Related Manuals for Coapt GEN2
Summary of Contents for Coapt GEN2
- Page 1 HANDBOOK (V 4.0) COMPLETE CONTROL SYSTEM GEN2 © 2020 Coapt, LLC 222 W Ontario St., Suite 300 Chicago, IL 60654 844.262.7800 www.coaptengineering.com...
- Page 2 Caution: Federal law restricts this device to sale by or on the order of a physician. © 2020 Coapt, LLC 222 W Ontario St., Suite 300 Chicago, IL 60654 844.262.7800 www.coaptengineering.com...
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Page 3: Table Of Contents
Placing the Complete Control system................................21 Connect the EMG Interface Cable ..................................23 Connect the Device Interface Cable.................................. 24 Making sure the prosthetic components are set up for ideal Coapt control ..............25 GENERAL INSTALLATION PRECAUTIONS ................................26 MORE INFORMATION ........................................26... - Page 4 BUTTON SOUNDS & LED COLORS ................................... 38 COMPLETE CONTROLROOM GEN2: USER INTERFACE ....................40 INSTALLATION ............................................40 UPDATES ..............................................40 COMPLETE CONTROLROOM GEN2 ENVIRONMENTS ..........................41 Dashboard ............................................. 41 Connect ..............................................42 Inputs ..............................................44 Calibrate ..............................................46 Actuate ..............................................48 TROUBLESHOOTING ..................................
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Page 5: User Assistance & Safety
Gen2 may be found online at www.coaptengineering.com GENERAL WARNINGS AND PRECAUTIONS For safety and to prevent damage to the Complete Control System Gen2 and/or prosthetic device, please read and adhere to all safety precautions found in this handbook. In addition, please follow the safety guidelines found in the user manual(s) for any connected electrodes or prosthetic device(s). - Page 6 Modifying or disassembling device. Do not disassemble componentry or modify in any way. Maintenance, repairs, and upgrades may only be performed by Coapt, LLC. Unauthorized device modification or disassembly could cause damage to the device resulting in device malfunction, unintended prosthesis movement, and injury to the user.
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Page 7: Overview
This is where pattern recognition goes to work. The complex sets of myoelectric patterns need to be “decoded” in real time and matched to their arm or hand action. Coapt’s pattern recognition is a system of finely tuned machine learning algorithms that does just that. Specifically, for the residual muscle signals of those with upper limb loss or difference. -
Page 8: What Is Key To Making Pattern Recognition Function At Its Best
considers the signal level from one electrode to control each prosthesis movement. In other words, standard myoelectric control is like listening to music and only knowing how loud the sound is, while pattern recognition is like hearing what song is playing. Key benefits of pattern recognition over standard myoelectric control include the following: •... -
Page 9: Successful Use Of Pattern Recognition Control Relies On Two Priorities
1. Placing electrodes at locations that make reliable contact with the skin. 2. Good understanding of pattern recognition calibration by the user and the practitioner. INDICATIONS FOR USE The Complete Control System Gen2 is to be used exclusively for external prosthetic fittings of the upper limb. CONTRAINDICATIONS None known. -
Page 10: Compatible Devices
COMPATIBLE DEVICES Electrodes The Complete Control System Gen2 can be used with commercially available non-filtering, passive EMG electrode contacts. Coapt recommends the use of stainless-steel electrode domes as contacts. The compatible electrodes are shown below. Please contact a Coapt representative with any questions about compatible electrodes. -
Page 11: Prosthetic Devices
The chart below depicts the common compatibilities and capabilities of the Complete Control System Gen2. Each navigating-line of color in the chart indicates devices that are compatible with each other in a valid Complete Control System Gen2 configuration. -
Page 12: Conditions For Use
(e.g., pushups or mountain biking). The Coapt Complete Control System Gen2 should only be used by the individual to whom it was prescribed. This system is a custom solution that may not perform well for individuals other than the intended recipient. -
Page 13: Clinician Guide
1. Determining where there is underlying muscle tissue on the residual limb of your user. 2. Planning the Coapt electrode contacts to reliably cover those areas of residual muscle activity. H A N D B O O K ( V 4 . 0 ) -
Page 14: Step 1: Have A Thorough Discovery Chat With Your User
Step 1: Have a thorough discovery chat with your user Before you dive into any palpation for muscle activity with a prospective user, plan to have a thorough discussion with them about what they can feel and do with their limb. Forget instructing them to imagine isolating wrist flexion and extension or simple elbow up/down (we know—it can be hard to change old habits) but instead, have them tell you ALL of what their finger, hand, wrist, elbow, etc. - Page 15 A HELPFUL APPROACH TO LEADING THIS DISCUSSION: • Ask questions to determine what movements the user can perceive and produce with their phantom limb, such as: o “Can you feel your hand? Which fingers do you feel you can move?” o “Can you imagine making a fist? What about opening your hand with your fingers spread apart?”...
