Mindray DP-50 Operator's Manual

Mindray DP-50 Operator's Manual

Digital ultrasonic diagnostic imaging system
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DP-50
Digital Ultrasonic Diagnostic
Imaging System
Operator's Manual
[Basic Volume]

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Summary of Contents for Mindray DP-50

  • Page 1 DP-50 Digital Ultrasonic Diagnostic Imaging 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 ....................III Important Information ........................IV About This Manual ..........................V Notation Conventions ........................V Operator’s Manuals ........................... V Manuals on Paper ..........................
  • Page 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 ......................3-8 Analog Video Printer ......................3-9 3.10 External DVD ........................
  • Page 5 6.2.4 Linked Cine Review ...................... 6-5 Cine Memory ........................6-5 6.3.1 Cine Memory Setting ....................6-5 6.3.2 Cine Memory Clear ....................... 6-6 Preset ........................... 6-6 Measurement ....................... 7-1 Basic operations ........................7-1 General Measurements ......................7-1 7.2.1 2D General Measurements ..................7-1 7.2.2 M General Measurements ....................
  • Page 6 9.7.3 System Login ......................9-16 9.7.4 Add/ Delete a User ..................... 9-16 9.7.5 Modify Password ......................9-18 10 DICOM ........................10-1 10.1 DICOM Preset ........................10-1 10.1.1 Network Preset ......................10-1 10.1.2 DICOM Preset ......................10-2 10.1.3 DICOM Service ......................10-4 10.2 Verify Connectivity ......................
  • Page 7 12.1.5 Probes Cleaning and Disinfection ................12-8 12.1.6 Storage and Transportation ..................12-11 12.2 Biopsy Guide ........................12-11 12.2.1 Basic Procedures for Biopsy Guiding ............... 12-14 12.2.2 Needle-guided Brackets ................... 12-14 12.2.3 Biopsy Preset ......................12-19 12.2.4 Needle-guided Bracket Inspection and Installation ..........12-20 12.2.5 Biopsy Menu ......................
  • 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: Customer Service Department

    Customer Service Department Manufacturer: Shenzhen Mindray Bio-Medical Electronics Co., Ltd. Address: Mindray Building,Keji 12th Road South,High-tech industrial park,Nanshan,Shenzhen 518057,P.R.China Website: www.mindray.com service@mindray.com E-mail Address: Tel: +86 755 81888998 Fax: +86 755 26582680 Mindray DS USA, Inc. 800 MacArthur Blvd. Mahwah, NJ 07430-0619 USA...
  • Page 12: 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 13: About This Manual

    About This Manual This operator’s manual describes the operating procedures for this diagnostic ultrasound system DP-50 and the compatible probes. To ensure safe and correct operations, carefully read and understand the manual before operating the system. Notation Conventions In this operator’s manual, the following words are used besides the safety precautions (refer to "Safety Precautions").
  • Page 14: 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: <Buttons>: The angular bracket indicates buttons, knobs and other controls on control panel.
  • 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: IP68 According to the degree of safety of application in the presence of a FLAMMABLE...
  • 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 DO NOT touch the Signal I/O ports if in contact with the patient; otherwise patient injury may result. 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 19. The ultrasound system use a mains plug as isolation means to the mains power supply. Please do not set the ultrasound system in a place difficult to operate the mains plug. 20. Do not modify this equipment without authorization of the manufacture.
  • Page 20 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 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 The system should be powered by battery when the integrality and reliability of the protective grounding of external power supply is indeterminate. The replaceable fuse is inside the chassis. Refer replacing job to Mindray service engineers or engineers authorized by Mindray only.
  • Page 23 Please read the following precautions carefully to ensure the safety of the patient and the operator when using the probes. The ultrasonic probe is only for use with the specified WARNING: ultrasonic diagnostic system. Please refer to the “2.5.2 Probes Available” to select the proper probe. The ultrasonic probe must be used only by qualified professionals.
  • Page 24 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 Service Department sales representative. The probe sheath contains natural rubber that can cause allergic reactions in some individuals.
  • Page 25: Latex Alert

    Latex Alert When choosing a probe sheath, it is recommended that you directly contact CIVCO for obtaining probe sheath, pricing information, samples and local distribution information. For CIVCO information, please contact the following: CIVCO Medical Instruments Tel: 1-800-445-6741 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),...
  • Page 26: 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 Digital Ultrasonic Diagnostic Imaging System is applicable for adults, pregnant women, pediatric patients and neonates. It is intended for use in fetal, abdominal, pediatric, small organ(breast, thyroid, testes), neonatal and adult cephalic, trans-rectal, trans-vaginal, musculo-skeletal(conventional, superficial), cardiac(pediatric) and peripheral vascular exams. Contraindication The diagnostic ultrasound system is not intended for ophthalmic use.
  • Page 28: Environmental Conditions

