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Mindray Resona I9 Exp Resona I9S Operator's Manual

Diagnostic ultrasound system

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Resona I9/Resona I9 Exp/Resona I9S/

Resona I9T/Resona I9 Easi/Resona I9

Nasa/Anesus I9/Anesus I9 Easi/Eagus I9/

Resona IV/Imagyn I9/Imagyn I9S/Imagyn

I9 Easi/Nuewa I9/Nuewa I9S/Nuewa I9

Easi/Nuewa I9T/Nuewa I9 Exp/Recho I9/

Recho I9 Pro/Recho I9 Exp/Recho I9S/

Recho I9T/Resona I9W

Diagnostic Ultrasound System

Operator's Manual

[Basic Volume]

Table of Contents

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Page 1 Resona I9/Resona I9 Exp/Resona I9S/ Resona I9T/Resona I9 Easi/Resona I9 Nasa/Anesus I9/Anesus I9 Easi/Eagus I9/ Resona IV/Imagyn I9/Imagyn I9S/Imagyn I9 Easi/Nuewa I9/Nuewa I9S/Nuewa I9 Easi/Nuewa I9T/Nuewa I9 Exp/Recho I9/ Recho I9 Pro/Recho I9 Exp/Recho I9S/ Recho I9T/Resona I9W Diagnostic Ultrasound System Operator’s Manual [Basic Volume]...
Page 3: 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 4: Customer Service Department
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 5: About This Manual
• Important data must be backed up on external memory media. • Mindray shall not be liable for loss of data stored in the memory of this system caused by operator error or accidents. • This manual contains warnings regarding foreseeable potential dangers, but you shall also be continuously alert to dangers other than those indicated.
Page 6: Software Interfaces In This Manual
As a health care provider, you may report the occurrence of certain events to SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD., and possibly to the competent authority of the Member state in which the user and / or patient is established.
Page 7 LTD. requests to be notified of device failures or malfunctions. This information is required to ensure that SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD. provides only the highest quality products.
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Page 9: Table Of Contents
Contents Intellectual Property Statement ....................I Responsibility on the Manufacturer Party ................I Warranty ..........................I Important Information ......................II About This Manual ........................ III 1 Safety Precautions ....................1 - 1 1.1 Meaning of Safety Symbols ................... 1 - 1 1.2 Safety Precautions ......................
Page 10 Contents 3.2.3 Equipotential Terminal ..................3 - 3 3.3 Power ON/OFF ......................3 - 4 3.3.1 Check before Powering ON ................. 3 - 4 3.3.2 Power the System ON ..................3 - 5 3.3.3 Checking After Powering On ................3 - 5 3.3.4 Power the System Off ..................
Page 11 Contents 4.4.2 Comment Group Define ..................4 - 27 4.5 iWorks Preset ....................... 4 - 28 4.5.1 Protocol Management ..................4 - 28 4.5.2 View Management .................... 4 - 28 4.5.3 Create a New Protocol ..................4 - 28 4.6 Stress Echo Preset ......................4 - 29 4.6.1 Protocol Edit ......................
Page 12 Contents 6.1.1 Image Adjustment ....................6 - 1 6.1.2 Quickly Saving Image Settings ................6 - 3 6.2 B Mode ........................... 6 - 4 6.2.1 B-mode Image Scanning ..................6 - 4 6.2.2 B-mode Image Parameters ................... 6 - 4 6.3 Color Mode ........................
Page 13 Contents 6.15.7 Measurement/Comment .................. 6 - 46 6.15.8 Data Export ..................... 6 - 46 6.15.9 FH Tissue Tracking QA .................. 6 - 46 6.16 Fusion Imaging ......................6 - 47 6.16.1 Overview ......................6 - 47 6.16.2 Magnetic Positioning System ................6 - 48 6.16.3 Screen Description ..................
Page 14 Contents 7.6.2 Smart 3D Acquisition Preparation ..............7 - 18 7.7 STIC (Spatio-Temporal Image Correlation) ..............7 - 19 7.8 iLive ..........................7 - 20 7.9 3D Layout ........................7 - 22 7.10 3D Reference Point ....................7 - 23 7.11 3D-Print Format ......................
Page 15 Contents 8.4.3 Image Parameters ....................8 - 13 9 Contrast Imaging ....................9 - 1 9.1 Basic Procedures for Contrast Imaging ................. 9 - 1 9.2 Left Ventricular Opacification ..................9 - 2 9.3 CEUS Chrono-Parametric Mode ................... 9 - 2 9.3.1 2D ........................
Page 16 Contents 13.5 Image Compare ......................13 - 6 13.5.1 Image Compare in Review Mode ..............13 - 6 13.5.2 Frame Compare ....................13 - 6 13.5.3 iCompare ......................13 - 7 13.6 Cine Saving ........................ 13 - 7 13.7 Setting Cine Length ....................13 - 8 13.7.1 Live capture .....................
Page 17 Contents 16.1 Image File Management .................... 16 - 1 16.1.1 Storage Media ....................16 - 1 16.1.2 Image File Formats ..................16 - 1 16.1.3 Image Storage Setting ..................16 - 2 16.1.4 Saving Images to the System ................16 - 2 16.1.5 Saving Images/Cines File to USB Flash Drive ..........
Page 18 Contents 17.2.8 Disposal ......................17 - 62 17.3 Needle Navigation Guiding ..................17 - 62 17.3.1 Basic Procedures for Needle Navigation Guiding ......... 17 - 64 17.3.2 Installation ..................... 17 - 65 17.3.3 Accuracy Verification ..................17 - 71 17.3.4 Mark ....................... 17 - 72 17.3.5 Screen Display in the Guiding ...............
Page 19 Contents C.5 Measurement, Comments, and Body Mark ..............C - 2 D iVision .........................D - 1 E Acoustic Output ....................E - 1 E.1 Concerns with Bioeffects ....................E - 1 E.2 Prudent Use Statement ....................E - 1 E.3 ALARA Principle (As Low As Reasonably Achievable) ..........E - 1 E.4 MI/TI Explanation ......................
Page 20 Contents K Indications For Use ................... K - 1 Operator’s Manual...
Page 21: Safety Precautions
Safety Precautions Meaning of Safety Symbols Symbol Description Type-BF applied part The ultrasound probes connected to this system are type-BF applied parts. The PCG leads within this system is type-BF applied part. General warning sign. Patient injury or tissue damage from ultrasonic radiation. The ALARA principle must be practiced when operating the ultrasound system.
Page 22: Safety Precautions
• DO NOT use a probe that has a damaged, scratched surface, or exposed wiring of any kind. Immediately stop using the probe and contact Mindray Customer Service Department or sales representative. There is risk of electric shock if using a damaged or scratched transducer.
Page 23 1 Safety Precautions • The auxiliary power output outlet in the system is used to supply power for the recommended peripheral devices. Do not connect other devices to the outlet, otherwise, the rated output power may be exceeded and failure may be resulted.
Page 24 If the circuit protector is tripped, it indicates that the system or a peripheral device was improperly shut down and the system is unstable. You cannot repair the system under this circumstance and must call the Mindray Customer Service Department or sales representative.
Page 25 1 Safety Precautions • Do not use a USB memory device (e.g., a USB flash drive, removable hard disk) which has unsafe data. Otherwise, system damage may result. • It is recommended to only use the video devices specified in this manual. •...
Page 26 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 27 • Please use the disinfection or sterilization solution recommended in this operator's manual; otherwise Mindray will not be liable for damage caused by other solutions. If you have any questions, please contact Mindray Customer Service Department or sales representative.
Page 28: Latex Alert
1 Safety Precautions Latex Alert When choosing a probe sheath, it is recommended that you directly contact CIVCO for obtaining information regarding probe sheaths, pricing, samples and local distribution. For CIVCO information, please contact the following: CIVCO Medical Instruments Tel: 1-800-445-6741 www.civco.com WARNING Allergic reactions in patients sensitive to latex (natural rubber) may range from...
Page 29: System Overview
System Overview Intended Use Resona I9 series Diagnostic Ultrasound System is applicable for adults, pregnant women, pediatric patients and neonates. It is intended for use in fetal, abdominal, Intra-operative (includes abdominal, thoracic, and vascular), Laparoscopic, pediatric, small organ (breast, thyroid, testes), neonatal and adult cephalic, trans-rectal, trans-vaginal, musculo-skeletal (conventional, superficial), Thoracic/Pleural, adult and pediatric cardiac, trans-esoph.
Page 30: Product Specifications
2 System Overview CONTINUOUS OPERATION • The device equipped with the applied part of defibrillation protection: The device is not equipped with the applied part of defibrillation protection. • According to the signal input and output parts of the device: The device is equipped with signal input and output parts •...
Page 31: Dimensions And Weight
2 System Overview 2.4.3 Dimensions and Weight • Dimensions (The monitor and the control panel are kept to a minimum position): – Length: 1020±20mm – Width: 550±10mm – Height: 1000±20mm • Weight: 105kg±4kg (Standard configuration) Product Differences Model B-Hist B-Hist B-Hist B-Hist Profile Spline...
Page 32: System Configuration
2 System Overview Model B-Hist B-Hist B-Hist B-Hist Profile Spline Color Cross Double (Ellipse) (Trace) (Spline) (Rectangle) Length dist Recho I9T √ √ × √ × √ × √ √ Resona I9W √ × √ √ √ √ × √ √...
Page 33 2 System Overview Item Remarks Intra-cavity probe holder (with screws) ECG Module Kit(AHA) ECG cable 3-Lead Leadset, Adt/Ped, AHA, Clip, Long The ECG module should be configured. DC-IN cable The ECG module should be configured. PCG Transducer Kit The ECG module should be configured. Ultrasound Fusion Imaging •...
Page 34 2 System Overview Item Remarks iVocal Microphone Package iVocal should be configured. Wipes box bracket Probe Container LAP13-4Cs should be configured. iScape View Free Xros M Free Xros CM Tissue Doppler Imaging Cardiology Package should be configured. TDI QA Tissue Doppler Imaging should be configured. Contrast Imaging Contrast Imaging QA Contrast Imaging should be configured.
Page 35 2 System Overview Item Remarks Smart Face 4D module and Obstetrics Package should be configured. Smart ICV Smart Planes CNS should be configured. Smart Scene 3D 4D module should be configured. Ultrasound Fusion Imaging • Fusion imaging module or Fusion imaging module (including trolley) should be configured.
Page 36 2 System Overview Item Remarks Small Parts Package 100. Urology Package 101. Vascular Package 102. Pediatrics Package 103. Nerve Package 104. Emergency&Critical Package 105. Pelvic Floor Package Gynecology Package should be configured. 106. Smart Pelvic Pelvic Floor Package should be configured. 107.
Page 37: Peripherals Supported
2 System Overview 2.6.4 Peripherals Supported Item Model Graph/text printer HP OFFICEJET PRO 8100 CANON TS708 Epson L130 HP 8100 (CM752A) Black/white video printer (digital) MITSUBISHI P95DW-N Black/white video printer (analog) SONY UP-X898MD Digital color video printer SONY UP-D25MD iVocal Microphone SAMSON XPD2 (iVocal should be configured) Barcode reader LS2208...
Page 38: Introduction Of Each Unit
2 System Overview Introduction of Each Unit 2 - 10 Operator’s Manual...
Page 39 2 System Overview Item Description Monitor Displays the images and parameters during scanning. Touch Screen Screen-touching operator-system interface or control. Ultrasound gel warmer Used for heating the ultrasound gel. Transducer& ultrasound gel Used for placing transducers or ultrasound gel temporarily. holder Control panel Key- pressing operator-system interface or control.
Page 40 2 System Overview Item Description Touch control handle Holding the right part of the handle to display the battery indicator on the control panel. NOTE: Available only after the battery assembly is configured. Control panel adjusting lever Used for lifting or swiveling the control panel. Central brake Used for locking the 3 full-lock casters.
Page 41: Power Supply Panel
2 System Overview 2.7.1 Power Supply Panel Name Function Alternative current Supply power for optional peripheral devices. auxiliary output 1 Alternative current Supply power for optional peripheral devices. auxiliary output 2 AC Power inlet AC power inlet Equipotential Used for equipotential connection, that balances the protective terminal earth potentials between the system and other electrical equipment.
Page 42: I/O Panel
2 System Overview 2.7.2 I/O Panel Front I/O Panel <1> <2> <3> <4> <5> <6> Name Function Used for connecting a pencil probe. PCG signal input port. Used for connecting PCG cables. ECG/DC IN • ECG lead signal input port/external ECG signal input terminal. •...
Page 43 2 System Overview Back I/O Panel Name Function High definition multimedia interface. Used for connecting TV, projector, ultrasound workstation video capture card, etc. VGA signal output. Used for connecting TV, Projector, ultrasound workstation video capture card, etc. High speed USB port. Used for connecting storage device such as USB disk, Fusion imaging module, bar code reader, printer, footswitch, DVD recorder, etc.
Page 44: Control Panel
2 System Overview 2.7.3 Control Panel Name Description Power button/ Power button: Turn on/turn off the system. Indicator Indicator: • AC (Alternating current). It turns on at AC supply. • Standby. It blinks in orange in standby status. • Hard disk indicator. It blinks when reading the disk. Soft menu key (1- •...
Page 45 2 System Overview Name Description • Press to enter or exit Color mode • Rotate to adjust Color/Power gain; while in 3D/4D mode, rotate the knob to make the 3D image rotates around Z axis. • Press to enter or exit the 3D mode. •...
Page 46 2 System Overview Name Description Press to enter or exit Comment status. Cursor Press to display/hide the cursor. Set key. The function is determined based on the actual situation. For example, next one or previous one; or special command of some special modes.
Page 47: Keyboard
2 System Overview 2.7.4 Keyboard Common functional keys Function Confirm the input data; or moves the cursor to the head of next row of the text or the input field. Cancel the operation or exit. Jump to the next operable item. Space key Insert a space.
Page 48 2 System Overview Description Function F9 DVR Enter VCR/DVR mode. F10 Setup Setup Enter/ Exit Setup. F11 Biopsy Biopsy Display/ hide the guide line. User-defined keys, functions of which can be defined in preset. Functions of key combination The system supports multi-language input; you can use the key combinations. The key combinations include <Shift>, <Alt Gr>, <Ctrl>...
Page 49: Basic Screen & Operation
2 System Overview Basic Screen & Operation 2.8.1 Monitor Display Item Description System Information Displays the manufacturer’s logo and product model. Area Parameters Area/Menu • Displays the image parameters for the active window. If there are more than one imaging modes, the parameters are displayed by each mode.
Page 50: Dialog Box
2 System Overview Item Description Patient Information Displays the hospital name, the exam time, patient information, Area the probe model, the exam mode, etc. 2.8.2 Dialog Box A dialog box screen consists of title, page tabs, contents and buttons, etc. Item Description Title bar...
Page 51: Touch Screen
2 System Overview Menu title Menu item Operate the menu by the trackball and left/right <Set> key. Press <Cursor> to show the cursor. Roll the trackball to locate the cursor onto the item to be adjusted. – For a commanding item or command optional item: press <Set> to directly activate the item.
Page 52 2 System Overview Operation area Operations The mapping menu, and toolbar are displayed. It is available to perform the image adjustment, measures, image review, etc. Flick the edge upwards to exit. NOTE: If there is a dialog box in the screen, the mapping mode is unavailable. •...
Page 53: Warning Labels
2 System Overview NOTE: You cannot enter the stage from cine review mode or when there is a dialogue box on the screen. This stage cannot switch to mapping mode. Tap and hold the screen to enter control editing stage. Function Operations Adding a control...
Page 54: Symbols
2 System Overview The general meaning assigned to geometric shapes, safety colors and contrast colors for safety signs are as follows: Geometric Meaning Safety color Contrast color Graphical shape symbol color Prohibition White Black Mandatory action Blue White White Warning Yellow Black Black...
Page 55 2 System Overview Symbol Description Standby Standby indicator Harddisk indicator Battery indicator Direction of the probe cable Battery status indicator Positive inside and negative outside Atmospheric pressure limitation Humidity limitation Temperature limit Product serial number Manufacture date Manufacturer Federal law restricts this device to sale by or on the order of a licensed healthcare practitioner (USA).
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Page 57: System Preparation
• When using peripherals not powered by the auxiliary output of the ultrasound system, or using peripherals other than permitted by Mindray, make sure the overall leakage current of peripherals and the ultrasound system meets the requirement of the local medical device electrical regulation (like enclosure leakage current should be no more than 500uA of IEC60601-1), and the responsibility is held by the user.
Page 58: Connecting The Power Cord
3 System Preparation Unlock the four casters; hold the handle to move the system. When you move the system to a desired location, lock the four casters. CAUTION Maintain a generous – free air flowing space around the back and both sides of the system;...
Page 59: Powered By Batteries
: Indicates the battery is charging. • : Indicates the battery is not installed. • : Indicates the battery cannot be used. Please contact the Mindray service engineer. 3.2.3 Equipotential Terminal The symbol represents the equipotential terminal that is used for balancing the protective earth potentials between the system and other electrical equipment.
Page 60: Power On/Off
If the system begins to function improperly, immediately stop scanning. If the system continues to function improperly, fully shut down the system and contact the Mindray Customer Service Department or a sales representative. If you use the system in a persistent improperly functioning state, you may harm the patient or damage the equipment.
Page 61: Power The System On
3 System Preparation There are no obstacles around the system and its air vent. • Probe cleaning and disinfection. • The entire scanning environment and field must be clean. • The locking mechanism of the casters can work normally. 3.3.2 Power the System ON After the power indicator on the touch panel becomes green, press the power button to power the system on.
Page 62: Power The System 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. 3.3.4 Power the System Off You must follow the correct procedures to power the system off. Also, after you upgrade the software or when the system is down, you need to power off and restart it.
Page 63: Monitor Position Adjustment
3 System Preparation To Exit Standby Press the power button. TIP: When the system enters the standby status, and you need to power off: Press the power button to exit the standby status and then power off the system. Monitor Position Adjustment Gently hold the bottom edge of the monitor when adjusting its position.
Page 64: Rotate The Monitor
3 System Preparation NOTE: Take care not to trap your hands when adjusting the monitor up and down. 3.4.2 Rotate the Monitor The monitor can be rotated 90° to the left and 180° to the right along with the supporting arm. 180°...
Page 65: Monitor Brightness/Contrast Adjustment
3 System Preparation monitor can be locked. For more details, please refer to the operation diagram that is attached to the supporting arm. Monitor Brightness/Contrast Adjustment Monitoring the brightness and contrast adjustment is one of the most important factors for proper image qualities.
Page 66: Connecting/Disconnecting A Probe
Hang the probe cable to the hanger located under the control panel to avoid excessively bending and damaging the cable. • Only use the probes provided by Mindray. Aftermarket probes may result in damage or cause a fire. NOTE: If a probe port is not used for a long period of time, use the dustproof cover to protect the probe port from dust.
Page 67: Disconnecting A Probe
3 System Preparation Toggle the locking lever to the left side to lock the transducer connector. Position the probe properly to avoid it being treaded on or becoming wrapped around other devices. DO NOT allow the probe head to hang free. 3.7.2 Disconnecting a Probe Perform the following procedure: Toggle the locking lever to the right side.
Page 68: Probe Adapter Installation
3 System Preparation 3.7.3 Probe Adapter Installation Probe adapter illustration: Front View of the probe adapter Back View of the probe adapter Probe adapter connector Probe adapter port Handle mounting hole Tightening part Perform the following procedure: Keep the cable of the transducer downward, insert the connector into the system port. Toggle the locking lever to the left side to lock the probe adapter connector.
Page 69: Connecting Peripheral Devices
