Mindray Z5 Operator's Manual
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Mindray Z5 Operator's Manual

Diagnostic ultrasound system
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Z5/Z5BW/Z5T/Z50/Z50BW/Z50T
Diagnostic Ultrasound System
Operator's Manual
[Basic Volume]

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Summary of Contents for Mindray Z5

  • Page 1 Z5/Z5BW/Z5T/Z50/Z50BW/Z50T 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 ........................III Operator’s Manuals ........................IV Manuals on Paper ........................
  • Page 4 Connecting / Disconnecting a Probe ................3-4 3.4.1 Connecting a Probe ....................3-4 3.4.2 Disconnecting a Probe ..................... 3-4 Connecting the Footswitch....................3-5 Connecting/ Removing a USB Storage Device ..............3-5 Graph / Text Printer ......................3-5 Digital Video Printer ......................3-9 Analog Video Printer ......................
  • Page 5 Anatomical M Mode (Free Xros M) ................5-20 5.10 TDI ..........................5-22 5.10.1 Basic Procedures for TDI Imaging ................5-22 5.10.2 TDI Image Parameters ................... 5-22 5.10.3 TDI Image Optimization..................5-22 5.11 iScape ........................... 5-23 5.11.1 Basic Procedures for iScape Imaging ..............5-23 5.11.2 Image Acquisition ....................
  • Page 6 8.1.5 Editing Comments ....................8-3 8.1.6 Deleting Comments ....................8-3 Body Mark ........................8-4 8.2.1 Body Mark Operation Procedures................8-4 8.2.2 Menu ........................8-4 8.2.3 Adding Body Marks ....................8-4 8.2.4 Moving Body Marks....................8-4 8.2.5 Deleting Body Marks ....................8-5 Patient Data Management..................
  • Page 7 11 Setup........................11-1 11.1 System Preset ........................ 11-1 11.1.1 Region ........................11-1 11.1.2 General ........................11-2 11.1.3 Image Preset ......................11-3 11.1.4 Application ......................11-4 11.1.5 OB .......................... 11-5 11.1.6 Key Config ......................11-5 11.1.7 Admin ........................11-6 11.2 Exam Preset........................11-6 11.3 Measure Preset ......................
  • Page 8 14.3 ALARA Principle (As Low As Reasonably Achievable) ........... 14-1 14.4 MI/TI Explanation ......................14-2 14.4.1 Basic Knowledge of MI and TI ................14-2 14.4.2 MI/TI Display ......................14-2 14.5 Acoustic Power Setting ....................14-3 14.6 Acoustic Power Control ....................14-3 14.7 Acoustic Output ......................

  • Page 9: 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 10: 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 11: 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 12: 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 13: Software Interfaces In This Manual

    Software Interfaces in this Manual Depending on the software version, preset settings and optional configuration, the actual interfaces may be different from those in this manual. Conventions In this manual, these conventions are used to describe the buttons on the control panel, the items in menu, buttons in dialog box and some basic operations: ...

  • Page 15: Safety Precautions

    Safety Precautions Safety Classification  According to the type of protection against electric shock: CLASS I EQUIPMENT  According to the degree of protection against electric shock: Type-BF applied part  According to the degree of protection against harmful ingress of water: Main unit: IPX0 Probes: IPX7 Footswitch: 971-SWNOM (2-pedal or 3-pedal) belongs to IP68...

  • Page 16: Meaning Of Signal Words

    Meaning of Signal Words DANGER WARNING ”, “ ”, “ ”, CAUTION In this manual, the signal words" “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 17: Safety Precautions

    You must use the power adapter provided with the system; otherwise electric shock may result. You can only adopt the power supply method provided by Mindray, other power supply modes (e.g. using a UPS) may result in electric shock. Connect the protective grounding conductor before turning ON the system.
  • Page 18 I / O ports. Electric shock may occur. 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.
  • Page 19 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 20 The system and its accessories are not disinfected or sterilized prior to delivery. The operator is responsible for the cleaning and disinfection of transducers 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 harmful to the human body, but also damage the accessory.
  • Page 21 If the system is used in a small room, the room temperature may rise. Please provide proper ventilation and free air exchange. 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 22 Please use the disinfection or sterilization solution that 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...
  • Page 23 The probe sheath contains natural rubber that can cause allergic reactions in some individuals. Do not use pre-lubricated condoms as a sheath. Lubricant may not be compatible with the transducer material and damage may result. Transducer damage may be caused by inappropriate gel, detergent or cleanser: Do not soak or saturate transducers with solutions containing...

  • Page 24: Latex Alert

    NOTE: 1. The following definition of the WEEE label applies to EU member states only: The use of this symbol indicates that this system should not be treated as household waste. By ensuring that this system is disposed of correctly, you will help prevent bringing potential negative consequences to the environment and human health.

  • Page 25: Warning Labels

    Warning Labels The warning labels are attached to this system in order to call your attention to potential hazards. The warning labels use the same signal words as those used in the operator’s manual. Read operator’s manual carefully before using the system. The name, pattern and meaning of each warning label are described as follows: No.

  • Page 27: System Overview

    System Overview Intended Use The Diagnostic Ultrasound System intended for use in Gynecology, Obstetrics, Abdominal, Cardiac, Pediatric, Vascular, Cephalic, Musculo-skeletal, Orthopedics, Nerve, Transcranial, Small organ and Urology exams. 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: Power Supply

    2.4.2 Power supply Voltage 100-240V～ Frequency 50/60Hz Input Power 1.5-0.8A Fuse 250V~ T3.15AH 2.4.3 Environmental Conditions Operational Conditions Storage and Transportation Conditions Ambient 0℃～40℃ -20℃～55℃ temperature Relative 30%～85% (no condensation) 30%～95% (no condensation) humidity Atmospheric 700hPa～1060hPa 700hPa～1060hPa pressure Do not use this system in the conditions other than those WARNING: specified.

  • Page 29: Probes Available

    2.5.2 Probes Available Probe Model Category Intended Use Region Applied Convex Gynecology, Obstetrics, Pediatric, 35C50EA Body surface Abdominal, Vascular, Urology Convex Gynecology, Urology, Transvaginal 65EC10EA Pediatric, Small organ, Musculo- Body surface 75L38EA Linear skeletal, Vascular, Orthopedics, Nerve Convex Abdominal, Pediatric, Cephalic, Body surface 65C15EA Transcranial, Cardiac...

  • Page 30: Options

    Needle-guided Biopsy Angle/ Probe Model Applicable Biopsy Needle Bracket Model Depth (± 1° ) NGB-005 65C15EA 12.7° , 24.2° 13G, 15G, 16G, 18G, 20G metal/needle un- detachable NGB-016 10L24EA 30° , 40° , 50° 14G, 16G, 18G, 20G, 22G Metal/needle detachable 2.5.3 Options...

  • Page 31: Peripherals Supported

    Item 4D module Network accessory package 2.5.4 Peripherals Supported Item Model Graph/ text printer HP OFFICEJET PRO 8100 MITSUBISHI P93W-Z Black and White Video Analog Printer SONY UP-X898MD USB port: 971-SWNOM (2-pedal) Footswitch USB port: 971-SWNOM (3-pedal) LAN Accessory LPA11 This system complies with IEC60601-1-2:2014, and its RF WARNING: emission meets the requirements of CISPR11 Class B.
  • Page 32  Left View  Rear View  Bottom View 2-6 System Overview...

