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Mindray DC-33 Operator's Manual

Diagnostic ultrasound system
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Diagnostic Ultrasound System
Operator's Manual
[Basic Volume]

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Summary of Contents for Mindray DC-33

  • Page 1 DC-33/DC-35/DC-36/DC-38/DC-39/ DC-40/DC-41/DC-42/DC-43/DC-44/ DC-45/DC-40S/DC-40 Pro/ DC-40 Exp/DC-40T Diagnostic Ultrasound System Operator’s Manual [Basic Volume]...

  • Page 3: Table Of Contents

    Contents 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 ........................
  • Page 4 3.3.1   Powering ON the System ..................... 3-3   3.3.2   Powering OFF the System ................... 3-5   3.3.3   Standby ......................... 3-5   3.4   Monitor Adjusting ........................3-6   3.4.1   Monitor Position Adjusting .................... 3-6   3.4.2   Adjusting Brightness/Contrast on the Monitor .............. 3-7   3.4.3  ...
  • Page 5 5.4   Color Mode Image Optimization ..................5-13   5.4.1   Basic Procedures for Color Mode Imaging ..............5-13   5.4.2   Color Mode Image Parameters .................. 5-13   5.4.3   Color Mode Image Optimization ................. 5-13   5.5   Power Mode Image Optimization ..................
  • Page 6 6.2.3   iZoom (Full-screen Zooming) ..................6-2   6.3   Freeze/Unfreeze the Image ....................6-2   6.3.1   Imaging Mode Switching When Frozen ................ 6-2   6.3.2   Imaging Display Format Switching When Frozen ............6-3   6.4   Cine Review ......................... 6-3   6.4.1  ...
  • Page 7 10.2.3   Image Storage Preset ....................10-3   10.2.4   Quickly Saving Images to the System ................ 10-3   10.2.5   Quickly Saving Full Screen Image to the System ............10-4   10.2.6   Thumbnails ......................... 10-4   10.2.7   Image Review and Analysis ..................10-4   10.2.8  ...
  • Page 8 12.2   Exam Preset ........................12-8   12.3   Measure Preset ........................12-8   12.4   Print Preset ......................... 12-9   12.5   Network Preset ......................... 12-10   12.5.1   Local TCP/IP ......................12-10   12.5.2   iStorage ........................12-12   12.5.3  ...
  • Page 9 16.1.4   Checking the Power Cable and Plug ................16-5   16.1.5   Checking Appearance ....................16-5   16.1.6   Backup of the System Hard Drive ................16-6   16.2   Troubleshooting ........................16-7   Appendix A   Barcode Reader ..................A-1   Appendix B  ...

  • Page 11: Intellectual Property Statement

    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 12: Warranty

    FITNESS FOR ANY 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 13: Important Information

    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 always be alert to dangers other than those indicated as well.

  • Page 14: Operator's Manuals

    Operator’s Manuals You may receive multi-language manuals in compact disc or paper. Please refer to English manual for latest information and register information. The content of the operator manual, such as screens, menus or descriptions, may be different from what you see in your system. The content varies depending upon the software version, options and configuration of the system.

  • Page 15: Software Interfaces In This Manual

    [Item in Menu] [Item in Submenu]: Select a submenu item following the path. [Dyn Rng (Value)]: Indicates menu items with parameter, (value) shows the current value of the item. Product Differences Product Model B-Hist B-Profile PPSA Color Velocity DC-33 √ × √ √ DC-35 × × √...

  • Page 17: Safety Precautions

    Safety Precautions Safety Classification According to the type of protection against electric shock: Class I equipment powered by outer power & equipment powered by inner batteries According to the degree of protection against electric shock: Type-BF applied part According to the degree of protection against harmful ingress of water: Main unit: IPX0 Probes: IPX7 Footswitch: FS-81-SP-2 (one-pedal) belongs to IPX8.

  • Page 18: Meaning Of Signal Words

    Meaning of Signal Words DANGER WARNING In this manual, the signal words" ”, “ ”, “ ”, CAUTION “NOTE” and "Tips" 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 19: Safety Precautions

    When using peripherals not powered by the auxiliary output of the ultrasound system, or using peripherals other than permitted by Mindray, make sure the overall leakage current of peripherals and the ultrasound system meets the requirement of the local medical device electrical regulation...
  • Page 20 Electric shock may occur. 11. Do not use an aftermarket probe other than those specified by Mindray. The probes may damage the system causing a profound failure, e.g. a fire in the worst case. 12. Do not subject the probes to knocks or drops. Use of a defective probe may cause an electric shock.
  • Page 21 If the circuit protector is tripped, it indicates that the system or a peripheral device was improperly shut down and the system is unstable. You cannot repair the system under this circumstance and must call the Mindray Customer Service Department or sales representative. There is no risk of high-temperature burns during normal ultrasound examinations.
  • Page 22 The system and its accessories are not disinfected or sterilized prior to delivery. The operator is responsible for the cleaning and disinfection of probes and sterilization of biopsy brackets according to the manuals, prior to the use. All items must be thoroughly processed to completely remove harmful residual chemicals, which will not only be harmful to the human body, but also damage the accessory.
  • Page 23 10. If the system is used in a small room, the room temperature may rise. Please provide proper ventilation and free air exchange. 11. To dispose of the system or any part, contact Mindray Customer Service Department or sales representative. Mindray is not responsible for any system content or accessories that have been discarded improperly.
  • Page 24 Please use the disinfection or sterilization solution recommended in this operator’s manual; otherwise Mindray will not be liable for damage caused by other solutions. If you have any questions, please contact Mindray Customer Service Department or sales representative.

  • Page 25: Latex Alert

    10. The damage of the probe may be caused by the contact of improper gel or cleaner: DO NOT soak or saturate probes in the strong polar solution of ethanol, chloride of lime, ammonium chloride, acetone or formaldehyde. DO NOT contact the probe with solutions or ultrasound gels containing oily medium such as mineral oil or lanoline.

  • Page 26: Warning Labels

    WWW.civco.com Allergic reactions in latex (natural rubber) sensitive patients may WARNING: range from mild skin reactions (irritation) to fatal anaphylactic shock, and may include difficulty in breathing (wheezing), dizziness, shock, swelling of the face, hives, sneezing or itching of the eyes (FDA Medical Alert on latex products, “Allergic Reactions to Latex-containing Medical Devices”, issued on March 29, 1991).

  • Page 27: System Overview

    System Overview Intended Use The Diagnostic Ultrasound System is intended for use in gynecology, obstetrics, abdominal, pediatric, small parts, cephalic, transcranial, musculo-skeletal, cardiac, vascular, urology, orthopedics, nerve exam. Contraindication This system is not intended for ophthalmic use. Product and Model Code Model code Product code The functions described in the operator’s manual may vary depending upon the...

  • Page 28: Imaging Mode

    2.4.1 Imaging Mode B Mode M Mode Color M Mode (CM) Color C Mode Power（Dirpower） PW Doppler D Mode CW Doppler Tissue Doppler Imaging Special Imaging TDI QA iScape View Free Xros M/Free Xros CM 3D/4D Smart 3D Static 3D iPage iLive Contrast Imaging...

  • Page 29: Size And Weights

    2.4.4 Size and Weights External dimensions: 812mm (L)X600mm (W)X1331(1515)mm (H) Net weight: 130.87Kg (without the battery) System Configuration 2.5.1 Standard Configuration Main unit Accessories Operator's manuals Ultrasound gel Dust-proof cover Probe ports dust-proof cover Tray assembly Left bracket for the intra-cavity probe Right bracket for the intra-cavity probe Probe holder Probe holder for pencil probe...

  • Page 30: Options

    Probe Model Intended Use Region Applied pediatric abdomen, pediatric cardia, P7-3 neonatal cephalilc, neonatal abdomen, Body surface neonatal cardiac, nerve, orthopedic Urology CB10-4E Intracavitary Musculoskeletal, nerve, small parts, L12-3E Body surface vascular, pediatric, abdominal D7-2E Obstetrics, gynecology, abdominal Abdomen Small parts, musculo-skeletal, nerve, L14-6NE Body surface vascular, pediatric...
  • Page 31 Item Built-in Wireless Adapter Pencil probe port Footswitch: (one-pedal/two-pedal/three-pedal) 1D barcode reader Nerve Package Emergency&Critical Package Application software package Smart OB Smart NT Smart Bladder Tissue Doppler Imaging iScape View Free Xros M Free Xros CM Smart 3D Static 3D iPage (configured with 4D module) Contrast Imaging Elastography Imaging...

  • Page 32: Peripherals Supported

    2.5.4 Peripherals Supported Item Model HP Deskjet Ink Advantage 2020hc Graph / text printer HP Officejet Pro 8100 Digital Color Video SONY UP-D23/25MD Printer Digital Black and White SONY UP-D897 Video Printer MITSUBISHI P93W-Z Analog Black and White Video Printer SONY UP-X898MD Bar code reader LS2208...

  • Page 33: Introduction Of Each Unit

    Introduction of Each Unit System Overview 2-7...
  • Page 34 Name Function Displays the images and parameters during scanning. Monitor (Support optional 15-inch or 17-inch monitor or 19- inch monitor) 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 holder probe or intra-cavity probe).
  • Page 35 Name Function Control panel adjusting Used for lifting or swiveling the control panel. lever USB port Hanger Intracavitary probe holder Used for fixing the intracavitary probe. Ultrasound gel holder/gel Used for placing the ultrasound gel or installing the gel warmer warmer.

