601 TEST...
Page 283 TABLE 4 RECOMMENDED SEPARATION DISTANCES BETWEEN PORTABLE AND MOBILE RF COMMUNICATION DEVICE AND THE SYSTEM The system is intended for use in an electromagnetic environment in which radiated RF disturbance are controlled. The customer or the user of system can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communication equipment (transmitters) and system as recommended below, according to the maximum output power of the communication equipment.
Page 285 The responsibility for maintenance and management of the product after delivery resides with the customer who has purchased the product. If you have any questions, please contact the Mindray Customer Service Department or a sales representative. 1. Only an authorized Mindray service engineer can perform WARNING: maintenance which is not specified in this operator’s manual.
Page 286  Cleaning the probe cover and connector:  Tools: mild soapy water, soft dry cloth, soft brush  Method: a) Wipe away dust attached to the surface of the probe head, connector and cable. b) Use a soft brush to gently brush away dust from inside the probe connector. c) Remaining stains or dust attached to the surface of the cable or connector should be wiped away using a cloth with a little soapy water and then air dried.
Page 287  Cleaning the trackball  Tools: paper, dry cloth, mild soapy water  Method: 1. Disassembling the trackball: Press the bulges on the clamping ring using both hands and turn the ring about 35° clockwise until it lifts. Take out the ring and the rotary ball. Be careful not to drop the ball. See the figure below.
Page 288  Cleaning the main panel  Tools: soft dry cloth, soapy water  Method: Use a soft dry cloth to clean the surface of the control panel (including the keystrokes, encoders and sliders). If the control panel is dirty, moisten the soft cloth with a little mild soapy water and wipe away any stains.
Page 289 Please clean all the system's dustproof covers periodically (once per CAUTION: month). Failure to do so may result in system damage. Cleaning times can be increased when the system is used in the open air or somewhere more dusty. NOTE: Use a soft brush to brush away dust attached to all visible sockets or interfaces (such as probe sockets, sockets or interfaces in the IO panel and power supply panel).
Page 290 If any persistent system malfunction is experienced, e.g., an onscreen error message, blank imaging screen, absent menus, see the table below. If the failure cannot be resolved, contact the Mindray Customer Service Department or a sales representative.  Troubleshooting Table...
Page 291 Appendix A iScanHelper By providing the referential information, such as, the ultrasonic image, the anatomic graphic, scanning pictures/other scanning tips or diagnosis comments, the system helps the doctors to operate the scanning by iScanHelper. Furthermore, it is a good platform for the self-learning and training of ultrasound scanning technique for doctors.
Page 292 Basic Screen and Operation Section selecting box Image area Help information area A.4.1 View Selecting Area Rotate the trackball to move the cursor onto the target view and press <Set>, related information will be displayed on the help information area. A.4.2 Help Information Area Help information area displays on the lower right corner of the screen, providing...
Page 293  Scanning tips You can read tissue related anatomical information and adjacent tissue information here. A.4.3 Single/quad-window Display You can zoom in the anatomic graphic, ultrasonic image as well as scanning picture to view those information more conveniently. Press <Cursor> to obtain the cursor. Move the cursor on the anatomic graphic, the ultrasonic image or scanning tips.
Page 295 Appendix B Barcode Reader The product supports two kinds of readers for logging data as patient ID: 1-D barcode reader (SYMBOL LS2208) and 2-D barcode reader (SYMBOL DS6707). The laser transmitted by the two readers is Class 2 laser. Class 2 laser adopts low power, visible LED. DO NOT stare WARNING: into beam because of unknown hazards of transient radiation provided by class 2 laser.
Page 296 B.1.3 Setting The reader has factory settings; please refer to A.4 for details. The reader supports some user-defined functions as introduced below. For more details, please contact the SYMBOL reader agents or Mindray Customer Service Department.  Volume setting: Scan the following barcode to set the volume parameter.
Page 297 To enable Codebar, scan the appropriate barcode below.  code 39 full ASCII scanning: Code 39 Full ASCII is a variant of Code 39 which pairs characters to encode the full ASCII character set. To enable or disable Code 39 Full ASCII, scan the appropriate barcode below.
Page 298 B.1.4 Scanning in Hand-Held Mode 1. Ensure all connections are secure. 2. Aim the reader at the barcode. Press the trigger. Note: Ensure the scan line crosses every bar and space of the symbol, see the figure below. 3. Upon successful decode, the reader beeps and the LED turns green. Tips: Do not hold the reader directly over the barcode.
