Page 1 Hepatus 7/Hepatus 6/Hepatus 5/Hepatus 7S/Hepatus 6S/Hepatus 5S/Hepatus 7T/ Hepatus 6T/Hepatus 5T/Fibrous 7/ Fibrous 6/Fibrous 5 Diagnostic Ultrasound System Operator’s Manual...
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
As a health care provider, you may report the occurrence of certain events to SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD., and possibly to the competent authority of the Member state in which the user and / or patient is established.
Page 7: 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 2.12 Symbols ........................2 - 16 3 System Preparation ..................... 3 - 1 3.1 Move/Position the System ....................3 - 1 3.2 Connecting the Power Cord ................... 3 - 1 3.2.1 Connecting Power ....................3 - 1 3.2.2 Powered by Batteries ................... 3 - 1 3.3 Power ON/OFF ......................
Page 9 Contents 4.3.4 Q-Path Preset ..................... 4 - 26 4.3.5 HIS Preset .....................4 - 27 5 Exam Preparation ....................5 - 1 5.1 Patient Information ......................5 - 1 5.1.1 New Patient Information ..................5 - 1 5.1.2 Retrieve Patient Information ................5 - 2 5.2 Activate an Exam ......................
Page 10 Contents 8.2 Image Parameters ......................8 - 2 8.3 Image Saving ........................8 - 3 8.4 Micro Flow Enhancement ....................8 - 3 8.5 Contrast Imaging QA ..................... 8 - 4 9 Physiological Unit Signal ..................9 - 1 9.1 ECG ..........................9 - 1 9.2 ECG Review ........................
Page 11 Contents 11.3.10 Ratio (A) ...................... 11 - 10 11.3.11 Time ......................11 - 11 11.3.12 Slope ......................11 - 11 11.3.13 HR ....................... 11 - 12 11.3.14 Velocity ....................... 11 - 12 11.3.15 D Trace ......................11 - 12 11.3.16 PS/ED ......................11 - 15 11.3.17 Volume Flow ....................
Page 12 Contents 13.3.3 Viewing Exam times ..................13 - 5 13.4 Recycle bin ......................... 13 - 5 13.5 iStorage ........................13 - 5 13.6 Print ..........................13 - 6 13.6.1 Image Print ....................... 13 - 6 13.6.2 Report Printing ....................13 - 6 13.7 Back up Files using the DVD Drive ................
Page 13 Contents 15.2.6 Storage and Transportation ................15 - 18 15.2.7 Disposal ......................15 - 18 15.3 Middle Line ......................15 - 18 16 DVR Recording ....................16 - 1 16.1 Start Recording ......................16 - 1 16.2 Sending Image ......................16 - 1 16.3 DVR Video Replaying ....................
Page 14 Contents C.2.3 Control Panel Position Adjustment ..............C - 5 C.3 Table Stand ........................C - 6 D iScanHelper ......................D - 1 D.1 Use iScanHelper for Reference ..................D - 1 D.2 Use iScanHelper for Learning or Training ..............D - 1 D.3 iScanhelper Menu ......................
Page 15 J.3 Acoustic Output Reporting Table for Track 3 ..............J - 4 J.3.1 C5-1s ........................J - 4 J.3.2 LFP5-1s .......................J - 12 Operator’s Manual 1 - ix...
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Page 17: Safety Precautions
Safety Precautions Meaning of Safety Symbols Symbol Description Type-BF applied part The ultrasound probes connected to this system are type-BF applied parts. The ECG leads within this system is type-BF applied part. Caution! General warning sign. Patient injury or tissue damage from ultrasonic radiation. The ALARA principle must be practiced when operating the ultrasound system.
Page 18 • 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 19 1 Safety Precautions • Do not use this system when any digital device such as a high-frequency electrotome, high-frequency therapeutic device or defibrillator is applied already. Otherwise, there is a risk of electric shock to the patient. • Only use the ECG leads provided with the physiology module; otherwise, electric shock may be resulted.
Page 20 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 21 1 Safety Precautions • It is recommended to only use the video devices specified in this manual. • Do not use gel, disinfectant, probes, probe sheath or needle-guided brackets that are not compatible with the system. • The applied contrast agency should be compliant with the relevant local regulations.
Page 22 1 Safety Precautions • 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. • Electrical and mechanical performance may be degraded due to long usage (such as current leakage or distortion and abrasion);...
Page 23: Latex Alert
• 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 24 1 Safety Precautions www.civco.com WARNING Allergic reactions in patients sensitive to latex (natural rubber) may range from mild skin reactions (irritation) to fatal anaphylactic shock, and may include difficulty breathing (wheezing), dizziness, shock, swelling of the face, hives, sneezing, or itching of the eyes (FDA Medical Alert on latex products, “Allergic Reactions to Latex-containing Medical Devices”, issued on March 29, 1991).
Page 25: System Overview
System Overview Intended Use Hepatus 7/Hepatus 6/Hepatus 5/Hepatus 7S/Hepatus 6S/Hepatus 5S/Hepatus 7T/Hepatus 6T/ Hepatus 5T/Fibrous 7/Fibrous 6/Fibrous 5 Diagnostic Ultrasound System is applicable for adults, pregnant women, pediatric patients and neonates. It is intended for use in fetal, abdominal, Pediatric and Peripheral vessel exams.
Page 26: Product Specifications
2 System Overview • According to the degree of protection against harmful ingress of water: – The main unit is rated as IPX0 – The probes are rated as IPX7 – The foot switch (can be applied in the operating room) is rated as IPX8 –...
Page 27: Dimensions And Weight
Dimensions (including probe holder): 130±10(Depth) × 380±10(Width) × 380±5(Height)mm • Weight (including two batteries and one probe): < 8.2 kg. Product Differences Model Double-Dist Depth Parallel line Spline length Hepatus 7 √ √ √ √ √ √ √ Hepatus 6 ×...
Page 28: Probes And Needle-Guided Brackets Available
2 System Overview 2.6.2 Probes and Needle-guided Brackets Available Please see “15 Probes and Biopsy”. 2.6.3 Options Item Remarks Mobile Trolley (For details, see “C Trolley Retractable cable and Accessories”) Without retractable cable and power cable Batteries (built-in) ECG module ECG cables ECG module should be configured.
Page 29: Peripherals Supported
2 System Overview Item Remarks Application Abdomen/General packages Package Obstetrics Package Gynecology Package Vascular Package LiSA Others iVocal iWorks DVR Module McAfee 2.6.4 Peripherals Supported Item Model Digital graph/text printer HP OFFICEJET PRO 8100 (the printer driver requires manually installed) Black/ white video printer SONY UP-D898MD (digital)
Page 30: Parts That Can Be Used Within Patient Environment
2 System Overview 2.6.5 Parts that can be used within patient environment • Main unit • Probes • Footswitch • Printers Introduction of Each Unit Figure 2-1 Main unit overview Name Description Touch screen and display Operator-system interface or control; displays the image and parameters during the scan.
Page 31: Audio/Video Extend Module
2 System Overview Name Description Probe holder Used for placing the probe. Kensington lock Locks the main unit to the trolley in case of loss. Power inlet Connects with the power adapter. Network port Network port. Used for connecting router, ultrasound workstation, server, etc.
Page 32: Ecg Module
2 System Overview NOTE: • When connecting an external video device (HDMI/VGA), make sure the display resolution setting is 1920×1080, otherwise the image quality may be degraded. • For a better audio/video signal performance, please connect the module to the ultrasound system before the system is powered on.
Page 33: Basic Operations
2 System Overview 2.10 Basic Operations 2.10.1 Control Panel 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 (ViTE mode) Patient, Start/Stop ViTE capturing, Save Result, Report, Freeze/...
Page 34: Imaging Adjustment Menu
2 System Overview Name Function Menu area • Imaging parameter menu: swipe the menu downwards/ upwards to see parameter controls. • Cine review menu (under frozen or cine review status). • Measurement menu. • Annotation and body mark menu. 2.10.2 Imaging Adjustment Menu Name Function Displays the current modes, tap to enter the corresponding mode.
