Bionet Wireless Mobile Diagnostic Ultrasound System SonoMe User Manual 5C, 10L, 14L, 5CB, 10LB H5C10L, H5C, H10L Rev. 1.01 2022-03-24 www.sonome.com Copyright © 2021 By Bionet CO., LTD.
Rev.1.01 Revision History Revision Date Reason for Change Rev.1.00 2021-08-12 Initial Release Rev.1.01 2022-03-24 Replace of wireless charger Add of FCC warning & Logo 2022. 03.
Rev.1.01 Table of Contents Chapter 1. Introduction ········································································ 6 1.1 Safety Symbols ··················································································································· 7 1.2 Intended use ······················································································································· 8 1.
Rev.1.01 3.2.2 Color Doppler Imaging Mode ······················································································ 21 3.2.3 Power Doppler Imaging Mode ···················································································· 22 3.2.4 PW(Pulse Wave) Spectral Doppler Mode ································································ 23 3.3 Patient Information········································································································· 24 3.
Rev.1.01 5.2 Biopsy Procedure ············································································································ 38 5.3 Needle Guideline Alignment ······················································································ 39 5.4 Biopsy Specification ······································································································· 40 Chapter 6. Safety ················································································· 41 6.
Rev.1.01 Chapter 1. Introduction SonoMe is the new generation instruments for ultrasonography with the outstanding feature of wireless. Different with traditional ultrasound system with a cable connecting from probe to main unit, no cable appears at the end of the probe of the system. SonoMe is highly integrated with ultrasound image processing, power management and a wireless signal provider to be connected by the main units.
Rev.1.01 1.
Rev.1.01 1.2 Intended use SonoMe is designed to obtain ultrasound images, measure and analyze anatomical structures and fluids 1.3 Guidelines for Safe Usage SonoMe is indicated for examining the adult, pregnant woman, and children. This product is intended for use by, or by the order of, and under the supervision of, a licensed physician who is qualified for direct use of medical devices. 1.
Rev.1.01 direct sunlight, or a heater is near the product; that are frequently exposed to vibration; that are too dusty or are not properly ventilated; or where chemicals or gases are present. Do not place anything on top of the instrument. - The product shall be operated in undisturbed conditions to avoid data transmission interruption. - When there is wireless channel congestion, switch the channel (Refer to Section 3.6 SETTINGS), and then restart the probe. - Prescription Use.
Rev.1.01 Consult the dealer or an experienced radio/TV technician for help. - The device has been evaluated to meet general RF exposure requirement. - Patients using cardiac pacemakers are guided by doctors' suggestions. - You may lose user settings or patient information files because of physical shocks to the product or internal errors. Therefore, you should backup this information on a regular basis. 2022. 03.
Rev.1.01 Chapter 2. Preparing for Use FOR YOUR PROTECTION, please read safety instructions completely before turning the power on CAUTIONS Too high ultrasonic intensity and / or long exposure time may cause injury. Please do not apply the probe of this product to the scope not covered in this manual. 2.1 Unpacking The product is carefully packed to prevent damage during shipment. Before unpacking, please note any visible damage to the outside of the shipping containers.
Rev.1.01 2.1.1 H5C10L [Figure 2-1] H5C10L ◼ ◼ # Items Descriptions 1 Battery Level Indicator Indicate Battery Level 2 Wireless Signal Status Show Wireless Signal Status 3 Convex On/Off Indicator Indicate Convex Array’s Activation Status 4 Power On/Off & Freeze 5 Linear On/Off Indicator Indicate Convex Array’s Activation Status 6 USB Cable Supply Power for Wireless Charger 7 Wireless Charger Charging H5C10L Power ON/OFF : Press button for about 5 sec.
Rev.1.01 2.1.2 H5C & H10L [Figure 2-2] H5C & H10L # Items 1 Power On/Off & Freeze 2 Depth Button Control Depth 3 Gain – Button Reduce Gain 4 Gain + Button Increase Gain 5 Wireless Signal Status Show Wireless Signal Status 6 Battery Level Indicator Indicate Battery Level 2022. 03. Descriptions Power ON/OFF : Press button for about 5 sec. Freeze : Press button for about 1 sec.
