Infinite Element Instructions de montage
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Element
Installation and Setup Guide
for the Prosthetist
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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
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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Table of Contents
1 Meet Element ����������������������������������������������� 5
2 Component Description���������������������������������������� 7
3 Specifications ����������������������������������������������� 8
4 Installation ������������������������������������������������� 9
Before you Begin ������������������������������������������� 9
Connecting IBT Electrodes and Batteries ����������������������� 10
Powering Element with FlexCell ������������������������������ 11
Element Software ����������������������������������������� 12
Incorporating IBT Electrodes Into Socket������������������������ 17
Installing Element into the Prosthesis �������������������������� 21
5 Testing Element��������������������������������������������� 26
Troubleshooting������������������������������������������� 26
6 Maintaining Element ����������������������������������������� 26
Maintenance ��������������������������������������������� 26
Disposal������������������������������������������������� 27
Repairs, Returns, and Warranty������������������������������� 27
7 Safety and Warnings ����������������������������������������� 28
8 Regulatory Info ��������������������������������������������� 29
The Element System has three components:
• IBT Electrodes (up to 2)
• Signal Processing Box
• Element Desktop Software
Element should only be powered by FlexCell Batteries.
Element outputs standard envelope EMG signals detected from the IBT
Electrodes placed on the user’s skin. The Element System is an alternative to
standard suction socket myoelectrodes, with the advantages of a lower profile,
digital signal processing, and wireless gain adjustment. Element does not
replace or modify any functionality of connected prosthetic components.
Meet Element
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Element is compatible with most hands, wrists, and elbows that accept standard
analog EMG electrode inputs. The Element system is typically sold with three-
port kidney-style connectors to connect with quick-disconnect terminal devices.
Alternative connectors may be available upon request. If you have a question
about compatibility with other devices, please contact us.
For detailed information on connections and cables, refer to the Element
Connections Guide.
The Element system was developed for everyday use and must not
be used for unusual activities. These unusual activities include, for
example, sports with excessive strain and/or shocks to the wrist
unit (pushups, downhill mountain biking) or extreme sports (free
climbing, paragliding, etc.). Furthermore the Element system should
not be used for the operation of motor vehicles, heavy equipment
(e.g. construction machines), industrial machines or motor-driven
equipment.
IBT ELECTRODES
SIGNAL PROCESSING BOX
ELEMENT SOFTWARE
The electrodes detect and amplify raw electromyography (EMG) signals from
the user’s skin. The electrodes plug into the signal processing box.
The signal processing box collects and filters the electrode EMG signals, and
outputs envelope EMG signals to the terminal device. The signal processing box
contains a Bluetooth module, which allows Element to communicate with the
desktop software.
The user can visualize EMG signals and adjust electrode gains through the
desktop software.
Component
Description
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Dimensions (Element Box LxWxH) 38mm x 22.8mm x 3.85mm
Dimensions (IBT Electrodes LxWxH) 28.8mm x 16.8mm x 6.7mm
Temperature range (use) -10°C to +50°C (14°F to 122°F)
Temperature range
(transport/storage)
-20°C to +65°C (-4°F to 149°F)
Humidity range (use) 45% - 75%
Humidity range
(transport/storage)
15% - 93%
Atmospheric pressure range 860 hPa - 1060 hPa
Input voltage 5 to 10V
Maximum Output Current 3A
Compatible battery FlexCell
Recommended battery capacity Depends on terminal device. Contact
us for recommendations.
Expected service life 3 years
Compatible electrode IBT Electrodes
Bluetooth FCC, IC, CE, RoHS, and Bluetooth®
4.0 Certified ISM 2.4GHz module
Hands Wrists Elbows
SensorHand Speed bebionic small
MC ProWrist (with 4 or
6 band coaxial plug)
DynamicArm
MyoHand VariPlus Speed i-limb access
ProHand i-limb ultra
ProETD i-limb ultra revolution
Ottobock OB 10S17 with
Myorotronic
Steeper MyoHand i-limb quantum
bebionic3
Voltage Output 7.4V DC
Capacity Range * 550 mAh - 2200 mAh
Current Output Up to 7A
Temperature range (use) 0oC to +49oC (32oF to 120oF)
Temperature range
(transport and storage)
0oC to +49oC (32oF to 120oF)
Included in the Package
• Element signal processing box
• IBT Electrodes
• Molding dummies for IBT Electrodes
• Molding dummy for signal processing box (if requested)
• USB Thumb drive containing Element desktop software
• Bluetooth Adapter
• FlexCell batteries (if ordered with Element)
What You’ll Need
• PC
• FlexCell batteries (if not ordered with Element)
• Terminal device
• Coaxial plug (if not using a wrist or elbow)
• Lamination collar parts
Terminal Devices That Have Been Tested For Compatibility With Element
For FlexCell
* Capacity range is dependent on how many FlexCell batteries are installed.
