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Ultrasound diagnostic system Model SonidoSmart Dec. 2017 Instructions for use For: SonidoSmart from SN 1701001 Ident. no. EN 10102699TM 1217...
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Before using the system, please read this manual carefully and completely. The instructions for use constitute an integral part of the appliance. Please keep the instructions for use in an easily accessi- ble place after reading. If you have any questions or doubts, please contact ZIMMER MEDIZINSYS- TEME or your authorised service technician.
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Damage or loss due to use of the system outside the region in which the system was origi- nally sold. f) Damage or loss caused by the purchase of the system from a source other than ZIMMER MEDIZINSYSTEME or one of its authorised dealers.
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ZIMMER MEDIZINSYSTEME shall not be liable for consequences arising from negligence or failure to follow the instructions for use. Before and after each ultrasound examination, please check the probe surface and the probe cable and covering for abnormalities such as cracking, peeling and deformation. Please also check that the lens is firmly mounted.
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SONIDOSMART digital ultrasound Acoustic power ........................42 5.7.7 SRA ........................... 42 5.7.8 Utility software ........................42 5.7.9 Advance ..........................42 5.7.10 PW image adjustment ........................44 Steering angle ........................44 5.8.1 Frequency .......................... 44 5.8.2 D 2D map ........................... 44 5.8.3 Enhance ..........................
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SONIDOSMART digital ultrasound Deleting comments ......................47 5.10.8 Setting a body marker ........................48 5.11 General description ......................48 5.11.1 Using body markers ......................52 5.11.2 Set the direction of the arrow ......................52 5.12 Image and cine configuration ......................53 5.13 The principle of cine storage ....................
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SONIDOSMART digital ultrasound B mode general measurement methods ................... 61 Distance meas........................61 6.2.1 Ellipse ..........................61 6.2.2 Trace ..........................62 6.2.3 Histogram........................... 62 6.2.4 Cross-sectional diagram ...................... 63 6.2.5 B quick measurement ........................63 Normal measurement and calculation in B mode ................64 ABD measurement and calculation....................
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SONIDOSMART digital ultrasound Urology M measurement ......................... 81 6.19 Small parts M measurement ......................81 6.20 Paediatrics M measurement ......................81 6.21 PW mode measurement methods ....................81 6.22 Velocity ..........................82 6.22.1 Time ..........................82 6.22.2 Heart rate ........................... 82 6.22.3 Auto trace ..........................
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SONIDOSMART digital ultrasound Library of body markers ..................... 101 7.4.1 Edit the body marker library....................101 7.4.1.1 Editing body markers ......................102 7.4.2 Body marker options ......................102 7.4.3 Examination mode ........................102 Editing the examination mode .................... 102 7.5.1 Examination mode selection ....................
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SONIDOSMART digital ultrasound Cleaning and disinfection ....................114 9.2.2 Probe operating instructions ......................121 Scanning the patient ......................121 9.3.1 Operating the transvaginal probe ..................122 9.3.2 Cleaning and disinfecting TV and TR probes ............... 122 9.3.3 Thermal and probe tip angle monitoring................123 9.3.4 Service responsibility ........................
The system is NOT intended for ophthalmic use or any examinations that cause the acoustic beam to pass through the eye. 1.1.3 Contact information For additional information or assistance, please contact your local distributor or the appropriate support resource as specified below: The ZIMMER MEDIZINSYSTEME website www.Zimmer.de Service support Zimmer MedizinSysteme GmbH Junkersstrasse 9...
Chapter 2 System safety Safety overview This section deals with measures for ensuring the safety of users and patients. In order to ensure the safety of users and patients, please read the corresponding information in this chapter before putting the system into operation. Failure to observe the warnings or breach of the relevant regulations can lead to injuries, or even the loss of life, to users or patients.
NOTE: The system has a built-in screensaver to prevent damage to the display. It is not recommended to continually turn the unit on and off. To dispose of this product properly, please contact your local service department. Electrical safety Type of device protection against electric shock CLASS I DEVICE, where protection against electric shock is based not solely on BASE ISOLATION;...
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Ensure that you use only the cable supplied or intended by ZIMMER MEDIZINSYSTEME. Connect the cable and, while doing so, adhere strictly to the installation procedures (e.g., lay the power cable so that it is separated from the signal cables).
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Notice on the ban against modification by the user The user should under no circumstances modify this product. User modifications may lead to inferior electrical safety. Modification of the product includes changes to: - Cables (length, material, wiring, etc.) - System configuration/ - components User modifications can lead to deterioration of the EMC properties.
Label/icon Type plate 2.3.1 Warning symbols Dangerous electrical voltage. Unplug the mains plug before Caution, pay attention to the accompanying documents. opening the system! This symbol advises the reader to consult the accompa- nying documents for important safety-related information, such as warnings and safety precautions, that cannot be added to the device itself.
The devices listed above have been classified as suitable for operation in the PATIENT ENVIRONMENT. CAUTION: DO NOT connect any probes or accessories that have not been approved by ZIMMER MEDIZINSYSTEME for use within the PATIENT ENVIRONMENT. Do not touch the patient or devices that are not approved in...
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CAUTION: DO NOT use ANY non-approved devices. If devices are connected without the approval of ZIMMER MEDIZINSYSTEME, the warranty will become VOID. The system cannot be used with RF surgical equipment, otherwise there is a risk of causing burns to the patient.
Such a malfunction can affect the stability, effectiveness, and safety of the system and probes. Users should immediately discontinue use of the system and probes until the Zimmer-approved technician has re- viewed the system and confirms the effectiveness and safety of the system and probes.
ble or air pocket (for example, in the lung or intestines). During the cavitation process, the sound wave may cause the bubble to contract or vibrate. This vibration can cause the bubbles to explode and damage the tissue. The mechanical index (MI) was created to help users evaluate the likelihood of cavitations and the related side effects.
(e.g. during transcranial applications), the TIC (thermal index in cranial bone) must be monitored. MI> 0.3 There is the possibility of minor damage to the lungs or intestine of the neonate. If such exposure is necessary, reduce the exposure time to the degree necessary. MI>...
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for thermal effects can be expected as the TI increases. A high index does not mean that bioeffects are occurring, but only that the potential for them exists, and there is no consideration in the TI for the scan duration, so minimising the overall scan time will reduce the potential effects.
