Coapt GEN2 User manual

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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Coapt LLC |222 W Ontario St, Suite 300, Chicago, IL 60654 USA |844.262.7800 |www.coaptengineering.com
CONTENTS
CONTENTS.............................................................................................................................. 1
USER ASSISTANCE & SAFETY ............................................................................................ 3
USER ASSISTANCE ....................................................................................................................................................................3
GENERAL WARNINGS AND PRECAUTIONS ................................................................................................................3
EVALUATION KIT OVERVIEW............................................................................................ 5
DESCRIPTION.............................................................................................................................................................................5
PURPOSE ......................................................................................................................................................................................5
INDICATIONS FOR USE .........................................................................................................................................................5
CONDITIONS FOR USE..........................................................................................................................................................6
LIMITATIONS..............................................................................................................................................................................6
IN THE KIT...................................................................................................................................................................................6
ACCESSORIES .............................................................................................................................................................................7
EMG Interface Cable.............................................................................................................................................................7
Electrodes ................................................................................................................................................................................8
CLINICIAN GUIDE ................................................................................................................. 9
PATTERN RECOGNITION INTRODUCTION................................................................................................................9
MYOTESTING AND ELECTRODE PLACEMENT FOR PATTERN RECOGNITION..........................................10
Step 1: Discussion ................................................................................................................................................................11
Step 2: Palpation ...................................................................................................................................................................12
Step 3: Positioning Electrode Contacts..........................................................................................................................13
EVALUATION KIT INSTRUCTIONS ................................................................................. 15
CHARGING ...............................................................................................................................................................................15
POWERING ON.......................................................................................................................................................................15
CONNECTING AN EMG INTERFACE CABLE ..............................................................................................................16
BLUETOOTH CONNECTION............................................................................................................................................16
SOFTWARE/APPLICATION SETUP ...................................................................................................................................17
Installation..............................................................................................................................................................................17
Updates...................................................................................................................................................................................18
CALIBRATING PATTERN RECOGNTION CONTROL..............................................................................................18
Calibration Initialize/Reset.................................................................................................................................................18
Starting Calibration from the Software/Application ...................................................................................................19
Starting Calibration from the Evaluation Kit.................................................................................................................19
Full Sequence Calibration...................................................................................................................................................20
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.......................................................................................................................................................................................28
Calibrate .................................................................................................................................................................................30
Actuate ...................................................................................................................................................................................33
TROUBLESHOOTING ......................................................................................................... 35
PATTERN RECOGNITION TROUBLESHOOTING .....................................................................................................35
HARDWARE TROUBLESHOOTING ................................................................................................................................36

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Coapt LLC |222 W Ontario St, Suite 300, Chicago, IL 60654 USA |844.262.7800 |www.coaptengineering.com
ADDITIONAL INFORMATION........................................................................................... 37
LIMITED US WARRANTY .....................................................................................................................................................37
EXTENDED WARRANTY.....................................................................................................................................................38
RETURNS....................................................................................................................................................................................38
PRODUCT RETURN POLICY..............................................................................................................................................38
TECHNICAL INFORMATION .............................................................................................................................................38
REGULATORY INFORMATION .........................................................................................................................................39

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Coapt LLC |222 W Ontario St, Suite 300, Chicago, IL 60654 USA |844.262.7800 |www.coaptengineering.com
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
GENERAL WARNINGS AND PRECAUTIONS
For safety and to prevent damage to the Evaluation Kit, 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 and other devices. Failure to heed all warnings and precautions could cause
injury to the user, patient, damage to the device, or 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.
Refer to Operating Instructions prior to use.
Read and follow safety instructions. Read this entire manual before operating the
Evaluation Kit. Failure to do so could result in suboptimal system performance, injury,
or damage to the device.
NEVER attempt to remove or modify the battery 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, and injury to the user.
NO 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, and injury to the user.
Use with implanted electronic devices. Do not bring the Evaluation Kit 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 Evaluation Kit and the implanted device could cause the implanted device
to malfunction.
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

