Qisda UH100N Diagnostic Ultrasound System User Manual 2

Qisda Corporation Diagnostic Ultrasound System Users Manual 2

Contents

Users Manual-2

53Basic operations  Identify the main screen layoutNo. Function No. Function15ROI (region of interest) areaUse the zoom function to zoom in and pan across the current image.16End Exam buttonClose the current exam for the current patient, and start a new exam for the next patient. All the value settings adjusted during this exam will be stored automatically.17 (High) Resolution: Move the cursor to the right for a clearer yet superficial image. (Deep) Penetration: Move the cursor to the left for a deeper yet less clear image.18PW Update buttonStart/stop the PW trace.19 TGC (Time Gain Compensation)Slide any of the 8 TGC sliders to adjust the gain for the desired section of the 2D image. M Update buttonStart/stop the M trace.20Tuning buttonOptimize the image quality during a real-time scan.21Function keyAssign this button as a shortcut to perform a function.22Thumbnail listThumbnails of the scanned images/clips that are saved23Touch the left/right arrow to toggle through different sets of image control settings when using duplex or triple modes.24Freeze buttonFreeze the current scan. 25Open the next page of the image control settings (See page 56).26Image control settings(See page 70)27Mode selection buttons
54Basic operations  Identify the main screen layoutImaging screen (Frozen)During an exam, touch Freeze to review all the ultrasound images stored in the cine buffer frame by frame, or play back these frames in a continuous loop. The operator can also measure, calculate and add annotations to the frozen images or clips.Menu Adam, Smith123456727 01/01/1988Liver09/03/2015 02:56PMDr. JohnsonMedical CenterDistance Ellipse TI MI ProbeTrace CalcMeasure DelAnnot LabelArrow Annot DelBDMK Probe PosRotate Erase BDMKPrint12B FunctionFreeze Save Image Fun.Key Set Start Set End1 490End ExamControl panel104678935121211Figure 7  Frozen imaging screen (example)No. Function No. Function1This image is added to a report.2Cine clip3The progress bar4Play back the recent image frame sequence.5Set the end point of the cine clip.6Set the start point of the cine clip.7Save Image buttonSave a frozen image or a clip to the system hard drive.8Freeze button (Enabled)Touch this button again to return to the real-time scan.9Open the next page of the image control settings. (See page 56)10Print out the image from the thermal printer connected to the system via the USB connector.11Add annotations, including arrows, texts and body marks, to the current image using the virtual keyboard .12Perform measurements and calculations on the current image.
55Basic operations  Identify the main screen layoutSystem toolsTouch anywhere on the system toolbar to open the system tools widget. Touch an item to adjust its setting.MenuB14:56 2015. 08. 07TuesdayM LAN onCast display offUsed 85%ConnectingFreeze Save Image124678935System toolbarFigure 8  System tool widgetNo. Function No. Function1Manually set current date and time.2Enable/Disable the Bluetooth function.3Cast the system screen to an external display.4Check and manage outgoing queues.5Adjust the brightness.6Adjust the volume.7Display the percentage of the system storage used. Follow the pop-up message to free up storage space by deleting exams done in the appointed number of weeks.8Manage the Ethernet settings9Enable/Disable the WLAN function.Virtual keyboardWhenever the operator needs to enter text in a text field, simply touch the field, and a virtual keyboard appears on the lower part of the screen.Touch a letter to enter text; when finishing inputs, touch Done.Figure 9  Virtual keyboard
56Basic operations  Identify the main screen layoutScan properties displayThe imaging window includes a text display information about the current scan.Medical CenterTI 0.27MI 1.04CLA0Gn 5815.0cm 4FPS1/ 1M/ 80.0Gn 45M/ 80.01.020.01/ 315-15124635Figure 10  Scan properties display (example)No. Function No. Function1Thermal index/Mechanical index2Transducer type32D image control settings: Gain/Depth/FPS/QBeam/PWR4Color image control settings: Gain/PWR/PRF/Wall Filter/Persistence5Color wedge6Grayscale wedgeSwitch the control panel pagesThe functions available on the control panel vary, depending on the scan mode and the transducer connected.Touch to display more functions (page 3).Page 3Touch to return to the first page (page 1).Touch to return to the previous page (page 2).Touch to open the next page (page 2).Page 1 Page 2
57Basic operations  Add a new patientAdd a new patientThe system allows skipping entering patient information if the operator needs to start the ultrasound exam immediately. However, the images and cine loops cannot be saved. We recommend that the operator defines the patient within the system before scanning to avoid mix-ups and to generate reports.1. On the imaging screen, touch Menu > Patient.Menu Patient Patient InformationEdit Patient First name Middle Name Last NameID Gender DOB Age:New Patient Exam HistoryCardiology GY OB Abdomen Small Part Urology VascularPause Exam Height cm Weight kg BSA: m2HR bpmBlood Press /mmHg RA Press mmHgCurrent Exam HistoryAccession Institution OperatorSave Referring physician Interpreting PhysicianDescriptionCommentScan Previous End ExamFigure 11  Patient screen2. Touch New Patient. Enter the patient information as much detail as possible: » Touch in a text entry field, and use the virtual keyboard below to input contents. » Touch Next on the keyboard to go to the next field. » Touch Done on the keyboard.To create a valid patient profile, at least the patient’s First name and ID number should be filled in.3. Touch Save.To start scanning the patient, touch Scan.To update patient information1. On the patient screen, touch Edit Patient.2. Enter the new information in the appropriate fields.
58Basic operations  Load a work list3. Touch anywhere on the screen, the following system message appears. Touch Save to save changes.Load a work listThe system conforms with the Digital Imaging and Communications in Medicine (DICOM) standard, which is the industrial standard for the communication and management of patient data between devices in the hospital. The operator can load patient information in a work list via the DICOM server.1. On the imaging screen, touch Menu > Work list.Menu Worklist Query WorklistStart exam Name ID 234567|Accession#Worklist: 1 2015.08.29 AllName ID Accession# Gender DOBKeane Fox 234567 123456 M 19991109DetailsScan Previous23Figure 12  Work list screen2. Enter the query criteria in any of the Name/ID/Accession# fields, and touch to start the query. Patients matching the query will be listed on the screen.3. Select the number of patients to scan on the worklist from the drop-down menu.To start scanning, select a patient, and then touch Start exam.
59Basic operations  Select a presetSelect a presetThe system provides predefined presets for all supported transducers. Choosing an exam loads optimized presets for image control settings, based on the anatomy to be scanned, the transducer used, and the scanning mode. The presets also specify the measurements appropriate for the exams. The operator can directly use the optimized presets, or adjust any of the image control settings as necessary for the specific patient and the specific exam.1. On the imaging screen, touch Menu > Preset. All the available presets compatible with the connected transducer displays on the preset screen.Menu Preset Select PresetSave current used preset asManagementExportImport Liver ObstetricPreset SetupCurrently used presetScan PreviousFigure 13  Preset screen2. Touch the exam/preset to scan, and the operator will be redirected automatically to the real-time imaging screen.To modify current presets1. On the preset screen, touch Movement.2. Touch Move, and drag to re-arrange the order of the presets. To hide an unwanted preset, touch Hide & Show Preset, and touch Off on the preset.3. Touch anywhere on the screen, the following system message appears. Touch Save to save changes.
60Basic operations  Set the transducer orientationSet the transducer orientationUpon entering all imaging modes, the orientation marker ( ) displays at the default location (usually at the top left side of the image), and suggests the operator the direction of holding the transducer. The orientation marker on the screen corresponds to the position of the orientation marking on the side of the transducer.Orientation markerFigure 14  Transducer orientation (Example transducer-C52A)The operator can change the left/right orientation of the image (real-time or frozen) in various imaging (single or dual) without rotating the transducer head itself. To reverse left and rightOn the imaging screen (real-time or frozen), touch > L/R. To reverse up and downOn the imaging screen (real-time or frozen), touch > U/D.Adjust the displayed imageOn the real-time imaging screen, touch the corresponding mode selection button to select a scan mode. Use the image control settings to further optimize the image. For explanations and usage of these settings on specific modes, please refer to their respective chapters.The operator can also perform the following operations to adjust the contents of the imaging window.
61Basic operations  Adjust the displayed imageEnlarge an area of the imageTo further examine the anatomy by enlarging a region of the image (real-time or frozen), use the zoom function.1. On the imaging screen, touch > > Zoom. The ROI (Region of Interest) box appears on the center of the image.Menu Adam, Smith123456727 01/01/1988Liver09/03/2015 02:56PMDr. JohnsonMedical CenterChroma Map 0Sector Width 26 TI 0.11MI 0.92CLA0Gn 5815.0cm 15FPS1/ 1M/ 80.060/ 00/ 4GSC 0Sector Pos ROI boxAcoustic 1540 TX Power 80.0Zoom Image Reverse Needle Erase BDMKAnnot Label Arrow Annot DelBDMK Probe Pos Rotate CloseZoom View: 1.0xB FunctionFreeze Save Image Fun.Key Tuning TGC Penetration Resolution End ExamFigure 15  Enlarge a ROI (normal image)Touch and drag inside of the ROI box to move it to the area to enlarge. Touch on any of the box’s four corners and drag to resize the ROI box.2. Touch anywhere outside the ROI box to enlarge selected area.Menu Adam, Smith123456727 01/01/1988Liver09/03/2015 02:56PMDr. JohnsonMedical CenterChroma Map 0Sector Width 26 TI 0.11MI 0.92CLA0 Gn 5815.0cm 15FPS1/ 1M/ 80.060/ 00/ 4GSC 0Sector PosAcoustic 1540 TX Power 80.0Zoom Image Reverse Needle Erase BDMKAnnot Label Arrow Annot DelBDMK Probe Pos Rotate CloseZoom View: 2.0xB FunctionFreeze Save Image Fun.Key Tuning TGC Penetration Resolution End ExamFigure 16  Enlarge a ROI (zoomed image)The operator can still move the enlarged area by touching and dragging anywhere on the image.