    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. 2.4.4 Size and weights Size: 190mm×415mm×378mm (Depth×Width×Height) Net Weight: 8.6 kg (including battery and ACDC module) System Configuration...
  • Page 29 Region Probe Model Category Intended Use Applied Linear Abdominal, Pediatric, Small organ, Neonatal 75L53EA Cephalic, Musculo-skeletal (conventional, Body surface superficial), Peripheral Vascular Abdominal, Pediatric, Small organ, Neonatal 10L24EA Linear Cephalic, Musculo-skeletal (conventional, Body surface superficial), Peripheral Vascular Some of the probes have matched needle-guided brackets for biopsy, the available probes and the corresponding needle-guided brackets are listed as follows: Needle-guided Biopsy Angle/...
  • Page 30: Options

    2.5.3 Options Item iClear module IMT module DICOM basic module (including: task management, DICOM storage, DICOM print, DICOM storage commitment, DICOM media storage (including DICOM DIR) and etc.) DICOM worklist module (only can be applied with the DICOM basic function module configured) DVD R/W Drive: Model: SE-S224 (USB port)
  • Page 31: Introduction Of Each Unit

    This system complies with IEC60601-1-2:2007, and its RF WARNING: emission meets the requirements of CISPR11 Class B. In a domestic environment, the customer or the user should guarantee to connect the system with Class B peripheral devices; otherwise RF interference may result and the customer or the user must take adequate measures accordingly.
  • Page 32 Name Function Probe holder Used to place the probe Displays the image and parameters during scanning (tilt angle LCD Display adjustable) Control Panel Refer to the 2.6.3 Control Panel. Lock button (x2) Press to release the control panel while it’s folded Handle Used to carry the machine 2-6 System Overview...
  • Page 33: I/O Panel

    Name Function Interface panel used for inputting and outputting signals, refer I/O Panel to 2.6.1 I/O Panel. Power supply panel Electrical port panel, refer to 2.6.2 Power Supply Panel. Probe ports Used to connect the probe Battery cover Used to hold the battery USB ports Used to connect USB devices 2.6.1...
  • Page 34: Control 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 Name Description Function Off: when system is turned off; Power button Green: when system is turned on by pressing this button.
  • Page 35 Name Description Function User-defined You can assign a function to the key. F1~F4 Biopsy Press to show or hide the biopsy guide line. Setup Press to open/close the setup menu. Press to delete the comment, etc. Alphanumeric Same as on PC keys Arrow Press to enter or exit the arrow comment status.
  • Page 36 Name Description Function Caliper Press to enter/ exit General Measurement Rotate: to adjust B or M gain Gain/ iTouch Press: to enter/ exit iTouch Save 1 Press to save, user-defined key Save 2 Press to save, user-defined key Press to confirm an operation, same as the left- button of a mouse.
  • Page 37: 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: System Preparation

    System Preparation Move/Posit 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 40: Powering On/ Off

    – 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 41: 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 42: 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 43: 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; WARNING: otherwise , the ultrasound system or the USB device and/ or data stored in the device may be damaged.
  • Page 44 3. Power on the system and the printer. 4. Install the printer driver (drivers of printers listed in “2.5.4 Peripherals Supported” have already installed): (1) Enter [Setup]-> [Print Preset]. Enter “Printer Driver” page and the printers that are installed automatically will be displayed in the list with the “Status”...
  • Page 45 Drivers of some HP printers have already been integrated in the system, and will be installed automatically. If the auto-installation fails, a warning icon will display on the right lower corner of the screen. You need to install the printer driver manually: a) Download the ppd file from the printer’s official website (contact R&D engineer if necessary), and copy the ppd file to the storage device (USB disk as an example).
  • Page 46: Digital Video Printer

    Print Service You can use a graph/ text printer to print report or images. 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;...
  • Page 47: Analog Video Printer

    Analog Video Printer 1. Connect the printer (VIDEO IN port) and the ultrasound system (S-Video on IO panel) with the signal cable; 2. Connect the Remote cable on printer to the Remote port on the ultrasound system. 3. Connect the power cord to a power supply receptacle that is well grounded. 4.
  • Page 48 Information Area The information area displays manufacturer logo, hospital name, exam date & time, acoustic power & MI/TI, freeze icon, patient information, probe model, current exam mode, and accession #, etc. It can be preset whether to display the operator, patient gender, age, ID, name etc.
  • Page 49 Menu title Tags Items Menu title Displays the menu name. Tags Attribute tags of the item. Items Refers to the items on a menu. For item that is applicable for more than one mode, the item appears as universal item in the certain mode. Items of image modes and measurement can be preset (refer to "11 Setup"...
  • Page 50: Basic Operations Of Screens