Page 35: Annotations And Body Marks
2 System Overview 2.10.3 Annotations and Body Marks Name Function Arrow button Tap to add arrow a comment to the image. Keyboard button Tap to activate the soft keyboard to type the alphanumeric characters. Clear Comments Tap to delete all the annotations. button (on Comment menu) Clear Markers...
Page 36: Ivocal
2 System Overview 2.10.4 iVocal TIP: • If the microphone is not to be used for the moment, you can put the microphone into the vacant probe holder temporarily. • When the iVocal function is enabled, the system can perform operations both through inputting vocal commands and through tapping icons on the touch screen.
Page 37 2 System Overview 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. Operator’s Manual 2 - 13...
Page 38 2 System Overview • Add: tap [Add] to enter the Adding New Command menu, tap [Function Description] to select the desired function, enter the user-defined command in the [Command] text box, and then select OK. User-defined command naming rules: only Chinese characters, English letters, and digits are supported;...
Page 39: Warning Labels
2 System Overview • Recover: Tap [Recover] to enter the Confirm menu. You can select Yes to restore to the default settings. Icon Function Audition the vocal command Delete the vocal command Rename the vocal command Add the failure time by 1 Clear the Success Rate test record of the selected vocal command 2.11 Warning Labels The warning labels are attached to this system in order to call your attention to potential hazards.
Page 40: Symbols
2 System Overview 2.12 Symbols This system uses the symbols listed in the following table. Their meanings are explained as follows: Symbol Description Type-BF applied part Caution! Standby No user serviceable parts (power adapter) Product serial number Manufacture date Manufacturer Temperature limit Humidity limitation Atmospheric pressure limitation...
Page 41 2 System Overview Symbol Description Probe connector locking symbol Extending port ECG lead port Power consumption Maximum load for printer bracket on the UMT-400 trolley Maximum load for storage bin on the UMT-400 trolley UMT-400 Trolley output Maximum load for storage bin on the HMT-600 trolley HMT-600 Trolley input Unique Device Identifier...
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Page 43: 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 44: 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 45: Check Before Powering On
3 System Preparation 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, for details see “2.4.2 Environmental Conditions”. • There is no condensation. •...
Page 46: Check The System After It Is Powered On
If you find anything not functioning properly, this may indicate that the system is defective. In this case, shut down the system immediately and contact Mindray Customer Service Department or sales representative. NOTE: When you start the system or switch between transducers, you will hear clicking sounds – this is expected behavior.
Page 47: Standby
3 System Preparation If you will not use the system for a long period of time, you shall: • Disconnect the power adapter. • Disconnect the mains power. • Turn off powers of all peripherals connected to the system. To power the system off Perform the following procedure: Press the power button to see the option: –...
Page 48: Display Position Adjustment
When connecting or disconnecting a probe, place it in the proper position to prevent the probe from falling off or becoming damaged. • Only use probes provided by Mindray. Aftermarket probes may result in damage or cause a fire. 3 - 6...
Page 49: Connecting A Probe
3 System Preparation 3.6.1 Connecting a Probe WARNING The probes, cables and connectors should be in proper operating order and free from surface defects, cracks and peeling. Otherwise, this may lead to electrical shock. NOTE: Before inserting the connector into the probe port, inspect the connector pin. If the pin is bent, do not use the probe until it has been inspected/repaired/replaced.
Page 50: 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 51: Connecting The Footswitch
• Unless otherwise specified, printers listed in Section 2.6.4 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 52 3 System Preparation 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 53: 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 54: 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 55: Image Preset
4 Setup Type Item Description Storage Image Size To set the image size when saving an image or print an image. Save Image Beep To set the key volume for saving single/multi-frame image. Screen Saver Screen Saver • To select a system dormancy type. After the screen saver function is enabled, tap [Browse] to select the figure used for the screen saver and tap [Preview] to see the effect.
Page 56: Measure
4 Setup Type Item Description ViTE Default Image Mode To set the system state after the image is frozen. Elast.Metric To set the default Elast.Metric mode for the ViTE. Dynamic Data Curve To set whether to display the dynamic data curve. Delete invalid results automatically when Q- Scan used...
Page 57: Key Configuration
Tap [Install] to begin installing a disabled option. • Tap [Uninstall] to begin uninstalling a previously-installed option. Please contact the Mindray Customer Service Department or a sales representative for details. 4.1.8 Access Control The system supports two types of users: administrator and operator.
Page 58 4 Setup The operator can only access the function modules with assigned privileges. The operator can only view exam information saved in the system and operated by him or herself, such as patient information, images and reports, etc. Enabling Access Control The system administrator can preset the access controls, that is, whether an operator has the right to access data in the system.
Page 59 4 Setup Tap [Password Policy Config]: Item Description Remark Lockout Set the maximum time that a user can input the For example, assume that the Threshold wrong password. If you exceed the maximum “Lockout Threshold” is set times, your account will be locked. to 5, the “Reset Account Lockout Threshold after”...
Page 60: Scan Code Preset
4 Setup Item Description Days to keep cached Set days to keep the cached passwords in the local system. password Users can log in to the server even without accessing the network within the setting days. • Empty: the passwords are kept in the local system permanently. •...
Page 61 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 62 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 63: 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 64 4 Setup Tap [Import] to open the Load Data screen. Select the imported file. Tap [OK], a progress bar will appear and the setup data is imported to the specified path. To restore the factory setup data, tap [Load Factory] on the right side of the screen. Probe Check This function is used to check the condition of transducer elements to evaluate the probe performance.
Page 65: Ivision
4 Setup 4.1.12 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). Add the contents to be played and select demo mode. Select an item in the list and tap [Start] (in the bottom-left corner of the screen) to begin the demonstration.
Page 66: System Information
4 Setup • When you set password, multi-language and Chinese characters are not supported. Anti-Virus The system provides two anti-virus software: Windows Defender and McAfee. They can effectively prevent the ultrasound system from being attacked by virus, spyware, or other malware. If the McAfee software is installed, the system displays “McAfee is running”;...
Page 67: Exam Related Preset
4 Setup Exam Related Preset You can assign exam modes for each probe or set measurement, body mark and annotation settings for current exam mode. 4.2.1 Exam Mode Preset You can assign available exam modes for probes. Perform the following procedure: Select the probe model in the drop-down list beside Probe column.
Page 68 4 Setup Modify the property of a measurement item. The following takes D trace as an example to show how to set the property of a measurement tool. Select [D Trace] from the [Selected Items] and tap [Property] to bring up the following dialog box.
Page 69: Body Mark/Comment Preset
4 Setup Setting Default Report Template Perform the following procedure: Select the exam mode. 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.
Page 70: Network Related Preset
4 Setup • Tap [Move to Top]/[Move to Bottom] to move the selected protocol to the top or bottom of the list. View Management • Tap to select the views in the list. The image, annotation, body mark and measurement settings can be checked on the right.
Page 71: Dicom Service Preset
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 72 4 Setup Perform the following procedure: Select the DICOM service tab to enter the corresponding settings screen. Enter the correct AE Title, port, etc. – Tap [Add] to add the service to the Service List. – Select an item in the service list, change the parameters in the above area, and tap [Update] to update the item in the service list.
Page 73 4 Setup Item Description Max Frame Rate Set the frame range of transferring cin file into DCM multi-frame file. It is editable to the user. SR Storage Option To enable or disenable structured reporting sending. Encapsulated PDF Select if to encapsulate PDF format report in DICOM standard. It becomes available if SCP supports the function.
Page 74 4 Setup Item Description Copies Refer to copies of printed files. You can select among 1 through 5, or directly enter the numeral. Settings The system supports RGB (color printing) and MONOCHROME2 (black and white printing). Please select the type the printer supports. Film Orientation Select between LANDSCAPE and PORTRAIT.
Page 75 4 Setup Item Description Transport Layer Security. Select whether to encrypt the data during network transportation. MPPS Preset MPPS setting items are described as follows: Item Description Device Name After you set the server (s) in DICOM Server Setting, the name (s) will appear in the drop-down list, select the name of the MPPS server.
Page 76 4 Setup Name NOTE Transport Layer Security. Select whether to encrypt the data during network transportation. Query/Retrieve DICOM query/retrieve setting items are described as follows: Item Description Device Name Select the name of a device that can be added (including the local). Service Name Default is server-queryRetrieve, and it can be modified.
