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Mindray Eagus TEX21 Operator's Manual

Diagnostic ultrasound system

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Diagnostic Ultrasound System

Operator's Manual

[Basic Volume]

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Summary of Contents for Mindray Eagus TEX21

Page 1 TEX20/TEX20 Pro/TEX20S/TEX20T/ TEX20 Exp/TEX20 Elite/Anesus TEX20 Pro/Eagus TEX20/Eagus TEX20T/Eagus TEX21/Eagus TEX21T/Eros/TEX10/TEX10 Pro/TEX10S/TEX10T/TEX10 Exp/TEX10 Elite/TE X/TE X Lite/TE X Plus/Anesus TEX10 Pro/TEX9U/TEX9M/Eagus TEX11/ Eagus TEX11T/Eagus TEX10/Eagus TEX10T/Eagus TEX/Ares Diagnostic Ultrasound System Operator’s Manual [Basic Volume]...
Page 3 Contents of this manual are subject to change without prior notice. All information contained in this manual is believed to be correct. Mindray shall not be liable for errors contained herein or for incidental or consequential damages in connection with the furnishing, performance, or use of this manual.
Page 4 FITNESS FOR ANY PARTICULAR PURPOSE. Exemptions Mindray's obligation or liability under this warranty does not include any transportation or other charges or liability for direct, indirect or consequential damages or delay resulting from the improper use or application of the product or the use of parts or accessories not approved by Mindray or repairs by people other than Mindray authorized personnel.
Page 5 • Important data must be backed up on external memory media. • Mindray shall not be liable for loss of data stored in the memory of this system caused by operator error or accidents. • This manual contains warnings regarding foreseeable potential dangers, but you shall also be continuously alert to dangers other than those indicated.
Page 6 As a health care provider, you may report the occurrence of certain events to SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD., and possibly to the competent authority of the Member state in which the user and / or patient is established.
Page 7 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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Page 9 Contents Intellectual Property Statement ....................I Responsibility on the Manufacturer Party ................I Warranty ..........................II Exemptions ........................II Customer Service Department ..................II Important Information ......................II About This Manual ........................ III Meaning of Signal Words ....................III Hardcopy Manuals ......................IV Software Interfaces in this Manual .................
Page 10 Contents 2.10.5 Quickly Saving Image Settings ............... 2 - 20 2.10.6 Annotations and Body Marks .............. 2 - 21 2.10.7 iVocal Plus ..................2 - 22 2.10.8 Splitting Display ....................2 - 24 2.10.9 Image Magnification ..................2 - 24 2.10.10 iZoom (Full Screen View) ................
Page 11 Contents 4 Setup ........................4 - 1 4.1 System Preset ......................... 4 - 1 4.1.1 Region ......................... 4 - 1 4.1.2 General ........................ 4 - 2 4.1.3 Image Preset ......................4 - 4 4.1.4 Application Preset ....................4 - 5 4.1.5 OB ........................4 - 7 4.1.6 Footswitch Function ....................
Page 12 Contents 6 Image Acquisition ....................6 - 1 6.1 B Mode ........................... 6 - 1 6.1.1 B-mode Image Scanning ..................6 - 1 6.1.2 B-mode Image Parameters ................... 6 - 1 6.2 Color Mode ........................6 - 5 6.2.1 Color Mode Image Scanning ................6 - 6 6.2.2 Color Mode Image Parameters ................
Page 13 Contents 6.19 Smart Nerve ....................6 - 36 6.20 Smart FHR OB1 ......................6 - 37 6.21 Smart TTQA ......................6 - 38 6.21.1 Basic Procedures for Smart TTQA ..............6 - 38 6.21.2 Screen Display of Smart TTQA ..............6 - 39 6.21.3 Select Image and Cardiac Cycle ..............
Page 14 Contents 10.2.2 Moving Annotations ..................10 - 4 10.2.3 Modifying (Editing) Annotations ..............10 - 4 10.2.4 Deleting Annotations ..................10 - 4 10.2.5 Setting Annotations ..................10 - 4 10.3 Body Mark ........................10 - 5 10.3.1 Adding Body Marks ..................10 - 5 10.3.2 Moving Body Marks ..................
Page 15 Contents 12.7.2 Media review ....................12 - 5 12.7.3 Data Restore ....................12 - 5 12.8 Structured Report ....................... 12 - 5 12.8.1 Send structured reports for storage ..............12 - 5 12.8.2 Back up structured report ................12 - 6 13 Probes and Biopsy ...................13 - 1 13.1 Probes .........................
Page 16 Contents A Wireless LAN ..................... A - 1 A.1 Use the Wireless feature ....................A - 2 A.2 Add the WLAN Allow List ..................A - 2 A.3 IP Configuration ......................A - 2 A.4 EAP Network ....................... A - 3 A.5 Specifications .......................
Page 17 Contents H.4 MI/TI Explanation ......................H - 2 H.4.1 Basic Knowledge of MI and TI ................. H - 2 H.4.2 MI/TI Display ....................H - 3 H.5 Acoustic Power Setting ....................H - 3 H.6 Acoustic Power Control ....................H - 4 H.7 Acoustic Output ......................
Page 19 • 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 500 uA of IEC60601-1), and the responsibility is held by the user.
Page 20 • DO NOT use a probe that has a damaged, scratched surface, or exposed wiring of any kind. Immediately stop using the probe and contact Mindray Customer Service Department or sales representative. There is risk of electric shock if using a damaged or scratched transducer.
Page 21 1 Important Information • Accessory equipment (analog or digital) connected to the ultrasound system must comply with the relevant IEC standards (e.g., IEC 60950 information technology equipment safety standard and IEC 60601-1 medical equipment standard). Furthermore, all configurations must comply with the standard IEC60601-1.
Page 22 If the circuit protector is tripped, it indicates that the system or a peripheral device was improperly shut down and the system is unstable. You cannot repair the system under this circumstance and must call the Mindray Customer Service Department or sales representative.
Page 23 If the system is used in a small room, the room temperature may rise. Please provide proper ventilation and free air exchange. • To dispose of the system or any part, contact Mindray Customer Service Department or sales representative. Mindray is not responsible for any system content or accessories that have been discarded improperly.
Page 24 1 Important Information • Use detachable power supply cord as mains power breaking device. DO NOT set equipment in place where difficult for disconnection of detachable power supply cord. Please read the following precautions carefully to ensure the safety of the patient and the operator when using the probes.
Page 25 1 Important Information • Please use the disinfection or sterilization solution recommended in this operator's manual; otherwise Mindray will not be liable for damage caused by other solutions. If you have any questions, please contact Mindray Customer Service Department or sales representative.
Page 26 1 Important Information • Video Printers 1 - 8 Operator’s Manual...
Page 27 System Overview Intended Use For FDA region This device is a general purpose diagnostic ultrasound system intended for use by qualified and trained healthcare professionals for ultrasound imaging, measurement, display and analysis of the human body and fluid, which is intended to be used in a hospital or medical clinic. TEX20/TEX20 Pro/TEX20S/TEX20T/TEX20 Exp/TEX20 Elite/TEX10/TEX10 Pro/TEX10S/ TEX10T/TEX10 Exp/TEX10 Elite/TE X/TE X Lite Diagnostic Ultrasound System is applicable for adults, pregnant women, pediatric patients and neonates.
Page 28 2 System Overview EQUIPMENT not suitable for use in the presence of a FLAMMABLE ANESTHETIC MIXTURE WITH AIR OR WITH OXYGEN OR NITROUS OXIDE • According to the mode of operation: Continuous operation • Does the equipment has any defibrillation-proof applied parts: Non-defibrillation-proof applied part •...
Page 29 2 System Overview Model B-Hist B-Hist B-Hist B-Hist Trace Len Profile (Ellipse) (Trace) (Spline) (Rectangl (Spline) TEX20 √ √ √ √ √ √ TEX20 Pro × √ √ √ √ √ TEX20S √ × √ √ √ √ TEX20T √ √...
Page 30 2 System Overview Model B-Hist B-Hist B-Hist B-Hist Trace Len Profile (Ellipse) (Trace) (Spline) (Rectangl (Spline) Eagus × √ × × √ × TEX10T Eagus TEX × √ × √ × × Ares × √ √ × × × System Configuration 2.6.1 Standard Configuration •...
Page 31 2 System Overview Item Remarks Rear storage bin After the rear storage bin is configured, towelette holster, lockable storage box or air probe charging holder can’t be configured. Lockable storage box After the lockable storage box is configured, towelette holster, rear storage bin or air probe charging holder can’t be configured.
Page 32 2 System Overview Item Remarks Smart VTI Cardiology Package should be configured. Smart VTI Plus Cardiology Package should be configured. Smart B-line Smart FHR OB1 Obstetrics Package should be configured. Auto GA Abdomen/General Package should be configured. Smart Nerve Nerve Package should be configured. Auto DFR Cardiology Package should be configured.
Page 33 2 System Overview Item Remarks Emergency & Critical Package iVocal Plus iWorks DVR Module ClamAV Shock Application Respiration Application Trauma Application Smart Bladder Abdomen/General Package or Urology Package should be configured. iClear VA Grid Vascular Package should be configured. 2.6.4 Peripherals Supported Item Model Digital graph/text printer...
Page 34 2 System Overview Introduction of Each Unit Figure 2-1 Overview of main unit Name Function Probe holder Used for placing the probe. Speaker Outputs the audio. Power button/Power Used for turning on/ off the power. indicator The indicator lights up when the system is powered on. Power output Provided a power interface for the peripheral devices.
Page 35 2 System Overview Name Function AC power cord Retractable AC power cord. Air Charge Module Configured with the air station to charge the main unit. Battery pack Supply power without AC power supply. Storage bin Used for keeping the cases, towelette, etc. Trolley back handle Used for moving the trolley.
Page 36 2 System Overview 2.7.1 Control Panel Name Description User-defined keys Undefined buttons, set by the user in preset. Clear Press to clear off the comments or measurement calipers on the screen. Cursor button Press to show/hide the cursor. Confirm key Press to confirm the operation.
Page 37 2 System Overview Name Description Save static image button Save images in a preset way. Gain control Adjust the gain of the image in various modes. Depth adjustment button Adjust the depth parameter when the indicator is on. Freeze button Press to freeze or unfreeze the image.
Page 38 2 System Overview 2.7.3 Indicators Monitor Indicators Figure 2-3 Monitor indicators Name Description Standby indicator Standby status: the indicator blinks in orange. Other status: the indicator is off. Battery capacity indicator When the battery is in charge, the battery symbol border is in green and the battery capacity indicators are as follows: •...
Page 39 2 System Overview Name Description Distance sensor Used to turn on the battery capacity indicators of the main screen. Battery Pack Indicators Figure 2-4 Battery pack indicators Name Description Power reset key Press to reset the lithium battery pack. Power capacity key Press to check the remaining battery capacity of the lithium battery pack.
Page 40 2 System Overview ECG Module Figure 2-5 ECG module Name Description Serial connector Connects to the serial port for connecting to ECG of the system. NOTE: Ensure the system is powered off before connecting the ECG module. ECG lead port Used for ECG signal input.
Page 41 2 System Overview Air Station Figure 2-6 Air Station Name Description AC indicator Turns on in white color when connecting the Air Station to the power supply. Bar indicator Indicates the connection status of wireless charging to the Air Charge Module. Power cord Connects to power on the Air Station.
Page 42 2 System Overview 2.10 Basic Operations 2.10.1 Screen Display Figure 2-7 Landscape orientation of the monitor 2 - 16 Operator’s Manual...
Page 43 2 System Overview Figure 2-8 Portrait orientation of the monitor Name Function Function menu tab Select to enter the corresponding function menu. Parameter Area Displays the image parameters for the active window. If there are more than one imaging modes, the parameters are displayed by each mode.
