Page 1 TE7/TE5/TE7 Max/TE5 Max/TE9 Diagnostic Ultrasound System Operator’s Manual [Basic Volume]...
Page 3: Intellectual Property Statement
Contents of this manual are subject to change without prior notice. All information contained in this manual is believed to be correct. Mindray shall not be liable for errors contained herein or for incidental or consequential damages in connection with the furnishing, performance, or use of this manual.
Page 4: Warranty
FITNESS FOR ANY PARTICULAR PURPOSE. Exemptions Mindray's obligation or liability under this warranty does not include any transportation or other charges or liability for direct, indirect or consequential damages or delay resulting from the improper use or application of the product or the use of parts or accessories not approved by Mindray or repairs by people other than Mindray authorized personnel.
Page 5: About This Manual
• Important data must be backed up on external memory media. • Mindray shall not be liable for loss of data stored in the memory of this system caused by operator error or accidents. • This manual contains warnings regarding foreseeable potential dangers, but you shall also be continuously alert to dangers other than those indicated.
Page 6: Hardcopy Manuals
Signal word Meaning Important information that helps you to use the system more effectively. Hardcopy Manuals • Operator’s Manual [Basic Volume] Describes the basic functions and operations of the system, safety precautions, exam modes, imaging modes, preset, maintenance and acoustic output, etc. •...
Page 7: Table Of Contents
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 8 Contents 2.10.9 Splitting Display ....................2 - 18 2.10.10 Image Magnification ..................2 - 18 2.10.11 iZoom (Full Screen View) ................2 - 19 2.10.12 Freeze/Unfreeze the Image................2 - 19 2.10.13 Imaging Mode Switching When Frozen ............2 - 20 2.11 Cine Review .......................
Page 9 Contents 4.1.14 Security ......................4 - 13 4.1.15 System Information ..................4 - 15 4.2 Exam Related Preset ....................4 - 15 4.2.1 Exam Mode Preset .................... 4 - 15 4.2.2 Measurement Preset ..................4 - 15 4.2.3 Body Mark/Comment Preset ................4 - 17 4.2.4 iWorks Preset ....................
Page 10 Contents 6.9.3 Evaluate image quality ..................6 - 14 6.9.4 Cine Review ....................... 6 - 15 6.10 Smart B-line ....................... 6 - 15 6.10.1 Basic Procedures for Smart B-line ..............6 - 15 6.10.2 Overview ......................6 - 16 6.11 Smart VTI ........................6 - 17 6.12 Smart IVC ........................
Page 11 Contents 9.3.1 Adding Body Mark ....................9 - 5 9.3.2 Moving Body Marks ................... 9 - 5 9.3.3 Deleting Body Marks ..................9 - 5 9.4 Voice Comments ......................9 - 5 9.4.1 Voice Comment Panel ..................9 - 5 9.4.2 Adding Voice Comments ..................
Page 12 Contents 11.7.2 Media review ....................11 - 5 11.7.3 Data Restore ..................... 11 - 5 11.8 Showcase Recording ....................11 - 5 11.9 Structured Report ....................... 11 - 5 11.9.1 Send structured reports for storage ..............11 - 6 11.9.2 Back up structured report ................. 11 - 6 12 Probes and Biopsy ...................
Page 13 Contents A Barcode Reader ....................A - 1 A.1 1-D Barcode Reader ..................... A - 1 A.1.1 Setting Up the Reader ..................A - 2 A.1.2 Setting ........................ A - 2 A.1.3 Scanning in Hand-Held Mode ................A - 5 A.1.4 Scanning in Hands-Free Mode ................
Page 14 Contents H.2 Prudent Use Statement ....................H - 1 H.3 ALARA Principle (As Low As Reasonably Achievable) ..........H - 1 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 ....................
Page 15: Important Information
• 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 16 • 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 17 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 18 1 Important Information • Except accessories that have been stated as sterile, the system and its accessories are not disinfected or sterilized prior to delivery. The operator is responsible for the cleaning and disinfection of probes and sterilization of biopsy brackets according to the manuals, prior to the use. All items must be thoroughly processed to completely remove harmful residual chemicals, which will not only harmful to the human body, but also damage the accessory.
Page 19 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 20 • 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 21: Latex Alert
1 Important Information – Before connecting or disconnecting the probe, freeze or turn off the system. – Clean and disinfect the probe before and after each examination. – After the examination, wipe off the ultrasound gel thoroughly. Otherwise, the ultrasound gel may solidify and the image quality would be degraded.
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Page 23: System Overview
(Contrast agent for Liver), and iScape View. For Canada region TE7 Diagnostic Ultrasound System is applicable for adults, pregnant women, pediatric patients and neonates. It is intended for use in fetal, abdominal, intra-operative (abdominal, thoracic, and vascular), pediatric, small organ (breast, thyroid, testes), neonatal and adult cephalic, trans-esoph.
Page 24: Product Specifications
2 System Overview According to the degree of safety of application in the presence of a FLAMMABLE ANESTHETIC MIXTURE WITH AIR OR WITH OXYGEN OR NITROUS OXIDE EQUIPMENT not suitable for use in the presence of a FLAMMABLE ANESTHETIC MIXTURE WITH AIR OR WITH OXYGEN OR NITROUS OXIDE •...
Page 25: Dimensions And Weight
√ √ √ √ √ √ √ × NOTE: Only TE7 is available in Canada. System Configuration NOTE: The following features are available for FDA region only: • Clinical application: Thoracic/Pleural. • Trolley: UMT-400Plus. • Probes: L12-3VNs, LAP13-4Cs, C9-3Ts, SP5-1Ns, SC5-1Ns, P8-2Ts and P8-3Ts.
Page 26: Probes And Needle-Guided Brackets Available
2 System Overview • Wireless adapter (built-in) • Accessories – Operator’s manuals and Quick Reference Guide – Probe holder – Ultrasound gel • Applied part: probes. 2.6.2 Probes and Needle-guided Brackets Available Please refer to the Probes and Biopsy chapter for a listing of available probes. Some of the probes have corresponding needle-guided brackets for biopsy.
Page 27: Options
2 System Overview 2.6.3 Options Item Remarks ECG module The ECG module should be configured. ECG cables ECG module should be configured. DC-IN cable ECG module should be configured. Travelling case After the travelling case is configured, power adapter and cables must be selected.
Page 28 2 System Overview Item Remarks DICOM Worklist DICOM Basic should be configured. DICOM MPPS DICOM OB/GYN SR DICOM Vascular SR DICOM Cardiac SR DICOM Query/Retrieve DICOM Breast SR DICOM Small Parts SR Abdomen/General Package / Obstetrics Package Gynecology Package Cardiology Package Small Parts Package Urology Package Vascular Package...
Page 29: Peripherals Supported
2 System Overview 2.6.4 Peripherals Supported Item Model Black/white video MITSUBISHI P95DW-N printer(digital) SONY UP-D898MD Black/white video printer SONY UP-X898MD (analog) Digital color video Printer SONY UP-D25MD Barcode reader LS2208 DS4308 JADAK HS-1M JADAK HS-1R Footswitch 971-SWNOM (2-pedals) 971-SWNOM (3-pedals) External DVD R/W drive SDRW-08D2S-U iVocal...
Page 30: Introduction Of Each Unit
2 System Overview NOTE: The disposable needle-guided brackets are not configured or sold by Mindray. The user can purchase them based on the specific needs. See CIVCO for the use of each disposable needle- guided bracket. To order Civco brackets or probe sheaths, contact: Multi-Modality Imaging and Corporate Office: Toll-free within the U.S.
Page 31 2 System Overview Figure 2-2 Overview of 15-inch screen Name Function Touch screen and display Operator-system interface or control; displays the image and parameters during the scan. • Charging status: It illuminates in orange when batteries are charging; Battery status indicator It illuminates in green when batteries are charged fully.
Page 32: Ecg Module
2 System Overview Name Function Serial port for connecting Connects with the ECG module Probe holder Used for placing the probe. Probe ports Connects a probe to the main unit. ECG Module Figure 2-3 ECG module Name Description Serial connector Connects to the serial port of the system.
Page 33 2 System Overview Operator’s Manual 2 - 11...
Page 34: Control Panel
2 System Overview Name Function 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. iNeedle button Select to enter/exit iNeedle iTouch button Select to optimize the images. Image Quality Select to switch B/THI and adjusting the frequency.