Page 77: Network Preset
4 Setup 4.3.3 Network Preset iStorage Preset You can send exam data or images to the iStorage server and perform analysis using UltraAssist. For details about this feature, see the UltraAssist manual. Item Description Service Name The name of the iStorage service. IP Address IP address of the iStorage service device.
Page 78: Q-Path Preset
4 Setup Select [Upload logs to remote server] to upload logs to the remote server, the service engineer can acquire and handle those log. Check the process in “Task Management” screen. 4.3.4 Q-Path Preset Q-path is a network server provided by Telexy Healthcare Inc. for digital image storage. Q-View is a client viewing tool for the server.
Page 79: His Preset
4 Setup Select a worksheet in the right “Worksheets” column. Tap [Save] to exit, and the system will shut down. 4.3.5 HIS Preset Item Description Server Name The name of the service. Script Select the valid script. Server Address/User Input the Server address. name/Password You should also input user name and password if needed.
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Page 81: 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 82: 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 83: Image Acquisition
WARNING • The images displayed in this system are only reference for diagnosis. Mindray is not responsible for the correctness of diagnostic results. • In Dual-B imaging mode, the measurement results of the merged image may be inaccurate. Therefore, the results are provided for reference only, not for confirming a diagnosis.
Page 84: B Mode
6 Image Acquisition Name Description Patient information The Information area consists of the hospital name, the exam area time, patient information, the exam mode, etc. Probe model, Displays the current probe mode, account power, MI/TI index acoustic output value. value and MITI index Image parameter Displays the image parameters for the active window.
Page 85: B-Mode Image Parameters
6 Image Acquisition 6.2.2 B-mode Image Parameters Image Quality To switch between the fundamental frequency and harmonic frequency as well as select the corresponding frequency type. The real-time frequency value is displayed in the image parameter area in the top-left corner of the screen, and if harmonic frequency is used “F H” is displayed as the harmonic frequency value.
Page 86 6 Image Acquisition Dynamic Range Adjusts contrast resolution of an image, compresses or expands gray display range. The real-time dynamic range value is displayed on the image parameter area. The more the dynamic range, the more specified the information, and the lower the contrast with more noise.
Page 87: Color Mode
6 Image Acquisition Two pages of adjustable parameters are displayed on the touch screen as well; where, shared parameters and left window parameters are displayed in the B (L) page, while right window parameters are displayed in the B(R) page. In the image parameter area, parameters of the both windows are displayed.
Page 88: Power Mode
6 Image Acquisition Line Density The function determines the quality and information of the image. The higher the line density is, the higher the resolution becomes. Packet Size This function is an indication of the ability to detect flow, which is used to adjust the accuracy of color flow.
Page 89: Power Mode Image Scanning
6 Image Acquisition TIP: In Power mode, the acoustic power is synchronous with that of B mode. Adjustment of the depth to the B mode image will lead to corresponding changes in Power mode image. 6.4.1 Power Mode Image Scanning Perform the following procedure: Select a high-quality image during B mode or B + Color scanning, and adjust to position the area of interest in the center of the image.
Page 90: M Mode Image Parameters
6 Image Acquisition Tap [Image] to open the image menu. Adjust the parameters to optimize the image. 6.5.2 M Mode Image Parameters Gain To adjust the gain of M mode image, the real-time gain value is displayed in the image parameter area.
Page 91: Cm Image Parameters
6 Image Acquisition 6.6.2 CM Image Parameters In CM mode, parameters that can be adjusted are in accordance with those in B, M and Color modes; please refer to relevant sections of B, Color and M mode for details. The ROI size and position determine the size and position of the color flow displayed in the color M mode image.
Page 92: Pw Mode
6 Image Acquisition PW Mode PW (Pulsed Wave Doppler) mode is used to provide blood flow velocity and direction utilizing a real-time spectral display. The horizontal axis represents time, while the vertical axis represents Doppler frequency shift. PW mode provides a function to examine flow at one specific site for its velocity, direction and features.
Page 93 6 Image Acquisition Auto Calculation This function is used to trace the spectrum and calculate the PW mode image parameters. The results are displayed in the results window. In real-time scanning, the results displayed are derived from the calculation of the latest cardiac cycle.
Page 94: Iworks (Auto Workflow Protocol)
6 Image Acquisition Quick Angle Adjusts the angle faster in increments of 60°, and the real-time value of which is displayed in the image parameter area. Dynamic Range The dynamic range conveys the information that being transformed from echo intensity to gray scale.
Page 95: Manual Examination
6 Image Acquisition View Operation In the current active view, you can perform image scanning, measurements, and adding comments and body marks, etc. Operations are the same as those for manual operation. See the relevant chapters for details. Tips: If the selected view is configured with measurement items, you can tap [Freeze] and then tap [Update] to start measurement.
Page 96: Check Image Parameter And Change Layout
6 Image Acquisition 6.10.2 Check image parameter and change layout Perform the following procedure: Tap [Edit] to enter the screen for checking the current image menu display for the current exam mode of the particular probe. The [Quick Save] and [Edit] controls are available under all imaging modes Tap and hold any parameter until it floats, then you can: –...
Page 97: Visual Transient Elastography
Visual Transient Elastography DANGER ViTE is available for liver only. CAUTION • It is provided for reference, not for confirming a diagnosis. • Elastography Imaging is an advanced imaging mode. It is used for providing hardness information of lesions, which can be used for clinical reference.
Page 98: Image Acquisition
7 Visual Transient Elastography Image Acquisition Perform the following procedure: Find the examination area. Place the probe head to the right hypochondriac area located at the intersection of the transverse line at the level of the xiphoid process and the midaxillary line, and keep the probe button facing up.
Page 99 7 Visual Transient Elastography to select automatic and continuous acquisition method. – Smart Acquisition The system activates acquisition automatically until 10 valid values are obtained or the system activates acquisition 15 times. If 10 valid values have not been obtained after 15 acquisition attempts, activate smart acquisition again, and the system will start acquisition until 10 valid values are obtained.
Page 100: Image Parameters
7 Visual Transient Elastography Complete a set of scans according to the selected number of automatic acquisition. The times of vibration scan is the times of image triggering. If the probe leaves the skin during the automatic and continuous acquisition, the scan will be suspended. The image is frozen after the final acquisition.
Page 101 7 Visual Transient Elastography Invert Invert the map to satisfy the needs of different doctors when they define the color of shear wave transmission path. M-STB Index Motion stability indicates the degree of motion interference, and reflects the motion interference degree of the currently-captured elasto image and if the elasto image is stable and reliable.
Page 102: Screen Description
7 Visual Transient Elastography Screen Description Image Parameter Area The image parameter area displays the real-time parameter values. The parameter “ROI D” denotes the depth of ROI. 7 - 6 Operator’s Manual...
Page 103 7 Visual Transient Elastography 2D Image Area This area displays 2D image and ROI. Before image acquisition, adjust the position and size of ROI according to needs. • Adjust ROI position: tap the center of the ROI and drag the ROI upwards and downwards to adjust the depth of ROI.
Page 104 7 Visual Transient Elastography Elasto Image Elasto image reflects the property that shear wave transmission changes with time and depth. The slope of the dotted line reflects the transmission speed of the shear wave. The higher the speed is, the harder the tissue is. The Calculation and Display of Elastography and Liver Acoustic Attenuation The calculation results of hepatic fibrosis and liver steatosis analysis (LiSA) are displayed and updated in the real time according to the measured valid observation value.
Page 105 7 Visual Transient Elastography • RLB Ratio: the ratio of valid result number to acquired result number in current exam. It is the success rate of scanning. The success rate is affected by obesity, narrow intracostal space, seroperitoneum, and etc. TIP: •...
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Page 107: Contrast Imaging
Contrast Imaging The contrast imaging is used in conjunction with ultrasound contrast agents to enhance imaging of blood flow and microcirculation. Injected contrast agents re-emit incident acoustic energy at a harmonic frequency much more efficient than the surrounding tissue. Blood containing the contrast agent stands out brightly against a dark background of normal tissue.