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Coapt LLC |222 W Ontario St, Suite 300, Chicago, IL 60654 USA |844.262.7800 |www.coaptengineering.com
flame may cause the device to exceed safe temperature limits and may cause device
malfunction and injury.
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.
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 malfunctioning of the device.
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, 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, and minor injury to the user.
Crushing of device. Take care not to allow the device to become smashed or
crushed. Crushing of the device can cause device malfunction, 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
and minor injury to the user.
Opening enclosures. Never open the Evaluation Kit
enclosure. Opening the
enclosure could cause permanent damage to the Evaluation Kit resulting in device
malfunction and minor injury to the user.
Use of heat guns. Do not bring a heat gun or other heating device into proximity to
the Evaluation Kit. Overheating can cause damage to the Evaluation Kit, resulting in
device malfunction and minor injury to the user.
Use with incorrect or incompatible electrodes. Make sure the Evaluation Kit is
only connected to a EMG Interface Cable referenced in this instruction manual. Use
with an 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.

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Coapt LLC |222 W Ontario St, Suite 300, Chicago, IL 60654 USA |844.262.7800 |www.coaptengineering.com
EVALUATION KIT OVERVIEW
DESCRIPTION
The Coapt Evaluation Kit is a handheld clinical tool created with technology from the Coapt
COMPLETE CONTROL System Gen2. COMPLETE CONTROL employs pattern recognition
technology to revolutionize the way muscles’ bioelectrical activity (electromyogram, EMG) signals are
analyzed, recorded, and used for the control of upper limb prostheses.
The Evaluation Kit allows for visualization and evaluation of myoelectric signals generated from muscle
contractions. The Evaluation Kit also permits virtual practice and training for pattern recognition
myoelectric control.
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. It permits visualization
of EMG control signals and enables control of a virtual prosthetic arm in real time using the
COMPLETE CONTROLROOM Gen2 user interface application. The Evaluation Kit can also
be used as a training tool to assist users in enhancing their function with pattern recognition
myoelectric control.
2. The Evaluation Kit assists with determining location of electrodes in the socket by allowing the
clinician to validate potential for pattern recognition myoelectric control. This enables efficient
planning of the prosthesis socket. With less time spent in the clinic searching for the best
muscle control sites, more time will be available for in-clinic functional practice.
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.
POWER ON/OFF
SWITCH
POWER ON LED
INDICATOR
COMPLETE
CALIBRATE BUTTON
COMPLETE COMMUNICATOR
BLUETOOTH USB DONGLE
EMG INTERFACE
PORT
AUX INTERFACE
PORT
MICRO-USB
CHARGING PORT
CHARGING STATUS
INDICATOR LED

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Coapt LLC |222 W Ontario St, Suite 300, Chicago, IL 60654 USA |844.262.7800 |www.coaptengineering.com
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.
See General Warnings and Precautions for more information regarding acceptable use conditions.
LIMITATIONS
Careful evaluation is required to determine if individuals with brachial plexopathy or high-level
amputations without targeted muscle reinnervation surgery could benefit from Coapt COMPLETE
CONTROL. The Coapt 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. Evaluation Kit main unit
2. COMPLETE COMMUNICATOR USB Bluetooth Dongle – provided with the
Evaluation Kit to enable Bluetooth connection to a personal computer
3. USB Charging Cable – micro-USB cable for main unit charging via a USB port or USB IEC
62133 certified external wall plug (wall plug not provided by Coapt)
Figure 2: Components of the Coapt Evaluation Kit
Accessories to the Evaluation Kit and not included but may be required:
1. EMG Interface Cable(s) (sold separately)
2. Coapt Dome Electrodes (if necessary, sold separately)
1
2
3

