ACP Synchrony User manual

© COPYRIGHT 2015-2021, ACCELERATED CARE PLUS CORP., ALL RIGHTS RESERVED
CONFIDENTIAL AND PROPRIETARY
Synchrony
Equipment User Manual
Revised 09.15.2021
Part No. MNL-0001 Rev 3
This manual contains confidential and proprietary information owned by Accelerated Care Plus (“ACP”), division of Hanger Inc. which is
protected by copyright. This manual or any portion thereof may not be photocopied, reproduced or translated to another language without the
express prior written consent of ACP. This manual may only be used by entities who purchased the equipment or have implemented the ACP
program and are covered by an executed Lease Agreement with ACPL containing a Confidentiality Agreement, which is incorporated by
reference in its entirety. This manual may not be used for any other purpose.
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and written authorization from ACP. No authorization is given to market, sell, disclose, or exploit this manual except as for purposes of using the
equipment as contemplated by the Lease Agreement.
ACCELERATED CARE PLUS MAKES NO WARRANTY OF ANY KIND WITH REGARD TO THIS MANUAL, INCLUDING, BUT NOT
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Accelerated Care Plus and Hanger Inc., shall not be liable for errors contained herein or for incidental or consequential damages in connection
with the furnishing, performance or use of this manual. The information contained in this document is subject to change without notice.

© COPYRIGHT 2015-2021, ACCELERATED CARE PLUS CORP., ALL RIGHTS RESERVED
CONFIDENTIAL AND PROPRIETARY
Synchrony
ACP manufactures a premier line of rehabilitation technologies to assist health care professionals with improved
outcomes and quality-of-life for patients. The ACP product line includes Pain Control Systems, Muscle Stimulators,
Interferential Therapy, Therapeutic Ultrasound, Pulsed Shortwave Diathermy devices, and advanced Therapeutic
Exercise Systems. Our OMNICYCLE®,OMNISTAND®, OMNISWD®,OMNIVR®, OMNIVERSA®,
SYNCHRONY and OMNIsEMG™products represent the most recent worldwide advances available for therapeutic
application of electro medical devices and other rehabilitation technology.
ACP is internationally recognized for its contribution to research in the development of medical applications for
therapeutic rehabilitation. The company sponsors and conducts research at leading health care institutions and major
universities throughout the world. This new medical frontier holds great promise and opportunity, which will result
in substantial advancements in the health care industry and for ACP.

SYNCHRONY EQUIPMENT USER MANUAL
© COPYRIGHT 2015-2021, ACCELERATED CARE PLUS CORP., ALL RIGHTS RESERVED
CONFIDENTIAL AND PROPRIETARY
TABLE OF CONTENTS
INDICATIONS & CONTRAINDICATIONS ..................................................................................................1
Indications for Use ........................................................................................................................................ 1
Contraindications .......................................................................................................................................... 1
WARNINGS & PRECAUTIONS ..................................................................................................................2
Warnings ....................................................................................................................................................... 2
Precautions .................................................................................................................................................... 2
SYNCHRONY AND OMNISEMG™INTRODUCTION .................................................................................3
OPERATION OF SYNCHRONY..................................................................................................................4
Main Menu .................................................................................................................................................... 5
Continue Treatment ...................................................................................................................................... 6
New Treatment ........................................................................................................................................... 12
Performing an Exercise .............................................................................................................................. 15
Performing an Assessment ......................................................................................................................... 20
Set-Up Assistant.......................................................................................................................................... 21
Administrator Section ................................................................................................................................ 22
Improving Connectivity ............................................................................................................................. 23
Electrode Setup – Connecting the sEMG sensor ........................................................................................ 24
INFECTION CONTROL EQUIPMENT AND PRINCIPLES OF USE ........................................................25
TECHNICAL SPECIFICATIONS ...............................................................................................................27
TROUBLESHOOTING...............................................................................................................................28
STANDARD LIMITED PRODUCT WARRANTY.......................................................................................29
SYNCHRONY AND OMNIsEMG™ACCESSORIES .................................................................................31

