Contents Intellectual Property Statement ....................I Responsibility on the Manufacturer Party ................I Warranty ..........................II Important Information ......................II About This Manual ........................ III 1 Safety Precautions ....................1 - 1 1.1 Meaning of Safety Symbols ................... 1 - 1 1.2 Safety Precautions ......................
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Contents 3.2.2 Equipotential Terminal ..................3 - 2 3.3 Powering ON/OFF ......................3 - 3 3.3.1 Checking Before Powering ON ................3 - 3 3.3.2 Powering the System ON ..................3 - 3 3.3.3 Checking After Powering On ................3 - 4 3.3.4 Powering the System Off ..................
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.
FITNESS FOR ANY PARTICULAR PURPOSE. Exemptions Mindray's obligation or liability under this warranty does not include any transportation or other charges or liability for direct, indirect or consequential damages or delay resulting from the improper use or application of the product or the use of parts or accessories not approved by Mindray or repairs by people other than Mindray authorized personnel.
• 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.
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Signal word Meaning Important information that helps you to use the system more effectively. Operator’s Manuals You may receive multi-language manuals on compact disc or paper. Please refer to the English manual for the latest information and registration information. The content of the operator manual, such as screens, menus or descriptions, may be different from what you see in your system.
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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.
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. The ECG leads within this system is type-BF applied part. Caution! General warning sign.
• 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.
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1 Safety Precautions • When moving the system, you should hold the handle; otherwise, damage may be resulted by abnormal force. Do not push the system from the left/ right side, otherwise, it may be toppled over. • The auxiliary power output outlet in the system is used to supply power for the recommended peripheral devices.
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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.
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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. •...
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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.
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• 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.
1 Safety Precautions – Heat generators • Repeated disinfection will eventually damage the probe, please check the probe performance periodically. 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...
System Overview Intended Use NOTE: The system is not intended for central cardiovascular or central nervous system use. Diagnostic Ultrasound System is applicable for adults, pregnant women, pediatric patients and neonates. It is intended for use in fetal, abdominal, Intra-operative, pediatric, small organ (breast, thyroid, testes), neonatal and adult cephalic, trans-rectal, trans-vaginal, musculo-skeletal (conventional, superficial), adult and pediatric cardiac, trans-esoph.
2 System Overview • According to the mode of operation: 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 •...
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2 System Overview Item Remarks Battery Ultrasound gel warmer Should be configured with the bracket of the ultrasound gel warmer. Ultrasound gel warmer Should be configured with the ultrasound gel warmer. holder Storage Tray Kit ECG module ECG cable The ECG module should be configured. DC-IN cable The ECG module should be configured.
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2 System Overview Item Remarks Footswitch (1-pedal, 2- USB interface pedal, or 3-pedal) 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.
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2 System Overview Item Remarks Smart ICV Smart Planes CNS should be configured. Smart Scene 3D 4D Function should be configured. Ultrasound Fusion Imaging Fusion imaging module or Fusion imaging module (including trolley) should be configured. Endocavity Fusion Imaging Fusion imaging module or Fusion imaging module (including trolley) should be configured.
2 System Overview Item Remarks Smart FLC Gynecology Package should be configured. Can be accessed in 2D or 3D mode. Cardiology Package Small Parts Package Urology Package Vascular Package 100. Pediatrics Package 101. Nerve Package 102. Emergency&Critical Package 103. Pelvic Floor Package Gynecology Package should be configured.
2 System Overview Item Model Digital color video printer SONY UP-D25MD Barcode reader • LS2208 • DS4308 Footswitch • FS-81-SP-2 (1-pedal) • 971-SWNOM (2-pedal) • 971-SWNOM (3-pedal) WARNING This system complies with IEC60601-1-2: 2014, and its RF emissions meet the requirements of CISPR11 Class B.
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2 System Overview Item Description Monitor Used for displaying the images and parameters during scanning. Speaker Used for outputting the audio. Touch Screen Screen-touching operator-system interface or control. Control panel Key-pressing operator-system interface or control. Ascending/descending Used for ascending or descending the system electrically. button Control panel moving Used for locking or unlocking the move of the control panel.
2 System Overview I/O Panel Figure 2-2 I/O Panel Name Function High speed USB port. Used for connecting storage device such as USB disk, Fusion imaging module, bar code reader, printer, footswitch, DVD recorder, etc. High definition multimedia interface. Used for connecting TV, projector, ultrasound workstation video capture card, etc.
2 System Overview Name Function 5 V indicator 3.3 V indicator PC_LVDS indicator Preserved function, PHV_OP protection indicator. Battery status indicator: • Charging status: It illuminates in green when batteries are charged fully. • Discharging status: It illuminates in green when the power of the batteries is more than 20%;...
2 System Overview 2.10 Physio Unit Panel (ECG) Figure 2-4 Physio Unit Panel (ECG) Name Function Connects USB devices.Used for connecting storage device such as USB disk, Fusion imaging module, bar code reader, printer, footswitch, DVD recorder, etc. Microphone input. Used for connecting a microphone. Used for connecting a pencil probe.
2 System Overview 2.11 Control Panel Figure 2-5 Control Panel Angle Name Description Power button • Press the button to turn on the system, the system enters the work status and the indicator becomes green. • AC (Alternating current). It turns green at AC supply. •...
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2 System Overview Name Description • Press: to adjust the angle in increments of 60°. • : Toggle to adjust the Baseline. • : Rotate to adjust the angle. • : Slide to adjust the steer. Press to enter PW mode, and rotate to adjust PW (in PW mode) or CW gain (in CW mode);...
2 System Overview Name Description Print Print; user-defined key. Freeze Freeze/unfreeze the image. TIP: “/” means the key / knob has no silk-printed name. 2.12 Keyboard Figure 2-6 QWERTY keyboard Common functional keys Description Enter Confirms the input data; or moves the cursor to the head of next row of the text or the input field.
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2 System Overview Description Delete the character after the cursor Functions of the Keys F1 to F12 Description Function F1 Help Help Open or close the accompanying help documents. F2 iStation iStation Enter or exit patient information system. F3~F6 F3~F6 User-defined keys, functions of which can be defined in preset.
2 System Overview Name Function ← Home Activate the Home function: return to start position of comment. 2.13 Basic Screen & Operation 2.13.1 Monitor Display The system monitor displays ultrasound images, parameters, menus and measurement results window. The following diagram maps out the different areas, such as patient information, image parameter &...
2 System Overview Item Description Cine Review Area Displays the cine review progress bar to indicate the cine replay progress. Hint (trackball and • Displays the current functions of trackball and <Set> keys. <Set> key function • Displays the items that simultaneously appear at the bottom indications)/Soft Menu of the touch screen.
2 System Overview Item Description Contents • Radio box: click to select the item. • Check box: click to check or uncheck the item. • Entry box: enter characters manually via the keyboard. • Drop-down list: click ▼ to show the list and select an item. Controls When the operation of a screen is completed, save or cancel the operation, and close the screen.
2 System Overview – For a parameter optional item: press <Set> to extend the available parameter the cursor is positioned onto the list. Roll the trackball to locate the cursor onto the item to be adjusted, and press <Set> to set the value. For details about menu operation of measurements, please refer to the [Advanced Volume].
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2 System Overview Swipe the touch screen from left to right (area 2) under the mapping mode. The mapping menu appears on the touch screen. Tap or sweep right or left to adjust the image parameter, measures, etc. see “6.1.1 Image Adjustment”. Tap the blank area on the touch screen.
2 System Overview • Controls on the touch screen Tap and hold the screen to enter control editing stage. Function Operations Add a control to select a button to add and tap [Confirm]. Add a user-defined In comment and body mark editing status, tap and then tap control [Custom] to bring out the dialogue box for adding user-defined...
2 System Overview Geometric Meaning Safety color Contrast color Graphical shape symbol color Warning Yellow Black Black 2.15 Symbols This system uses the symbols listed in the following table. Their meanings are explained as follows: Symbol Description Type-BF applied part Caution! AC (Alternating current) Protective earth (ground)
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2 System Overview Symbol Description Central brake straight forward moving symbol 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). Unique Device Identifier Conforms to ANSI Std.
• 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.
3 System Preparation Connecting the Power Cord This system can work normally only when it is connected to the external power supply. 3.2.1 Connecting Power The connection method is described as follows: Plug the power cable in the socket of the ultrasound system. Plug the other end power plug into an appropriate outlet.
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.
3 System Preparation NOTE: You must log in again after system restart or dormancy. To Login onto the System Perform the following procedure: Select the login type (Local or LDAP), and user name in the drop-down list. Enter the password and click [Login]. When the user has logged onto the system, is visible in the bottom-right corner of the screen.
If you find anything not functioning properly, this may indicate that the system is defective. In this case, shut down the system immediately and contact Mindray Customer Service Department or sales representative. NOTE: If there is over loading to the system, the breaker will switch into OFF to discontinue the power supply.
3 System Preparation • Press the power button to select [Standby]. The system enters standby status. 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.
3 System Preparation NOTE: Take care not to trap your hands when adjusting the monitor up and down. 3.4.2 Rotating the Monitor The monitor can be rotated 90° to the left and 180° to the right along with the supporting arm. 180°...
3 System Preparation Adjusting Monitor Brightness/Contrast Monitoring the brightness and contrast adjustment is one of the most important factors for proper image qualities. If set incorrectly, the gain, TGC, dynamic range or even acoustic output have to be changed more often than necessary to compensate. •...
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. 3.7.1 Connecting a Probe...
3 System Preparation 3.7.2 Disconnecting a Probe Perform the following procedure: Turn the locking lever 90°counterclockwise to the horizontal position. Pull the probe connector straight out vertically. 3.7.3 Installing a Probe Adapter Figure 3-1 Probe Adapter Illustration Description Probe socket : Probe socket unlock position : Probe socket lock position Probe locking lever...
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3 System Preparation Perform the following procedure: Firstly, move the probe adapter locking lever to horizontal direction and keep the probe locking lever to unlock position. Then, push probe adapter to probe port slowly and carefully while keeping the socket position upward. Rotate the probe adapter locking lever 90°...