  • Page 33: I/O Panel

    Name Function Probe holder Used to place the probe Display Displays the image and parameters during scanning Control Panel Refer to 2.6.3 Control Panel USB ports Used to connect USB devices Handle Used to carry the machine Interface panel used for inputting and outputting signals, refer I/O Panel to 2.6.1 I/O Panel.

  • Page 34: Power Supply Panel

    2.6.2 Power Supply Panel Name Function Power inlet AC power inlet Used for equipotential connection, that balances the Equipotential terminal protective earth potentials between the system and other electrical equipment. 2.6.3 Control Panel 2-8 System Overview...
  • Page 35 Name Description Function Off: when system is turned off; Power button Green: when system is turned on by pressing this button. Exit Press to exit the current status to the previous status. Press to display or hide the help information on Help screen.
  • Page 36 Name Description Function 3D/4D Press to enter or exit the 3D/4D status. Cursor Press to show the cursor. Trackball Roll the trackball to change the cursor position. Press to confirm an operation, same as the left- button of a mouse. Press to enter PW mode Color Press to enter Color mode...
  • Page 37 Name Description Function Indicator 3 Standby indicator Standby: blinking in orange Other status: light off HDD status indicator Read/ write: blinking in green Other status: light off Indicator 4 NOTE: DO NOT move the machine when the indicator blinking in green. Otherwise the HDD may be damaged by sudden shake.

  • Page 38: Symbols

    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 Dangerous voltage Equipotentiality Power button Network port USB ports Video output Remote control port VGA signal output AC (Alternating current) Battery Status Indicator Standby indicator...
  • Page 39 Symbol Description This product is provided with a CE marking in accordance with the regulations stated in Council Directive 93/42/EEC concerning Medical Devices as amended by 2007/47/EC. The number adjacent to the CE marking (0123) is the number of the EU-notified body certified for meeting the requirements of the Directive.

  • Page 41: System Preparation

    System Preparation Move/Position the System Please read and understand the safety precautions before placing the system to ensure safety for both operator and devices. 1. Switch off the power, and pull out the plug. 2. Disconnect the system from all peripherals. 3.

  • Page 42: Powered By Battery

    – 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 – you may harm the patient or damage the equipment.

  • Page 43: Powering Off

    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. NOTE: When you start the system or switch between probes, you will hear clicking sounds –...

  • Page 44: Connecting / Disconnecting A Probe

    When connecting or disconnecting a probe, place it in a CAUTION: proper position, to prevent the probe from falling off or becoming damaged. Only use the probes provided by Mindray. Aftermarket probes may result in damage or cause a fire. 3.4.1 Connecting a Probe...

  • Page 45: Connecting The Footswitch

    Connecting the Footswitch Connect the footswitch to the main unit via a USB port. Set the functions of the footswitch in the [Key Config] page. Refer to "11.1.6 Key Config" for details. Connecting/ Removing a USB Storage Device DO NOT detach an USB storage device directly; otherwise, WARNING: the ultrasound system or the USB device and/ or data stored in the device may be damaged.
  • Page 46 4. Check the printer status: Enter [Setup]-> [Print Preset]->“Printer Driver” page, printers that are installed  automatically will be displayed in the list with the “Status” of “Ready”. 5. Return to “Print Service” page, and select “Report Print” in the list, and set attributes in the Property box under the screen: ...
  • Page 47 6. Click [Save] to finish the installation. Tips: Click [Printer Driver]->[Printer Supported] to view the drivers of some popular printers that have already been integrated in the system. These drivers willbe installed automatically. You need to check the following information to check if the auto-installation fails: Model of the connected printer is not displayed in the “Printer Driver”...
  • Page 48 3. Enter [Setup]->[Print Preset]->”Printer Driver” page, click [Add Network Printer] to enter the screen, type in the IP address of the network printer. (Port is 9100 in default). 4. Click [Verify Net Printer], the IP address, name and port information of the network printer will be displayed under the “Port”...

  • Page 49: Digital Video Printer

     To set the default report printer and its attribute: In "[Setup]-> [Print Preset]" screen, select the "Print Service", select “Report Print” column in the service list, set the items in the "Property" box.  Report print: Click [Print] in the report dialog box to print a report; or, use the user-defined key to print, see "11.1.6 Key Config"...

  • Page 50: External Dvd

    3. Connect the power cord to a power supply receptacle that is well grounded. 4. Install the printer driver (steps are the same as of graph/text printer, please refer to “3.7 Graph / Text Printer” for details). And you need not install the driver of the printer listed in section “2.5.4 Peripherals Supported”.
  • Page 51  Menu area Include image menu, measurement menu, comment menu, bodymark menu and so on. Use the trackball or the multifunctional knob to operate on the menu.  Image area The image area displays the ultrasound images, probe mark (or activating window mark), time line (in M mode), coordinate axis (including depth, time, velocity/frequency), focus position (located at depth axis in the form of ), besides, the annotation, bodymark,...

  • Page 52: Basic Operations Of Screens

    3.11.2 Basic Operations of Screens Title Contents Control button Composition Description The title bar is used to give a description for the content and Title Bar function of the screen. Use the selection pointer and <Set> key to open / close the Page Tab available pages.

  • Page 53: Exam Preparation

    Exam Preparation Before examining a new patient, press <End Exam> to end the CAUTION: exam of the previous patient, update the patient ID and information, to avoid mixing data of the next new patient. Start an Exam You can start a patient exam in the following situations: ...
  • Page 54 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 up/down controls. Information includes: 1.
  • Page 55 age is less than one year, the system will automatically calculate the age in months or days.  Also, you can manually enter the age. NOTE: When you enter the date manually, please enter it in the format as that of the system.
  • Page 56 Exam Type Information Description Para Times of delivery Aborta Times of abortion Last menstrual period Gravida Times of pregnancy. Para Times of delivery (Gynecology) Ectopic Times of abnormal pregnancy. e.g. extrauterine pregnancy Aborta Times of abortion Height Weight BSA (body After the height and weight are inputted, the system will surface automatically calculate the BSA based on the formula which...

  • Page 57: Retrieve Patient Information

     [OK]: click to save the patient data entered and exit the screen.  [Cancel]: click to cancel the patient data entered and exit the screen. 4.2.2 Retrieve Patient Information 4.2.2.1 iStation The patient data can be obtained in iStation from the system hardware or USB memory device.
  • Page 58 Button Function Description Review Click to enter the Review screen. Image Patient Click to enter the Patient Info screen. Info Review Click to enter the Diagnostic Report screen. Report Delete Click to delete the selected record. Exam Backup Click to export the selected patient data to media supported. Exam Restore Click to import the patient data from an external media.

  • Page 59: Select Exam Mode And Probe

     Or select the keyword type, enter the keywords and then click [Query] to search.  To reset the criteria, click [Clear] button. 3. Select the desired patient from the list.  Click [Start Exam], the patient information is imported into the system and then an exam is started.

  • Page 60: Selecting Imaging Mode

     To save the image parameters for the current exam mode quickly: Click [QSave] to save the image parameters in the current image mode as presets. A dialogue box pops up to prompt you the operation will cover the current image preset data. ...