Page 44 2 System Overview Name Function System icons area Displays the relevant system icons, such as USB memory device, network, task manager, used space of the hard disk, etc. System tool button Access the system tools. Thumbnail area Displays the thumbnail of the saved image in the current exam. Gain control Adjust the gain of the image in various modes.
Page 45 2 System Overview 2.10.2 Select Exam Mode and Probe CAUTION If the exam mode is changed during a measurement, all measurement calipers on the image will be cleared. The data of general measurements will be lost, but the data of application measurements will be stored in the reports. NOTE: •...
Page 46 2 System Overview Name Function Imaging mode area Select imaging buttons to switch tab. Imaging parameter menu Swipe the menu downwards/upwards to see parameter controls. Setup Edit button Select to view/edit the image parameter menu under the current exam mode and probe. QSave Select [QSave], and input the name of the exam mode in the pop-up dialog box.
Page 47 2 System Overview Select [QSave] in the Menu area to bring out the Quick Save dialogue box. Select [Create] to save the current image parameters, measurements, comments, body mark settings to the exam mode. The system will ask for a new name of the exam. Restore the factory default settings Perform the following procedure: Select [QSave] in the Menu area to bring out the Quick Save dialogue box.
Page 48 2 System Overview Name Function Edit Comments Select to enter comment preset page, you can add custom comments button (on and change comment layout. Comment menu) Edit Markers Select to enter body mark preset page, you can change body mark button (on Body layout.
Page 49 2 System Overview Input a vocal command using the microphone, and after the command is recognized, the system automatically performs the corresponding operation. Select the icon in the Audio Control menu to pause the vocal command recognition. Setup Select the icon in the Audio Command menu to check the system recognizable commands and enter the iVocal Setup menu.
Page 50 2 System Overview through selecting the icon, while the numerator remains the same. For example: 2/3 represents 2 times of success and 1 time of failure. • Clear: Select [Clear] to clear all the Success Rate test records. • Recover: Select [Recover] to enter the Confirm menu. You can select Yes to restore to the default settings.
Page 51 2 System Overview – – B+PW/CW – B+Color+PW/CW – B+Power+PW/CW The image magnification factor value will display in real time in the image parameter area. 2.10.10iZoom (Full Screen View) This feature magnifies the image area in full screen for a better observation. Exit iZoom button : Select to exit full-screen zoom status.
Page 52 2 System Overview • Cine files stored in the system's hard drive should contain patient information, to avoid the selection of an incorrect image file and potential misdiagnosis. 2.11.1 Entering/Exiting Cine Review To Enter Cine Review • Enter Tap > [Setup] > [System]> [Image] > “Freeze Config” screen to set “Status after Freeze”...
Page 53 2 System Overview 2.11.3 Auto Review Reviewing all Perform the following procedure: In manual cine review status, Select to activate auto cine review. Review speed: in auto cine review status, drag the mark to select different speeds: 1/10x, 1/5x, 1/4x, 1/3x, 1/2x, 1x, 2x, 3x. In auto play status, Select to stop auto play.
Page 54 2 System Overview Select the image, and the icon appears on the image, which indicates the image is to be compared. If select the wrong image, click the image again to cancel the selection. – Select image size display on “Thumbnail Size” bar to display more images at a time. –...
Page 55 2 System Overview • Retrospective saving is to save the specified images before the current moment; to save the images stored in the cine memory to the system hard disk. • Prospective saving is to save the specified images later than the current moment; to save the images to both the cine memory and the system hard disk.
Page 56 2 System Overview TIP: It is only available to save the cine retrospectively in the frozen status. 2.15 Warning Labels This system uses the symbols and warning labels listed in the following table to describe the important information and potential hazards. The warning labels use the same signal words as those used in the operator’s manual.
Page 57 2 System Overview Geometric shape Meaning Safety Contrast Graphical symbol color color color Prohibition Red White Black Mandatory Blue White White action Warning Yellow Black Black 2.16 Symbols This system uses the symbols listed in the following table. Their meanings are explained as follows: Symbol Description Type-BF applied part...
Page 58 2 System Overview Symbol Description USB interface (Type C) Probe direction indicator Power input Maximum load for front storage bin. Maximum load for printer bracket Battery power input Power consumption DC output for air probe charging holder Equipotentiality Product serial number Manufacture date Manufacturer Temperature limit...
Page 59 2 System Overview Symbol Description CONFORMS TO AAMI Std. ES 60601-1, IEC Std. 60601-2-37, IEC Std. 60601-2-18; CERTIFIED TO CSA Std. C22.2 NO. 60601-1, 60601-2-37, 60601-2-18 MR Unsafe – the system is not intended to be used within magnetic resonance (MR) environment.
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Page 61 System Preparation Move/Position the System Read and understand the safety precautions before positioning the system to ensure the safety of both the operator and the devices. Switch off the power, and pull out the power plug. Disconnect all cables from off-board peripheral devices. Unlock the four casters;...
Page 62 When disconnected from the external power supply, the system is powered by the lithium ion batteries. WARNING • The battery is inside the machine. Only Mindray technical professionals or engineers authorized by Mindray following training can perform battery installation and uninstallation. •...
Page 63 If the system begins to function improperly, immediately stop scanning. If the system continues to function improperly, fully shut down the system and contact the Mindray Customer Service Department or a sales representative. If you use the system in a persistent improperly functioning state, you may harm the patient or damage the equipment.
Page 64 If you use a probe giving off excessive heat, it may burn the patient. • If you find anything not functioning properly, this may indicate that the system is defective. In this case, shut down the system immediately and contact Mindray Customer Service Department or sales representative. 3 - 4 Operator’s Manual...
Page 65 3 System Preparation NOTE: When you start the system or switch between transducers, you will hear clicking sounds – this is expected behavior. 3.3.4 Power the System Off You must follow the correct procedures to power the system off. Also, after you upgrade the software or when the system is down, you need to power off and restart it.
Page 66 3 System Preparation To exit standby • Touch the screen lightly. • Press the power button. Monitor Brightness/Contrast Adjustment Perform the following procedure: in the top-right corner of the screen to open the system tool bar. Drag the slider to change the brightness/contrast on the brightness control or contrast control NOTE:...
Page 67 When connecting or disconnecting a probe, place it in the proper position to prevent the probe from falling off or becoming damaged. • Only use probes provided by Mindray. Aftermarket probes may result in damage or cause a fire. Operator’s Manual...
Page 68 3 System Preparation 3.6.1 Connecting a Probe WARNING The probes, cables and connectors should be in proper operating order and free from surface defects, cracks and peeling. Otherwise, this may lead to electrical shock. NOTE: Before inserting the connector into the probe port, inspect the connector pin. If the pin is bent, do not use the probe until it has been inspected/repaired/replaced.
Page 69 USB memory device. NOTE: If the USB disk cannot be recognized by the system, please try disconnecting and then connecting again several times, or try another USB disk. If the problem still exists, please contact Mindray service engineer. Connecting the Footswitch The system supports USB port-type foot switches.
Page 70 3 System Preparation Power supply cable Connect to power supply. Data cable Connect to the USB port of this system. Perform the following procedure: Connect the data cable to USB port of the ultrasound device. Power on the system and the printer. Preset the default report printer and its attribute: Select in the top-right corner of the screen and enter “[Setup] >...
Page 71 Installation tools: Phillips screwdriver Item list: Check if the items are complete according to the packing list below. If not, please contact Mindray Customer Service Department or sales representative. The following items are supplied with each ultrasound gel holder. Name...
Page 72 3 System Preparation Use a Phillips screwdriver to fix the screw. Paste screw labels to the front and back of the screw. 3 - 12 Operator’s Manual...
Page 73 CD/DVD or USB memory device. CAUTION When the preset data is changed, be sure to save the preset data according to the methods described in this chapter. Mindray is not responsible for the loss of preset data. •...
Page 74 4 Setup Item Description System Date To set the date for the system. System Time Move the cursor over the corresponding field and enter the time manually using the keyboard, or, move the cursor over the time segment, then increase or decrease the required value by clicking the icons on the right side.
Page 75 4 Setup Type Item Description Exam Setup Status after exam ends To set the system status when an exam ends. Auto Screenshot of Report After selected, perform measure application and save Page by Page single frame image, then end the patient exam, the system will save the report image in iStation.
Page 76 4 Setup Type Item Description Screen Saver Enable Screen Saver • To select a system dormancy type. After the screen saver function is enabled, tap [Browse] to select the figure used for the screen saver and tap [Preview] to see the effect. Only BMP format images with no more than 768*1024 pixels and 1-bit/8-bit/24-bit/32-bit depth are supported.
Page 77 4 Setup Type Item Description Parameter Steer To set the steer mode in B + Color + PW imaging mode. • C&PW: select to adjust the sample volume in color mode and sample line in PW mode together. • C/PW: select to adjust the sample volume in color mode and sample line in PW mode separately.
Page 78 4 Setup Measure Parameter Controls are as follows: Item Description Cursor Type Type of cursor displayed on the measurement caliper and results window. Value options: • Number: the cursor always displays as “+” while different measurements are marked with numbers. •...
Page 79 4 Setup ICA/CCA && RAR Set the measurement properties of ICA, CCA, Renal A and Aorta. Cardiac Value Range Display Set whether to display the EMINCA study. Physiology Parameter Set the unit of Temp, CVP, ICP, and Pressure. 4.1.5 OB Set the relevant information regarding the fetal gestational age, fetal growth formula and fetal weight.
Page 80 4 Setup The author name Value of standard Unit of the Unit of the deviation measurement standard deviation value Row Num Row number (N) of the table Meas Value GA value Minimum value Measurement Maximum value value … … … …...
Page 81 4 Setup • Value of standard deviation. Select from one of the following: None, ±1SD, ±2SD, 3%~97%, 5%~95%, 10%~90%. • Unit of the measurement value: according to the table to import, select from mm, cm, g, kg, cm² or mm². •...
Page 82 Tap [Install] to begin installing a disabled option. • Tap [Uninstall] to begin uninstalling a previously-installed option. Please contact the Mindray Customer Service Department or a sales representative for details. 4.1.9 Access Control The system supports two types of users: administrator and operator.
Page 83 4 Setup Select the user to be deleted in the User List. Tap [Delete] to delete the selected user. Editing Privilege Turn on the access control function and log in to the system as Administrator before you edit privileges. Select a user, tap [Edit Privilege] to enter the “Edit user privilege” dialog box, and select or deselect the check box from the privilege list.
Page 84 4 Setup Item Description Remark Enable strong Enable strong password to improve security. password • If the strong password is enabled and you log in to the system with the account that is added before the strong password is enabled, the system prompts a warning message to inform you whether your password conforms to the password policy.
Page 85 A is 1+2+4+8+16+32+64+128=255. MLDAP Privilege Management Turn on the access control function and log in to the system as Administrator before you edit privileges for the MLDAP (Mindray Lightweight Directory Access Protocol) users. Tap [MLDAP Config]: Item...
Page 86 4 Setup Item Description Member of filter/Privilege • Enter the member name, and select or deselect privileges from the drop-down list of “Privilege”. • Tap [Add], and the new members and privileges will appear in the Member of filter list. •...
Page 87 4 Setup Item Description Default Item If the default item is set to “No”, and both the 2D and 1D barcodes fail to be matched, the obtained data of the barcode is input as a string of characters. After selecting a default item from the drop down list of “Default Item”, the obtained data of the scanned barcode will be displayed in the corresponding selected default item.
Page 88 4 Setup Item Description Parameters • Input a barcode example, and you can change the information of Patient ID, Other ID, First Name, Last Name, Middle Name, Birth (Day), Birth (Month), Birth (Year), Age, Gender and etc. in the “Content” list. Note: Ignore item is used to add one line below the selected item to hide unimportant patient information.
Page 89 The [Maintenance] function is designed for you to import or export user data, restore factory setting and export log. You may also execute self-test and option installation/trial through the maintenance menu. If you require other maintenance functions, please contact Mindray Customer Service Department or sales representative.