    position (located at depth axis in the form of ), besides, the annotation, bodymark, measurement calipers, grayscale bar are also displayed here. Thumbnail preview & Zoom Window (image-in-image) In the zoom status, this area displays the thumbnail of a complete image, and a rectangular frame is used to highlight the currently magnified area.
  • Page 51 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. For some screens, contents are distributed across several pages. Use the selection pointer and <Set> key to Page Tab open/close the 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: New patient information: to start a new patient exam, enter the patient information first, for details, please refer to “4.2.1 New Patient Information”.
  • Page 54 You can also change the cursor position by <Tab>, <Enter> or up/down controls Information includes: 1. General information Name Enter patient name through the keyboard. Characters of A through Z and 0 through 9 and “.” are allowed. “\”, “^”, “=” and “, ” are not permitted. Patient ID Patient ID is generated automatically by the system after starting a new patient, and can be modified manually.
  • Page 55 NOTE: When you enter the date manually, please enter it in the format as that of the system. 2. Exam Type Exam application type You can select among: ABD (Abdomen), OB (Obstetrics), GYN (Gynecology), CARD (Cardiac), VAS (Vascular), URO (Urology), SMP (Small Part), and PED (Pediatrics). Select the exam type tab to enter the exam-specific information.
  • Page 56 Exam Type Information Description (Gynecology) Gravida Times of pregnancy. Para Times of delivery 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 CARD area)
  • Page 57: Retrieve Patient Information

    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. You can enter the searching conditions for the patient. 1. To enter iStation screen (the screen is shown as follows): Press <iStation>...
  • 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: Dual Probe Switching

    (2) Roll the trackball and press <Set> to select the exam mode, and use the direction keys to turn pages of the exam modes. To save the image parameters for the current exam mode quickly: (1) Click [Save] 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: Bi-Plane Endocavity Probe (65Eb10Ea)

    4.3.4 Bi-plane Endocavity Probe (65EB10EA) Selecting Exam Mode 1. Connect 65EB10EA to the ultrasound system. 2. Press <Probe> on the control panel to enter the exam mode selecting screen. Roll the trackball and press <Set> to switch the S or T plane of the probe, or select the exam mode of the S/T plane of 65EB10EA probe.
  • Page 62: Activate& Continue An Exam

    Activate& Continue an Exam 4.5.1 Activate an Exam Select an exam finished within 24 hours, select the exam record, click from the menu popped up; or, click [Active Exam] in “iStation” or “Review” screen to activate the exam. Note: The system can automatically load the patient information and exam data to continue the exam.
  • 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: B Mode

    Requirement Available Operations Adjust [Dynamic Range] Adjust [Map] To modify gray scale image effect Adjust [Persistence] Adjust [iClear] Decrease [Depth] Decrease the [Focus Number] To increase frame Decrease the [FOV] rate Decrease [Line Density] Turn on [High FR] in harmonic mode Adjusting through Image Menu: Press <Menu>...
  • Page 65: B Mode Image Optimization

    5.3.3 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. Operation Rotate the <Gain/iTouch> knob clockwise to increase the gain, and anticlockwise to decrease.
  • Page 66 A. power Description Refers to the power of ultrasonic wave transmitted by the probe, the real-time value of which is displayed in the image parameter area in the upper left corner of the screen. Operation Adjust through the [Acoustic Power] item in the image menu; The adjusting range is 7%-100% in increments of 3%.
  • Page 67 Dynamic Range Description This function is used to adjust the B image resolution to compress or expand the gray display range. The real-time dynamic range value is displayed on the image parameter area in the upper left corner of the screen. Operation Adjust through the [Dyn Ra.] item in the menu.
  • Page 68 iBeam Description This function is used to superimpose and average images of different steer angles to obtain image optimization. Operation Adjust through the [iBeam] item in the menu; Off: no iBeam On: maximum iBeam optimization Effects Images after iBeam processing can be optimized with less spot noise and higher resolution, so that more details for the structure are revealed.
  • Page 69 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

    Operation In single B mode when THI is turned on, click the [High FR] item in the menu to obtain images with high frame rates. HScale Description Display or hide the width scale (horizontal scale). The scale of the horizontal scale is the same as that of vertical scale (depth), they change together in zoom mode, or when the number of the image window changes.
  • Page 71 Operation Rotate the <Gain/ iTouch> knob clockwise to increase the gain, and anti- clockwise to decrease. The adjusting range is 0-100. Effects Increasing the gain will brighten the image and you can see more received signals. However, noise may also be increased. Focus Position Description To change the focus position in M mode, symbols as "...
  • Page 72 Colorize and Colorize Map Description Colorize function provides an imaging process based on color difference rather than gray distinction. Operation Turn on or off the function through the [Colorize] item in the menu; Select the colorize map through the [Colorize Map] item in the menu; The system provides 16 different maps to be selected among.
  • Page 73: Image Preset