3 System Preparation Aim the mounting hole to the handle end of the ultrasound system, and push the probe adapter slowly and carefully. Turn the tightening part to the right. Insert the probe connector into the probe adapter port, and turn the lock handle 90° clockwise to lock it securely.
Page 70: Connecting The Footswitch
3 System Preparation • To remove the USB device: click to open the [Remove USB Device] screen. Select the device to be removed and click [OK]. A sound is heard when removing the USB memory device. • The diagnostic ultrasound system supports USB 3.0. 3.8.2 Connecting the Footswitch WARNING Do not connect two or more footswitches to the main unit;...
Page 71: Connecting A Video Printer
3 System Preparation In the “Property” frame, select printer from the driver list next to “Printer” in the lower screen and set the items. Click [OK] after you have finished setting. 3.8.4 Connecting a Video Printer NOTE: • Unless otherwise specified, printers listed in Chapter “2.6.4 Peripherals Supported” have drivers installed already.
Page 72 3 System Preparation Description Click to speak to the microphone (the system recognizes the vocal order). The system conducts the operations after recognizing the voice. Click to stop the voice Recognition. Click to open the Setup menu. Setup Select to enter the iVocal Setup menu. •...
Page 73 3 System Preparation Icon Function Audition the vocal command Edit the vocal command Delete the vocal command Clear the Success Rate test record of the selected vocal command Operator’s Manual 3 - 17...
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Page 75: Setup
CD/DVD or USB memory device. CAUTION When the preset data is changed, be sure to save the preset data according to the methods described in this chapter. Mindray is not responsible for the loss of preset data. •...
Page 76: Region
4 Setup Item Description Key Probe To assign the functions to the buttons on the probe. iConsole&Footswitch To assign functions to the foot switch and user-defined keys. Key Board To assign functions to the F keys of the key board. Gesture Preset the gesture on the touch screen.
Page 77: General
4 Setup 4.1.2 General Set patient information, exam setup, screen saver, Ambient Light, dispaly, iVocal setting and so on. Type Item Description PATIENT Patient Banner To select whether to display the available patient information INFO Display Content items on the screen. H&W Unit To set the unit for calculating patient height and weight.
Page 78: Image Preset
Saver • After enabling the screen saver, check “Select Picture- Mindray” to select the image from the system. Or click [Browse] to select the image on your own; you can set the interval time for the screen saver slideshow in the drop- down list beside “Interval”.
Page 79: Application
4 Setup Type Item Description Parameter Steer To set the steer mode in B + Color + PW/CW imaging mode. • C&(PW/CW): select to adjust the sample volume in color mode and sample line in PW or CW mode together. •...
Page 80 4 Setup Measure Parameter Controls are as follows: Item Description Cursor Type Type of cursor displayed on the measurement caliper and results window. Value options: • Number: the cursor always displays as “+” while different measurements are marked with numbers. •...
Page 81 4 Setup ICA/CCA && RAR Set the measurement properties of ICA, CCA, Renal A and Aorta. Preview Thumbnail Image 4.1.5 OB Set the relevant information regarding the fetal gestational age, fetal growth formula and fetal weight. To set the default formula Perform the following procedure: On the [Fetal Gestational Age], [Fetal Growth] or [Fetal Calc] page, select an OB Item in the left column.
Page 82 4 Setup Table Type Author Name SD Type Meas Value SD Unit Unit The author name Value of standard Unit of the Unit of the deviation measurement standard deviation value Row Num Row number (N) of the table Meas Value GA value Minimum value Measurement...
Page 83: Key Probe Preset
4 Setup • Measurement value, Standard deviation (-), GA value, Standard deviation (+): enter the number of days without the unit. User-defined OB Items NOTE: The calculation results of the user-defined OB formulae are used for reference rather than clinical diagnosis.
Page 84: Key Board
4 Setup 4.1.8 Key Board Select the application from the drop-down list of the “Control Panel Layout:”. Different applications have different set of key configurations. Click [Apply for All] to apply the key configuration of the current application to all applications. You can set the functions for the F keys of the key board.
Page 85: Access Control
4 Setup Type Item Description Digital Output Output Size: Select the output size. Size Resolution: Select VGA, HDMI output image resolution. DVR Output Output Size: Select DVR recording area. Max Frame Rate Select DVR recording Max Frame Rate. Retrospective Time(s) To set the time duration of the retrospective cine saving Cine Length with ECG disabled.
Page 86: Deleting A User
4 Setup Select or deselect the check box from the privilege list. Users can only access the function module with assigned privilege. Click [OK] to confirm the setting and exit the dialog box. The new user and the privilege will appear in the User List. Deleting a User Turn on the access control function and log in to the system as Administrator before you delete the user.
Page 87 4 Setup Click [Password Policy Config]: Item Description Remark Lockout Set the maximum time that a user can input For example, assume that the Threshold the wrong password. If you exceed the “Lockout Threshold” is set to maximum times, your account will be locked. 5, the “Reset Account Lockout Threshold after”...
Page 88: Scan Code Preset
4 Setup Item Description Days to keep Set days to keep the cached passwords in the local system. cached password Users can log in to the server even without accessing the network within the setting days. • Empty: the passwords are kept in the local system permanently. •...
Page 89 4 Setup Item Description Delete Add or delete a selected item. (Only the default item can be added or deleted.) Load default Restore the parameter value to the default value. 2-dimension barcode reader (2D) • General Analysis Mode Select “General” from “Analysis Mode” drop-down list: The scan codes consist of Patient ID, Other ID, Patient Name, Birth, etc.
Page 90: Workstation
For example, if the default item is set to “Patient ID”, and both the 2D and 1D barcodes fail to be matched, the obtained data is displayed in the “Patient ID” item in Patient page automatically. Import/Export Set the barcode by importing/exporting configure file. You can contact Mindray service engineer also. Worklist Options •...
Page 91: Measurement Preset
4 Setup Select/delete exam modes: On the left side, you can view all the available exam modes in the exam library for the probe. On the right side of the screen, you can view the current exam modes assigned to the probe. –...
Page 92 4 Setup Select the [2D], [M] or [Doppler] tab to go to the corresponding preset menu. – [Available Items]: general measurement tools configured by the system in the current scanning mode which are available but not assigned yet. – [Selected Items]: displays the tools to be added to the menu. Add/Remove the general measurement item using the following buttons: –...
Page 93: Application Measurement Preset
4 Setup Descriptions of the attributes are shown in the following table: Item Description Item Name Results obtained from Auto Trace are listed. The selected items will be displayed in the results window after measurement. Result Unit Select the measurement unit. Click “Unit”...
Page 94 4 Setup • Adjusting Package Positions: Select a package from the [Selected Items] and click [Move Up]/ [Move Down] to adjust the sequence that the packages in the menu are arranged in. Measurement Menu Preset The following operations are available. •...
Page 95 Report template. If the item is completed in an exam, the results will be displayed in the report. User-defined Calculations NOTE: • Please ensure the correctness and validity of the defined formula, otherwise Mindray will not be liable for damage caused by improper definition of the formula. • Trigonometric functions are in degrees, not radians.
Page 96 4 Setup • PI is accurate to 7 digits. User-defined calculations are derived from arithmetic operations in which the parameters are measurement, calculation or study results obtained in measurement items which exist in the system or are user-defined. Perform the following procedure: Select the [Measure] tab page.
Page 97: Function Description
4 Setup Attributes Descriptions Formula Displays the user-defined formula. Verify Used to verify if the formula is valid. App Region Select the application region for the user-defined item. Item Name All available measurement items of the application region selected in the previous step.
Page 98 4 Setup Function Method Number of Parameters Function Description Constant π, 3.1415926 NOTE: The letter “a” and “b” in the “Method” Column are parameters. The following physiological indicators can be added to the formula. Name Definition Unit Body surface area Prostate specific antigen ng/ml PPSA Coefficient...
Page 99: Report Preset
4 Setup Edit User-defined Items NOTE: • Adding B-Hist or B-Profile to the study is not supported. • Click [Export Custom] in the measurement preset window to export the user-defined measurement. Select the target defined item in the “Available Items”, and click [Edit]. Remove User-defined Items •...
Page 100: Comment Preset
4 Setup Select an item from the “Selected:” list, click [Up]/[Down] to adjust the position of the item in the list, as well as in the report template. Click [OK] to save the settings and exit the dialog box. Set the module display in the report: click [Setting] to make a selection; –...
Page 101: Comment Configure
4 Setup 4.4.1 Comment Configure Add comments Directly enter user-defined comment texts, or select available items (select comment texts for the comment library or select comment in groups). • Directly enter user-defined comment texts: posit the cursor in the field box above [Add Comment], enter the text comment through the keyboard, and then click [Add Comment].
Page 102: Iworks Preset
4 Setup • Delete groups: select a user-defined group, click [Delete Group]. After a user-defined group is deleted, it will not be available. • Add comments to groups: the operation is the same to that of the “Comment Configure” tab. •...
Page 103: Stress Echo Preset
4 Setup Select [OK] to confirm and exit the screen. Stress Echo Preset 4.6.1 Protocol Edit You can create, edit, delete, copy, export and load the Stress Echo protocols using the Protocol Editor dialog box. Item Description Protocol Name Enter the protocol name. Trigger Set the trigger type.
Page 104: Maintenance
4 Setup Click an available protocol on the Select Protocol screen. Click [Edit] to enter the Protocol Editor screen. Edit the protocol as described in the create protocol. Deleting a Stress Echo Protocol Click an user-defined protocol on the Select Protocol screen, click [Delete Protocol]. 4.6.2 Maintenance Item Description...
Page 105 4 Setup DICOM local preset items are described as follows: Item Description Local Host AE Title Application Entity title. DICOM Port Communication port, DICOM communication port. Service Maximum PDU data package size (not need to change), Properties ranging from 16384 to 65536; if the value is less than 16384 (Including or greater than 65536, the system automatically sets it to the SCU and...
Page 106: Dicom Service Preset
4 Setup Perform the following procedure: Click [Set DICOM Strategy]. Edit the DICOM strategy: – Add: Enter strategy name and description, and click [Add] to add a new strategy. Then the added strategy will be added to the Strategy List. –...
Page 107 4 Setup If the verification is successful, the system displays “xxx Verify Succeed.” Otherwise, it displays “xxx Verify Failed.” If verification failed, possible causes may be: wrong IP address, not able to access IP address, remote DICOM server is not running, wrong port, incorrect application name. Storage Service Preset DICOM storage preset items are described as follows: Item...
Page 108 4 Setup Item Description Encapsulated PDF Select if to encapsulate PDF format report in DICOM standard. It becomes available if SCP supports the function. Doppler Audio Set to save the audio of PW mode. Measurement • If “All” is selected, the structured report will contain all the latest measurement values displayed on the measurement report.
Page 109 4 Setup Item Description Interval Time(Sec) Reserved time. Timeout(Sec) Refers to the amount of time after which the system will stop trying to establish a connection to the service. Transport Layer Security. Select whether to encrypt the data during network transportation.
Page 110 4 Setup Item Description Port DICOM communication port, 104 by default. The port should be consistent with that of the Worklist server port. Maximum Retries Reserved feature. Interval Time(Sec) Reserved feature. Timeout(Sec) Refers to time after which the system will stop trying to establish a connection to the service.
Page 111 4 Setup Name NOTE AE Title Application Entity title. Here, it should be consistent with that of the storage commitment server. Port DICOM communication port, 104 by default. Here, the port should be consistent with that of the storage commitment server port. Maximum Retries Reserved feature.
Page 112: Network Preset
4 Setup Item Description Port DICOM communication port, 104 by default.Here, the port should be consistent with that of the HL7 server port. Maximum Retries Reserved feature. Interval Reserved feature. Time(Sec) Timeout(Sec) Refers to the amount of time after which the system will stop trying to establish a connection to the service.
Page 113: Istorage Preset
4 Setup Item Description Advance Enters the “VPN Advance Config” interface. • Reset: if the system does not respond after you click [Config], click [Reset]. • Config: enters the “OpenConnect-GUI VPN client” interface. For details about the settings, please refer to the TAP manual. NOTE: After exiting the “VPN Advance Config”...
Page 114: Q-Path Preset
4 Setup 4.8.4 Q-Path Preset You can use the ultrasound system to check data on browser directly. After you have ordered storage service of a network website service, you can check data using the website, authorized account and password (provided by the service vendor). You can open the browser (Q-View) to review previously sent DICOM data.
Page 115: Miot Preset
Click [OK] to exit, and the system will shut down. 4.8.5 MIOT Preset After the MIOT (Mindray Internet of Things) service is enabled and configured, the Ultrasound device information such as Usage, Operating duration, can be transmitted to MIOT. Item...
Page 116: Maintenance
The system enters the Option page after entering the Maintenance screen. In the Option list, the system lists all the system-supported options and their installation status (not installed or installed). Please contact the Mindray Customer Service Department or a sales representative for details. 4.10.2 Exporting Setup Data This function is used to write all setup data of the system into a disk for backup.
Page 117: Other Settings
4 Setup • If a transducer element is in malfunction, it is displayed as a red spot. • If a transducer element functions well, it is displayed as a green spot. You can export the result image to the external device. 4.10.6 Other Settings For Windows System Other preset settings are described as follows:...
Page 118: Security
Windows Defender is already installed on the system. • The McAfee software is an option. If the McAfee software is installed, the system displays “McAfee is running”. If you want to buy McAfee, contact Mindray representatives. NOTE: • McAfee cannot be uninstalled after successful installation.
Page 119: System Information
4 Setup After the ClamAV is installed, click [System Scanning] or [Global Scanning] on the [Security] Setup screen to scan the virus. When the system is connected to the Internet, click [Update] to update the antivirus library to the latest version. Transmission Encryption NOTE: This function is only applicable to Linux system.
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Page 121: Exam Preparation
Exam Preparation You can start a patient exam in the following situations: • New patient information: to start a new patient exam, patient information must first be entered. • New exam: to start a new exam for patient who is already registered, the recorded information can be obtained through either iStation or Worklist.
Page 122: Retrieve Patient Information
5 Exam Preparation NOTE: • BSA body surface area: After the height and weight are inputted, the system will automatically calculate the BSA and BMI (Body Mass Index) based on the formula. • ALT: Alanine transaminase. • Gravida: times of pregnancy •...
Page 123: Select Exam Mode And Probe
5 Exam Preparation – Click [iStation] in the “Patient Info” screen; – Click [iStation] in the Review screen. Select the data source. Select the data source in the drop-down list of “Data Source”. Search for patient information. Select [Search Options] to set up search options. The search options include “Search Field”, “Exam Date”, “Exam Type”, “Gender”, and “DOB”.
Page 124: Dual-Probe Switch
5 Exam Preparation Tap to select the probe type and exam mode, and the system exits the dialogue box to enter the selected exam mode and probe. The activation indicator of the selected probe on the front I/O panel lights in blue. Quickly switch to recently used probes and exam modes The recently used probes and exam modes are displayed on the right side of the touch screen.
Page 125: Activate& Continue An Exam
5 Exam Preparation Activate& Continue an Exam 5.3.1 Activate an Exam In iStation screen, select the exam record finished within 24 hours, and click [Activate Exam] from the menu popped up; or, click [Activate Exam] in iStation or Review screen to activate the exam. NOTE: •...
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Page 127: Image Acquisition
WARNING • The images displayed in this system are only reference for diagnosis. Mindray is not responsible for the correctness of diagnostic results. • In Dual-B imaging mode, the measurement results of the merged image may be inaccurate. Therefore, the results are provided for reference only, not for confirming a diagnosis.
Page 128 6 Image Acquisition Item Description Mode displaying Displays the current modes, click the tab to enter the mode. area (or main functional tabs) Other application Displays the available application modes related, click to enter the mode entrance modes. Parameter Displays the parameters in the current imaging mode or function. adjusting area •...
Page 129: Quickly Saving Image Settings
6 Image Acquisition Item Description Parameter Displays the parameters in the current imaging mode or function. adjusting area • Value adjustment: click the parameter item. The value increases as swiping from left to right; the value decreases as swiping from right to left.
Page 130: B Mode
6 Image Acquisition • Scenario and Subpreset: the item can be deleted, added, and set to default active item, and the position can be adjusted. Item Description Delete Delete a selected scenario or subpreset. Click a blank button, and select a desired scenario or subpreset under the currently activated probe and exam mode.
Page 131: Image Quality
6 Image Acquisition Items Remark iClear Display when the function is activated. iBeam iTouch Zoom Echo Boost Image Quality Used for switching B/THI and adjusting the frequency. The real-time value of frequency is displayed in the image parameter area, and if harmonic frequency is used, “F H” is displayed as harmonic frequency value.
Page 132 6 Image Acquisition The system compensates the signals from deeper tissue by segments to optimize the image. There are 8-segment TGC sliders on the touch screen corresponding to the areas in the image. • To increase the gain compensation at an area of interest, move the TGC slider to the right. •...
Page 133: Line Density
6 Image Acquisition B Steer To steer the beam the probe transmits. Use the <Angle> knob to complete the adjustment. TIP: Steer is available only for linear probes. ExFov Tap [ExFov] on the touch screen to turn on/off the function. For linear probes, the ExFOV function displays as trapezoid imaging.
Page 134 6 Image Acquisition • Persistence can remove image noise to make image clearer. • Persistence increase may lead to signal missing. Rotation/Flip This function provides a better observation for image display. • Invert: To invert the image horizontally or vertically. Tap [U / D] or [L / R] on the touch screen to adjust the parameters, and identify the image orientation through the “M”...
Page 135 6 Image Acquisition HDScope The image inside the ROI is clearer than these outside when the function is enabled. Tap [HDScope] on the touch screen, the ROI appears. The image inside the ROI is clearer than the outside. • When the ROI box is solid line, roll the trackball to change its position. •...
Page 136 6 Image Acquisition TIP: The system provides several preset parameters for imaging. Echo Boost The contrast is increased and the noise is decreased with the clear boundary after generating the function. Tap [Echo Boost] on the touch screen. Echo Boost value appears on the parameter area. TIP: Use phased probe to activate the function in cardiac mode.
Page 137: Color Mode