3 System Preparation Connecting Peripheral Devices 3.8.1 Connecting USB Devices WARNING DO NOT directly remove a USB memory device, as the USB device and/or the system may become damaged. • When connecting a USB memory device to the ultrasound system via a USB port, a sound is heard if it is connected successfully and the symbol appears in the bottom-right corner of the screen.
3 System Preparation 3.8.3 Connecting a Graph/Text Printer NOTE: • Unless otherwise specified, printers listed in Chapter “2.6.4 Peripherals Supported” have drivers installed already. • Please refer to the accompanying manuals of the printers for more details. To add a local printer As shown in the figure below, a graph/text printer has a power cord and data cable.
3 System Preparation The system starts to search all available printers within the network. Select the target printer and click [Next], the system tries to connect to this printer. When the connection is successful, the system prompts the dialogue box, click [Next] according to the screen tips and then click [Finish].
The storage tray kit consists of a storage tray of control panel base, a storage tray of main unit top cover, and an intra-cavity probe holder connector. The installation procedures of the two storage trays are described in this section. For details on installing the intra-cavity probe holder connector, contact Mindray Customer Service Department or sales representative. Operator’s Manual...
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3 System Preparation Storage Tray of Control Panel Base Hold the storage tray of control panel base with both hands, with the U-shaped opening facing the control panel base, make the upper edge of the storage tray lap on the control panel base, and push it into place along the plane.
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3 System Preparation Description Main unit top cover storage tray Base arm Turbine protective cover Operator’s Manual 3 - 17...
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. •...
4 Setup Item Description Key Config To assign functions to the F keys of the key board. Gesture Preset the gesture on the touch screen. Output Set the output format, the range and the resolution for the image. Access Control To set the user account control relevant information.
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4 Setup 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. BP Unit To set the blood pressure unit. Surface Formula To set the surface formula.
Screen Saver • Select the different saver methods to the system. Saver • After enabling the screen saver, check “Mindray'” to select the image from the system. Or click [Preview] to select the image on your own. • To set the waiting time before the system enters dormancy status in the drop-down list beside “Wait”.
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. •...
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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. •...
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4 Setup Intelligent Input Set to enable the Input Method Association. ICA/CCA && RAR Set the measurement properties of ICA, CCA, Renal A and Aorta. Cardiac Value Range Display Set whether to display value range of EMINCA Study for cardiac measurement results. 4.1.5 OB Set the relevant information regarding the fetal gestational age, fetal growth formula and fetal weight.
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4 Setup • FG table 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.
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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 formula are used for reference rather than clinical diagnosis.
4 Setup Item Description References To display the reference information of a specific measurement item. NOTE: Before starting measurement, ensure that the GA data is acquired by manually entering the LMP in the “Patient Info” page. 4.1.6 Key Configuration Assign functions to the foot switch and user-defined keys. Key function setting You can set the functions for <Save>, <Print>, user-defined keys (including F3, F4, F5, F6, K1 to K8).
4 Setup 4.1.8 Output Set the output format, the range and the resolution for the image. Type Item Description Send To BMP/TIFF/JPG To set the image parameters when sending to other locations. AVI/MP4/WMV DICOMDIR Digital Output Output Size: To select the VGA, HDMI output size. Size Resolution: To select the VGA, HDMI output image resolution.
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4 Setup • If “Enable User Account Control” is selected, you must be authorized before accessing the data, and you can configure password policy and LDAP, and change password. If unselected, you can access all the data without authorization, and you cannot configure password policy and LDAP, and change password.
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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”...
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. •...
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4 Setup Item Description Move Down Move up or Move down a selected item. Move Up 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) •...
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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 •...
4 Setup 4.1.11 Key Probe This page is used to set the functions of keys on the key probe by Short Press, Long Press, and Double Click. 4.1.12 Biopsy This page is used to set the biopsy grid parameters, such as Guide Line Dot Type, Grid Size, and Grid Type.
4 Setup Measurement Preset “Exam Mode XX” on the upper left side refers to the currently configured exam mode. The configured general/application menus are only related to the current exam mode. There are three kinds of measurement items. Measurement Results of measurements are directly obtained via the measurement tools, which are indicated by “...
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4 Setup Adjust the item position. Select an item from the right column and click [Move Up]/[Move Down] to adjust the sequence in which the items are arranged in the corresponding general measurement menu (touch screen display). Modify the properties of a measurement item. The following takes D Trace as an example to show how to set the properties of a measurement tool.
4 Setup – [Repeat]: after the current measurement is completed, the system automatically activates the current tool again. – [Next]: after the current measurement is completed, the system automatically activates the next tool in the menu. – [None]: after the current measurement is completed, the cursor can be moved over the whole screen.
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4 Setup • Adjusting Item Positions: Select an item from the [Selected Items], click [Move Up]/[Move Down]. The order in the list is also the item position in the menu. User-defined Measurement Perform the following procedure: Select the [Measure] tab page. Click [New].
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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.
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4 Setup The “Measurement Custom Wizard” dialog box appears. Enter the Name in the “Measurement Custom Wizard” dialog box, select “Add Calc”, then select [Next]. Select the [App Region] and edit the formula. Descriptions of the attributes in the dialog box are shown in the following table. Attributes Descriptions Formula...
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4 Setup Attributes Descriptions Unit Used to enter numbers and functions in the formula. For example, to create a user-defined measurement item (HC/AC): Enter name for the item, such as “calculation 1.” In Region select “Obstetric,” then select the measurement tool sources “2D” and “Measurement”.
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4 Setup Name Definition Unit Body surface area Prostate specific antigen ng/ml PPSA Coefficient PPSA Coefficient ng/ml Right atrial pressure mmHg Gestational age Height Height Weight Weight Heart Rate Heart rate High BP(CAR) High blood pressure (Cardiac) mmHg Low BP(CAR) Low blood pressure (Cardiac) mmHg High BP(VAS Left)
4 Setup Remove User-defined Items • Remove Measurement/Calculation Select “User-defined” in the “Available Items”, and select the desired item. Click [Delete]. • Remove Study Select a user-defined study, and click [<]. 4.3.3 Report Preset NOTE: • Deleting is not supported in IVF, IMT and EM reports. •...
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4 Setup – Change the template used in the report layout: click [New Layout] to select another template. – Double click the information lines to be edited in “Report body”. The dialog box of font setting appears. Set the font size, font weight or hidden key words. –...
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4 Setup Setting Analysis Model The measurement parameters in different clinical diagnostic scenarios that are used for reproductive function evaluation are integrated into a dedicated report template, and a user-defined diagnostic model is supported. Perform the following procedure: Select the [Report] on the [Measure] page. Select the report template that supports Analysis Model from the list.
4 Setup Comment Preset You can preset the custom comments library for current exam mode. The comments in the library are provided by the system or user-defined ones. 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).
4 Setup • Rename groups: select a user-defined group, click [Rename], enter the group name through the keyboard, and then click [Confirm]. Then the new group name will be displayed in the group lists. • Delete groups: select a user-defined group, click [Delete Group]. After a user-defined group is deleted, it will not be available.
4 Setup – In the measurement setting, if “Image without measurement(s) stored together” is selected, the system will save two images after finishing the section operation. One of the two image will include the measurement result. – In the measurement setting, if “Store image with measurement(s) first and then store image without measurement(s).”...
4 Setup – Select the number of loops to acquire (per view in the selected phase) in the Loops list (for non-continuous stages). – Select the type: exercise or drug. Click [Save] to save changes and quit. Editing a Stress Echo Protocol Perform the following procedure: Click an available protocol on the Select Protocol screen.
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4 Setup • IP address should be the address of the remote server. 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), Property ranging from 16384 to 65536;...
4 Setup Setting DICOM Strategy NOTE: • The DICOM strategy must be configured by qualified personnel with good knowledge of DICOM standards. • The qualified personnel must ensure the validity of the DICOM strategy. Perform the following procedure: Click [Set DICOM Strategy]. Edit the DICOM strategy: –...
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4 Setup – Click [Add] to add the service to the Service List. – Select an item in the service list, change the parameters in the above area, and click [Update] to update the item in the service list. – Click to delete the selected service in the service list.
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• If “Single” is selected, the structured report will contain only the final measurement value. SR Compatibility Select the structure report format: Mindray or ViewPoint Storage mode Set the storage mode for image and cine file: • Parallel file: save the current file, and is ready for the storage of the next file.
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4 Setup Print Service Preset DICOM print preset items are described as follows: Item Description Device After you set the server (s) in DICOM Preset screen, the name (s) will appear in the drop-down list, select the name of the print server. Service Name Default is xxx-Print, user-changeable.
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4 Setup Worklist Setting DICOM service setting for Worklist is described as follows: Item Description Device After you set the server (s) in DICOM Server Setting screen, the name (s) will appear in the drop-down list, select the name of the Worklist server.
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4 Setup Storage Commitment Setting DICOM storage commitment setting items are described as follows: Name NOTE Device After you set the server (s) in DICOM Server Setting, the name (s) will appear in the drop-down list, select the name of the storage commitment server.
4 Setup HL7 service setting for Worklist is described as follows: Item Description Device After you set the server (s) in DICOM Server Setting screen, the name (s) will appear in the drop-down list, select the name of the Worklist server. Service Name Default is server-HL7Query, and it can be modified.
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”...
For detailed operation information, see the Remote Maintenance manual. Perform the following procedure: Select [Remote Maintenance Permission]. Select [Upload logs to remote server] to upload logs to the remote server, Mindray service engineers can acquire and handle those log. 4.8.4 Q-Path Preset This screen is used to set the Q-Path parameters.
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 install 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.
4 Setup 4.10.5 Probe Check This function enables users to check if a transducer element is in malfunction, so as to evaluate the transducer performance. Before performing the probe check, ensure the probe head must be clean and the probe is in nonscanning state.
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.
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.
