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myomo MyoPro 2x Motion G User Manual

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PN 30159 Rev 001
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Summary of Contents for myomo MyoPro 2x Motion G

  • Page 1 User Manual PN 30159 Rev 001...

  • Page 2: Contact Information

    The information contained in this document represents the current view of Myomo as of the date of publication and is subject to change without notice. Because Myomo must respond to changing market conditions, it should not be interpreted to be a commitment on the part of Myomo and cannot guarantee the accuracy of any information presented after the date of publication.

  • Page 3: Table Of Contents

    CAUTIONS ......................8 FUNCTIONAL AUDIBLE ALERTS ................9 MYOPRO 2x MOTION G COMPONENTS ..............11 PUTTING MYOPRO 2x MOTION G ON (“DONNING”) ..........18 STEPS FOR PUTTING ON MYOPRO 2x ORTHOSIS ..........20 STEPS FOR PUTTING ON MYOPRO 2x HARNESS ..........35 TAKING OFF MYOPRO 2x (“DOFFING”) ..............
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  • Page 5: Introduction

    INTRODUCTION PN 30159 Rev 001...
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  • Page 7: Customer Support

    MyoPro 2x. Your Provider is the first resource for all fit and operational issues. If your Provider is unable to address an issue, he or she may contact Myomo customer support for assistance. See Page 2 for contact information.

  • Page 8: Intended Use

    INTENDED USE The MyoPro 2x, an upper limb orthosis, is a compensatory device to increase ability to perform functional tasks with the affected limb. The user voluntarily activates movement of the orthotic device with their remaining electromyography (EMG) muscle signal. INDICATIONS FOR USE The MyoPro 2x is indicated for use by adolescents and adults diagnosed with long-term muscle weakness OR partial paralysis.

  • Page 9: Myopro 2X Description

    MYOPRO 2x DESCRIPTION The MyoPro 2x consists of a combination of the following components: a custom- made upper limb orthosis (brace), a powered elbow orthosis with surface electromyography (EMG) sensors, a static or manually set multi-articulating wrist (MAW), a static hand orthosis or powered hand orthosis with EMG sensors, and two shoulder harness configurations (Figure 8 (Part Number 27679) and Cross-body (in two sizes) (Part Number 28027 and 28028)) for added comfort and secure fit of the MyoPro 2x.

  • Page 10: Warnings

    WARNINGS The following statements warn against injury risk when using the MyoPro 2x: The MyoPro 2x is a prescription device and should only be used as indicated under clinical supervision of a Provider, or after receiving instruction from a clinical Provider for at-home use. The MyoPro 2x is only to be used by the person for whom it is prescribed.
  • Page 11 WARNINGS, CONTINUED Each component of the device is supplied for safety and best performance. Use all provided components for optimal operation. No modification or disassembly of the mechanical or electrical components of the MyoPro 2x is allowed as it may expose other dangers.

  • Page 12: Cautions

    CAUTIONS The following cautions apply to the MyoPro 2x device and accompanying components: Do not expose to flame or excessive heat. Do not incinerate the Lithium Ion battery pack. Do not use a hairdryer to dry components of the MyoPro 2x. Use only the battery and battery charger provided with the MyoPro 2x.

  • Page 13: Functional Audible Alerts

    FUNCTIONAL AUDIBLE ALERTS The following Audible Alerts may be heard when operating the device. Sound Trigger Meaning Prompted Action Long Beep Motor temperature is too Motor is disabled until it Please wait for your hot. cools down. motor to cool down. It will resume its function once the motor temperature has cooled...
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  • Page 15: Myopro 2X Motion Gcomponents

    MYOPRO 2x MOTION G COMPONENTS PN 30159 Rev 001...
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  • Page 18 MYOPRO 2x MOTION G COMPONENTS Reference the diagram below to understand the various components of your MyoPro 2x Motion G Orthosis. MYOPRO 2x HAND AND WRIST COMPONENTS Reference the diagram below to understand the various hand and wrist components of your MyoPro 2x Motion G Orthosis.
  • Page 19 MYOPRO 2x MOTION G SENSORS Reference the diagram below to understand the various components related to the MyoPro 2x forearm sensors. PN 30159 Rev 001...
  • Page 20 MYOPRO 2x BICEPS & TRICEPS SENSORS Reference the diagram below to understand the various components related to the MyoPro 2x biceps & triceps sensors. MYOPRO 2x CROSS-BODY HARNESS COMPONENTS Reference the diagram below to understand the various components related to the MyoPro 2x cross-body harness.
  • Page 21 MYOPRO 2x FIGURE 8 HARNESS COMPONENTS Reference the diagram below to understand the various components related to the MyoPro 2x figure 8 harness. • NOTE: Your Provider may have provided you with a harness which differs from the figure 8 harness shown below.

