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1 | User Manual | Users Manual | 5.42 MiB | May 18 2022 |
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. All rights reserved Rev.1.01 Revision History Revision Rev.1.00 Rev.1.01 Date Reason for Change 2021-08-12 Initial Release 2022-03-24 Replace of wireless charger Add of FCC warning & Logo 2022. 03.
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Doc # : BN-SM-EOP-01 Rev.1.01 Table of Contents Chapter 1. Introduction 6 1.1 Safety Symbols 7 1.2 Intended use 8 1.3 Guidelines for Safe Usage 8 1.4 CONTRAINDICATIONS 8 1.5 Precautions & Warnings for Use 8 Chapter 2. Preparing for Use 11 2.1 Unpacking 11 2.1.1 H5C10L 12 2.1.2 H5C & H10L 13 2.1.3 10L, 14L, 10LB, 5C & 5CB 14 2.1.4 Application for each probe 15 2.2 How to Install App 15 2.3 Using Probe 16 2.3.1 Visual Inspection 16 2.3.2 Cleaning Probe 16 2.3.3 Booting 16 2.4 Wireless Connection 17 Chapter 3. Using SonoMe 18 3.1 Basic Information & B Mode 18 3.2 Basic Mode 20 3.2.1 M Mode 20 2022. 03. 3 / 96 Doc # : BN-SM-EOP-01 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 3.4 Measurement 25 3.4.1 Basic Measurement 25 3.4.2 Heart Rate Measurement 28 3.5 Report 29 3.6 Storage & Review 30 3.6.1 Image Storage 30 3.6.2 Video Storage 30 3.6.3 Review image & Video 30 3.7 Change Wi-Fi Channel 31 Chapter 4. Maintenance 32 4.1 Charging Probe 32 4.1.1 USB Charging 32 4.1.2 Wireless Charging 32 4.2 Cleaning and Disinfecting Probes 33 4.3 Storage 33 4.4 Troubleshooting 34 4.5 Disposal 34 4.6 Maintenance & Protection 35 4.7 Contact 36 Chapter 5. Biopsy (Only for 14L) 37 5.1 Biopsy Components 37 2022. 03. 4 / 96 Doc # : BN-SM-EOP-01 Rev.1.01 5.2 Biopsy Procedure 38 5.3 Needle Guideline Alignment 39 5.4 Biopsy Specification 40 Chapter 6. Safety 41 6.1 Important Safety Considerations 41 6.1.1 Electrical Safety 41 6.1.2 Mechanical Safety 42 6.1.3 Probe Safety Precautions 42 6.1.4 Cyber Security 43 6.2 Acoustic Power Principle 44 6.2.1 Biological Safety 44 6.2.2 Thermal Index (TI) & Mechanical Index (MI) 44 6.2.3 Acoustic Power Statement 45 6.2.4 Acoustic Power Setting 47 6.2.5 ALARA 48 6.3 Electromagnetic Compatibilities 48 6.3.1 Electromagnetic Emission 48 6.3.2 Electromagnetic Immunity 49 6.3.3 Recommended Separation Distance 51 Appendix A. Specification 54 Appendix B. Acoustic Output Data 64 2022. 03. 5 / 96 Doc # : BN-SM-EOP-01 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. The main units different with traditional devices are now changed to be Tablet PC or Mobile Phone which supports by iOS, Android OS System. The probe acts as a Wi-Fi Access Point and can be connected by Tablet PC or Mobile Phone. With the probe be connected through Wi-Fi and the App is running, enjoy your days of working without the troubles made by cables. This manual is intended to provide a thorough overview of the SonoMe and should be carefully read before starting to operate the device.
[Figure 1-1] SonoMe App & Wireless Probes 2022. 03. 6 / 96 Doc # : BN-SM-EOP-01 1.1 Safety Symbols Rev.1.01 Symbols Description Symbols Description WARNING: Warnings to or damage to property prevent a serious accident, Manufacturing date Follow the User Manual Serial Number Type BF applied part
(Classification based on Direct Current(DC) degree of protection against Voltage source electric hazard) Dripping-proof device:
Protected against vertically prevent a minor accident or CAUTION: Precautions to falling water drops Non-ionizing damage to property The manufacturers name electromagnetic radiation and address are provided. The waste of electrical and electronic equipment must not be disposed as unsorted municipal waste and must be collected separately This way up: For the duration of shipping/
delivery, the carton should face upright Recycling: Dispose of properly in accordance with all state, province, and country regulations Use no hooks: Absolutely no hand hooks should be attached to pull the parcel Fragile: Handle with care Keep away from rain The Authorized European Federal Communications Representatives address is Commission logo provided 2022. 03. 7 / 96 Doc # : BN-SM-EOP-01 Rev.1.01 1.2 Intended use structures and fluids SonoMe is designed to obtain ultrasound images, measure and analyze anatomical 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. 1.4 CONTRAINDICATIONS
This product must not be used for ophthalmological applications, or any other use that involves the ultrasound beam passing through the eyeball.
- Do not use this product in the following situations. Doing so may produce images with inaccurate results:
measured density. examining tissue Patients who have had surgery, which may have changed the composition of the examining tissue (for example, a mastectomy), as this could skew or alter the Patients whose bodies contain foreign artifacts (for example, implants), in the Endo-cavitary use: i.e., defined as introducing a scanner within a (body) cavity or organ. E.g. atrium, esophagus, rectum or vagina 1.5 Precautions & Warnings for Use Precautions:
- Keep this manual near the product and refer to it when using the product. Bionet is not responsible for any product issues caused by the users careless operation or negligence in maintenance.
The product must work in a clean environment, should avoid areas where moisture, 2022. 03. 8 / 96 Doc # : BN-SM-EOP-01
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. This product must only be used by persons who have sufficient knowledge of and/or a qualification in clinical pathology. Unqualified operators are prohibited from using the product. The product shall be repaired by professional recognized by Bionet. The product does not have shelf life. Its expected use life is 10 years. After 10 years, though the product still works normally, it is recommended to have it checked by
- Useless components must be disposed of in compliance with local regulations.
- Be careful when holding the device, for the device is handheld, it may fall.
The words Insufficient Storage Space will appear on the interface to remind the user to clean up space when storage space will be insufficient. Bionet. Warnings:
cause an explosion.
- Never use the product in the presence of flammable or anesthetic gas. Doing so may
- Do not allow the interior of the product to be exposed to, or immersed in, liquid. Otherwise, fire, electric shock, injury, or damage to the product may occur.
- Changes or Modifications not expressly approved by the party responsible could void the users authority to operate this device.
If the product 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 product and receiver. Connect the product into an outlet on a circuit different from that to which the receiver is connected. 2022. 03. 9 / 96 Doc # : BN-SM-EOP-01 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. 10 / 96 Doc # : BN-SM-EOP-01 Rev.1.01 Chapter 2. Preparing for Use FOR YOUR PROTECTION, please read safety instructions completely before turning the 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 power on 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. Items should be checked whether all ordered items have been received. The following table lists the items which should be received with each product.
[Table 2-1] Item List H5C10L H5C, H10L Remarks 10L,14L, 10LB, 5C, 5CB List Probe User Manual USB Cable (1m) Quick Guide Pouch Strap Wireless Charger Needle Guide
Micro 5pin Only 14L Check the item damage or defects (e.g. cracks, broken parts, liquid leaks, sharp edges, etc.). If there is any damage or defects, stop using the probe immediately and contact Bionets Customer Service Department. 2022. 03. 11 / 96 Doc # : BN-SM-EOP-01 Rev.1.01 2.1.1 H5C10L
[Figure 2-1] H5C10L Items Descriptions Battery Level Indicator Indicate Battery Level Wireless Signal Status Show Wireless Signal Status Convex On/Off Indicator Indicate Convex Arrays Activation Status Power On/Off & Freeze Power ON/OFF : Press button for about 5 sec. Freeze : Press button for about 1 sec. Linear On/Off Indicator Indicate Convex Arrays Activation Status USB Cable Supply Power for Wireless Charger Wireless Charger Charging H5C10L Switch Probe type: Press power button for about 3 seconds If Convex Array is On, #3 indicator is On. If Linear Array is On, #5 indicator is On. Only H5C10L is available for wireless charging 2022. 03. 12 / 96 Doc # : BN-SM-EOP-01
1 2 3 4 5 6 7
Rev.1.01 2.1.2 H5C & H10L
[Figure 2-2] H5C & H10L
1 2 3 4 5 6 Items Descriptions Power On/Off & Freeze Power ON/OFF : Press button for about 5 sec. Freeze : Press button for about 1 sec. Depth Button Gain Button Gain + Button Control Depth Reduce Gain Increase Gain Wireless Signal Status Show Wireless Signal Status Battery Level Indicator Indicate Battery Level 2022. 03. 13 / 96 Doc # : BN-SM-EOP-01 Rev.1.01 2.1.3 10L, 14L, 10LB, 5C & 5CB
[Figure 2-3] 10L, 14L, 10LB, 5C & 5CB Items Descriptions Power On/Off & Freeze Power ON/OFF : Press button for about 5 sec. Freeze : Press button for about 1 sec. Wireless Signal Status Show Wireless Signal Status Battery Level Indicator Indicate Battery Level
1 2 3 2022. 03. 14 / 96 Doc # : BN-SM-EOP-01 Rev.1.01 2.1.4 Application for each probe Probe H5C10L Application Abdomen, Gynecology, Obstetrics, Cardiac, Urology, Convex Linear Kidney, Lung MSK, Nerve Thyroid, Small Parts, Pediatrics, Vascular, Carotid, Breast, H5C, 5C, 5CB Abdomen, Gynecology, Obstetrics, Cardiac, Urology, Kidney, Lung H10L, 10L, 10LB, 14L Thyroid, Small Parts, Pediatrics, Vascular, Carotid, Breast, MSK, Nerve 2.2 How to Install App Download the SonoMe app via Google Play Store or Apple App Store depending on user Tablet PC or Mobile Phone OS. 2022. 03. 15 / 96 Doc # : BN-SM-EOP-01 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 Warning 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 Bionets Customer Service Department. 2.3.2 Cleaning Probe Cleaning and disinfection. All probes must be cleaned and disinfected after each use. Refer to Chapter 4.2. Probes that have not been cleaned or disinfected may cause bacterial and viral infections 2.3.3 Booting Please check the following before scanning 1. The probe should not be abnormally heated during use. If the temperature of the probe is much higher than body temperature, or the surface temperature of the probe exceeds 40 C, the probe is stopped Do not use the probe which is heated abnormally to patient, as it may burn patients skin 2. After turning on the power, check whether the functions of ultrasound image, app, button, etc. are working properly. 2022. 03. 16 / 96 Doc # : BN-SM-EOP-01 Rev.1.01 Warning If there are any of the above problems, there may be a problem with the product, so please contact Bionets 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. (Refer to chapter
The wireless signal indicator flashes after a few seconds after turning on the probe. This lets you know that the probe is ready to connect with your tablet PC 4 for how to charge) or mobile phone.
