ACP Synchrony - User Manual

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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.

Any additional copies of the manual shall be ordered from ACP. No changes or modifications shall be made to the manual without prior review

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

LIMITED TO, THE IMPLIED WARRANTIES OF MERCHANTABILITY AND FITNESS FOR A PARTICULAR PURPOSE.

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.

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The Synchrony is a virtual reality augmented biofeedback rehabilitation unit, specifically designed to assist patients with dysphagia (difficulty swallowing) resulting from oral or pharyngeal muscle dysfunction. It integrates with the Omnistim® FX2 Portable PENS and an OMNISEMG™ surface electromyography (sEMG) biofeedback system. The device provides swallowing data and interactive exercise activities displayed on a color monitor using specialized computer software. Research suggests that virtual reality augmented sEMG biofeedback, when used with traditional Speech and Language Pathologist (SLP) therapy techniques, can motivate patients to perform more exercise repetitions due to positive feedback in an interactive "virtual reality" environment.

Function Description:

The Synchrony system facilitates relaxation of tense or hypertonic muscles, helps discriminate among different types of muscle activity, differentiates the effects of posture or other variables on muscle activity, and aids in learning new behaviors, including those difficult to conceptualize or identify under normal circumstances. It is a professional rehabilitation tool intended for patients of all ages diagnosed with dysphagia or experiencing difficulty in the oral or pharyngeal phase of swallowing. The system requires the skills, knowledge, and judgment of a qualified practitioner, such as a Speech and Language Pathologist, for safe and efficacious use.

Important Technical Specifications:

OMNISEMG™ Transmitter / Sensor:

Geometry: Variable
Electrodes: Standard sensing electrode with clip connection
Battery: Rechargeable lithium ion
Dimensions: 17mm x 36mm x 8mm
Weight: <9g battery included
Frequency: ISM band 2.4GHz (standard IEEE802.15.4)
Input Impedance: >10G Ohms
CMMR: >110db @ 50-60Hz
Resolution: 16bit
Acquisition frequency: Up to 4KHz
Sensitivity: 1µV

OMNISEMG™ Receiver / Dongle:

Dimensions: 152mm x 82mm x 22mm
Weight: 240g

OMNISEMG™ Ambient Conditions:

Operation: -20 °C to +45 °C, 50 to 80% Rh, non-condensing
Storage or Transportation: 0 °C to +40 °C, 50 to 80% Rh, non-condensing
Altitude: 0 to 2000M
Autonomy: Up to 24 hours with rechargeable battery

Usage Features:

The Synchrony system features a user-friendly interface with a main menu offering "Continue treatment," "New treatment," "Single exercise," and "Review patient records" options.

Turning ON: The cart should be plugged in to keep OMNISEMG™ sensors charged. Turn on the computer by pressing the green (GO) button, then the monitor, and enter the password. The Main Menu screen will load automatically.
Turning OFF: A message will appear asking for confirmation to turn off the computer. Click OK. The cart can remain plugged in to charge sensors unless being transported.
Main Menu (Software v4.0):
- Continue treatment: For existing patients, clinicians may need to sign in.
- New treatment: To create a new patient record; clinicians may need to sign in.
- Single exercise: Allows performing an exercise and saving data to a patient record during or after the session without requiring a sign-in initially.
- Review patient records: Accesses the patient database, requiring clinician sign-in.
- System tray items: Includes "Shut down," "Administrator" (for system administrative fields), and "Help."
- Sensor connections: Battery icons display charge levels for connected sEMG sensors.
- Improve connectivity: Optimizes Wi-Fi connection for sEMG sensors.
Clinician Sign-in: Requires a Clinician ID and Password (case sensitive) to access patient data or create new treatments.
Patient Selection: Allows selecting an existing patient to continue treatment or adding a new patient.
Session Dashboard: Provides an at-a-glance view of the patient's treatment history, including previous exercises, dates, and outcomes.
Exercise Setup: Allows clinicians to select exercises, set parameters (sEMG, timing, sound, visualization), and establish a resting baseline.
- sEMG Parameters: Channel #1 display, high target (125%), and automatic high target adjustment.
- Timing: Manual timing or duration based on time/repetitions.
- Exercise Visualizations: Bar graph, trace display, work-rest cycles, and kangaroo animation.
Pre-exercise Process:
- Resting Baseline: Automatic or manual capture of a 5-second quiet baseline.
- Mark 3 Typical Swallow Repetitions: Calibrates the exercise target based on patient's needs. Allows marking, removing last, and pausing.
- Review Marked Repetitions: Allows editing or deleting marked repetitions.
Exercise Display Screen: Shows sEMG trace with patient visualization. Displays progressive target adjustments (increase/decrease) based on performance.
Pausing an Exercise: Provides options to "End exercise," "Resume," or "Edit parameters." Pauses are marked in the graph display.
Editing Parameters: Allows modification of all exercise parameters, with a recommendation to "Save before editing."
Exercise Summary Report: Displays a dashboard with multiple views of the completed exercise in a tabbed format, including a summary of repetitions, graphs, and detailed results. Green bars indicate contractions meeting or exceeding targets, red bars indicate those that did not.
Generate QR Code: At the end of a session, a QR code with embedded device information, protocol parameters, and outcome results can be scanned into the patient's Electronic Medical Record using the ACPlus™ application.
Single Exercise Pathway: An express path to initiate an exercise or assessment, allowing data to be linked to an existing or new patient record.
Assessment: Used to validate sensor performance and quantify specific swallow activity (e.g., typical swallow, swallow duration, effortful swallow, pre-motor time) or oral motor activity.
Set-up Assistant: A clinical pathway to help select therapeutic exercises based on "Functional impairment" or desired "Intervention" (swallow or oral exercise).
Foot Switch: L, M, or R buttons on the foot switch can be used in place of the mouse for left, middle, or right pedals.

Maintenance Features:

Infection Control and Cleaning:
- Universal Precautions (UP): Wear personal protective equipment (gloves, masks, gowns) when exposed to bloodborne pathogens.
- Cleaning and Low-Level Disinfection: Daily housekeeping practice. Clean equipment, control panel, and lead wires with ACP germicidal wipes. Discard disposable items. Reusable electrodes are for individual patient use only.
- Intermediate Level Disinfection and Barriers: Use barrier film for surface protection from cross-contamination. Apply intermediate level disinfection prior to barrier application. Discard film and plastic sleeves from lead wires after each patient treatment. Use intermediate level disinfection of the device prior to the next treatment application.
Troubleshooting: A table lists common problems, causes, and remedies, such as dongle reconnection, sensor functionality, sensor/electrode noise, printer issues, monitor display, audio output, and power-on issues.
Service Center: For repairs or service, contact ACP Customer Service at (800) 350-1100 during business hours (6:00 am to 5:00 pm Pacific Standard Time).
Battery Replacement: The device uses a lithium-ion battery. Replacement and disposal should only be performed by the ACP Service Center or an authorized repair facility.
Power Cable: If the power cable appears damaged or frayed, discontinue use and contact Customer Support.
Component Integrity: Periodically test the integrity of the device and its components. If transducers are dropped or damaged, retest immediately. Do not attempt internal maintenance; seek authorized technical support.