  • Page 36: I/O Panel

    I/O Panel Symbol Function <1><2> USB port, used for connecting USB devices. <3> VGA signal output; connects a monitor or projector. <4> Ethernet interface. <5> Separate video input (reserved). <6> Separate video output. <7> DVI signal output. <8><9> Audio signal input port, left channel(reserved). <10><11>...

  • Page 37: Power Supply Panel

    Power Supply Panel <3> <2> <1> Name Function Used for equipotential connection, balancing the <1> protective earth potentials between the system and other Equipotential terminal electrical equipment. <2> AC Auxiliary Output Power supply port for peripherals. <3> AC Input AC power inlet. Physiological-signal Panel <2>...

  • Page 38: Control Panel

    Name Function <1> Pencil probe port Pencil probe port (reserved). <2> Use for connecting microphone to record vocal Mic In port comments (reserved) <3> Two USB ports Used for connecting USB devices. <4> ECG lead signal input Connects to ECG leads, to directly obtain patient port/external ECG signal input electrocardiosignal/used for connecting the signal port...
  • Page 39 English Name Description Patient Enter/exit Patient Info screen. Probe Switch probe and exam mode. Review Review the stored images. Report Open/close the exam report. End Exam End the current exam. Text Enter/exit the textual comment status. Clear Clear the comments or measurement caliper. Press to enter the Cine Review status from non-cine status Cine when there is a multi-frame cine file playing.
  • Page 40 English Name Description Focus Change the focus position. Cursor Show/hide the cursor. Confirm an operation. The function is same with the left-button of the mouse. Move the trackball to change the cursor position. Confirm an operation. The function is same with the left-button of the mouse.
  • Page 41 Common functional keys Function Confirm the entered data, or move the cursor to the top of Enter the next row of the text or input field. Cancel the operation or exit. Jump to the next operable item. Back space Insert a space. Caps Lock Switch between upper/lowercase.
  • Page 42 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 → editable unit. ←...

  • Page 43: Symbols

    2.11 Symbols This system uses the symbols listed in the following table, and their meanings are explained as well. Symbol Description Type-BF applied part Caution AC (Alternating current) Equipotentiality Power button Foot switch Transducer sockets Network port USB port Used for VGA output. Reserved, used for separate video output S-VIDEO Separate video input, reserved.

  • Page 45: System Preparation

    5. When using peripherals not powered by the auxiliary output of the ultrasound system, or using peripherals other than permitted by Mindray, make sure the overall leakage current of peripherals and the ultrasound system meets the requirement of the local medical...

  • Page 46: Power Supply

    Power Supply This system can work normally only when it is connected to the external power supply or the battery capacity is sufficient. 3.2.1 Connecting AC Power Supply 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.

  • Page 47: Powered By Batteries

    If the system begins to function improperly – immediately stop scanning. If the system continues to function improperly – fully shut down the system and contact Mindray Customer Service Department or sales representative. If you use the system in a persistent improperly functioning state –...
  • Page 48 Checking before Power ON To check the system before the system is turned on: Check Item The temperature, relative humidity and atmospheric pressure shall meet the <1> requirements of operating conditions. See "2.4.3 Environmental Conditions" for details. <2> There shall be no condensation. There shall be no distortion, damage or dirt on the system and peripheral devices.

  • Page 49: Powering Off The System

    WARNING: the patient. 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. 3.3.2 Powering OFF the System You need to follow the correct procedures to power off the system.

  • Page 50: Monitor Adjusting

    waiting time set for screensaver, and if there is still no operation, the system enters standby after the waiting time for standby. Press the power button and select “Standby”. Disconnect the power plug, and select “Standby” in the prompted dialogue box. When the system enters the standby status, the standby status indicator blinks in orange.

  • Page 51: Adjusting Brightness/Contrast On The Monitor

    Tilt the monitor When positioned vertically, the monitor can be tilted 20° backward and can be tilted forward to a horizontal position. When transporting or moving the system, keep the monitor in the horizontal position, as shown below: 3.4.2 Adjusting Brightness/Contrast on the Monitor Monitoring the brightness and contrast adjustment is one of the most important factors for proper image qualities.

  • Page 52: Control Panel Position Adjustment

    On the monitor, the brightness adjustment comes before contrast. After NOTE: readjusting the monitor’s contrast and brightness, adjust all preset and peripheral settings. 3.4.3 Control Panel Position Adjustment Press the control lever downwards for about 30° to rotate the control panel ±90°. Press the lever downwards for about 60°...

  • Page 53: Connecting A Probe

    Only use the probes provided by Mindray. Aftermarket probes may result in damage or cause a fire. If a probe port is not used for a long period of time, please use the dustproof NOTE: cover to protect the probe port from dust;...

  • Page 54: Connecting Peripheral Devices

    loose Connecting Peripheral Devices 3.6.1 Connecting the USB Devices DO NOT directly remove a USB memory device; WARNING: otherwise, the USB memory device and/or the system may be damaged. Available USB ports on the system: 1. Two USB ports on the physiological-signal panel. 2.

  • Page 55: Graph /Text Printer

    USB port Function setting The function of the footswitch can be set, for details, please refer to “12.1.6 Key Configuration”. 3.6.3 Graph /Text printer 3.6.3.1 Connecting a Local Printer As shown in the figure below, a graph / text printer has a power cord and data cable. The power cord shall be directly connected to a wall receptacle as required.
  • Page 56 5. Return to “Print Service” page, and select “Report Print” in the list, and set attributes in the Property box under the screen: Select the printer model from the drop-down list right to the “Printer”; Set Paper Size. 6. Click [Save] to finish the installation. Tips: Drivers of some popular printers have already been integrated in the system, and will be installed automatically.
  • Page 57 a) Download the ppd file from the printer manufacturer’s official website (contact service engineer if necessary), and copy the ppd file to the storage device (USB disk as an example). b) Connect the USB disk to the ultrasound system, click [Setup] [Print Preset] ”Printer Driver”...

  • Page 58: Installing Analog Video Printer

    2. Click “Print Service” to enter the screen, and select AssistPrinter@IP address to be the printer for the Report Print service. 3. Verify the status of the network connection. Click the [Ping] button in the [Status] column of the iStorage printer list, and the system pops a dialog box to display whether the connection with the iStorage server is ready or not.
  • Page 59 1. Printer room window 2. Printer 3. Room cover Color analog video printer: use the I/O panel at the rear side of the machine to connect the printer, as shown in the following figure: Connect to S-Video out cable Connect the remote cable of the printer 4.

  • Page 60: Installing Digital Video Printer

    3.6.5 Installing Digital Video Printer 1. Put the printer in a proper place. 2. Plug the printer power cord to an appropriate outlet. 3. Use a USB cable to connect between the USB port of the system and the USB port of the printer.
  • Page 61 Uninstalling Press the clip in the direction of the arrow to get out the holder. Clip System Preparation 3-17...

  • Page 62: Basic Screen And Operation

    Basic Screen and Operation 3.7.1 Basic Screen The following diagram maps out the different areas in the screen: Patient Hospital name Accession# Freeze icon name Logo DOB/ Exam Operator Gender date&time Probe&acoustic power Menu/exam mode/image parameter Thumbnails Image area ECG trace Image-in- Image image...
  • Page 63 Hospital name Display the hospital name. Hospital name can be set via "[Setup] [System Preset] [Region]". Exam time Displays the exam time, including date and time. Exam time format can be set via "[Setup] [System Preset] [Region]". Exam time will be frozen with the frozen image.
  • Page 64 Menu title Items Drop-down list button Menu title Displays the menu name. Items Refers to the items on a menu. For item that is applicable for more than one mode, the item appears as shared item in the certain mode. Items of image modes and measurement can be preset.
  • Page 65 Image manage area Page up/down: when there are more than one page images have been stored, you can turn to the next or preview page by respectively. Delete: select a thumbnail image, and click to delete it. Send to: select a thumbnail image, and click to send it to external devices.

  • Page 66: Basic Operations Of Screens

    3.7.2 Basic Operations of Screens A screen consists of title, page tabs, contents and buttons, as shown in the following figure: Title Content Control button Composition Description The title bar is used to give a description for the content and Title Bar function of the screen.

  • Page 67: Touchscreen

    3.7.3 Touchscreen Adjust through the touch screen 1. Mode displaying area (or main functional tabs): displays the current modes, touch the tab to enter the mode. 2. Other application mode entrance: displays the available application modes related; tap to enter the modes. 3.

  • Page 68: Soft Keyboard

    3.7.4 Soft keyboard Under report, setup, comment adding and iStation screen, the soft keyboard icon is displayed on the touch screen. Tap the icon to enter the soft keyboard typing screen. Or, under patient info screen, you can see the soft keyboard typing screen on the touch screen directly.