Page 299 B.1.5 Scanning in Hands-Free Mode B.1.5.1 Assembling the Intellistand NOTE Before tightening the wingnut under the base, ensure that the flat areas on the flexible neck fit securely in the grooves in the base. B.1.5.2 Mounting the Stand (optional) You can attach the base of the reader’s stand to a flat surface using two screws or double-sided tape (not provided).
Page 300  Screw Mount 1. Position the assembled base on a flat surface. 2. Screw one #10 wood screw into each screw-mount hole until the base of the stand is secure  Tape Mount 1. Peel the paper liner off one side of each piece of tape and place the sticky surface over each of the three rectangular tape holders.
Page 301 2-D Barcode Reader (Take DS6707 as an example) B.2.1 Overview 1. LED Green: A barcode was successfully decoded. Red: A data transmission error or reader malfunction occurred. 2. Scan window Scan the barcode. 3. Trigger Press to decode B.2.2 Setting Up the Digital Imager Reader B.2.2.1 Installing the Interface Cable 1.
Page 302 B.2.3 Setting The reader has factory settings; please refer to A.4 for details. The reader supports some user-defined functions as introduced below. For more details, please contact the SYMBOL reader agents or Mindray Customer Service Department.  Volume setting: Scan the following barcode to set the volume parameter.
Page 303  code 39 full ASCII setting Code 39 Full ASCII is a variant of Code 39 which pairs characters to encode the full ASCII character set. To enable or disable Code 39 Full ASCII, scan the appropriate barcode below.  I 2 of 5 symbols setting Select this option to decode only I 2 of 5 symbols containing a selected length.
Page 304 3. When the digital imager reader senses movement, in its default Auto Aim trigger mode, it projects a red laser aiming pattern which allows positioning the barcode or object within the field of view. If necessary, the digital imager reader turns on its red LEDs to illuminate the target barcode.
Page 305 B.2.5 Scanning in Hands-Free Mode The optional Intellistand adds greater flexibility to scanning operation. When the digital imager reader is seated in the stand’s “cup,” the digital imager reader’s built-in sensor places the digital imager reader in hands-free mode. When the digital imager reader is removed from the stand it operates in its normal hand-held mode.
Page 306 Setting in Ultrasound System 1. Press <F10 Setup> to enter the Setup menu. 2. Select [System]- [General]. Setting items are described as follows: Parameter Description Bar Code Reader Select type: 1D or 2D. Select the mode for inputting patient data. Only Patient ID: only patient ID is acquired from barcode reader.
Page 307 Parameter Description Set the start and end position of each item. Patient ID Note: Patient Name 1. Length of birth month and data are of 2 letters. 2. If one item of information is not included in the barcode, set the Birth start and end position of the item to be 0 respectively.
Page 308 Parameter Defaults Convert I 2 of 5 to EAN 13 Disable Codabar (NW - 7) Codabar Enable Set Lengths for Codabar 5 to 55 CLSI Editing Disable NOTIS Editing Disable 2-D Symbologies PDF417 Enable MicroPDF417 Disable Code 128 Emulation Disable Data Matrix Enable Maxicode...
Page 309 Appendix C iWorks (Auto Workflow Protocol) Overview The main objective of ultrasound workflow automation (iWorks) is to speed up exam times and reduce the excessive number of user interface manual key strokes that can lead to repetitive strain injuries over time. It automates a clinical workflow in common exam protocols in a logical “step by step” manner. It also prevents missing important parts of examinations as well as decreasing exam times.
Page 310 iWorks OB Procedure iWorks OB is a variation on the “iWorks” feature. iWorks is based on protocol events occurring in a linear “step by step” succession. iWorks OB accommodates protocol events that occur in a “random” or non-linear manner. 1. Enter the patient information. 2.
Page 311 Name Description Displays the protocol name and the number of views contained. There may be prompt information here to indicate the following operation. Displays the view steps in the protocol. The current active view, with a solid green frame around the image. ...
Page 312 View Operation In iWorks status, you can perform view selection, repeat, replacement and delete operations using the touch screen. For some views, the system switches to the relevant imaging modes if necessary. The comment for the current view has been automatically added to the bottom-left corner of the image, ready for you to scan the specified anatomy.
