Page 1 DP-7 Digital Ultrasonic Diagnostic Imaging System Operator’s Manual [Basic Volume]...
Page 3: Table Of Contents
Contents Intellectual Property Statement ......................I Responsibility on the Manufacturer Party ..................I Warranty ............................II Exemptions ........................... II Customer Service Department ..................... II Important Information ........................III About This Manual ........................... III Notation Conventions ........................IV Operator’s Manuals .......................... IV Manuals on Paper ..........................
Page 4 Symbols ..........................2-10 System Preparation ....................3-1 Move/Posit the System ......................3-1 Power Supply ........................3-1 3.2.1 Connecting External Power Supply ................3-1 3.2.2 Equipotential Terminal ....................3-3 3.2.3 Powered by Battery ...................... 3-3 Powering ON/ OFF ....................... 3-4 3.3.1 Powering ON ........................
Page 5 4.6.1 Pause and Exam ......................4-10 4.6.2 End an Exam ......................4-10 Image Optimization ....................5-1 Switching Between Image Modes ..................5-1 Basic Operations ........................5-1 B Mode ..........................5-2 5.3.1 B Mode Exam Protocol ....................5-2 5.3.2 B Mode Parameters ...................... 5-2 5.3.3 B Mode Image Optimization ..................
Page 6 8.1.1 Comment Basic Procedures ..................8-1 8.1.2 Comment Menu ......................8-1 8.1.3 Adding Comments ......................8-2 8.1.4 Moving Comments ......................8-3 8.1.5 Editing Comments ......................8-3 8.1.6 Deleting Comments ...................... 8-3 Body Mark ..........................8-4 8.2.1 Body Mark Operation Procedures ................8-4 8.2.2 Menu ..........................
Page 7 10 DICOM ........................10-1 10.1 DICOM Preset ........................10-1 10.1.1 Network Preset ......................10-1 10.1.2 DICOM Preset ......................10-2 10.1.3 DICOM Service ......................10-4 10.2 Verify Connectivity ......................10-11 10.3 DICOM Service ........................ 10-12 10.3.1 DICOM Storage ......................10-12 10.3.2 DICOM Print ......................10-13 10.3.3 DICOM Worklist ......................
Page 8 11.11 Maintenance ........................11-18 11.12 System Information ......................11-18 12 Probes and Biopsy ....................12-1 12.1 Probe ..........................12-1 12.1.1 Name and Function of Each Part of the Transducer ..........12-2 12.1.2 Orientation of the Ultrasound Image and the Transducer Head ......... 12-3 12.1.3 Operating Procedures ....................
Page 9 14.7.2 Limits of Acoustic Output .................... 14-5 14.7.3 Differences between Actual and Displayed MI and TI ..........14-5 14.8 Measurement Uncertainty ....................14-6 14.9 References for Acoustic Power and Safety ................ 14-6 15 Guidance and Manufacturer’s Declaration ............15-1 16 System Maintenance ....................16-1 16.1 Daily Maintenance ......................
Page 11: Intellectual Property Statement
©2011-2015 Shenzhen Mindray Bio-Medical Electronics Co., Ltd. All rights Reserved. For this Operator’s Manual, the issue date is 2015-07. This version of the manual applies to 01.00.00, 01.01.00 and 02.00.00 software for the DP-7 Digital Ultrasonic Diagnostic Imaging System. Intellectual Property Statement SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD.
Page 12: 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 13: Important Information
7. Important data must be backed up on external memory media. 8. Mindray shall not be liable for loss of data stored in the memory of this system caused by operator error or accidents. 9. This manual contains warnings regarding foreseeable potential dangers, but you shall always be alert to dangers other than those indicated as well.
Page 14: Notation Conventions
Notation Conventions In this operator’s manual, the following words are used besides the safety precautions (refer to "Safety Precautions"). Please read this operator’s manual before using the system. The diagnostic ultrasound system is not intended for CAUTION: ophthalmic use. Its use in this clinical specialty is contraindicated.
Page 15: Conventions
Conventions In this manual, these conventions are used to describe the buttons on the control panel, the items in menu, buttons in dialog box and some basic operations: <Buttons>: The angular bracket indicates buttons, knobs and other controls on control panel. [Items in menu and buttons in dialog box]: The square bracket indicates items in menu or buttons in dialog box.
Page 17: Safety Precautions
Safety Precautions Safety Classification According to the type of protection against electric shock: CLASS I EQUIPMENT According to the degree of protection against electric shock: Type-BF applied part According to the degree of protection against harmful ingress of water: Main unit: IPX0 Probes: IPX7 Footswitch: IP68 According to the degree of safety of application in the presence of a FLAMMABLE...
Page 18: Meaning Of Signal Words
Meaning of Signal Words DANGER WARNING CAUTION In this manual, the signal words" ”, “ ”, “ ”, “NOTE” and "Tips" are used regarding safety and other important instructions. The signal words and their meanings are defined as follows. Please understand their meanings clearly before reading this manual.
Page 19: Safety Precautions
You must use the power adapter provided with the system; otherwise electric shock may result. You can only adopt the power supply method provided by Mindray, other power supply modes (e.g. using a UPS) may result in electric shock. Connect the protective grounding conductor before turning ON the system.
Page 20 DO NOT touch the Signal I/O ports if in contact with the patient; otherwise patient injury may result. Do not use an aftermarket probe other than those specified by Mindray. The probes may damage the system causing a profound failure, e.g. a fire in the worst case.
Page 21 Precautions concerning clinical examination techniques: CAUTION: This system must be used only by qualified medical professionals. This operator’s manual does not describe clinical examination techniques. The clinician should select the proper examination techniques based on specialized training and clinical experience. Malfunctions due to radio wave: If a radio wave emitting device is used in the proximity of this system, it may interfere with operations.
Page 22 You cannot repair the system under this circumstance and must call the Mindray Customer Service Department or sales representative. There is no risk of high-temperature burns during normal ultrasound examinations.
Page 23 If the system is used in a small room, the room temperature may rise. Please provide proper ventilation and free air exchange. To dispose of the system or any part, contact Mindray Customer Service Department or sales representative. Mindray is not responsible for any system content or accessories that have been discarded improperly.
Page 24 Please read the following precautions carefully to ensure the safety of the patient and the operator when using the probes. The ultrasonic probe is only for use with the specified WARNING: ultrasonic diagnostic system. Please refer to the “2.5.2 Probes Available” to select the proper probe. The ultrasonic probe must be used only by qualified professionals.
Page 25 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. The probe sheath contains natural rubber that can cause allergic reactions in some individuals.
Page 26: Latex Alert
Latex Alert When choosing a probe sheath, it is recommended that you directly contact CIVCO for obtaining probe sheath, pricing information, samples and local distribution information. For CIVCO information, please contact the following: CIVCO Medical Instruments Tel: 1-800-445-6741 WWW.civco.com Allergic reactions in latex (natural rubber) sensitive patients WARNING: may range from mild skin reactions (irritation) to fatal anaphylactic shock, and may include difficulty in breathing...
Page 27 No. Warning Labels Meaning Caution! DO NOT open the system covers, because the high voltage inside may cause electric shock. CONFORMS TO UL 60601-1, IEC 60601- 2-37 CERTIFIED TO CSA C22.2 No 601.1, CSA C22.2.60601.2.37 Safety Precautions 1-11...
