Related Manuals for Coapt GEN 2
Summary of Contents for Coapt GEN 2
- Page 1 HANDBOOK (V 4.0) EVALUATION © 2022 Coapt, LLC 303 W Institute Pl., Suite 200 Chicago, IL 60610 844.262.7800 www.coaptengineering.com...
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Page 2: Table Of Contents
CONTENTS CONTENTS ......................................1 USER ASSISTANCE & SAFETY ................................. 3 USER ASSISTANCE ..........................................3 GENERAL WARNINGS AND PRECAUTIONS ................................ 3 ADVERSE REACTIONS .......................................... 5 LABEL SYMBOL DESCRIPTIONS ....................................6 OVERVIEW ......................................7 PURPOSE OF THE DEVICE ........................................ 7 INDICATIONS FOR USE ........................................7 CONTRAINDICATIONS ......................................... - Page 3 CONTROL COMAPNION COMPLETE CONTROLROOM USER APPS ..............29 INSTALLATION ............................................29 CORE APP USES ............................................ 29 Configuration ............................................. 29 Input Validation ..........................................30 EMG Pattern Exploration ......................................30 Calibration............................................. 30 Practice and Games ........................................30 ADDITIONAL INFORMATION ................................ 31 LIMITED US WARRANTY ........................................31 EXTENDED WARRANTY ........................................
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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 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.
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Page 6: Adverse Reactions
You must report the event as soon as possible. Please contact Coapt if you have any questions or need assistance. -
Page 7: Label Symbol Descriptions
Signifies the identification information for the Serial Number device. Manufacturer Manufacturer Name and Address 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
OVERVIEW PURPOSE OF THE DEVICE 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 9: Description Of The Device
DESCRIPTION OF THE DEVICE The Coapt Evaluation kit is to be used in conjunction with a Coapt EMG Interface Cable (sold separately) and either Coapt’s Control Companion mobile app or Complete ControlRoom software app. COMPONENTS 1. Evaluation Kit main unit 2. -
Page 10: Compatible Devices
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 11: Electrode Contacts
Osseointegration-Style Cuff Elastic cuff for definitive Osseointegration use only EMG Interface Cable Electrode Contacts The Evaluation Kit is designed to work with non-filtering, passive electrode contacts. Coapt recommends using these compatible electrode contacts: COMPATIBLE ELECTRODE CONTACTS PART NUMBER(S) FDA 510(K) -
Page 12: 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 13: Instructions For Use
INSTRUCTIONS FOR PATTERN RECOGNITION FUNDAMENTALS Muscle electrical (myoelectric) signals contain a lot of information. Pattern recognition uses the combined information gathered from an array of electrode contacts to control multiple prosthesis movements intuitively. Electrode Contact: All electrode contacts must maintain good contact with the user’s skin for ideal pattern recognition function. -
Page 14: Planning Pattern Recognition Electrode Locations
Contact a 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. Step 1: Discussing User Contractions Having a user explore all of the possible muscle contractions they can imagine, feel, and produce –... -
Page 15: Step 3: Planning Electrode Locations
While feeling the limb, take note of all areas where underlying muscle activity is felt, even if it is subtle. This will guide where electrode contacts should be placed. Consider taking notes, capturing images, or making temporary markings on the user’s skin. Feel for the overall muscle activity –... - Page 16 Contact Sharing – For a limb that is too small to reliably fit all 17 electrode contacts, it is ok to have a few of the signal channels share an electrode contact. See the Coapt ControlSeal product handbook for assembly detail when sharing.
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Page 17: Charging The Battery
PLACING THE EVALUATION-STYLE CUFF OR OSSEOINTEGRATION-STYLE CUFF EMG INTERFACE CABLE: For best results, clean and dampen underlying skin areas and secure the Evaluation-style cuff snugly around the most muscular section of the limb being evaluated. Specific rotational position is not crucial but consider aligning the connection cable with the Ulna (below elbow) or laterally (above elbow) for repeatability. -
Page 18: 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 19: Bluetooth Connection
2. Plug the Complete Communicator USB Bluetooth Dongle into a USB port on your personal computer. TROUBLESHOOTING Contact a Coapt representative for assistance as required if encountering situations out of the ordinary, not covered in this product handbook, or not found via the online resources at www.coaptengineering.com... -
Page 20: Guidance For Users
FOR USERS PATTERN RECOGNITION CALIBRATION Calibration is how the Coapt system learns your muscle signals patterns – specifically, the patterns you will use to personalize the control of your prosthesis. The better you calibrate, the easier it will be to control. - Page 21 USING THE SOFTWARE APP Connect vis Bluetooth and navigate to the Calibrate screen of the Complete ControlRoom software app. Once the desired prosthesis’ motions are selected, get ready to provide muscle contraction data and press the “Calibrate Enabled Motions” button to initiate full-sequence calibration.
