Sonostar UProbe-C User Manual

Wireless probe type ultrasound scanner
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Wireless Probe Type
Ultrasound Scanner
UProbe-C & UProbe-L
User's Guide
No.:SS-IFU-1501-02 Versions:A/2
Date:2021.12

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Summary of Contents for Sonostar UProbe-C

  • Page 1 Wireless Probe Type Ultrasound Scanner UProbe-C & UProbe-L User's Guide No.:SS-IFU-1501-02 Versions:A/2 Date:2021.12...
  • Page 2: Table Of Contents

    Table of Content Section 1 INTRODUCTION .......................1 1.1 Signs and Meaning ......................1 1.2 TECHNICAL PARAMETERS ....................2 1.3 INDICATIONS FOR USE ....................2 1.4PRECAUTIONS & WARNINGS ..................2 Section 2 GETTING STARTED ....................3 2.1 UNPACKING ........................3 2.2 INSTALLING APP ......................3 2.3 STARTING PROBE ......................7 2.4 WIRELESS CONNECTION ....................8 Section 3 APP OPERATIONS ....................9 3.1 ULTRASOUND SCAN ....................9...
  • Page 3 5.2.3.2 Differences between Actual and Displayed MI and TI 5.2.3.3 Uncertainty of Measurement 5.2.4 Operator Control Property 5.2.5 Acoustic Power Settings 5.2.6 ALARA 5.3 Electromagnetic Compatibilities 5.3.1 Electromagnetic Emission 5.3.2 Electromagnetic Immunity 5.3.3 Recommended Separation Distance Appendix A Specifications Appendix B Acoustic Output Data...
  • Page 4: Section 1 Introduction

    Section 1 INTRODUCTION The Wireless Probe Type Ultrasound Scanner (Model: Uprobe-C 、 Uprobe-L) is the new generation instruments for ultrasonography with the outstanding feature of wireless. Different with traditional ultrasound scanner with a cable connecting from probe to main unit, no cable appears at the end of the probe of the Scanners.
  • Page 5: Technical Parameters

    Keep dry IPX5 Prevent the water from the nozzle from invading in all directions and cause damage to the electrical apparatus. 1.2 TECHNICAL PARAMETERS Display: iPad / iPhone Series Probe: 3.5MHz (convex)/7.5MHz(line) Operation frequency 3.5MHz 7.5MHz Depth ≥160mm ≥60mm Lateral Resolution: ≤3(Deep≤80);...
  • Page 6: Precautions & Warnings

    1.4 PRECAUTIONS & WARNINGS PRECAUTION 1: Read the user manual carefully before operating the device, be familiar with  the equipment and operation procedures, and strictly implement; the company is not responsible for the damage caused by the improper use of the machine and the resulting potential adverse consequences;...
  • Page 7: Installing App

    USB Cable for Charging √ The Wireless Ultrasound Scanner Users’ Guide √ √ IPad Optional Each item should be examined for any noticeable defects or damage that may have occurred during shipment although it is packed carefully. If any defect or damage exists, please contact your local representative immediately to report the problem.
  • Page 8 2.2.2 Method 2 Using the two-dimensional code scanning software to scan the two-dimensional code below, you can get the download link of APP for installation.
  • Page 9: Starting Probe

    2.3 STARTING PROBE Figure 2-1 The Wireless Ultrasound Probe The Wireless Connection Indicator and the Battery Capacity Indicator on the probe may be invisible before the probe is turned on. Press the button to turn on the probe. The Battery Capacity Indicator will be light to indicate the capacity of the battery.
  • Page 10: Section 3 App Operations

    Section 3 APP OPERATIONS 3.1 ULTRASOUND SCAN Figure 3-1 Main Screen 1. Transmission Gain +: increase image gain. 2. Transmission Gain -: reduce image gain. 4. Focus: adjust the focus position of the image. 5. Dynamic range: adjust the dynamic range of the image. 5.
  • Page 11: Enter Patient Information

    3.2 ENTER PATIENT INFORMATION First,click on the top right of the ultrasonic software interface with your finger Pop-up screen In ID, enter the name of the patient information bar, click on sex selection, picture mode, and then click OK, the patient information will be entered, if an input error, you can click again to modify or create new cases.
  • Page 12 BM mode: In the BM mode, by clicking with your finger to move here, you can adjust the position of M sample lines:...
  • Page 13: Measuing

    3.4 MEASUING Click “Measure” in the B mode freeze state, and then the ten measurement functions of the screen shown in Picture 3-8 will pop up. Users should select the appropriate measurement function according to the product probe model, the applicable range and the data to be measured. Picture 3-9 Measurement function After selecting the “LENGTH”...
  • Page 14 o'clock position to be measured in the frozen screen and click it will appear 3 moving points on the screen. 3 moving points will automatically form an angle. Click the moving point to adjust the measuring angle. The measured data is displayed in real time on the upper right. After selecting the “TRACE”...
  • Page 15: Storage Of Images

    Click on the right data ○ ,Measurement data can be deleted: 3.5 STORAGE OF IMAGES When image is showing in image area, Save Image Button (11) can be pressed to save the image to the album of the iPad. By pressing the Browse Stored Image Button (12), users can select a stored image and show it on the image area.
  • Page 16 Figure 3-2 Settings Screen Switch ON/OFF the Left Hand Operation to adjust the screen to convenience operators. When the system is using in an environment where the WiFi channel is crowd, a new channel can be selected for the probe by pick a channel from the picker and tap Select button. After 2 seconds, please restart the probe to make the new channel available and the user also have to reconnect the probe with a different SSID.
  • Page 17: Section 4 Mainteance