Page 35: Select Exam Mode And Probe
2 System Overview Name Function Exam operating area Tap each button to enter the screen. • Patient information • Exam mode and probe switching • iStation • Image review • Report review. Functional buttons You can perform operations using those buttons, including End exam, Update, Save image, Save Clip, Print and Freeze/Unfreeze image.
Page 36: Imaging Adjustment
2 System Overview 2.10.5 Imaging Adjustment Perform the following procedure: Tap [Image] on the control panel to open the image parameter control menu under different imaging modes. Swipe the menu downwards/upwards to check and change parameter controls. 2.10.6 Quickly Saving Image Settings TIP: The [Quick Save] and [Edit] controls are available under all imaging modes.
Page 37: Annotations And Body Marks
2 System Overview Enter the name in the box after “To” to assign a name for a user-defined exam mode. Tap [Save] to save the current image parameters for the user-defined exam mode. Check image parameter and change layout Perform the following procedure: Tap [Edit] in the image menu to enter the screen for checking the current image menu display for the current exam mode of the particular probe.
Page 38: Ivocal
2 System Overview Name Function Set Home button Tap to activate the home box, and move the home box to the target position, then Tap the Set Home button again to set the start position of the comment. NOTE: This function is only available for the system of 21.5-inch screen. Clear Comments Tap to delete all the annotations.
Page 39 2 System Overview Input a vocal command using the microphone, and after the command is recognized, the system automatically performs the corresponding operation. Tap the icon in the Audio Control menu to pause the vocal command recognition. Setup Tap the icon in the Audio Command menu to check the system recognizable commands and enter the iVocal Setup menu.
Page 40: Splitting Display
2 System Overview • Test: Tap [Test] and input a vocal command to the microphone device. After the vocal command is recognized, the Success Rate is displayed in fraction. Tap [Test] again to close the vocal command test. If the vocal command is successfully recognized by the system, both the denominator and numerator of the Success Rate are added by 1 for each time;...
Page 41: Izoom (Full Screen View)
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. 2.10.11iZoom (Full Screen View) This feature magnifies the image area in full screen for a better observation. For 21.5-inch screen •...
Page 42: Imaging Mode Switching When Frozen
2 System Overview TIP: After freezing an image, the system may enter cine review, measure, comment adding, body mark mode or current mode, depending on what has been preset. Tap [UnFreeze] in freeze mode to unfreeze the image, and the system continues image scanning. 2.10.13Imaging Mode Switching When Frozen Imaging mode switching in freeze mode follows these principles: •...
Page 43: Manual Cine Review
2 System Overview Start mark Playback mark End mark Auto Review Region For B/B+Color/B+Power mode, bottom-left corner will indicate current frame and total frames. For B/B+M/B+PW/B+CW mode, bottom-left corner will indicate time played and total time. To Exit Cine Review Tap [Freeze] or [B] and the system will return to image scanning and exit cine review.
Page 44: Auto Review
2 System Overview 2.11.3 Auto Review Reviewing all Perform the following procedure: In manual cine review status, tap to activate auto cine review. Review speed: in auto cine review status, tap to select different speeds: 1/10x,1/5x,1/4x,1/ 2x,1x. In auto play status, tap to stop auto play.
Page 45 2 System Overview The name, pattern and meaning of each symbol and warning label are described as follows: Symbol Description Type-BF applied part The ultrasound probes connected to this system are type-BF applied parts. The ECG leads within this system is type-BF applied part.
Page 46 2 System Overview Symbol Description Battery status indicator Equipotentiality Product serial number Manufacture date Manufacturer Federal law restricts this device to sale by or on the order of a licensed healthcare practitioner (USA). CONFORMS TO AAMI STD ES60601-1, IEC STD 60601-2-37, IEC STD 60601-1-6; CERTIFIED TO CSA STD C22.2 NO.
Page 47: System Preparation
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. Place the system in a desired location.
Page 48: Power On/Off
3 System Preparation WARNING • The battery is inside the machine. Only Mindray technical professionals or engineers authorized by Mindray following training can perform battery installation and uninstallation. • If you need to change the battery or buy a new one, contact your sales representative.
Page 49: Check Before Powering On
3 System Preparation or a sales representative. If you use the system in a persistent improperly functioning state, you may harm the patient or damage the equipment. 3.3.1 Check before Powering ON Check before the system is powered on: • The temperature, relative humidity and atmospheric pressure meet the requirements of the operating conditions.
Page 50: Check The System After It Is Powered On
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 51: Power The System Off
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 52: Monitor Brightness/Contrast Adjustment
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 53: Connecting A Probe
3 System Preparation • Only use probes provided by Mindray. Aftermarket probes may result in damage or cause a fire. 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.
Page 54: Disconnecting A Probe
• 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. 3 - 8 Operator’s Manual...
Page 55: Connecting The Footswitch
Unless otherwise specified, printers listed in the System Overview chapter have drivers installed already. • If the printer driver is required, please contact Mindray Customer Service Department or sales representative. • Please refer to the accompanying manuals of the printers for more details.
Page 56 3 System Preparation Perform the following procedure: Place the printer appropriately. Connect the power cord of the printer to a receptacle. Connect the USB port of the system to the USB port of the printer with USB cable. Load a paper roll and turn on the system and printer. Add a print service: Enter “[System] >...
Page 57: Setup
CD/DVD or USB memory device. CAUTION When the preset data is changed, be sure to save the preset data according to the methods described in this chapter. Mindray is not responsible for the loss of preset data. •...
Page 58: General
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 and press <Set>, then increase or decrease the required value by clicking the icons on the right side.
Page 59: Image Preset
4 Setup Type Item Description Image/clip While Storing Image to To set if an image is sent to local default printer/ Storage Hard Disk DICOM Storage/DICOM Printer/iStorage/USB flash drive when the image is saved. While Storing Image to To set if cine is sent to DICOM Storage/iStorage/USB Hard Disk flash drive when the cine is saved.
Page 60: Measure
4 Setup Type Item Description Reset Probe To set the default probe model for the Config. system. Use the default set-ting when start a new After it is ticked, when the exam of a exam new patient is started, image parameters will be preset parameters.
Page 61: Footswitch Function
To install and uninstall: • 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. Operator’s Manual 4 - 5...
Page 62: Access Control
4 Setup 4.1.9 Access Control The system supports two types of users: administrator and operator. • Administrator The system administrator can access all function modules, and view all patient data, such as patient information, images and reports, etc. Only one administrator is configured by default. The administrator can add or delete operators.
Page 63 4 Setup An operator can only modify his/her own password. Select the user name to be modified in User List. Tap [Change Password] to open the dialog box. Enter the new password and confirm the password, and then tap [OK]. Configure Password Policy Turn on the access control function and log in to the system as Administrator before you configure the password policy.
Page 64: Scan Code Preset
4 Setup Enter the User name and password in the field boxes of the Authentication test area, and tap [Test LDAP server] to test whether the LDAP server is accessible. If the LDAP is accessible, the system prompts the following message “Server test succeeded.” Item Description Days to keep cached...
Page 65 4 Setup 1-dimension barcode reader (1D) Item Description Scan Item After scanning 1D bar code, the regular expression is matched in the priority order: “Patient ID > Other ID > First name > Last name > Middle name > Accession# > Operator > Diagnostician”. If the regular expression is matched successfully, the data of 1D bar code will be displayed in this item in Patient page automatically.
Page 66 4 Setup Item Description Worklist Default • Select a default item for searching the Worklist server. For example, users select “Patient ID” from the drop down list of “Worklist Default”, and the system searches Patient ID in the Worklist server. •...
Page 67: Peripheral Preset
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 68 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 69: Ivision
4 Setup Item Description Setup Configure Cloud Set to upload the configuration information to the assigned server. If you have any questions, please contact the service engineer or your sales representative. 4.1.13 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).
Page 70 4 Setup Tap [Wipe] or [Security Wipe] and operate according to the screen prompts to clear patient data. Select [User Define] again, and tap [Confirm]. Input the password and tap [Confirm] to finish the password setting. NOTE: • If you want to switch to Factory Default, perform steps above again. The password is the same as that of the User Define.
Page 71: System Information
4 Setup Item Description Advance Enters the “VPN Advance Config” interface. Reset: if the system does not respond after you tap [Config], tap [Reset]. Config: enters the “Open Connect-GUI VPN client” interface. For details about the settings, please refer to the TAP manual. Note: after exiting the “VPN Advance Config”...
Page 72 4 Setup Select the Exam Mode. – [Available Items]: basic measurement tools configured by the system in the current exam mode which are available but not assigned yet. – [Selected Items]: displays the tools to be added to the menu. Add/Remove the item.