Page 29: System Overview
System Overview Intended Use The Digital Ultrasonic Diagnostic Imaging System is applicable for adults, pregnant women, pediatric patients and neonates. It is intended for use in fetal, abdominal, pediatric, small organ, neonatal cephalic, adult cephalic, trans-rectal, trans-vaginal, musculo-skeletal, pediatric cardiac, adult cardiac, peripheral vessel and urology exams. Contraindication None.
Page 30: Environmental Conditions
2.4.3 Environmental Conditions Operational Conditions Storage and Transportation Conditions Ambient 0℃～40℃ -20℃～55℃ temperature Relative 30%～85% (no condensation) 30%～95% (no condensation) humidity Atmospheric 700hPa～1060hPa 700hPa～1060hPa pressure Do not use this system in the conditions other than those WARNING: specified. 2.4.4 Size and weights Size: 670mm×520mm×(1265~1415mm) (Depth×Width×Height) Net Weight: <55 kg (including battery) System Configuration...
Page 31: Options
Probe Region Category Intended Use Model Applied Abdominal, Pediatric, Small organ, Neonatal Body 7L5P Linear Cephalic, Musculo-skeletal Conventional, surface Musculo-skeletal Superficial, Peripheral Vessel Abdominal, Pediatric, Small organ, Neonatal Body L14-6P Linear Cephalic, Musculo-skeletal Conventional, surface Musculo-skeletal Superficial, Peripheral Vessel Abdominal, Pediatric, Neonatal Cephalic, Body 2P2P Phased...
Page 32: Peripherals Supported
Item DICOM basic module (including: task management, DICOM storage, DICOM print, DICOM storage commitment, DICOM media storage (including DICOM DIR) and etc.) DICOM worklist module (only can be applied with the DICOM basic function module configured) Build-in DVD R/W Drive Footswitch Battery Pack Needle-guided bracket...
Page 33: Introduction Of Each Unit
NOTE: Printers supported by the ultrasound system software of version 01.01.00 and later version: Printer HP LaserJet p1007 HP LaserJet 1020 plus; If the ultrasound system can not recognize the SONY UP-X898MD and SONY UP-D898MD printers automatically, you may need to change the settings on the printer: push <PUSH ENTER>...
Page 34: I/O Panel
Name Function Placing table Used to place objects or video printer Display support arm Used to support and adjust the position of display Interface panel used for inputting and outputting signals, I/O Panel refer to 2.6.1 I/O Panel. Power supply panel Electrical port panel, refer to 2.6.2 Power Supply Panel.
Page 35: Power Supply Panel
2.6.2 Power Supply Panel <2> <3> <1> Name Function Used for equipotential connection, that balances the protective Equipotential earth potentials between the system and other electrical terminal equipment. Auxiliary power output, used to supply power for optional Power outlet peripheral devices Power inlet AC power inlet System Overview 2-7...
Page 36: Control Panel
2.6.3 Control Panel <2> <3> <4> <5> <11> <6> <7> <8> <9> <10> <12> <13> <14> <1> <20> <15> <18> <19> <16> <17> <21> <23> <24> <25> <26> <22> <36> <39> <40> <27> <28> <38> <30> <29> <41> <44> <45> <43>...
Page 37 Name Description Function Press to enter or exit the patient information iStation management system. User-defined You can assign a function to the key. F1~F4 Biopsy Press to show or hide the biopsy guide line. Setup Press to open/close the setup menu. Press to delete the comment, etc.
Page 38: Symbols
Name Description Function Measurement status: press to switch between the fixed and active end of the caliper; Update Multi-imaging mode: press to change the currently active window. Caliper Press to enter/ exit General Measurement Rotate: to adjust B or M gain Gain/ iTouch Press: to enter/ exit iTouch Save 1...
Page 39 Symbol Description Remote control port Audio output VGA signal output AC (Alternating current) Battery Status Indicator Standby indicator Hard disk indicator Probe port A Probe port B Probe port C Product serial number Manufacture date System Overview 2-11...
Page 41: System Preparation
System Preparation Move/Posit the System Please read and understand the safety precautions before placing the system to ensure safety for both operator and devices. 1. Switch off the power, and pull out the plug. 2. Disconnect the system from all peripherals. 3.
Page 42 Retaining clamp Power plug Receptacle a) Push the retaining clamp downward, and lock the power cord, as shown in the figure below. b) Plug the other end power plug into an appropriate power socket. The grounding terminal should be connected with a power grounding cable to ensure that protective grounding works normally.
Page 43: Equipotential Terminal
2. Be sure to connect this system and its peripheral devices to wall receptacles, which meet the rated power requirement written on the nameplate. If adapters or multifunctional receptacles are used, it may cause the leakage current to exceed the safety requirement. In addition, please connect the video printer to the special auxiliary power outlet of this system, and use the cable provided with this system to connect the printer.
Page 44: Powering On/ Off
– immediately stop scanning. If the system continues to function improperly – fully shut down the system and contact Mindray Customer Service Department or sales representative. If you use the system in a persistent improperly functioning state – you may harm the patient or damage the equipment.
Page 45: Powering Off
If you find anything not functioning properly, this may indicate that the system is defective. In this case, shut down the system immediately and contact Mindray Customer Service Department or sales representative. NOTE: When you start the system or switch between probes, you will hear clicking sounds –...
Page 46: Display Adjusting
Shut down: To power off the system normally. Standby: To enter the standby status. Cancel: To cancel the operation. To shut down the system in a direct way if you cannot do it normally: Press and hold the power button for a long time and the system will power off without displaying the [Shutdown Confirm] screen.
Page 47: Connecting / Disconnecting A Probe
When connecting or disconnecting a probe, place it in a CAUTION: proper position, to prevent the probe from falling off or becoming damaged. Only use the probes provided by Mindray. Aftermarket probes may result in damage or cause a fire. 3.5.1 Connecting a Probe...
Page 48: Disconnecting A Probe
NOTE: Before inserting the connector into the probe port, inspect the connector pin. If the pin is bent, don’t use the probe until it has been inspected/repaired or replaced. 3.5.2 Disconnecting a Probe 1. Turn the locking lever 90° counterclockwise to th e horizontal position (Shown in the left figure).
Page 49 Power cord Data cord USB port 1. Connect the data cable with the USB port on the system. 2. Plug the other end power plug into an appropriate outlet. 3. Power on the system and the printer. 4. Install the printer driver (drivers of printers listed in “2.5.4 Peripherals Supported” have already installed): (1) Enter [Setup]->...
Page 50 Drivers of some HP printers have already been integrated in the system, and will be installed automatically. If the auto-installation fails, a warning icon will display on the right lower corner of the screen. You need to install the printer driver manually: a) Download the ppd file from the printer’s official website (contact R&D engineer if necessary), and copy the ppd file to the storage device (USB disk as an example).
Page 51: Digital Video Printer
Print Service You can use a graph/ text printer to print report or images. To set the default report printer and its attribute: In "[Setup]-> [Print Preset]" screen, select the "Print Service", select “Report Print” column in the service list, set the items in the "Property" box. Report print: Click [Print] in the report dialog box to print a report;...