6 Image Acquisition Color Mode The Color mode is used to detect color flow, and the color is designed to judge the direction and speed of blood flow. Generally, the color above the color bar indicates the flow towards the probe, while the color below the color bar indicates the flow away from the probe;...
Page 138 6 Image Acquisition Increasing the gain will increase the flow signal presented as well as noise, while the signals may be missing when the gain is adjusted too low. Image Quality Refers to the transmitting frequency in Doppler mode of the probe, the real-time value of which is displayed in the image parameter area.
Page 139 6 Image Acquisition Flow State Refers to optimizing the various flow states. Tap [Flow State] on the touch screen to adjust the parameters. Persistence This function is to adjust the temporal smooth to optimize the image. Rotate the knob under [Persistence] on the touch screen to adjust the parameters. 0 represents no persistence.
Page 140: Smart Track
6 Image Acquisition Smart Track To optimize image parameters as per the current tissue characteristics for a better image effect. The angle and the position of the ROI are adjusted after the function is enabled. The area is tracked without being affected by the dynamic moves. Tap [Smart Track] on the touch screen under Color/Power mode.
Page 141: Power Mode
6 Image Acquisition UMA (Ultra-Micro Angiography) This function filters out low-velocity tissue signals so as to optimize the display of blood flow of low velocity in capillary vessels. After entering UMA, select the sub-mode: • cUMA (Color UMA): it is the velocity sub-mode of Color mode, used to observe color flow and provide flow direction and velocity information.
Page 142: Power Mode Image Parameters
6 Image Acquisition 6.4.2 Power Mode Image Parameters In Power mode scan, the image parameter area on the left side of the screen displays the real-time parameter values as follows: Items Meaning Frequency Color Gain Color Wall Filter Pulse Repetition Frequency PRF Because both are based on Doppler color imaging, the adjustments of Power mode are same with these of Color mode’s.
Page 143: Basic Operations
6 Image Acquisition • During V Flow scan, menus of image optimizing for B mode, Color mode and V Flow are displayed on the touch screen at the same time. You can switch among them by tapping the mode tabs. •...
Page 144: Image Optimization
6 Image Acquisition The image is frozen after completing the capture. Review the single-frame or cine file. Measure speed, volume flow and WSS. Save the single-frame and multi-frame image if necessary. Press <B> on the control panel or the user-defined key to quit V Flow mode. 6.5.2 Image Optimization Quality Tap [Quality] to adjust the image quality.
Page 145 6 Image Acquisition • The arrow becomes less with the density becoming fewer. Persistence Used for adjusting the temporal smooth to optimize the image. Rotate the knob under [Persistence] on the touch screen. 0 represents no persistence. The bigger the value is, the stronger the effect becomes. WF (Wall Filter) It filters out flow noise.
Page 146: M Mode
6 Image Acquisition ROI Size Adjust the size of ROI. Tap [ROI Size] on the touch screen to adjust. Acquire Time Tap [Acquire Time] on the touch screen to adjust the acquisition time. Sensitivity This function is an indication of the ability to detect flow, which is used to adjust the accuracy of color flow.
Page 147: Display Format
6 Image Acquisition Items Meaning Depth M Gain M Speed M Dynamic Range Gain To adjust the gain of M mode image, the real-time gain value is displayed in the image parameter area. Rotate <M> knob clockwise to increase the gain, and anticlockwise to decrease. Increasing the gain will brighten the image and you can see more received signals.
Page 148: Color M Mode (Cm)
6 Image Acquisition M Soften This feature is used to process the scan lines of M images to reject noise, making the image details to be clearer. Rotate the knob under [M Soften] to adjust the parameters on the touch screen. 0 represents the function is disabled.
Page 149: Free Xros M
6 Image Acquisition moved easily. However, in the Anatomical M mode, you can manipulate the M-mark line and move it to any position at desired angles. The system supports anatomical M scanning (including Free Xros M mode and Free Xros CM mode) in 2D imaging modes (B, Color, Power and TVI mode). CAUTION Anatomical M Mode and Color Anatomical M mode images are provided for reference only, not for confirming diagnoses.
Page 150: Anatomical M Mode Parameters
6 Image Acquisition NOTE: Only phased probe supports Free Xros CM. Perform the following procedure: In real-time 2D mode, adjust the probe and image to obtain the desired plane. Tap [TDI] on the touch screen or the user-defined TDI key to obtain the image. Tap [Free Xros CM] on the touch screen or the user-defined key to enter the mode.
Page 151: Pw/Cw Mode Image Scanning
6 Image Acquisition • In PW/CW mode, acoustic power of the transducer is synchronous with that of B mode. 6.9.1 PW/CW Mode Image Scanning Perform the following procedure: Select a premium image during B mode or B+ Color (Power) scan, and adjust to place the area of interest in the center of the image.
Page 152 6 Image Acquisition Increasing the gain will brighten the image and you can see more received signals. However, noise may also be increased. PW Sampling Gate Adjusts the SV position and size of sampling in PW mode, the real-time value of SV and SVD are displayed in the image parameter area, in which SV represents the size of the sampling gate, and SVD represents the sampling depth.
Page 153 6 Image Acquisition • Trace Smooth: To set the smooth level when tracing. • Trace Sensitivity: This function is used to set the sensitivity of tracing in the spectrum. Invert This function is used to set the display manner of spectrum. Tap [Invert] on the touch screen to complete the adjustment.
Page 154: Quick Angle
6 Image Acquisition Baseline Refers to the area where the velocity in zero in the spectrum. The map changes after being edited. To optimize the image, adjust baseline according to the actual situation to change the range of flow velocity. Rotate the knob under [Baseline] to complete the adjustment.
Page 155: Tdi Mode Image Scanning
6 Image Acquisition • Tissue Velocity Imaging (TVI): This imaging mode is used to detect tissue movement with direction and speed information. Generally the warm color indicates the movement towards the transducer, while the cool color indicates the movement away from the transducer. •...
Page 156: Tdi Quantitative Analysis
6 Image Acquisition Items Meaning Pulse Repetition Frequency PRF SV depth SV Size Angle Angle • Image parameters combine the parameters of TVI mode and M mode. In each TDI mode, the parameters that can be adjusted are similar to those in the color flow modes (Color, PW, and Power).
Page 157 6 Image Acquisition TDI review Sampling area: indicates the sampling position of the curve. The sampling lines are marked with color numbers. It can mark 8 ROIs at most. 2D grey image • Use the trackball; the images in TDI review window and 2D review review window are reviewed synchronously, since the two images are frozen at the same time.
Page 158 6 Image Acquisition Mark the interested myocardium area. One image can save 8 ROIs at most, and draw the corresponding curve in image area. Each ROI has different color; the corresponding curve is painted with each color. ROI settings: Tap [Standard ROI]/[Ellipse ROI] to select a ROI method. The cursor moves into the review area (TDI review window or 2D grey review window.
Page 159: Iscape View
6 Image Acquisition 6.11 iScape View The iScape panoramic imaging feature extends your field of view by piecing together multiple B images into a single, extended B image. Use this feature, for example, to view a complete hand or thyroid. When scanning, move the probe linearly and acquire a series of B images.
Page 160: Image Review
6 Image Acquisition Scan slowly to obtain a single extended field of view image. You can also erase and retrace if the image is not satisfactory. – During image acquisition, none of the parameters are adjustable, and functions such as measurement, comments and body marks are not available.
Page 161: Rotating The Image
6 Image Acquisition • Rotate the button anticlockwise to zoom out the image. • Roll the trackball to change position of the magnified image. • Press <Zoom> again to exit zoom mode. • When the image displayed is bigger than the image area, the thumbnail is automatically displayed.
Page 162: R-Vqs
6 Image Acquisition • In cine review mode, press <Freeze> on the control panel to return to the acquisition preparation status. 6.12 R-VQS R-VQS (RF-data based quantification on arterial stiffness) tracks movements of the upper and lower vessel walls and measures vessel diameter, displacement, coefficient of hardness and PWV (dimensionless pulse wave velocity).
Page 163: Smart B-Line
6 Image Acquisition Adjust parameters. – “Speed”: Adjust refresh speed of vessel wall motion curve. – “Position”: Adjust the location of the motion curve upwards and downwards. – “Curve Disp(Min)”/“Curve Disp(Max)”: Adjust amplitude of vessel wall motion curve. Tap [Stop Calc] or press <Freeze> to freeze the image and stop updating motion curve and result data.
Page 164: Basic Procedures For Smart B-Line
6 Image Acquisition 6.13.1 Basic Procedures for Smart B-line Perform the following procedure: Select an appropriate probe and exam mode. The system enters the B mode by default. Adjust the image parameters to obtain optimized images. Tap [Smart B-line] on the touch screen or the user-defined key to enter Smart B-line mode. Tap [Scan Areas] to select different zone combinations for examination.
Page 165: Overview
6 Image Acquisition – Avg Dist (B Line average distance): indicates the average distance of all B lines. According to the quantitative index calculated by the system, you can add image and diagnosis information. Tap the check box under the [Image] or [Diagnosis] tab to select items: Press the <Save>...
Page 166: Tissue Tracking Quantitative Analysis
6 Image Acquisition Tap [Start Calc] to measure RIMT of left carotid and right carotid. 6 RIMT values (each RIMT value represents maximum IMT value within one cardiac cycle), RIMT average value (arithmetic mean value of the 6 RIMT values), SD (standard deviation of the 6 RIMT values) and ROI length are displayed in the result pane.
Page 167: Screen Display Of Tissue Tracking Qa
6 Image Acquisition Select the corresponding section name and locate one frame image with good image effect by cine play. Use the cursor to set the reference point: – Long axis section: use the “3-point” method or “Manual” method to set. –...
Page 168 6 Image Acquisition Displays corresponding time of AVO (aortic valve open)/AVC (aortic valve close)/MVO (mitral valve open)/MVC (mitral valve close). Display curve: Velocity/ Each curve on the image is matched with a certain segment Displacement/Strain/Strain in the cardiac segmentation model (6), identified by Rate.
Page 169: Select Image And Cardiac Cycle
6 Image Acquisition Displays measurement and • EDV: Maximum value of the end diastolic volume calculation results during the trace. • EDA: Maximum value of the end diastolic area (Left Ventricular) during the trace. • ESV: Maximum value of the end systolic volume (Left Ventricular) during the trace.
Page 170: Basic Operations Of Ttqa
6 Image Acquisition • Manual trace method Press <Set> and move the cursor by using the trackball along the boundary to add the trace points gradually, after trace is finished, press <Set> twice to finish tracing. NOTE: At least 6 points should be determined by you before the system generates automated trace. Press <Set>...
Page 171: Parameter Adjustment
6 Image Acquisition • [A4C]: apical four chamber. • [A2C]: apical two chamber. • [ALAX]: apical long-axis view, also called 3-chamber view. • [PSAXB]: short axis view of base section, short axis view of mitral valve. • [PSAXM]: short axis view of base section, short axis view of papillary muscle. •...
Page 172: Bulleye
6 Image Acquisition – Circumferential Rotation curve: The X-axis represents time (s); the Y-axis represents rotation of the tissue (Deg). – Circumferential Rotation Rate curve: The X-axis represents time (s); the Y-axis represents rotation by time (Deg/s). Torsion & Torsion Rate Curve The system provides left ventricular torsion data based on short axis sections of PSAX AP and PSAX B.
Page 173: Fusion Imaging
6 Image Acquisition You can tap [Free Xros M] to enter Free Xros M mode and adjust the sampling line to help you observe the image and determine the heart rate cycle. If necessary, use the trackball to move the frame mark, and tap [MVC] or [MVC’] to set the frame as the starting tracking point or ending tracking point of a needed cardiac cycle.
Page 174: Magnetic Positioning System
Power off the ultrasound system to turn off the magnetic positioning system controller before reconnecting/disconnecting magnetic transmitter. • Mindray does not provide the sterile sheath. Users should prepare it according to the own needs. Plug the auxiliary output power supply cable, USB data cable, magnetic generator and sensor(s) to the magnetic positioning system respectively following the arrow’s guide.
Page 175 6 Image Acquisition Auxiliary output power supply cable USB Data cable Magnetic generator Positioning (probe) sensor port Respiratory compensation sensor Sensor (2) Probe positioning sensor port Motion (abdomen) sensor support sterile sheath Magnetic positioning system (rear) Magnetic positioning system (front) The description of the magnetic positioning system is given in details.
Page 176 6 Image Acquisition No. Device Port Description Name Auxiliary Power supply port Plug the auxiliary output power supply cable to the port of output the magnetic positioning system, and connect the power power supply. supply cable USB data USB port Plug one end of the USB data cable to the USB port of the cable magnetic positioning system, and another end to the USB...
Page 177 6 Image Acquisition No. Device Port Description Name 4-9 / Probe positioning 2. Probe positioning sensor support: fix the support to the sensor port probe. See the method below: Respiratory • Ensure that the plastic markers on the probe (1 in the compensation figure) and on the probe positioning sensor support (2 sensor...
Page 178 6 Image Acquisition No. Device Port Description Name 4-9 / Probe positioning 3. Fix the probe positioning sensor (2 in the figure) which is sensor port already plugged in the probe positioning sensor port to the cavity of the probe positioning sensor support (1 in the Respiratory figure) following guide.
Page 179: Screen Description
6 Image Acquisition Sensor Magnetic generator Magnetic positioning system controller 6.16.3 Screen Description You should connect the magnetic devices, and then enter Fusion Imaging. The Fusion Imaging screen appears. Image Description Ultrasound When Fusion Ratio is among -1 to 0, the Ultrasound System registers Display CT/MR/PET/freehand image to ultrasound image.
Page 180: Basic Procedures
6 Image Acquisition Image Description Transverse R, L, A, and P imply the right, left, anterior and posterior of the plane patient. Coronal plane R, L, H, and F imply the right, left, head and foot of the patient. Sagittal plane H, F, A, and P imply the head, foot, anterior and posterior of the patient.
Page 181 6 Image Acquisition Get magnetic positioning system prepared. Connect the magnetic positioning system. Power on the magnetic positioning system controller. Activating the magnetic positioning: Tap [Fusion] on the touch screen or user-defined key to enter Fusion Imaging mode (see also Chapter 12 Setup for key preset operations). Tap [Tracking System] on the touch screen.
Page 182 6 Image Acquisition – The icons for different plane operations appear after pressing <Set> for multiple times. – Tap [View Type] to change the active plane of CT/MR/PET image (sagittal plane, transverse plane, coronal plane). Varied planes can be panned, scrolled or rotated through the axis.
Page 183 6 Image Acquisition Freehand plane which is identical with that on the ultrasound image (the CT/MR/ PET/Freehand plane moved). Tap [Confirm Registration] to complete the fine tuning. NOTE: • Use the plane concentrated with the patient’s lesions to perform the fine tuning. •...
Page 184: Acquiring/Importing Volume Data
6 Image Acquisition display ratio that contrast image registers with CT/MR/PET/freehand image (see window 3 and window 4). Inject the contrast agent. Enable the timer, and save the dynamic image. Refer to “9 Contrast Imaging”. Data registration of same patient/body part in different phases When different phases of CT/MR/PET data from the same patient/body part exist and one CT/MR/ PET data has been registered already, system will register the data by previous information if other phases data are imported.
Page 185 6 Image Acquisition • The storage path should be short and clear for network server obtaining. Space or Chinese character is not allowed. • Refer to “15 DICOM/HL7” to configure DICOM. Perform the following procedure: Configure DICOM service and Query/Retrieve service. Load volume data to iStation.
Page 186: Marks
6 Image Acquisition Volume data is loaded to Fusion Imaging exam. The page is given below: Acquiring Freehand Volume Data Except importing existing volume data, the operator can also acquire freehand 3D cine on fusion imaging mode. 6.16.6 Marks Mark tumor position, lesion position on CT/MR/PET/Freehand image. Be sure of the lesion appearing on US and CT/MR/PET/Freehand image at the same time after the registration is completed.
Page 187 6 Image Acquisition Tap [Axial]/[Coronal]/[Sagittal] to toggle the top-left reference plane. Press <Cursor> to show the cursor. Mark on the axial plane (top-right)/coronal plane (bottom- left)/sagittal plane (bottom-right). The procedures to make marks are given below: NOTE: • The Ultrasound System adds 3-dimesnsional sphere mark to CT/MR/PET/Freehand volume data.
Page 188 6 Image Acquisition Mark the tumor (a maximum of 20 tumors can be marked). The color of the mark can be green, blue, or red in turn. These colors appear in circle. The sphere diameter and ablative margin appear in the result window. Click [Esc] to exit.
Page 189: Respiratory Compensation
6 Image Acquisition Saving/Loading the Mark • Saving the mark Enter tumor mark page. Mark varied tumors on CT/MR/PET/Freehand image. Tap [Save Marks] to type the mark name. Click [OK]. Save the tumor mark of the patient. It is convenient to load the tumor mark when conducting the tumor ablation for the patient.
Page 190 6 Image Acquisition bar appears on the screen. The ultrasound cine plays automatically after the capturing is finished. NOTE: The Ultrasound System selects one premium phase of respiration curve automatically after the capturing is finished. It is prepared for the motion modeling. You can set the start frame and end frame to select one phase of the respiration curve.
Page 191 6 Image Acquisition Press <Set> again to adjust ROI position and size, and to set the start frame and end frame of the motion modeling. Tap [Motion Modeling]. If modelling succeeds, the system will play the cineloop automatically, and ROI moves along with the motion of the respiration curve. NOTE: •...
Page 192: Freehand 3D
6 Image Acquisition 6.16.8 Freehand 3D NOTE: The effect of freehand 3D image acquisition is dependent on the technique of the operator. Thus, there is a risk of low registration accuracy. Perform the following procedure: Select a proper probe and correct exam. Enter real-time B/Contrast mode (non-cardiac Contrast Imaging mode).
Page 193 6 Image Acquisition Nav System Tap [Tracking System] to enable or disable the function. CT/MR/PET/freehand image and the ultrasound image build up the coordinate relation. The sensor indicator becomes green (navigation signal state indicator). Fusion Ratio Adjust the display ratio that the ultrasound image registers with the CT/MR/PET/freehand image. Rotate the knob beneath [Fusion Ratio] to set the ratio.
Page 194: Rotating/Scrolling Ct/Mr/Pet/Freehand Image
6 Image Acquisition Tap [Window W/L Set by Trackball]. Move the trackball to set the window width and window level. Move the trackball left; the window width becomes smaller, and the window level becomes larger; the image contrast becomes more visible. Move the trackball right;...
Page 195: Measuring
6 Image Acquisition The relations of X-axis, Y-axis and Z-axis are given below: • Rotate the knob <M> clockwise to cycle CT/MR/PET/freehand image clockwise through X- axis. • Rotate the knob <PW> clockwise to cycle CT/MR/PET/freehand image clockwise through Y- axis.
Page 196: Smart Vti
6 Image Acquisition • During image acquisition, the user is recommended to stably hold the ultrasound probe to acquire fetal heart ultrasound video. If the Smart Fetal HR measurement is not satisfactory (e.g., the heart rate cycles are not marked accurately on the M-mode image), the user can manually modify the sampling lines of heart rate cycles on the M-mode image or change the number of heart rate cycles.
Page 197: Smart Ivc
6 Image Acquisition – Automatically recognize the cardiac cycle: when there are ECG inputs, the ECG signals are preferred; when there are no ECG signals, the system automatically starts calculation. – Trace the LVOT spectrum in a cardiac cycle in real time to gain the VTI, HR, and CO results of the LVOT.
