Instruction Manual for BEACON BIOSIGNALS models including: BB420 SpotLite EEG Device, BB420, SpotLite EEG Device, EEG Device, Device
Beacon Biosignals, Inc BB420 2A9Z6-BB420 2A9Z6BB420 bb420
File Info : application/pdf, 18 Pages, 821.92KB
DocumentDocumentSpotLite EEG Device Instructions for Use LB-10001 Rev A -DRAFT 27APR2023 SpotLite IFU Current Issues to Resolve: Distribution: Per Jean, digital is satisfactory for 510K submission, but physical copies could be needed. That need is based on the preference of the hospitals. Should we plan to include a physical copy within the SpotLite System box? References · Peer IFUs and FDA Guidance · Draft SpotLite User manual for compliance testing · STAT Hardware Manual · Byteflies Kit LB-10001_RevA_DRAFT Confidential and Proprietary 2 SpotLite IFU Table of Contents (Go to View > Show Outline and it should appear to the left of the document) Getting Started What's in the boxCompleted Your box includes: · SpotLite EEG Device · Charging Dock · Power Adapter · USB-C Cable You should also have received · A number of patch envelopes which contain o The patch with SpotLite cradle attached o 2 skin prep wipes You should also have · A mobile device with the SpotLite app installed and it is connected to the Wi-Fi Descriptions Ready for ReviewThe Beacon SpotLite System is a wearable self-contained EEG system designed to amplify and digitize and record the electroencephalogram (EEG) from a patient's scalp. The recorded EEG signals are acquired by the SpotLite Device, transmitted to a mobile device in real time, and uploaded to the cloud storage after a recording session is completed. The recorded data is available for access for viewing on the Beacon Platform (not included in the SpotLite system). The Beacon platform provides the recorded signals for post-hoc review ONLY. Indications for Use Ready for ReviewThe SpotLite EEG System is intended to record, store, and display EEG signals. A reusable SpotLite Device is intended to amplify, capture and wirelessly transmit the signals to the cloud storage via a mobile device. A single use, disposable SpotLite Patch is an EEG electrode array to be used with the SpotLite Device to record up to 8 channels of EEG signals. The Beacon SpotLite EEG System does not provide any diagnostic conclusion about the subject's condition and does not provide any automated alerts of an adverse clinical event. It is intended for prescription use in the home, healthcare facility or clinical site where reduced montage EEG monitoring may be desired. Contraindications Completed LB-10001_RevA_DRAFT Confidential and Proprietary 3 SpotLite IFU · The SpotLite EEG System should not be used when real time EEG monitoring is required. · The SpotLite EEG System does not provide real time alarms and should not be used to make life saving decisions. · The SpotLite System should not be used on children under the age of 6 · The SpotLite Patch is manufactured with medical grade adhesives containing silicones, acrylics and conductive hydrogels. The Patch should not be used on patients with a suspected or known allergy to skin adhesives, acrylics, hydrogels, or silicones. Warnings Ready for Review · The SpotLite Device and SpotLite Patch have not been evaluated for safety in the MR environment. The SpotLite Device and SpotLIte Patch have not been tested for heating or unwanted movement in the MR environment. The safety of the SpotLite Device within the MR environment is unknown. Performing an MR exam on a person who has this medical device may result in injury or device malfunction. · Only place the Patch on intact skin, do not place the Patch on open wounds or abrasions. · Depending on wireless connectivity, a temporary interruption of data transmission is possible. Data will be stored on the device for transfer once connectivity is reestablished. · Do not use the SpotLite EEG Device or Patch in conjunction with defibrillation devices PrecautionsIn Progress · Wireless electronic devices may cause signal interference during data transmission. Avoid close proximity with interfering devices. · The Patch is single use only. Do not reapply or reuse the patch once it is removed. · Do not use the SpotLite EEG Device or Patch if the package has been opened, or appears used, damaged, or expired. · If prolonged discomfort or irritation occurs, the Patch should be removed. If mild soreness or redness is experienced after removing the Patch, take care to let the area heal prior to applying another Patch. · Incorrect handling, excessive force, or