Myolex mScan User manual

1
11
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.”

2
22
2
20-10026 Rev 1.0.0
1309 Beacon Street, Suite 300
Brookline, MA 02446
IMPO TANT 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 prepare with the objective of provi ing the user all of the
information necessary to operate the investigational Myolex mScan™ accor ing to stu y
protocols approve by an Institutional Review Boar . The Stu y Protocol shoul be rea
carefully before using the investigational system for the first time, an shoul be strictly
followe .
User Assistance Information
For information an /or issues regar ing usage of the Myolex mScan™, please call Myolex
at 888.382.8824 x10 or email [email protected]

3
33
3
20-10026 Rev 1.0.0
1309 Beacon Street, Suite 300
Brookline, MA 02446
Table of Contents
1. Myolex mScan™ System Overview………………………….……………………………….page 4
• What’s inclu e
• Power up
2. Primary App Actions…………………………………………………………………………………page 7
• Logging in
• A 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 evice
• Account etails
• Firmware up ate
6. Technical Specification……………..…………………………………………………………page 21
• Power an calibration requirements
• Cleaning, storage, maintenance, an repairs
• Transport

4
44
4
20-10026 Rev 1.0.0
1309 Beacon Street, Suite 300
Brookline, MA 02446
• Troubleshooting an a verse reaction information
1. Myolex mScan™ System Overview
What’s included
1. Apple iPa an charging cable
2. Myolex mScan™ evice, carrying case,
an charging cable.
3. Myolex mScan™ foam electro es sensor

5
55
5
20-10026 Rev 1.0.0
1309 Beacon Street, Suite 300
Brookline, MA 02446
mScan™ Device
LED light in icator: use to in icate evice operating status while evice is on. It will
change color epen ing on operating status. It will blink or isplay a stea y light for epen ing
on the specific operation.
Charge in ication LED light: use to in icate evice charging status while evice is in sleep
mo e (not turne on). When it blinks re slowly, it means the evice is being charge . When it
blinks green slowly, it means the evice is at least 80% charge an rea y for use.
Charge port: use to connect to a charge source via USB C cable for charging the evice.
Electro e sensor ejection button. Pushing the button will eject the electro e sensor.
Power on/off buttons: Press both buttons together to turn on the evice; press both
buttons again to turn off the evice.
5
2
3
4
2
3
1
5
1
4

6
66
6
20-10026 Rev 1.0.0
1309 Beacon Street, Suite 300
Brookline, MA 02446
mScan™ foam electrodes sensor
The sensor has two si es, one si e is be place against the metal contacts on mScan™ evice
an the other si e contacts the subject’s skin. The Myolex label shoul face out (ie be rea able)
when being inserte into the evice.
Power up
iPa
1. Charge your iPa with the cable provi e
2. Press the Home button to enter the iPa
3. Enter the passco e provi e
4. Ensure your iPa is connecte to a WiFi network
mScan™
1. Charge the evice with the cable provi e
2. When the charger is plugge in, the evice LED lights blinks re slowly if battery is not
fully charge . The LED light will change to flashing green when it is charge .
3. Once the evice is charge , press an hol the left button to turn on the evice until the
LED light in icator turns stea y green.

7
77
7
20-10026 Rev 1.0.0
1309 Beacon Street, Suite 300
Brookline, MA 02446

8
88
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 a ress an passwor provi e for your log in.
1. Launch the Myolex mScan™ app on your iPa .

9
99
9
20-10026 Rev 1.0.0
1309 Beacon Street, Suite 300
Brookline, MA 02446
Adding a new patient
1. The first screen that appears after
logging in will look like this.
2. To begin, tap the A a Patient button
on the top right corner of the screen.
3. The Save button will become enable
once all the require fiel s are
complete .

10
1010
10
20-10026 Rev 1.0.0
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 filtere to show
results for your search.

11
1111
11
20-10026 Rev 1.0.0
1309 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 isplaye .
From here, you can e it patient information,
select prior scans, or start a new scan.