SYNCHRONY EQUIPMENT USER MANUAL 1
© COPYRIGHT 2015-2021, ACCELERATED CARE PLUS CORP., ALL RIGHTS RESERVED
CONFIDENTIAL AND PROPRIETARY
INDICATIONS & CONTRAINDICATIONS
Indications for Use
Synchrony consists of a Dysphagia Cart, Omnistim®FX2 Portable PENS, and an OMNIsEMG™surface
electromyography (sEMG) biofeedback system. These devices are used in adjunct to oral motor and swallowing
exercise and treatment. sEMG biofeedback has been found to assist clinicians and patients with the following:
•Facilitate relaxation of tense or hypertonic muscles
•Discriminate among different types of muscle activity
•Differentiate effects of posture or other variables on muscle activity
•Learn new behaviors
•Learn unfamiliar behaviors
•Learn behaviors difficult to conceptualize or identify under normal circumstances
Contraindications
Treatment should be paused or terminated should the clinician observe any of the following patient behaviors:
•Chest pain
•Severe shortness of breath
•Significant blood pressure changes
•BP > 200/110
•Lightheadedness; BP drops > 20mmHg
•Severe headache
•Sudden onset of numbness or weakness
•Onset of confusion
•Ataxia
•Pallor
•Cyanosis
•Cold and clammy skin
•Noticeable changes in heart rhythm
•Patient requests the exercise/activity be stopped

2 SYNCHRONY EQUIPMENT USER MANUAL
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WARNINGS & PRECAUTIONS
Warnings
•Use the product according to its indications.
•Avoid connecting the sensors to the charger with inverted polarity, as this may damage the sensors.
The correct polarity is shown on the charger station.
•Do not immerse components in water.
•Only apply the electrodes on undamaged skin according to electrode labeling.
•Use appropriate hypoallergenic double-sided tape, compatible with the usage on undamaged skin for brief
periods of time to hold wires or skin jowling in place during treatment.
•Periodically test the integrity of the device and of its components.
•Should elements of the device, such as the transducers be dropped, or appear to be damaged in any way,
retest them immediately for proper function. If they are non-functioning, do not attempt any kind of
internal maintenance of the device. Always seek authorized technical support.
•In addition to the users’ instructions, the prescriptions regarding accident prevention and technical
regulations regarding occupational safety must also be complied with. The appertaining national
regulations and standards of the country of use, with regards to prevention of accidents and environment,
are an extension of the users’ instructions.
•The device uses a lithium ion battery. Battery replacement and disposal should only be performed by the
ACP Service Center or an authorized repair facility.
•If the power cable for your Synchrony equipment appears damaged or frayed, please don’t use it and
contact our Customer Support department for a replacement.
Precautions
Synchrony is a professional rehabilitation tool intended for patients of all ages who have been diagnosed with
dysphagia or are experiencing difficulty in the oral or pharyngeal phase of swallowing. Synchrony requires the
skills, knowledge and judgment of a qualified practitioner licensed in the state of practice, such as a Speech and
Language Pathologist. Their guidance and supervision is required for the safe and efficacious use of Synchrony
with patients.
Synchrony cannot monitor nor guarantee patient safety. The practitioner should judge whether a particular
individual is able to perform a specific exercise or activity, and monitor the patent's performance and safety
throughout the treatment session.
Additional specific “Precautions” are noted below:
•Do not apply any electrode gel or equivalent directly on the sensor snap terminals.
•Always use ACP electrodes as a medium between the sensor and the skin surface.
•Make sure to remove electrodes from sensor lead wires immediately after use.
•Do not connect third party sensors directly into instrument inputs.
•Use only ACP sensors, cables and electrodes.
•Use appropriate infection control and cleaning.

