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HANDBOOK (V

4.0)

COMPLETE CONTROL SYSTEM GEN2

60

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

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.

FCC Warning Statements

•

This device 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.

•

Radiation Exposure Statement for Portable Devices: This equipment complies with
FCC radiation exposure limits set forth for an uncontrolled environment. This
equipment is in direct contact with the body of the user under normal operating
conditions. This transmitter must not be co-located or operating in conjunction with
any other antenna or transmitter.

•

This equipment was tested and found to meet the radio interference radiated
emission requirements of FCC “Rules and Regulations,” Part 15, subpart B, Section
15.109a for Unintentional Radiators, Class B digital devices.

•

Any changes or modifications not expressly approved by Coapt, LLC could void the
user’s authority to use this device.

•

FCC ID: T9JRN4020

This equipment was tested and found to meet the requirements of International Standard IEC
60601-1-2:2007 Medical Electrical Equipment Part 1: General Requirements for Safety and Essential
Performance - Collateral Standard: Electromagnetic Compatibility Requirements and Tests using
test procedures from: IEC 61000-4-2, IEC 61000-4-3, and IEC 61000-4-8.

This equipment was tested and found to meet the Radio Interference Power Line Conducted and
Radiated Emission requirements of CISPR 11 for Measuring RF Emissions from Group 1, Class B ISM
Equipment as part of IEC 60601-1-2:2007 Medical Electrical Equipment Part 1: General
Requirements for Safety and Essential Performance - Collateral Standard: Electromagnetic
Compatibility Requirements and Tests using CISPR 11:2009, A1:2010 – Class B, Group 1 Industrial,
Scientific and Medical (ISM) Radio-Frequency Equipment 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.

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Содержание GEN2

Страница 1: ... 2020 Coapt LLC 222 W Ontario St Suite 300 Chicago IL 60654 844 262 7800 www coaptengineering com HANDBOOK V 4 0 COMPLETE CONTROL SYSTEM GEN2 ...

Страница 2: ... 2020 Coapt LLC 222 W Ontario St Suite 300 Chicago IL 60654 844 262 7800 www coaptengineering com Caution Federal law restricts this device to sale by or on the order of a physician ...

Страница 3: ...IAN GUIDE 11 PLANNING EMG ELECTRODE SITES FOR COAPT GEN2TM PATTERN RECOGNITION 11 Step 1 Have a thorough discovery chat with your user 12 Step 2 Determine where there is underlying muscle tissue on the residual limb 14 PLACING AND CONNECTING COAPT DOME ELECTRODES 16 Assembly Instructions for placing Dome Electrodes into the prosthesis 18 CONNECTING THE COAPT SYSTEM COMPONENTS 20 Complete Control S...

Страница 4: ...Light 37 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 49 SETUP 49 LIGHTS AND SOUNDS 51 FUNCTION CALIBRATION 52 SOFTWARE APPLICATION 54 BLUETOOTH 55 UPDATES 56 ADDITIONAL INFORMATION 57 LIMITED US WARRANTY 57 EXTENDED WARRANTY 58 R...

Страница 5: ...ng possible damage to product or equipment Read and follow safety instructions Read this entire manual before operating the Complete Control system Failure to do so could result in suboptimal system performance or injury the device or the connected prosthesis Use with implanted electronic devices Do not bring the Complete Control system into the immediate proximity of active implanted devices e g ...

Страница 6: ... could cause unintended movements of the prosthesis resulting in minor pinch injuries Use in a corrosive environment Do not expose the device to excessive amounts of corrosive substances e g salt water sweat or clean with acetone benzene or similar solution Exposure of electronics to corrosive substances can cause damage to the device resulting in device malfunction unintended prosthesis movement ...

Страница 7: ... hand movement results in a unique but repeatable set of these myoelectic patterns like different songs in our concert Myoelectric signals are very tiny but they can be detected by electrodes on the surface of our skin Using a full array of electrode contacts on the skin covering the whole area of these underlying muscle contractions lets all of the rich muscle pattern information be captured akin...

Страница 8: ...ic inputs do not need to be limited by thresholds and a broader range of input levels can be recognized by the algorithms Flexible Electrode Placement There is much less need for isolated signals or precise electrode placements This opens the door to more functional myotesting freedom to place electrodes for socket comfort or limb constraints and provides helpful forgiveness in prosthesis donning ...

