Coapt GEN2 User manual

Gen2 EVALUATION KIT

Handbook

v1.0

Coapt, LLC

222 W Ontario St., Suite 300

Chicago, IL 60654

844.262.7800 (toll free)

www.coaptengineering.com

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

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

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

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.

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

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)

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

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.

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