The probe can be turned off by holding the power button down for about 5 seconds. When the probe is turned off, all indicators (wireless signal status and battery level) are turned off, too. 2.4 Wireless Connection If the probe is ready for wireless connection as described previously, turn on Wi-Fi (if not turned on) in the settings of your tablet PC or mobile phone, and find the SSID of the probe. The SSID is something like "SX-xxxxxxx000 (X=uppercase, x=lowercase, 0=number)". Before connecting, check that the last 7 digits of the 11-digit ID written on the back of the probe match the last 7 digits of the SSID. When connecting for the first time, you need to enter a password, which is a total of 11 digit ID written on the back of the probe. After Wi-Fi is connected, launch the SonoMe app. When the app confirms the connection with the probe, the wireless signal indicator on the probe stops blinking. When the connection is complete, start to Scan. 2022. 03. 17 / 96 Doc # : BN-SM-EOP-01 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. The higher the value, the smoother the displayed image. 6. Harmonic: Optimize image using various frequency 7. Reject: Reduces noise or echoes from an image to make the image clearer 8. Image mode
-. 5CB & 10LB: B Mode Only
-. 5C, 10L, 14L, H5C10L, H5C, H10L
: B Mode, B/M Mode, Color Mode, PDI Mode, PW Mode 2022. 03. 18 / 96 Doc # : BN-SM-EOP-01 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. (Image) Save: Save an image 17. (Video) Save: Save a Video 18. Preset (Setting): Select Wi-Fi Channel to avoid channel blocking 19. TGC: Adjust the Gain based on the depth (When you click that area, you can find a TGC menu) 2022. 03. 19 / 96 Doc # : BN-SM-EOP-01 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. 20 / 96 Doc # : BN-SM-EOP-01 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 Interest) box 4. Move, Zoom: Use the finger to change the location and size of ROI(Region of 2022. 03. 21 / 96 Doc # : BN-SM-EOP-01 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 Interest) box 4. Move, Zoom: Use the finger to change the location and size of ROI(Region of 2022. 03. 22 / 96 Doc # : BN-SM-EOP-01 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. 23 / 96 Doc # : BN-SM-EOP-01 Rev.1.01 3.3 Patient Information Figure 3-6. When you press PATIENT( ) button, you can see a Patient Information Menu as
[Figure 3-6] Patient Information Menu
[Figure 3-7] Edit Patient Information 2022. 03. When you complete to enter a patient information, Press OK button for save. 24 / 96 Doc # : BN-SM-EOP-01 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 be measured automatically. Choose LENGTH. Use the Finger and Set to specify both end points of the measurement area. Specify both end points and then the distance between them will If the color of both end points is green, you can move or change but if white, complete to measure and cannot move or change. 2022. 03. 25 / 96 Doc # : BN-SM-EOP-01 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. Draw a straight line at first(Please refer to LENGTH). Specify 3rd point and then measure the angle formed by the points automatically. When you click the one of 3 points, you can adjust the 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. 2022. 03. 26 / 96 Doc # : BN-SM-EOP-01 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. And then you can see the area will be measured automatically Note Measurement for GA (CRL), GA (BPD), GA (GS), GA (FL), GA (HC), GA (AC) is ONLY available to obstetrics application The above measurement functions can be fine-tuned using the on-screen virtual trackball. The virtual trackball(please refer to bottom-right corner in Figure 3-9) can be fine-tuned according to the direction of the measurement point. Up to 4 measurements can be compared at the same time. Delete all measurements using Clear(X) button. When you want to delete one specific measurement, select that measurement and then you can see green column as Figure 3-10. After pressing button, you can delete.
[Figure 3-10] Delete specific measurement 2022. 03. 27 / 96 Doc # : BN-SM-EOP-01 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. 28 / 96 Doc # : BN-SM-EOP-01 Rev.1.01 When you press PATIENT( ) button, you can see a Report button at bottom-right in Patient Information Menu as Figure 3-12. 3.5 Report
[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. The report is automatically saved to your phone or tablet's photo album.
[Figure 3-13] Report 2022. 03. 29 / 96 Doc # : BN-SM-EOP-01 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 3.6.2 Video Storage As shown in Figure 3-14, if you select Save Video ( ) at the bottom-right of the App screen, the saved video is automatically saved in the photo album of your phone or tablet PC within 100 seconds. 3.6.3 Review image & Video Open the photo album on your phone or tablet and view the saved images and videos. 2022. 03. 30 / 96 Doc # : BN-SM-EOP-01 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. 31 / 96 Doc # : BN-SM-EOP-01 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. When charging is complete, remove the USB cable and then put the rubber cover into the USB charging port to avoid liquid and device damage.
[Figure 4-1] Probe Charging via USB Cable 4.1.2 Wireless Charging
- Plug one endo of the USB cable into the wireless charging pad. Place the probe on the wireless charging pad. The probe lights up and starts charging after 1~2 seconds.
Ensure the probe is centered on the wireless charging pad. For efficient charging, place the probe, place the probe within 7 left and right from the center of the wireless charging pad. If it is significantly out of the range, it may be unstable or may not charge. 2022. 03. 32 / 96 Doc # : BN-SM-EOP-01 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 Adapters 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. Use a soft cloth or appropriate cleaning sheet, lightly dampened with Isopropyl alcohol (or proper cleaner), to remove any foreign substances left on the probe, the edges, corners, and curved parts of the probes. Dry the probe with a clean, soft cloth. Alternatively, dampen a soft cloth in a glutaraldehyde-based hospital disinfectant solution such as Cidex. Wipe the probe with a dampened cloth. If still wet or left a stain, wipe with a clean water-dampened cloth. Before use, dry the probe completely with clean, soft cloth. 4.3 Storage When not in use, it is recommended to put the probe in its case. During storage, the 2022. 03. 33 / 96 Doc # : BN-SM-EOP-01 Rev.1.01 probe must be protected from extreme operating temperatures Inspection : Check whether connection between probe and host(smart phone or tablet) 4.4 Troubleshooting is OK or not Error handling:
1 3 4 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 ready or not. tablet) Check whether Wi-Fi signal channel is Check whether Wi-Fi password is correct or not. Check whether other equipment Displayed on the screen with noise started which cause electromagnetic and interference like snow interference. If so, shut down the The brightness of image is not enough Adjust the brightness and gain device or get far from the device. 5 Charging is NOT work circuit and electrical outlet are Check whether the USB interface, damaged or not. 4.5 Disposal Warning 2022. 03. 34 / 96 Doc # : BN-SM-EOP-01 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. If the product is not used for a long time, charge it at least 2 times a week for at 4. Do not tamper with the probe cover to clean or disassemble the components inside least 1 hour. the probe. 5. Clean the cover with alcohol-cotton after turning off. 6. This product should not be started up and shut down too often. If you need to restart, wait at least 1 minute for booting after shutdown. 7. If any problem is happened, stop using the device and contact Bionets Customer Service department. 8. Since the probe is vulnerable to external impact, collision or falling is prohibited. 9. If you want to pause during scanning, use the Freeze function. In freeze status, the device can be kept on standby for a long time. 10. Only use the appropriate ultrasound gels for medical standard. 11. The probe is waterproof but, do not immerse the probe in conductive liquid to 12. Check for cracks regularly to avoid liquid immersion and damage of internal minimize corruption. components. 13. Refer to chapter 4.2 about how to clean and disinfect. 14. To maintain the performance and safety of the system, regular electrical and mechanical safety inspections of the system must be performed by professional technicians in less than six months. 15. Excessive shocks, such as a fall, may seriously damage the product. In this case, contact Bionets Customer Service Department for maintenance and repair. 2022. 03. 35 / 96 Doc # : BN-SM-EOP-01 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 Toll Free: 1-877-924-6638 / Fax: 1-714-734-1761 / E-mail: support@bionetus.com Bionet America, Inc.:
2691, Dow Ave, Suite B Tustin, CA92780 U.S.A. Website: www.bionetus.com Bionet Europe GmbH 2Li Bessemerstr. 51, D-12103 Berlin, Germany European sales & service representative Tel: +49-30-240-374-52 / E-mail: bionetEU@ebionet.com Website: www.ebionet.com 2022. 03. 36 / 96 Doc # : BN-SM-EOP-01 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. Warning
- An ultrasound examination that requires the use of a biopsy components must be performed by a physician or other certified, skilled healthcare professional. Make sure that you take preventative safety measures and ensure sterilization in all environments.
- Do not use the biopsy components for ultrasonographic studies for other purposes, such as human anatomical dissection.
- The user will be responsible for using the biopsy components for ultrasonographic studies.
- Please be sure to read the User Manual thoroughly. 5.1 Biopsy Components The biopsy consists of the needle guide and needle.
[Figure 5-1 Biopsy Components]
- Needle Guide: Secures the needle guide to the probe tightly and guides the angle of the needle so that it may reach the biopsy target accurately.
- Needle: This is the needle that is inserted into the patients body. The item supplied by Bionet does not contain a needle. 2022. 03. 37 / 96 Doc # : BN-SM-EOP-01 Rev.1.01
- 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. For more information about conducting ultrasonographic studies using the needle and the needle guide, contact the manufacturers. Ensure that the biopsy components you are using is compatible with only 14L. Warning Caution Warning
- The needle guides not supplied by Bionet may not be compatible with the probes.
- Use Bionet-approved biopsy components only. Improper installation may adversely
- Be sure to read the instructions for installing and aligning the needle guide thoroughly before performing a biopsy.
- Always ensure that the probe and the needle guide are secured on both the left affect the patient. and the right sides. 5.2 Biopsy Procedure The system generates a needle guideline through the displayed real-time ultrasound images to indicate the anticipated path of the needle. Use this guideline to ensure that the needle or other instrument follows the correct path. Ready the patient according to the procedure appropriate for the examination objectives. Install the needle guide. Set the system controls for the biopsy procedure. If necessary, apply acoustic gel 2022. 03. 38 / 96 Doc # : BN-SM-EOP-01 Rev.1.01 Scan the patient. Adjust the patient so that the location for examination fits into to the patient. the needle guideline on the screen. 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. To prevent the needle from shaking, press down on the top of the needle guide with your index finger during examinations. When the examination site is reached, take the needle out of the needle guide. Detach the needle guide from the probe. Dispose of the needle and the guide that are not designed for reuse Caution Dispose of non-reusable components according to infectious waste regulations 5.3 Needle Guideline Alignment Alignment of the needle guide displayed on the system is for the purpose of verifying whether the needle and the needle guide are properly installed. This must be done prior to biopsy. If the needle fails to follow an accurate path while verifying the alignment of needle guide, stop using the product and contact Bionet. Reverberation or other tissue artifacts may produce false needle images on the screen. Ensure that the needle path is along the guideline and that you are not using a false needle image to locate the needle. Warning
- The needle used for alignment verification must not be used for the actual procedure. Always use a sterile needle for each biopsy procedure.
- To assist in accurate projection of the needle, use a straight, new needle for each alignment procedure.
- The needle guideline only displays the projected path of the needle. Since the default line may be different from the actual line, the actual location of the needle 2022. 03. 39 / 96 Doc # : BN-SM-EOP-01 Rev.1.01 must be checked by monitoring the echo from the needle. Attach the biopsy components. Set the system depth for the procedure to be performed and select the Biopsy Immerse the probe into the water bath and insert the needle into the needle guide. Confirm that the needle image is on the needle guidelines. If it is, then the needle menu. guide is properly aligned. check the needle guide. If the needle image displayed on the screen is outside of the needle guide lines, 5.4 Biopsy Specification Probes Components 14L
- Needle Guide
- Needle Biopsy Reusable/
Disposable Needle gauge Multi Depth Disposable 21 1, 1.5, 2 () 2022. 03. 40 / 96 Doc # : BN-SM-EOP-01 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. Periodically review operating procedures and safety precautions. 6.1.1 Electrical Safety
- The biocompatibility has been verified so that it does not harm users or patients under normal circumstances
- Never attempt to modify the product in any way.
- The battery is a consumable and will lose performance over time. If the battery life becomes less than 2 hours, it is time for a replacement. When you want to purchase or replace a battery, please contact Customer Service Department.
- Warning: Class I The product must be connected to a power supply with a protective earth to prevent electric shock.
- Do not pour liquids on the system surface. Liquids seeping into electrical circuits can cause excessive leakage currents or system failure. If water is unavoidably poured into the system, immediately stop using the system and contact a Customer Service Department.
- Use only probes provided by the manufacturer. Otherwise, the system will not work and the worst accidents such as fire may occur.
- The system that are not maintained may not be used on patients. 2022. 03. 41 / 96 Doc # : BN-SM-EOP-01 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:
cause an explosion. of electric shock electric shock.
- 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.
- Always use application-specific probes in order to obtain the best quality images.
- Never use the product in the presence of flammable or anesthetic gas. Doing so may
- Do not use the system simultaneously with other equipment such as electric knives, defibrillators, and other high-frequency therapy equipment. Otherwise, there is a risk
- Keep the system dry and do not transport to sites with rapid environment changes to avoid short circuits caused by condensation or water droplets.
- The product must be connected to a power supply with a protective earth to prevent
- After reading the manual thoroughly, set and control the acoustic power level. 6.1.2 Mechanical Safety
- Be careful when holding the device, for it is handhold, it may fall.
- Do not use shell cracking equipment. 6.1.3 Probe Safety Precautions
- Please only use the ultrasound gels sold legally. Always follow the instructions in the User Manual. To prevent contamination, use and take care of ultrasound gel properly. Warnings:
Warnings:
- Disconnect the probe from the system after freezing the image or turning the system down. Otherwise, the system or probe may be damaged. 2022. 03. 42 / 96 Doc # : BN-SM-EOP-01 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. 6.1.4 Cyber Security
- Backup the database regularly to avoid loss or damage of the database.
The probe can connect to Tablet PC or Smart Phone via local wireless network. The software itself cannot connect to external network. The network which is connected to the software is a local wireless network connected by the probe.