Page 108: Image Parameters
8 Contrast Imaging For every single contrast imaging procedure, use [Timer 2] for timing. If necessary, activate destruction function by tapping [Destruct] to destruct the micro-bubbles left by the last contrast imaging; or to observe the reinfusion effect in a continuous agent injecting process.
Page 109: Image Saving
8 Contrast Imaging • DestructAP: Adjust the destruct acoustic power via the touch screen. • Destruct Time: Adjust the destruct time via the touch screen. Dual Live In live mode or freeze mode, tap [Dual Live] to enable dual live function. Both the contrast mode and tissue mode are displayed.
Page 110: Contrast Imaging Qa
8 Contrast Imaging Contrast Imaging QA CAUTION Contrast Imaging QA images are provided for reference only, not for confirming a diagnosis. TIP: • In case of inaccuracy of the data, do not adjust the depth and the pan-zoom when saving the cine.
Page 111 8 Contrast Imaging Time-intensity curve • Y axis represents the intensity (unit: dB), while X axis represents the time (unit: s). • Frame marker: a yellow line that is perpendicular to the X axis, can be moved horizontally left to right (right to left). •...
Page 112 8 Contrast Imaging This function provides a motion compensated ROI as precise time-intensity information can be acquired using active tracking. It can enhance the calculation accuracy as reducing the impact of probe or patient respiratory movement. If necessary, tap [Fit Curve] to perform curve fitting on the time-intensity curve, where color of the fitted curve is consistent with color of the current ROI curve.
Page 113: 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 114 9 Physiological Unit Signal Connect the ECG module to the serial port on the rear cover of the main unit. Place the ECG electrodes on the patient’s body. Turn off the power supply of the system, and connect the ECG module to the system. Connect the ECG cable to the ECG module.
Page 115: Ecg Review
9 Physiological Unit Signal Triggering Mode This system supports 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: Select exam mode.
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Page 117: Display & Cine Review
Display & Cine Review 10.1 Splitting Display The system supports dual-split display format. However, only one window is active. Dual-split: Select [Dual] to be “on” from B image menu to enter dual-split mode. Tap each window to switch the active window (marked with “m” icon.) Tap [B] or select [Dual] to be “Off”...
Page 118: Imaging Mode Switching When Frozen
10 Display & Cine Review 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. (Setting path: [Setup] > [System] > [Image] > “Freeze Config”). Tap [Unfreeze] in freeze mode to unfreeze the image, and the system continues image scanning.
Page 119 10 Display & Cine Review 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 mode, bottom-left corner will indicate time played and total time. Manual Cine Review After entering cine review in 2D mode, drag playback mark to review the cine images on the screen one by one.
Page 120: Linked Cine Review
10 Display & Cine Review 10.5.3 Linked Cine Review The linked cine review refers to review of the images captured at the same moment. • • Duplex mode (B+PW/CW) • Triplex mode Frame synchronization mark The frame mark on the time mark of the M/PW image indicates the corresponding 2D image. 10.6 Image Compare TIP: For B/B+COLOR/B+POWER mode image, you can select at most 2 images;...
Page 121: Frozen Image Storage
10 Display & Cine Review • Tap [Pro Capture] or [Retro Capture] in contrast imaging real-time mode. • Tap [Save Clip] to pro/retro capture the images (setting path: [Setup] > [System] > [General] > “Live Capture” > [Save Clip]) 10.7.2 Frozen image storage In frozen mode, tap [Save Cine].
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Page 123: Measurement And Report
Measurement and Report 11.1 Measurement There are general measurements and application measurement. You can perform measurements on a zoomed image, cine reviewing image, real-time image, or frozen image. There are two types of measurement tools. • Basic tools: the measurement tools for Basic Measurements which are general and have no specific clinical definitions.
Page 124: Measurement Accuracy
11 Measurement and Report • Tapping [UnFreeze] to unfreeze the image during a measurement will clear the basic Measurement data. • Tapping [Clear All] will clear the measurement caliper and all data in the result window, such as comments and body marks. •...
Page 125: Measurement Preset
11 Measurement and Report Table 11-4 Liver Elasticity Index Item Range or Error Elasticity display range of Young's modulus 1.5 kPa - 75 kPa Max. detection depth The depth of the lower interface of the deepest target image that can be observed ≥ 70 mm Accuracy of ViTE velocity measurement Within ±20% Repeatability of ViTE velocity measurement...
Page 126: Measurement Menu
11 Measurement and Report Keys Basic Operations Report To enter the report preview page. 11.1.4 Measurement Menu Select [Measure] > [Basic]/[Advanced] to enter the basic/advanced measurement. The measurement menus are shown in the following figures: TIP: • The order of the measurement items can be preset. •...
Page 127: Measurement, Calculation And Study
11 Measurement and Report • Location (Prox./Mid./Dist.): belongs to items (e.g., vascular) that contain measurements of Proximal, Middle or Distal parameters. Measurement Tool There are two types of measurement tools. • Basic tools: the measurement tools for Basic Measurements which are general and have no specific clinical definitions.
Page 128: Measurement Caliper
11 Measurement and Report On the touch screen, calculation tools are displayed using square button. Study A group of measurements and/or calculations for a specific clinical application, which are indicated by “ ” in the preset screen. For example, AFI in the OB measurement. 11.2.1 Measurement Caliper A measurement caliper is a graphic consisting of several points and a straight line or curve drawn on the ultrasound image.
Page 129: Basic Measurement
11 Measurement and Report 11.3 Basic Measurement 11.3.1 Depth • Phased array probe: the depth is the distance from the center of the sector to the cursor. • Convex array probe: the depth is the distance from the transducer surface to the measuring cursor in the direction of the ultrasonic wave.
Page 130: Area & Circumference
11 Measurement and Report The angle appears in the results window after setting the line segments. 11.3.4 Area & Circumference Measures the area and circumference of a closed region on the image. Four measurement methods are available: • Ellipse: fix an ellipse region by two equal-cut perpendicular axes. •...
Page 131: Double Distance
11 Measurement and Report Where D1, D2 and D3 are the length of three axes of the target object. Perform the following procedure: Select [Volume] in the measurement menu. The cursor appears on the screen. Here D1, D2 and D3 are the lengths of three axes of the target object. For detailed procedures, see “11.3.2 Distance”.
Page 132: Spline Length
11 Measurement and Report confirmed. During the measurement, tap the screen twice to set the last parallel line and complete the measurement. 11.3.8 Spline Length Measures the length of a curve on the image. Perform the following procedure: Select [Trace Len (Spline)] in the measurement menu. The cursor appears on the screen. Drag the cursor to an area of interest.
Page 133 11 Measurement and Report Tap on the screen twice to anchor the last reference point. The spline is fixed and the results display in the results window. Cross Perform the following procedure: Select [Cross] in the measurement menu. The cursor appears on the screen. Move the cursor to an area of interest.
Page 134 11 Measurement and Report Tap on the screen to set the end point. 11.3.13HR On M/Doppler image, measures the time interval of n (n≤8) cardiac cycles on the M Mode image and calculates the heart rate. The number of cardiac cycles “n” can be preset, see “4.1.4 Measure”. CAUTION During the measurement, the number of cardiac cycles between the measurement start and end points must be exactly the same as preset.
Page 135: Velocity
11 Measurement and Report A heartbeat cycle ▼ PS ▲ ED Base line ▲ MD Systolic Diastolic cycle cycle NOTE: When doing D trace, please set systolic starting time as the starting point and diastolic ending time as end point. That is, by tracing the Doppler spectrum from systolic to diastolic to calculate indices. Perform the following procedure: Select [D Trace] in the measurement menu.
Page 136: Ps/Ed
11 Measurement and Report Parameters Descriptions PS/ED S/D (No unit) = PS (m/s) / ED (m/s) Pulsative Index Pulsatility index. PI (No unit) = |(PS (m/s) - ED (m/s)) / TAMAX (m/s)| Resistive Index Resistance index.RI (No unit) = |(PS (m/s) - ED (m/s)) / PS (m/s)| θ...
Page 137: Volume Flow
11 Measurement and Report Perform the following procedure: Tap [Auto Calc.] in the PW image menu to activate it. The system traces automatically and displays the results on the screen. Tap [Auto Calc] in the PW image menu. You can select the parameters to be calculated. Tap [Auto Cardiac Cycle] in [Auto Calc] image menu.