Rev.1.01 2.1.3 10L, 14L, 10LB, 5C & 5CB [Figure 2-3] 10L, 14L, 10LB, 5C & 5CB # Items 1 Power On/Off & Freeze 2 Wireless Signal Status Show Wireless Signal Status 3 Battery Level Indicator Indicate Battery Level 2022. 03. Descriptions Power ON/OFF : Press button for about 5 sec. Freeze : Press button for about 1 sec.
Rev.1.01 2.1.4 Application for each probe Probe H5C10L Application Convex Linear H5C, 5C, 5CB H10L, 10L, 10LB, 14L Abdomen, Gynecology, Obstetrics, Cardiac, Urology, Kidney, Lung Thyroid, Small Parts, Pediatrics, Vascular, Carotid, Breast, MSK, Nerve Abdomen, Gynecology, Obstetrics, Cardiac, Urology, Kidney, Lung Thyroid, Small Parts, Pediatrics, Vascular, Carotid, Breast, MSK, Nerve 2.
Rev.1.01 2.3 Using Probe 2.3.1 Visual Inspection Check the probe for cracks, broken parts, liquid leaks, sharp edges, etc. Warning Using damaged probes may result in electric shocks and other hazards to the patients and/or users. If damaged, stop using them immediately and contact to Bionet’s Customer Service Department. 2.3.2 Cleaning Probe All probes must be cleaned and disinfected after each use. Refer to “Chapter 4.2. Cleaning and disinfection”.
Rev.1.01 Warning If there are any of the above problems, there may be a problem with the product, so please contact Bionet’s Customer Service Department. - The Indicators of Wireless Signal Status and Battery Level in the probe are not invisible till the probe is turned on. - Press the power button for a second and turn on. After turning on, you can check the status of battery level. There are 4-Step battery level.
Rev.1.01 Chapter 3. Using SonoMe 3.1 Basic Information & B Mode [Figure 3-1] B Mode Information: 1. Gain +: Increase the brightness of the applicable Operation mode 2. Gain -: Decrease the brightness of the applicable Operation mode 3. Depth: Adjusts the scanning depth of an image. The range varies depending on the probe in use 4. Focus: Adjusts the focus of an image 5. Dynamic: Adjusts contrast by changing the ratio of the minimum and maximum values of input signals.
Rev.1.01 9. Patient: Displays the Patient Information screen, which is used for selecting a patient ID from the list or entering new patient information 10. Freeze: Pauses an image being scanned or reactivates a paused image 11. Play: Play saved or stopped video 12. Measure: Starts to measure distance, circumference, area, and volume. 13. Annotation: Enter a text on the image 14. Biopsy: Draw a puncture line for puncture guidance 15. Clear: Deletes text and measurement result displayed on an image. 16.
Rev.1.01 3.2 Basic Mode 3.2.1 M Mode [Figure 3-2] M Mode Information: 1. M Line: The M Line indicates the relative position of the M Mode image in the 2D image. You can move the M Line to change the observation area. Use the finger to move the M Line to the right or left. 2022. 03.
Rev.1.01 3.2.2 Color Doppler Imaging Mode [Figure 3-3] Color Doppler Imaging Mode Information: 1. Steer: Adjust ultrasound beam angle to minimize loss of color information 2. Gain +: Increase the color brightness 3. Gain -: Decrease the color brightness 4. Move, Zoom: Use the finger to change the location and size of ROI(Region of Interest) box 2022. 03.
Rev.1.01 3.2.3 Power Doppler Imaging Mode [Figure 3-4] Power Doppler Imaging Mode Information: 1. Steer : Adjust ultrasound beam angle to minimize loss of color information 2. Gain +: Increase the color brightness 3. Gain -: Decrease the color brightness 4. Move, Zoom: Use the finger to change the location and size of ROI(Region of Interest) box 2022. 03.
Rev.1.01 3.2.4 PW(Pulse Wave) Spectral Doppler Mode [Figure 3-5] PW Spectral Doppler Mode Information: 1. Steer: Changes in the direction specified in Sample Volume 2. Gain +: Increase the pulse brightness 3. Gain -: Decrease the pulse brightness 4. Volume: Adjust the size of Sample Volume 5. Angle: Adjust the angle of Sample Volume 2022. 03.
