Coapt GEN2 Manual de usuario

HANDBOOK (V 4.0)

COMPLETE

CONTROL

SYSTEM

GEN2

Caution: Federal law restricts this device to sale by or on the order of a physician.

HANDBOOK (V

4.0) COMPLETE CONTROL SYSTEM GEN2

CONTENTS

CONTENTS..............................................................................................................................................................................................1

USER ASSISTANCE & SAFETY.........................................................................................................................................................3

USER ASSISTANCE ..................................................................................................................................................................................................................3

GENERAL WARNINGS AND PRECAUTIONS........................................................................................................................................................3

OVERVIEW ............................................................................................................................................................................................5

PURPOSE OF THE DEVICE................................................................................................................................................................................................5

PATTERN RECOGNITION INTRODUCTION ...........................................................................................................................................................5

What Is Coapt Pattern Recognition?...................................................................................................................................................................5

Benefits of Pattern Recognition Over Standard Myoelectric Prosthesis Control ............................................................... 5

What Is Key to Making Pattern Recognition Function at Its Best?...............................................................................................6

Practicing Pattern Recognition Control............................................................................................................................................................6

Successful Use of Pattern Recognition Control Relies on Two Priorities: .................................................................................7

INDICATIONS FOR USE........................................................................................................................................................................................................7

CONTRAINDICATIONS .........................................................................................................................................................................................................7

LIMITATIONS................................................................................................................................................................................................................................7

DESCRIPTION OF THE DEVICE......................................................................................................................................................................................7

COMPATIBLE DEVICES........................................................................................................................................................................................................8

Electrodes ................................................................................................................................................................................................................................8

Prosthetic Devices .............................................................................................................................................................................................................9

CONDITIONS FOR USE ......................................................................................................................................................................................................10

CLINICIAN 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 System Gen2 Label Symbol Descriptions .........................................................................................................20

In the Complete Control Kit...................................................................................................................................................................................... 21

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

GUIDANCE FOR USERS.................................................................................................................................................................. 27

SETUP AND TRAINING ...................................................................................................................................................................................................... 27

First pattern recognition trial or fitting?.........................................................................................................................................................27

Maintenance visits with your prosthetist or therapist ......................................................................................................................... 27

POWERING ON.......................................................................................................................................................................................................................29

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4.0) COMPLETE CONTROL SYSTEM GEN2

CALIBRATING PROSTHESIS CONTROL ................................................................................................................................................................29

Calibrating control with the press of a button........................................................................................................................................... 29

Calibrating control on-screen (via mobile or desktop) ......................................................................................................................... 31

CALIBRATION ADAPTATION: ADAPTIVE ADVANCETM ............................................................................................................................ 33

CALIBRATION: ADDITIONAL TOOLS....................................................................................................................................................................... 33

Calibration Clearing/Resetting .............................................................................................................................................................................. 33

Calibration Undo’s...........................................................................................................................................................................................................34

Calibration Restore Points ........................................................................................................................................................................................ 35

CONTROL COACH®.............................................................................................................................................................................................................36

Control Coach®Quality Rating System..........................................................................................................................................................36

Using Control Coach®Information ...................................................................................................................................................................36

The Control Coach®“Check Engine” 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

ADDITIONAL INFORMATION....................................................................................................................................................... 57

LIMITED US WARRANTY..................................................................................................................................................................................................57

EXTENDED WARRANTY...................................................................................................................................................................................................58

RETURNS.....................................................................................................................................................................................................................................58

PRODUCT RETURN POLICY..........................................................................................................................................................................................58

TECHNICAL INFORMATION...........................................................................................................................................................................................59

Power Requirements ...................................................................................................................................................................................................59

Operating Temperature .............................................................................................................................................................................................59

Humidity ................................................................................................................................................................................................................................59

Transport Temperature...............................................................................................................................................................................................59

Altitude....................................................................................................................................................................................................................................59

Minimum System Requirements for Complete ControlRoom Application ........................................................................ 59

Physical Dimensions ..................................................................................................................................................................................................... 59

REGULATORY INFORMATION .....................................................................................................................................................................................60

HANDBOOK (V

4.0) COMPLETE CONTROL SYSTEM GEN2

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 Complete Control System

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). Failure to heed all warnings

and precautions could cause damage to the device and void the warranty. The following symbol definitions

pertain to warnings in this handbook and on all device labels.

