FCC ID: 2AWC6-1301 EIM1301 mScan System

1111 User Manual Caution Investigational Device. Limited by United States Law to Investigational Use. 20-10026 Rev 1.0.0 1309 Beacon Street, Suite 300 Brookline, MA 02446 2222 IMPORTANT NOTE:

THE MYOLEX MSCAN IS AN INVESTIGATIONAL DEVICE INTENDED FOR USE BY A TRAINED OPERATOR ACCORDING TO PROTOCOLS APPROVED BY INSTITUTIONAL REVIEW BOARDS. THE MSCAN SHOULD NOT BE USED FOR ANY OTHER PURPOSE. This preliminary App User Manual is prepared with the objective of providing the user all of the information necessary to operate the investigational Myolex mScan according to study protocols approved by an Institutional Review Board. The Study Protocol should be read carefully before using the investigational system for the first time, and should be strictly followed. User Assistance Information For information and/or issues regarding usage of the Myolex mScan, please call Myolex at 888.382.8824 x10 or email support@myolex.com 20-10026 Rev 1.0.0 1309 Beacon Street, Suite 300 Brookline, MA 02446 Table of Contents 3333 1. Myolex mScan System Overview..page 4 Whats included Power up 2. Primary App Actionspage 7 Logging in Add a patient Search for a patient Select a patient 3. Scanning.page 11 Select muscle Scan muscle 4. Review Scans..page 14 Review results Explanation of results Summary page Past scans 5. Settings...page 17 Settings page Pair device Account details Firmware update 6. Technical Specification..page 21 Power and calibration requirements Cleaning, storage, maintenance, and repairs Transport 20-10026 Rev 1.0.0 1309 Beacon Street, Suite 300 Brookline, MA 02446 4444 Troubleshooting and adverse reaction information 1. Myolex mScan System Overview Whats included 1. Apple iPad and charging cable 2. Myolex mScan device, carrying case, and charging cable. 3. Myolex mScan foam electrodes sensor 20-10026 Rev 1.0.0 1309 Beacon Street, Suite 300 Brookline, MA 02446 5555 mScan Device 2 1 LED light indicator: used to indicate device operating status while device is on. It will 1 change color depending on operating status. It will blink or display a steady light for depending 5 4 3 on the specific operation. Charge indication LED light: used to indicate device charging status while device is in sleep 2 mode (not turned on). When it blinks red slowly, it means the device is being charged. When it blinks green slowly, it means the device is at least 80% charged and ready for use. Charge port: used to connect to a charge source via USB C cable for charging the device. 3 Electrode sensor ejection button. Pushing the button will eject the electrode sensor. 4 Power on/off buttons: Press both buttons together to turn on the device; press both 5 buttons again to turn off the device. 20-10026 Rev 1.0.0 1309 Beacon Street, Suite 300 Brookline, MA 02446 mScan foam electrodes sensor The sensor has two sides, one side is be placed against the metal contacts on mScan device 6666 and the other side contacts the subjects skin. The Myolex label should face out (ie be readable) when being inserted into the device. Power up iPad 1. Charge your iPad with the cable provided 2. Press the Home button to enter the iPad 3. Enter the passcode provided 4. Ensure your iPad is connected to a WiFi network mScan 1. Charge the device with the cable provided 2. When the charger is plugged in, the device LED lights blinks red slowly if battery is not fully charged. The LED light will change to flashing green when it is charged. 3. Once the device is charged, press and hold the left button to turn on the device until the LED light indicator turns steady green. 20-10026 Rev 1.0.0 1309 Beacon Street, Suite 300 Brookline, MA 02446 7777 20-10026 Rev 1.0.0 1309 Beacon Street, Suite 300 Brookline, MA 02446 8888 2. Primary App Actions Logging in 1. Launch the Myolex mScan app on your iPad. 2. Enter your email address and password provided for your log in. 20-10026 Rev 1.0.0 1309 Beacon Street, Suite 300 Brookline, MA 02446 Adding a new patient 9999 1. The first screen that appears after logging in will look like this. 2. To begin, tap the Add a Patient button on the top right corner of the screen. 3. The Save button will become enabled once all the required fields are completed. 20-10026 Rev 1.0.0 1309 Beacon Street, Suite 300 Brookline, MA 02446 Search for a patient 20-10026 Rev 1.0.0 10101010 1309 Beacon Street, Suite 300 Brookline, MA 02446 1. Use the search bar at the top to search for a patient by either their name or ID. Tap on Search. 2. Patients will be filtered to show results for your search. Select a patient 11111111 1. Tap on the Select button to view patient information. 2. The Review Patient page is displayed. From here, you can edit patient information, select prior scans, or start a new scan. 20-10026 Rev 1.0.0 1309 Beacon Street, Suite 300 Brookline, MA 02446 3. Scanning Load foam electrode to mScan device 12121212 1. Remove a sensor from sealed bag. 2. Load the sensor into the mScan device. Make sure the correct marked side is placed against the device in order for it to click in properly. See image below. The word Myolex should face out and should be positioned so that it is in proximity to the on/off buttons. 20-10026 Rev 1.0.0 1309 Beacon Street, Suite 300 Brookline, MA 02446 Select muscles to scan 13131313 1. Switch between Anterior and Posterior views to select the muscles you want to measure. 2. Tap the muscle or checkbox next to the muscle name to select. Start Scanning button is enabled once at least one muscle is selected. 3. Tap Start Scanning to start the scan. Note: Left and right switch sides depending on which view you are using (anterior/posterior). 20-10026 Rev 1.0.0 1309 Beacon Street, Suite 300 Brookline, MA 02446 Scan muscles 14141414 1.1.1.1. View instructions for scanning the muscle. The mScan device LEDs change from green to blinking blue when you Start Scan. 2.2.2.2. The mScan device LEDs change to a steady blue light when scanning begins and during the scanning process. The iPad will display a Blue circle signifying scanning. The mScan app will ping a noise and the mScan LED will change to a green light when the scan is complete. 3.3.3.3. An error message will be displayed if the mScan is unable to connect to the app or scan the muscle properly. Simply reposition the mScan on the muscle and attempt scanning again. 20-10026 Rev 1.0.0 1309 Beacon Street, Suite 300 Brookline, MA 02446 4. Review Scans Review results 20-10026 Rev 1.0.0 15151515 1. After your scan is complete on a single muscle, review your results. Toggle between Overview and Data Detail to view different charts. 2. Choose to either perform another scan on the same muscle by tapping 2nd Scan, or move on by tapping Next Muscle. If it is the last muscle to be measured, tap View Summary. 3. Up to 3 scans can be completed for a single muscle. All scans will be plotted. You will be required to select one scan to keep and the others will be automatically discarded. It will default to keeping the last scan performed (e.g. second scan if you scanning twice and third scan if you scanned three times). You will have an opportunity to return to this muscle and obtain more data after you have completed scanning all muscles. 1309 Beacon Street, Suite 300 Brookline, MA 02446 16161616 Explanation of Results 20-10026 Rev 1.0.0 The Overview Tab 1. Normalized Value Provides an image of showing the expected normal range of the muscle for the 50 kHz phase (light green) as a percent predicted of normal values for the subjects sex, height, and weight. Dark green color represents above normal. Maize color shows values below normal. The larger circle represents the most recent measurement during the session; small circles represent the earlier measurements of the session. 2. Data at 50 kHz displays the raw impedance values at 50 kHz for each of the measurements, color coded to match the figure above. 3. Percent predicted (PP) trend shows the percent predicted values comparing the current measurement results to previous measurements. The Data Detail Tab 1. Four graphs portray the multifrequency values of each of the main impedance parameters between 10 kHz and 10 MHz versus frequency and the Reactance versus Resistance Plot in the lower right