Rev.1.01 3.3 Patient Information When you press “PATIENT( )” button, you can see a Patient Information Menu as Figure 3-6. [Figure 3-6] Patient Information Menu [Figure 3-7] Edit Patient Information When you complete to enter a patient’ information, Press “OK” button for save. 2022. 03.
Rev.1.01 3.4 Measurement 3.4.1 Basic Measurement Press “Measure” button at Freeze in B mode, you can see 10 measurement items (When scrolling, the rest of the measurements are also visible.) as Figure 3-8. The available measurement methods vary depending on the current Operation mode and Application. [Figure 3-8] Measurement ◼ LENGTH Choose “LENGTH”. Use the Finger and Set to specify both end points of the measurement area.
Rev.1.01 [Figure 3-9] Measure the LENGTH ◼ AREA/CIRCUMFERENCE Choose “AREA/CIRCUM”. Using the Finger, Set to specify 3 points of the measurement area and then you can see elliptical trajectory. When you click the one of 3 points, you can adjust the size and location and the area and circumstance will be measured automatically. If the color of 3 points is green, you can move or change but if white, complete to measure and cannot move or change. ◼ ANGLE Choose “ANGLE”.
Rev.1.01 ◼ TRACE Measure the area of an irregularly shaped object. Choose “TRACE”. Set to specify the starting point for tracing on the contour of the area to be measured. Trace the curve so that the measurement point returns to the start point.
Rev.1.01 3.4.2 Heart Rate Measurement [Figure 3-11] Heart Rate Measurement At Freeze in M Mode or PW mode, Select “Heart Rate” from the Measurement menu. A green bar appears, with which you can specify the range. To set the measurement range, use the Finger to place the bar at the desired location (In M mode, there are 3 bars, In PW mode, there are 5 bars). The system will automatically measure the heart rate within the measurement range. 2022. 03.
Rev.1.01 3.5 Report When you press “PATIENT( )” button, you can see a “Report” button at bottom-right in Patient Information Menu as Figure 3-12. [Figure 3-12] Patient Information Menu If you select “Report” at the bottom-right of the patient information, a report window appears as shown in Figure 3-13 and clicks the “Obs(Observations)” box to allow the user to input opinions or opinions. You can download the report by selecting the download icon " " at the bottom-right of the page.
Rev.1.01 3.6 Storage & Review 3.6.1 Image Storage As shown in Figure 3-14, if you select “Save Image ( )” at the bottom right of the App screen, the image currently displayed on the screen is saved. The saved image is automatically saved to your phone or tablet's photo album. [Figure 3-14] Complete to save image 3.6.
Rev.1.01 3.7 Change Wi-Fi Channel In a congested Wi-Fi environment, the user can choose a different Wi-Fi channel for the probe. Press the "Preset( )" button, then select the appropriate channel selection by referring to the signal channel selection list (see Figure 3-15). Restart the probe after 2 seconds and reconnect with the mobile phone or tablet according to chapter 3.1. [Figure 3-15] Wi-Fi Chanel Setting 2022. 03.
Rev.1.01 Chapter 4. Maintenance 4.1 Charging Probe 4.1.1 USB Charging When the battery is low, the probe needs to be charged. Remove the rubber cover from the tip of the probe and then plug one end of the USB cable into the USB charging port in the probe as shown in Figure 4-1. The battery level indicator blinks while charging. The battery is fully charged when both the battery level indicator and the wireless link indicator are not blinking.
Rev.1.01 [Figure 4-2] Wireless Charging with wireless charging pad Warning It should not be used if the adapter power supply voltage is outside the adaptive range of the appliance (Normal Adapter’s output voltage : 5V ± 0.5V). Check the condition of power cable at first. If the power cable is damaged or broken, replace new one immediately. 4.2 Cleaning and Disinfecting Probes All probes must be cleaned and disinfected before and after each use.
Rev.1.01 probe must be protected from extreme operating temperatures 4.4 Troubleshooting Inspection : Check whether connection between probe and host(smart phone or tablet) is OK or not Error handling: # 1 Symptoms Solutions No response after pressing power Check the status of charging and button power supply Wi-Fi is NOT connected between the 2 probe and host (smart phone or tablet) Check whether Wi-Fi signal channel is ready or not. Check whether Wi-Fi password is correct or not.