Page 73: Body Mark/Comment Preset
4 Setup Select the report from the report template list. Tap [Default]. Tap [Save] to confirm. 4.2.3 Body Mark/Comment Preset You can change the annotation menu for current exam mode. The comments in the library are provided by the system or are user-defined ones. In Body Mark preset page, you can change the body mark menu for current exam mode.
Page 74: Network Related Preset
4 Setup View Management • Tap to select the views in the list. The image, annotation, body mark and measurement settings can be checked on the right. • Tap to select a user-defined protocol in the list. Tap [Add View] to add a view template to the protocol.
Page 75 4 Setup DICOM local preset items are described as follows: Name Description DICOM Local AE Title Application Entity title. Port DICOM communication port. Maximum PDU data package size, ranging from 16384 to 65536. If the value is less than 16384 or greater than 65536, the system automatically sets it to the value 32768.
Page 76: Dicom Service Preset
4 Setup – Add: Enter strategy name and description, and tap [Add] to add a new strategy. Then the added strategy will be added to the Strategy List. – Delete: Select a strategy from the Strategy List, and tap [Delete]. –...
Page 77 4 Setup Storage Service Preset DICOM storage preset items are described as follows: Item Description Device After you set the server (s) in DICOM Preset screen, the name (s) will appear in the drop-down list, select the name of the storage server. Service Name Default is xxx-Storage, user-changeable.
Page 78 4 Setup TIP: • If the server software supports the compression algorithm, select JPEG, RLE, JPEG2000. Otherwise, original data should be used (RLE is the default method). • RLE, JPEG and JPEG2000 are not supported by all SCPs. Refer to the SCP’s DICOM CONFORMANCE STATEMENT electronic file to check whether SCP supports it or not.
Page 79 4 Setup Item Description Configuration Info Enter configuration information in the field. Min Density Enter the minimum density of the film. Max Density Enter the maximum density of the film. Destination Specify where the file is exposed: MAGAZINE (stored in the magazine), or, PROCESSOR (exposed in the processor).
Page 80 4 Setup Item Description Port DICOM communication port, 104 by default. The port should be consistent with that of the MPPS server. Maximum Retries It starts retrying if it fails to send DICOM task to the server. The retry entry times should be this value. Interval Time(s) Reserved feature.
Page 81: Egateway Preset
4 Setup Item Description Timeout Refers to the amount of time after which the system will stop trying to establish a connection to the service. HL7 Query Service Preset The protocol version that the ultrasound system supports: V2.3, V2.4, V2.5, V2.6. HL7 service setting for Worklist is described as follows: Item Description...
Page 82 4 Setup Item Description 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. Delete Click to delete the selected service in the service list Default Set the eGateway server as the default.
Page 83: Network Preset
4 Setup Set the iStorage server properties as described above. Tap [Add] to add the service to the service list. To modify a network service Select the service to be updated in the service list. Modify the parameters in the upper part of the screen and tap [Update] to update the setting. 4.3.4 Network Preset iStorage Preset You can send exam data or images to the iStorage server and perform analysis using UltraAssist.
Page 84 4 Setup access to Q-path from the ultrasound system to complete the exam report on the ultrasound system and submit for QA, For details, please contact Q-Path service provider. Item Description Advanced Sets the sub URLs of “QView full” and “QView lite”. The sub URL is set by default.
Page 85: Exam Preparation
Exam Preparation You can start a patient exam in the following situations: • New patient information: to start a new patient exam, patient information must first be entered. • New exam: to start a new exam for patient who is already registered, the recorded information can be obtained through either iStation or Worklist.
Page 86: Retrieve Patient Information
5 Exam Preparation Accession # To enter the exam number used in DICOM. MRN: To enter the secondary indications. Diagnostician: Person responsible for the exam. Operator: Person responsible for image collection and scanning. Ref. Physician: Person who requires the operator to carry out the ultrasound. Comment: To enter the exam-specific explanation or remarks.
Page 87: Image Acquisition
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 the System Overview chapter.
Page 88 6 Image Acquisition Increase the depth to see tissue in deeper locations, or decrease the depth to see tissue in shallower locations. The system compensates the signals from deeper tissue by segments to optimize the image. Acoustic power Refers to the power of ultrasonic waves transmitted by the probe, the real-time value of which is displayed in the top-left part of the screen.
Page 89 6 Image Acquisition iClear The function is used to enhance the image profile so as to distinguish the image boundary for optimization. Persistence Used to superimpose and average adjacent B images, so as to optimize the image and remove noises. Rotation/Invert (U/D Flip and L/R Flip) This function provides a better observation for image display.
Page 90: Color Mode
6 Image Acquisition Echo Boost This function can improve contrast and decrease noise, so that a much clearer boundary can be seen. Patient Temperature If the current active probe is TEE probe, the parameter will display under the B mode menu. You can enter the patient temperature by this function.
Page 91 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. Frequency values vary according to probe types. Select the frequency according to the needs of the detection depth and the current tissue characteristics.
Page 92: Power Mode
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 93: M Mode
6 Image Acquisition Color Map This feature indicates the display effect of power image. The maps in Power mode image are grouped into two categories: Power maps and Directional Power maps. • The Power maps provide information of blood flow, which are highly sensitive to the low- velocity flows.
Page 94: Color M Mode (Cm)
6 Image Acquisition Edge Enhance This function is used to increase image profile, so as to distinguish the image boundary. Larger edge enhance may lead to noise increase. Dynamic Range Adjusts contrast resolution of an image, compresses or expands gray display range. The real-time dynamic range value will be displayed on the image parameter area on the top of the screen.
Page 95: Linear Anatomical M (Free Xros M)
6 Image Acquisition 6.6.1 Linear Anatomical M (Free Xros M) Free Xros M imaging is supported on frozen B image, B+M image and B+Power/Color image. Perform the following procedure: Adjust the probe and image to obtain the desired plane in real-time B mode or M mode. Or select the B mode cine file to be observed.
Page 96: Pw/Cw Mode Image Parameter
6 Image Acquisition 6.7.2 PW/CW Mode Image Parameter Gain This function is intended to adjust the gain of spectrum map. The real-time gain value is displayed in the image parameter area. To adjust the SV position and size of sampling in PW mode, the real-time value of SV and SVD are displayed in the image parameter area in the top-left corner of the screen.
Page 97: Tdi
6 Image Acquisition Tint Map This function provides an imaging process based on color difference rather than gray distinction. Gray Map Selects among post processing map curves to optimize grayscale images. Display Format Sets the display proportion of PW mode image and B mode image. Duplex/Triplex This function is used to set if B image or B+Color image (Power) is scanned synchronously.
Page 98: Tdi Mode Image Scanning
6 Image Acquisition • Tissue Velocity Doppler Mode (TVD): This imaging mode provides direction and speed information of the tissue. • Tissue Velocity M Mode (TVM): This function assists to observe the cardiac motion through a direct angle. 6.8.1 TDI Mode Image Scanning Perform the following procedure: Select [TDI] button to enter the TDI mode.
Page 99: Basic Procedures For Iscape Imaging
6 Image Acquisition when you perform measurements in iScape mode. A smooth and even speed will help produce optimal image results. NOTE: • Guidance and precautions for even movement: – Make sure there is enough coupling gel along the scan path. –...
Page 100: Image Review
6 Image Acquisition Status ROI Color Speed too high Moving speed of the probe is too high. Do one of following to end image capture: – Select [Stop Capture]. – Select [Update]. – Wait until the acquisition completes automatically. After the acquisition is completed, the panoramic image will be displayed and the system enters iScape viewing mode.
Page 101: Cine Review
6 Image Acquisition 6.9.4 Cine Review Select [Review Cine] in panoramic image viewing status to enter cine reviewing mode. In cine reviewing mode, a frame marker indicates the sequence of the currently reviewed images in the panoramic image on the left-hand side of screen. In cine review status: •...
Page 102: Overview
6 Image Acquisition – B Lines: indicates the number of B lines of the current frame. The number can be 1, 2, 3, 4, or ≥5. When the number is equal to or greater than 5, the system does not display a specific number.
Page 103: Smart Vti
6 Image Acquisition 6.11 Smart VTI Smart VTI (Velocity-Time Integral) is used to calculate the CO (cardiac output) of the LVOT (left ventricular output tract), so as to quickly evaluate the cardiac function. TIP: Smart VTI supports calculation in real time. Perform the following procedure: Select a phased probe and Adult Cardiac exam mode.