  • Page 69: Exam Preparation

    Exam Preparation Before examining a new patient, press <End Exam> to end CAUTION: the exam of the previous patient, update the patient ID and information, to avoid mixing data of the next new patient. To Start an Exam You can start a patient exam in the following situations: New patient information: enter the patient information, if it is a new patient, refer to "4.2.1 New Patient Information"...
  • Page 70 Place the cursor onto the targeted 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 position by <Tab>, <Enter> or direction keys. Detailed information is described as follows: 1.
  • Page 71 Age: Auto generated age: once the DOB is entered, the system can display an auto-generated age in the field box; the unit can be “Years”, “Months” or “Days”. If the age is less than one year, the system will automatically calculate the age in months or days.
  • Page 72 Exam Type Information Description According to the entered index (can be selected in the drop-down list); including LMP (last menstrual period), date of conception (DOC), IVF (in vitro fertilization), PRV (previous exam date), BBT (basic body temperature)), the system can automatically calculate GA and EDD (estimated delivery date);...

  • Page 73: Retrieve Patient Information

    Exam Type Information Description BP(L) Input left blood pressure. BP(R) Input right blood pressure. Serum PSA PPSA (Urology) coefficient SMP (Small None Parts) None (Pediatrics) Height Breast Weight 3. Operating Information Accession #: exam number used in DICOM. It should be entered within 16 letters or characters;...
  • Page 74 2. Select the data source: Select the data source in the drop-down list of "Data Source". The occupying space percentage of the selected data source will be displayed. 3. Set the searching condition Define the searching item: Name, ID, BOD or Exam Date; and then enter the related keyword.
  • Page 75 Button Function Description Delete Exam Click to delete the selected record. Click to back up the selected patient record to media Backup Exam supported. Restore Click to import the patient data from an external media. Exam Click to send the selected patient data to external device, Send Exam DICOM storage server or printer.

  • Page 76: Select Exam Mode And Probe

    Select Exam Mode and Probe If the exam mode is changed during a measurement, all CAUTION: measurement calipers on the image will be cleared. The general measurement data will be lost, but application measurement data will be stored in the reports. Selecting exam mode 1.

  • Page 77: Select The Imaging Mode

    2. Select [Image Mode] [Dual Probe]. 3. Click [OK] to confirm the setting or exit. The setting comes into effect then. Select the Imaging Mode Use the corresponding keys in the control panel to enter the imaging modes. Activate& Continue an Exam 4.5.1 Activate an Exam In iStation screen, select the exam record finished within 24 hours, and click [Activate...

  • Page 78: End Exam

    4.6.2 End Exam Before examining a new patient, press <End Exam> to end the exam of the previous patient, update the patient ID and information, to avoid mixing data of the next new patient. To end an exam, you can do one of the following: Press <End Exam>...

  • Page 79: Image Optimization

    Image Optimization WARNING: The images displayed in this system are for 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: Quickly Saving Image Settings

    2. Other application mode access: displays the available related application modes. Tap to enter the modes. 3. Parameter adjusting area: displays the parameters in the current imaging mode or function. Parameter magnitude setting: tap 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: B Mode Image Optimization

    Check image parameter level and other settings: Click [Show Parameter] to check levels of different image parameters. Click [OK] to save the current image values for the current exam mode of the particular probe. This function is not available under dual-probe frozen mode. B Mode Image Optimization B mode is the basic imaging mode that displays real-time images of anatomical tissues and organs.
  • Page 82 5.2.3 B Mode Image Optimization Frequency Description This function is used to select the operating frequency of the current probe, the real-time value of which is displayed in the image parameter area in the upper left corner of the screen, where “F” represents B mode frequency.
  • Page 83 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. To increase the gain compensation in an area of interest, move the TGC Operations slider to the right.
  • Page 84 Imaging Adjustment Description More information can be obtained without moving the probe or changing the sampling position. 1. To change the scan range, tap [FOV] on the touch screen to enter the FOV (Field FOV range and FOV position adjustment status. of View) 2.
  • Page 85 iClear Description The function is used to enhance the image profile so as to distinguish the image boundary for optimization. Adjust using the [iClear] item on the touch screen. Operations The system provides 1-4 levels of iClear adjustment: off represents no iClear effect, and the bigger the value the stronger the effect.
  • Page 86 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.
  • Page 87 H Scale Description Display or hide the width scale (horizontal scale). The scale of the horizontal scale is the same as that of the vertical scale (depth). They change together in zoom mode, or when the number of the image window changes. When the image is turned up/down, the H Scale will also be inverted.

  • Page 88: M Mode Image Optimization

    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 89 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. Rotate the <M> knob clockwise to increase the gain, and counter- Operations clockwise to decrease it.
  • Page 90 Gray Map Description This function applies the gray correction to obtain optimum images. To select from among the maps, turn the knob under [Gray Map] item on Operations the touch screen. The system provides 25 different gray effect maps. Edge Enhance Description This function is used to enhance the image profile so as to distinguish the image boundary for optimization.

  • Page 91: Color Mode Image Optimization

    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 92 ROI Adjustment Description This function adjusts the width and position of the ROI in Color mode. When the ROI box is a dotted line, roll the trackball to change the size. Operations When the ROI box is a solid line, roll the trackball to change the position. Press <Set>...
  • Page 93 Packet Size Description This function is an indication of the ability to detect flow, which is used to adjust the accuracy of color flow. Rotate the knob under the [Packet Size] item on the touch screen to adjust Operations the value. There are 0-3 levels of packet size available: 0 represents no packet size control and the bigger the value the higher the sensitivity.
  • Page 94 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.
  • Page 95 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. Select using the [WF] item on the touch screen.

  • Page 96: Power Mode Image Optimization

    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 97 Increasing the gain will increase the flow signal presented and noise. The Effects signals may be missing when the gain is adjusted too low. 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.

  • Page 98: Pw/Cw Doppler Mode

    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 99: Pw/Cw Mode Image Parameters

    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 Wall SV Size Angle Filter Position Parameter Angle Meaning Frequency Gain...

  • Page 100: Pw/Cw Mode Image Optimization

    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. Rotate the [PW] knob clockwise to increase the gain, and counter- Operations clockwise to decrease it.
  • Page 101 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. Rotate the knob under the [Scale] item on the touch screen.
  • Page 102 Speed This function is used to set the scanning speed of PW mode imaging. Description Rotate the knob under the [Speed] item on the touch screen. Operations There are 6 levels of scan speed available: the smaller the value the faster the speed.
  • Page 103 Display Format To set the display format of PW mode images with B mode images. Description Tap the different display format ratio buttons on the touch screen to adjust. Operations There are 5 formats for displaying the images: H2:3, V2:3, V3:2, V3:1, Full.
  • Page 104 Dynamic Range Description The dynamic range conveys the information which is being transformed from echo intensity to grayscale. Adjust using the [Dyn. Ra.] item on the touch screen. Operations The adjusting range is 24-72dB. The more the dynamic range, the more specific the information and the Effects lower the contrast with more noise.

  • Page 105: Color M Mode

    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 106: Anatomical M Mode

    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 107: Free Xros Cm (Curved Anatomical M-Mode)

    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. Perform the selection using the [Show A], [Show B] or [Show C] item on M-mark the touch screen, and the corresponding image will be displayed on the Line...

  • Page 108: Tdi

    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 109: Basic Procedures For Tdi Imaging

    Tissue Velocity Doppler Imaging (TVD): this imaging mode provides quantifiable direction and velocity information about the tissue. Tissue Velocity M Imaging (TVM): this function assists in observing the cardiac motion through a direct angle. TVM mode is also called Color Tissue M mode which has been introduced in the Color M mode chapter.

  • Page 110: Tdi Quantitative Analysis (Qa)

    5.9.4 TDI Quantitative Analysis (QA) TDI Quantitative Analysis results are provided for reference CAUTION: only, not 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 111 5.9.4.1 TDI QA Screen Description TDI QA Screen 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: The images in the TVI cineloop window and B cineloop window are the frozen image of the same moment.
  • Page 112 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 113 Delete an ROI Press the <Clear> key to clear the last ROI. Tap [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. Standard Height/Standard Width/Standard Angle Use the touch screen selections [Std.

  • Page 114: Overview

    5.10 3D/4D 3D/4D imaging is largely environment-dependent, so the images obtained are NOTE: 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 can’t be achieved by standard 2D-mode to improve understanding of complex structures.
  • Page 115 View point ROI and VOI Before image acquisition after the system enters 3D/4D imaging, a B image with ROI displays on the screen. A line (shown in the following figure) that shows the cut plane position of VOI is inside ROI. B image Cut plane ROI size and position...
  • Page 116 View Curved VOI At the upper part of curved VOI At the lower part of curved VOI At the left part of curved VOI At the right part of curved VOI Displays as a dot Displays as a dot To define a ROI, please try to cut the useless data as to reduce the volume NOTE: data, shortening the time for image storing, processing and rendering.
  • Page 117 Tips: changing the view direction only changes the 3D/4D image; images of the 3 sections do not change. Probe A 2D imaging probe can be applied for Smart 3D imaging, however, to realize static 3D imaging or 4D imaging, a volume probe should be selected. Sectional plane The principle of 3D imaging is to render a 3D image from multiple 2D image information.

  • Page 118: Note Before Use

    Section B: it is the horizontal section in fetal face up posture, as shown in the figure B above. Section C: it is the coronal section in fetal face up posture, as shown in the figure C above. Tips: the upper part of the 3D image in the D window is corresponding to the orientation mark on the probe, if the fetal posture is head down (orientating the mother’s feet), and the orientation mark is orientating the mother’s head, then the fetus posture is head down in the 3D image, you can make the fetus head up by...
  • Page 119 (3) Amniotic fluid (AF) isolation The desired region is adequately isolated by amniotic fluid. The region to be imaged is not obscured by limbs or umbilical cord. (4) The fetus keeps still. If there is fetal movement, it is necessary to rescan. Angle of a B tangent plane The optimum tangent plane to the fetal face 3D/4D imaging is the sagittal section of the face.