  • Page 22: Putting Myopro 2X Motion G On ("Donning")

    PUTTING MYOPRO 2x MOTION G ON (“DONNING”) PN 30159 Rev 001...
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  • Page 24: Warnings Review

    MyoPro 2x and if so, whoever assists you should receive training for proper MyoPro 2x donning. Myomo offers donning instructional videos for the MyoPro 2x on its website (www.myomo.com). If you still have difficulty donning the MyoPro 2x, consult with your Provider and/or therapist for tips and strategies specific to your situation.
  • Page 25 DONNING SETUP Before donning your MyoPro 2x, perform the following steps: 1. Ensure that the MyoPro 2x is powered off. NOTE: Pads and straps should be fully air-dried from the previous use. CAUTION: Do not use a hairdryer to dry components of the MyoPro Powered-off MyoPro Pull on the blue tabs to unstrap the forearm and humeral straps.
  • Page 26 Supination/Pronation Latch 4. The MyoPro will now be able to rotate. Find the blue stickers to align the MyoPro for donning. If your device no longer has blue stickers, align the ring to your preferred donning orientation. Re-latch the supination / pronation latch. Configuration 1 versus Configuration 2 5.
  • Page 27 Flexion / Extension Button 6. If the MyoPro is not in a straight position, push the silver button allowing the MyoPro hand to pivot. If it is already aligned, skip to step 8. 7. Straighten the MyoPro and press the silver button again to lock the MyoPro in place.
  • Page 28 MyoPro Finger Saddle 9. Pinch the lever to release the finger saddle. Set aside in a reachable position to retrieve later. Taking off Finger Saddle 10. On the MyoPro hand, locate the lever. Push down on the lever to open the hand motor.
  • Page 29 Opening the Hand Motor 11. Pull on the blue tab to unstrap the MyoPro hand strap. Unstrapping the MyoPro hand 12. The MyoPro hand can rotate to provide easier donning access. Rotate the MyoPro hand to your preferred position to make it easier to ‘grab the green’. PN 30159 Rev 001...
  • Page 30 Twisting the Hand Shell 13. Straighten out the MyoPro to finish the setup process. Setup MyoPro 2x PN 30159 Rev 001...

  • Page 31: Donning Instructions

    DONNING INSTRUCTIONS Prep: If you have tone/spasticity in your hand/fingers, it may be beneficial to employ various techniques to relax your wrist flexors/extensor muscles before proceeding with donning. Consult your therapist/physician for tone/spasticity management solutions. 1. When donning, position the MyoPro 2x on a surface with adequate friction to prevent it moving away from you, such as your lap.
  • Page 32 Configuration 1 Hand Placement NOTE: If your hand is tight, you will have to uncurl your fingers to pull the hand sufficiently into the hand shell. 5. Position your hand so the base of the thumb is in full contact with the hand shell. Everything is aligned in comparison to the thumb being fully seated against the hand shell.
  • Page 33 Donning the MyoPro Hand Configuration 1 7. Jump to step 12 if you’ve completed the hand donning process Hand Placement Configuration 2 8. Using your unaffected limb to help your affected limb, place your arm on the multi- articulating wrist. It may help to have the MyoPro either on your lap or stabilized on another surface.
  • Page 34 Guiding the affected hand 10. Place your thumb in the thumb piece. 11. Feed the blue tab of the hand strap through the blue ring and tighten the strap securing your hand in place. Donning the MyoPro Hand Configuration 2 12.
  • Page 35 Closing the Hand Motor ⚠ FIT CHECK ⚠ CONFIRM THE HAND SHELL PLASTIC IS AGAINST THE THUMB WEB SPACE AND THAT THE KNUCKLES ARE PAST THE PALMAR CREASE. MAKING CHANGES TO THE FIT OF THE HAND PAST THIS POINT IS IMPOSSIBLE WITHOUT REMOVING THE BRACE AND STARTING OVER.
  • Page 36 Placing Forearm in Cuff 15. Pull the humeral cuff UP to align with your arm. Pulling up Humeral Cuff 16. When the humeral cuff is up, be sure to press your elbow down toward the bottom, near the motor, to ensure proper MyoPro fit. PN 30159 Rev 001...
  • Page 37 Pressing Elbow Down NOTE: If needed, unlatch the black ring (Multi-Articulating Wrist) and rotate to a more comfortable position. Re-latch the black wrist ring before moving to the next step. 17. Pull the blue tab of the forearm strap through the blue ring on the forearm cuff. Tighten until you see the white line.
  • Page 38 Donning the Humeral Cuff 20. Attach the finger saddle. First position the finger saddle on the end of your index and middle fingers with the finger loop emerging from between your fingers. Then position the finger loop around the anvil-you may pull the anvil down towards the loop without damaging the motor.