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Page 16: Step 2: Determine Where There Is Underlying Muscle Tissue On The Residual Limb
Step 2: Determine where there is underlying muscle tissue on the residual limb Palpation isn’t what it used to be. For single- or dual-site, conventional myoelectric control electrode planning, you may have been used to feeling for strong, isolated contractions using your fingertips. Forget that. For pattern recognition go all in. - Page 17 A HELPFUL APPROACH TO PERFORMING THIS PALPATION: • Perform this exercise in a relaxed environment • Take time with this process. • Be patient and listen. • Grasp and cover as much of the user’s limb as possible; do not use only your fingertips to feel.
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Page 18: Placing And Connecting Coapt Dome Electrodes
• The Coapt system has 8 EMG channels (16 Dome Electrode contact points) and one ground/reference contact (17 Dome Electrode contact points in total). • In some space-constrained fittings, the 17 Coapt Dome Electrodes can be reduced to as few as 9, by way of contact-sharing (see below for details). - Page 19 EMG channel (same color) on the same Dome Electrode—that will result in zero signal for that channel and not be helpful for pattern recognition. Also very important: All Coapt Conductor wires must be connected to a Dome Electrode contact; do not leave any unconnected.
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Page 20: Assembly Instructions For Placing Dome Electrodes Into The Prosthesis
Contact your Coapt representative with any questions about myotesting and/or electrode placement. Coapt is willing and able to assist with placement instruction and suggestion— these can often be accomplished by submitting socket and/or limb shape images to Coapt. Assembly Instructions for placing Dome Electrodes into the prosthesis For more information, see Coapt’s Dome Electrode Handbook (available on the Coapt website) - Page 21 NEED TO CLEAN THE DOME ELECTRODES? • Coapt recommends cleaning of the Dome Electrodes’ skin contact side as needed using isopropyl alcohol on a clean cloth. Avoid using anything abrasive like sandpaper or steel wool.
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Page 22: Connecting The Coapt System Components
CONNECTING THE COAPT SYSTEM COMPONENTS The Coapt system is a stand-alone prosthesis control system. Its inputs are EMG signals from the user and its outputs are commands to the prosthesis. This section will guide you through connecting the EMG inputs cable and the prosthesis connection cable to the Coapt main controller unit. -
Page 23: In The Complete Control Kit
Placing the Complete Control system The main processing unit of the Coapt system is the Complete Controller. Permanently attached to that is the Complete Calibrate button. That button is designed to be secured into the outer socket wall of the prosthesis with its button side exposed to the user. - Page 24 The Complete Calibrate button is a module connected to the Complete Controller. It has one central button, an indicator LED, and the Coapt logo on its top face intended to be accessible to the user. The button is primarily used to initiate the prosthesis calibration process and is NOT a prosthesis power on/off button.
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Page 25: Connect The Emg Interface Cable
Connect the EMG Interface Cable The gray jacketed cable is the EMG Interface Cable. One end of this cable has a wide connector that mates with the Complete Controller while the other end will be your EMG interface of choice, e.g. a set of ring-terminal eyelets, snap connectors, or perhaps even an EMG cuff. -
Page 26: Connect The Device Interface Cable
To connect the Device Interface Cable to the controller, line up the arrows on the bottom labels that point directly at each other and push the connector on until it clicks in place. Coapt logo halves printed on the Device Interface Cable connector and the device connection of the Complete Controller will combine to complete the logo when properly connected. -
Page 27: Making Sure The Prosthetic Components Are Set Up For Ideal Coapt Control
Coapt website, or on visual instructions within the Coapt software applications. Pro tip: There is a two- character code on the label of your Coapt Device Connection Cable. Use that code to find and follow the settings and connection diagrams specific to your cable type. Please contact a Coapt representative for assistance if you are not comfortable adjusting any of the settings of the prosthetic components. -
Page 28: General Installation Precautions
MORE INFORMATION Additional information, including videos, about connecting and using the Complete Control System Gen2 can be found online at www.coaptengineering.com H A N D B O O K ( V 4 . 0 ) -
Page 29: Guidance For Users
SETUP AND TRAINING Only use a Coapt Complete Control System Gen2 after it has been set up by a prosthetist. Your prosthetist will train proper use of the Complete Control System Gen2 and can answer any questions about operating the device. - Page 30 USE THIS SPACE TO RECORD NOTES FROM SESSIONS WITH YOUR PROSTHETIST. H A N D B O O K ( V 4 . 0 ) C O M P L E T E C O N T R O L S Y S T E M G E N 2...