If there are any software bugs during use, users can give feedback through Bionet e-
mail account(sales@ebionet.com) and the Bionet will analyze and fix the bug, and if an update is required, the user will be notified of it by posting on the website or e-
mail. 2022. 03. 43 / 96 Doc # : BN-SM-EOP-01 Rev.1.01 6.2 Acoustic Power Principle
- 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 Warnings:
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. Take special care to the fetal whose bones are growing. 6.2.1 Biological Safety Ultrasound waves may have damaging effects on cells and, therefore, may be harmful to the patient. If there is no medical benefit, minimize the exposure time and maintain the ultrasound wave output level at a low setting. Please refer to the ALARA principle. 6.2.2 Thermal Index (TI) & Mechanical Index (MI) The system output display comprises two basic indices: a thermal index (TI) and a mechanical index (MI). These shows on the Right-Top side on the app.
- Meaning of MI & TI Mechanical bioeffects are threshold phenomena that occur when a certain level of output is exceeded. The threshold level varies, however, with the type of tissue. The MI accounts for these two factors. The higher the MI value, the greater the likelihood of mechanical bioeffects occurring. However, there is no specific MI value that means that a mechanical effect will occur. The MI should be used as a guide for implementing the ALARA principle. The TI informs the user of the potential for temperature increase occurring at the body surface, within body tissue, or at the point of focus of the ultrasound beam on bone. The TI is an estimate of the temperature increase in specific body tissues. The actual amount of any temperature rise is influenced by factors such as tissue type, vascularity, and mode of operation. The TI should be used as a guide for implementing the ALARA principle. Depending on the examination and type of tissue 2022. 03. 44 / 96 Doc # : BN-SM-EOP-01 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. The cranial bone thermal index (TIc) : the user about the potential heating of bone at or near the surface, for example, the cranial bone.
- Mechanical and Thermal Indices Display Precision and Accuracy 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 Mechanical and Thermal Indices on the system are precise to 0.1 units. 6.2.3 Acoustic Power Statement 6.2.3.1 Acoustic Measurement Precision and Uncertainty When estimating accuracy of displayed numerical values, many factors are considered:
The Probe Changeability 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 6.2.3.2 Differences between Actual and Displayed MI and TI For many assumptions used in the process of measurement and calculation, they actually are conservative. For most organizations path, high estimate is made in the measurement and calculation process of tissue exposure intensity. For example, using attenuation coefficient 0.3 -1 -1 much lower than the actual human tissue 2022. 03. 45 / 96 Doc # : BN-SM-EOP-01 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. 6.2.3.3 Uncertainty of Measurement Sound pressure is the most basic data of sound field measurement, and other sound field parameters can be deduced from sound pressure, so when analyzing measurement uncertainty, only take sound pressure for analysis and uncertainty of other parameters can be deduced from the sound pressure. Measurement uncertainty mainly include repeated measurement uncertainty and the system uncertainty, the system uncertainty is an order of magnitude higher than repeated measurement uncertainty, so the main analysis is the system uncertainty. Mainly decided by the following factors:
1) The sensitivity of hydrophone: According to hydrophone calibration report provided by ONDA company, the maximum allowable error of sound pressure for 2) Scope: according to Agilent DSO6502A specifications, its effect on the sound hydrophone is 12%
pressure is 2%
3) Temperature: effect of the thermocouple on sound pressure error is 4%
Above all uncertainty components are not related, synthetic standard uncertainty of sound pressure is 13%
6.2.3.4 Operator Control Property There are several system controls that the operator can use to adjust the image quality and limit the acoustic intensity. These controls are related to the techniques that an operator might use to implement ALARA and can be divided into three categories: direct, indirect, and receiver controls 2022. 03. 46 / 96 Doc # : BN-SM-EOP-01 Rev.1.01 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
- Direct Controls 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 non-
scanning. Thermal effect is closely connected to M Mode, PW and Color Mode. Acoustic attenuation of tissue is directly related to transducer frequency. The focal point number and position is related to active aperture of transducer and beam width. For the pulse repetition frequency (PRF), the higher the PRF, the more acoustic output power increased over a period of time.
- Receiver Controls 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. When acquiring images, it is recommended to use the default (or as low as possible) acoustic output location and use the gain control to compensate. The default setting is commonly 70% of maximum allowed acoustic output value, which will not cause harm to the operator, and for the probe is the most effective value. 6.2.4 Acoustic Power Setting The ultrasound system has been preset the parameters for each exam mode with different probes before shipment. When the ultrasound system is powered on, a new 2022. 03. 47 / 96 Doc # : BN-SM-EOP-01 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. The output intensity necessary for examinations differs depending on the patient and clinical case. Not all examinations can be performed with an extremely low level of acoustic energy. Controlling the acoustic level at an extremely low-level leads to low-quality images or insufficient Doppler signals, adversely affecting the reliability of the diagnosis. However, the sound power which is used greater than the actual needs does not contribute to improving the quality of diagnostic information either, it will increase the risk of biological effects. The operator must take responsibility for the safety of patients. 6.3 Electromagnetic Compatibilities Electromagnetic compatibilities are the abilities of the system or equipment to operate normally in the electromagnetic environment and not to radiate any electromagnetic interruptions to any other objects which are in the same environment. This system is designed in accordance with the current EMC requirement. And the ultrasound image will degrade instantly if the system is used in the electromagnetic field environment. If the degradation of the image is found, it is recommended to inspect the operation environment to confirm the radiation source. 6.3.1 Electromagnetic Emission This product is intended for use in the electromagnetic environment specified below. Users should make sure that the product is being used in such an environment. 2022. 03. 48 / 96 Doc # : BN-SM-EOP-01 Rev.1.01 Guidance and Manufacturers 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 Compliance Emission Test Electromagnetic environment -
guidance RF CISPR 11 Group1, The Ultrasound System uses RF energy Emission EN 55011 Class A for its internal functions only. Therefore, RF CISPR 11 Group1, The Ultrasound System is suitable for Emission EN 55011 Class A use in all establishments, including its RF emissions are very low and are not likely to cause any interference in nearby electronic equipment. domestic establishments and those directly connected to the public low-
voltage power supply network that supplies buildings used for domestic purposes. Harmonic IEC 61000-
Class A Emission 3-2 EN 61000-
3-2 Flicker IEC 61000-
Pst: 1 Emission 3-3 Plt: 0.65 EN 61000-
Tmax:0.5 3-3 dmax: 4%
dc: 3.3%
6.3.2 Electromagnetic Immunity Guidance and Manufacturers Declaration Electromagnetic Immunity The Wireless Probe Series Ultrasound Scanner is intended for use in the electromagnetic environment specified below. The customer or the user of the Wireless Probe Series Ultrasound Scanner should assure that it is used in such an environment. Type Immunity Compliance Electromagnetic environment -
Test Level guidance Electrostatic discharge
(ESD) IEC 61000-
4-2 EN 61000-
8 kV/Contact Floors should be wood, concrete or ceramic tile. If floors are covered with synthetic material, the relative humidity 2022. 03. 49 / 96 Doc # : BN-SM-EOP-01 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 Immunity 4-3 1, 2 location from the fixed RF transmitter as determined by electromagnetic field survey should be less than 3V/m. Interference may occur in the vicinity of equipment marked with the following Table #9 at IEC 60601-1-
2: 2014 Near Field Immunity for RF Wireless Communica tion Equipment IEC 61000-
EN 61000-
4-3 4-3 symbol:
Electrostatic IEC 61000-
2 kV, 100 transient 4-4 k burst EN 61000-
Repeated The quality of the mains power must be that of a typical commercial or hospital 4-4 Frequency environment. Surge IEC 61000-
(Wire to 4-5 Wire) EN 61000-
0.5 kV, 1 4-5 kV The quality of the mains power must be that of a typical commercial or hospital environment. Conducted IEC 61000-
3V The Ultrasound System is designed for RF 4-6 0.15 - 80 use in electromagnetic environments EN 61000-
where radiated RF disturbances are 4-6 controlled. Customers or users of the V in ISM ultrasonic scanner series can avoid bands electromagnetic interference by between maintaining a minimum distance. It can 0.15 and be used between portable and mobile RF 80 communication equipment (transmitter) and ultrasonic scanner series depending 80% AM at 1 on the maximum power of the k, 2 communication equipment as 50 / 96 Doc # : BN-SM-EOP-01 2022. 03. Rev.1.01 recommended below. Power IEC 61000-
30 A/m Frequency 4-8 50 and 60 Magnetic EN 61000-
Field 4-8 Iunity Power frequency magnetic fields should be at levels characteristic of a typical location in a typical commercial or hospital environment. 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. If the user of the Wireless 4-11 90, 135, Probe Series Ultrasound Scanner requires 180, 225, continued operation during power mains 270 and interruptions, it is recommended that the 315 Wireless Probe Series Ultrasound Scanner be powered from an uninterruptible power supply or a battery. Voltage IEC 61000-
0 % UT;
interruption 4-11 250/300 s EN 61000-
cycle 4-11
[Notice] UT is the a.c. mains voltage prior to application of the test level. 6.3.3 Recommended Separation Distance The SonoMe is intended for use in an electromagnetic environment in which radiated RF disturbance are controlled. The customer or the user of the Wireless Probe Series Ultrasound Scanner can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment
(transmitters) and the SonoMe as recommended below, according to the maximum output power of the communications equipment. 2022. 03. 51 / 96 Doc # : BN-SM-EOP-01 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.