Rev.1.01 Do not dispose of the product carelessly. - Battery recycling must meet local requirements. - Waste must be disposed of in compliance with local regulations. 4.6 Maintenance & Protection 1. This product usage and storage conditions shall comply with the environmental conditions of Appendix A in this manual. 2. The product power supply shall be in accordance with Appendix A in this manual. 3.
Rev.1.01 4.7 Contact Headquarters & International Sales & service Bionet Co., Ltd.: 5F, 61 Digital-ro 31 gil, Guro-gu, SEOUL 08375, REPUBLIC OF KOREA Tel: +82-2-6292-6410 / Fax: +82-2-6499-7789 / E-mail: sales@ebionet.com Website: www.ebionet.com U.S.A sales & service representative Bionet America, Inc.: 2691, Dow Ave, Suite B Tustin, CA92780 U.S.A. Toll Free: 1-877-924-6638 / Fax: 1-714-734-1761 / E-mail: support@bionetus.com Website: www.bionetus.
Rev.1.01 Chapter 5. Biopsy (Only for 14L) A biopsy is an examination method that surgically extracts tissue from the patient for examination. The probe and the biopsy components are used together when conducting a biopsy with the ultrasonographic image scanner. The ultrasound system shows the needle, which penetrates through the skin surface and veins, along with the examination location, minimizing the risk to the patient.
Rev.1.01 Warning - Only use needle approved for use in your country. - Verify the condition of the biopsy needle before use. Do not use a bent biopsy needle. - The needle and guide must be sterilized before use. - The needle may bend while penetrating tissue. Therefore, the actual location of the needle must be checked by monitoring the echo generated from the needle.
Rev.1.01 to the patient. ④ Scan the patient. Adjust the patient so that the location for examination fits into the needle guideline on the screen. ⑤ Insert the needle into the needle guide. Perform the puncture by sliding the needle through the groove in the guide until the needle intercepts the target. ⑥ To prevent the needle from shaking, press down on the top of the needle guide with your index finger during examinations. ⑦ When the examination site is reached, take the needle out of the needle guide.
Rev.1.01 must be checked by monitoring the echo from the needle. ① Attach the biopsy components. ② Set the system depth for the procedure to be performed and select the Biopsy menu. ③ Immerse the probe into the water bath and insert the needle into the needle guide. ④ Confirm that the needle image is on the needle guidelines. If it is, then the needle guide is properly aligned. ⑤ If the needle image displayed on the screen is outside of the needle guide lines, check the needle guide. 5.
Rev.1.01 Chapter 6. Safety To prevent damage of the equipment or injury to yourself or others, read the following safety instruction before using SonoMe. 6.1 Important Safety Considerations Read the following safety instruction before using SonoMe. Warnings: - Do not use for any purpose other than the intended use. Otherwise, the system may be damaged or serious injury may result. - This device is for diagnostic use only and is not intended for therapeutic use. Always keep this manual with the system.
Rev.1.01 - Check the probe for cracks, broken parts, liquid leaks, sharp edges, etc. If there is any damage, stop using the probe immediately and contact Customer Service Department. Warnings: - This product is intended for use by, or by the order of, and under the supervision of, a licensed physician who is qualified for direct use of medical devices. - This system may only be maintained by persons approved or trained by Bionet.
Rev.1.01 Warnings: - Check the probe for cracks, broken parts, liquid leaks, sharp edges, etc. If there is any damage, stop using the probe immediately. Using damaged probes may result in electric shocks and other hazards to the patients and/or users. - After disinfecting the accessory, it is necessary to flush the chemicals out of the accessory. Residual chemicals or gases left behind can not only damage the accessory but can also be harmful to human health. 6.1.
Rev.1.01 6.2 Acoustic Power Principle Warnings: - Guidance for the use of diagnostic ultrasound is defined by the “As Low As Reasonably Achievable (ALARA)” principle. By keeping ultrasound exposure as low as possible while obtaining diagnostic images, users can minimize ultrasonic bioeffects. - The operator should notice the effect of the heat on the patient body when the exam is performed around the bones and the nearby soft tissues which can transform the ultrasound energy to heat energy.