Page 104: Smart Ivc
6 Image Acquisition Select [Graph] to check the quantitative index trend curve. VTI, SV, and CO have different trend curves and are differentiated by colors. A maximum of 6 sets of Smart VTI results can be saved and displayed. 6.12 Smart IVC Smart IVC is used to automatically measure the IVC inner diameter and calculate the change rate in the B mode image.
Page 105: Contrast Imaging
6 Image Acquisition Volume responsiveness B Mode Image IVC CI Corresponds to the selected breath type: (Collapsibility Index), DI • Spontaneous Breath: displays the CI curve. (Distensibility Index), IVCV • Mechanical Ventilation: displays the DI and IVCV curve. trend curve IVC Sampling Line IVC Trending Line The horizontal axis represents the time, which is displayed in...
Page 106: Basic Procedures For Contrast Imaging
6 Image Acquisition • Read contrast agent accompanied manual carefully before using contrast function. NOTE: • Make sure to finish parameter setting before injecting the agent into the patient to avoid affecting image consistency. This is because the acting time of the agent is limited. •...
Page 107: Image Parameters
6 Image Acquisition Inject the contrast agent, and set [Timer 1] at “ON” to start the contrast timing. When the timer begins to work, the time will be displayed on the screen. Observe the image, use [Pro Capture] and [Retro Capture] button to save the images. Press the Freeze button to end the live capture.
Page 108: Image Saving
6 Image Acquisition • Destruct Time: Adjust the destruct time. Dual Live In live mode or freeze mode, set [Dual Live] as “ON” to enable dual live function. Both the contrast mode and tissue mode are displayed. The THI and B image are displayed on the screen if the [Dual Live] is enabled.
Page 109: Contrast Imaging Qa
6 Image Acquisition Perform the following procedure: During real-time scanning, select [MFE] to start MFE imaging. Use [MFE Period] to select different imaging period suitable for current flow. Where, MAX is the maximum superimposing effect. 6.13.6 Contrast Imaging QA CAUTION Contrast Imaging QA images are provided for reference only, not for confirming a diagnosis.
Page 110 6 Image Acquisition Time-intensity curve • Y axis represents the intensity (unit: dB), while X axis represents the time (unit: s). • Frame marker: a white line that is perpendicular to the X axis, can be moved horizontally left to right (right to left) by using the trackball.
Page 111 6 Image Acquisition Ellipse ROI Follow the steps below: 1. Tap and hold the hand icon to move the cursor to the desired position, you can also tap the arrows around the hand icon to fine-tune the cursor position. 2. Tap the hand icon to fix the end point. 3.
Page 112: Auto Ga
6 Image Acquisition Set starting point of the fit curve: Use the trackball to select the starting time and select [Set Fit Start]. Set end of the fit curve: Use the trackball to select the end time and select [Set Fit End]. Use [X Scale] on the touch screen to choose different value, so that the X scale display manner will be changed.
Page 113: Iworks (Auto Workflow Protocol)
6 Image Acquisition NOTE: • While using this feature, ensure the frame rate is at least 20 frames per second. Different imaging presets or setups (e.g. frequency, depth) may affect the frame rate. You can increase the frame rate by adjusting the image parameter. •...
Page 114: View Operation
6 Image Acquisition After the system enters the iWorks screen, the available protocol is displayed. Perform the scanning and saving according to the screen prompt. Perform measurements or add comments/body marks to the image according to the screen prompt. After a view scanning is complete, tap [Save Image] to switch to the next view according to the screen prompt.
Page 115: Insert
6 Image Acquisition • Start manual examination: select [Suspend] to pause the current iWorks protocol. The system enters manual examination status. • Return to iWorks: select [iWorks] to return to automated status. You can continue the previous iWorks scan. 6.16.5 Insert Insert is a specialized protocol event within iWorks and iWorks OB.
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Page 117: Smart 3D
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 118: Roi And Voi
7 Smart 3D 7.1.2 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 119: Mpr
7 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 120: Note Before Use
7 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 121 7 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 122: Smart 3D Image Acquisition
7 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 123: Smart 3D Image Viewing
7 Smart 3D Exit Smart 3D – Tap [Update] or [Freeze] to return to Smart 3D acquisition preparation status. – Or tap [B] to exit the mode. 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 124 7 Smart 3D View Direction The Region of Interest (ROI) contains the section of the volume you want to render. You can adjust the view direction of the ROI. The system supports the observation of 3D image from 6 directions. a.
Page 125 7 Smart 3D Accept VOI This function is usually used for section image observation and to determine the relative position of the section image to the VR. Tap [Accept VOI]. Select a desired MPR image by tapping [A], [B], [C] or [VR]. Swipe on the current active MPR to view the image.
Page 126 7 Smart 3D Reset Curve Do one of the following to reset the curve: Item Description To reset the volume rotation, shifting and zooming of 3D image to original status. To reset the parameters, rendering rotation, VOI and image effect. Reset Curve To reset the curve to be the original beeline.
Page 127: Image Saving
7 Smart 3D Image Saving Image saving In the 3D Review mode, tap [Save Image] to save the current image and volume data to the patient information management system in the set format. 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.
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Page 129: Physiological Unit Signal
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 130 8 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 131: Ecg Review
8 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.
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Page 133: Measurement, Annotations And Body Mark
Measurement, Annotations and Body Mark 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 • Be sure to measure areas of interest from the most optimal image plane to avoid misdiagnosis from inaccurate measurement values.
Page 134 9 Measurement, Annotations and Body Mark Table 9-1 Basic Dimension Measurements Parameter Range Error Angle Full Screen Within ±3% Volume Full Screen Within ±12% Table 9-2 Basic Time Motion Measurements Parameter Range Error Distance Full Screen Within ±4% Time Timeline Display Within ±2% Heart Rate Timeline Display...
Page 135: Annotations
9 Measurement, Annotations and Body Mark Annotations WARNING Ensure that the entered annotations are correct. Incorrect annotations may lead to misdiagnosis! Annotations can be added to an ultrasound image to bring attention, notate or communicate information observed during the examination. You can add annotations to: zoomed images, cine review images, real-time images, frozen images.
Page 136: Modifying (Editing) Annotations
9 Measurement, Annotations and Body Mark 9.2.3 Modifying (Editing) Annotations Modifying (Editing) characters Perform the following procedure: In annotation status, tap to select the annotations to be modified. Tap to select the added annotation, the annotation turns into green in editing status. –...
Page 137: Adding Body Mark
9 Measurement, Annotations and Body Mark 9.3.1 Adding Body Mark Perform the following procedure: Select [Annotate] > [Body Markers] on the operating panel to enter Body Mark status as well as open the body marker menu. Tap to select the desired body mark to bring out the Position Probe Marker dialog box. To adjust the probe position and orientation marker: –...
Page 138: Adding Voice Comments
9 Measurement, Annotations and Body Mark 9.4.2 Adding Voice Comments Perform the following procedure: To perform voice comments adding, the function should be enabled,see “4.1.2 General”. Connect the microphone to the mic port of the physic unit panel. Acquire the necessary images and tap [Freeze] to freeze the image. Select [iVocal] >...
Page 139: Patient Data Management
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. 10.1 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 140: Image Storage Setting
10 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 141: Sending Image Files
10 Patient Data Management 10.1.6 Sending Image Files NOTE: Data saved this way can only be reviewed on the PC and cannot be restored to the ultrasound system. Perform the following procedure: Do one of the following to bring up the “Send To” screen: –...
Page 142: Istation - Patient Data Management
10 Patient Data Management Export reports in Report screen Perform the following procedure: Tap [Report] on the operating panel to enter the report preview page. Tap [Export] to open the exporting dialog box. Select the path to export. Report printing Use a connected graph/text printer to print a report.
Page 143: Image Compare
10 Patient Data Management Item Description Send Exam The system supports sending data to external memory devices, print or iStorage. You can use this function to export the exam data to external devices (in PC data or DICOMDIR data format) and then import to PC or restore to the ultrasound system to review the data (DICOMDIR).
Page 144: Istorage
10 Patient Data Management – Tap [Restore Items] to restore the item to iStation. – Tap [Delete] to delete the item permanently. The item can never be restored again. Tap [Done] to exit the screen. To set maximum number of days for deleted data to be kept in the recycle bin NOTE: The patient exams which exceed the preset maximum will be deleted and unrecoverable, it is recommended to perform patient data backup before enabling this function to avoid data loss.