Page 52: Analog Video Printer
3.10 Analog Video Printer 1. Connect the printer (Video input port) and the ultrasound system (Video output on IO panel) with the signal cable; 2. Connect the Remote cable on printer to the Remote port on the ultrasound system. 3. Connect the power cord to a power supply receptacle that is well grounded or with the auxiliary power output port on the system.
Page 53 mode, and accession #, etc. It can be preset whether to display the operator, patient gender, age, ID, name etc. via [Setup]-> [System Preset]-> [General]. See “11.1.2 General” for detailed preset procedures. Manufacturer logo Manufacturer logo, displayed in the upper left corner of the screen. Hospital name Displays the hospital name.
Page 54 Menu title Tags Items Menu title Displays the menu name. Tags Attribute tags of the item. Items Refers to the items on a menu. For item that is applicable for more than one mode, the item appears as universal item in the certain mode. Items of image modes and measurement can be preset (refer to "11 Setup"...
Page 55 position (located at depth axis in the form of ), besides, the annotation, bodymark, measurement calipers, grayscale bar are also displayed here. Thumbnail preview & Zoom Window (image-in-image) In the zoom status, this area displays the thumbnail of a complete image, and a rectangular frame is used to highlight the currently magnified area.
Page 56: Basic Operations Of Screens
3.11.2 Basic Operations of Screens A screen consists of title, page tabs, contents and buttons, as shown in the following figure: Title Contents Control button Composition Description The title bar is used to give a description for the content and Title Bar function of the screen.
Page 57: Exam Preparation
Exam Preparation Before examining a new patient, press <End Exam> to end the CAUTION: exam of the previous patient, update the patient ID and information, to avoid mixing data of the next new patient. Start an Exam You can start a patient exam in the following situations: New patient information: to start a new patient exam, enter the patient information first, for details, please refer to “4.2.1 New Patient Information”;...
Page 58: New Patient Information
Click [Quick Register] on the screen to save the patient information quickly and return to the main screen. 4.2.1 New Patient Information The Patient Info page is shown as below: Place the cursor onto the targeted box. The field box is highlighted and a flashing cursor appears.
Page 59 Or, click to select the date, and click [OK] to confirm. Auto generated age: once the DOB is gotten, the system can display an auto- generated age in the field box, the unit can be “Years”, “Months” or “Days”. If the age is less than one year, the system will automatically calculate the age in months or days.
Page 60 Exam Type Information Description Gravida Times of pregnancy. Ectopic Times of abnormal pregnancy. e.g. extrauterine pregnancy Gestations Number of embryos (1, 2, 3; 1 is default) Para Times of delivery Aborta Times of abortion Last menstrual period Gravida Times of pregnancy. Para Times of delivery (Gynecology)
Page 61: Retrieve Patient Information
[Pause Exam]: to pause the current exam. [OK]: click to save the patient data entered and exit the screen. [Cancel]: click to cancel the patient data entered and exit the screen. 4.2.2 Retrieve Patient Information 4.2.2.1 iStation The patient data can be obtained in iStation from the system hardware or USB memory device.
Page 62: Dicom Worklist
Button Function Description Review Click to enter the Review screen. Image Patient Click to enter the Patient Info screen. Info Review Click to enter the Diagnostic Report screen. Report Delete Click to delete the selected record. Exam Backup Click to export the selected patient data to media supported. Exam Restore Click to import the patient data from an external media.
Page 63: Select Exam Mode And Probe
Select exam date period, click [Query] to search the patient data in the period. Enter patient ID, patient name, accession #, the system affords the result in real- time. Or select the keyword type, enter the keywords and then click [Query] to search. To reset the criteria, click [Clear] button.
Page 64: Dual Probe Switching
(2) Roll the trackball and press <Set> to select the exam mode, and use the direction keys to turn pages of the exam modes. To save the image parameters for the current exam mode quickly: (1) Click [Save] to save the image parameters in the current image mode as presets. A dialogue box pops up to prompt you the operation will cover the current image preset data.
Page 65: Bi-Plane Endocavity Probe (Cb10-4P)
3. Click [OK] to confirm the setting and exit the dialog box. 4. After returning the preset, the setting will take effect. 4.3.4 Bi-plane Endocavity Probe (CB10-4P) When active the probe, system displays sagittal plane B-mode image by default, you can switch the plane by clicking [Select Plane] on the menu to select the plane among S (sagittal) Plane, T (transverse) Plane.
Page 66: Pause & End An Exam
If you want to continue an exam which data lies in an external memory database, you have to first allow the system to load the patient data to the system’s patient database. Pause & End an Exam 4.6.1 Pause and Exam Sometimes, you have to stop an uncompleted exam due to some special causes.
Page 67: Image Optimization
Image Optimization The images displayed in this system are only reference for WARNING: diagnosis. Mindray is not responsible for the correctness of diagnostic results. It is the responsibility of the clinician, who performs the exam, to capture the correct diagnostic results.
Page 68: B Mode
Requirement Available Operations Adjust [Dynamic Range] Adjust [Map] To modify gray scale image effect Adjust [Persistence] Adjust [iClear] (optional) Decrease [Depth] Decrease the [Focus Number] To increase frame Decrease the [FOV] rate Decrease [Line Density] Turn on [High FR] in harmonic mode Adjusting through Image Menu: Press <Menu>...
Page 69: B Mode Image Optimization
Display F 2.5M D 21.3 G 100 FR 34 IP 1 DR 65 Parameter Frequency Depth Gain Frame Rate B IP B Dynamic Range Parameters that can be adjusted to optimize the B Mode image are indicated in the following. Adjustment Items Control Panel...
Page 70 Description The system compensates the signals from deeper tissue by segments to optimize the image. There are 8-segment TGC sliders on the control panel corresponding to the areas in the image. Operation To increase the gain compensation at an area of interest, move the TGC slider to the right.
Page 71 Impacts The greater the number of focus, the slower the frame rate to image. Imaging Display Adjustment Description More information can be obtained without moving the probe or changing the sampling position. Operation Change the scan range through the [FOV] item in the menu; The system provided levels of: ExFOV, W, N, M1, M2.
Page 72 Smooth Description Rejects image noise and makes images smooth. Operation Adjust through the [Smooth] item in the menu; The system provides 4 levels of smooth function, the bigger the value the higher the smooth adjustment. Persistence Description This function is used to superimpose and average adjacent B images, so as to optimize the image and remove noises.
Page 73 Operation Turn on/ off the function through the [Auto Merge] item in the menu; Impacts Available only for linear probes. The function is available in real-time imaging, freeze or cine review status. Gray Map Description Adjusting grayscale contras to optimize the image. Operation Select among the maps through the [Gray Map] item in the menu;...
Page 74 Operation Press <Gain/ iTouch> on the control panel, the iTouch symbol will display in the image parameter area. Click [iTouch] on the image menu to adjust gain in iTouch status among -12 through 12dB. Click [iTouch Bright] on the image menu to adjust brightness in iTouch status among -2 through +2.
Page 75: M Mode
M Mode 5.4.1 M Mode Exam Protocol 1. Select a high-quality image during B mode scanning, and adjust to place the area of interest in the center of the B mode image. 2. Press <M> on the control panel, and roll the trackball to adjust the sampling line. 3.
Page 76 Operation Rotate the <Gain/ iTouch> knob clockwise to increase the gain, and anti- clockwise to decrease. Or adjust it in the image parameter area. The adjusting range is 0-100. Effects Increasing the gain will brighten the image and you can see more received signals.
