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Summary of Contents for Sonostar BProbe
- Page 1 Wireless Probe Type Ultrasound Scanner BProbe User's Guide No.：SS-IFU-1501-03 Versions：A/2 Date：2021.12...
- Page 2 1. Introduction The Wireless Probe Type Ultrasound Scanner is the new generation instruments for bladder volume calculating with the outstanding feature of wireless. Different from traditional ultrasound scanner with a cable connecting from probe to main unit, no cable appears at the end of the probe of the Scanner. The probe of a Scanner is highly integrated with ultrasound image processing, power management and a wireless signal provider to be connected by the main unit.
- Page 3 1.2. SPECIALIST 1) Intended Use The ultrasound system is intended for examining the adult, pregnant woman and children. It is mainly used for measuring urinary volume of bladder. 2) Contraindication The basic equipment is not suitable for injuries or acute inflammatory site inspection, to avoid cross infection.
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Page 4: Getting Started
Operation mode Continuous working Applied part Probe 2. Getting started FOR YOUR PROTECTION, please read these safety instructions completely before applying power to, or operating the system. 2.1. Unpacking The Scanner is carefully packed to prevent damage during shipment. Before unpacking, please note any visible damage to the outside of the shipping containers. -
Page 5: Starting Probe
2.3. Starting probe Figure 2-1 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 6: App Operation
the prefix of “WBP”. It can be found on the surface of the probe. After Wi-Fi is connected, launch the Bladder Scanner App, after the connection from the app to the probe is confirmed, the Wireless Connection Indicator on the probe will be light with no blinking. -
Page 7: Patient Information
There is a center indicate line (3) in the middle of the image area . Touch the patient information area (2) to enter the patient interface to edit or create a new case. Please refer to section 3.2 for detail information. - Page 8 When you touch “Create New Case”, all the information will be cleared. The Phantom Mode is default as closed. After all the information has been set ,you can touch “OK” to save or “Cancel” to give up, then the patient information interface will be closed. 3.3.
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Page 9: Scanning Mode
Figure 3-4 pre-Scanning 3.3.2. Scanning mode When the cycle is green, press the button again to enter scanning mode. The device will obtain and deal with images. When the probe stops vibrating it means the scanning is finished. The 12 scanning images and the measurement result will be displayed on the screen (see Figure 3-3 scanning result menu). -
Page 10: Printer Connection
On the scanning result menu, there are 12 section images. The serial number of the image is shown on the left upper of the single image. You can touch one single image to be full-screen to see the details, and swipe left/right to see the previous/next image and touch again shift back to total scanning result menu. - Page 11 Figure3-7 printed case report Note: if the printer is not used the POWER LED will be blinking between red and blue. Note: if you charge the printer, the FEED LED will be blue and blinking. 3.5. Storage and Review the image Press button ”Save”...
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Page 12: Set Parameter
3.6. Set parameter Figure 3-9 setting menu 1) Gain When t a new gain is needed, the add and subtract button can used to change the gain from 30 to 105 dB 2) Wireless Channel When the system is using in an environment where the Wi-Fi channel is crowded, A new channel can be selected for the probe by pick a channel from the picker and tap Select button. -
Page 13: Cleaning And Disinfection
Figure 4-1 Charge the Probe 2) Wireless Charging Applying power to the wireless charging pad, put the probe on the portable wireless charger as shown in the right picture of figure 4-1.if the relative position is right ,there will be a notification tone and the capacity indicator on the probe will be light. -
Page 14: Troubleshooting
between patients may spread infections to other patients and users. Put on a condom that meets the medical qualification for use, dispose the used condom in the medical waste recycling box after use, and then disinfect and clean the probe 4.2.2 Cleaning and Disinfection the probe 1. -
Page 15: Safety Instructions
Fault handling: Serial number problem Solution method No response after pressing the power switch Check wires and plugs Display on the screen to show the band or 1.Check if any other device is snowflake like interference started 2.Check the electric field or magnetic field in the surrounding environment. - Page 16 ● Do not connect other devices to multi-socket outlet; otherwise, the rated output power may be exceeded and failure may be resulted. ● The multi-socket outlet can only be used to provide power to the recommended peripheral devices of this system. ●...
- Page 17 5.1.3 Accessories Safety...
- Page 19 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 20 adjacent soft tissue. ■ Precision of MI/TI TI and MI values are displayed in real time on the screen. The operator should observe these index values during examinations and ensure that exposure time and output values are maintained at minimum amounts needed for effective diagnosis. The MI and TI precision is 0.1. 5.2.3 Acoustic Output Statement 5.2.3.1 The Influencing Factors of Acoustic Uncertainty When estimating accuracy of displayed numerical values, many factors are considered:...
- Page 21 1. The sensitivity of hydrophone: According to hydrophone calibration report provided by ONDA company, the maximum allowable error of sound pressure for hydrophone is plus or minus 12%; 2. Scope: according to agilent DSO6502A specifications, its effect on the sound pressure is plus or minus 2%;...
- Page 22 5.2.6 ALARA It is required to practice ALARA when using ultrasound energy. Practicing ALARA ensures that the total energy level is controlled below a low level at which bioeffects are not generated while diagnostic information is being accumulated. The total energy is controlled by output intensity and total radiation time.
- Page 23 5.3.2 Electromagnetic Immunity Immunity IEC 60601 Compliance Electromagnetic Environment and Test Test Level Level Guidance Electrostati Floors should be wood, discharge ±6kV Contact ±6kV Contact concrete or ceramic tile. (ESD) If floors are covered with synthetic material, ±8kV Air ±8kV Air the relative humidity should be at least 30%.
- Page 24 5.3.3 Recommended Minimum Distance BetweenBProbe and Mobile RF Equipment The equipment is intended for use in an electromagnetic environment in which radiated RF disturbance are controlled. The customer or the user of the equipment can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and the equipment as recommended below, according to the maximum output power of the communications equipment.
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Page 25: 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 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 26: Appendix B Acoustic Output Data
Appendix B Acoustic Output Data Transducer Model: Bprobe, SN: Operating Mode: B mode WBPBGBB004 Non-scan Index label Non- Scan ≤1 >1 scan aprt aprt Maximum index value 0.47 0.037 0.81 r.α 3.39 min of [P α ta.α Associated acoustic z at max I 3.80... - Page 27 Transducer Model: Bprobe, SN: Operating Mode: B+M mode WBPBGBB004 Non-scan Index label Non- Scan ≤1 >1 scan aprt aprt Maximum index value 0.47 0.037 0.029 0.11 0.81 r.α 3.39 3.41 min of 2.06 α ta.α 2.50 2.19 Associated acoustic 3.45...
- Page 28 SUNGO Europe B.V. Olympisch Stadion 24, 1076DE Amsterdam, 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 E-mail:sonostar@sonostar.net...
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