  • Page 61: End An Exam

    2. Save the exam information, including report, imaging mode, exam mode, image parameters, operation mode, imaging / measurement data and so on. 4.6.2 End an 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.

  • Page 63: Image Optimization

    Image Optimization The images displayed in this system are only reference for WARNING: diagnosis. Mindray is not responsible for the correctness of diagnostic results. It is the responsibility of the clinician, who performs the exam, to capture the correct diagnostic results.

  • Page 64: Quickly Saving Image Setting (Qsave)

    Requirement Available Operations Adjust [Frequency] Adjust [Scale] To modify flow images effect Adjust [Packet Size] (Resolution and sensitivity) Adjust [Line Density] Adjust [Smooth]  Adjusting through Image Menu: Use the trackball and <Set> or the multifunctional knob to adjust.  Adjusting through control panel: Trackball, control panel key, knob or sliders.

  • Page 65: B Mode Image Optimization

    Parameter Frequency Depth Gain Frame Display when the function is Rate turned on Dynamic Range 5.4.3 B Mode Image Optimization Gain Description To adjust the gain of the whole receiving information in B mode. The real-time gain value is displayed in the image parameter area in the upper left corner of the screen.
  • Page 66 Operation Adjust it through [Frequency] on the image menu or rotate the <Focus/Freq./THI> knob on the control panel, wherein “H” means the harmonic frequency. Values of frequency vary depending upon the probe types. Select the frequency according to the detection depth and current tissue characteristics. Effects The higher the frequency the better the near field resolution but the worse the force of penetration.
  • Page 67 ExFov Click [ExFov] on the image menu to turn on/off the function. For linear probes, the ExFOv function displays as trapezoid imaging. For convex probes, the ExFOv function displays as extending the scanning angle. Impacts You can get a much larger field of view when selecting a larger FOV, but the frame rate will decrease.
  • Page 68 Invert To invert the image horizontally or vertically. Click [L/R Flip] or [U/D Flip] in the menu to invert the image. Rotation Rotate the image through the [Rotation] item in the menu. Image can be rotated by the manners in angle of 0° , 90° , 180° , 270° . When the image rotates in the angle of 90°...

  • Page 69: M Mode

    Description The TSI function is used to optimize the image by selecting acoustic speed according to tissue characteristics. Operation Select among the TSI modes through the [TSI] item in the menu; The system provided 4 ways of optimization for specific tissues: general, muscle, fluid and fat.

  • Page 70: M Mode Parameters

    3. Press <M> on the control panel again or <Update> to enter M mode, then you can observe the tissue motion along with anatomical images of B mode. 4. During the scanning process, you can also adjust the sampling line accordingly when necessary.
  • Page 71 Speed Description This function is used to set the scanning speed of M mode imaging, and the real-time speed value is displayed in the image parameter area in the upper left corner of the screen. Operation Change the speed through the [Speed] item in the menu; There are 6 levels of scan speed available, the smaller the value the faster the speed.

  • Page 72: Color Mode Image Optimization

    M Soften Description This feature is used to process the scan lines of M images to reject noise, making the image details to be clearer. Operation Adjust through the [M Soften] item in the menu; The system provides 14 levels of M Soften adjustment, the bigger the value the stronger the effect.
  • Page 73 Color Gain Description Refers to the overall sensitivity to flow signals, and this function is used to adjust the gain in Color mode. The real-time gain value is displayed in the image parameter area in the upper right corner of the screen. Operations Rotate the <Gain/iTouch>...
  • Page 74 Operations Turn on or off the function through the [Invert] item on the image menu. Select “Auto Invert” in the “[Setup] → [System Preset] → [Image]”, then the color bar can automatically invert when the color flow is steered to a certain angle to accommodate operator’s habit of distinguishing flow direction.

  • Page 75: Power Mode Image Optimization

    B/C Align Description To set and constrain the maximum width of the B mode image to that of the Color ROI. Operations Turn on or off the function through the [B/C Align] item on the image menu. Impacts Frame rate increases when the function is turned on. Dual Live Description This function is used to display B image and Color image synchronously.

  • Page 76: Power Mode Image Parameters

    2. Click [Power] on image menu to enter B + Power mode. Roll the trackball to change position of the Region of Interest (ROI) and press the <Set> key to set. Roll the trackball to change the size and position of ROI. 3.

  • Page 77: Pw Doppler Mode

    Effects Increasing dynamic range will lead to higher sensitivity to low-power signals, thus enhances the range of signals to display. PW Doppler Mode PW (Pulsed Wave Doppler) mode is used to provide blood flow velocity and direction utilizing a real-time spectral display. The horizontal axis represents time, while the vertical axis represents Doppler frequency shift.

  • Page 78: Pw Mode Image Parameters

    5.8.2 PW Mode Image Parameters In PW mode scanning, the image parameter area in the upper right corner of the screen displays the real-time parameter values as follows: Parameter Angle Meaning Frequency Gain Wall Filter SV Position SV Size Angle ...
  • Page 79 Invert Description This function is used to set the display manner of spectrum. Operations Turn on or off the function through the [Invert] item on the image menu. Select “Auto Invert” in the “[Setup] → [System Preset] → [Image]”, thus the spectrum can automatically invert when the color flow is steered to a certain angle to accommodate operator’s habit of distinguishing flow direction.
  • Page 80 HPRF Description HPRF mode is used when detected velocities exceed the processing capabilities of the currently selected PW Doppler scale, or when the selected anatomical site is too deep for the selected PW Doppler scale. Operations Turn on or off the function through the [HPRF] item on the image menu. Effects HPRF enhances the range of detecting high-velocity flow.
  • Page 81 Operations Click [Duplex/ Triplex] on the image menu to turn on or off the synchronization. Auto Calculation Description This function is used to trace the spectrum and calculate parameters of PW mode image, and the results of which are displayed in the result window. Auto Turn on or off the auto calculation function through the [Auto Calc] item on the Calculation...

  • Page 82: Anatomical M Mode (Free Xros M)

    Quick Angle Description To adjust the angle faster, in increments 60° , and the real-time value of which is displayed on the right part of the spectrum map. Operations Click the [Quick Angle] item on the image menu. There are 3 angles for quickly adjustment: -60° , 0° , and 60° . Anatomical M Mode (Free Xros M) Anatomical M Mode and Color Anatomical M mode images are CAUTION:...
  • Page 83 Operations Press <Set> to hide or show between the M-mark lines and press <Cursor> to show the cursor. The activated M-mark line will be green. Adjustment of the M-mark Line Description To adjust the position and angle of the M-mark line. ...

  • Page 84: Tdi

    5.10 TDI TDI is provided for reference only, not for confirming a diagnosis. CAUTION: TDI (Tissue Doppler imaging) mode is intended to provide information of low-velocity and high-amplitude tissue motion, specifically for cardiac movement. There are 3 types of TDI mode available: ...

  • Page 85: Iscape

    5.11 iScape 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, you move the probe linearly and acquire a series of B images, the system pieces these images together into single, extended B image in real time.

