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Related Manuals for Sonostar UProbe-C
Summary of Contents for Sonostar UProbe-C
- Page 1 No.: SS-IFU-1501-02 Versions: A/4 lssued date: October, 17, 2024...
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Page 2: Table Of Contents
Section 1 INTRODUCTION ......................4 1.1 Signs and Meaning ........................4 1.2 TECHNICAL PARAMETERS ..................... 6 1.2.1 General performance ......................6 1.3 INDICATIONS FOR USE ......................8 1.4 PRECAUTIONS & WARNINGS ....................8 Section 2 GETTING STARTED .....................10 2.1 Configuration And Equipment .................... 10 2.1.1UNPACKING ........................10 2.1.2 STARTING PROBE ...................... - Page 3 5.1.3 Probe Safety ........................31 5.1.4 Cybersecurity ........................31 5.2 Principles of Using Acoustic Power ..................33 5.2.1 Biological Safety .......................33 5.2.2 Mechanical and Thermal Indices ..................33 5.2.3 Acoustic Output Statement ..................... 34 5.2.3.1 The Influencing Factors of Acoustic Uncertainty ............34 5.2.3.2 Differences between Actual and Displayed MI and TI ..........35 5.2.3.3 Uncertainty of Measurement ..................
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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. The probe of the Scanner is highly integrated with ultrasound image processing, power management and a wireless signal provider to be connected by the main unit. - Page 5 Class II equipment Degree of IP protection Non-ionizing electromagnetic radiation Manufacturer Date of manufacture Serial number Keep dry IPX1 There is no harmful effect on vertically falling water droplets. The device can be immersed in water within a depth of 1 meter for up to 30 IPX7 minutes without damage.
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Page 6: Technical Parameters
25% to 93%, non-condensing Ambient Temperature 5°C to +35°C -20°C to +55°C Atmospheric Pressure； 700hPa to 1060hPa； 700hPa to 1060hPa; Altitude ≤3000m ≤3000m Mmeasurement accuracy of Uprobe-C Type BW（black and white） Array Type Element Scanning Radius 60° Probe Type Curved Display Mode... - Page 7 Measurement accuracy of Uprobe-L Type BW（black and white） Array Type Element Scanning Length 40mm Probe Type Linear Display Mode B, B/M Frequency 7.5/10MHz Depth 55mm B Mode Axial Distance Tolerance ＜±2% B Mode Lateral Distance Tolerance ＜±2% M Mode Distance Tolerance ＜±2% M Mode Time Tolerance ＜±2%...
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Page 8: Indications For Use
Supported software: SmartUS.ipa 1.3 INDICATIONS FOR USE The Wireless Probe Type Ultrasound Scanner (Model: UProbe) is intended for diagnostic ultrasound echo imaging, measurement, and analysis of the human body for general clinical applications including obstetrics (OB), gynecology (GY) and general (abdominal) imaging. Contraindications: This device is not suitable for the examination of the site of injury or acute inflammation. - Page 9 WARNING 1: The device is not explosion-proof. Do not use it in an inflammable and explosive environment (such as in the presence of anesthetic gas, oxygen or hydrogen, etc.); WARNING 2: Instrument is not waterproof, do not spill water or other liquids on the instrument.
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Page 10: Section 2 Getting Started
Section 2 GETTING STARTED FOR YOUR PROTECTION, please read these safety instructions completely before applying power to, or operating the system. The over-high ultrasonic intensity and/ or overtime exposure may cause injury. Please do not apply the probe of this device to the indication of use Caution not covered in this manual. -
Page 11: Starting Probe
2.1.2 STARTING PROBE Button for Power ON/OFF & LIVE/FREEZE Battery Wireless Capacity Connection Indicator Indicator 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. -
Page 12: Method 2
Find the software and download and install it. 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 13: Starting Probe
Abnormal probes can cause electric shock or injury to people. Waring Therefore, once any abnormalities are found, you must immediately stop using the probe and contact Sonostar. 2.3.2 Probe cleaning Ultrasonic probes should be cleaned and disinfected before and after the ultrasound examination. -
Page 14: Wireless Connection
In the event of any of the above anomalies, the ultrasound imaging Caution diagnostic apparatus may be defective, please contact SonoStar. The Wireless Connection Indicator and the Battery Capacity Indicator on the scanner may be invisible before the scanner is turned on. -
Page 15: Section 3 App Operations
Section 3 APP OPERATIONS 3.1 ULTRASOUND scanning Main interface (Figure 3-1) The meaning of each icon: 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 16: Patient Information Input
11.Movie playback: replay after the image freezes. 12.Measurement: distance / area / obstetrical measurement. 13.Note: enter a comment on the image. 14.Puncture: draw a puncture line for puncture guidance. 15. Delete measurements and notes: delete measurement results and notes on images. 16.Save the image: save a single image. -
Page 17: Data Measurement
Picture 3-3 Patient Information Editing Interface 3.3 Data measurement In B/M mode, the position of the sampling line can be adjusted by tapping the moving circle on the screen with your finger (as shown in Picture 3-7 below). First, the interface needs to be frozen. You can freeze the interface by pressing the Freeze Button of the scanner or by clicking the Freeze option on the screen. - Page 18 Picture 3-7 Measuring the heartbeat interface 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 scanner model, the applicable range and the data to be measured.