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Distance Frequency (MHz) (cm) 0.9332 0.8128 0.7080 0.5957 0.8710 0.6607 0.5012 0.3548 0.8128 0.5370 0.3548 0.2113 0.7586 0.4365 0.2512 0.1259 0.7080 0.3548 0.1778 0.0750 0.6607 0.2884 0.1259 0.0447 0.6166 0.2344 0.0891 0.0266 0.5754 0.1903 0.0631 0.0158 I’=I*R F , where I’ is the intensity in the soft tissue, and I is the time-averaged intensity measured in water. Tissue model: Tissue temperature elevation depends on the power, tissue type, beam width, and scanning mode.
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Wdeg = 210/fc, for models 1 to 4, where fc is the mean frequency in MHz. Wdeg = 40 KD for models 5 and 6, where K (beam shape factor) is 1.0 and D is the diameter of the aperture in cm at the depth of the area being examined. Cavitation is more likely to occur at high pressures and low frequencies of the ultrasonic wave pulse in tissue that con- tains bubbles or air pockets (for instance, the lungs, intestines, or when scanning with contrast agents that contain gas).
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Control elements that affect the acoustic output The potential for producing mechanical bioeffects (MI) or thermal bioeffects (TI) can be influenced by certain control ele- ments. Direct: The acoustic output control has the most significant effect on acoustic output. Indirect: Indirect effects may occur when adjusting controls. Controls that can influence MI and TI are detailed under the bioeffect portion of each control in the Image Optimisation chapter.
Instructions for handling the battery 2.6.3 Caution: Read and observe the following warnings and precautions to ensure the correct and safe use of Li-ion batteries. Do not immerse the battery in water and do not allow it to get wet. ...
Introduction to functions Has a B, B/B, 4B, B/M, M, PW display mode, M, the B/M mode has 4 kinds of scan velocity; Has many focus combinations, total gain control, 8-segment STC; Has a deep scan and an image left-right-up-down rollover function; Has a range of imaging technologies, such as multi-link (space-frequency) imaging, multi-frequency, multi-zoom, adjustable zoom, scrolling, harmonic imaging, etc.;...
Scope of delivery 3.4.4 Below you will find a list of what is included in the standard scope of delivery, further options which are not included in the standard scope of delivery, and accessories. Options, and in particular licences, are dependent on the scope of the order. Subject to change.
Environmental conditions 3.5.1 The system should be operated under the following environmental conditions. Technical specifications: AC/DC adapter: Input: 100-250 V ~, 50-60 Hz, 1.5-0.75 A Output: 19 V , 3.15 A Main unit: 19 V , 3.15 A OR Battery: 14.8 V , 4400 mAh Dimensions: 335 mm length ×...
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3.5.1.2 Environmental conditions for transport and storage The following environmental conditions for transport and storage fall within the system tolerances: Temperature: from 5° to 40°C Relative humidity: ≤80% RH non-condensing Atmospheric pressure: 700 hPa ~ 1060 hPa 3.5.1.3 Electrical requirements Power consumption <...
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3.5.1.5 Positioning & transporting the system Moving the system When moving or transporting the system, take the precautions described below to ensure maximum safe- ty for personnel, the system and other devices. Before moving the system Press for 3 seconds to force system shutdown and completely switch the system off. Disconnect all cables belonging to off-board peripheral devices (external printer, etc.) from the console.
Turning the system on 3.5.2 3.5.2.1 Acclimatisation period After being transported, the unit requires one hour for each 2.5º of heating or cooling if the temperature was below 10ºC or above 40ºC. NOTE: Please keep at least 20 to 30 cm of wall clearance at the back of the system to ensure good ventilation. Oth- erwise, malfunctions may occur as the temperature increases inside the unit.
3.5.3.1 Probe disassembly Turn the mortise lock switch 90 degrees in an anticlockwise direction and pull the probe connector plug out vertically. Installation of accessories 3.5.4 CAUTION: Use only the supplied optional or manufacturer-recommended parts! Other types of additional devices may cause damage to the system and to the connected additional devices.
Chapter 4 System Controls Alphanumeric keyboard Alphanumeric keyboard for entering patient number, name, characters, etc. Function keys/knobs SWITCH 4.2.1 Turn the device on or off PATIENT 4.2.2 Input patient data PROBE 4.2.3 Press this button to select the connected probes...
SETUP 4.2.4 Press this button to enter and exit the system settings 4.2.5 Press END key to complete an examination. Body marker 4.2.6 Press this key to enter the body markers menu, select body markers, and confirm the scan position on the screen. On- ly available in Freeze mode.
4.2.9 Press this button to delete measurement lines, body markers and text. Pressure 4.2.10 Use the Print1 or Print2 button to print the on-screen display and report via the connected video printer. Archive 4.2.11 This key takes you to archive management, where patient information can be viewed and edited. Report 4.2.12 Use this button to create, save, and retrieve examination reports.
Central control unit 5 MENU 4 Change 6 Measurement distance (Dist) 3 Cursor 7 Measurement curves (Trace) 2 EXIT 8 Calculate (Calc) 1 UPDATE 9 ENTER 10 Trackball ENTER 4.3.1 This multifunction button works in conjunction with the trackball and, depending on the device status, certain functions can be executed.
Distance measurement (DIST) 4.3.6 Press this key for distance measurement. Curve (TRACE) 4.3.7 Press this key to enter into trace measurement, and press UPDATE to toggle between trace and ellipse. Calculate (CALC) 4.3.8 Press this button to enter the menu for various measurement packages. MENU 4.3.9 Press the MENU knob a second time to select a menu item and change the parameters.
4.4.3 Press this button to switch between B/M and M mode. Image control 4.5.1 Press this key to open or close the THI function. 4.5.2 Press this key for automatic image optimisation. CINE 4.5.3 Press this key to save the current cine loop. SAVE 4.5.4 Press this key to save the current image.
Invert up/down 4.5.6 Press this key to invert the image from top to bottom. 4.5.7 STC can be used to adjust the gain compensation at different image depths. GAIN 4.5.8 Rotate the knob to adjust the gain in B mode and M mode ANGLE/ZOOM knob 4.5.9 Rotate the knob to adjust the angle or zoom.