  • Page 86: Image Acquisition

    5.11.2 Image Acquisition To create an iScape image, you start with an optimized 2D image. The 2D image serves as the mid-line for the resulting iScape image. 1. Press the <Update> key or click [Start Capture] on the image menu to start the iScape image capture.
  • Page 87  Image parameters setting, for details, please refer to “5.11.3.1 Image Parameters ”.  Image zooming, for details, please refer to “5.11.3.2 Image Zooming”.  Image rotation, for details, please refer to “5.11.3.3 Rotating the Image”.  Measurement, comment, and body mark, for details, please refer to “5.11.3.4 Measurement, Comment, and Body Mark”.

  • Page 88: Cine Review

     No shadow or absent signal along the scan plane.  Clear profile of anatomy through the entire scan plane without distortion.  Skin line is continuous.  The images are captured from the same plane.  There is no large black area in the image. 5.11.4 Cine Review Click [Review Cine] on the image menu in panoramic image viewing status to enter cine reviewing mode.

  • Page 89: Note Before Use

    5.12 3D/4D 5.12.1 Note before Use 5.12.1.1 Smart 3D Image Quality Conditions NOTE: In accordance with the ALARA (As Low As Reasonably Achievable) principle, please try to shorten the sweeping time after a good 3D imaging is obtained. The quality of images rendered in the Smart 3D mode is closely related to the fetal condition, angle of a B tangent plane and scanning technique.

  • Page 90: Overview

    NOTE: 1. A region with qualified image in B mode may not be optimal for Smart 3D imaging. E.g. adequate AF isolation for one section plane doesn’t mean the whole desired region is isolated by AF. 2. More practices are needed for a high success rate of qualified Smart 3D imaging.
  • Page 91 image Cut plane  ROI size and position Roll the trackball to change the ROI size and position, press the <Set> key to toggle between setting the size (dotted line) and position (solid line, with a small box at each corner of ROI).
  • Page 92 View Direction a. Up/Down b. Down/Up c. Left/Right d. Right/Left e. Front/Back f. Back/Front  Wire cage When you view a Smart 3D image on the display monitor, it’s sometimes difficult to recognize the orientation. To help, the system displays a three-dimensional drawing to illustrate the orientation.

  • Page 93: Static 3D

    Wire Cage The ultrasound images are provided for reference only, not for CAUTION: confirming a diagnosis. Please use caution to avoid misdiagnosis. 5.12.3 Static 3D Static 3D provides single frame image acquisition of 3D images. During scanning, the probe performs the scanning automatically. The probe D6-2EA supports the static 3D.
  • Page 94 Draw a circle here ROI cover this area Cross cursor on the VOI curve For setting the ROI, be sure to:  Set the ROI on the 2D image with the largest section area of the fetal face.  Set the ROI a little larger than the fetal head. NOTE: When defining a ROI, try to eliminate useless data so as to reduce the volume data and shorten the time for image storing, processing and rendering.
  • Page 95 5.12.3.2 Static 3D Acquisition Preparation Description of parameters: Type Parameter Description Function: to set the range for imaging. Angle Range: 10-70° . Parameter Function: to adjust the image quality by changing the line adjusting density. Image quality can affect the imaging speed: the Quality better the image quality, the longer the time.
  • Page 96  Window A is blue, and the lines (representing MPR A) displayed in the other two windows are also blue.  Window B is yellow, and the lines (representing MPR B) displayed in the other two windows are also yellow. ...
  • Page 97 View Direction a. Up/Down b. Down/Up c. Left/Right d. Right/Left e. Front/Back f. Back/Front Adjust VOI  VOI On The VR image displays VOI information. 1. In image viewing status, click [VOI] to turn it to “On.” 2. Roll the trackball to adjust the VOI position, size and curved VOI, and press <Set> to switch between the adjusting status.Or use [Slice] item to adjust the relative position of MPRs so as to slice through the VR.
  • Page 98 Image Rendering Parameters In image viewing status, render the image by adjusting the relevant parameters. Render setting parameters description: Click [VR/MPR] on the screen to select VR or MPR parameter adjustments.  When [VR] is highlighted in green, parameter adjustment is performed on the VR image.
  • Page 99  Reset Curve Parameter Description Reset Ori To reset the volume rotation, shifting and zooming to its original 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 100 Rotate an Image The system supports the following rotation modes:  Axial rotation  Auto rotation  Axial rotation Axial rotation rotates the currently activated image around the X-, Y- or Z-axis.  Procedures a) Select the current image. b) Rotate the corresponding knobs to make the image rotate: ...
  • Page 101 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. Tip:  In image editing status, no image parameters can be changed. A cutting cursor is , and the system enters “Accept VOI”...

  • Page 102: Smart 3D

     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.  Image review Open an image file to enter the image review mode. In this mode, you can perform the same operations as in VR viewing mode.
  • Page 103  Rocked scanning Rotate the probe once from the left to the right side (or from the right to the left) to include the entire desired region. See the figure.  Description of parameters: Parameter Description Function: select the image acquisition method. Selection: Rocked, Linear.
  • Page 104 5.12.4.3 Smart 3D Image Viewing In VR viewing, the system supports the following functions:  Render setting.  B-mode parameter adjustment.  Setting the display format.  Viewing MPR.  Image zooming.  Rotation.  Image editing.  VR parameter adjustment. ...

  • Page 105: Ilive

    6. Press <Freeze> on the control panel to freeze the image. Perform image cutting, rotation, annotation and image saving if necessary. For detailed operations, see “5.12.3.3 Static 3D Image Viewing.” 7. Exit 4D. Press <Update> to return to 4D image acquisition preparation, or, press <B>...

  • Page 106: Ipage

    5.12.7 iPage iPage is a new “Visualization” mode for displaying sectional images. The data is presented as slices through the data set, which are parallel to each other. iPage is an option and is not available for Smart 3D images. 5.12.7.1 Basic Procedures for iPage 1.
  • Page 107 5.12.7.2 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 108: Smart Face

     Slice position (to the central slice): displayed in the top-left corner of each image, indicating the position of each image (such as -7 mm, -3 mm, 3 mm, 8 mm).  Coordinate axis: indicated on the three A, B, C reference images. Correspond to the central slice line, and will move accordingly with the central slice line.
  • Page 109 2. Click [SmartFace] to enter the function and the system adjust fetal face angle (fetal head facing up and face is at the front with [Direct] to be up/down) automatically and remove the shading obstacle data. Parameter adjusting Parameters under Smart Face are similar to those under Static 3D mode. ...

  • Page 111: 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.  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 112: Freeze/ Unfreeze The Image

     Press <Depth/Zoom>.  Unfreeze the image, the system exit pan zooming status automatically. 6.1.2.3 iZoom (Full-screen Zooming) Function: to magnify the image in full screen. According to the region to be zoomed, the system supports two types of full-screen zooming: ...

  • Page 113: Cine Review

     Dual/quad splitting display mode (Press <Freeze> key in dual/quad splitting display mode)  When enters freeze mode, the default activated window is the real-time window before frozen. Other image windows display the corresponding cine memories, if a certain cine memory is empty, then no image is displayed. ...

  • Page 114: Cine Review In M/ Pw /Tvd Mode

    If you roll the trackball to the left, the review sequence is reversed to the image-storing sequence, thus the images are displayed in descending order. Whereas, if you roll the trackball to the right, the review sequence is the same as the image-storing sequence, thus the images are displayed in ascending order.

