BTS TMJOINT User manual
version 3.0.0
user manual
english
BTS TMJOINT
Document Number : ERTMJ-00998-04
Published: January 2013
Copyright © 2010 - 2013 BTS SpA. All Rights Reserved.
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contents 1
icons, symbols and acronyms 5
radio regulation 9
disposal (WEEE) 10
intended use 11
regulatory label 12
receiving unit regulatory label 12
EMG wireless probes regulatory label 12
charger regulatory label 13
warnings 14
copyright 17
introduction 18
general description 18
case contents 20
system components 22
receiving unit 22
wireless EMG probes 23
charger 26
installation 28
user PC minimum conguration 28
connections 28
description of the software on the user PC 29
software installation 29
hardware installation 31
rst software use 34
contents
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contents
patient setup 37
POC4 protocol 37
POC6 protocol 39
guide to the use of BTS DCA 41
initial screen 41
menu bar 42
tool bar 47
probes status bar 47
patient list and research lter 49
patient, session and trial information 52
trial viewing and report generation area 53
main features of the BTS DCA software 59
new patient 59
new session 59
edit pathology 62
new trial 63
data acquisition 66
edit patient 72
edit session 73
delete patient 74
delete session 75
delete trial 76
more features of the BTS DCA software 77
database and data folder 77
managing les in the recycle bin 80
guide to of the data report reading 83
INT tab 83
EXT tab 89
POC tab 94
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contents
ISTO tab 96
MAST tab 98
INFO tab 100
appendix A – technical specications 103
wireless probes 103
receiving unit 103
appendix B – environmental specications 105
appendix C – power supply and switch o 106
appendix D – battery 107
appendix E – troubleshooting guide 108
warning – invalid trigger mode 108
appendix F – declaration of conformity 109
appendix G– bibliography 110
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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 Notied Body. e CE mark certies that
the product conforms to the standards applicable in the member states of
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icons, symbols and acronyms
the European Union (see Declaration of Conformity).
Symbol on the equipment:
CE mark with the code of the Notied Body. e CE mark certies
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
DCA Dental Contact Analyzer
POC Percent Overlapping Coecent
MVC Maximum Voluntary Contraction
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radio regulation
Radio equipment identication:
- EMG probes:
FCC ID: YQH-BTSWEMG2
IC: 9188A-BTSWEMG2
- 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.
Modications not expressly approved by BTS SpA could void the
user’s authority to operate the equipment under FCC rules.
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BTS TMJOINT
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 classied 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 dier 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, classied
as medical equipment in accordance with European Directive 93/42/CE
(and its amendments).
BTS TMJOINT must always be used only for this purpose, by qualied
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.
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regulatory label
Probe ID
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:
Charger Regulatory label
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BTS TMJOINT
We recommend to carry out any kind of operation keeping strictly
to the security regulations contained in this manual.
TMJOINT 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 qualied and authorized personnel, according to
the laws in force in the nation it is in use. e EMG probes are classied 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 uses of the device for other purposes and with methodologies dierent
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 dierent 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).
- 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.
- TMJOINT is a device that is able to function CONTINUOUSLY,
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warnings
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 specications 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 specied, 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 TMJOINT is the solution for the functional analysis of dental
occlusion. Functional information is provided on the neuromuscular
alterations induced by occlusal contact.
BTS TMJOINT integrates the latest wireless technology available today.
Based on wireless technology, this solution includes a set of EMG probes
with active electrodes, the only one of its kind in the world due to its
light weight (weighing less than 9 grams), compact size and data capturing
accuracy, a USB receiving unit and the dedicated software BTS Dental
Contact Analyzer.
BTS TMJOINT uses surface electromyographic analysis to measure the
dierential inuence of the occlusal function through indices validated
and published in scientic literature.
Special feature of this system is the standardization of the electromyographic
signal that is provided by the comparison between two test of clenching,
done with and without the interposition of cotton rolls between the
dental arches. is method allows the elimination of problems of the
wrong positioning of the electrodes, of the dierence of impedance of
the patient’s skin, of the dierences of muscular tropism, etc. making it
accurate and repeatable.
e results are shown via a special graphic interface that is easy to
introduction
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