  • Page 39: Steps For Putting On Myopro 2X Harness

    STEPS FOR PUTTING ON MYOPRO 2x HARNESS A harness is provided with the MyoPro 2x. It serves to both protect your shoulder joint and to suspend the MyoPro 2x in correct position on your arm, so it does not slide off. WARNING: A harness should always be worn when the MyoPro 2x is donned, unless directed otherwise by your physician and/or therapist.
  • Page 40 1. Place the harness saddle on your shoulder. The suspension straps should straddle your shoulder. The middle of the saddle should be at the midline of the shoulder, touching neither the neck or shoulder joint. You may have to lift your arm out to the side in order to move the saddle into the correct position.
  • Page 41 4. Abduct the shoulder with the MyoPro 2x (lifting it to the side), or use furniture to help lift while pulling the finger adjust loop to tension. When your arm returns to your torso, you should feel the tension of the harness saddle on your shoulder, indicating the MyoPro 2x is suspended from your shoulder girdle, not your shoulder joint.
  • Page 42 CROSS BODY HARNESS DOFFING: When doffing the Cross Body Harness, remove the cross body strap by pulling the release tab from the front portion of the shoulder saddle Note: Do not remove the harness clips from the MyoPro unless you are removing for laundering purposes.
  • Page 43 FIGURE 8 HARNESS DONNING If your MyoPro 2x was provided with a cross-body harness, skip this section and refer to the cross-body harness donning instructions in the preceding section. For donning the figure 8 harness, following the steps below: Orient the harness and check for twists in the strapping. The puck has a surface covered in gray fabric, while the other surface is an intersection of the strapping.
  • Page 44 Method 2 (back-pack method) 2.1 Starting with the harness behind your back, locate the puck using your sound side. Orient the puck so that the fabric side is towards your back, while the straps face away from you. This will keep the harness oriented in the correct position as you move your hand into the sound side loop.
  • Page 45 Adjust the sound side loop so it rests between the chest and shoulder, protecting the collar bone. It shouldn’t make contact with the neck. The anterior suspension strap coming off the front of the MyoPro may require small adjustments to rest similarly. PN 30159 Rev 001...
  • Page 46 ADJUSTING WRIST MODULE The wrist module position along the user’s forearm (proximal-distal) can be adjusted two different ways. 1. Method 1: Move the Hand Carrier Bar in the Flexion/Extension Joint. This can be done by loosening and retightening these set screws with a 3 mm hex key. It is recommended to tighten the set screws to 5 inch/lbs, or approximately a ¼...
  • Page 47 Method 1 Method 2 Open the Supination/Pronation (SP) Latch to adjust the pronation and ADJUST supination of the SP Joint. Close the SP Latch once the joint is in the desired location. PN 30159 Rev 001...
  • Page 48 Caution: The SP latch should be closed when the device is not in use to avoid accidental damage to the components. Push the Flexion/Extension Button to the unlocked position (shown below) ADJUST to unlock the Hand Carrier Bar, then adjust the Hand Carrier Bar. Push the Flexion/Extension Button to the locked position to lock the Hand Carrier Bar in the desired position.
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  • Page 50: Taking Off Myopro 2X ("Doffing")

    TAKING OFF MYOPRO 2x (“DOFFING”) PN 30159 Rev 001...
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  • Page 52 WARNINGS REVIEW WARNING: If at any time during the use of this device, you notice any of the following, discontinue use and seek guidance from your Provider. Movement does not match the User’s desired motion. • Persistent redness, swelling, or skin breakdown (bleeding, chafing, •...
  • Page 53 MyoPro 2x, contact your provider for adjustments. NOTE: The MyoPro 2x should remain OFF any time the MyoPro 2x is not being worn. PN 30159 Rev 001...

  • Page 54: Battery & Charging

    BATTERY & CHARGING PN 30159 Rev 001...
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  • Page 56 BATTERY & CHARGING CAUTION: Do not expose to flame or excessive heat. CAUTION: If you detect fumes, flames, melting of components around the battery or battery charger, or the device is hot to touch, TURN THE DEVICE OFF IMMEDIATELY and contact your Provider. NOTE: Charge the battery before using the device.

  • Page 57: Setting Up The Charger

    SETTING UP THE CHARGER CAUTION: Charge the battery indoors only. The battery and battery charger should only be operated in temperatures ranging from 0-40 °C (32-104 °F). CAUTION: Use only the battery and battery charger provided with the MyoPro 2x. CAUTION: Do not expose to flame or excessive heat.

  • Page 58: Charging The Battery

    CHARGING THE BATTERY CAUTION: Charge the battery indoors only. The battery and battery charger should only be operated in temperatures ranging from 0-40 °C (32-104 °F). CAUTION: Use only the battery and battery charger provided with the MyoPro 2x. CAUTION: Do not expose to flame or excessive heat. NOTE: Charging time for a battery with <10% capacity is approximately 3 hours.
  • Page 59 3. Check the light on the charging dock. Illuminated Illuminated Flashing (blinking) Illuminated GREEN ORANGE between RED & The battery is GREEN There is a problem with the The battery is charged. battery. Remove the battery The charger is charging. detecting the from the charger and battery.
  • Page 60 INSERTING THE BATTERY INTO THE MYOPRO 2x CAUTION: Insert only the battery pack that came with the MyoPro 2x into the MyoPro 2x battery compartment. To insert a charged battery into the MyoPro 2x’s battery compartment: Remove the battery from the charging port & unplug the Charging Dock from the wall outlet.
  • Page 61 NOTES ON BATTERY HEALTH WARNING: If storing the MyoPro 2x for more than one month, remove the battery from the battery compartment. NOTE: If a battery is unused (stored), it should be recharged at least once every 6 months. If uncharged for more than 6 months, the battery could get so depleted that it could be unable to be recharged.