Page 90 Needles List Replace Update the list of needles that support eSpacial Navi function. NOTE: The list of needles must be release version provided by Mindray. Needles List Recover Restore the list of needles that support eSpacial Navi function to the last version.
Page 91 4 Setup Repetition You can choose whether to repeat the demonstration or exit after a demonstration is complete. Exhibition If the function is enabled, the system will play AVI/MP4 format files automatically. 4.1.14 Security Drive Encryption/Secure Data Wipe Encrypt the patient data stored in the hard disk. The system provides two encryption methods: Factory Default and User Define.
Page 92 4 Setup Transmission Encryption After accessing the network, tap [VPN Config] to enter the “VPN Config” interface. Item Description Status No driver: tap [Setup Driver] to enter the "TAP-Windows 9.21.2 Setup" interface, and do as instructed. • Ready: the VPN is ready for use. •...
Page 93 4 Setup Tap and hold any exam mode until it floats, then you can: – Drag the exam mode from “Library” column to “Selected” column to make the exam mode available for the probe. – Drag the exam mode from “Selected” column to “Library” column to make the exam mode unavailable for the probe.
Page 94 4 Setup Descriptions of the attributes are shown in the following table. Attributes Descriptions Item Name & Result Results obtained from D trace are listed. The selected items will be displayed in the results window after measurement. • If PV is selected, other results become deselected. •...
Page 95 4 Setup • Adding/Removing Items: Add/Remove the general measurement item using the [>], [>>], [<] and [<<]. • Setting Default Items: Select an item from the [Selected Items] list, select [Default]. The defaulted item is marked with a √. To deselect the default tool, select it and click [Default] or set another item as the default. If a particular item is set as the default item, it automatically displays the submenu of the study when entering this measurement menu.
Page 96 4 Setup Select [Next] to Step 2. 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 Displays the user-defined formula. Verify Used to verify if the formula is valid. Application Region Select the application region for the user-defined item.
Page 97 4 Setup Function Method Parameter Number Function Description log(a) Logarithm with 10 as the base avg(a,...) ≥1 Average value abs(a) Absolute value Constant π, 3.1415926 NOTE: The letter “a” and “b” in the “Method” Column are parameters. The following physiological indicators can be added to the formula. Name Definition Unit...
Page 98 4 Setup Edit User-defined Items Perform the following procedure: Select defined items in the “Available Items”. Select the target item and select [Edit] on the right Remove User-defined Items • Remove Measurement/Calculation Select “User-defined” in the “Available Items”, and select the desired item. Select [Delete] on the right.
Page 99 4 Setup Set the module display in the report: select [Setting] to make a selection; – Tick the check box in front of the module name to display the module in the report; – Select [OK] to save the setting and exit. Change the patient information layout in the report template: –...
Page 100 4 Setup 4.4.1 Comment Configure Add a user-defined item Select button or tap a empty comment box to bring up the soft keyboard, then type the alphanumeric characters. Select button again to confirm it. Select available items Perform the following procedure: Select available items: Select a comment library in the drop-down list below “Application”.
Page 101 4 Setup iWorks Preset You can customize the protocols and views in the iWorks preset screen. 4.5.1 Protocol Management • Select [Multi Select] and you can select multiple views to be copied in the list on the left. • Tap to select the protocol in the list. The protocol type can be checked on the lower part. Check to select applied exam modes in the “Exam Mode(s) applied to”...
Page 102 4 Setup 4.6.1 DICOM Local Preset TIP: • AE Title should be the same with the SCU AE Title preset in the server (PACS/RIS/HIS), for example, if the AE Title of the server preset in the storage server is Storage, and the AE Title of the accepted SCU is preset as Machine, then in the figure above, the AE Title of Local should be Machine, and the AE Title of storage server should be Storage.
Page 103 4 Setup Set DICOM Strategy TIP: • 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: Tap [Set DICOM Strategy]. Edit the DICOM strategy: –...
Page 104 4 Setup – Select an item in the service list, change the parameters in the above area, and tap [Update] to update the item in the service list. – Click to delete the selected service in the service list. – Select an item in the service list, click [Default] and you can see “Y”...
Page 105 4 Setup Item Description Encapsulated PDF Select if to encapsulate PDF format report in DICOM standard. It becomes available if SCP supports the function. 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.
Page 106 4 Setup Item Description Settings The system supports RGB (color printing) and MONOCHROME2 (black and white printing). Please select the type the printer supports. Film Orientation Select between LANDSCAPE and PORTRAIT. Priority Specify printing task priority among HIGH, MED and LOW. Film Size Select film size among the selections listed in the drop-down list.
Page 107 4 Setup Item Description Transport Layer Security. Select whether to encrypt the data during network transportation. Strategy Name Select the preset DICOM strategy. Remove Attributes (0) Preset what DICOM elements that will not be used in worklist query. MPPS Preset MPPS setting items are described as follows: Item Description...
Page 108 4 Setup Query/Retrieve DICOM query/retrieve setting items are described as follows: Item Description Device Name Select the name of a device that can be added (including the local). Service Name Default is server-queryRetrieve, and it can be modified. AE Title Application Entity title.Here, it should be consistent with that of the storage commitment server.
Page 109 4 Setup eGateway Query Item Description Service Name The name of the eGateway service. IP Address Input the ADT Source IP address in the eGateway Server configuration interface. Port Input the MAQ Server Port in the eGateway Server configuration interface. Clear Click to cancel the parameter setting.
Page 110 4 Setup Type Item Description Clear Tap to cancel the parameter setting. Tap to add the Network service to the service list. Update 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.
Page 111 The SSID of hotspot. Password The password to connect hotspot equipment. MIOT Preset After the MIOT (Mindray Internet of Things) service is enabled and configured, the Ultrasound device information such as Usage, Operating duration, can be transmitted to MIOT. Item Description IP Address IP address of the MIOT service device.
Page 112 4 Setup Type Item Description Network type WLAN Connect X-Link by WLAN. Tap [Select Network] to set X-Link SSID or select [Other Network] to input Network SSID. Bedside Hotspot Tap to input password to connect X-Link by bedside hotspot. Connect X-Link by LAN. Department Filter / Tap to input filter of department.
Page 113 4 Setup Perform the following procedure: Select “Enable Q-Path”. Enter the website, account and password of the target service. Select user type: Personal User or Default User. – Personal User: the personal user needs to enter the user name and password in every-time login.
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Page 115 Exam Preparation You can start a patient exam in the following situations: • New patient information: to start a new patient exam, patient information must first be entered. • New exam: to start a new exam for patient who is already registered, the recorded information can be obtained through either iStation or Worklist.
Page 116 The system supports logging data as patient ID by using the barcode reader. CAUTION Ensure the information acquired by barcode reader is consistent with the actual information. Contact Mindray Customer Service Department to obtain the model information of the barcode scanner supported by this product. 5.1.2 Retrieve Patient Information You can import patient information from iStation or DICOM Worklist for anonymous patients.
Page 117 5 Exam Preparation Activate& Continue an Exam 5.2.1 Activate an Exam In iStation screen, select the exam record finished within 24 hours, and click [Activate Exam] from the menu popped up; or, click [Active Exam] in iStation or Review screen to activate the exam. NOTE: •...
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Page 119 Image Acquisition WARNING • The images displayed in this system are only reference for diagnosis. Mindray is not responsible for the correctness of diagnostic results. • Tissue Harmonic Imaging does not use contrast agents. TIP: Operations for switching between different image modes and optimizing images, see “2 System Overview”.
Page 120 6 Image Acquisition The adjustment function is disabled for wireless probe. Steer To steer the beam the probe transmits. FOV Size You can get a much larger field of view when selecting a larger FOV, but the frame rate will decrease.
Page 121 6 Image Acquisition Dynamic Range Adjusts contrast resolution of an image, compresses or expands gray display range. The real-time dynamic range value is displayed on the image parameter area. The more the dynamic range, the more specified the information, and the lower the contrast with more noise.
Page 122 6 Image Acquisition H Scale Display or hide the width scale (horizontal scale). The scale of the horizontal scale is the same as that of vertical scale (depth), they change together in zoom mode, or when the number of the image window changes.The H Scale will be inverted when image is turned upwards/downwards.
Page 123 6 Image Acquisition The function is disabled for wireless probe. V 1:1 This function is to display images in vertical format in the dual-split mode. After the feature is enabled, one image appears above, and the other image appears below. In the dual-split mode, tap [V 1:1] to enable this function.
Page 124 6 Image Acquisition Generally, the color above the color bar indicates the flow towards the probe, while the color below the color bar indicates the flow away from the probe. The brighter the color, the faster the flow speed, while the darker the color, the slower the flow speed. TIP: In Color Mode, acoustic power is synchronous with that of B Mode.
Page 125 6 Image Acquisition B/C Align To set and constrain the maximum width of the B mode image to that of the Color ROI. Steer The feature is used to adjust the ROI of the color flow of different angles with immobility of the linear probe.
Page 126 6 Image Acquisition WF (Wall Filter) It filters out low-velocity signals to provide effective information, and this function is used to adjust the filtered frequency. The real-time value (WF) is displayed in the image parameter area. Priority This function is used to set levels of the flow display, to display the grayscale signal or color signal. The color image is preferred with higher value;...
Page 127 6 Image Acquisition 6.3.2 Power Mode Image Parameters Because both are based on Doppler color imaging, the adjustments of Power mode are same with these of Color mode’s. Hence, only the adjustments of Power mode are introduced. Power Gain Refers to the overall sensitivity to flow signals, and this function is used to adjust the gain in Power mode.
Page 128 6 Image Acquisition Priority This function is used to set levels of the flow display, to display the grayscale signal or color signal. The color image is preferred with higher value; while grayscale signals are displayed with the lower value. Line Density The function determines the quality and information of the image.
Page 129 6 Image Acquisition M Mode 6.4.1 M Mode Image Scanning Perform the following procedure: Select a high-quality image during B mode scanning, and adjust to position the area of interest in the center of the B mode image. Tap [M] to enter M sampling line status, and drag the sampling line to the desired position. Tap [M]/ [Update] or double-tap the sampling line to enter M mode.
Page 130 6 Image Acquisition Dual To enter the Dual-split display mode, and to switch between the windows. Color M Mode (CM) To know the cardiac motion state, CM is overlaid with flow based on M mode, which is more sensitive to the instantaneous signal changes. Then, it shows the diagnosis information in detail. 6.5.1 CM Image Scanning Perform the following procedure: To enter CM mode:...
Page 131 6 Image Acquisition – Angle Adjustment: When the M-mark line is activated, tap the dotted circle and drag along the sampling line to adjust the fulcrum of the line, and adjust the angle by rotating the sampling line. Tap [Image] to open the image menu. Adjust the parameters to optimize the image. 6.6.2 Anatomical M Mode Parameters In anatomical M mode, adjustable parameters are similar with these in M mode.
Page 132 6 Image Acquisition Image Quality Refers to the transmitting frequency in Doppler mode of the probe, the real-time value of which is displayed in the image parameter area. Scale This function is used to adjust the speed range of color flow, which is adjusted through PRF in the system.
Page 133 6 Image Acquisition HPRF HPRF mode is used when detected velocities exceed the processing capabilities of the currently selected PW Doppler scale or when the selected anatomical site is too deep for the selective PW Doppler scale. Baseline Refers to the area where the velocity in zero in the spectrum. The map changes after being edited. Angle This function is used to adjust the angle between Doppler vector and flow to make the velocity more accurate.
Page 134 6 Image Acquisition 6.8.1 TDI Mode Image Scanning Perform the following procedure: Select [TDI] button to enter the TDI mode. – In B or B+Color mode: to enter TVI Mode, parameters of TVI mode will be displayed. – In Power mode: to enter TEI Mode, parameters of TEI mode will be displayed. –...