Page 198 6 Image Acquisition Tap [Smart IVC] on the touch screen or the user-defined key to enter Smart IVC mode and start calculation. Tap to select a breath type: “Spontaneous Breath” or “Mechanical Ventilation”. Select [Change Resp Time] > [Resp Time] to set a respiratory time. The system measures the IVC inner diameter of the image in every frame, calculates the maximum and minimum IVC diameters, and draws a quantitative index change curve in real time.
Page 199: Iota (International Ovarian Tumour Analysis)
6 Image Acquisition Calculation Results Window • Displays the calculation results within the current calculation range. • Dmax: indicates the maximum IVC inner diameter within a respiratory cycle. • Dmin: indicates the minimum IVC inner diameter within a • respiratory cycle. •...
Page 200: Screen Display
6 Image Acquisition A Protocol Event contains series workflow events (annotation comments, body marks and measurements) and image modal commands to assist the user in routine ultrasound examinations. NOTE: The system provides different protocol events based on the different application regions. Perform the following procedure: Input the patient information.
Page 201: Manual Examination
6 Image Acquisition The comment for the current view has been automatically added to the bottom-left corner of the image, ready for you to scan the specified anatomy. View Selection Tap [Prev]/[Next] to select the view to be scanned. The current view is surrounded by a solid frame. View Operation In the current active view, you can perform image scanning, measurements, and adding comments and body marks, etc.
Page 202 6 Image Acquisition – Press the knob under [Continue] to continue the creating. Press the knob under [Stop] to enter Protocol Setup and Review page. – You can rename Groups, Views, or Protocols. – Select type from the drop-down list as Sequence, Random, or Insert Protocol. –...
Page 203: Overview
3D/4D NOTE: 3D/4D imaging is largely environment-dependent, so the images obtained are provided for reference only, not for confirming a diagnosis. Overview The ordinary 2D imaging has the limitations on viewing the overall structure and different planes of the target. However, 3D imaging can obtain the reference information by overall observation. 7.1.1 Terms View point •...
Page 204: Roi And Voi
7 3D/4D • ROI (Region of Interest): a volume box used to determine the height and width of scanning volume. • VOI (Volume of Interest): a volume box used to display 3D image (VR) by adjusting interesting region in MPR. 7.1.2 ROI and VOI After the system enters 3D/4D imaging, a B image with ROI displays on the screen.
Page 205: About The Probes
7 3D/4D 7.1.3 About the probes A 2D imaging probe can be applied for Smart 3D imaging, however, to realize Static 3D imaging, 4D imaging, STIC, iPage, SCV, CMPR, Color 3D or Niche, a volume probe should be selected. 7.1.4 MPR MPR represents three different views of 3D image.
Page 206: Free View
7 3D/4D • Section C: it is the coronal section in fetal face up posture, as shown in the figure C above. The upper part of the 3D image in the 3D window is corresponding to the orientation mark on the probe, if the fetal posture is head down (orientating the mother’s feet), and the orientation mark is orientating the mother’s head, then the fetus posture is head down in the 3D image, you can make the fetus head up by rotating the 3D image by taping [180°] on the touch screen.
Page 207 7 3D/4D Fetal Condition • Gestational age Fetuses of 24~30 weeks old are the most appropriate to 3D imaging. • Fetal body posture Recommended: Cephalic face up (figure a) or face aside (figure b); NOT recommended: Cephalic face down (figure c). •...
Page 208: Static 3D
7 3D/4D Move the probe across the surface. – 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. • Scanning plane and probe movement Move the probe across the body surface.
Page 209 7 3D/4D Select the proper probe and exam mode; make sure there is sufficient gel on the probe for scanning. Obtain a 2D image, and optimize the image if necessary. Press the user-defined <3D> key to enter Static 3D acquisition preparation status, and define the ROI and curved VOI.
Page 210: Static 3D Acquisition Preparation
7 3D/4D Press <Update> to start capturing 3D. During the acquisition, a progress bar is displayed to indicate the acquisition progress. The system enters into 3D image review status when the acquisition is completed. In image review status, you can perform operations like VOI setting, parameter adjustment, comments, image saving, image cutting, etc.
Page 211 7 3D/4D Activate MPR On the [VR] subtab, tap [A], [B], [C] or [VR] to activate sectional plane image (MPR) or 3D image (VR). MPR Viewing In actual display, different colors of the window box and the section line are used to identify the section A, B and C.
Page 212 7 3D/4D The system supports the observation of 3D/4D image from 6 directions. a Up/Down b Down/Up c Left/Right d Right/Left e Front/Back f Back/Front Select [Up/Down], [Left/Right] or [Front/Back] on the [Adv.] subtab to select the direction of the figure a, c and e.
Page 213 7 3D/4D In Accept VOI status, when the 3D image is active or the section image which is perpendicular to the view direction is active, center point of the 3D image displays, and you can adjust the position by rolling the trackball. The adjustment of Rendering Parameters In image viewing status, you can render the image by adjusting the relevant parameters.
Page 214: Render Mode
7 3D/4D Parameter Description 3D iClear • Function: Use the 3D self-adaptation filter to strengthen the space continuity of the tissue structure, and provide speckle noise suppression, and improve the image contrast effect, so as to optimize the volume image data.
Page 215: Rotate The Image
7 3D/4D Set Max as 3D image rendering mode, displays the maximum echo intensity in the observation direction. This is helpful for viewing bony structures. Set Min as 3D image rendering mode, displays the minimum echo intensity in the observation direction. This is helpful for viewing vessels and hollow structures.
Page 216 7 3D/4D Select [Step] to set the auto rotation increment. to start auto rotation. Select [Speed] to adjust the rotation speed. Inversion Function: vessel shape is correct with the capture target. The vessel wall is smooth and clear. Surface Enhancement This function is to make the edge structure of the image and surface details clearer, so as to enhance the overall contrast.
Page 217: Image Saving
7 3D/4D selected or you can press <Set> twice to finish tracing. Move the cursor to the region you want to edit and press <Set> again to edit. – Contour: Press <Set> to position the start point, roll the trackball to trace the region. When the start point and the end point coincide, the region is selected or you can press <Set>...
Page 218: Operation Controls
7 3D/4D Save image as necessary. 7.4.2 Operation Controls Display You can choose to display only color images or gray scale images, or to mix them. Priority To determine color information displayed on gray scale images. Threshold To eliminate color noise and motion artifacts. Affects MPR as well as VR.
Page 219: Acquisition Preparation
7 3D/4D Obtain a 2D image, and optimize the image if necessary. Press the <4D> key to enter 4D image acquisition preparation status. Adjust ROI size and position and the VOI. The operations are same with these in static 3D mode.
Page 220: Smart 3D Procedures
7 3D/4D If the system is only set up with Smart 3D module, press the user-defined <3D> key to enter Smart 3D imaging mode. NOTE: • 4D probe does not support Smart 3D imaging. • In Smart 3D image scanning, if the probe orientation mark is oriented to the operator’s finger, perform the scan from right to left in linear scan, or rotate the probe from left to right in rocked scanning.
Page 221: Stic (Spatio-Temporal Image Correlation)
7 3D/4D STIC (Spatio-Temporal Image Correlation) WARNING Diagnoses made only by assessing this 3D/4D acquisition are not permitted. Every diagnostic finding has to be evaluated in 2D as well. STIC function provides sectional images of high spatial resolution as well as good time resolution, which is mainly used in fetal heart observation and cardiac hemodynamic exams.
Page 222: Ilive
7 3D/4D NOTE: The system also supports color STIC 3D flow image function. Perform the following procedure: Obtain a feasible 2D image (fetus heart). To observe a small structure, zoom in the interested part (Usually Res Zooming is applied for good image quality).
Page 223: Lighting Mode
7 3D/4D NOTE: iLive is available under Smart 3D, Static 3D and 4D modes. To Activate iLive Perform the following procedure: Enter 3D/4D image viewing status, or double-click the saved 3D/4D cine file in the iStation or Review screen. Tap [iLive] under the [Adv.] page on the touch screen to turn the function on, and adjust the parameters.
Page 224: Layout
7 3D/4D Operation Controls for Lighting Mode Settings Parameter Description VL Saturat. Adjust the saturation for light 1/2/3. VL Hue Adjust the color for light 1/2/3. VL Dist Adjust the distance for light 1/2/3 when the light source is set to torch or point.
Page 225: Reference Point
7 3D/4D 7.10 3D Reference Point The function enables operators to define one or more reference points on MPRs, which are then projected to VR image. It is helpful for operators to better understand the corresponding spatial relations of VR image and MPRs. Select the [VR] >...
Page 226: Smart Volume
7 3D/4D NOTE: • If you want to view the 3D print files on the mobile phone, please download and install “EMB3D” application program first. • The Windows 10 computers supports to view 3D print files directly (except files in off format). 7.12 Smart Volume CAUTION The Smart Volume result is provided for reference only, not for confirming...
Page 227 7 3D/4D – There are yellow solid curves enclosing target region on each MPR image (A, B, C) window. – 3D image (VR) displays image of the target region in red; – The calculation result is displayed on the lower left part of the screen. Modify the contour of the calculated area and recalculate its volume, if necessary.
Page 228: Result Display
7 3D/4D Auto calculation is finished: – There are yellow solid curves enclosing target region on each MPR image (A, B, C) window. – 3D image (VR) displays image of the target region in red; – The calculation result is displayed on the lower left part of the screen. Modify the contour of the calculated area and recalculate its volume, if necessary.
Page 229: Trace Mode
7 3D/4D Trace Mode • Trace Rotate the knob under [Trace Mode] to select [Trace]. Rotate the trackball to place the cursor and press right <Set> key to fix the starting point, move the cursor along the target to trace the outline, and press right <Set> twice to finish tracing.
Page 230: Ipage
7 3D/4D 7.13 iPage iPage is iPage+SCV function. iPage (Multi-Slice Imaging) is a “Visualization” mode for displaying sectional images. The data is presented as slices through the data set, which are parallel to each other. When SCV (Slice Contrast View) function is turned on, the system expands the parallel section images into a slice region with a specified thickness, and draws this region with 3D rendering effect to enhance the image.
Page 231: Basic Screen & Operation
7 3D/4D 7.13.2 Basic Screen & Operation A plane (the current B plane C plane reference image) Central slice line Slice line Space between two (Current active slice) slice lines Y-axis X-axis Slice position (to the central slice) Slice order number Central slice mark Active slice be highlighted in green...
Page 232 7 3D/4D • Coordinate axis: indicated on the A, B, C three reference images, match together with the central slice line, and will move accordingly with the central slice line. Slice shifting Roll the trackball to shift the crossing point of central axis up/down, left/right, and the slice lines will shift accordingly with the crossing point.
Page 233: Image Rotation
7 3D/4D After Image rotation Rotate <M>, <PW>, <C> to perform axial rotation or rotate <4D> knob to adjust the nearest VOI section (cut plane) position. Hide/show reference image The system displays 3 standard sectional images (A plane, B plane, C plane) on the left side indicating the position of the slice lines;...
Page 234: Basic Procedures
7 3D/4D 7.14.1 Basic Procedures SCV operation Perform the following procedure: Acquire necessary 3D/4D data. Tap [SCV ] tab on the touch screen to enter SCV imaging, and the system displays three section images in A, B and C window. Rotate the knob under [Thickness] on the touch screen to adjust imaging thickness.
Page 235 7 3D/4D Tap [A Plane], [B Plane] and [C Plane] to select current active section image. • Reset Click [Reset All] in Reset field to reset parameters, orientation and zooming status. CMPR Trace Options • Line Perform the following procedure: Tap [Line] on the touch screen.
Page 236: Smart Planes Cns
7 3D/4D • Zoom in Same as these in 3D/4D mode. • Rotation Rotate <M>, <PW>, <C> to perform X/Y/Z rotation or rotate <4D> knob to adjust the nearest VOI section (cut plane) position. • Comment and Body Mark Same as these in other modes. •...
Page 237 7 3D/4D Tap [MSP]. There are A/B/C images appearing on the screen. The sagittal plane of the fetus appears on window C. Rotate A, B or C plane respectively, or rotate <4D> to adjust each plane. NOTE: To ensure the correctness of the result, please make sure the cerebral midline on the anatomical plane is displayed clearly and ROI enclose the whole cranial region.
Page 238: Smart Icv
7 3D/4D • The automatic measurement results appear only for these having the same characteristics on the planes. • Once the automatic measurements are completed, the operations to axial rotation, reference line rotation, parameter adjustment, MSP editing, zooming/panning, dual/ quad-split display will remove the measurement results. Tap [Edit] to modify the measurements.
Page 239: Other Operations
7 3D/4D NOTE: To ensure the accuracy of the result, please make sure that the traced contour has entirely enclosed the target and is approximate to the target before using the Smart ICV function. Perform the following procedure: Acquire necessary 3D/4D data. Tap [Smart ICV] to enter Smart ICV interface, and the system measures the volume of fetal cerebral automatically.
Page 240: Smart Flc (Smart Follicles Calculation)
7 3D/4D • Current plane Acquire 3D data. Tap [S-Planes CNS] to enter the automatic detection of the mode. Reset the following operations: – Tap [Current Plane] to reset the plane. The position of the current plane returns to the initial condition.
Page 241: Operation Controls
7 3D/4D NOTE: To ensure the correctness of the results, please select an image with clear follicle boundary when entering smart FLC. 7.16.2 Operation Controls Edit ROI Same as the operation in ROI editing in Smart-V. Edit/ Undo Select the button in the [Edit] area to turn on the editing function. It supports dividing, merging, adding and deleting of the follicle.
Page 242: Basic Procedures
7 3D/4D TIP: Smart Planes FH is an option and not available under STIC or Smart 3D mode. 7.17.1 Basic Procedures Perform the following procedure: Acquire necessary 3D/4D data of fetal heart and save the file. Open the saved cine file. Tap [S-Planes FH] and [Navigate] to enter the screen.
Page 243: Smart Face
7 3D/4D 7.18 Smart Face NOTE: Smart Face is only used for obtaining fetal face features, not for confirming a diagnosis. This feature allows the system to recognize fetal face and remove the shading obstacle data automatically, then display the face in a recommended viewing angle. Perform the following procedure: Acquire Static 3D image or frozen 4D single-frame image of fetal face.
Page 244: Volume Ceus
7 3D/4D VR Orientation Rotate the image quickly. Adjust in VR Orientation: 0°, 90°, 180°, 270°. 7.19 Volume CEUS It is only to view the microbubbles injection of a certain plane once in the 2D ultrasound contrast imaging, however it is possible to view stereo microbubbles injection in the 3D ultrasound contrast imaging.
Page 245 7 3D/4D – If necessary, select the desired organ type manually. – If necessary, tap [Refresh] to reset the ROI. – If necessary, adjust the ROI size and position manually. Press <Update> to begin 3D/4D acquisition. Operator’s Manual 7 - 43...
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Page 247: Elastography
Elastography CAUTION It is provided for reference, not for confirming a diagnosis. Strain Elastography It is produced based on the slight manual-pressure or human respiration in 2D real-time mode. The tissue hardness of the mass can be determined by the image color and brightness. Besides, the relative tissue hardness is displayed in quantitative manners.
Page 248 8 Elastography Rotate the knob under [Opacity] on the touch screen to complete the adjustment. The bigger the value the stronger the effect. Invert Invert the E color bar and therefore invert the colors of benign and malignant tissue. Tap [Invert] on the touch screen. Display Format Adjust the display format of ultrasound image and the Elasto image.
Page 249: Mass Measurement
8 Elastography When the E Average function is enabled or disabled, the elasto curve is displayed based on different statistical amounts. 8.1.3 Mass Measurement Press <Measure> to enter measurement status. You can measure shell thick, strain ratio, strain-hist, etc. For details, see “Advanced Volume”. 8.1.4 Cine Review Press <Freeze>...
Page 250: Image Parameters
8 Elastography 8.2.2 Image Parameters E Quality Used to select the transmitting frequency of the current probe, the real-time value of which is displayed in the image parameter area in the upper left side of the screen. Rotate the knob under [E Quality] on the touch screen to select the different THI frequency value. Please select the frequency according to the detection depth and current tissue features.
Page 251 8 Elastography Tap [HQElasto] to enable the function and the button will be highlighted. When the feature is activated, the system turns into single-frame scanning mode. Pressing <Update> acquires one frame image of B and Elasto. RLB Map Used to help the user judge the region where it is suitable for elasto measurements based on the distinctive colors in elasto image in quality map.
Page 252: Measuring
8 Elastography The bigger the level is, the higher the smooth effect achieves. Persistence This feature is used to superimpose and average adjacent elasto images, so as to optimize the image. Tap [Persistence] on the touch screen to adjust the parameter. The bigger the value is, the higher the frame optimization effect achieves.
Page 253: Stq Imaging (Sound Touch Quantification)
8 Elastography STQ Imaging (Sound Touch Quantification) 8.3.1 Basic Procedures for the STQ Imaging Perform the following procedure: Select a proper probe. Perform 2D scan to locate the lesion. Tap [Elasto] > [STQ] on the touch screen. Or press the user-defined <STQ> key to enter the STQ mode.
Page 254 8 Elastography Rotate the knob under [Fixed ROI] on the touch screen to adjust the ROI fixed size. The cross “+” shows the center of the ROI, and the depth appears at the right bottom of the screen. Elas. Metric Display the changes of elasto metric’s average value inside the ROI by elasto curve.
Page 255: Fatty Liver Lab
8 Elastography HQElasto Enable the high-quality scan mode and optimize the penetrability. Tap [HQElasto] to enable the function. The soft key becomes highlighted. Press <Update> to acquire the high-quality image. It produces single-frame B image and ROI elasto metric data. The measurement, comment and body mark is not available in HQElasto status.
Page 256: Usat
8 Elastography NOTE: • Input the fatty liver related parameters in the Abdomen tab of the patient information page. For details, see “5.1.1 New Patient Information”. • Keep the patient breathing smoothly. 8.4.1 USAT It is used to measure the acoustic attenuation coefficient value of the target liver region and display its 2D spatial distribution, according to the ultrasonic echo signal.
Page 257: Hri
8 Elastography Histogram area • The horizontal axis represents time, while the vertical axis represents USAT value. • The rectangle histogram above the horizontal axis represents the USAT value of every frame. The metric unit can be adjusted through “Att.Metric”. •...
Page 258 8 Elastography One is renal ROI, with the letter R in the upper left corner, and the other one is hepatic ROI, with the letter H in the upper left corner. Measurement result window: • Single frame MeanR: indicates ratio of the mean hepatic brightness value to mean renal brightness value.
Page 259: Image Parameters
8 Elastography After the acquisition is completed, the system calculates and displays the measurement curve and statistic results. The image is in freezing mode. Rotate the knob under [Frame Average] on the touch screen to select the number of frames. The system calculates and updates the measurement curve and statistics results in real time.
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Page 261: Contrast Imaging
Contrast Imaging The contrast imaging is used in conjunction with ultrasound contrast agents to enhance imaging of blood flow and microcirculation. Injected contrast agents re-emit incident acoustic energy at a harmonic frequency much more efficient than the surrounding tissue. Blood containing the contrast agent stands out brightly against a dark background of normal tissue.
Page 262: Left Ventricular Opacification
9 Contrast Imaging Press <B> button to return to B mode. Left Ventricular Opacification Perform the following procedure: Acquire ECG signal. Select an appropriate probe and LVO exam mode. Workflow of LVO is similar to abdomen contrast imaging, see “9.1 Basic Procedures for Contrast Imaging”.