(Cole-Cole Plot). 1309 Beacon Street, Suite 300 Brookline, MA 02446 17171717 1. After all muscles are scanned, tap on View Summary to see a summary of all muscles scanned. Summary Page 20-10026 Rev 1.0.0 2. Tap on individual muscles to view details in a new page. If user ends a session without performing all scans, unfinished scans appear as an X. 3. Return to patient screen by tapping Session List at the top. (Note: since only one of the three measurements had been selected earlier, the other measurements are no longer visible.) Or tap Redo Muscle Scan to scan the selected muscle again and replace the data you previously collected. 1309 Beacon Street, Suite 300 Brookline, MA 02446 1. After selecting a patient, select a past session and muscles you would like to review. 18181818 Past scans 20-10026 Rev 1.0.0 1309 Beacon Street, Suite 300 Brookline, MA 02446 5. Settings Settings page 19191919 1. The Settings icon is visible on certain screens before scanning begins. 2. Settings is where you can pair mScan, check mScan battery percentage, and update your mScan device firmware and account details. 20-10026 Rev 1.0.0 1309 Beacon Street, Suite 300 Brookline, MA 02446 Pair a device 20202020 1. To pair the mScan device with the app, go to Settings and tap on Pair mScan. 2. Follow the directions on the next pair to complete the pairing process. 20-10026 Rev 1.0.0 1309 Beacon Street, Suite 300 Brookline, MA 02446 Account details 21212121 1. To change your account email or password, go to Settings and tap on Account. 20-10026 Rev 1.0.0 1309 Beacon Street, Suite 300 Brookline, MA 02446 Firmware update 22222222 1. To update mScan device, go to Settings and follow the instructions after tapping Update mScan. 20-10026 Rev 1.0.0 1309 Beacon Street, Suite 300 Brookline, MA 02446 23232323 6. Technical Specification Electrical Impedance Myography (EIM) Electrical Impedance Myography (EIM) is a relatively new technology based on the older concept of bioelectrical impedance analysis.1 Whereas many standard bioimpedance approaches utilize electrodes spaced across the body (e.g., placed on the hand and foot), in EIM, the electrodes are placed on a specific location over a muscle or muscle group of interest. A weak electrical current is passed through the tissue across a wide range of frequencies through one set of electrodes and the resulting voltages are measured via a second set. Alterations in the health of the muscle are reflected in the measured voltages. Bluetooth Bluetooth is a type of wireless RF (Radio Frequency) communication. Cell phones use Bluetooth wireless technology as do many other devices. mScan device uses Bluetooth to pair with the iPad to send results to mScan App. Power Requirements mScan is powered by a rechargeable Lithium-polymer battery with 3.7V, 1.2AH. The battery should be charged with provided battery charger which rated as AC input 110-