Supply power to this system in other ways other than the way used currently
- Contact Bionets Customer Service Department ASAP Use of this equipment adjacent to or stacked with other equipment may result in improper operation and should be avoided. If such use is required, this and other equipment should be observed to ensure normal operation. The use of accessories, converters and cables not specified or provided by the manufacturer may increase electromagnetic emissions or decrease electromagnetic immunity of this equipment and may cause malfunction. The emission characteristics of this equipment make it suitable for use in industrial areas and hospitals (CISPR 11 Class A). For use in a residential environment (which normally requires CISPR 11 Class B), this equipment may not provide adequate protection for radio frequency communications services. Users may need to take mitigation measures such as relocating or reorienting equipment. Warning Warning Caution Warning This device complies with part 15 of the FCC Rules. Operation is subject to the following two conditions:
2022. 03. 52 / 96 Doc # : BN-SM-EOP-01 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. 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. This device complies with FCC radiation exposure limits set forth for an uncontrolled environment and it also complies with Part 15 of the FCC RF Rules. This equipment must not be co-located or operating in conjunction with any other antenna or transmitter. End-users and installers must be provide with antenna installation instructions and consider removing the no-collocation statement. 2022. 03. 53 / 96 Doc # : BN-SM-EOP-01 Rev.1.01 Appendix A. Specification A-1. 5C-10L-14L-5CB-10LB <Common>
Complied Standard EN/IEC 60601-1:2012 Medical electrical equipment Part 1: General requirements for basic safety and essential performance, BF, Non-continuous operation EN/IEC 60601-2-37:2015 Medical Electrical Equipment Part 2-37: Particular Requirements for the Basic Safety and Essential Performance of Ultrasonic Medical Diagnostic and EN/IEC 60601-1-2:2014 Electromagnetic Compatibility Requirement and tests, Monitoring Equipment Class A Circumstance Operation Ambient Temperature 5C ~ +35C Relative Humidity 25% ~ 80%, Non-Condensing Atmospheric Pressure, 700hPa ~ 1060hPa, Max. Altitude 3000m Ambient Temperature
-20C ~ +55C Storage / Shipping Relative Humidity 25% ~ 93%, Non-Condensing Atmospheric Pressure, 700hPa ~ 1060hPa, Max. Altitude 3000m Safety Type of protection Internal-Power Type, 3.8 VDC / 4,200 h against electric shock Type BF Applied Parts Degree of protection Non-continuous operation Operating mode: 1:2 duty cycle (ON: 5 min / OFF: 10 min) against electric shock Hand-Held Type 2022. 03. 54 / 96 Doc # : BN-SM-EOP-01 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 802.11n:OFDM Channel Number 11 Channel for 20 bandwidth (2,412~2,462 ) Channel Separation 5 Wireless Power 10 / or below Common Technical Parameters Description iOS 8.0 or above, Android OS 7.0 or above, Windows
- Display: Tablet PC or Mobile Phone which supports by Element System. 128 Measurement Length, Area, Angle, Obstetrics Image Frame Rate 16f/s Battery Operation Time 3.5 hours Charging Mode USB Charging Supported Device Brand SAMSUNG, HUAWEI, MI / Apple Equipment name Specific low power wireless device (Wireless device for wireless data communication system) Manufacturer/Country Bionet/S.Korea 2022. 03. 55 / 96 Doc # : BN-SM-EOP-01 Rev.1.01 A-1. 5C-10L-14L-5CB-10LB <Difference among devices>
Type Color Doppler Dimension & Weight 157 67 29, 250g Display Mode B, B/M, Color, PDI, PW Application Abdomen, Obstetrics, Gynecology Antenna Description Chip Antenna, 2.1dBi(Max.), AH104N2450D1 Type Color Doppler Dimension & Weight 157 67 29, 200g Display Mode B, B/M, Color, PDI, PW Array Type Probe Type Frequency Depth Array Type Probe Type Frequency Depth Electronic array R60 Convex 3.2/5 90~305 Electronic array L40 Linear 7.5/10 20~55 5C 10L 14L Application Peripheral Vessel, Superficial Organ Antenna Description Chip Antenna, 1.6dBi(Max.), AF216M245001-T Type Color Dopller Dimension & Weight 157 67 29, 200g Electronic array L25 Linear Array Type Probe Type 2022. 03. 56 / 96 Doc # : BN-SM-EOP-01 Rev.1.01 Display Mode B, B/M, Color, PDI, PW Frequency Depth 10/14 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 Probe Type Display Mode Frequency Depth Electronic array R60 Convex B, B/M 3.2/5 90~280 Application Abdomen, Obstetrics, Gynecology Antenna Description Chip Antenna, 1.6dBi(Max.), AF216M245001-T 10LB Type BW Dimension & Weight 157 67 29, 200g Electronic array L40 Linear B, B/M 7.5/10 20~55 Array Type Probe Type Display Mode Frequency Depth 2022. 03. Application Peripheral Vessel, Superficial Organ Antenna Description Chip Antenna, 1.6dBi(Max.), AF216M245001-T 57 / 96 Doc # : BN-SM-EOP-01 A-2. H5C10L Rev.1.01 Complied Standard EN/IEC 60601-1:2012 Medical electrical equipment Part 1: General requirements for basic safety and essential performance, BF, Non-continuous operation EN/IEC 60601-2-37:2015 Medical Electrical Equipment Part 2-37: Particular Requirements for the Basic Safety and Essential Performance of Ultrasonic Medical Diagnostic and EN/IEC 60601-1-2:2014 Electromagnetic Compatibility Requirement and tests, Monitoring Equipment Class A Circumstance Operation Ambient Temperature 5C ~ +35C Relative Humidity 25% ~ 80%, Non-Condensing Atmospheric Pressure, Max. Altitude 700hPa ~ 1060hPa, 3,000m Ambient Temperature
-20C ~ +55C Storage / Shipping Relative Humidity 25% ~ 93%, Non-Condensing Atmospheric Pressure, Max. Altitude Safety 700hPa ~ 1060hPa, 3,000m Type of protection Internal-Power Type, 3.8 VDC / 2,800 h against electric shock Type BF Applied Parts Degree of protection Non-continuous operation Operating mode: 1:2 duty cycle (ON: 5 min / OFF: 10 min) against electric shock Hand-Held Type Degrees of protection against harmful liquid IPX1 Degree of safety of The equipment is not suitable for use in the presence of 2022. 03. 58 / 96 Doc # : BN-SM-EOP-01 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 7.0 or above, Windows System. Element 192 Dimension & Weight 159 69 29, 250g Array Type Probe Type Mode Frequency Depth Electronic array R60 / L40 Convex array probe, Linear array probe B, B/M, Color, PDI, PW 3.2/5 Convex, 7.5/10 Linear Convex 90~305, Linear 20~80 Measurement
[For Obstetrics] GA(CRL), GA(BPD), GA(GS), GA(FL),
[Common] Length, Area, Angle, Velocity, HR, S/D, Depth GA(HC), GA(AC), EFW(BPD), EFW(FL) Abdomen, Obstetrics, Gynecology, Peripheral Vessel, Application Superficial Organ Image Frame Rate 18f/s Battery Operation Time 2.5 hours Charging Mode Wireless Charging 2022. 03. 59 / 96 Doc # : BN-SM-EOP-01 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 Bionet/S.Korea 2022. 03. 60 / 96 Doc # : BN-SM-EOP-01 Rev.1.01 A-3. H5C & H10L <Common>
Complied Standard EN/IEC 60601-1:2012 Medical electrical equipment Part 1: General requirements for basic safety and essential performance, BF, Non-continuous operation EN/IEC 60601-2-37:2015 Medical Electrical Equipment Part 2-37: Particular Requirements for the Basic Safety and Essential Performance of Ultrasonic Medical Diagnostic and EN/IEC 60601-1-2:2014 Electromagnetic Compatibility Requirement and tests, Monitoring Equipment Class A Circumstance Operation Ambient Temperature 5C ~ +35C Relative Humidity 25% ~ 80%, Non-Condensing Atmospheric Pressure, Max. Altitude 700hPa ~ 1060hPa, 3,000m Ambient Temperature
-20C ~ +55C Storage / Shipping Relative Humidity 25% ~ 93%, Non-Condensing Atmospheric Pressure, Max. Altitude Safety 700hPa ~ 1060hPa, 3,000m Type of protection Internal-Power Type, 3.8 VDC / 5,600 h against electric shock Type BF Applied Parts Degree of protection Non-continuous operation Operating mode: 1:2 duty cycle (ON: 5 min / OFF: 10 min) against electric shock Hand-Held Type Degrees of protection against harmful liquid IPX1 Degree of safety of The equipment is not suitable for use in the presence of 2022. 03. 61 / 96 Doc # : BN-SM-EOP-01 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 Tablet PC or Mobile Phone which supports by iOS 8.0 or above, Android OS 7.0 or above, Windows System. Description Element Mode 192 B, B/M, Color, PDI, PW Measurement
[For Obstetrics] GA(CRL), GA(BPD), GA(GS), GA(FL),
[Common] Length, Area, Angle, Velocity, HR, S/D, Depth GA(HC), GA(AC), EFW(BPD), EFW(FL) Abdomen, Obstetrics, Gynecology, Peripheral Vessel, Application Superficial Organ Image Frame Rate 18f/s Battery Operation Time 5.0 hours Charging Mode USB Charging Supported Device Brand SAMSUNG, HUAWEI, MI / Apple Equipment name Specific low power wireless device (Wireless device for wireless data communication system) Manufacturer/Country Bionet/S.Korea 2022. 03. 62 / 96 Doc # : BN-SM-EOP-01 Rev.1.01 A-3. H5C & H10L < Difference among devices >
Dimension Array Type Probe Type Frequency Depth Dimension Array Type Probe Type Frequency Depth Application Abdomen, Obstetrics, Gynecology H5C 160 70 23, 250g Electronic array R60 Convex probe 3.2/5 90~305 H10L 160 64 23, 200g Electronic array L40 Linear probe 7.5/10 20~100 Application Peripheral Vessel, Superficial Organ 2022. 03. 63 / 96 Doc # : BN-SM-EOP-01 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 5C B Mode 2022. 03. 64 / 96 Doc # : BN-SM-EOP-01 Rev.1.01 IEC 60601-2-37:2007 +AMD1:2015 CSV IEC 2015 MODE 5C B + M Mode 2022. 03. 65 / 96 Doc # : BN-SM-EOP-01 Rev.1.01 IEC 60601-2-37:2007 +AMD1:2015 CSV IEC 2015 MODE 5C B + Color / B + PDI Mode 2022. 03. 66 / 96 Doc # : BN-SM-EOP-01 Rev.1.01 IEC 60601-2-37:2007 +AMD1:2015 CSV IEC 2015 MODE 5C PW Mode 2022. 03. 67 / 96 Doc # : BN-SM-EOP-01 Rev.1.01 IEC 60601-2-37:2007 +AMD1:2015 CSV IEC 2015 MODE 10L B Mode 2022. 03. 68 / 96 Doc # : BN-SM-EOP-01 Rev.1.01 IEC 60601-2-37:2007 +AMD1:2015 CSV IEC 2015 MODE 10L B + M Mode 2022. 03. 69 / 96 Doc # : BN-SM-EOP-01 Rev.1.01 IEC 60601-2-37:2007 +AMD1:2015 CSV IEC 2015 MODE 10L B + Color / B + PDI Mode 2022. 03. 70 / 96 Doc # : BN-SM-EOP-01 Rev.1.01 IEC 60601-2-37:2007 +AMD1:2015 CSV IEC 2015 MODE 10L PW Mode 2022. 03. 71 / 96 Doc # : BN-SM-EOP-01 Rev.1.01 IEC 60601-2-37:2007 +AMD1:2015 CSV IEC 2015 MODE 14L B Mode 2022. 03. 72 / 96 Doc # : BN-SM-EOP-01 Rev.1.01 IEC 60601-2-37:2007 +AMD1:2015 CSV IEC 2015 MODE 14L B + M Mode 2022. 03. 73 / 96 Doc # : BN-SM-EOP-01 Rev.1.01 IEC 60601-2-37:2007 +AMD1:2015 CSV IEC 2015 MODE 14L B + Color / B + PDI Mode 2022. 03. 74 / 96 Doc # : BN-SM-EOP-01 Rev.1.01 IEC 60601-2-37:2007 +AMD1:2015 CSV IEC 2015 MODE 14L PW Mode 2022. 03. 75 / 96 Doc # : BN-SM-EOP-01 Rev.1.01 IEC 60601-2-37:2007 +AMD1:2015 CSV IEC 2015 MODE 5CB B Mode 2022. 03. 76 / 96 Doc # : BN-SM-EOP-01 Rev.1.01 IEC 60601-2-37:2007 +AMD1:2015 CSV IEC 2015 MODE 5CB B + M Mode 2022. 03. 77 / 96 Doc # : BN-SM-EOP-01 Rev.1.01 IEC 60601-2-37:2007 +AMD1:2015 CSV IEC 2015 MODE 10LB B Mode 2022. 03. 78 / 96 Doc # : BN-SM-EOP-01
1 | User Manual2 | Users Manual | 3.23 MiB | May 18 2022 |
Rev.1.01 IEC 60601-2-37:2007 +AMD1:2015 CSV IEC 2015 MODE 10LB B + M Mode 2022. 03. 79 / 96 Doc # : BN-SM-EOP-01 Rev.1.01 These data are acquired through the test report of IEC 60601-2-37. IEC 60601-2-37:2007 +AMD1:2015 CSV IEC 2015 MODE H5C10L(C) B Mode 2022. 03. 80 / 96 Doc # : BN-SM-EOP-01 Rev.1.01 IEC 60601-2-37:2007 +AMD1:2015 CSV IEC 2015 MODE H5C10L(C) B + M Mode 2022. 03. 81 / 96 Doc # : BN-SM-EOP-01 Rev.1.01 IEC 60601-2-37:2007 +AMD1:2015 CSV IEC 2015 MODE H5C10L(C) B + Color / B + PDI Mode 2022. 03. 82 / 96 Doc # : BN-SM-EOP-01 Rev.1.01 IEC 60601-2-37:2007 +AMD1:2015 CSV IEC 2015 MODE H5C10L(C) PW Mode 2022. 03. 83 / 96 Doc # : BN-SM-EOP-01 Rev.1.01 IEC 60601-2-37:2007 +AMD1:2015 CSV IEC 2015 MODE H5C10L(L) B Mode 2022. 03. 84 / 96 Doc # : BN-SM-EOP-01 Rev.1.01 IEC 60601-2-37:2007 +AMD1:2015 CSV IEC 2015 MODE H5C10L(L) B + M Mode 2022. 03. 85 / 96 Doc # : BN-SM-EOP-01 Rev.1.01 IEC 60601-2-37:2007 +AMD1:2015 CSV IEC 2015 MODE H5C10L(L) B + Color / B + PDI Mode 2022. 03. 86 / 96 Doc # : BN-SM-EOP-01 Rev.1.01 IEC 60601-2-37:2007 +AMD1:2015 CSV IEC 2015 MODE H5C10L(L) PW Mode 2022. 03. 87 / 96 Doc # : BN-SM-EOP-01 Rev.1.01 These data are acquired through the test report of IEC 60601-2-37. IEC 60601-2-37:2007 +AMD1:2015 CSV IEC 2015 MODE H5C B Mode 2022. 03. 88 / 96 Doc # : BN-SM-EOP-01 Rev.1.01 IEC 60601-2-37:2007 +AMD1:2015 CSV IEC 2015 MODE H5C B + M Mode 2022. 03. 89 / 96 Doc # : BN-SM-EOP-01 Rev.1.01 IEC 60601-2-37:2007 +AMD1:2015 CSV IEC 2015 MODE H5C B + Color / B + PDI Mode 2022. 03. 90 / 96 Doc # : BN-SM-EOP-01 Rev.1.01 IEC 60601-2-37:2007 +AMD1:2015 CSV IEC 2015 MODE H5C PW Mode 2022. 03. 91 / 96 Doc # : BN-SM-EOP-01 Rev.1.01 IEC 60601-2-37:2007 +AMD1:2015 CSV IEC 2015 MODE H10L B Mode 2022. 03. 92 / 96 Doc # : BN-SM-EOP-01 Rev.1.01 IEC 60601-2-37:2007 +AMD1:2015 CSV IEC 2015 MODE H10L B + M Mode 2022. 03. 93 / 96 Doc # : BN-SM-EOP-01 Rev.1.01 IEC 60601-2-37:2007 +AMD1:2015 CSV IEC 2015 MODE H10L B + Color / B + PDI Mode 2022. 03. 94 / 96 Doc # : BN-SM-EOP-01 Rev.1.01 IEC 60601-2-37:2007 +AMD1:2015 CSV IEC 2015 MODE H10L PW Mode 2022. 03. 95 / 96 Doc # : BN-SM-EOP-01 Rev.1.01 PRODUCT WARRANTY Brand Name SonoMe Product Name Wireless Probe Series Ultrasound Scanner Model Name 5C, 10L, 14L, 5CB, 10LB, H5C10L, H5C, H10L Hospital Name :
Address :
Name :
Phone :
Approval Number Approval Date Serial Number Warranty Period Date of Purchase Customer Section Sales Agency Manufacturer inspection. Thank you for purchasing SonoMe The product is manufactured and passed through strict quality control and through Compensation standard concerning repair, replacement, refund of the product complies with Consumers Protection Law noticed by Korea Fair Trade Commission.