  • Page 120: Static 3D

    5.10.3 Static 3D Static 3D provides single frame image acquisition of 3D images. During scanning, the probe performs the scanning automatically. 5.10.3.1 Basic Procedures for Static 3D Imaging To perform Static 3D imaging: 1. Select the appropriate probe and exam mode. Make sure there is sufficient gel on the probe for scanning.
  • Page 121 For setting the ROI, be sure to: Set the ROI on the 2D image with the largest section area of the fetal face. Set the ROI a little larger than the fetal head. When defining an ROI, try to eliminate useless data so as to reduce the volume NOTE: data and shorten the time for image storing, processing and rendering.
  • Page 122 Type Parameter Description Function: set Min. as the 3D image rendering mode. Displays the minimum echo intensity in the observation Min. direction. This is useful for viewing vessels and hollow structures. Function: set X-ray as the 3D image rendering mode. Displays the average value of all gray values in the ROI.
  • Page 123 Sectional A Sectional C Sectional B MPR Only on the touch screen to display MPR only. The adjustable image parameters are changed to MPR parameters automatically. Only A, B and C MPR are displayed, and VR is not displayed. The MPR Only function is available in image acquisition status. Asymmetric on the touch screen to display MPR along with VR.
  • Page 124 View Direction a. Up/Down b. Down/Up c. Left/Right d. Right/Left e. Front/Back f. Back/Front Tap [U/D], [L/R] or [F/B] on the second page of the touch screen to select the direction of the above Figure a, c and e. Tap [Flip] on the touch screen to view in the opposite direction to the current direction, as shown in Figures b, d and e.
  • Page 125 4. Roll the trackball to view the current active MPR. The other two MPRs change correspondingly. Or rotate the <4D> knob to adjust the relative position of MPRs so as to slice through the VR. In Accept VOI status, when the VR is active or the MPR which is perpendicular to the view direction is active, the center point of the VR displays.
  • Page 126 Parameter Description Enhances the B mode image profile for better boundary details. iClear Range: Off, 1-4. Reset Curve Parameter Description To reset the volume rotation, shifting and zooming to its original Reset Ori. status. Reset Curve To reset the curve to its original status. Reset All To reset the volume to its original orientation and original parameters.
  • Page 127 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: To rotate along the X-axis: rotate the <M>...
  • Page 128 In the following image, the current active plane is MPR A. After performing Sync on Figure A, you can see the same fetal face profile in VR. Figure A Figure B 5-50 Image Optimization...
  • Page 129 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 130: Ilive

    Type Parameters Description Displays a box you can use to define the portion of the Rect. In image you want to cut. Inside Rect removes all portions of the image that fall inside of the box. Displays a box you can use to define the portion of the Rect.
  • Page 131 Or, use 4D probe and press <4D> to enter 4D mode or Static 3D mode. 2. Select the render mode to be iLive by touching the touch screen, and set the related parameters (quality and angle, etc.). 3. Press <Update> to begin acquisition. 4.
  • Page 132 Rotation Roll the trackball to view sectional images as necessary. Rotate <M>, <PW>, <C> to perform axial rotation or rotate the <4D> knob to adjust the nearest VOI section (cut plane) position. Comments and Body Marks Same as in other modes. 5.10.5 4D 4D provides continuous, high-volume acquisition of 3D images.

  • Page 133: Smart 3D

    5.10.5.4 4D Image Saving In 3D viewing mode, press the single image Save key (Save Image to hard drive) to save the current image to the patient information management system in the set format and image size. Save clip: in 3D viewing mode, press the user-defined Save key (Save Clip (Retrospective) to hard drive) to save a CIN-format clip to the hard drive.
  • Page 134 5.10.6.2 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.” Method Capture images using Linear scan or Rocked scan.

  • Page 135: Ipage (Multi-Slice Imaging)

    5.10.6.3 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. Scanning plane and probe movement Move the probe across the body surface. The arrow in the figure below indicates the movement of the probe (you can move the probe in the opposite direction to the arrow.).
  • Page 136 Single-frame VR: 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. Perform operations such as rotation and VOI adjusting to the image to find the region of interest.
  • Page 137 5.10.7.2 iPage Basic Functions and Operations <1> A plane <2> B plane (the current <3> C plane reference image) <4> Y-axis <5> X-axis <6> Central section line (Current active section line) <7> Section line <8> Space between two <9> Image parameter planes <10>...
  • Page 138 Slice order number: indicates the order of the slices. The position of the central slice is “0”, the slices before the central slice are marked with negative integral numbers, and the slices after the central slice are marked with positive integral numbers.

  • Page 139: Iscape View (Real-Time Panoramic Imaging)

    5.11 iScape View (Real-time Panoramic Imaging) The iScape panoramic imaging feature extends your field of view by piecing together multiple B images into a single, extended B image. Use this feature, for example, to view a complete hand or thyroid. When scanning, move the probe linearly and acquire a series of B images.

  • Page 140: Image Acquisition

    5. Exit iScape: Press <Freeze> or <Update>, or tap [ReCapture] on the touch screen to enter image acquisition status. Press the <B> button to return to B mode. 5.11.2 Image Acquisition To create an iScape image, start with an optimized 2D (color) image. The 2D image serves as the mid-line for the resulting iScape image.
  • Page 141 Setting image parameters. For details, see “5.11.3.1 Adjusting Image Parameters.” Image zooming. For details, see “5.11.3.2 Image Zooming.” Image rotation. For details, see “5.11.3.3 Rotating the Image.” Measurement, comments and body marks. For details, see “5.11.3.4 Measurement, Comments and Body Marks.” 5.11.3.1 Adjusting Image Parameters In image viewing mode, you can adjust the following parameters: Image size...

  • Page 142: Cine Review

    iScape panoramic imaging is intended for use by well-trained ultrasound NOTE: operators or physicians. The operator must recognize image items that will produce a sub-optimal or unreliable image. The following items may produce a sub-optimal image. If the image quality does not meet the following criteria, you must delete the image and repeat image acquisition.

  • Page 143: Enter/Exit

    4. Adjust the image parameters to obtain the optimized image and necessary information. 5. Adjust the ROI on the frozen image if necessary. 6. Save the image or review the image if necessary. 7. Perform measurement or add comments/body marks to the image if necessary. 8.

  • Page 144: Cine Review

    Invert Description To invert the E color bar and therefore invert the colors of benign and malignant tissue. Tap [Invert] on the touch screen. Operation Single E Description To switch between the B+E dual window and the single E window. E represents the Elastography image.

  • Page 145: Basic Procedures For Contrast Imaging

    5.13.1 Basic Procedures for Contrast Imaging To perform a successful contrast imaging, you should start with an optimized 2D image and have the target region in mind. To perform a contrast imaging: 1. Select an appropriate probe, and perform 2D imaging to obtain the target image, and then fix the probe.
  • Page 146 Type Parameter Description In real time mode, the time displayed is the elapsed time. Timing (If timer is “ON”) In freeze mode, the timer stops working, the elapsed time is displayed. 5.13.1.2 Image Optimization Parameters in Contrast mode are similar to those in B mode; please refer to B chapter for details, special Contrast imaging parameters are introduced in the following.

  • Page 147: Measurement, Comment And Body Mark

    Image position The contrast appears on the left of the screen if the contrast image position is enabled. 5.13.1.6 Mix Map This function is to mix the contrast image with the tissue image, so that interested contrast regions can be located. Tap [Mix] to select different mixing mode, and select different maps by knobs under [Gray Map]/[Tint Map] on the touch screen.

  • Page 149: Display & Cine Review

    Display & Cine Review Image Display 6.1.1 Splitting Display The system supports dual-split and quad-split display format. However, only one window is active at one time. Dual-split: press <Dual> key on the control panel to enter the dual-split mode, and using <Dual> key to switch between the two images; press <B> on the control panel to exit.

  • Page 150: Pan

    6.2.2 Procedures: 1. Press <Zoom> knob to directly enter the pan zooming status. Image-in-image is displayed. 2. Rotate <Zoom> knob to change the magnification factor. The system provides a zoom range of 0.8-10. 3. Exit pan zooming: press <Zoom> knob. 6.2.3 iZoom (Full-screen Zooming) Function: to magnify the image in full screen.

  • Page 151: Imaging Display Format Switching When Frozen

    6.3.2 Imaging Display Format Switching When Frozen Image display format switching in freeze mode follows the following principles: 2D＋M/PW (Press <Freeze> in 2D＋M/PW scanning mode) If the imaging mode before frozen is 2D (frozen) +M/PW (real time) or 2D (real time) +M/PW (frozen), then in freeze mode, you can switch between 2D (frozen) +PW (activated) or 2D (activated) +PW (frozen) by pressing <Update>...

  • Page 152: Entering/ Exiting Cine Review

    6.4.1 Entering/ Exiting Cine Review To enter cine review: Enter "[Setup] [System Preset] [Image Preset]" and set "Status after Freeze" to be "Cine". Press <Freeze> to freeze the image and enter the cine status, the <Cine> key indicator lights on automatically. Open cine files in thumbnail, iStation or Review, the system enters automatic cine review status.

