BTS FREEEMG 100 RT User manual

version 2.0.3
user manual
english

Document Number : EREMB-01091-06
Published: June 2013
Copyright © 2010 - 2013 BTS SpA. All Rights Reserved.

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BTS Bioengineering
contents 1
icons, symbols and acronyms 3
radio regulation 7
disposal (WEEE) 8
intended use 9
regulatory label 10
receiving unit regulatory label 10
EMG wireless probes regulatory label 10
AUX wireless probes regulatory label 11
BTS charger regulatory label 12
warnings 13
copyright 16
introduction 17
general description 17
case contents 18
system components 21
receiving unit 21
wireless EMG probes 22
wireless FSW/EGN probes (optional) 25
on-o analysis (optional) 27
electrogoniometers (optional) 29
charger 30
installation 33
user PC minimum conguration 33
connections 33
contents

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contents
hardware installation 34
description of the software on the user PC 37
BTS EMG-Analyzer conguration check 38
acquisition protocol 41
appendix A – technical specications 47
wireless probes 47
receiving unit 47
BTS internal coding 48
appendix B – environmental specications 49
appendix C – power supply and switch o 50
appendix D – battery 51
appendix E – troubleshooting guide 52
warning – invalid trigger mode 52
appendix F – declaration of conformity 53
appendix G – regulatory notice 54
FDA medical device reporting system—reportable events 54
adverse event report (21 CFR 803.32) 55

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icons, symbols and acronyms
Symbol in the instructions for the function.
e icon represents the information which requires special attention.
Symbol in the instructions for the function.
is icon makes reference to a more detailed discussion of the subject in
hand.
Symbol on the equipment:
e data appearing next to the manufacturer’s symbol refer to the place of
manufacture of the equipment itself.
Symbol on the equipment:
e “FCC” simbol refers to the Federal Communication Commission of
the USA. e device complies with the relevant regulations put forth by
the FCC as long as it is operated according to the instructions contained
in this manual and to all national and local regulations.

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icons, symbols and acronyms
Symbol on the equipment:
e gure in the square indicates the insulation class and the part types
used. In accordance with Standard ISO 60601-1, the equipment has an
internal power supply and the parts used are type BF.
Symbol on the equipment:
Attention, read the information in the users’ manual carefully before using
the equipment.
Symbol on the equipment:
e double square indicates that the product is a medical device of II
Class (In accordance with the law EN 60601-1).
Symbol on the equipment:
CE mark with the code of the Notied Body. e CE mark certies that
the product conforms to the standards applicable in the member states of

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BTS Bioengineering
icons, symbols and acronyms
the European Union (see Declaration of Conformity).
Symbol on the equipment:
CE mark with the code of the Notied Body. e CE mark certies
that the product conforms to the Directive 99/05/EEC - R&TTE and
obtained the Expert Opinion by IMQ.
Symbol on the equipment and in the users’ instructions:
Symbol for the separate disposal of electrical and electronic equipment, in
accordance with Directive 2002/96/CE (WEEE).
e equipment belongs to Group 8 (medical equipment).
In force in the nations of the European Union, Norway and Switzerland.
Rx only
Symbol for prescription only. U.S. Federal law restricts this device to sale
by or on the order of a physician or properly licensed practitioner.

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icons, symbols and acronyms
REF
Symbol on the equipment:
Symbol located next to the model number (ref.to catalogue).
SN
Symbol on the equipment:
Symbol located next to the series number on the equipment.
Acronyms used in this manual:
RU Receiving Unit
EMG Electromyography
WS Workstation

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radio regulation
Radio equipment identication:
- EMG probes:
FCC ID: YQH-BTSWEMG2
IC: 9188A-BTSWEMG2
- FSWEGN probes:
FCC ID: YQH-BTSWAUX
IC: 9188A-BTSWAUX
- Receiving Unit contains:
FCC ID: TFB-MATRIXLP
IC: 5969A-MATRIXLP
is device complies with part 15 of the FCC Rules. Operation
is subject to the following two conditions: (1) is device may
not cause harmful interference, and (2) this device must accept
any interference received, including interference that may cause
undesired operation.
Modications not expressly approved by BTS SpA could void the
user’s authority to operate the equipment under FCC rules.