Page 135 6 Image Acquisition Figure 6-1 Quantitative analysis display (taking velocity-time curve as the example) TDI review Sampling area: indicates the sampling position of the curve. The sampling lines are marked with color numbers. It can mark 8 ROIs at most. 2D grey image review •...
Page 136 6 Image Acquisition • Only after the user chooses the image review, the quantitative analysis is available. If the user chooses the static image (only one frame), the quantitative analysis is not available. Tap [TDI QA] to enable the function. Mark the interested myocardium area.
Page 137 6 Image Acquisition Select [Exit] to exit the quantitative analysis. iScape View (Real-time Panoramic Imaging) The iScape panoramic imaging feature extends your field of view by piecing together multiple B images into a single, extended B image. Use this feature, for example, to view a complete hand or thyroid.
Page 138 6 Image Acquisition Optimize the B mode image: In the capture preparation status, select the B mode page tab to select B mode image optimization. Do measurement or add comment/bodymark to the image if needed. Switch to [iScape] page to enter the iScape acquisition preparation status. Select [Start Capture] or [Update] button to begin the capture.
Page 139 6 Image Acquisition 6.9.3 Evaluate image quality Many variables may affect the overall image quality. It is important to evaluate the image content and quality before an image is used for diagnosis or measurements. NOTE: • iScape panoramic imaging is intended for use by well-trained ultrasound operators or physicians.
Page 140 6 Image Acquisition • It supports single-frame and multi-frame image file detection in B mode. 6.10.1 Basic Procedures for Smart B-line Perform the following procedure: Select an appropriate probe and exam mode. The system enters the B mode by default. Adjust the image parameters to obtain optimized images.
Page 141 6 Image Acquisition the lung consolidation and pleural effusion occur at the same time, it is marked as C/P in the brackets and the score is 3. – Dist n (B Line distance): indicates the distance between the 2 neighboring lines and is measured in the pleura line area, among which, n corresponds to the number between the 2 B lines.
Page 142 6 Image Acquisition After adjustment, the LVOT spectrum tracing and calculation results display in real time. Tap [Freeze] button to freeze the image, and check the Smart VTI calculation results. If necessary, you can edit the LOVT spectrum manually: Select [Edit VTI] to activate the cursor. Move the cursor to the spectrum tracing line.
Page 143 6 Image Acquisition – MAP (Mean Artery Pressure) and CVP (Central Venous Pressure) can be inputed manually to obtain LVOT SVR and Eadyn results. If necessary, adjust the PW sampling line and sampling volume: Adjust the PW sampling line position and the PW sampling volume. After adjustment, the LVOT spectrum tracing and calculation results display in real time.
Page 144 6 Image Acquisition The system measures the IVC inner diameter of the image in every frame, calculates the maximum and minimum IVC diameters, and draws a quantitative index change curve in real time. If necessary, you can adjust the IVC sampling line manually: –...
Page 145 6 Image Acquisition 6.14 RIMT (Real-time Intima-Media Thickness) This function is used to calculate the thickness of the carotid intima automatically. TIP: • It is merely available to enter RIMT imaging mode in B single window and dual window when adopting linear probe for carotid exam.
Page 146 6 Image Acquisition – Preview report: Select [Preview] to preview the report. The RIMT mean value, standard variance and ROI length of the patient's previous exams (including the current exam) are displayed. For details about the report, refer to the Operator’s Manual Advanced Volume. Select [RIMT] again to exit.
Page 147 6 Image Acquisition Exit contrast imaging. Select the B mode button to return to B mode. 6.15.2 Left Ventricular Opacification Perform the following procedure: Acquire ECG signal. Select an appropriate probe and LVO exam mode. Adjust the acoustic power experientially to obtain a good image. Set [Dual Live] to be “On”...
Page 148 6 Image Acquisition Micro-bubble Destruction CAUTION Use the contrast imaging according to the residual level of the micro-bubbles, using contrast imaging continuously may result in human harm. Destruct the micro-bubbles left by the last contrast imaging; or to observe the reinfusion effect in a continuous agent injecting process.
Page 149 6 Image Acquisition In live mode, you can save the interested images by selecting [Pro Capture] and [Retro Capture]. • Cine saving In live mode, select the Freeze button to enter cine review status. Tap [Save Clip] button. 6.15.5 Micro Flow Enhancement MFE superimposes and processes multiple frames of contrast image during the cycle;...
Page 150 6 Image Acquisition Figure 6-2 Contrast QA Screen Contrast cineloop Sample area: indicates sampling position of the analysis curve. The window sample area is color-coded, 8 (maximum) sample areas can be indicated. B cineloop window Sample areas are linked in the contrast cineloop window and B cineloop window.
Page 151 6 Image Acquisition Use [ROI Type] to select the method for determining the shapes of the sample area: Trace ROI and Ellipse ROI. The cursor is evolved in the image review area. Move the cursor to position the caliper on the reference image at the start point. Tap the arrows around the hand icon to fine-tune the cursor position if needed.
Page 152 6 Image Acquisition – Select [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.
Page 153 6 Image Acquisition Select [Smart] > [Auto GA], the system will automatically recognize and trace the target boundary to calculate. The calculation result is displayed on the screen. If the calculation result is not satisfactory, adjust the trace to recalculate. Tap the traced contour to activate the cursor.
Page 154 6 Image Acquisition WARNING This function is not applicable for the patient whose cardiac structure can hardly be recognized under ultrasound scanning (such as obesity), or the entire cardiac structure has severely been changed (such as congenital heart disease). NOTE: If the user adjusts parameters in cardiac exam mode, such as Gain, Dynamic Range, or perform irregular scanning, such as quickly moving the probe, applying insufficient ultrasound gel, the results may not be correct.
Page 155 6 Image Acquisition Select the linear probe and nerve exam mode, and enter B mode. Perform scanning for the nerve area until the clear nerve area image is found. Visually check the structure of the nerve area, if no abnormality occurs, tap [Smart Nerve] to enter this function.
Page 156 6 Image Acquisition 6.21 Smart TTQA CAUTION Smart Tissue Tracking Quantitative Analysis images are provided for reference only, not for confirming diagnoses. Apart from TDI imaging function, the system also provides smart tissue tracking QA function for myocardial movement evaluation. By smart 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...
Page 157 6 Image Acquisition Tap [Accept & Compute] to calculate and display the curve. Adjust the parameters if necessary. Tap [Bull’s Eye] to see the result. Tap [Data Export] to export analyzed data. Tap [Exit] to exit. 6.21.2 Screen Display of Smart TTQA Displays cardiac segmentation •...
Page 158 6 Image Acquisition Display curve: Velocity/ Each curve on the image is matched with a certain segment in the Displacement/Strain/Strain Rate. cardiac segmentation model (6), identified by different colors. • Velocity curve: X-axis represents time (s); Y-axis represents velocity (cm/s). •...
Page 159 6 Image Acquisition As shown in the following figure, after operation by tapping to place 3 points on the image, the system generates the trace automatically. • Manual trace method Move the cursor along the boundary to add the trace points gradually, after trace is finished, tap the cursor twice to finish tracing.
Page 160 6 Image Acquisition • [A4C]: apical four chamber. • [A2C]: apical two chamber. • [ALAX]: apical long-axis view, also called 3-chamber view. Parameter Adjustment • [Thickness]: adjusts the tracing thickness, i.e., the distance between the endocardium wall and the tracking points on the epicardium. •...
Page 161 6 Image Acquisition Comments and Body Mark operations are the same as those of other modes. 6.21.8 Data Export The system provides data exporting function, so that you can export calculation result for analysis (for instance, SPSS analysis). Tap [Data Export] to export analyzed data of each segment in .csv format. 6.22 Application This function is used to evaluate respiratory failure, shock and trauma in emergency treatment, quickly determine the cause of respiratory failure, identify the type of shock, and determine...
Page 162 6 Image Acquisition Repeat step 3 and step 4 to acquire all the necessary images. – If a pathology is discovered, select [Insert] to select a protocol outside of the normal routine to start scanning. – [Repeat]: add a copy of the selected view to work on if necessary. –...
Page 163 6 Image Acquisition 6.23.5 Insert Insert is a specialized protocol event within iWorks and iWorks OB. It assists with the workflow for documenting and measuring common pathological (disease) states (i.e. Mass, Cyst, Stenosis, Thrombus) that occurs outside a routine, normal examination. Select [Insert] to enter the status.
Page 164 6 Image Acquisition 6.24.2 Micturition Volume Calculation The micturition volume can be calculated by subtracting the measurement results before micturition from the measurement results after micturition. Perform the following procedure: After entering the [Smart Bladder] function, tap [Pre/Post] in the tab to enable the function. Select [Pre-BL] and measure the volume of the urine in the bladder before micturition.
Page 165 Strain Elastography CAUTION It is provided for reference, not for confirming a diagnosis. It is produced based on the slight manual-pressure or human respiration in 2D real-time mode. The tissue hardness of the mass can be determined by the image color and brightness. Besides, the relative tissue hardness is displayed in quantitative manners.
Page 166 7 Strain Elastography Tap [H 1:1], [V 1:1], [Full] on the touch screen to adjust. The system provides 3 types of display format: • H 1:1: Right and left display (the real-time ultrasound image appears on the left, and the elasto image appears on the right);...
Page 167 Smart 3D The operator moves the probe to change its position/angle when performing the scanning. After the scanning, the system carries out image reconstruction, and then displays a single frame of 3D image. NOTE: Smart 3D imaging is largely environment-dependent, so the images obtained are provided for reference only, not for confirming a diagnosis.
Page 168 8 Smart 3D 8.1.2 ROI and VOI After the system enters 3D imaging, a B image with ROI displays on the screen. A line (shown in the following figure) that shows the upper edge position of VOI is inside ROI. ROI size adjustment ROI position adjustment Cut plane...
Page 169 8 Smart 3D TIP: 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. This is helpful for viewing bony structures. Set Min as 3D image rendering mode.
Page 170 8 Smart 3D • 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. •...
Page 171 8 Smart 3D • 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.
Page 172 8 Smart 3D Scanning plane and probe movement Move the probe across the body surface. The arrow in the figure below indicates the movement of the probe. You can move the probe in the opposite direction to the arrow. Smart 3D Image Acquisition NOTE: In Smart 3D image scanning, if the probe orientation mark is oriented to the operator’s finger, perform the scan from right to left in linear scan, or rotate the probe from left to right in rocked...
Page 173 8 Smart 3D Smart 3D Image Viewing Activate MPR Tap [A], [B], [C] or [VR] to activate MPR or 3D image (VR). MPR Viewing In actual display, different colors of the window box and the section line are used to identify the section A, B and C.
Page 174 8 Smart 3D The system supports the observation of 3D image from 6 directions. a. Up/Down b. Down/Up c. Left/Right d. Right/Left e. Front/Back f. Back/Front Tap [Up/Down], [Left/Right] or [Front/Back] to select the direction of the figure a, c and e. Tap [Flip] on the first page to observe by the converse direction of the current direction, which is equivalent of the 180°...
Page 175 8 Smart 3D Swipe on the current active MPR to view the image. The other two MPRs change correspondingly. The adjustment of Rendering Parameters In image viewing status, you can render the image by adjusting the relevant parameters. Tap [VR] or [MPR] to select the VR parameters or MPR parameters. •...
Page 176 8 Smart 3D Item Description To reset the parameters, rendering rotation, VOI and image effect. Reset Curve To reset the curve to be the original beeline. Render Mode Set 3D image rendering mode. The rendering manners can be applied to inversion mode. Inversion This function is to inverse the echo of the 3D image, so as to enhance observation for low-echo region, applicable for vessel, cyst and etc.
Page 177 8 Smart 3D Image review Open an image file to enter the image review mode. In this mode, you can perform the same operations as what you can in review mode. Operator’s Manual 8 - 11...