  • Page 153: Cine Review In M Or D Mode

    this region; but the manual cine review can be performed beyond this region. When the cine file is saved, only the images within this region are saved. a) Set first frame: Manually review the images until the frame which you want to set it as start point, and then click [Set First Frame] to set it as the start point.

  • Page 154: Image Compare

    The frame mark on the time mark of M/PW image indicates the corresponding 2D image. In the statuses rather than the dual live, you can only review images in the currently active window. Image Compare 6.5.1 Cine Compare 1. Press <Review> to enter Review screen, press <Ctrl>+<Set> to select files to be compared.

  • Page 155: Cine Memory

    Live capture can be divided into 2 kinds: retrospective and prospective. Retrospective saving is to save the specified images before the current moment; to save the images stored in the cine memory to the system hard disk. Prospective saving is to save the specified images later than the current moment; to save the images to both the cine memory and the system hard disk.

  • Page 156: Cine Settings

    Cine Settings You can set the cine length via “[Setup] [System Preset] [General]”. The items are shown as follows: Non-live storage (the items are shown as follows) For Time without ECG(s), 1~60s. For Time (with ECG Loop): the unit is Beat, 1~16. Live capture (the setting items are shown as follows) Type: Retrospective, Prospective.

  • Page 157: Ecg

    The system can be configured with the optional physio module. In that case, the ECG signal is displayed on the image, and can be reviewed simultaneously with the image. When the system is connected with the ECG module: The Physio menu is available. The ECG icon including heart-shaped symbol and heart rate symbol are displayed on the screen.

  • Page 158: Ecg Operation Basic Procedures

    ECG Operation Basic Procedures 1. Connect the ECG device. Turn off the power supply of the system, and connect the ECG cable to the port in the system (For connection, please refer to “2.9 Physiological-signal Panel”) Turn on the power supply of the system Place the ECG electrodes on the patient’s body (as shown in the following figure) Right Right...

  • Page 159: Parameter Description

    Parameter Description Parameter Description Function: to control the display of ECG trace in live status. Value: On/Off, On is to display the trace, while Off is to hide the trace. In scanning mode, turn off ECG display will stop ECG signal acquisition. In freeze mode, this is used to show or hide the ECG trace.

  • Page 161: Measurement

    Measurement You can perform measurements on a zoomed image, cine reviewing image, real-time image, or frozen image. For measurements details, please refer to the [Advanced Volume]. 1. Be sure to measure areas of interest from the most WARNING: optimal image plane to avoid misdiagnosis from inaccurate measurement values.

  • Page 162: General Measurements

    General Measurements 8.2.1 2D General Measurements 2D general measurements refer to general measurements on images of 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. The distance between probe surface and the probing point along Depth ultrasound beam.

  • Page 163: M General Measurements

    8.2.2 M General Measurements M general measurements refer to general measurements on M mode, Color M mode, Free Xros M mode images. The measurements listed below can be performed: Measurement Function Tools Distance The vertical distance between two points. Time The time interval between any two points.

  • Page 164: Measurement Accuracy

    Abdomen measurements - Used for measurements of abdominal organs (liver, gall bladder, pancreas and kidney, etc.) and large abdominal vessels. OB measurements - Used for measurements of fetal growth indexes (including EFW) as well as GA and EDD calculations. The fetus can be evaluated through growth graph analysis and fetal biophysical profile.
  • Page 165 Parameter Value Range Error Velocity (CW 10-300cm/s (for P4- When angle≤60º, ≤5%. (not including pencil mode) probe) Table 4 Doppler Velocity Measurements Parameter Value Range Velocity (PW mode) Min.≤0.10cm/s, Max.≥462cm/s Velocity (CW mode) Min.≤0.06cm/s, Max.≥3080m/s Velocity (Color mode) Min.≤1cm/s, Max..≥239.5cm/s Within the selected field range, the measurement accuracy is ensured within NOTE: the range mentioned above.

  • Page 167: Comments And Body Marks

    Comments and Body Marks Comments (Annotations) 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 image, cine review image, real-time image, frozen image. You can type the character as comments;...

  • Page 168: Touch Screen Display In Comments

    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 169: Adding Comments

    Tracing (1) In comment status, tap [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.

  • Page 170: Moving Comments

    b) Rotate the multifunctional knob to view the comments one by one c) Press the knob again to add the selected item onto the image (comment added in an editable state) d) Rotate the multifunctional knob to search for the next part, and press the knob again to add the second part of the combined comment.

  • Page 171: Modifying (Editing) Comments

    9.1.5 Modifying (Editing) Comments Modifying (Editing) characters 1. In comment status, move the cursor over the comments to be modified. Press the alphabetic keys to enter the character at the cursor position. Or, double press <Set> to enter comment editing status and use the direction keys to move the cursor to the desired location to insert/delete characters.

  • Page 172: Comment Setting

    9.1.7 Comment Setting Comment Setting Enter the “[Setup] [System] [Application]” screen to perform the following setting: You can preset whether to clear the comments when unfreezing the image or changing the probe/exam. Set whether body marks are erased when the image is unfrozen. Body Marks The Body Mark feature is used for indicating the exam position of the patient as well as probe position and orientation.

  • Page 173: Moving Body Marks

    Rotate the <Angle/Steer> knob to adjust the orientation. Tap [Save Probe] to save the current probe mark direction and position for the body mark. 4. Press <Set> to confirm the position and orientation of the probe marker and exit body mark mode. 9.2.3 Moving Body Marks You can move the body mark graphics to any desired position within the image area.

  • Page 175: Patient Data Management

    2. The system patient database space is limited, please back up or clear patient data in time. 3. Mindray is not responsible for lost data if you DO NOT follow suggested backup procedures. 10.1 Patient Information Management 10.1.1 Enter Patient Information The general patient information and exam information are entered through the Patient Info screen, for details;...

  • Page 176: Image File Management

    10.2 Image File Management You can store the image files either in the patient database in the system, or to external memory devices. For a saved image, you can perform operations like image reviewing, analyzing and demonstration (iVision). 10.2.1 Memory Media System supported memory media including: System hard disk USB memory devices: USB flash drive, removable USB hard disk...

  • Page 177: Image Storage Preset

    10.2.3 Image Storage Preset Set image size You can set the image size via “[Setup] [System Preset] [General]”. The items are shown as follows: Set cine saving length For details, please refer to “6.4 Cine Review”. Storage image/clip linked operation You can set to send image/clip to other media when you save/clip to hard disk (10.2.4 Quickly Saving Images to the System), the setting path is: [Setup] [System...

  • Page 178: Quickly Saving Full Screen Image To The System

    10.2.5 Quickly Saving Full Screen Image to the System 1. Set the user-defined key through the path: [Setup] [System Preset] [Key Config]. Select a key in the Key Function field on the left side and select “Save Full Screen Image to hard drive” in the Output page of Function field on the right side. 2.
  • Page 179 To exit Review: Click [Exit] on the Review screen Press <Esc> Basic operations Select an exam from the “Exam History” drop-down list. The function buttons are described as follows: Exam History: You can select one certain exam from the exam directory to review the images. If entered from iStation, the screen displays the record(s) selected in the iStation.

  • Page 180: Ivision

    [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 (ended already) and enter the image scanning screen. [iStation]: click to enter the iStation screen. [Exit]: click to exit the Review status, and return to the main screen.
  • Page 181 Demonstration item The demonstration items are the image files in the formats that the system supports. You can add the exam data in patient database (D:\PatientData) or system supported image files and folders to demonstration item list. For files and folders in demonstration list, the images in the directory and subdirectory are played one by one, and the system will automatically jump over the files that can’t be opened.

  • Page 182: Sending Image File

    Option of Demo You can choose whether to repeat the demonstration or exit after a demonstration is completed. 10.2.9 Sending Image File On the image screen, select a stored image thumbnail (press <Shift> to select more than one at the same time), click (Send To) on the lower right corner of the screen, the image can be sent to the external devices.

  • Page 183: Report Management

    10.3 Report Management Report storage The exam reports are stored under the directory of the exam of the patient. Importing, exporting and sending a report In the iStation screen, select patient data, click [Restore Exam] or [Backup Exam] to import or export patient information, images and reports from or to an external memory device or network storage server.

  • Page 184: Patient Data Management (Istation)

    For details on report relevant operations, please refer to [Advanced Volume]. 10.4 Patient Data Management (iStation) The patient data include 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 <iStation>...

  • Page 185: Searching A Patient

    10.4.2 Searching a Patient 1. Select the data source. 2. Set search conditions of Name, ID, DOB, Exam Date in the "Item" drop-down list. 3. Enter the keyword in accordance with the “Item” selected, and the system searches and displays the results in the patient list. 4.
  • Page 186 Send Exam The system supports to send data to external memory devices or print. Select the patient record, click [Send Exam] in the menu to send exam data or images of the selected record. Send patient exam data to USB devices, DVD-RW/DVD+RW drive. Send images to USB devices, disc, DICOM storage server, DICOM printer, video printer, text/ graph printer.