SYNCHRONY EQUIPMENT USER MANUAL 3
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SYNCHRONY and OMNIsEMG™Introduction
Synchrony incorporates a virtual reality augmented biofeedback rehabilitation unit called the OMNIsEMG™
(sEMG) which has been specifically designed to accommodate patients with difficulty swallowing as a result of oral
or pharyngeal muscle dysfunction. Synchrony provides swallowing data and interactive exercise activities are
displayed on a color monitor using specialized computer software. Research supports the use of virtual reality
augmented sEMG biofeedback in conjunction with traditional Speech and Language Pathologist (SLP) therapy
techniques. Specifically, patients appear to benefit from what is referred to as the “virtuous cycle”, where patients
perform more exercise repetitions when they are motivated by the positive feedback provided in an interactive
“virtual reality” based environment.
Delivery of Synchrony and OMNIsEMG™
Upon receipt of Synchrony, inspect the shipping container and contents for any obvious or concealed damage. All
ACP products are packaged carefully for rapid, safe delivery. We guarantee delivery in perfect condition to the
postal or delivery services. However, any damage or loss incurred during transportation or delivery is the postal or
Delivery Company’s responsibility. If damage or loss to the product and/or container is obvious or suspected,
appropriate notation must be made on the signed freight bill at the time of delivery. All damage claims should be
promptly filed with the delivering carrier and must be initiated by the addressee where the package was to be
delivered. Retain the original shipping container and inserts for validation of damage claim or use at a later date.
Please contact your ACP Clinical Program Consultant or call ACP Customer Service at 800-350-1100 to report any
damage.
NOTE: The purpose of this manual is to acquaint medical and therapy professionals with Synchrony.
Please read the manual carefully before attempting to operate Synchrony. If questions remain
unanswered, contact your ACP Clinical Program Consultant or call ACP Customer Service at
800-350-1100. Outside the USA, call 1-775-685-4000.

4 SYNCHRONY EQUIPMENT USER MANUAL
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OPERATION OF SYNCHRONY
To Turn ON Synchrony
1. The Synchrony cart should be plugged in when not in use to allow the OMNIsEMG™sensors to remain
charged. Ensure the charging station is turned on and the sensors are plugged in properly and charging.
Fully charged sensors should be available at the start of the day. Replace the sensors on the charger cradle
after each use so they remain fully charged.
2. Turn on the computer by pressing the green (GO) button on the front of the computer module located in the
top tray storage compartment.
3. Turn on the monitor (as needed).
4. Enter password. Your SLP rep or Customer Support will supply you the password.
5. The Main Menu screen will appear automatically after a series of start-up screens load.
To Turn OFF Synchrony
2. A message appears asking for confirmation. Click OK to confirm the intent to turn off the computer.
3. Remove the power strip plug from the wall outlet if the cart is being transported. Otherwise, leave the cart
plugged in, to charge the OMNIsEMG™sensors.
NOTE: Do not remove power cord from the wall outlet before Synchrony is powered “OFF” using the
procedure above. Synchrony may remain "on" for extended periods, including overnight, without
harming it or reducing the unit's longevity.

SYNCHRONY EQUIPMENT USER MANUAL 5
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Main Menu – Software version v4.0
The Synchrony home screen is created in simple workflow modules explained below.
Continue treatment – selecting the intended patient to continue treatment. – continue an existing patient’s
treatment. Clinicians may be prompted to sign-in prior to selecting the intended patient to continue treatment.
New treatment – create a new patient for treatment with Synchrony. Clinician may be prompted to sign-in prior to
creating new patient treatment.
Single exercise – allows the user to perform an exercise and decide to save the data to a patient record during or at
the completion of the exercise session.
Review patient records – access to the Synchrony database of patients. Clinician will be promoted to sign-in prior
to accessing the database.
System tray items
Shut down –select to power down the Synchrony system
Administrator – provides access to the Synchrony Administrator
Help – provides access to informational items pertaining to the use and operation of Synchrony
Sensor 1 and 2 connections – when a sEMG sensor is connected its battery icon will display
with its current level of charge, as in sensor 1 example. If not connected, as in the example of sensor 2, the sensor
will appear faded out.
Improve connectivity – optimizes the Wi-Fi connection of the sEMG sensor to the computer.