Page 77 Operation Select among the IP groups through the [IP] item in the menu; Or adjust it in the image parameter area. The system provides 8 groups of IP combinations, and the specific value of each parameter can be preset. Colorize and Colorize Map Description Colorize function provides an imaging process based on color difference rather than gray distinction.
Page 78: Image Preset
Operation Select among the maps through the [Gray Map] item in the menu; You can also adjust through the grayscale bar: move the cursor to the grayscale bar and press <Set> on the control panel to adjust. The system provides 8 gray maps to be selected among. Impacts The function is available in real-time imaging, freeze or cine review status.
Page 79 3. Select an exam mode and probe. Select “ABD” (Abdomen) from the drop-down list of “Exam Mode”. Select “6CV1P” (for example) from the drop-down list of “Probe”. 4. Image parameter preset The [ABD-- All Probe] field on the left side of the screen displays the parameter preset for all probes in ABD exam mode.
Page 80 Probe Specific Items Drop-down list To set the default FOV in B Mode. Focus Position Drop-down list To set the default focus position in B Mode. Focus Number Drop-down list To set the default focus number in B Mode. To set the default steer angle for the linear probe in Steer Drop-down list B mode.
Page 81: Display & Cine Review
Display & Cine Review Image Display 6.1.1 Splitting Display The system supports dual-split (B/B) and quad-split (4B) display format. However, only one window is active. Dual-split: press <Dual> key on the control panel to enter the dual-split mode, and using <Dual> key to switch between the two images; press <B> on the control panel to exit.
Page 82: Izoom (Full-Screen Zooming)
6.1.2.2 Pan Zoom Procedures: 1. Enter Zoom: Freeze the image, press <Depth/Zoom> knob on the control panel to light the Zoom indicator. Image-in-image is displayed. 2. Rotate <Depth/Zoom> knob to change the magnification factor among 0.8-10. 3. Exit: Press <Depth/Zoom>. Unfreeze the image, the system exit pan zooming status automatically.
Page 83: Cine Review
In splitting display B mode, press <B> to exit splitting display mode and display the image of the currently activated window in full screen. In freeze mode, the system supports imaging mode switching between the sub- modes (only for the activated window). The imaging mode and parameters of an unfrozen image is the same as the corresponding one that before frozen;...
Page 84: Entering/ Exiting Cine Review
6.2.1 Entering/ Exiting Cine Review To enter cine review: Enter "[Setup]-> [System Preset]-> [Image Preset]-> “Freeze Config”, to set "Status after Freeze" to be "Cine". Then the system enters the manual cine review status once press <Freeze> to freeze the image. Open cine files in thumbnail, iStation or Review, the system enters automatic cine review status.
Page 85: Cine Review In M Mode
6.2.3 Cine Review in M Mode After entering the cine review of M mode, rolling the trackball or rotating the multifunctional knob will display the cine images on the screen one by one. Roll the trackball to the left, the review progress slider moves to the left, the images moves to the right, and the earlier stored images are invoked.
Page 86: Cine Memory Clear
Imaging Mode Single-B Dual Quad Split The memory splits The memory splits One memory, with into two, with into four, with Auto capacity N frames. capacity N/2 frames capacity N/4 frames each each The memory splits The memory splits The memory splits into two, with into two, with into four, with...
Page 87: Measurement
Measurement There are general measurement and application measurement. You can perform measurements on a zoomed image, cine reviewing image, real-time image, or a frozen image. For measurements details, please refer to the [Advanced Volume]. Be sure to measure areas of interest from the most optimal WARNING: image plane...
Page 88: General Measurements
General Measurements 7.2.1 2D General Measurements 2D general measurements refer to general measurements on 2D mode: Measurement Function Tools Distance Measures the distance between two points of interest. The distance between probe surface and the probing point along Depth ultrasound beam. Angle The angle between two intersected planes.
Page 89: Application Measurement
Application Measurement The system support following measurement types: Abdomen measurements - Used for measurements of abdominal organs (liver, gall bladder, pancreas and kidney, etc.) and large abdominal vessels. OB measurements- Used for measurements of fetal growth indexed (including EFW) as well as GA and EDD calculations.
Page 90: Measurement Accuracy
Measurement Accuracy Table 1 Error of 2D Images Parameter Value Range Error Within ±3%; or when the measured value is less Distance Full screen than 40 mm, the error is less than1.5 mm. Within ±7%; or when the measured value is less Area (Trace) Full screen than 16 cm...
Page 91: Comments And Body Marks
Comments and Body Marks Comments Comments can be added to an ultrasound image to bring attention, notate or communicate information observed during the examination. You can add comments to: zoomed image, cine review image, real-time image, frozen image. You can type the character as comments; insert the pre-defined comments from the comment library;...
Page 92: Adding Comments
comment adding. When clicking [Home], the cursor will turn to the default setting position. Change Font Size/Arrow Size Click [Font Size] to change the font size of comment: Small, Mid, Big. Click [Arrow Size] to change the arrow size of comment: Small, Mid, Big. The default is the comment text library in the current exam mode.
Page 93: Moving Comments
Press the <Arrow> key, and an arrow will appear at the default position. Adjust the arrow Adjust the position and orientation of the arrow: roll the trackball to the desired position and use the multifunctional knob to change the orientation in 15° increments.
Page 94: Body Mark
Deleting a recently-added character, text or arrow After you add several comments and the cursor is in the “|” or “ ” status, pressing <Clear> can delete the recently-added or recently-edited comment. Erase All Text Long press the <Clear> to delete all the comments. NOTE: When no object is selected, pressing the <Clear>...
Page 95: Moving Body Marks
Move the cursor onto the desired bodymark to highlight your choice, and press <Set> to add the selected bodymark; or rotate the multifunctional knob to view the bodymarks. (4) Press <Set> to confirm the selection. (5) To adjust the probe position and orientation marker: Roll the trackball to place the probe marker at the correct position.
Page 97: Patient Data Management
External storage media is recommended for image archive. 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. Patient Information Management 9.1.1...
Page 98: Image File Management
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 demonstration (iVision). 9.2.1 Storage Media System supported memory media including: System hard disk USB memory devices: USB flash drive, removable USB hard disk...
Page 99: Image Storage Preset
Multi-frame file format, general cine file format. DICOM files (DCM) DICOM standard files format, single-frame or multi-frame format, used to record patient information and images. 9.2.3 Image Storage Preset Set image size You can set the image size via [Setup] →[System Preset]→ [General]. The items are shown as follows: Set single frame export format Format...
Page 100: Quickly Saving Full Screen Image To The System
The image file is stored in the directory: U disk\ US Export\ patient folder\ exam folder\ Image ID.bmp, here, Patient folder name: patient name+ patient ID Exam folder name: exam mode+ exam time To store single-frame image to USB flash drive: (1) Set the user-defined key through the path: [Setup]→...
Page 101 To enter Review: Press <Review> to enter Review screen. The system display the images stored in this exam of the current patient (if there is no current patient information, you can review the images of the latest exam). Select an exam of a patient in the iStation screen, and click to enter the Review screen to review the images of the patient.