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5 Exam Preparation Select the exam type tab to enter general information/operating information, and exam-specific information. Item Description General Study description To enter description for each exam. information Primary indications To enter the primary indications (reason to perform the exam.) Secondary indications To enter the secondary indications.
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5 Exam Preparation Item Description Calculation index Calculate gestation age (GA) and estimated delivery date (EDD) based on last menstrual period (LMP), in vitro fertilization (IVF), basic body temperature (BBT), previous exam date (PRV). Select LMP, IVF, PRV, BBT, or EDD from the drop-down list; or, calculates GA and LMP according to the EDD and entered date.
5 Exam Preparation – [Cancel Exam]: to cancel the current exam. The canceled exam can’t be restored. – [New Patient]: click to clear the current patient information in the patient information screen in order to input new patient information. – [New Exam]: click to clear the current exam information in order to create a new exam for the current patient.
5 Exam Preparation Restore Exam Click to import the patient data from an external media. Send Exam Click to send the selected patient data to external device, storage server or printer. Activate Exam Click to continue an exam that has been finished within 24 hours. Resume Exam Click to continue an exam that has been paused within 24 hours.
5 Exam Preparation • IP switch will not cause the system to return to real-time B mode. After the IP is switched, only the image parameter is switched at the same time. Measurements, comments, and bodymarks remain the same as those before switching. •...
5 Exam Preparation If you want to select a patient data in an external memory database, you have to first allow the system to load the patient data to the system’s patient database. The patient ID can be modified for the exam only with one exam record and being activated again. Pause &...
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.
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6 Image Acquisition Item Description 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 Parameter magnitude setting: Click to increase/ decrease the value.
6 Image Acquisition Item Description Sub-menu 6.1.2 Quickly Saving Image Settings Tap [QSave] on the probe and exam mode selection page, press <F7> or the user-defined key to QSave to enter the page. To save image parameters Click [Save] to save the current image values for the current exam mode of the certain probe. New Exam Click [Create] to save the current image parameters, measurements, comments, body mark settings to the exam mode.
6 Image Acquisition 6.2.2 B-mode Image Parameters In B Mode scan, the image parameter area on the right part of the screen will display the real-time parameters: Items Remark Frequency Depth Gain Frame Rate B Dynamic Range Tissue characteristics iClear Display when the function is activated.
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6 Image Acquisition NOTE: You should perform exams according to actual situation and follow the ALARA Principle. Scan range and FOV position More information can be obtained without moving the probe or changing the sampling position. NOTE: • The FOV position/range is available only for the convex and phased probes. •...
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6 Image Acquisition iBeam This function is used to superimpose and average images of different steer angles to obtain image optimization. TIP: The phased probe does not support iBeam. Auto Merge In the Dual-split mode, when the images of the two windows have the same probe type, depth, invert status, rotation status and magnification factor, the system will merge the two images so as to extend the field of vision.
6 Image Acquisition Adjust the gain along the scan line to improve the lateral resolution of the image. 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.
6 Image Acquisition NOTE: • During color mode imaging, menus of image optimizing for B-Mode and C-Mode are displayed on the touch screen at the same time. You can switch between the 2 modes by clicking the mode tabs. • In Color Mode, acoustic power is synchronous with that of B Mode.
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6 Image Acquisition Dual Live This function is used to display B image and Color image synchronously. Steer The feature is used to adjust the ROI of color flow with different angles with immobility of the probe. This function is used to adjust the scan angle of linear probes, so as to change the angle between the transmitting beam and flow direction.
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6 Image Acquisition Color Map This function is a combination of several image parameters, which indicates the display effect of color image. Wall Filter (WF) It filters out low-velocity signals to provide effective information, and this function is used to adjust the filtered frequency.
6 Image Acquisition • pUMA (Power UMA): it is the power sub-mode of Color mode, used to display the density and power of the red blood cells in the blood flow for a certain period of time, and express it with different brightness colors, providing perfusion information of the blood flow, but not velocity information.
6 Image Acquisition 6.4.2 Power Mode Image Parameters In Power mode scan, the image parameter area on the right 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.
6 Image Acquisition • In Color Mode, acoustic power is synchronous with that of B Mode. Adjustment of the depth to the B mode image will lead to corresponding changes in V Flow mode image. 6.5.1 Basic Operations Perform the following procedure: Scan the carotid artery on the real-time B/Color mode;...
6 Image Acquisition The image is frozen after completing the capture. Review the single-frame or cine file. Measure speed, volume flow and WSS. Click [Data Export] to import result window and velocity curve data. Press <B> on the control panel or the user-defined key to quit V Flow mode. 6.5.2 Image Optimization Quality The filling, smoothness and the image effect have slight change after completing the v flow...
6 Image Acquisition WF (Wall Filter) It filters out flow noise. The bigger the value, the more the filtered noise. The real-time value (WF) is displayed in the image parameter area. Flow Brightness Used for adjusting the blood brightness of the grey background. The grey background of the blood flow effect becomes brighter with the value becoming larger.
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6 Image Acquisition Tap [Velocity A/B/C] on the touch screen. The single point-time curve appears at the bottom of the screen. (The speed of either point changes with the time. Besides, horizontal axis represents the time; vertical axis represents the speed. Single point-time curve appears in white.) The starting point and the end point of heart rate cycle and heart rate are also displayed at the bottom of the screen.
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6 Image Acquisition A purple dot appears inside the smaller ROI indicating the maximum speed position. The maximum speed-time curve appears at the bottom of the screen. (The speed of purple dot changes with the time. Besides, horizontal axis represents the time; vertical axis represents the speed.
6 Image Acquisition Move the cursor to other locations and press <Set> to anchor continuously. Corresponding velocities and velocity ratio of the two adjacent points are displayed on the Velocity Ratio result window. Tap [Velocity Ratio] again and repeat step 4 to measure the 2nd and 3rd velocity ratio measurement.
6 Image Acquisition Tap [Volume Flow] again and repeat step 4 to measure the 2nd and 3rd volume flow measurement. Press <Update> to switch the volume flow results. Set the range for VF and VF' measurement. Press <Cursor> to see the indication area switch to status. Roll the trackball to review the cine.
6 Image Acquisition Tap [WSS] again and repeat step 4 to add more stress points. Press <Update> to switch the stress points. Press <Set> to select WSS points, then move the track ball to adjust the position and direction of WSS point. Press <Save>...
6 Image Acquisition 6.6.1 M Mode Image Scanning Perform the following procedure: Select a premium image during B mode or B+ Color scan, and adjust to place the area of interest in the center of the image. Press <M> on the control panel, and use the trackball to adjust the sampling line. Press <M>...
6 Image Acquisition Dynamic Range (Dyn Ra.) Adjusts contrast resolution of an image, compresses or expands gray display range. The real-time dynamic range value will be displayed on the image parameter area. M Soften This feature is used to process the scan lines of M images to reject noise, making the image details to be clearer.
6 Image Acquisition Anatomical M Mode For an image in the traditional M mode, the M-mark line goes along the beams transmitted from the probe. Thus it is difficult to obtain a good plane for difficult-to-image patients who cannot be moved easily.
6 Image Acquisition CAUTION Curved anatomical M image in the operator’s manual that it is provided for reference, not for confirming a diagnosis. Generally it should be compared with other device or make a diagnosis by non-ultrasonic methods. 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.
6 Image Acquisition NOTE: • During PW/CW mode imaging, menus of image optimizing for B Mode and PW/CW mode are displayed on the touch screen at the same time; if there is also Color mode (Power mode) working, menus of certain modes will also be displayed on the touch screen synchronously, and you can switch by clicking the mode tabs.
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6 Image Acquisition Items Meaning Angle Angle Gain This function is intended to adjust the gain of spectrum map. The real-time gain value is displayed in the image parameter area. Increasing the gain will brighten the image and you can see more received signals. However, noise may also be increased.
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6 Image Acquisition • Trace Area: To set the trace area of the Doppler wave in the spectrum map, applicable for auto calculation, V Max and V Mean display. • Trace Smooth: To set the smooth level when tracing. • Trace Sensitivity: This function is used to set the sensitivity of tracing in the spectrum.
6 Image Acquisition Quick Angle Adjusts the angle faster in increments of 60°, and the real-time value of which is displayed in the image parameter area. The function is available in real-time imaging, freeze or cine review status. Dynamic Range (Dyn Ra.) The dynamic range conveys the information that being transformed from echo intensity to gray scale.
6 Image Acquisition – PW mode: Tap <TDI> on the screen or the user-defined <TDI> key and then press <PW> or <Update> to enter TVD. The parameters of TVD are displayed on the touch screen. – M mode: Tap <TDI> on the screen or the user-defined <TDI> key and then press <M> or <Update>...
6 Image Acquisition 6.10.3 TDI Quantitative Analysis CAUTION TDI is provided for reference, not for confirming a diagnosis. NOTE: To perform the strain and strain curve, the ECG curve is in need in case of the deviation in curve. It is about analyzing the data of TVI imaging and measuring the velocity of the myocardium with the cardiac cycle.
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6 Image Acquisition Display analysis • Y-axis represents the velocity (unit: cm/s) [in strain-time curve, Y- curve axis represents the strain (%); in strain-time curve, Y-axis represents the strain (unit: 1/s)]. • X-axis represents time (s); • Frame mark: a white straight line perpendicular to the X-axis, and can be moved left and right by using the trackball.
6 Image Acquisition NOTE: • Elliptical ROIs can be positioned in any manner that keeps their center within the image boundaries. In the case that part of the ROI is outside the image boundary, only data from within the image boundary is used for calculating the mean intensity value. •...
6 Image Acquisition NOTE: • Guidance and precautions for even movement: – Make sure there is enough coupling gel along the scan path. – Always move the probe slowly and steadily. – Continuous contact is required throughout the length of the extended image. Do not lift the probe from the skin's surface.
6 Image Acquisition After the acquisition is completed, the panoramic image will be displayed and the system enters iScape viewing mode. 6.11.2 Image Review After the acquisition is completed, the panoramic image will be displayed and the system enters iScape viewing mode. In image reviewing mode, you can adjust the following parameters.