Rev.1.01 involved, TI could be one of three types. The soft tissue thermal index (TIs) : the user about the potential for heating within soft homogeneous tissue. The bone thermal index (TIb) : the user about potential heating at or near the focus after the ultrasound beam has passed through soft tissue or fluid, such as the skeletal structure of a 2-3 month-old fetus.
Rev.1.01 attenuation coefficient, choosing conservative values of tissue characteristic. Therefore, displayed MI and TI values should be relative information for reference, they serve to indicate to the operator whether a particular setting of the system increases or decreases the possibility of Thermal or Mechanical effect, used to help the operator be careful to use ultrasonic diagnostic system and follow the ALARA principle, these values cannot be equal to actual values. 6.2.3.
Rev.1.01 - Direct Controls The direct control of the acoustic output of this system is adjusting voltage size. But its maximum acoustic output shouldn't be more than displayed acoustic output limit in any modes. - Indirect Controls The controls that indirectly affect output are many imaging parameters. These are operating modes, frequency, focal point number/position, image depth and pulse repetition frequency (PRF). The operating mode determines whether the ultrasound beam is scanning or nonscanning.
Rev.1.01 patient is created or the application mode is changed, the system will retrieve the default settings. You can also reset the parameters. 6.2.5 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.
Rev.1.01 Guidance and Manufacturer’s Declaration – Electromagnetic Emissions The Wireless Probe Series Ultrasound Scanner is intended for use in the electromagnetic environment specified below. The customer or the user of Wireless Probe Series Ultrasound Scanner should assure that it is used in such environment. Type Emission Test Electromagnetic environment - Compliance guidance RF CISPR 11 Group1, The Ultrasound System uses RF energy Emission EN 55011 Class A for its internal functions only.
Rev.1.01 4-2 ±2, ±4, ±8, should be at least 30%. ±15 kV/Air RF IEC 61000- 3V/m Electromag 4-3 80 ㎒ - 2.7㎓ The field strength outside the shielded netic EN 61000- 80% AM at location from the fixed RF transmitter as Immunity 4-3 1㎑, 2㎐ determined by electromagnetic field Near Field Table #9 at Immunity IEC 60601-1- for RF Wireless Communica tion IEC 610004-3 2: 2014 survey should be less than 3V/m.
Rev.1.01 recommended below. Power IEC 61000- 30 A/m Frequency 4-8 50 ㎐ and 60 Magnetic EN 61000- ㎐ Field 4-8 Power frequency magnetic fields should be at levels characteristic of a typical location in a typical commercial or hospital environment. I㎜unity Voltage IEC 61000- 0 % UT: 0.5 Mains power quality should be that of dips 4-11 cycle atypical commercial or hospital EN 61000- At 0°, 45°, environment.
Rev.1.01 If the system has generated the interference (confirmed by powering on and off the system), the qualified service personnel should solve the problem by following the steps as below - Change the location of the affected system. - Place SonoMe further away from the affected system.
Rev.1.01 (1) this device may not cause harmful interference, and (2) this device must accept any interference received, including interference that may cause undesired operation. This equipment has been tested and found to comply with the limits for a Class A 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.
Rev.1.01 Appendix A. Specification A-1.
Rev.1.01 Degrees of protection against harmful liquid IPX1 Degree of safety of The equipment is not suitable for use in the presence of application a flammable anesthetic mixture with air, oxygen, or nitrous oxide. Wireless Parameters WI-FI Type 2.4G Band Supported Type IEEE 802.11n(HT20) Modulation IEEE 802.
Rev.1.01 A-1. 5C-10L-14L-5CB-10LB 5C Type Color Doppler Dimension & Weight 157㎜ × 67㎜ × 29㎜, 250g Array Type Electronic array R60 Probe Type Convex Display Mode B, B/M, Color, PDI, PW Frequency 3.2/5㎒ Depth 90㎜~305㎜ Application Abdomen, Obstetrics, Gynecology Antenna Description Chip Antenna, 2.1dBi(Max.