Page 263 9 Contrast Imaging Color Map Color map is used during color coding of the contrast agent arriving time in the contrast image. It consists of multiple color blocks. Different color blocks indicate different arriving time points/ image frames of the contrast agent and are separated by each scale. Tap [Color Map Edit] in the touch screen to enter the editing dialogue.
Page 264: Tcmr (Tissue-Contrast Mix Rendering)
9 Contrast Imaging Select [CCPM] to enter CCPM mode. The system starts calculating. Adjust length, tint, and other parameters if necessary. Perform measurement, or add annotations or body marks if necessary. Save images and exit the CCPM mode. Entry 2 Perform the following procedure: Select a volume probe.
Page 265: Image Parameters
9 Contrast Imaging In the acquisition preparation mode, select [TCMR]. Press <Update> to start the acquisition. – The “FixTissue” parameter is enabled by default. In this status, you can switch active windows. – Adjust mix color, mix ratio, tissue render, and other parameters if necessary. Save images and exit the TCMR mode.
Page 266 9 Contrast Imaging Timer NOTE: The starting time displayed may be inconsistent with the actual one due to system error or some other man-made mistakes; please check the agent-injecting time. The two timers are used to record total time of contrast imaging and single time of one contrast exam.
Page 267: Micro Flow Enhancement
9 Contrast Imaging Tap [Mix] to select different mixing mode, and select different maps by knobs under [Gray Map]/ [Tint Map]/[Mix Map] on the touch screen. • When dual live function is on, you can see the mixed effect on the contrast image. •...
Page 268: Contrast Imaging Qa
9 Contrast Imaging MFE Period Rotate the knob under [MFE Period] on the touch screen to select different imaging period suitable for current flow. Where, MAX is the maximum superimposing effect. Contrast Imaging QA CAUTION Contrast Imaging QA images are provided for reference only, not for confirming a diagnosis.
Page 269 9 Contrast Imaging Time-intensity • Y axis represents the intensity (unit: dB), while X axis represents the curve time (unit: s). • Frame marker: a white line that is perpendicular to the X axis, can be moved horizontally left to right (right to left) by using the trackball. •...
Page 270 9 Contrast Imaging This function provides a motion compensated ROI as precise time-intensity information can be acquired using active tracking. It can enhance the calculation accuracy as reducing the impact of probe or patient respiratory movement. NOTE: Elliptical ROIs can be positioned in any manner that keeps their center within the image boundaries.
Page 271 9 Contrast Imaging The parameters are included in the trace file if the user has fixed a ROI. After the exporting is succeeded, a .BMP format image is displayed in the thumbnail area of the screen. Only data from the user selected image range is included in the exported trace file. Tap [Exit] to exit Contrast QA.
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Page 273: Physiological Unit Signal
Physiological Unit Signal The physiological unit signal waveform is used for checking ultrasound image in ultrasound exam (cardiac exam mainly). The system provides the physiological unit input panel, on which ECG and other signals can be input. The system is equipped with physiological unit signal module. Tap [Physio] to enable the function. The image area shows ECG curves.
Page 274: Ecg
10 Physiological Unit Signal • When abnormality is detected in physio trace, please check if ECG leads are properly connected with the system. 10.1 ECG Perform the following procedure: Connect the device and place ECG electrodes. Turn off the power supply of the system, and connect the ECG cable to ECG port. Turn on the power supply of the system.
Page 275: Triggering Mode
10 Physiological Unit Signal NOTE: • The triggering mark is displayed in both freeze mode and live mode. • The marks in Dual trigger are in different colors. • Triggering function is unavailable if the ECG trace is disappeared. Only the live 2D image can be triggered.
Page 276: Pcg
10 Physiological Unit Signal Switch the imaging modes and display formats, adjusting the parameters to get an optimized image. Parameter adjusting: Tap [RESP]. Adjust [Speed], [RESP Gain], [Position] and [Invert]. Exit Respiratory display mode, and remove ECG electrodes from the patient. Tap [RESP] or press the user-defined <Physio>...
Page 277: Pcg Sensor Cleaning
10 Physiological Unit Signal Aortic valve auscultation area Tricuspid valve auscultation area Pulmonary valve auscultation area 4 Mitral auscultation area Tap [Physio] or press the user-defined <Physio> key. Tap [PCG] on. The PCG wave appears. Press the different mode buttons to change the imaging mode. Adjust the parameter to obtain the optimized image.
Page 278: Parameter Description
10 Physiological Unit Signal 10.4 Parameter Description The physio parameters are described as follows: Type Parameter Description ECG Source Select ECG source. parameter Gain Set the amplitude of the trace. Position Set the vertical position of the both traces on the image display.
Page 279: Stress Echo
Stress Echo Only the phased probes support stress echo function under the cardiac mode. CAUTION Stress echo data are provided for reference only, not for confirming diagnoses. The Stress Echo feature allows you to capture and review cardiac loops for multiple-phase (multiple-stage) Stress Echo protocols.
Page 280: Selecting Preferred Stress Echo Loops (Select Mode)
11 Stress Echo Press <Save> to start acquisition. The system displays the Protocol window on the screen, listing the phases for the selected protocol along with the first phase views (phases are stages). The system selects the first view for acquisition by default. Proceed through each view in each stage according to the following instructions: Non-continuous stages: –...
Page 281 11 Stress Echo To select “preferred” loops: Use the <Update> key according to tips in the trackball hint area or select [Select] to enter the Select Mode, or the system enters the Select Mode directly after the acquisition is finished. Select the loop.
Page 282: Review/Wms Mode
11 Stress Echo Selection Description Delete Unselected Delete clips that are not selected. If selected, the system will delete all clips that are not selected after the exam is ended. Suspend Exam Pauses the stress echo exam but does not end the stress echo exam. When a stress echo exam is suspended, the user can perform image acquisition of all other imaging modes, or perform operations such as measurement.
Page 283: Wall Motion Scoring
11 Stress Echo Description of review/WMS mode keys (keys with the same function as in select mode are not described below): Item Description Review/WMS Perform side-by-side comparison of the same views at different stages (PLAX, PSAX, A4C, A2C at “Rest” compared to PLAX, PSAX, A4C, A2C “Post-Exercise”).
Page 284: Saving Stress Echo Data
11 Stress Echo Repeat step 2 to perform value assign for all segments. – To assign a normal wall motion score (WMS) to all currently displayed views: Select [Set All Normal] on the touch screen. – To assign a normal wall motion score (WMS) to the currently selected view: Select [Set Current Normal] on the touch screen.
Page 285: Smart Pelvic
Smart Pelvic The Smart Pelvic function is used to measure distances and angles of anterior, central and posterior compartments according to the feature point inputs on 2D images of rest and stress, and then calculate BND and URA; Automatically measure the size of levator hiatus etc. according to the axial plane automatically obtained from volume data;...
Page 286: 4D Image Data
12 Smart Pelvic 12.2 3D/4D image data VR Mode Perform the following procedure: Select probe and GYN/pelvic floor exam mode. Enter 3D/4D preparation status, and then acquire 3D/4D image to enter Smart Pelvic. Auto: Select [Pelvic] under the [Smart Scene 3D] scenario, and then press <Update>. The system enters [Smart Pelvic] tab automatically.
Page 287 12 Smart Pelvic • Measurement Parameter Tap [Meas Parm.] to set the automatic measurement items for Rest, Valsalva, and Contraction frame. • Orientation Refresh Tap [Refresh Ori], and the system adjusts the current image automatically to display the minimum levator ani muscle gap slice. Operator’s Manual 12 - 3...
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Page 289: Display & Cine Review
Display & Cine Review 13.1 Splitting Display The system supports dual-split and quad-split display format. However, only one window is active. The multi-window display can complete the image and multi-frame image comparison. Dual-split Press <Dual> on the control panel to enter the dual-split mode, and use <Dual> / <Update> key to switch between the two images;...
Page 290: Pan Zoom
13 Display & Cine Review 13.2.2 Pan Zoom Perform the following procedure: Rotate the <Zoom> knob to directly enter the pan zoom status. Or enter the touch screen mapping mode, and zoom the image by pinching the two fingers on the touch screen. Image- in-image is displayed.
Page 291: Cine Review
13 Display & Cine Review • In splitting display B mode, press <Dual>/user-defined <Quad> key to switch among the windows; press <B> to exit splitting display mode and enter the image of the currently activated window in full screen. • In frozen mode, the system supports imaging mode switching between the sub-modes (only for the activated window).
Page 292 13 Display & Cine Review The cine progress bar at the bottom of the screen (as shown in the figure below): Start mark Playback mark End mark Current frame Total frames Auto Review Region Reviewing all of Auto Review Perform the following procedure: In the manual cine review status, use the [Auto Play] to set the review speed to activate auto cine review.
Page 293: Cine Review In M/Pw/Cw/Tvd Mode
13 Display & Cine Review 13.4.3 Cine Review in M/PW/CW/TVD Mode Enter cine review in M mode, PW mode, CW mode TVD mode, and then use the trackball the cine images are displayed on the screen one by one. Move the playback mark to the left by using the trackball. The review progress slider moves to the left, the images moves to the right, and the earlier stored images are invoked.
Page 294: Image Compare
13 Display & Cine Review 13.5 Image Compare 13.5.1 Image Compare in Review Mode NOTE: For B/B+COLOR/B+TVI/B+POWER/B+TEI mode image, you can select at most 4 images; for PW/M/CW/TVD mode image, you can select at most 2 images. Perform the following procedure: Tap [Compare] on iStation screen or Review screen.
Page 295: Icompare
13 Display & Cine Review Save the image if it is necessary. Measurements, adding comments and body marks are allowed. Tap [Frame Compare] again to return to image frozen status; press <Freeze> to enter real-time imaging. 13.5.3 iCompare NOTE: iCompare can only be performed on B, Color, Power, PW, CW, or M mode for FRM/CIN/PNG/ DCM files.
Page 296: Setting Cine Length
13 Display & Cine Review Frozen Image Storage In frozen mode, tap [Pro Capture] / [Retro Capture] on the touch screen or press the user-defined key (The key has already been assigned the function as “Save Cine (Prospective)/Save Cine (Retrospective)”). After the cine is successfully saved, there is a thumbnail displayed on the screen.
Page 297: Measurement, Comments And Body Mark
Measurement, Comments and Body Mark 14.1 Measurement There are general measurements and application measurement. You can perform measurements on a zoomed image, cine reviewing image, real-time image, or frozen image. For measurement details, please refer to the “Advanced Volume”. WARNING •...
Page 298 14 Measurement, Comments and Body Mark Parameter Value Range Error Distance Full screen Within ±5% (for linear, wide-convex, and (iScape View) phased probes) Full screen Within ±10% (for micro-convex probes) • Error of 3D Images Parameter Value Range Error Distance A/B/C sectional plane image (MPR), Within ±5%.
Page 299 14 Measurement, Comments and Body Mark Measurement Item Error Smart NT Within ±10% Smart FLC Within ±20% Smart Fetal HR Within ±10% Smart ICV Within ±20% Smart ERA Within ±20% Smart Hip Within ±20% Smart HRI Within ±5% Smart Trace Within ±5% Smart Calc Within ±10%...
Page 300: Comments
14 Measurement, Comments and Body Mark 14.2 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 301: Adding Comments
14 Measurement, Comments and Body Mark • User-defined Adjust comments display on touch screen menu, including adding/deleting comments. • Page-turning If there is more than one page of comment texts for the current exam mode, you can slide to view more. •...
Page 302: Moving Comments
14 Measurement, Comments and Body Mark – Rotate the <Angle> knob counter-clockwise to cancel 1 pixel of trace. – Rotate the <Angle> knob clockwise to restore 1 pixel of trace. – Short press <Clear> to clear last trace. Long press <Clear> to delete all tracing. Press <Set>...
Page 303: Deleting Comments
14 Measurement, Comments and Body Mark 14.2.6 Deleting Comments Deleting Comments Characters, Texts or Arrows Perform the following procedure: Move the cursor to the comments to be deleted. Press <Set> to select the comment. Press <Back>, <Del>, <Delete Word> or <Clear> on the keyboard to complete the deletion. Or, rotate the knob under [Grab/Del Word] on the touch screen to select the comment, then press the knob to delete the comment.
Page 304: Voice Comment Panel
14 Measurement, Comments and Body Mark 14.3.1 Voice Comment Panel After the system enters the voice comment status, the voice comment panel will be displayed on the lower right corner of the screen. Recording Start Play Start/Stop Recording Duration 14.3.2 Adding Voice Comments NOTE: •...
Page 305: Adding Body Mark
14 Measurement, Comments and Body Mark Library Rotate the knob under the [Library] button on the touch screen or press the knob to switch the body mark library, the corresponding body marks are shown on the left. Page-turning If there is more than one page, slide the touch screen to turn the page. Save Probe Under the condition that the probe mark direction and position is determined for the current adding body mark, tap [Save Probe] to save the current direction and position for the probe mark of the...
Page 306: Deleting Body Marks
14 Measurement, Comments and Body Mark 14.4.4 Deleting Body Marks NOTE: • Preset returning, switching the exam mode/patient/probe will clear the body marks. • Set if body mark is erased when the image is unfrozen, see “4.1.4 Application”. Perform the following procedure: Press <Cursor>...
Page 307: Dicom/Hl7
DICOM/HL7 NOTE: • Before using DICOM, please read the electronic file DICOM CONFORMANCE STATEMENT along with the device. • The DICOM package is optional, so the description here is only applicable for the system configured with the DICOM package. The 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.
Page 308: Dicom Storage
15 DICOM/HL7 15.1 DICOM Storage DICOM Storage is used to send images (single-frame or multi-frame) or structured report to the DICOM storage server for storage. 15.1.1 Send images on iStation/Review/Main screens Perform the following procedure: Do one of the following to select images: –...
Page 309: Encapsulate Pdf
15 DICOM/HL7 • Set the storage option to Attach SR When Store Images, or Only Store SR. Send SR on iStation. Choose the storage option to Attach SR When Store Images, or Only Store SR. Create new patient information or load the patient information. Perform obstetric (gynecology, cardiac, Abdomen, Urology, Small Parts, breast or vascular) measurements.
Page 310: Worklist
15 DICOM/HL7 Click in the top-right part or [Send To]. Click to select “DICOM” in the Target box on the left side, then select the DICOM print server on the right side, and click [OK]. To send images using a shortcut key You can send single-frame images to a DICOM print server while saving to hard drive using a shortcut key.
Page 311: Mpps
15 DICOM/HL7 – “DICOM Server”: Search via patient ID, accession #, key words, AE title, worklist server or exam date. – “HL7 Server”: Search via patient ID, patient name. Click [Query]. The scheduled patients, which meet the criteria, are displayed in the lower part of the screen.
Page 312: To Send Storage Commitment Automatically After An Exam Ends
15 DICOM/HL7 The system will send all the images stored in the exam record to the storage server. Meanwhile, it will send storage commitment to the storage commitment server. 15.5.2 To send storage commitment automatically after an exam ends NOTE: •...
Page 313: Dicom Media Storage (Dicomdir Review)
15 DICOM/HL7 15.7 DICOM Media Storage (DICOMDIR Review) Patient data in the ultrasound system can be saved on external media in DCM format, while DCM files can be accessed in the ultrasound system. DICOM media storage and DICOMDUR review should meet the following conditions: •...
Page 314: Showcase Recording
15 DICOM/HL7 In iStation, review the data stored on the external media. Select the data to be restored in iStation. Click [Restore Exam] on the iStation screen. 15.8 Showcase Recording NOTE: To view the DCM files successfully, it is suggested to install NET Framework (Visual Studio.Net) of a version later than 2.0, if your computer was installed with TortoiseSVN.
Page 315: Patient Data Management
Compression type for image compression and storage may cause loss of image data. • Mindray is not responsible for lost data if you DO NOT follow suggested backup procedures. 16.1 Image File Management You can store the image files either in the patient database in the system, or to external memory devices.
Page 316: Image Storage Setting
16 Patient Data Management PC-compatible formats • Screen file (BMP) Single-frame file format, used to save the current screen, non-compressed format; • JPG: Single frame export format. • TIFF: Single frame export format • Multi-medium files: Multi-frame export format. • DICOM files DICOM standard files format, single-frame or multi-frame format, used to record patient information and images;...
Page 317: Thumbnails
16 Patient Data Management • Send image to DICOM Storage • Send image to DICOM Printer • Send image to USB Disk • Send image to iStorage • Send image to local default Printer • Send image to Workstation • Send image to Workstation Cache Retrospective/prospective saving cine: •...
Page 318: Image Analysis
16 Patient Data Management • During mapping mode, slide to left or right on the touch screen to review the image. • Select an exam of a patient in the iStation screen, and click [Review] or double-click the exam to enter the Review screen to review the images of the patient. During image scan, saved image thumbnails will display on the right of the screen.
Page 319 16 Patient Data Management To enter image analysis • In the image scanning or freeze status, double-click a thumbnail stored in this exam to enter the image analysis status; or • In the image review status, double-click the selected thumbnail to open the image. To exit the image analysis •...
Page 320: Report Management
16 Patient Data Management • You can select whether to hide patient info: if “Default Info” is selected, the patient name is hidden after backup; if “Custom Info” is selected, the system prompts a message requiring you to input the patient name, which will be displayed after backup. 16.2 Report Management 16.2.1 Report storage The exam reports are stored under the directory of the exam of the patient.
Page 321: Patient Data Management (Istation)
16 Patient Data Management 16.3 Patient Data Management (iStation) The patient data include basic patient information, exam information, image files and reports.You can search, view, backup, send, restore, delete or export patient data in iStation. Do one of the following to enter iStation: •...
Page 322: Recycle Bin
16 Patient Data Management Item Description Send Exam You can use this function to export the exam data to external devices (in PC data or DICOMDIR data format) and then import to PC or restore to the ultrasound system to review the data. 1.
Page 323: Istorage
NOTE: To use iStorage function, you need UltraAssist software in 2.0 version (with V1.0 network protocol); consult Mindray service engineer for details. Network storage is used to save image files and measurement reports to the remote PC server. For network storage setting, see “4.8.2 iStorage Preset”.
Page 324: Report Printing
16 Patient Data Management Click [OK] to start printing. Please refer to the accompanying manuals of the printers for more details. 16.7.2 Report Printing Both reports and images can be printed on a graph/text printer. For detailed information about the report printing, see Advanced Manual.
Page 325: Log Upload
16 Patient Data Management • Send to external devices (including disc and USB devices): Select exam data or images in the iStation or Review screen. Click [Send Exam] for the image. • iStorage task: In iStation screen, select the target exam and click [Send Exam], then click iStorage in the menu which appears.
Page 326: V-Access
16 Patient Data Management Send stored images or worksheet reports from iStation/Review/thumbnail area to the Q-Path server. In iStation screen, click [Q-Path] to enable the function. Log in to the Q-Path server through the Q-View browser to check the stored images and worksheet reports.
Page 327: Probes And Biopsy
Probes and Biopsy 17.1 Probes SC6-1s SC6-1E SC5-1Ns C6-2Gs SC8-2s SD8-1E C11-3s C9-3Ts C4-1s L9-3s Operator’s Manual 17 - 1...
Page 328 17 Probes and Biopsy L20-5s L14-3Ws L13-3Ns 7LT4s L16-4Hs CB10-4s L12-3RCs L12-3VNs DE11-3Ws SP5-1s SP5-1E SP5-1U SP5-1Ns P10-4s P8-2s V11-3Hs V11-3HBs SD8-1s 17 - 2 Operator’s Manual...