Страница 9: ...S Careful evaluation is required to determine if individuals with brachial plexopathy or high level amputations without targeted muscle reinnervation surgery could benefit from the COMLETE CONTROL System Gen2 DESCRIPTION OF THE DEVICE The Complete Control System Gen2 is a packaged electronic control system used in conjunction with an upper limb prosthetic device The Complete Control System Gen2 ha...

Страница 10: ...l Limb Establishment Number Liberating Technologies Inc 1220851 Product Code and Regulation Number IRE 890 3420 none Manufacturer Motion Control Inc Product Name Remote Electrode Single Part Number s 1070001 Proprietary Name Electric Terminal Device Motion Control Hand Motion Control Wrist Procontrol 2 Registered Establishment Number Motion Control Inc 1723997 Product Code and Regulation Number IQ...

Страница 11: ... 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 Compatibilities and capabilities of the Complete Control System Gen2 are subject to change at any time The displayed chart may not illustrate full compatibilities and capabilities of the Complete Control System Gen2 Visit the Coapt website or ...

Страница 12: ...gliding etc or activities causing excessive strain and or shock to the prosthetic device 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 See General Warnings and Precautions section for more information re...

Страница 13: ...heir limb has to offer You are likely already aware that pattern recognition is quite different than conventional single or dual site myoelectric control Maybe it is no surprise that myotesting and evaluating users for electrode placement is quite different too Yes there may be a higher number of electrode contacts with pattern recognition BUT as you will experience that will produce some wonderfu...

Страница 14: ... but instead have them tell you ALL of what their finger hand wrist elbow etc perceptions are Why Well this is a great way for both you clinicians AND your users to work together explore and learn what intuitive motions and feelings they may want to use for their prosthesis control Let them tell you what they can do And don t mistakenly limit them by cornering them into the old flex extend box GOA...

Страница 15: ...that they hold them at a medium intensity and for about 3 4 seconds each This is good practice for the eventual prosthesis controls and users self led calibration procedure Encourage the user to mirror their perceived motions with their sound limb if possible Start the discussion with the most intuitive motions and add variations as needed i e try natural hand close for hand close and if they have...

Страница 16: ... repeat and continue the discussion from Step 1 Why do you want to do this The continued discussion helps to further discover their intuitive motion plans while at the same time lets you feel for the general and global areas of underlying muscle tissue Remember pattern recognition doesn t always require strong and isolated sites it wants to get info from lots of muscle areas even the areas that ma...

Страница 17: ... at multiple areas simultaneously Do not ignore areas of slight subtle weak underlying muscle contraction these signals are just as valuable Note any unique and unexpected areas of underlying muscle contraction o For transhumeral amputees this may mean unique muscle activity distal on their residual limb If the user tenses muscles quite hard for all motions ask them to make contractions a little m...

Страница 18: ...formation o If you picture an imaginary oval encircling the two placed Dome Electrode contact points this is the general region the EMG channel data will be from The farther apart the pair of Dome Electrodes the larger and deeper the sensed area will be Conversely Dome Electrodes close to each other will detect a more focused channel of EMG The Coapt system has 8 EMG channels 16 Dome Electrode con...

Страница 19: ...ition to place some of the electrode pairs off axis This is helpful when fitting a residual limb with unique areas of EMG interest and for geometrically unique and congenital limb presentations Contact Sharing For a limb that is too small to reliably fit all 17 Dome Electrode contacts it is acceptable to have a few of the EMG channels share an electrode contact Take care however that you do not pl...

Страница 20: ...ctrode 3 Place the ring terminal of a conductor cable on top of the Flat Washer Same color conductor cables should be planned for nearby Dome Electrodes 4 If you are sharing a Dome Electrode place the other conductor cable s ring terminal s different color s on this threaded stud Keep in mind that same color conductors must NOT share the same Dome Electrode Also make sure the black ground connecti...

Страница 21: ... be secured behind a mounting socket wall or enclosure Trimmed electrode studs Ensure any excess length of electrode dome threaded studs are sufficiently trimmed and smoothed Sharp edges and protrusions can cause damage to other prosthesis wiring socket materials and installed components Conductive socket material It is important to consider electrode interference when using of electrically conduc...