6 Image Acquisition • If the image quality cannot satisfy the following criteria, you shall remove the image and capture it again. – The Image must be continuous (no part of an image moves suddenly or disappears.) – No shadow or absent signal along the scan plane. –...
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6 Image Acquisition Tap [Start Calc] to start tracking. Upper wall and lower wall are marked by the line in the ROI box. Motion curve of vessel walls display under the image in real time. 6 cardiac cycles are calculated in total with each results display in the result window on the left synchronously. Where, Dist = [maximum diameter within 1 s] –...
6 Image Acquisition 6.13 RIMT (Real-time Intima-Media Thickness) RIMT detects the changes of the vascular intima in real time, and monitors and calculates the thickness of the carotid intima automatically. NOTE: • It is merely available to enter RIMT imaging mode in B single window and dual window when adopting linear probe for carotid exam.
6 Image Acquisition 6.14 Tissue Tracking Quantitative Analysis CAUTION Tissue Tracking Quantitative Analysis images are provided for reference only, not for confirming diagnoses. Apart from TDI imaging function, the system also provides tissue tracking QA function for myocardial movement evaluation. By tissue tracking QA function, the ultrasound system will scan each pixel position by frame within the cardiac cycle, and then use region matching method and auto-correlation searching method to trace each spot and calculate the movement, so as to determine myocardial motion in a more...
6 Image Acquisition If necessary, repeat steps 3-8 to track the next section. NOTE: The screen displays the result of the current section, and the bull’s eye graph shows the average value of all the tracked sections. 10. Tap [Data Export] to export analyzed data. 11.
6 Image Acquisition Displays cardiac segmentation • In the figure, marks the peak position of the curve. model, and each segment name • Under tracking status, click on a segment in the cardiac is illustrated beneath the model. segmentation model. The segment has “X” mark and its corresponding calculating is eliminated.
6 Image Acquisition Switch cardiac cycle within the cine file Tap [Cycle] to select when opening a cine which includes multiple cardiac cycles. 6.14.4 Myocardial Boundary Tracing Tracing The system provides 2 kinds of tracing method for 2 kind of sections. Long axis section (A4C, A2C, ALAX): 3-point method and manual tracing method are both available.
6 Image Acquisition 6.14.5 Basic Operations of TTQA Switch among the operation controls • [Start Tracking]: tap to start tracking. • [Accept & Compute]: tap to start calculation and display the curve. • [Exit]: tap to exit tissue tracking. • [Parameter]: rotate to select the curve type.
6 Image Acquisition – Volume: The X-axis represents time(s); the Y-axis represents volume (ml). – Strain curve (Longitudinal, Transversal): The X-axis represents time (s); the Y-axis represents strain deformation of the tissue (%). – Strain-rate curve (Longitudinal, Transversal): The X-axis represents time (s); the Y-axis represents strain by time (s •...
6 Image Acquisition 6.15 Fusion Imaging 6.15.1 Overview WARNING The Fusion Imaging is contraindicated to the person wearing the internal pacemaker, cochlear implant or nerve stimulator. People wearing the implant or intra-corporeal devices should keep one-meter away when the magnetic generator starts working.
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6 Image Acquisition Auxiliary output power supply cable USB Data cable Magnetic generator Positioning (probe) sensor port Motion (abdomen) sensor port Sensor (2) Positioning (probe) navigation support 8 Motion (abdomen) sensor support sterile sheath Magnetic navigator (rear) Magnetic navigator (front) The description of the magnetic navigator is given in details.
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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 navigator, and connect the power supply. power NOTE: supply Please use the auxiliary output power supply cable cable equipped with the Ultrasound System.
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6 Image Acquisition No. Device Port Description Name 4-9 / Positioning 2. Positioning (probe) navigation support: fix the support to (probe) sensor port the probe. See the method below: Motion (abdomen) • The plastic markers on the probe (1 in the figure) and sensor port on the positioning (probe) navigation support (2 in the figure) must be on the same side.
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6 Image Acquisition No. Device Port Description Name 4-9 / Positioning 3. Positioning (probe) sensor: fix the positioning (probe) (probe) sensor port sensor (2 in the figure) which is already plugged in positioning (probe) sensor port to the cavity of the Motion (abdomen) positioning (probe) navigation support (1 in the figure) sensor port...
6 Image Acquisition Magnetic devices positioning: Sensor Magnetic generator Magnetic navigator 6.15.3 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.
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.
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6 Image Acquisition Get magnetic devices prepared. Connect the magnetic devices. Power on the magnetic navigator. 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.
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6 Image Acquisition – 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. – Rotate CT/MR/PET image axially (rotate the <C> knob to cycle through Z-axis). See XX for operations.
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6 Image Acquisition NOTE: • Use the plane concentrated with the patient’s lesions to perform the fine tuning. • The adjusting levels of the CT/MR/PET/Freehand plane and the ultrasound plane become finer after entering the fine-tuning. The ultrasound image and CT/MR/PET/ Freehand image can precisely be registered after several times of fine tuning.
6 Image Acquisition 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.
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6 Image Acquisition Select the volume data disk from the drive drop-list (or portable hard disk, optical disk). Click [OK]. The icon appears after the volume data is acquired successfully. NOTE: • The icon at the right lower corner of the screen shows the progress of the task. Click the icon to see the progress.
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. 6.15.6 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.
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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.
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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.
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.
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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.
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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: •...
6 Image Acquisition 6.15.8 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).
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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.
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;...
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.
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.
6 Image Acquisition • Tap [Vertical Dir] to place the slice lines vertically, and touch [Horizontal Dir] to place the slice lines horizontally. • Active slice: the green slice line corresponding plane is the active slice, which is marked with a green box.
6 Image Acquisition Repeat steps 3 to 5 to acquire all the necessary images. After all views are finished, the system will prompt you to exit iWorks. Tap [Yes] to exit. 6.17.1 Screen Display The monitor displays the following screen: Displays the protocol name, and the number of views contained.
6 Image Acquisition Delete View Tap [Prev]/[Next] to select the view to be deleted. Tap [Delete] to delete the selected view. 6.17.3 Manual Examination Suspend - Exit the protocol so the user can run the system manually. This is used when an unusual or atypical workflow is required.
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 •...
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.
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. A 2D imaging probe can be applied for Smart 3D imaging, however, to realize Static 3D imaging, 4D imaging, iPage, SCV, CMPR, Color 3D or Niche, a volume probe should be selected.
7 3D/4D • Section A: corresponds to the 2D image in B mode.Section A is the sagittal section in fetal face up posture, as shown in the figure A above. • Section B: it is the horizontal section in fetal face up posture, as shown in the figure B above. •...
7 3D/4D M: the front of the probe, when the operator holds the probe and the probe mark points forward. U: the side of the probe cable. D: the side of the probe head. R: the right of the probe, when the operator holds the probe and the probe mark points forward. L: the left of the probe, when the operator holds the probe and the probe mark points forward.
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7 3D/4D • Amniotic fluid (AF) isolation – The region desired is isolated by amniotic fluid adequately. – The region for imaging is not covered by limbs or umbilical cord. • The fetus keeps still. If there is a fetal movement, you need a rescan when the fetus is still. Angle of a B tangent plane The optimum tangent plane to the fetal face 3D imaging is the sagittal section of the face.
7 3D/4D Move the probe across the body surface. The arrow in the figure below indicates the movement of the probe. You can move the probe in the opposite direction to the arrow. Static 3D Static 3D provides single frame image acquisition of 3D images. During the scanning; the probe performs the scanning automatically.
7 3D/4D Move the cursor over the VOI, and move the cursor to the desired area to adjust the VOI curve. Cross cursor on the VOI curve To setting the ROI, make sure: – Set ROI on the 2D image with the largest section area of the fetal face. –...
7 3D/4D Type Parameter Description Main/Sub Surface Set Surface as 3D image rendering mode. Render Applicable for surface imaging, such as fetus face/hand or foot. NOTE: You may have to adjust the threshold to obtain a clear body boundary. Set Max as 3D image rendering mode, displays the maximum echo intensity in the observation direction.
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7 3D/4D • The color of window A is blue, and the color of the lines (representing section A) displayed in the other two windows is blue as well. • The color of window B is yellow, and the color of the lines (representing section B) displayed in the other two windows is yellow as well.
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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 second page to select the direction of the figure a, c and e.
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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.
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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.
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7 3D/4D • Axial rotation Axial rotation is to rotate the 3D image around the X, Y or Z axis. Rotate the corresponding knobs to make the image rotate: – To rotate along X-axis: rotate <M> button on the control panel clockwise, the image rotates right along the X-axis, and rotate the button anticlockwise, the image rotates left.
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7 3D/4D Switch the current window to 3D window. • Rotate <Zoom> to change the magnification factor. • Zoom in or out by pinching or stretching in mapping mode. Sync This function is to switch the direction of the image to the direction that is perpendicular to the current active plane, so as to get a better observation.
7 3D/4D NOTE: Capturing preparation does not support the measurement. Image Saving • Image saving: – In the 3D Review mode, press <Save> (with user-defined saving function) to save the current image and volume data to the patient information management system in the set format.
7 3D/4D To adjust mix percentage of gray scale information and color information. When display format is 2D&C, you can adjust this parameter. Image Zooming Same as in 3D/4D mode. Comment & Body Mark Operations are the same as those in the other modes. MPR Measurement 2D related measurement can be performed on MPR.
7 3D/4D 7.5.2 4D Acquisition Preparation Set the parameters before the acquisition. The settings for 4D mode are same with static 3D’s. 7.5.3 4D Image Review The settings for 4D mode are same with static 3D’s. 4D image Review on Frozen State In 4D real-time display mode, press <Freeze>...
7 3D/4D Adjust ROI size and position and the position of VOI. Select the render mode. Set the scan method and the movement of the probe (angle and distance). Press <Update> to start 3D imaging. The system enters into 3D image review status when the acquisition is completed; or, you can finish the acquisition ahead by pressing <Freeze>...