- End of Document -
2022. 03. 96 / 96 Doc # : BN-SM-EOP-01
1 | User Manual3 | Users Manual | 3.56 MiB | May 18 2022 |
SONOFINDER Wireless Mobile Diagnostic Ultrasound System User Manual SF14L25 Rev. 1.01 2022-03-24 Copyright 2021 By SONOFINDER CO., LTD. All rights reserved Rev.1.01 Revision History Revision Rev.1.00 Rev.1.01 Date Reason for Change 2021-08-12 Initial Release 2022-03-24 Add of FCC warning & Logo 2022. 03.
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Doc # : BN-SF-EOP-01 Rev.1.01 Table of Contents Chapter 1. Introduction 6 1.1 Safety Symbols 7 1.2 Intended use 8 1.3 Guidelines for Safe Usage 8 1.4 Contraindications 8 1.5 Precautions & Warnings for Use 8 Chapter 2. Preparing for Use 11 2.1 Unpacking 11 2.1.1 SF14L25 12 2.1.2 Application for each probe 12 2.2 How to Install App 12 2.3 Using Probe 13 2.3.1 Visual Inspection 13 2.3.2 Cleaning Probe 13 2.3.3 Booting 13 2.4 Wireless Connection 14 Chapter 3. Using SONOFINDER 15 3.1 Basic Information & B Mode 15 3.2 Basic Mode 17 3.2.1 M Mode 17 3.2.2 Color Doppler Imaging Mode 18 3.2.3 Power Doppler Imaging Mode 19 3.2.4 PW(Pulse Wave) Spectral Doppler Mode 20 3.3 Patient Information 21 3.4 Measurement 22 3.4.1 Basic Measurement 22 2022. 03. 3 / 57 Doc # : BN-SF-EOP-01 Rev.1.01 3.4.2 Heart Rate Measurement 25 3.5 Report 26 3.6 Storage & Review 27 3.6.1 Image Storage 27 3.6.2 Video Storage 27 3.6.3 Review image & Video 27 3.7 Change Wi-Fi Channel 28 Chapter 4. Maintenance 29 4.1 Charging Probe 29 4.1.1 USB Charging 29 4.2 Cleaning and Disinfecting Probes 30 4.3 Storage 30 4.4 Troubleshooting 30 4.5 Disposal 31 4.6 Maintenance & Protection 31 4.7 Contact 32 Chapter 5. Biopsy 33 5.1 Biopsy Components 33 5.2 Biopsy Procedure 34 5.3 Needle Guideline Alignment 35 5.4 Biopsy Specification 36 Chapter 6. Safety 37 6.1 Important Safety Considerations 37 6.1.1 Electrical Safety 37 6.1.2 Mechanical Safety 38 6.1.3 Probe Safety Precautions 38 6.1.4 Cyber Security 39 6.2 Acoustic Power Principle 40 6.2.1 Biological Safety 40 2022. 03. 4 / 57 Doc # : BN-SF-EOP-01 Rev.1.01 6.2.2 Thermal Index (TI) & Mechanical Index (MI) 40 6.2.3 Acoustic Power Statement 41 6.2.4 Acoustic Power Setting 43 6.2.5 ALARA 44 6.3 Electromagnetic Compatibilities 44 6.3.1 Electromagnetic Emission 44 6.3.2 Electromagnetic Immunity 45 6.3.3 Recommended Separation Distance 47 Appendix A. Specification 50 Appendix B. Acoustic Output Data 53 2022. 03. 5 / 57 Doc # : BN-SF-EOP-01 Rev.1.01 Chapter 1. Introduction SONOFINDER 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. SONOFINDER is highly integrated with ultrasound image processing, power management and a wireless signal provider to be connected by the main units. The main units different with traditional devices are now changed to be Tablet PC or Mobile Phone which supports by iOS, Android OS System. The probe acts as a Wi-Fi Access Point and can be connected by Tablet PC or Mobile Phone. With the probe be connected through Wi-Fi and the App is running, enjoy your days of working without the troubles made by cables. This manual is intended to provide a thorough overview of the SONOFINDER and should be carefully read before starting to operate the device.
[Figure 1-1] SONOFINDER App & Wireless Probes 2022. 03. 6 / 57 Doc # : BN-SF-EOP-01 1.1 Safety Symbols Rev.1.01 Symbols Description Symbols Description WARNING: Warnings to or damage to property prevent a serious accident, Manufacturing date Follow the User Manual Serial Number Type BF applied part
(Classification based on Direct Current(DC) degree of protection against Voltage source electric hazard) Dripping-proof device:
Protected against vertically prevent a minor accident or CAUTION: Precautions to falling water drops Non-ionizing damage to property The manufacturers name electromagnetic radiation and address are provided. The waste of electrical and electronic equipment must not be disposed as unsorted municipal waste and must be collected separately This way up: For the duration of shipping/
delivery, the carton should face upright Recycling: Dispose of properly in accordance with all state, province, and country regulations Use no hooks: Absolutely no hand hooks should be attached to pull the parcel Fragile: Handle with care Keep away from rain The Authorized European Representatives address is provided Federal Communications Commission logo 2022. 03. 7 / 57 Doc # : BN-SF-EOP-01 Rev.1.01 1.2 Intended use structures and fluids SONOFINDER is designed to obtain ultrasound images, measure and analyze anatomical 1.3 Guidelines for Safe Usage SONOFINDER 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. 1.4 Contraindications
This product must not be used for ophthalmological applications, or any other use that involves the ultrasound beam passing through the eyeball.
- Do not use this product in the following situations. Doing so may produce images with inaccurate results:
measured density. examining tissue Patients who have had surgery, which may have changed the composition of the examining tissue (for example, a mastectomy), as this could skew or alter the Patients whose bodies contain foreign artifacts (for example, implants), in the Endo-cavitary use: i.e., defined as introducing a scanner within a (body) cavity or organ. E.g. atrium, esophagus, rectum or vagina 1.5 Precautions & Warnings for Use Precautions:
- Keep this manual near the product and refer to it when using the product. Bionet is not responsible for any product issues caused by the users careless operation or negligence in maintenance.
The product must work in a clean environment, should avoid areas where moisture, 2022. 03. 8 / 57 Doc # : BN-SF-EOP-01
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. This product must only be used by persons who have sufficient knowledge of and/or a qualification in clinical pathology. Unqualified operators are prohibited from using the product. The product shall be repaired by professional recognized by Bionet. The product does not have shelf life. Its expected use life is 10 years. After 10 years, though the product still works normally, it is recommended to have it checked by
- Useless components must be disposed of in compliance with local regulations.
- Be careful when holding the device, for the device is handheld, it may fall.
The words Insufficient Storage Space will appear on the interface to remind the user to clean up space when storage space will be insufficient. Bionet. Warnings:
cause an explosion.
- Never use the product in the presence of flammable or anesthetic gas. Doing so may
- Do not allow the interior of the product to be exposed to, or immersed in, liquid. Otherwise, fire, electric shock, injury, or damage to the product may occur.
- Changes or Modifications not expressly approved by the party responsible could void the users authority to operate this device.
If the product 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 product and receiver. Connect the product into an outlet on a circuit different from that to which the receiver is connected. 2022. 03. 9 / 57 Doc # : BN-SF-EOP-01 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. 10 / 57 Doc # : BN-SF-EOP-01 Rev.1.01 Chapter 2. Preparing for Use FOR YOUR PROTECTION, please read safety instructions completely before turning the 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 power on 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. Items should be checked whether all ordered items have been received. The following table lists the items which should be received with each product.
[Table 2-1] Item List SF14L25 Remarks List Probe User Manual USB Cable (1m) Quick Guide Pouch Strap Wireless Charger Needle Guide
Micro 5pin Check the item damage or defects (e.g. cracks, broken parts, liquid leaks, sharp edges, etc.). If there is any damage or defects, stop using the probe immediately and contact Bionets Customer Service Department. 2022. 03. 11 / 57 Doc # : BN-SF-EOP-01 2.1.1 SF14L25 Rev.1.01
[Figure 2-1] SF14L25
1 2 3 Items Descriptions Power On/Off & Freeze Power ON/OFF : Press button for about 5 sec. Freeze : Press button for about 1 sec. Wireless Signal Status Show Wireless Signal Status Battery Level Indicator Indicate Battery Level 2.1.2 Application for each probe Probe Application SF14L25 Thyroid, Small Parts, Pediatrics, Vascular, Carotid, Breast, MSK, Nerve 2.2 How to Install App Download the SONOFINDER app via Google Play Store or Apple App Store depending on user Tablet PC or Mobile Phone OS. 2022. 03. 12 / 57 Doc # : BN-SF-EOP-01 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 Warning 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 Bionets Customer Service Department. 2.3.2 Cleaning Probe Cleaning and disinfection. All probes must be cleaned and disinfected after each use. Refer to Chapter 4.2. Probes that have not been cleaned or disinfected may cause bacterial and viral infections 2.3.3 Booting Please check the following before scanning 1. The probe should not be abnormally heated during use. If the temperature of the probe is much higher than body temperature, or the surface temperature of the probe exceeds 40 C, the probe is stopped Do not use the probe which is heated abnormally to patient, as it may burn patients skin 2. After turning on the power, check whether the functions of ultrasound image, app, button, etc. are working properly. 2022. 03. 13 / 57 Doc # : BN-SF-EOP-01 Rev.1.01 Warning If there are any of the above problems, there may be a problem with the product, so please contact Bionets 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. (Refer to chapter
The wireless signal indicator flashes after a few seconds after turning on the probe. This lets you know that the probe is ready to connect with your tablet PC 4 for how to charge) or mobile phone.