dropping the SpotLite EEG Device may cause malfunction or permanent damage · The SpotLite Device and Patch are not intended to be used in a wet environment; do not use the device while showering or under water. · Keep the SpotLite EEG Device away from children and pets. The device may be a choking hazard, and may be harmful if swallowed. · If the SpotLite EEG Device fails to operate, contact your healthcare provider immediately. · This device has not been evaluated for use in a HF surgical environment. System Overview System ComponentsReady for Review · SpotLite EEG Device The device is electrically connected to the Patch, samples the EEG signals, monitors the impedance of each Patch electrode, and wirelessly transmits the data to a connected mobile device. · Charging Dock A wireless charging dock used to both charge and protect the SpotLite EEG Device when not in use. When LB-10001_RevA_DRAFT Confidential and Proprietary 4 SpotLite IFU the SpotLite EEG Device is placed within the charging dock, all EEG acquisition functions are automatically disabled. · Patch Multiple electrodes are attached to the forehead with adhesive on each electrode. Each Patch has a cradle to securely mount the EEG device. The conductive pads allow the EEG device to electrically connect to the Patch. · Power Adaptor 100-240 V AC power adapter used to charge the SpotLite EEG Device. Only use the included power adapter to charge the SpotLite EEG Device. · USB-C Cable Cable used to connect the SpotLite EEG Device to the power adapter for charging. · Mobile Device A user interacts with the SpotLite system with a mobile device. The app installed on the device will guide the user on how to set up, start and stop the EEG recording. · Cloud Storage When the EEG recording is completed on the mobile device, the data is uploaded to the cloud storage for retrieval and analysis. System Description Ready for Review The EEG device is connected to a wearable patch attached to the forehead that acquires brain wave signals continuously. The EEG device, the patch, the wireless charger, the companion mobile app and the cloud storage, collectively known as the SpotLite System, are custom designed by Beacon. LB-10001_RevA_DRAFT Confidential and Proprietary 5 SpotLite IFU Phone Requirements Ready for Review Supported phones and OS versions OS Phone model OS version iOS Apple iPhone 14 16.2.X iOS Apple iPhone 13 16.2.X iOS Apple iPhone 12 16.2.X iOS Apple iPhone 11 16.2.X iOS Apple iPhone XR 16.2.X Android Google Pixel 6, 7 12, 13, 14 Android Samsung Galaxy S2x 12, 13, 14 Charging the Battery Ready for Review The SpotLite EEG Device is powered by a rechargeable battery. To charge the battery, align the front of the SpotLite EEG Device (with logo) with the front of the Charging Dock (the opposite side of the charging cable). LB-10001_RevA_DRAFT Confidential and Proprietary 6 SpotLite IFU Gently push the device all the way into the charging dock. During the charging, the light in the front of the charging dock is blinking. When the charging is complete, the light turns solid. The charging time should be less than 90 minutes. If you notice longer charging time or significant reduction in the duration of the SpotLite EEG Device operating time, the device may need to be replaced. Powering On and Off the SpotLite EEG Device To turn on the SpotLite EEG Device, press the green power button on the back of the device. To turn off the SpotLite EEG Device, press and hold the green power button for 5 seconds. Quick Start Guide For Self-Application Author: Elliott Munoz Stephen Johnson Laura Edinger, in draft state In Progress Step 1 Confirm the LED on the SpotLite Device is green. This means the Device is on and paired with the SpotLite App. Step 2 Remove a SpotLite EEG Patch from an envelope. Step 3 Carefully place the SpotLite Device, bottom first, into the Cradle of the SpotLite Patch and listen for a click. Step 4 Turn the Patch over and, using the plastic tab, remove the backing from the center of the Patch. LB-10001_RevA_DRAFT Confidential and Proprietary 7 SpotLite IFU Step 5 Use a mirror to help place the patch about ½ an inch above the eyebrows with the Device centered between the eyes. Firmly press the Device against your forehead. Step 6 Use the plastic tab to remove the backing from the left sensor and, taking care to avoid the hairline, place the sensor along the left side of the forehead. Step 7 1. Plug in and ensure you have access to your phone 2. Be in the place where you plan to relax or sleep. 