SYMBOL DEFINITIONS

Warning regarding possible risk of severe accidents or injury.

Warning regarding possible risks of accident or injury.

Warning regarding 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., pacemakers, defibrillators) unless assured

by a qualified healthcare professional that it is safe to do so. Interference between the Complete

Control system and the implanted device could cause the implanted device to malfunction.

Operation of motor vehicles. Do not use the Complete Control system to operate a motor

vehicle. Unintended movements of the prosthesis may cause an accident.

Operation of industrial machines, heavy equipment, motor-driven equipment, or

machinery. Do not use the Complete Control system to operate industrial machines, heavy

equipment, motor-driven equipment, or machinery. Unexpected actions of the prosthesis may

cause injury.

Use with firearms. NEVER use a Coapt Complete Control system to operate a firearm.

Unintended prosthesis movements during firearm operation could result in death or significant

injury.

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4.0) COMPLETE CONTROL SYSTEM GEN2

Use with sharp objects. Do not use the Complete Control system to handle sharp tools or

objects (e.g., knives or blades). Unintended movements of the prosthesis while handling a sharp

object could result in death or significant injury.

Use with power tools. Do not use the Complete Control system to operate power tools.

Unintended movements of the prosthesis could cause injury.

Use of system while charging. Do not use the device while it is charging (i.e., connected to an

A.C Mains supply) unless advised by a qualified healthcare provider that it is safe to do so. Use of

the device while charging could cause injury.

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. Do not expose to extreme low (<-20ºC) or high (>45ºC)

temperatures. Exposure to extreme temperatures could cause damage to the device and minor

injury caused by unintended movements of the prosthesis.

Use near sources of high radio frequency (RF) energy. Use caution when operating the device

in proximity to sources of high RF energy (e.g., broadcast antennas or radar systems).

Interference 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, and minor injury to the user.

Exposure to excessive moisture, vibration, dust, or shock. Do not expose to excessive

moisture, liquid, dust, vibration, or shock. Doing so can cause damage to the device resulting in

device malfunction, unintended prosthesis movement, and minor injury to the user.

Crushing of device or socket. Take care not to allow the device to become smashed or crushed.

Crushing of the device can cause device malfunction, unintended prosthesis movement, and

minor injury to the user.

Use in areas of large static buildup. Take care when operating the device in areas with large

amounts of electrostatic buildup (e.g., very low humidity). Exposure to electrostatic discharge

can cause damage to the device resulting in device

malfunction, unintended prosthesis

movements, and minor injury to the user.

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.

HANDBOOK (V

4.0) COMPLETE CONTROL SYSTEM GEN2

OVERVIEW

PURPOSE OF THE DEVICE

The Complete Control System Gen2 is an advanced control solution designed to provide the functionality of a

powered upper limb prosthesis. Complete Control employs pattern recognition technology to revolutionize

the way muscles’ bioelectrical activity (electromyogram, EMG) signals are used to control a prosthesis. With

Complete Control, users can achieve intuitive control of their devices, eliminate control switching, and benefit

from quick and powerful calibration. Complete Control simplifies electrode location dependence and allows

prosthetists to spend less time adjusting system settings and configurations.

The Complete Control System Gen2 is designed to work seamlessly with most major manufacturers’ devices

as an easy plug-and-play add-on (for a list of compatible devices and electrodes, see up-to-date information

online or visit the Compatible Devices section of this Handbook). Complete Control does not require an

additional battery.

PATTERN RECOGNITION INTRODUCTION

What Is Coapt Pattern Recognition?