  • Page 115: Linked Cine Review

    Auto Review Region Time played Total time Start mark Playback mark End mark Cine review operations are the same as those of 2D mode. Tips: There is no audio when the spectrum is reviewed in manual status but audio synchronization can be realized in auto review status with speed of ×1. 6.2.4 Linked Cine Review The linked cine review refers to review of the images captured at the same moment.

  • Page 116: Frame Compare

    Press <Cursor> and double click the image in the thumbnail area at the bottom of the screen to change the current active window 4. Save the image if it is necessary. 5. Click [Return] on the screen or press <Freeze> to exit image compare. Image compare of different exams for the same patient: a) Select different exams in iStation screen, select [Review] in the popped up menu to enter Review screen.

  • Page 117: Cine Memory Clear

    Imaging Mode Single-B/ Color Dual Quad Split The memory splits The memory splits The memory splits into two, with into two, with into four, with Split capacity N/2 capacity N/2 frames capacity N/4 frames frames each each each 6.4.2 Cine Memory Clear In the following conditions, the cine review memory will be cleared: ...

  • Page 119: Measurement

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

  • Page 120: M General Measurements

    Measurement Tools Function Volume The volume of a target. The length of two line segments, which are perpendicular to each Cross Line other. Parallel Line The distance between each pair of parallel lines in a sequence. Trace Length(Trace) Measures the length of a curve on the image. Trace Len (Spline) Measures the length of a curve on the image.

  • Page 121: Doppler General Measurements

    7.2.3 Doppler General Measurements Doppler general measurements refer to general measurements on PW-mode images. The measurements listed below can be performed: Measurement Function Tools Time The time interval between any two points. N intervals (n≤8) are measured to calculate a PW mode derived HR value in Beats Per Minute (BPM).

  • Page 122: Measurement Accuracy

    Measurement Accuracy Table 1 Error of 2D Images Parameter Value Range Error Distance Full screen Within ± 4% Area Full screen Within ± 8% Circumference Within ± 20% Angle Full screen Within ± 3%. Linear and convex-wide probe: within ± 10% Distance (iScape) Full screen Micr-convex probe: within ±...

  • Page 123: Comments And Body Marks

    Comments and Body Marks Comments Comments can be added to an ultrasound image to bring attention, notate or communicate information observed during the examination. You can add comments to: zoomed image, cine review image, real-time image, frozen image. You can type the character as comments; insert the pre-defined comments from the comment library;...

  • Page 124: Adding Comments

     ABC Display Click [ABC Display] to display or hide the added comments. Assign the user-defined key for the function in “[Setup]-> [System Preset]->“Key Config” ”.  Set comment language Click [English] to turn on or off the English comments. If “English” is turned on, the comments will display in English;...

  • Page 125: Moving Comments

    5. Press <Arrow> key, <ESC> or to exit the arrow comment status. 8.1.4 Moving Comments 1. Move the cursor onto the comment that needs to be moved. Press <Set> to select it, where a highlighted box appears around the comment. 2.

  • Page 126: Body Mark

    Body Mark The Body Mark (Pictogram) feature is used for indicating the exam position of the patient and transducer position and orientation. The system supports body marks for Abdomen, Cardiology, GYN, OB, Urology, Small Part, Emergency, Nerve, Orthopedics and Vascular applications. In addition, the system supports user-defined body marks, and body marks can be imported.

  • Page 127: Deleting Body Marks

    2. Press <Set> key to select the body mark, and a frame will appear around the graphics. 3. Roll the trackball to move the Body Mark graphic to the desired position. 4. Press <Set> to anchor and confirm the new graphics position. NOTE: In Dual B Mode, a body mark cannot be moved between the separated image windows.

  • Page 129: Patient Data Management

    External storage media is recommended for image archive. The system patient database space is limited, please back up or clear patient data in time. Mindray is not responsible for lost data if you DO NOT follow suggested backup procedures. Patient Information Management 9.1.1...

  • Page 130: Image Storage Preset

    System-defined multi-frame file format; you can perform manual or auto cine review, and perform measurements or add comments for the reviewed images. After you open a stored CIN file, the system automatically enters cine review status. The system can save FRM files as BMP, JPG, TIFF or DCM files, or save CIN files as AVI, DCM files.

  • Page 131: Quickly Saving Images To Usb Flash Drive

     To save cineloop image in the system: (1) Enter [Setup]-> [System Preset] -> [Key Config]-> [Output], set a user-defined key for function “Save cine”. (2) Freeze an image. Click the user-defined key to save the current image file in the default file directory in the dynamic image format .CIN.

  • Page 132: Image Review And Analysis

    9.2.8 Image Review and Analysis You can review and analyze the stored images (only refer to the images stored in the system default path). 9.2.8.1 To review images You can review all images stored in an exam, and send, delete or analyze the stored images. ...
  • Page 133  If entered from iStation, the screen displays the record(s) selected in the iStation. If no patient is selected when it was in iStation, then all the patients in the system database will be displayed, and the current patient exam is listed. ...

  • Page 134: Ivision

    9.2.9 iVision iVision function is used for demonstration of the images stored. Image files are played according to file names one by one (including the image of system-relevant and PC- compatible format). To perform image demonstration: 1. Enter iVision screen: Press the user-defined key for iVision on the control panel (setting path: [Setup]→...

  • Page 135: Sending Image File

    [<]: to delete the selected data. [<<]: to delete all data.  Customize Catalog: what saved here is the catalog of the displayed image. The system plays the images in the catalog when performs demonstration. Operate the catalog by the buttons on the right: [Add File]: to add files to the file list.
  • Page 136 In the iStation screen, click [Send Exam]; or, in Review screen, click [Send To] to send patient data to an external memory device, you can choose if reports are exported with images. See the figure below. To export the report: (1) Check “Export Report”...

  • Page 137: Patient Data Management (Istation)

    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> key on the control panel; or ...

  • Page 138: Patient Data View & Management

    (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) When you select a patient in the patient list, the images of this patient will be displayed at the bottom of the screen.
  • Page 139  Send To The system supports to send data to external memory devices or print.  Select the patient record, click in the menu to send exam data or images of the selected record.  Select the image, click the Send To Arrow to send the selected image. ...

  • Page 140: Backing Up And Erasing Files Through Dvd Drive

    Backing Up and Erasing Files through DVD Drive The system supports DVD-RW to write data in CD/DVD and to read data from CD/DVD in PC. Support media: DVD± RW, CD-R/W.  To write data to a CD/DVD: (1) Put a CD/DVD in the tray. (2) Select the data to be backed up, click in the screen (in iStation or Review).
  • Page 141 Including:  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 iStation and click ...

  • Page 142: Access Control

     Task Status Select the undergoing task, the system will display its detailed status information or error information. When there is/are task(s) undergoing, the task management icon displays as , you can click the icon to check the process. When there is/are task(s) failed, the task management icon displays as , you can click the icon to check the failure reason.