62Basic operations  Freeze an imageSplit the imaging screenThe system allows splitting the imaging screen into two sections to view two current scans for a patient. The operator can acquire one scan for the patient, enable split screen, and then acquire another scan from a different angle, location or with a different scan mode.On the imaging screen, touch > Dual. The ultrasound software immediately freezes the current scan, and copies the current settings for the image to the second screen.Menu Adam, Smith123456727 01/01/1988Liver09/03/2015 02:56PMDr. SmithMedical CenterB Color PW TI 0.27MI 1.04CLAM Power 0 0 Gn 5815.0cm 4FPS1/ 1M/ 80.0Color Gain 45Gn 45M/ 80.01.020.01/ 3PRF 1.0 15Steering 0-15WF 20.012Color FunctionFreeze Save Image Fun.Key Tuning TGC Penetration Resolution End ExamFigure 17  Dual screenTo select a screen, touch Toggle. Only one screen can be active at a time. The operator can then apply any image control settings and use scan modes independently to either screen. For example, the operator can acquire a 2D scan, activate dual screen, and then acquire a Color Doppler scan in the second screen.To leave the dual screen, touch Dual again. Freeze an imageDuring a real-time scan, touch Freeze to freeze live ultrasound images recorded by frame and stored temporarily in the cine buffer. Depending on the mode selected, a certain number of frames are recorded. To view the saved images frame by frame, touch / . To play back saved images in a continuous cine loop, touch . To re-start a new live scan, touch Freeze again. If no frozen image or cine loop are saved, restart live scanning erases the frame data. Make sure any needed images are saved or printed before acquiring new scan data.
63Basic operations  Add annotations and measurementsAdd annotations and measurementsOn the frozen imaging screen, the operator can add annotations and measurements to the ultrasound images in order to explain the anatomy. If you return to the real-time imaging screen without saving the image, all the annotations and measurements added will be cleared.AnnotationsbacMenu Adam, Smith123456727 01/01/1988Liver09/03/2015 02:56PMDr. JohnsonMedical CenterTI 0.11MI 0.92CLALeft RightUpper Lower 0Gn 5815.0cm 15FPS1/ 1M/ 80.060/ 00/ 4Medial LateralAnterior PosteriorSAG TRANSPROX MIDLT Kidney RT Kidney TumorLT Lobe RT LobeAorta LiverCBD IVC LowerDuodenum FluidAppendix PancreasGallbladder SpleenCaudate BowelDelete Set Home Go home1 490End ExamCloseFigure 18  Add annotationsArrowTouch Arrow. An arrow appears at the text home position. Drag the arrow to place it to the desired location a.Text1. Touch Annot. A virtual keyboard and a text cursor (I-beam) appear at the text home position.2. Type the texts directly. Touch Done on the keyboard to finish inputs. 3. Drag the text cursor to where you want the new texts to be, and release it to place the texts b.Set the text home positionThe operator can choose a specified position in the image display as the starting location, which is the text home position.1. Touch Annot.2. Drag the text cursor to the desired text home position.3. Touch Set Home.
64Basic operations  Add annotations and measurementsLabel1. Touch Label. A predefined text menu and a text cursor (I-beam) appears at the text home position c.2. Select a text label to place it at the current cursor position, and touch Close.3. Drag the cursor/label to where you want the texts to be.The text labels are still editable. Touch the label to display the virtual keyboard, and start editing the texts. Touch Done on the keyboard to finish editing.BDMK1. Touch BDMK to display the body marker menu.Menu Adam, Smith123456727 01/01/1988Liver09/03/2015 02:56PMDr. JohnsonMedical CenterDistance TI 0.11MI 0.92CLATrace 0Gn 5815.0cm 15FPS1/ 1M/ 80.060/ 00/ 4AnnotArrowBDMKRotatePrintFreeze Save Image Fun.Key Set Start Set End1 490End ExamBody Mark (12)CloseFigure 19  Add a body mark2. Select a body mark. A pictogram of the body mark with a transducer indicator displays on the image.Figure 20  Pictogram of the body mark (example)3. Touch Probe Pos, Touch anywhere on the image and move to place the body marker to the desired location on the body mark.4. Touch Rotate. Touch anywhere on the image and move to rotate the transducer indicator.
65Basic operations  Add annotations and measurements5. Touch and hold the pictogram, and drag to move it to the desired location on the image. To delete annotations added, including texts and arrows, touch Annot Del to delete the last added annotations. To delete the body mark added, touch Erase BDMK.MeasurementsMeasurements accompanying ultrasound images supplement other clinical procedures available to the attending physician. The operator can perform as many measurements as needed.acbMenu Adam, Smith123456727 01/01/1988Liver09/03/2015 02:56PMDr. JohnsonMedical CenterDistance Ellipse TI 0.11MI 0.92CLA1 D 66.7 mm2 TA 2641.5 mm2 TB 0.5 mm3 EA 119.8 mm2 EP 122.6 mm Ea 61.2 mm Eb 2.5 mmTrace Calc 0Gn 5815.0cm 15FPS1/ 1M/ 80.060/ 00/ 4Measure DelAnnot Label 2Arrow Annot DelBDMK Probe PosRotate Erase BDMKPrint51B FunctionFreeze Save Image Fun.Key Set Start Set End1 490End ExamFigure 21  Perform measurementsTo delete measurements added, touch Measure Del to delete the last added measurements.DistanceUsed to measure a distance.1. Touch Distance. A “cross” cursor appears on the image. Move the target cursor to where you want to start measuring and release it.2. Drag the target cursor to where you want to finish measuring, and then release it a.The measured results (values) appear on the top left corner of the ultrasound image.TraceUsed to trace an irregular shape.1. Touch Trace. A “cross” cursor appears on the image. Move the cursor to where you want to start measuring and release it.
66Basic operations  Save and print the image2. Drag the cursor along the outline of the object to trace.Figure 22  Trace an outline3. When the tracing is nearly done, release your finger and the system completes the loop by drawing a line from the current cursor position to the starting point b.The measured results (values) appear on the top left corner of the ultrasound image.EllipseUsed to measure a circumference.1. Touch Ellipse. A “cross” cursor appears on the image. Move the target cursor to one end of the area you want to measure and release it to set the start point of measurement.2. Drag the target cursor to the other end of the desired area, and release it to set the end point of measurement. An oval area is then measured c.The measured results (values) appear on the top left corner of the ultrasound image.Save and print the imageAfter adding needed annotations/measurements to the image, the operator can save or print the image.Save an imageOn the frozen imaging screen, touch Save Image to save the current frame as an image. The saved image will be displayed in the thumbnail list.Save a cine clipTo save the frames as a cine clip, touch and hold Save Image.Print an imageTo print out the image, touch Print.
67Basic operations  Review the imageReview the imageOn the frozen screen, scroll up and down on the thumbnail list to view the thumbnails of all the saved images/clips. To further examine one or a set of images/clips, touch the thumbnail(s) of the needed image or cine clip to display the review screen. Menu Adam, Smith123456727 01/01/1988Liver07/08/2015 02:56PMDr. JohnsonMedical CenterAdd to Report Gen ReportTI 0.11MI 0.92CLA1Gn 609.0cm 28FPS0/ 1M/ 80.03/ 10/ 4Export study DeleteMulti-Select 1*1Multi-Image 1*1Print Study List3/12B FunctionFreeze Save Image Fun.Key Set Start Set End End ExamFigure 23  Review the imagePerform multiple selectionsThe operator can perform actions to more than one image/clip at a time.MenuAdd to Report Gen ReportExport study DeleteMulti-Select 3*3Multi-Image 1*1Print Study List12B FunctionFreeze Save Image Fun.Key Select All Deselect All End ExamFigure 24  Perform multiple selections1. Touch the + button under Multi-Select. Scroll up and down on the thumbnail window and touch to select up to 9 images/clips. To quickly select all images, touch Select All. To cancel all selections, touch Deselect All.
68Basic operations  Review the image2. Touch an action button. For example, touch Delete to delete all selected images/clips.Compare imagesTo compare the scanned images/clips, touch the + button under Multi-Image.MenuAdd to Report Gen ReportExport study Delete Please touch thumbnail to add to review list.Multi-Select 1*1Multi-Image 2*2Print Study List12Please touch thumbnail to add to review list. Please touch thumbnail to add to review list.B FunctionFreeze Save Image Fun.Key End ExamFigure 25  Compare imagesScroll up and down the thumbnail list, and touch to select up to 4 images/clips to display for comparison.Generate a report1. On the review screen, touch the thumbnails of the desired images and touch Add to Report.2. Touch Gen Report to display the following screen.Menu Report Signature: / Study date: 2015/09/03 / Exam type: Cardiology Institution: / Referring: / Interpreting:Print Print Preview Template template_1Patient informationImage Layout 1 columnName DOB AgeIDAdd Image Rem Image Study Specific InformationExam History ExportHeight cm Weight kg BSA: m2HR bpmBlood Press /mmHg RA Press mmHgSave as Save Prompts FindingsCommentsUltrasound ImageScan PreviousEnd ExamFigure 26  Report screen
69Basic operations  Export the exam3. Fill in information about the patient and the study, if not complete, and add comments using the virtual keyboard.4. Scroll down to review the images added, and add comments to individual images, if needed.The operator can still add/remove images to/from the report without going back to the review screen. Touch Add Image/Rem Image to display the image editing screen. Check the desired images and touch Add to Report or Remove from report.5. Touch the + button under Image Layout to select the numbers of columns for placing the images on a report.6. Touch Print Preview to preview the report.7. To print out the report, touch Print; to save the report, touch Save as, select the file format and directory, and then touch Save.Export the examThe operator can export exams and images to an external storage or the DICOM server. When exporting an exam, an image or a cine loop, the system creates a uniquely named subdirectory for each exam, image or loop.The system provides three ways of exporting the exam: On the review screen, touch Export study > Export to DICOM or Export to external storage. On the exam history screen, check the completed exams, and touch Export Exam > Export to DICOM or Export to external storage. On the report screen, touch Export > Export to DICOM or Export to external storage.To set the default export directory, exporting to DICOM automatically after ending the exam and more, please go to Menu > Setting.End the examAn exam is not complete if the operator proceeds with a new exam without ending the previous one.To end the exam, touch End exam on the imaging screen.To check the exam status, please go to Menu > Exam history.