    Operation Adjust through the [Edge Enhance] item in the menu; The system provides 14 levels of edge enhance effects, off represents no edge enhance is turned on, and the bigger the value the stronger the effect. Impacts Larger edge enhance may lead to noise increasing. Dynamic Range Description Adjusts contrast resolution of an image, compresses or expands gray display...
  • Page 74 3. Select an exam mode and probe. Select “ABD” (Abdomen) from the drop-down list of “Exam Mode”. Select “35C50EA” (for example) from the drop-down list of “Probe”. 4. Image parameter preset The [ABD-- All Probe] field on the left side of the screen displays the parameter preset for all probes in ABD exam mode.
  • Page 75 Probe Specific Items Focus Position Drop-down list To set the default focus position in B Mode. Focus Number Drop-down list To set the default focus number in B Mode. To set the default steer angle for the linear probe in Steer Drop-down list B mode.
  • Page 77: Display & Cine Review

    Display & Cine Review Image Display 6.1.1 Splitting Display The system supports dual-split (B/B) and quad-split (4B) 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 78: Freeze/ Unfreeze The Image

    6.1.2.2 Pan Zoom Procedures: 1. Enter Zoom: Freeze the image, press <Depth/Zoom> knob on the control panel to light the Zoom indicator. Image-in-image is displayed. 2. Rotate <Depth/Zoom> knob to change the magnification factor among 0.8-10. 3. Exit: Press <Depth/Zoom>. Unfreeze the image, the system exit pan zooming status automatically.
  • Page 79: Cine Review

    In freeze mode, the system supports imaging mode switching between the sub- modes (only for the activated window). The imaging mode and parameters of an unfrozen image is the same as the corresponding one that before frozen; but the display format is the same as the one before unfrozen.
  • Page 80: Cine Review In 2D Mode

    Open cine files in thumbnail, iStation or Review, the system enters automatic cine review status. To exit cine review: Press <Freeze> key again, the system will return to image scanning and exit cine review. Press <Cine> or <Esc>, the images are still frozen but the system exits cine review. 6.2.2 Cine Review in 2D Mode Manual cine review...
  • Page 81: Linked Cine Review

    stored images are invoked. When you review the images until the earliest or the latest frame, further rolling the trackball will display the last or first frame. The cine progress bar at the bottom of the screen (as shown in the figure below): Start mark Cursor Time played Time in all...
  • Page 82: Cine Memory Clear

    6.3.2 Cine Memory Clear In the following conditions, the cine review memory will be cleared: Start an exam of a new patient. Start a new exam for the same patient. Switching the probe (if the cine memory is split, only the cine memory corresponding to the currently activated window is cleared) Changing the exam condition (if the cine memory is split, only the cine memory corresponding to the currently activated window is cleared)
  • Page 83: 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...
  • Page 84: 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 Measures the length of a curve on the image. Measures the lengths of any two line segments and the calculated Distance Ratio ratio.
  • Page 85: Application Measurement

    Application Measurement The system support following measurement types: 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 indexed (including EFW) as well as GA and EDD calculations.
  • Page 86: Measurement Accuracy

    Measurement Accuracy Table 1 Error of 2D Images Parameter Value Range Error Within ±3%; or when the measured value is less Distance Full screen than 40 mm, the error is less than1.5 mm. Within ±7%; or when the measured value is less Area (Trace) Full screen than 16 cm...
  • Page 87: 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 88: Adding Comments

    The default is the comment text library in the current exam mode. When entered the comment status, the system displays the customized comment text library for the current exam. If there is no customized comment text library for the current exam, it will display the comment text libraries of all the exam modes assigned for the current probe.
  • Page 89: Moving Comments

    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. Roll the trackball to move the comment to the new position. 3.
  • Page 90: 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 and Vascular applications. You can preset the system configured general body marks for each exam mode, also, you can customize the body mark.
  • Page 91: Moving Body Marks

    8.2.4 Moving Body Marks You can move the body mark graphic to any desired position within the image area. 1. Roll the trackball to move the cursor onto the body mark. The cursor changes into indicating you can move the pictogram to a new position. 2.
  • Page 93: 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 94: Image File Management

    Image File Management You can store the image files either in the patient database in the system, or to external memory devices. For a save image, you can perform operations like image reviewing, analyzing and demonstration (iVision). 9.2.1 Storage Media System supported memory media including: System hard disk USB memory devices: USB flash drive, removable USB hard disk...
  • Page 95: Saving Images To The System

    Set single frame export format Format You can select the image export format in the Send To dialogue box. NOTE: Compression in a JPEG format may result in image distortion. Set cine saving length For details, please refer to “6.4 Preset”. 9.2.4 Saving Images to the System To save a single-frame image in the system:...
  • Page 96: Quickly Saving Full Screen Image To The System