  • Page 143: Add/ Delete A User

     Login the system: (1) If the system requires you to log on the system before you access the data, you can see the following dialogue box. (2) Select the user name in the drop-down list of User Name. (3) Enter password and click [Login]. For emergency users, click [Emergency] directly to log on.
  • Page 144 2. Click [Add] to enter the following page. 3. Enter the user name(you are not allowed to enter the same name or modify the name already exist). 4. Enter user name and the password. 5. Set the user role in the drop-down list: administrator or operator. 6.

  • Page 145: Modify Password

    9.7.5 Modify Password The system administrator can modify password of all users. The administrator password by factory is empty, you can set the password for it. The operator can only modify his/her own password. To modify the password, the user has to login the system first. There are two ways to modify password: modify it on “Admin”...

  • Page 147: Dicom

    DICOM NOTE: Before using DICOM, please read the electronic file DICOM CONFORMANCE 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 148: Dicom Preset

    1. Press <Setup> to enter the [Setup] menu. 2. Select [Network Preset]. 3. Local TCP/ IP preset items are described as follows: Name Description Current Net Adapter To select network connection mode. DHCP DHCP: IP address will be automatically obtained from DNS server; / Static Static: you need to enter the IP address.
  • Page 149 3. Preset local DICOM properties and DICOM server.  Localhost DICOM Service Property Name Description Application entity title of the ultrasound system. AE Title The AE title here should be the same with the one of the acceptable SCU set in the server. DICOM communication port, which should be the same with the one Port in the server.

  • Page 150: Dicom Service

    Name Description You can ping other machines to verify connection after entering the Ping correct IP address. Also you can check the connection of the already added server in the list. [Add] Click to add servers to the device list. Click to enter DICOM service preset, see “10.1.3 DICOM Service”.
  • Page 151 DICOM storage setting items are described as follows: Name Description After you set the server (s) in DICOM Server Setting, the name Device (s) will appear in the drop-down list, select the name of the storage server. Service Name Default is xxx-Storage, and it can be modified. Application Entity title, Here, it should be consistent with that of AE Title the storage server.
  • Page 152 Name Description Select an item in the service list, change the parameters in the [Update] above area, and click [Update] to update the item in the service list. [Delete] Click to delete the selected service in the service list Select an item in the service list, click [Default] and you can see [Default] “Y”...
  • Page 153 DICOM print setting items are described as follows: Name Description After you set the server (s) in DICOM Server Setting, the Device name (s) will appear in the drop-down list, select the name of the print server. Service Name Default is xxx-Print, and it can be modified. Application Entity title.
  • Page 154 Name Description Specify quantity of printed files,e.g. STANDARD\2, 3 Display Format indicates 6 images are printed for each page. Medium Type Specify print medium: Paper, Clear Film, Blue Film. Specify whether you want a trim box to be printed around Trim each image on the film: Yes or No.

  • Page 155: Verify Connectivity

    DICOM Worklist service parameters are similar to those described in DICOM Storage Preset, please refer to “10.1.3.1 Storage” for details. 10.1.3.4 MPPS Preset 1. On DICOM Service screen, click [MPPS] page tab to enter the MPPS page: 2. Select device, enter the right AE Title, port, etc. 3.

  • Page 156: Dicom Service

     The server supports the verification, but this function is not activated. Please check if the verification function is activated. Note: Not all the SCPs can support verification; please consult SCP belongings to confirm whether SCP can support this service. If not, the verification won’t pass. 10.3 DICOM Service If the system is configured with DICOM modules, and connected to the relevant DICOM servers, after verifying connection, you can perform storage, print, Worklist, storage...

  • Page 157: Dicom Print

     To send image for storage after an exam ends (1) Open “[Setup] → [System Preset] → [General]”, and then check (2) Set a default storage server. a) Enter the DICOM Service Preset screen via “[Setup] → [DICOM Preset] → [Set DICOM Service]”.
  • Page 158  To query patient information via Worklist server: (1) Press <Patient> to enter Patient Info screen. (2) Click [WorkList] to enter the WorkList page. (3) Retrieve Patient Information a) Set query criteria among Patient ID, Patient Name, Accession #, Search Key, Worklist Server or Exam Date.

  • Page 159: Mpps

    (4) Press <Patient> to enter Patient Info screen. (5) Click [WorkList] to enter the WorkList page. (6) The system queries intraday patients via Worklist server automatically and the patient records will appear in the list. In the off-line status, you can: ...

  • Page 160: Query/Retrieve

    If images are successfully sent to the storage server, the storage commitment server will return information about the successful image storage. In the iStation screen, you will see there is a tick “√” marked in the list below Tips: Storage commitment is confined to the whole exam; not each image sending can be indicated. Multi-frame storage is not allowed if “Allow Multiframe”...

  • Page 161: Dicom Media Storage

    You can perform further query basing on the results by entering new query information. 6. Select one or more patient records according to the actual situation. Click [Select All] to select all the patient records in the list. Click [Deselect All] to deselect all the patient records in the list. 7.

  • Page 162: Structured Report

     Data Restore: 1. If the DICOM format data is backed up to external media, you can restore the data to the system from the media. 2. Review the data stored in the external media. 3. Select the data to be restored in iStation. 4.

  • Page 163: Setup

    CD/DVD or USB memory devices. When the setup data is changed, be sure to save the preferences CAUTION: according to the methods described in this chapter. Mindray is not responsible for the loss of the setup data.  To enter Setup: ...

  • Page 164: General

    Item Description To select a language for the system, the available languages are Chinese, English, French, German, Italian, Portuguese, Russian, Spanish, Polish, Czech, Turkish, Finnish, Danish, Icelandic, Language Norwegian, and Swedish. The system will restart automatically after you change the language and return from the Setup menu.

  • Page 165: Image Preset

    Type Item Description To select if to display the following patient information Info displays in on the image banner: Gender, Age, Operator, ID, image banner Name, Hospital Patient Info H&W Unit To set the unit for patient height and weight. Surface Formula To set the surface formula.

  • Page 166: Application

    Type Item Description Reset Config Probe To set the default probe model for the system. To set MI TI indexes displayed for current probe/exam MITI mode. Freeze Status after Freeze To set the system status after image is frozen. Config To set the steer mode in B+ Color +PW imaging mode.

  • Page 167: Key Config

    11.1.5 OB Open the OB page via [Setup]-> [System Preset]-> [OB]. Through the page, you can set the gestational age formula, fetal growth formula, fetal weight formula and the relevant information. For details, please refer to the Operator’s Manual [Advanced Volume]. 11.1.6 Key Config Open the page via [Setup]->...

  • Page 168: Admin

     Other Settings Item Description Key Brightness To set the lightness for the keys. Key Volume To set the key volum. Zero means no sound. Trackball Speed To set the trackball speed when move the trackball. Trackball Brightness To set the color for the trackball. 11.1.7 Admin Open the Admin page via [Setup]->...

  • Page 169: Measure Preset

     [>]: add a selected exam mode in the [Exam Library] to the [Exam Selected] list.  [>>]: add all exam modes in the library to the [Exam Selected] list.  [<]: remove an exam mode selected from the [Exam Selected] list. ...

  • Page 170: Bodymark Preset

     Select Available Items: First select a comment library in the drop-down list beside “Available Items”, and then click [Set] on one item displayed below “Available Items”.  Click [>] to add the item in Available Items on the left into Selected Items on the right.