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Page 179 Physiological Unit Signal The physiological unit signal waveform is used for checking ultrasound image in ultrasound exam (cardiac exam mainly). WARNING • Do not use the physiological traces for diagnosis and monitoring. • To avoid electric shock, the following checks shall be performed prior to an operation: –...
Page 180 9 Physiological Unit Signal Place the ECG electrodes on the patient’s body (as shown in the following figure). Right Left Right Left Yellow Black White Black Green Green (a)IEC标准 (b)AHA标准 IEC standard AHA standard Tap [Physio] to enter physio operation interface. Switch the imaging modes and display formats, adjusting the parameters to get an optimized image.
Page 181 9 Physiological Unit Signal Single Trigger: When an R waveform is detected, an image will be triggered after delay time T1. The time of T1 can be edited in single mode. The image triggering operation is described as follows (Take single trigger as an example): Select exam mode.
Page 182 9 Physiological Unit Signal Parameter Description Gain Set the amplitude of the trace. Position Set the vertical position of the both traces on the image display. Speed Change the speed of the physio trace. RESP Gain Set gain of the respiratory wave trace on the image display.
Page 183 Measurement, Annotations and Body Mark 10.1 Measurement There are general measurements and application measurement. You can perform measurements on a zoomed image, cine reviewing image, real-time image, or frozen image. For measurement details, please refer to the Advanced Volume. WARNING •...
Page 184 10 Measurement, Annotations and Body Mark Table 10-1 Error of 2D Images Parameter Range Error Area Full Screen Within ±10% Circ Full Screen Within ±10% Angle Full Screen Within ±3% Volume Full Screen Within ±12% Table 10-2 Time/Motion Measurements Parameter Range Error Distance...
Page 185 10 Measurement, Annotations and Body Mark Table 10-3 Auto Measurements Measurement Item Error Auto GA Within ±10% Smart TTQA Within ±20% Smart VTI Plus Within ±20% Smart Bladder Within ±10% NOTE: Within the selected field range, the measurement accuracy is ensured within the range mentioned above.
Page 186 10 Measurement, Annotations and Body Mark Select [Arrow] button. To position the arrow on the area of interest and change the orientation: tap and rotate the arrow icon to change the arrow position; tap and rotate the dotted line under arrow icon to change the arrow orientation.
Page 187 10 Measurement, Annotations and Body Mark Select [Edit Comments] button in the Menu area and open Edit Comments dialog box. – Select button or tap a empty comment box to bring up the soft keyboard, then type the alphanumeric characters. Select button again to confirm it.
Page 188 10 Measurement, Annotations and Body Mark Deleting all body marks Select [Clear Markers] button in the Menu area or [Clear All] in Image area to delete all the body marks. 10.3.4 Setting Body Mark Perform the following procedure: Select [Edit Markers] button in the Menu area and open Edit Body Makers dialog box. –...
Page 189 The system patient database space is limited, please back up or clear patient data in time. • Mindray is not responsible for lost data if you DO NOT follow suggested backup procedures. 11.1 Image File Management You can store the image files either in the patient database in the system, or to external memory devices.For a save image, you can perform operations like image reviewing, analyzing and...
Page 190 11 Patient Data Management 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 (AVI) Multi-frame export format. • DICOM files (DCM) DICOM standard files format, single-frame or multi-frame format, used to record patient information and images;...
Page 191 11 Patient Data Management • During image scan, saved image thumbnails will display on the right of the screen. Move the cursor onto a thumbnail, and tap twice to open the image; if the stored image is a cine file, double-click the thumbnail to enter the auto cine review.
Page 192 11 Patient Data Management 11.2.2 Importing, exporting and sending a report Import/export report via Backup In iStation screen, select patient data, tap [Options] > [Back up]/[Restore] in the popped up menu to import or export patient information, images and reports from or to an external memory device. Perform the following procedure: Select the destination.
Page 193 11 Patient Data Management When you select a patient in the patient list, the images of this patient will be displayed at the bottom of the screen. 11.3.2 Patient Data View & Management Tap to select the desired patient exam in the list, you can: Item Description Delete Exam...
Page 194 TIP: 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 the Setup chapter.
Page 195 11 Patient Data Management Print current screen image In the main screen, use [Freeze] to freeze the image and tap [Print] to print the current screen image. Image print via send to function Perform the following procedure: Select the desired image in the iStation or Review screen. Tap [Send To] and select the printer in the dialog box which appears.
Page 196 11 Patient Data Management Print Task Displays image or report printing tasks. In the Task Management dialog box, the patient ID, name, destination, progress, type, contents and task created time are displayed. You can perform the following operations: • Click [Delete] to delete the task. •...
Page 197 For X-Link settings, see “4.6.7 X-Link”. • This function must be used with the monitor or ventilator of the specified model and version. Consult Mindray service engineer for details. Perform the following procedure: Tap [X-Link] and select a Bed No. in Bed Selection window.
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Page 199 DICOM/HL7 NOTE: Before using DICOM, please read the electronic file DICOM CONFORMANCE STATEMENT along with the device. TIP: The DICOM package is optional, so the description here is only applicable for the system configured with the DICOM package. This system supports the following DICOM functions: •...
Page 200 12 DICOM/HL7 12.1.2 To send images to storage after an exam ends TIP: To preset Sending/printing after End Exam and set a default storage server, for details see the Setup chapter. Start the ultrasound exam scan. Tap [End] to send the image or the cine to DICOM storage automatically.
Page 201 12 DICOM/HL7 Select the desired patient record in the displayed patient list. Select the desired patient and click [Start Exam]. The patient information is imported into the system and then an exam is started. Select [Transfer] and the patient information is imported into the [Patient Info] screen. After editing the patient information in the Patient Info screen, select [OK] to start a new exam.
Page 202 12 DICOM/HL7 Start the scan and obtain the image. Tap [End] each time; the system will send the image to the default DICOM storage server for storage and send storage commitment to the storage commitment server. Storage commitment is confined to the whole exam. Not each image sending can be indicated. 12.6 Query/Retrieve The query/retrieve function is used to query and retrieve patient exam records in a designated server.
Page 203 12 DICOM/HL7 TIP: There must be no DICOMDIR/DCMIMG/IHE_PDI files on the external storage media of the same name as the one being backed up. Otherwise, the backup cannot proceed. Ensure there is enough storage space, or the backup may fail due to shortage of space. 12.7.2 Media review Perform the following procedure: Connect the external media with DCM files to the system.
Page 204 12 DICOM/HL7 Select “DICOM” in the Target box on the left side, then select the DICOM storage server in the Storage Server box on the right side. Tap [Send]. Check for the result in the DICOM Task Management dialog box. The structured report can be sent automatically.
Page 205 Probes and Biopsy 13.1 Probes Probe model Probe Type Probe Figure 7LT4s Linear L14-6s Linear C4-1s Convex C5-1s Convex P10-4s Phased P7-3Ts Phased L14-6Ns Linear Operator’s Manual 13 - 1...
Page 206 13 Probes and Biopsy Probe model Probe Type Probe Figure C11-3s Convex SP5-1s Phased L16-4Hs Linear C6-2Gs Convex L20-5s Linear P8-3Ts Phased P4-2s Phased SC6-1s Convex V11-3Hs Convex P8-2s Phased 13 - 2 Operator’s Manual...
Page 207 13 Probes and Biopsy Probe model Probe Type Probe Figure P8-2Ts Phased LAP13-4Cs Convex L14-5sp Linear L11-3VNs Linear L12-3RCs Linear L12-3VNs Linear C9-3Ts Convex Phased i3PA Phased Operator’s Manual 13 - 3...
Page 208 13 Probes and Biopsy Probe model Probe Type Probe Figure L14-3Ws Linear SC10-2RCs Convex SC5-1Ns Convex L15-3RCs Linear L16-3RCs Linear L24-6RCs Linear L24-6Hs Linear 13 - 4 Operator’s Manual...
Page 209 13 Probes and Biopsy Probe model Probe Type Probe Figure ELC13-4s Biplane SP5-1Ns Phased Biplane TIP: For details of TEE probe, see the relevant Operator’s Manual. 13.1.1 Probe Functions by Part The basic structures and corresponding functions of probes are basically the same; take the following probe as an example.
Page 210 13 Probes and Biopsy Item Description Probe connector Connects the probe and cable to the ultrasonic diagnostic system. 13.1.2 Orientation of the Ultrasound Image and the Probe Head The orientation of the ultrasound image and the probe are shown as below. The “M” side of the ultrasound image on the monitor corresponds to the mark side of the probe, for the laparoscopic probe, the probe orientation starting side is located on the end of the distal tip away from the handle.
Page 211 13 Probes and Biopsy Procedures for operating (with biopsy function) Inspection before examination Connection to the system Examinations Biopsy procedure Disconnection to the system Thoroughly cleaning the needle- guided bracket Wiping off the ultrasound gel Sterilization of the needleguided bracket Thoroughly cleaning the probe Inspection after use Drying the probe...
Page 212 13 Probes and Biopsy Procedures for operating (with no biopsy function) Inspection before examination Connection to the system Examinations Disconnection to the system Wiping off the ultrasound gel Thoroughly cleaning the probe Drying the probe Disinfecting the probe Rinsing the probe Drying the probe Inspection after use Storage...
Page 213 13 Probes and Biopsy A legally marketed probe sheath must be installed over the probe before performing intra-cavitary and intra-operative examination. Protective barriers may be required to minimize disease transmission. Probe sheaths are available for use with all clinical situations where infection is a concern.
Page 214 13 Probes and Biopsy 13.1.5 Probes Cleaning and Disinfection/Sterilization Before and after completing each examination, clean and disinfect (or sterilize) the probes as required. When biopsy procedures have been performed, be sure to sterilize the needle-guided bracket. Fail to do so may result in the probe and the needle-guided bracket to becoming sources of infection.
Page 215 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...
Page 216 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.
Page 217 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.
Page 218 Store the probe in a cool, clean and dry environment. And repeat the cleaning and sterilization process before the next use. Compatible Cleaner, Disinfectants/Sterilants For the cleaner, disinfectants and sterilants information, please refer to Mindray Transducer Disinfectant Recommendation. 13.1.6 Probe Environmental Conditions...
Page 219 13 Probes and Biopsy Table 13-2 Probe Environmental Conditions Probe Conditions Ambient Relative humidity Atmospheric Model temperature (no condensation) pressure C6-2Gs Operating 0°C ~ 40°C 20% ~ 85% 700 hPa ~ 1060 hPa Storage and -20°C ~ 55°C 20% ~ 95% 700 hPa ~ 1060 hPa transportation C11-3s...
Page 220 13 Probes and Biopsy Table 13-2 Probe Environmental Conditions Probe Conditions Ambient Relative humidity Atmospheric Model temperature (no condensation) pressure P10-4s Operating 0°C ~ 40°C 30% ~ 85% 700 hPa ~ 1060 hPa Storage and -20°C ~ 55°C 30% ~ 95% 700 hPa ~ 1060 hPa transportation SP5-1s...
Page 221 Excessive vibration – 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. Operator’s Manual 13 - 17...
Page 222 If an abnormality is found on the needle-guided bracket, immediately stop using it and contact MINDRAY Customer Service Department or sales representative. •...
Page 223 13 Probes and Biopsy • When performing biopsy procedures, use only sterile ultrasound gel that is certified to be safe. And manage the ultrasound gel properly to ensure that it does not become a source of infection. • When performing the operation concerning biopsy, wear sterile gloves. •...
Page 224 13 Probes and Biopsy 13.2.1 Needle-guided Brackets Available Some of the probes have corresponding needle-guided brackets for biopsy. The available probes and the corresponding needle-guided brackets are listed as follows: Table 13-3 Needle-guided Brackets Available Needle-guided Bracket Probe model Biopsy angle/ Applicable Biopsy Model depth...