  • Page 187: Istorage

    Click [Empty Recycle Bin] to empty the recycle bin and all items can never be restored again. (2) Click [Exit] to exit Recycle Bin screen. 10.5 iStorage iStorage is used to save image files and measurement reports to the remote PC server. Open “[Setup] [Network Preset] [iStorage]”...

  • Page 188: Report Print

    10.6.3 Report Print Both report and image can be printed on a graph / text printer. 1. Press <Report> to enter the report dialog box. 2. Select [Print] to print the report. Please refer to the accompanying manuals of the printers for more details. 10.7 Backup Files through DVD Drive The system supports CD-R/RW, DVD±RW drive to write data in CD/DVD and to read data from CD/DVD in PC.

  • Page 189: Patient Task Management

    10.8 Patient Task Management Click at the lower right corner of the screen to pop up the following dialogue box: The system supports four types of task management: Storage Task: displays the DICOM storage task. DICOM Print Task: displays the DICOM print task. Media Storage Task: DICOM media storage task(including disc and USB devices) Backup task (system-relevant format): select the exam to be backed up in...

  • Page 190: Administration

    When the task management icon displays as , it means no task is undergoing or failed. DICOM Service Setting In the Storage Task and DICOM Print Task page, click [Service Setting] to enter the DICOM service setting screen. For details, please refer to DICOM chapter. Troubleshooting If any serious error occurred like network disconnection or operation timeout, the system can try to reconnect the network.

  • Page 191: Adding/Deleting A User

    (2) Select the user name in the drop-down list of User Name. (3) Enter password and click [Login]. To change user: (1) To log out the current user and change to another user, click at the lower right corner of the screen to pop up the following dialogue box: (2) Click [Change User] to pop up the Login dialogue box.

  • Page 192: Modify Password

    6. Click [OK] to confirm the setting and exit the dialogue box, then the new user will appear on the User List. Delete a User Premise: you must log on the system as the system administrator. If not, you will be required to enter administrator name and password before the setting.

  • Page 193: Dicom

    DICOM Before using DICOM, please read the electronic file DICOM CONFORMANCE NOTE: STATEMENT along with the device. This chapter is confined to the preset, connection verification and DICOM services of the DICOM- configured ultrasound machine, not including SCP configurations like PACS/ RIS/ HIS. The DICOM package is optional, so the description here is only applicable for the system configured with the DICOM package.

  • Page 194: Dicom Local Preset

    11.1.2 DICOM Local Preset 1. Enter the DICOM local preset screen through the path: [Setup] [DICOM Preset]. 2. Enter AE Title, Port, and PDU according to the actual situation, and then click [Save] to exit the screen, setting items are introduced in the following. Name Description AE Title...

  • Page 195: Service Preset

    (2) Click [Add] to add the server to the device list, and its name and address are displayed in the list. Tips: AE Title should be the same with the SCU AE Title preset in the server (PACS/RIS/HIS), for example, if the AE Title of the server preset in the storage server is Storage, and the AE Title of the accepted SCU is preset as Machine, then in the figure above, the AE Title of Local should be Machine, and the AE Title of storage server should be Storage.
  • Page 196 DICOM storage preset items are described as follows: Name Description After you set the server (s) in DICOM Preset screen, the Device name (s) will appear in the drop-down list, select the name of the storage server. Service Name Default is xxx-Storage, user-changeable. Application Entity title, here, it should be consistent with that AE Title of the storage server.
  • Page 197 11.1.3.2 Print Service Preset 1. On DICOM Service screen, click [Print] page tab to enter the Print page. 2. Select device, enter the right AE Title, port, etc. 3. Click [Add] to add the service to the Service List. DICOM print preset items are described as follows: Name Description After you set the server (s) in DICOM Preset screen, the name...
  • Page 198 Name Description Film Orientation Select between LANDSCAPE and PORTRAIT. Priority Specify printing task priority among HIGH, MED and LOW. Select film size among the selections listed in the drop down Film Size list. Specify quantity of printed files, e.g. STANDARD\2, 3 indicates Display Format 6 images are printed for each page.
  • Page 199 11.1.3.3 DICOM Worklist Preset 1. On DICOM Service screen, click [Worklist] page tab to enter the Worklist page. 2. Select device, enter the right AE Title, port, etc. 3. Click [Add] to add the service to the Service List. DICOM Worklist service parameters are similar to those described in DICOM Storage Preset, please refer to “11.1.3.1 Storage Service Preset”...

  • Page 200: Verify Connectivity

    11.2 Verify Connectivity If you want to verify connectivity (it is not a must-do operation), you can click [Verify] button on Storage, Print, Worklist, MPPS, Storage Commitment, and Query/Retrieve pages respectively. If the verification succeeded, the system prompts “xxx Verify Succeed”. Otherwise, it prompts “xxx Verify Failed”.
  • Page 201 (3) Click to select “DICOM” in the Target box on the left side, and then select the DICOM storage server in the Storage Server box on the right side. (4) Click [OK] to start the sending. (5) Tap [Send To] on the touch screen. To send images by shortcut key You can save single frame image or multi-frame images to DICOM server while saving to hard drive by shortcut key.

  • Page 202: Dicom Print

    To send image for storage after an exam ends (1) Open “[Setup] (F10) [System Preset] [General]”, and then check in the Exam Setup area. (2) Set a default storage server. a) Enter the DICOM Service Preset screen via “[Setup] (F10) [DICOM Preset] [Set DICOM Service]”.

  • Page 203: Dicom Worklist

    b) Click [Print] to open the Print page. c) Select a Print server in the Service List and click [Default]; you can see “Y” is marked in the Default column. d) Click [Exit] to exit the page and return to Setup menu, then click [Save] on the Setup menu to make the preset to take effect.

  • Page 204: Mpps

    (4) Select the desired patient record in the displayed patient list: a) Select the desired patient and click [Start Exam], the patient information is imported into the system and then an exam is started. b) Click [Transfer], the patient information is imported into the [Patient Info] screen. After you edited the patient information in the Patient Info screen, select [OK] to start a new exam.

  • Page 205: Query/Retrieve

    To send storage commitment after an exam ends (1) Open [Setup] (F10) [System Preset] [General], and then check in the Extam Setup area. (2) Set the default storage server and storage commitment server. a) Enter the DICOM Service Preset screen via “[Setup] (F10) [DICOM Preset] [Set DICOM Service]”.

  • Page 206: Dicom Media Storage

    3. Select the server in “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 207: Structured Report

    There should be no DICOMDIR/DCMIMG/IHE_PDI files in the external storage media of the same name with the one being backed up; otherwise, the backup can’t be preceded. Besides, make sure there is enough storage space; otherwise, the backup may fail due to space shortage. Data Restore After DICOM format data are saved to external media, you can restore the data to the ultrasound system.

  • Page 209: Setup

    When the preset data is changed, be sure to save the preset CAUTION: data according to the methods described in this chapter. Mindray is not responsible for the loss of the preset data. To enter Setup: Press the <F10> key on the keyboard to enter setup menu.

  • Page 210: System Preset

    12.1 System Preset The system enters System Preset screen automatically 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, General system dormancy, display, operation log and so on.

  • Page 211: Region

    12.1.1 Region Open the Region page via [Setup] [System Preset] [Region]. Item Description Hospital To set the hospital relevant information like name, address, Information telephone and so on. Language To select a language for the system. Time Zone To select the time zone. Time Format To select the time format.

  • Page 212: General

    12.1.2 General Open the page via [Setup] [System Preset] [General]. Type Item Description Info displays in To select if 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 213: Image Preset

    Type Item Description Brightness/Contrast To set if use the factory setting values of brightness Load Factory and contrast. To select a system dormancy type. After screen saver function is enabled, click [Browse] to select the figure used for screen saver, Screen and click [Preview] to see the effect.

  • Page 214: Application

    Type Item Description Cine Memory To set the cine memory splitting type. To set if to display the iScape ruler on iScape iScape Ruler Display imaging mode. 12.1.4 Application Open the page via [Setup] [System Preset] [Application].Through the page, you can set the measure ruler and relevant information.

  • Page 215: Admin

    Footswitch function setting You can assign a function to the left/mid/right key of footswitch. Setting method is similar to key function setting, please refer to the above steps for setting. Other Settings Item Description Key Brightness To set the brightness for the keys. Key Volume To set the key volume, 0 means no sound.

  • Page 216: Exam Preset

    12.2 Exam Preset Open “[Setup] [Exam Preset]” to enter the following screen. You can assign available exam modes for probes. 1. To select a probe, move the cursor onto the Probe column, and select the probe model through the drop-down list. 2.

  • Page 217: Print Preset

    12.4 Print Preset The settings of a printer include print service and print driver. For details about print service and printer installation, please refer to “3.6.3 Graph /Text printer” chapter. Print Service Setting Add Service: click to begin print service adding. Remove Service: click to delete the selected print service.

  • Page 218: Network Preset

    12.5 Network Preset 12.5.1 Local TCP/IP DO Not edit IP address in Network Preset page as the network task is executed, NOTE otherwise it fails. View if there is any undergoing task in task manager of the system. This page is used for setting network property of the ultrasound system, which is also applicable for DICOM function.
  • Page 219 Note: The IP address of the system should not be occupied by other devices in the LAN, otherwise DICOM function will fail. Wireless LAN It is prohibited to use the wireless LAN function in WARNING airplane, as it may violate the relevant provisions in the aviation regulations.