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7 3D/4D CAUTION • One or more of the following artifacts in the data set indicate a disturbance during acquisition. In all of the following cases the data set has to be discarded and the acquisition has to be repeated. –...
7 3D/4D Adjust the size and position of the sample box to contain the interested region within the sample box. However, the box should be small enough to contain only the heart, not the whole thorax. In order to archive a good result, try to adjust the volume box and the sweep angle to be as small as possible.
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7 3D/4D The system finishes acquisition and enters the image viewing screen. In image review status, you can perform operations such as VOI setting, image editing, comment adding, body mark adding, etc. Or press <B> or toggle to exit the mode. Operation Controls Adjustable parameters for iLive are on the [Adv.] tab.
7 3D/4D 3D Layout The function compiles the 3 MPRs together according to their relative positions, to provide a much clearer interior anatomical structure. NOTE: This function is provided by the [Niche] option, and does not support Smart 3D image data. Niche Perform the following procedure: Select the [Tools] >...
7 3D/4D 7.11 3D-Print Format It is used to export 3D facial and limb data to external storage devices through 3D print format. Users can view the 3D contour model of the fetus on the external electronic devices at any time. Users can also send the 3D print file to the 3D printing vendor to print the physical model.
7 3D/4D ellipsoid that can be most approximate to the target) and then calculate this volume. It can be used to measure the volume of mass, gestational sac, bladder or gall bladder. • Smart-V Trace: The method uses computer technology to enclose a boundary of the target traced by the operator and then calculate this volume.
7 3D/4D Rotate the knob under [Trace Mode] to select the desired trace mode. Tap [Calc], and the system starts to calculate. Auto calculation is finished: – There are yellow solid curves enclosing target region on each MPR image (A, B, C) window.
7 3D/4D V represents calculated volume value. MG represents Mean gray value; VI represents Vascularization Index; FI represents Flow Index; VFI represents Vascularization Flow Index. 7.12.3 Operation Controls Edit After the calculation, you can modify the contour of the calculated area and recalculate its volume. •...
7 3D/4D Rotate the knob under [Trace Mode] to select [Smart 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> key twice to finish tracing.
7 3D/4D Observe the interested structure through multiple slices. Select the proper image layout and space according to the size of the target structure. To observe the details or the tiny part of the interested region, do image zooming please. Rotate the 3D image to observe the slices of other orientations.
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7 3D/4D Reference image Tap [A], [B], or [C] to select the reference image. Slice and slice line • Central slice: the central slice line corresponding plane are the central slice, which is marked with a green “*” at the upper left corner of the image. •...
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7 3D/4D Figures below are the effect before and after the SCV function is turned on. You can see the body structure within the range of the thickness is added to the image after the SCV function is on. Before After Image rotation Rotate <M>, <PW>, <C>...
7 3D/4D Reset Ori. Tap [Reset Ori] to reset the orientation and zoom status of the image. 7.14 SCV is SCV (Slice Contrast View) +CMPR (Curved MPR). SCV imaging can reduce speckle noise and improve contrast resolution as well as enhance signal- noise ratio, which helps in discovering diffuse pathology in organs.
7 3D/4D Perform rotation and shifting operation to reference line. Save images as necessary. 7.14.2 Operation Controls • Current Quadrant Tap [A Plane], [B Plane] and [C Plane] to select current active section image. • Reset Click [All] in Reset field to reset parameters, orientation and zooming status. CMPR Trace Options •...
7 3D/4D After tracing, press left <Set> key to change tracing outline position. Tap [Reset Curve] to cancel current drawing. Press <set> to display “Cancel” status on the track ball region, move the track ball to cancel the trace. • Spline Perform the following procedure: Tap [Spline] on the touch screen.
7 3D/4D 7.15.1 Basic Procedures for Smart Planes CNS Perform the following procedure: Acquire necessary 3D data. Tap [S-Planes CNS]. There are four views detected by the system, which includes TCP, TTP, MSP and TVP. Adjust the parameters to obtain the image. Tap [MSP].
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7 3D/4D Tap [TCP]/[TTP]/[TVP] to select the plane, and rotate <M>, <PW> or <C> knob to rotate the image plane along with X/Y/Z axis. The angle value appears on the right of the image. Rotate the reference line on the MSP plane. Press <Cursor>...
7 3D/4D • Organ comments describe the position of the organ, referring to CSP (cavum septum pellucidum), T (thalamus), CH (cerebellar hemisphere), CV (cerebellar vermis), CM (cisterna magna), LV (lateral ventricles). Rotate [Font Size] knob to adjust the font size of the comment. see “14.2 Comments”...
7 3D/4D – Tap [Next Slice]/[Previous Slice] to go to the next or previous slice. – Tap [Undo], [Redo] or [Undo All] to undo, redo or cancel previous editing. Tap [Update Vol] to calculate the volume based on the new contour. If necessary, tap [Undo], [Redo] or [Undo All] to undo, redo or cancel previous measurement.
7 3D/4D 7.16 Smart FLC (Smart Follicles Calculation) CAUTION • Smart FLC result is provided for reference only, not for confirming a diagnosis. • Smart FLC is not available in Smart 3D mode. 7.16.1 Basic Procedures Perform the following procedure: Acquire necessary 3D/4D data and freeze.
7 3D/4D 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. Tap [Undo], [Redo] or [Undo All] to undo, redo or cancel previous editing.
7 3D/4D Save the file. 7.17.2 Operation Controls Axis rotation and shifting Rotate <M>/<PW>/<C> knob to rotate the view along X/Y/Z-axis. Rotate the knob to scroll the view. Quick adjustment After corresponding views are displayed, select the view and tap [Quick Adjust] to adjust the view. If four-chamber view, 3VV-T view or stomach bubble view is selected, tap [Quick Adjust] to scroll the view along Z-axis.
7 3D/4D The higher the merge value, the clearer the shading obstacles on the image. Tap [MixRender] to select the levels between 0-3. Tap [SubTint] to select the obstacle display color. If the value is set 0, no obstacle data will be displayed. Eraser NOTE: This function is available only under “Surface”...
7 3D/4D Press <Update> to start capturing volume CEUS image. During the acquisition, a progress bar is displayed to indicate the acquisition progress. The system saves the single frame image when the acquisition is completed and enters the review status of 3D image. Tap [Contrast]/[Tissue] on the touchscreen. The image on the main monitor is switched between the contrast image and the tissue image.
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.
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8 Elastography Turn 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.
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>...
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.
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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.
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.
8 Elastography 8.2.5 PZ Tracking (Peripheral Zone Tracking) It is used to automatically recognize the peripheral zone boundary of the prostate, as well as automatically measure the prostate, and hardest/softest point of the prostate. Select the ELC13-4U probe and prostate exam mode, and then switch to the linear plane. Perform 2D scan to locate the region.
8 Elastography 11. Tap [Elasto] > [STQ] on the touch screen. Or press the user-defined <STQ> key to enter the STQ mode. 12. Adjust the ROI based on the lesion size and the position. 13. Press <Update> to generate the acquisition. Place the probe still with stable force (not pressing, sweeping or moving the probe) to acquire the image.
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8 Elastography The square height of the elasto curve (Y-axis represents elasto metric; X-axis represents the time) represents the average value of the elasto metric for current frame. Rotate [Elas. Metric] knob to adjust the value of the elasto metric. The metric includes Young’s modulus E (unit: kPa), and shear modulus G (unit: kPa).
8 Elastography Filter This feature is used to filter the noise of the elasto image. Tap [Filter] item on the touch screen. The higher the level is, the smaller the noise of the elasto image becomes, and the clearer the edge of the field target appears.
8 Elastography 8.4.1 E Compare (Non Real Time) B mode image STE image StrainE image B mode image Perform the following procedure: Open a saved STE single frame image or cine file. Or perform STE imaging and freeze the image. For details, see “8.2.1 Basic Procedures for STE Imaging”. NOTE: The image should be saved under an appropriate probe and exam mode.
8 Elastography Play the cine file to select an image with good similarity, and then perform measurement. Save a single frame image or cine file. 8.4.2 E Compare Live (Real Time) NOTE: • You can enter E Compare Live from STE or StrainE. Entering from STE is taken as an example.
8 Elastography Press the probe gently and stably to acquire the image. Freeze the image. Play the cine file to select a high quality image, and then perform measurement. Save a single frame image or cine file. 8.4.3 Image Parameters Display B It is used to select whether to display the B mode images in a quad window.
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8 Elastography B mode image Perform the following procedure: Select the ELC13-4U probe and prostate exam mode, and then switch to the linear plane. Perform 2D scan to locate the region. Tap [Elasto] > [STE] on the touch screen. Or press the user-defined <STE> key to enter the STE mode.
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.
9 Contrast Imaging 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”. Image Parameters When entering contrast imaging mode, the screen displays the contrast image, and if [Dual Live] item on the touch screen is “ON”, both the contrast image (marked with ) and tissue image (marked with...
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9 Contrast Imaging Tap [Timer1] to start the timing at the moment you inject the contrast agent. Here, the screen displays the times at the lower corner. • The time begins at 0. • In live mode, there displays the elapsed time. For example, 00:00:08, it means the elapsed time is 8s.
9 Contrast Imaging Select different levels of iTouch effect through [iTouch] on the touch screen. Long press or double press <iTouch> to exit the function. High Frame Rate CEUS This function is used to improve the frame rate (FR) for contrast imaging. Tap [HiFR CEUS] to turn on the function.
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9 Contrast Imaging NOTE: • In case of inaccuracy of the data, do not adjust the depth and the pan-zoom when saving the cine. Also, during image scanning, ask the patient to hold breath for several seconds, and keep the probe still until the image is frozen. •...
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9 Contrast Imaging Review the image to a desired frame. Tap [Contrast Imaging QA] to activate the function. Mark out the interested part (ROI). Up to 8 ROIs can be saved on the reference image, with the corresponding eight traces plotted simultaneously on the graph.