  • Page 171: Print Preset

    To preset body mark for exam mode: 1. Select an exam mode in the drop-down list, the current exam mode is set by default. 2. Enter the library name of custom body marks. 3. Select a package from the drop-down list besides Available Item. 4.

  • Page 172: Network Preset

     Print Service Setting  Add Service: click to begin print service adding.  Remove Service: click to delete the selected print service.  Rename Service: click to rename the selected print service.  Property: to preset the property of print services. ...

  • Page 173: Maintenance

    Click to select the function(s) and click [Trial]. Tips: Every trial option can be used only once. Please refer to the dependence relationship between options in chapter “2.5.3 Options”. Please contact Mindray Customer Service Department or sales representative for details. Setup 11-11...

  • Page 174: Other Settings

    11.8.2 Other Settings Type Item Description Export Log Export the operation log. Upload Log Upload the operation log. Load Factory Local factory default settings. Preset Manager Export Export preset data to disk. Import Import the preset data into the system. 11.9 System Information Click [About] in the Setup menu to enter the system information screen.

  • Page 175: Probes And Biopsy

    Probes and Biopsy 12.1 Probe The system supports the following probes: Probe model Illustration 35C50EA 65C15EA 65EC10EA 75L38EA Probes and Biopsy 12-1...
  • Page 176 Probe model Illustration 10L24EA 35C20EA 35C50EB 75L38EB 65EC10EB D6-2EA 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 12-2 Probes and Biopsy...

  • Page 177: Name And Function Of Each Part Of The Transducer

    12.1.1 Name and Function of Each Part of the Transducer Basic structures and functions of all probes listed above are similar, and are described as follows.  Probe 35C50EA <2> <1> <3> <4> <5> Name Function It converts the electrical signal into ultrasound signal, making the sound beams focus in the given direction;...

  • Page 178: Operating Procedures

    Orientation mark Mark 12.1.3 Operating Procedures This section describes general procedures for operating the transducer. The proper clinical technique to be used for operating the transducer should be selected on the basis of specialized training and clinical experience. 12-4 Probes and Biopsy...
  • Page 179  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 180  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 181: Wearing The Transducer Sheath

    12.1.4 Wearing the Transducer Sheath A transducer sheath must be installed over the transducer before performing examination. Probe sheaths are available for use with all clinical situations where infection is a concern. A probe sheath must be installed over the probe before performing intra-cavity or biopsy examination.

  • Page 182: Probes Cleaning And Disinfection

    12.1.5 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 183 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 into...

  • Page 184: Storage And Transportation

    Relative humidity: 20% to 95% (no condensation)  Atmospheric pressure: 700 hPa ~ 1060 hPa 4. When the transducer 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 185: 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 186 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. When performing the operation concerning biopsy, wear sterile gloves. Image of the biopsy target and the actual position of the biopsy needle: Diagnostic ultrasound systems produce tomographic...

  • Page 187: Basic Procedures For Biopsy Guiding

    A needle-guided bracket is available for purchase as an optional accessory; it is used in combination with this transducer. Part of the probes have matched needle-guided bracket and needles. To order needle-guided brackets, contact MINDRAY Customer Service Department or sales representative.
  • Page 188  NGB-001, NGB-002, NGB-003, and NGB-005 (Metal/needle un-detachable) The structure of plastic needle-guided bracket NGB-001, NGB-002, NGB-003 and NGB- 005 are similar to each other. The following figure shows the structure with NGB-001 as an example. Clamping knob of the needle guide Needle guide Needle guide hole...
  • Page 189 Name Description Angle shift sign <4> Matched with the biopsy angle (11°, 23°) (11°, 23°) <5> Angle pinch nut Used for fixing the angle lock at a chosen angle Used for determining the angle of the biopsy; different <6> Angle block specifications of blocks can be used Used for installing biopsy needle;...

  • Page 190: Needle-Guided Bracket Inspection And Installation

    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 191 4. Adjust the dial scale to the required needle type shift, and then screw the needle fixing nut to lock the dial scale.(To adjust the dial scale you have to loose the needle fixing nut first.) 5. Pull the lock pin and close the V-shaped cover to fix the lock pin in the groove of the needle type adjusting base, so as to install the needle into the guiding hole.
  • Page 192 2. Open the retaining clamp, align the needle-guided bracket with the transducer to locate the locating bulge on the needle guide to the locating grooves on the transducer, and then turn the retaining clamp to match it with the transducer. 3.

  • Page 193: Biopsy Menu

    6. Insert a biopsy needle with the same specification as that of the guiding block into the hole of the guiding block. Ensure that all guide parts are seated properly prior to performing CAUTION: a biopsy. 12.2.4 Biopsy Menu Press <Biopsy> to show the biopsy menu. ...
  • Page 194 penetrate the metal needle, a reflecting boundary is formed. As in Figure 1, if the deflection angle is very large, the needle display is not clear. In the condition of deflected ultrasonic transmission, the beam direction is perpendicular to the needle direction, and the reflection direction will be the same with the needle, as shown in Figure 2, when the needle display in the ultrasound image is very clear.

  • Page 195: Verify Biopsy Guide Line

    12.2.6 Verify Biopsy Guide Line Prior to each biopsy procedure, be sure to verify the guide WARNING: line. If the needle is not consistent with the guide line, DO NOT perform the biopsy procedure. NOTE: You can perform guide line verification on a single live B image only, and all biopsy-irrelevant operations are forbidden.

  • Page 196: Removing The Needle-Guided Bracket

    12.2.7 Removing the Needle-guided Bracket  NGB-001/ NGB-002/ NGB-003/ NGB-005 metal/needle un-detachable needle-guided bracket: While holding the transducer and the needle-guided bracket, open the Grip knob of the needle-guided bracket.  NGB-001 Metal-needle detachable 1. Pull the lock pin and open up the V-shaped cover to expose the needle. 2.

  • Page 197: Clean And Sterilizethe Needle-Guided Bracket

    Please follow the instructions in the manual for cleaning. 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 sterilant.
  • Page 198  Glutaraldehyde-based sterilant: Chemical Trade name Procedures name Cidex Please refer to the instructions provided by the manufacturer of the solution for details. Glutaraldehyde Activated Soak the transducer into the activated solution for 10 (2.2-2.7%) Glutaraldehyde hours (20-25℃) Solution  Hydrogen Peroxide and Peroxyacetic Acid -based sterilant: Trade Name Chemical Name Procedures...

  • Page 199: 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 201: Battery

    Battery DO NOT install or detach the battery ad arbitrium WARNING: The batteries have protective mechanism and circuit. DO NOT disassemble or alter the battery. DO NOT short-circuit the batteries by directly connecting the negative terminals with metal objects. DO NOT heat the battery or discard it in a fire. Keep the batteries away from fire and other heat sources.

  • Page 202: Precautions

    13.2 Precautions 1. Before using the battery, carefully read the description in the label on the surface of the battery. 2. When you use the battery at the first time and find that it is dirty or emit an odor, do not use it.

  • Page 203: One Full Discharge / Charge Cycle

    Warning! Battery is out of power! Please connect to power supply or system will be shut down in one minute. Connect the power supply to afford normal work. 13.5 One Full Discharge / Charge Cycle If the battery has not been used for over 2 months, you are recommended to perform one full discharge / charge cycle.

