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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BTS Bioengineering
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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BTS Bioengineering
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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BTS Bioengineering
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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BTS Bioengineering
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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BTS Bioengineering
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.