9 Contrast Imaging – Tap [Table display] to check parameters: Item Description GOF (Goodness of Fit) Calculate the fit degree of the curve; range: 0-1, where 1 means the fit curve fits the raw curve perfectly. BI (Base Intensity) Basic intensity of no contrast agent perfusion status. AT (Arrival Time) Time point where contrast intensity appears, generally, the actual time value is 110% higher than the base intensity.
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9 Contrast Imaging NOTE: You can either enter M-Ref. C&E from Contrast image or Contrast Imaging QA images. Entering from Contrast imaging is taken as an example. Figure 9-1 Quad Window Tissue image Contrast image STE image B mode image 9 - 8 Operator’s Manual...
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9 Contrast Imaging Figure 9-2 Mix Window B mode image Mixed image of Contrast and STE Perform the following procedure: Open a saved Contrast single frame image or cine file. Or perform Contrast imaging to acquire images. For details, see “9.1 Basic Procedures for Contrast Imaging”. NOTE: The image should be saved under an appropriate probe and exam mode.
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9 Contrast Imaging 10. Save a single-frame image or cine file. Tap [Mix] again to exit the Mix mode. 11. Repeat the above steps for other Contrast multi-frame images. It is used to enable or disable mix mode. In mix mode, the left window is the B mode image and the right window is the mixed image of Contrast and STE.
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.
10 Physiological Unit Signal parts of the body. Generally, signals by connecting to limbs are stronger than by connecting to the chest. • 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.
10 Physiological Unit Signal • 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. • No delay time or time interval shall be less than the time required to scan a single image. •...
10 Physiological Unit Signal Tap [RESP]. Adjust [Speed], [RESP Gain], [Position] and [Invert]. Exit Respiratory display mode, and remove ECG electrodes from the patient. Tap [Physio] or press the user-defined <Physio> key to exit physio mode. 10.3 PCG NOTE: • Check PCG each time before use.If there are any cracks or scratch, please contact the sales representative.
10 Physiological Unit Signal 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.
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10 Physiological Unit Signal Type Parameter Description Control the display of PCG trace. parameter PCG gain Set the amplitude of PCG trace. PCG smooth Smoothen PCG trace. 10 - 6 Operator’s Manual...
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.
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: –...
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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.
11 Stress Echo Selection Description 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.
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”).
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.
Smart Pelvic Floor (Smart Pelvic) The Smart Pelvic Floor function is used to Automatically 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;...
12 Smart Pelvic Floor (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.
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12 Smart Pelvic Floor (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.
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;...
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.
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).
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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.
13 Display & Cine Review Rotate the knob under [Adjust Frame] to review the cine frame by frame. 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.
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.
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.
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.
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 •...
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14 Measurement, Comments and Body Mark Parameter Value Range Error Distance Full screen Within ±5% (for linear, wide-convex, and (iScape) 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%.
14 Measurement, Comments and Body Mark Measurement Item Error Smart ICV Within ±20% Smart Hip Within ±5% Smart HRI Within ±5% Smart Trace Within ±20% Smart Caliper Within ±5% AutoEF Within ±10% Within ±10% RIMT Within ±10% TTQA Within ±20% Smart Planes CNS Within ±20% Smart Pelvic...
14 Measurement, Comments and Body Mark Tap [Settings] to enter – Change active text color/fix text color: select a desired color block to change the active text color or fix text color. The default active text color is green and fix text color is yellow.
14 Measurement, Comments and Body Mark – Adjust the arrow size: rotate the knob under the [Arrow Size] button on the touch screen to change the size. Press <Set> or <Enter> to anchor the arrow position, and then the arrow becomes yellow. Press <Arrow>...
14 Measurement, Comments and Body Mark Press <Del> on the keyboard to delete the comment character or text on the right side of the cursor; press to delete the comment character or text on the left side of the cursor. Press <Set>, or move the cursor to confirm the added comments text and exit the edit status.
14 Measurement, Comments and Body Mark 14.3 Voice Comments The system supports adding voice comment to the frozen images. NOTE: • To perform voice comments adding, the function should be enabled through the path: [Setup] > [System] > [Application]. Check “Voice comment enabled”. The voice comment panel appears on the right corner of the screen.
14 Measurement, Comments and Body Mark 14.4 Body Mark NOTE: After powering off, the system will clear all comments on the image. The Body Mark feature is used for indicating the exam position of the patient and transducer position and orientation. You can preset the system configured general body marks for each exam mode.
14 Measurement, Comments and Body Mark NOTE: In Dual B Mode, a Body Mark cannot be moved between the separate image windows. Perform the following procedure: Press <Cursor> and move the cursor onto the body mark. The cursor then becomes indicating you can move the Body Mark graphic to a new position.
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.
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: –...
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, Small Parts, breast, vascular, urology) measurements: Save the image or the cine.
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.
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: •...
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: •...
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.
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.
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;...
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: •...
16 Patient Data Management Exit the review Click [Exit] on the Review screen; or, Press <ESC> or tap [Review] to exit. Basic Operations Select an exam from the [Exam History] drop-down list. Double-click the image thumbnail to analyze an image. The function buttons are described as follows: •...
16 Patient Data Management To exit the image analysis • Press <Freeze> to exit and enter the real-time scan status. • Press [Return] to exit from the image analysis to the Review status.In image analysis status, the selected image is displayed on the screen, and the thumbnails of the same exam are displayed on the thumbnail area, you can turn pages using the buttons on the right side of the thumbnail.
16 Patient Data Management 16.2 Report Management 16.2.1 Report storage The exam reports are stored under the directory of the exam of the patient. 16.2.2 Importing, exporting and sending a report Import/export report via Backup In iStation screen, select patient data, click [Restore Exam] or [Backup Exam] in the popped up menu to import or export patient information, images and reports from or to an external memory device.
16 Patient Data Management Do one of the following to enter iStation: • Press <F2 iStation> key on the control panel • Select [iStation] in the Patient Info screen. • Click [iStation] in the Review screen. 16.3.1 Searching a Patient Perform the following procedure: Select the data source.
16 Patient Data Management Item Description Activate an After you select an exam, which has been performed within 24 hours, click Exam [Activate Exam] to activate the exam and load the basic patient information and measurement data to continue the exam. If you want to select a patient data in an external memory database to start a new exam or recover the exam, you have to first allow the system to load the patient data to the system’s patient database.
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”.
16 Patient Data Management NOTE: • Writing data using “Send To” supports the PC format transfer function, while CD/DVD writing using “Backup” supports only system-relevant formats. • symbol indicates that the input CD/DVD is damaged or contains data in an incorrect format.
16 Patient Data Management You can perform the following operations: • Click [Delete] to delete the task. • Click [Retry] to retry the failed task. • Click [Select All] to select all the tasks. • Click [Priority] to set priority for tasks. Task Status When there are tasks underway, the task management icon displays as .
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16 Patient Data Management NOTE: After logging in to the remote server, you can switch from the Ultrasound System and the remote server as follows: click [Minimize] to exit the remote server and enter the Doppler interface, and press the user-defined key for V Access to enter the remote server again. 16 - 12 Operator’s Manual...
Probes and Biopsy 17.1 Probes Model Region Probe Figure Applied C5-1U Body surface SC6-1U Body surface Operator’s Manual 17 - 1...
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17 Probes and Biopsy Model Region Probe Figure Applied SC5-1U Body surface C4-1U Body surface C11-3U Body surface C6-2Gs Body surface 17 - 2 Operator’s Manual...
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17 Probes and Biopsy Model Region Probe Figure Applied C6-2GU Body surface L9-3U Body surface L20-5U Body surface V11-3HU Trans- vaginal, Trans- rectal Operator’s Manual 17 - 3...
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17 Probes and Biopsy Model Region Probe Figure Applied SP5-1U Body surface D8-4U Body surface D8-2U Body surface DL14-3U Body surface 17 - 4 Operator’s Manual...
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17 Probes and Biopsy Model Region Probe Figure Applied DE10-3U Trans- vaginal, Trans- rectal DE10- Trans- vaginal, Trans- rectal CW5s Body surface CW2s Body surface P7-3TU Trans- esophage P7-3Ts Trans- esophage P8-3Ts Trans- esophage Operator’s Manual 17 - 5...
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17 Probes and Biopsy Model Region Probe Figure Applied SC8-2U Body surface L14-6WU Body surface L15-3WU Body surface 17 - 6 Operator’s Manual...
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17 Probes and Biopsy Model Region Probe Figure Applied L14-5WU Body surface L14-3WU Body surface L13-3WU Body surface Operator’s Manual 17 - 7...
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17 Probes and Biopsy Model Region Probe Figure Applied L11-3U Body surface ELC13- Trans- rectal 7LT4s Body surface, Intra- operative L16-4Hs Body surface, Intra- operative L16-4HU Body surface, Intra- operative 17 - 8 Operator’s Manual...
17 Probes and Biopsy Model Region Probe Figure Applied P10-4U Body surface P7-3U Body surface 17.1.1 Probe Functions by Part The basic structures and corresponding functions of probes are basically the same; take the following probe as an example. Item Description Probe head Converts the electrical signal into an ultrasonic signal, focusing the...
17 Probes and Biopsy Item Description Needle-guided Provides mounting support of the needle-guided bracket. bracket fix tabs and NOTE: grooves This structure of probes in the figure above may vary with the matched needle-guided brackets. Probe cable Transmits electrical signals between the probe head and connector. Probe connector Connects the probe to the ultrasonic diagnostic system.
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17 Probes and Biopsy The proper clinical technique to be This section describes general procedures for operating the probe. used for operating the probe should be selected on the basis of specialized training and clinical experience. Procedures for operating (with biopsy function) Inspection before examination Connection to the system Examinations...
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...
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.
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17 Probes and Biopsy bracket. Fail to do so may result in the probe and the needle-guided bracket to becoming sources of infection. Please follow the instructions in the manual for cleaning. WARNING Never immerse the probe connector into liquid such as water or disinfectant. Immersion may cause electrical shock or malfunction.