USB: Displays whether this system is connected to a USB flash disk or not; press this icon to show the safe removal of the USB interface. From left to right in the bottom line: Input method, DICOM task sequence, battery indicator Input method: Press this icon to switch between the English and German input methods.
Chapter 5 Operating and examination mode This chapter mainly describes the process for normal operation of the device, including preparation for an examination, how to cre- ate and optimise the image, how to add comments and body markers, and so on. Preparing the system for use Device inspection 5.1.1...
Inputting patient information Press the button to bring up the patient screen Patient information screen Function buttons on the patient screen [Archive]: Retrieve patient information from the archive. [Worklist] Retrieve patient information from the worklist. The DICOM function must be opened for this; [New patient] Creates a new patient;...
CAUTION: When creating a diagnostic record, please check that the patient data is accurate before saving the measurement or image; otherwise, you will be recording incorrect patient information. After checking the patient, press the [END] key to save the patient information in the system. Image editing interface 1, Logo 2, Menu control 3, Image status prompt 4, Image parameter area 5, System status prompt 6, Grey curve 7, Im- age parameter area 8, Greyscale strip 9, Start point for the scan 10, Image region 11, Cine loop...
B/M mode 5.5.4 If you press the [B/M] button, a real-time B-mode image and a real-time M-mode image are displayed at the same time. A scanning line appears in the B-mode image area, which indicates the active scanning position for the M image in the B image area.
Scan hints for Doppler mode: The best Doppler data is obtained when the scan runs parallel to the direction of blood flow. You will get the best B-mode image when the scan direction is perpendicular to the anatomical target. You should therefore maintain a balance, as you usually do not get both an ideal B-mode image and ideal Doppler data at the same time.
5.6.5 Display PW mode M speed adjustment 5.6.6 In real-time M status, press the corresponding button for [Speed] to adjust the M speed within the range of 1~4. GAIN 5.6.7 In real-time status, rotate the [Gain] button to adjust the gain, in increments of 5 within a range of 0~255. 5.6.8 STC can be used to adjust the gain compensation at different image depths.
The Z icon serves as the orientation position of the probe. The Z icon on the left means that the first scan line on the left side of the screen corresponds to the probe's initial scan position; depending on the probe type, this page is marked accordingly on the probe. 5.6.14 TURN THI ON/OFF 5.6.15...
Smoothing 5.7.5 The smoothing function is used for restricting image noises and for performing axial smooth processing to make the image smoother. Move the cursor to [Smoothness] to adjust within the range of 0~7. Edge enhancement 5.7.6 Edge enhancement is used to enhance the image outline. In this way, the user can view the tissue structure more clear- Move the cursor to the [Smoothness] selection to adjust within the range of 0~7.
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Zoom coef. Adjust the size of the ruler. Update [Zoom coef], and turn the [MENU] control to adjust within the range of 60~100%. By opening MB, the image quality is improved. Update [ MB], and turn the [MENU] control to adjust within the range of 0~3. Trapezoidal mode Press [MENU] to turn the trapezoidal function on or off.
PW image adjustment Parameters in PW mode: Steering angle 5.8.1 Adjusts the steering angle. Activate [Steering angle] and rotate [MENU] to adjust the steering angle; the adjustment range is -10/-5/0/5/10. Frequency 5.8.2 Adjusts the frequency of the PW mode. Press the parameter control button and then [Freq] to change the frequency. The adjustment range depends on the type of probe.
Colour map 5.8.8 Changes the type of colour map. Activate [Colour map] and turn [MENU] to adjust the D colour map; the adjustment range is 0~8. Availability depends on the device model. Audio 5.8.9 Adjusts the volume. Activate [Audio] and turn [MENU] to adjust the volume; the adjustment range is 0~15. Acoustic power 5.8.10 Changes the acoustic power.
Full-screen display (this feature must be activated in setup) Full screen in the image area. Press the [GAIN] knob to activate the function; press the [EXIT] button or the [GAIN] knob again to exit full screen. When full screen is entered, press the [MENU] knob to display the menu for the current mode (except Bodymark). Edit comments 5.10 Overview...
Inputting comments from the character library 5.10.3 In comment status, move the trackball to the image area for editing; Press [Font size] to adjust the font size of the comments; the range is 10~20; Rotate [MENU] to select the required comments, then confirm using [MENU] to exit input; Editing quick comments 5.10.4 Press [Edit] to quickly retrieve the quick comments editing box;...
Operation: 1 Press [Save Start Pos.] to move the cursor to the start position; 2 Press [Load Start Pos.] to set the start position; Setting a body marker 5.11 General description 5.11.1 The body marker indicates the patient’s examination position and the direction of the probe scan on the image. Body markers are divided into: obstetrics, abdomen, gynaecology, heart and small parts;...
Using body markers 5.11.2 Usage Press to enter the body status. Select the body marker that you need. After adding the body marker image, move the trackball and then adjust the position of the probe. By rotat- ing the [MENU] control you can adjust the probe direction. Press the Enter key to confirm the entry. Move the trackball to change the position of the body marker;...
Image and cine configuration 5.13 The principle of cine storage 5.13.1 In real-time status, the image can be stored in the cine memory in its chronological order; maximum frame rates can be set for this. The maximum number of frames for the cine storage can be set; please refer to the chapter on presets. If the cine memory is full, the last frame is saved to memory and the previous frame is deleted.
Manual loop 5.13.2 Press [FREEZE] to freeze the image and display the cine playback bar; here, move the cursor to manual playback; the trackball is rolled to the right and the loop is played back page by page in ascending order. Or press [Forward/Pre] to play.
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Assessment ID: ID of the current patient. Name: Name of current patient. User interface for assessment Information: Access to the user interface for the current patient’s information. Report: Access to the user interface for reports on the current patient; Send images: Send image to the USB disk or DICOM memory unit and print; Delete pictures: Delete the selected image;...
Archive management 5.15 Archive management can be used to search through patient information that has been stored in system. Press [Archive] for the archive management user interface; all processes can be opened by moving the cursor. User interface for the archive: Type selection, selection using patient ID or name;...