Page 102: Ivision
Click to enter the Patient Info screen, you can review or edit the currently-selected patient information. Report Click to review or edit the currently-selected patient report. Image operations [Select All]: click to select all images in the thumbnail window. [Deselect All]: after clicking the [Select All], the button changes into [Deselect All], you can cancel all the selections by clicking [Deselect All].
Page 103 Enter image menu-> [Advanced], select [iVision]; or, press the user-defined key for iVision on the control panel (setting path: [Setup]→[System Preset]→[Key Config]). 2. Add the contents to be played and select the demo mode. 3. Select an item in the list, and click [Start] to begin the demonstration. 4.
Page 104: Sending Image File
[Add Catalog]: to add catalog to the file list. [Delete]: to delete the selected file or catalog in the file list. [Clear]: to clear all the files or catalogs in the file list. Demonstration mode Interval: refer to the interval time for demonstration, the adjusting range is 1~500s. Option of Demo You can choose whether to repeat the demonstration or exit after a demonstration is completed.
Page 105: Report Management
For a video printer, send images to the video printer connected with the system. For a graph/ text printer, send the images to the default graph/ text printer. Report Management Report storage: The exam reports are stored under the directory of the exam of the patient. Importing, exporting and sending a report In the iStation screen, select patient data, click (Restore) or...
Page 106: Patient Data Management (Istation)
To export the report: (1) Check “Export Report” on the screen. (2) Click [OK] to confirm. You can select paper size for the report in the path: [Setup] → [Print Preset] Printing report Use a connected graph/text printer to print a report. Please refer to “11.7 Print Preset” for details about default report printer setting.
Page 107: Searching A Patient
Viewing Patient Information Data Source Select the data source of patient data, the system patient database is default. Patient List Display patient information, exam mode, number of images and cines, exam state, backed up or not. New Exam: After you select a patient data or exam in the iStation screen, click the [New Exam] to enter the Patient Info screen, where you can select a new exam mode and click [OK] to begin a new exam.
Page 108: Patient Data View & Management
Select “Find in results”, the system will do searching based on the last searched results. 9.4.2 Patient Data View & Management Select the desired patient information in the list. The following menu pops up: Review Select an exam of a patient, click to enter Review screen.
Page 109: Backing Up And Erasing Files Through Dvd Drive
Send patient exam data to USB devices, DVD drive or iStorage server. Send images to USB devices, DVD drive, DICOM storage server, DICOM printer, video printer, text/ graph printer or iStorage server. Send images with report to USB devices, DVD drive or iStorage server. Format transfer is available when sending images to USB devices, DVD or iStorage server.
Page 110: Patient Task Manager
To write data to a CD/DVD: (1) Put a CD/DVD in the tray. (2) Select the data to be backed up, click the screen (in iStation or Review). Select the target drive in the Send To or Back Up Patient Record dialogue box. (3) Click or [OK] to start writing with the symbol displays (4) After the writing process is completed, click...
Page 111 Including: Storage Task: displays the DICOM storage task. DICOM Print Task: displays the DICOM print task. Media Storage Task: DICOM media storage task(including disc and USB devices) Backup task (system-relevant format): select the exam to be backed up in iStation and click Send to external devices (including disc and USB devices): select exam data or images in iStation or Review screen, click...
Page 112: Access Control
Task Status Select the undergoing task, the system will display its detailed status information or error information. When there is/are task(s) undergoing, the task management icon displays as , you can click the icon to check the process. When there is/are task(s) failed, the task management icon displays as , you can click the icon to check the failure reason.
Page 113: Add/ Delete A User
Before entering the system Changing user As long as the system is in working status, you can enter the above screens without inputting user name and password repeatedly. You need to login again after system restart or dormancy. Login the system: (1) If the system requires you to log on the system before you access the data, you can see the following dialogue box.
Page 114: Delete A User
2. Click [Add] to enter the following page. 3. Enter the user name (you are not allowed to enter the same name or modify the name already exist). 4. Enter user name and the password. 5. Set the user role in the drop-down list: administrator or operator. 6.
Page 115: Modify Password
9.7.5 Modify Password The system administrator can modify password of all users. The administrator password by factory is empty, you can set the password for it. The operator can only modify his/her own password. To modify the password, the user has to login the system first. There are two ways to modify password: modify it on “Admin”...
Page 117: Dicom
DICOM NOTE: Before using DICOM, please read the electronic file DICOM CONFORMANCE STATEMENT along with the device. This chapter is confined to the preset, connection verification and DICOM services of the DICOM-configured ultrasound machine, not including SCP configurations like PACS/ RIS/ HIS.
Page 118: Dicom Preset
2. Select [Network Preset]. 3. Local TCP/ IP preset items are described as follows: Name Description Current Net Adapter To select network connection mode. DHCP DHCP: IP address will be automatically obtained from DNS server; / Static Static: you need to enter the IP address. IP Address IP address of the system.
Page 119 3. Preset local DICOM properties and DICOM server. Localhost DICOM Service Property Name Description Application entity title of the ultrasound system. AE Title The AE title here should be the same with the one of the acceptable SCU set in the server. DICOM communication port, which should be the same with the Port one in the server.
Page 120: Dicom Service
Name Description [Add] Click to add servers to the device list. [Set DICOM Service] Click to enter DICOM service preset, see “10.1.3 DICOM Service”. [Delete] Click to delete the selected server (s) in the device list. Note: If the currently entered name has already existed, the system will pop up: “The server name exists!”...
Page 121 DICOM storage setting items are described as follows: Name Description After you set the server (s) in DICOM Server Setting, the name Device (s) will appear in the drop-down list, select the name of the storage server. Service Name Default is xxx-Storage, and it can be modified. Application Entity title, Here, it should be consistent with that of AE Title the storage server.
Page 122 Name Description Select an item in the service list, change the parameters in the [Update] above area, and click [Update] to update the item in the service list. [Delete] Click to delete the selected service in the service list Select an item in the service list, click [Default] and you can see [Default] “Y”...
Page 123 DICOM print setting items are described as follows: Name Description After you set the server (s) in DICOM Server Setting, the Device name (s) will appear in the drop-down list, select the name of the print server. Service Name Default is xxx-Print, and it can be modified. Application Entity title.
Page 124 Name Description [Add] Add the DICOM service to the service list. [Cancel] Click to cancel the parameter setting. Select an item in the service list, change the parameters in the above area, and click [Update] to update the item in the [Update] service list.
Page 125 DICOM service setting for Worklist is described as follows: Name Description After you set the server (s) in DICOM Server Setting screen, the Device name (s) will appear in the drop-down list, select the name of the Worklist server. Service Name Default is xxx-Worklist, and it can be modified.
Page 126 Name Description Click to verify if the two DICOM application entities are normally [Verify] connected. [Exit] Click to exit the screen. Note: In terms of “Scheduled Station AE Title”, if you set this item in the Worklist server, then “Scheduled Station AE Title” configured here should be consistent with the one set in the server.
Page 127: Verify Connectivity
Name Description After you set the server (s) in DICOM Server Setting, the name Device (s) will appear in the drop-down list, select the name of the storage commitment server. Service Name Default is xxx-SC, and it can be modified. Application Entity title, Here, it should be consistent with that of AE Title the storage commitment server.