Page 313 Manual Examination Suspend - Exit the protocol so the user can run the system manually. This is used when an unusual or atypical workflow is required. You can run the system manually if necessary.  Start manual examination: touch [Suspend] to pause the current iWorks protocol. The system enters manual examination status.
Page 314 C.9.1 Protocol Management  Click to select the protocol in the list. The protocol type can be checked on the right.  Click [Add Protocol] to create a new protocol. It can be customized.  Click to select a protocol in the list on the left and click [Copy]. A protocol named “copy of XXX” is created with the copied views, which can be customized.
Page 315 C.9.3 Create New Protocol You can create user-defined protocols and customize the automated procedure. 1. In the iWorks preset screen, click [Add Protocol] to create a new protocol. Enter the protocol name, type and select the application region. Or, select an existing protocol and click [Copy] to customize the protocol based on the previous template.
Page 316 3. Add comments, body marks and perform measurement settings, as shown in the following figure: In the image setting, if “Measurement on next section” is selected, the system will save two section images after finishing the section operation. One of the two sections will include the measurement result.
Page 317 Appendix D Wireless LAN The system provides wireless net adapter configuration, so as to assist information query and unlimited network service. It is prohibited to use the wireless LAN function in an airplane, as this WARNING may violate the relevant provisions in the aviation regulations. Use the wireless LAN function prudently in emergency ambulances (or other vehicles) as other devices or communication signals may be interfered with.
Page 318  IP Config Note: When the system background is processing network task (DICOM sending for example), please do not enter network setting to change the IP, otherwise the background task may fail. You can check if there are tasks undergoing in the task manager. IP config is used for setting local network parameters, which is also applied to DICOM connection.
Page 319 Appendix E Battery The battery is inside the machine. Only Mindray technical WARNING: professionals or engineers authorized by Mindray following training can perform battery installation and uninstallation. If you need to change the battery or buy a new one, contact your sales representative.
Page 321 Appendix F Ultrasound Gel Warmer Ultrasound gel warmer is a system option used for heating the ultrasound gel. Overview As shown in the figure above, the warmer is installed on the left side of the control panel, where the ultrasound gel is positioned. Structure Name Function...
Page 322 Specifications  Power supply Voltage 12 V Power consumption 12 W  Environmental conditions Operating conditions Storage and transportation conditions Ambient temperature 0°C~40°C -20°C~55°C Relative humidity 30%~85% (no condensation) 20%~95% (no condensation) Atmospheric pressure 700hPa~1060hPa 700hPa~1060hPa Function and Requirement The ultrasound gel warmer can heat the ultrasound gel to about 40± 1°C at the most. When the gel is placed inside the warmer, the time it takes to heat from an ambient temperature of 18°C to 28°C should be no more than 0.5 hours.
Page 323 Install the Warmer 1. As shown in the figure below, install the gel warmer into the gel holder on the control panel. 2. Align the buckle of the holder to the slot at the side of the control panel and then insert the buckle into the slot, push the warmer in the direction of the arrow until the buckle clicks and locks.
Page 324 Remove the Warmer 1. Pull out the power cable from the control panel jack. 2. As shown in the above figure, press the clip in the direction of the arrow to remove the warmer. Clip Cleaning 1. Press the clasp on the bottom cover to release the cover. 2.
Page 325 Appendix G Electrical Safety Inspection The following electrical safety tests are recommended as part of a comprehensive preventive maintenance program. They are a proven means of detecting abnormalities that, if undetected, could prove dangerous to either the patient or the operator. Additional tests may be required according to local regulations.
Page 326 Device Enclosure and Accessories G.2.1 Visual Inspection Test Item Acceptance Criteria No physical damage to the enclosure and accessories. No physical damage to meters, switches, connectors, etc. The enclosure and accessories No residue of fluid spillage (e.g., water, coffee, chemicals, etc.). No loose or missing parts (e.g., knobs, dials, terminals, etc.).
Page 327 Earth Leakage Test Run an Earth Leakage test on the device being tested before performing any other leakage tests. The following outlet conditions apply when performing the Earth Leakage test.  normal polarity (Normal Condition);  reverse polarity (Normal Condition); ...
Page 328  LIMITS For BF applied parts: 100 μA in Normal Condition.  500 μA in Single Fault Condition.  Mains on Applied Part Leakage The Mains on Applied Part test applies a test voltage, which is 110% of the mains voltage using a limiting resistance, to selected applied part terminals.
Page 329 P/N: 046-007183-03 (1.0)

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