6 SYNCHRONY EQUIPMENT USER MANUAL
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Continue treatment
Enter assigned Clinician ID and
Password. When signed in, the current
database of patients is presented
Note – clinician ID and Password are
case sensitive
Hover the mouse over the Continue
treatment section and click to continue
If not signed in, the therapist will be
prompted to enter their Clinician ID and
Password
Select patient – select the patient to continue
treatment and either double click their Patient
ID or click Start session to continue
Note – the Clinician ID who is signed in will
be displayed in the top right of the screen

SYNCHRONY EQUIPMENT USER MANUAL 7
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Session dashboard
When selecting an existing patient to continue treatment, the selected patient’s Session dashboard is displayed. The
Session dashboard is an at a glance display of recent patient activity. The dashboard will always display the Patient
ID in the upper right of the screen and the two most recent exercises performed in the middle of the screen. Other
items accessible from the Session dashboard include; Patient record, date and notes from the last session, outcome
measurers directly linked to the patient record, and a new “Session Notes” field.
Continuing a previous exercise
After selecting an exercise to continue, the specific exercise’s visualization, exercise parameters as well as the last
bolus type and volume used will be displayed. All of these can be edited and changed.
Start exercise
Bolus type and volume – the bolus type and
volume used in the last session are
displayed. To change, click on the dropdown
arrow in either box.
Visualizations and parameters – the values
for both are displayed on the right side of the
screen. To edit, click on the Visualization
box or Edit parameters icon.
Start exercise – clicking this advances to the
live exercise screen
Session dashboard
Select existing exercise – to continue a
previous exercise type, click on the
specific exercise
From the System admin start screen, select
Select other exercise – provides access to
the the library of therapeu
Manage patient’s option tic exercises,
assessment and “Set-up Assistant” Left
click the patient account to be edited and
then left
Last session – click the the date and
recorded notes
Manage patient’s button from the last
session are displayed in the lower left of
the screen

8 SYNCHRONY EQUIPMENT USER MANUAL
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Pre-exercise process – Resting baseline
All initial exercises will start with a pre-exercise session unless the clinician indicates differently. The software
prompts the patient to remain still and quiet for 5 seconds to obtain the “resting baseline.” To capture the resting
baseline manually, select “Mark manually”. To skip the resting baseline, select “Skip baseline”
Pre-exercise process – Mark 3 repetitions
The “Mark Repetitions” step will calibrate the exercise specific to the patient’s needs. Capturing three (3) typical
swallows prior to beginning of the effortful swallow exercise customizes the exercise target level for the specific patient.
Automatic –requests patient to
remain still and quiet for 5 seconds
Mark manually – the therapist
controls the start and stop time of the
resting baseline
Skip baseline – the resting baseline
will default to 10mV
Note – when footplate is attached the
footplate command L-M-R are
displayed on the command boxes.
Mark repetition – use the footplate or
mouse to mark 3 typical swallow
repetitions.
Remove last –allows the therapist to
remove the last captured/marked repetition
Pause/menu –pauses the pre-exercise
process

SYNCHRONY EQUIPMENT USER MANUAL 9
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Pre-exercise process – Review marked repetitions
After marking 3 typical swallow repetitions a review dashboard is provided. Each repetition can be edited or deleted.
If a marked repetition is deleted, the opportunity to resume the pre-exercise is provided.
Exercise display screen
The exercise display provides a way to observe the sEMG trace display along with the featured patient visualization.
The exercise command boxes, Mark repetition, Mark event and Pause will always be located in the lower right of
the screen for all exercises. When the footplate is connected, footplate commands (M, R and L) appear to aid in
navigation.
Editing a marked repetition - to edit a
marked repetition, click on the repetition and
reposition the repetition marker
Deleting a marked repetition – uncheck the
blue box to delete a repetition
Pause/menu - pauses the pre-exercise
process
Effortful swallow exercise screen
Progressive target – a 125% target is the
starting goal and is progressive. The target will
progressively increase or decrease based on the
patient’s performance during the exercise
Progressive increase of target – if during
three consecutive swallows the patient reaches
or exceeds the target, the target will reset
higher by 10%
Progressive decrease of target – if during
three consecutive swallows the patient does not
reach the target, the target will reset lower by
10%

10 SYNCHRONY EQUIPMENT USER MANUAL
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Pausing an exercise
All exercies can be paused and a menu of options — End exercise, Resume and Edit — is provided,
Editing parameters
All exercise parameters can be edited. When “Edit parameters” is selected a dialogue box offers the opportunity to
“Save before editing”. This is recommended. When “Save” is selected, the screen advances to the exercise
parameter screen to edit the selected exercise. After new parameters are set, advance to the exercise start screen
which now incorporates the newly established parameters.
End exercise – exercise stops and advances
to the “Exercise summary” page
Edit parameters – provides a way to save
the current exercise and edit the desired
parameters prior to re-starting
Resume – resumes exercise from the time
the pause started.
Note: all pauses will be marked in the Graph
display of the results