Page 138: Advanced Measurement
11 Measurement and Report 11.4 Advanced Measurement Basic Measurement Procedures: Tap [Patient] and register the patient information. Tap [Measure] and select [Advanced] to enter the Advanced Measurements. Select the measurement tool in the menu to start the measurement. For measurement methods, see “11.3 Basic Measurement”. 11.4.1 Abdomen Measurement Tools Measurement, calculation and study measurement items in 2D and Doppler mode (no M mode measurement items) are listed below.
Page 139 11 Measurement and Report Tools Descriptions Methods in Basic Measurement Pericardial Sac L Pericardial Sac Length Distance Pericardial Sac H Pericardial Sac Height Pericardial Sac W Pericardial Sac Width Prox ABD Aorta D Trace Mid Sup ABD Aorta Mid Suprarenal ABD Aorta Mid Inf ABD Aorta Mid Infrarenal ABD Aorta Distal ABD Aorta...
Page 140: Obstetric Measurement Tools
11 Measurement and Report Tools Measurement items included Methods or formulae Pleural Pleural L, Pleural H, Pleural W Use Distance to measure the 3 distances and UQ (Upper Quadrant) UQ L, UQ H, UQ W calculates the Volume. Pelvis Pelvis L, Pelvis H, Pelvis W Pericardial Sac Pericardial Sac L Pericardial Sac H...
Page 141 11 Measurement and Report Tools Descriptions Methods in Basic Measurement Thoracic Diameter Distance Sac Diam1 Gestational Sac Diameter 1 Sac Diam2 Gestational Sac Diameter 2 Sac Diam3 Gestational Sac Diameter 3 Amniotic Fluid 1 Amniotic Fluid 2 Amniotic Fluid 3 Amniotic Fluid 4 Cervix L Cervical Length...
Page 142 11 Measurement and Report GA will be automatically calculated after the corresponding measurements are completed. The system will recalculate the GA after new measurements are completed. The GA formulae are shown in the table below: NOTE: “/” means no formula provided for the item. Tools EFW/EFW2 Tokyo...
Page 143 11 Measurement and Report Tools Hadlock Jeanty Hansmann ChittyPL ChittyDer Nicolaides ASUM Hadlock Jeanty Merz Nicolaides ASUM CFEF Hansmann Chitty Hadlock Tokyo Jeanty Hohler Merz Hansmann Warda Chitty Osaka China Nicolaides ASUM CFEF Hansmann Nicolaides ASUM Jeanty OSAKA Hansmann Jeanty ASUM Hill Nicolaides...
Page 144 11 Measurement and Report EFW is a calculation item. If all tools required for the EFW formula have been performed, EFW will be obtained automatically. The system will recalculate the EFW after new measurements are completed. The Fetal Weight formulae are shown in the following table : Formulae Descriptions Units...
Page 145 11 Measurement and Report average EFW x1.25 > EFW > average EFW x0.75 E.g. EFW-GP(LMP) is the EFW Clinical Percentile calculated from the LMP obtained from the patient information. • Ultrasound Percentile (UP) This has the same calculation method as CP except for using the ultrasound GA instead of clinical GA.
Page 146: Gynecology Measurement Tools
11 Measurement and Report AUA is the average of the valid GAs that are calculated according to the biparietal diameter (BPD), head circumference (HC), abdomen circumference (AC), femur length (FL), Gestational Sac (GS), crown rump length (CRL), etc. All valid values of all the above items will be included in the AUA calculation in the system default method.
Page 147 11 Measurement and Report Calculation and Study items Types Tools Descriptions Methods or formulae Calculation Ovary Vol. Ovary Volume Measures the Ovary L, Ovary H and Ovary W, calculates the Ovary Vol. UT Vol. UT Volume Measures the UT L, UT H and UT W, calculates the UT Vol.
Page 148 11 Measurement and Report Types Tools Descriptions Methods or formulae Study Uterus Measures the UT L, UT H, UT W and Endo, calculates the UT Vol., UT SUM and UT-L/CX- Ovary Measures the Ovary L, Ovary H and Ovary W, calculates the Ovary Vol.
Page 149: Report
11 Measurement and Report Tools Descriptions Methods in basic measurement Internal Iliac Vein Velocity Common Femoral Vein Superficial Femoral Vein Deep Femoral Vein Calculation and Study items Types Tools Descriptions Methods or formulae Calculation Stenosis D Stenosis Diameter Stenosis D (No unit) = (Normal Diam. (cm) - Resid Diam.
Page 150 11 Measurement and Report • Select ultrasound image layout: Select from the drag-down list of Ultrasound Image Layout. • Print report: Tap [Print]. • Select Image/B Image/Elastograms/Trend/Comments: Tap the checkbox to select if the selected image/B image/Elastograms/trend/comments are included when printing the report. •...
Page 151: Editing Reports
11 Measurement and Report 11.5.2 Editing Reports TIP: History reports can be viewed, but cannot be edited. On the report preview page, tap [Worksheet] to enter the report edit page. • Each measurement contains one measured value. • The report only displays results of tools that are displayed in the report template by default and are completed, as shown in the figure above.
Page 152: Obstetric Exam Report
11 Measurement and Report NOTE: • Only measurement values are editable, while calculation values and ViTE data are not. • After a measurement value is modified, the corresponding calculation value will be updated automatically. The measurement values in the text boxes are editable. Move the cursor to the text box and tap on the screen to type on the popped up keyboard.
Page 153: Printing Reports
11 Measurement and Report Fetal growth Score 0 Score 2 Observation index time No FBM or duration ≤ 30 s FBM ≥ 1 times; duration ≥ 30 s 30 minutes Limbs and spine stretch/bend ≥ 1 Limbs stretch, no bend, fingers loose times One or more AF volumes ≥...
Page 154 11 Measurement and Report Degroff, C. G. Doppler Echocardiography. Third Edition. Lippincott-Raven, Philadelphia, 1999, p. 102-103 Burns, P.N., “The Physical Principles of Doppler and Spectral Analysis,” Journal of Clinical Ultrasound, November/December 1987, Vol. 15, No. 9, p. 586 Burns, Peter N., “The Physical Principles of Doppler and Spectral Analysis,” Journal of Clinical Ultrasound, November/December 1987, Vol.
Page 155 11 Measurement and Report • Hadlock FP, et al. Fetal Crown-Rump Length: Reevaluation of Relation to Menstrual Age (5-18 weeks) with High-Resolution Real-time US. Radiology 182:501-505. • Jeanty P, Romero R. “Obstetrical Sonography”, p. 56. New York, McGraw-Hill, 1984. • Nelson L.
Page 156 11 Measurement and Report • Chitty LS, Altman DG British Journal of Obstetrics and Gynaecology January 1994, Vol.101 P29-135. • China Written by Zhou Yiongchang & Guo Wanxue in Chapter 38 of “Ultrasound Medicine” (3rd edition) Science & Technology Literature Press, 1997 •...
Page 157 11 Measurement and Report British Journal of Obstetrics and Gynaecology January 1994, Vol.101 P29-135. • Chitty L.S., Altman D.G., Hendesson A., Campell S., Charts of fetal size: 2 Head measurements, Br J Obstetric Gynecology 1994, Vol 101, P 35-43. Altmann D.G.; Chitty L.S. “New charts for ultrasound dating of pregnancy” Ultrasound in Obstetrics and Gynecology Vol.
Page 158 11 Measurement and Report • Hansmann M, Hackelöer BJ, Staudach A Ultraschalldiagnostik in Geburtshilfe und Gynäkologie 1995 • Hadlock FP, et al. Estimating Fetal Age: Computer-Assisted Analysis of Multiple Fetal Growth Parameters. Radiology 1984; 152 (No. 2):499. • Warda A. H., Deter R. L. & Rossavik, I. K., 1985. Fetal femur length: a critical re-evaluation of the relationship to menstrual age.