240V, 50/60Hz; 0.6A, Output USB type C DC3.6-6V, 3A. mScan battery takes 2 hours to 80% charged from fully discharged, it takes 4 hours to fully charge the battery. Warning: Always use the hospital grade, AC power cable delivered with the mScan to connect to an AC power source. DO NOT, under any circumstances, use any other cable than the one provided, notably to provide extra cable length. The use of any other cable may result in increased emissions or decreased immunity of the mScan with regards to electromagnetic interference. Warning: Do not connect the mScan to an AC outlet that is controlled using a switch or dimmer. Warning: Do not, under any circumstances, remove the grounding conductor from the power plug. Warning: Do not use extension cords of any type. Warning: The power cable, supply, and plug must be intact and undamaged. Before starting a patient study:

20-10026 Rev 1.0.0 1309 Beacon Street, Suite 300 Brookline, MA 02446 24242424 1. Make sure the iPad and mScan device is sufficiently charged (>50%) to conduct the study. 2. Make sure the iPad is connected to a WiFi network with good Internet connection Electrical Safety and Standards The mScan device has been tested and found to be appropriate for use at home and clinical setting. In most cases, it should not interfere with other devices if used as instructed. However, the device gives off radio frequency (RF) energy from the Bluetooth feature. If not used correctly, the mScan device may interfere with TV, radio, or other electronic devices that receive or transmit RF signals. While mScan device is in operation, other electronics wireless devices that are used nearby, such as another mobile device or a wireless network, may prevent or delay the transmission of data between your mScan device and your iPad with mScan App. Moving away from or turning off these electronic devices may allow communication. If you experience mScan device interference problems, try moving your mScan device away from the source of the interference. You can also move the electronic device or its antenna to another location to solve the problem. If you continue to experience interference, contact Customer Service. This mScan device complies with part 15 of the FCC Rules. Operation is subject to the following two conditions: (1) This mScan device may not cause harmful interference, and (2) this device must accept any interference received, including interference that may cause undesired operation. However, changes or modifications not expressly approved by the party responsible for compliance could void the user's authority to operate the mScan device. FCC guidelines help ensure that the mScan device will not affect the operation of other nearby electronic devices. Additionally, other electronic devices should not affect the use of mScan system. mScan device 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: (1)Reorient or relocate the receiving antenna; (2) Increase the separation between the equipment and receiver; (3)Connect the equipment into an outlet on a circuit different from that to which the receiver is connected.