Page 128: Dicom Service
10.3 DICOM Service If the system is configured with DICOM modules, and connected to the relevant DICOM servers, after verifying connection, you can perform storage, print, Worklist, storage commitment, and query/ retrieve applications. 10.3.1 DICOM Storage DICOM Storage is used to send image(s) to DICOM storage server f or storage.
Page 129: Dicom Print
10.3.2 DICOM Print DICOM Print is used to send image(s) to DICOM print server to print images Print image in iStation/Review/main screens (1) Select image(s), operations are the same with DICOM storage. (2) In the Send To dialogue box, select a DICOM print server. (3) Click [OK] to send print task.
Page 130 (3) Retrieve Patient Information a) Set query criteria among Patient ID, Patient Name, Accession #, Search Key, Worklist Server or Exam Date. The default exam date is the current date. b) Click [Query]. c) The scheduled patients, which meet the criteria, are displayed in the lower part of the screen.
Page 131: Storage Commitment
In the off-line status, you can: Perform a second query; or, Click [Show Detail] to view the patient information in details: 10.3.4 Storage Commitment Storage commitment is used to make sure the images are successfully stored in the DICOM server. Before storage commitment, you should set a default storage commitment server.
Page 132: Dicom Task Manager
Tips: There should be no DICOMDIR/ DICMIMG/IHE_PDI files in the external storage media of the same name with the one being backed up, otherwise, the backup can’t proceed. Please make sure there is enough storage space; otherwise, backup may fail due to space shortage. Media review: 1.
Page 133: Setup
When the setup data is changed, be sure to save the CAUTION: preferences according to the methods described in this chapter. Mindray is not responsible for the loss of the setup data. To enter Setup: Press the <Setup> to enter Setup;...
Page 134: System Preset
[Load Factory]: click [Load Factory], and all parameter settings will be restored to the original factory default. 11.1 System Preset Click [System Preset] on the Setup menu, you can preset: Page Description To set the hospital name, language, time zone, time format, system Region date/time, logo and so on.
Page 135: Region
11.1.1 Region Open the Region page via [Setup]-> [System Preset]-> [Region], as shown in the figure below. Item Description To set the hospital relevant information like name, address, Hospital Information telephone and so on. To select a language for the system, the available languages are Chinese, English, French, German, Italian, Portuguese, Russian, Spanish, Polish, Czech, Turkish, Finnish, Danish, Icelandic, Language...
Page 136: General
11.1.2 General Open the General page via [Setup]-> [System Preset]-> [General], as shown in the figure below. Type Item Description To select if to display the following patient information Info displays in on the image banner: Gender, Age, Operator, ID, Name, image banner Hospital Patient...
Page 137: Image Preset
Type Item Description Brightness/Contrast Load the factory data of the display brightness and Load Factory contrast. Font size Small/ Medium/ Large Arrow Size Small/ Medium/ Large Comments Clear comments while unfreezing To set if clear comments while unfreezing an image or image or changing changing probe/exam probe/exam...
Page 138: Meas
11.1.4 Meas Open the Meas page via [Setup]-> [System Preset]-> [Meas]. Through the page, you can set the measure ruler, unit and relevant information. For details, please refer to the Operator’s Manual [Advanced Volume] 11.1.5 OB Open the OB page via [Setup]-> [System Preset]-> [OB]. Through the page, you can set the gestational age formula, fetal growth formula, fetal weight formula and the relevant information.
Page 139 (1) Select F4 in the “Key Function” list at the left side of the page. (2) Select “Save AVI Cine to USB disk” in “Function” at the right side of the page. (3) Click [OK] to complete the setting. In Function area, the functions of user-defined keys can be divided into five categories: Output, Print, Advances Features, Measurement and Other.
Page 140: Biopsy
Type Function Description Send image and measurement data to Send to Workstation the workstation Other Settings Item Description Key Lightness To set the lightness for the keys: 0, 1, 2, 3. Key Volume To set the key volume: 0-2, 0 means no sound. To set the trackball speed when move the trackball: Slow, Trackball Speed Medium, Fast.
Page 141: Exam Selection
11.2.1 Exam Selection After the Exam Preset screen is entered, the screen will display the Exam Selection page, as shown in the figure below. This page is used to assign an exam type to a specific probe. 1. To select a probe: Move the cursor to [Probe], and select a probe from the drop-down list.
Page 142 The system supports: Copying Exam Mode Select an exam mode you want to copy from the list. Click [copy]. Select another exam mode and click [Paste]. The parameters in the source exam mode are copied to the target exam mode (target exam mode will not be renamed). Tips: loading or pasting exam setup data will overwrite previous presets and can't be reverted.
Page 143: Image Preset
11.3 Image Preset Enter [Setup]-> [Image Preset]. Image preset is used to set the image parameters for each imaging mode. Image parameters can be divided into the following three categories: Imaging mode relevant parameters Parameters pertinent to both exam mode and probe. Other image specific parameters For details, please refer to the relevant imaging modes in “5 Image Optimization”.
Page 144: Custom Body Marks
2. Selecting exam modes Select the exam mode in the drop-down list, the current exam mode is by default. 3. Set library: enter the library name of custom body marks. 4. Add or delete body mark(s) To add the item selected from the [Available Items] into the [Selected [>] Items].
Page 145: Comment Preset
Click [Import Custom] in the Body Mark Preset screen above, enter the user-defined body mark screen (as shown in the figure below). [Load File]: load a single body mark file. [Load Directory]: load all body mark files located in a directory specified. [Return]: exit the current screen.
Page 146 2. Select exam mode. 3. Enter Library Name: you can enter characters for the library name, or accept the default name (the same as that for the exam mode). 4. Add user-defined comments: directly enter comment texts, or select comment texts for the comment library.
Page 147: Print Preset
7. After you customize comments, click [OK] to confirm and exit the [Comment Preset] screen. 11.7 Print Preset The settings of a printer include print service and print driver. Print Service Setting Add Service: click to begin print service adding. Remove Service: click to delete the selected print service.
Page 148: Network Preset
11.8 Network Preset For local TCP/IP preset and DICOM preset, please refer to “10.1 DICOM Preset”. The IStorage screen is as follows: Name Description Service Name Name of the device, cannot be empty IP address of the PC installed with iStorage software, cannot be IP Address empty Press to verify connection with the PC server.
Page 149: Workstation Preset
3. Modify the parameters and click [Update] to update setting. Tips: in order to make network storage function normally, setting of the sharing folder of the PC server in advance is a must, e.g. machine name, IP address, should be confirmed at first. NOTE: The iStorage functions applies to the ultrasound software of version 01.01.00 and later version.
Page 150: Maintenance
11.11 Maintenance The [Maintenance] function is designed for you to update the system software or other special functions. If you require these functions, please contact Mindray Customer Service Department or sales representative. You can install options, preset measurement, bodymark, comment and export and upload operation logs here.
Page 151: Probes And Biopsy
Probes and Biopsy 12.1 Probe The system supports the following probes: Probe model Probe Type Illustration 3C5P Convex 6C2P Convex 6CV1P Intra-cavity CB10-4P Convex Probes and Biopsy 12-1...
Page 152: Name And Function Of Each Part Of The Transducer
Probe model Probe Type Illustration 7L4P Linear 7L5P Linear L14-6P Linear 2P2P Phased Note: For details of storage time and condition for disinfected probes or sterilized probes and brackets, please refer to Technical standard for Disinfection of Medical and Health Structures 12.1.1 Name and Function of Each Part of the Transducer...