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BTS Bioengineering
disposal (WEEE)
In disposing of the equipment observe the legal prescriptions.
In accordance with Directive 2002/96/CE (WEEE) all equipment supplied
after 13/08/2005 may not be disposed of in general domestic waste. is
equipment belongs to Category 8 (medical equipment) and is classied in
the Business-to-Business sector.
e symbol of the crossed out rubbish bin
indicates that the equipment must not be
disposed of in normal domestic waste.
e regulations for disposal may dier between
individual countries in the EU. In cases of doubt,
refer to the respective sales outlet.
is is a battery-powered equipment.
See Appendix D for information about the batteries used. Operate
and dispose of this equipment according to the instructions set in
the “warnings” section.

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intended use
is equipment is an instrument for the EMG surface analysis, classied
as medical equipment in accordance with European Directive 93/42/CE
(and its amendments).
BTS FREEEMG 100 RT must always be used only for this purpose, by
qualied persons, in an environment suitable for the execution of EMG
analyses and respecting the prevailing regulations in the countries in which
it is being utilized.

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Probe ID
regulatory label
Receiving Unit Regulatory label
EMG Wireless Probes Regulatory label
Label on the probes:

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regulatory label
Label not on actual probes due to size constraints:
AUX Wireless Probes Regulatory label
Label on the probes:
Label not on actual probes due to size constraints:
Probe ID

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regulatory label
BTS Charger Regulatory label
3A
3A 9V
3A 9V

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We recommend to carry out any kind of operation keeping
strictly to the security regulations contained in this manual. e
safety of the instrument cannot be guaranteed if these conditions
are not respected.
BTS FreeEMG 100 RT is a medical device (EU Directive 93/42/CE and
its amendments, including Directive 2007/47/CE) which use must be at
all times be supervised by qualied and authorized personnel, according to
the laws in force in the nation it is in use. e EMG probes are classied as
ETSI EN 300 440 “Receiver category 3” according to Directive R&TTE
99/5/EEC.
e results of the acquisitions must be assessed by people legally authorised
by national law, who possess the suitable necessary knowledge of anatomy
and muscular function.
e instrument must be used in a medical environment, since it has a high
level of sensitivity (measured voltage levels of between 1 microvolt and 6
millivolt).
e uses of the device for other purposes and with methodologies
dierent from of those indicated in this manual are not to be
considered congruent with the precise use of the device.
During the preparation of the patient, take particular care that the system’s
components do not impede in any way the normal movements of the
subject. Apply the probes only on undamaged skin.
warnings

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BTS Bioengineering
warnings
• Only use CE branded probes and hypoallergenic double-sided tape,
compatible with the usage on undamaged skin for brief periods of time
• Periodically verify the integrity of the system and of its components.
• To not wet or dip in water the parts which make up the system.
No modication of this equipment is allowed.
• Only BTS S.p.A. authorized technicians may maintain and operate
servicing to the instrument. BTS S.p.A. cannot be held responsible
for system safety should the instrument be opened, repairs carried out,
third parties software be installed, or system components be replaced by
persons other than those authorized by BTS S.p.A.
• Users cannot change any software conguration (including O.S. and
CD writer software).
• In case the device accidentally falls, tear of the probes or other accidents
always address authorized technical support.
• Use only the provided power supply unit FW7363M/09 (FRIWO) or
the one provided by BTS S.p.A. for supplying the charger unit. If a
dierent power supply unit is used, the compliance to IEC 60601-1 is
not ensured.
• Only original cables must be used, otherwise BTS S.p.A. cannot assure
the safety of the instrument. Should it be necessary to replace any part
of the system, only original BTS S.p.A. parts may be used.
In addition to the users’ instructions, the prescriptions regarding
accident prevention and technical regulations regarding
occupational safety must also be complied with. e appertaining
national regulations and standards of the country of use, with
regards prevention of accidents and environment, are an extension
of the users’ instructions.