Страница 22: ...This device is only intended for sale to a licensed medical professional Consult Accompanying Documents Symbol Please read the entire instruction manual before using the device FCC Symbol This device is certified with the United States Federal Communications Commission Non ionizing Radiation Symbol This device emits non hazardous levels of non ionizing radiation CE Mark The device is certified wit...

Страница 23: ... fabrication aids to ensure the Complete Controller and the Complete Calibrate button fit perfectly The Complete Controller main unit arrives in its box with two cables already attached One should have white sleeving and the other gray sleeving If you have not already feel free to detach those cables for easier fabrication The logo on one side and some instructive arrows on the other side will hel...

Страница 24: ...ion where the user can easily see and access it To aid in fabrication planning for the Complete Calibrate button a cut out template is provided as part of the Complete Control kit It can be used to mark the required cut out hole on the socket wall The desired cut out area equates to two overlapping holes of 12 7mm in diameter Instructions for socket mounting hole preparation are embossed on the Cu...

Страница 25: ...er first To connect the EMG 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 Note there are NO logo parts printed on the EMG Interface Cable connector nor the EMG connection half of the Complete Controller Foreign material in cable interconnects Ensure cable interconnects are free of forei...

Страница 26: ...face Cable connector and the device connection of the Complete Controller will combine to complete the logo when properly connected Do not forget the Device Interface Cable is how the Complete Controller receives power Batteries already incorporated in the prosthesis will supply switched power through the Device Interface Cable When you are ready to test that proper connections of the Device Inter...

Страница 27: ...s of the prosthetic components PROPER PROSTHETIC DEVICE CONNECTIONS Connectors coming from the Coapt system white jacketed Device Connection Cable need to be properly connected to your prosthetic device s To assist all Coapt terminal connections are labeled and match instructions on illustrative connection diagrams available on the Coapt website or on visual instructions within the Coapt software ...

Страница 28: ... can cause damage to the device resulting in device malfunction and minor injury to the user Use with incorrect or incompatible prosthetic device Make sure the device is only connected to the prosthetic components indicated during product order Use with a prosthetic device that is incompatible with the system or was not indicated during product order may cause damage to and or malfunction of the d...

Страница 29: ... for receiving your muscle signals simultaneously Once these placements are mapped your prosthetist will assemble Stainless Steel Dome Electrodes within the socket liner of your prosthesis and wire them to your Coapt Complete Control Gen2 controller system From here they will fit your prosthesis and help you learn how to calibrate motions and functions If the fit is correct all electrodes should s...

Страница 30: ...HANDBOOK V 4 0 COMPLETE CONTROL SYSTEM GEN2 28 USE THIS SPACE TO RECORD NOTES FROM SESSIONS WITH YOUR PROSTHETIST ...

Страница 31: ...thesis As you hold these contractions the Coapt system listens and learns these signals in order to compute a memory of what your patterns look like After any calibration the Coapt system uses these memories to understand how you are controlling your prosthesis in real time If Coapt calibration is new to you some helpful hints to keep in mind make sure the muscle contractions you calibrate with fe...

Страница 32: ... muscle contractions For example if the prosthetic wrist is turning up hold your intended muscle motion for an upward wrist Same for hand actions and so on As you hold these corresponding muscle signal contractions Coapt PGC is recording building and adapting the pattern recognition memory to match Once PGC goes through all of its pre selected motions these are settable in the Coapt Complete Contr...

Страница 33: ...t the system back to a starting state and turn the button s LED magenta Don t expect control of the prosthesis when the LED is magenta the control memory is empty and it will have to get at least one calibration to operate a prosthesis again 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 to...

Страница 34: ...pted and relaxing when it instructs At the end of the calibration sequence prosthesis control will be returned to you and your Control Coach quality ratings will be updated CALIBRATING INDIVIDUAL MOTIONS FROM THE SOFTWARE While you are in the Calibrate panel you will see that each available prosthesis motion has a small arrow icon next to its name and quality rating Clicking on that arrow brings u...

Страница 35: ...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 To help with this there are a few convenient ways to reset all calibrated motions or to reset one motion at a time CLEARING RESETTING ALL CALIBRATED MOTIONS To reset ALL calibrated motions to a blank starting stat...

