Summary of Contents for Myolex mScan
- Page 1 1 1 1 1 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...
- Page 2 2 2 2 2 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™...
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Page 3: Table Of Contents
3 3 3 3 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. -
Page 4: Myolex Mscan™ System Overview
4 4 4 4 • Troubleshooting and adverse reaction information 1. Myolex mScan™ System Overview What’s included 2. Myolex mScan™ device, carrying case, 1. Apple iPad and charging cable and charging cable. 3. Myolex mScan™ foam electrodes sensor 20-10026 Rev 1.0.0... - Page 5 5 5 5 5 mScan™ Device 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.
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Page 6: Power Up
6 6 6 6 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. - Page 7 7 7 7 7 20-10026 Rev 1.0.0 1309 Beacon Street, Suite 300 Brookline, MA 02446...
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Page 8: Primary App Actions
8 8 8 8 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... - Page 9 9 9 9 9 Adding a new patient 1. The first screen that appears after 3. The Save button will become enabled logging in will look like this. once all the required fields are completed. 2. To begin, tap the Add a Patient button on the top right corner of the screen.
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Page 10: Search For A Patient
10 10 10 10 Search for a patient 2. Patients will be filtered to show 1. Use the search bar at the top to search results for your search. for a patient by either their name or ID. Tap on Search. 20-10026 Rev 1.0.0 1309 Beacon Street, Suite 300 Brookline, MA 02446... -
Page 11: Select A Patient
11 11 11 11 Select a patient 1. Tap on the Select button to view patient 2. The Review Patient page is displayed. information. 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... -
Page 12: 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”... -
Page 13: Select Muscle
13 13 13 13 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. -
Page 14: Scan Muscle
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. -
Page 15: Review Scans
15 15 15 15 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. -
Page 16: Explanation Of Results
16 16 16 16 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. -
Page 17: Summary Page
17 17 17 17 Summary Page 1. After all muscles are scanned, tap on View Summary to see a summary of all muscles scanned. 3. Return to patient screen by tapping Session 2. Tap on individual muscles to view details in a new page. -
Page 18: Past Scans
18 18 18 18 Past scans 1. After selecting a patient, select a past session and muscles you would like to review. 20-10026 Rev 1.0.0 1309 Beacon Street, Suite 300 Brookline, MA 02446... -
Page 19: Settings
19 19 19 19 5. Settings Settings page 1. The Settings icon is visible on certain screens 2. Settings is where you can pair mScan™, before scanning begins. check mScan™ battery percentage, and update your mScan™ device firmware and account details. -
Page 20: Pair Device
20 20 20 20 Pair a device 1. To pair the mScan device with the app, 2. Follow the directions on the next pair to go to Settings and tap on Pair mScan. complete the pairing process. 20-10026 Rev 1.0.0... -
Page 21: Account Details
21 21 21 21 Account details 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... -
Page 22: Firmware Update
22 22 22 22 Firmware update 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... -
Page 23: Technical Specification
The use of any other cable may result in increased emissions or decreased immunity of the mScan™ with regards to electromagnetic interference. Do not connect the mScan™ to an AC outlet that is controlled using a switch Warning: or dimmer. - Page 24 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.
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Page 25: Transport
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™... - Page 26 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.
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