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20-10026 Rev 1.0.0

 

 

 

 

1309 Beacon Street, Suite 300

 

Brookline, MA 02446

 

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®

 

B

luetooth® 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: 

Содержание mScan

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 7: ...7 7 7 7 20 10026 Rev 1 0 0 1309 Beacon Street Suite 300 Brookline MA 02446...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

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