Related Manuals for Coapt GEN2
Summary of Contents for Coapt GEN2
- Page 1 Gen2 EVALUATION KIT Handbook v1.0 © 2019 Coapt, LLC 222 W Ontario St., Suite 300 Chicago, IL 60654 844.262.7800 (toll free) www.coaptengineering.com...
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Page 2: Table Of Contents
Single Motion Calibration..............................22 CONTROL COACH ................................22 ADAPTIVE ADVANCE ..............................23 COMPLETE CALIBRATE LED COLOR INDICATIONS ....................24 COMPLETE CONTROLROOM GEN2: USER INTERFACE APPLICATION ....25 OVERVIEW ....................................25 COMPLETE CONTROLROOM ENVIRONMENTS ....................... 25 Dashboard ....................................25 Connect ....................................26 Inputs ....................................... - Page 3 ADDITIONAL INFORMATION ................... 37 LIMITED US WARRANTY ..............................37 EXTENDED WARRANTY ..............................38 RETURNS ....................................38 PRODUCT RETURN POLICY .............................. 38 TECHNICAL INFORMATION ............................. 38 REGULATORY INFORMATION ............................39 Coapt LLC 222 W Ontario St, Suite 300, Chicago, IL 60654 USA 844.262.7800 www.coaptengineering.com...
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Page 4: User Assistance & Safety
USER ASSISTANCE & SAFETY USER ASSISTANCE Contact your prosthetist if you have difficulty operating your device. You may also contact Coapt for support (toll free) at 844-262-7800. Additional information about connecting and using the Evaluation Kit may be found online at www.coaptengineering.com... - Page 5 EMG input that is incompatible with the system, may cause damage to and/or malfunction of the device and could result in minor injury to the user. Coapt LLC 222 W Ontario St, Suite 300, Chicago, IL 60654 USA 844.262.7800...
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Page 6: Evaluation Kit Overview
Figure 1: Features of the Coapt Evaluation Kit PURPOSE The Coapt Evaluation Kit is intended to be used for the planning and/or practice phases of an upper limb myoelectric prosthesis fitting with two main purposes: 1. The Evaluation Kit allows potential upper limb prosthesis users to “test drive” Coapt COMPLETE CONTROL myoelectric pattern recognition technology. -
Page 7: Conditions For Use
The Evaluation Kit was developed for clinical use and must not be used for unusual activities. The Coapt Evaluation Kit should only be used by a trained and licensed medial professional or under supervision of a trained and licensed medical professional. -
Page 8: Accessories
When purchasing an Evaluation Kit, the EMG Interface Cable(s) are not included and must be ordered separately. The Evaluation Kit is only compatible with Coapt EMG Interface Cable types shown in the table below. Please contact a Coapt representative with any questions about EMG Interface Cable types and uses. -
Page 9: Electrodes
Interface Cable Electrodes Where the Evaluation Kit is used with an Eyelets style EMG Interface Cable (CCEE), Coapt recommends the use of FDA cleared, non-filtering, passive, stainless-steel, electrode domes as EMG contacts. Please contact a Coapt representative with any questions about use of other potentially compatible electrodes. -
Page 10: Clinician Guide
With less time spent in the clinic searching for the muscle Coapt LLC 222 W Ontario St, Suite 300, Chicago, IL 60654 USA 844.262.7800... -
Page 11: Myotesting And Electrode Placement For Pattern Recognition
The following guidelines describe an approach to how this is accomplished through use of the Coapt Evaluation Kit. Coapt LLC 222 W Ontario St, Suite 300, Chicago, IL 60654 USA 844.262.7800... -
Page 12: Step 1: Discussion
Incorporate the discussed and practiced motions into a home exercise program for pre- prosthetic control. • Encourage the user to make and hold the muscle contractions. Coapt LLC 222 W Ontario St, Suite 300, Chicago, IL 60654 USA 844.262.7800 www.coaptengineering.com... -
Page 13: Step 2: Palpation
If desired, make temporary markings on user’s residual limb to help remember areas of activity. • Take time with this process. • Be patient and listen to the user. • Perform this exercise in a relaxed environment. Coapt LLC 222 W Ontario St, Suite 300, Chicago, IL 60654 USA 844.262.7800 www.coaptengineering.com... -
Page 14: Step 3: Positioning Electrode Contacts
Areas with active EMG during positional loading (e.g. deltoids, brachioradialis). The Evaluation Kit connects to a Coapt EMG Interface Cable to evaluate eight EMG signal channels. To make up a single EMG channel, a pair of passive electrode contacts work together and pick up an oval-shaped area of muscle signal underlying these two contacts. - Page 15 NOTE: 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.