  • Page 62: Control Panel

    CONTROL PANEL & SENSITIVITY SETTINGS PN 30159 Rev 001...
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  • Page 64 CONTROL PANEL BUTTONS & LIGHTS DIAGRAM Power Light & Battery Capacity Power Button Indicator (color) Bluetooth Light Elbow Mode Button Triceps Light Biceps Light Close Light Open Light Grasp Mode Button PN 30159 Rev 001...
  • Page 65 CONTROL PANEL LIGHTS, DESCRIBED & POWER LIGHT BATTERY CAPACITY INDICATOR COLOR NOT Illuminated (off) The MyoPro 2x is powered OFF. The MyoPro 2x is powered ON. Illuminated Green The battery has greater than 15% chargeremaining. The MyoPro 2x is powered ON. Illuminated Yellow The battery has between 15% and 5% charge remaining.
  • Page 66 HOW TO POWER THE MYOPRO 2x ON AND OFF WARNING: Do not use the MyoPro 2x to drive an automobile or operate machinery. WARNING: The MyoPro 2x is NOT waterproof. Do not shower, swim, or expose the device to rain or other sources of water. Do not wear the device for assistance to wash dishes by hand as risk for water exposure to the grasp motor is high.

  • Page 67: Power Off

    POWER OFF Press the power button. Observe: All the lights will stop being illuminated, indicating that the MyoPro 2x has successfully powered off. NOTE: The MyoPro 2x should remain OFF any time the MyoPro 2x is not being worn. PN 30159 Rev 001...

  • Page 68: Sensitivity Settings

    SENSITIVITY SETTINGS Your device will have unique sensitivity settings which will be programmed by your Provider when the device is fit to you. These settings correspond to how the device detects and responds to your muscle signal. The sensitivity may be adjusted over time as you continue to use the device.
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  • Page 70: Operating Myopro 2X

    OPERATING MYOPRO 2x PN 30159 Rev 001...
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  • Page 72: Control Panel

    CONTROL PANEL the User Manual – Sections for All MyoPro 2x Models document for a comprehensive Control Panel Buttons & Lights Diagram. Power Button Mode Buttons PN 30159 Rev 001...

  • Page 73: Modes Of Use

    MODES OF USE WARNING: Use caution when using the device in shoulder positions where it is possible for the User to hit him or herself. The MyoPro 2x may be used in a variety of modes. The different modes allow you to operate the MyoPro 2x by tensing or relaxing different muscles.
  • Page 74 These are explained in the following pages. NOTE: You may experience a slight vibration of the finger support when the grasp reaches a fully closed or fully open position. This would be caused by the hand motor turning on and off as it detects the limits of its range of motion. This is normal operation, and nothing to worry about.

  • Page 75: Elbow Modes

    ELBOW MODES In this mode, neither the Biceps or Triceps Light will be illuminated. The elbow motor will not respond to your EMG signal from either muscle group. Though the MyoPro 2x is powered on, no assistance is being given to your elbow, and the arm will neither flex nor extend.
  • Page 76 ELBOW MODES, CONTINUED In this mode, the Triceps Light will be illuminated. The elbow motor will respond to your triceps EMG signal. Actions: When you relax your triceps, the elbow will flex. • When you contract your triceps, the elbow will •...
  • Page 77 When you contract your biceps, the elbow will • flex, as long as your biceps signal is greater than your triceps signal. When you contract your triceps, the elbow will • extend, as long as your triceps signal is greater than your biceps signal.

  • Page 78: Grasp Modes

    GRASP MODES In this mode, neither the Close or Open Light will be illuminated. The grasp motor will not respond to your EMG signal. Though the MyoPro 2x is powered on, no assistance is being given to your hand, and the grasp will neither open nor close.
  • Page 79 GRASP MODES, CONTINUED In this mode, the Open Light will be illuminated. The grasp motor will respond to your wrist extensor EMG signal. Actions: When you relax your wrist extensors, the grasp Open mode • will close. When you contract your wrist extensors, •...
  • Page 80 grasp will close, as long as your wrist flexor signal is greater than your wrist extensor signal. When you contract your wrist extensors, the • grasp will open, as long as your wrist extensor signal is greater than your wrist flexor signal. PN 30159 Rev 001...

  • Page 81: Changing Elbow Mode With The Control Panel

    CHANGING ELBOW MODE WITH THE CONTROL PANEL PN 30159 Rev 001...

  • Page 82: Go To Meeting And Zoom

    GO TO MEETING AND ZOOM PN 30159 Rev 001...
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  • Page 84: On Your Desktop Or Task Bar (At The Bottom Of Your Screen)

    ON YOUR DESKTOP or TASK BAR (at the bottom of your screen): Double click on this icon to open Go-To-Meeting Enter the meeting ID (this ID will have been provided to you in an e- mail from Myomo) and click “JOIN”. The meeting will start PN 30159 Rev 001...
  • Page 85 Zoom ON YOUR DESKTOP or TASK BAR (at the bottom of your screen): Double click on this icon to open Zoom Click “JOIN MEETING” (Do not sign in 3. Enter the code that you received on your Telehealth email OR click the link within your email Do not click the box for “Do not connect to audio”...
  • Page 86 5. Join Video and Audio 6. You should then be connected to the Myomo Representative and you will be added to the meeting. PN 30159 Rev 001...
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  • Page 88: Myconfig View (User)