Page 159 11 Measurement and Report APAD Merz E., Werner G. & Ilan E. T., 1991 Ultrasound in Gynecology and Obstetrics Textbook and Atlas 312, 326-336. Hansmann M, Hackelöer BJ, Staudach A Ultraschalldiagnostik in Geburtshilfe und Gynäkologie 1985 Fetal Growth Chart Using the Ultrasonotomographic Technique Keiichi Kurachi, Mineo Aoki Department of Obstetrics and Gynecology, Osaka University Medical School Revision 3 (September 1983)
Page 160 11 Measurement and Report Jeanty P., Cousaert E., Cantraine F., Hobbins J.C., Tack B., Struyven J. “A longitudinal Study of fetal limb growth” American Journal of Perinatology; Volume 1; Number 2; January 1984;136-144 Tibia Merz E., Werner G. & Ilan E. T., 1991 Ultrasound in Gynaecology and Obstetrics Textbook and Atlas 312, 326-336.
Page 161 11 Measurement and Report • Studies on Fetal Growth and Functional Developments Takashi Okai Department of Obstetrics and Gynecology, Faculty of Medicine, University of Tokyo • Brenner W.E., Edelman D.A., Hendricks C.H. A standard of fetal growth for the United States of America.
Page 162 11 Measurement and Report FL/BPD Hohler C.W., Quetel, T:A: Comparison of Ultrasound Femur Length and Biparietal Diameter in Late pregnancy. American Journal of Obstetrics and Gynecology, volume 14, No. 7: 759-762, 1- Dec.-1981 Ut A RI/MCA RI Kurmanavicius J, Florio I, Wisser J, Hebisch G, Zimmermann R, Muller R et al. Reference resistance indices of the umbilical, fetal middle cerebral and uterine arteries at 24-42 weeks of gestation.
Page 163: Annotations And Body Marks
Annotations and Body Marks WARNING Ensure that the entered annotations (body marks) are correct. Incorrect annotations may lead to misdiagnosis! 12.1 Annotations 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 164: Modifying (Editing) Annotations
12 Annotations and Body Marks Under annotation status (annotation menu is highlighted in blue), tap to select the annotation to be moved. Tap the desired position to move the annotation to current position. Tap regions other than the moved annotation on the image area to confirm the position. 12.1.3 Modifying (Editing) Annotations Modifying (Editing) characters Perform the following procedure:...
Page 165: Adding Body Mark
12 Annotations and Body Marks 12.2.1 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 166: Adding Voice Comments
12 Annotations and Body Marks 12.3.2 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 167: 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. 13.1 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 168: Image Storage Setting
13 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 169: Sending Image Files
13 Patient Data Management In image review status, double-click the selected thumbnail to open the image. You can perform cine review operations in image analysis status. Tap [Return] to exit image analysis. 13.1.6 Sending Image Files NOTE: Data saved this way can only be reviewed on the PC and cannot be restored to the ultrasound system.
Page 170: Patient Data Management (Istation)
13 Patient Data Management NOTE: • If the password is forgotten, you cannot open the backup package. • The password cannot be multi-language or Chinese characters. Export report via Send To In the iStation or Review screen, use [Send To] to send patient data to an external memory device or network storage, you can choose if reports are exported.
Page 171: Patient Data View & Management
13 Patient Data Management 13.3.2 Patient Data View & Management Tap to select the desired patient exam in the list, you can: Item Description Delete Exam Select an exam record, tap [Delete] to delete the record. You cannot delete patient data which is being printed, exported or sent, or delete the current exam. Backup/ You can back up the selected patient data to the system-supported media in order Restore...
Page 172: Print
13 Patient Data Management For network storage setting, see “4.3 Network Related Preset”. Enter iStation, select one (or more than one) patient data or image in the local data source. Tap [Send To]. Select [iStorage] in the Send To dialog box, and select the PC server of the right side. Select PC transfer format and check whether to send report.
Page 173: Patient Task Management
13 Patient Data Management 13.8 Patient Task Management in the top-right part of the screen to bring up the following dialog box. In the Task Management dialog box, the patient name, destination, progress, type and task created time are displayed. You can perform the following operations: •...
Page 174: V-Access
13 Patient Data Management Task Status • When there are tasks underway, the task management icon displays as • When tasks have failed, the task management icon displays as . Tap the icon to check the reason for the failure. •...
Page 175 13 Patient Data Management Log in to the Q-Path server through the Q-View browser to check the stored images and worksheet reports. If network connection is not normal, the system will prompt “Loading Q-path application, please wait..”. to exit the function. Operator’s Manual 13 - 9...
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Page 177: 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 178: To Send Images To Storage After An Exam Ends
14 DICOM/HL7 Tap [Send] to start sending. 14.1.2 To send images to storage after an exam ends TIP: • To preset Sending/printing after End Exam, for details see “4.1.2 General”. • To set a default storage server, for details see “4.3.2 DICOM Service Preset”. Start the ultrasound exam scan.
Page 179: Worklist
14 DICOM/HL7 14.3 Worklist When the DICOM basic package is configured and the Worklist server has been set, click [Worklist] in the “Patient Info” screen to query or import the patient data. The system supports: DICOM, HL7 and HIS. Perform the following procedure: In Patient screen, select [Worklist] in the bottom-left corner to enter the import screen.
Page 180: Storage Commitment
14 DICOM/HL7 • When you begin an exam or send images during an exam, the system sends “Active” status information to the MPPS server. • When the exam is complete, the system sends “End” status information to the MPPS server. •...
Page 181: Dicom Media Storage
14 DICOM/HL7 After setting the DICOM query/retrieve server, you can perform the query/retrieve function in the iStation screen. Tap [iStation] to enter iStation screen. Tap [Query/Retrieve] to open Query/Retrieve screen. Select the server (both the source and the destination). Enter the query information, such as Patient ID, Patient Name, Accession #, Exam Date or key words.
Page 182: Data Restore
14 DICOM/HL7 14.7.3 Data Restore NOTE: Only system-accessible media can be selected. After the DICOM format data are saved to external media, restore the data to the ultrasound system. Connect the external media containing DCM files to the system. In iStation, review the data stored on the external media. Select the data to be restored in iStation.
Page 183: Probes And Biopsy
Probes and Biopsy 15.1 Probes Table 15-1 Available probes Probe Mode Region Applied Intended Use Mode of Operation Probe Figure C5-1s Body surface Fetal, B, M, Color, Power, Abdominal, PW, B+M, PW+B, Pediatric, Color+B, Power+B, Peripheral PW+Color+B, vessel Power+PW+B, Tissue Harmonic Imaging, Biopsy Guidance, Color M, Contrast...
Page 184: Probe Functions By Part
15 Probes and Biopsy 15.1.1 Probe Functions by Part 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.
Page 185: Procedures For Operating
15 Probes and Biopsy Orientation mark Mark 15.1.3 Procedures for Operating WARNING Disinfect the probe and sterilize the needle-guided bracket before and after an ultrasound-guided biopsy procedure is performed. Failure to do so may cause the probe and the needle-guided bracket becomes a source of infection. The proper clinical technique to be This section describes general procedures for operating the probe.
Page 186 15 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 187: Wearing The Probe Sheath
15 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 188: Probes Cleaning And Disinfection
15 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 189 15 Probes and Biopsy NOTE: • After the examination, wipe off the ultrasound gel thoroughly. Otherwise, the ultrasound gel may solidify and degrade the image quality of the probe. • DO NOT make the probe to become overheated (more than 55 °C) during cleaning and disinfections.
Page 190 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. Low-level disinfection of a non-critical probe CAUTION Use protective eyewear when disinfecting using sprays.
Page 191 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 192: Cleaning The Probe Cable And Connector
Store the probe in a cool, clean and dry environment. And repeat the cleaning and disinfection process before the next use. Compatible Disinfectants For the disinfectants information, see Mindray Transducer Disinfectant Recommendation. 15.1.6 Cleaning the probe cable and connector NOTE: Do not use cloth with water to clean the probe connector.
Page 193: Biopsy Guide
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. 15.2 Biopsy Guide WARNING •...
Page 194 15 Probes and Biopsy cause the probe and the needle-guided bracket become sources of infection. • The needle mark displayed on the ultrasound image does not indicate the actual position of the biopsy needle. Therefore, it should only be used as a reference.