(4) contact Customer Service for help. 20-10026 Rev 1.0.0 1309 Beacon Street, Suite 300 Brookline, MA 02446 The mScan device comply with IEC 60601-1 and IEC 60601-1-2. The mScan device is tested to meet requirements of IEC 60601-1 and IEC 60601-1-2. The recommended wireless security measures include AES encryption. mScan device FCC ID is 2AWC6-1301. 25252525 Calibration Requirements No calibration is required for the mScan . Cleaning Caution: To avoid transmission of infection, wipe down the mScan between each patient use. The mScan may be wiped down with alcohol wipes. Under no conditions should the mScan be submerged in water or any other fluid. Care should be taken to prevent fluids from coming into contact with any part of the mScan . Storage, Maintenance and Repairs The mScan should be stored in a dry, clean, dust-free environment away from harmful chemicals, where the temperature never exceeds 95 degrees Fahrenheit. If the mScan appears to be malfunctioning, contact Myolex technical support for assistance by calling 888-382-8824 x10 or emailing support@myolex.com. All repairs to the mScan must be carried out by Myolex authorized technicians. Transport The mScan should always be transported in the case provided to ensure proper protection. When being shipped, the mScan should be placed inside the case, ensuring a snug fit, and the case should be placed in a shipping box with bubble wrap or shipping Styrofoam to minimize movement within the box. A label should be placed on the outside of the box indicating that its contents are fragile. Troubleshooting 1. mScan Turns Off: If the mScan turns off, simply press the button on handheld device to turn it back on. The mScan will turn off automatically if not used for more than 3 minutes. 20-10026 Rev 1.0.0 1309 Beacon Street, Suite 300 Brookline, MA 02446 26262626 2. mScan blink red three times rapidly: If the mScan blinks red rapidly at turn on, plug in charger to charge the device. This shows that the battery is low on charge. 3. mScan does not turn on: If the mScan does not turn on, plug in charger to charge the device. 4. Connectivity: If the iPad does not work, check the internet connection to make sure the iPad has good Internet connection. If this does not work, please contact Myolex at 888-382-8824 x10. Adverse Reaction Information Warning: Do not use the mScan on open wounds, rashes, burns, and other dermatological disorders. 20-10026 Rev 1.0.0 1309 Beacon Street, Suite 300 Brookline, MA 02446

Third Floor, 1309 Beacon St., Brookline MA, USA June 30, 2020 Attention: Application Examiner RE:

Request for Confidentiality Applicant: Myolex Inc. FCC ID: 2AWC6-1301 To Whom It May Concern:

Permanent Confidentiality Request is hereby submitted by Myolex Inc. to withhold permanently from public review certain portions of the application for equipment certification for the referenced FCC identifiers. This request for confidentiality is made pursuant to 47 CFR 0.457(d) and 0.459 of the FCC Rules. In particular, the following sections of the application are to be kept permanently confidential:

Schematics Detailed Block Diagrams Parts list Rationale for request for confidentiality:

Myolex Inc. has invested considerable time and materials in research and development to produce the referenced product. Permanent confidentiality: Disclosure of the permanently confidential portions of this application to competitors would not only give them significant competitive advantages in developing similar products, but would also disclose successful implementation of unpublished, leading edge technology developed by us. If you have questions or need further information, please contact the undersigned. Sincerely, Baoguo Wei VP Engineering, Myolex Inc. 1(1)

EIM1301 System Description Item #: DOC-1301-022 Rev:3.0.0 1.0 General System Description Intended Use: The EIM1301 is intended to measure, monitor and assess muscle status. Indications for Use: The EIM1301 is indicated as an aid in the diagnosis and monitoring of muscle disorders. Intended user: The EIM1301 will be used by physical therapist and medical staff including physicians, nurses, technicians, and research assistants The EIM1301 system comprises the following:

1. A cloud backend for storing data. 2. A mobile device with software for interacting with a user, communicating with the handheld device for acquiring data and communicate with a cloud backend for storing data. 3. A handheld EIM device for measuring localized bioimpedance at one or more angles and frequencies;

4. Disposable sensor which attach to the handheld device and make contact with the patient;

The EIM1301 Hardware includes the mobile device, the handheld device, a disposable sensor, the mobile device is a commercial off-the-shelf mobile device requiring no hardware development. The handheld device includes the following:

1. Electronics a. Analog front end circuitry to measure voltages and currents from multiple electrodes;

Confidential-Unauthorized Use is Prohibited Page 1 of 5 User of this document is responsible for using current revision Myolex, Inc. EIM1301 System Description Item #: DOC-1301-022 Rev:3.0.0 b. Mixed-signal circuitry to generate analog signals based on digital commands, and to convert measured analog signals to digital signals for post-processing, analysis and storage;

c. Digital circuitry to generate necessary controls, to acquire data from two analog-to-

digital converters, to perform signal processing, and to communicate between the handheld device and the mobile device. 2. Mechanical housing with the following features a. Two pushbuttons to initiate EIM tests;

b. Mechanisms to mechanically and electrically attach to the electrode array and dispose the electrode array after use. c. LEDs to indicate measurement status and battery charging/Discharge status The electrode array includes the following:

1. Electronics pad. to the handheld. 2. Mechanical loaded into the handheld. a. An electrode array is made of flexible, biocompatible material adhered to a conformable b. Each electrode array has 6 landing pads that electrically connect the electrode array a. 6 landing pads on top to mechanically and electrically connect to the handheld when Myolex, Inc. Confidential-Unauthorized Use is Prohibited Page 2 of 5 User of this document is responsible for using current revision EIM1301 System Description Item #: DOC-1301-022 Rev:3.0.0 2.0 Technical Description The EIM1301 applies a swept sinusoid electrical current across two electrodes and measures the resulting voltage across a second set of electrodes. The handheld portion of the device is rechargeable battery powered and could be charged by a USB charger. The handheld device shall be certified to meet the safety standards set by IEC 60601-1, Ed 2: Medical Electrical Equipment Part 1: General Requirements for Safety. Min. Val 3.3V Max. Val 4.2V Note Nominal Val 3.7 V 4.75V 5.50V 5.0V Charger maximum current 1.0A N/A (AC coupled) 500 mV 10 mV Measured voltage on skin 5 mV N/A (AC coupled) 1.2AH 100 uA 3 sec 0.1 0 0 40 C 70 C 90%

Applied signal is swept sinusoid with 42 total frequencies for impedance greater than 50 . for impedance less than 50 between 10KHz to 1MHz for impedance greater than 50 . Less than 10KHz and Greater than 1MHz for impedance greater than 50

. between 10KHz to 1MHz for impedance less than 50 Less than 10KHz and Greater than 1MHz for impedance less than 50 . 3.0 Key Requirements Specification 3.0.1 Handheld Device Battery power 3.0.2 Handheld Device Battery Charger 3.0.3 Handheld Device Battery Capacity 3.0.4 Applied AC current

(RMS) 3.0.5 Applied DC current

(RMS) 3.0.6 Resulting AC voltage

(RMS) 3.0.7 Applied differential DC voltage 3.0.8 Signal frequency range

(Hz) 3.0.9 Measurement time 3.0.10 Impedance range 3.0.11 Frequency range 3.0.12 Phase range 3.0.13 Phase resolution 3.0.14 Precision Raw Impedance 3.0.15 Precision Raw Impedance 3.0.16 Accuracy Raw Impedance 3.0.17 Accuracy Raw Impedance 3.0.18 Accuracy Raw Impedance 3.0.19 Accuracy Raw Impedance 3.0.20 Operating Temperatures 3.0.21 Storage Temperatures 3.0.22 Operating Humidity 0 0 0 0 1 kHz 10 MHz 2 sec 1 1kHz

-180 8 sec 3000 10kkHz

+180 3%

1 mA

<1 uA 1 1%

5%

1 5 10 C

-40 C 10%

Myolex, Inc. Confidential-Unauthorized Use is Prohibited Page 3 of 5 User of this document is responsible for using current revision EIM1301 System Description Item #: DOC-1301-022 Rev:3.0.0 4.0 Radio transmitter mScan device use Nordic NRF51822 chip as the base with an external chip antenna AMCA31-2R450G-

S1F-T made by Abracon LLC. NRF51822 Bluetooth transmitter brief spec:

Frequency band: 2.4GHz ISM (2.402 2.480GHz) On air data rate: 250 kbps, 1 Mbps or 2Mbps Output power: 0.51dBm Sensitivity: -93dBm Bluetooth low energy; -96dBm at 250kb; -90dBm at 1Mbs; -85dBm at 2Mbs Oscillators: 16MHz crystal oscillator; 32kHz crystal oscillator AMCA31-2R450G-S1F-T chip antenna brief spec:

RF Family/Standard: Bluetooth, WiFi Frequency Group: UHF (2GHz ~ 3GHz) Frequency (Center/Band): 2.4GHz Frequency Range:

Antenna Type:

Number of Bands:

VSWR: 2 Gain: 0.5dBi Power Max: 3W 2.405GHz ~ 2.495GHz Chip 1 Myolex, Inc. Confidential-Unauthorized Use is Prohibited Page 4 of 5 User of this document is responsible for using current revision System Description Item #: DOC-1301-022 Rev:3.0.0 EIM1301 Revision History Revision DCO#

Description of Changes Changed By 2.0.0 DCO 19-007 Initial document release 3.0.0 DCO 20-002 Accuracy spec refined based engineering development B. Wei B.Wei Myolex, Inc. Confidential-Unauthorized Use is Prohibited Page 5 of 5 User of this document is responsible for using current revision