  • Page 220: Istorage

    The data display in the [Network SSID] and [Security] control. If the hotspot wanted is not in the list, you can input the data manually in the controls and click [Connect]. When connecting an encrypted network, enter the password in the box on the left first.

  • Page 221: Medtouch/Medsight Preset

    MedTouch/MedSight manual for details. 12.6 Maintenance In the Setup menu, select [Maintenance] enter the screen. If you require other maintenance functions, please contact Mindray Customer Service Department or sales representative. 12.6.1 Option The system enters Option page after you enter the Maintenance screen. In Option list, the system lists out all the system supported options and the installation status (Disabled or Installed).

  • Page 222: Other Settings

    For functions that are not configured, you can use the function for free for 90 days. Click to select the function(s) and click [Trial]. Tips: every trial option can be used only once. Please contact Mindray Customer Service Department or sales representative for details. 12.6.2 Other Settings Type...

  • Page 223: Probes And Biopsy

    Probes and Biopsy Note: For details of storage time and condition for disinfected probes or sterilized probes and brackets, please refer to Technical standard for Disinfection of Medical and Health Structures. 13.1 Probe The system supports the following probes: Probe Model Illustration Probe Model Illustration...
  • Page 224 Probe Model Illustration Probe Model Illustration   CB10-4E L12-3E D7-2E L14-6NE V11-3 P4-2 CW5s V10-4 13-2 Probes and Biopsy...

  • Page 225: Name And Function Of Each Part Of The Probe

    13.1.1 Name and Function of Each Part of the Probe The basic structures and corresponding functions of probes are basically the same; the following will take probe 3C5A as an example. <2> <1> <3> <4> <5> Name Function <1> Probe head It converts the electrical signal into ultrasound signal, making the sound beams focus in the given direction;...

  • Page 226: Procedures For Operating

    13.1.2 Orientation of the Ultrasound Image and the Probe Head The orientation of the ultrasound image and the probe are shown as below. The “Mark” side of the ultrasound image on the monitor corresponds to the mark side of the probe. Check the orientation before the examination (Here takes linear probe as an example).
  • Page 227 Procedures for operating (with biopsy function): 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...
  • Page 228 Procedures for operating (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 229: Wearing The Probe Sheath

    Disinfect the probe and sterilize the needle-guided bracket WARNING: before and after an ultrasound-guided biopsy procedure is performed. Failure to do so may cause the probe and the needle-guided bracket become source of infection. 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 examination.

  • Page 230: Probes Cleaning And Disinfection

    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.
  • Page 231 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.Do not soak the transducer connector or the cable near it...

  • Page 232: Storage And Transportation

    Relative humidity: 30% ～ 95% (no condensation) Atmospheric pressure:700 hPa ～ 1060 hPa 3. When the probe is sent to MINDRAY Customer Service Department or sales representative for repair, be sure to disinfect it and keep it in the carrying case to prevent infection.

  • Page 233: Biopsy Guide

    If an abnormality is found on the needle-guided bracket, immediately stop using it and contact MINDRAY Customer Service Department or sales representative. DO NOT use a needle-guided bracket when scanning is performed.
  • Page 234 10. Adjust the needle mark before the biopsy procedure is performed. When performing biopsy procedures, use only sterile ultrasound gel that is certified to be safe. And manage the ultrasound gel properly to ensure that it does not become a source of infection. 12.

  • Page 235: Basic Procedures For Biopsy Guiding

    Probe Needle Target Ultrasound beam Dispersion of the ultrasound beam The biopsy needle may not have actually entered the target object even though it appears to have done so on the image. To avoid this problem, note points below: Do not rely only on the needle tip on the image. Pay careful attention to that, when the biopsy needle comes into the target object or contacts with it, the object should shift slightly.

  • Page 236: Needle-Guided Brackets

    A needle-guided bracket is available for purchase as an optional accessory; it is used in combination with the probe. Some of the probes have matched needle-guided bracket and needles. To order needle-guided brackets, contact MINDRAY Customer Service Department or sales representative.
  • Page 237 NGB-005 Needle-guided bracket Probe NGB-006 Metal/needle detachable needle-guided bracket: Probes and Biopsy 13-15...
  • Page 238 Name Description <1> Support of needle- Used for installing the needle-guided bracket on the guided bracket probe. <2> Groove and tab of Respectively matched with the tab and groove of the the needle-guided probe. bracket <3> Angle adjusting There are 3 types of angles available to be adjusted. base <4>...
  • Page 239 Plastic/needle detachable needle-guided bracket: Name Description Support of needle- Used for installing the needle-guided bracket on the <1> guided bracket probe. Used for determining the angle of the biopsy; there are <2> Angle block three specifications of blocks of angle. Used for installing biopsy needle;...
  • Page 240 NGB-007 Metal needle-guided bracket: No. Name Description Support of needle-guided Used for installing the needle-guided bracket on the bracket probe. Groove and tab of the Respectively matches with the tab and groove of the needle-guided bracket probe Angle adjusting base There are 3 types of angles available to be adjusted.
  • Page 241 Plastic needle-guided bracket: Name Description Support of needle-guided Used for installing the needle-guided bracket on the <1> bracket probe. Used for determining the angle of the biopsy; there <2> Angle block are three specifications of blocks of angle. Used for installing biopsy needle; there are five <3>...
  • Page 242 NGB-011 Needle guide Clamping knob of the needle guide Locating Clamp Needle guide hole Locating groove Needle guide rack Grip knob Needle-guided bracket Probe NGB-016 Name Description Clamp of needle-guided Used for installing the needle-guided bracket on the <1> bracket probe.
  • Page 243 Be sure to perform inspections before and after use of the needle-guided bracket. If an abnormality is found on the needle-guided bracket, immediately stop using it and contact MINDRAY Customer Service Department or sales representative. 1. Sterilize the needle-guided bracket before and after use.
  • Page 244 (3) When the retaining clamp is turned to the right position, the locking nut will lock the retaining clamp and the needle-guided bracket is then mounted to the right position. NGB-005 (1) Inosculate the locating groove on the clamp with the two raised edges on the probe head and aligning the locating pit of the clamp to the convex point on the probe head.
  • Page 245 (2) Hold the probe by one hand, select proper needle-guided bracket, and hold it with the other hand. Align the narrow end tab of the needle-guided bracket with the groove of the probe, then push the needle-guided bracket forward, making the tabs and the grooves of the needle-guided bracket to match with the grooves and tabs of the probe.
  • Page 246 (5) Screw the nut of the block to secure the block. (6) Insert a biopsy needle with the same specification as that of the guiding block into the hole of the guiding block. Plastic needle-guided bracket: (1) Put on the sterile probe sheath. (2) Hold the probe by one hand, select the proper needle-guided bracket, and hold it with the other hand.
  • Page 247 NGB-011 (1) Inosculate the locating groove on the clamp with the two raised edges on the probe head and align the locating pit of the clamp to the convex point on the probe head. (2) Turn the grip knob at the tail of the needle-guided bracket tightly. NGB-016 (1) Put on the probe sheath.

  • Page 248: Verifying The Biopsy Guide Line

    Ensure that all guide parts are seated properly prior to CAUTION: performing a biopsy. 13.2.4 Verifying the Biopsy Guide Line Adjusting the needle mark is necessary before every biopsy procedure. 1. Confirm that the needle-guided bracket has been installed securely in the correct position.

  • Page 249: Removing The Needle-Guided Bracket

    Adjust the guide line position Rotate the knob under [Position] on the touch screen to change the position of the guide line. Adjust the angle Rotate the knob under [Angle] on the touch screen to change the guide line angle. Save the verified settings After the position and angle of the guide line are adjusted, tap [Save] and the system saves the current guide line settings.
  • Page 250 (4) Hold the transducer with one hand, and then separate the needle-guided bracket from the transducer. Plastic needle-guided bracket: (1) Remove the guiding block slightly along the direction of the needle’s tail. (2) Separate the residual part of the needle-guide bracket and the probe from the needle.

  • Page 251: Clean And Sterilize The Needle-Guided Bracket

    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 to sterilize the needle-guided bracket. 3. Follow local regulations when selecting and using the disinfectant.
  • Page 252 Glutaraldehyde-based sterilant (only applicable for plastic needle-guided bracket): Chemical Trade name Procedures name Please refer to the instructions provided by the Cidex Activated manufacturer of the solution for details. Glutaraldehyde Glutaraldehyde Soak the transducer into the activated solution for (2.2-2.7%) Solution 10 hours ( ℃).

  • Page 253: Storage And Transportation

    Between examinations, keep the needle-guided bracket in a sterile environment. When 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 254 There is a mark icon of “×” located on the middle line which can be moved up and down along the line by rolling the track ball. To use the Middle Line function of the ultrasound system: a) Use the trackball to change the mark position and by adjusting lithotripsy machine tools or patient posture to locate the stone center at the mark.

  • Page 255: Acoustic Output

    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 operators of the device, pertaining to acoustic output and how to control patient exposure through use of the ALARA (as low as reasonably achievable) principle.

  • Page 256: Mi/Ti Explanation

    Users must take responsibility for the safety of patients and utilize ultrasound deliberately. Deliberate use of ultrasound means that output power of ultrasound must be selected based on ALARA. Additional information regarding the concept of ALARA and the possible bioeffects of Ultrasound is available in a document from the AIUM (American Institute of Ultrasound Medicine) title “Medical Ultrasound Safety”.