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Page 31: Powering On
POWERING ON The Complete Control System Gen2 takes about 1-2 seconds to start each time the prosthesis is powered on. It will signal ‘readiness’ with a short beep and a synchronized green light flash on the Complete Calibrate button. CALIBRATING PROSTHESIS CONTROL Good prosthesis control depends on good calibration from you. - Page 32 • Release your hold on the button, and your prosthesis will begin to move on its own. • The following minute or so is what Coapt calls Prosthesis Guided Calibration (PGC). PGC is when the prosthesis goes through a sequence of motions on its own (like it is being remotely controlled) and you simply follow along with your corresponding muscle contractions.
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Page 33: Calibrating Control On-Screen (Via Mobile Or Desktop)
Calibrating control on-screen (via mobile or desktop) In case you would prefer to calibrate your Coapt system by watching on-screen prompts, great calibration tools are provided in the Coapt Complete ControlRoom software interface or app. - Page 34 CALIBRATING ALL MOTIONS USING THE SOFTWARE: Once you’ve established a Bluetooth connection to your Coapt system in the Complete ControlRoom application, navigate to the “Calibrate” panel. This is a screen area where your available prosthesis motions can be selected/deselected for calibration, and where an orange button labeled “Calibrate Enabled Motions” sits.
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Page 35: Calibration Adaptation: Adaptive Advance
CALIBRATION: ADDITIONAL TOOLS Calibration Clearing/Resetting Sometimes you may want or need to erase/reset the calibration control memory of your Coapt system. This can be helpful if there has been a major socket change (such as electrode relocation) or simply if reliable control has become unstable. -
Page 36: Calibration Undo's
This is not a big deal—and no reason to let that affect your control in a bad way. At any time, the Coapt system lets you “Undo” your last (most recent) calibration activity, whether that was a single motion ‘Add Data’... -
Page 37: Calibration Restore Points
Calibration Restore Points Another convenient feature of Coapt calibration is the ability to store up to 3 calibration Restore Points. Restore points act as saved ‘snapshots in time’ of your control. Whenever you would like to save your current calibration—... -
Page 38: Control Coach
® Your Coapt system is smart. Not only can it be calibrated to learn and know your muscle signals patterns for prosthesis control, it also has a built-in coach to help you get the best out of calibrating. Coapt’s artificial intelligence (A.I.) Control Coach... -
Page 39: The Control Coach ® "Check Engine" Light
Check Engine light to let you know. Control Coach of the Coapt system has its own light to let you ® know there is helpful performance information available—the LED on the Complete... -
Page 40: Button Sounds & Led Colors
Somewhere on the surface of the prosthesis, you will have access to the Coapt Complete Calibrate button. This oval unit has one pressable button, a Coapt logo, a multi-colored LED, and it can make a series of tones for you to hear. - Page 41 Critical Error Solid Critical Error. Not to worry, this usually means the Coapt system had to put itself in a protective state because of something else going on with the prosthesis. This can usually be overcome with a quick chat with your prosthetist or Coapt, and you probably don’t even need to take your prosthesis off.
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Page 42: Complete Controlroom Gen2: User Interface
It can be downloaded and installed as a PC application or found in the Apple store as an iOS app. Complete ControlRoom connects to a Complete Control System Gen2 via Bluetooth and is used for setup, configuration, calibration assistance, and controls practice. -
Page 43: Complete Controlroom Gen2 Environments
COMPLETE CONTROLROOM GEN2 ENVIRONMENTS Dashboard The Dashboard environment appears when Complete ControlRoom is launched and presents navigation to the four other Complete ControlRoom environments. H A N D B O O K ( V 4 . 0 ) C O M P L E T E C O N T R O L S Y S T E M G E N 2... -
Page 44: Connect
Connect The Connect environment has two main purposes: 1. Manage Bluetooth connection to a Complete Controller System Gen2 2. Guide the correct configuration and physical connections of the Complete Controller System Gen2 to the prosthesis. CONNET PANEL ELEMENTS (BLUETOOTH SUB-PANEL) A Bluetooth-connected Complete Controller will be named by its serial number starting with “CC”. - Page 45 If proper setup with prosthetic devices is not complete, the Complete Control System Gen2 will not be able to function at its ideal capacity. H A N D B O O K ( V 4 . 0 )
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Page 46: Inputs
3. Display a real-time classification output (when calibrated) corresponding to inputs’ patterns The Complete Control System Gen2 is designed to function at its ideal capacity with all eight EMG channel inputs. Any EMG channels that are turned off should be corrected to ensure reliable electrode contact and then turned back on for optimal performance. - Page 47 INPUTS PANEL ELEMENTS Dynamic signal activity on eight horizontal bars of color represent the eight EMG channel inputs of the Complete Control System Gen2. The on-screen colors correspond to the EMG wire colors of the EMG Interface Cable. EMG INPUT BARS A real-time signal quality assistant monitors for EMG electrodes losing contact with user’s skin (“lift-off”).