70Scan modes overview  B mode overview5    Scan modes overviewAll of the information in this chapter pertains to real-time imaging. Many of the controls and functions change when the operator freeze the scan. For information on using functions when the scan is frozen, please refer to “Annotations” and “Measurements”.On the real-time imaging window: Touch the mode selection buttons to select a scan mode (See “Imaging screen (Real-time)”). Touch > to switch the control panel pages to go through the available functions (See “Switch the control panel pages”).B mode overviewThe system delivers 2-dimensional digital imaging using 256 digital beam-forming channels. This imaging mode delivers excellent image uniformity, tissue contrast resolution, and steering flexibility in frequencies from 2 MHz to 15 MHz.Menu Adam, Smith123456727 01/01/1988Liver09/03/2015 02:56PMDr. SmithMedical CenterBColor PW TI 0.11MI 0.92CLAM Power 0Gn 5815.0cm 15FPS1/ 1M/ 80.060/ 00/ 4B Gain 58Depth 15.0Focus 8.0DYN Range 6012B FunctionFreeze Save Image Fun.Key Tuning TGC Penetration Resolution End ExamFigure 27  B mode real-time scan
71Scan modes overview  B mode overviewB mode image controlsUse the following 2D image controls during live scanning.BColor PWM PowerB Gain 58Depth 15.0Focus 8.0DYN Range 6012Focal Zone 1QScan 1Focal Span 1Persist 4Steering 0Reject 4FreqMTrap DensityHTHIL/R U/D QRange0QBeam1Dual Toggle Full ScrChroma Map 0Sector Width 256GSC 0Sector PosAcoustic 1540 TX Power 80.0Zoom Image Reverse Needle Erase BDMKAnnot Label Arrow Annot DelBDMK Probe Pos Rotate CloseFigure 28  B mode image controls Gain: adjust amplification of the returning echoes, which adjust the amount of echo information displayed in an image. Scan depth: adjust the field of view. Focus depth: increase the resolution for a specific area. Dynamic range: control the range of acoustic levels displayed in the image, which affect the contrast of the image. Focal zones: select the focal number which also affect the acoustic power indices. Focal span: adjust the distance between the focal zones. QScan: allow scanning from different angles, which helps reinforce the real structures of an ultrasound image by eliminating artifacts, such as speckle, noise or refractive shadows. Persistence: adjust the amount of averaging (real-time) images. Reject: adjust the display priority of the 2D grayscale pixels. Frequency: change the scan frequency. As frequency increases, the resolution becomes higher while the penetration becomes lower. Trapezoidal imaging: increase the range of view of the ultrasound image. Chroma map: adjust the chroma (color tone and saturation) value with different brightness. Gray scale curve (GSC): change how the amplitude is converted to brightness. Acoustic: set the minimum acoustic output power value while still sufficient for diagnostically acceptable information. QBeam: permit electronic steering of the ultrasound beam to acquire scans of an ROI from several directions.
72Scan modes overview  Color/Power Doppler mode overview Sector width and position: adjust the imaging area of both the sector and the transducer to the ROI. A smaller sector width increases the frame rate. Image reverse: reverse the image orientation horizontally and vertically.Color/Power Doppler mode overviewColor Doppler mode is used to detect the presence, direction, and relative velocity of blood flow by assigning color-coded information to these parameters. The color is depicted in a region of interest (ROI) that is overlaid on the 2D image. Non-inverted flow towards the transducer is assigned shades of red, and flow away from the transducer displays in shades of blue. The mean Doppler shift is then displayed against a grayscale scan of the structures.All forms of ultrasound-based imaging of red blood cells are derived from the received echo of the transmitted signal. The primary characteristics of this echo signal are its frequency and its amplitude (or power). The frequency shift is determined by the movement of the red blood cells relative to the transducer – flow towards the transducer produces a higher-frequency signal than flow away from the transducer. Amplitude depends on the amount of moving blood within the volume sampled by the ultrasound beam. The operator can also apply a high frame rate or high resolution to control the quality of the scan. Higher frequencies generated by rapid flow are displayed in lighter colors, and lower frequencies in darker colors.Menu Adam, Smith123456727 01/01/1988Liver09/03/2015 02:56PMDr. SmithMedical CenterB Color PW TI 0.27MI 1.04CLAM Power 0Gn 5815.0cm 4FPS1/ 1M/ 80.0Color Gain 45Gn 45M/ 80.01.020.01/ 3PRF 1.0 15Steering 0-15WF 20.012Color FunctionFreeze Save Image Fun.Key Tuning TGC Penetration Resolution End ExamFigure 29  Color Doppler mode real-time scanIn Power Doppler Mode, low flow rate in small vessels are clearly observed. Colors are carried out only to demonstrate the blood flow, but contain no velocity information, thus, offers no directional information.
73Scan modes overview  Color/Power Doppler mode overviewBoth Color and Power Doppler modes can work with other scan modes to form duplex and triplex modes.Color/Power Doppler mode image controlsUse the following Color/Power Doppler mode image controls during live scanning.B Color PWM PowerColor Gain 45PRF 1.0Steering 0WF 20.012Depth 15.0 QScan 1Focus 8.0 Persist 3Baseline 15 Reject 255FreqMFlow InvertDensityHTHIL/R U/D QBeam1Dual Toggle Full ScrColor Map 1Sector Width 256Threshold 4Sector PosTX Power 80.0Zoom Image Reverse Needle Erase BDMKAnnot Label Arrow Annot DelBDMK Probe Pos Rotate CloseFigure 30  Color Doppler mode image controls Pulse Repetition Frequency (PRF): adjust the velocity range of the display, which manifests as a scale. Wall filter (WF): adjust the wall filter setting to reduce or eliminate unwanted low-frequency, high-intensity signals generated by movements of blood vessel walls.BColor PWMPowerPower Gain 50PRF 0.8WF 16.0Dir Power Flow Invert12Depth 15.0 QScan 1Focus 8.0 Persist 3Steering 0 Reject 255FreqMZoom DensityHTHIL/R U/D QBeam1Dual Toggle Full ScrColor Map 1Sector Width 256Threshold 4Sector PosBaseline 15 TX Power 80.0Image Reverse Needle Erase BDMKAnnot Label Arrow Annot DelBDMK Probe Pos Rotate CloseFigure 31  Power Doppler mode image controls Dir Power: activate Directional DPI with the DPI indicator displaying the direction of flow for use in applications where sensitivity and directional information are both required.
74Scan modes overview  M mode overviewM mode overviewM mode imaging is used simultaneously with 2-dimensional (B mode) imaging, to determine patterns of motion for objects within the ultrasound beam. M mode displays scan data of the anatomy in the 2D Imaging window a, and the motion scan in the Time Series window b. Typically, this mode is used for viewing motion patterns of the heart.baMenu Adam, Smith123456727 01/01/1988Liver09/03/2015 02:56PMDr. JohnsonMedical CenterTI 0.14MI 0.95CLABColor PWMPower 0Gn 5815.0cm 13FPS1/1M/ 80.0M Gain 50Steer M 0Gn 50M/ 80.0PEKM Process PEKSpeed1/2x Video Invert12M FunctionFreeze Save Image Fun.Key Tuning M Update Penetration Resolution End ExamFigure 32  M mode real-time scanM mode image controlsUse the following M mode image controls during live scanning.BColor PWMPowerM Gain 50Steer M 0M Process PEKSpeed1/2x Video Invert12Depth 15.0 DYN Range 1Focus 8.0 Display V 1/2Steering 0 Reject 4FreqMZoom TX Power 80.0L/R U/D Line Pos 128Dual Toggle Full ScrChroma Map 0ECG Erase BDMKAnnot Label Arrow Annot DelBDMK Probe Pos Rotate CloseFigure 33  M mode image controls M process: select the method for detection processing the M trace display. Steer M: adjust the M mode cursor line (M-line) position. Sweep speed: adjust how fast the timeline is scanned across the Time Series window. Video invert: invert the M trace display in relation to brightness. Scan lined position: adjust the scan line position.
75Scan modes overview  Pulsed-Wave (PW) Doppler mode overview Display format: adjust the layout of the B+M mode ultrasound image.Pulsed-Wave (PW) Doppler mode overviewA pulsed-wave Doppler scan produces a series of pulses used to study the motion of blood flow selectively in a small region along a desired ultrasound cursor, called the Doppler Range Gate (RG) located on the spectral Doppler cursor. A short line across the sample volume is called the Flow Direction cursor. This cursor line should be aligned to the blood flow direction when measuring the flow velocity.Menu Adam, Smith123456727 01/01/1988Liver09/03/2015 02:56PMDr. JohnsonMedical CenterTI 0.28MI 0.4CLABColor PWSpectral Doppler CursorM Power 0Gn 5815.0cm 7FPS1/1M/ 80.0PW Gain 50Flow direction cursorPRF 2.0Gn 50M/ 80.02.040.060 degree8.08 cm2.49 mmAngle 60Angle±60 2D Refresh12 UpdatePW FunctionFreeze Save Image Fun.Key Tuning TGC PW Update Penetration Resolution End ExamFigure 34  PW Doppler mode real-time scanPW Doppler mode image controlsUse the following PW mode image controls during live scanning.BColor PWM PowerPW Gain 50PRF 20Angle 60Angle±60 2D Refresh12Baseline 8DYN Range 4WF 40.0 SV Size 2.49Steering -20 Reject 4FreqMFlow InvertVideo InvertOutput cm/sL/R U/D Speed 1.2x SoundDual Toggle Full ScrChroma Map 0Line Pos 128Display V 1/2 SV Pos 8.08TX Power 80.0Zoom ECG Erase BDMKAnnot Label Arrow Annot DelBDMK Probe Pos Rotate CloseFigure 35  PW Doppler mode image controls Baseline: adjust the zero baseline up or down in the Time Series window. Sample Volume (SV) size: adjust the SV size which controls the size of the Doppler region being examined.