Report 5.16 Press [ENTER] on the image to add the image to the report page. The report can be saved and printed. It is convenient for the doctor to be able to view and edit the patient information. The reports contain normal reports, abdominal reports, cardiac reports, small part reports etc. Move the cursor to the desired report page and press [ENTER] to select.
DICOM 5.17 DICOM Worklist 5.17.1 Press [Worklist] in the patient interface and the following dialogue box appears. ID: Entry for ID or some characters, the fuzzy query requires a server Search for: Choice of term, ID or name; ID: Display of patient ID Name: Display of patient's name Date of birth: Display of patient's date of birth Gender: Display of patient's gender Doctor: Display of the name of the treating physician Account no.: Display of the patient number Search: Press this button to start a search operation Apply: Select the searched patient and press this button, inputs all patient information into the new patient interface...
DICOM send interface Select DICOM storage on the left, select the DICOM server and press the export button to store to DICOM. Enter the DICOM task sequence and view/edit the DICOM procedure. DICOM printing 5.17.3 The DICOM printing procedure is the same as that for DICOM storage 5.15.4 DICOM SR. Press the Send DICOM SR button on the report interface, and that task is added to the DICOM task sequence.
Chapter 6 Measurements and calculations Main content of this chapter: During normal calculation and measurement of the image in B and M image mode, and during obstetrics calculation and measurements in urology, etc., the system can, depending on the current examination mode, enter the appropriate measurement mode and, depending on the measurement mode, access the appropriate report.
[DEL] 6.1.4 The main functions of this button are as follows: In freeze-frame status, press [DEL] to delete all measurement results, comments and traces. [Change] 6.1.5 Press [Change] to switch to another menu; press [Exit] to exit the menu; [Exit] 6.1.6 Press [Exit] to exit the measurement menu.
6. After fixing the next axis, you can complete the measurement using the [ENTER] key. 7. After measurement, the result is displayed in the measurement results area. 8. Repeat steps 1 to 6 to start the next “ellipse” measurement. Press the [DEL] key to delete all measurements. NOTE: Each measurement group has a limited number of measurements;...
Cross-sectional diagram 6.2.5 The cross-sectional diagram is used to measure the greyscale distribution of the ultrasonic signals in a vertical or horizon- tal direction on a particular profile (section). This measurement is only available in the still-frame mode. Measure- ment steps: Click on the [STILL FRAME] button to obtain a still-frame im- age.
Measurement Measurement method/ Submenu Unit Comments menu Measurement formula V=(π/6)×A×B×M Normal measurement and calculation in B mode Click on [B], [B/B] or 4B display to enter into B, B/B or 4B mode, then click on the [Calc] button to enter the measure- ment status.
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See distance meas. Formula: D1: First distance D2: Ratio meas. R = D1 / D2 Second distance Ratio See ellipse A1: First area A2: Distance Ratio Area Second area Formula: R = A1 / A2 See distance Angle range: Angle Degrees Distance 0°~180°...
ABD measurement and calculation Select ABD examination mode. Freeze the desired image, then press [Calc] to enter ABD measurement status. Or press [Change] to select the ABD measurement. Distance method/ Distance Submenu Unit Comments Distance formula menu See distance meas. Distance See distance Distance...
Distance method/ Distance Submenu Unit Comments Distance formula menu ×L×H×W Volume Length Height Kidney vol. See distance meas. Width (Rt/Lt) See distance Height Distance See distance Width Distance See distance meas. Formula: D1: Length of normal D2: StD% D1-D2 ÷D1 Length of stenosis ×...
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Distance Submenu Unit Distance method Comments menu Rempen, Robinson, Shinozuka See distance meas- urement. Formulae for selection: Bes- sis, CFEF, Campbell, Chitty, Hadlock, See distance meas- Hansmann, Jeanty, Johnsen, urement. Korean Kurtz, Merz, Osaka, Rempen, Sabbagha, Shinozuka distance Formulae for selection Distance Hansmann, Korean Formulae...
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Distance Submenu Unit Distance method Comments menu Distance Jeanty, Korean, Merz, Osaka See meas. on Ulna, long Formula: Jeanty, meas. See meas. on distance Formulae selection Tibia, long Jeanty, Merz Bones See meas. on distance Radius, long See meas. on distance Fibula, long See meas.
Distance Submenu Unit Distance method Comments menu Formula in the EFBW setup See meas. on distance AFI=AFI1+AFI2+AFI3 +AFI4 See meas. on distance Cervical See meas. on distance length Estimated date of delivery 6.6.1 Calculating the EDD using LMP (last menstrual period) 6.6.1.1 1.
Paediatric measurement Select obstetrics mode [Rep.] to enter it, then enter paediatrics mode. Or press [Change] to switch to the paediatrics measurement menu HIP angle 6.7.1 The HIP function is used for evaluating fetal growth. In order to perform a calculation, three lines need to be added to the image that conform to the fetal anatomic structure.
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Distance Submenu Unit Distance method Comments distance meas. Distance distance UT_L Distance on meas. CUT_L Dis- UT W See distance meas. Distance Submenu Unit Distance method Comments Distance meas. UT_H Dis- meas. L: UT_L H: UT_V UT_H π/6 meas. UT_W dis- L: UT_L H: tance meas.
Small parts measurement and calculation Freeze the required image in the small parts examination, then click on [Calc] to enter the small parts measurement sta- tus. Distance method/ Distance Submenu Unit Comments Distance formula menu meas. Distance meas. Distance meas. For- L: Thyroid_L Thyroid Volume...
B mode vessel measurement and calculation 6.10 The same as normal measurement in B mode. Urology measurement and calculation 6.11 Normally, urology measurements are performed in B and B/B mode. Freeze the desired image under the urology examination, then click on [Calc] to enter urology measurement status. Distance method/ Distance Submenu...
Cardiac measurement and calculation 6.12 Normally, urology measurements are performed in B and B/B mode. Freeze the required image under cardiac examination, then click on [Calc] to enter cardiac status. Distance method/ Distance Submenu Unit Comments Distance formula menu See distance meas.
Normal measurement and calculation in M, B/M mode 6.13 In real-time status, click on the [B/M] key twice and click on [Calc] to enter M mode (measurement status). In real-time status, click on [B/M] to enter B/M mode, and press [Calc] to enter M mode calculation status. meas.