    Section 4 MAINTEANCE 4.1 PROBE CHARGING When battery goes down, it is necessary to recharge the probe. Pull the insertion at the end of the probe, then connect the USB Charger and USB Cable with the probe to charge the probe as shown in figure 4-1.
  • Page 18: Storage

    • Repeated use and cleaning over the course of the scanner ’ s life may deteriorate its cleanliness. • Using incompatible solutions to clean the scanner may damage its surface. • Cleaning or disinfecting the scanner while the battery is installed may cause the battery to short-circuit and overheat, causing an electric shock or burn.
  • Page 19: Section 5 Safety

    WARNING: The user and/or patient should be reported “any serious incident that has occurred in relation to the device ” to the our company and the competent authority of the Member State. Section 5 Safety The operation safety is the most important concern of the designer . To ensure the safety and efficiency of the system, the operator should read carefully about this chapter before using the system.
  • Page 20: Mechanical Safety

    No modification of this equipment is allowed. ● any operator requests more information such as circuit diagrams, parts list and product ● descriptions, for repairs carried out by qualified technical personnel, please contact us. ● Please check and replace the battery periodically, please use batteries as power supply when ●...
  • Page 21: Accessories Safety

    5.1.3 Accessories Safety...
  • Page 22: Principles Of Using Acoustic Power

    5.2 Principles of Using Acoustic Power 5.2.1 Biological Safety Diagnostic ultrasound is recognized as being safe, but the risk of biological effects exists when using it in high exposure levels and long exposure times. Thus ultrasound should be used in a prudent manner to provide medical benefit to the patient.
  • Page 23 ●The system changeability ●Changeability and accuracy of measurement ●Possible operating conditions and testing numbers needed to obtain displayed result accuracy of the diagnostic system ●Whether the display accuracy depends on specific system combination, mode combination , probe component and launch mode combination, or all of above ●Algorithm accuracy of the system software used to calculate the MI/TI ●Approximation engineering method used in real time computation 5.2.3.2 Differences between Actual and Displayed MI and TI...
  • Page 24 the more acoustic output power increased over a period of time. ■ The receiver control The receiver control does not affect the acoustic output, including gain, dynamic range, and image processing, etc. Therefore, in the image optimization, should adjust the receiver control to optimize images firstly, the second are through direct control and indirect control.
  • Page 25 Guidance and manufacturer’s declaration - electromagnetic emission The UProbe-C Wireless Probe Type Ultrasound Scanner is intended for use in the electromagnetic environment specified below. The customer or the user of UProbe-C Wireless Probe Type Ultrasound Scanner should assure that it is used in such environment.
  • Page 26 5.3.2 Electromagnetic Immunity Guidance and manufacturer’s declaration - electromagnetic immunity The UProbe-C Wireless Probe Type Ultrasound Scanner is intended for use in the electromagnetic environment specified below. The customer or the user of the UProbe-C Wireless Probe Type Ultrasound Scanner should assure that it is used in such an environment.
  • Page 27 5.3.3 Recommended Separation Distance The UProbe-C Wireless Probe Type Ultrasound Scanner is intended for use in an electromagnetic environment in which radiated RF disturbance are controlled. The customer or the user of the UProbe-C Wireless Probe Type Ultrasound Scanner can help prevent electromagnetic interference by...
  • Page 28 Appendix A Specifications EN 60601-1 (IEC 60601-1), Medical electrical equipment Part 1: General requirements for basic safety and essential performance, Class I, BF, continuous operation EN 60601-2-37:2008 (IEC 60601-2-37:2007), Medical Electrical Complied Equipment Part 2-37: Particular Requirements for the Basic Safety and Essential Standards Performance of Ultrasonic Medical Diagnostic and Monitoring Equipment EN 60601-1-2:2007 (IEC 60601-1-2: 2007), Class A...
  • Page 30 Appendix B Acoustic Output Data These data are acquired through the test report of IEC 60601-2-37. Transducer Model: Uprobe-C, Operating Model: B mode Index label At surface Below Below surface surface surface Maximum index value 0.78 0.17 0.17 Index component value 0.17...
  • Page 31 Transducer Model: Uprobe-C, Operating Model: B+M mode Index label At surface Below Below surface surface surface Maximum index value 0.78 0.17 0.26 Index component value B:0.17 B:0.17 B:0.17 M:N/A M:0.07 M:0.26 Acoustic 1.36 at z (MPa) α Parameters (mW) B:11.56 M:10.88 B:11.56 M:10.88...
  • Page 32 Transducer Model: Uprobe-L, Operating Model: B mode Index label At surface Below At surface Below surface surface Maximum index value 0.94 0.03 0.03 Index component value 0.03 0.03 0.03 Acoustic 2.39 at z (MPa) α Parameters (mW) 0.90 0.90 (mW) 0.90 0.90 (cm)
  • Page 33 Transducer Model: Uprobe-L, Operating Model: B+M mode Index label At surface Below Below surface surface surface Maximum index value 0.94 0.05 0.11 Index component value B:0.03 B:0.03 B:0.03 M:0.02 M: N/A M:0.11 Acoustic at z (MPa) 2.39 α Parameters (mW) B:0.90 M:0.89 B:0.90 M:0.89 (mW)

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