76Scan modes overview  Pulsed-Wave (PW) Doppler mode overview Reject: adjust noise rejection which controls rejection of low-level returned signals. Sound: adjust the volume of the Doppler signal. PW update: select whether or not to continue scanning the anatomy (displayed in the 2D imaging window) while acquiring PW Doppler scan data (displayed in the Time Series window).
77IT Network  Introduction6    IT NetworkIntroductionTo exchange ultrasound images and patient data, the system conforms with the Digital Imaging and Communications in Medicine (DICOM) standard and can therefore be connected to Picture Archiving and Communication System (PACS) and Modality Worklist (MWL). The former allows the system to store the acquired examination data (static images or cine clips) in PACS, while the latter allows the system to query examination orders from the MWL server and start the examinations. In order to achieve the purposes above, the system offers two ways of connecting to the IT network, hard-wired LAN and wireless LAN connections, for DICOM communication.To ensure the data security, use an IT network isolated from the external environment by a firewall.SpecificationsHardware802.11 a/b/g/n, Gigabit EthernetSoftware The system is connected to PACS and MWL by DICOM standard.Please refer to the system’s DICOM Conformance Statement for detailed instructions. The system connects to the network time server at startup when available.SecurityThe system has no listening ports open to the WLAN interface. So a network entity cannot initiate a connection to the system from the WLAN. However, the system can initiate a connection to servers on the WLAN, Gigabit Ethernet and beyond.Use the USB port ONLY to export data to a USB memory stick. Computer access to the system through the USB port is blocked.The system allows connection via Bluetooth with limited devices (HID) only.
78IT Network  Information flowUse the following TCP/IP ports for outgoing communication to the WLAN and Gigabit Ethernet. Port for DICOM communication (typically port 104, 2762 or 11112; to specify the port, on the system’s imaging screen, touch Menu > Setting > DICOM.) Port 80 for HTTP web servers (not supported by the system) Anti-virus software is not installed on the systemInformation flowFrom\To Worklist server UH100 PACSWorklist server X DICOM worklist responses XUH100 DICOM worklist queries X1. Study data (DICOM Storage)2. Ping/Echo requestPACS X Ping and Echo response XTable 8 Information flowPlease refer to the system’s DICOM Conformance Statement for detailed instructions.IT network failure recovery measuresIT network connection stability depends on many factors. Unreliable connection may later lead to failure and cause the following hazardous situations.
79IT Network  IT network failure recovery measuresIT Network failureImpact on the equipment Hazard System countermeasuresIT network becomes unstableUnable to transmit exam data to a PACS Delay of diagnosisExam data is stored in the system’s internal storage. After the IT network has resumed stability, the operator can re-initiate the data transfer.Delay of transmission to a PACSIncorrect data transmitted to a PACS MisdiagnosisThe system uses the TCP/IP and DICOM protocols to ensure the integrity of the data. Unable to retrieve order data from an MWL server. Delay of examThe operator can initiate/create a new exam from the systemDelay of retrieving order data from an MWL server.Incorrect data from a MWL server Incorrect examThe system uses the TCP/IP and DICOM protocols to ensure the integrity of the data. Firewall has broken downAttack via network Manipulation of the exam dataThe system closes unnecessary network ports.Infection by computer virus Exam data leakageThe system forbids installation of any software by any user.Table 9 IT network failure recovery measuresAny connection of the equipment, this system (UH100) or/and other systems, to the IT network risks the unidentified data leakage of the patients, operators or third parties. Therefore, the operator must evaluate and identify all potential risks as well as prepare suitable countermeasures before connecting the equipment to an uncontrolled IT network. For guidance addressing these risks, please refer to IEC 80001-1:2010.Even when the connection to an IT network is trusted, any change of the network settings requires immediate checkup and possible measures taken. Should any of the changes below occur, perform additional evaluation to the IT network. Changes in the network configuration (IP address, router, proxy, and so on) Connection of additional items
80IT Network  IT network failure recovery measures Disconnection of items Equipment update Equipment upgrade
81Maintenance  System maintenance7    MaintenanceSystem maintenanceTo maintain the best performance of the system and extend its life, please clean the ventilation slots, all connection ports/sockets and the touchscreen regularly or whenever the operator observes dust or other particles.Before cleaning the system, perform the following operations to avoid the risk of electric shock.1. Turn off the system power.2. Unplug the power cord from both the system and the power outlet.Running the system for a period of time may generate excessive heat. Do not clean the system until it completely cools down. Clean the ventilation slots and connection ports/socketsUse a suitable dust blower or a can of compressed air to blow off the dust accumulated in and around the slots/sockets.Clean the touchscreen1. Gently wipe the screen with a lint-free, non-abrasive and dry cloth.2. If any smear or spots remain, apply a small amount of monitor specific cleaning solution to the cloth, and gently wipe it across the screen in one direction. Repeat the application and cleaning process several times until the spots are dissolved.Moving the cloth back and forth will damage the screen.3. Wipe off any excess moisture and then leave the screen completely dry before powering the system back on.Transducer precautions and maintenanceThe transducers provided with the system are durable and have reliable performance. Inspect these precision instruments daily and handle with care. Please observe the following precautions:
82Maintenance  Transducer precautions and maintenance Do not drop the transducer on the hard surface, as this will damage the transducer elements and compromise the electrical safety of the transducer. Avoid kinking or pinching the transducer cable. Use only the approved ultrasound coupling gels. Do not immerse the transducer into liquids beyond its binding line, and must not immerse the transducer connector into any liquids at all times. Do not use damaged or flawed transducers. Use only couplants specifically designed for ultrasound examinations. Do not use mineral-oil or vegetable-based couplants, which can damage transducers. Do not expose transducers to direct heat such as strong sunlight or local heat sources. Heat ages the crystal and causes loss of sensitivity. Transducers are highly-sensitive instruments and are easily damaged due to improper operations. Use the transducers with extra care and avoid damages when not in use. A recommendation calling the operator’s attention to the need for regular testing and periodic maintenance including inspection of the transducer assembly for cracks that allow the ingress of conductive fluid shall be provided.Inspect the transducer Inspect the transducer’s acoustic lens, outer cover, the cable, and the transducer connector before each use. Check the transducer carefully and see if there are cracks, cuts, or any other damages which may admit fluids. Do not use the transducer if it is damaged. If the transducer is dropped accidentally, examine it immediately for signs for damage. Perform a sample scan to make sure it operates correctly. Contact the Qisda dealer for service or replacement if any abnormalities are found.To avoid any possibilities of hurting the patient, check if the transducer has a smooth edge and an even surface before each use.Cleaning and disinfection Clean the transducer and the transducer handle after use. For surface transducers, disinfect the transducer periodically. Keep a log of maintenance (inspection, cleaning and disinfection) and malfunction.
83Maintenance  Transducer precautions and maintenanceTransducer immersion levelWhen using surface transducers, do not immerse the transducer beyond its immersion line.Cable sheathTransducer handleScan headImmersion lineFigure 3  Surface transducer (Example transducer-C52A) Do not use solutions containing alcohol, mineral oil for cleaning or disinfecting transducers. Wear medical sterile gloves to prevent potential disease transmission. Wear protective goggle if necessary. Do not apply solutions containing ethyl oxides on the transducer.Cleaning instructions1. Disconnect the transducer from the system.2. Remove all the coupling gel and clean the transducer with soft cloth and flowing potable water.3. If the transducer surface carries too much residue, remove all visible residue with wet cloth soaked in mild soap water. Use wet soft cloth to scrub the surface if dried residue exists. Remove all soap water residue with damp cloth soaked in potable water.4. Air dry or dry with a soft cloth.Take extra care when cleaning the transducer surface. Avoid causing damages to the transducer by excessive and forceful cleaning.Disinfection instructionsThe level of disinfection is directly related to the duration of contact with the germicide. Legally marketed liquid chemical germicides (e.g. Cidex) are highly recommended. Prepare use the germicides following the manufacturer’s instructions.
84Maintenance  Transducer precautions and maintenanceThe following statement from AIUM outlines instructions for cleaning the intracavitary transducer:AIUM Guidelines for Cleaning and Preparing Endocavitary Ultrasound Transducers between PatientsApproved June 4, 2003The purpose of this document is to provide guidance regarding the cleaning and disinfection of transvaginal and transrectal ultrasound transducers.All sterilization / disinfection represents a statistical reduction in the number of microbes present on a surface. Meticulous cleaning of the instrument is the essential key to an initial reduction of the microbial / organic load by at least 99%. This cleaning is followed by a disinfecting procedure to ensure a high degree of protection from infectious disease transmission, even if a disposable barrier covers the instrument during use.Medical instruments fall into different categories with respect to potential for infection transmission. The most critical levels of instruments are those that are intended to penetrate skin or mucous membranes. These require sterilization. Less critical instruments (often called “semi-critical” instruments) that simply come into contact with mucous membranes such as fiber optic endoscopes require high-level disinfection rather than sterilization.Although endocavity ultrasound transducers might be considered even less critical instruments because they are routinely protected by single use disposable transducer covers, leakage rates of 0.9 % to 2 % for condoms and 8 % to 81 % for commercial transducer covers have been observed in recent studies. For maximum safety, one should therefore perform high-level disinfection of the transducer between each use and use a transducer cover or condom as an aid in keeping the transducer clean.There are four generally recognized categories of disinfection and sterilization.Sterilization is the complete elimination of all forms or microbial life including spores and viruses.Disinfection, the selective removal of microbial life, is divided into three classes: High-level disinfection includes destruction / removal of all microorganisms except bacterial spores. Mid-level disinfection includes inactivation of Mycobacterium Tuberculosis, bacteria, most viruses, fungi, and some bacterial spores.