- Page 19 After selecting the “LENGTH” length measurement function, click on the two points to be measured in the frozen screen, the measurement trajectory will appear, click the moving point on the trajectory line (as shown in the middle of Figure 3-7), move the trajectory, and adjust the length.
- Page 20 Picture 3-10 Up to 4 sets of data can be measured in the same frozen screen. After the measurement, press “Clear X” to delete all measurement results. If you want to delete a measurement, click on the measurement data at the top right of the screen to display the result. 3-11，...
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Page 21: Report Download
3.4 Report download Click on the "patient information" on the lower left of the software interface , then pop-up below patient information interface. Figure 3-12 pop-up patient information interface. Click on "report", pop up the interface below as shown in figure 3-13, click on the "tip" box, the user can input content in dialog box. -
Page 22: Image And Video Storage
figure 3-13 patient information download interface 3.5 Image and Video storage 3.5.1 Image storage Click on "save image" on the bottom right in below interface (FIG. 3-14), then save the image displaying on the screen at the moment. The image is automatically stored in the smart terminal display system (apple mobile phone, or tablet) photo album. -
Page 23: Video Storage
Picture3-14 3.5.2 Video storage Click on "save Video" on the bottom right in above interface (FIG. 3-14),then the Video starting from the operation within 100seconds are stored in the smart terminal display system (apple mobile phone, or tablet) photo album. 3.6 Image and Video review Open the photo album of the smart terminal display system (apple mobile phone, or tablet), and then review the saved image and Video. - Page 24 Figure 3-15...
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Page 25: Section 4 Mainteance
Section 4 MAINTEANCE 4.1 scanner CHARGING When battery goes down, it is necessary to recharge the scanner. Pull the insertion at the end of the scanner, then connect the USB Charger and USB Cable with the scanner to charge the scanner as shown in figure 4-1. When in charging, the battery indicator will be blinking and the grids indicate the capacity of the battery charged. -
Page 26: Cleaning And Disinfection The Scanner
• Follow the procedures in the order they are described in this guide, without skipping steps. • Follow the manufacturer's instructions, recommendations, and guidelines for cleaners and disinfectants, as well as your regional regulations. • Check expiry dates, concentration, and efficacy of the chemicals used. •... -
Page 27: Disposal
Check the WIFI signal channel is ready; Intelligent display can't connect test whether the WIFI password input scanner WIFI is correct Check if other equipment started Displayed on the screen with which cause electromagnetic interference like snow interference,shut down the device or get far from the device. - Page 28 11, the structure of the scanner is watertight, prohibit any conductive liquid immersion so as to avoid corrosion of the scanner and the fuselage. 12,Scanner into liquid shall not exceed the scanner water lines, and regularly check for cracks in order to avoid liquid immersion and damage to internal components. 13, After each usage, please refer to chapter 4.3 of this manual for cleaning and disinfection.
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Page 29: Section 5 Safety
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. 5.1 Safety Instructions Read and understand all precautions in this manual before using the system. Keep this manual with the system at all times. -
Page 30: Mechanical Safety
● The machine that are not serviced or maintained can not be used on the patient. ● The outer surface of the portions of transducer assembly which is intended to be inserted into a PATIENT should be checked to ensure that there are no unintended rough surfaces, sharp edges or protrusions which may cause harm. -
Page 31: Probe Safety
● During usage, if there is any software bug, the user can do feedback via company email: sonostar@sonostar.net, then the company will do analysis and modification according to the bug, if there is needs for update, there will be update notification via email to remind the user to do update. - Page 32 For security purposes, only the preset security password can be used to connect to WiFi. The scanner can only be connected to one iPad device, successfully locking your smart device. The following behaviors may bring new risks to patients, operators, and third parties. Your organization is responsible for identifying, analyzing, evaluating, and controlling these risks: Change network configuration.