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warnings
• Make sure that the cables have been connected correctly. When
disconnecting cables, use the connectors and not the cables themselves
to unplug the connectors.
• Mains plug of external power supply unit is considered as disconnecting
device. Avoid connecting the probes to the charger with inverted
polarity with respect to that shown on the cover of the recharger – is
could cause irreparable damage to them.
• For a safe use and adequate maintenance of rechargeable batteries strictly
follow the instructions given in this manual. If rechargeable batteries
are used in such a way that is not the one specied by BTS S.p.A. the
shelf life, functionality and the integrity of the batteries is not ensured.
• ESD application to EGN probes, causes a loss of link to the device.
Temporary loss of function or performance which is recoverable with
operator action.
BTS FREEEMG 100 RT is a device that is able to function
COUNTINUOUSLY, this is of course limited by the battery
duration and by the memory available for the acquisition data
storing.
e device uses lithium ion battery. For the battery replacement
and disposal please contact the technical support. At any rate,
ensure that device component (i.e.) probes, receiving unit, …)
integrity is never compromised.
e information contained in this manual is subject to change
without notice and does not constitute product specications or
any obligation on the part of BTS S.p.A.

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copyright
e software of the system described in this manual is supplied with the
“licence to use” contract. e software may be used or copied only as
stipulated under the terms of this contract.
No part of this manual may be copied or transmitted in any form or
means, electronic or mechanical, including photocopying, without prior
written permission from BTS S.p.A.
Unless otherwise specied, any reference to companies, names, data and
addresses used in the reproduction of the screens and the examples are
purely incidental, and has the sole purpose of illustrating the use of the
BTS product. All trademarks are registered by the respective owners.
is publication contains reserved information which is the
property of BTS S.p.A.
e recipient acknowledges that the illustrations and information
supplied in this manual shall not be made available to third parties
without explicit written agreement by BTS S.p.A.

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General description
BTS FREEEMG 100 RT allows for a functional evaluation and a real-
time visualization of the acquired signals for biofeedback and monitoring
applications.
at makes it an indispensable instrument in the elds of sport,
rehabilitation, ergonomics, neurology and orthopaedics.
With BTS FREEEMG 100 RT the patient set up in very quick: the
lightweight probes are attached directly to the pre-gelled electrodes and do
not require any additional xing such as adhesive tape. anks to the total
absence of cables the patient can move around freely.
BTS FREEEMG 100 RT is supplied with EMG-Analyzer the most
complete software solution for analyzing electromyographic signals and
with BTS MIOFEED, an easy-to-use therapeutic solution, studied also
for home applications.
BTS EMG-Analyzer software includes predened templates for evaluations
in the clinical, sports, and research eld: Jump, plyometrics, walking,
fatigue analysis, isokinetic, etc...
BTS EMG-Analyzer also has an editor for creating elaboration protocols:
thanks to an innovative object interface, that translates the biomechanical
analysis language into graphical form, the user can develop quickly and
eectively customized analysis protocols.
introduction

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introduction
BTS MIOFEED software allows a real-time monitoring of muscular
activations during rehabilitative or sports tests execution.
e EMG signal acquired with BTS FREEEMG 100 RT are transmitted
in real-time directly at the receiving unit connected to the PC and
transformed in graphic form and sounds to provide a prompt audio-visual
feedback to the subject. is increase of audio and visual aerences is
fundamental in order to improve the contractile capacities of the muscles.,
also of the paretic ones.
BTS FREEEMG 100 RT seamlessly integrates with BTS motion analysis
systems, through the SMART (and ELITE) dedicated software.
Case contents
Standard components:
• Receiving Unit
• Up to 6 wireless EMG probes (identicative labels available in 4 dierent
colors)
• Magnet for EMG probes activations