BTS FREEEMG 300 User manual

BTS FREEEMG
version 3.1.0e
user manual
english

Document Number : ERFNC-00782-01e
Published: October 2010
Copyright © 2010 BTS SpA. All Rights Reserved.

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BTS Bioengineering
BTS FREEEMG
contents 1
icons, symbols and acronyms 5
disposal (WEEE) 8
intended use 9
label 9
warnings 10
copyright 13
introduction 14
general description 14
case contents 16
system components 19
physical description 19
acquisition unit 20
PDA (Personal Digital Assistant) 22
wireless EMG probes 24
wireless FSW/EGN probes 28
on-o analysis (optional) 29
electrogoniometers (optional) 30
charger 31
docking station 33
installation 38
user PC minimum conguration 38
installation of the Wi-Fi interface 38
description of the software on the user PC 40
switching on BTS FREEEMG 300 41
contents

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contents
rst connection 43
connection check 43
correct data visualization check 45
acquisition protocol 47
create a new protocol 47
tting the patient 52
guide to the use of onboard software 55
initial screen 55
“Active” button 55
selecting the work mode 59
description of the main bars and menu 60
protocol 63
probes setup 64
digital oscilloscope (gane) 67
digital oscilloscope (cross check) 70
footswitches 72
“Local” button: holter mode 74
“Remote” button: lab mode 86
“Download” button 90
“Cong” button 92
“Exit” button 101
BTS FREEEMG 300 updating 102
updating the onboard software 102
creating a backup image 103
maintenance and cleaning 105
appendix A – technical specications 107
wireless probes 107
receiving unit 107

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contents
appendix B – environmental specications 109
appendix C – power supply and switch o 110
appendix D – battery 111
appendix E – declaration of conformity 113
appendix F – troubleshooting guide 114
1708 error - Incorrect IP address or port set up 114
1709 error - Impossibility to connect to the unit 115
backup restoring 115

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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 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.

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BTS FREEEMG
icons, symbols and acronymi
Symbol on the equipment:
Attention, read the information in the users’ manual carefully before using
the equipment.
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 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:
Symbol located next to the series number on the equipment.

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icons, symbols and acronyms
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
the European Union (see Declaration of Conformity).
Symbol on the equipment:
e double square indicates that the product is a Class II device according to
EN 60601-1.
The device must be operated with the provided power supply unit.
Radio equipment identification
EMG probes:
FCC ID: YQH-BTSWEMG IC: 9188A-BTSWEMG
FSWEGN probes:
FCC ID: YQH-BTSWAUX IC: 9188A-BTSWEMG
Acquisition Unit contains:
FCC ID: TFB-MATRIXLP IC: 5969A-MATRIXLP
This device complies with part 15 of the FCC Rules. Operation is subject
to the following two conditions: (1) This device may not cause harmful
interference, and (2) this device must accept any interference received,
including interference that may cause undesired operation.
Modifications not expressly approved by BTS SpA could void the
user's authority to operate the equipment under FCC rules.
Acronyms used in this manual:
AP Access Point
AU Acquisition Unit
EMG Electromyography
FSW Footswitch
PDA Personal Digital Assistant
RU Receiving Unit
WS Workstation

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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.
disposal (WEEE)

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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).
e BTS FREEEMG 300 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 utilised.
Acquisition Unit Regulatory label
intended use
XX-XX-XX
BTSWEMG
Internally powered device
0123
BTS SpA
V.le orlanini 40
Garbagnate M.se
I-20024 Italy
btsbioengineering.com
This device complies with Part 15 of the CC Rules. Operation is subject to the
following two conditions: (1) this device may not cause harmful interference, and (2)
this device must accept any interference received, including interference that may
cause undesired operation.
CC ID: YQH-BTSWEMG
IC: 9188A-BTSWEMG
XX-XX-XX
BTSWAUX
Internally powered device
0123
BTS SpA
V.le Forlanini 40
Garbagnate M.se
I-20024 Italy
btsbioengineering.com
This device complies with Part 15 of the FCC Rules. Operation is subject to the
following two conditions: (1) this device may not cause harmful interference, and (2)
this device must accept any interference received, including interference that may
cause undesired operation.
FCC ID: YQH-BTSWAUX
IC: 9188A-BTSWAUX
Wireless Probes Regulatory labels (not on actual probes due to size constraints)