85Maintenance  Transducer precautions and maintenance Low-Level Disinfection includes destruction of most bacteria, some viruses and some fungi. Low-level disinfection will not necessarily inactivate Mycobacterium Tuberculosis or bacterial spores.The following specific recommendations are made for the use of endocavity transducers. Operators should also review the Centers for Disease Control and Prevention document on sterilization and disinfection of medical devices to be certain that their procedures conform to the CDC principles for disinfection of patient care equipment.Procedures for cleaning1. After removing the transducer cover, use running water to remove any residual gel or debris from the transducer.2. Use a damp gauze pad or other soft cloth and a small amount of mild non-abrasive liquid soap (household dishwashing liquid is ideal) to thoroughly cleanse the transducer.3. Use a small brush especially for crevices and areas of angulations depending on the design of your particular transducer.4. Rinse the transducer thoroughly with running water, and then dry the transducer with a soft cloth or paper towel.Procedures for disinfection1. Follow the above cleaning procedures to clean the transducer first with a detergent/water solution, and ensure all visible residues are removed from the transducer.2. Use high-level disinfectant to ensure further statistical reduction in microbial load. Because of the potential invisible disruption of the transducer sheath, additional high level disinfection with chemical agents is necessary.Examples of such high level disinfectants include but are not limited to: 2.4% to 3.2% Glutaraldehyde products (a variety of available proprietary products including “Cidex”, “Metricide”, or “Procide”) Non-glutaraldehyde agents including Cidex OPA (o-phthalaldehyde), Cidex PA (hydrogen peroxide & peroxyacetic acid). 7.5% Hydrogen Peroxide solution Common household bleach (5.25% sodium hypochlorite) diluted to yield 500 parts per million chlorine (10 cc in one liter of tap water). This agent is effective, but generally not recommended by transducer manufacturers because it can damage metal and plastic parts.
86Maintenance  Transducer precautions and maintenance Other agents such as quaternary ammonium compounds are not considered high level disinfectants and should not be used. Isopropanol is not a high level disinfectant when used as a wipe and transducer manufacturers generally do not recommend soaking transducers in the liquid. The FDA has published a list of approved sterilant and high level disinfectants for use in processing reusable medical and dental devices. Consult the list to find agents that may be useful for transducer disinfection.3. Operators should follow the instructions of proprietary products to prepare, store and use the disinfectant. Regarding the compatibility of these agents with transducers, consult the manufacturers. Many of the chemical disinfectants are potentially toxic and many require adequate precautions, such as proper ventilation, personal protective devices (gloves, face/eye protection, etc.) and rinsing before reusing the transducer.Transducer sheathWhen using E94A endocavity transducers, the transducers must be protected with a transducer sheath. If condoms are used, they should be non-lubricated and non-medicated. Operators should be aware that condoms have been shown to be less prone to leakage than commercial transducer covers, and have a six-fold enhanced AQL (acceptable quality level) when compared to standard examination gloves. They have an AQL equal to that of surgical gloves. Operators should be aware of latex-sensitivity issues and have available nonlatex-containing barriers.Aseptic techniqueFor the protection of the patient and the health care worker, all endocavitary examinations should be performed by the operator wearing gloves properly throughout the ultrasound diagnostic process. Gloves should be used to remove the condom or other barrier from the transducer and to wash the transducer as mentioned above. As the transducer sheath is removed, care should be taken not to contaminate the transducer with secretions from the patient. At the completion of the procedure, hands should be thoroughly washed with soap and water. Do not use high pressure steam to disinfect the transducer. Do not use thermal disinfection. Temperatures higher than 66°C or 150°F will damage the transducer.
87Maintenance  Transducer precautions and maintenance Obvious disruption in condom integrity does not require modification of this protocol. These guidelines take into account possible transducer contamination due to a disruption in the barrier sheath. In summary, routine high-level disinfection of the endocavity transducer between patients, plus the use of a transducer cover or condom during each examination is required to properly protect patients from infection during endocavitary examinations. Ensure that all visible residues have been removed. Prepare the germicide solutions according to the manufacturer’s instructions. Please also follow the manufacturer’s instructions for storage and disposal of the germicide. Immerse the transducer head into the germicide for time interval specified by the germicide manufacturer. The immersion level should be kept below the binding line. Note that you may need to rotate and shake the transducer in order to remove the air bubbles between the transducer surface and germicide solution. After removing the transducer from the germicide solution, rinse it thoroughly with clean, potable water to remove all visible germicide. Dry the transducer with a soft cloth.
Appendix Acoustic output Reporting for Track 31    AppendixAcoustic output Reporting for Track 3Qisda Corporation follows Track 3 of the FDA’s information for manufacturers seeking marketing clearance of diagnostic ultrasound systems and transducers. Track 3 does not require evaluation of acoustic output on an application-specific basis, but the global maximum derated ISPTA must not exceed 720 mW/cm2 and the global maximum MI must not exceed 1.9.888
Appendix Acoustic output Reporting for Track 3Acoustic output tables for UH100 TransducersAcoustic output reporting table for Track 3 for the C52A transducerUH100 Diagnostic Ultrasound System in B modeIndex label MITIS TIBTICScan Non-scanAaprt ≤ 1 cm2Aaprt > 1 cm2Global maximum index value 0.0282 0.088 # # # (b)Associated acoustic parameterPr.3 (MPa) 0.053W0(mW) 24.4 # # #Min of W.3(z1), ITA.3(z1)] (mW) #z1(cm) #zbp (cm) #zsp (cm) #z@PII.3max (cm) 5.9deq(zsp) (cm) #fc(MHz) 3.5 3.5 # # # #Dim of AaprtX (cm) 2.25 # # # #Y (cm) 1.1 # # # #Other informationPD (microsec) 0.37PRF (Hz) 5900pr@PIImax (MPa) 0.109deq@PIImax (cm) #Focal length FLx (cm) 7 # # #FLy (cm) 7 # # #Ipa.3 at MImax (W/cm2) 0.09Operating control conditionsControl 1 B B # # # #Control 2 7 cm 7 cm # # # #Control 3 5917 5917 # # # #Control 4 100% 100% # # # # # No data are reported for this operating condition since the global maximum index value is not reported for the reason listed. (a) This index is not required for this operating mode. (b) This transducer is not intended for transcranial or neonatal cephalic uses. (c) This formulation for TIS is less than that for an alternate formulation in this mode. (d) Control 1: Mode (e) Control 2: Focal distance (f) Control 3: PRF (g) Control 4: Power89
Appendix Acoustic output Reporting for Track 3Acoustic output reporting table for Track 3 for the C52A transducerUH100 Diagnostic Ultrasound System in CFM-B modeIndex label MITIS TIBTICScan Non-scanAaprt ≤ 1 cm2Aaprt > 1 cm2Global maximum index value 0.132 0.138 # # # (b)Associated acoustic parameterPr.3 (MPa) 0.209W0(mW) 58 # # #Min of W.3(z1), ITA.3(z1)] (mW) #z1(cm) #zbp (cm) #zsp (cm) #z@PII.3max (cm) 4.6deq(zsp) (cm) #fc(MHz) 2.5 2.5 # # # #Dim of AaprtX (cm) 2.25 # # # #Y (cm) 1.1 # # # #Other informationPD (microsec) 1.5PRF (Hz) 5000pr@PIImax (MPa) 0.303deq@PIImax (cm) #Focal length FLx (cm) 5 # # #FLy (cm) 7 # # #Ipa.3 at MImax (W/cm2) 2.96Operating control conditionsControl 1 CFM CFM # # # #Control 2 5 cm 5 cm # # # #Control 3 5 KHz 5 KHz # # # #Control 4 100% 100% # # # # # No data are reported for this operating condition since the global maximum index value is not reported for the reason listed. (a) This index is not required for this operating mode. (b) This transducer is not intended for transcranial or neonatal cephalic uses. (c) This formulation for TIS is less than that for an alternate formulation in this mode. (d) Control 1: Mode (e) Control 2: Focal distance (f) Control 3: PRF (g) Control 4: Power90