    (3) Press the user-defined key to save the cineloop. 9.2.6 Quickly Saving Full Screen Image to the System This function can save the current full screen image to the system with the image in real-time status. 1. Set the user-defined key through the path: [Setup](by pressing <Setup>)→ [System Preset]→...
  • Page 97 To exit Review: Click [Exit] on the Review screen; or, Press <ESC> or <Review> again. Basic operations Move the cursor onto an exam item in the Exam History area and press <Set>. The selected item is highlighted. Click [Info] or [Report] to view patient information or report. Double-click a thumbnail to view and analyze an image.
  • Page 98: Ivision

    [Delete]: click to delete the selected image. Or, select the image and click Thumbnail Size Small: 4x4 Middle: 2x2 Full: 1x1 Switching operations: [New Exam]: click to create a new exam for the selected patient and open the Patient Info screen. [Activate Exam]: click to enter the currently selected exam and enter the image scanning screen;...
  • Page 99 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 or system supported image files and folders to demonstration 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 100: Sending Image File

    Option of Demo You can choose whether to repeat the demonstration or exit after a demonstration is completed. 9.2.10 Sending Image File On the image screen, select a stored image thumbnail, click (Send To) on the right corner of the image, the image can be sent to the external device, DVD recorder, DICOM storage server, DICOM print server, system connected printer and etc.
  • Page 101 Importing, exporting and sending a report In the iStation screen, select patient data, click (Restore) or (Backup) to import or export patient information, images and reports from or to an external memory device. See the following figure: In the iStation screen, click ;...
  • Page 102: Patient Data Management (Istation)

    Printing report Use a connected graph/text printer to print a report. Please refer to “11.7 Print Preset” for details about default report printer setting. For details on report relevant operations, please refer to [Advanced Volume]. 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.
  • Page 103: Searching A Patient

    Select All Exams/ Deselect All Exams Click [Select All Exams] to select all patient data listed. Then the button changes into [Deselect All Exams], you can cancel all the selections by clicking [Deselect All]. 9.4.1 Searching a Patient (1) Select the data source. (2) Set search conditions of Name, ID, DOB, Exam Date in the "Item"...
  • Page 104 : Backup. Click to export the selected patient data to the system- supported media. : Restore. Click to import the patient data from an external media. If no external data source is connected, then the button is unavailable. Send To The system supports to send data to external memory devices or print.
  • Page 105: Backing Up And Erasing Files Through Dvd Drive

    Click [Empty Recycle Bin] to empty the recycle bin and all items can never be restored again. Click [Exit] to exit Recycle Bin screen and return to iStation. 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.
  • Page 106: Patient Task Manager

    Patient Task Manager Click at the lower right corner of the screen to pop up the following dialogue box: 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 Send to external devices (including disc and USB devices): select exam data or...
  • Page 107: Access Control

    Delete Click [Cancel] to cancel the selected task. Retry Click [Retry] to retry the failed task. When the printer ran out of ink or paper, tasks in print list will be paused. Click [Retry] to continue the paused print task. Select All Click [Select All] to select all the tasks.
  • Page 108: System Login

    9.7.3 System Login If [Enable User Account Control] is selected, you can access the data in the system only after you login the system. You need to enter user name and password in the following cases: Before entering the system Changing user As long as the system is in working status, you can enter the above screens without inputting user name and password repeatedly.
  • Page 109 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 110: 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 111: 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 112: Dicom 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. IP Address IP address of the system.
  • Page 113 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 114 Name Description [Add] Click to add servers to the device list. [Set DICOM Service] Click to enter DICOM service preset, see “10.1.3 DICOM Service”. [Delete] Click to delete the selected server (s) in the device list. Note: If the currently entered name has already existed, the system will pop up: “The server name exists!”...
  • Page 115 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 116 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 117 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 118 Name Description [Add] Add the DICOM service to the service list. [Cancel] Click to cancel the parameter setting. Select an item in the service list, change the parameters in [Update] the above area, and click [Update] to update the item in the service list.
  • Page 119 DICOM service setting for Worklist is described as follows: Name Description After you set the server (s) in DICOM Server Setting screen, the Device name (s) will appear in the drop-down list, select the name of the Worklist server. Service Name Default is xxx-Worklist, and it can be modified.
  • Page 120 Name Description Click to verify if the two DICOM application entities are normally [Verify] connected. [Exit] Click to exit the screen. Note: In terms of “Scheduled Station AE Title”, if you set this item in the Worklist server, then “Scheduled Station AE Title” configured here should be consistent with the one set in the server.
  • Page 121 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 commitment server. Service Name Default is xxx-SC, and it can be modified. Application Entity title, Here, it should be consistent with that of AE Title the storage commitment server.
  • Page 122: 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 123: Dicom Print

    10.3.2 DICOM Print DICOM Print is used to send image(s) to DICOM print server to print images . Print image in iStation/Review/main screens (1) Select image(s), operations are the same with DICOM storage. (2) In the Send To dialogue box, select a DICOM print server. (3) Click [OK] to send print task.
  • Page 124 (3) Retrieve Patient Information a) Set query criteria among Patient ID, Patient Name, Accession #, Search Key, Worklist Server or Exam Date. The default exam date is the current date. b) Click [Query]. c) The scheduled patients, which meet the criteria, are displayed in the lower part of the screen.
  • Page 125: Storage Commitment

