2 3
Thank you for choosing Element to provide EMG inputs for an upper limb
myoelectric prosthesis. This guide will familiarize you with Element and help
you install the hardware and software.
Have any questions? We’re happy to help. Call us or send us an email.
(443) 451-7175
support@i-biomed.com
INTENDED USE
The Element system is intended to detect, process, and transmit physiological
signals for use with a prosthesis
INDICATIONS FOR USE
The Element system is intended to be used exclusively for myoelectric exo-
prosthetic fittings of the upper limb.
CONDITIONS FOR USE / PATIENT TARGET GROUP
Element is intended for use on one patient only, for users with unliteral or
bilateral amputation, hand, forearm and upper arm amputation or dysmelia.
Use of the product by another person is not approved by the manufacturer.
Installation of the system should be performed exclusively by a licensed
prosthetist or technician. Any unauthorized handling or installation of Element
could void its warranty.
All rights reserved. Element is a trademark of Infinite Biomedical
Technologies, LLC.
This document provides information for the prosthetist who will be installing
Element and IBT Electrodes.
Element
INSTALLATION AND SETUP GUIDE
FOR THE PROSTHETIST
This symbol is used throughout the guide to indicate important
cautionary information. Text following this symbol should be
read carefully.
Caution: Federal law restricts this device to sale by or on the
order of a prosthestist.
This device includes an RF transmitter or applies radio frequency
electromagnetic energy.
Mdi Europa GmbH
Langenhagener Str. 71
30855 Langenhagen
Germany
SRN: DE-AR-000006218
LEGEND OF SYMBOLS USED
Medical
Device
Consult
Instructions
for Use
Single
Patient,
Multiple
Use
ImporterDistributorKeep
Dry
Translated
Serial
Number
ManufacturerEuropean
Authorized
Representative
CE Mark
Catalogue
Number
Model
Number
Contains FCC ID: XDULE40-D2 Contains IC: 8456A-LE4D2
Infinite Biomedical Technologies, LLC.
8 Market Place, Suite 500
Baltimore, MD 21202
(443) 451-7175
www.i-biomed.com
SRN: US-MF-000007619 www.i-biomed.com/support.html
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