User Manual “Caution – Investigational Device. Limited by United States Law to Investigational Use.” 20-10026 Rev 1.0.
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.
Table of Contents 1. Myolex mScan™ System Overview………………………….……………………………….page 4 • What’s included • Power up 2. Primary App Actions…………………………………………………………………………………page 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……………………………………………..………………………………………………….
• Troubleshooting and adverse reaction information 1. Myolex mScan™ System Overview What’s 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.
mScan™ Device 1 2 3 4 5 1 LED light indicator: used to indicate device operating status while device is on. It will change color depending on operating status. It will blink or display a steady light for depending on the specific operation. 2 Charge indication LED light: used to indicate device charging status while device is in sleep mode (not turned on). When it blinks red slowly, it means the device is being charged.
mScan™ foam electrodes sensor The sensor has two sides, one side is be placed against the metal contacts on mScan™ device and the other side contacts the subject’s 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.
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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.
Adding a new patient 1. The first screen that appears after logging in will look like this. 3. The Save button will become enabled once all the required fields are completed. 2. To begin, tap the Add a Patient button on the top right corner of the screen. 20-10026 Rev 1.0.
Search for a patient 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. 20-10026 Rev 1.0.
Select a patient 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.
3. Scanning Load foam electrode to mScan™ device 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.
Select muscles to scan 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.
Scan muscles 1. View instructions for scanning the muscle. The mScan™ device LEDs change from green to blinking blue when you Start Scan. 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.
4. Review Scans Review results 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.
Explanation of Results 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 subject’s 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.
Summary Page 1. After all muscles are scanned, tap on View Summary to see a summary of all muscles scanned. 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.
Past scans 1. After selecting a patient, select a past session and muscles you would like to review. 20-10026 Rev 1.0.
5. Settings Settings page 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.
Pair a device 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.
Account details 1. To change your account email or password, go to Settings and tap on Account. 20-10026 Rev 1.0.
Firmware update 1. To update mScan device, go to Settings and follow the instructions after tapping Update mScan. 20-10026 Rev 1.0.
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.
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.
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. 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.
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.