Page 225 (optional accessory) and a biopsy needle (provided by the user). Be sure to perform inspections before and after use of the needle-guided bracket. If an abnormality is found on the needle-guided bracket, immediately stop using it and contact MINDRAY Customer Service Department or sales representative. •...
Page 226 13 Probes and Biopsy NGB-007 Metal/needle detachable needle-guided bracket Support for needle-guided bracket Tab and groove for the needle-guided bracket Angle-adjusting base Angle shift sign Angle pinch nut Angle block Guiding block Guiding block specification Needle guide hole Needle-guided bracket pinch nut Perform the following procedure: Install the needle-guided bracket: Put on the sterile probe sheath.
Page 227 13 Probes and Biopsy Adjust the needle angle to the proper shift as required: Loosen the angle pinch nut. Adjust the angle block to the desired level. Tighten the angle pinch nut. Install the guiding block Select a suitable guiding block and push it into the groove above the angle block, then clamp it tightly Screw the block's nut to secure the block.
Page 228 13 Probes and Biopsy Remove the needle-guided bracket: Unscrew the Needle-guided bracket pinch nut, and remove the needle-guided bracket from the probe. Separate the probe and the needle-guided bracket. NGB-007 Plastic/needle detachable needle-guided bracket Support of needle-guided bracket Angle block Guiding block Groove and tab of the needle-guided bracket Specification of guiding block...
Page 229 13 Probes and Biopsy Check manually to confirm that the needle-guided bracket is securely installed on the probe. Install the guiding block: Select a proper guiding block and push it into the groove above the angle block, and clamp it tightly. Insert a biopsy needle with the same specification as that of the guiding block into the hole of the guiding block.
Page 230 13 Probes and Biopsy Separate the residual part of the needle-guide bracket and the probe from the needle. Remove the needle-guided bracket: Remove the support of needle-guided bracket from the probe. NGB-010 Metal-needle detachable needle-guided bracket Guiding block Guiding hole of the biopsy needle Support of needle-guided bracket Knob of fixing needle-guided bracket Grooves of the needle-guided bracket...
Page 231 13 Probes and Biopsy Hold the probe by one hand, select the proper needle-guided bracket, and hold it with the other hand. Match the groove of the bracket with the tab of the probe. Amount the bracket onto the probe. Hold the probe by one hand, select proper needle-guided bracket, and hold it with the other hand, and align the grooves of the needle-guided bracket with the tabs of the probe, then push the needle-guided bracket forward, making the grooves of the needle-guided...
Page 232 13 Probes and Biopsy Remove the guiding block slightly along the direction of the needle’s tail, and separate the residual part of the needle-guide bracket and the probe from the needle. Remove the support of needle-guided bracket from the probe. NGB-011 Metal-needle undetachable needle-guided bracket Clamp Locating groove...
Page 233 13 Probes and Biopsy NGB-016 Metal-needle detachable needle-guided bracket 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.
Page 234 13 Probes and Biopsy Loosen the angle pinch nut. Adjust the angle block to the desired level. Tighten the angle pinch nut. Install the guiding block: Select a suitable guiding block and push it into the groove above the angle block Screw the block's nut to secure the block.
Page 235 13 Probes and Biopsy NGB-018 Metal-needle detachable needle-guided bracket 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.
Page 236 13 Probes and Biopsy Install the guiding block: Select a suitable guiding block and push it into the groove above the angle block Screw the block's nut to secure the block. Insert a biopsy needle with the same specification as that of the guiding block into the guiding block hole.
Page 237 13 Probes and Biopsy V-shaped cover Angle adjusting base Angle shift sign Angle pinch nut Angle block Pinch nut Perform the following procedure: Install the needle-guided bracket: Put on the sterile probe sheath. Hold the probe by one hand, select the proper needle-guided bracket, and hold it with the other hand.
Page 238 13 Probes and Biopsy Pull the lock pin and open up the V-shaped cover to expose the needle. Separate the 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.
Page 239 13 Probes and Biopsy Put on the sterile probe sheath. Select the needle-guided bracket, and match the groove with the tab of the probe. Mount the bracket onto the probe. Rotate the retaining nut to fix the bracket and the probe. Adjust the needle angle to the proper shift as required: Loosen the angle pinch nut.
Page 240 13 Probes and Biopsy Hold the probe, 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. Release the needle from the bracket: Hold the probe.
Page 241 13 Probes and Biopsy Remove the needle-guided bracket: Rotate the clamping nuts of the needle guided-bracket on right and left side (following the direction of the arrow). The needle guided-bracket is separate from the probe. Hold the probe and take out the bracket. NGB-025 Metal-needle undetachable needle-guided bracket Pinch nut Intra-cavity probe...
Page 242 13 Probes and Biopsy Open the clamp. Insert the front clamp to the front groove, and align front clamp with front groove. Push the biopsy forward (arrow’s direction) until the locating pole inserting into the location hole. Turn the lower clamp against the intra-cavity probe. Tighten the nut to lock the biopsy (arrow’s direction) Remove the needle-guided bracket: Hold the prober in the left hand;...
Page 243 13 Probes and Biopsy NGB-034 Metal-needle detachable needle-guided bracket 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.
Page 244 13 Probes and Biopsy Adjust the needle angle to the proper shift as required: Loosen the angle pinch nut. 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. Pull the lock pin and close the V-shaped cover to fix the lock pin in the groove of the needle type adjusting base, so as to install the needle into the guiding hole.
Page 245 13 Probes and Biopsy NGB-036 Metal-needle detachable needle-guided bracket Angle locking nut Angle adjusting block Angle marker Angle adjusting base Groove Slot Right, left retaining nut Right, left clamp Perform the following procedure: Install the needle-guided bracket: Put on the sterile probe sheath. Select the needle-guided bracket, and match the groove with the tab of the probe.
Page 246 13 Probes and Biopsy Adjust the needle angle to the proper shift as required: Loosen the angle pinch nut. Adjust the angle block to the desired level. Tighten the angle pinch nut. Insert the biopsy needle: Hold the probe. Press the biopsy needle to separate needle guided V-shaped block from pressure position of the needle Put the needle into the needle guided-bracket, and the needle leans to V-shaped block.
Page 247 13 Probes and Biopsy Release the needle from the bracket: Hold the probe. Press the biopsy needle to separate the needle from pressure position of the needle. Separate the bracket and the probe from the needle. Remove the needle-guided bracket: Rotate the clamping nuts of the needle guided-bracket on right and left side (following the direction of the arrow).
Page 248 13 Probes and Biopsy Hold the probe and take out the bracket. NGB-043 Metal-needle detachable needle-guided bracket Locking nut of left and right clamps Groove Guide frame Guide block hole Clamps Perform the following procedure: Install the needle-guided bracket: Put on the sterile probe sheath. Hold the probe in one hand, select the correct needle-guided bracket and hold it with the other hand.
Page 249 13 Probes and Biopsy Rotate the locking nut in the direction of the arrow shown on the figure to separate the bracket from the probe. Hold the probe and take out the bracket. NGB-044 Metal-needle detachable needle-guided bracket Right clamp Groove Guiding block fixing frame Locking nut of left and right clamps...
Page 250 13 Probes and Biopsy Put on the sterile probe sheath. Hold the probe in one hand, select the correct needle-guided bracket and hold it with the other hand. Match the grooves of the needle-guided bracket to the tabs of the probe. Mount the bracket onto the probe, and rotate the locking nut to fix the bracket.
Page 251 13 Probes and Biopsy Insert a biopsy needle with the same specification as that of the guiding block into the guiding block hole Remove the needle-guided bracket: Hold the probe and remove the needle. Loosen the guiding block nut, and remove it from the guiding block fixing frame. Rotate the clamping nuts of the needle guided-bracket.
Page 252 13 Probes and Biopsy NGB-054 metal-needle detachable needle-guided bracket Angle adjusting block Angle locking nut Right clamp of the bracket Left clamp of the bracket Needle clamping cover Needle-shaped adjusting nut Locking nuts of the guided bracket at the right and left sides 13 - 48 Operator’s Manual...
Page 253 13 Probes and Biopsy Torsion spring of the needle pressure cover Biopsy needle pressure position Angle adjusting base Perform the following procedure: Install the needle-guided bracket: Put on the sterile transducer sheath. Hold the transducer in one hand, select the correct needle-guided bracket and hold it with the other hand.
Page 254 13 Probes and Biopsy Hold the transducer, and release the pressure position of the needle. Adjust the needle- shaped adjusting nut manually (following the direction of the arrow). The needle moves smoothly at the vertical direction due to its gravity. Release the needle from the bracket: Hold the probe.
Page 255 13 Probes and Biopsy Hold the transducer. Press the biopsy needle pressure position to separate the biopsy needle from the pressure position. Separate the bracket and the transducer from the needle. Rotate the locking nuts of the needle guided-bracket at the right and left sides (following the direction of the arrow).
Page 256 13 Probes and Biopsy Name Description Knob of fixing the Used for fixing the guiding block. guiding block 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.
Page 257 13 Probes and Biopsy Turn on the knob of fixing guiding block and remove the guiding block from the hole of installing guiding block. Turn on the knob of fixing needle-guided bracket and remove the needle-guided bracket. NGB-058 <1> <2> <3>...
Page 258 13 Probes and Biopsy Hold the probe. Press the biopsy needle pressure position to separate it from the needle guided 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).
Page 259 13 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. 13.2.3 Verifying the Biopsy Guide Line WARNING •...
Page 260 13 Probes and Biopsy – Save the verified settings: After the position and angle of the guide line are adjusted, tap [Save] and the system saves the current guide line settings. If biopsy is entered again, the displayed Position and Angle are the verified value. –...
Page 261 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.
Page 262 13 Probes and Biopsy Inspect the needle-guided bracket. If visible dirt still exists, repeat the preceding steps to wash the bracket until it is all clean. Sterilization with a sterilant Perform the following procedure: Wear a pair of gloves to prevent infection. Clean thoroughly in accordance with the cleaning procedure before sterilization.
Page 263 Between examinations, keep the needle-guided bracket in a sterile environment. • If the needle-guided bracket is sent to your MINDRAY representative for repair, be sure to disinfect or sterilize it and keep it in the carrying case to prevent infection.
Page 264 13 Probes and Biopsy needle mark guides the needle path on the ultrasound image. Based on the magnetic induction technology, the eSpacial Navi function aids in and enhance the ultrasound needle guidance. WARNING • Ultrasound images should be referenced during the whole process of needle guidance.
Page 265 13 Probes and Biopsy Appears when the insertion angle of a needle relative to the skin surface exceeds 60° to notify users to adjust the angle. In Plane Needle Guidance GUI Needle position in the ultrasound plane Needle tip position in the ultrasound plane Needle guidance trajectory Scale of guideline (5 mm/scale) Out of Plane Needle Guidance GUI...
Page 266 13 Probes and Biopsy Scale of guideline (5mm/scale) 13.4.2 Preset eSpacial Navi Needle Menu Enter the Needle menu, and controls are as shown in Table 13-6. Table 13-6 eSpacial Navi Needle settings Item Description Needle Select the desired needle from the drop-down list. You can set the most frequently used needle to a favorite one.
Page 267 13 Probes and Biopsy Introduce a needle into the cap, and ensure that the needle tip contacts the bottom of the needle cap. If the needle cap associated with the needle does not meet the requirements, you are recommended to use BBraunSterican <35 mm needles cap or B&D Microlance <35 mm needles cap.
Page 268 13 Probes and Biopsy • No cleaning and disinfecting may result in the magnetizer becoming a source of infection. • Please follow the disinfectant manufacturer's manual for performing cleaning and disinfection, including preparing sterile water and cleaning and disinfection time. NOTE: •...
