Related Manuals for Coapt GEN2
Summary of Contents for Coapt GEN2
- Page 1 HANDBOOK (V 3.2) EVALUATION © 2021 Coapt, LLC 303 W Institute Pl., Suite 200 Chicago, IL 60610 844.262.7800 www.coaptengineering.com...
- Page 2 Caution: Federal law restricts this device to sale by or on the order of a physician. © 2021 Coapt, LLC 303 W Institute Pl., Suite 200 Chicago, IL 60610 844.262.7800 www.coaptengineering.com...
-
Page 3: Table Of Contents
CLINICIAN GUIDE ....................................12 PLANNING EMG ELECTRODE SITES FOR COAPT GEN2 PATTERN RECOGNITION ............12 Step 1: Have a thorough discovery chat with your user ......................... 13 Step 2: Determine where there is underlying muscle tissue on the residual limb ............15 PLACING AND CONNECTING COAPT ELECTRODE CONTACTS ...................... - Page 4 BUTTON SOUNDS & LED COLORS .................................... 30 COMPLETE CONTROLROOM GEN2: USER INTERFACE ....................32 INSTALLATION ............................................32 UPDATES ................................................ 32 COMPLETE CONTROLROOM GEN2 ENVIRONMENTS ..........................34 Dashboard .............................................. 34 Connect ..............................................35 Inputs ................................................37 Calibrate ..............................................39 Actuate ............................................... 41 TROUBLESHOOTING ..................................
-
Page 5: User Assistance & Safety
& 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 6 Use near open flame. Use care when operating device near an open flame, and do not allow device to remain directly over an open flame. Direct exposure to an open flame may cause the device to exceed safe temperature limits and may cause device malfunction. Exposure to extreme temperatures.
-
Page 7: Label Symbol Descriptions
Medical Device Directives (93/42/EEC). Signifies the identification information for the Serial Number device. Date of Manufacture Date the device was assembled at Coapt. European Representative Signifies the European Representative for Coapt. The device has conductive contact with the Type BF Applied Part patient. -
Page 8: Overview
The Evaluation Kit permits virtual practice and training for pattern recognition myoelectric control. 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. -
Page 9: Pattern Recognition Introduction
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 10: What Is Key To Making Pattern Recognition Function At Its Best
2. Good understanding of pattern recognition calibration by the user and the practitioner. INDICATIONS FOR USE The Coapt Evaluation Kit is an accessory tool intended to be used during the planning and alignment of myoelectric control contact locations for an upper limb prosthetic socket. -
Page 11: Conditions For Use
Evaluation Kit can aid in determining this. IN THE KIT The Coapt Evaluation kit is to be used in conjunction with a Coapt EMG Interface Cable (sold separately) and the Coapt Complete ControlRoom Gen2 user interface application. The Coapt Evaluation Kit contains the following components: 1. -
Page 12: 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 13: Electrodes
Coapt Dome Electrodes. Contact a Coapt representative to purchase these separately. Where the Evaluation Kit is used with a Snap Style EMG Interface Cable, Coapt recommends the use of FDA cleared, Temporary Evaluation Electrode “Stickers”. Contact a Coapt representative to purchase these separately. -
Page 14: 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 3 . 2 ) -
Page 15: 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 fingers, hand, wrist, elbow, etc. - Page 16 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?”...
-
Page 17: 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 18 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.
-
Page 19: Placing And Connecting Coapt Electrode Contacts
(17 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). Contact sharing is not possible when using the Temporary Evaluation Electrode “Stickers”... - Page 20 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 21 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. Contact sharing is not possible when using the Temporary Evaluation Electrode “Stickers”...