Page 145: Report Printing
10 Patient Data Management See the accompanying printer manuals for more details. 10.6.2 Report Printing Both reports and images can be printed on a graph/text printer. Tap [Report] to enter the report dialog box. Tap [Preview] to enter report preview screen. Select [Print] to print the report.
Page 146 10 Patient Data Management In the Task Management dialog box, the patient name, destination, progress, type and task created time are displayed. You can perform the following operations: • Tap [Delete] to delete the task. • Tap [Retry] to retry the failed task. Storage Task Displays the DICOM storage task.
Page 147: V-Access
10 Patient Data Management • When tasks have failed, the task management icon displays as ). Tap the icon to check the reason for the failure. • When the task management icon displays as ), it means no task is underway. Troubleshooting If a serious error occurs, such as network disconnection or operation timeout, the system can try to reconnect the network.
Page 148 10 Patient Data Management Set the DICOM storage server. Send stored images or worksheet reports from iStation/Review to the Q-Path server. in the top-right corner of the screen and select Log in to the Q-Path server through the Q-View browser to check the stored images and worksheet reports.
Page 149: Dicom/Hl7
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 150: To Send Images To Storage After An Exam Ends
11 DICOM/HL7 11.1.2 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 151: Mpps
11 DICOM/HL7 In Patient screen, select [Worklist] in the bottom-left corner to enter the import screen. Select the data source: select the server type, choose a Worklist server in the “Server Type” drop-down list. All the patient exam records are listed. Enter the search condition: –...
Page 152: Storage Commitment After An Exam Ends
11 DICOM/HL7 11.5.2 Storage commitment after an exam ends Perform the following procedure: Preset Sending/printing after End Exam, for details the Setup chapter. Set the default storage server and storage commitment server. After finishing the presets, perform image scanning. Each time [End] is tapped, the system will send the image to the default DICOM storage server for storage and send storage commitment to the storage commitment server.
Page 153: Media Review
11 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. 11.7.2 Media review Perform the following procedure: Connect the external media with DCM files to the system.
Page 154: Send Structured Reports For Storage
11 DICOM/HL7 NOTE: Only the PACS system from the Medstreaming company (http://www.medstreaming.com/ default.aspx) supports sending self-defined measurements by DICOM SR. 11.9.1 Send structured reports for storage Perform the following procedure: Create new patient information or load scheduled patient information. Perform measurements. Save the images.
Page 155: Probes And Biopsy
Probes and Biopsy 12.1 Probes Probe model Probe Type Probe Figure 7L4s Linear 6CV1s Convex 7LT4s Linear L14-6s Linear L7-3s Linear C4-1s Convex C5-2s Convex Operator’s Manual 12 - 1...
Page 156 12 Probes and Biopsy Probe model Probe Type Probe Figure C5-1s Convex L12-4s Linear P10-4s Phased P7-3Ts Phased L14-6Ns Linear V11-3Ws Convex C11-3s Convex SP5-1s Phased P7-3s Phased L20-5s Linear P8-3Ts Phased 12 - 2 Operator’s Manual...
Page 157 12 Probes and Biopsy Probe model Probe Type Probe Figure P4-2s Phased SC6-1s Convex L9-3s Linear P8-2Ts Phased LAP13-4Cs Convex L14-5sp Linear L11-3VNs Linear L14-5Ws Linear L12-3RCs Linear L12-3VNs Linear Operator’s Manual 12 - 3...
Page 158: Laparoscopic Probe
12 Probes and Biopsy Probe model Probe Type Probe Figure C9-3Ts Convex SP5-1Ns Phased SC5-1Ns Linear TIP: For details of TEE probe, see the relevant Operator’s Manual. 12.1.1 Laparoscopic Probe CAUTION • Under normal conditions at full acoustic power the temperature of the tip does not exceed 41°C.
Page 159 12 Probes and Biopsy Overview Name Function Handle Operates on the probe deflection. Up/Down deflection lever Controls up/down deflection of the distal tip. Left/Right deflection lever Controls left/right deflection of the distal tip. Hard shaft Flexible shaft Used to control the deflection of distal tip. Distal tip with transducer Converts the electrical signal to an ultrasonic signal, focusing the sound beams in a given direction while it...
Page 160: Probe Functions By Part
12 Probes and Biopsy The flexible shaft can be deflected up to 90° (tolerance: -5°~10°) in four planes of up, down, left and right. Use the 2 deflection levers to adjust the distal tip with transducer as the following figure. Left Zero position Right...
Page 161: Orientation Of The Ultrasound Image And The Probe Head
12 Probes and Biopsy Item Description Probe head Converts the electrical signal into an ultrasonic signal, focusing the sound beams in a given direction; meanwhile, it receives the reflected ultrasonic signal and converts it into an electrical signal for transmission over the cable. The lens on the surface is the acoustic lens.
Page 162: Procedures For Operating
12 Probes and Biopsy Orientation mark Mark 12.1.4 Procedures for Operating WARNING Disinfect the probe and sterilize the needle-guided bracket before and after an ultrasound-guided biopsy procedure is performed. Failure to do so may cause the probe and the needle-guided bracket becomes a source of infection. This section describes general procedures for operating the probe.
Page 163 12 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 164: Wearing The Probe Sheath
12 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 165 12 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 166: Probes Cleaning And Disinfection/Sterilization
12 Probes and Biopsy 12.1.6 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 167 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 168 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 169 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 170 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 sterilization process before the next use.
Page 171: Cleaning The Probe Cable And Connector
12 Probes and Biopsy Compatible Cleaners and Disinfectants For the detailed information about cleaners and disinfectants, see Mindray Transducer Disinfectant Recommendation. 12.1.7 Cleaning the probe cable and connector NOTE: Do not use cloth with water to clean the probe connector.
Page 172 12 Probes and Biopsy Table 12-3 Probe Environmental Conditions Probe Conditions Ambient Relative humidity Atmospheric Model temperature (no condensation) pressure L12-3VNs Operating 0°C ~ 40°C 20% ~ 85% 700 hPa ~ 1060 hPa Storage and -20°C ~ 55°C 20% ~ 95% 700 hPa ~ 1060 hPa transportation L12-3RCs Operating...
Page 173: Storage And Transportation
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 12 - 19...
Page 174: Biopsy Guide
If an abnormality is found on the needle-guided bracket, immediately stop using it and contact MINDRAY Customer Service Department or sales representative. •...
Page 175 12 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 176: Needle-Guided Brackets Available
A needle-guided bracket is available for purchase as an optional accessory; it is used in combination with the probe. Some of the probes have matched needle-guided bracket and needles. To order needle-guided brackets, contact MINDRAY Customer Service Department or sales representative.
Page 177 12 Probes and Biopsy 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 178 12 Probes and Biopsy When the retaining clamp is turned to the correct position, the locking nut will lock the retaining clamp and the needle-guided bracket is then mounted in the correct position. Remove the needle-guided bracket: Hold the probe in your left hand. Unscrew the locking nut with your right hand to open the retaining clamp, then raise the needle-guided bracket to separate the locating bulge from the locating grooves.
Page 179 12 Probes and Biopsy 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. Match the groove and tab with the tab and groove of the probe respectively. Mount the bracket onto the probe.
Page 180 12 Probes and Biopsy Release the needle from the bracket: Screw the nut of the guiding block and remove the guiding block slightly along the direction of the needle’s tail. Separate the residual part of the needle-guide bracket and the probe from the needle. Remove the needle-guided bracket: Unscrew the Needle-guided bracket pinch nut, and remove the needle-guided bracket from the probe.
Page 181 12 Probes and Biopsy Guiding block Groove and tab of the needle-guided bracket Specification of guiding block Guiding hole of the biopsy needle Specification of angle block 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 182 12 Probes and Biopsy Release the needle from the bracket: Remove the guiding block slightly along the direction of the needle’s tail. 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.
Page 183 12 Probes and Biopsy 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 Needle guide angle Knob of fixing the guiding block Specification of guiding block Perform the following procedure: Install the needle-guided bracket:...
Page 184 12 Probes and Biopsy Check manually to confirm 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 support of needle- guided bracket, then turn tightly the knob of fixing the guiding block to fix the guiding block on the support of needle-guided bracket.
Page 185 12 Probes and Biopsy NGB-011 Metal-needle undetachable needle-guided bracket Clamp Locating groove Grip knob Needle guide rack Needle guide hole Needle guide clamping knob Needle guide Locating pit Perform the following procedure: Install the needle-guided bracket: Put on the sterile probe sheath. Connect the locating groove on the clamp with the two raised edges on the probe head and align the locating pit of the clamp with the convex point on the probe head.