    MyConfig View USER GUIDE PN 30159 Rev 001...
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  • Page 90 MYCONFIG VIEW MyConfig View is a software application pre-installed on the Myomo laptop to visualize what your muscles are doing and how the MyoPro is interpreting them. The MyoPro, when used with MyConfig View, is one of the most sensitive EMG-detection devices available- capable of detecting faint muscle activity.
  • Page 91 Step 1: Turn on the MyoPro Press the power button on the MyoPro control panel. Step 2: Locate MyConfig View MyConfig View is located on the Myomo laptop desktop. Step 3: Launch MyConfig View Double click the MyConfig View icon to launch MyConfig View.
  • Page 92 This may occur if MyConfig is started before the MyoPro is powered on or if the signal is interrupted during transmission. Moving the MyoPro closer to the Myomo laptop resolves this issue. MYOPRO CONNECT This feature is only available if the MyoPro was previously connected and the EMG screens were closed, or if the “auto-connect”...
  • Page 93 Caution: Do not interrupt the data download during this connection process. MYOPRO CONNECTION After a brief search, a window will appear for each MyoPro joint: Elbow PN 30159 Rev 001...
  • Page 94 Hand The MyoPro is now connected to MyConfig View PN 30159 Rev 001...
  • Page 95 Maximize Window Minimize Close Window Window VISUALIZATION RESIZE WINDOWS Note: The hand window will appear only if you are using a Motion G. Quickly minimize, maximize, or close windows by using the icons in the upper right window corner, respectively. Alternatively, while hovering the mouse cursor over the window edge, left-click and hold with one finger, while using a second finger on the trackpad to resize the window.
  • Page 96 The MyoPro Motion G elbow and hand both feature four operating modes, with dual mode having 4 behavior options. With these modes, the MyoPro may be configured to your unique abilities, allowing you to select an appropriate setup for your current level of ability and modify settings as you become more proficient with your MyoPro.

  • Page 97: Device Modes

    DEVICE MODES ELBOW MODES Elbow (MyoPro Motion-W and Motion-G) Standby mode – motors are inactive In Standby mode the motor is on, but it will not assist motion. It will actually offer more resistance to motion than if the MyoPro were powered off. The sensors are still reading the EMG signals and will be visible on the MyConfig graph.
  • Page 98 • Proportional- motor speed is directly related to measured effort Ramped- rate of motor speed increases with effort (exponential) • HAND MODES Hand (Motion-G only) Standby mode – motors are inactive Close mode – single-site control; hand/wrist flexors only When flexors relax the hand motor opens. •...

  • Page 99: Changing Modes

    CHANGING MODES Modes for both the elbow and the hand can be changed by clicking the gray button with the name of the desired mode in the corresponding hand/elbow window. The selected button appears green, displaying the current mode. EMG visualizations will change color to indicate the EMG mode that is active.
  • Page 100 MYCONFIG SETTINGS MyConfig View Settings only apply to the single-modes, e.g. Biceps, Triceps, Close, and Open, and Classic with Hold Dual Mode at the elbow and hand. These settings are set by your clinician or therapist. MyoPro settings are not adjustable in the MyConfig View.
  • Page 101 THRESHOLD When using the MyoPro in single mode, (e.g. biceps) the threshold should be set such that when the muscle is activated, you can get the EMG signal over the threshold to create smooth movement of the MyoPro at the desired joint/direction. When you relax that muscle, the EMG signal should drop below the threshold to allow the MyoPro to move back to the starting position of the desired joint/direction.

  • Page 102: Range Of Motion (Rom)

    Biceps Threshold The visible EMG lines can be customized for each mode. Only the relevant EMGs will show by default, e.g. both EMGs being visible in dual mode, or the biceps EMG in Biceps mode in the preceding picture; the triceps EMG can be added to the graph by checking the “Triceps”...
  • Page 103 Hand ROM is shown in % (0%=open, 100%=close). The current ROM end-ranges are displayed numerically in green above the ROM sliders. The current joint position is indicated by the red square between the ROM sliders, which will move in real-time with elbow position, with a black-colored numerical readout below the ROM header [image above].
  • Page 104 In most cases of arm dysfunction, we can expect the arm to become stronger and your functional needs will change. The settings that were correct for you a month ago may no longer be correct for how you present today. If you believe the Gain, Threshold, or ROM settings are incorrect, please inform your therapist or the clinician responsible for your MyoPro Management.
  • Page 105 MYCONFIG TROUBLESHOOTING Watching MyConfig View, I see my EMG signal floating high on the graph, and/or is unresponsive to my attempts to activate it or relax my muscles. If the EMG signals in MyConfig View do not mimic your muscle activation and relaxation, consider the following: 1) Relax: Ensure you are relaxed.

  • Page 106: Myconfig Set (Clinician)