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Page 48: Calibrate
Calibrate The Calibrate environment assists the user with calibration of their Complete Control System Gen2. CALIBRATE PANEL ELEMENTS ACTION/FUNCTION Allows selection of which actions/functions are included in calibration for prosthetic TOGGLES control. Displays the A.I. Control Coach ACTION/FUNCTION estimated calibration quality for each action/function ®... - Page 49 Reverts the system to the calibrated state it was in just before the most recent UNDO – BUTTON calibration activity, that activity either being single-motion or full-sequence (COUNTER- calibration. CLOCKWISE The Undo functionality only applies to one calibration step; that is, undoing more than ARROW ICON) one calibration step is not possible.
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Page 50: Actuate
Actuate The Actuate environment assists the user with on-screen prosthesis control practice using their Complete Control System Gen2. ACTUATE PANEL ELEMENTS VIRTUAL Allows the user to direct their real-time pattern recognition control to either the on- ARM/DEVICE - screen arm or their prosthesis. -
Page 51: Troubleshooting
Coapt has created, available online or withing the Complete ControlRoom software application. If you are encountering an issue that seems out of the ordinary, Coapt hopes you will find the guided troubleshooting in this section helpful. - Page 52 The EMG Inputs display is showing warnings on some of the channels, what do I need to do? The Coapt system has built-in detection to know if any EMG channel is not receiving signals from the skin. Before you can expect good prosthesis control performance, corrective action for any EMG channel showing this warning should be made.
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Page 53: Lights And Sounds
You should be able to get it going again with these steps: 1. Bluetooth connect to your Coapt system in the Complete ControlRoom application 2. On the Connect screen, find and press the “Reset” button (it is be located near a message, “Your Coapt Controller is in an error state.”) 3. -
Page 54: Function/Calibration
Address any that are. 2. It is possible that the Coapt system sees your data for that motion (the one that is moving when you are relaxed) as very similar to your data for the actual relax state. A few things that may help: a. - Page 55 Connection Guide for the cable type of your prosthesis (e.g. “H0”, “I4”, etc.) 3. Ensure all of the settings on the other manufacturers’ devices are set exactly as shown in the Coapt guidance documentation specific to the components connected by the cable type of your prosthesis (e.g.
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Page 56: Software/Application
Connection Guide for the cable type of your prosthesis (e.g. “H0”, “I4”, etc.) 2. Ensure all of the settings on the other manufacturers’ devices are set exactly as shown in the Coapt guidance documentation specific to the components connected by the cable type of your prosthesis (e.g. -
Page 57: Bluetooth
Am I supposed to use the big Coapt USB dongle or the small Coapt USB dongle? Coapt’s Gen2 system uses a small USB Bluetooth radio dongle. It protrudes from a USB port less than 1 cm. If you have the larger, Gen1 USB dongle it will not communicate to a Gen2 Coapt system and vice versa. -
Page 58: Updates
1. Ensure the prosthesis’ battery is charged and the prosthesis is turned on. 2. If your Coapt system has been powered on for a while, it may have turned off its own Bluetooth radio to save power. You can wake it back up by pressing the Complete Calibrate button once quickly. -
Page 59: Additional Information
Coapt, a “Non-Warranty Evaluation Charge” may be invoiced to the Customer. Coapt warrants its Items will be free from defects in material and/or workmanship for a period up to two (2) years. In the absence of a prompt notice from the clinician regarding a delay in fitting the patient, Coapt will set the Limited Warranty start date at 30 days after the shipping date. -
Page 60: Extended Warranty
Users should return all malfunctioning, damaged, or undesired Complete Control System Gen2 components directly to their clinician. Clinicians should return all unserviceable Complete Control System Gen2 components directly to their regional distributor. In the United States, Clinicians should return all unserviceable Complete Control System Gen2... -
Page 61: Technical Information
• The Complete Control System Gen2 is NOT provided with a battery • The Complete Control System Gen2 will operate on supply voltages between 5–20 V • The Complete Control System Gen2 consumes approximately 50 mA at 7.4 V (370mW) -
Page 62: Regulatory Information
(Registration Number: 3010605876; Owner Operator Number: 10045459) for the manufacture and supply of prosthetics and orthotics products. The Coapt Complete Control System Gen2 has been cleared as substantially equivalent to a legally marketed predicate device as a Class II device via Section 510(k) premarket notification; K191083. - Page 63 222 W Ontario St., Suite 300 Chicago, IL 60654 844.262.7800 www.coaptengineering.com © 2020...
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