The probe can be turned off by holding the power button down for about 5 seconds. When the probe is turned off, all indicators (wireless signal status and battery level) are turned off, too. 2.4 Wireless Connection If the probe is ready for wireless connection as described previously, turn on Wi-Fi (if not turned on) in the settings of your tablet PC or mobile phone, and find the SSID of the probe. The SSID is something like "SX-xxxxxxx000 (X=uppercase, x=lowercase, 0=number)". Before connecting, check that the last 7 digits of the 11-digit ID written on the back of the probe match the last 7 digits of the SSID. When connecting for the first time, you need to enter a password, which is a total of 11 digit ID written on the back of the probe. After Wi-Fi is connected, launch the SONOFINDER app. When the app confirms the connection with the probe, the wireless signal indicator on the probe stops blinking. When the connection is complete, start to Scan. 2022. 03. 14 / 57 Doc # : BN-SF-EOP-01 Rev.1.01 Chapter 3. Using SONOFINDER 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. The higher the value, the smoother the displayed image. 6. Harmonic: Optimize image using various frequency 7. Reject: Reduces noise or echoes from an image to make the image clearer 8. Image mode : B Mode, B/M Mode, Color Mode, PDI Mode, PW Mode 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. 2022. 03. 15 / 57 Doc # : BN-SF-EOP-01 Rev.1.01 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. (Image) Save: Save an image 17. (Video) Save: Save a Video 18. Preset (Setting): Select Wi-Fi Channel to avoid channel blocking 19. TGC: Adjust the Gain based on the depth (When you click that area, you can find a TGC menu) 2022. 03. 16 / 57 Doc # : BN-SF-EOP-01 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. 17 / 57 Doc # : BN-SF-EOP-01 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 Interest) box 4. Move, Zoom: Use the finger to change the location and size of ROI(Region of 2022. 03. 18 / 57 Doc # : BN-SF-EOP-01 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 Interest) box 4. Move, Zoom: Use the finger to change the location and size of ROI(Region of 2022. 03. 19 / 57 Doc # : BN-SF-EOP-01 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. 20 / 57 Doc # : BN-SF-EOP-01 Rev.1.01 3.3 Patient Information Figure 3-6. When you press PATIENT( ) button, you can see a Patient Information Menu as
[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. 21 / 57 Doc # : BN-SF-EOP-01 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 be measured automatically. Choose LENGTH. Use the Finger and Set to specify both end points of the measurement area. Specify both end points and then the distance between them will If the color of both end points is green, you can move or change but if white, complete to measure and cannot move or change. 2022. 03. 22 / 57 Doc # : BN-SF-EOP-01 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. Draw a straight line at first(Please refer to LENGTH). Specify 3rd point and then measure the angle formed by the points automatically. When you click the one of 3 points, you can adjust the 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. TRACE 2022. 03. Measure the area of an irregularly shaped object. Choose TRACE. Set to specify the starting point for tracing on the contour of the 23 / 57 Doc # : BN-SF-EOP-01 Rev.1.01 area to be measured. Trace the curve so that the measurement point returns to the start point. And then you can see the area will be measured automatically Note Measurement for GA (CRL), GA (BPD), GA (GS), GA (FL), GA (HC), GA (AC) is ONLY available to obstetrics application The above measurement functions can be fine-tuned using the on-screen virtual trackball. The virtual trackball(please refer to bottom-right corner in Figure 3-9) can be fine-tuned according to the direction of the measurement point. Up to 4 measurements can be compared at the same time. Delete all measurements using Clear(X) button. When you want to delete one specific measurement, select that measurement and then you can see green column as Figure 3-10. After pressing button, you can delete.
[Figure 3-10] Delete specific measurement 2022. 03. 24 / 57 Doc # : BN-SF-EOP-01 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. 25 / 57 Doc # : BN-SF-EOP-01 Rev.1.01 When you press PATIENT( ) button, you can see a Report button at bottom-right in Patient Information Menu as Figure 3-12. 3.5 Report
[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. The report is automatically saved to your phone or tablet's photo album. 2022. 03.
[Figure 3-13] Report 26 / 57 Doc # : BN-SF-EOP-01 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 3.6.2 Video Storage As shown in Figure 3-14, if you select Save Video ( ) at the bottom-right of the App screen, the saved video is automatically saved in the photo album of your phone or tablet PC within 100 seconds. 3.6.3 Review image & Video Open the photo album on your phone or tablet and view the saved images and videos. 2022. 03. 27 / 57 Doc # : BN-SF-EOP-01 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. 28 / 57 Doc # : BN-SF-EOP-01 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. When charging is complete, remove the USB cable and then put the rubber cover into the USB charging port to avoid liquid and device damage.
[Figure 4-1] Probe Charging via USB Cable 2022. 03. 29 / 57 Doc # : BN-SF-EOP-01 Rev.1.01 4.2 Cleaning and Disinfecting Probes All probes must be cleaned and disinfected before and after each use. Use a soft cloth or appropriate cleaning sheet, lightly dampened with Isopropyl alcohol (or proper cleaner), to remove any foreign substances left on the probe, the edges, corners, and curved parts of the probes. Dry the probe with a clean, soft cloth. Alternatively, dampen a soft cloth in a glutaraldehyde-based hospital disinfectant solution such as Cidex. Wipe the probe with a dampened cloth. If still wet or left a stain, wipe with a clean water-dampened cloth. Before use, dry the probe completely with clean, soft cloth. 4.3 Storage When not in use, it is recommended to put the probe in its case. During storage, the 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 tablet) 2022. 03. 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 ready or not. Check whether Wi-Fi signal channel is Check whether Wi-Fi password is correct or not. 30 / 57 Doc # : BN-SF-EOP-01 3 4 Rev.1.01 Displayed on the screen with noise started which cause electromagnetic and interference like snow interference. If so, shut down the Check whether other equipment device or get far from the device. The brightness of image is not enough Adjust the brightness and gain Check whether the USB interface, 5 Charging is NOT work circuit and electrical outlet are damaged or not. 4.5 Disposal Warning 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. If the product is not used for a long time, charge it at least 2 times a week for at 4. Do not tamper with the probe cover to clean or disassemble the components inside least 1 hour. the probe. 5. Clean the cover with alcohol-cotton after turning off. 6. This product should not be started up and shut down too often. If you need to restart, wait at least 1 minute for booting after shutdown. 7. If any problem is happened, stop using the device and contact Bionets Customer 31 / 57 Doc # : BN-SF-EOP-01 2022. 03. Rev.1.01 Service department. 8. Since the probe is vulnerable to external impact, collision or falling is prohibited. 9. If you want to pause during scanning, use the Freeze function. In freeze status, the device can be kept on standby for a long time. 10. Only use the appropriate ultrasound gels for medical standard. 11. The probe is waterproof but, do not immerse the probe in conductive liquid to 12. Check for cracks regularly to avoid liquid immersion and damage of internal minimize corruption. components. 13. Refer to chapter 4.2 about how to clean and disinfect. 14. To maintain the performance and safety of the system, regular electrical and mechanical safety inspections of the system must be performed by professional technicians in less than six months. 15. Excessive shocks, such as a fall, may seriously damage the product. In this case, contact Bionets Customer Service Department for maintenance and repair. 4.7 Contact Headquarters & International Sales & service 51, Dolma-ro, Bundang-gu, Seongnam-si, Gyeonggi-do, SONOFIDNER Co., Ltd.:
13615, Republic of Korea Tel: +82-31-602-1772~3/ Fax: +82-31-602-1771/ E-mail: info@sonofinder.com 2022. 03. 32 / 57 Doc # : BN-SF-EOP-01 Rev.1.01 Chapter 5. Biopsy 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. Warning
- An ultrasound examination that requires the use of a biopsy components must be performed by a physician or other certified, skilled healthcare professional. Make sure that you take preventative safety measures and ensure sterilization in all environments.
- Do not use the biopsy components for ultrasonographic studies for other purposes, such as human anatomical dissection.
- The user will be responsible for using the biopsy components for ultrasonographic studies.
- Please be sure to read the User Manual thoroughly. 5.1 Biopsy Components The biopsy consists of the needle guide and needle.
[Figure 5-1 Biopsy Components]
- Needle Guide: Secures the needle guide to the probe tightly and guides the angle of the needle so that it may reach the biopsy target accurately.
- Needle: This is the needle that is inserted into the patients body. The item supplied by Bionet does not contain a needle. 2022. 03. 33 / 57 Doc # : BN-SF-EOP-01 Rev.1.01
- 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. For more information about conducting ultrasonographic studies using the needle and the needle guide, contact the manufacturers. Ensure that the biopsy components you are using is compatible with only 14L. Warning Caution Warning
- The needle guides not supplied by Bionet may not be compatible with the probes.
- Use Bionet-approved biopsy components only. Improper installation may adversely
- Be sure to read the instructions for installing and aligning the needle guide thoroughly before performing a biopsy.
- Always ensure that the probe and the needle guide are secured on both the left affect the patient. and the right sides. 5.2 Biopsy Procedure The system generates a needle guideline through the displayed real-time ultrasound images to indicate the anticipated path of the needle. Use this guideline to ensure that the needle or other instrument follows the correct path. Ready the patient according to the procedure appropriate for the examination objectives. Install the needle guide. Set the system controls for the biopsy procedure. If necessary, apply acoustic gel 2022. 03. 34 / 57 Doc # : BN-SF-EOP-01 Rev.1.01 Scan the patient. Adjust the patient so that the location for examination fits into to the patient. the needle guideline on the screen. 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. To prevent the needle from shaking, press down on the top of the needle guide with your index finger during examinations. When the examination site is reached, take the needle out of the needle guide. Detach the needle guide from the probe. Dispose of the needle and the guide that are not designed for reuse Caution Dispose of non-reusable components according to infectious waste regulations 5.3 Needle Guideline Alignment Alignment of the needle guide displayed on the system is for the purpose of verifying whether the needle and the needle guide are properly installed. This must be done prior to biopsy. If the needle fails to follow an accurate path while verifying the alignment of needle guide, stop using the product and contact Bionet. Reverberation or other tissue artifacts may produce false needle images on the screen. Ensure that the needle path is along the guideline and that you are not using a false needle image to locate the needle. Warning
- The needle used for alignment verification must not be used for the actual procedure. Always use a sterile needle for each biopsy procedure.
- To assist in accurate projection of the needle, use a straight, new needle for each alignment procedure.
- The needle guideline only displays the projected path of the needle. Since the default line may be different from the actual line, the actual location of the needle 2022. 03. 35 / 57 Doc # : BN-SF-EOP-01 Rev.1.01 must be checked by monitoring the echo from the needle. Attach the biopsy components. Set the system depth for the procedure to be performed and select the Biopsy Immerse the probe into the water bath and insert the needle into the needle guide. Confirm that the needle image is on the needle guidelines. If it is, then the needle menu. guide is properly aligned. check the needle guide. If the needle image displayed on the screen is outside of the needle guide lines, 5.4 Biopsy Specification Components Needle gauge Multi Depth Biopsy Reusable/
Disposable Disposable 21 1, 1.5, 2 () Probes SF14L25
- Needle Guide
- Needle 2022. 03. 36 / 57 Doc # : BN-SF-EOP-01 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 SONOFINDER. 6.1 Important Safety Considerations Read the following safety instruction before using SONOFINDER. 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. Periodically review operating procedures and safety precautions. 6.1.1 Electrical Safety
- The biocompatibility has been verified so that it does not harm users or patients under normal circumstances
- Never attempt to modify the product in any way.
- The battery is a consumable and will lose performance over time. If the battery life becomes less than 2 hours, it is time for a replacement. When you want to purchase or replace a battery, please contact Customer Service Department.
- Warning: Class I The product must be connected to a power supply with a protective earth to prevent electric shock.
- Do not pour liquids on the system surface. Liquids seeping into electrical circuits can cause excessive leakage currents or system failure. If water is unavoidably poured into the system, immediately stop using the system and contact a Customer Service Department.
- Use only probes provided by the manufacturer. Otherwise, the system will not work and the worst accidents such as fire may occur.
- The system that are not maintained may not be used on patients. 2022. 03. 37 / 57 Doc # : BN-SF-EOP-01 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:
cause an explosion. of electric shock electric shock.
- 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.
- Always use application-specific probes in order to obtain the best quality images.
- Never use the product in the presence of flammable or anesthetic gas. Doing so may
- Do not use the system simultaneously with other equipment such as electric knives, defibrillators, and other high-frequency therapy equipment. Otherwise, there is a risk
- Keep the system dry and do not transport to sites with rapid environment changes to avoid short circuits caused by condensation or water droplets.
- The product must be connected to a power supply with a protective earth to prevent
- After reading the manual thoroughly, set and control the acoustic power level. 6.1.2 Mechanical Safety
- Be careful when holding the device, for it is handhold, it may fall.
- Do not use shell cracking equipment. 6.1.3 Probe Safety Precautions
- Please only use the ultrasound gels sold legally. Always follow the instructions in the User Manual. To prevent contamination, use and take care of ultrasound gel properly. Warnings:
Warnings:
- Disconnect the probe from the system after freezing the image or turning the system down. Otherwise, the system or probe may be damaged. 2022. 03. 38 / 57 Doc # : BN-SF-EOP-01 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. 6.1.4 Cyber Security
- Backup the database regularly to avoid loss or damage of the database.
The probe can connect to Tablet PC or Smart Phone via local wireless network. The software itself cannot connect to external network. The network which is connected to the software is a local wireless network connected by the probe.