    MyConfig Set CLINICAL GUIDE PN 30159 Rev 001...
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  • Page 108 MyConfig is a software application developed for using the MyoPro. It is pre-installed on the Myomo laptop, or available for download via the clinical resource center on Myomo.com. MyConfig is used to determine what the user’s muscles are doing and how the MyoPro is interpreting them.
  • Page 109 Press the power button on the MyoPro control panel. Step 2: Locate and Launch MyConfig Set MyConfig Set is located on the Myomo laptop desktop. Double click the MyConfig Set icon to launch the application. The first screen you see should look like this: MyConfig is searching for the MyoPro via a wireless Bluetooth connection.
  • Page 110 This may occur if MyConfig is started before the MyoPro is powered on or if the signal is interrupted during transmission. Moving the MyoPro closer to the Myomo laptop resolves this issue. MYOPRO FOUND Click Connect for the desired MyoPro. If multiple MyoPros are powered on, you will see multiple serial numbers listed.
  • Page 111 MYOPRO CONNECTION After a brief search, a window will appear for each MyoPro joint: Elbow Hand The MyoPro is now connected to MyConfig Set. PN 30159 Rev 001...
  • Page 112 VISUALIZATION Maximize Window Minimize Close Window Window RESIZE WINDOWS Quickly minimize, maximize, or close windows by using the icons in the upper right window corner, respectively. Alternatively, while hovering the mouse cursor over the window edge, left-click and hold with one finger, while using a second finger on the trackpad to resize the window.
  • Page 113 JOINT MODES ELBOW Elbow (all MyoPros) Standby mode – motors are inactive In Standby mode the motor is on, but it will not assist motion. It will actually offer more resistance to motion than if the MyoPro were powered off. The sensors are still reading the EMG signals and will be visible on the MyConfig graph.
  • Page 114 HAND Hand (Motion G only) Standby mode – motors are inactive Close mode – single-site control; hand/wrist flexors only When flexors relax the hand motor opens. • When flexors contract the hand motor closes. • Open mode – single-site control; hand/wrist extensors only •...
  • Page 115 CHANGING MODES Modes for both the elbow and the hand can be changed by clicking the gray button with the name of the desired mode in the corresponding hand/elbow window. The selected button appears green, displaying the current mode. Clicking the button of the desired mode will instantly change which muscle signals the MyoPro is responding to.
  • Page 116 MYCONFIG SETTINGS GAIN Gain refers to amplification of EMG signal that takes place through the sensor hardware. In the case of the MyoPro, the EMG gain is amplified via software as well to create a large degree of adjustment. Changes to the gain value occur at 0.2 intervals. With a maximum value is 20.0, there are 100 available values for each gain slider, offering a great degree of fine-tuning.
  • Page 117 How to save records and run Configuration Reports can be found on page 22 and 23. THRESHOLD Threshold (Thresh) refers to the value that the EMG signal must exceed to initiate the motor (in response to either an active muscle signal or a relaxing muscle signal). Once in an active mode (anything other than Standby mode), click the Thresh button to make the adjustment sliders appear.
  • Page 118 Just like the gain settings, all changes to the threshold settings are updated in real-time on the device and will save automatically. It is important to write your values down prior to changing them if you want to revert back to them. Another way to retrieve your settings is by Configuration Report prior to changing your settings.
  • Page 119 RANGE OF MOTION (ROM) The Range of Motion (ROM) for the motor is accessible on each joint window. For each joint, the left-column slider controls the extension end-range, while the right-column slider controls the flexion end-range. Appropriate device ROM will be determined primarily by the user’s passive ROM, but other considerations include functional tasks, resting position, and mechanical advantage of different arm positions and finger-contact at the hand.
  • Page 120 changing them if you want to revert back to them. Another way to retrieve your settings is by Configuration Report prior to changing your settings. A graphical representation of the current joint position in the top-left corner of each window. This is a quick way to recognize the current joint position while looking at the computer screen without having to interpret the numbers.

  • Page 121: Start Mode

    1) Start Mode 2) Donning Mode 3) Dual Mode 4) Advanced START MODE The motors are pre-set to be in Standby mode when the MyoPro is first powered on. However, you may prefer a different Start Mode for each MyoPro joint. To change the Start Mode: Select the Configure button on the right-hand side of either the hand or elbow window.
  • Page 122 DONNING MODE Donning Mode is a feature designed to assist the user in independently donning the device once it is activated. The behavior of donning mode is programmed through MyConfig Set but can only be initiated on the physical MyoPro. Any combination of the joint motors can be involved in Donning Mode by sliding the slider at the top of the Donning Mode window.
  • Page 123 tested here so the only way to experience the Hold Force is by initiating donning assist at the elbow on the MyoPro. Please note: Donning mode does not support Hold Force when the value is less than 20. Donning Mode parameters can be saved and retrieved through the “Records Management”...
  • Page 124 ADVANCED DUAL MODE MyConfig software has four Dual Mode settings. - Classic with Hold - Constant Speed - Proportional - Ramped The Dual Mode menu allows the clinician to choose from the four available Dual Mode selections. All four Dual modes have settings that can only be accessed and programmed through this menu.
  • Page 125 The graphs in this Dual Mode tab are different than the EMG graph that is displayed for single modes or Classic Dual Mode. The two-tailed graph shows how the biceps, triceps, open, and close EMGs relate to each other. It communicates a lot of information in a small amount of space.
  • Page 126 Effort is the conversion of each EMG signal into a bar visualization. This represents the user’s current muscle exertion relative to their maximum ability. On this screen we aren’t tracking the EMG signals over time, but we are able to visually estimate the difference between the flexor and extensor EMG signals.
  • Page 127 Constant Speed This mode allows the clinician to select and limit the motor speed. Otherwise, it behaves very similarly to Classic with Hold mode. The graph indicates that the motor has only one speed with which to move into extension or flexion, while it won’t move at all between the two response sliders.