Page 195: Needle-Guided Brackets Available
(optional accessory) and a biopsy needle (provided by the user). Be sure to perform inspections before and after use of the needle-guided bracket. If an abnormality is found on the needle-guided bracket, immediately stop using it and contact MINDRAY Customer Service Department or sales representative. •...
Page 196 15 Probes and Biopsy 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. Hold the probe by one hand, select the proper needle-guided bracket, and hold it with the other hand.
Page 197: Verifying The Biopsy Guide Line
15 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 198: Starting The Biopsy Procedure
15 Probes and Biopsy – Save the verified settings: After the position and angle of the guide line are adjusted, tap [Save] and the system saves the current guide line settings. If biopsy is entered again, the displayed Position and Angle are the verified value. –...
Page 199: 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 200: 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 201 15 Probes and Biopsy • The middle line is a vertical dotted line located in the middle of the screen, the position and direction of which cannot be changed. • There is a mark icon of “×” located on the middle line which can be moved up and down along the line by swiping downwards/upwards.
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Page 203: 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 204: Dvr Video Replaying
16 DVR Recording 16.3 DVR Video Replaying You can replay the video and audio record. 16.3.1 Replay on PC Connect the USB disk or optical disk with the file to the PC, and open the file directly. 16.3.2 Replay on the ultrasound system Perform the following procedure: >...
Page 205: 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 206 17 System Maintenance • 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. Cleaning probes Tools: mild soapy water , dry soft cloth, soft brush Method: Wipe out the dust attached to surface of probe head, connector and cable.
Page 207 17 System Maintenance Cleaning the dust-proof cover CAUTION Please clean all the system’s dustproof covers periodically (once per month). Failure to do so may result in system damage. Cleaning times can be increased when the system is used in the open air or somewhere more dusty. Perform the following procedure: Press the clip of the dust-proof cover and unfold it outwards (shown in the figure below).
Page 208: Cleaning The Peripherals
17 System Maintenance 17.1.2 Cleaning the peripherals Do the cleaning maintenance according to your actual peripheral configuration; items which are not configured can be skipped. Content Description Color and B/W video First wipe off dust or stain attached to the cover of printer with soft dry printer cloth, then clean the inside of printer.
Page 209: Troubleshooting
17.2 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 211: A Barcode Reader
Barcode Reader The product supports logging data as patient ID by using 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. CAUTION Ensure the information acquired by barcode reader is consistent with the actual information.
Page 212: Overview
A Barcode Reader A.1.1 Overview • Green: A barcode was successfully decoded. • Red: A data transmission error or reader malfunction occurred. Scan window Scan the barcode. Trigger Press to decode. A.1.2 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.
Page 213: Setting
A.1.3 Setting The reader has factory settings, for details see “A.1.5 Parameter Defaults”. The reader supports some user-defined functions as introduced below. For more details, please contact the SYMBOL reader agents or Mindray Customer Service Department. Volume setting Scan the following barcode to set the volume parameter.
Page 214 A Barcode Reader • To enable Codabar, scan the appropriate barcode below Code 39 full ASCII setting Code 39 Full ASCII is a variant of Code 39 which pairs characters to encode the full ASCII character set. 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 215: Scanning In Hand-Held Mode
A Barcode Reader A.1.4 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 216: Parameter Defaults
A Barcode Reader Hold the trigger until the digital imager reader beeps, indicating the barcode is successfully decoded. Steps 2 - 4 above may be required to repeat on poor quality or difficult barcodes. The aiming pattern is smaller when the digital imager reader is closer to the symbol and larger when it is farther from the symbol.
Page 217: Jadak Barcode Reader
The Ultrasound System supports the following barcode readers: HS-1M JDK-2413 and HS-1R JDK-2601. 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. Operator’s Manual A - 7...
Page 218: Setting Up The Jadak Barcode Reader
A Barcode Reader A.2.2 Setting Up the JADAK Barcode Reader Perform the following procedure: Turn off the power to the Ultrasound System. Connect the appropriate interface cable to the barcode reader. Plug the other end of the cable into a free USB port on the Ultrasound system. Once the imager has been fully connected, power on the Ultrasound System.
Page 219 A Barcode Reader Configuration before use Perform the following procedure: Scan the following 1-D barcode to configure the barcode reader: Scan the following 1-D barcode to enable the suffix: 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.
Page 220: Maintenance
A Barcode Reader For scanning RFID Maintenance Cleaning the exit window is the only maintenance required. A dirty window can affect scanning accuracy. • Do not allow any abrasive material to touch the window. • Remove any dirt particles with a damp cloth. •...
Page 221 • Keep at least 20 cm away from the ultrasound system when the wireless LAN function is in use. • Please contact the Mindray service engineers when the cybersecurity threat is detected. NOTE: • For a better wireless LAN transmission effect, please take the following settings: –...
Page 222: B Wireless Lan
IP address of the system should be in the same network segment with the server. Tap [Save] to save current setting. Tap [Cancel] to exit. B.1.2 EAP Network For setting EAP network, contact Mindray Customer Service Department or the sales representatives. Specifications...
Page 223: 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 224 B Wireless LAN Failure Measure The ultrasonic device is frequently off line or • Check if Mindray recommended wireless disconnects from the network. AP is used. If not, verify the AP effective transmission rate meets the throughput The transmission delay is too long.
Page 225: 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 226: Introduction Of Each Unit
C Trolley and Accessories C.1.2 Introduction of Each Unit 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> Trolley handle Used for ascending/descending the trolley or moving the trolley.
Page 227: 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 228: Trolley
C Trolley and Accessories HMT-600 Trolley C.2.1 Trolley Accessories • Probe/Gel holder • Storage bin C.2.2 Introduction of Each Unit Name Function Main unit of ultrasound system Probe/Gel holders Used for placing probes temporarily or placing the gel. Control panel Key- pressing operator-system interface or control.
Page 229: Control Panel Position Adjustment
• Equipotential terminal: Used for equipotential connection, balancing the protective earth potentials between the system and other electrical equipment. NOTE: Retractable cable can be configured before factory. For details, please contact Mindray service engineer. C.2.3 Control Panel Position Adjustment Lock Unlock •...
Page 230 C Trolley and Accessories Table Stand Name Function <1> Main unit support Used for fixing the ultrasound system. <2> Base Used for fixing the main unit support. C - 6 Operator’s Manual...
Page 231: 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 232: Iscanhelper Menu
D iScanHelper Tap [Exit] or on the operating panel 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. D.3.2 Help Information Area Ultrasonic image, anatomic graphic, scanning picture and scanning tips are provided in the “View” menu.
Page 233: Single/Quad-Window Display
D iScanHelper • 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 235: 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 237 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 238: F List Of Vocal Commands
F List of Vocal Commands Vocal command Operation Zoom Out Zoom Out Image Sound Volume Up Turn Sound Volume Up Sound Volume Down Turn Sound Volume Down Angle More Angle More One Angle Less Angle Less One BaseLine Down Decrease the Baseline Position BaseLine Up Increase the Baseline Position Save Image...
Page 239 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 240: 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 241 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 242 G EMC Guidance and Manufacturer’s Declaration Table G-2 GUIDANCE AND MINDRAY DECLARATION-ELECTROMAGNETIC IMMUNITY The system is intended for use in the electromagnetic environment specified below. The customer or the user of system should assure that it is used in such an environment.
Page 243 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 244 G EMC Guidance and Manufacturer’s Declaration Table G-4 RECOMMENDED SEPARATION DISTANCES BETWEEN PORTABLE AND MOBILE RF COMMUNICATION DEVICE AND THE SYSTEM The system is intended for use in an electromagnetic environment in which radiated RF disturbance are controlled. The customer or the user of system can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communication equipment (transmitters) and system as recommended below, according to the maximum output power of the communication equipment.
Page 245: H Electrical Safety Inspection
Electrical Safety Inspection The following electrical safety tests are recommended as part of a comprehensive preventive maintenance program. They are a proven means of detecting abnormalities that, if undetected, could prove dangerous to either the patient or the operator. Additional tests may be required according to local regulations.