12
1212
12
20-10026 Rev 1.0.0
1309 Beacon Street, Suite 300
Brookline, MA 02446
3. Scanning
Load foam electrode to mScan™ device
1. Remove a sensor from seale bag.
2. Loa the sensor into the mScan™ evice. Make sure the correct marke si e is place
against the evice in or er for it to click in properly. See image below. The wor
“Myolex” shoul face out an shoul be positione so that it is in proximity to the
on/off buttons.

13
1313
13
20-10026 Rev 1.0.0
1309 Beacon Street, Suite 300
Brookline, MA 02446
Select muscles to scan
1. Switch between Anterior an 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
enable once at least one muscle is selecte .
3. Tap Start Scanning to start the scan.
Note: Left an right switch si es epen ing on
which view you are using (anterior/posterior).

14
1414
14
20-10026 Rev 1.0.0
1309 Beacon Street, Suite 300
Brookline, MA 02446
Scan muscles
2.
2.2.
2. The mScan™ device LEDs change o a s eady
blue ligh when scanning begins and during he
scanning process. The iPad will display a Blue
circle signifying scanning. The mScan™ app will
ping a noise and he mScan™ LED will change
o a green ligh when he scan is comple e.
1.
1.1.
1.
View
ins ruc ions
for
scanning
he
muscle.
The mScan™ device LEDs change from green
o blinking blue when you S ar Scan.
3.
3.3.
3. An error message will be displayed if he mScan™
is unable o connec o he app or scan he muscle
properly. Simply reposi ion he mScan™ on he
muscle and a emp scanning again.

15
1515
15
20-10026 Rev 1.0.0
1309 Beacon Street, Suite 300
Brookline, MA 02446
4. eview Scans
eview results
1. After your scan is complete on a single muscle,
review your results. Toggle between Overview an
Data Detail to view ifferent charts.
2. Choose to either perform another scan on the
same muscle by tapping 2n Scan, or move on by
tapping Next Muscle. If it is the last muscle to be
measure , tap View Summary.
3. Up to 3 scans can be complete for a single
muscle. All scans will be plotte . You will be
required to select one scan to keep and the
others will be automatically discarded. It will
efault to keeping the last scan performe (e.g.
secon scan if you scanning twice an thir scan if
you scanne three times). You will have an
opportunity to return to this muscle an obtain
more ata after you have complete scanning all
muscles.

16
1616
16
20-10026 Rev 1.0.0
1309 Beacon Street, Suite 300
Brookline, MA 02446
Explanation of esults
The
Overview
Tab
1. Normalize Value Provi es an image of showing the expecte norma range of the muscle for the 50
kHz phase (light green) as a percent pre icte of normal values for the subject’s sex, height, an
weight. Dark green color represents above norma . Maize color shows values be ow norma . The larger
circle represents the most recent measurement uring the session; small circles represent the earlier
measurements of the session.
2. Data at 50 kHz isplays the raw impe ance values at 50 kHz for each of the measurements, color
co e to match the figure above.
3. Percent pre icte (PP) tren shows the percent pre icte 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 impe ance parameters between
10 kHz an 10 MHz versus frequency an the Reactance versus Resistance Plot in the lower right
(Cole-Cole Plot).

17
1717
17
20-10026 Rev 1.0.0
1309 Beacon Street, Suite 300
Brookline, MA 02446
Summary Page
3. Return to patient screen by tapping Session
List at the top. (Note: since only one of the three
measurements ha been selecte earlier, the
other measurements are no longer visible.) Or
tap Re o Muscle Scan to scan the selecte
muscle again an replace the ata you
previously collecte .
1. After all muscles are scanne , tap on View Summary to see a summary of all muscles scanne .
2. Tap on in ivi ual muscles to view etails
in a new page. If user en s a session without
performing all scans, unfinishe scans
appear as an X.

18
1818
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
an
muscles
you
woul
like
to
review.

19
1919
19
20-10026 Rev 1.0.0
1309 Beacon Street, Suite 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, an up ate
your mScan™ evice firmware an account
etails.

20
2020
20
20-10026 Rev 1.0.0
1309 Beacon Street, Suite 300
Brookline, MA 02446
Pair a device
1. To pair the mScan evice with the app,
go to Settings an tap on Pair mScan.
2. Follow the irections on the next pair to
complete the pairing process.