Rev.1.01 Display Mode B, B/M, Color, PDI, PW Frequency 10/14㎒ Depth 20㎜~55㎜ Application Peripheral Vessel, Superficial Organ Antenna Description Chip Antenna, 2.1dBi(Max.), AH104N2450D1 5CB Type BW Dimension & Weight 157㎜ × 67㎜ × 29㎜, 250g Array Type Electronic array R60 Probe Type Convex Display Mode B, B/M Frequency 3.2/5㎒ Depth 90㎜~280㎜ Application Abdomen, Obstetrics, Gynecology Antenna Description Chip Antenna, 1.6dBi(Max.
Rev.1.01 A-2.
Rev.1.01 application a flammable anesthetic mixture with air, oxygen, or nitrous oxide. Wireless Parameters WI-FI Type 2.4G Band Supported Type IEEE 802.11n(HT20) Modulation IEEE 802.11n:OFDM Channel Number 11 Channel for 20㎒ bandwidth (2,412~2,462 ㎒) Channel Separation 5㎒ Antenna Description Chip Antenna, 2.1dBi(Max.), AH104N2450D1 Wireless Power 10 ㎽/㎒ or below Common Technical Parameters Description - Display: Tablet PC or Mobile Phone which supports by iOS 8.0 or above, Android OS 7.
Rev.1.01 Supported Device Brand SAMSUNG, HUAWEI, MI / Apple Equipment name Specific low power wireless device (Wireless device for wireless data communication system) Manufacturer/Country 2022. 03. Bionet/S.
Rev.1.01 A-3.
Rev.1.01 application a flammable anesthetic mixture with air, oxygen, or nitrous oxide. Wireless Parameters WI-FI Type 2.4G Band Supported Type IEEE 802.11n(HT20) Modulation IEEE 802.11n:OFDM Channel Number 11 Channel for 20㎒ bandwidth (2,412~2,462 ㎒) Channel Separation 5㎒ Antenna Description Chip Antenna, 2.1dBi(Max.), AH104N2450D1 Wireless Power 10 ㎽/㎒ or below Common Technical Parameters Description Tablet PC or Mobile Phone which supports by iOS 8.0 or above, Android OS 7.
Rev.1.01 A-3. H5C & H10L < Difference among devices > H5C Dimension 160㎜ × 70㎜ × 23㎜, 250g Array Type Electronic array R60 Probe Type Convex probe Frequency 3.2/5㎒ Depth 90㎜~305㎜ Application Abdomen, Obstetrics, Gynecology H10L Dimension 160㎜ × 64㎜ × 23㎜, 200g Array Type Electronic array L40 Probe Type Linear probe Frequency 7.5/10㎒ Depth 20㎜~100㎜ Application 2022. 03.
Rev.1.01 Appendix B. Acoustic Output Data These data are acquired through the test report of IEC 60601-2-37. IEC 60601-2-37:2007 +AMD1:2015 CSV © IEC 2015 MODE 2022. 03.
Rev.1.01 IEC 60601-2-37:2007 +AMD1:2015 CSV © IEC 2015 MODE 5C B + M Mode 2022. 03.
Rev.1.01 IEC 60601-2-37:2007 +AMD1:2015 CSV © IEC 2015 MODE 5C 2022. 03.
Rev.1.01 IEC 60601-2-37:2007 +AMD1:2015 CSV © IEC 2015 MODE 5C 2022. 03.
Rev.1.01 IEC 60601-2-37:2007 +AMD1:2015 CSV © IEC 2015 MODE 10L B Mode 2022. 03.
Rev.1.01 IEC 60601-2-37:2007 +AMD1:2015 CSV © IEC 2015 MODE 10L B + M Mode 2022. 03.
Rev.1.01 IEC 60601-2-37:2007 +AMD1:2015 CSV © IEC 2015 MODE 10L B + Color / B + PDI Mode 2022. 03.
Rev.1.01 IEC 60601-2-37:2007 +AMD1:2015 CSV © IEC 2015 MODE 10L PW Mode 2022. 03.
Rev.1.01 IEC 60601-2-37:2007 +AMD1:2015 CSV © IEC 2015 MODE 14L B Mode 2022. 03.
Rev.1.01 IEC 60601-2-37:2007 +AMD1:2015 CSV © IEC 2015 MODE 14L B + M Mode 2022. 03.
Rev.1.01 IEC 60601-2-37:2007 +AMD1:2015 CSV © IEC 2015 MODE 14L B + Color / B + PDI Mode 2022. 03.
