Coapt GEN2 Manuale utente

HANDBOOK (V 4.0)

EVALUATION

KIT

HANDBOOK (V

4.0) GEN2 EVALUATION KIT

CONTENTS

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

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

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

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

ADVERSE REACTIONS..........................................................................................................................................................................................................5

LABEL SYMBOL DESCRIPTIONS...................................................................................................................................................................................6

OVERVIEW ............................................................................................................................................................................................7

PURPOSE OF THE DEVICE................................................................................................................................................................................................7

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

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

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

DESCRIPTION .............................................................................................................................................................................................................................7

DESCRIPTION OF THE DEVICE......................................................................................................................................................................................8

COMPATIBLE DEVICES........................................................................................................................................................................................................9

EMG Interface Cable Types .........................................................................................................................................................................................9

Electrode Contacts..........................................................................................................................................................................................................10

CONDITIONS FOR USE ....................................................................................................................................................................................................... 11

INSTRUCTIONS FOR USE ............................................................................................................................................................... 12

PATTERN RECOGNITION FUNDAMENTALS ...................................................................................................................................................... 12

PLANNING PATTERN RECOGNITION ELECTRODE LOCATIONS........................................................................................................ 13

Step 1: Discussing User Contractions................................................................................................................................................................. 13

Step 2: Palpating to find Underlying Muscle on the Residual Limb ........................................................................................... 13

Step 3: Planning Electrode Locations................................................................................................................................................................14

CHARGING THE BATTERY................................................................................................................................................................................................16

POWERING ON........................................................................................................................................................................................................................17

CONNECTING AN EMG INTERFACE CABLE.......................................................................................................................................................17

BLUETOOTH CONNECTION...........................................................................................................................................................................................18

TROUBLESHOOTING...........................................................................................................................................................................................................18

GUIDANCE FOR USERS................................................................................................................................................................... 19

PATTERN RECOGNITION CALIBRATION ..............................................................................................................................................................19

Calibrating All Motions in a Sequence..............................................................................................................................................................19

Calibrating Individual Motions................................................................................................................................................................................ 21

ADDITIONAL CALIBRATION TOOLS........................................................................................................................................................................ 22

Undoing Last Calibration........................................................................................................................................................................................... 22

Clearing/Resetting All Calibrated Motions ................................................................................................................................................... 23

Clearing/Resetting Individual Motions............................................................................................................................................................24

Calibration Restore Points ........................................................................................................................................................................................ 25

CONTROL COACH®..............................................................................................................................................................................................................26

ADAPTIVE ADVANCE®.......................................................................................................................................................................................................26

CALIBRATION BUTTON UNIT: SOUNDS & LED COLOR MEANINGS................................................................................................ 27

HANDBOOK (V

4.0) GEN2 EVALUATION KIT

CONTROL COMAPNION AND COMPLETE CONTROLROOM USER APPS................................................................... 29

INSTALLATION.........................................................................................................................................................................................................................29

CORE APP USES ....................................................................................................................................................................................................................29

Configuration .....................................................................................................................................................................................................................29

Input Validation ................................................................................................................................................................................................................30

EMG Pattern Exploration...........................................................................................................................................................................................30

Calibration.............................................................................................................................................................................................................................30

Practice and Games ......................................................................................................................................................................................................30

ADDITIONAL INFORMATION........................................................................................................................................................ 31

LIMITED US WARRANTY................................................................................................................................................................................................... 31

EXTENDED WARRANTY................................................................................................................................................................................................... 32

RETURNS..................................................................................................................................................................................................................................... 32

PRODUCT RETURN POLICY.......................................................................................................................................................................................... 32

INTELLECTUAL PROPERTY DISCLAIMER ........................................................................................................................................................... 32

TECHNICAL INFORMATION........................................................................................................................................................................................... 33

REGULATORY INFORMATION .....................................................................................................................................................................................34

HANDBOOK (V

4.0) GEN2 EVALUATION KIT

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 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 Evaluation

Kit. Failure to do so could result in suboptimal system performance or 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.

HANDBOOK (V

4.0) GEN2 EVALUATION KIT

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.

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 cor

rosive 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 an 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.

HANDBOOK (V

4.0) GEN2 EVALUATION KIT

ADVERSE REACTIONS

MedWatch is the Food and Drug Administration's (FDA) program for reporting serious reactions, product

quality problems, therapeutic inequivalence/failure, and product use errors with human medical products,

including drugs, biologic products, medical devices, dietary supplements, infant formula, and cosmetics.