  • Page 257: Mi/Ti Display

    TIB: Thermal index for applications, such as fetal (second and third trimester) or neonatal cephalic (through the fontanel), in which the ultrasound beam passes through soft tissue and a focal region is in the immediate vicinity of bone. TIC: Thermal index for applications, such as pediatric and adult cranial applications, in which the ultrasound beam passes through bone near the beam entrance into the body.

  • Page 258: Acoustic Power Control

    NOTE: This system automatically returns to the settings whenever changes are made to the values (when you turn on the power, switch between probes, press <End Exam>, or select Return in the Setup menu).In the factory default settings, the Acoustic Output is limited below 100%. Following the ALARA restriction, you are allowed to increase the acoustic power under FDA 510(k) Guidance-Track3 limits and to set it in the image preset screen.

  • Page 259: Limits Of Acoustic Output

    intensity of ultrasound will be reduced by 0.3 dB/MHz for every centimeter of travel from the transducer. This can be expressed by the following equation: × × × － atten water Where I is the attenuated intensity, I is the intensity measured in a water tank (at atten water distance z), fc is the center frequency of the ultrasound wave (as measured in water),...

  • Page 260: Measurement Uncertainty

    Similarly, the Mechanical Index was derived to indicate the relative possibility of mechanical (cavitation) effects. The MI is based on the derated peak-rarefactional pressure and the center frequency of the ultrasound wave. The actual peak-rarefactional pressure is affected by the actual attenuation caused by tissue in the path between the transducer and the focal point.

  • Page 261: Emc Guidance And Manufacturer's Declaration

    EMC Guidance and Manufacturer’s Declaration The system complies with the EMC standard IEC 60601-1-2: 2007. The use of unapproved accessories may diminish system WARNING: performance. Use of components, accessories, probes, and cables other than those specified may result in increased emission or decreased immunity of system.
  • Page 262 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－ EMISSIONS TEST...
  • Page 263 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 264 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 COMPLIANCE...
  • Page 265 Field strengths from fixed transmitters, such as base stations for radio (cellular /cordless) telephones and land mobile radios, amateur radio, AM and FM radio broadcast and TV broadcast cannot be predicted theoretically with accuracy. To assess the electromagnetic environment due to fixed RF transmitters, an electromagnetic site survey should be considered.
  • Page 266 TABLE 4 RECOMMENDED SEPARATION DISTANCES BETWEEN PORTABLE AND MOBILE RF COMMUNICATION DEVICE AND 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 267 and can radiate radio frequency energy and, if not installed and used in accordance with the instructions, may cause harmful interference to radio communications. However, there is no guarantee that interference will not occur in a particular installation. If this equipment does cause harmful interference to radio or television reception, which can be determined by turning the equipment off and on, the user is encouraged to try to correct the interference by one or more of the following measures:...

  • Page 269: System Maintenance

    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 Mindray Customer Service Department or sales representative. 1. Only an authorized Mindray service engineer can WARNING: perform maintenance not specified in this operator’s...
  • Page 270 Cleaning the probe Tools: mild soapy water , dry soft cloth, soft brush Method: Wipe out the dust attached to surface of probe head, connector and cable with dry soft cloth. Use soft brush to brush the dust inside probe connector gently. Remained stain or dust attached to surface of cable or surface of connector should be washed out by cloth with a little soapy water, and then air-dry.
  • Page 271 NOTE: Be sure to use soft brush to brush the dust attached to all the sockets or interfaces which can be seen (such as probe sockets, sockets or interfaces in IO panel and power supply panel),not the cloth with water. Cleaning the trackball Tools: paper, dry cloth, mild soapy water Method:...
  • Page 272 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 273: Clean The Peripherals

    Please clean all dust-proof covers of the system periodically CAUTION: (1 time per month); otherwise, system damage may result. Cleaning times can be increased when the system is used in the open air or somewhere dust is more. 16.1.2 Clean the Peripherals Do the cleaning maintenance according to your actual peripheral configuration;...

  • Page 274: Backup Of The System Hard Drive

    Ultrasound system covers Probe appearance 16.1.6 Backup of the System Hard Drive To prevent deterioration or loss of data stored in the system hard drive, create a backup copy of the hard drive at regular intervals. 16-6 System Maintenance...

  • Page 275: Troubleshooting

    16.2 Troubleshooting If any persistent system malfunction is experienced, e.g. an onscreen error message, blank imaging screen, absent menus, please refer to the table below. If the failure can’t be eliminated, please contact Mindray Customer Service Department or sales representative. Failure...

  • Page 277: Appendix A Barcode Reader

    Appendix A Barcode Reader The product supports readers for logging data as patient ID: 1-D barcode reader (SYMBOL LS2208) . The laser transmitted by the reader is Class 2 laser. Class 2 laser adopts low power, visible LED. DO NOT stare into WARNING: beam because of unknown hazards of transient radiation provided by class 2 laser.
  • Page 278 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 279 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. I 2 of 5 symbols setting: Select this option to decode only I 2 of 5 symbols containing a selected length.
  • Page 280 A.1.4 Scanning in Hand-Held Mode 1. Ensure all connections are secure. 2. Aim the reader at the barcode. Press the trigger. Tips: Ensure the scan line crosses every bar and space of the symbol, see the figure below. A-4 Barcode Reader...
  • Page 281 3. Upon successful decode, the reader beeps and the LED turns green. Tips: Do not hold the reader directly over the barcode. Laser light reflecting directly back into the reader from the barcode is known as specular reflection. This specular reflection can make decoding difficult.
  • Page 282 A.1.5 Scanning in Hands-Free Mode 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. 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 283 Scanning in Hands-Free Mode When the reader is seated in the stand’s “cup”, the reader’s built-in sensor places the reader in hands-free mode. When you remove the reader from the stand it operates in its normal hand-held mode. Parameter Defaults Refer to the following table for parameter defaults of LS2208.
  • Page 284 Parameter Defaults Code 39 Full ASCII Conversion Disable Buffer Code 39 Disable Code 93 Code 93 Enable Set Length(s) for Code 93 4 to 55 Interleaved 2 of 5 (ITF) Interleaved 2 of 5 (ITF) Enable Enable Set Lengths for I 2 of 5 I 2 of 5 Check Digit Verification Disable Transmit I 2 of 5 Check Digit...

  • Page 285: Appendix B Electrical Safety Inspection

    Appendix B 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 286 Device Enclosure and Accessories B.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 287 normal polarity( Normal Condition), reverse polarity( Normal Condition), normal polarity with open neutral(Single Fault Condition), reverse polarity with open neutral(Single Fault Condition) LIMITS For UL60601-1, 300 μA in Normal Condition 1000 μA in Single Fault Condition For IEC60601-1, 500 μA in Normal Condition 1000 μA in Single Fault Condition Enclosure Leakage Test The following outlet conditions apply when performing the Enclosure Leakage test.
  • Page 288 normal polarity( Normal Condition); reverse polarity( Normal Condition), normal polarity with open neutral(Single Fault Condition); reverse polarity with open neutral(Single Fault Condition). normal polarity with open earth(Single Fault Condition); reverse polarity with open earth(Single Fault Condition). LIMITS For CF applied parts 10μA in Normal Condition 50μA in Single Fault Condition For BF...
  • Page 289 normal polarity( Normal Condition); reverse polarity( Normal Condition), normal polarity with open neutral(Single Fault Condition); reverse polarity with open neutral(Single Fault Condition). normal polarity with open earth(Single Fault Condition); reverse polarity with open earth(Single Fault Condition). LIMITS For CF applied parts, 10μA in Normal Condition 50μA in Single Fault Condition For BF...

  • Page 291: Appendix C Iscanhelper

    Appendix C 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 C.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. C.4.2 Help Information Area Help information area displays on the lower right corner of the screen, providing ultrasonic...
  • Page 293 C.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. Double-click <Set> to go to the single window of each of them. Double-click single window again to return to quad-window display.

  • Page 295: Appendix D Wireless Lan

    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 WARNING this may violate the relevant provisions in the aviation regulations.

  • Page 297: Appendix E Ultrasound Gel Warmer

    Appendix E 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 298 Name Function Bottom cover Specifications Power supply Voltage 12 V 12 W Power consumption Environmental conditions Operating conditions Storage and transportation conditions 0°C~40°C -20°C~55°C Ambient temperature 30%~85% (no condensation) 20%~95% (no condensation) Relative humidity 700hPa~1060hPa 700hPa~1060hPa Atmospheric pressure Function and Requirement The ultrasound gel warmer can heat the ultrasound gel to about 40±1°C at the most.
  • Page 299 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 300 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 301: Appendix F Batteries

    The battery is inside the machine; only technical WARNING: professionals from Mindray or engineers authorized by Mindray after training can perform battery installation and uninstallation. If you need to change the battery or buy a new one, please contact your sales representative.
  • Page 302 One Full Discharge / Charge Cycle: 1. Full discharge of the battery to let the system automatically shut down. 2. Charge the system to 100% FCC (full current capacity). 3. Discharge of the system for complete shutdown. Checking Battery Performance The battery performance may be degraded over time, so you need to check the battery performance periodically.
  • Page 303 P/N: 046-008904-00 (V4.0)

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