-
Page 22: Evaluation Kit Instructions
EVALUATION KIT INSTRUCTIONS CHARGING A micro-USB cable is provided with the Evaluation Kit for charging the internal battery of the main unit. To charge the battery at any time, connect the USB 3.0 side of the cable to a USB computer port or suitable USB wall-charging “brick”... -
Page 23: Powering On
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 24: Bluetooth Connection
2. Plug the Complete Communicator USB Bluetooth Dongle into a USB port on your personal computer. 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 iOS devices. See the comprehensive instructions in the COMPLETE CONTROLROOM GEN2: USER INTERFACE section before using the Evaluation Kit. -
Page 25: Calibrating Control On-Screen (Via Mobile Or Desktop)
Coapt Complete ControlRoom application software from the Coapt website. To use a mobile device version of the application, visit the Apple or Google Play store for the Coapt Complete ControlRoom app. - Page 26 ® so, Control Coach ® has useful calibration performance info waiting in the Coapt Complete ControlRoom application. H A N D B O O K ( V 3 . 2 ) G E N 2 E V A L U A T I O N K I T...
-
Page 27: 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 an electrode location change or simply if reliable control has become unstable. To help with this, there are a few convenient ways to reset all calibrated motions or to reset one motion at a time. -
Page 28: 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 29: 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 30: 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 31: Using Control Coach ® Information
Using Control Coach ® Information In Coapt’s Complete ControlRoom software application, connect to your device with Bluetooth, navigate to the Calibrate panel, and you will see Control Coach quality star ratings for each control motion (on the PC ® software you will also see an overall quality score). Clicking on the small arrow icon next to any motion brings up your Control Coach ®... -
Page 32: Button Sounds & Led Colors
On the Evaluation Kit, 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. This reference section helps you with what all those colors and sounds mean. - Page 33 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 system. This can usually be overcome with a quick chat with your prosthetist or Coapt, and you probably don’t even need to take the system off.
-
Page 34: Complete Controlroom Gen2: User Interface
COMPLETE CONTROLROOM GEN2: USER INTERFACE Complete ControlRoom Gen2 is an easy to use and convenient user interface application available to both clinicians and users. It can be downloaded and installed as a PC application or a mobile application in the Apple or Google Play store. - Page 35 2. The update procedure will be initiated and will restart the Complete ControlRoom application when complete. When an update is available for the Complete ControlRoom application, the iOS device should automatically initiate the update when the application is opened. iOS applications can also be updated manually: 1.
-
Page 36: 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 3 . 2 ) G E N 2 E V A L U A T I O N K I T... -
Page 37: 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) - Page 38 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 3 . 2 )
-
Page 39: 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 40 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”).
-
Page 41: 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. ACTION/FUNCTION Displays the A.I. Control Coach ® estimated calibration quality for each action/function... - Page 42 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.
-
Page 43: 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 44: Troubleshooting
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. -
Page 45: Function/Calibration
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 46: Bluetooth
1. Ensure the battery is charged and the system 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 47: Updates
Some of the updates are for the software of the Complete ControlRoom application while other updates will be for the code (firmware) that lives on the Coapt hardware system inside the prosthesis. This second type of update can take longer to complete and typically requires about 10 minutes. -
Page 48: 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 49: Extended Warranty
ATTN: Returns 303 W Institute Pl., Suite 200 Chicago, IL 60610 If sending the Evaluation Kit to Coapt for repair or return, it is the shipper's responsibility to follow all applicable regulations for shipping lithium-ion batteries. PRODUCT RETURN POLICY • Item(s) returned in resaleable condition within 30 days of receipt are refunded or credited at full value without a restocking fee. -
Page 50: Adverse Events
You must report the event as soon as possible. Please contact Coapt if you have any questions or need assistance. -
Page 51: Technical Information
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 Humidity •... -
Page 52: Regulatory Information
REGULATORY INFORMATION 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. The Coapt Evaluation Kit has been listed with the FDA under device number D362224. - Page 53 303 W Institute Pl., Suite 200 Chicago, IL 60610 844.262.7800 www.coaptengineering.com © 2021...
Need help?
Do you have a question about the GEN2 and is the answer not in the manual?
Questions and answers