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We recommend to carry out any kind of operation keeping strictly
to the security regulations contained in this manual.
BTS FREEEMG 300 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 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 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.
- Use the product according to the usage that it has been
intended.
- Avoid connecting the probes to the charger with inverted polarity
with respect to that shown on the cover of the recharger - this
could cause irreparable damage to them.
- To not wet or dip in water the parts that make up the system.
warnings

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warnings
- Apply the probes only on undamaged skin.
- 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.
- In case the device accidentally falls, tear of the probes or other
accidents always address authorized technical support.
- Do not undertake any kind of internal maintenance of the device:
in case of need always address to authorized technical support.
- e use of any components dierent from the original ones
declines the conformity of the device.
- 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).
- 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.
- In addition to the users’ instructions, the prescriptions regarding
accident prevention and technical regulations regarding
occupational safety must also be complied with.

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warnings
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.
- BTS FREEEMG 300 is a device that is able to function
CONTINUOUSLY, this is of course limited by the battery
duration and by the memory available for the acquisition data
storing.
- the 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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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.
copyright

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BTS FREEEMG
General description
BTS FREEEMG 300 is an indispensable instrument for laboratories
which are concerned with the study of muscular activity in the elds
of rehabilitation, sports medicine, ergonomics, clinical research, and
assessment of functional ability and muscular fatigue.
BTS FREEEMG 300 makes the selection of muscles, the setting of
duration and frequency of acquisition, amplication gain and the correct
positioning of electrodes, simple and rapid.
BTS FREEEMG 300 can be applied in research, sports, occupational
medicine, gnatology, neurology, and orthopaedics.
With the software tools available, BTS FREEEMG 300 becomes an
advanced diagnostic tool to evaluate neurological and orthopaedic
disorders, pharmacological therapy, progression of motor decits, use
of ortheses, rehabilitative follow-up, and to optimize sports training
programmes,...
BTS FREEEMG 300 is generally supplied with Myolab the easy to
use BTS software programmes for displaying, processing and reporting
electromyograph signals.
BTS Myolab is an extremely exible solution with numerous analysis tools
available making it possible to perform even advanced elaborations of,
introduction

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BTS FREEEMG
introduction
for example, the study of myoelectric manifestations of localized muscle
fatigue, even for cyclical movements.
BTS EMGenius and BTS EMG-Analyzer are also available as option:
• BTS EMGenius is the application software for functional evaluation
of cyclical movements such as ambulation, through automatic
identication of gait phases, and in movements such as “hand to
mouth, “sit-to-stand”, exion-extension of the hand, reaching, etc...
BTS EMGenius has been designed and developed to be easy to learn
how to use in very short time: e friendly and intuitive interface
makes the analysis laboratory immediately productive.
• BTS EMG-Analyzer is the most complete software solution for
analysing electromyographic signals. It 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.
BTS FREEEMG 300 seamlessly integrates with BTS motion analysis
systems, through the SMART (and ELITE) dedicated software.

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introduction
Case contents
Standard components:
• Receiving Unit
• Acquisition Unit
• HP iPAQ hx4700 Pocket PC
• Belts for attachment to patient
• Stylus (located in the Pocket PC)
• Probes Kit
• up to 16 wireless probes (identicative labels available in 4
dierent colors)
• Access Point
• Set of disposable electrodes
Acquisition Unit
Pocket PC

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introduction
• Probes Chargers:
• up to 2 “Charger” units: each charger handles up to 8 probes
and 2 FSW/EGN). e second unit is included in the standard
kit only for FREEEMG with at least 12 probes, or available as
an option.
• e optional “Docking Station” version is also available
• Accessories
• USB-PDA cable •AC adaptor
(RoHS conform)
• Manuals
• BTS FREEEMG 300 user • HP iPAQ PocketPC manual
manual complete of CD and Companion CD

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introduction
Optional components:
• Footswitch Kit
• 2 FSW/EGN Wireless Probes • 2 Connectors of 4 Switches
• 10 single Switches
• Electrogoniometer Kit
• 1 FSW/EGN Wireless Probe • 1 Electrogoniometer
• 1 Connector
• Supplementary Receiving Unit
• Secure Digital
You will receive the instructions for use for other possible op-
tional components not mentioned in this manual.