Appendix Acoustic output Reporting for Track 3Acoustic output reporting table for Track 3 for the C52A transducerUH100 Diagnostic Ultrasound System in B/M modeIndex label MITIS TIBTICScan Non-scanAaprt ≤ 1 cm2Aaprt > 1 cm2Global maximum index value 0.133 # # 0.0199 0.077 (b)Associated acoustic parameterPr.3 (MPa) 0.246W0(mW) # # 37 #Min of W.3(z1), ITA.3(z1)] (mW) 1.23z1(cm) 5zbp (cm) 2.66zsp (cm) 4.5z@PII.3max (cm) 5deq(zsp) (cm) 3.4fc(MHz) 3.4 # # 3.4 3.4 #Dim of AaprtX (cm) # # 2.25 2.25 #Y (cm) # # 1.1 1.1 #Other informationPD (microsec) 1.2PRF (Hz) 250pr@PIImax (MPa) 0.47deq@PIImax (cm) 3.2Focal length FLx (cm) # # 7 #FLy (cm) # # 7 #Ipa.3 at MImax (W/cm2) 3.4Operating control conditionsControl 1 M # # M M #Control 2 7 cm # # 7 cm 7 cm #Control 3 250 # # 250 250 #Control 4 100% # # 100% 100% # # No data are reported for this operating condition since the global maximum index value is not reported for the reason listed. (a) This index is not required for this operating mode. (b) This transducer is not intended for transcranial or neonatal cephalic uses. (c) This formulation for TIS is less than that for an alternate formulation in this mode. (d) Control 1: Mode (e) Control 2: Focal distance (f) Control 3: PRF (g) Control 4: Power91
Appendix Acoustic output Reporting for Track 3Acoustic output reporting table for Track 3 for the C52A transducerUH100 Diagnostic Ultrasound System in PW modeIndex label MITIS TIBTICScan Non-scanAaprt ≤ 1 cm2Aaprt > 1 cm2Global maximum index value 0.127 # # 0.209 0.52 (b)Associated acoustic parameterPr.3 (MPa) 0.241W0(mW) # # 165 #Min of W.3(z1), ITA.3(z1)] (mW) 12.1z1(cm) 5zbp (cm) 2.66zsp (cm) 4.2z@PII.3max (cm) 5deq(zsp) (cm) 2.22fc(MHz) 3.6 # # 3.6 3.6 #Dim of AaprtX (cm) # # 2.25 2.25 #Y (cm) # # 1.1 1.1 #Other informationPD (microsec) 1.08PRF (Hz) 3000pr@PIImax (MPa) 0.43deq@PIImax (cm) 2.1Focal length FLx (cm) # # 7 #FLy (cm) # # 7 #Ipa.3 at MImax (W/cm2) 2.84Operating control conditionsControl 1 PW # # PW PW #Control 2 7 cm # # 7 cm 7 cm #Control 3 3000 # # 3000 3000 #Control 4 100% # # 100% 100% # # No data are reported for this operating condition since the global maximum index value is not reported for the reason listed. (a) This index is not required for this operating mode. (b) This transducer is not intended for transcranial or neonatal cephalic uses. (c) This formulation for TIS is less than that for an alternate formulation in this mode. (d) Control 1: Mode (e) Control 2: Focal distance (f) Control 3: PRF (g) Control 4: Power92
Appendix Acoustic output Reporting for Track 3Acoustic output reporting table for Track 3 for the L115A transducerUH100 Diagnostic Ultrasound System in B modeIndex label MITIS TIBTICScan Non-scanAaprt ≤ 1 cm2Aaprt > 1 cm2Global maximum index value 0.055 0.07 # # # (b)Associated acoustic parameterPr.3 (MPa) 0.142W0(mW) 1.4 # # #Min of W.3(z1), ITA.3(z1)] (mW) #z1(cm) #zbp (cm) #zsp (cm) #z@PII.3max (cm) 1.79deq(zsp) (cm) #fc(MHz) 6.7 6.7 # # # #Dim of AaprtX (cm) 0.6 # # # #Y (cm) 0.6 # # # #Other informationPD (microsec) 0.183PRF (Hz) 9800pr@PIImax (MPa) 0.209deq@PIImax (cm) #Focal length FLx (cm) 1.5 # # #FLy (cm) 1.9 # # #Ipa.3 at MImax (W/cm2) 1.13Operating control conditionsControl 1 B B # # # #Control 2 1.5 cm 1.5 cm # # # #Control 3 9804 9804 # # # #Control 4 100% 100% # # # # # No data are reported for this operating condition since the global maximum index value is not reported for the reason listed. (a) This index is not required for this operating mode. (b) This transducer is not intended for transcranial or neonatal cephalic uses. (c) This formulation for TIS is less than that for an alternate formulation in this mode. (d) Control 1: Mode (e) Control 2: Focal distance (f) Control 3: PRF (g) Control 4: Power93
Appendix Acoustic output Reporting for Track 3Acoustic output reporting table for Track 3 for the L115A transducerUH100 Diagnostic Ultrasound System in CFM-B modeIndex label MITIS TIBTICScan Non-scanAaprt ≤ 1 cm2Aaprt > 1 cm2Global maximum index value 0.107 0.188 # # # (b)Associated acoustic parameterPr.3 (MPa) 0.237W0(mW) 32 # # #Min of W.3(z1), ITA.3(z1)] (mW) #z1(cm) #zbp (cm) #zsp (cm) #z@PII.3max (cm) 2.57deq(zsp) (cm) #fc(MHz) 4.9 4.9 # # # #Dim of AaprtX (cm) 3.8 # # # #Y (cm) 0.6 # # # #Other informationPD (microsec) 0.81PRF (Hz) 3000pr@PIImax (MPa) 0.37deq@PIImax (cm) #Focal length FLx (cm) 1.5 # # #FLy (cm) 1.9 # # #Ipa.3 at MImax (W/cm2) 5.6Operating control conditionsControl 1 CFM CFM # # # #Control 2 3 cm 3 cm # # # #Control 3 3 KHz 3 KHz # # # #Control 4 100% 100% # # # # # No data are reported for this operating condition since the global maximum index value is not reported for the reason listed. (a) This index is not required for this operating mode. (b) This transducer is not intended for transcranial or neonatal cephalic uses. (c) This formulation for TIS is less than that for an alternate formulation in this mode. (d) Control 1: Mode (e) Control 2: Focal distance (f) Control 3: PRF (g) Control 4: Power94
Appendix Acoustic output Reporting for Track 3Acoustic output reporting table for Track 3 for the L115A transducerUH100 Diagnostic Ultrasound System in B/M modeIndex label MITIS TIBTICScan Non-scanAaprt ≤ 1 cm2Aaprt > 1 cm2Global maximum index value 0.13 # 0.36 # 0.047 (b)Associated acoustic parameterPr.3 (MPa) 0.35W0(mW) # 10.7 10.7 #Min of W.3(z1), ITA.3(z1)] (mW) #z1(cm) #zbp (cm) #zsp (cm) 2.01z@PII.3max (cm) 2.11deq(zsp) (cm) 1.85fc(MHz) 7.1 # 7.1 # 7.1 #Dim of AaprtX (cm) # 0.71 # 0.71 #Y (cm) # 0.6 # 0.6 #Other informationPD (microsec) 0.68PRF (Hz) 250pr@PIImax (MPa) 0.58deq@PIImax (cm) 1.82Focal length FLx (cm) # 1.5 # #FLy (cm) # 1.9 # #Ipa.3 at MImax (W/cm2) 7.7Operating control conditionsControl 1 M # # M M #Control 2 3 cm # # 3 cm 3 cm #Control 3 250 # # 250 250 #Control 4 100% # # 100% 100% # # No data are reported for this operating condition since the global maximum index value is not reported for the reason listed. (a) This index is not required for this operating mode. (b) This transducer is not intended for transcranial or neonatal cephalic uses. (c) This formulation for TIS is less than that for an alternate formulation in this mode. (d) Control 1: Mode (e) Control 2: Focal distance (f) Control 3: PRF (g) Control 4: Power95
Appendix Acoustic output Reporting for Track 3Acoustic output reporting table for Track 3 for the L115A transducerUH100 Diagnostic Ultrasound System in PW modeIndex label MITIS TIBTICScan Non-scanAaprt ≤ 1 cm2Aaprt > 1 cm2Global maximum index value 0.1 # 1.18 # 0.38 (b)Associated acoustic parameterPr.3 (MPa) 0.27W0(mW) # 34 34 #Min of W.3(z1), ITA.3(z1)] (mW) #z1(cm) #zbp (cm) #zsp (cm) 2.06z@PII.3max (cm) 2.15deq(zsp) (cm) 0.71fc(MHz) 7.3 # 7.3 # 7.3 #Dim of AaprtX (cm) # 0.41 # 0.41 #Y (cm) # 0.6 # 0.6 #Other informationPD (microsec) 1.03PRF (Hz) 4000pr@PIImax (MPa) 0.46deq@PIImax (cm) 0.69Focal length FLx (cm) # 1.5 # #FLy (cm) # 1.9 # #Ipa.3 at MImax (W/cm2) 6.4Operating control conditionsControl 1 PW # PW # PW #Control 2 3 cm # 3 cm # 3 cm #Control 3 4000 # 4000 # 4000 #Control 4 100% # 100% # 100% # # No data are reported for this operating condition since the global maximum index value is not reported for the reason listed. (a) This index is not required for this operating mode. (b) This transducer is not intended for transcranial or neonatal cephalic uses. (c) This formulation for TIS is less than that for an alternate formulation in this mode. (d) Control 1: Mode (e) Control 2: Focal distance (f) Control 3: PRF (g) Control 4: Power96
Appendix Acoustic output Reporting for Track 3Acoustic output reporting table for Track 3 for the P42A transducerUH100 Diagnostic Ultrasound System in B modeIndex label MITIS TIBTICScan Non-scanAaprt ≤ 1 cm2Aaprt > 1 cm2Global maximum index value 0.149 0.39 # # # (b)Associated acoustic parameterPr.3 (MPa) 0.235W0(mW) 44 # # #Min of W.3(z1), ITA.3(z1)] (mW) #z1(cm) #zbp (cm) #zsp (cm) #z@PII.3max (cm) 5.7deq(zsp) (cm) #fc(MHz) 2.48 2.48 # # # #Dim of AaprtX (cm) 1.92 # # # #Y (cm) 1.4 # # # #Other informationPD (microsec) 0.53PRF (Hz) 5600pr@PIImax (MPa) 0.35deq@PIImax (cm) #Focal length FLx (cm) 6 # # #FLy (cm) 8 # # #Ipa.3 at MImax (W/cm2) 2.14Operating control conditionsControl 1 B B # # # #Control 2 6 cm 6 cm # # # #Control 3 5555 5555 # # # #Control 4 100% 100% # # # # # No data are reported for this operating condition since the global maximum index value is not reported for the reason listed. (a) This index is not required for this operating mode. (b) This transducer is not intended for transcranial or neonatal cephalic uses. (c) This formulation for TIS is less than that for an alternate formulation in this mode. (d) Control 1: Mode (e) Control 2: Focal distance (f) Control 3: PRF (g) Control 4: Power97