  • Page 128: Advanced Configuration

    The Advanced Configuration menu contains fields that are both useful to understand in rare circumstances, and options that should never be touched unless instructed to by a Myomo engineer. The relevant settings will be described first, and are indicated in green, while the options...
  • Page 129 that shouldn’t be adjusted are in red. Advanced Settings on the left side of the screen, the green settings below, must be set separately for the elbow and hand by choosing the drop down under “Advanced Settings”. Extension Effort/Flexion Effort or Open Effort/Close Effort describes the maximum value for the extension or flexion effort bars, respectively, in the dual mode tab.
  • Page 130 Otherwise, to continue without saving, click the “Close” button or return to another tab inside the Configuration menu. MYCONFIG RECORDS Click the Records button to open the Records Management window and features. Save MyoPro settings to a file archive. Select Usage Report to print or create a PDF of: Device Details Compliance...

  • Page 131: Configuration Report

    The Usage Report is a powerful tool to document user compliance and device value. It can also inform the clinician about where the user is having difficulty with use. A usage report may also be requested when working with technical support to provide device details.
  • Page 132 Select Config Report to launch the report form Input user’s name, notes, and/or comments. Select Print or PDF, or both. Select Generate Report. A confirmation of report generation will be displayed. PN 30159 Rev 001...
  • Page 133 OPTIONS To access additional options for MyConfig features select Options in the lower left of the launch window. Start-up Search/Connect Advanced Window Options Controls for EMG Software and screen User Firmware auto- Interface Update Transfer Log Files upon Connection Screen displays MyConfig Display Motor Amps Language...

  • Page 134: Maintenance

    MAINTENANCE PN 30159 Rev 001...
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  • Page 136 BEST PRACTICES FOR SMOOTH PERFORMANCE Several factors can result in erratic movement of the orthosis. NOTE: The metal components of each sensor must have contact with the skin in order to properly read EMG signal. FACTOR A: STRAP TENSION Make sure the Upper Sensor Cuff and Upper Cuff Closure are comfortably snug – not too tight, not too loose.
  • Page 137 REPAIRING THE MYOPRO 2x Repairs should be made only by your Provider, or by Myomo, directly. To ensure absolute safety of device and personnel, only Myomo staff may address repairs to the mechanical or electrical components of the MyoPro 2x. If such a repair is needed, your Provider will send your MyoPro 2x to Myomo, Inc.
  • Page 138 STORING THE MYOPRO 2x After taking the device off, rest in a clean, dry place to allow the MyoPro to dry. CAUTION: Do not use a hairdryer to dry components of the MyoPro 2x. CAUTION: Protect the MyoPro 2x from damage, always use the carrying bag provided with the unit to store or transport the MyoPro NOTE: Ensure the MyoPro 2x is completely dry before storing.
  • Page 139 AVOIDING DAMAGE TO THE MYOPRO 2x The MyoPro 2x is designed to facilitate voluntary movements. It can be damaged by excessive force, either from a User forcibly moving the motor too hard, or if something (such as the arm of a chair) restricts the MyoPro 2x’s movement as it is trying to assist the User.
  • Page 140 MYOPRO 2x ERROR CAUTION: If you detect fumes, flames, melting of components around the battery or battery charger, or the device is hot to touch, TURN THE DEVICE OFF IMMEDIATELY and contact your Provider. RECOGNIZING WHEN THE MYOPRO 2x IS EXPERIENCING AN ERROR When the MyoPro 2x detects an error and initiates an error code, it will not function normally.
  • Page 141 When the power button is □ Biceps □ Triceps □ Close □ Open Green, what mode lights are illuminated? When the power button is Red, □ Biceps □ Triceps □ Close □ Open what mode lights are illuminated? Contact your Provider for assistance with a continuing error. PN 30159 Rev 001...
  • Page 142 LOCATION OF IDENTIFYING NUMBERS Elbow Motor Unit The primary identifying number for each individual MyoPro 2x is located on the back of the battery and electronics case: it is the serial number for the elbow motor. It is written as “M000” followed by a 3 or 4 digit number.
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  • Page 144: Technical Specifications & Markings

    TECHNICAL SPECIFICATIONS & MARKINGS PN 30159 Rev 001...
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  • Page 146: Environmental Requirements

    TECHNICAL SPECIFICATIONS WARNING: The MyoPro 2x is not suitable for use in the presence of flammable anesthetic mixtures with air, or flammable anesthetic mixtures with oxygen or nitrous oxide. ENVIRONMENTAL REQUIREMENTS MyoPro 2x Device Temperature Operating: 0 to 40 °C (32 to 104 °F) Storing: -10 to 60 °C (14 to 140 °F) Humidity 10% - 90% relative humidity, non-condensing...

  • Page 147: Electromagnetic Compatibility

    15 of the FCC Rules. These limits are designed to provide reasonable protection against harmful interference in a residential installation. Only Myomo personnel may inspect or repair mechanical or electrical components of the MyoPro 2x in order to maintain basic safety and essential performance with regard to electromagnetic disturbances.
  • Page 148 ON-DEVICE MARKINGS Symbol Description Attention – Refer to the accompanying instructions Power “On/Off” (push-push) IEC 60417-5010 The product should be disposed of according to local guidelines Complies with FCC Part B Standards- Medical Equipment Safety Tested to 60601-1 3rd Edition as amended 1 and 60601-1-2 electromagnetic disturbances.