    Perform a second query; or, Click [Show Detail] to view the patient information in details: 10.3.4 Storage Commitment Storage commitment is used to make sure the images are successfully stored in the DICOM server. Before storage commitment, you should set a default storage commitment server. Storage commitment after sending images on iStation screen (1) Open iStation screen: press <iStation>...
  • Page 126: Dicom Task Manager

    Media review: 1. Connect the external media with DCM files to the system. 2. Select the data source in iStation screen, and the visible data will be shown. If there are several kinds of data on the media, the system will ask you to select the format from a dialog box.
  • Page 127: 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: Press the <Setup>...
  • Page 128: System Preset

    [Load Factory]: click [Load Factory], and all parameter settings will be restored to the original factory default. 11.1 System Preset Click [System Preset] on the Setup menu, you can preset: Page Description To set the hospital name, language, time zone, time format, system Region date/time, logo and so on.
  • Page 129: General

    Item Description To set the hospital relevant information like name, address, telephone Hospital Information and so on. 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.
  • Page 130: Image Preset

    Type Item Description To select if to display the following patient information on Info displays in the image banner: Gender, Age, Operator, ID, Name, image banner Hospital Patient Info H&W Unit To set the unit for patient height and weight. Surface Formula To set the surface formula.
  • Page 131: Meas

    Type Item Description Reset Config Probe To set the default probe model for the system. Freeze Status after Freeze To set the system status after image is frozen. Config Image Cine Memory To set the cine memory splitting type: Auto, Split. 11.1.4 Meas Open the Meas page via [Setup]->...
  • Page 132 Key function setting You can set the functions for <Print>, <Save>, F-key (F1-F4) and footswitch. To assign a function to a key: (1) Click to select the desired key in the Key Function column at the left side of the page. (2) Click to select a function in Function area.
  • Page 133: Biopsy

    11.1.7 Biopsy Open the Biopsy page via [Setup]-> [System Preset]-> [Biopsy], as shown in the figure below. Bracket To select the default needle-guided bracket for the probe. Parameter Press to display the biopsy guideline. 11.1.8 Admin Open the Admin page via [Setup]-> [System Preset]-> [Admin]. For details of access control, please refer to “9.7 Access Control”.
  • Page 134: Exam Configuration

    On the right side of the screen, you can view the exam types supported by the current probe. On the left side, you can view all the exam modes supported by the system, i.e., Exam Library. [>]: 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.
  • Page 135: Image Preset

    Tips: the user-defined exam mode supports duplicating, deleting, renaming, copying and pasting functions. Renaming Exam Mode (available to user-defined exam mode only) Select an exam mode, click [Rename]. Changing application region (available to user-defined exam mode only) Select an exam, click the application region from the [Application] column, select a value from the drop-down list.
  • Page 136: Custom Body Marks

    2. Selecting exam modes Select the exam mode in the drop-down list, the current exam mode is by default. 3. Set library: enter the library name of custom body marks. 4. Add or delete body mark(s) To add the item selected from the [Available Items] into the [Selected [>] Items].
  • Page 137: Comment Preset

    [Load File]: load a single body mark file. [Load Directory]: load all body mark files located in a directory specified. [Return]: exit the current screen. 11.6 Comment Preset You can preset the custom comments library for each exam mode to your preference. 11.6.1 Custom Comments You can preset the custom comments library for each exam mode to your preference.
  • Page 138 2. Select exam mode. 3. Enter Library Name: you can enter characters for the library name, or accept the default name (the same as that for the exam mode). 4. Add user-defined comments: directly enter comment texts, or select comment texts for the comment library.
  • Page 139: Print Preset

    11.7 Print Preset The settings of a printer include print service and print driver. 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 140: Network Preset

    11.8 Network Preset For local TCP/IP preset and DICOM preset, please refer to “10.1 DICOM Preset”. The IStorage screen is as follows: Name Description Service Name Name of the device, cannot be empty IP address of the PC installed with iStorage software, cannot be IP Address empty Press to verify connection with the PC server.
  • Page 141: Workstation Preset

    Tips: in order to make network storage function normally, setting of the sharing folder of the PC server in advance is a must, e.g. machine name, IP address, should be confirmed at first. 11.9 Workstation Preset You can preset to send the image and measurement data to Workstation, which is an image data management system.
  • Page 142: Maintenance

    11.11 Maintenance The [Maintenance] function is designed for you to update the system software or other special functions. If you require these functions, please contact Mindray Customer Service Department or sales representative. You can manage preset data, export and upload operation logs here.
  • Page 143: Probes And Biopsy