Appendix Acoustic output Reporting for Track 3Acoustic output reporting table for Track 3 for the P42A transducerUH100 Diagnostic Ultrasound System in CFM-B modeIndex label MITIS TIBTICScan Non-scanAaprt ≤ 1 cm2Aaprt > 1 cm2Global maximum index value 0.205 1.74 # # # (b)Associated acoustic parameterPr.3 (MPa) 0.32W0(mW) 207 # # #Min of W.3(z1), ITA.3(z1)] (mW) #z1(cm) #zbp (cm) #zsp (cm) #z@PII.3max (cm) 5.1deq(zsp) (cm) #fc(MHz) 2.48 2.48 # # # #Dim of AaprtX (cm) 1.92 # # # #Y (cm) 1.4 # # # #Other informationPD (microsec) 1.46PRF (Hz) 2000pr@PIImax (MPa) 0.49deq@PIImax (cm) #Focal length FLx (cm) 6 # # #FLy (cm) 8 # # #Ipa.3 at MImax (W/cm2) 5.5Operating control conditionsControl 1 CFM CFM # # # #Control 2 7 cm 7 cm # # # #Control 3 2 KHz 2 KHz # # # #Control 4 100% 100% # # # # # No data are reported for this operating condition since the global maximum index value is not reported for the reason listed. (a) This index is not required for this operating mode. (b) This transducer is not intended for transcranial or neonatal cephalic uses. (c) This formulation for TIS is less than that for an alternate formulation in this mode. (d) Control 1: Mode (e) Control 2: Focal distance (f) Control 3: PRF (g) Control 4: Power98
Appendix Acoustic output Reporting for Track 3Acoustic output reporting table for Track 3 for the P42A transducerUH100 Diagnostic Ultrasound System in B/M modeIndex label MITIS TIBTICScan Non-scanAaprt ≤ 1 cm2Aaprt > 1 cm2Global maximum index value 0.242 # # 0.043 0.207 (b)Associated acoustic parameterPr.3 (MPa) 0.38W0(mW) # # 67 #Min of W.3(z1), ITA.3(z1)] (mW) 3.6z1(cm) 4.8zbp (cm) 2.77zsp (cm) 4.6z@PII.3max (cm) 4.8deq(zsp) (cm) 3.2fc(MHz) 2.48 # # 2.48 2.48 #Dim of AaprtX (cm) # # 1.92 1.92 #Y (cm) # # 1.4 1.4 #Other informationPD (microsec) 1.49PRF (Hz) 250pr@PIImax (MPa) 0.56deq@PIImax (cm) 3.12Focal length FLx (cm) # # 6 #FLy (cm) # # 8 #Ipa.3 at MImax (W/cm2) 9.5Operating control conditionsControl 1 M # # M M #Control 2 7 cm # # 7 cm 7 cm #Control 3 250 # # 250 250 #Control 4 100% # # 100% 100% # # No data are reported for this operating condition since the global maximum index value is not reported for the reason listed. (a) This index is not required for this operating mode. (b) This transducer is not intended for transcranial or neonatal cephalic uses. (c) This formulation for TIS is less than that for an alternate formulation in this mode. (d) Control 1: Mode (e) Control 2: Focal distance (f) Control 3: PRF (g) Control 4: Power99
Appendix Acoustic output Reporting for Track 3Acoustic output reporting table for Track 3 for the P42A transducerUH100 Diagnostic Ultrasound System in PW modeIndex label MITIS TIBTICScan Non-scanAaprt ≤ 1 cm2Aaprt > 1 cm2Global maximum index value 0.248 # # 0.77 2 (b)Associated acoustic parameterPr.3 (MPa) 0.39W0(mW) # # 340 #Min of W.3(z1), ITA.3(z1)] (mW) 65z1(cm) 4.8zbp (cm) 2.77zsp (cm) 4.5z@PII.3max (cm) 4.8deq(zsp) (cm) 1.72fc(MHz) 2.48 # # 2.48 2.48 #Dim of AaprtX (cm) # # 1.92 1.92 #Y (cm) # # 1.4 1.4 #Other informationPD (microsec) 1.53PRF (Hz) 4000pr@PIImax (MPa) 0.59deq@PIImax (cm) 1.69Focal length FLx (cm) # # 6 #FLy (cm) # # 8 #Ipa.3 at MImax (W/cm2) 10.9Operating control conditionsControl 1 PW # # PW PW #Control 2 7 cm # # 7 cm 7 cm #Control 3 4000 # # 4000 4000 #Control 4 100% # # 100% 100% # # No data are reported for this operating condition since the global maximum index value is not reported for the reason listed. (a) This index is not required for this operating mode. (b) This transducer is not intended for transcranial or neonatal cephalic uses. (c) This formulation for TIS is less than that for an alternate formulation in this mode. (d) Control 1: Mode (e) Control 2: Focal distance (f) Control 3: PRF (g) Control 4: Power100
Appendix Acoustic output Reporting for Track 3Acoustic output reporting table for Track 3 for the E94A transducerUH100 Diagnostic Ultrasound System in B modeIndex label MITIS TIBTICScan Non-scanAaprt ≤ 1 cm2Aaprt > 1 cm2Global maximum index value 0.109 0.069 # # # (b)Associated acoustic parameterPr.3 (MPa) 0.266W0(mW) 4.1 # # #Min of W.3(z1), ITA.3(z1)] (mW) #z1(cm) #zbp (cm) #zsp (cm) #z@PII.3max (cm) 2.47deq(zsp) (cm) #fc(MHz) 6 6 # # # #Dim of AaprtX (cm) 1.75 # # # #Y (cm) 0.6 # # # #Other informationPD (microsec) 0.216PRF (Hz) 7000pr@PIImax (MPa) 0.44deq@PIImax (cm) #Focal length FLx (cm) 3.5 # # #FLy (cm) 2.6 # # #Ipa.3 at MImax (W/cm2) 3.9Operating control conditionsControl 1 B B # # # #Control 2 3.5 cm 3.5 cm # # # #Control 3 6973 6973 # # # #Control 4 100% 100% # # # # # No data are reported for this operating condition since the global maximum index value is not reported for the reason listed. (a) This index is not required for this operating mode. (b) This transducer is not intended for transcranial or neonatal cephalic uses. (c) This formulation for TIS is less than that for an alternate formulation in this mode. (d) Control 1: Mode (e) Control 2: Focal distance (f) Control 3: PRF (g) Control 4: Power101
Appendix Acoustic output Reporting for Track 3Acoustic output reporting table for Track 3 for the E94A transducerUH100 Diagnostic Ultrasound System in CFM-B modeIndex label MITIS TIBTICScan Non-scanAaprt ≤ 1 cm2Aaprt > 1 cm2Global maximum index value 0.113 0.195 # # # (b)Associated acoustic parameterPr.3 (MPa) 0.284W0(mW) 13.2 # # #Min of W.3(z1), ITA.3(z1)] (mW) #z1(cm) #zbp (cm) #zsp (cm) #z@PII.3max (cm) 2.02deq(zsp) (cm) #fc(MHz) 6.3 6.3 # # # #Dim of AaprtX (cm) 1.75 # # # #Y (cm) 0.6 # # # #Other informationPD (microsec) 0.48PRF (Hz) 3010pr@PIImax (MPa) 0.43deq@PIImax (cm) #Focal length FLx (cm) 2.5 # # #FLy (cm) 2.6 # # #Ipa.3 at MImax (W/cm2) 7.6Operating control conditionsControl 1 CFM CFM # # # #Control 2 2.5 cm 2.5 cm # # # #Control 3 3 KHz 3 KHz # # # #Control 4 100% 100% # # # # # No data are reported for this operating condition since the global maximum index value is not reported for the reason listed. (a) This index is not required for this operating mode. (b) This transducer is not intended for transcranial or neonatal cephalic uses. (c) This formulation for TIS is less than that for an alternate formulation in this mode. (d) Control 1: Mode (e) Control 2: Focal distance (f) Control 3: PRF (g) Control 4: Power102
Appendix Acoustic output Reporting for Track 3Acoustic output reporting table for Track 3 for the E94A transducerUH100 Diagnostic Ultrasound System in B/M modeIndex label MITIS TIBTICScan Non-scanAaprt ≤ 1 cm2Aaprt > 1 cm2Global maximum index value 0.15 # # 0.049 0.034 (b)Associated acoustic parameterPr.3 (MPa) 0.37W0(mW) # # 4 #Min of W.3(z1), ITA.3(z1)] (mW) 1.64z1(cm) 1.96zbp (cm) 1.73zsp (cm) 1.82z@PII.3max (cm) 1.96deq(zsp) (cm) 3.4fc(MHz) 6.3 # # 6.3 6.3 #Dim of AaprtX (cm) # # 1.75 1.75 #Y (cm) # # 0.6 0.6 #Other informationPD (microsec) 0.62PRF (Hz) 250pr@PIImax (MPa) 0.55deq@PIImax (cm) 1.14Focal length FLx (cm) # # 2.5 #FLy (cm) # # 2.6 #Ipa.3 at MImax (W/cm2) 12.3Operating control conditionsControl 1 M # # M M #Control 2 2.5 cm # # 2.5 cm 2.5 cm #Control 3 250 # # 250 250 #Control 4 100% # # 100% 100% # # No data are reported for this operating condition since the global maximum index value is not reported for the reason listed. (a) This index is not required for this operating mode. (b) This transducer is not intended for transcranial or neonatal cephalic uses. (c) This formulation for TIS is less than that for an alternate formulation in this mode. (d) Control 1: Mode (e) Control 2: Focal distance (f) Control 3: PRF (g) Control 4: Power103
Appendix Acoustic output Reporting for Track 3Acoustic output reporting table for Track 3 for the E94A transducerUH100 Diagnostic Ultrasound System in PW modeIndex label MITIS TIBTICScan Non-scanAaprt ≤ 1 cm2Aaprt > 1 cm2Global maximum index value 0.153 # 0.84 # 0.32 (b)Associated acoustic parameterPr.3 (MPa) 0.38W0(mW) # 28.1 28.1 #Min of W.3(z1), ITA.3(z1)] (mW) #z1(cm) #zbp (cm) #zsp (cm) 1.82z@PII.3max (cm) 1.93deq(zsp) (cm) 0.86fc(MHz) 6.3 # 6.3 # 6.3 #Dim of AaprtX (cm) # 1.14 # 1.14 #Y (cm) # 0.6 # 0.6 #Other informationPD (microsec) 0.62PRF (Hz) 3000pr@PIImax (MPa) 0.56deq@PIImax (cm) 0.84Focal length FLx (cm) # 2.5 # #FLy (cm) # 2.6 # #Ipa.3 at MImax (W/cm2) 11.4Operating control conditionsControl 1 PW # # PW PW #Control 2 2.5 cm # # 2.5 cm 2.5 cm #Control 3 3000 # # 3000 3000 #Control 4 100% # # 100% 100% # # No data are reported for this operating condition since the global maximum index value is not reported for the reason listed. (a) This index is not required for this operating mode. (b) This transducer is not intended for transcranial or neonatal cephalic uses. (c) This formulation for TIS is less than that for an alternate formulation in this mode. (d) Control 1: Mode (e) Control 2: Focal distance (f) Control 3: PRF (g) Control 4: Power104