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Check whether the probe has defects such as peeling, rifts, bumps, cracks, or liquid spill. If such defects exist, the probe has reached the end of its service life. In this case, stop using it and contact the Mindray service department. Operator’s Manual...
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In this case, stop using it and contact the Mindray service department. Store the probe in a cool, clean and dry environment. And repeat the cleaning and disinfection process before the next use.
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In this case, stop using it and contact the Mindray service department. Store the probe in a cool, clean and dry environment. And repeat the cleaning and disinfection process before the next use.
Store the probe in a cool, clean and dry environment. And repeat the cleaning and sterilization process before the next use. Compatible Cleaners and Disinfectants For the detailed information about cleaners and disinfectants, see Mindray Transducer Disinfectant Recommendation. For TEE probes, refer to accompanied manual for disinfection and sterilization.
17 Probes and Biopsy 17.1.7 Probe Environmental Conditions Operating Conditions Use the probes in the following ambient conditions: Probe Ambient Relative humidity Atmospheric temperature pressure C5-1U 0°C - 40°C 30% - 85%RH (no condensation) 700hPa - 1060hPa SC8-2U 0°C - 40°C 30% - 85%RH (no condensation) 700hPa - 1060hPa V11-3HU...
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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:...
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...
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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.
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.
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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.
If an abnormality is found on the needle-guided bracket, immediately stop using it and contact MINDRAY Customer Service Department or sales representative. •...
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17 Probes and Biopsy Diagnostic ultrasound systems produce tomographic plane images with information of a certain thickness in the thickness direction of the probe. (That is to say, the information shown in the images consist all the information scanned in the thickness direction of the probe.) So, even though the biopsy needle appears to have penetrated the target object in the image, it may not actually have done so.
17 Probes and Biopsy 17.2.1 Needle-guided Brackets Available Some of the probes have matched needle-guided brackets for biopsy, the available probes and the corresponding needle-guided brackets are listed as follows Probe Model Needle-guided Biopsy angle/ Applicable Biopsy Bracket Model depth (±1°) Needle L14-6WU NGB-007...
CIVCO 658-007 EX3 Stepper 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.
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17 Probes and Biopsy • 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. • Select the proper needle according to the specification above, and adjust the needle shift to the same specification of the selected needle.
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17 Probes and Biopsy Needle guide hole Used for installing the biopsy needle. Pinch nut of needle- Used for locking the needle-guided bracket and the probe. guided bracket 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.
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17 Probes and Biopsy Separate the residual part of the needle-guide bracket and the transducer from the needle. Screw the pinch nut of the bracket, and remove the needle-guided bracket from the transducer. Separate the transducer and the needle-guided bracket. NGB-007 (Plastic) Support of needle-guided bracket Used for installing the needle-guided bracket...
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17 Probes and Biopsy Specification of angle block (60°) The corresponding biopsy angle is 60°. 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.
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17 Probes and Biopsy Remove the support of needle-guided bracket from the transducer. NGB-010 Guiding block Used for installing biopsy needle; there are five specifications of guiding blocks for different biopsy needles. Guiding hole of the biopsy needle Used for installing the biopsy needle. Support of needle-guided bracket Used for installing the needle-guided bracket on the probe.
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17 Probes and Biopsy Perform the following procedure: Install the needle-guided bracket: Put on the probe cover. 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 bracket to match with the tabs of the probe.
17 Probes and Biopsy NGB-011 Clamp Locating groove Grip knob Needle guide rack Needle guide hole Needle guide clamping knob Needle guide Locating pit Perform the following procedure: Install the needle-guided bracket: Put on the sterile probe sheath. Connect the locating groove on the clamp with the two raised edges on the probe head and align the locating pit of the clamp with the convex point on the probe head.
17 Probes and Biopsy 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.
17 Probes and Biopsy Separate the residual part of the needle-guide bracket and the probe from the needle. Remove the needle-guided bracket: Screw the pinch nut to release the needle-guided bracket Separate the bracket and the probe. NGB-021 <5> <2> <4>...
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17 Probes and Biopsy Remove the needle-guided bracket: Hold the transducer in the left hand; unscrew the locking nut with the right hand to loosen the retaining clamp. Raise the needle-guided bracket to separate the locating clamp/ bulge from the locating grooves. NGB-022 ...
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17 Probes and Biopsy Adjust the angle block to the desired level. Tighten the angle pinch nut. Insert the biopsy needle: Adjust the dial scale to the required needle type shift, and then screw the needle fixing nut to lock the dial scale. (To adjust the dial scale you have to loosen the needle fixing nut first.) Pull the lock pin and close the V-shaped cover to fix the lock pin in the groove of the needle type adjusting base, so as to install the needle into the guiding hole.
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17 Probes and Biopsy 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 Needle guided V-shaped Guiding hole of the block needle Needle separate pressure position Perform the following procedure: Install the needle-guided bracket:...
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17 Probes and Biopsy Rotate the clamping nuts of the guided bracket on right and left side to fix the bracket and the transducer. Rotate the needle-type adjusting nut to the ultimate position as shown in the figure. Hold the transducer. Press the biopsy needle to separate needle guided V-shaped block from pressure position of the needle.
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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: Hold the transducer.
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17 Probes and Biopsy NGB-025 Pinch nut Intra-cavity probe Lower clamp Location hole Front slot Front clamp Location clamp Upper clamp Perform the following procedure: Install the needle-guided bracket: Put on the sterile probe sheath. Open the clamp. Insert the front clamp to the front groove, and align front clamp with front groove.
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17 Probes and Biopsy Remove the needle-guided bracket: Hold the prober in the left hand; unscrew the locking nut with the right hand to loose the clamp (arrow’s direction). Lift the biopsy up (towards arrow’s direction). The locating pole, front clamp, the locating hole and the front clamp become loose.
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17 Probes and Biopsy 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 transducer. Mount the bracket onto the transducer. Tighten the pinch nut of the needle-guided bracket to confirm that the needle-guided bracket is properly installed on the transducer.
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17 Probes and Biopsy Pull the lock pin and close the V-shaped cover to fix the lock pin in the groove of the needle type adjusting base, so as to install the needle into the guiding hole. Remove the needle-guided bracket: Screw the pinch nut to release the needle-guided bracket.
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17 Probes and Biopsy NGB-029 Fixing nut of clamps Clamp Groove Clamp Needle guide hole Needle clamp cover Pinch nut Needle separation V-shaped guiding block pressure position Angle adjusting block Angle fixing nut Needle mark Angle adjusting base Torsion spring of the Groove needle pressure cover Perform the following procedure:...
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17 Probes and Biopsy Tighten the fixing nut of clamps of the needle-guided bracket to confirm that the needle-guided bracket is properly installed on the probe. And tighten the pinch nut (following the arrow’s direction). Hold the transducer. Press the pressure position of the needle to separate needle guided V- shaped block from pressure position of the needle.
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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: Hold the transducer.
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17 Probes and Biopsy NGB-031 <11> <1> <10> <2> <3> <9> <4> <5> <8> <7> <6> Block hole V-shaped cover Lock pin Needle-shaped base Needle-shaped scale Angle adjusting block Angle fixing nut Groove Pinch nut Bracket clamp V-shaped block Perform the following procedure: Install the needle-guided bracket.
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17 Probes and Biopsy Tighten the pinch nut of the needle-guided bracket (following the arrow's direction) to confirm that the needle-guided bracket is properly installed on the probe. Adjust the dial scale to the required needle type shift. Adjust the needle angle to the proper shift as required (loosen the nut first, and then tighten the nut based on the shift you need).
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17 Probes and Biopsy Pull the lock pin and close the V-shaped cover to fix the lock pin in the groove of the needle type adjusting base, so as to install the needle into the guiding hole. Separate the needle in the operation. Open the block pin until the V-shaped cover can be rotated.
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17 Probes and Biopsy NGB-034 Needle fixing nut Guiding groove 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.
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17 Probes and Biopsy Insert the biopsy needle: Adjust the dial scale to the required needle type shift. Pull the lock pin and close the V-shaped cover to fix the lock pin in the groove of the needle type adjusting base, so as to install the needle into the guiding hole. Release the needle from the bracket: Pull the lock pin out until the V-shaped cover can be turned and opened up.
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17 Probes and Biopsy NGB-035 <13> <1> <12> <14> <2> <11> <10> <3> <6> <9> <8> <5> <4> <7> Clamp The clamping nut of left/right clamp The locating position block Groove V-shaped guiding block The pressing block for separating needle Needle guide hole Needle clamping cover of needle- guided bracket...
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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.
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17 Probes and Biopsy Release the pressing block, adjust the angle adjusting nut to confirm that the needle can freely slide in a vertical direction. Remove the needle-guided bracket: Hold the probe and press the pressing block to separate V-shaped guiding block from the pressing block.
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17 Probes and Biopsy Perform the following procedure: Install the needle-guided bracket: Put on the sterile probe sheath. 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.
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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: Pull the lock pin and open up the V-shaped cover to expose the needle.
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17 Probes and Biopsy Hold the transducer. Press the biopsy needle pressure position to separate it from needle guided V-shaped block. 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).
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17 Probes and Biopsy Remove the transducer and the needle-guided bracket to separate the biopsy needle. Rotate the clamping nuts of the guided bracket on the right and left side to release the bracket and the transducer. Remove the bracket from the transducer. NGB-042 <7>...
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17 Probes and Biopsy Tighten left/right clamp pinch nut to confirm that the needle-guided bracket is properly installed on the probe. Loosen left/right clamp pinch nut, and put it onto the guiding block fixing frame, then tighten left/right clamp pinch nut. Hold the probe, and insert the needle into guided hole.
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17 Probes and Biopsy NGB-051 Name Description Support of needle-guided Used for installing the needle-guided bracket on the transducer. bracket Knob of fixing needle- Used for fixing the needle-guided bracket on the transducer. guided bracket Groove Match with the tab on the transducer. Hole for installing Used for installing the knob of fixing needle-guided bracket.