Page 246: Device Enclosure And Accessories
H Electrical Safety Inspection Device Enclosure and Accessories H.2.1 Visual Inspection Test Item Acceptance Criteria The enclosure and No physical damage to the enclosure and accessories. accessories No physical damage to meters, switches, connectors, etc. No residue of fluid spillage (e.g., water, coffee, chemicals, etc.). No loose or missing parts (e.g., knobs, dials, terminals, etc.).
Page 247: Enclosure Leakage Test
H Electrical Safety Inspection • normal polarity with open neutral (Single Fault Condition); • reverse polarity with open neutral (Single Fault Condition). LIMITS • For ES 60601-1: 300 μA in Normal Condition. – 1000 μA in Single Fault Condition. – •...
Page 248: Mains On Applied Part Leakage
H Electrical Safety Inspection Mains on Applied Part Leakage The Mains on Applied Part test applies a test voltage, which is 110% of the mains voltage using a limiting resistance, to selected applied part terminals. Current measurements are then taken between the selected applied part and earth.
Page 249: I 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 250: Mi/Ti Explanation
I 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 I.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 251: Mi/Ti Display
I 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 252: Acoustic Power Control
I Acoustic Output NOTE: This system automatically returns to the settings whenever changes are made to the values (when you turn on the power, switch between probes, end the exam, or select OK or Cancel in 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.
Page 253: Limits Of Acoustic Output
I Acoustic Output  –   10     f c z  atten water 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 254: Measurement Uncertainty
I Acoustic Output Measurement Uncertainty The total estimated measurement uncertainty (where the total uncertainty includes the uncertainties in hydrophone response, measurement, calculation, and positioning) are: Acoustic Quantities Total Uncertainties (Standard) Power • 26.48% for non-scan modes • 6.03% for scan modes Frequency 0.22% Pressure...
Page 255: J Acoustic Power Data And Surface Temperature Data
Acoustic Power Data and Surface Temperature Data This manual gives all the transducers Acoustic Output Power data and Surface Temperature Data for this Diagnostic Ultrasound System. Please refer to correlative tables in use. The acoustic output data of transducers are shown respectively in the following imaging modes. The mode in the parenthesis refers to the imaging mode mentioned in this Manual.
Page 256 J Acoustic Power Data and Surface Temperature Data Symbol Description Bone Thermal Index at-surface, non-scanning as,ns Bone Thermal Index below surface, scanning bs,sc Bone Thermal Index below surface, non-scanning bs,ns Cranial-bone Thermal Index Attenuated peak-rarefactional acoustic pressure, value of the peak- r,α...
Page 257: Transducer Maximum Surface Temperature
According to the requirements of the section 201.11 in the standard IEC 60601-2-37: 2015, the transducer surface temperature has been tested in two kinds of conditions: the transducer suspended in still air or transducer contacting human-tissue mimicking material. The measurement data were obtained under the test conditions employed at Mindray. Transducer Maximum surface temperature(°C)
Page 258 J Acoustic Power Data and Surface Temperature Data Acoustic Output Reporting Table for Track 3 J.3.1 C5-1s Transducer Model: C5-1s Imaging Mode: M-mode Index label Below Below surface surface surface surface Maximum index value 1.31 0.14 0.24 0.23 Index component value 0.14 0.11 0.23...
Page 259 J Acoustic Power Data and Surface Temperature Data Transducer Model: C5-1s Imaging Mode: B-mode/Tissue Harmonic Imaging/Free Xros M/Contrast imaging (Contrast agent for Liver) Index label Below Below surface surface surface surface Maximum index value 1.41 0.14 0.38 0.38 Index component value 0.14 0.14 0.38...
Page 260 J Acoustic Power Data and Surface Temperature Data Transducer Model: C5-1s Imaging Mode: B+M-mode Index label Below Below surface surface surface surface Maximum index value 1.43 0.10 0.16 0.25 Index component value 0.10 0.09 0.10 0.16 at z (MPa) 2.16 r,α...
Page 261 J Acoustic Power Data and Surface Temperature Data Transducer Model: C5-1s Imaging Mode: PW-mode Index label Below Below surface surface surface surface Maximum index value 0.54 0.28 1.18 0.60 Index component value 0.28 0.23 0.56 1.18 at z (MPa) 0.77 r,α...
Page 262 J Acoustic Power Data and Surface Temperature Data Transducer Model: C5-1s Imaging Mode: B+PW-mode Index label Below Below surface surface surface surface Maximum index value 1.43 0.27 1.15 0.60 Index component value 0.27 0.22 0.17 1.15 at z (MPa) 2.16 r,α...
Page 263 J Acoustic Power Data and Surface Temperature Data Transducer Model: C5-1s Imaging Mode: Color+B-Mode / Power+B-Mode Index label Below Below surface surface surface surface Maximum index value 1.17 0.27 0.27 1.39 Index component value 0.27 0.27 0.27 0.27 at z (MPa) 1.77 r,α...
Page 264 J Acoustic Power Data and Surface Temperature Data Transducer Model: C5-1s Imaging Mode: Color+B+PW-Mode/Power+B+PW-Mode Index label Below Below surface surface surface surface Maximum index value 0.92 0.12 0.58 0.33 Index component value 0.11 0.12 0.10 0.58 at z (MPa) 1.40 r,α...
Page 265 J Acoustic Power Data and Surface Temperature Data Transducer Model: C5-1s Imaging Mode: CM/B+CM Index label Below Below surface surface surface surface Maximum index value 1.03 0.55 1.47 0.82 Index component value 0.55 0.46 0.32 1.47 at z (MPa) 1.78 r,α...
Page 266 J Acoustic Power Data and Surface Temperature Data J.3.2 LFP5-1s Transducer Model: LFP5-1s Imaging Mode: M-mode Index label Below Below surface surface surface surface Maximum index value 1.00 0.09 0.40 0.14 Index component value 0.02 0.09 0.14 0.40 at z (MPa) 1.70 r,α...
Page 267 J Acoustic Power Data and Surface Temperature Data Transducer Model: LFP5-1s Imaging Mode: B-mode/Tissue Harmonic Imaging/Free Xros M/ViTE Index label Below Below surface surface surface surface Maximum index value 1.28 0.09 0.57 0.57 Index component value 0.09 0.09 0.57 0.08 at z (MPa) 2.14...
Page 268 J Acoustic Power Data and Surface Temperature Data Transducer Model: LFP5-1s Imaging Mode: B+M-mode Index label Below Below surface surface surface surface Maximum index value 1.21 0.07 0.09 0.38 Index component value 0.06 0.07 0.06 0.09 at z (MPa) 1.64 r,α...
Page 269 J Acoustic Power Data and Surface Temperature Data Transducer Model: LFP5-1s Imaging Mode: PW-mode Index label Below Below surface surface surface surface Maximum index value 0.81 0.29 1.17 0.50 Index component value 0.08 0.29 0.50 1.17 at z (MPa) 1.16 r,α...
Page 270 J Acoustic Power Data and Surface Temperature Data Transducer Model: LFP5-1s Imaging Mode: B+PW-mode Index label Below Below surface surface surface surface Maximum index value 1.28 0.26 1.09 0.54 Index component value 0.08 0.26 0.10 1.09 at z (MPa) 1.92 r,α...
Page 271 J Acoustic Power Data and Surface Temperature Data Transducer Model: LFP5-1s Imaging Mode: Color+B-Mode / Power+B-Mode Index label Below Below surface surface surface surface Maximum index value 1.25 0.10 0.10 0.53 Index component value 0.10 0.10 0.10 0.10 at z (MPa) 1.89 r,α...
Page 272 J Acoustic Power Data and Surface Temperature Data Transducer Model: LFP5-1s Imaging Mode: Color+B+PW-Mode/Power+B+PW-Mode Index label Below Below surface surface surface surface Maximum index value 0.75 0.13 0.59 0.25 Index component value 0.05 0.13 0.06 0.59 at z (MPa) 1.12 r,α...
Page 273 J Acoustic Power Data and Surface Temperature Data Transducer Model: LFP5-1s Imaging Mode: CM/B+CM Index label Below Below surface surface surface surface Maximum index value 1.28 0.25 1.07 0.47 Index component value 0.07 0.25 0.09 1.07 at z (MPa) 2.02 r,α...
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Page 276 P/N: 046-019205-00 (5.0)

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