Page 329: Probe Functions By Part
17 Probes and Biopsy ELC13-4s LAP13-4Cs CW5s CW2s P8-2Ts P8-3Ts P7-3Ts P7-3TE P7-3TU NOTE: • For details of the P7-3TU, P8-3Ts, P8-2Ts, P7-3Ts and P7-3TE probes, refer to TEE Ultrasonic Transducer Operator’s Manual. • For details of the LAP13-4Cs probe, refer to LAP13-4Cs Ultrasonic Laparoscopic Transducer. 17.1.1 Probe Functions by Part The basic structures and corresponding functions of probes are basically the same;...
Page 330: Orientation Of The Ultrasound Image And The Probe
17 Probes and Biopsy Item Description Probe head Converts the electrical signal into an ultrasonic signal, focusing the sound beams in a given direction; meanwhile, it receives the reflected ultrasonic signal and converts it into an electrical signal for transmission over the cable. The lens on the surface is the acoustic lens.
Page 331: Procedures For Operating
17 Probes and Biopsy Orientation mark Mark 17.1.3 Procedures for Operating WARNING Disinfect the probe and sterilize the needle-guided bracket before and after an ultrasound-guided biopsy procedure is performed. Failure to do so may cause the probe and the needle-guided bracket becomes a source of infection. The proper clinical technique to be This section describes general procedures for operating the probe.
Page 332 17 Probes and Biopsy Procedures for operating (with biopsy function) Inspection before examination Connection to the system Examinations Biopsy procedure Disconnection to the system Thoroughly cleaning the needle- guided bracket Wiping off the ultrasound gel Sterilization of the needle-guided bracket Thoroughly cleaning the probe Inspection after use Drying the probe...
Page 333: Wearing The Probe Sheath
17 Probes and Biopsy Procedures for operating (with no biopsy function) Inspection before examination Connection to the system Examinations Disconnection to the system Wiping off the ultrasound gel Thoroughly cleaning the probe Drying the probe Disinfecting the probe Rinsing the probe Drying the probe Inspection after use Storage...
Page 334 17 Probes and Biopsy A legally marketed probe sheath must be installed over the probe before performing intra-cavitary and intra-operative examination. Protective barriers may be required to minimize disease transmission. Probe sheaths are available for use with all clinical situations where infection is a concern.
Page 335 17 Probes and Biopsy Model Length(mm) Width(mm) Height(mm) SC6-1s 109.5 76.7 SC6-1E 109.5 76.7 SC5-1Ns 109.5 76.7 C6-2Gs 39.4 SC8-2s 67.7 C11-3s C9-3Ts 44.5 37.3 C4-1s 98.1 45.8 25.4 L9-3s L20-5s 24.1 L14-3Ws 102.1 66.8 25.5 L13-3Ns 98.7 56.8 21.5 7LT4s 49.1 20.4...
Page 336: Probes Cleaning And Disinfection/Sterilization
17 Probes and Biopsy Model Length(mm) Width(mm) Height(mm) P8-2Ts 1150.8 11.9 The above is a dimension illustration of the V11-3Hs probe. You can select the probe sheath according to the actual application situation. 17.1.5 Probes Cleaning and Disinfection/Sterilization For the detailed information, see Ultrasound System Cleaning, Disinfection & Sterilization Guide [Advanced].
Page 337 17 Probes and Biopsy Probe Model Ambient Relative humidity (no Atmospheric temperature condensation) pressure C6-2Gs 0℃-40℃ 20%-85%RH 700hPa-1060hPa SC6-1s 0℃-40℃ 20%-85%RH 700hPa-1060hPa SC6-1E 0℃-40℃ 20%-85%RH 700hPa-1060hPa V11-3Hs 0℃-40℃ 20%-85%RH 700hPa-1060hPa L9-3s 0℃-40℃ 20%-85%RH 700hPa-1060hPa SD8-1E 18℃-30℃ 20%-85%RH 700hPa-1060hPa SD8-1s 18℃-30℃ 20%-85%RH 700hPa-1060hPa L20-5s...
Page 338 Heat generators • When the probe is sent to MINDRAY Customer Service Department or sales representative for repair, be sure to disinfect it and keep it in the carrying case to prevent infection. Store and transport the probes in the following ambient conditions:...
Page 339: Storage And Transportation
Heat generators • When the probe is sent to MINDRAY Customer Service Department or sales representative for repair, be sure to disinfect it and keep it in the carrying case to prevent infection. 17.1.9 Sensor (Fusion Imaging) Support Cleaning and...
Page 340 17 Probes and Biopsy The efficacy of disinfectants and sterilizing solutions is not guaranteed by MINDRAY. Contact the manufacturers for information on the activity of the products. Cleaning Perform the following procedure: Disconnect the sensor support from the system. Wear sterile gloves to prevent infection.
Page 341 17 Probes and Biopsy Compatible Disinfectants Manufacturer Trade Name Procedures Type Metrex MetriZyme Please refer to the instructions Solution provided by the manufacturer of the solution for details. Cidex Activated Please refer to the instructions Solution Glutaraldehyde Solution provided by the manufacturer of the solution for details.
Page 342: Biopsy Guide
No cleaning and disinfecting may result in the sensor becoming a source of infection. • The efficacy of disinfectants and sterilizing solutions is not guaranteed by MINDRAY. Contact the manufacturers for information on the activity of the products. Disinfecting with Sprays or Wipes CAUTION Use protective eyewear when disinfecting using sprays.
Page 343 If an abnormality is found on the needle-guided bracket, immediately stop using it and contact MINDRAY Customer Service Department or sales representative. •...
Page 344: Needle-Guided Brackets Available
17 Probes and Biopsy If the target object and the biopsy needle appear in the image as shown in the figures below (For reference only): The biopsy needle appears to reach Dispersion of the ultrasound beam the target object in the image Biopsy Target Probe...
Page 345 17 Probes and Biopsy Probe Model Needle-guided Biopsy Angle Applicable Biopsy Bracket Model Needle SP5-1s/SP5-1E/ NGB-011 11°, 23° 13G, 15G, 16G, 18G, SP5-1U/SP5-1Ns Metal-needle undetachable C11-3s NGB-018 15°, 25°, 35° 14G, 16G, 18G, 20G, Metal-needle detachable SC6-1s/SC6-1E/ NGB-022 25°, 35°, 45° 14G, 16G, 18G, 20G, SC5-1Ns Metal-needle detachable...
Page 346: Needle-Guided Bracket Installation And Removal
NOTE: Mindray does not offer the biopsy needle; please purchase it according to your own needs. 17.2.2 Needle-Guided Bracket Installation and Removal A needle-guided bracket is available for purchase as an optional accessory; it is used in combination with the probe.
Page 347 17 Probes and Biopsy • Put on the sterile probe sheath before installing to the probe. • Confirm that the needle-guided bracket is free of damage, deformation, stripping, malfunction, loose, or missing parts. • Confirm that the needle-guided bracket is securely mounted in the correct position. •...
Page 348 17 Probes and Biopsy 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. When the retaining clamp is turned to the right position, the locking nut will lock the retaining clamp and the needle-guided bracket is then mounted to the right position.
Page 349 17 Probes and Biopsy Hold the probe by one hand, select the proper needle-guided bracket, and hold it with the other hand. Match the groove of the bracket with the tab of the probe. Amount the bracket onto the probe. Hold the probe by one hand, select proper needle-guided bracket, and hold it with the other hand, and align the grooves of the needle-guided bracket with the tabs of the probe, then push the needle-guided bracket forward, making the grooves of the needle-guided...
Page 350 17 Probes and Biopsy Remove the needle-guided bracket: Remove the guiding block slightly along the direction of the needle’s tail, and separate the residual part of the needle-guide bracket and the probe from the needle. Remove the support of needle-guided bracket from the probe. NGB-011 ...
Page 351 17 Probes and Biopsy NGB-018 Pinch nut of bracket Angle pinch nut Angle block Clamp Groove Angle-adjusting base Angle shift sign Guiding block specification Guiding block Needle guide hole Perform the following procedure: Install the needle-guided bracket: Put on the sterile probe sheath. Select a suitable needle-guided bracket and match the groove to the tab of the probe.
Page 352 17 Probes and Biopsy Select a suitable guiding block and push it into the groove above the angle block Screw the block's nut to secure the block. Insert a biopsy needle with the same specification as that of the guiding block into the guiding block hole.
Page 353 17 Probes and Biopsy Angle pinch nut Angle block Pinch nut Perform the following procedure: Install the needle-guided bracket: Put on the sterile probe sheath. Hold the probe by one hand, select the proper needle-guided bracket, and hold it with the other hand.
Page 354 17 Probes and Biopsy Remove the needle-guided bracket: Screw the pinch nut to release the needle-guided bracket. Separate the bracket and the probe. NGB-024 Angle locking nut Angle adjusting block Angle marker Angle adjusting base Slot Groove Right, left retaining nut Right, left clamp Needle shape adjusting Needle clamping cover...
Page 355 17 Probes and Biopsy Select a proper needle-guided bracket, and match the groove with the tab of the transducer. Mount the bracket onto the transducer. Rotate the clamping nuts of the guided bracket on right and left side to fix the bracket and the transducer.
Page 356 17 Probes and Biopsy Put the needle into the needle guided-bracket, and the needle leans to V-shaped block. Hold the transducer, and release the pressure position of the needle. Adjust the needle- type adjusting nut manually (following the direction of the arrow). The needle moves smoothly at the vertical direction due to its gravity.
Page 357 17 Probes and Biopsy Rotate the clamping nuts of the needle guided-bracket on right and left side (following the direction of the arrow). The needle guided-bracket is separate from the transducer. Hold the transducer and take out the bracket. NGB-025 Pinch nut Intra-cavity probe Lower clamp...
Page 358 17 Probes and Biopsy Open the clamp. Insert the front clamp to the front groove, and align front clamp with front groove. Push the biopsy forward (arrow’s direction) until the locating pole inserting into the location hole. Turn the lower clamp against the intra-cavity probe. Tighten the nut to lock the biopsy (arrow’s direction) Remove the needle-guided bracket: Hold the prober in the left hand;...
Page 359 17 Probes and Biopsy Angle adjusting block Angle fixing nut Needle mark Angle adjusting base Torsion spring of the Groove needle pressure cover Perform the following procedure: Install the needle-guided bracket: Put on the sterile probe sheath. Select a proper needle-guided bracket, and match the locating groove with the tab of the probe.
Page 360 17 Probes and Biopsy Hold the transducer. Press the pressure position of the needle to separate needle guided V- shaped block from pressure position of the needle. Put the needle into the needle guided-bracket, and the needle leans to V-shaped block. Hold the transducer, and release the pressure position of the needle.
Page 361 17 Probes and Biopsy Hold the transducer. Press the biopsy needle to separate the needle from pressure position of the needle. Separate the bracket and the transducer from the needle. Rotate the clamping nuts of the needle guided-bracket (following the direction of the arrow).
Page 362 17 Probes and Biopsy Angle fixing nut Angle adjusting base Needle type dial scale Needle adjusting base V-shape cover Lock pin Needle guide hole V-shaped guiding block Clamp Perform the following procedure: Install the needle-guided bracket: Put on the sterile probe sheath. Select a proper needle-guided bracket, and match the locating groove with the tab of the probe.
Page 363 17 Probes and Biopsy Pull the lock pin out until the V-shaped cover can be turned and opened up. Turn over the V-shaped cover to expose the needle. Remove the probe and bracket. Remove the needle-guided bracket: Unscrew the pinch nut to release the needle-guided bracket. Hold the probe and take out the bracket.
Page 364 17 Probes and Biopsy NGB-036 <2> <1> <7> <6> <5> <3> <4> <12> <11> <8> <10> <9> Left/right clamp Left/right clamp pinch nut Angle adjusting base Angle shift sign Angle adjusting block Angle pinch nut Separation pressure position Guiding hole V-shaped guiding block Needle clamp cover Needle type adjusting nut...
Page 365 17 Probes and Biopsy Select a proper needle-guided bracket, and match the tab with the groove of the transducer. Mount the bracket onto the transducer. Rotate the clamping nuts of the guided bracket on the right and left side to fix the bracket and the transducer.
Page 366 17 Probes and Biopsy Hold the transducer, and release the pressure position of the needle. Adjust the needle- type adjusting nut manually (following the direction of the arrow). The needle moves smoothly at the vertical direction due to its gravity. Remove the needle-guided bracket.
Page 367 17 Probes and Biopsy NGB-039 Angle blocking nut Angle adjusting block Angle mark Angle adjusting base Clamp The clamping nut Groove Needle-guided bracket adjusting nut Needle clamping cover Needle guide hole The pressing block for separating V-shaped guiding block needle Perform the following procedure: Install the needle-guided bracket:...
Page 368 17 Probes and Biopsy Tighten the pinch nut of the needle-guided bracket to confirm that the needle-guided bracket is properly installed on the probe. Loosen the angle adjusting nut. Hold the probe and press the pressing block to separate V-shaped guiding block from the pressing block.
Page 369 17 Probes and Biopsy Remove the needle-guided bracket: Hold the probe and press the pressing block to separate V-shaped guiding block from the pressing block. Remove the needle. Rotate the clamping nut to separate the bracket from the probe. Operator’s Manual 17 - 43...
Page 370 17 Probes and Biopsy NGB-043 Left clamp Groove Guide frame Locking nut of left and right clamps Right clamp Perform the following procedure: Install the needle-guided bracket: Put on the sterile probe sheath. Hold the probe in one hand, select the correct needle-guided bracket and hold it with the other hand.
Page 371 17 Probes and Biopsy Insert a biopsy needle with the same specification as that of the guiding block into the guiding block hole. Adjust the biopsy angle of the needle, and ensure that the needle can be adjusted continuously within the range of 30°-85°. Remove the needle-guided bracket.
Page 372 17 Probes and Biopsy NGB-044 Right clamp Groove Guiding block fixing frame Locking nut of left and right clamps Left clamp Depth pinch nut Depth shift sign Guiding blocks Perform the following procedure: Install the needle-guided bracket: Put on the sterile probe sheath. Hold the probe in one hand, select the correct needle-guided bracket and hold it with the other hand.
Page 373 17 Probes and Biopsy Loosen the depth pinch nut and fix it into the designated position of the depth shift sign after setting the desired depth. Select a suitable guiding block and loosen its nut, install the guiding block to the guiding block fixing frame and then tighten the block nut tightly.
Page 374 17 Probes and Biopsy Hold the probe and remove the needle from the guiding block hole. Loosen the guiding block nut, and remove it from the guiding block fixing frame. Rotate the clamping nuts on both sides of the needle guided-bracket to. separate The needle guided- the bracket is separate from the probe.
Page 375 17 Probes and Biopsy NGB-045 Needle exit Needle guide Needle entry Retaining clamp Locating bulges Perform the following procedure: Install the needle-guided bracket: Put on the sterile probe sheath. Align the needle-guided bracket with the probe to align the locating bulges on the needle guide with the locating grooves on the probe, then turn the retaining clamp to the correct position.
Page 376 17 Probes and Biopsy Hold the probe and remove the needle. Hold the probe and raise the needle-guided bracket to separate the locating bulge from the locating grooves. NGB-047 Intra-cavity probe Pinch nut Upper clamp Position block Front clamp Lower clamp Front slot Positioning block...
Page 377 17 Probes and Biopsy Open the clamp. Insert the front clamp to the front groove. Align the front clamp with the front slot. Push the biopsy forward (arrow’s direction) until the locating pole inserting into the location hole. Turn the lower clamp against the intra-cavity probe. Tighten the nut to lock the biopsy (arrow’s direction).
Page 378 17 Probes and Biopsy bracket forward to insert the clamp into the installation grove at the back of the probe. Mount the bracket onto the probe. Arrange the probe sheath in order. Press the left and right clamps of the bracket to crosswise clamp the probe.
Page 379 17 Probes and Biopsy Hold the probe in one hand, and hold the bracket with the other hand. Press the separating button of the bracket to open the clamp. Hold the clasp at the end of the bracket to separate the bracket from probe. NGB-051 Name Description...
Page 380 17 Probes and Biopsy Name Description Guiding block Used for installing biopsy needle; there are five specifications of guiding blocks for different needles. Knob of fixing the needle Used for fixing the needle. Guiding hole of the Used for installing the biopsy needle. needle Specification of guiding Matched with the corresponding biopsy needle.
Page 381 17 Probes and Biopsy Insert a biopsy needle with the same specification as that of the guiding block into the hole of the guiding block and turn tightly the knob of fixing the needle. Remove the needle-guided bracket: Turn on the knob of fixing the needle and separate the needle from the needle-guided bracket.
Page 382 17 Probes and Biopsy Put the needle into the needle guided-bracket, and the needle leans to V-shaped block. Hold the probe, and release the pressure position of the needle. Adjust the needle-type adjusting nut manually. The needle moves smoothly at the vertical direction due to its gravity.
Page 383 17 Probes and Biopsy right and left sides to fix the bracket and the probe. Rotate the needle-shaped adjusting nut to the ultimate position as shown in the figure. Hold the probe. Press the biopsy needle pressure position to separate it from the V-shaped guiding block.
Page 384: Verifying The Biopsy Guide Line
17 Probes and Biopsy Hold the probe. Press the biopsy needle pressure position to separate the biopsy needle from the pressure position. Separate the bracket and the probe from the needle. Rotate the locking nuts of the needle guided-bracket at the right and left sides (following the direction of the arrow).
Page 385: Starting The Biopsy Procedure
17 Probes and Biopsy – Select the biopsy bracket angle/guide line: If the needle-guided bracket supports more than one biopsy angle, select the angle/guideline by using [Biopsy Kit]. – Select the guide line dot size: Tap [Dot Size] to select the dot size. NOTE: •...
Page 386: Ineedle (Needle Visualization Enhancement)
17 Probes and Biopsy • Failure to match the guide zone displayed to the guide may cause the needle to track a path outside the zone. • It is extremely important that when using the adjustable angle biopsy guides, the angle displayed on the screen matches the angle set on the guide, otherwise the needle will not follow the displayed guide zone and this could result in repeated biopsies or patient injury.
Page 387: Clean And Sterilize The Needle-Guided Bracket
17 Probes and Biopsy 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 below, when the needle display in the ultrasound image is very clear. The system provides an additional deflection transmission that is approximately perpendicular to the metal needle, as the normal transmission (perpendicular to the transducer surface) is contained as well.
Page 388: Storage And Transportation
Between examinations, keep the needle-guided bracket in a sterile environment. • If the needle-guided bracket is sent to your MINDRAY representative for repair, be sure to disinfect or sterilize it and keep it in the carrying case to prevent infection.
Page 389 17 Probes and Biopsy • The needle mark displayed on the ultrasound image does not indicate the actual position of the needle. Therefore, it should only be used as a reference. Always monitor the relative positions of the biopsy needle during the procedures.
Page 390: Basic Procedures For Needle Navigation Guiding
17 Probes and Biopsy NOTE: • Refer to navigation device accompanied manual about installation, operation and disinfection of navigation device. Contact navigation device manufacturer if necessary. • During needle navigation guiding procedure, please keep the navigation device, ultrasound system and the probe away from electromagnetic interference, such as: power filter, signal indication, magnetic materials, cellphone and metal instruments.
Page 391: Installation
17 Probes and Biopsy Connect all accessories of magnetic positioning system. Refer to chapter “6.16.2 Magnetic Positioning System” and “17.3.2 Installation” for details. Activate needle navigation guiding feature and select needle type and length. Perform accuracy verification. For details, refer to chapter “17.3.3 Accuracy Verification”. Enter Fusion imaging and load CT/MR/PET/freehand data.
Page 392 17 Probes and Biopsy vTRAX Needle Needle bracket Needle sensor Sterile cover Specifications: • Biopsy needle 10~17G hard needle (vTRAX). Diameter: 2.0-3.3mm. Needle should be of non-interference to the sensor. Refer to manual provided by manufacturer for disinfection information. • Needle sensor Manufacturer: CIVCO.