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Page 22: Calibrating Individual Motions
Calibrating Individual Motions This is a method to provide a muscle signals pattern (to compute the pattern recognition memory) for one of the enabled motions of your prosthesis at a time. USING THE SOFTWARE APP Connect vis Bluetooth and navigate to the Calibrate screen of the Complete ControlRoom software app. -
Page 23: Additional Calibration Tools
There are various ways to undo the most recent calibration activity: USING THE PHYSICAL BUTTON Hold the Coapt Complete Calibrate button for 6 seconds and release it once you hear the double beep and see the LED flashing. After a few moments to recompute, prosthesis control will be returned. -
Page 24: Clearing/Resetting All Calibrated Motions
There are various ways to fully reset all calibrated motions to a blank, starting state: USING THE PHYSICAL BUTTON Hold the Coapt Complete Calibrate button for 10 seconds and release it once you hear the jingle. The button’s LED will turn magenta, indicating the blank pattern recognition memory starting state. -
Page 25: Clearing/Resetting Individual Motions
Clearing/Resetting Individual Motions When the need arises to reset the pattern recognition memory of one motion while leaving others as-is, calibrated motions can be individually reset to a blank, starting state. USING THE SOFTWARE APP Complete From Calibrate screen ControlRoom software app, press on the name or star rating of any one of the enabled motions to access a menu specific to that motion. -
Page 26: Calibration Restore Points
Calibration Restore Points It is possible to store up to 3 Restore Points that are saved ‘snapshots in time’ of your pattern recognition control memory. This feature can be used to store and recall a control setup that is particularly functional, is tailored to a specific need (work, home, leisure, etc.), and more. -
Page 27: Control Coach
CONTROL COACH ® Each time calibration data is provided, the artificial intelligence (A.I.) Control Coach system analyzes data ® nuances and conditions that it knows could limit functional potential. Control Coach ® was programmed with clinical experience to provide tips and tricks to help you tweak further calibrations and get the most out of your control. -
Page 28: Calibration Button Unit: Sounds & Led Color Meanings
Indicates the system has powered on and “booted” properly. Double blink Low Power Source Indicates the power supplying the Coapt system is very low. Solid MAGENTA Reset State Indicates the system is in a blank/empty starting state. Calibration will have to be performed before controlling the prosthesis. - Page 29 Indicates that informational and assistive Control Coach “messages are available in the ® Coapt Complete ControlRoom software app or Control Companion mobile app. This indicator is present whenever the overall Control Coach star rating drops below a set value. ®...
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Page 30: Control Comapnion And Complete Controlroom User Apps
Both apps use Bluetooth to wirelessly communicate with the Evaluation Kit. INSTALLATION For iOS Control Companion, search for “Complete ControlRoom” in the App Store. • For Android Control Companion, search for “Coapt” in the Google Play Store. • For PC Complete ControlRoom Gen2 download, visit www.coaptengineering.com •... -
Page 31: Input Validation
Input Validation Similar to validating the correct output connectivity, it is important to validate EMG signals from all 8 myoelectric input channels before proceeding with calibration. Electrode contacts not touching the skin, loose electrode hardware, disconnected EMG connection wires, and more can all contribute to a bad EMG channel. Bad channels need to be corrected for optimal functional performance. -
Page 32: 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 33: Extended Warranty
INTELLECTUAL PROPERTY DISCLAIMER The Coapt name, Coapt logo, products, and other Coapt trademarks and graphics are all property of Coapt, LLC. The aforementioned intellectual properties are protected by United States and international copyright, trademark, patent, trade secret, and other intellectual property laws where appropriate. -
Page 34: Technical Information
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. H A N D B O O K ( V 4 . 0 ) -
Page 35: 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 36 303 W Institute Pl., Suite 200 Chicago, IL 60610 844.262.7800 www.coaptengineering.com © 2023...
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