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Page 33: Principles Of Using Acoustic Power
authenticate and authorize users. The recovery equipment can be operated according to the scanner provided by Apple. IT Security or Wi-Fi IPad is the Wi-Fi signal transmitted by the Wi-Fi module of the scanner. It is a local area network, not connected to the Internet, but only used for signal and data transmission. The information using wifi communication is as follows: Working frequency band (MHz) 2400-2483.5... -
Page 34: Acoustic Output Statement
■ Meaning of MI/TI Mechanical bioeffects are threshold phenomena that occur when a certain level of output is exceeded. The threshold level varies with tissue type. The potential mechanical bioeffects varies with peak pressure and ultrasound frequency. The higher the MI value, the greater the likelihood of mechanical bioeffects occurring. -
Page 35: Differences Between Actual And Displayed Mi And Ti
● Whether the display accuracy depends on specific system combination, mode combination, scanner 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 For many assumptions used in the process of measurement and calculation, actually they are conservative. -
Page 36: Operator Control Property
Displayed acoustic output Measurement uncertainty Parameter accuracy B-mode and Color doppler mode Pressure, MI ±25% ±15% Power, TI ±50% ±30% Accuracy of the displayed acoustic output = (Measured value - Acoustic output display value) / Acoustic output display value * 100% 5.2.4 Operator Control Property There are three types of operation control related to the generation of mechanical/thermal effect: direct control and indirect control, receiver control. -
Page 37: Alara
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 38: Electromagnetic Immunity
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 39 40%U (60% typical commercial or hospital interruptions dip in U 40%U (60% environment. If the user of the UProbe-C and voltage for 5 cycles dip in U Wireless Probe Type Ultrasound Scanner variations on for 5 cycles requires continued operation during power...
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Page 40: 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 maintaining a minimum distance between portable and... -
Page 41: Secrecy
5.4 Secrecy The confidentiality guarantee of information is as follows: The scanner does not contain patient identification information. When the scanner is connected to a wireless network, it encrypts and stores WiFi passwords. The data transmitted between the scanner and the app on the iPad is transmitted through an encrypted local area network. - Page 42 The operator chooses whether to exit the software according to the current temperature of the probe sound head. If the probe sound head temperature exceeds 43 °C, click Quit to exit the software, if not over 43 °C, click Ignore and continue working. Once the system detects that the surface temperature of the probe reaches 43 ℃, the software will give the following prompt and the machine will be forced to shut down after 10 seconds.
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Page 43: Appendix A Specifications
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 Equipment Part 2-37: Particular Requirements for the Basic Safety and Essential Performance of Ultrasonic Medical Diagnostic and Monitoring Equipment EN 60601-1-2:2007 (IEC 60601-1-2: 2007), Class A Type of protection against... -
Page 44: Appendix B Acoustic Output Data
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 0.17... - Page 45 Transducer Model: Uprobe-C, Operating Model: B+M mode Index label Below Below At surface surface surface surface Maximum index value 0.78 0.17 0.26 B:0.17 B:0.17 B:0.17 Index component value M:N/A M:0.07 M:0.26 at z (MPa) 1.36 r.α (mW) B:11.56 M:10.88 B:11.56 M:10.88 (mW) B:11.56 M: N/A...
- Page 46 Transducer Model: Uprobe-L, Operating Model: B mode Index label Below Below surface surface surface surface Maximum index value 0.94 0.03 0.03 Index component value 0.03 0.03 0.03 at z (MPa) 2.39 r.α (mW) 0.90 0.90 (mW) 0.90 0.90 (cm) (cm) (cm) 1.02 (cm)
- Page 47 Transducer Model: Uprobe-L, Operating Model: B+M mode Index label Below Below surface surface surface surface Maximum index value 0.94 0.05 0.11 B:0.03 B:0.03 B:0.03 Index component value M:0.02 M: N/A M:0.11 at z (MPa) 2.39 r.α (mW) B:0.90 M:0.89 B:0.90 M:0.89 (mW) B:0.90 M: N/A B:0.90 M: N/A...
- Page 48 SUNGO Europe.B.V. Fascinatio Boulevard 522, Unit 1.7, 2909VA Capelle aan den IJssel, The Netherlands 2862 Manufacturer: Guangzhou Sonostar Technologies Co., Ltd. Address of facility: 504#, C Building, #27 Yayingshi Road, Science Town, 510655 Guangzhou, PEOPLE'S REPUBLIC OF CHINA Tel: 020-32382095 Fax: 020-62614030 Website: www.Sonostar .cn...
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