Page 393 17 Probes and Biopsy Refer to “6.16.2 Magnetic Positioning System” for installation of magnetic controller, auxiliary power line, USB cable, and magnetic generator and probe sensor. Abdomen sensor is necessary under Fusion imaging mode. Wear the probe sterile sheath after probe sensor and bracket are installed. Connect the needle sensor to the 3rd port on the magnetic controller.
Page 394 17 Probes and Biopsy Loose the knob on the bracket anti-clockwise and insert the vTRAX needle into the bracket by the arrow direction. Anchor the bracket at the bottom of the needle and then tighten the knob. Turn on the magnetic positioning system power and perform needle navigation guiding operation after the signal is stabilized.
Page 395 17 Probes and Biopsy Specifications: • Needle sensor – Manufacturer: CIVCO. – Product number: 610-1112 – Wear sterile sheath for sensor. • eTRAX needle and sterile sheath (disposable) – Manufacturer: CIVCO – Product number: 16G eTRAX needle – eTRAX needle model: 610-1057, 610-1606-10, 610-1608-10, 610-1610-10, 610-1613-10, 610-1615-10 •...
Page 396 17 Probes and Biopsy Put on the sterile sheath onto the needle sensor. Insert the sensor into the needle. Tighten the knob, and make sure not to break the sterile sheath. Turn on the magnetic positioning system power and perform needle navigation guiding operation after the signal is stabilized.
Page 397: Accuracy Verification
17 Probes and Biopsy Anticlockwise rotate the eTRAX needle interface to take out the needle from trocar after the eTRAX needle access the target tissue. Select the proper Biopsy/melt needle according to the actual situation. 17.3.3 Accuracy Verification WARNING • This manual describes simple accuracy verification only.
Page 398: Mark
17 Probes and Biopsy Precisely measure the distance between tip to the bottom. NOTE: • Use disinfected tool to measure the distance. • Precise length data of the needle is important to the space magnetic navigation. Tap [Needle Navigation] on the touch screen to turn on the feature. Select needle type and set needle length.
Page 399: Screen Display In The Guiding
17 Probes and Biopsy NOTE: Be sure to use the section displaying the maximum of the lesion for marking. The lesion is enveloped by 3 circles from the inside and out: real-time mark, maximum diameter mark and safety boundary. – Perform the marking steps repeatedly for multiple marks.
Page 400 17 Probes and Biopsy Out-plane biopsy Out-plane navigation applies to needle path not inside the ultrasound image plane. Image Description Orientation Orientation of the needle to the surface of the acoustic lens. indication • Needle color turns green if the needle is inside the real-time ultrasound image plane.
Page 401: Image Description
Dispose needle, sensor support, sterile cover by requirements of the manufacturer. Contact the manufacturer for details. Dispose the bracket after sterilization. Contact Mindray for bracket disposal. 17.4 Middle Line Middle Line helps to locate and observe the focus point of lithotripsy wave during lithotripsy treatment.
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Page 403: Dvr Recording
Mindray is not responsible for any data loss. The system provides built-in DVR recording function. You can use the DVR to record and replay videos and audios that can be stored in DVD disc or hard disc.
Page 404: Dvr Video Replay
18 DVR Recording Select the destination and the target file, click [Send To] to send the file to the selected path. During sending progress, the icon displays as 18.3 DVR Video Replay You can replay the video and audio record. 18.3.1 Replay on PC Connect the USB disk or optical disk with the file to the PC, open the file directly.
Page 405: System Maintenance
The responsibility for maintenance and management of the product after delivery resides with the customer who has purchased the product. If you have any questions, please contact Mindray Customer Service Department or sales representative. WARNING •...
Page 406: Cleaning The System
19 System Maintenance 19.1.1 Cleaning the System WARNING • Before cleaning the system, be sure to turn off the power and disconnect the power cord from the outlet. Cleaning the system while the power is “On” may result in electric shock. •...
Page 407: Cleaning The Control Panel
19 System Maintenance Cleaning the monitor and the touch screen NOTE: • DO NOT use hydrocarbon glass cleaner or cleaner for OA (Office Automation) equipment to clean the monitor. These substances may cause deterioration of the monitor. • Clean the monitor and the touch screen periodically. Tool: soft dry cloth, soapy water The surfaces of the monitor and touch screen should be cleaned with a soft dry cloth.
Page 408 19 System Maintenance Cleaning: Bearing Main shaft Main shaft Use a clean soft cloth or dry paper tissue to clean the two main shafts inside the trackball, bearings, plastic housing, and inner part of the pressure ring. Meanwhile, clean the ball. Installing: Put the ball in.
Page 409 19 System Maintenance Pull out the dust-proof cover. Cleaning: with soft brush and then wipe off the dust. Assemble dust-proof covers. Insert the dust-proof cover into the slot of the main unit. Cleaning the Ultrasound gel heater NOTE: • Avoid liquid flowing into the gap of the heater. Do not use organic solvent to scrub the heater. Turn on and use the heater only after its surface is fully dried.
Page 410: Cleaning The Peripherals
19 System Maintenance Press the pad on the bottom cover to remove the bottom cover. Install the bottom cover. Install the gel heater back to the bracket and connect the power supply. 19.1.2 Cleaning the peripherals NOTE: Clean the peripherals periodically. Do the cleaning maintenance according to your actual peripheral configuration;...
Page 411: Checking The Power Cable And Plug
19 System Maintenance • Visually check to confirm that there are no cracks or expansion of the probe head. • Visually check to confirm that there is no deterioration or erosion of the probe cable. • Visually check to confirm that none of the connector pins are bent, destroyed or falling off. Checking the Power Cable and Plug NOTE: Check the power cable and plug periodically.
Page 412: System Hard Drive Backup
19 System Maintenance Content Method Footswitch Check whether the footswitch implements the configured functions according to the program. External DVD Check if DVD-R/W is working properly (burning, reading and Recorder ejecting). Bar code Check whether the scanner works normally and the output is correct. scanner DICOM Check whether DICOM works normally.
Page 413: Troubleshooting
19.3 Troubleshooting If any persistent system malfunction is experienced, e.g., an onscreen error message, blank imaging screen, absent menus, see the table below. If the failure cannot be resolved, contact the Mindray Customer Service Department or a sales representative. Failure...
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Page 415: Barcode Reader
Barcode Reader The product supports logging data as patient ID by using barcode reader. For details of the Honeywell barcode reader, please refer to the accompanying manuals. The laser transmitted by SYMBOL LS2208 is Class 2 laser. SYMBOL DS4308 is classified as “EXEMPT RISK GROUP” according to IEC 62471:2006 and EN 62471:2008.
Page 416: Setting Up The Reader (Take Ls2208 As An Example)
A.1.2 Setting The reader has factory settings. For details, please see “A.3 Parameter Defaults”. The reader supports some user-defined functions as introduced below. For more details, please contact the SYMBOL reader agents or Mindray Customer Service Department. A - 2...
Page 417: Volume Setting
A Barcode Reader Volume setting Scan the following barcode to set the volume parameter. • Low Volume: • Medium Volume: • High Volume: Code 93 and codebar scanning • To enable or disable Code 93, scan the appropriate barcode below. •...
Page 418: Scanning In Hand-Held Mode
A Barcode Reader Select this option to decode only I 2 of 5 symbols containing a selected length. Select the length using the numeric barcodes below. For example, to decode only I 2 of 5 symbols with 8 characters, scan I 2 of 5 - One Discrete Length, then scan 0 followed by 8. A.1.3 Scanning in Hand-Held Mode Perform the following procedure: Ensure all connections are secure.
Page 419: Scanning In Hands-Free Mode
A Barcode Reader decoding difficult. You can tilt the reader up to 55° forward or back and achieve a successful decode. A.1.4 Scanning in Hands-Free Mode Assembling the Intellistand One piece scanner “cup” with flexible Flat areas neck Stand base Wingnut Perform the following procedure: Unscrew the wingnut from the bottom of the one piece scanner “cup”.
Page 420: Mounting The Stand (Optional)
A Barcode Reader 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). Two screw-mount holes For Screw Mount, follow the steps below: 1. Position the assembled base on a flat surface. 2.
Page 421: Barcode Reader (Take Ds4308 As An Example)
A Barcode Reader 2D Barcode Reader (Take DS4308 as an example) The 2-D barcode reader supports hand-held operation mode. Hand-held mode: press the trigger to decode. A.2.1 Overview • Green: A barcode was successfully decoded. • Red: A data transmission error or reader malfunction occurred. Scan window Scan the barcode.
Page 422: Removing The Interface Cable
A.2.3 Setting The reader has factory settings, for details see “A.3 Parameter Defaults”. 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 423: Scanning In Hand-Held Mode
A Barcode Reader Code 93 and codabar setting • To enable Code 93, scan the appropriate barcode below. • To enable Codabar, scan the appropriate barcode below Code 39 full ASCII setting Code 39 Full ASCII is a variant of Code 39 which pairs characters to encode the full ASCII character set.
Page 424 A Barcode Reader Aim the digital imager reader at the barcode. When the digital imager reader senses movement, in its default Auto Aim trigger mode, it projects a red LED dot which allows positioning the barcode within the field of view. If necessary, the digital imager reader turns on its red LEDs to illuminate the target barcode.
Page 425: Parameter Defaults
A Barcode Reader Parameter Defaults Refer to the following table for parameter defaults of LS2208 and DS4308. Parameter Defaults Parameter Defaults 1-D Symbologies Interleaved 2 of 5 (ITF) UPC/EAN Interleaved 2 of 5 (ITF) Enable Enable UPC-A Enable Set Lengths for I 2 of 5 UPC-E Enable I 2 of 5 Check Digit Verification Disable...
Page 426 A Barcode Reader Parameter Defaults Parameter Defaults Code 39 Check Digit Disable Verification Transmit Code 39 Check Disable Digit Code 39 Full ASCII Disable Conversion Buffer Code 39 Disable Code 93 Code 93 Enable Set Length(s) for Code 93 4 to 55 A - 12 Operator’s Manual...
Page 427: Wireless Lan
Other non-medical devices in the same frequency band may cause interference, please be cautious. • Wireless network designing, deploying, debugging, and maintenance should be executed by Mindray service personnel or authorized technicians. • Always set the wireless network according to local wireless regulations. •...
Page 428: Use The Wireless Feature
B Wireless LAN • SSID > 80% with stable WLAN network. • Wireless router and the server are in the same network segment. • Router setting: – Wireless standard IEEE 802.11 ac/a/b/g/n. – Maximum transmission speed 300 Mbps. – Number of the devices connected to the same router ≤5. •...
Page 429: Eap Network
B Wireless LAN Click [OK] to save current setting. EAP Network For setting EAP network, contact Mindray Customer Service Department or the sales representatives. Operator’s Manual B - 3...
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Page 431: Use Iscanhelper For Reference
iScanHelper By providing the referential information, such as, the ultrasonic image, the anatomic graphic, scanning pictures/other scanning tips or diagnosis comments, the system helps the doctors to operate the scanning by iScanHelper. Furthermore, it is a good platform for the self-learning and training of ultrasound scanning technique for doctors.
Page 432: Basic Screen And Operation
C iScanHelper Basic Screen and Operation Ultrasonic image It is used to compare with images scanned by the operator. Anatomic graphic Related anatomical tissue information are provided here. Scanning tips You can read tissue related anatomical information and adjacent tissue information here. Scanning picture Ordinary scanning tips can be observed here, including posture, probe mark, probe swing/sweep techniques.
Page 433 iVision The iVision function is used to demonstrate the stored images. Image files are played one by one according to file names (including system-relevant and PC-compatible format images). Perform the following procedure: Press the user-defined <iVision> key to enter the iVision screen. Add the contents to be played and select demo mode.
Page 434: D Ivision
D iVision Plug the USB disk, and click [Copy File]. Select the path of the source file from the “Drive” and “File Name”. Click [Choose Catalog]. Select the path of the source file from the “Drive” and “File Name”, and then click [OK]. Click [OK] again to complete the task.
Page 435: 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 436: Mi/Ti Explanation
E Acoustic Output Additional information regarding the concept of ALARA and the possible bioeffects of Ultrasound is “Medical available in a document from the AIUM (American Institute of Ultrasound Medicine) title Ultrasound Safety”. MI/TI Explanation E.4.1 Basic Knowledge of MI and TI Mechanical Bioeffect and Thermal Bioeffect The relationship of various ultrasound output parameters (frequency, acoustic pressure and intensity, etc.) to bioeffects is not fully understood presently.
Page 437: Mi/Ti Display
E Acoustic Output Although the output power is automatically controlled for the selected applications, high TI values should be kept to a minimum or avoided in obstetric applications. WFUMB (World Federation for Ultrasound in Medicine and Biology) guidelines: state that temperature increase of 4 degree C for 5 min or more should be considered as potentially hazardous to embryonic and fetal tissue.
Page 438: Acoustic Power Control
E Acoustic Output Following the ALARA restriction, you are allowed to increase the acoustic power under FDA 510 (k) Guidance-Track 3 limits and to set it in the image preset screen. The acoustic output of the system has been measured and calculated in accordance with IEC60601- 2-37: 2015, FDA 510(K) GUIDANCE, IEC 62359: 2017, Ultrasonics-Field characterization-Test methods for the deter mination of thermal and mechanical indices related to medical diagnostic ultrasonic fields.
Page 439: Limits Of Acoustic Output
E Acoustic Output Where I is the attenuated intensity, I is the intensity measured in a water tank (at distance atten water z), fc is the center frequency of the ultrasound wave (as measured in water), and z is the distance from the probe.
Page 440: Measurement Uncertainty
E Acoustic Output Measurement Uncertainty The total estimated measurement uncertainty (where the total uncertainty includes the uncertainties in hydrophone response, measurement, calculation, and positioning) are: Acoustic Quantities Total Uncertainties (Standard) Power 26.48% for non-scan modes; 6.03% for scan modes. Frequency 0.22% Pressure 13.01%...
Page 441: F Electrical Safety Inspection
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 442: Device Enclosure And Accessories
F Electrical Safety Inspection Device Enclosure and Accessories F.2.1 Visual Inspection Test Item Acceptance Criteria The enclosure and No physical damage to the enclosure and accessories. accessories 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.).
Page 443: Enclosure Leakage Test
F Electrical Safety Inspection • normal polarity with open neutral (Single Fault Condition). • reverse polarity with open neutral (Single Fault Condition). LIMITS • For UL 60601-1: – 300 μA in Normal Condition. – 1000 μA in Single Fault Condition. •...
Page 444: Mains On Applied Part Leakage
F Electrical Safety Inspection Mains on Applied Part Leakage The Mains on Applied Part test applies a test voltage, which is 110% of the mains voltage using a limiting resistance, to selected applied part terminals. Current measurements are then taken between the selected applied part and earth.
Page 445: Emc Guidance And Manufacturer's Declaration
EMC Guidance and Manufacturer’s Declaration Resona I9 series complies with the EMC standard IEC60601-1-2:2014+A1:2020. 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). WARNING •...
Page 446 G EMC Guidance and Manufacturer’s Declaration We suggest that you position system further from sources of conducted RF noise. • Portable and mobile RF communications equipment could affect system. See below tables. • Resona I9 series should be away from RFID, MRI, diathermy, and electrocautery testing, wireless power transfer, 5G cellular and security equipment (such as electromagnetic anti-theft system and metal detector).
Page 447 • Date/time information. Table G-1 GUIDANCE AND MINDRAY DECLARATION-ELECTROMAGNETIC EMISSIONS Resona I9 series 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.
Page 448 G EMC Guidance and Manufacturer’s Declaration Table G-3 GUIDANCE AND MINDRAY DECLARATION-ELECTROMAGNETIC IMMUNITY Resona I9 series 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.
Page 449 G EMC Guidance and Manufacturer’s Declaration Table G-4 GUIDANCE AND MINDRAY DECLARATION-ELECTROMAGNETIC IMMUNITY Resona I9 series 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.
Page 450 G EMC Guidance and Manufacturer’s Declaration Table G-4 GUIDANCE AND MINDRAY DECLARATION-ELECTROMAGNETIC IMMUNITY Resona I9 series 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.
Page 451 G EMC Guidance and Manufacturer’s Declaration Table G-6 Test specifications and minimum distances Recommended separation distances between portable and mobile RF communications equipment and system Resona I9 series is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled.
Page 452 G EMC Guidance and Manufacturer’s Declaration Table G-7 RECOMMENDED SEPARATION DISTANCES BETWEEN PORTABLE AND MOBILE RF COMMUNICATION DEVICE AND THE SYSTEM Resona I9 series 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 453: Radio Regulatory Compliance
G EMC Guidance and Manufacturer’s Declaration Radio Regulatory Compliance RF parameter Features 2.4GHz 5GHz Frequency Rage 2412MHz - 2483.5MHz 5.15 - 5.25GHz 5.25 - 5.35GHz 5.47 - 5.725GHz 5.725 - 5.850GHz Modulation DSSS and OFDM OFDM Output Power ≤20dBm NOTE: Keep a distance of at least 20cm away from the monitor when Wi-Fi function is in use.
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Page 455: H List Of Vocal Commands
After the input command is recognized, the system automatically performs the corresponding operations. Vocal command Operation Hello Mindray Open Audio Control Turn Off Close Audio Control B Mode...
Page 456 H List of Vocal Commands Vocal command Operation Turn on Smart Track Mode Turn on Smart Track Mode Turn off Smart Track Mode Turn off Smart Track Mode Sound Volume Up Turn Sound Volume Up Sound Volume Down Turn Sound Volume Down Angle More Angle More One Angle Less...
Page 457 H List of Vocal Commands Vocal command Operation Lower External Vein Switch Exam Mode to Lower Ext Vein Thyroid Switch Exam Mode to Thyroid Breast Switch Exam Mode to Breast Testicle Switch Exam Mode to Testicle Musculoskeletal Switch Exam Mode to Musculoskeletal Superficial Switch Exam Mode to Superficial Shoulder...
Page 458 H List of Vocal Commands Vocal command Operation Smart IVC Smart IVC Smart VTI Smart VTI Smart B-lines Smart B-lines H - 4 Operator’s Manual...
Page 459: I Ultrasound Gel Heater
Ultrasound Gel Heater NOTE: Ultrasound gel heater is a system option used for heating the ultrasound gel. Structure Name Description Ultrasound gel box Used for placing the gel. Indicator • The indicator is off when switching off the heater. • Set the heater temperature to low; one indicator on the right becomes white.
Page 460: Function And Requirement
I Ultrasound Gel Heater – Ambient temperature: 0°C~40°C – Relative humidity: 20%~85% (no condensation) – Atmospheric pressure: 700hPa~1060hPa • Storage and transportation conditions – Ambient temperature: -20°C~55°C – Relative humidity: 20%~95% (no condensation) – Atmospheric pressure: 700hPa~1060hPa Function and Requirement NOTE: •...
Page 461: J Software And Hardware Specification
Software and Hardware Specification Operating Environment Hardware Configuration CPU: Intel X86, 3.7GHz Hard disk: 128G SSD + 1T HDD Monitor: 23.8 inch Software Environment Windows 10 64bit or Linux 64bit Network Condition Cable network: 10M/100M/1000M adaption Wireless network: • Protocol compatible with IEEE 802.11 ac/a/b/g/n standard •...
Page 462: Electronic Interface
J Software and Hardware Specification Supplier Component Name Version Description libpng libpng 1.6.37 Image Coding&decoding libtiff libtiff 3.6.1 Image Coding&decoding ffmpeg Ffmpeg 5.1.2 Video Codec Trillium Technology Dicom Viewer 6.0.3.21 DICOM Viewer 7-zip 7-zip 16.02 Compress Tool libjpeg libjpeg Image Coding&decoding ascension technology ATC3DG 36.0.19.8...
Page 463: Wireless Specification
S-Video 4-core 2-component separate video interface. • Mindray ECG interface, using USB communication, and complied with Mindray internal standard. • The timestamp is defined by the data packet. Mindray PCG interface, complied with Mindray internal standard.
Page 464: Interoperability
J Software and Hardware Specification Item Specifications Vision Distance The ultrasound diagnostic system can be connected Communications within 3 meters of the wireless network, and the system can perform the following operations and realize its intended use: • Support DICOM transferring patient data through the wireless network (Wi-Fi).