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Page 16: Evaluation Kit Instructions
To power on the Evaluation Kit, use the power switch located on the side of the main unit. The Power ON LED light next to the power switch will illuminate orange and remain on when the Evaluation Kit is powered on. Coapt LLC 222 W Ontario St, Suite 300, Chicago, IL 60654 USA 844.262.7800... -
Page 17: Connecting An Emg Interface Cable
The Evaluation Kit will operate for approximately 6 hours from a full charge. CONNECTING AN EMG INTERFACE CABLE The Coapt Evaluation Kit will need to be connected to a compatible EMG Interface Cable (see Accessories section) for proper operation. All EMG Interface Cable types have the same mating connector for attaching to the Evaluation Kit. -
Page 18: Software/Application Setup
The Evaluation Kit is designed to be used in conjunction with the COMPLETE CONTROLROOM Gen2 user interface application. This is an easy-to-use user interface application for Windows PCs and coming soon to iOS devices. See the comprehensive instructions in the COMPLETE CONTROLROOM: USER INTERFACE APPLICATION section before using the Evaluation Kit. -
Page 19: Updates
The Evaluation Kit provides calibration via the COMPLETE CONTROLROOM Gen2 user interface application. Instead of a prosthesis moving and the user copying its actions (as done with COMPLETE CONTROL System Gen2), a virtual arm and/or a displayed prompt of functions will guide the user through collection of muscle signal patterns. -
Page 20: Starting Calibration From The Software/Application
USING COMPLETE CONTROLROOM GEN2 USER INTERFACE APPLICATION: 1. Open the COMPLETE CONTROLROOM Gen2 user interface application and connect via Bluetooth to an Evaluation Kit that is powered on. 2. Navigate to the Calibrate environment and click the cogwheel icon to access the settings pop- up menu. -
Page 21: Full Sequence Calibration
1. Open the COMPLETE CONTROLROOM Gen2 user interface application and connect via Bluetooth to an Evaluation Kit that is powered on. 2. Navigate to the Inputs environment and verify all EMG channels are not indicating any skin- contact errors. 3. Navigate to the Calibrate environment. - Page 22 2 when ready. seconds (see CONTROL COACH section): assistant detected something in the calibration data that is noteworthy. Click on an actions’ arrow/chevron to Coapt LLC 222 W Ontario St, Suite 300, Chicago, IL 60654 USA 844.262.7800 www.coaptengineering.com...
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Page 23: Single Motion Calibration
The user adds calibration data to this single action/function in a “fill-the-bucket” type process. Single Motion Calibration is only available from within the COMPLETE CONTROLROOM Gen2 user interface application. Steps to calibrate using Single Motion Calibration: 1. -
Page 24: Adaptive Advance
When overall star rating is below a threshold value, the visible LED on the COMPLETE CALIBRATE Button will be white with a short blip every 2 seconds. This encourages the user to connect to the COMPLETE CONTROLROOM Gen2 user interface application for the detailed information and corrective action. -
Page 25: Complete Calibrate Led Color Indications
Magenta Solid pattern recognition output should be expected until calibration is performed. White with a CONTROL COACH has valuable information waiting short blip in the COMPLETE CONTROLROOM Gen2 user every 2 interface application to assist with control seconds improvements. Cyan Solid The COMPLETE CALIBRATE Button is being pressed. -
Page 26: Complete Controlroom Gen2: User Interface Application
Actuate Figure 15: COMPLETE CONTROLROOM Gen2 main dashboard, shown when an Evaluation Kit is not wirelessly connected via Bluetooth – the Bluetooth icon is red, the status indicator is inactive (grey), and the only available environment to click is Connect... -
Page 27: Connect
Figure 16: COMPLETE CONTROLROOM Gen2 main dashboard, shown when an Evaluation Kit is wirelessly connected via Bluetooth – the Bluetooth icon is blue, the status indicator is active (green in this example), and all environments are available to click Connect The COMPLETE CONTROLROOM Gen2 Connect environment manages the Bluetooth connection to the Evaluation Kit. - Page 28 Figure 17: COMPLETE CONTROLROOM Gen2 Connect screen shown when a COMPLETE CONTROLLER or Evaluation Kit is not yet wirelessly connected via Bluetooth – the only clickable item is the Scan button BLUETOOTH: Action Button: Scan/Disconnect – Clicking “Scan” displays a list of any Evaluation Kits (or nearby Coapt COMPLETE CONTROL Gen2 controller systems) currently broadcasting over Bluetooth.