    Probes and Biopsy 12.1 Probe The system supports the following probes: Probe Model Probe Type Illustration 35C50EA Convex 65C15EA Convex 65EC10EA Intra-cavity 75L38EA Linear array Probes and Biopsy 12-1...
  • Page 144: Name And Function Of Each Part Of The Transducer

    Probe Model Probe Type Illustration 75L53EA Linear array 10L24EA Linear array 65EB10EA Convex 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 12.1.1 Name and Function of Each Part of the Transducer...
  • Page 145 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; meanwhile, it will receive the ultrasound signal and then <1> Transducer head convert the received signal into electrical signal. The lens on the surface is the acoustic lens.
  • Page 146: Orientation Of The Ultrasound Image And The Transducer Head

    Name Function It utilizes the piezoelectric effect to convert electrical <1>Transducer head signals into ultrasound waves, which are transmitted <1> (convex, vertical section) to the body, and to generate electrical signals when receiving the reflected ultrasound waves (echoes).The <2> <2>Transducer head lens on the surface is the acoustic lens.
  • Page 147: Operating Procedures

    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. Procedures for operating (with biopsy function) Inspection before examination Connection to the ultrasonic diagnostic system...
  • Page 148 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 149: Utilizing The Transducer Sheath

    12.1.4 Utilizing 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 150: 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 151 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 152 Strain relief Probe handle NOTE: Observe the graph here carefully to immerse the transducer. Only soak parts of the transducer below the strain relief. Compatible Disinfectants Manufacturer Trade Name Procedures Type Please refer to the instructions Pharmaceutical provided by the manufacturer Spray T-Spray II Innovations, Inc.
  • Page 153: Storage And Transportation

    Relative humidity: 30% to 95% (no condensation) Atmospheric pressure: 700 hPa ~ 1060 hPa 3. 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 154 Do not use a needle-guided bracket when scanning is performed. The needle may advance in an incorrect direction and possibly injure the patient. Never perform a biopsy during image scanning. Do not freeze an image while performing biopsy procedure. During biopsy procedures, the needle may deviate from desired course...
  • Page 155 Image of the biopsy target and the actual position of the biopsy needle: Diagnostic ultrasound systems produce tomographic plane images with information of a certain thickness in the thickness direction of the transducer. (That is to say, the information shown in the images consist all the information scanned in the thickness direction of the transducer.) So, even though the biopsy needle appears to have penetrated the target object...
  • Page 156: 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 157 NGB-001 Metal-needle detachable Guiding hole Groove V-shaped guiding block Lock pin Needle fixing nut Needle type adjusting base Needle type dial scale V-shaped cover Clamp Angle block Angle adjusting base Angle pinch Angle shift sign Pinch nut Metal-needle undetachable Clamping knob of the needle guide Needle guide Needle guide...
  • Page 158 NGB-002 Clamping knob of the needle guide Needle guide hole Needle guide Clamp Locating pit Needle guide rack Grip knob Locating groove Needle-guided bracket Transducer NGB-004 Locking nut Needle guide Retaining clamp Locating bulge Transducer Locating groove 12-16 Probes and Biopsy...
  • Page 159 NGB-005 Clamping knob of the needle guide Needle guide rack Needle guide Clamp Locating pit Needle guide hole Grip knob Locating groove Needle-guided bracket Transducer NGB-007 Metal: <8> <7> <6> <10> <9> <3> <4> <1> <5> <2> Probes and Biopsy 12-17...
  • Page 160 Name Description Support of needle-guided Used for installing the needle-guided bracket on <1> bracket the transducer Groove and tab of the Respectively matched with the tab and groove of <2> needle-guided bracket the transducer There are 3 types of angles available to be <3>...
  • Page 161: Biopsy Preset

    Name Description Specification of <5> Matched with the corresponding biopsy needle(13G) guiding block(13G) <6> Needle guide hole Used for installing the biopsy needle Specification of angle Corresponding to the size of the biopsy angle(60°) <7> block(60°) NGB-016 Name Description Clamp of needle-guided Used for installing the needle-guided bracket on the <1>...
  • Page 162: 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 163 Inosculate the locating groove on the clamp with the two raised edges on the transducer head and aligning the locating pit of the clamp to the convex point on the transducer head. Turn the grip knob at the tail of the needle-guided bracket tightly. NGB-002 1.
  • Page 164 2) Hold the transducer by one hand, select the proper needle-guided bracket, and hold it with the other hand. Match the groove and tab with the tab and groove of the transducer respectively. Amount the bracket onto the transducer. 3) Screw the pinch nut of the needle-guided bracket to confirm that the needle- guided bracket is properly installed on the transducer.
  • Page 165 4) Select a proper guiding block and push it into the groove above the angle block, and clamp it tightly. 5) Insert a biopsy needle with the same specification as that of the guiding block into the hole of the guiding block. NGB-016 1.
  • Page 166: Biopsy Menu