Page 465: Security Policy
Data Interact/ Interface interface data s used interface transmissi Communic exchange on method ation Content UltraView Communicat Transmit Mindray Wired/ Image data, ion with private wireless patient data UltraView protocol and Device software Information Medical Transmit Image data, Interface image and...
Page 466 The device does not support patching by the customer. Any updates or patches applied to the system need to be evaluated thoroughly by Mindray. Software and hardware version updates are notified to users by Mindray service engineers or engineers authorized by Mindray only. •...
Page 467: Indications For Use
Indications For Use N=new indication; P=previously cleared by FDA Additional comments: Combined modes--B+M, PW+B, Color + B, Power + B, PW +Color+ B, Power + PW *Intraoperative includes abdominal, thoracic, and vascular. **Small organ-breast, thyroid, testes. ***Other use includes Urology. ****For detection of fluid and pleural motion/sliding.
Page 468 K Indications For Use Resona I9, Resona I9 Exp, Resona I9S, Resona I9T, Resona I9 Easi, Resona I9 Nasa, Resona IV, Imagyn I9, Imagyn I9S, Imagyn I9 Easi, Nuewa I9, Nuewa I9S, Nuewa I9 Easi, Nuewa I9T, System: Nuewa I9 Exp, Anesus I9, Anesus I9 Easi, Eagus I9, Recho I9, Recho I9 Pro, Recho I9 Exp, Recho I9S,Recho I9T, Resona I9W Diagnostic Ultrasound System Transducer: / Intended...
Page 469 K Indications For Use Transducer: SC6-1s Intended Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: Use: Clinical Application Mode of Operation General Combine Color Amplitud (Track 1 Specific (Track 1 & 3) B PWD CWD Other (Specify) Doppler e Doppler...
Page 470 K Indications For Use Transducer: SC6-1E Intended Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: Use: Clinical Application Mode of Operation General Combine Color Amplitud (Track 1 Specific (Track 1 & 3) B PWD CWD Other (Specify) Doppler e Doppler...
Page 471 K Indications For Use Transducer: SC5-1Ns Intended Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: Use: Clinical Application Mode of Operation General Combine Color Amplitud (Track 1 Specific (Track 1 & 3) B PWD CWD Other (Specify) Doppler e Doppler...
Page 472 K Indications For Use Transducer: C6-2Gs Intended Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: Use: Clinical Application Mode of Operation General Combine Color Amplitud (Track 1 Specific (Track 1 & 3) B PWD CWD Other (Specify) Doppler e Doppler...
Page 473 K Indications For Use Transducer: SC8-2s Intended Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: Use: Clinical Application Mode of Operation General Combine Color Amplitud (Track 1 Specific (Track 1 & 3) B PWD CWD Other (Specify) Doppler e Doppler...
Page 474 K Indications For Use Transducer: C11-3s Intended Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: Use: Clinical Application Mode of Operation General Combine Color Amplitud (Track 1 Specific (Track 1 & 3) B PWD CWD Other (Specify) Doppler e Doppler...
Page 475 K Indications For Use Transducer: C9-3Ts Intended Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: Use: Clinical Application Mode of Operation General Combine Color Amplitud (Track 1 Specific (Track 1 & 3) B PWD CWD Other (Specify) Doppler e Doppler...
Page 476 K Indications For Use Transducer: C4-1s Intended Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: Use: Clinical Application Mode of Operation General Combine Color Amplitud (Track 1 Specific (Track 1 & 3) B PWD CWD Other (Specify) Doppler e Doppler...
Page 477 K Indications For Use Transducer: L9-3s Intended Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: Use: Clinical Application Mode of Operation Combine General(Trac Color Amplitud Specific(Track 1 & 3) PWD CWD Other (specify) k 1 Only) Doppler e Doppler (specify)
Page 478 K Indications For Use Transducer: L20-5s Intended Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: Use: Clinical Application Mode of Operation General Combine Color Amplitud (Track 1 Specific (Track 1 & 3) B PWD CWD Other (Specify) Doppler e Doppler...
Page 479 K Indications For Use Intended Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: Use: Clinical Application Mode of Operation General Combine Color Amplitud (Track 1 Specific (Track 1 & 3) B PWD CWD Other (Specify) Doppler e Doppler Only)
Page 480 K Indications For Use Transducer: L13-3Ns Intended Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: Use: Clinical Application Mode of Operation General Combine Color Amplitud (Track 1 Specific (Track 1 & 3) B PWD CWD Other (Specify) Doppler e Doppler...
Page 481 K Indications For Use Transducer: 7LT4s Intended Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: Use: Clinical Application Mode of Operation General Combine Color Amplitud (Track 1 Specific (Track 1 & 3) B PWD CWD Other (Specify) Doppler e Doppler...
Page 482 K Indications For Use Transducer: L16-4Hs Intended Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: Use: Clinical Application Mode of Operation General Combine Color Amplitud (Track 1 Specific (Track 1 & 3) B PWD CWD Other (Specify) Doppler e Doppler...
Page 483 K Indications For Use Transducer: L12-3RCs Intended Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: Use: Clinical Application Mode of Operation General Combine Color Amplitud (Track 1 Specific (Track 1 & 3) B PWD CWD Other (Specify) Doppler e Doppler...
Page 484 K Indications For Use Transducer: L12-3VNs Intended Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: Use: Clinical Application Mode of Operation General Combine Color Amplitud (Track 1 Specific (Track 1 & 3) B PWD CWD Other (Specify) Doppler e Doppler...
Page 485 K Indications For Use Transducer: SP5-1s Intended Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: Use: Clinical Application Mode of Operation General Combine Color Amplitud (Track 1 Specific (Track 1 & 3) B PWD CWD Other (Specify) Doppler e Doppler...
Page 486 K Indications For Use Transducer: SP5-1E Intended Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: Use: Clinical Application Mode of Operation General Combine Color Amplitud (Track 1 Specific (Track 1 & 3) B PWD CWD Other (Specify) Doppler e Doppler...
Page 487 K Indications For Use Transducer: SP5-1U Intended Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: Use: Clinical Application Mode of Operation General Combine Color Amplitud (Track 1 Specific (Track 1 & 3) B PWD CWD Other (Specify) Doppler e Doppler...
Page 488 K Indications For Use Transducer: SP5-1Ns Intended Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: Use: Clinical Application Mode of Operation General Combine Color Amplitud (Track 1 Specific (Track 1 & 3) B PWD CWD Other (Specify) Doppler e Doppler...
Page 489 K Indications For Use Transducer: P10-4s Intended Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: Use: Clinical Application Mode of Operation General Combine Color Amplitud (Track 1 Specific (Track 1 & 3) B PWD CWD Other (Specify) Doppler e Doppler...
Page 490 K Indications For Use Transducer: P8-2s Intended Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: Use: Clinical Application Mode of Operation General Combine Color Amplitud (Track 1 Specific (Track 1 & 3) B PWD CWD Other (Specify) Doppler e Doppler...
Page 491 K Indications For Use Transducer: V11-3Hs Intended Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: Use: Clinical Application Mode of Operation General Combine Color Amplitud (Track 1 Specific (Track 1 & 3) B PWD CWD Other (Specify) Doppler e Doppler...
Page 492 K Indications For Use Transducer: V11-3HBs Intended Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: Use: Clinical Application Mode of Operation General Combine Color Amplitud (Track 1 Specific (Track 1 & 3) B PWD CWD Other (Specify) Doppler e Doppler...
Page 493 K Indications For Use Transducer: ELC13-4s Intended Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: Use: Clinical Application Mode of Operation General Combine Color Amplitud (Track 1 Specific (Track 1 & 3) B PWD CWD Other (Specify) Doppler e Doppler...
Page 494 K Indications For Use Transducer: CB10-4s Intended Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: Use: Clinical Application Mode of Operation General Combine Color Amplitud (Track 1 Specific (Track 1 & 3) B PWD CWD Other (Specify) Doppler e Doppler...
Page 495 K Indications For Use Transducer: CW5s Intended Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: Use: Clinical Application Mode of Operation General Combine Color Amplitud (Track 1 Specific (Track 1 & 3) B PWD CWD Other (Specify) Doppler e Doppler...
Page 496 K Indications For Use Transducer: CW2s Intended Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: Use: Clinical Application Mode of Operation General Combine Color Amplitud (Track 1 Specific (Track 1 & 3) B PWD CWD Other (Specify) Doppler e Doppler...
Page 497 K Indications For Use Transducer: DE11-3Ws Intended Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: Use: Clinical Application Mode of Operation General Combine Color Amplitud (Track 1 Specific (Track 1 & 3) B PWD CWD Other (Specify) Doppler e Doppler...
Page 498 K Indications For Use Transducer: SD8-1s Intended Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: Use: Clinical Application Mode of Operation General Combine Color Amplitud (Track 1 Specific (Track 1 & 3) B PWD CWD Other (Specify) Doppler e Doppler...
Page 499 K Indications For Use Transducer: SD8-1E Intended Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: Use: Clinical Application Mode of Operation General Combine Color Amplitud (Track 1 Specific (Track 1 & 3) B PWD CWD Other (Specify) Doppler e Doppler...
Page 500 K Indications For Use Transducer: P7-3Ts Intended Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: Use: Clinical Application Mode of Operation General Combine Color Amplitud (Track 1 Specific (Track 1 & 3) B PWD CWD Other (Specify) Doppler e Doppler...
Page 501 K Indications For Use Transducer: P7-3TE Intended Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: Use: Clinical Application Mode of Operation General Combine Color Amplitud (Track 1 Specific (Track 1 & 3) B PWD CWD Other (Specify) Doppler e Doppler...
Page 502 K Indications For Use Transducer: P7-3TU Intended Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: Use: Clinical Application Mode of Operation General Combine Color Amplitud (Track 1 Specific (Track 1 & 3) B PWD CWD Other (Specify) Doppler e Doppler...
Page 503 K Indications For Use Transducer: P8-3Ts Intended Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: Use: Clinical Application Mode of Operation General Combine Color Amplitud (Track 1 Specific (Track 1 & 3) B PWD CWD Other (Specify) Doppler e Doppler...
Page 504 K Indications For Use Transducer: P8-2Ts Intended Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: Use: Clinical Application Mode of Operation General Combine Color Amplitud (Track 1 Specific (Track 1 & 3) B PWD CWD Other (Specify) Doppler e Doppler...
Page 505 K Indications For Use Transducer: LAP13-4Cs Intended Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: Use: Clinical Application Mode of Operation General Combine Color Amplitud (Track 1 Specific (Track 1 & 3) B PWD CWD Other (Specify) Doppler e Doppler...
Page 506 K Indications For Use Resona I8W, Resona I8, Resona I8 Exp, Resona I8S, Resona I8T, Resona IY, Nuewa I8W, Nuewa System: I8, Nuewa I8 Exp, Nuewa I8S, Nuewa I8T, Imagyn I8, Imagyn I8S, Imagyn I8T, Imagyn I8 Exp, Nuewa IY, Resona I8 Easi, Eagus I8 Easi Diagnostic Ultrasound System Transducer: / Intended Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:...
Page 507 K Indications For Use Transducer: SC6-1s Intended Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: Use: Clinical Application Mode of Operation General Combine Color Amplitud (Track 1 Specific (Track 1 & 3) B PWD CWD Other (Specify) Doppler e Doppler...
Page 508 K Indications For Use Transducer: SC6-1E Intended Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: Use: Clinical Application Mode of Operation General Combine Color Amplitud (Track 1 Specific (Track 1 & 3) B PWD CWD Other (Specify) Doppler e Doppler...
Page 509 K Indications For Use Transducer: SC5-1Ns Intended Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: Use: Clinical Application Mode of Operation General Combine Color Amplitud (Track 1 Specific (Track 1 & 3) B PWD CWD Other (Specify) Doppler e Doppler...
Page 510 K Indications For Use Transducer: C6-2Gs Intended Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: Use: Clinical Application Mode of Operation General Combine Color Amplitud (Track 1 Specific (Track 1 & 3) B PWD CWD Other (Specify) Doppler e Doppler...
Page 511 K Indications For Use Transducer: SC8-2s Intended Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: Use: Clinical Application Mode of Operation General Combine Color Amplitud (Track 1 Specific (Track 1 & 3) B PWD CWD Other (Specify) Doppler e Doppler...
Page 512 K Indications For Use Transducer: C11-3s Intended Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: Use: Clinical Application Mode of Operation General Combine Color Amplitud (Track 1 Specific (Track 1 & 3) B PWD CWD Other (Specify) Doppler e Doppler...
Page 513 K Indications For Use Transducer: C9-3Ts Intended Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: Use: Clinical Application Mode of Operation General Combine Color Amplitud (Track 1 Specific (Track 1 & 3) B PWD CWD Other (Specify) Doppler e Doppler...
Page 514 K Indications For Use Transducer: C4-1s Intended Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: Use: Clinical Application Mode of Operation General Combine Color Amplitud (Track 1 Specific (Track 1 & 3) B PWD CWD Other (Specify) Doppler e Doppler...
Page 515 K Indications For Use Transducer: L9-3s Intended Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: Use: Clinical Application Mode of Operation Combine General(Trac Color Amplitud Specific(Track 1 & 3) PWD CWD Other (specify) k 1 Only) Doppler e Doppler (specify)
Page 516 K Indications For Use Transducer: L20-5s Intended Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: Use: Clinical Application Mode of Operation General Combine Color Amplitud (Track 1 Specific (Track 1 & 3) B PWD CWD Other (Specify) Doppler e Doppler...
Page 517 K Indications For Use Transducer: L14-3Ws Intended Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: Use: Clinical Application Mode of Operation General Combine Color Amplitud (Track 1 Specific (Track 1 & 3) B PWD CWD Other (Specify) Doppler e Doppler...
Page 518 K Indications For Use Transducer: L13-3Ns Intended Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: Use: Clinical Application Mode of Operation General Combine Color Amplitud (Track 1 Specific (Track 1 & 3) B PWD CWD Other (Specify) Doppler e Doppler...
Page 519 K Indications For Use Transducer: 7LT4s Intended Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: Use: Clinical Application Mode of Operation General Combine Color Amplitud (Track 1 Specific (Track 1 & 3) B PWD CWD Other (Specify) Doppler e Doppler...
Page 520 K Indications For Use Transducer: L16-4Hs Intended Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: Use: Clinical Application Mode of Operation General Combine Color Amplitud (Track 1 Specific (Track 1 & 3) B PWD CWD Other (Specify) Doppler e Doppler...
Page 521 K Indications For Use Transducer: L12-3RCs Intended Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: Use: Clinical Application Mode of Operation General Combine Color Amplitud (Track 1 Specific (Track 1 & 3) B PWD CWD Other (Specify) Doppler e Doppler...
Page 522 K Indications For Use Transducer: L12-3VNs Intended Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: Use: Clinical Application Mode of Operation General Combine Color Amplitud (Track 1 Specific (Track 1 & 3) B PWD CWD Other (Specify) Doppler e Doppler...
Page 523 K Indications For Use Transducer: SP5-1s Intended Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: Use: Clinical Application Mode of Operation General Combine Color Amplitud (Track 1 Specific (Track 1 & 3) B PWD CWD Other (Specify) Doppler e Doppler...
Page 524 K Indications For Use Transducer: SP5-1E Intended Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: Use: Clinical Application Mode of Operation General Combine Color Amplitud (Track 1 Specific (Track 1 & 3) B PWD CWD Other (Specify) Doppler e Doppler...
Page 525 K Indications For Use Transducer: SP5-1U Intended Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: Use: Clinical Application Mode of Operation General Combine Color Amplitud (Track 1 Specific (Track 1 & 3) B PWD CWD Other (Specify) Doppler e Doppler...
Page 526 K Indications For Use Transducer: SP5-1Ns Intended Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: Use: Clinical Application Mode of Operation General Combine Color Amplitud (Track 1 Specific (Track 1 & 3) B PWD CWD Other (Specify) Doppler e Doppler...
Page 527 K Indications For Use Transducer: P10-4s Intended Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: Use: Clinical Application Mode of Operation General Combine Color Amplitud (Track 1 Specific (Track 1 & 3) B PWD CWD Other (Specify) Doppler e Doppler...
Page 528 K Indications For Use Transducer: P8-2s Intended Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: Use: Clinical Application Mode of Operation General Combine Color Amplitud (Track 1 Specific (Track 1 & 3) B PWD CWD Other (Specify) Doppler e Doppler...
Page 529 K Indications For Use Transducer: V11-3Hs Intended Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: Use: Clinical Application Mode of Operation General Combine Color Amplitud (Track 1 Specific (Track 1 & 3) B PWD CWD Other (Specify) Doppler e Doppler...
Page 530 K Indications For Use Transducer: V11-3HBs Intended Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: Use: Clinical Application Mode of Operation General Combine Color Amplitud (Track 1 Specific (Track 1 & 3) B PWD CWD Other (Specify) Doppler e Doppler...
Page 531 K Indications For Use Transducer: ELC13-4s Intended Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: Use: Clinical Application Mode of Operation General Combine Color Amplitud (Track 1 Specific (Track 1 & 3) B PWD CWD Other (Specify) Doppler e Doppler...
Page 532 K Indications For Use Transducer: CB10-4s Intended Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: Use: Clinical Application Mode of Operation General Combine Color Amplitud (Track 1 Specific (Track 1 & 3) B PWD CWD Other (Specify) Doppler e Doppler...
Page 533 K Indications For Use Transducer: CW5s Intended Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: Use: Clinical Application Mode of Operation General Combine Color Amplitud (Track 1 Specific (Track 1 & 3) B PWD CWD Other (Specify) Doppler e Doppler...
Page 534 K Indications For Use Transducer: CW2s Intended Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: Use: Clinical Application Mode of Operation General Combine Color Amplitud (Track 1 Specific (Track 1 & 3) B PWD CWD Other (Specify) Doppler e Doppler...
Page 535 K Indications For Use Transducer: DE11-3Ws Intended Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: Use: Clinical Application Mode of Operation General Combine Color Amplitud (Track 1 Specific (Track 1 & 3) B PWD CWD Other (Specify) Doppler e Doppler...
Page 536 K Indications For Use Transducer: SD8-1s Intended Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: Use: Clinical Application Mode of Operation General Combine Color Amplitud (Track 1 Specific (Track 1 & 3) B PWD CWD Other (Specify) Doppler e Doppler...
Page 537 K Indications For Use Transducer: SD8-1E Intended Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: Use: Clinical Application Mode of Operation General Combine Color Amplitud (Track 1 Specific (Track 1 & 3) B PWD CWD Other (Specify) Doppler e Doppler...
Page 538 K Indications For Use Transducer: P7-3Ts Intended Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: Use: Clinical Application Mode of Operation General Combine Color Amplitud (Track 1 Specific (Track 1 & 3) B PWD CWD Other (Specify) Doppler e Doppler...
Page 539 K Indications For Use Transducer: P7-3TE Intended Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: Use: Clinical Application Mode of Operation General Combine Color Amplitud (Track 1 Specific (Track 1 & 3) B PWD CWD Other (Specify) Doppler e Doppler...
Page 540 K Indications For Use Transducer: P7-3TU Intended Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: Use: Clinical Application Mode of Operation General Combine Color Amplitud (Track 1 Specific (Track 1 & 3) B PWD CWD Other (Specify) Doppler e Doppler...
Page 541 K Indications For Use Transducer: P8-3Ts Intended Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: Use: Clinical Application Mode of Operation General Combine Color Amplitud (Track 1 Specific (Track 1 & 3) B PWD CWD Other (Specify) Doppler e Doppler...
Page 542 K Indications For Use Transducer: P8-2Ts Intended Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: Use: Clinical Application Mode of Operation General Combine Color Amplitud (Track 1 Specific (Track 1 & 3) B PWD CWD Other (Specify) Doppler e Doppler...
Page 543 K Indications For Use Transducer: LAP13-4Cs Intended Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: Use: Clinical Application Mode of Operation General Combine Color Amplitud (Track 1 Specific (Track 1 & 3) B PWD CWD Other (Specify) Doppler e Doppler...
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Page 546 P/N: 046-021502-04 (2.0)

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