Page 153 Probe 3C5P <1> <2> <3> <4> <5> Name Function It converts the electrical signal into ultrasound signal, making the sound beams focus in the given direction; meanwhile, it will receive the ultrasound signal and then <1> Transducer head convert the received signal into electrical signal. The lens on the surface is the acoustic lens.
Page 154: Operating Procedures
Orientation mark Mark 12.1.3 Operating Procedures This section describes general procedures for operating the transducer. The proper clinical technique to be used for operating the transducer should be selected on the basis of specialized training and clinical experience. 12-4 Probes and Biopsy...
Page 155 Procedures for operating (with biopsy function) Inspection before examination Connection to the ultrasonic diagnostic system Examinations Biopsy procedure Disconnection to the ultrasonic diagnostic system Sterilization of the needle- guided bracket Wiping off the ultrasound gel Inspection after use Washing the transducer with water Storage Draining/drying Immersion into disinfectant...
Page 156 Procedures for operating (with no biopsy function) Inspection before examination Connection to the ultrasonic diagnostic system Examinations Disconnection to the ultrasonic diagnostic system Wiping off the ultrasound gel Washing the transducer with water Draining/drying Disinfection Immersion into disinfectant Removing the transducer from disinfectant Rinsing the transducer into sterile water Draining/drying...
Page 157: Wearing The Transducer Sheath
12.1.4 Wearing the Transducer Sheath A transducer sheath must be installed over the transducer before performing examination. Probe sheaths are available for use with all clinical situations where infection is a concern. A probe sheath must be installed over the probe before performing intra-cavity or biopsy examination.
Page 158: Probes Cleaning And Disinfection
Probe sizes 6CV1P: (L)181mm, (D)38mm CB10-4P: (L)191.5mm, (D)40mm The above is a dimension illustration of the intra-cavity probe. Customers can purchase appropriate sterile sheaths according to the provided probe sizes. We recommend a general kind of transducer cover produced by CIVCO which identified as GENERAL PURPOSE LATEX TRANSDUCER COVERS (Sterile), 610-214(E8285CN,UA0006).
Page 159 Disinfecting by Immersion 1. Wear sterile gloves to prevent infection. 2. Clean the transducer before disinfecting it.MINDRAY recommends the following solutions to disinfect the transducer. Refer to the instructions provided by the chemical manufacturer concerning concentration of the disinfectant solution, method of disinfection and dilution and cautions during use.Do not soak the transducer connector or the cable near it into...
Page 160 3. Rinse the transducer with plenty of sterile water (about 2 gallons) for at least 1 minute to remove all chemical residues on it.Or, follow the rinsing method recommended by the disinfectant manufacturer to rinse the transducer. 4. Wipe off the water on the transducer with sterile cloth or gauze after rinsing it.Do not dry the transducer by heating.
Page 161: Storage And Transportation
Relative humidity: 30% to 95% (no condensation) Atmospheric pressure: 700 hPa ~ 1060 hPa 3. When the transducer 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.
Page 162 Do not use a needle-guided bracket when scanning is performed. The needle may advance in an incorrect direction and possibly injure the patient. Never perform a biopsy during image scanning. Do not freeze an image while performing biopsy procedure. During biopsy procedures, the needle may deviate from desired course...
Page 163 Image of the biopsy target and the actual position of the biopsy needle: Diagnostic ultrasound systems produce tomographic plane images with information of a certain thickness in the thickness direction of the transducer. (That is to say, the information shown in the images consist all the information scanned in the thickness direction of the transducer.) So, even though the biopsy needle appears to have penetrated the target object...
Page 164: Basic Procedures For Biopsy Guiding
A needle-guided bracket is available for purchase as an optional accessory; it is used in combination with this transducer. Part of the probes have matched needle-guided bracket and needles. To order needle-guided brackets, contact MINDRAY Customer Service Department or sales representative.
Page 165 NGB-004 Locking nut Needle guide Retaining clamp Locating bulge Transducer Locating groove NGB-005 Clamping knob of the needle guide Needle guide rack Needle guide Clamp Locating pit Needle guide hole Grip knob Locating groove Needle-guided bracket Transducer NGB-006 Metal/ needle detachable: Probes and Biopsy 12-15...
Page 166 Name Description Support of needle- Used for installing the needle-guided bracket on the <1> guided bracket transducer. Groove and tab of Respectively matched with the tab and groove of the <2> the needle-guided transducer. bracket <3> Angle adjusting base There are 3 types of angles available to be adjusted. Angle shift sign <4>...
Page 167 Name Description Support of needle- <1> Used for installing the needle-guided bracket on the transducer guided bracket Used for determining the angle of the biopsy; there are three <2> Angle block specifications of blocks of angle Used for installing biopsy needle; there are five specifications of <3>...
Page 168 <3> <4> <1> <5> <2> Name Description Support of needle-guided Used for installing the needle-guided bracket on <1> bracket the transducer Groove and tab of the Respectively matched with the tab and groove of <2> needle-guided bracket the transducer There are 3 types of angles available to be <3>...
Page 169 Name Description Support of needle- Used for installing the needle-guided bracket on the <1> guided bracket transducer Used for determining the angle of the biopsy; there are <2> Angle block three specifications of blocks of angle Used for installing biopsy needle; there are five specifications of guiding blocks for different biopsy <3>...
Page 170: Biopsy Preset
NGB-016 Name Description Clamp of needle-guided Used for installing the needle-guided bracket on the <1> bracket transducer. Groove of the needle- <2> Matches with the tab of the transducer. guided bracket <3> Angle adjusting base There are 3 types of angles available to be adjusted. Matches with the biopsy angle Angle shift sign (30°...
Page 171: Needle-Guided Bracket Inspection And Installation
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. 1. Sterilize the needle-guided bracket before and after use.
Page 172 NBG-005 1. Put on the sterile transducer sheath. 2. Inosculate the locating groove on the clamp with the two raised edges on the transducer head and aligning the locating pit of the clamp to the convex point on the transducer head.
Page 173 (3) Check manually to confirm that the needle-guided bracket is securely installed on the transducer. (4) Select a proper guiding block and push it into the groove above the angle block, and clamp it tightly. (5) Insert a biopsy needle with the same specification as that of the guiding block into the hole of the guiding block.
Page 174 5) Screw the nut of the block to secure the block. 6) Insert a biopsy needle with the same specification as that of the guiding block into the hole of the guiding block. Plastic 1) Put on the sterile transducer sheath. 2) Hold the transducer by one hand, select proper needle-guided bracket, and hold it with the other hand.
Page 175 NGB-011 1 Inosculate the locating groove on the clamp with the two raised edges on the transducer head and aligning the locating pit of the clamp to the convex point on the transducer head. 2 Turn the grip knob at the tail of the needle-guided bracket tightly. NGB-016 1.
Page 176: Biopsy Menu
Ensure that all guide parts are seated properly prior to CAUTION: performing a biopsy. 12.2.5 Biopsy Menu Press <Biopsy> to show the biopsy menu. Select biopsy bracket angle If the needle-guided bracket supports more than one biopsy angle, you can select the angle from the drop-down list.