  • Page 149: Additional Information

    Ingress Protection rating 21 40C° Operating Temperature Range: 0 to 40 °C (32 to 104 °F) 0C° Operating Humidity Range: 10% to 90% non-condensing 1060 hPa Operating Atmospheric Pressure Range:700 hPa to 1060 hPa 700 hPa Manufacturer: Myomo Inc. PN 30159 Rev 001...
  • Page 150 BATTERY AND CHARGER MARKINGS Symbol Description General warning sign Instructions for use For indoor use only The battery and battery charger comply to the current regulations of the EU guidelines The battery complies with part 15 of the FCC Rules. Operation is subject to the following two conditions: (1) This device may not cause harmful interference, and (2) this device must accept any interference received, including interference that may cause undesired operation.
  • Page 151 TOOLKIT Anti-slip Ball-end 2.5 mm mat, Screwdriver, Hex Key, 8” x 25” T8 Torx L-Wrench 2 mm 3 mm Hex Key, Hex Key, L-Wrench PN 30159 Rev 001...

  • Page 152: Client Information Guide

    CLIENT INFORMATION GUIDE • MEDICARE SUPPLIER STANDARDS • CLIENT BILL OF RIGHTS • CLIENT RESPONSIBILITIES • HOME SAFETY INFORMATION • INFECTION CONTROL • DISASTER PREPAREDNESS • ADVANCE DIRECTIVES INFORMATION • CLIENT COMMUNICATION FORM PN 30159 Rev 001...
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  • Page 154 MEDICARE DMEPOS SUPPLIER STANDARDS Note: This is an abbreviated version of the supplier standards every Medicare DMEPOS supplier must meet in order to obtain and retain their billing privileges. These standards, in their entirety, are listed in 42 C.F.R. 424.57(c). 1.
  • Page 155 30. A supplier must remain open to the public for a minimum of 30 hours per week except physicians (as defined in section 1848(j) (3) of the Act) or physical and occupational therapists or a DMEPOS supplier working with custom made orthotics and prosthetics.
  • Page 156 • To express concerns or grievances or recommend modifications to your equipment without fear of discrimination or reprisal. • The right to contact HQAA, in the event Myomo does not address your concerns in a timely manner, by US Mail or E-Mail.
  • Page 157 • To treat Myomo personnel with respect. • To notify Myomo when you will NOT be home at the time of a scheduled demonstration, delivery, or service of requested products. • To notify Myomo when experiencing any problem or difficulty with provided equipment or service.
  • Page 158 Home Safety Information As a valued client of Myomo, we are concerned for your personal safety. Listed below is important educational information regarding home safety: Home Safety • Check your home for potential barriers such as excess clutter or blocked hallways and exits that may prevent evacuation during an emergency.
  • Page 159 • Keep an Eye on Smokers. Careless smoking is the leading cause of fire deaths in North America. Refrain from smoking around oxygen and never smoke in bed or when lying down, especially if the smoker is on medication that increases drowsiness. •...
  • Page 160 Infection Control Avoiding contagious diseases like the common cold, strep throat, and other contagious viruses is important to everyone. Here are some easy things you can do to fight the spread of infection. Clean Your Hands • Use soap and warm water. Rub your hands vigorously for at least 20 seconds. Rub your palms, fingernails, in between your fingers, and the back of your hands.
  • Page 161 • Make sure that your vaccinations are current – even for adults. Check with your doctor about shots you may need. Vaccinations are available to prevent many diseases. PN 30159 Rev 001...
  • Page 162 Disaster Preparedness Being prepared for emergencies can reduce the fear, panic, and inconvenience that surrounds a disaster. Check for hazards in the home. • During and right after a disaster, ordinary items in the home can cause injury or damage. Anything that can move, fall, break or cause fire is a home hazard. Check for items such as bookcases, hanging pictures, or overhead lights that could fall in an earthquake or a flood and block an escape path.
  • Page 163 Contact your local emergency information management office now. • Many local emergency management offices maintain registers of people with disabilities so they can be located and assisted quickly in a disaster. Check with your local county authorities for information on registration and special needs emergency shelters. Wearing medical alert tags or bracelets to identify your disability may help in case of an emergency.
  • Page 164 Myomo's policy regarding advance directives. Myomo has provided you with a Bill of Rights and shall honor those rights. We understand that the information of Advance Directives and/or Living Wills are part of your rights as a patient. Myomo will not assist in the formation of advance directives.
  • Page 165 CPR (Cardio-Pulmonary Resuscitation) may provide assistance to the level of their training, education and/or professional experience in the course of performance of duties. Myomo does not assume any responsibility for any injury, temporary or permanent, as a result of assistance provided.
  • Page 166 Client Communication Form Myomo provides the highest quality products and services for our clients. To ensure that our products and services meet your satisfaction, we encourage you to notify us and to describe any concern you may have regarding your care, treatment, service and client safety issues.
  • Page 167 Phone: 877.736.9666 Email: MyoCare@myomo.com Corporate Hours: Monday – Friday (EST) 9:00 am – 5:00 pm 45 Blue Sky Drive, Suite 101 Burlington, MA, 01803 Myomo.com PN 30159 Rev 001...

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