Страница 36: ... even held a motion in a way that was too different from how you did it in the past and so on 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 or a full sequence calibration Undoing a calibration jumps your control back to the state it was...

Страница 37: ...rol performance is noticeably dialed in simply access the Coapt Complete ControlRoom software application and store the current calibration state in an available Restore Point slot To do this connect to your device with Bluetooth in the Complete ControlRoom application navigate to the Calibrate panel then click the Restore Points button it is an orange button with a bookmark icon Whenever you have...

Страница 38: ...st and fewer stars is well not as good Control Coach has its own 5 star rating system to give feedback on the quality for each of your calibrated motions A 5 star rating for a motion means that you are likely getting great reliable control for that particular action As the A I engine in Control Coach detects things it believes are limiting your full potential it will lower the ratings for affected...

Страница 39: ... the selected motion The existing data for this motion will be discarded and the new data you provide will be used to recalibrate your control Once the button is pressed an empty circle appears As you hold your muscle contraction steady for this motion the circle will begin filling up with orange segments Hold your signals until the whole circle fills The Control Coach Check Engine Light When sens...

Страница 40: ...he health of your battery as the other prosthesis components should but the double red blink will let you know the source power is dangerously low for Coapt to keep operating for much longer Reset State Solid MAGENTA Reset state The Coapt system is in a blank empty starting state Calibration will have to be performed to gain control of the prosthesis Calibration Start One high pitched beep after t...

Страница 41: ...eturn your control to the state it was just before that Calibration Reset A 6 note high pitch jingle after the button has been depressed for 10 seconds This initiates Calibration Reset Letting the button go after this jingle will reset erase the Coapt system to a blank starting state The LED will turn solid magenta System Updating Flashing GREEN System is Updating When the internal code firmware o...

Страница 42: ...nce the installation is complete click on the desktop icon to use the Complete ControlRoom application software as needed 1 On an iOS device visit the App Store To install apps sign in with an Apple ID or create one 2 Search for the Coapt Complete ControlRoom application by name 3 Tap the app 4 Tap GET then tap INSTALL UPDATES Windows PC iOS The Complete ControlRoom application will alert you when...

Страница 43: ...TE CONTROL SYSTEM GEN2 41 COMPLETE CONTROLROOM GEN2 ENVIRONMENTS Dashboard The Dashboard environment appears when Complete ControlRoom is launched and presents navigation to the four other Complete ControlRoom environments ...

Страница 44: ...ontroller will be named by its serial number starting with CC Check the serial number displayed on the screen and the serial number of the device located on its label to ensure you are connected to the correct Complete Controller SCAN DISCONNECT BUTTON Displays a list of any Complete Controller devices currently broadcasting over Bluetooth Clicking on the serial number identifier of one will estab...

Страница 45: ...ions represent the known possible devices compatible with that particular Device Interface Cable Take care to select their prosthetic devices accordingly MANUAL TEST BUTTON Opens a pop up window where all available prosthesis actions functions will be listed on individual buttons Clicking and holding on any of these buttons is intended to result in the corresponding prosthesis action Direction fli...

Страница 46: ...ggle of EMG input channels for diagnostic purposes 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 ...

Страница 47: ... will determine its inclusion or exclusion from the set of pattern recognition inputs It is strongly suggested that all eight EMG inputs are used to ensure optimal performance SCROLLING OUTPUTS DISPLAY Below the set of EMG inputs is a scrolling display that shows real time control outputs from the current state of the Complete Control system s calibrated pattern recognition classifier No motions w...

Страница 48: ...sthetic control ACTION FUNCTION STAR RATINGS Displays the A I Control Coach estimated calibration quality for each action function see Control Coach section for more ACTION FUNCTION CONTROL COACH ARROWS Clicking the arrow next to any action function will expand its specific Control Coach information in the Control Coach sub panel see Control Coach section for more CALIBRATE ENABLED MOTIONS BUTTON ...