If you think you or someone in your family has experienced a serious reaction to a medical product, you are

encouraged to take the reporting form to your doctor. Your healthcare provider can provide clinical

information based on your medical record that can help FDA evaluate your report.

However, we understand that for a variety of reasons, you may not wish to have the form filled out by

your health care provider, or your health care provider may choose not to complete the form. Your

health care provider is NOT required to report to the FDA. In these situations, you may complete the

Online Reporting Form yourself.

You will receive an acknowledgement from FDA when your report is received. Reports are reviewed by FDA

staff. You will be personally contacted only if we need additional information.

SUBMITTING ADVERSE EVENT REPORTS TO FDA

Use one of the methods below to submit voluntary adverse event reports to the FDA:

•Report Online at www.accessdata.fda.gov/scripts/medwatch/index.cfm?action=reporting.home

•Consumer Reporting Form FDA 3500B. Follow the instructions on the form to either fax or mail it in for

submission. For help filling out the form, see MedWatchLearn. The form is available at

www.fda.gov/downloads/aboutFDA/reportsmanualsforms/forms/ucm349464.pdf

•Call FDA at 1-800-FDA-1088 to report by telephone

•Reporting Form FDA 3500 commonly used by health professionals. The form is available at

https://www.fda.gov/safety/medical-product-safety-information/medwatch-forms-fda-safety-reporting

SUBMITTING ADVERSE EVENT REPORTS IN THE EU

If you or someone in your family has experienced a serious adverse event, you are encouraged to report this

event to Coapt and/or the national competent authority of the country in which the event occurred. Serious

adverse events are defined as: any incident that led to or may lead to a death, serious deterioration of health, or

public health threat. You must report the event as soon as possible. Please contact Coapt if you have any

questions or need assistance.

HANDBOOK (V

4.0) GEN2 EVALUATION KIT

LABEL SYMBOL DESCRIPTIONS

SYMBOL

INFORMATION

EXPLANATION

Waste Electrical and

Electronic Equipment

Directive Symbol

Electrical and electronic items should not be

disposed of in your dustbin or wheelie bin, but

should be recycled.

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 with the European Union

under the Medical Device Directives (93/42/EEC).

Serial Number Signifies the identification information for the

device.

Manufacturer Manufacturer Name and Address

Date of Manufacture Date the device was assembled at Coapt.

European Representative Signifies the European Representative for Coapt.

Type BF Applied Part The device has conductive contact with the

patient.

HANDBOOK (V

4.0) GEN2 EVALUATION KIT

OVERVIEW

PURPOSE OF THE DEVICE

The Coapt Evaluation Kit is intended to be used for the planning and/or practice phases of an upper limb

myoelectric prosthesis fitting with two main purposes:

1. The Evaluation Kit allows potential upper limb prosthesis users to “test drive” Coapt COMPLETE

CONTROL myoelectric pattern recognition technology. 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.

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 Coapt Complete Control System Gen2

The Coapt Evaluation Kit can aid in determining this.

DESCRIPTION

The Coapt Evaluation Kit is a handheld clinical tool created with technology from the Coapt Complete Control

System Gen2 using 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 permits virtual practice and training for pattern recognition myoelectric control.

HANDBOOK (V

4.0) GEN2 EVALUATION KIT

DESCRIPTION OF THE DEVICE

The Coapt Evaluation kit is to be used in conjunction with a Coapt EMG Interface Cable (sold separately) and

either Coapt’s Control Companion mobile app or Complete ControlRoom software app.

COMPONENTS

1. Evaluation Kit main unit

2. Complete Communicator USB

Bluetooth Dongle

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)

ACCESSORIES

4. EMG Interface Cable(s) (sold separately)

5. Electrodes Contacts (if necessary, sold separately)

HANDBOOK (V

4.0) GEN2 EVALUATION KIT

COMPATIBLE DEVICES

EMG Interface Cable Types

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

DESCRIPTION

Standard Eyelets EMG Interface

Cable

17 ring/eyelet terminations for use with a set of non-filtering, passive

electrode contacts (see below)

Snap Style EMG Interface Cable

17 snap terminations for use with with disposable, Temporary

Evaluation Electrode “Stickers” (see below)

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