SYNCHRONY EQUIPMENT USER MANUAL 11
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Exercise summary report
Upon completion of an exercise the exercise summary dashboard is displayed, providing multiple views of the
completed exercise in a tabbed format. The default display is the Summary report providing an at-a-glance view of
each repetition.
Summary – an overview of each repetition.
The bar-graphs in green represent activity that
met or exceeded the exercise target values,
those in red did not.
Multiple tabs – multiple ways to observe the
exercise data are provided for editing and
documenting purposes
Redo exercise – a direct pathway to the start
page of the same exercise.
Done – returns to the patient’s dashboard
Generate QR Code – At the end of a
treatment session, a QR-code with
embedded device information, protocol
parameters and outcome results will appear.
The QR-code can be scanned so this
information can be added to the patient’s
Electronic Medical Record using the
ACPlus application.

12 SYNCHRONY EQUIPMENT USER MANUAL
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New treatment
“New treatment” allows the addition of a new patient into the Synchrony database. When selected, the therapist will
be prompted to sign-in if not already signed in. The process to add a new patient is simplified to only request the
minimum information to establish a record for each patient. The Patient record can be accessed throughout the
session or later to update all fields.
Sign in clinician
Add patient
Add patient requests the minimum amount of data to initiate a patient record. If the new patient is a patient
previously discharged from Synchrony, click the blue text below the Start treatment area “Continue with discharged
patients”. A list of discharged patients is provided to add onto caseload.
Hover the mouse (or use the touch
screen) over the New treatment section
and click
If not signed in a prompt will appear
requiring Clinician ID and Password
Enter assigned Clinician ID and
Password. When signed in, the current
database of patients is provided.
Note - clinician ID and Password are
case sensitive
Patient ID – please use a unique and HIPPA
compliant patient identification. Do not use any
patient identifiable information.
Start treatment – advance to the patient
dashboard.
Continue with discharged patient – presents a
list of previously discharged patients to add
back onto caseload.

SYNCHRONY EQUIPMENT USER MANUAL 13
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Session dashboard
The new treatment session dashboard will always display the Patient ID in the upper right of the screen alongside
the signed in treating clinician. The two main options, ‘Introduce patient to Synchrony’ and ‘Select exercise’ are
discussed below. The Session dashboard also provides access to other tools including access to the Patient record,
Outcome measures and a notes field.
Patient record
The Patient record provides several fields to track the patient’s progress and outcomes. It is suggested all the
relevant information is recorded to facilitate complete documentation. All fields are completed by using the
provided dropdown boxes or fields can be manually completed.
Multiple tab views of patient data – As the patient is progressed through the use of Synchrony, progress can be
reviewed by selecting the tabs.
Return to patient dashboard –To return to the Patient dashboard, use the Back arrow or click on the
Dashboard icon
Introduce patient to Synchrony – – a
free-form area intended to allow the
therapist to introduce sEMG to the patient
Select exercise – access to the library of
pharyngeal and oral therapeutic exercises,
Assessment and the Set-up
Assistant feature
Outcome measures – a file directly linked
to the patient record to allow the
patient record to be kept current
Note - to access any of the dashboard
functions, hover over the desired area and
click to continue
Patient information – Several fields of patient
data intended to help track the patient’s progress
and outcomes. Use the provided dropdown
boxes to make quick selections.
Cancel changes – to cancel any changes made
select the “Cancel changes” button.
Discharge patient – to discharge a patient from
Synchrony caseload click the “Discharge
patient” box. A prompt will appear requesting
the therapist update all the patient information.