Page 269 Disinfecting by Immersion Perform the following procedure: Wear sterile gloves to prevent infection. Clean the magnetizer before disinfecting it. MINDRAY recommends the compatible solutions to disinfect the magnetizer. – Refer to the instructions provided by the chemical manufacturer concerning concentration of the disinfectant solution, method of disinfection and dilution and cautions during use.
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Page 271 DVR Recording NOTE: Strictly observe the procedures described here to perform the recording and replaying operations; otherwise it may result in data loss or system malfunction. The system provides built-in DVR recording function. You can use the DVR to record and replay videos and audios that can be stored in DVD disc or hard disc.
Page 272 14 DVR Recording Select the destination and the target file, tap [Send] to send the file to the selected path. During sending progress, the icon displays as 14.3 DVR Video Replaying You can replay the video and audio record. 14.3.1 Replay on PC Connect the USB disk or optical disk with the file to the PC, and open the file directly.
Page 273 The responsibility for maintenance and management of the product after delivery resides with the customer who has purchased the product. If you have any questions, please contact Mindray Customer Service Department or sales representative. WARNING •...
Page 274 15 System Maintenance Cleaning probes 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.
Page 275 15 System Maintenance Cleaning the dust-proof cover CAUTION Please clean all the system’s dustproof covers periodically (once per month). Failure to do so may result in system damage. Cleaning times can be increased when the system is used in the open air or somewhere more dusty. Perform the following procedure: Press the clip of the dust-proof cover and unfold it outwards (shown in the figure below).
Page 276 15.2 Troubleshooting If any persistent system malfunction is experienced, e.g., an onscreen error message, blank imaging screen, absent menus, see the table below. If the failure cannot be resolved, contact the Mindray Customer Service Department or a sales representative. Failure...
Page 277 15 System Maintenance Failure Cause Measure The image quality is The exam mode is incorrect. Select an appropriate exam degraded mode. The image parameter settings Adjust the image parameters. are incorrect. The image presets are Reset the factory default inappropriate. presets.
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Page 279 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 •...
Page 280 A Wireless LAN Use the Wireless feature Perform the following procedure: Tap the icon in the System icons area, and open the wireless network manager. Tap to select the target network, tap [Connect] to connect to the network. When connecting an encrypted network, enter the password in the box first. You can select to hide password characters or not.
Page 281 A Wireless LAN EAP Network For setting EAP network, contact Mindray Customer Service Department or the sales representatives. Specifications Table A-1 Wireless specification and technology Item Specifications Standards IEEE 802.11 b/g/n Modulation mode 802.11b: DSSS 802.11g/n: OFDM Operating frequency 2.412-2.472 GHz, 2.484 GHz...
Page 282 AP. • Check for IP address conflict. If yes, set the IP address correctly. • Check if Mindray recommended wireless AP is used. If not, verify the AP effective transmission rate meets the throughput requirements of the connected devices.
Page 283 (required in special installation environment), and steel nails (required in special installation environment) Item list: Check if the items are complete according to the installation method. If not, please contact Mindray Customer Service Department or sales representative. Name Quantity Remarks...
Page 284 B Wireless Charging • A pad is required in two ways: using expansion rubber stopper or steel screw. • Dimensions of the pad: Length >300 mm, width >300 mm, and height greater than d (skirting line distance) • Material: Plastic or wood is recommended Figure B-1 Wall Type No skirting wall Step skirting wall...
Page 285 B Wireless Charging Wall Tapping screw Install the pad 120 ~150 mm above the ground and make marks on the wall at positions corresponding to the four via-holes of the pad. Use a percussion drill to drill holes in 6 mm diameter and 30 mm depth at the marked positions on the wall.
Page 286 B Wireless Charging Fix the two M3X6 cross recessed countersunk head screws in the position shown in the figure. Remove the release paper from the foot pad and attach the foot pad to the position as shown in the figure. B - 4 Operator’s Manual...
Page 287 B Wireless Charging Clean the floor and ensure it is clean, flat and smooth. Observe the wall. If the pad is required, please see “B.1.2 Installing the Pad”. Select an appropriate cushion pad according to the gap between the Air Station and the wall (or the pad), and attach it to the back of the Air Station, as shown in the following figure.
Page 288 B Wireless Charging Connect the power cord to the external power supply and use a Velcro to organize the power cord. Wall Mounting Method If wall mounting installation is selected and the pad is installed, the operation steps are as follows: Mark a straight line at the pad 15 cm above the ground with a marking pen.
Page 289 B Wireless Charging Install the transmitting module onto the wall mounting bracket, as shown in the following figure. Connect the power cord to the external power supply and use a Velcro to organize the power cord. If wall mounting installation is selected and the pad does not need to be installed, the operation steps are as follows: Mark a straight line at the wall 15 cm above the ground with a marking pen.
Page 290 B Wireless Charging Use a marking pen to mark the position of the mounting hole on the wall mounting bracket. Use a percussion drill to drill holes in the four marked positions on the wall, with a diameter of 6 mm and a depth of 30 mm. Hit the expansion rubber stopper into the drilled hole with a hammer.
Page 291 B Wireless Charging Connect the power cord to the external power supply and use a Velcro to organize the power cord. Battery Charged by the Air Station NOTE: • Before using the Air Station, check the surface of the Air Station and the surface of the Air Charging Module of the device.
Page 292 "zizi". Push the device to the correct position for charging. • Dark blue indicator on: Hardware error occurred in the Air Station. Please charge the ultrasound device again. If the air station malfunction still exists, please contact Mindray Customer Service Department or sales representative. •...
Page 293 iScanHelper By providing the referential information, such as, the ultrasonic image, the anatomic graphic, scanning pictures/other scanning tips or diagnosis comments, the system helps the doctors to operate the scanning by iScanHelper. Furthermore, it is a good platform for the self-learning and training of ultrasound scanning technique for doctors.
Page 294 C iScanHelper Basic Screen and Operation C.3.1 Help Information Area Ultrasonic image, anatomic graphic, scanning picture and scanning tips are provided in the “iScanHelper” menu. Anatomic Ultrasonic graphic image Scanning Scanning picture tips • Ultrasonic image It is used to compare with images scanned by the operator. •...
Page 295 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: and select [Setup] > [System] > [iVision] to enter the iVision setting screen. Add the contents to be played and select demo mode.
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Page 297 After the input command is recognized, the system automatically performs the corresponding operations. Vocal command Operation Hello Mindray Turn On Audio Control Bye Mindray Turn Off Audio Control...
Page 298 E List of Vocal Commands Vocal command Operation Zoom Out Zoom Out Image Smart Track Turn on/Turn off Smart Track Mode Sound Volume Up Turn Sound Volume Up Sound Volume Down Turn Sound Volume Down Angle More Angle More One Angle Less Angle Less One Left Steer...
Page 299 E List of Vocal Commands Vocal command Operation Needle Visualized Switch Exam Mode to Needle Visualized Optimization Optimization Open Patient Info Open Patient Info Dialog Dialog Close Patient Info Close Patient Info Dialog Dialog Open Probe Dialog Open Probe Dialog Close Probe Dialog Close Probe Dialog Open Review Dialog...
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Page 301 Electrical Safety Inspection The following electrical safety tests are recommended as part of a comprehensive preventive maintenance program. They are a proven means of detecting abnormalities that, if undetected, could prove dangerous to either the patient or the operator. Additional tests may be required according to local regulations.
Page 302 F Electrical Safety Inspection Device Enclosure and Accessories F.2.1 Visual Inspection Test Item Acceptance Criteria The enclosure and No physical damage to the enclosure and accessories. accessories No physical damage to meters, switches, connectors, etc. No residue of fluid spillage (e.g., water, coffee, chemicals, etc.). No loose or missing parts (e.g., knobs, dials, terminals, etc.).
Page 303 F Electrical Safety Inspection • normal polarity with open neutral (Single Fault Condition); • reverse polarity with open neutral (Single Fault Condition). LIMITS • For ES 60601-1: – 300 μA in Normal Condition. – 1000 μA in Single Fault Condition. •...
Page 304 F Electrical Safety Inspection Mains on Applied Part Leakage The Mains on Applied Part test applies a test voltage, which is 110% of the mains voltage using a limiting resistance, to selected applied part terminals. Current measurements are then taken between the selected applied part and earth.
Page 305 EMC Guidance and Manufacturer’s Declaration The system complies with the EMC standard IEC 60601-1-2: 2014+A1:2020 . Intended Environments: Professional healthcare environment ( except for near active HF SURGICAL EQUIPMENT and the RF shielded room of an ME SYSTEM for magnetic resonance imaging ) WARNING •...
Page 306 G EMC Guidance and Manufacturer’s Declaration diagnosis), the user should immediately take mitigation measures, such as redirecting, repositioning or shielding the RF transmitter. • This equipment has been tested and found to comply with the limits for a Class B digital device, pursuant to part 15 of the FCC Rules. These limits are designed to provide reasonable protection against harmful interference in a residential installation.
Page 307 Date/time information. Table G-1 GUIDANCE AND MINDRAY DECLARATION-ELECTROMAGNETIC EMISSIONS The system configured with wireless charging module is intended for use in the electromagnetic environment specified below. The customer or the user of system should assure that it is used in such an environment.
Page 308 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.
Page 309 G EMC Guidance and Manufacturer’s Declaration Table G-4 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.
Page 310 Over the frequency ranges 150 kHz to 80 MHz, field strengths should be less than 3V/m. Table G-5 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.
Page 311 G EMC Guidance and Manufacturer’s Declaration Table G-6 Recommended separation distances between portable and mobile RF communications equipment and system The system is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The customer or the user of system can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and the system as recommended below, according to the maximum output power of the communications equipment.
Page 312 G EMC Guidance and Manufacturer’s Declaration Table G-7 RECOMMENDED SEPARATION DISTANCES BETWEEN PORTABLE AND MOBILE RF COMMUNICATION DEVICE AND THE SYSTEM The system is intended for use in an electromagnetic environment in which radiated RF disturbance are controlled. The customer or the user of system can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communication equipment (transmitters) and system as recommended below, according to the maximum output power of the communication equipment.
Page 313 G EMC Guidance and Manufacturer’s Declaration Radio Regulatory Compliance RF parameter Features 2.4GHz 5GHz Frequency Rage 2.412 - 2.472 GHz 5.180 - 5.825 GHz Modulation DSSS and OFDM OFDM Output Power ≤20dBm NOTE: Keep a distance of at least 20cm away from the monitor when Wi-Fi function is in use. Operator’s Manual G - 9...
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Page 315 Acoustic Output This section of the operator’s manual applies to the overall system including the main unit, probes, accessories and peripherals. This section contains important safety information for operators of the device, pertaining to acoustic output and how to control patient exposure through use of the ALARA (as low as reasonably achievable) principle.
Page 316 H 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 H.4.1 Basic Knowledge of MI and TI Mechanical Bioeffect and Thermal Bioeffect The relationship of various ultrasound output parameters (frequency, acoustic pressure and intensity, etc.) to bioeffects is not fully understood presently.
Page 317 H Acoustic Output Although the output power is automatically controlled for the selected applications, high TI values should be kept to a minimum or avoided in obstetric applications. WFUMB (World Federation for Ultrasound in Medicine and Biology) guidelines: state that temperature increase of 4 degree C for 5 min or more should be considered as potentially hazardous to embryonic and fetal tissue.
Page 318 H Acoustic Output the Setup menu). In the factory default settings, the Acoustic Output is limited below 100%. Following the ALARA restriction, you are allowed to increase the acoustic power under FDA 510 (k) Guidance-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...
Page 319 H Acoustic Output Where I is the attenuated intensity, I is the intensity measured in a water tank (at distance atten water z), fc is the center frequency of the ultrasound wave (as measured in water), and z is the distance from the probe.
Page 320 H Acoustic Output • Marketing Clearance of Diagnostic Ultrasound Systems and Transducers, June 27, 2019. Center for Devices and Radiological Health. • Medical electrical equipment-Part 2-37: Particular requirements for the basic safety and essential performance of ultrasonic medical diagnostic and monitoring equipment issued by IEC in 2015 •...