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Page 29: Inputs
Figure 19: COMPLETE CONTROLROOM Gen2 Connect screen shown when an Evaluation Kit is wirelessly connected via Bluetooth – showing Bluetooth-connected device ID, the connected controller’s cable type, all available action buttons, and the active title bars to enter the other software environments NOTE: After a period of inactive Bluetooth communication (e.g. - Page 30 Figure 20: COMPLETE CONTROLROOM Gen2 Inputs screen showing all eight channels of input EMG signals, channel selection toggles, an output notification track at the bottom of the screen, and two ‘peek’ windows for the Actuate and Calibrate environments A real-time signal quality assistant monitors for EMG electrodes losing contact with user’s skin (“lift- off”).
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Page 31: Calibrate
Figure 22: COMPLETE CONTROLROOM Gen2 Inputs screen showing an example of two EMG input channels (Orange and Blue) turned “off” IMPORTANT: The Evaluation Kit 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 32 Figure 23: COMPLETE CONTROLROOM Gen2 Calibrate screen showing a list of available and selectable classification actions, their asscoiated CONTROL COACH star-ratings, a calibration prompt area, and two ‘peek’ windows for the Inputs and Actuate environments Action Buttons: Action Button: Calibrate – This single-press button initiates User Interface-Guided Calibration Action Button: Undo (counterclockwise arrow icon) –...
- Page 33 Figure 24: COMPLETE CONTROLROOM Gen2 Calibrate screen showing the CONTROL COACH call-out for one motion – CONTROL COACH presents its helpul findings and analysis as well as instructive tips for functional improvement and an action button that allows the user to bolster his/her motion with additioaonl EMG contraction data The COMPLETE CONTROLROOM Gen2 Calibration environment has a settings menu accessible via click of the cogwheel icon at the top right of the environment.
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Page 34: Actuate
EMG contraction data during the “fill-the-bucket” type process of Single Motion Calibration (the maximum is 10 seconds of valid contraction data). Figure 25: COMPLETE CONTROLROOM Gen2 Calibrate screen settings pop-up showing controls for Calibration Pace, Adapative Advance, Control Coach LED Sensitivity, and One-Class Caloibration Data Amount... - Page 35 Calibrate environments Action Buttons: Action Button: Virtual Arm/Device – This toggle button will be set to “Virtual Arm” and be inactive when using the Coapt Evaluation Kit. Coapt LLC 222 W Ontario St, Suite 300, Chicago, IL 60654 USA 844.262.7800...
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Page 36: Troubleshooting
Control seems to be ok The electrode contacts may have Recalibrate for a while and then adapted to new skin conditions of changes after a short the user period Coapt LLC 222 W Ontario St, Suite 300, Chicago, IL 60654 USA 844.262.7800 www.coaptengineering.com... -
Page 37: Hardware Troubleshooting
COMPLETE that are degrading Bluetooth radio communicating devices CONTROLROOM Gen2 communication software are very jumpy and seem to lag Coapt LLC 222 W Ontario St, Suite 300, Chicago, IL 60654 USA 844.262.7800... -
Page 38: Additional Information
Coapt and other suppliers/manufacturers, in the event that such a system is sent into Coapt for warranty review, if it is found during evaluation the reported problem(s) is associated with a product or component not supplied by Coapt, a “Non- Warranty Evaluation Charge”... -
Page 39: Extended Warranty
Evaluation Kit resulting in device malfunction and minor injury to the user. Battery Servicing. Never open the Evaluation Kit to evaluate or replace the internal battery. Battery servicing must only be done by an authorized Coapt technician. OPERATING TEMPERATURE: •... -
Page 40: Regulatory Information
• 22.10 mm (0.87 in) REGULATORY INFORMATION FDA: Coapt, LLC is registered with the Food and Drug Administration of the United States Government (Registration Number: 3010605876; Owner Operator Number: 10045459) for the manufacture and supply of prosthetics and orthotics products. - Page 41 Electromagnetic Disturbance Characteristics Limit and Methods of Measurement. This device is fully compliant with the CE Marking Requirements under the European Medical Device Directive (MDD). Coapt, LLC’s European Union Authorized Representative (EC REP) is Fillauer Europe AB. Coapt LLC 222 W Ontario St, Suite 300, Chicago, IL 60654 USA 844.262.7800...
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