    Ensure that all guide parts are seated properly prior to performing CAUTION: a biopsy. 12.2.5 Biopsy Menu Press <Biopsy> to show the biopsy menu. Select biopsy bracket angle If the needle-guided bracket supports more than one biopsy angle, you can select the angle from the drop-down list.
  • Page 167: Removing The Needle-Guided Bracket

    NOTE: You can perform guide line verification on a single live B image only, and all biopsy-irrelevant operations are forbidden. For bi-planar probe applied biopsy, the verification is performed on the first guide line, the other guide lines can move together with the first one in parallel.
  • Page 168 Separate the bracket and the transducer from the needle. Screw the pinch nut to release the needle-guided bracket. Separate the bracket and the transducer. Metal-needle undetachable While holding the transducer and the needle-guided bracket, open the Grip knob of the needle-guided bracket.
  • Page 169 Plastic 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 transducer from the needle. 3) Remove the support of needle-guided bracket from the transducer. NGB-016 1.
  • Page 170: Clean And Sterilize The 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 disinfectant.
  • Page 171: 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 173: 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 174: Precautions

    NOTE: Only use the specified batteries. If there is only one battery in the system, it cannot supply power and cannot be charged. 13.2 Precautions 1. Before using the battery, carefully read the description in the label on the surface of the battery.
  • Page 175: Battery Status Indicator

    Battery cover To remove the battery: 1. Turn off the unit and detach the power cord from the main unit. 2. Open the battery cover. 3. Push the battery to left until it’s released. 4. Take out the battery from the bay. 13.4 Battery Status Indicator The battery status indicator is located in the lower right corner of the screen, indicating the battery capacity.
  • Page 176: Battery Disposal

    13.6 Battery Disposal NOTE: You should observe the local regulations when disposing of the battery. 13-4 Battery...
  • Page 177: 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 178: 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 179: 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 14.5 Acoustic Power Setting Acoustic power adjustment Click [A. power] in the menu to adjust the acoustic power percentage, and the value is displayed on the screen.
  • Page 180: 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. Acoustic attenuation of tissue is directly related to transducer frequency.
  • Page 181: 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 182: Measurement Uncertainty

    14.8 Measurement Uncertainty I spta 28.5% I sppa 28.5% Center frequency (f c ) Total power (W) 28.5% (5.1% for Scan-mode and Combined-mode) Peak-rarefactional pressure 14.7% 14.9 References for Acoustic Power and Safety “Bioeffects and Safety of Diagnostic Ultrasound” issued by AIUM in 1993 “Medical Ultrasound Safety”...
  • Page 183: Guidance And Manufacturer's Declaration

    Guidance and Manufacturer’s Declaration The system complies with the EMC standard IEC60601-1-2: 2007. The use of unapproved accessories may diminish system WARNING: performance. NOTE: 1 Use of accessories, probes, and cables other than those specified may result in increased emission or decreased immunity of system. 2 The system or its components should not be used adjacent to or stacked with other equipment.
  • Page 184 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 185 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 186 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 187 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 189: 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 190 Disassembling the trackball: Rotate the trackball clamp ring 35 degrees anticlockwise. When the clamping ring lifts, remove the clamping ring and trackball. You can draw out the ball with the help of adhesive tape. See the figures below. Clamp ring Track ball Rotate clamp ring 35 degrees anticlockwise Remove clamp ring...
  • Page 191: Checking Transducer

    16.2 Maintenance Checks by Service Engineer The following checks must be performed to ensure and maintain system safety and performance. Please contact Mindray Customer Service Department or sales representative to schedule and carry out these checks. Check Category Check Item...
  • Page 192: Consumables And Periodic Part Replacement

    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 193 Troubleshooting Table Failure Cause Measure After the Abnormal power system Verify that the plug has not power supply or incorrect connection become loosened or is turned on, of the power cord. dislodged from the back of the power the system. indicator does not light on.
  • Page 195: 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 196 Test Item Acceptance Criteria No physical damage to meters, switches, connectors, etc. No residue of fluid spillage (e.g., water, coffee, chemicals, etc.). No loose or missing parts (e.g., knobs, dials, terminals, etc.). A.2.2 Contextual Inspection Test Item Acceptance Criteria No unusual noises (e.g., a rattle inside the case).
  • Page 197 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. normal polarity (Normal Condition); reverse polarity (Normal Condition); normal polarity with open neutral (Single Fault Condition);...
  • Page 198 Reversed Polarity. LIMITS For BF applied parts: 5000 μA. Patient Auxiliary Current Patient Auxiliary currents are measured between any selected Applied Part connector and the remaining Applied Part connectors. All measurements may have a true RMS only response. The following outlet conditions apply when performing the Patient Auxiliary Current test. normal polarity (Normal Condition);...
  • Page 199 P/N: 046-001834-01 (V1.0)

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