BEFORE YOU BEGIN
Specifications Installation
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WARNING: Turn the battery OFF before plugging in any cables. Do
not attempt to connect the battery or electrodes in a way that is
not specified. This could cause permanent damage to Element, the
battery or electrodes.
CONNECTING IBT ELECTRODES AND BATTERIES
BATTERY OUTPUT CABLE ELEMENT BATTERY INPUT CABLE
IBT ELECTRODE INPUT CABLEELECTRODE OUTPUT CABLE
EMG OUTPUT IBT ELECTRODE INPUT
POWERING ELEMENT WITH FLEXCELL
Turning FlexCell On and Off
To turn on FlexCell, press and hold the charging port button for 3 seconds.
To turn off FlexCell, press and hold the Control Unit button for 3 seconds.
For detailed information on additional FlexCell functions, please refer to the
FlexCell Instructions for Use.
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ELEMENT SOFTWARE
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Adjusting Gains
Click the “Gain Settings” button to hide or show the gain sliders. To change the
gains, drag the slider button left or right to adjust the gain for each electrode.
If the gain is modified, the new gain is sent automatically to the signal processing
box and the changes are immediately reflected in the signal viewer. However,
to save these gains permanently, you must press the “Save Gains” button,
which becomes red after any gain is adjusted. If you try to close the application
without saving the gains, a popup window will ask if you want to save the gains
or discard the changes.
The figure above shows signals in single plot mode. The gains were changed but
not saved, therefore the Save Gains button is active. The signals are currently
active and scrolling.
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The figure above shows the signals in multi-plot mode. Gains were changed
and saved, therefore the Save Gains button is inactive. The signals are also
paused and the Play Graph button can be clicked to reactivate them.
INCORPORATING IBT ELECTRODES
INTO SOCKET
Selecting Ideal Electrode Sites
Site selection for the IBT Electrodes should be performed using the same
techniques for standard dry electrodes. Electrode signals can be viewed through
the Element software to determine contraction strength in various locations.
NOT TO SCALE
WARNING: Ensure IBT Electrodes are placed only on intact skin.
WARNING: After removing the prosthesis, always check for skin
irritation and pressure sores under the electrode sites. If irritation is
present, discontinue the use of the prosthesis until the skin is healed
and check if socket adjustments are necessary to alleviate pressure.
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Fabricating Electrodes into the Inner Socket
Once electrode sites have been marked on the plaster cast, place the electrode
dummies on the cast and check to make sure they lay flat against the plaster
surface. Make sure the surface of the electrode dummy marked “CAST SIDE” is
placed against the plaster cast (see image).
For more detailed instructions, refer to the Electrode Fabrication Tips guide.
CAST
CAST SIDE - NOT VISIBLE
WHEN INSTALLED TOP SIDE
Secure 2 of the nails provided (14ga or 15ga standard nails, roughly 1/2" long)
through the two holes in the electrode dummy to the cast. Alternatively, you
may use thin double stick tape to secure the dummy to the surface of the cast.
CAST CAST
Inner Socket Fabrication
IBT Electrodes are designed to fit in a self-retaining pocket that is formed into
the inner socket using the provided electrode molding dummies. The same
dummies can be used for vacuum-forming thermoplastic inner sockets and
rolled silicone inner sockets.
For more detailed instructions, refer to the Electrode Fabrication Tips guide.
Inner Socket Fabrication - Thermoplastic
SOCKET CROSSSECTION VIEW
Electrode Pocket Dimple
Hole
Electrode
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