1
11
20-10026 Rev 1.0.0
1309 Beacon Street, Suite 300
Brookline, MA 02446
User Manual
“Caution – Investigational Device. Limited by United States Law to Investigational Use.”
Page 1: ...1 1 1 1 20 10026 Rev 1 0 0 1309 Beacon Street Suite 300 Brookline MA 02446 User Manual Caution Investigational Device Limited by United States Law to Investigational Use...
Page 2: ...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...
Page 3: ...gging 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 Setting...
Page 4: ...ite 300 Brookline MA 02446 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 charg...
Page 5: ...ndicate device charging status while device is in sleep 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...
Page 6: ...ower 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 dev...
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Page 8: ...20 10026 Rev 1 0 0 1309 Beacon Street Suite 300 Brookline MA 02446 2 Primary App Actions Logging in 2 Enter your email address and password provided for your log in 1 Launch the Myolex mScan app on yo...
Page 9: ...ine MA 02446 Adding a new patient 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 w...
Page 10: ...0 1309 Beacon Street Suite 300 Brookline MA 02446 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...
Page 11: ...Beacon Street Suite 300 Brookline MA 02446 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 sel...
Page 12: ...o 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 b...
Page 13: ...r 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 T...
Page 14: ...e signifying scanning The mScan app will ping a noise and the mScan LED will change to a green light when the scan is complete 1 1 1 1 View instructions for scanning the muscle The mScan device LEDs c...
Page 15: ...an 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 sel...
Page 16: ...rcle 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...
Page 17: ...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 1 After all muscles are scann...
Page 18: ...18 18 18 18 20 10026 Rev 1 0 0 1309 Beacon Street Suite 300 Brookline MA 02446 Past scans 1 After selecting a patient select a past session and muscles you would like to review...
Page 19: ...ite 300 Brookline MA 02446 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 u...
Page 20: ...Rev 1 0 0 1309 Beacon Street Suite 300 Brookline MA 02446 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 complet...
Page 21: ...21 21 21 21 20 10026 Rev 1 0 0 1309 Beacon Street Suite 300 Brookline MA 02446 Account details 1 To change your account email or password go to Settings and tap on Account...
Page 22: ...22 22 22 22 20 10026 Rev 1 0 0 1309 Beacon Street Suite 300 Brookline MA 02446 Firmware update 1 To update mScan device go to Settings and follow the instructions after tapping Update mScan...
Page 23: ...ce 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 pr...
Page 24: ...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 Howeve...
Page 25: ...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...
Page 26: ...tery 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 th...