Appendix Ultrasound validationUltrasound validation1. Set up the phantom for validation. Make sure the notch is filled with some water.2. Insert the transducer for ultrasound validation.3. Initiate the ultrasound software. Confirm Ultrasound software has scanned images as below photos. You can see the bright dot on Phantom, and the background should be the same speckle without any particular dark lines or streaks.105
Appendix Ultrasound validationThe actual scan area of the phantom is shown as the image below.4. Touch Color to switch to Color Doppler mode and keep the transducer stationary. Confirm there is no stationary color image signal in the Green block area as the photo below.106
Appendix Troubleshooting5. Touch PW to switch to PW Doppler mode and keep the transducer stationary. Confirm the picture is evenly distributed without any particular waveform signal as the photo below.6. Remove the transducer.TroubleshootingItem Error description Possible root cause Possible swap partsSystem - Power on System can’t power on 1. SOM board damage2. Carrier board damage3. Screen off / Screen cable damage 4. Battery no power (can charge Battery) / Battery damage (can use adapter to check)5. Disconnect gauge cable6. Disconnect bottom cable / bottom board damage1. SOM board2. Carrier board3. LCD / LCD cable4. Battery5. Connect gauge cable6. Bottom cable/boardSystem - Charging System can’t charge 1. Power supply damage 2. Adapter damage 3. Carrier board damage4. Gauge cable / connector damage1. Power supply2. Adapter3. Carrier board4. Gauge cable / connector107
Appendix TroubleshootingItem Error description Possible root cause Possible swap partsSystem - eMMC Can’t read and write date from eMMCSOM board damage SOM boardSystem - SD card Can’t read and write data from SD card1. SOM board damage2. Carrier board damage 1. SOM board2. Carrier boardSystem - USB 2.0 Can’t read and write data from USB 2.01. SOM board damage2. Carrier board damage 1. SOM board2. Carrier boardSystem - USB 3.0 Can’t read and write data from USB 3.01. SOM board damage2. Carrier board damage 1. SOM board2. Carrier boardSystem - mSATA Can’t read and write data from mSATA1. SOM board damage2. Carrier board damage3. mSATA module damage1. SOM board2. Carrier board3. mSATASystem - System fan System fan can’t work 1. System fan damage2. Carrier board damage 1. System fan2. Carrier boardSystem - Engine fan Engine fan can’t work 1. Engine fan damage2. Carrier board damage 1. Engine fan2. Carrier boardSystem - Ethernet Ethernet not function 1. SOM board damage2. Carrier board damage 1. SOM board2. Carrier boardSystem - OTG OTG not function 1. SOM board damage2. Carrier board damage 1. SOM board2. Carrier boardSystem - LCD LCD screen abnormal or no display1. LCD damage2. LCD cable damage3. SOM board damage4. Carrier board damage1. LCD module2. LCD cable3. SOM board4. Carrier boardSystem - Touch Touch not function or abnormal1. Touch module damage2. Touch control board damage3. Touch cable disconnect or damage4. SOM board damage5. Carrier board damage1. LCD (including touch module)2. Touch control board3. Touch cable4. SOM board5. Carrier boardSystem - Camera Camera not function or display abnormally1. Camera PCBA damage 2. Camera cable disconnect or damage3. SOM board damage4. Carrier board damage1. Camera PCBA2. Camera cable3. SOM board4. Carrier boardSystem - HDMI HDMI not function or abnormal1. HDMI cable damage2. SOM board damage3. Carrier board damage1. LCD cable2. SOM board3. Carrier boardSystem - MIC Recording no sound or unclear1. The received voice hole of Mic is covered by something2. SOM board damage3. Carrier board damage1. Remove anything that covered the hole of mic2. SOM board3. Carrier board108
Appendix FCC statementItem Error description Possible root cause Possible swap partsSystem -SpeakerSpeaker no sound or noise when playing sound1. Speaker damage2. SOM board damage3. Carrier board damage1. Speaker2. SOM board3. Carrier boardSystem -HeadsetHeadset no sound or noise when playing sound1. Headset damage2. SOM board damage3. Carrier board damage1. Headset2. SOM board3. Carrier boardSystem -Power buttonPower button not function 1. Power button damage2. SOM board damage3. Carrier board damage1. Power button2. SOM board3. Carrier boardSystem - RTC RTC not function 1. Coin cell damage2. SOM board damage3. Carrier board damage1. Coin cell2. SOM board3. Carrier boardSystem - Temperature Temperature does not show or abnormal1. SOM board damage2. Carrier board damage 1. SOM board2. Carrier boardSystem - LED LED indicator not function 1. SOM board damage2. Carrier board damage 1. SOM board2. Carrier boardSystem - Wi-Fi Wireless not response or no connection1. Antenna cable disconnect or damage2. Antenna board damage3. SOM board damage1. Antenna cable2. Antenna board3. SOM boardSystem - Bluetooth Bluetooth not response or no connection1. Antenna cable disconnect or damage2. Antenna board damage3. SOM board damage1. Antenna cable2. Antenna board3. SOM boardEngine Can’t open ultrasound app1. SOM board damage2. Carrier board damage3. USB 3.0 cable (for engine) damage4. Power cable (for engine) damage1. SOM board2. Carrier board3. USB 3.0 cable4. Power cableFCC statementFederal Communications Commission (FCC) Statement15.21You are cautioned that changes or modifications not expressly approved by the part responsible for compliance could void the user’s authority to operate the equipment.15.105(b)109
Appendix FCC statementThis equipment has been tested and found to comply with the limits for a Class B digital device, pursuant to part 15 of the FCC rules. These limits are designed to provide reasonable protection against harmful interference in a residential installation.This equipment generates uses and can radiate radio frequency energy and, if not installed and used in accordance with the instructions, may cause harmful interference to radio communications. However, there is no guarantee that interference will not occur in a particular installation. If this equipment does cause harmful interference to radio or television reception, which can be determined by turning the equipment off and on, the user is encouraged to try to correct the interference by one or more of the following measures:Reorient or relocate the receiving antenna. Increase the separation between the equipment and receiver. Connect the equipment into an outlet on a circuit different from that to which the receiver is connected. Consult the dealer or an experienced radio/TV technician for help.This device complies with part 15 of the FCC Rules. Operation is subject to the following two conditions: 1. This device may not cause interference and2. This device must accept any interference, including interference that may cause undesired operation of the device.RF Radiation Exposure Statement:1. This Transmitter must not be co-located or operating in conjunction with any other antenna or transmitter.2. This equipment complies with FCC RF radiation exposure limits set forth for an uncontrolled environment. This equipment should be installed and operated with a minimum distance of 20 centimeters between the radiator and your body. *CEStatement regarding the disposal of UH100 products containing electronic components:110
Appendix FCC statement 111As a company, UH100 is committed to sustainable business practices, which are aimed to preserve, protect and improve the quality of the environment. We apply these to product technologies, design and the selection of the materials used in our products. Adhering to corresponding environmental laws, directives and guidelines are a core element of our sustainability principles. Since the UH100 concept is equipped with electronic components, we will ensure that it complies with actual or planned directives and laws, which are mandatory for electronic products and may require specific measures regarding labeling, collection and recycling.NOTE: If not disposed of properly, batteries can be harmful. Protect the environment by taking exhausted batteries to authorized disposal stations.European Commission (CE) StatementEuropean Union Regulatory NoticeThis device bearing the CE marking is compliance with the essential requirements and other relevant provisions of Directive 2004/108/EC, 2014/53/EU, 2011/65/EU, 2012/19/EU and 93/42/EEC.This device complies with the following harmonized European standards,EMC: EN55022, EN55024Radio: EN300328,EN301893,EN301489-1,EN301489-17, EN62311Medical: IEC 60601-1, EN60601-1-2, IEC 60601-1-6, IEC 60601-2-37, IEC 62304, EN ISO10993-1, EN ISO10993-5, EN ISO10993-10, EN ISO 14971ROHS: EN50581The following CE marking is valid for EU harmonized telecommunications products.

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