Page 321 Probe Dimensions Model Length (mm) Width (mm) Height (mm) C5-1s 111.9 76.7 P10-4s 82.5 28.5 21.2 P7-3Ts 1500 59.6 59.1 L14-6Ns 101.6 25.7 C11-3s 96.4 32.8 SP5-1s 102.6 38.2 30.4 C6-2Gs 117.4 39.4 L16-4Hs 41.8 34.6 11.5 P8-3Ts 67.8 L20-5s 24.1 SC6-1s 111.9...
Page 322 I Probe Dimensions Model Length (mm) Width (mm) Height (mm) L24-6RCs 107.7 24.8 L24-6Hs 136.6 35.3 22.4 SP5-1Ns 102.6 38.1 30.4 SC5-1Ns 111.9 76.7 51.4 31.6 ELC13-4s 378.7 Length Height (Max.) Width (Max.) I - 2 Operator’s Manual...
Page 323 Software and Hardware Specification Operating Environment Hardware Configuration CPU: i3-6100U Hard disk: 256GB Monitor: 23.8 inch Software Environment Linux, 64bit Network Condition Cable network: 10M/100M/1000M adaption Wireless network: • Protocol compatible with IEEE 802.11 ac/a/b/g/n standard • Working frequency: 2.4G/5G •...
Page 324 J Software and Hardware Specification Item Description Version/Kernel Supplier Operating Version Environment Openconnect VPN Client 9.01 infradead Linux QT Framework 5.15.8 The Qt Company Linux Xerces-C++ XML Parser 3.2.3 apache.org Linux OpenLDAP Platform- 2.6.2 OpenLDAP Linux independent protocol libpng Image 1.6.37 libpng Linux...
Page 325 J Software and Hardware Specification Electronic Interface Specification Network port TCP/IP protocol bottom layer. DICOM/HL7 protocol application layer. RJ45 interface, supporting wired network 10 M/100 M/1000 M, and complied with technical standard IEEE802.3. NTP/SNTP Calibration protocol of TCP/IP. The intended information flow is from the ultrasound system in the client site to the workstation server.
Page 326 J Software and Hardware Specification Interoperability External Purpose Users Type of Standards Network Data Interact/ Interface data used Type transmis Communicati interface exchang sion on Content method Dicom/ Communica qualified Transmit Comply with Wired/ DICOM Image data and tion with and trained the standard wireless...
Page 327 J Software and Hardware Specification External Purpose Users Type of Standards Network Data Interact/ Interface data used Type transmis Communicati interface exchang sion on Content method Bedside qualified Transmit Wired/ Bedside patient data Communicatio Device and trained protocol wireless Device n with Bedside healthcare...
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Page 329 Indications for use Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: Clinical Application Mode of Operation General(Track 1 Specific (Track 1 & 3) Color Power Combine Other (Specify) Only) Doppler Doppler (specify Ophthalmic Ophthalmic Note 1 Fetal...
Page 330 K Indications for use Transducer: C5-1s Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: Clinical Application Mode of Operation General(Track 1 Specific (Track 1 & 3) Color Power Combine Other (Specify) Only) Doppler Doppler (specify Ophthalmic...
Page 331 K Indications for use Transducer: C4-1s Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: Clinical Application Mode of Operation General(Track 1 Specific (Track 1 & 3) Color Power Combine Other (Specify) Only) Doppler Doppler (specify Ophthalmic...
Page 332 K Indications for use Transducer: SC6-1s Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: Clinical Application Mode of Operation General(Track 1 Specific (Track 1 & 3) Color Power Combine Other (Specify) Only) Doppler Doppler (specify Ophthalmic...
Page 333 K Indications for use Transducer: C11-3s Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: Clinical Application Mode of Operation General(Track 1 Specific (Track 1 & 3) Color Power Combine Other (Specify) Only) Doppler Doppler (specify Ophthalmic...
Page 334 K Indications for use Transducer: C9-3Ts Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: Clinical Application Mode of Operation General(Track 1 Specific (Track 1 & 3) Color Power Combine Other (Specify) Only) Doppler Doppler (specify Ophthalmic...
Page 335 K Indications for use Transducer: C6-2Gs Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: Clinical Application Mode of Operation General(Track 1 Specific (Track 1 & 3) Color Power Combine Other (Specify) Only) Doppler Doppler (specify Ophthalmic...
Page 336 K Indications for use Transducer: SC10-2RCs Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: Clinical Application Mode of Operation General(Track 1 Specific (Track 1 & 3) Color Power Combine Other (Specify) Only) Doppler Doppler (specify Ophthalmic...
Page 337 K Indications for use Transducer: SC5-1Ns Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: Clinical Application Mode of Operation General(Track 1 Specific (Track 1 & 3) Color Power Combine Other (Specify) Only) Doppler Doppler (specify Ophthalmic...
Page 338 K Indications for use Transducer: L14-6s Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: Clinical Application Mode of Operation General(Track 1 Specific (Track 1 & 3) Color Power Combine Other (Specify) Only) Doppler Doppler (specify Ophthalmic...
Page 339 K Indications for use Transducer: L14-5sp Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: Clinical Application Mode of Operation General(Track 1 Specific (Track 1 & 3) Color Power Combine Other (Specify) Only) Doppler Doppler (specify Ophthalmic...
Page 340 K Indications for use Transducer: L14-6Ns Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: Clinical Application Mode of Operation General(Track 1 Specific (Track 1 & 3) Color Power Combine Other (Specify) Only) Doppler Doppler (specify Ophthalmic...
Page 341 K Indications for use Transducer: L9-3s Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: Clinical Application Mode of Operation General(Track 1 Specific (Track 1 & 3) Color Power Combine Other (Specify) Only) Doppler Doppler (specify Ophthalmic...
Page 342 K Indications for use Transducer: L20-5s Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: Clinical Application Mode of Operation General(Track 1 Specific (Track 1 & 3) Color Power Combine Other (Specify) Only) Doppler Doppler (specify Ophthalmic...
Page 343 K Indications for use Transducer: L16-4Hs Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: Clinical Application Mode of Operation General(Track 1 Specific (Track 1 & 3) Color Power Combine Other (Specify) Only) Doppler Doppler (specify Ophthalmic...
Page 344 K Indications for use Transducer: 7LT4s Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: Clinical Application Mode of Operation General(Track 1 Specific (Track 1 & 3) Color Power Combine Other (Specify) Only) Doppler Doppler (specify Ophthalmic...
Page 345 K Indications for use Transducer: L12-3RCs Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: Clinical Application Mode of Operation General(Track 1 Specific (Track 1 & 3) Color Power Combine Other (Specify) Only) Doppler Doppler (specify Ophthalmic...
Page 346 K Indications for use Transducer: L11-3VNs Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: Clinical Application Mode of Operation General(Track 1 Specific (Track 1 & 3) Color Power Combine Other (Specify) Only) Doppler Doppler (specify Ophthalmic...
Page 347 K Indications for use Transducer: L12-3VNs Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: Clinical Application Mode of Operation General(Track 1 Specific (Track 1 & 3) Color Power Combine Other (Specify) Only) Doppler Doppler (specify Ophthalmic...
Page 348 K Indications for use Transducer: L14-3Ws Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: Clinical Application Mode of Operation General(Track 1 Specific (Track 1 & 3) Color Power Combine Other (Specify) Only) Doppler Doppler (specify Ophthalmic...
Page 349 K Indications for use Transducer: L15-3RCs Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: Clinical Application Mode of Operation General(Track 1 Specific (Track 1 & 3) Color Power Combine Other (Specify) Only) Doppler Doppler (specify Ophthalmic...
Page 350 K Indications for use Transducer: L16-3RCs Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: Clinical Application Mode of Operation General(Track 1 Specific (Track 1 & 3) Color Power Combine Other (Specify) Only) Doppler Doppler (specify Ophthalmic...
Page 351 K Indications for use Transducer: L24-6RCs Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: Clinical Application Mode of Operation General(Track 1 Specific (Track 1 & 3) Color Power Combine Other (Specify) Only) Doppler Doppler (specify Ophthalmic...
Page 352 K Indications for use Transducer: L24-6Hs Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: Clinical Application Mode of Operation General(Track 1 Specific (Track 1 & 3) Color Power Combine Other (Specify) Only) Doppler Doppler (specify Ophthalmic...
Page 353 K Indications for use Transducer: V11-3Hs Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: Clinical Application Mode of Operation General(Track 1 Specific (Track 1 & 3) Color Power Combine Other (Specify) Only) Doppler Doppler (specify Ophthalmic...
Page 354 K Indications for use Transducer: ELC13-4s Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: Clinical Application Mode of Operation General(Track 1 Specific (Track 1 & 3) Color Power Combine Other Only) Doppler Doppler (Specify) (specify Ophthalmic...
Page 355 K Indications for use Transducer: P4-2s Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: Clinical Application Mode of Operation General(Track 1 Specific (Track 1 & 3) Color Power Combine Other (Specify) Only) Doppler Doppler (specify Ophthalmic...
Page 356 K Indications for use Transducer: SP5-1s Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: Clinical Application Mode of Operation General(Track 1 Specific (Track 1 & 3) Color Power Combine Other (Specify) Only) Doppler Doppler (specify Ophthalmic...
Page 357 K Indications for use Transducer: P10-4s Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: Clinical Application Mode of Operation General(Track 1 Specific (Track 1 & 3) Color Power Combine Other (Specify) Only) Doppler Doppler (specify Ophthalmic...
Page 358 K Indications for use Transducer: P8-2s Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: Clinical Application Mode of Operation General(Track 1 Specific (Track 1 & 3) Color Power Combine Other (Specify) Only) Doppler Doppler (specify Ophthalmic...
Page 359 K Indications for use Transducer: Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: Clinical Application Mode of Operation General(Track 1 Specific (Track 1 & 3) Color Power Combine Other (Specify) Only) Doppler Doppler (specify Ophthalmic Ophthalmic...
Page 360 K Indications for use Transducer: i3PA Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: Clinical Application Mode of Operation General(Track 1 Specific (Track 1 & 3) Color Power Combine Other (Specify) Only) Doppler Doppler (specify Ophthalmic...
Page 361 K Indications for use Transducer: SP5-1Ns Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: Clinical Application Mode of Operation General(Track 1 Specific (Track 1 & 3) Color Power Combine Other (Specify) Only) Doppler Doppler (specify Ophthalmic...
Page 362 K Indications for use Transducer: i5M linear Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: Clinical Application Mode of Operation General(Track 1 Specific (Track 1 & 3) Color Power Combine Other (Specify) Only) Doppler Doppler (specify...
Page 363 K Indications for use Transducer: i5M convex Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: Clinical Application Mode of Operation General(Track 1 Specific (Track 1 & 3) Color Power Combine Other (Specify) Only) Doppler Doppler (specify...
Page 364 K Indications for use Transducer: P7-3Ts Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: Clinical Application Mode of Operation General(Track 1 Specific (Track 1 & 3) Color Power Combine Other (Specify) Only) Doppler Doppler (specify Ophthalmic...
Page 365 K Indications for use Transducer: P8-3Ts Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: Clinical Application Mode of Operation General(Track 1 Specific (Track 1 & 3) Color Power Combine Other (Specify) Only) Doppler Doppler (specify Ophthalmic...
Page 366 K Indications for use Transducer: P8-2Ts Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: Clinical Application Mode of Operation General(Track 1 Specific (Track 1 & 3) Color Power Combine Other (Specify) Only) Doppler Doppler (specify Ophthalmic...
Page 367 K Indications for use Transducer: LAP13-4Cs Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: Clinical Application Mode of Operation General(Track 1 Specific (Track 1 & 3) Color Power Combine Other (Specify) Only) Doppler Doppler (specify Ophthalmic...
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Page 370 P/N: 046-023006-01 (2.0)

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