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Coapt LLC |222 W Ontario St, Suite 300, Chicago, IL 60654 USA |844.262.7800 |www.coaptengineering.com
ACCESSORIES
EMG Interface Cable
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.
EMG
INTERFACE
CABLE
PART
NUMBER DESCRIPTION
Standard Eyelets
EMG Interface
Cable
CCEE 17 ring/eyelet terminations for use with Coapt Dome Electrode Set
(p/n ELSA)
Snap Style EMG
Interface Cable
CCES 17 snap terminations for use with set of liner-snap electrode contacts
(sold by third party) or with disposable, self-adhesive snap contacts

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Coapt LLC |222 W Ontario St, Suite 300, Chicago, IL 60654 USA |844.262.7800 |www.coaptengineering.com
Evaluation-Style
Cuff EMG Interface
Cable
CCEC Wrap-around, Velcro cuff for evaluation use with transradial and
small circumference transhumeral limbs
Osseointegration-
Style Cuff EMG
Interface Cable
CCEO Elastic cuff for definitive Osseointegration use only
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.
PRODUCT
INFORMATION
RELATED PRODUCT
REGISTRATION 510(K)
Manufacturer: Coapt, LLC
Product Name: Dome
Electrodes (ELSA)
Part Number(s):
D37C13T4L50, ELSA
Proprietary Name: Dome Electrode
Registered Establishment Number: Coapt, LLC,
3010605876
Product Code and Regulation Number: GXY,
882.1320
K190416
Skin irritation.
Use of non-
biocompatible materials (or materials to which the user is
allergic) for electrode contacts may cause skin rash or
skin irritation. Ensure
electrode
contacts are made of biocompatible material and do not cause an allergic reaction.

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Coapt LLC |222 W Ontario St, Suite 300, Chicago, IL 60654 USA |844.262.7800 |www.coaptengineering.com
CLINICIAN GUIDE
PATTERN RECOGNITION INTRODUCTION
WHAT IS PATTERN RECOGNITION?
Multiple muscles work together each time we move our arms and hands. The contractions of these
muscles create a pattern of activity that is unique to each movement. For example, the pattern of
forearm muscle activity for hand opening is different than the pattern for hand closing. Electrodes
placed on the skin over multiple muscle areas (which we often call “control sites”) can detect these
overall patterns of activity.
HOW IS PATTERN RECOGNITION AN IMPROVEMENT 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 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:
•Control motions are intuitive – With standard myoelectric control, users are often required to
make non-intuitive contractions to command prosthesis actions. A good example of this is
using wrist extension and flexion contractions to command a prosthetic hand to open and
close. With pattern recognition, natural intuitive control is possible: hand open and close
contractions will control the prosthetic hand, and wrist contractions will control the prosthetic
wrist.
•Mode switching is eliminated – With standard myoelectric control, muscle control sites are
limited because of the need for signal isolation. This typically means fewer control sites are
available than the desired prosthesis functions and users have to use “switches” to cycle
between prosthesis functions. Examples include using co-contractions of two control signals
to toggle between hand and wrist control or a physical/electrical switch the user must activate
with another movement of their body. With pattern recognition, users can directly control
each of their prosthesis’s motions without cumbersome and non-intuitive switching.
•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.
•Enhanced proportional control – Because of the difficulty of isolating control sites with standard
myoelectric control, much of a user’s ability to modulate the intensity of their prosthesis’s
motor speed is often tuned out of the system. With pattern recognition, the system can take
full advantage of the user’s ability and relates a wide range of the muscle contraction intensities
to prosthesis speeds.
•Simplified electrode placement – With pattern recognition, there is much less need to search
for, or precisely place control site electrodes over exact muscle locations. This means less
time is spent myotesting for isolated signals; clinicians have freedom to place electrodes in
socket areas that promote fit and comfort; clinicians can use sockets/liners that may be
positioned differently upon each donning; the system is forgiving of changes due to muscle
fatigue; and many other benefits. With less time spent in the clinic searching for the muscle