Page 186 12 Probes and Biopsy Needle fixing nut 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 187 12 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 188 12 Probes and Biopsy Guiding block specification Guiding block Needle guide hole Perform the following procedure: Install the needle-guided bracket: Put on the sterile probe sheath. Select a suitable needle-guided bracket and match the groove to the tab of the probe. Mount the bracket onto the probe.
Page 189 12 Probes and Biopsy Screw the pinch nut to release the needle-guided bracket Separate the bracket and the probe. 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...
Page 190 12 Probes and Biopsy Put on the sterile probe sheath. Select a suitable needle-guided bracket and match the groove to the tab of the probe. Mount the bracket onto the probe. Screw the pinch nut of the needle-guided bracket to ensure that the needle-guided bracket is properly installed on the probe.
Page 191 12 Probes and Biopsy NGB-022 Metal-needle detachable needle-guided bracket 9 10 11 Groove Clamp Needle type adjusting base Needle type dial scale Needle fixing nut 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.
Page 192 12 Probes and Biopsy Adjust the dial scale to the required needle type shift, and then screw the needle fixing nut to lock the dial scale. (To adjust the dial scale you have to loosen the needle fixing nut first.) Pull the lock pin and close the V-shaped cover to fix the lock pin in the groove of the needle type adjusting base, so as to install the needle into the guiding hole.
Page 193 12 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 194 12 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 195 12 Probes and Biopsy NGB-035 Metal-needle detachable needle-guided bracket Angle locking nut Angle adjusting block Buckle Clamp The clamping nut of left/right clamp The locating position block Groove V-shaped guiding block The Pressing block for separating needle Needle guide hole Needle clamping cover of needle guided bracket Needle adjusting nut of needle-guided bracket Angle adjusting base...
Page 196 12 Probes and Biopsy Put on the sterile probe sheath. Select a proper needle-guided bracket, and match the locating groove with the tab of the probe. Mount the bracket onto the probe. Tighten the pinch nut of the needle-guided bracket to confirm that the needle-guided bracket is properly installed on the probe.
Page 197 12 Probes and Biopsy Hold the probe and press the pressing block to separate V-shaped guiding block from the pressing block. Remove the needle. Rotate the clamping nut to separate the bracket from the probe. NGB-036 Metal-needle detachable needle-guided bracket Angle locking nut Angle adjusting block Angle marker...
Page 198 12 Probes and Biopsy 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. Adjust the angle block to the desired level. Tighten the angle pinch nut. Insert the biopsy needle: Hold the probe.
Page 199 12 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 200 12 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-043 Metal-needle detachable needle-guided bracket Locking nut of left and right clamps Groove...
Page 201 12 Probes and Biopsy Insert a biopsy needle into the guiding block hole. Adjust the biopsy angle of the needle, and ensure that the needle can be adjusted continuously within the range of 30º to 85º. Release the needle from the bracket: Hold the probe, and remove the biopsy needle form the guiding hole of the guiding block.
Page 202 12 Probes and Biopsy 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. 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 203 12 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 204: Verifying The Biopsy Guide Line
12 Probes and Biopsy 12.2.3 Verifying the Biopsy Guide Line WARNING • Prior to each biopsy procedure, be sure to verify the guide line. • If the needle is not consistent with the guide line, DO NOT perform the biopsy procedure. NOTE: You can perform guide line verification on a single live B/C image, and all biopsy-irrelevant operations are forbidden.
Page 205: Starting The Biopsy Procedure
12 Probes and Biopsy – Adjust the angle Tap and drag the bottom dot on the line to change the guide line angle. – 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.
Page 206: Clean And Sterilize The Needle-Guided Bracket
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 207 12 Probes and Biopsy Rinse the needle-guided bracket thoroughly by using a large amount of distilled or softened water (about 2 gallons) at room temperature for about 30 s to remove the residual dirt and cleaning solvent. Repeat the operation twice. Wipe away the water on the needle-guided bracket by using a piece of disposable lint-free soft cloth.
Page 208: Storage And Transportation
Between examinations, keep the needle-guided bracket in a sterile environment. • If the needle-guided bracket is sent to your MINDRAY representative for repair, be sure to disinfect or sterilize it and keep it in the carrying case to prevent infection.
Page 209: Espacial Navi
12 Probes and Biopsy 12.4 eSpacial Navi The eSpacial Navi function builds up the connection between the ultrasound system and the processed needles. The needle position appears on the image in real time. Meanwhile, the virtual 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.
Page 210 12 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 211: Preset
12 Probes and Biopsy Scale of guideline (5mm/scale) 12.4.2 Preset eSpacial Navi Needle Menu Enter the Needle menu, and controls are as shown in Table 12-6. Table 12-6 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 212: Procedure
12 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 213: Dvr Recording
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 214: Dvr Video Replaying
13 DVR Recording 13.3 DVR Video Replaying You can replay the video and audio record. 13.3.1 Replay on PC Connect the USB disk or optical disk with the file to the PC, and open the file directly. 13.3.2 Replay on the ultrasound system Perform the following procedure: ) to open the dialog box and select desired playing type.
Page 215: System Maintenance
The responsibility for maintenance and management of the product after delivery resides with the customer who has purchased the product. If you have any questions, please contact Mindray Customer Service Department or sales representative. WARNING •...
Page 216 14 System Maintenance NOTE: • DO NOT use hydrocarbon glass cleaner or cleaner for OA (Office Automation) equipment to clean the monitor. These substances may cause deterioration of the monitor. • Please clean the control panel periodically, otherwise the button may be blocked by dirt and the system will be buzzing while the button makes no response.
Page 217 14 System Maintenance NOTE: Use a soft brush to brush away dust attached to all visible sockets or interfaces (such as probe sockets, sockets or interfaces in the IO panel and power supply panel). Do not use a cloth and water. Cleaning the dust-proof cover CAUTION Please clean all the system’s dustproof covers periodically (once per month).
Page 218: Cleaning The Peripherals
14.1.3 Disinfecting the Main Unit WARNING • Use only Mindray approved disinfectants and methods listed in this section to disinfect the main unit. Warranty does not cover damage caused by unapproved substances or methods. •...
Page 219 14 System Maintenance • Disinfectants listed in this section are used for disinfecting the housing of the main unit and the monitor only, not for disinfecting the probes or the trolley. • During cleaning, wear medical gloves to prevent infection. Compatible Disinfectants Table 14-1 Compatible disinfectants for 15-inch screen Manufacturer...
Page 220 14 System Maintenance Table 14-2 Compatible disinfectants for 21.5-inch screen Manufacturer Product Name Type Diversey Inc VIREX TB Solution Laboratoires ANIOS WIP ANIOS Premium Wipe Bode Chemie Gmbh Mikrobac Tissues Wipe ® Professional Disposables Sani-Cloth Plus Wipe International Inc Advanced Ultrasound Solutions Inc. SONO ULTRASOUND WIPES Wipe...
Page 221 14 System Maintenance Figure 14-3 21.5-inch screen Ventilation holes Handle Probe sockets I/O panel Power supply panel Loudspeaker Loudspeaker Dust-proof Operator’s Manual 14 - 7...
Page 222: Checking The Probe
14 System Maintenance Figure 14-4 15-inch screen Ventilation holes Handle Probe sockets I/O panel Power supply panel Dust-proof Loudspeaker Remove any residue with a water-moistened soft cloth on the main unit. Wipe off water on the main unit using sterile cloth or gauze. Do not dry the main unit by heating.
Page 223: Checking Appearance
14.2 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...
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Page 225: 1-D Barcode Reader
Barcode Reader 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. TIP: The reader does not support decoding of Multi-language. 1-D Barcode Reader The laser transmitted by SYMBOL LS2208 is Class 2 laser.
Page 226: Setting Up The Reader
A Barcode Reader Trigger Press to decode. A.1.1 Setting Up the Reader Cable interface port Interface cable modular connector Perform the following procedure: Plug the interface cable modular connector into the cable interface port on the bottom of the reader handle, and ensure the connector is properly secured. Connect the other end of the interface cable to the host.
Page 227 Set Length(s) for Code 93 4 to 55 The reader supports some user-defined functions as introduced below. For more details, please contact the SYMBOL reader agents or Mindray Customer Service Department. Volume setting Scan the following barcode to set the volume parameter.
Page 228 A Barcode Reader • Medium Volume: • High Volume: Code 93 and codebar scanning • To enable or disable Code 93, scan the appropriate barcode below. • To enable Codebar, scan the appropriate barcode below. Code 39 full ASCII scanning Code 39 Full ASCII is a variant of Code 39 which pairs characters to encode the full ASCII character set.