Page 177: Verify Biopsy Guide Line
In B mode image menu, you can also display, hide or select the needle-guide bracket via [Biopsy Kit] item. 12.2.6 Verify Biopsy Guide Line Prior to each biopsy procedure, be sure to verify the guide WARNING: line. If the needle is not consistent with the guide line, DO NOT perform the biopsy procedure.
Page 178: Removing The Needle-Guided Bracket
12.2.7 Removing the Needle-guided Bracket NGB-004 Hold the transducer in the left hand, unscrew the locking nut with the right hand to open the retaining clamp, and then raise the needle-guided bracket to separate the locating bulge from the locating grooves. NGB-005 While holding the transducer and the needle-guided bracket, open the Grip knob of the needle-guided bracket.
Page 179 NGB-007 Metal 1) Screw the nut of the guiding block and remove the guiding block slightly along the direction of the needle’s tail. 2) Separate the residual part of the needle-guide bracket and the transducer from the needle. 3) Screw the pinch nut of the bracket, and remove the needle-guided bracket from the transducer.
Page 180: Clean And Sterilize The Needle-Guided Bracket
Please follow the instructions in the manual for cleaning. Sterilization 1. Wear sterile gloves to prevent infection. 2. Clean the needle-guided bracket before sterilizing it. MINDRAY recommends the following solution or sterilizing system to sterilize the needle-guided bracket. 3. Follow local regulations when selecting and using the disinfectant.
Page 181: Storage And Transportation
Between examinations, keep the needle-guided bracket in a sterile environment. When 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 182: Disposal
12.2.10 Disposal Be sure to dispose the needle-guided bracket only after sterilizing it. Contact your MINDRAY representative when disposing of this device. 12-32 Probes and Biopsy...
Page 183: Battery
Battery DO NOT install or detach the battery ad arbitrium WARNING: The batteries have protective mechanism and circuit. DO NOT disassemble or alter the battery. DO NOT short-circuit the batteries by directly connecting the negative terminals with metal objects. DO NOT heat the battery or discard it in a fire. Keep the batteries away from fire and other heat sources.
Page 184: Precautions
13.2 Precautions 1. Before using the battery, carefully read the description in the label on the surface of the battery. 2. When you use the battery at the first time and find that it is dirty or emit an odor, do not use it.
Page 185: 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 186: Mi/Ti Explanation
Additional information regarding the concept of ALARA and the possible bioeffects of Ultrasound is available in a document from the AIUM (American Institute of Ultrasound Medicine) title Medical Ultrasound Safety” “ 14.4 MI/TI Explanation 14.4.1 Basic Knowledge of MI and TI The relationship of various ultrasound output parameters (frequency, acoustic pressure and intensity, etc) to bioeffects is not fully understood presently.
Page 187: Mi/Ti Display
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. The smaller the MI/TI values, the lower the bioeffects. 14.4.2 MI/TI Display TI and MI values are displayed in the upper part of the screen in real-time.
Page 188: Acoustic Power Control
14.6 Acoustic Power Control The qualified operator may use the system controls to limit the ultrasound output and to adjust the quality of the images. There are three categories of system controls relative to output. They are controls that have direct effect on the output, controls that indirectly control output and controls that are receiver controls.
Page 189: Limits Of Acoustic Output
the transducer and the fetus, and the attenuation of fluid is very small. Therefore the attenuation coefficient was lowered to account for this case. 14.7.2 Limits of Acoustic Output In accordance with the FDA Track 3 requirements, the derating (or attenuated) approach was incorporated into the FDA Acoustic Output Limits, as listed below.
Page 190: Measurement Uncertainty
14.8 Measurement Uncertainty I spta 28.5% I sppa 28.5% Center frequency (f c ) Total power (W) 28.5% (5.1% for Scan-mode and Combined-mode) Peak-rarefactional pressure 14.7% 14.9 References for Acoustic Power and Safety “Bioeffects and Safety of Diagnostic Ultrasound” issued by AIUM in 1993 “Medical Ultrasound Safety”...
Page 191: Guidance And Manufacturer's Declaration
Guidance and Manufacturer’s Declaration The system complies with the EMC standard IEC60601-1-2: 2007. The use of unapproved accessories may diminish system WARNING: performance. NOTE: 1 Use of accessories, probes, and cables other than those specified may result in increased emission or decreased immunity of system. 2 The system or its components should not be used adjacent to or stacked with other equipment.
Page 192 TABLE 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. ELECTROMAGNETIC ENVIROMENT－－－－...
Page 193 TABLE 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. IEC 60601 COMPLIANCE ELECTROMAGNETIC...
Page 194 TABLE 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. IMMUNITY IEC 60601 COMPLIANCE...
Page 195 TABLE 4 RECOMMENDED SEPARATION DISTANCES BETWEEN PORTABLE AND MOBILE RF COMMUNICATION DEVICE AND 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 197: System Maintenance
Routine system maintenance shall be carried out by the user. Service maintenance will be provided by Mindray service engineers while the system is under warranty. System maintenance after the warranty has expired is the full responsibility of the owner / operator.
Page 198 Method: (1) Disassembling the trackball Press the bulges on the clamping ring by both hands and turn the ring about 45° clockwise until it lifts. Take out the ring and the rotary ball. Be careful not to drop the ball. Rotary ball Clamping ring Top cover...
Page 199: Checking Transducer
16.2 Maintenance Checks by Service Engineer The following checks must be performed to ensure and maintain system safety and performance. Please contact Mindray Customer Service Department or sales representative to schedule and carry out these checks. Check Category Check Item...
Page 200: Consumables And Periodic Part Replacement
16.3 Consumables and Periodic Part Replacement This system contains some consumables and parts requiring periodic replacement. Before replacing them, please contact Mindray Customer Service Department or sales representative for instructions. 16.4 Troubleshooting To ensure proper system operation and function, it is recommended that a maintenance and inspection plan be established to periodically check the safety of the system.
Page 201: Troubleshooting Table
Troubleshooting Table Failure Cause Measure After the Abnormal power system Verify that the plug has not power supply or incorrect connection become loosened or is turned on, of the power cord. dislodged from the back of the power the system. indicator does not light on.
Page 203: Appendix A Electrical Safety
Appendix A 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 204: Device Enclosure And Accessories
Device Enclosure and Accessories A.2.1 Visual Inspection Test Item Acceptance Criteria No physical damage to the enclosure and accessories. No physical damage to meters, switches, connectors, etc. The enclosure and accessories No residue of fluid spillage (e.g., water, coffee, chemicals, etc.). No loose or missing parts (e.g., knobs, dials, terminals, etc.).
Page 205: Earth Leakage Test
Earth Leakage Test Run an Earth Leakage test on the device being tested before performing any other leakage tests. The following outlet conditions apply when performing the Earth Leakage test. normal polarity( Normal Condition); reverse polarity( Normal Condition); normal polarity with open neutral(Single Fault Condition); reverse polarity with open neutral(Single Fault Condition).
Page 206: Mains On Applied Part Leakage
LIMITS For BF applied parts, 100µA in Normal Condition. 500µA in Single Fault Condition. Mains on Applied Part Leakage The Mains on Applied Part test applies a test voltage, which is 110% of the mains voltage, through a limiting resistance, to selected applied part terminals. Current measurements are then taken between the selected applied part and earth.
Page 207 P/N: 046-002738-00 (V7.0)

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