If there are any software bugs during use, users can give feedback through Bionet e-
mail account(sales@ebionet.com) and the Bionet will analyze and fix the bug, and if an update is required, the user will be notified of it by posting on the website or e-
mail. 2022. 03. 39 / 57 Doc # : BN-SF-EOP-01 Rev.1.01 6.2 Acoustic Power Principle
- 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 Warnings:
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. Take special care to the fetal whose bones are growing. 6.2.1 Biological Safety Ultrasound waves may have damaging effects on cells and, therefore, may be harmful to the patient. If there is no medical benefit, minimize the exposure time and maintain the ultrasound wave output level at a low setting. Please refer to the ALARA principle. 6.2.2 Thermal Index (TI) & Mechanical Index (MI) The system output display comprises two basic indices: a thermal index (TI) and a mechanical index (MI). These shows on the Right-Top side on the app.
- Meaning of MI & TI Mechanical bioeffects are threshold phenomena that occur when a certain level of output is exceeded. The threshold level varies, however, with the type of tissue. The MI accounts for these two factors. The higher the MI value, the greater the likelihood of mechanical bioeffects occurring. However, there is no specific MI value that means that a mechanical effect will occur. The MI should be used as a guide for implementing the ALARA principle. The TI informs the user of the potential for temperature increase occurring at the body surface, within body tissue, or at the point of focus of the ultrasound beam on bone. The TI is an estimate of the temperature increase in specific body tissues. The actual amount of any temperature rise is influenced by factors such as tissue type, vascularity, and mode of operation. The TI should be used as a guide for implementing the ALARA principle. Depending on the examination and type of tissue 2022. 03. 40 / 57 Doc # : BN-SF-EOP-01 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. The cranial bone thermal index (TIc) : the user about the potential heating of bone at or near the surface, for example, the cranial bone.
- Mechanical and Thermal Indices Display Precision and Accuracy 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 Mechanical and Thermal Indices on the system are precise to 0.1 units. 6.2.3 Acoustic Power Statement 6.2.3.1 Acoustic Measurement Precision and Uncertainty When estimating accuracy of displayed numerical values, many factors are considered:
The Probe Changeability 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 6.2.3.2 Differences between Actual and Displayed MI and TI For many assumptions used in the process of measurement and calculation, they actually are conservative. For most organizations path, high estimate is made in the measurement and calculation process of tissue exposure intensity. For example, using attenuation coefficient 0.3 -1 -1 much lower than the actual human tissue 2022. 03. 41 / 57 Doc # : BN-SF-EOP-01 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. 6.2.3.3 Uncertainty of Measurement Sound pressure is the most basic data of sound field measurement, and other sound field parameters can be deduced from sound pressure, so when analyzing measurement uncertainty, only take sound pressure for analysis and uncertainty of other parameters can be deduced from the sound pressure. Measurement uncertainty mainly include repeated measurement uncertainty and the system uncertainty, the system uncertainty is an order of magnitude higher than repeated measurement uncertainty, so the main analysis is the system uncertainty. Mainly decided by the following factors:
1) The sensitivity of hydrophone: According to hydrophone calibration report provided by ONDA company, the maximum allowable error of sound pressure for 2) Scope: according to Agilent DSO6502A specifications, its effect on the sound hydrophone is 12%
pressure is 2%
3) Temperature: effect of the thermocouple on sound pressure error is 4%
Above all uncertainty components are not related, synthetic standard uncertainty of sound pressure is 13%
6.2.3.4 Operator Control Property There are several system controls that the operator can use to adjust the image quality and limit the acoustic intensity. These controls are related to the techniques that an operator might use to implement ALARA and can be divided into three categories: direct, indirect, and receiver controls 2022. 03. 42 / 57 Doc # : BN-SF-EOP-01 Rev.1.01 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
- Direct Controls 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 non-
scanning. Thermal effect is closely connected to M Mode, PW and Color Mode. Acoustic attenuation of tissue is directly related to transducer frequency. The focal point number and position is related to active aperture of transducer and beam width. For the pulse repetition frequency (PRF), the higher the PRF, the more acoustic output power increased over a period of time.
- Receiver Controls 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. When acquiring images, it is recommended to use the default (or as low as possible) acoustic output location and use the gain control to compensate. The default setting is commonly 70% of maximum allowed acoustic output value, which will not cause harm to the operator, and for the probe is the most effective value. 6.2.4 Acoustic Power Setting The ultrasound system has been preset the parameters for each exam mode with different probes before shipment. When the ultrasound system is powered on, a new 2022. 03. 43 / 57 Doc # : BN-SF-EOP-01 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. The output intensity necessary for examinations differs depending on the patient and clinical case. Not all examinations can be performed with an extremely low level of acoustic energy. Controlling the acoustic level at an extremely low-level leads to low-quality images or insufficient Doppler signals, adversely affecting the reliability of the diagnosis. However, the sound power which is used greater than the actual needs does not contribute to improving the quality of diagnostic information either, it will increase the risk of biological effects. The operator must take responsibility for the safety of patients. 6.3 Electromagnetic Compatibilities Electromagnetic compatibilities are the abilities of the system or equipment to operate normally in the electromagnetic environment and not to radiate any electromagnetic interruptions to any other objects which are in the same environment. This system is designed in accordance with the current EMC requirement. And the ultrasound image will degrade instantly if the system is used in the electromagnetic field environment. If the degradation of the image is found, it is recommended to inspect the operation environment to confirm the radiation source. 6.3.1 Electromagnetic Emission This product is intended for use in the electromagnetic environment specified below. Users should make sure that the product is being used in such an environment. 2022. 03. 44 / 57 Doc # : BN-SF-EOP-01 Rev.1.01 Guidance and Manufacturers 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 Compliance Emission Test Electromagnetic environment -
guidance RF CISPR 11 Group1, The Ultrasound System uses RF energy Emission EN 55011 Class A for its internal functions only. Therefore, RF CISPR 11 Group1, The Ultrasound System is suitable for Emission EN 55011 Class A use in all establishments, including its RF emissions are very low and are not likely to cause any interference in nearby electronic equipment. domestic establishments and those directly connected to the public low-
voltage power supply network that supplies buildings used for domestic purposes. Harmonic IEC 61000-
Class A Emission 3-2 EN 61000-
3-2 Flicker IEC 61000-
Pst: 1 Emission 3-3 Plt: 0.65 EN 61000-
Tmax:0.5 3-3 dmax: 4%
dc: 3.3%
6.3.2 Electromagnetic Immunity Guidance and Manufacturers Declaration Electromagnetic Immunity The Wireless Probe Series Ultrasound Scanner is intended for use in the electromagnetic environment specified below. The customer or the user of the Wireless Probe Series Ultrasound Scanner should assure that it is used in such an environment. Type Immunity Compliance Electromagnetic environment -
Test Level guidance Electrostatic discharge
(ESD) IEC 61000-
4-2 EN 61000-
8 kV/Contact Floors should be wood, concrete or ceramic tile. If floors are covered with synthetic material, the relative humidity 2022. 03. 45 / 57 Doc # : BN-SF-EOP-01 Rev.1.01 4-2 2, 4, 8, should be at least 30%. 15 kV/Air 3V/m 80 -
2.7 80% AM at 1, 2 Table #9 at IEC 60601-1-
2: 2014 RF Electromag netic Immunity Near Field Immunity for RF Wireless Communica tion Equipment IEC 61000-
4-3 4-3 EN 61000-
IEC 61000-
4-3 4-3 EN 61000-
The field strength outside the shielded location from the fixed RF transmitter as determined by electromagnetic field survey should be less than 3V/m. Interference may occur in the vicinity of equipment marked with the following symbol:
Electrostatic IEC 61000-
2 kV, 100 transient 4-4 k burst EN 61000-
Repeated The quality of the mains power must be that of a typical commercial or hospital 4-4 Frequency environment. Surge IEC 61000-
(Wire to 4-5 Wire) EN 61000-
0.5 kV, 1 4-5 kV The quality of the mains power must be that of a typical commercial or hospital environment. Conducted IEC 61000-
3V The Ultrasound System is designed for RF 4-6 0.15 - 80 use in electromagnetic environments EN 61000-
where radiated RF disturbances are 4-6 controlled. Customers or users of the V in ISM ultrasonic scanner series can avoid bands electromagnetic interference by between maintaining a minimum distance. It can 0.15 and be used between portable and mobile RF 80 communication equipment (transmitter) and ultrasonic scanner series depending 80% AM at 1 on the maximum power of the 46 / 57 Doc # : BN-SF-EOP-01 2022. 03. Rev.1.01 k, 2 communication equipment as recommended below. Power IEC 61000-
30 A/m Frequency 4-8 50 and Magnetic EN 61000-
60 Field 4-8 Iunity Power frequency magnetic fields should be at levels characteristic of a typical location in a typical commercial or hospital environment. 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. If the user of the Wireless 4-11 90, 135, Probe Series Ultrasound Scanner requires 180, 225, continued operation during power mains 270 and interruptions, it is recommended that the 315 Wireless Probe Series Ultrasound Scanner be powered from an uninterruptible power supply or a battery. Voltage IEC 61000-
0 % UT;
interruption 4-11 250/300 s EN 61000-
cycle 4-11
[Notice] UT is the a.c. mains voltage prior to application of the test level. 6.3.3 Recommended Separation Distance The SONOFINDER is intended for use in an electromagnetic environment in which radiated RF disturbance are controlled. The customer or the user of the Wireless Probe Series Ultrasound Scanner can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and the SONOFINDER as recommended below, according to the maximum output power of the communications equipment. 2022. 03. 47 / 57 Doc # : BN-SF-EOP-01 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 SONOFINDER further away from the affected system.
Supply power to this system in other ways other than the way used currently
- Contact Bionets Customer Service Department ASAP Use of this equipment adjacent to or stacked with other equipment may result in improper operation and should be avoided. If such use is required, this and other equipment should be observed to ensure normal operation. The use of accessories, converters and cables not specified or provided by the manufacturer may increase electromagnetic emissions or decrease electromagnetic immunity of this equipment and may cause malfunction. The emission characteristics of this equipment make it suitable for use in industrial areas and hospitals (CISPR 11 Class A). For use in a residential environment (which normally requires CISPR 11 Class B), this equipment may not provide adequate protection for radio frequency communications services. Users may need to take mitigation measures such as relocating or reorienting equipment. Warning Warning Caution Warning This device complies with part 15 of the FCC Rules. Operation is subject to the following two conditions:
2022. 03. 48 / 57 Doc # : BN-SF-EOP-01 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. 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. This device complies with FCC radiation exposure limits set forth for an uncontrolled environment and it also complies with Part 15 of the FCC RF Rules. This equipment must not be co-located or operating in conjunction with any other antenna or transmitter. End-users and installers must be provide with antenna installation instructions and consider removing the no-collocation statement. 2022. 03. 49 / 57 Doc # : BN-SF-EOP-01 Rev.1.01 Appendix A. Specification A-1. SF14L25 Complied Standard EN/IEC 60601-1:2012 Medical electrical equipment Part 1: General requirements for basic safety and essential performance, BF, Non-continuous operation EN/IEC 60601-2-37:2015 Medical Electrical Equipment Part 2-37: Particular Requirements for the Basic Safety and Essential Performance of Ultrasonic Medical Diagnostic and EN/IEC 60601-1-2:2014 Electromagnetic Compatibility Requirement and tests, Monitoring Equipment Class A Circumstance Operation Ambient Temperature 5C ~ +35C Relative Humidity 25% ~ 80%, Non-Condensing Atmospheric Pressure, 700hPa ~ 1060hPa, Max. Altitude 3000m Ambient Temperature
-20C ~ +55C Storage / Shipping Relative Humidity 25% ~ 93%, Non-Condensing Atmospheric Pressure, 700hPa ~ 1060hPa, Max. Altitude 3000m Safety Type of protection Internal-Power Type, 3.8 VDC / 4,200 h against electric shock Type BF Applied Parts Degree of protection Non-continuous operation Operating mode: 1:2 duty cycle (ON: 5 min / OFF: 10 min) against electric shock Hand-Held Type Degrees of protection IPX1 2022. 03. 50 / 57 Doc # : BN-SF-EOP-01 against harmful liquid Rev.1.01 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 Wi-Fi 802.11n(HT20) Modulation Wi-Fi 802.11n:OFDM Channel Number 11 Channel for 20 bandwidth (2,412~2,462 ) Channel Separation 5 Antenna Description Chip Antenna, 2.1dBi(Max.) Wireless Power 10 / or below Common Technical Parameters Description iOS 8.0 or above, Android OS 7.0 or above, Windows
- Display: Tablet PC or Mobile Phone which supports by Element System. 128 Measurement Length, Area, Angle, Obstetrics Image Frame Rate 16f/s Battery Operation Time 3.5 hours Charging Mode USB Charging Supported Device Brand SAMSUNG, HUAWEI, MI / Apple Equipment name Specific low power wireless device (Wireless device for wireless data communication system) Manufacturer/Country Bionet/S.Korea Type Color Dopller Dimension & Weight 157 67 29, 200g Array Type Electronic array L25 2022. 03. 51 / 57 Doc # : BN-SF-EOP-01 Rev.1.01 Probe Type Linear Display Mode B, B/M, Color, PDI, PW Frequency Depth 10/14 20~55 Application Peripheral Vessel, Superficial Organ 2022. 03. 52 / 57 Doc # : BN-SF-EOP-01 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 SF14L25 B Mode 2022. 03. 53 / 57 Doc # : BN-SF-EOP-01 Rev.1.01 IEC 60601-2-37:2007 +AMD1:2015 CSV IEC 2015 MODE SF14L25 B + M Mode 2022. 03. 54 / 57 Doc # : BN-SF-EOP-01 Rev.1.01 IEC 60601-2-37:2007 +AMD1:2015 CSV IEC 2015 MODE SF14L25 B + Color / B + PDI Mode 2022. 03. 55 / 57 Doc # : BN-SF-EOP-01 Rev.1.01 IEC 60601-2-37:2007 +AMD1:2015 CSV IEC 2015 MODE SF14L25 PW Mode 2022. 03. 56 / 57 Doc # : BN-SF-EOP-01 Rev.1.01 PRODUCT WARRANTY Brand Name SONOFINDER Product Name Wireless Probe Series Ultrasound Scanner Model Name SF14L25 Hospital Name :
Address :
Name :
Phone :
Approval Number Approval Date Serial Number Warranty Period Date of Purchase Customer Section Sales Agency Manufacturer inspection. Thank you for purchasing SONOFINDER The product is manufactured and passed through strict quality control and through Compensation standard concerning repair, replacement, refund of the product complies with Consumers Protection Law noticed by Korea Fair Trade Commission.