Page 229: Scanning In Hand-Held Mode
A Barcode Reader Select this option to decode only I 2 of 5 symbols containing a selected length. Select the length using the numeric barcodes below. For example, to decode only I 2 of 5 symbols with 8 characters, scan I 2 of 5 - One Discrete Length, then scan 0 followed by 8. A.1.3 Scanning in Hand-Held Mode Perform the following procedure: Ensure all connections are secure.
Page 230: Scanning In Hands-Free Mode
A Barcode Reader Do not hold the reader directly over the barcode. Laser light reflecting directly back into the reader from the barcode is known as specular reflection. This specular reflection can make decoding difficult. You can tilt the reader up to 55° forward or back and achieve a successful decode.
Page 231 A Barcode Reader Mounting the Stand (optional) You can attach the base of the reader’s stand to a flat surface using two screws or double-sided tape (not provided). Two screw-mount holes For Screw Mount, follow the steps below: 1. Position the assembled base on a flat surface. 2.
Page 232: Barcode Reader (Take Ds4308 As An Example)
A Barcode Reader 2D Barcode Reader (Take DS4308 as an example) SYMBOL DS4308 is classified as “EXEMPT RISK GROUP” according to IEC 62471:2006 and EN 62471:2008. WARNING DO NOT stare into beam emitted by SYMBOL DS4308 for more than 10 s. The 2-D barcode reader supports hand-held operation mode.
Page 233: Setting Up The Digital Imager Reader
A Barcode Reader A.2.2 Setting Up the Digital Imager Reader Installing the Interface Cable Perform the following procedure: Plug the interface cable modular connector into the cable interface port on the bottom of the reader handle and ensure the connector is properly secure. Connect the other end of the interface cable to the host.
Page 234 A Barcode Reader Parameter Defaults Parameter Defaults UPC/EAN Interleaved 2 of 5 (ITF) Enable Enable UPC-A Enable Set Lengths for I 2 of 5 UPC-E Enable I 2 of 5 Check Digit Verification Disable UPC-E1 Disable Transmit I 2 of 5 Check Digit Disable EAN-8/JAN 8 Enable...
Page 235 Set Length(s) for Code 93 4 to 55 The reader supports some user-defined functions as introduced below. For more details, please contact the SYMBOL reader agents or Mindray Customer Service Department. Volume setting Scan the following barcode to set the volume parameter.
Page 236 A Barcode Reader Code 39 full ASCII setting Code 39 Full ASCII is a variant of Code 39 which pairs characters to encode the full ASCII character set. To enable or disable Code 39 Full ASCII, scan the appropriate barcode below. I 2 of 5 symbols setting Select this option to decode only I 2 of 5 symbols containing a selected length.
Page 237: Scanning In Hand-Held Mode
A Barcode Reader A.2.4 Scanning in Hand-Held Mode Perform the following procedure: Ensure all connections are secure (see the appropriate host chapter.) Aim the digital imager reader at the barcode. When the digital imager reader senses movement, in its default Auto Aim trigger mode, it projects a red LED dot which allows positioning the barcode within the field of view.
Page 238: Jadak Barcode Reader
TIP: Users can customize the JADAK barcode reader based on specific requirements or contact the Mindray service engineers. This configuration guide is applicable for the Ultrasound System only. A.3.2 Operating System Version If you need to use the JADAK barcode reader with the Ultrasound System, ensure that the operating system version is 3.9.8 or later versions.
Page 239: Hs-1R Jdk-2601 Configuration
A Barcode Reader Configuration before use Perform the following procedure: Scan the following 1-D barcode to configure the barcode reader: Scan the following 2-D barcode to enable the suffix: Scan the following 2-D barcode to set the suffix to Enter: Reset the barcode reader Perform the following procedure: If the barcode reader is in malfunction, scan the following 1-D barcode to reset to default...
Page 240: Maintenance
A Barcode Reader For scanning Barcode For scanning RFID Reset the barcode reader Perform the following procedure: If the barcode reader is in malfunction, scan the following 1-D barcode to reset to default settings. Follow the following steps to reconfigure the barcode reader: Scan the following 1-D barcode to configure the barcode reader: Scan the following 1-D barcode to enable the suffix: For scanning Barcode...
Page 241 A Barcode Reader • Do not allow any abrasive material to touch the window. • Remove any dirt particles with a damp cloth. • Wipe the window using a tissue moistened with ammonia/water. • Do not spray water or other cleaning liquids directly into the window. Operator’s Manual A - 17...
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Page 243 Wireless LAN The system provides wireless net adapter configuration, so as to assist information query and unlimited network service. WARNING • Use the wireless LAN function prudently in OR/ICU/CCU as it may interfere with other devices. • When the wireless LAN function is turned on, the ultrasound system may suffer interference from other equipment, even if that other equipment complies with CISPR EMISSION requirements.
Page 244: B Wireless Lan
Host Name: displays the machine name of the system, if changed, the system should be restarted. Tap [Save] to save current setting or tap [Cancel] to exit. EAP Network For setting EAP network, contact Mindray Customer Service Department or the sales representatives. B - 2 Operator’s Manual...
Page 245: Specifications
B Wireless LAN Specifications Table B-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 Channel spacing 5 MHz Output power ≤17dbm Wireless network mode Infrastructure, ad-hoc Table B-2 Wireless Quality of Service Item Specifications...
Page 246: Troubleshooting
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 247: C Trolley And Accessories
Trolley and Accessories WARNING • DO NOT connect the trolley to the outlets with the same circuit breakers and fuses that control the current to devices such as life-support systems. If the trolley or the system malfunctions and generates over-current, or when there is an instantaneous current at power ON, the circuit breakers and fuses of the building’s supply circuit may be tripped.
Page 248: Introduction Of Each Unit (Taking Umt-400 As An Example)
C Trolley and Accessories C.1.2 Introduction of Each Unit (taking UMT-400 as an example) NOTE: Retractable cable and telescoping mechanism of the trolley are options before factory. For details, please contact Mindray service engineer. Name Function <1> Main unit of ultrasound system <2>...
Page 249: Install Towelette Container
C Trolley and Accessories Name Function <11> Printer bracket Used for placing the printer. NOTE: Use a power cable no less than 1.5 m and no longer than 1.8 m for the printer on the trolley. <12> Retractable cable AC power supply cable. <13>...
Page 250: Wall Mount
C Trolley and Accessories Table Stand Name Function Main unit support Used for fixing the ultrasound system. Base Used for fixing the main unit support. Wall Mount Name Function Guide way of wall mount Used for fixing the wall mount. C - 4 Operator’s Manual...
Page 251 C Trolley and Accessories Name Function Support arm of wall mount Used for adjusting the angle of wall mount. Main unit support Used for fixing the ultrasound system. Storage tray Used for holding tissue, etc. Adapter holder Used for fixing the external adapter. Operator’s Manual C - 5...
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Page 253: D Iscanhelper
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 254: Iscanhelper Menu
D iScanHelper You can zoom in a single window in the help information area to see the information. For details, see “D.3.3 Single/quad-window Display”Single/quad-window Display. Tap [Exit] or [iScanHelper] again to exit. iScanhelper Menu iScanHelper information area is displayed on the menu. D.3.1 View Selecting Area Swipe the menu to select target view.
Page 255: Single/Quad-Window Display
D iScanHelper Related anatomical tissue information are provided here. • Scanning picture Ordinary scanning tips can be observed here, including posture, probe mark, probe swing/ sweep techniques. • Scanning tips You can read tissue related anatomical information and adjacent tissue information here. D.3.3 Single/quad-window Display You can zoom in the anatomic graphic, ultrasonic image as well as scanning picture to view those information more conveniently.
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Page 257: E Ivision
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: 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 259 After the input command is recognized, the system automatically performs the corresponding operations. Vocal command Operation Hello Mindray Turn On Audio Control Turn Off Turn Off Audio Control...
Page 260: F List Of Vocal Commands
F List of Vocal Commands Vocal command Operation Zoom In Zoom In Image Zoom Out Zoom Out Image Open Smart Track Turn on Smart Track Mode Close Smart Track Turn off Smart Track Mode Sound Volume Up Turn Sound Volume Up Sound Volume Down Turn Sound Volume Down Angle More...