Velocity 6.13.4 Measurement step: Select the speed menu item to start the measurement. Select the start point for the measurement and click on the screen. The yellow “+” cursor is active. Drag the cursor to the peak systolic wave. Click on the switch to active another point. Drag the active point to the last diastolic wave. Repeat steps 1-3 to perform another measurement.
M abdomen measurement 6.15 The same as for general measurement in M mode. Obstetrics measurements in M mode 6.16 The same as for general measurement in M mode. GYN measurement in M mode 6.17 The same as for general measurement in M mode. Cardiac measurement in M mode 6.18 Urology measurements are normally performed in M and B/M mode.
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Distance method/ Distance Submenu Unit Comments Distance formula menu Distance Diameter at diastole Left ventricular See M distance diameter at systole LVIDs Distance Left ventricular posterior wall See M distance meas. diastole LVPWd Inter-ventricular septum See M distance thickness at systole IVSs Distance Left ventricular posterior wall...
MVCF Average reduction of MVCF LVIDd-LVIDs/ length LVIDd×LVET Distance method/ Distance Submenu Unit Comments Distance formula menu EF velocity cm/s See M HR meas. AC velocity cm/s See M HR meas. See M distance A peak/E peak Distance Mitral valve See M HR and DEV: Mitral valve...
Velocity 6.22.1 See velocity of the general M mode measurement. Time 6.22.2 See time of the general M mode measurement. Heart rate 6.22.3 See heart rate of the general M mode measurement. Auto trace 6.22.4 Measurement steps: Move the trackball to select the start point of the single cycle and press the [ENTER] button to fix it. A second cursor "^"...
Measurement Measurement method/ Submenu Unit Comments menu Measurement formula VMid /10000 Formula: SD =Vs/Vd Formula: SD=(Vs-Vd)/Vs Formula: SD=(Vs-Vd)/VMid HR(Single wave) PW general measurement 6.24 Press [Calc] to enter PW measurement in PW mode. Press the corresponding parameter control button to change the object of general measurement.
Measurement Measurement method/ Submenu Unit Comments menu Measurement formula Flow volume Diameter See B distance measurement. Time See M time measurement. HR(Single wave) Formula: 0.785* diam.* am.*|TVI| Formula: SV*HR (Single l/min wave)/1000 PW abdomen measurement 6.25 See PW general measurement. PW OB measurement 6.26 arameter control button...
Measurement Measurement method/ Submenu Unit Comments menu Measurement formula Formula: SD =Vs/Vd Formula: SD=(Vs-Vd)/Vs Formula: SD=(Vs-Vd)/VMid HR(Single wave) PW cardiology measurement 6.28 arameter control button Press [Calc] to enter PW measurement in the PW cardiology mode. Or press the corresponding p change the cardiology measurement point.
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Measurement Measurement method/ Submenu Unit Comments menu Measurement formula AR Vmax velocity cm/s See M speed measurement Formula: Pressure = 4 × velocity AR Vmax pressure mmHg × velocity / 10000 AR PHT VPeak cm/s See M speed measurement Formula: Pressure = 4 × VPeak x AR PHT pressure mmHg VPeak / 10000...
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Measurement Measurement method/ Submenu Unit Comments menu Measurement formula TV PHT VPeak cm/s See M speed measurement Formula: PPG = 4 × Vpeak x TV PHT pressure mmHg Vpeak / 10000 TV PHT slope cm/s TV PHT TV PHT area Formula:220/TV PHT R-R interval TR manual curve...
Measurement Measurement method/ Submenu Unit Comments menu Measurement formula Pul. vein SD Formula: SD=Vs/Vd cm/s See M speed measurement See M time measurement. PW vascular measurement 6.29 Press [Calc] to enter PW measurement in PW vascular mode, or press the corresponding parameter control button to change the vascular item.
Chapter 7 Presets This chapter deals with the procedure for setting the system using the preset menu in preset mode. The preset func- tion is used to set up the working environment, the status and the parameters for each examination mode. Settings are stored in the system memory and are not lost, even after the system has been switched off.
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Form 1 General Setup Function name Setup method Description of functions Enter the name of the hospital shown in the top-left corner of Hospital Free input the "General settings" dialogue. A max. of 20 characters can Department be entered. Set the system date (calendar format); select the current date Date and time Free input straight away.
Measurement Measurement includes general measurement settings and measurement formula setup. General measurement setup 7.2.1 General settings can only change the display of the measurement unit. General settings range for the measurements Distance: cm, mm Area: cm 2 , mm 2 Volume: ml, l User interface for general measurement settings Time: s, ms Velocity: cm/s, mm/s...
Measurement formula setup 7.2.2 7.2.2.1 User interface menu for measurement descriptions Interface for processing measurement formulae Area: Drag down and select the desired measurement menu Manage: Displays the user interface for the measurement software display; add sequences for add, change, delete and change ranking order in the measurement menu.
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Check : Display the required items on the measurement menu, otherwise these are not displayed Sheet 2: Edit folders, content description Label Display the names of all items with names in the Measurement menu Variable name The name of the built-in and selected measurement menu; the user does not need to modify this in line with the names during the request Unique name Built-in code;...
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Verify the desired item and it is displayed in the measurement menu. If Display in the not verified, the item is not displayed in the measurement menu. menu Selection Check the procedure in the measurement menu. Press [Update] to toggle the procedure, otherwise the measurement will not be available Measurement process Display...
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Sheet 4 Measurement calculations – Editing content descriptions Label Display the name of the selected term for the display name in the Measurement menu Variable name The name of the built-in and selected measurement menu; the user does not need to modify this in line with the names during the request Unique name Built-in code;...
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Sheet 5 Operation of content descriptions for creating new measurements Label Display the name of the selected term for the display name in the Measurement menu Variable name The name of the built-in and selected measurement menu; the user does not need to modify this in line with the names during the request Unique name Built-in code;...
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Unit: Select the unit for the calculation sequence Measurement items: Display all available measurement procedures in the measurement menu. Function: Built-in formula, input for numbers and some parameters that the system needs, such as BSA, SPSA etc. Can- cel: Cancel editing the formula and close the user interface OK: Save edits and close the user interface 7.2.2.6 Edit formula –...
