ACP Synchrony User Manual Download Page 5

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SYNCHRONY EQUIPMENT USER MANUAL

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

Summary of Contents for Synchrony

Page 1: ... 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 contemplate...

Page 2: ... 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 an...

Page 3: ...ons 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 L...

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Page 5: ... 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...

Page 6: ...on 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 ...

Page 7: ...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 cont...

Page 8: ...n 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 compu...

Page 9: ... 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 Admin...

Page 10: ...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 b...

Page 11: ...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 Visua...

Page 12: ...rk 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 ...

Page 13: ...een 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 1...

Page 14: ... 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 an...

Page 15: ...h 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 co...

Page 16: ...tient 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 ...

Page 17: ...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 A...

Page 18: ...ibrary 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 g...

Page 19: ... 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 an...

Page 20: ...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 manu...

Page 21: ...t s level Pre exercise process Review marked repetitions After markeing 3 typical swallow repetitions a review dashboard is provided in which each repetition can be edited or deleted If a marked repetition is deleted the opportunity to resume the pre exercise is provided Mark 3 Typical swallow repetitions Mark repetition use the footplate or themouse to mark 3 typical swallow repetitions Remove la...

Page 22: ...ise Resume and Edit 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 swallows the patient reaches or exceeds the target the target will reset higher by 10 Progressive decrease of target if during three consecutive swallows t...

Page 23: ...splayed 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 contractions 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 ed...

Page 24: ...g the Sign in patient box Performing an Assessment A patient assessment is typically performed in order to validate sensor performance and the patient s abilities It is used to measure and quantify specific swallow activity e g typical swallow swallow duration effortful swallow pre motor time etc or oral motor activity The flow of the assessment pathway will allow the clinician to capture repetiti...

Page 25: ...ssistant Set up Assistant is a clinical pathway to assist in the selection of a therapeutic exercise based on either the Functional impairment presented or the Intervention swallow exercise or oral exercise the therapist desires to perform Set up assistant Functional impairment The Set up assistant Functional impairment option presents eleven common functional impairments encountered in clinical p...

Page 26: ...exercise After the user s response common therapeutic exercises are presented Administrator section The Administrator section is a user ID and password controlled area intended to be used by the individual identified as the Synchrony administrator The administrator has access to a control panel of system administrative fields including ways to manage the patient database provide clinicians credent...

Page 27: ... should be used if the therapist suspects slow or poor communication between the sEMG sensors and the Synchrony software Manage patients access to the patient database to edit or delete patient information Manage clinicians provides access to edit or delete clinicians from the database of previously entered clinicians and enables the addition of new Synchrony users Utilization review access to the...

Page 28: ... sensor and then remove the electrode patch from the plastic liner card Attach the lead wire to the electrode snap by squeezing the clip and releasing onto the post Prepare the patient s skin by thoroughly cleaning the area of application using the included Prep Pad Allow the skin to fully dry before applying the electrode Clip the OMNIsEMG sensor to the patient s clothing in a location that minim...

Page 29: ...cleaned disinfected per facility infection control policy ACP recommends the following guidelines Cleaning and Low Level Disinfection This is a recommended daily housekeeping practice to keep the equipment clean and free of contaminants which could contribute to transmission of infection The following practices are recommended for use when treating intact skin without the presence of physiologic f...

Page 30: ...lm is discarded after each patient treatment The procedure for use is as follows 1 Wash hands 2 Apply Intermediate Level Disinfection prior to barrier application 3 Select tear or cut with clean scissors a length of barrier film to fit over the operator surfaces 4 Prepare any items which may become in contact with the therapist during treatment such as ultrasound gel pens assessment tools cart han...

Page 31: ...y 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 for operation 20 ºC to 45 ºC 50 to 80 Rh non condensing Ambient conditions for storage or transportation 0 ºC to 40 ºC 50 to 80 Rh non condensing Altitude...

Page 32: ...ready for use Run the sensor across the magnetic section of the charging tray This will activate the sensor It will show active and ready with a white flashing light Sensor electrode noise The site has not been cleaned and skin debrided properly to eliminate artifact in the signal Remove electrodes and clean the patient s skin with ACP pumice based skin prep pad The OMNIsEMG electrodes are designe...

Page 33: ...ty Exclusion Any and all warranty coverage will be void if any of the following have occurred 1 The product contains repairs or replacement parts not furnished by ACP 2 The product is damaged resulting from misuse or negligence 3 The product has been tampered with and or altered including serial number alteration 4 The product was used with accessories and or supplies including electrodes not appr...

Page 34: ...the shipping charges and related costs to return the unit to the customer provided repair is deemed to be under warranty ACP is not responsible for any loss or damage to the Equipment prior to receipt at the ACP Service Center Equipment returned for warranty service must be shipped complete with all accessories except for manuals in its original packing or equivalent so as not to be damaged while ...

Page 35: ...300800A Synchrony Synchrony incorporates a virtual reality augmented biofeedback rehabilitation unit called the OMNIsEMG which has been specifically designed to accommodate patients with difficulty swallowing as a result of oral or pharyngeal muscle dysfunction 39593 Mouse Wireless M325 59441 Keyboard Wireless K400 18669 Charging Station OMNIsEMG 64187 Sensor OMNIsEMG 93477 Dongle OMNIsEMG ...

Page 36: ...M NO DESCRIPTION https acplus com acp technology user manuals Synchrony Equipment User Manual DOC 290SYN 74921 Electrodes Face Neck PENS w snap 10packs box 34184 Electrodes Pharyngeal sEMG 1 Use 15 box 61879 Electrodes Oro Facial sEMG 1 Use 15 box 69854 Pad Electrode Skin Prep Pad w Pumice 100 box 34774 Lead Wire PENS 4ft 3mm pinch style 61977 Lead Wire sEMG 12in 3mm pinch style ...

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ACP Synchrony, User Manual, Page: 5 / 36

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