Страница 49: ...e ADAPTIVE ADVANCETM TOGGLE When On default enables the Adaptive AdvanceTM continuous learning algorithms to meld any new calibration data into the existing state of users control see Adaptive AdvanceTM section for more CONTROL COACH LED SENSITIVITY SELECTOR Adjusts when the Control Coach white LED on the Complete Calibrate button will come on For example when set to 2 stars the Complete Calibrate...

Страница 50: ...onment assists the user with on screen prosthesis control practice using their Complete Control System Gen2 ACTUATE PANEL ELEMENTS VIRTUAL ARM DEVICE TOGGLE Allows the user to direct their real time pattern recognition control to either the on screen arm or their prosthesis ...

Страница 51: ... found in the Clinician Resources section of our website To determine your cable type check the printed label on your Coapt Device Connection Cable the first two characters after SN are the type e g H2 Once you are connected to the Complete ControlRoom application connection and settings guides can also be found by pressing the Connection Guide button in the Connect screen I m using the Manual Tes...

Страница 52: ...thesis control performance corrective action for any EMG channel showing this warning should be made Finding the root of the issue is best but any EMG channel can be toggled off temporarily until further diagnosis can be made Coapt does not recommend leaving EMG channels turned off long term nor turning too many channels off at once a limited number of active EMG inputs can significantly limit con...

Страница 53: ...ire 6 band wrist connection ensure proper wrist connection componentry is in place 3 The grasp control functionality on the hand may have not yet been setup via the software interface of that device 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 ...

Страница 54: ...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 H0 I4 etc The specific function motion is not working correctly 1 Ensure the prosthesis battery is charged and the prosthesis is turned on 2 Ensure all wired connections to the prosthetic devic...

Страница 55: ... getting you great function Control Coach can be a great help to achieve that but it also assesses other key calibration things such as making sure you are making calibration contractions at the correct times When I calibrate everything works fine but if I move go about my day it sometimes changes There are a number of things that can change your muscle signals over time Some are natural like musc...

Страница 56: ...ware but my computer keeps taking me to the app store If you are looking to install the PC version of Complete ControlRoom make sure you download the installer file from the Coapt website If you are looking for the Complete ControlRoom iOS app visit the app store What information is contained in the i at the top of the software Clicking on the i icon in the Complete ControlRoom application will di...

Страница 57: ...computer b Close the Complete ControlRoom Gen2 software application if it is open c Ensure your Windows computer is connected to the internet d Open Device Manager type Device Manager in the search bar at the lower left of the Windows Desktop then Press Enter e With the Device Manager window open and visible plug the BT Dongle into an available USB port and watch for the Device Manager to refresh ...

Страница 58: ...Coapt update I just completed an update but it is asking me to do another update Coapt makes sure that updates are never more frequent than necessary and each one contains important changes to enhance the performance of your Coapt Gen2TM system 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 ...

Страница 59: ... which does not materially affect the function of the system is not covered Any warranty claim shall be reported to Coapt immediately upon discovering the defect The defective Items must be returned to Coapt or any other Coapt authorized representative In returning the Items for repair the Items must be delivered in packaging offering a sufficient degree of protection The Items must be accompanied...

Страница 60: ...ould return all unserviceable Complete Control System Gen2 components directly to Coapt LLC at Coapt LLC ATTN Returns 222 W Ontario St Suite 300 Chicago IL 60654 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 Item s returned in resaleable condition between 30 120 days of receipt will be subject...

Страница 61: ... Complete ControlRoom Application Operating System Windows 10 64 bit or 32 bit or newer RAM At least 1GB of system memory Storage At least 1GB of available space Screen Resolution Minimum 1280 x 960 Physical Dimensions Complete Controller with Device Interface Cable and EMG Interface Cable connected Width 60 3 mm 2 37 in Length 52 2 mm 2 05 in Thickness 8 0 mm 0 31 in Complete Calibrate button Wid...

Страница 62: ... radiated emission requirements of FCC Rules and Regulations Part 15 subpart B Section 15 109a for Unintentional Radiators Class B digital devices Any changes or modifications not expressly approved by Coapt LLC could void the user s authority to use this device FCC ID T9JRN4020 This equipment was tested and found to meet the requirements of International Standard IEC 60601 1 2 2007 Medical Electr...

Страница 63: ...222 W Ontario St Suite 300 Chicago IL 60654 844 262 7800 www coaptengineering com 2020 ...

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