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Measurement point: Obstetrics measurement point Gestational age tables: Gestation list for the current measurement project. Growth table: Growth table for the current measurement. Fetal weight: Fetal weight – calculation formula. EFW equation: Fetal weight calculation for the current measurement. EFW growth: Fetal weight –...
Annotation User interface for setting annotations Annotations library 7.3.1 The database for the system's annotations is arranged according to: Abdomen, obstetrics, cardiology, small parts. An annotation on pathological changes can be made by entering characters via the programmable keyboard or by retriev- ing terms from the annotations database.
Edit an annotation 7.3.2 The operator uses only the current annotation instead of providing the content of all annotation statuses and, where necessary, inputs general annotations. If necessary, the user can import annotations or automatically include created annotations in the root of annotations. 7.3.2.1 Adding annotations from the annotation library Operation: 1.
Body markers User interface for body marker setup Library of body markers 7.4.1 Integrated body markers: Abdomen, obstetrics, GYN, cardiology, small parts, urology, vascular Press the [BodyMarkerLib] arrow key and display the name of the integrated body markers and the required body mark- ers using the trackball and [ENTER] button.
Editing body markers 7.4.2 1. Select the required source body markers using the trackball and press [ENTER] 2. Select the required body markers in the column for the [BodyMarkerLib], then press [ENTER] to activate them. 3. Press [ENTER] on [>] to import the selected body markers into the user-selected status; press [ENTER] on [>] to move the selected body markers in the [Selection of body markers] column into the original body markers.
Select Extras and press [MENU] and the following interface appears. Open the function via the corresponding control area. The user interface for setting the examination mode of the probe: Select the required probe and the appropriate examination mode. Exam mode Lib: Display all available examination modes. Exam mode selected: Display the examination modes in the probe column.
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User interface for setting the examination mode: Display of all examination modes available in the system Comment: Double-click on [ENTER] to activate the widget box; available status names for the annotation can be selected here. After setup, the default for the examination mode is selected by the user. Body marker: The default body markers required by the user are selected the same way as for comments.
DICOM has been activated. In the system page of the settings interface, you can check whether DICOM is open or not. If you want to activate DICOM, please contact Zimmer MedizinSysteme. A DICOM SCP or other appropriate DICOM server software must have been installed with the PACS.
Adding/editing the DICOM function 7.6.1 Default: Check this option to set the DICOM function as default; Service: Select DICOM storage, the DICOM worklist, DICOM print or DICOM SR; AE server title: Entry for the DICOM AE server name; Server IP address: Entry for the DICOM IP ad- dress;...
Full screen show: see DICOM. Installation setup 7.8.4 In order to enter the appropriate key for starting the trial and detailed function, please contact ZIMMER MEDIZINSYS- TEME. Video VGA 7.8.5 Select the video data: NTSC or PAL.
3. If it becomes necessary to clean the probe port and the peripheral device, please contact the sales office, customer service team or representative of ZIMMER MEDIZINSYSTEME. Any self-attempted cleaning may result in a malfunction or a deterioration in the functionality of the device.
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If the probe displays any abnormal phenomena, immediately stop operation and contact the sales office, customer service department or representative of the manufacturer. Cleaning The cleaning procedure is fit for all probes. After use, the probes must be cleaned according to the cleaning procedure described in this chapter.
CAUTION: Do not immerse the probe connector in any liquid Do not exceed the insertion depth of the intra-cavitary probe. It is essential to avoid leaving the probe in the liquid for more than twelve hours. Use only the appropriate test solution. Storage: Please place the probe to a clean and dry environment, and avoid direct sunshine.
Checking for malfunctions Serial Error Reason Measures The switch key lights up The battery loses power, the Check the plug adapter works irregularly but the LED for the power indi- between the cable and power cator does not The LED for the power indicator The interval time is too Restart after 1 minute lights up, but the LED for the...
Function test 1. Switch the device on 2. Position the selected probe on a suitable body part with ultrasound gel. 3. Move the probe while watching the screen to see if the desired body part is displayed with the movement on the screen.
Chapter 9 Probes General description Cable Strain relief Handle Connecting line Transducer Scanhead (lens) Convex probe overview The probes provide high spatial and contrast ultrasound imaging at frequencies of 2.0 MHz to 11.0 MHz. These probes operate by pulsing sound waves through the body; the returning echoes are used to produce a high-resolution bright- ness mode, and a real-time display.
WARNING: The probes are designed to be used with this ultrasound system only. Use of these probes on any other system or use of any non-appropriate probe may cause an electric shock or damage to the sys- tem/transducer. Cleaning and disinfection 9.2.2 Disconnect the probe from the ultrasound console and remove all coupling gel from the probe by wiping it with a soft cloth and rinsing with running water.
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Before inserting the connector into the probe port, inspect the probe connector pins. If a pin is bent, DO NOT use the probe until it has been inspected and repaired/replaced by a ZIMMER MEDIZINSYSTEME representative. The ZIMMER MEDIZINSYSTEME service team or qualified clinicians should routinely perform electrical leakage tests. Mechanical risks: A defective probe or excessive force can cause injury to the patient or damage to the probe: Observe the depth markings and do not apply excessive force when inserting or guiding the endocavitary probe.
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Special handling instructions Using protective sheaths The use of market-approved probe sheaths is recommended for clinical applications. See FDA 29 March 1991 "Medi- cal Alert on Latex Products". Protective sheaths are generally required to minimise the risk of transmitting diseases. Probe sheaths are provided for all clinical situations where infection is a concern.
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reused between patients. It is therefore very important to minimise the risk of disease transmission by using barri- ers and safe processing between patients. Risk of infection ALWAYS clean and disinfect the probe between patients to the level appropriate for the type of examination, and use FDA-approved probe sheaths where appropriate.
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DO NOT use ANY gels (lubricants) that have not been recommended, as these can damage the probe and void the warranty. The gel made by Zimmer MedizinSysteme or the AQUASONIC Gel made by US manufacturer R. P. Kincheloe are recommended.
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Scheduled maintenance The following maintenance schedule is suggested for the system and probes to ensure optimum operation and safety. Daily: Inspect the probes After each use: Clean and disinfect the probes. As necessary: Check, clean and disinfect the probes. Returning/shipping the probes and replacement parts Our transport department and our policy require that equipment returned for servicing must be CLEAN and free of blood and other infectious substances.