Page 261 F List of Vocal Commands Vocal command Operation Superficial Switch Exam Mode to Superficial Adult Abdomen Switch Exam Mode to Adult Abdomen Pediatric Abdomen Switch Exam Mode to Pediatric Abdomen Left ventricular Switch Exam Mode to LVO opacification TEE Cardiac Switch Exam Mode to TEE Cardiac Vascular Switch Exam Mode to Vascular...
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Page 263 EMC Guidance and Manufacturer’s Declaration The system complies with the EMC standard IEC 60601-1-2: 2014. Intended Environments: HOME HEALTHCARE ENVIRONMENT (except for near active HF SURGICAL EQUIPMENT and the RF shielded room of an ME SYSTEM for magnetic resonance imaging). WARNING •...
Page 264: G Emc Guidance And Manufacturer's Declaration
• Date/time information. Table G-1 GUIDANCE AND MINDRAY DECLARATION-ELECTROMAGNETIC EMISSIONS The system is intended for use in the electromagnetic environment specified below. The customer or the user of system should assure that it is used in such an environment. EMISSIONS TEST...
Page 265 G EMC Guidance and Manufacturer’s Declaration Table G-1 GUIDANCE AND MINDRAY DECLARATION-ELECTROMAGNETIC EMISSIONS The system is intended for use in the electromagnetic environment specified below. The customer or the user of system should assure that it is used in such an environment.
Page 266 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 267 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 268 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 269 G EMC Guidance and Manufacturer’s Declaration Table G-6 Name Cable length (m) Shield or not Remarks Power input 2.5 m Not shielded SIP/SOP < 3.0 m Shielded ECG cable 4.0 m Shielded Probe Cable < 3.0 m Shielded Footswitch Cable 2.9 m Shielded Operator’s Manual G - 7...
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Page 271: H Acoustic Output
Acoustic Output This section of the operator’s manual applies to the overall system including the main unit, probes, accessories and peripherals. This section contains important safety information for operators of the device, pertaining to acoustic output and how to control patient exposure through use of the ALARA (as low as reasonably achievable) principle.
Page 272: Mi/Ti Explanation
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 273: Mi/Ti Display
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 274: Acoustic Power Control
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 275: Limits Of Acoustic Output
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 276: References For Acoustic Power And Safety
H Acoustic Output Acoustic Quantities Total Uncertainties (Standard) Power 26.48% for non-scan modes; 6.03% for scan modes. Frequency 0.22% Pressure 13.01% 26.48% for non-scan modes; 26.95% for scan modes. 26.5% Mechanical Index 13.01% Total Uncertainty for TIS 26.48% for non-scan modes; 6.03% for scan modes.
Page 277 Probe Dimensions Model Length (mm) Width (mm) Height (mm) Cable Length (mm) C5-1s 111.9 76.7 2050±50 L12-4s 101.6 25.7 2050±50 P10-4s 82.5 28.5 21.2 2050±50 P7-3Ts 1500 59.6 59.1 1530±50 L14-6Ns 101.6 25.7 2050±50 V11-3Ws 320.5 41.5 32.5 2050±50 C11-3s 96.4 32.8 2050±50...
Page 278: I Probe Dimensions
I Probe Dimensions Model Length (mm) Width (mm) Height (mm) Cable Length (mm) 6CV1s 318.2 32.5 2050±50 7L4s 101.6 25.7 2050±50 Length Height (Max.) Width (Max.) I - 2 Operator’s Manual...
Page 279 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 Specific (Track 1 & 3) Color Amplitude Combined Other (Track 1 Only) Doppler Doppler (specify) (specify) Ophthalmic...
Page 280: J Indications For Use
J Indications for use Transducer: C5-2s Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: Clinical Application Mode of Operation General Specific (Track 1 & 3) Color Amplitude Combined Other (Track 1 Only) Doppler Doppler (specify) (specify)
Page 281 J 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 Specific (Track 1 & 3) Color Amplitude Combined Other (Track 1 Only) Doppler Doppler (specify) (specify)
Page 282 J Indications for use Transducer: L12-4s Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: Clinical Application Mode of Operation General Specific (Track 1 & 3) Color Amplitude Combined Other (Track 1 Only) Doppler Doppler (specify) (specify)
Page 283 J Indications for use Transducer: L7-3s Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: Clinical Application Mode of Operation General Specific (Track 1 & 3) Color Amplitude Combined Other (Track 1 Only) Doppler Doppler (specify) (specify)
Page 284 J 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 Specific (Track 1 & 3) Color Amplitude Combined Other (Track 1 Only) Doppler Doppler (specify) (specify)
Page 285 J 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 Specific (Track 1 & 3) Color Amplitude Combined Other (Track 1 Only) Doppler Doppler (specify) (specify)
Page 286 J 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 Specific (Track 1 & 3) Color Amplitude Combined Other (Track 1 Only) Doppler Doppler (specify) (specify)
Page 287 J Indications for use Transducer: V11-3Ws Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: Clinical Application Mode of Operation General Specific (Track 1 & 3) Color Amplitude Combined Other (Track 1 Only) Doppler Doppler (specify) (specify)
Page 288 J 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 Specific (Track 1 & 3) Color Amplitude Combined Other (Track 1 Only) Doppler Doppler (specify) (specify)
Page 289 J 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 Specific (Track 1 & 3) Color Amplitude Combined Other (Track 1 Only) Doppler Doppler (specify) (specify)
Page 290 J 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 Specific (Track 1 & 3) Color Amplitude Combined Other (specify) (Track 1 Only) Doppler Doppler (specify)
Page 291 J 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 Specific (Track 1 & 3) Color Amplitude Combined Other (Specify) (Track 1 Only) Doppler Doppler (specify)
Page 292 J 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 Specific (Track 1 & 3) Color Amplitude Combined Other (specify) (Track 1 Only) Doppler Doppler (specify)
Page 293 J 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 Specific (Track 1 & 3) Color Amplitude Combined Other (specify) (Track 1 Only) Doppler Doppler (specify)
Page 294 J Indications for use Transducer: 6CV1s Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: Clinical Application Mode of Operation General Specific (Track 1 & 3) Color Amplitude Combined Other (Specify) (Track 1 Only) Doppler Doppler (specify)
Page 295 J Indications for use Transducer: 7L4s Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: Clinical Application Mode of Operation General Specific (Track 1 & 3) Color Amplitude Combined Other (Specify) (Track 1 Only) Doppler Doppler (specify)
Page 296 J Indications for use Transducer: P7-3s Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: Clinical Application Mode of Operation General Specific (Track 1 & 3) Color Amplitude Combined Other (Track 1 Only) Doppler Doppler (specify) (specify)
Page 297 J 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 Specific (Track 1 & 3) Color Amplitude Combined Other (Track 1 Only) Doppler Doppler (specify) (specify)
Page 298 J 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 Specific (Track 1 & 3) Color Amplitude Combined Other (Track 1 Only) Doppler Doppler (specify) (specify)
Page 299 J 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 Specific (Track 1 & 3) Color Amplitude Combined Other (Track 1 Only) Doppler Doppler (specify) (specify)
Page 300 J 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 Specific (Track 1 & 3) Color Amplitude Combined Other (Track 1 Only) Doppler Doppler (specify) (specify)
Page 301 J 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 Specific (Track 1 & 3) Color Amplitude Combined Other (Track 1 Only) Doppler Doppler (specify) (specify)
Page 302 J Indications for use Transducer: L14-5Ws Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: Clinical Application Mode of Operation General Specific (Track 1 & 3) Color Amplitude Combined Other (Track 1 Only) Doppler Doppler (specify) (specify)
Page 303 J 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 Specific (Track 1 & 3) Color Amplitude Combined Other (Track 1 Only) Doppler Doppler (specify) (specify)
Page 304 J 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 Specific (Track 1 & 3) Color Amplitude Combined Other (Track 1 Only) Doppler Doppler (specify) (specify)
Page 305 J 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 Specific (Track 1 & 3) Color Amplitude Combined Other (Track 1 Only) Doppler Doppler (specify) (specify)
Page 306 J 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 Specific (Track 1 & 3) Color Amplitude Combined Other (Track 1 Only) Doppler Doppler (specify) (specify)
Page 307 J 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 Specific (Track 1 & 3) Color Amplitude Combined Other (Track 1 Only) Doppler Doppler (specify) (specify)
Page 308 J 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 Specific (Track 1 & 3) Color Amplitude Combined Other (specify) (Track 1 Only) Doppler Doppler (specify)
Page 309 J 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 Specific (Track 1 & 3) Color Amplitude Combined Other (Track 1 Only) Doppler Doppler (specify) (specify)
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Page 312 P/N: 046-019812-00 (1.0)

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