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17 Probes and Biopsy Perform the following procedure: Install the needle-guided bracket: Put on the transducer cover. Cover the support of needle-guided bracket on the transducer, making the groove of the needle-guided bracket to match with the tab of the transducer. Set the needle-guided bracket at the desired position, turn tightly the knob of fixing needle-guided bracket to fix the needle-guided bracket.
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17 Probes and Biopsy NGB-054 Angle adjusting block Angle locking nut Right clamp of the bracket Needle-shaped adjusting nut Needle clamping cover Left clamp of the bracket Angle adjusting base Locking nuts of the guided bracket at the right and left sides Torsion spring of the needle pressure cover 10 Biopsy needle pressure position Perform the following procedure:...
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17 Probes and Biopsy Hold the probe. Press the biopsy needle pressure position to separate it from the V-shaped guiding block. Put the needle into the V-shaped guiding block of the needle guided- bracket. Hold the probe, and release the pressure position of the needle. Adjust the needle-shaped adjusting nut manually (following the direction of the arrow).
17 Probes and Biopsy Rotate the locking nuts of the needle guided-bracket at the right and left sides (following the direction of the arrow). The needle guided-bracket is separate from the probe. Hold the probe and take out the bracket. 17.2.3 Verifying the Biopsy Guide Line WARNING •...
17 Probes and Biopsy – Tap [Biopsy] or press <F11 Biopsy> to exit. NOTE: In real-time status, press <F11 Biopsy> to exit biopsy status; in frozen status, press <F11 Biopsy> to hide/show the guide line if biopsy function is enabled. Tap [Verify] in the Biopsy tab to open the Biopsy Verify menu.
17 Probes and Biopsy Tap [iNeedle] again to exit iNeedle. Scan to locate the target. Center the target in the electronic guidezone path. Direct the needle into the area of interest for specimen. After extracting the biopsy sample is complete, gently remove the probe from the body. Press <F11 Biopsy>...
If such defects exist, the bracket has reached the end of its service life. In this case, stop using it and contact the Mindray service department. • It is recommended to use immersion sterilization for plastic needle-guided brackets and high-pressure steam sterilization for metal needle-guided brackets.
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17 Probes and Biopsy NOTE: Disposable components are packaged sterile and are single-use only. Do not use if integrity of packaging is violated or if expiration date has passed. Please use the disposable components compliant with the relevant local regulations. Cleaning Perform the following procedure: Wear a pair of gloves to prevent infection.
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.
17 Probes and Biopsy 17.3 Needle Navigation Guiding WARNING • The person performing needle navigation guiding procedures must understand diagnostic ultrasound thoroughly and have been trained adequately, otherwise, side effects may be caused in the patient. • Wear sterile gloves before performing the needle navigation. •...
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17 Probes and Biopsy • When the target for biopsy is small, dispersion of the ultrasound beam may lead to image deviate from the actual position. Pay attention to this. Image deviation is shown as the figures below: The biopsy needle appears to reach Dispersion of the ultrasound beam the target object in the image Needle...
17 Probes and Biopsy • The Fusion Imaging is contraindicated to the person wearing the internal pacemaker, cochlear implant or nerve stimulator. People wearing the implant or intra-corporeal devices should keep one-meter away when the magnetic generator starts working. Needle navigation feature combines technology of real-time imaging and mini-magnetic locating to provide GPS real-time guiding biopsy.
17 Probes and Biopsy The guideline turns green if it is able to reach the lesion mark. Perform biopsy by the guideline. The distance indicating box shrinks by the time needle tip goes towards the lesion mark. When the tip reaches the lesion mark, the box turns green and merges with the tip. For detailed conversion procedure description, refer to chapter “17.3.5 Screen Display in the Guiding”.
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17 Probes and Biopsy 10~17G hard needle (vTRAX). Diameter: 2.0-3.3mm. Needle should be of non-inference to the sensor. Refer to manual provided by manufacturer for disinfection information. • Needle sensor Manufacturer: CIVCO. Product number: 610-1080 • Needle sensor support and sterile cover (disposable) Manufacturer: CIVCO Product number: 610-1059 •...
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17 Probes and Biopsy Connect needle sensor to the bracket. 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 navigator power and perform needle navigation guiding operation after the signal is stabilized.
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17 Probes and Biopsy • http://www.civco.com Perform the following procedure: Refer to “6.15.2 Magnetic Navigator” for installation of magnetic controller, auxiliary power line, USB cable, magnetic generator and probe sensor. Abdomen sensor is necessary under Fusion imaging mode. Connect the needle sensor to the 3rd port on the magnetic controller. Put on the sterile sheath onto the needle sensor.
17 Probes and Biopsy Perform needle navigation guiding; refer to “17.3.1 Basic Procedures for Needle Navigation Guiding” for details. Anticlockwise 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 •...
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.
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.
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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.
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 Biopsy Grid It is used to correctly position the needle insertion coordinate in the prostate biopsy operation, in conjunction with the positioning grid bracket.
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.
18 DVR Recording Select the destination and the target file, click [Send] 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.
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 •...
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19 System Maintenance Cleaning probes Cleaning the probe Tools: mild soapy water, dry soft cloth, soft brush Method: Wipe out the dust attached to surface of probe head, connector and cable. Use soft brush to brush the dust inside probe connector gently. Remained stain or dust attached to surface of cable or surface of connector should be washed out by cloth with a little soapy water, and then air-dry.
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19 System Maintenance Press the bulges on the clamping ring by both hands and turn the ring about 45° anticlockwise until it lifts. Take out the ring and the rotary ball. Be careful not to drop the ball. As shown in figure below.
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19 System Maintenance Cleaning the cover Tools: soft dry cloth, soapy water Method: Use a soft dry cloth to clean the system's cover. If the system is dirty, moisten the soft cloth with mild soapy water, wipe away any stains, then air dry. Cleaning dust-proof cover Tool: Soft brush Method:...
19 System Maintenance CAUTION Please clean all dust-proof covers of the system periodically (1 time per month); otherwise, system damage may result. Cleaning times can be increased when the system is used in the open air or somewhere dust is more. Cleaning the peripherals Do the cleaning maintenance according to your actual peripheral configuration;...
If any persistent system malfunction is experienced, e.g. an onscreen error message, blank imaging screen, absent menus, please refer to the table below. If the failure can't be eliminated, please contact Mindray Customer Service Department or sales representative. Troubleshooting Table...
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19 System Maintenance Failure Cause Measure The power indicator of • The interval between • Turn off the system and wait the monitor is light on, turning off and restarting a minimum time of 1 minute, but image is blank. the system is too short –...
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Barcode Reader The product supports kinds of readers for logging data as patient ID: 1-D barcode reader (SYMBOL LS2208), 2-D barcode reader (SYMBOL DS4308), and JADAK barcode reader. 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.
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...
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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. •...
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.
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”.
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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.
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.
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.
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.
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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.
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...
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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...
Wireless LAN The system provides wireless net adapter configuration, so as to assist information query and unlimited network service. The ultrasound system can be connected to router, mobile phone, tablet, ultrasound workstation, server network device and so on via wireless network. WARNING •...
DICOM server. Open the file (DCM Editor Tool, eZDicom.exe) to view the service name (iStation Name). Click [OK] to save current setting. Click [Cancel] to exit. EAP Network For setting EAP network, contact Mindray Customer Service Department or the sales representatives. B - 2 Operator’s Manual...
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.
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.
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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.
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.
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.
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.
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.
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.
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.
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%...
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.
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.).
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. •...
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.
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EMC Guidance and Manufacturer’s Declaration The system complies with the EMC standard IEC 60601-1-2: 2014. Intended Environments: HOME HEALTHCARE ENVIRONMENT (except for near active HF SURGICAL EQUIPMENT and the RF shielded room of an ME SYSTEM for magnetic resonance imaging). WARNING •...
Patient information; Date/time information. Table G-1 GUIDANCE AND MINDRAY DECLARATION-ELECTROMAGNETIC EMISSIONS The system is intended for use in the electromagnetic environment specified below. The customer or the user of system should assure that it is used in such an environment.
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G EMC Guidance and Manufacturer’s Declaration Table G-1 GUIDANCE AND MINDRAY DECLARATION-ELECTROMAGNETIC EMISSIONS The system is intended for use in the electromagnetic environment specified below. The customer or the user of system should assure that it is used in such an environment.
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G EMC Guidance and Manufacturer’s Declaration Table G-2 GUIDANCE AND MINDRAY DECLARATION-ELECTROMAGNETIC IMMUNITY The system is intended for use in the electromagnetic environment specified below. The customer or the user of system should assure that it is used in such an environment.
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G EMC Guidance and Manufacturer’s Declaration Table G-3 GUIDANCE AND MINDRAY DECLARATION-ELECTROMAGNETIC IMMUNITY The system is intended for use in the electromagnetic environment specified below. The customer or the user of system should assure that it is used in such an environment.
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G EMC Guidance and Manufacturer’s Declaration Table G-4 RECOMMENDED SEPARATION DISTANCES BETWEEN PORTABLE AND MOBILE RF COMMUNICATION DEVICE AND THE SYSTEM The system is intended for use in an electromagnetic environment in which radiated RF disturbance are controlled. The customer or the user of system can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communication equipment (transmitters) and system as recommended below, according to the maximum output power of the...
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.
• The intended information flow is from the ultrasound system in the client site to the workstation server. S-Video 4-core 2-component separate video interface. • Mindray ECG interface, using USB communication, and complied with Mindray internal standard. • Time stamp of packet definition. Mindray PCG interface, complied with Mindray internal standard.
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Indications For Use N=new indication ; P=previously cleared by FDA ; E=added under Appendix E Additional comments:Combined modes--B+M、 PW+B、 Color + B、 Power + B、 PW +Color+ B、 Power + PW +B. *Intraoperative includes abdominal, thoracic, and vascular. **Small organ-breast, thyroid, testes. ***Other use includes Urology.
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