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The following specific recommendations are made for the use of endocavitary ultrasound transducers. Users should also review the documents from the Centers for Disease Control and Prevention on sterilisation and disinfection of medical devices to be certain that their procedures conform to the CDC principles for disinfection of patient care equipment.
4. USE OF ASEPTIC TECHNIQUES For the protection of the patient and the health care worker, for all endocavitary examinations, the operator should wear proper gloves throughout the entire procedure. Gloves should be worn to remove the condom or other barrier from the transducer and to wash the transducer as outlined above.
Operating the transvaginal probe 9.3.2 The transvaginal probe is an endocavity probe. For safe operation, please refer to “Care and maintenance” for correct cleaning and disinfection. The temperature at the tip of the probe is displayed on the monitoring screen. Temperatures above 43ºC are not al- lowed.
CAUTION: Please remove the sheath (if present) before cleaning the probe. (Sheaths, such as condoms, are for single use only). When cleaning TV and TR probes, it is important to ensure that all surfaces are thoroughly cleaned. Disinfection 2% glutaraldehyde-based solutions have been shown to be extremely effective for this purpose. Cidex is the only ger- micide that has been tested for compatibility with the material used to manufacture the probes.
The warranty for the system and probes ex factory is as stated in the warranty card. The system is a precise electronic system. Defective parts may only be replaced by a ZIMMER MEDIZINSYSTEME-authorised service technician. Any assembly, disassembly, handling, repair, or replacement by any other persons may have an adverse impact on the safety and effectiveness of the systems and probes, and thus will reduce the lifespan of the system and probes;...
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ZIMMER MEDIZINSYSTEME headquarters to arrange the required safety check and calibration by the authorised service technician. If the head office of the ZIMMER MEDIZINSYSTEME service centre issues the calibration certificate for the system or probe in question, the user may continue to use the system or probes in accordance with the calibration certificate.
Appendix A: Acoustic output report table Acoustic power table System: SonidoSmart Transducer model: C3-A Operating mode: B No scan Index sign Scan No scan Aaprt≤1c Aaprt>1c Global maximum index value Associated 0.92 acoustic parameters Min. of [P α ta.α Z at max pi.α...
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Acoustic power table System: SonidoSmart Transducer model: C3-A Operating mode: THI-B No scan Index sign Scan No scan Aaprt≤1c Aaprt>1c Global maximum index value Associated 0.94 acoustic 2.01 parameters Min. of [P α ta.α Z at max pi.α 3.55 3.68 2.09 Attenuation of A...
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Acoustic power table System: SonidoSmart Transducer model: C3-A Operating mode: B+M No scan Index sign Scan No scan Aaprt≤1c Aaprt>1c Global maximum index value Associated 0.66 acoustic parameters Min. of [P 10.27 α ta.α 3.06 2.59 3.54 Z at max 2.91 pi.α...
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Acoustic power table System: SonidoSmart Transducer model: C3-A Operating mode: THI-B+M No scan Index sign Scan No scan Aaprt≤1c Aaprt>1c Global maximum index value Associated 0.66 acoustic 23.55 parameters Min. of [P 10.27 α ta.α 3.05 2.59 3.54 Z at max 2.91 pi.α...
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Acoustic power table System: SonidoSmart Transducer model: C3-A Operating mode: PW No scan Index sign Scan No scan Aaprt≤1c Aaprt>1c Global maximum index value Associated acoustic parameters Min. of [P 22.03 α ta.α 2.61 4.95 Z at max pi.α 0.28 2.89 2.89 6.96...
Acoustic power table System: SonidoSmart Transducer model: V6-A Operating mode: B No scan Index sign Scan No scan Aaprt≤1c Aaprt>1c Global maximum index value Associated 0.91 acoustic parameters Min. of [P α ta.α Z at max 3.43 pi.α 5.68 5.71 0.86 Attenuation of A...
Acoustic power table System: SonidoSmart Transducer model: V6-A Operating mode: THI-B No scan Index sign Scan No scan Aaprt≤1c Aaprt>1c Global maximum index value Associated 1.44 acoustic parameters Min. of [P α ta.α Z at max pi.α 5.74 5.74 0.86 Attenuation of A aprt...
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Acoustic power table System: SonidoSmart Transducer model: V6-A Operating mode: B+M No scan Index sign Scan No scan Aaprt≤1c Aaprt>1c Global maximum index value Associated 1.89 acoustic parameters Min. of [P α ta.α 3.97 Z at max 3.97 pi.α 0.07 5.03 5.54 5.03...
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Acoustic power table System: SonidoSmart Transducer model: V6-A Operating mode: THI-B+M No scan Index sign Scan No scan Aaprt≤1c Aaprt>1c Global maximum index value Associated 1.89 acoustic parameters Min. of [P α ta.α 3.97 Z at max 3.95 pi.α 0.07 5.05 5.48 5.05...
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Acoustic power table System: SonidoSmart Transducer model: V6-A Operating mode: PW No scan Index sign Scan No scan Aaprt≤1c Aaprt>1c Global maximum index value Associated 0.84 acoustic parameters Min. of [P α ta.α Z at max 3.47 pi.α 0.23 2.87 2.87 Attenuation of aprt...
Acoustic power table System: SonidoSmart Transducer model: L7M-A Operating mode: B No scan Index sign Scan No scan Aaprt≤1c Aaprt>1c Global maximum index value Associated acoustic parameters Min. of [P α ta.α Z at max 1.95 pi.α 7.23 7.21 1.22 Attenuation of A 0.45...
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Acoustic power table System: SonidoSmart Transducer model: L7M-A Operating mode: THI-B No scan Index sign Scan No scan Aaprt≤1c Aaprt>1c Global maximum index value Associated 0.69 acoustic parameters Min. of [P α ta.α Z at max 1.35 pi.α 6.85 6.85 1.22 Attenuation of A...
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Acoustic power table System: SonidoSmart Transducer model: L7M-A Operating mode: B+M No scan Index sign Scan No scan Aaprt≤1c Aaprt>1c Global maximum index value Associated 0.83 acoustic parameters Min. of [P α ta.α Z at max pi.α 1.65 6.86 6.85 6.82 4.08 4.08...