3. If you need to get up at any time while recording, please take your phone with you and keep your patch on until you're able to return to where you plan to relax or sleep. Step 8: Monitoring 1. When you are ready to begin, press "Start Monitoring" 2. If there is an issue with a sensor during the monitoring, the screen will go red and direct you on how to address the issue Step 9: Stop the EEG Monitoring 1. Press the "Stop" button to end monitoring For Assisted-Application Author: Elliott Munoz Stephen Johnson Laura Edinger, in draft stateIn Progress Step 1 Assist the user in turning on the device and confirm the LED on the SpotLite Device is green. This means the Device is on and paired with the SpotLite App. Step 2 Assist the user in removing a SpotLite Patch from an envelope. Step 3 Place SpotLite Device, bottom first, into the cradle until you hear a click. Step 4 Turn the Patch over and use the plastic tab to remove the backing from the center of the Patch. Step 5 Place the patch about ½ an inch above the eyebrows with the Device centered between the user's eyes. Firmly press the Device against their forehead. Step 6 Use the plastic tab to remove the backing from the left sensor and, taking care to avoid the hairline, place the sensor along the left side of the forehead. LB-10001_RevA_DRAFT Confidential and Proprietary 8 SpotLite IFU Step 7 4. Plug in and ensure the participant has access to their phone 5. Be in the place where the participant plans to relax or sleep. 6. If the participant needs to get up at any time while recording, instruct them to take their phone with them and keep the patch on until they're able to return to where they plan to relax or sleep. Step 8: Monitoring 3. When they are ready to begin, press "Start Monitoring" 4. If there is an issue with a sensor during the monitoring, the screen will go red and direct you on how to address the issue Step 9: Stop the EEG Monitoring 2. Press the "Stop" button to end monitoring SpotLite App Signing in Author: Jean Wheeler Elliott Munoz, in draft stateBlocked After you receive your SpotLite EEG Device, you should receive a welcome email to the email address you provided your administrator. If you have not received the welcome email, please first check any junk or spam folders prior to contacting your administrator. The welcome email will include a link to finish setting up your [SpotLite] account. Click the link and follow the instructions on how to update your account password. This password, along with your email address will be the credentials used for signing into the SpotLite app. To access the SpotLite app, log in using the credentials provided to you by your health care network administrator. Home Screen Author: Elliott Munoz In Progress The home screen is divided into two sections. The top section contains an Overview carousel that orients the participant to the contents of the SpotLite System. The bottom section contains a button to start a recording. Navigation Author: Elliott Munoz In Progress The Navigation consists of 3 menu items: Home, Record, and More. Each Menu item contains a representative icon and a label. Home Pressing "Home" will take you back to the Home Screen. Record Pressing "Record" will initiate a monitoring session. LB-10001_RevA_DRAFT Confidential and Proprietary 9 SpotLite IFU Menu Author: Elliott Munoz Not StartedReady for Review) Pressing "Menu" will display five submenu items: 1. Account Pressing "Account" will display "Sign Out" and five additional submenu items: a. Notification Preferences b. Consent Documents c. Legal Notices d. License Agreement e. Privacy Policy 2. The SpotLite System 3. Instructions 4. Contact 5. About Starting an EEG Recording Author: Elliott Munoz Ready for Review Once you click Start Monitoring from the "Monitoring Tips" screen, the Monitoring screen will appear as shown below. The Monitoring screen is composed of two sections. The top section displays LED Light settings, Battery life, and Signal Quality. The bottom section displays the elapsed time of the Monitoring session and the "Stop Monitoring" button. LB-10001_RevA_DRAFT Confidential and Proprietary 10 SpotLite IFU If there are issues with a sensor during the monitoring session, a sheet will appear with instructions for addressing the issue. A monitoring session will not be stopped unless more than one sensor has an issue. A user may end a monitoring session by clicking and confirming "Stop Monitoring." See the Stop Monitoring section of this manual on how to end a recording. Stopping an EEG Recording Author: Elliott Munoz Ready for Review It is possible to end a recording from the Monitoring screen by clicking on "Stop Monitoring." An alert -- as shown below -- will appear asking you to either "Cancel" which will send you back to the Monitoring screen or "Stop Monitoring" which will end your monitoring session. Click "Stop Monitoring" to end your monitoring session. Ending your monitoring session will begin the file transfer process. See the Uploading EEG Monitoring via Wi-Fi section of this manual for more information. LB-10001_RevA_DRAFT Confidential and Proprietary 11 SpotLite IFU Uploading EEG Monitoring via Wi-Fi Author: David Klaffenbach Elliott Munoz Not Started Maintenance Cleaning SpotLite and the Charger Author: David Klaffenbach Not Started Disposing of patches Author: Jean Wheeler Not Started Disposing of SpotLite Author: Jean Wheeler Not Started EEG Device Product SpecificationsReady for Review LB-10001_RevA_DRAFT Confidential and Proprietary 12 SpotLite IFU Parameter Value/Description Comments Battery Li-poly, 3.85V, 220mAh Dimensions 41 x 32 x 13 mm H x W x D [1] Mass approx. 14 g Wireless Protocol BLE 5.0 Operating Temperature 15 - 40 °C Operating Humidity 25 - 95 %RH w/o condensation Shipping Temperature -20 - 60 °C Shipping Humidity 15 - 95 %RH Battery Life > 12 hours, all features on Number of Channels 6 Minimum Bandwidth 0 - 70 Hz [2] EEG Sample Rate 250 sps Input range ±300.0 mV Impedance measurement Continuous [3] Resolution 35.8 nV Common Mode Rejection Ratio (CMRR) < 100V pk-valley for 1Vrms Crosstalk rejection 40 dB Noise < 1.0 Vrms Charging interface Qi (inductive) 5 W Charger Proprietary LB-10001_RevA_DRAFT Confidential and Proprietary 13 SpotLite IFU Charger dimensions 51 x 43 x 47 mm H x W x D Charger mass approx. 70 g EEG connection to Patch Proprietary [1] Not including protrusions of pogo pins or the latch feature. [2] The SpotLite does not high-pass filter the data. [3] Continuous, out of band (125Hz), AC impedance measurements. 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. Caution: Changes or modifications not expressly approved by the party responsible for compliance could void the user's authority to operate the equipment. NOTE: This equipment has been tested and found to comply with the limits for a Class B 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. If this equipment 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 equipment and receiver. --Connect the equipment into an outlet on a circuit different from that to which the receiver is connected. --Consult the dealer or an experienced radio/TV technician for help. 1* WARNING: Use of this equipment adjacent to or stacked with other equipment should be avoided because it could result in improper operation. If such use is necessary, this equipment and the other equipment should be observed to verify that they are operating normally." 2* WARNING: Use of accessories, transducers and cables other than those specified or provided by the manufacturer of this equipment could result in increased electromagnetic emissions or decreased electromagnetic immunity of this equipment and result in improper operation." 3* WARNING: Portable RF communications equipment (including peripherals such as antenna cables and external antennas) should be used no closer than 30 cm (12 inches) to any part of the ME equipment, including cables specified by the manufacturer. Otherwise, degradation of the performance of this equipment could result." 4* RF Exposure Compliance(Spotlite) This equipment complies with FCC radiation exposure limits set forth for an uncontrolled environment. This transmitter must not be co-located or operating in conjunction with any other antenna or transmitter. This equipment should be installed and operated with minimum distance 00cm between the radiator and your body. Table 1 LB-10001_RevA_DRAFT Confidential and Proprietary 14 SpotLite IFU 4* RF Exposure Compliance(Wireless charger) This equipment complies with FCC radiation exposure limits set forth for an uncontrolled environment. This equipment should be installed and operated with minimum distance 20cm between the radiator and your body. This transmitter must not be co-located or operating in conjunction with any other antenna or transmitter. Emissions test RF emissions CISPR 11 RF emissions CISPR 11 Harmonic emissions IEC 61000-3-2 Voltage fluctuations/ flicker emissions IEC 61000-3-3 FCC Declaration - Electromagnetic Emission Compliance Group 1 Class B Class A Clause 5 Immunity test Table 2 Declaration - Electromagnetic Immunity IEC 60601 test level Compliance level Electrostatic ±8 kV contact ±8 kV contact discharge (ESD) ±2 kV, ±4 kV, ±8 kV, ±15 ±2 kV, ±4 kV, ±8 kV, ±15 kV air IEC 61000-4-2 kV air Electrical fast ± 2 kV for power supply ± 2 kV for power supply lines transient/burst lines ± 1 kV for input/output lines IEC 61000-4-4 ± 1 kV for input/output lines Surge ± 0.5kV, ± 1 kV line(s) to ± 0.5kV, ± 1 kV line(s) to lines IEC 61000-4-5 lines ± 0.5kV, ± 1 kV, ± 2 kV line(s) to earth ± 0.5kV, ± 1 kV, ± 2 kV line(s) to earth Voltage dips, short 0 % UT; 0.5 cycle At 0°, 0 % UT; 0.5 cycle At 0°, 45°, 90°, 135°, 180°, 225°, interruptions and 45°, 90°, 135°, 180°, 225°, 270°and 315° voltage variations 270°and 315° on power supply 0 % UT; 1 cycle and input lines 0 % UT; 1 cycle and IEC 61000-4-11 70 % UT; 25/30 cycles 70 % UT; 25/30 cycles Single phase: at 0° Single phase: at 0° 0 % UT; 250/300 cycles 0 % UT; 250/300 cycles Power frequency 30 A/m 30 A/m (50/60 Hz) magnetic field IEC 61000-4-8 NOTE: UT is the a.c. mains voltage prior to application of the test level. Immunity test Conducted RF IEC 61000-4-6 Table 3 Declaration - Electromagnetic Immunity IEC 60601 test level 3 V 0.15 MHz to 80 MHz Compliance level 3 V 0.15 MHz to 80 MHz 6 V in ISM bands between 0.15 MHz and 80 MHz LB-10001_RevA_DRAFT Confidential and Proprietary 15 SpotLite IFU Radiated RF IEC 61000-4-3 6 V in ISM bands between 0.15 MHz 3Vrms (emf), and 80 MHz 6Vrms (emf) in ISM bands between 0.15 MHz and 80 MHz 80%, 1 kHz 10V/m 10V/m 80 MHz to 2.7 GHz Immunity to Immunity to proximity proximity magnetic magnetic fields fields in the in the frequency frequency range 9 range kHz to 13.56 IEC 61000-4-39 See table 11 of standard Any one of its nominal input voltages and frequencies Table 4 Declaration - IMMUNITY to proximity fields from RF wireless communications equipment Immunity test Test frequency IEC60601 test level Modulation Maximum power Immunity level Compliance level Radiated RF IEC 610004-3 385 MHz 450 MHz **Pulse Modulation: 18Hz *FM+ 5Hz deviation: 1kHz sine 710 MHz 745 MHz 780 MHz **Pulse Modulation: 217Hz 810 MHz 870 MHz 930 MHz **Pulse Modulation: 18Hz 1.8W 2 W 0.2 W 2 W 27 V/m 28 V/m 9 V/m 28 V/m 27 V/m 28 V/m 9 V/m 28 V/m 1720 MHz 1845 MHz 1970 MHz 2450 MHz 5240 MHz 5500 MHz 5785 MHz **Pulse Modulation: 217Hz **Pulse Modulation: 217Hz **Pulse Modulation: 217Hz 2 W 2 W 0.2 W 28 V/m 28 V/m 9 V/m 28 V/m 28 V/m 9 V/m LB-10001_RevA_DRAFT Confidential and Proprietary 16 SpotLite IFU Note* - As an alternative to FM modulation, 50 % pulse modulation at 18 Hz may be used because while it does not represent actual modulation, it would be worst case. Note** - The carrier shall be modulated using a 50 % duty cycle square wave signal. 1. Verdict summary section IEC 60601-1-2 referenced emission standards Clause Requirement Test case Basic standard 7.1 7.1 7.2.1 7.2.2 Terminal disturbance voltages Radiation disturbance AC-Mains Harmonics AC-Mains Voltage fluctuations and flicker CISPR 11:2015 +A1:2016 + A2:2019 CISPR 11:2015 +A1:2016 + A2:2019 IEC 61000-3-2:2005 +A1:2008 +A2:2009 IEC 61000-3-3:2013 IEC 60601-1-2 referenced immunity standards Clause Requirement Test case Basic standard 8.9 ELECTROSTATIC DISCHARGE IEC 61000-4-2:2008 8.9 Radiated RF EM fields 8.9 Electrical fast transients / bursts IEC 61000-4-3:2006 +A1:2007 +A2:2010 IEC 61000-4-4:2012 8.9 Surges IEC 61000-4-5:2014+A1:2017 8.9 Conducted disturbances induced by RF fields IEC 61000-4-6:2013 8.9 RATED power frequency magnetic fields IEC 61000-4-8:2009 8.9 Voltage dips IEC 61000-4-11:2004 + A1:2017 8.9 Voltage interruptions IEC 61000-4-11:2004 + A1:2017 8.10 IMMUNITY to proximity fields from RF wireless IEC 60601-1-2:2014 + A1:2020 communications equipment Table 9 8.11 Immunity to proximity magnetic fields IEC 61000-4-39:2017 Supplementary information: None. Verdict P P P P Verdict P P P P P P P P P P Clause 5 Troubleshooting Author: Yongbo Wang Not Started Contact Information Author: Jean Wheeler In Progress LB-10001_RevA_DRAFT Confidential and Proprietary 17 SpotLite IFU For [questions/issues] related to SpotLite, please email spotlite@beacon.bio For more information on Beacon Biosignals and SpotLite, visit www.beacon.bio Glossary Meaning of Symbols Single Use Only Not made with latex Non-Sterile Consult Instructions for use Upper limit of temperature Batch Code Manufacture Date Expiration Date Manufactured by Addendum Quantity Prescription Only LB-10001_RevA_DRAFT Confidential and Proprietary 18
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