14 SYNCHRONY EQUIPMENT USER MANUAL
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Introduction to Synchrony
Introduction to Synchrony allows the therapist to acquaint the patient to sEMG and swallowing exercise. Tools are
provided to demonstrate how events are marked in individual repetitions or as period markers. At the completion of
the Introduction, select “End introduction” and all the introduction data is removed and the screen will return to the
Patient dashboard.
Select exercise
A library of Swallow exercises, Oral exercises, Assessment and Set-up assistant are provided. Each therapeutic
exercises follows a common pathway of Pre-exercise set up, performing the exercise and viewing results.
Swallow exercises – offering includes
Typical swallow, Effortful swallow and
Mendelsohn Maneuver
Oral exercises – offering includes Tongue
against resistance, Tongue pull-back, Straw
sucking and Jaw grading
Assessment – an open assessment area that
allows the therapist to assess the patient’s
performance in conditions clinically
relevant for that patient
Set-up Assistant – a clinical pathway to
help clinicians determine the clinically
appropriate exercise based on functional
impairment or the intervention the therapist
desires to perform

SYNCHRONY EQUIPMENT USER MANUAL 15
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Performing an exercise – Example Effortful swallow
All exercises follow the same process of pre-exercise, exercise delivery and results. Each exercise also provides the
therapist with the recommended default visualizations and exercise parameter settings which can be edited and
tailored to the needs of each patient. Prior to initiating the exercise, follow the patient preparation guidelines as
presented in the “Innovations in Dysphagia Rehabilitation” course guideline. Refer to the Help Section of the
software for assistance.
Editing exercise parameters
When “Edit exercise” is selected, the selected exercises parameters are displayed with the default setting and values
highlighted in green. When changing the default settings, screen text appears, informing the therapist of the proposed
changes. It is suggested the therapist become familiar with the various parameters to optimize the exercise experience.
Start exercise
Bolus type and volume – the exercise bolus
type and volume can be set from the list
using the dropdown box in each section.
Exercise visualizations and parameters –
all exercises have clinician recommended
visualizations and parameters visualization
and exercise parameters default settings. To
edit, click on the Visualization box or “Edit
parameters” icon.
Start exercise live exercise screen –
clicking advances to the
sEMG Parameters
Channel #1 – display of the sEMG sensor in
use, either channel 1 or 2
High target: 125% - the percentage of the
target setting used in the exercise. To
change, use either use the + or – icons or the
slide bar
Automatically change high target –the
high target automatically changes higher or
lower depending on the response of the
patient. If this is changed, the exercise high
target value can be adjusted manually prior
to starting the exercise and throughout the
exercise

16 SYNCHRONY EQUIPMENT USER MANUAL
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Timing
Manual timing – the therapist controls the timing of the exercise duration (when the exercise starts and stops).
Other options include exercise duration based on time or number of repetitions.
Exercise parameters
Sound when marking repetition –the system default is a sound when a repetition is marked. This can be set on or
off.
Show last peak on bar – shadow of the prior repetition is displayed on the screen. This can be set on or off.
NOTE – Isometric based exercises will allow the therapist access to rest time and isometric work time
Changing exercise visualization types
Multiple exercise visualizations are provided for each exercise. The default visualization has been found to be the
clinician’s choice when initiating the exercise with a new patient. Not all visualizations are available for each
exercise. The visualization examples displayed here are for the Effortful swallow exercise. A video demonstration of
each visualization is provided within the Help section of the software.
Pre-exercise process – Resting baseline
All initial exercises will start with a pre-exercise unless the clinician changes the setting. The resting baseline is
automatic, requesting the patient to remain still and quiet for 5 seconds. To capture the resting baseline manually,
select “Mark manually.” To skip the resting baseline, select “Skip baseline.”
Bar graph – visualization of the intensity of
the exercise effort by the use of a bar graph
Trace display – visible sEMG trace of the
shape (quality) and intensity of muscle
activity
Work-rest cycles – adjustable on and off
exercise times to provide cues for timing and
or duration of muscle contractions
Kangaroo – animated visualization of the
intensity of the exercise effort shown by a
kangaroo jumping and collecting coins
Automatic - request patient to remain
and quiet for 5 seconds
Mark manually – the therapist
controls the start and stop of the
resting baseline
Skip baseline – the resting baseline
will be set at 10mv
Note - when footplate is attached the
footplate command L-M-R are
displayed on the command boxes.