- End of Document -
2022. 03. 57 / 57 Doc # : BN-SF-EOP-01
1 | Label LocationSF14 | ID Label/Location Info | 161.20 KiB | May 18 2022 |
This device complies with part 15 of the FCC Rules. Operation is subject to the following two conditions:
(1) this device may not cause harmful interference, and (2) this device must accept any interference received, including interference that may cause undesired operation.
1 | Label5C | ID Label/Location Info | 127.85 KiB | May 18 2022 |
This device complies with part 15 of the FCC Rules. Operation is subject to the following two conditions:
(1) this device may not cause harmful interference, and (2) this device must accept any interference received, including interference that may cause undesired operation.
1 | label14 | ID Label/Location Info | 131.91 KiB | May 18 2022 |
This device complies with part 15 of the FCC Rules. Operation is subject to the following two conditions:
(1) this device may not cause harmful interference, and (2) this device must accept any interference received, including interference that may cause undesired operation.
1 | Agent Authorization Rev 1.0 | Cover Letter(s) | 16.78 KiB | May 18 2022 |
Bionet Co., Ltd. Agent Authorization Company: Bionet Co., Ltd. Address: 5F, 61 Digital-ro 31-gil, Guro-gu, Seoul 08375, REPUBLIC OF KOREA Product Name: Wireless Probe Type Ultrasound Scanner Model Number(s): 5C, 14L, SF14L25 Product Description: Wireless Probe Type Ultrasound Scanner We authorize MiCOM Labs Inc., 575 Boulder Court, Pleasanton, California 94566, USA, to act on our behalf on all matters concerning the certification of above named equipment. We declare that MiCOM Labs Inc. is allowed to forward all information related to the approval and certification of equipment to the regulatory agencies as required and to discuss any issues concerning the approval application. Any and all acts carried out by MiCOM Labs on our behalf shall have the same effect as acts of our own. Date: 2022-03-23 Signature:
Name:
ChuelWon, Lee Title:
RA Manager Company: Bionet Co., Ltd.
1 | Declaration of authorization | Cover Letter(s) | 16.37 KiB | May 18 2022 |
Bionet Co., Ltd. Declaration of Authorization REPUBLIC OF KOREA We Name: Bionet Co., Ltd. Address: 5F, 61 Digital-ro 31-gil, Guro-gu, City: Seoul 08375, Country:
Declare that:
Name Representative of agent: Ms. Rose Liu Agent Company name: BTL Inc. Address: No.3,Jinshagang 1st Road, Dalang Town City: Dong Guan Country: China is authorized to apply for Certification of the following product(s) and signing all the related documents including 731 forms:
Product description: Wireless Probe Type Ultrasound Scanner 1)5C, 14L Type designation:
2)SF14L25 Trademark: 1) SonoMe FCC ID: 2A3TY-5C on our behalf. Date: 2022-05-12 City: Seoul 08375, Name: ChuelWon, Lee Function: RA Manager 2) SONOFINDER Signature:
1 | FCC Short & Long Term Confidentiality Request Rev4.1 | Cover Letter(s) | 17.65 KiB | May 18 2022 |
Bionet Co., Ltd. Office of Engineering Technology Federal Communications Commission 7435 Oakland Mills Road Columbia, MD 21046 USA Date: 2022.05.12 Subject; Request for Confidentiality FCC ID: 2A3TY-5C To Whom It May Concern, Pursuant to the provisions of the Commissions rules Title 47 Sections 0.457 and 0.459, we are requesting the Commission to withhold the following attachment(s) as confidential documents from public disclosure indefinitely. These documents contain detailed system and equipment descriptions and are considered as proprietary information in operation of the equipment. The public disclosure of these documents might be harmful to our company and would give competitors an unfair advantage in the market. Schematic Diagram Block Diagram Parts List Operational Description Tune-up Procedure Software security description External Photos Test Setup Photos Internal Photos User Manual In additional to above mentioned documents, in order to comply with the marketing regulations in Title 47 CFR 2.803 and the importation rules in Title 47 CFR 2.1204, while ensuring that business sensitive information remains confidential until the actual marketing of newly authorized devices, we request Short Term Confidentiality of the following attachment(s);
OR For 45 days, pursuant to Public Notice DA 04-1705. For 180 days pursuant to KDB 726920 D01. It is our understanding that all measurement test reports, FCC ID label format and correspondence during the certification review process cannot be granted as confidential documents and this information will be available for public review once the grant of equipment authorization is issued. Sincerely, Signature:
Name: ChuelWon, Lee Title: RA Manager
1 | Model Difference Declaration | Cover Letter(s) | 18.73 KiB | May 18 2022 |
Bionet Co., Ltd. Model Declaration Letter We, the undersigning company Company Name: Bionet Co., Ltd. Address: 5F, 61 Digital-ro 31-gil, Guro-gu, Seoul 08375, REPUBLIC OF KOREA Hereby confirm that the following products:
Product description: Wireless Probe Type Ultrasound Scanner Type designation: 1) 5C, 14L Trademark: 1)SonoMe That All versions of the model 5C, 14L and SF14L25 are electrically equal except the following difference:
1. The 5C, 14L and SF14L25 have the same structural composition and circuit configuration. The only difference is the probe type and probe software which will not influence the RF characteristics. 2) SONOFINDER 2) SF14L25 Date: 2022-05-12 Name: ChuelWon, Lee Telephone: 13267223120 E-mail: lixueli@deltates.com Signature:
1 | Wi-Fi Channel 12 and 13 Declaration Letter | Cover Letter(s) | 18.79 KiB | May 18 2022 |
Bionet Co., Ltd. Wi-Fi Channel 12 and 13 Declaration Letter Date: 2022-05-12 We, the undersigned company Company Name: Bionet Co., Ltd. Address: 5F, 61 Digital-ro 31-gil, Guro-gu, Seoul 08375, REPUBLIC OF KOREA Declare that:
Product description: Wireless Probe Type Ultrasound Scanner Type designation: 1)5C, 14L 2)SF14L25 2) SONOFINDER Brand: 1)SonoMe FCC ID: 2A3TY-5C Only channels 1~11 will be used in USA. Country code selection is disabled. If you have any questions regarding the authorization, please do not hesitate to contact us, thank you~
Sincerely, Signature: ________________________ Name: ChuelWon, Lee Tel: 13267223120 Email: lixueli@deltates.com
frequency | equipment class | purpose | ||
---|---|---|---|---|
1 | 2022-05-18 | 2412 ~ 2462 | DTS - Digital Transmission System | Original Equipment |
app s | Applicant Information | |||||
---|---|---|---|---|---|---|
1 | Effective |
2022-05-18
|
||||
1 | Applicant's complete, legal business name |
Bionet Co., Ltd.
|
||||
1 | FCC Registration Number (FRN) |
0031694888
|
||||
1 | Physical Address |
5F, 61 Digital-ro 31-gil Guro-gu
|
||||
1 |
Seoul, N/A
|
|||||
1 |
South Korea
|
|||||
app s | TCB Information | |||||
1 | TCB Application Email Address |
c******@micomlabs.com
|
||||
1 | TCB Scope |
A4: UNII devices & low power transmitters using spread spectrum techniques
|
||||
app s | FCC ID | |||||
1 | Grantee Code |
2A3TY
|
||||
1 | Equipment Product Code |
5C
|
||||
app s | Person at the applicant's address to receive grant or for contact | |||||
1 | Name |
C**** L********
|
||||
1 | Title |
RA Manager
|
||||
1 | Telephone Number |
+82-1********
|
||||
1 | Fax Number |
+82-2********
|
||||
1 |
c******@ebionet.com
|
|||||
app s | Technical Contact | |||||
1 | Firm Name |
Bionet Co., Ltd.
|
||||
1 | Physical Address |
South Korea
|
||||
1 |
l******@deltates.com
|
|||||
app s | Non Technical Contact | |||||
n/a | ||||||
app s | Confidentiality (long or short term) | |||||
1 | Does this application include a request for confidentiality for any portion(s) of the data contained in this application pursuant to 47 CFR § 0.459 of the Commission Rules?: | Yes | ||||
1 | Long-Term Confidentiality Does this application include a request for confidentiality for any portion(s) of the data contained in this application pursuant to 47 CFR § 0.459 of the Commission Rules?: | No | ||||
if no date is supplied, the release date will be set to 45 calendar days past the date of grant. | ||||||
app s | Cognitive Radio & Software Defined Radio, Class, etc | |||||
1 | Is this application for software defined/cognitive radio authorization? | No | ||||
1 | Equipment Class | DTS - Digital Transmission System | ||||
1 | Description of product as it is marketed: (NOTE: This text will appear below the equipment class on the grant) | Wireless Probe Type Ultrasound Scanner | ||||
1 | Related OET KnowledgeDataBase Inquiry: Is there a KDB inquiry associated with this application? | No | ||||
1 | Modular Equipment Type | Does not apply | ||||
1 | Purpose / Application is for | Original Equipment | ||||
1 | Composite Equipment: Is the equipment in this application a composite device subject to an additional equipment authorization? | No | ||||
1 | Related Equipment: Is the equipment in this application part of a system that operates with, or is marketed with, another device that requires an equipment authorization? | No | ||||
1 | Grant Comments | Output power listed is conducted power. SAR compliance for body-worn operating configurations is limited to the specific configurations tested for this filing. Body-worn operations are restricted to belt-clips, holsters or similar accessories that have no metallic component in the assembly and must provide at least 0 cm separation between the device and the body of the user. End-users must be informed of the body-worn operating requirements for satisfying RF exposure compliance. The highest reported SAR for body-worn accessory use conditions is 0.04W/kg. | ||||
1 | Is there an equipment authorization waiver associated with this application? | No | ||||
1 | If there is an equipment authorization waiver associated with this application, has the associated waiver been approved and all information uploaded? | No | ||||
app s | Test Firm Name and Contact Information | |||||
1 | Firm Name |
BTL Inc.
|
||||
1 | Name |
S**** H****
|
||||
1 | Telephone Number |
+86-7******** Extension:
|
||||
1 |
S******@newbtl.com
|
|||||
Equipment Specifications | |||||||||||||||||||||||||||||||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Line | Rule Parts | Grant Notes | Lower Frequency | Upper Frequency | Power Output | Tolerance | Emission Designator | Microprocessor Number | |||||||||||||||||||||||||||||||||
1 | 1 | 15C | 2412.00000000 | 2462.00000000 | 0.0649000 |
some individual PII (Personally Identifiable Information) available on the public forms may be redacted, original source may include additional details
This product uses the FCC Data API but is not endorsed or certified by the FCC