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Acoustic power table System: SonidoSmart Transducer model: L7M-A Operating mode: THI-B+M No scan Index sign Scan No scan Aaprt≤1c Aaprt>1c Global maximum index value Associated 0.83 acoustic parameters Min. of [P α ta.α Z at max pi.α 1.65 6.84 6.83 6.82 4.08 4.08...
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Acoustic power table System: SonidoSmart Transducer model: L7M-A Operating mode: PW No scan Index sign Scan No scan Aaprt≤1c Aaprt>1c Global maximum index value Associated 1.98 acoustic parameters Min. of [P α ta.α Z at max 3.35 pi.α 0.27 6.87 6.83 6.83 4.08...
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Acoustic power table System: SonidoSmart Transducer model: MC6-A Operating mode: B No scan Index sign Scan No scan Aaprt≤1c Aaprt>1c Global maximum index value Associated 1.94 acoustic parameters Min. of [P α ta.α Z at max pi.α 5.86 5.89 0.73 Attenuation of A aprt...
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Acoustic power table System: SonidoSmart Transducer model: MC6-A Operating mode: THI-B No scan Index sign Scan No scan Aaprt≤1c Aaprt>1c Global maximum index value Associated 1.49 acoustic parameters Min. of [P α ta.α Z at max pi.α 5.68 5.67 1.22 Attenuation of A aprt...
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Acoustic power table System: SonidoSmart Transducer model: MC6-A Operating mode: B+M No scan Index sign Scan No scan Aaprt≤1c Aaprt>1c Global maximum index value Associated 0.61 acoustic parameters Min. of [P α ta.α 1.95 Z at max 2.05 pi.α 3.39 5.56 5.46 5.46...
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Acoustic power table System: SonidoSmart Transducer model: MC6-A Operating mode: THI-B+M No scan Index sign Scan No scan Aaprt≤1c Aaprt>1c Global maximum index value Associated 0.61 acoustic parameters Min. of [P α ta.α 1.95 Z at max 2.05 pi.α 3.39 5.52 5.43 5.45...
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Acoustic power table System: SonidoSmart Transducer model: MC6-A Operating mode: PW No scan Index sign Scan No scan Aaprt≤1c Aaprt>1c Global maximum index value Associated 0.49 acoustic parameters Min. of [P α ta.α Z at max 0.01 pi.α 1.24 5.23 5.23 5.23 2.43...
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Acoustic power table System: SonidoSmart Transducer model: L7S-A Operating mode: B No scan Index sign Scan No scan Aaprt≤1c Aaprt>1c Global maximum index value Associated 1.92 acoustic parameters Min. of [P α ta.α Z at max pi.α 7.72 8.16 0.77 Attenuation of A aprt...
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Acoustic power table System: SonidoSmart Transducer model: L7S-A Operating mode: THI-B No scan Index sign Scan No scan Aaprt≤1c Aaprt>1c Global maximum index value Associated 0.99 acoustic parameters Min. of [P α ta.α Z at max 1.52 pi.α 6.15 6.42 0.77 Attenuation of A...
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Acoustic power table System: SonidoSmart Transducer model: L7S-A Operating mode: B+M No scan Index sign Scan No scan Aaprt≤1c Aaprt>1c Global maximum index value Associated 1.92 acoustic parameters Min. of [P α ta.α 1.55 Z at max pi.α 0.08 6.66 8.01 6.66 2.56...
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Acoustic power table System: SonidoSmart Transducer model: L7S-A Operating mode: THI-B+M No scan Index sign Scan No scan Aaprt≤1c Aaprt>1c Global maximum index value Associated 1.81 acoustic parameters Min. of [P α ta.α 1.55 Z at max pi.α 0.08 6.63 7.92 6.68 2.56...
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Acoustic power table System: SonidoSmart Transducer model: L7S-A Operating mode: PW No scan Index sign Scan No scan Aaprt≤1c Aaprt>1c Global maximum index value Associated 2.26 acoustic parameters Min. of [P α ta.α Z at max pi.α 0.18 7.95 8.15 7.97 2.56 2.56...
Appendix B: EMC guidelines and manufacturer's declaration 1. Guidelines and manufacturer's declaration – electromagnetic emissions The SONIDOSMART is intended for use in an electromagnetic environment as specified below. The customer or user of the SONIDOSMART should ensure that it is operated in such an environment. Emissions Compliance Electromagnetic environment –...
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Voltage dips, < 5 % U < 5 % U The supply voltage quality short-term inter- (> 95 % dip in U ) for (> 95 % dip in U ) for must correspond to that of a ruptions and fluc- ½...
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3. Guidelines and manufacturer’s declaration – Electromagnetic immunity The SONIDOSMART is intended for use in the electromagnetic environment specified below. The customer or user of the SONIDOSMART should ensure that it is used in such an environment. Immunity IEC 60601 test Compliance level Electromagnetic environment –...
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Recommended safety separation distances between portable and mobile RF telecommunications equipment and the SONIDOSMART unit The SONIDOSMART is intended for operation in an electromagnetic environment in which RF disturbances are controlled. The customer or user of the SONIDOSMART device can help prevent electromagnetic interfer- ence by maintaining a minimum distance between portable and mobile RF communications equipment (trans- mitters) and the SONIDOSMART unit –...
Appendix C: Summary of measurement results Measurement Area of usage Accuracy meas. Full screen <±5% Scope: Full screen <±5% Trace method, ellipse method Area: Full screen <±10% Trace method, ellipse method Volume Full screen <±10% Angle Full screen <±5% Time Full screen <±5% Heart rate...
Appendix D Display accuracy and acoustic measurement uncertainties In accordance with IEC60601-2-37 and NEMA UD-3 2004, the display accuracy and measurement uncertainty for acoustic measurement are summarised in the following table. The display accuracy of MI is ±20%, and TI is ±40% or <0.1, if MI,TI is below 0.5. Measurement uncertainty Item (Percentage at 95% confidence limit)
Three transducer samples were tested, and the confi- dence limit is 95%, the value of t.975 is 4.30. The measured data was obtained under the test conditions used by ZIMMER MEDIZINSYSTEME. Transducer Maximum surface tem- perature (°C)
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