  • Page 205: 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 206: Mi/Ti Explanation

    14.4 MI/TI Explanation 14.4.1 Basic Knowledge of MI and TI The relationship of various ultrasound output parameters (frequency, acoustic pressure and intensity, etc) to bioeffects is not fully understood presently. It is recognized that two fundamental mechanisms may induce bioeffects. One is a thermal bioeffect with tissue absorption of ultrasound, and another one is a mechanical bioeffect based on cavitations.

  • Page 207: Acoustic Power Setting

    NOTE: If there is a value of MI or TI exceeds 1.0, you must be careful to practice the ALARA principle. The display precision is 0.1. Display accuracy of MI is ±28.5%, TI is±38.7% 14.5 Acoustic Power Setting  Acoustic power adjustment Click [A.

  • Page 208: Acoustic Output

     Indirect Controls The controls that indirectly affect output are many imaging parameters. These are operating modes, frequency, focal point positions, image depth and pulse repetition frequency (PRF). The operating mode determines whether the ultrasound beam is scanning or non-scanning. Thermal bioeffect is closely connected to M mode.

  • Page 209: Differences Between Actual And Displayed Mi And Ti

    14.7.3 Differences between Actual and Displayed MI and In operation, the system will display to the operator the Acoustic Output Parameters Thermal Index, TI, or Mechanical Index, MI (or sometimes both parameters simultaneously). These parameters were developed as general indicators of risk from either thermal or mechanical action of the ultrasound wave.

  • Page 210: References For Acoustic Power And Safety

    14.9 References for Acoustic Power and Safety “Bioeffects and Safety of Diagnostic Ultrasound” issued by AIUM in 1993 “Medical Ultrasound Safety” issued by AIUM in 1994 "Acoustic Output Measurement Standard for Diagnostic Ultrasound Equipment, Revision 3" issued by AIUM/NEMA in 2004 "Standard for real-time display of thermal and mechanical acoustic output indices on diagnostic ultrasound equipment, Revision 2"...

  • Page 211: Emc Guidance And Manufacturer's Declaration

    EMC Guidance and Manufacturer's Declaration The system complies with the EMC standard IEC 60601-1-2: 2014. Intended Environments: HOME HEALTHCARE ENVIRONMENT(except for near active HF SURGICAL EQUIPMENT and the RF shielded room of an ME SYSTEM for magnetic resonance imaging). The use of unapproved accessories may diminish system WARNING: performance.
  • Page 212  Date/time information. TABLE 1 GUIDANCE AND MINDRAY DECLARATION—ELECTROMAGNETIC EMISSIONS The system is intended for use in the electromagnetic environment specified below. The customer or the user of system should assure that it is used in such an environment. ELECTROMAGNETIC ENVIROMENT－...
  • Page 213 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 214 TABLE 3 GUIDANCE AND MINDRAY DECLARATION—ELECTROMAGNETIC IMMUNITY The system is intended for use in the electromagnetic environment specified below. The customer or the user of system should assure that it is used in such an environment. IMMUNITY IEC 60601 TEST...
  • Page 215 TABLE 4 RECOMMENDED SEPARATION DISTANCES BETWEEN PORTABLE AND MOBILE RF COMMUNICATION DEVICE AND THE SYSTEM The system is intended for use in an electromagnetic environment in which radiated RF disturbance are controlled. The customer or the user of system can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communication equipment (transmitters) and system as recommended below, according to the maximum output power of the communication equipment.

  • Page 217: System Maintenance

    Routine system maintenance shall be carried out by the user. Service maintenance will be provided by Mindray service engineers while the system is under warranty. System maintenance after the warranty has expired is the full responsibility of the owner / operator.
  • Page 218 The trackball on the control panel is used to move the cursor and plays an importance part in man-machine communication. As one of the most frequently used parts on the control panel, it may become ineffective due to dirt that enters into the trackball module. Disassembling the trackball: Rotate the trackball clamp ring 35 degrees anticlockwise.

  • Page 219: Checking Transducer

    16.3 Consumables and Periodic Part Replacement This system contains some consumables and parts requiring periodic replacement. Before replacing them, please contact Mindray Customer Service Department or sales representative for instructions. 16.4 Troubleshooting To ensure proper system operation and function, it is recommended that a maintenance and inspection plan be established to periodically check the safety of the system.
  • Page 220 Otherwise it may result in malfunction or electric shock. When you want to clean probe connectors and TGC sliders, contact Mindray Customer Service Department or sales representative. Cleaning it yourself may result in malfunction or degradation of the performance.

  • Page 221: Appendix A Electrical Safety Inspection

    Appendix A 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 222 Device Enclosure and Accessories A.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 223  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 ...
  • Page 224  LIMITS For BF applied parts 100μA in Normal Condition  500μA in Single Fault Condition  Mains on Applied Part Leakage The Mains on Applied Part test applies a test voltage, which is 110% of the mains voltage, through a limiting resistance, to selected applied part terminals.

  • Page 225: Appendix B Barcode Reader

    Appendix B 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 WARNING: stare into beam because of unknown hazards of transient radiation provided by class 2 laser.
  • Page 226 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 227  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 228 B-4 Barcode Reader...
  • Page 229 B.1.4 Scanning in Hand-Held Mode 1. Ensure all connections are secure. 2. Aim the reader at the barcode. Press the trigger. Note: Ensure the scan line crosses every bar and space of the symbol, see the figure below. 3. Upon successful decode, the reader beeps and the LED turns green. Tips: Do not hold the reader directly over the barcode.
  • Page 230 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 231 Parameter Defaults Refer to the following table for parameter defaults of LS2208. Parameter Defaults 1-D Symbologies UPC/EAN UPC-A Enable UPC-E Enable UPC-E1 Disable EAN-8/JAN 8 Enable EAN-13/JAN 13 Enable Bookland EAN Disable Decode UPC/EAN/JAN Supplementals (2and 5 digits) Ignore UPC/EAN/JAN Supplemental Redundancy Transmit UPC-A Check Digit Enable Transmit UPC-E Check Digit...
  • Page 232 Parameter Defaults 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 Disable Convert I 2 of 5 to EAN 13 Disable Codabar (NW - 7) Codabar...

  • Page 233: Appendix C Iworks (Auto Workflow Protocol

    Appendix C iWorks (Auto Workflow Protocol) Overview The major objective of ultrasound workflow automation (iWorks) is to speed up exam time and reduce the excessive number of user interface manual key strokes that can lead to repetitive motion injuries over time. It automates a clinical work flow in common exam protocols in a logical, “step by step” manner.
  • Page 234 Screen Display  Normal iWorks For automated protocols of vascular, small parts, cardiac, abdomen and gynecology application regions, the monitor displays the following screen: Name Description Displays the protocol name, and the number of views contained; There may be prompt information here to indicate the following operation. The current active view, with green solid frame around the image.

  • Page 235: Appendix D Printer Adapter

    If peripherals other than those permitted by Mindray used within patient environment, user should ensure the overall leakage current of peripherals and the ultrasound system meets the requirement of the local medical device electrical regulations (e.g., the touch leakage current should be no...
  • Page 237 P/N: 046-017673-00 (1.0)

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