Muscles in arms and hands rarely work alone. Whenever we move our arms and hands, multiple muscles make

coordinated contractions in concert and each muscle emits its own small electrical signature (called

myoelectricity) like it is its own instrument in that orchestra. Each different arm and 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 to an array of microphones over our orchestra).

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. For example, the pattern of myoelectric activity recorded on the residual forearm during

hand opening is different from the pattern recorded while the hand is being closed.

The Complete Control System Gen2 from Coapt listens to the myoelectric activity and uses mathematical

algorithms to determine when a pattern matches the user’s intention to make an arm or hand movement. It

then tells the prosthesis to move accordingly, providing intuitive control of multiple prosthetic movements.

Benefits of Pattern Recognition Over Standard Myoelectric Prosthesis Control

Muscle signals contain a lot of information. Pattern recognition uses the combined information gathered from

all electrodes to control multiple prosthesis movements. In contrast, standard myoelectric control only

HANDBOOK (V

4.0) COMPLETE CONTROL SYSTEM GEN2

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:

•Intuitive Control – Natural movement intents are used to control the prosthesis, generally making it

easier to use. For example, the feeling of opening or closing a hand is used to control the prosthetic hand

open and close (instead of wrist flexion motions to control the hand common for basic myoelectric

devices).

•No Mode-Switching – There is no need to use cumbersome actions like co-contractions, pulses, fast-

slow gestures, etc. and this makes the control of a prosthesis more seamless.

•Strong muscle contractions are not required – Pattern recognition has the advantage of being able to

utilize low intensity muscle contractions as needed. This is beneficial for standard myoelectric control

users who were required to elicit strong control contractions that tire them out quickly.

•Superior Proportional Control – A wider range of control speeds are available because myoelectric

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.

•Calibration and Setup – Control can be refined and personalized at any time using the quick on-board

calibration. This makes addressing changes in socket fit, skin condition, fatigue, desired feelings for

control, and much easier to take on without the need to take the prosthesis off or make extra clinic visits.

What Is Key to Making Pattern Recognition Function at Its Best?

Repeatability:Pattern recognition works best if the user can replicate the patterns of muscle signals for each

motion the same way each time. Each motion should “feel” the same each time the user performs it.

Differentiation:Pattern recognition requires the pattern of muscle signals to be different for each distinct

motion. Each motion should “feel” different from all other motions.

Practicing Pattern Recognition Control

•No need for extra-hard muscle contractions. Contraction levels should be moderate – like the feeling in

the strength of a comfortable handshake.

•Start slow and practice patience. This new pattern recognition method of control can take a little time

and practice to get used to.

HANDBOOK (V

4.0) COMPLETE CONTROL SYSTEM GEN2

•Control is not position-based. Example: if a hand is commanded to close (and it does) and the user then

wishes to turn the wrist, there’s no need to “hold” the hand closed while rotating the wrist, as each motion

is a separate activity.

•If control becomes erratic, reflect on the “feeling” of the motions when calibrated. The system does not

forget the patterns it was calibrated with, so it can always be helpful to return to those perceptions when

needed.

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.

LIMITATIONS

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 has been validated for a specific set of

prosthetic elbow, wrist, and hand components (see Compatible Devices section). The Complete Control

System Gen2 is a module for processing EMG and computing pattern recognition algorithms (Complete

Controller) permanently connected to a user-interface calibration interface button (Complete Calibrate

button) and connected to the prosthesis and muscle signal inputs by connectable interface cables.

The Complete Control System Gen2 contains the following components:

1. Complete Controller main processor with a connected Complete Calibrate button

2. Device Interface Cable (clinician-specified termination type)

3. EMG Interface Cable (clinician-specified termination type)

HANDBOOK (V

4.0) COMPLETE CONTROL SYSTEM GEN2

Accessories to the Complete Control System Gen2 include the following:

1. Complete Controller Fabrication Aid (1:1 scale disposable model for use in prosthesis fabrication)

2. Prosthesis socket cut-out template for the Complete Calibrate button

3. Complete Communicator USB Bluetooth Dongle

4. Complete ControlRoom Gen2 User Interface Application

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.

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